You are here

Myers, Evan Robert

Overview:

My research interests are broadly in the application of quantitative methods, especially mathematical modeling and decision analysis, to problems in women's health. Recent and current activities include integration of simulation modeling and systematic reviews to inform decisions surrounding cervical, ovarian, and breast cancer prevention and control, screening for postpartum depression, and management of uterine fibroids.    We are also engaged in exploring methods for integrating guidelines development and research prioritization.    In addition, I have ongoing collaborations using the tools of decision analysis with faculty in other clinical areas  Research is conducted through the Division of Clinical and Epidemiological Research in the Department of Obstetrics and Gynecology, the Evidence Synthesis Group in the Duke Clinical Research Institute, and the Duke Cancer Institute.

Positions:

Walter L. Thomas Professor of Obstetrics and Gynecology in the School of Medicine

Obstetrics and Gynecology
School of Medicine

Professor of Obstetrics and Gynecology

Obstetrics and Gynecology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Member in the Duke Clinical Research Institute

Duke Clinical Research Institute
School of Medicine

Chief of the Division of Clinical & Epidemiologic Research

Obstetrics and Gynecology
School of Medicine

Education:

M.D. 1988

M.D. — University of Pennsylvania

M.P.H. 1992

M.P.H. — University of North Carolina at Chapel Hill

House Staff Resident, Ob/Gyn

Duke University

Associate, Ob/Gyn

Duke University

News:

Grants:

Translational Research in Surgical Oncology

Administered By
Surgery, Surgical Sciences
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
January 01, 2002
End Date
August 31, 2021

Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site

Administered By
Obstetrics and Gynecology, Urogynecology
AwardedBy
National Institutes of Health
Role
Collaborator
Start Date
April 01, 2007
End Date
June 30, 2021

COMPARE-UF

Administered By
Duke Clinical Research Institute
AwardedBy
Agency for Healthcare Research and Quality
Role
Principal Investigator
Start Date
September 30, 2014
End Date
September 29, 2019

Duke KURe Program

Administered By
Obstetrics and Gynecology, Urogynecology
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
August 01, 2013
End Date
July 31, 2018

Optimizing Lupus Management in Pregnancy

Administered By
Medicine, Rheumatology and Immunology
AwardedBy
Agency for Healthcare Research and Quality
Role
Co-Mentor
Start Date
September 30, 2015
End Date
September 29, 2017

Molecular Methods to Improve Cervical Cancer Screening in HIV+ Women

Administered By
Obstetrics and Gynecology
AwardedBy
Albert Einstein College of Medicine
Role
Principal Investigator
Start Date
April 01, 2016
End Date
March 31, 2017

Value of Information Analysis: PCORnet Aspirin Maintenance Doseage Trial

Administered By
Duke Clinical Research Institute
AwardedBy
Patient-Centered Outcomes Research Institute
Role
Co Investigator
Start Date
January 05, 2015
End Date
July 31, 2016

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program

Administered By
Duke Clinical Research Institute
AwardedBy
University of North Carolina - Chapel Hill
Role
Mentor
Start Date
July 01, 2011
End Date
June 30, 2016

Topic Refinement 2015

Administered By
Duke Clinical Research Institute
AwardedBy
Patient-Centered Outcomes Research Institute
Role
Co Investigator
Start Date
May 27, 2015
End Date
July 10, 2015

PCORI_Triage and FR Prioritization - Amendment #3

Administered By
Duke Clinical Research Institute
AwardedBy
Patient-Centered Outcomes Research Institute
Role
Co Investigator
Start Date
February 15, 2013
End Date
December 31, 2014

Smoking Resumption-Prevention in Postpartum Women

Administered By
Duke Cancer Institute
AwardedBy
National Institutes of Health
Role
Co-Principal Investigator
Start Date
April 15, 2008
End Date
March 31, 2014

Pregnancy and Response to Antiretroviral Therapy in South Africa

Administered By
Duke Global Health Institute
AwardedBy
National Institutes of Health
Role
Advisor
Start Date
September 27, 2010
End Date
August 31, 2013

Translational Research in Pelvic Floor Disorders

Administered By
Obstetrics and Gynecology, Urogynecology
AwardedBy
National Institutes of Health
Role
Co-Mentor
Start Date
May 15, 2011
End Date
February 28, 2013

Oral Contraceptive Use for the Primary Prevention of Ovarian Cancer

Administered By
Duke Clinical Research Institute
AwardedBy
Agency for Healthcare Research and Quality
Role
Co-Principal Investigator
Start Date
September 10, 2010
End Date
September 30, 2012

EPC: Postpartum Depression

Administered By
Duke Clinical Research Institute
AwardedBy
Agency for Healthcare Research and Quality
Role
Principal Investigator
Start Date
June 21, 2011
End Date
September 24, 2012

Effectiveness of a Vaccination Program in the Community ObGyn Setting

Administered By
Obstetrics and Gynecology, Maternal Fetal Medicine/Midwifery Service
AwardedBy
Centers for Disease Control and Prevention
Role
Co Investigator
Start Date
September 01, 2008
End Date
August 31, 2011

Ovarian Failure Among Hysterectomized Women

Administered By
Duke Cancer Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 30, 2003
End Date
August 31, 2010

Addressing Birth Defect Prevention in Women Veterans

Administered By
Obstetrics and Gynecology
AwardedBy
Department of Veterans Affairs
Role
Principal Investigator
Start Date
December 04, 2008
End Date
December 03, 2009

Effectiveness and Efficiency of Assisted Reproductive Technology

Administered By
Institutes and Centers
AwardedBy
Agency for Healthcare Research and Quality
Role
Principal Investigator
Start Date
July 01, 2005
End Date
September 30, 2008

Decision Analysis on Screening for Cervical Cancer

Administered By
Institutes and Centers
AwardedBy
Agency for Healthcare Research and Quality
Role
Investigator
Start Date
July 25, 2007
End Date
August 31, 2008

An interdisciplinary use of models for cancer prevention

Administered By
Obstetrics and Gynecology
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
August 22, 2006
End Date
August 31, 2008

Testing Pharmacological Therapies for Pregnant Smokers

Administered By
Duke Cancer Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
May 01, 2002
End Date
April 30, 2008

Cooperative Multi-Center Reproductive Medicine Network

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
March 10, 2000
End Date
January 31, 2008

Genomics Tests for Ovarian Cancer Detection and Management

Administered By
Institutes and Centers
AwardedBy
Agency for Healthcare Research and Quality
Role
Principal Investigator
Start Date
September 30, 2005
End Date
November 30, 2006

Mentored Clinical Research Scholar Program

Administered By
Medicine, Infectious Diseases
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
September 30, 2002
End Date
September 29, 2006

Management of Adnexal Mass

Administered By
Institutes and Centers
AwardedBy
Agency for Healthcare Research and Quality
Role
Principal Investigator
Start Date
September 01, 2004
End Date
July 15, 2006

Duke's Center for Muslim Women's Health

Administered By
Obstetrics and Gynecology
AwardedBy
Josiah Charles Trent Memorial Foundation
Role
Principal Investigator
Start Date
June 01, 2004
End Date
May 31, 2006

The Obstetrics and Gynecology Risk Group

Administered By
Obstetrics and Gynecology
AwardedBy
Josiah Charles Trent Memorial Foundation
Role
Co Investigator
Start Date
June 01, 2004
End Date
May 31, 2005

Partner Assisted Interventions For Pregnant Smokers

Administered By
Duke Cancer Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 26, 1997
End Date
December 30, 2003

Management of Post-Term Pregnancy

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 01, 2000
End Date
February 28, 2002

Management of Uterine Fibroids

Administered By
Institutes and Centers
AwardedBy
Agency for Health Care Policy and Research
Role
Co-Principal Investigator
Start Date
September 30, 1999
End Date
June 30, 2001

Risk Adjustment Methods For Complications Of Hysterectomy

Administered By
Obstetrics and Gynecology, Duke Women's Health Associates
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
May 01, 1998
End Date
April 30, 2000
Show More

Publications:

Disparities in Fibroid Incidence, Prognosis, and Management.

Health disparities in fibroid prevalence, prognosis, and treatment exist for underserved women. Access to fibroid treatment alternatives can have significant effect on choices and outcomes of fibroid disease.

Authors
Laughlin-Tommaso, SK; Jacoby, VL; Myers, ER
MLA Citation
Laughlin-Tommaso, SK, Jacoby, VL, and Myers, ER. "Disparities in Fibroid Incidence, Prognosis, and Management." Obstetrics and gynecology clinics of North America 44.1 (March 2017): 81-94. (Review)
PMID
28160895
Source
epmc
Published In
Obstetrics and Gynecology Clinics of North America
Volume
44
Issue
1
Publish Date
2017
Start Page
81
End Page
94
DOI
10.1016/j.ogc.2016.11.007

Future of the Palliative Care Workforce: Preview to an Impending Crisis.

Authors
Kamal, AH; Bull, JH; Swetz, KM; Wolf, SP; Shanafelt, TD; Myers, ER
MLA Citation
Kamal, AH, Bull, JH, Swetz, KM, Wolf, SP, Shanafelt, TD, and Myers, ER. "Future of the Palliative Care Workforce: Preview to an Impending Crisis." The American journal of medicine 130.2 (February 2017): 113-114.
PMID
27687068
Source
epmc
Published In
The American Journal of Medicine
Volume
130
Issue
2
Publish Date
2017
Start Page
113
End Page
114
DOI
10.1016/j.amjmed.2016.08.046

Cost Comparison of Genetic Testing Strategies in Women With Epithelial Ovarian Cancer.

The advent of multigene panels has increased genetic testing options for women with epithelial ovarian cancer (EOC). We designed a decision model to compare costs and probabilities of identifying a deleterious mutation or variant of uncertain significance (VUS) using different genetic testing strategies.A decision model was developed to compare costs and outcomes of two testing strategies for women with EOC: multigene testing (MGT) versus single-gene testing for BRCA1/2. Outcomes were mean cost and number of deleterious mutations and VUSs identified. Model inputs were obtained from published genetic testing data in EOC. One-way sensitivity analyses and Monte Carlo probabilistic sensitivity analyses were performed.No family history model: MGT cost $1,160 more on average than BRCA1/2 testing and identified an additional 3.8 deleterious mutations for every 100 women tested. For each additional deleterious mutation identified, MGT cost $30,812 and identified 5.4 additional VUSs. Family history model: MGT cost $654 more on average and identified an additional 7.0 deleterious mutations for every 100 women tested. For each additional deleterious mutation identified, MGT cost $9,909 and identified 2.6 additional VUSs.MGT was associated with a higher additional cost per deleterious mutation identified and a higher ratio of VUS burden to actionable information in women with no family history as compared with women with a family history. Family history should be considered when determining an initial genetic testing platform in women with EOC.

Authors
Foote, JR; Lopez-Acevedo, M; Buchanan, AH; Secord, AA; Lee, PS; Fountain, C; Myers, ER; Cohn, DE; Reed, SD; Havrilesky, LJ
MLA Citation
Foote, JR, Lopez-Acevedo, M, Buchanan, AH, Secord, AA, Lee, PS, Fountain, C, Myers, ER, Cohn, DE, Reed, SD, and Havrilesky, LJ. "Cost Comparison of Genetic Testing Strategies in Women With Epithelial Ovarian Cancer." Journal of oncology practice (January 3, 2017): JOP2016011866-.
PMID
28045615
Source
epmc
Published In
Journal of Oncology Practice
Publish Date
2017
Start Page
JOP2016011866

Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region

Authors
Castellsagué, X; Ault, KA; Bosch, FX; Brown, D; Cuzick, J; Ferris, DG; Joura, EA; Garland, SM; Giuliano, AR; Hernandez-Avila, M; Huh, W; Iversen, O-E; Kjaer, SK; Luna, J; Monsonego, J; Muñoz, N; Myers, E; Paavonen, J; Pitisuttihum, P; Steben, M; Wheeler, CM; Perez, G; Saah, A; Luxembourg, A; Sings, HL; Velicer, C
MLA Citation
Castellsagué, X, Ault, KA, Bosch, FX, Brown, D, Cuzick, J, Ferris, DG, Joura, EA, Garland, SM, Giuliano, AR, Hernandez-Avila, M, Huh, W, Iversen, O-E, Kjaer, SK, Luna, J, Monsonego, J, Muñoz, N, Myers, E, Paavonen, J, Pitisuttihum, P, Steben, M, Wheeler, CM, Perez, G, Saah, A, Luxembourg, A, Sings, HL, and Velicer, C. "Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region." Papillomavirus Research 2 (December 2016): 61-69.
Source
crossref
Published In
Papillomavirus research
Volume
2
Publish Date
2016
Start Page
61
End Page
69
DOI
10.1016/j.pvr.2016.03.002

Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial.

Most pregnant women who quit smoking return to smoking postpartum. Trials to prevent this return have been unsuccessful. We tested the efficacy of a nurse-delivered intervention in maintaining smoking abstinence after delivery among pregnant women who quit smoking that was tailored on their high risk of relapse (eg, had strong intentions to return).We recruited 382 English-speaking spontaneous pregnant quitters from 14 prenatal clinics and randomized them to receive either a smoking abstinence booklet plus newsletters about parenting and stress (control) or a nurse-delivered smoking abstinence intervention that differed in intensity for the high and low risk groups. Our primary outcome was smoking abstinence at 12 months postpartum.Using intent-to-treat analyses, there was a high rate of biochemically validated smoking abstinence at 12 months postpartum but no arm differences (36% [95% confidence interval [CI]: 29-43] vs.35% [95% CI: 28-43], P = .81). Among women at low risk of returning to smoking, the crude abstinence rate was significantly higher in the control arm (46%) than in the intervention arm (33%); among women at high risk of returning to smoking, the crude abstinence rate was slightly lower but not different in the control arm (31%) than in the intervention arm (37%).Low-risk women fared better with a minimal intervention that focused on parenting skills and stress than when they received an intensive smoking abstinence intervention. The opposite was true for women who were at high risk of returning to smoking. Clinicians might need to tailor their approach based on whether women are at high or low risk of returning to smoking.Results suggest that high-risk and low-risk women might benefit from different types of smoking relapse interventions. Those who are lower risk of returning to smoking might benefit from stress reduction that is devoid of smoking content, whereas those who are higher risk might benefit from smoking relapse prevention.

Authors
Pollak, KI; Fish, LJ; Lyna, P; Peterson, BL; Myers, ER; Gao, X; Swamy, GK; Brown-Johnson, A; Whitecar, P; Bilheimer, AK; Pletsch, PK
MLA Citation
Pollak, KI, Fish, LJ, Lyna, P, Peterson, BL, Myers, ER, Gao, X, Swamy, GK, Brown-Johnson, A, Whitecar, P, Bilheimer, AK, and Pletsch, PK. "Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial." Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 18.10 (October 2016): 1960-1966.
PMID
27091830
Source
epmc
Published In
Nicotine and Tobacco Research (OUP)
Volume
18
Issue
10
Publish Date
2016
Start Page
1960
End Page
1966
DOI
10.1093/ntr/ntw108

Levonorgestrel Intrauterine Device as an Endometrial Cancer Prevention Strategy in Obese Women: A Cost-Effectiveness Analysis.

To estimate the cost-effectiveness of the levonorgestrel intrauterine device (IUD) as an endometrial cancer prevention strategy in obese women.A modified Markov model was used to compare IUD placement at age 50 with usual care among women with a body mass index (BMI, kg/m) 40 or greater or BMI 30 or greater. The effects of obesity on incidence and survival were incorporated. The IUD was assumed to confer a 50% reduction in cancer incidence over 5 years. Costs of IUD and cancer care were included. Clinical outcomes were cancer diagnosis and deaths from cancer. Incremental cost-effectiveness ratios were calculated in 2015 U.S. dollars per year of life saved. One-way and two-way sensitivity analyses and Monte Carlo probabilistic analyses were performed.For a 50 year old with BMI 40 or greater, the IUD strategy is costlier and more effective than usual care with an incremental cost-effectiveness ratio of $74,707 per year of life saved. If the protective effect of the levonorgestrel IUD is assumed to be 10 years, the incremental cost-effectiveness ratio decreases to $37,858 per year of life saved. In sensitivity analysis, a levonorgestrel IUD that reduces cancer incidence by at least 68% in women with BMIs of 40 or greater or costs less than $500 is potentially cost-effective. For BMI 30 or greater, the incremental cost-effectiveness ratio of IUD strategy is $137,223 per year of life saved compared with usual care. In Monte Carlo analysis, IUD placement for BMI 40 or greater is cost-effective in 50% of simulations at a willingness-to-pay threshold of $100,000 per year of life saved.The levonorgestrel IUD is a potentially cost-effective strategy for prevention of deaths from endometrial cancer in obese women.

Authors
Dottino, JA; Hasselblad, V; Secord, AA; Myers, ER; Chino, J; Havrilesky, LJ
MLA Citation
Dottino, JA, Hasselblad, V, Secord, AA, Myers, ER, Chino, J, and Havrilesky, LJ. "Levonorgestrel Intrauterine Device as an Endometrial Cancer Prevention Strategy in Obese Women: A Cost-Effectiveness Analysis." Obstetrics and gynecology 128.4 (October 2016): 747-753.
PMID
27607867
Source
epmc
Published In
Obstetrics & Gynecology (Elsevier)
Volume
128
Issue
4
Publish Date
2016
Start Page
747
End Page
753
DOI
10.1097/aog.0000000000001616

Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial

Authors
Pal, L; Zhang, H; Williams, J; Santoro, NF; Diamond, MP; Schlaff, WD; Coutifaris, C; Carson, SA; Steinkampf, MP; Carr, BR; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Myers, E; Legro, RS
MLA Citation
Pal, L, Zhang, H, Williams, J, Santoro, NF, Diamond, MP, Schlaff, WD, Coutifaris, C, Carson, SA, Steinkampf, MP, Carr, BR, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Myers, E, and Legro, RS. "Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial." The Journal of Clinical Endocrinology & Metabolism 101.8 (August 2016): 3027-3035.
Source
crossref
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
101
Issue
8
Publish Date
2016
Start Page
3027
End Page
3035
DOI
10.1210/jc.2015-4352

An overview and discussion of the Patient-Centered Outcomes Research Institute's decision aid portfolio.

Decision aids (DAs) help patients make informed healthcare decisions in a manner consistent with their values and preferences. Despite their promise, DAs developed with public research dollars are not being implemented and adopted in real-world patient care settings at a rate consistent with which they are being developed. To appraise the sum of the parts of the portfolio and create a strategic imperative surrounding future funding, the Patient-Centered Outcomes Research Institute (PCORI) tasked the Duke Evidence Synthesis Group with evaluating its DA portfolio. This paper describes PCORI's portfolio of DAs according to the Duke Evidence Synthesis Group's analysis in the context of PCORI's mission and the field of decision science. The results revealed a diversity within PCORI's portfolio of funded DA projects. Findings support the movement toward more rigorous DA development, assessment and maintenance. PCORI's funding priorities related to DAs are clarified and comparative questions of interest are posed.

Authors
Gayer, CC; Crowley, MJ; Lawrence, WF; Gierisch, JM; Gaglio, B; Williams, JW; Myers, ER; Kendrick, A; Slutsky, J; Sanders, GD
MLA Citation
Gayer, CC, Crowley, MJ, Lawrence, WF, Gierisch, JM, Gaglio, B, Williams, JW, Myers, ER, Kendrick, A, Slutsky, J, and Sanders, GD. "An overview and discussion of the Patient-Centered Outcomes Research Institute's decision aid portfolio." Journal of comparative effectiveness research 5.4 (July 2016): 407-415.
PMID
27298206
Source
epmc
Published In
Journal of Comparative Effectiveness Research
Volume
5
Issue
4
Publish Date
2016
Start Page
407
End Page
415
DOI
10.2217/cer-2016-0002

Systematic reviews of observational studies: evaluating evidence quality.

Authors
Myers, ER
MLA Citation
Myers, ER. "Systematic reviews of observational studies: evaluating evidence quality." American journal of obstetrics and gynecology 215.1 (July 2016): 1-3.
PMID
27342386
Source
epmc
Published In
American Journal of Obstetrics & Gynecology
Volume
215
Issue
1
Publish Date
2016
Start Page
1
End Page
3
DOI
10.1016/j.ajog.2016.03.044

When can we be sure an intervention is cost-effective?

Authors
Myers, ER
MLA Citation
Myers, ER. "When can we be sure an intervention is cost-effective?." BJOG : an international journal of obstetrics and gynaecology 123.7 (June 2016): 1221-.
PMID
26879472
Source
epmc
Published In
Bjog : An International Journal of Obstetrics & Gynaecology
Volume
123
Issue
7
Publish Date
2016
Start Page
1221
DOI
10.1111/1471-0528.13913

Benefits and Harms of Breast Cancer Screening: A Systematic Review (vol 314, pg 1615, 2015)

Authors
Myers, ER; Moorman, P; Gierisch, JM
MLA Citation
Myers, ER, Moorman, P, and Gierisch, JM. "Benefits and Harms of Breast Cancer Screening: A Systematic Review (vol 314, pg 1615, 2015)." JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 315.13 (April 5, 2016): 1406-1406.
Source
wos-lite
Published In
JAMA : the journal of the American Medical Association
Volume
315
Issue
13
Publish Date
2016
Start Page
1406
End Page
1406

Breast Cancer Screening: Benefit or Harm?--Reply.

Authors
Myers, ER; Moorman, P; Sanders, GD
MLA Citation
Myers, ER, Moorman, P, and Sanders, GD. "Breast Cancer Screening: Benefit or Harm?--Reply." JAMA 315.13 (April 2016): 1402-1403.
PMID
27046371
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
315
Issue
13
Publish Date
2016
Start Page
1402
End Page
1403
DOI
10.1001/jama.2015.19129

Characterizing the Hospice and Palliative Care Workforce in the U.S.: Clinician Demographics and Professional Responsibilities.

Palliative care services are growing at an unprecedented pace. Yet, the characteristics of the clinician population who deliver these services are not known. Information on the roles, motivations, and future plans of the clinician workforce would allow for planning to sustain and grow the field.To better understand the characteristics of clinicians within the field of hospice and palliative care.From June through December 2013, we conducted an electronic survey of American Academy of Hospice and Palliative Medicine members. We queried information on demographics, professional roles and responsibilities, motivations for entering the field, and future plans. We compared palliative care and hospice populations alongside clinician roles using chi-square analyses. Multivariable logistic regression was used to identify predictors of leaving the field early.A total of 1365 persons, representing a 30% response rate, participated. Our survey findings revealed a current palliative care clinician workforce that is older, predominantly female, and generally with less than 10 years clinical experience in the field. Most clinicians have both clinical hospice and palliative care responsibilities. Many cite personal or professional growth or influential experiences during training or practice as motivations to enter the field.Palliative care clinicians are a heterogeneous group. We identified motivations for entering the field that can be leveraged to sustain and grow the workforce.

Authors
Kamal, AH; Bull, J; Wolf, S; Samsa, GP; Swetz, KM; Myers, ER; Shanafelt, TD; Abernethy, AP
MLA Citation
Kamal, AH, Bull, J, Wolf, S, Samsa, GP, Swetz, KM, Myers, ER, Shanafelt, TD, and Abernethy, AP. "Characterizing the Hospice and Palliative Care Workforce in the U.S.: Clinician Demographics and Professional Responsibilities." Journal of pain and symptom management 51.3 (March 2016): 597-603.
PMID
26550934
Source
epmc
Published In
Journal of Pain and Symptom Management
Volume
51
Issue
3
Publish Date
2016
Start Page
597
End Page
603
DOI
10.1016/j.jpainsymman.2015.10.016

Using percentile matching to simulate labor progression and the effect of labor duration on birth complications

© 2015 IEEE.Of the nearly 4 million births that occur each year in the U.S., almost 1 in 3 is a cesarean delivery. Due to the various increased risks associated with cesarean sections (C-sections) and the potential major complications in subsequent pregnancies, a re-evaluation of the C-section rate has been a topic of major concern for patients and health care providers. To evaluate the current C-section rate due to a "failure-to-progress" diagnosis, we implement a percentile matching procedure to derive labor progression times needed to replicate the delivery process in a discrete event simulation for women undergoing a trial of labor. The goals are to: (1) model the natural progression of labor in absence of C-sections, (2) determine the underlying rules responsible for the current rate of cesarean deliveries due to a "failure-to-progress" diagnosis, and (3) develop stopping rules that reduce the number of cesarean deliveries and the rate of complications.

Authors
Hicklin, K; Ivy, JS; Wilson, JR; Myers, E
MLA Citation
Hicklin, K, Ivy, JS, Wilson, JR, and Myers, E. "Using percentile matching to simulate labor progression and the effect of labor duration on birth complications." February 16, 2016.
Source
scopus
Published In
Proceedings - Winter Simulation Conference
Volume
2016-February
Publish Date
2016
Start Page
3104
End Page
3105
DOI
10.1109/WSC.2015.7408421

Association Between Patient Characteristics and Treatment Procedure Among Patients With Uterine Leiomyomas.

To analyze the association between patient characteristics and the probability of undergoing any uterine-sparing procedure (endometrial ablation, myomectomy, and uterine artery embolization) compared with hysterectomy as the first uterine leiomyoma (index) procedure and the probability of undergoing a specific uterine-sparing procedure.We conducted a retrospective analysis using a commercial insurance claims database containing more than 13 million enrollees annually. Based on the index procedure performed 2004-2009, women were classified into one of the four procedure cohorts. Eligible women were aged 25-54 years on the index date, continuously insured through 1-year baseline and 1-year follow-up, and had a baseline uterine leiomyoma diagnosis. Logistic regression was used to assess the association between patient characteristics and leiomyoma procedure.The study sample comprised 96,852 patients (endometrial ablation=12,169; myomectomy=7,039; uterine artery embolization=3,835; and hysterectomy=73,809). Patient characteristics associated with undergoing any uterine-sparing procedure compared with hysterectomy included health maintenance organization health plan enrollment, Northeast region residence, the highest income and education quintiles based on zip code, an age-race interaction, and baseline diagnoses including menstrual disorders, pelvic pain, anemia, endometriosis, genital prolapse, and infertility. Among those who had a uterine-sparing procedure, characteristics associated with undergoing uterine artery embolization or endometrial ablation compared with myomectomy included increasing age, being from the Midwest relative to the Northeast, and certain baseline conditions including menstrual disorder, pelvic pain, endometriosis, and infertility.Both clinical and nonclinical factors were associated with the receipt of alternatives to hysterectomy for uterine leiomyomas in commercially insured women.

Authors
Borah, BJ; Laughlin-Tommaso, SK; Myers, ER; Yao, X; Stewart, EA
MLA Citation
Borah, BJ, Laughlin-Tommaso, SK, Myers, ER, Yao, X, and Stewart, EA. "Association Between Patient Characteristics and Treatment Procedure Among Patients With Uterine Leiomyomas." Obstetrics and gynecology 127.1 (January 2016): 67-77.
PMID
26646122
Source
epmc
Published In
Obstetrics & Gynecology (Elsevier)
Volume
127
Issue
1
Publish Date
2016
Start Page
67
End Page
77
DOI
10.1097/aog.0000000000001160

Decision making about infertility treatment: does unlimited access lead to inappropriate treatment?

The proportion of women aged 40-44 undergoing IVF treatment covered by Maccabi Health Services increased between 2011 and 2014. Although age-specific birth rates did not substantially change over this time period, the demographic change was accompanied by an overall decrease in live births after IVF treatment. The relative contribution of changing population demographics vs. current age-related coverage policies to these trends is unclear. Additional research is needed to better understand the potential effect of changes in current policy on maternal, neonatal, and economic outcomes.

Authors
Myers, ER
MLA Citation
Myers, ER. "Decision making about infertility treatment: does unlimited access lead to inappropriate treatment?." Israel journal of health policy research 5 (January 2016): 23-.
PMID
27307986
Source
epmc
Published In
Israel Journal of Health Policy Research
Volume
5
Publish Date
2016
Start Page
23
DOI
10.1186/s13584-016-0083-6

Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients.

Although the implantable cardioverter-defibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death.To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients.The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov.Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groupsThe top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients.In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.

Authors
Al-Khatib, SM; Gierisch, JM; Crowley, MJ; Coeytaux, RR; Myers, ER; Kendrick, A; Sanders, GD
MLA Citation
Al-Khatib, SM, Gierisch, JM, Crowley, MJ, Coeytaux, RR, Myers, ER, Kendrick, A, and Sanders, GD. "Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients." Journal of general internal medicine 30.12 (December 2015): 1812-1820.
PMID
26014894
Source
epmc
Published In
Journal of General Internal Medicine
Volume
30
Issue
12
Publish Date
2015
Start Page
1812
End Page
1820
DOI
10.1007/s11606-015-3411-6

Trends in Treatment Patterns and Outcomes for Ductal Carcinoma In Situ.

Impact of contemporary treatment of pre-invasive breast cancer (ductal carcinoma in situ [DCIS]) on long-term outcomes remains poorly defined. We aimed to evaluate national treatment trends for DCIS and to determine their impact on disease-specific (DSS) and overall survival (OS).The Surveillance, Epidemiology, and End Results (SEER) registry was queried for patients diagnosed with DCIS from 1991 to 2010. Treatment pattern trends were analyzed using Cochran-Armitage trend test. Survival analyses were performed using inverse probability weights (IPW)-adjusted competing risk analyses for DSS and Cox proportional hazard regression for OS. All tests performed were two-sided.One hundred twenty-one thousand and eighty DCIS patients were identified. The greatest proportion of patients was treated with lumpectomy and radiation therapy (43.0%), followed by lumpectomy alone (26.5%) and unilateral (23.8%) or bilateral mastectomy (4.5%) with significant shifts over time. The rate of sentinel lymph node biopsy increased from 9.7% to 67.1% for mastectomy and from 1.4% to 17.8% for lumpectomy. Compared with mastectomy, OS was higher for lumpectomy with radiation (hazard ratio [HR] = 0.79, 95% confidence interval [CI] = 0.76 to 0.83, P < .001) and lower for lumpectomy alone (HR = 1.17, 95% CI = 1.13 to 1.23, P < .001). IPW-adjusted ten-year DSS was highest in lumpectomy with XRT (98.9%), followed by mastectomy (98.5%), and lumpectomy alone (98.4%).We identified substantial shifts in treatment patterns for DCIS from 1991 to 2010. When outcomes between locoregional treatment options were compared, we observed greater differences in OS than DSS, likely reflecting both a prevailing patient selection bias as well as clinically negligible differences in breast cancer outcomes between groups.

Authors
Worni, M; Akushevich, I; Greenup, R; Sarma, D; Ryser, MD; Myers, ER; Hwang, ES
MLA Citation
Worni, M, Akushevich, I, Greenup, R, Sarma, D, Ryser, MD, Myers, ER, and Hwang, ES. "Trends in Treatment Patterns and Outcomes for Ductal Carcinoma In Situ." Journal of the National Cancer Institute 107.12 (December 2015): djv263-.
PMID
26424776
Source
epmc
Published In
Journal of the National Cancer Institute
Volume
107
Issue
12
Publish Date
2015
Start Page
djv263
DOI
10.1093/jnci/djv263

Repeated In Vitro Fertilization Cycles for Infertility.

Authors
Myers, ER
MLA Citation
Myers, ER. "Repeated In Vitro Fertilization Cycles for Infertility." JAMA 314.24 (December 2015): 2627-2629.
PMID
26717028
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
314
Issue
24
Publish Date
2015
Start Page
2627
End Page
2629
DOI
10.1001/jama.2015.17297

Cost-Effectiveness of High-Risk Human Papillomavirus Testing With Messenger RNA Versus DNA Under United States Guidelines for Cervical Cancer Screening.

To compare the cost-effectiveness of high-risk human papillomavirus (hrHPV) testing using a hrHPV DNA and a hrHPV messenger RNA (mRNA) assay under current US cervical cancer screening guidelines.We constructed a Markov model for stochastic cost-effectiveness analysis using published data. We compared screening efficiency using DNA and mRNA testing for the following: (1) cotesting with cytology in women 30 to 65 years, and (2) triage of women with mild cervical cytological abnormalities (atypical squamous cells of undetermined significance [ASC-US]) in the United States. Screening end point is histologically confirmed high-grade lesions (cervical intraepithelial neoplasia grade 2, 3, or invasive cancer). Sensitivity and specificity estimates of DNA and mRNA testing to detect cervical intraepithelial neoplasia grade 2, 3, or invasive cancer were obtained from 2 published trials: the US Clinical Evaluation of APTIMA mRNA (CLEAR) study for ASC-US triage and the French APTIMA Screening Evaluation (FASE) study for cotesting. Costs of DNA and mRNA testing were assumed identical. Costs of screening, diagnosis, and treatment of cervical neoplasia and cancer were from previously published estimates, adjusted to 2012 US dollars. Inputs were modeled as distributions for Monte Carlo probabilistic sensitivity analysis. Model outcomes were costs per life-year saved for each strategy, discounted at 3% annually.For both cotesting and ASC-US triage, mRNA testing cost less than DNA testing, whereas life expectancies were widely overlapping. There was a 100% probability that DNA testing was not cost-effective at $100,000/life-year saved threshold for ASC-US triage and a 55% probability that DNA testing was not cost-effective at the same threshold for cotesting.Based on the available evidence, mRNA testing for cotesting or ASC-US triage is likely to be more efficient than DNA testing under current US cervical cancer screening guidelines.

Authors
Ting, J; Smith, JS; Myers, ER
MLA Citation
Ting, J, Smith, JS, and Myers, ER. "Cost-Effectiveness of High-Risk Human Papillomavirus Testing With Messenger RNA Versus DNA Under United States Guidelines for Cervical Cancer Screening." Journal of lower genital tract disease 19.4 (October 2015): 333-339.
PMID
26225945
Source
epmc
Published In
Journal of Lower Genital Tract Disease
Volume
19
Issue
4
Publish Date
2015
Start Page
333
End Page
339
DOI
10.1097/lgt.0000000000000143

How Should We Estimate the Cost-effectiveness of Interventions That Affect Reproduction?

Authors
Myers, ER
MLA Citation
Myers, ER. "How Should We Estimate the Cost-effectiveness of Interventions That Affect Reproduction?." Medical decision making : an international journal of the Society for Medical Decision Making 35.7 (October 2015): 812-814.
PMID
26296618
Source
epmc
Published In
Medical Decision Making
Volume
35
Issue
7
Publish Date
2015
Start Page
812
End Page
814
DOI
10.1177/0272989x15602227

Benefits and Harms of Breast Cancer Screening: A Systematic Review.

Patients need to consider both benefits and harms of breast cancer screening.To systematically synthesize available evidence on the association of mammographic screening and clinical breast examination (CBE) at different ages and intervals with breast cancer mortality, overdiagnosis, false-positive biopsy findings, life expectancy, and quality-adjusted life expectancy.We searched PubMed (to March 6, 2014), CINAHL (to September 10, 2013), and PsycINFO (to September 10, 2013) for systematic reviews, randomized clinical trials (RCTs) (with no limit to publication date), and observational and modeling studies published after January 1, 2000, as well as systematic reviews of all study designs. Included studies (7 reviews, 10 RCTs, 72 observational, 1 modeling) provided evidence on the association between screening with mammography, CBE, or both and prespecified critical outcomes among women at average risk of breast cancer (no known genetic susceptibility, family history, previous breast neoplasia, or chest irradiation). We used summary estimates from existing reviews, supplemented by qualitative synthesis of studies not included in those reviews.Across all ages of women at average risk, pooled estimates of association between mammography screening and mortality reduction after 13 years of follow-up were similar for 3 meta-analyses of clinical trials (UK Independent Panel: relative risk [RR], 0.80 [95% CI, 0.73-0.89]; Canadian Task Force: RR, 0.82 [95% CI, 0.74-0.94]; Cochrane: RR, 0.81 [95% CI, 0.74-0.87]); were greater in a meta-analysis of cohort studies (RR, 0.75 [95% CI, 0.69 to 0.81]); and were comparable in a modeling study (CISNET; median RR equivalent among 7 models, 0.85 [range, 0.77-0.93]). Uncertainty remains about the magnitude of associated mortality reduction in the entire US population, among women 40 to 49 years, and with annual screening compared with biennial screening. There is uncertainty about the magnitude of overdiagnosis associated with different screening strategies, attributable in part to lack of consensus on methods of estimation and the importance of ductal carcinoma in situ in overdiagnosis. For women with a first mammography screening at age 40 years, estimated 10-year cumulative risk of a false-positive biopsy result was higher (7.0% [95% CI, 6.1%-7.8%]) for annual compared with biennial (4.8% [95% CI, 4.4%-5.2%]) screening. Although 10-year probabilities of false-positive biopsy results were similar for women beginning screening at age 50 years, indirect estimates of lifetime probability of false-positive results were lower. Evidence for the relationship between screening and life expectancy and quality-adjusted life expectancy was low in quality. There was no direct evidence for any additional mortality benefit associated with the addition of CBE to mammography, but observational evidence from the United States and Canada suggested an increase in false-positive findings compared with mammography alone, with both studies finding an estimated 55 additional false-positive findings per extra breast cancer detected with the addition of CBE.For women of all ages at average risk, screening was associated with a reduction in breast cancer mortality of approximately 20%, although there was uncertainty about quantitative estimates of outcomes for different breast cancer screening strategies in the United States. These findings and the related uncertainty should be considered when making recommendations based on judgments about the balance of benefits and harms of breast cancer screening.

Authors
Myers, ER; Moorman, P; Gierisch, JM; Havrilesky, LJ; Grimm, LJ; Ghate, S; Davidson, B; Mongtomery, RC; Crowley, MJ; McCrory, DC; Kendrick, A; Sanders, GD
MLA Citation
Myers, ER, Moorman, P, Gierisch, JM, Havrilesky, LJ, Grimm, LJ, Ghate, S, Davidson, B, Mongtomery, RC, Crowley, MJ, McCrory, DC, Kendrick, A, and Sanders, GD. "Benefits and Harms of Breast Cancer Screening: A Systematic Review." JAMA 314.15 (October 2015): 1615-1634.
PMID
26501537
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
314
Issue
15
Publish Date
2015
Start Page
1615
End Page
1634
DOI
10.1001/jama.2015.13183

Improving NCCN guideline-adherent care for ovarian cancer: Value of an intervention.

To estimate the potential cost-effectiveness of an intervention to improve adherence to National Comprehensive Cancer Network (NCCN) guideline-based care for ovarian cancer.A modified Markov model with a 5-year time horizon estimated the potential cost-effectiveness of an intervention (AD-INT) to improve NCCN-guideline adherence compared to status quo (SQ) levels of adherence. Data were obtained from a population-based analysis of National Cancer Data Base records for ovarian cancer diagnosed from 1998 to 2002 (N=47,160). Cohorts were defined by race and adherence to NCCN guideline-based care. Costs were estimated using 2014 Medicare reimbursements. Incremental cost-effectiveness ratios (ICERs) were calculated in 2014 US dollars per year of life saved (YLS) using the standard threshold of $50,000/YLS. We simulated an AD-INT that reduced non-adherence by 25% and cost at least $100 per patient. One-way sensitivity analyses were performed.Although the individual components of guideline-adherent care are more costly than non-adherent care, a reasonably effective AD-INT is also highly likely to be cost-effective. An AD-INT costing $100 per patient and reducing non-adherence by 25% is cost-effective with an ICER of $22/YLS compared with SQ, while interventions costing over $1000 remain cost-effective, up to a per-patient intervention cost of up to $8000 (targeting only blacks) or $4000 (targeting all patients).An ovarian cancer intervention that moderately decreases racial disparities in NCCN guideline adherent care or improves adherence for all is potentially cost-effective. Further research may determine which modifiable factors may be targeted to help reduce adherence disparities.

Authors
Dottino, JA; Cliby, WA; Myers, ER; Bristow, RE; Havrilesky, LJ
MLA Citation
Dottino, JA, Cliby, WA, Myers, ER, Bristow, RE, and Havrilesky, LJ. "Improving NCCN guideline-adherent care for ovarian cancer: Value of an intervention." Gynecologic oncology 138.3 (September 2015): 694-699.
PMID
26072441
Source
epmc
Published In
Gynecologic Oncology
Volume
138
Issue
3
Publish Date
2015
Start Page
694
End Page
699
DOI
10.1016/j.ygyno.2015.06.013

Comparing Patient-centered Outcomes after Uterus-conserving Procedures for Uterine Fibroids Using a Linked Electronic Medical Record (EMR)-claims Database

Authors
Franke, KM; Mendelsohn, AB; Brinkley, E; Velentgas, P; Wang, T; Myers, ER; Lang, K
MLA Citation
Franke, KM, Mendelsohn, AB, Brinkley, E, Velentgas, P, Wang, T, Myers, ER, and Lang, K. "Comparing Patient-centered Outcomes after Uterus-conserving Procedures for Uterine Fibroids Using a Linked Electronic Medical Record (EMR)-claims Database." PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 24 (September 2015): 357-357.
Source
wos-lite
Published In
Pharmacoepidemiology and Drug Safety
Volume
24
Publish Date
2015
Start Page
357
End Page
357

Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations

Authors
Hayes, MG; Urbanek, M; Ehrmann, DA; Armstrong, LL; Lee, JY; Sisk, R; Karaderi, T; Barber, TM; McCarthy, MI; Franks, S; Lindgren, CM; Welt, CK; Diamanti-Kandarakis, E; Panidis, D; Goodarzi, MO; Azziz, R; Zhang, Y; James, RG; Olivier, M; Kissebah, AH; Alvero, R; Barnhart, HX; Baker, V; Barnhart, KT; Bates, GW; Brzyski, RG; Carr, BR; Carson, SA; Casson, P; Cataldo, NA; Christman, G; Coutifaris, C; Diamond, MP; Eisenberg, E; Gosman, GG; Giudice, LC; Haisenleder, DJ; Huang, H; Krawetz, SA; Lucidi, S et al.
MLA Citation
Hayes, MG, Urbanek, M, Ehrmann, DA, Armstrong, LL, Lee, JY, Sisk, R, Karaderi, T, Barber, TM, McCarthy, MI, Franks, S, Lindgren, CM, Welt, CK, Diamanti-Kandarakis, E, Panidis, D, Goodarzi, MO, Azziz, R, Zhang, Y, James, RG, Olivier, M, Kissebah, AH, Alvero, R, Barnhart, HX, Baker, V, Barnhart, KT, Bates, GW, Brzyski, RG, Carr, BR, Carson, SA, Casson, P, Cataldo, NA, Christman, G, Coutifaris, C, Diamond, MP, Eisenberg, E, Gosman, GG, Giudice, LC, Haisenleder, DJ, Huang, H, Krawetz, SA, and Lucidi, S et al. "Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations." Nature Communications 6 (August 18, 2015): 7502-7502.
Source
crossref
Published In
Nature Communications
Volume
6
Publish Date
2015
Start Page
7502
End Page
7502
DOI
10.1038/ncomms8502

Impact of coverage-dependent marginal costs on optimal HPV vaccination strategies.

The effectiveness of vaccinating males against the human papillomavirus (HPV) remains a controversial subject. Many existing studies conclude that increasing female coverage is more effective than diverting resources into male vaccination. Recently, several empirical studies on HPV immunization have been published, providing evidence of the fact that marginal vaccination costs increase with coverage. In this study, we use a stochastic agent-based modeling framework to revisit the male vaccination debate in light of these new findings. Within this framework, we assess the impact of coverage-dependent marginal costs of vaccine distribution on optimal immunization strategies against HPV. Focusing on the two scenarios of ongoing and new vaccination programs, we analyze different resource allocation policies and their effects on overall disease burden. Our results suggest that if the costs associated with vaccinating males are relatively close to those associated with vaccinating females, then coverage-dependent, increasing marginal costs may favor vaccination strategies that entail immunization of both genders. In particular, this study emphasizes the necessity for further empirical research on the nature of coverage-dependent vaccination costs.

Authors
Ryser, MD; McGoff, K; Herzog, DP; Sivakoff, DJ; Myers, ER
MLA Citation
Ryser, MD, McGoff, K, Herzog, DP, Sivakoff, DJ, and Myers, ER. "Impact of coverage-dependent marginal costs on optimal HPV vaccination strategies." Epidemics 11 (June 2015): 32-47.
Website
http://hdl.handle.net/10161/9500
PMID
25979280
Source
epmc
Published In
Epidemics: the journal of infectious disease dynamics
Volume
11
Publish Date
2015
Start Page
32
End Page
47
DOI
10.1016/j.epidem.2015.01.003

Vaginal native tissue repair versus transvaginal mesh repair for apical prolapse: how utilizing different methods of analysis affects the estimated trade-off between reoperation for mesh exposure/erosion and reoperation for recurrent prolapse.

Informed decision-making about optimal surgical repair of apical prolapse with vaginal native tissue (NT) versus transvaginal mesh (TVM) requires understanding the balance between the potential "harm" of mesh-related complications and the potential "benefit" of reducing prolapse recurrence. Synthesis of data from observational studies is required and the current literature shows that the average follow-up for NT repair is significantly longer than for TVM repair. We examined this harm/benefit balance. We hypothesized that using different methods of analysis to incorporate follow-up time would affect the balance of outcomes.We used a Markov state transition model to estimate the cumulative 24-month probabilities of reoperation for mesh exposure/erosion or for recurrent prolapse after either NT or TVM repair. We used four different analytic approaches to estimate probability distributions ranging from simple pooled proportions to a random effects meta-analysis using study-specific events per patient-time.As variability in follow-up time was accounted for better, the balance of outcomes became more uncertain. For TVM repair, the incremental ratio of number of operations for mesh exposure/erosion per single reoperation for recurrent prolapse prevented increased progressively from 1.4 to over 100 with more rigorous analysis methods. The most rigorous analysis showed a 70% probability that TVM would result in more operations for recurrent prolapse repair than NT.Based on the best available evidence, there is considerable uncertainty about the harm/benefit trade-off between NT and TVM for apical prolapse repair. Future studies should incorporate time-to-event analyses, with greater standardization of reporting, in order to better inform decision-making.

Authors
Dieter, AA; Willis-Gray, MG; Weidner, AC; Visco, AG; Myers, ER
MLA Citation
Dieter, AA, Willis-Gray, MG, Weidner, AC, Visco, AG, and Myers, ER. "Vaginal native tissue repair versus transvaginal mesh repair for apical prolapse: how utilizing different methods of analysis affects the estimated trade-off between reoperation for mesh exposure/erosion and reoperation for recurrent prolapse." International urogynecology journal 26.5 (May 2015): 721-727.
PMID
25644048
Source
epmc
Published In
International Urogynecology Journal
Volume
26
Issue
5
Publish Date
2015
Start Page
721
End Page
727
DOI
10.1007/s00192-014-2578-4

Costs, Effectiveness, and Workload Impact of Management Strategies for Women With an Adnexal Mass

Authors
Havrilesky, LJ; Dinan, M; Sfakianos, GP; Curtis, LH; Barnett, JC; Van Gorp, T; Myers, ER
MLA Citation
Havrilesky, LJ, Dinan, M, Sfakianos, GP, Curtis, LH, Barnett, JC, Van Gorp, T, and Myers, ER. "Costs, Effectiveness, and Workload Impact of Management Strategies for Women With an Adnexal Mass." Obstetrical & Gynecological Survey 70.4 (April 2015): 253-255.
Source
crossref
Published In
Obstetrical and Gynecological Survey
Volume
70
Issue
4
Publish Date
2015
Start Page
253
End Page
255
DOI
10.1097/01.ogx.0000464937.42384.2d

HPV clearance and the neglected role of stochasticity.

Clearance of anogenital and oropharyngeal HPV infections is attributed primarily to a successful adaptive immune response. To date, little attention has been paid to the potential role of stochastic cell dynamics in the time it takes to clear an HPV infection. In this study, we combine mechanistic mathematical models at the cellular level with epidemiological data at the population level to disentangle the respective roles of immune capacity and cell dynamics in the clearing mechanism. Our results suggest that chance-in form of the stochastic dynamics of basal stem cells-plays a critical role in the elimination of HPV-infected cell clones. In particular, we find that in immunocompetent adolescents with cervical HPV infections, the immune response may contribute less than 20% to virus clearance-the rest is taken care of by the stochastic proliferation dynamics in the basal layer. In HIV-negative individuals, the contribution of the immune response may be negligible.

Authors
Ryser, MD; Myers, ER; Durrett, R
MLA Citation
Ryser, MD, Myers, ER, and Durrett, R. "HPV clearance and the neglected role of stochasticity." PLoS computational biology 11.3 (March 13, 2015): e1004113-.
Website
http://hdl.handle.net/10161/9545
PMID
25769112
Source
epmc
Published In
PLoS computational biology
Volume
11
Issue
3
Publish Date
2015
Start Page
e1004113
DOI
10.1371/journal.pcbi.1004113

Pregnancy after Treatment for Cervical Cancer Precursor Lesions in a Retrospective Matched Cohort

Authors
Naleway, AL; Weinmann, S; Krishnarajah, G; Arondekar, B; Fernandez, J; Swamy, G; Myers, E
MLA Citation
Naleway, AL, Weinmann, S, Krishnarajah, G, Arondekar, B, Fernandez, J, Swamy, G, and Myers, E. "Pregnancy after Treatment for Cervical Cancer Precursor Lesions in a Retrospective Matched Cohort." Ed. MEL Consolaro. PLOS ONE 10.2 (February 11, 2015): e0117525-e0117525.
Source
crossref
Published In
PloS one
Volume
10
Issue
2
Publish Date
2015
Start Page
e0117525
End Page
e0117525
DOI
10.1371/journal.pone.0117525

A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: Incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer

© 2014 Elsevier Inc. All rights reserved.Objective. To estimate quality-of-life (QOL)-adjusted cost-utility with addition of bevacizumab (B) to intravenous paclitaxel/carboplatin (PC) for primary treatment of advanced-stage epithelial ovarian cancer. Methods. A modified Markov state transition model of 3 regimens evaluated in GOG 218 (PC, PC + concurrent B [PCB], and PCB + maintenance B [PCB + B]) was populated by prospectively collected survival, adverse event, and QOL data from GOG 218. Progression-free survival (PFS) and overall survival (OS) were modeled using primary event data. Costs of grade 4 hypertension, grade 3-5 bowel events, and growth factor support were incorporated. QOL scores were converted to utilities and incorporated into the model. Monte Carlo probabilistic sensitivity analysis was performed to account for uncertainty in estimates. Results. PC was the least expensive ($4044) and least effective (mean 1.1 quality-adjusted progression-free years [QA-PFY]) regimen. PCB ($43,703 and 1.13 QA-PFY) was dominated by a combination of PC and PCB + B. PCB + B ($122,700 and 1.25 QA-PFY) was the most expensive regimen with an incremental cost-effectiveness ratio of $792,380/QA-PFY compared to PC. In a model not incorporating QOL, the incremental cost-effectiveness ratio (ICER) of PCB + B was $632,571/PFY compared to PC. Conclusions. In this cost-utility model, incorporation of QOL into an analysis of GOG 218 led to less favorable ICER (by >$150,000/QA-PFY) in regimens containing B compared with those that do not include B. Continued investigation of populations with ovarian cancer in whom the efficacy of treatment with bevacizumab is expected to be increased (or in whom QOL is expected to increase with use) is critical.

Authors
Cohn, DE; Barnett, JC; Wenzel, L; Monk, BJ; Burger, RA; Straughn, JM; Myers, ER; Havrilesky, LJ
MLA Citation
Cohn, DE, Barnett, JC, Wenzel, L, Monk, BJ, Burger, RA, Straughn, JM, Myers, ER, and Havrilesky, LJ. "A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: Incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer." Gynecologic Oncology 136.2 (February 1, 2015): 293-299.
Source
scopus
Published In
Gynecologic Oncology
Volume
136
Issue
2
Publish Date
2015
Start Page
293
End Page
299
DOI
10.1016/j.ygyno.2014.10.020

A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer.

To estimate quality-of-life (QOL)-adjusted cost-utility with addition of bevacizumab (B) to intravenous paclitaxel/carboplatin (PC) for primary treatment of advanced-stage epithelial ovarian cancer.A modified Markov state transition model of 3 regimens evaluated in GOG 218 (PC, PC+concurrent B [PCB], and PCB+maintenance B [PCB+B]) was populated by prospectively collected survival, adverse event, and QOL data from GOG 218. Progression-free survival (PFS) and overall survival (OS) were modeled using primary event data. Costs of grade 4 hypertension, grade 3-5 bowel events, and growth factor support were incorporated. QOL scores were converted to utilities and incorporated into the model. Monte Carlo probabilistic sensitivity analysis was performed to account for uncertainty in estimates.PC was the least expensive ($4044) and least effective (mean 1.1 quality-adjusted progression-free years [QA-PFY]) regimen. PCB ($43,703 and 1.13 QA-PFY) was dominated by a combination of PC and PCB+B. PCB+B ($122,700 and 1.25 QA-PFY) was the most expensive regimen with an incremental cost-effectiveness ratio of $792,380/QA-PFY compared to PC. In a model not incorporating QOL, the incremental cost-effectiveness ratio (ICER) of PCB+B was $632,571/PFY compared to PC.In this cost-utility model, incorporation of QOL into an analysis of GOG 218 led to less favorable ICER (by >$150,000/QA-PFY) in regimens containing B compared with those that do not include B. Continued investigation of populations with ovarian cancer in whom the efficacy of treatment with bevacizumab is expected to be increased (or in whom QOL is expected to increase with use) is critical.

Authors
Cohn, DE; Barnett, JC; Wenzel, L; Monk, BJ; Burger, RA; Straughn, JM; Myers, ER; Havrilesky, LJ
MLA Citation
Cohn, DE, Barnett, JC, Wenzel, L, Monk, BJ, Burger, RA, Straughn, JM, Myers, ER, and Havrilesky, LJ. "A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer." Gynecologic oncology 136.2 (February 2015): 293-299.
PMID
25449568
Source
epmc
Published In
Gynecologic Oncology
Volume
136
Issue
2
Publish Date
2015
Start Page
293
End Page
299
DOI
10.1016/j.ygyno.2014.10.020

Simulation of labor: A study of the relationship between cesarean section rates and the time spent in labor

© 2014 IEEE.Cesarean delivery is the most common major abdominal surgery in many parts of the world. As of October 2012, the cesarean section rate in the United States was reported to be 32.8% in 2011, rising from 4.5% in 1970. Cesarean sections are associated with an increased risk of neonatal respiratory morbidity, increased risk of a hysterectomy and can cause major complications in subsequent pregnancies, such as uterine rupture. To evaluate the current cesarean delivery rate due to a 'failure to progress' diagnosis, our goal was to replicate the delivery process for women undergoing a trial of labor. In this simulation we evaluate the Friedman Curve and other labor progression rules to identify circumstances in which the cesarean rate can be decreased through the analysis of the total length of time a woman spends in labor as well as the duration of time a woman remains in a cervical dilation stage.

Authors
Hicklin, K; Ivy, JS; Myers, ER; Kulkarni, V; Viswanathan, M
MLA Citation
Hicklin, K, Ivy, JS, Myers, ER, Kulkarni, V, and Viswanathan, M. "Simulation of labor: A study of the relationship between cesarean section rates and the time spent in labor." January 1, 2015.
Source
scopus
Published In
Proceedings - Winter Simulation Conference
Volume
2015-January
Publish Date
2015
Start Page
1269
End Page
1280
DOI
10.1109/WSC.2014.7019983

Costs, effectiveness, and workload impact of management strategies for women with an adnexal mass.

BACKGROUND: We compared the estimated clinical outcomes, costs, and physician workload resulting from available strategies for deciding which women with an adnexal mass should be referred to a gynecologic oncologist. METHODS: We used a microsimulation model to compare five referral strategies: 1) American Congress of Obstetricians and Gynecologists (ACOG) guidelines, 2) Multivariate Index Assay (MIA) algorithm, 3) Risk of Malignancy Algorithm (ROMA), 4) CA125 alone with lowered cutoff values to prioritize test sensitivity over specificity, 5) referral of all women (Refer All). Test characteristics and relative survival were obtained from the literature and data from a biomarker validation study. Medical costs were estimated using Medicare reimbursements. Travel costs were estimated using discharge data from Surveillance, Epidemiology and End Results-Medicare and State Inpatient Databases. Analyses were performed separately for pre- and postmenopausal women (60 000 "subjects" in each), repeated 10 000 times. RESULTS: Refer All was cost-effective compared with less expensive strategies in both postmenopausal (incremental cost-effectiveness ratio [ICER] $9423/year of life saved (LYS) compared with CA125) and premenopausal women (ICER $10 644/YLS compared with CA125), but would result in an additional 73 cases/year/subspecialist. MIA was more expensive and less effective than Refer All in pre- and postmenopausal women. If Refer All is not a viable option, CA125 is an optimal strategy in postmenopausal women. CONCLUSIONS: Referral of all women to a subspecialist is an efficient strategy for managing women with adnexal masses requiring surgery, assuming sufficient capacity for additional surgical volume. If a test-based triage strategy is needed, CA125 with lowered cutoff values is a cost-effective strategy.

Authors
Havrilesky, LJ; Dinan, M; Sfakianos, GP; Curtis, LH; Barnett, JC; Van Gorp, T; Myers, ER
MLA Citation
Havrilesky, LJ, Dinan, M, Sfakianos, GP, Curtis, LH, Barnett, JC, Van Gorp, T, and Myers, ER. "Costs, effectiveness, and workload impact of management strategies for women with an adnexal mass." Journal of the National Cancer Institute 107.1 (January 2015): 322-.
PMID
25515232
Source
epmc
Published In
Journal of the National Cancer Institute
Volume
107
Issue
1
Publish Date
2015
Start Page
322
DOI
10.1093/jnci/dju322

Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype.

Do women with polycystic ovary syndrome (PCOS) seeking fertility treatment report smoking accurately and does participation in infertility treatment alter smoking?Self-report of smoking in infertile women with PCOS is accurate (based on serum cotinine levels) and smoking is unlikely to change over time with infertility treatment.Women with PCOS have high rates of smoking and it is associated with worse insulin resistance and metabolic dysfunction.Secondary study of smoking history from a large randomized controlled trial of infertility treatments in women with PCOS (N = 626) including a nested case-control study (N = 148) of serum cotinine levels within this cohort to validate self-report of smoking.Women with PCOS, age 18-40, seeking fertility who participated in a multi-center clinical trial testing first-line ovulation induction agents conducted at academic health centers in the USA.Overall, self-report of smoking in the nested case-control study agreed well with smoking status as determined by measure of serum cotinine levels, at 90% or better for each of the groups at baseline (98% of never smokers had cotinine levels <15 ng/ml compared with 90% of past smokers and 6% of current smokers). There were minor changes in smoking status as determined by serum cotinine levels over time, with the greatest change found in the smoking groups (past or current smokers). In the larger cohort, hirsutism scores at baseline were lower in the never smokers compared with past smokers. Total testosterone levels at baseline were also lower in the never smokers compared with current smokers. At end of study follow-up insulin levels and homeostatic index of insulin resistance increased in the current smokers (P < 0.01 for both) compared with baseline and with non-smokers. The chance for ovulation was not associated with smoking status, but live birth rates were increased (non-significantly) in never or past smokers.The limitations include the selection bias involved in our nested case-control study, the possibility of misclassifying exposure to second hand smoke as smoking and our failure to capture self-reported changes in smoking status after enrollment in the trial.Because self-report of smoking is accurate, further testing of smoking status is not necessary in women with PCOS. Because smoking status is unlikely to change during infertility treatment, extra attention should be focused on smoking cessation in current or recent smokers who seek or who are receiving infertility treatment.Sponsored by the Eugene Kennedy Shriver National Institute of Child Health and Human Development of the U.S. National Institutes of Health.ClinicalTrials.gov numbers, NCT00068861 and NCT00719186.

Authors
Legro, RS; Chen, G; Kunselman, AR; Schlaff, WD; Diamond, MP; Coutifaris, C; Carson, SA; Steinkampf, MP; Carr, BR; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Myers, ER; Zhang, H; Foulds, J
MLA Citation
Legro, RS, Chen, G, Kunselman, AR, Schlaff, WD, Diamond, MP, Coutifaris, C, Carson, SA, Steinkampf, MP, Carr, BR, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Myers, ER, Zhang, H, and Foulds, J. "Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype." Human reproduction (Oxford, England) 29.12 (December 2014): 2680-2686.
PMID
25324541
Source
epmc
Published In
Human Reproduction
Volume
29
Issue
12
Publish Date
2014
Start Page
2680
End Page
2686
DOI
10.1093/humrep/deu239

Factors associated with the change in prevalence of cardiomyopathy at delivery in the period 2000-2009: a population-based prevalence study.

Cardiomyopathy (CM) at delivery is increasing in prevalance. The objective of this study was to determine which medical conditions are attributable to this increasing prevalance.Population prevalence study from 2000 to 2009.The Nationwide Inpatient Sample (NIS).Pregnant women admitted for delivery were identified in the NIS for the years 2000-2009.Temporal trends in pre-existing medical conditions and in medical and obstetric complications at delivery admissions were determined by linear regression. The change in the prevalence of CM among all pregnant women was compared with the change in the prevalance of CM among pregnant women without pre-existing conditions or complications.Prevalence of CM.The prevalence of CM increased from 0.25 per 1000 deliveries in 2000 to 0.43 per 1000 deliveries in 2009 (P < 0.0001). Women with chronic hypertension had increased odds of developing CM compared with women without chronic hypertension (odds ratio, OR, 13.2; 95% confidence interval, 95% CI, 12.5-13.7). The linear increase in chronic hypertension over the 10-year period was the single identified pre-existing medical condition that explained the increasing prevalence of CM at delivery (P = 0.005 for the differences in slopes for linear trends).Pregnant women with chronic hypertenion are at an increased risk for CM at delivery, and the increasing prevalence of chronic hypertension is an important factor associated with the increasing prevalence of CM at the time of delivery. Among women without chronic hypertension, the prevalence of CM at delivery did not change during the time period.

Authors
Grotegut, CA; Kuklina, EV; Anstrom, KJ; Heine, RP; Callaghan, WM; Myers, ER; James, AH
MLA Citation
Grotegut, CA, Kuklina, EV, Anstrom, KJ, Heine, RP, Callaghan, WM, Myers, ER, and James, AH. "Factors associated with the change in prevalence of cardiomyopathy at delivery in the period 2000-2009: a population-based prevalence study." BJOG : an international journal of obstetrics and gynaecology 121.11 (October 2014): 1386-1394.
PMID
24661593
Source
epmc
Published In
Bjog : An International Journal of Obstetrics & Gynaecology
Volume
121
Issue
11
Publish Date
2014
Start Page
1386
End Page
1394
DOI
10.1111/1471-0528.12726

Attribution of 12 high-risk human papillomavirus genotypes to infection and cervical disease.

BACKGROUND: We estimated the prevalence and incidence of 14 human papillomavirus (HPV) types (6/11/16/18/31/33/35/39/45/51/52/56/58/59) in cervicovaginal swabs, and the attribution of these HPV types in cervical intraepithelial neoplasia (CIN), and adenocarcinoma in situ (AIS), using predefined algorithms that adjusted for multiple-type infected lesions. METHODS: A total of 10,656 women ages 15 to 26 years and 1,858 women ages 24 to 45 years were enrolled in the placebo arms of one of three clinical trials of a quadrivalent HPV vaccine. We estimated the cumulative incidence of persistent infection and the proportion of CIN/AIS attributable to individual carcinogenic HPV genotypes, as well as the proportion of CIN/AIS lesions potentially preventable by a prophylactic 9-valent HPV6/11/16/18/31/33/45/52/58 vaccine. RESULTS: The cumulative incidence of persistent infection with ≥1 of the seven high-risk types included in the 9-valent vaccine was 29%, 12%, and 6% for women ages 15 to 26, 24 to 34, and 35 to 45 years, respectively. A total of 2,507 lesions were diagnosed as CIN or AIS by an expert pathology panel. After adjusting for multiple-type infected lesions, among women ages 15 to 45 years, these seven high-risk types were attributed to 43% to 55% of CIN1, 70% to 78% of CIN2, 85% to 91% of CIN3, and 95% to 100% of AIS lesions, respectively. The other tested types (HPV35/39/51/56/59) were attributed to 23% to 30% of CIN1, 7% to 14% of CIN2, 3% to 4% of CIN3, and 0% of AIS lesions, respectively. CONCLUSIONS: Approximately 85% or more of CIN3/AIS, >70% CIN2, and approximately 50% of CIN1 lesions worldwide are attributed to HPV6/11/16/18/31/33/45/52/58. IMPACT: If 9-valent HPV vaccination programs are effectively implemented, the majority of CIN2 and CIN3 lesions worldwide could be prevented, in addition to approximately one-half of CIN1.

Authors
Joura, EA; Ault, KA; Bosch, FX; Brown, D; Cuzick, J; Ferris, D; Garland, SM; Giuliano, AR; Hernandez-Avila, M; Huh, W; Iversen, O-E; Kjaer, SK; Luna, J; Miller, D; Monsonego, J; Munoz, N; Myers, E; Paavonen, J; Pitisuttithum, P; Steben, M; Wheeler, CM; Perez, G; Saah, A; Luxembourg, A; Sings, HL; Velicer, C
MLA Citation
Joura, EA, Ault, KA, Bosch, FX, Brown, D, Cuzick, J, Ferris, D, Garland, SM, Giuliano, AR, Hernandez-Avila, M, Huh, W, Iversen, O-E, Kjaer, SK, Luna, J, Miller, D, Monsonego, J, Munoz, N, Myers, E, Paavonen, J, Pitisuttithum, P, Steben, M, Wheeler, CM, Perez, G, Saah, A, Luxembourg, A, Sings, HL, and Velicer, C. "Attribution of 12 high-risk human papillomavirus genotypes to infection and cervical disease." Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 23.10 (October 2014): 1997-2008.
PMID
25274978
Source
epmc
Published In
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
Volume
23
Issue
10
Publish Date
2014
Start Page
1997
End Page
2008
DOI
10.1158/1055-9965.epi-14-0410

Impact of the National Breast and Cervical Cancer Early Detection Program on cervical cancer mortality among uninsured low-income women in the U.S., 1991-2007.

The benefits of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) on cervical cancer screening for participating uninsured low-income women have never been measured.To estimate the benefits in life-years (LYs) gained; quality-adjusted life-years (QALYs) gained; and deaths averted.A cervical cancer simulation model was constructed based on an existing cohort model. The model was applied to NBCCEDP participants aged 18-64 years. Screening habits for uninsured low-income women were estimated using National Health Interview Survey data from 1990 to 2005 and NBCCEDP data from 1991 to 2007. The study was conducted during 2011-2012 and covered all 68 NBCCEDP grantees in 50 states, the District of Columbia, five U.S. territories, and 12 tribal organizations. Separate simulations were performed for the following three scenarios: (1) women who received NBCCEDP (Program) screening; (2) women who received screening without the program (No Program); and (3) women who received no screening (No Screening).Among 1.8 million women screened in 1991-2007, the Program added 10,369 LYs gained compared to No Program, and 101,509 LYs gained compared to No Screening. The Program prevented 325 women from dying of cervical cancer relative to No Program, and 3,829 relative to No Screening. During this time period, the Program accounted for 15,589 QALYs gained when compared with No Program, and 121,529 QALYs gained when compared with No Screening.These estimates suggest that NBCCEDP cervical cancer screening has reduced mortality among medically underserved low-income women who participated in the program.

Authors
Ekwueme, DU; Uzunangelov, VJ; Hoerger, TJ; Miller, JW; Saraiya, M; Benard, VB; Hall, IJ; Royalty, J; Li, C; Myers, ER
MLA Citation
Ekwueme, DU, Uzunangelov, VJ, Hoerger, TJ, Miller, JW, Saraiya, M, Benard, VB, Hall, IJ, Royalty, J, Li, C, and Myers, ER. "Impact of the National Breast and Cervical Cancer Early Detection Program on cervical cancer mortality among uninsured low-income women in the U.S., 1991-2007." American journal of preventive medicine 47.3 (September 2014): 300-308.
PMID
25015564
Source
epmc
Published In
American Journal of Preventive Medicine
Volume
47
Issue
3
Publish Date
2014
Start Page
300
End Page
308
DOI
10.1016/j.amepre.2014.05.016

TRADITIONAL REPAIR VERSUS MESH AUGMENTATION: ESTIMATING THE TRADE-OFF BETWEEN REOPERATION FOR MESH EXPOSURE VS REOPERATION FOR RECURRENT PROLAPSE

Authors
Dieter, AA; Weidner, AC; Willis-Gray, M; Visco, AG; Myers, ER
MLA Citation
Dieter, AA, Weidner, AC, Willis-Gray, M, Visco, AG, and Myers, ER. "TRADITIONAL REPAIR VERSUS MESH AUGMENTATION: ESTIMATING THE TRADE-OFF BETWEEN REOPERATION FOR MESH EXPOSURE VS REOPERATION FOR RECURRENT PROLAPSE." INTERNATIONAL UROGYNECOLOGY JOURNAL 25 (July 2014): S29-S30.
Source
wos-lite
Published In
International Urogynecology Journal
Volume
25
Publish Date
2014
Start Page
S29
End Page
S30

Prioritization of patient-centered comparative effectiveness research for osteoarthritis.

Osteoarthritis is a leading cause of disability in the United States. This article describes a prioritized research agenda about osteoarthritis management developed for the Patient-Centered Outcomes Research Institute. Evidence gaps were identified by reviewing existing literature and engaging diverse stakeholders to expand and refine gaps. Stakeholders ranked evidence gaps by importance from their perspectives.Prioritized evidence gaps included the need to determine or evaluate key patient-centered outcomes; optimal duration, intensity, and frequency of nonsurgical interventions; whether the comparative effectiveness of nonsurgical interventions varies by socioeconomic factors; when and how to transition from nonsurgical to surgical interventions; effective ways to engage patients in self-management and promote long-term behavior change; standardized screening tools that improve early diagnosis; biomechanical strategies that improve symptoms; mechanisms for promoting and delivering coordinated, longitudinal care; and comparative effectiveness of nonsurgical therapies. Searches of PubMed and ClinicalTrials.gov showed many recent and ongoing studies addressing comparative effectiveness of nonsurgical interventions; relatively few of these evaluated treatments across categories (for example, drug therapy vs. weight management) or combined categories of treatment. Few studies addressed other high-priority evidence gaps.

Authors
Gierisch, JM; Myers, ER; Schmit, KM; McCrory, DC; Coeytaux, RR; Crowley, MJ; Chatterjee, R; Kendrick, AS; Sanders, GD
MLA Citation
Gierisch, JM, Myers, ER, Schmit, KM, McCrory, DC, Coeytaux, RR, Crowley, MJ, Chatterjee, R, Kendrick, AS, and Sanders, GD. "Prioritization of patient-centered comparative effectiveness research for osteoarthritis." Annals of internal medicine 160.12 (June 2014): 836-841.
PMID
24821227
Source
epmc
Published In
Annals of internal medicine
Volume
160
Issue
12
Publish Date
2014
Start Page
836
End Page
841
DOI
10.7326/m14-0318

Impact of a routine, opt-out HIV testing program on HIV testing and case detection in North Carolina sexually transmitted disease clinics.

The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection.Adults aged 18 to 64 years who received an HIV test in a North Carolina STD clinic from July 1, 2005, through June 30, 2011, were included in this analysis, dichotomized at the date of implementation on November 1, 2007. HIV testing and case detection counts and rates were analyzed using interrupted time series analysis and Poisson and multilevel logistic regression.Preintervention, 426 new HIV-infected cases were identified from 128,029 tests (0.33%), whereas 816 new HIV-infected cases were found from 274,745 tests postintervention (0.30%). Preintervention, HIV testing increased by 55 tests per month (95% confidence interval [CI], 41-72), but only 34 tests per month (95% CI, 26-42) postintervention. Increases in HIV testing rates were most pronounced in women and non-Hispanic whites. A slight preintervention decline in case detection was mitigated by the intervention (mean difference, 0.01; 95% CI, -0.02 to 0.05). Increases in case detection rates were observed among women and non-Hispanic blacks.The impact of a routine HIV screening in North Carolina STD clinics was marginal, with the greatest benefit among persons not traditionally targeted for HIV testing. The use of a preintervention comparison period identified important temporal trends that otherwise would have been ignored.

Authors
Klein, PW; Messer, LC; Myers, ER; Weber, DJ; Leone, PA; Miller, WC
MLA Citation
Klein, PW, Messer, LC, Myers, ER, Weber, DJ, Leone, PA, and Miller, WC. "Impact of a routine, opt-out HIV testing program on HIV testing and case detection in North Carolina sexually transmitted disease clinics." Sexually transmitted diseases 41.6 (June 2014): 395-402.
PMID
24825338
Source
epmc
Published In
Sexually Transmitted Diseases
Volume
41
Issue
6
Publish Date
2014
Start Page
395
End Page
402
DOI
10.1097/olq.0000000000000141

Prioritization of research addressing management strategies for ductal carcinoma in situ.

Ductal carcinoma in situ is a common finding in women having mammography screening, and there is considerable uncertainty about the balance of harms and benefits of different management options. This article outlines the process for developing a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the management of ductal carcinoma in situ. Evidence gaps were identified by reviewing existing literature and engaging diverse stakeholders to refine these gaps. Stakeholders ranked evidence gaps by importance from their perspectives using a forced-ranking prioritization method. PubMed was searched for relevant recent studies, and ClinicalTrials.gov was searched for relevant ongoing trials for the 10 highest-ranked evidence gaps. Strengths and limitations of different study designs were assessed to address gaps. Stakeholders prioritized evidence gaps related to incorporation of patient-centered outcomes into future research, development of better methods to predict risk for invasive cancer, evaluation of a strategy of active surveillance, and testing of decision-making tools. The degree to which prioritized evidence gaps may have already been addressed is uncertain because a comprehensive systematic review has not been done.

Authors
Gierisch, JM; Myers, ER; Schmit, KM; Crowley, MJ; McCrory, DC; Chatterjee, R; Coeytaux, RR; Kendrick, A; Sanders, GD
MLA Citation
Gierisch, JM, Myers, ER, Schmit, KM, Crowley, MJ, McCrory, DC, Chatterjee, R, Coeytaux, RR, Kendrick, A, and Sanders, GD. "Prioritization of research addressing management strategies for ductal carcinoma in situ." Annals of internal medicine 160.7 (April 2014): 484-491.
PMID
24567146
Source
epmc
Published In
Annals of internal medicine
Volume
160
Issue
7
Publish Date
2014
Start Page
484
End Page
491
DOI
10.7326/m13-2548

Prioritization of research addressing antipsychotics for adolescents and young adults with bipolar disorder.

Despite a paucity of high-quality evidence about benefits and harms, antipsychotic medication use among adolescents and young adults with bipolar disorder is increasing. The Patient-Centered Outcomes Research Institute tasked the Duke Evidence Synthesis Group with creating a prioritized agenda for research in this area that would incorporate the perspectives of relevant stakeholders. We identified a list of potential evidence gaps by reviewing existing literature and engaged a diverse group of 9 stakeholders to expand and refine this list. Using a forced-ranking prioritization method, stakeholders prioritized 10 of 23 potential evidence gaps as the most pressing for future research. These evidence gaps relate to 3 areas: the comparative effectiveness of intervention strategies, the effect of antipsychotics on patient-centered outcomes, and the influence of various patient characteristics on antipsychotic effectiveness. In addition to presenting these findings, we suggest appropriate study designs for addressing the stakeholder-prioritized research questions.

Authors
Crowley, MJ; McCrory, DC; Chatterjee, R; Gierisch, JM; Myers, ER; Schmit, KM; Coeytaux, RR; Correll, CU; Kendrick, AS; Sanders, GD
MLA Citation
Crowley, MJ, McCrory, DC, Chatterjee, R, Gierisch, JM, Myers, ER, Schmit, KM, Coeytaux, RR, Correll, CU, Kendrick, AS, and Sanders, GD. "Prioritization of research addressing antipsychotics for adolescents and young adults with bipolar disorder." Annals of internal medicine 160.7 (April 2014): 492-498.
PMID
24567115
Source
epmc
Published In
Annals of internal medicine
Volume
160
Issue
7
Publish Date
2014
Start Page
492
End Page
498
DOI
10.7326/m13-2549

Oral contraceptive use and risk of cancer--response.

Authors
Gierisch, JM; Myers, ER
MLA Citation
Gierisch, JM, and Myers, ER. "Oral contraceptive use and risk of cancer--response." Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 23.4 (April 2014): 677-678.
PMID
24636973
Source
epmc
Published In
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
Volume
23
Issue
4
Publish Date
2014
Start Page
677
End Page
678
DOI
10.1158/1055-9965.epi-14-0082

Impact of the national breast and cervical cancer early detection program on cervical cancer mortality among uninsured low-income women in the U.S., 1991-2007

Background: The benefits of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) on cervical cancer screening for participating uninsured low-income women have never been measured. Purpose: To estimate the benefits in life-years (LYs) gained; quality-adjusted life-years (QALYs) gained; and deaths averted. Methods: A cervical cancer simulation model was constructed based on an existing cohort model. The model was applied to NBCCEDP participants aged 18-64 years. Screening habits for uninsured low-income women were estimated using National Health Interview Survey data from 1990 to 2005 and NBCCEDP data from 1991 to 2007. The study was conducted during 2011-2012 and covered all 68 NBCCEDP grantees in 50 states, the District of Columbia, five U.S. territories, and 12 tribal organizations. Separate simulations were performed for the following three scenarios: (1) women who received NBCCEDP (Program) screening; (2) women who received screening without the program (No Program); and (3) women who received no screening (No Screening). Results: Among 1.8 million women screened in 1991-2007, the Program added 10,369 LYs gained compared to No Program, and 101,509 LYs gained compared to No Screening. The Program prevented 325 women from dying of cervical cancer relative to No Program, and 3,829 relative to No Screening. During this time period, the Program accounted for 15,589 QALYs gained when compared with No Program, and 121,529 QALYs gained when compared with No Screening. Conclusions: These estimates suggest that NBCCEDP cervical cancer screening has reduced mortality among medically underserved low-income women who participated in the program.

Authors
Ekwueme, DU; Uzunangelov, VJ; Hoerger, TJ; Miller, JW; Saraiya, M; Benard, VB; Hall, IJ; Royalty, J; Li, C; Myers, ER
MLA Citation
Ekwueme, DU, Uzunangelov, VJ, Hoerger, TJ, Miller, JW, Saraiya, M, Benard, VB, Hall, IJ, Royalty, J, Li, C, and Myers, ER. "Impact of the national breast and cervical cancer early detection program on cervical cancer mortality among uninsured low-income women in the U.S., 1991-2007." American Journal of Preventive Medicine 47.3 (January 1, 2014): 300-308. (Review)
Source
scopus
Published In
American Journal of Preventive Medicine
Volume
47
Issue
3
Publish Date
2014
Start Page
300
End Page
308
DOI
10.1016/j.amepre.2014.05.016

Factors associated with the change in prevalence of cardiomyopathy at delivery in the period 2000-2009: A population-based prevalence study

© 2014 Royal College of Obstetricians and Gynaecologists.Objective Cardiomyopathy (CM) at delivery is increasing in prevalance. The objective of this study was to determine which medical conditions are attributable to this increasing prevalance. Design Population prevalence study from 2000 to 2009. Setting The Nationwide Inpatient Sample (NIS). Sample Pregnant women admitted for delivery were identified in the NIS for the years 2000-2009. Methods Temporal trends in pre-existing medical conditions and in medical and obstetric complications at delivery admissions were determined by linear regression. The change in the prevalence of CM among all pregnant women was compared with the change in the prevalance of CM among pregnant women without pre-existing conditions or complications. Main outcome measure Prevalence of CM. Results The prevalence of CM increased from 0.25 per 1000 deliveries in 2000 to 0.43 per 1000 deliveries in 2009 (P < 0.0001). Women with chronic hypertension had increased odds of developing CM compared with women without chronic hypertension (odds ratio, OR, 13.2; 95% confidence interval, 95% CI, 12.5-13.7). The linear increase in chronic hypertension over the 10-year period was the single identified pre-existing medical condition that explained the increasing prevalence of CM at delivery (P = 0.005 for the differences in slopes for linear trends). Conclusions Pregnant women with chronic hypertenion are at an increased risk for CM at delivery, and the increasing prevalence of chronic hypertension is an important factor associated with the increasing prevalence of CM at the time of delivery. Among women without chronic hypertension, the prevalence of CM at delivery did not change during the time period.

Authors
Grotegut, CA; Kuklina, EV; Anstrom, KJ; Heine, RP; Callaghan, WM; Myers, ER; James, AH
MLA Citation
Grotegut, CA, Kuklina, EV, Anstrom, KJ, Heine, RP, Callaghan, WM, Myers, ER, and James, AH. "Factors associated with the change in prevalence of cardiomyopathy at delivery in the period 2000-2009: A population-based prevalence study." BJOG: An International Journal of Obstetrics and Gynaecology 121.11 (2014): 1386-1394.
Source
scival
Published In
Bjog : An International Journal of Obstetrics & Gynaecology
Volume
121
Issue
11
Publish Date
2014
Start Page
1386
End Page
1394
DOI
10.1111/1471-0528.12726

Outcomes of donor oocyte cycles in assisted reproduction.

Authors
Myers, ER
MLA Citation
Myers, ER. "Outcomes of donor oocyte cycles in assisted reproduction." JAMA 310.22 (December 11, 2013): 2403-2404.
PMID
24135802
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
310
Issue
22
Publish Date
2013
Start Page
2403
End Page
2404
DOI
10.1001/jama.2013.280925

Oral contraceptives and risk of ovarian cancer and breast cancer among high-risk women: a systematic review and meta-analysis.

PURPOSE: To estimate the risks of ovarian cancer and breast cancer associated with oral contraceptive (OC) use among women at elevated risk owing to mutations in BRCA1/2 or a strong family history. METHODS: We searched PubMed, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for studies published 2000 to 2012 that evaluated associations between OC use and breast or ovarian cancer among women who are carriers of a BRCA1/2 mutation or have a family history of breast or ovarian cancer. RESULTS: From 6,476 unique citations, we identified six studies examining ovarian cancer risk in BRCA1/2 mutation carriers and eight studies examining breast cancer risk in BRCA1/2 mutation carriers. For BRCA1/2 mutation carriers combined, meta-analysis showed an inverse association between OC use and ovarian cancer (odds ratio [OR], 0.58; 95% CI, 0.46 to 0.73) and a nonstatistically significant association with breast cancer (OR, 1.21; 95% CI, 0.93 to 1.58). Findings were similar when examining BRCA1 and BRCA2 mutation carriers separately. Data were inadequate to perform meta-analyses examining duration or timing of use. For women with a family history of ovarian or breast cancer, we identified four studies examining risk for ovarian cancer and three for breast cancer, but differences between studies precluded combining the data for meta-analyses, and no overall pattern could be discerned. CONCLUSION: Our analyses suggest that associations between ever use of OCs and ovarian and breast cancer among women who are BRCA1 or BRCA2 mutation carriers are similar to those reported for the general population.

Authors
Moorman, PG; Havrilesky, LJ; Gierisch, JM; Coeytaux, RR; Lowery, WJ; Peragallo Urrutia, R; Dinan, M; McBroom, AJ; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Moorman, PG, Havrilesky, LJ, Gierisch, JM, Coeytaux, RR, Lowery, WJ, Peragallo Urrutia, R, Dinan, M, McBroom, AJ, Hasselblad, V, Sanders, GD, and Myers, ER. "Oral contraceptives and risk of ovarian cancer and breast cancer among high-risk women: a systematic review and meta-analysis." J Clin Oncol 31.33 (November 20, 2013): 4188-4198. (Review)
PMID
24145348
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
31
Issue
33
Publish Date
2013
Start Page
4188
End Page
4198
DOI
10.1200/JCO.2013.48.9021

Oral Contraceptive Pills as Primary Prevention for Ovarian Cancer: A Systematic Review and Meta-analysis Reply

Authors
Havrilesky, LJ; Myers, ER; Thomas, WL
MLA Citation
Havrilesky, LJ, Myers, ER, and Thomas, WL. "Oral Contraceptive Pills as Primary Prevention for Ovarian Cancer: A Systematic Review and Meta-analysis Reply." OBSTETRICS AND GYNECOLOGY 122.5 (November 2013): 1114-1114.
Source
wos-lite
Published In
Obstetrics & Gynecology (Elsevier)
Volume
122
Issue
5
Publish Date
2013
Start Page
1114
End Page
1114

Oral contraceptive use and risk of breast, cervical, colorectal, and endometrial cancers: a systematic review.

Oral contraceptives may influence the risk of certain cancers. As part of the AHRQ Evidence Report, Oral Contraceptive Use for the Primary Prevention of Ovarian Cancer, we conducted a systematic review to estimate associations between oral contraceptive use and breast, cervical, colorectal, and endometrial cancer incidence. We searched PubMed, Embase, and Cochrane Database of Systematic Reviews. Study inclusion criteria were women taking oral contraceptives for contraception or ovarian cancer prevention; includes comparison group with no oral contraceptive use; study reports quantitative associations between oral contraceptive exposure and relevant cancers; controlled study or pooled patient-level meta-analyses; sample size for nonrandomized studies ≥100; peer-reviewed, English-language; published from January 1, 2000 forward. Random-effects meta-analyses were conducted by estimating pooled ORs with 95% confidence intervals (CIs). We included 44 breast, 12 cervical, 11 colorectal, and 9 endometrial cancers studies. Breast cancer incidence was slightly but significantly increased in users (OR, 1.08; CI, 1.00-1.17); results show a higher risk associated with more recent use of oral contraceptives. Risk of cervical cancer was increased with duration of oral contraceptive use in women with human papillomavirus infection; heterogeneity prevented meta-analysis. Colorectal cancer (OR, 0.86; CI, 0.79-0.95) and endometrial cancer incidences (OR, 0.57; CI, 0.43-0.77) were significantly reduced by oral contraceptive use. Compared with never use, ever use of oral contraceptives is significantly associated with decreases in colorectal and endometrial cancers and increases in breast cancers. Although elevated breast cancer risk was small, relatively high incidence of breast cancers means that oral contraceptives may contribute to a substantial number of cases.

Authors
Gierisch, JM; Coeytaux, RR; Urrutia, RP; Havrilesky, LJ; Moorman, PG; Lowery, WJ; Dinan, M; McBroom, AJ; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Gierisch, JM, Coeytaux, RR, Urrutia, RP, Havrilesky, LJ, Moorman, PG, Lowery, WJ, Dinan, M, McBroom, AJ, Hasselblad, V, Sanders, GD, and Myers, ER. "Oral contraceptive use and risk of breast, cervical, colorectal, and endometrial cancers: a systematic review." Cancer Epidemiol Biomarkers Prev 22.11 (November 2013): 1931-1943. (Review)
PMID
24014598
Source
pubmed
Published In
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
Volume
22
Issue
11
Publish Date
2013
Start Page
1931
End Page
1943
DOI
10.1158/1055-9965.EPI-13-0298

In reply.

Authors
Havrilesky, LJ; Myers, ER; Thomas, WL
MLA Citation
Havrilesky, LJ, Myers, ER, and Thomas, WL. "In reply." Obstet Gynecol 122.5 (November 2013): 1114-. (Letter)
PMID
24150023
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
122
Issue
5
Publish Date
2013
Start Page
1114
DOI
10.1097/01.AOG.0000435077.65209.72

Cost effectiveness of alternative strategies for incorporating bevacizumab into the primary treatment of ovarian cancer.

BACKGROUND: The objective of this study was to evaluate the comparative effectiveness of strategies that incorporated bevacizumab into the primary platinum-based treatment of ovarian cancer: 1) no bevacizumab; 2) concurrent and maintenance bevacizumab for all; 3) bevacizumab for suboptimally debulked stage III and stage IV disease (high-risk cohort); and the evaluation of an alternative exploratory strategy of 4) directed bevacizumab therapy based on a predictive test for bevacizumab responsiveness. METHODS: A modified Markov state transition model with a 3-year time horizon that simulated publically available International Collaboration on Ovarian Neoplasms (ICON7) trial outcomes was used to evaluate the cost effectiveness of each strategy. Costs and adverse events were incorporated. An alternative strategy was used to model the impact on overall survival of a genetic-based predictive test. A Monte Carlo simulation simultaneously accounted for uncertainty in key parameters. RESULTS: The incorporation of bevacizumab for high-risk patients had an incremental cost-effectiveness ratio of $168,000 per quality-adjusted life-year (QALY) saved compared with chemotherapy alone and dominated a strategy of giving bevacizumab to all patients with ovarian cancer. Monte Carlo simulation acceptability curves indicated that, at a willingness-to-pay threshold of $200,000 per QALY, the treatment of high-risk women with bevacizumab was the strategy of choice in 84% of simulations. A predictive test had an incremental cost-effectiveness ratio of $129,000 per QALY compared with chemotherapy alone and dominated other bevacizumab treatment strategies. CONCLUSIONS: The selective treatment of women with suboptimal and/or stage IV ovarian cancer was a more cost-effective use of bevacizumab than universal treatment but still did not fall within the limits of common willingness-to-pay thresholds. Continued investigation of potentially cost-effective strategies, such as a predictive test, is necessary to optimize the use of this expensive treatment.

Authors
Barnett, JC; Alvarez Secord, A; Cohn, DE; Leath, CA; Myers, ER; Havrilesky, LJ
MLA Citation
Barnett, JC, Alvarez Secord, A, Cohn, DE, Leath, CA, Myers, ER, and Havrilesky, LJ. "Cost effectiveness of alternative strategies for incorporating bevacizumab into the primary treatment of ovarian cancer." Cancer 119.20 (October 15, 2013): 3653-3661.
PMID
23921967
Source
pubmed
Published In
Cancer
Volume
119
Issue
20
Publish Date
2013
Start Page
3653
End Page
3661
DOI
10.1002/cncr.28283

A Decision Analysis of Primary Radiation Therapy and Androgen Deprivation Therapy Versus Radical Prostatectomy for High-Risk Prostate Cancer

Authors
Dorth, JA; Lee, WR; Myers, ER
MLA Citation
Dorth, JA, Lee, WR, and Myers, ER. "A Decision Analysis of Primary Radiation Therapy and Androgen Deprivation Therapy Versus Radical Prostatectomy for High-Risk Prostate Cancer." October 1, 2013.
Source
wos-lite
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
87
Issue
2
Publish Date
2013
Start Page
S500
End Page
S500

How much is another randomized trial of lymph node dissection in endometrial cancer worth? A value of information analysis.

OBJECTIVE: This study aimed to assess the value of a randomized controlled trial (RCT) of lymph node dissection (LND) at the time of hysterectomy for high-risk subsets of women with endometrial cancer. METHODS: A modified Markov decision model compared routine LND to no LND for women with grade 3 or grades 2-3 endometrial cancer. Inputs were modeled as distributions for Monte Carlo probabilistic sensitivity and value of information (VOI) analyses. Survival without LND was modeled from Surveillance, Epidemiology and End Results program data. A hazard ratio (HR) describing survival in the high-risk group undergoing LND (estimate 0.9, 95% CI 0.6-1.1), adverse event rates, probability and type of adjuvant therapy were modeled from published RCTs. Costs were obtained from national reimbursement data. VOI estimated the value of reducing uncertainty regarding the survival benefit of LND. RESULTS: For grade 3, LND had an incremental cost-effectiveness ratio of $40,183/quality-adjusted life year (QALY) compared to no LND. Acceptability curves revealed considerable uncertainty, with an expected value of perfect information of $4,195 per patient at societal willingness to pay of $50,000/QALY. The estimated value of partial perfect information regarding the HR was $3,702 per patient. Assuming 8,000 individuals annually with grade 3 endometrial cancer in the US, the upper limit of VOI for the HR was $29.6 million annually. For grades 2 and 3 combined, analysis revealed a much lower likelihood of finding LND cost-effective. CONCLUSION: A clinical trial defining the survival effect of LND in women with grade 3 endometrial cancer is a worthwhile use of resources.

Authors
Havrilesky, LJ; Chino, JP; Myers, ER
MLA Citation
Havrilesky, LJ, Chino, JP, and Myers, ER. "How much is another randomized trial of lymph node dissection in endometrial cancer worth? A value of information analysis." Gynecol Oncol 131.1 (October 2013): 140-146.
PMID
23800699
Source
pubmed
Published In
Gynecologic Oncology
Volume
131
Issue
1
Publish Date
2013
Start Page
140
End Page
146
DOI
10.1016/j.ygyno.2013.06.025

GENDER AND INFERTILITY STATUS AFFECT STATED PREFERENCES FOR OUTCOMES OF IVF.

Authors
Shah, AA; Fang, L; Leon, JS; Steward, RG; Price, TM; Myers, ER
MLA Citation
Shah, AA, Fang, L, Leon, JS, Steward, RG, Price, TM, and Myers, ER. "GENDER AND INFERTILITY STATUS AFFECT STATED PREFERENCES FOR OUTCOMES OF IVF." September 2013.
Source
wos-lite
Published In
Fertility and Sterility
Volume
100
Issue
3
Publish Date
2013
Start Page
S411
End Page
S411

FORECASTING THE USE OF ASSISTED REPRODUCTIVE TECHNOLOGY (ART) IN THE UNITED STATES UNTIL 2030

Authors
Yeh, JS; Shah, AA; Myers, ER
MLA Citation
Yeh, JS, Shah, AA, and Myers, ER. "FORECASTING THE USE OF ASSISTED REPRODUCTIVE TECHNOLOGY (ART) IN THE UNITED STATES UNTIL 2030." September 2013.
Source
wos-lite
Published In
Fertility and Sterility
Volume
100
Issue
3
Publish Date
2013
Start Page
S91
End Page
S92

Risk of acute thromboembolic events with oral contraceptive use: a systematic review and meta-analysis.

To estimate the risk of venous thromboembolism, stroke, or myocardial infarction (MI) associated with the use of oral contraceptive pills (OCPs) and to describe how these risks vary by dose or formulation. We searched PubMed, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for studies published from January 1995 through June 2012 that evaluated the association between OCP use and risk of venous thromboembolism, stroke, or MI. We reviewed 6,476 citations. We included English-language, controlled studies with human participants reporting a quantitative association between exposure to OCPs and outcomes of venous thromboembolism, stroke, or MI. Two investigators independently reviewed articles for inclusion or exclusion; discordant decisions were resolved by team review and consensus. Random-effects meta-analysis was used to generate summary odds ratios (ORs). Fifty studies met inclusion criteria. There were no randomized clinical trials. We found threefold increased odds of venous thromboembolism among current compared with noncurrent OCP users (14 studies; OR 2.97, 95% confidence interval [CI] 2.46-3.59). We found twofold increased odds of ischemic stroke (seven studies; OR 1.90, 95% CI 1.24-2.91). There was no evidence of increased risk of hemorrhagic stroke (four studies; OR 1.03, 95% CI 0.71-1.49) or MI (eight studies; OR 1.34, 95% CI 0.87-2.08). Current use of combined OCPs is associated with increased odds of venous thromboembolism and ischemic stroke but not hemorrhagic stroke or MI.

Authors
Peragallo Urrutia, R; Coeytaux, RR; McBroom, AJ; Gierisch, JM; Havrilesky, LJ; Moorman, PG; Lowery, WJ; Dinan, M; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Peragallo Urrutia, R, Coeytaux, RR, McBroom, AJ, Gierisch, JM, Havrilesky, LJ, Moorman, PG, Lowery, WJ, Dinan, M, Hasselblad, V, Sanders, GD, and Myers, ER. "Risk of acute thromboembolic events with oral contraceptive use: a systematic review and meta-analysis." Obstetrics and gynecology 122.2 Pt 1 (August 1, 2013): 380-389. (Review)
Source
scopus
Published In
Obstetrics and Gynecology
Volume
122
Issue
2 Pt 1
Publish Date
2013
Start Page
380
End Page
389

Risk of acute thromboembolic events with oral contraceptive use: a systematic review and meta-analysis.

OBJECTIVE: To estimate the risk of venous thromboembolism, stroke, or myocardial infarction (MI) associated with the use of oral contraceptive pills (OCPs) and to describe how these risks vary by dose or formulation. DATA SOURCES: We searched PubMed, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for studies published from January 1995 through June 2012 that evaluated the association between OCP use and risk of venous thromboembolism, stroke, or MI. METHODS OF STUDY SELECTION: We reviewed 6,476 citations. We included English-language, controlled studies with human participants reporting a quantitative association between exposure to OCPs and outcomes of venous thromboembolism, stroke, or MI. Two investigators independently reviewed articles for inclusion or exclusion; discordant decisions were resolved by team review and consensus. Random-effects meta-analysis was used to generate summary odds ratios (ORs). TABULATION, INTEGRATION, AND RESULTS: Fifty studies met inclusion criteria. There were no randomized clinical trials. We found threefold increased odds of venous thromboembolism among current compared with noncurrent OCP users (14 studies; OR 2.97, 95% confidence interval [CI] 2.46-3.59). We found twofold increased odds of ischemic stroke (seven studies; OR 1.90, 95% CI 1.24-2.91). There was no evidence of increased risk of hemorrhagic stroke (four studies; OR 1.03, 95% CI 0.71-1.49) or MI (eight studies; OR 1.34, 95% CI 0.87-2.08). CONCLUSION: Current use of combined OCPs is associated with increased odds of venous thromboembolism and ischemic stroke but not hemorrhagic stroke or MI.

Authors
Peragallo Urrutia, R; Coeytaux, RR; McBroom, AJ; Gierisch, JM; Havrilesky, LJ; Moorman, PG; Lowery, WJ; Dinan, M; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Peragallo Urrutia, R, Coeytaux, RR, McBroom, AJ, Gierisch, JM, Havrilesky, LJ, Moorman, PG, Lowery, WJ, Dinan, M, Hasselblad, V, Sanders, GD, and Myers, ER. "Risk of acute thromboembolic events with oral contraceptive use: a systematic review and meta-analysis." Obstet Gynecol 122.2 Pt 1 (August 2013): 380-389. (Review)
PMID
23969809
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
122
Issue
2 Pt 1
Publish Date
2013
Start Page
380
End Page
389
DOI
10.1097/AOG.0b013e3182994c43

Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers.

Our goals were to (1) define a set of descriptive health states related to adverse events (AEs) associated with gynecologic cancer treatment with radical surgery and chemoradiation and (2) derive a set of quality of life-related utility scores corresponding to these health states. We developed a list of health states for grade 3/4 AEs related to gynecologic cancer treatment. Using the visual analog scale score and time trade-off (TTO) methods, valuation of each health state was obtained through interviews of 60 volunteers (15 cervical cancer survivors treated with surgery and/or chemoradiation and 45 women without a cancer diagnosis). Health states were ranked by mean/median TTO scores. Wilcoxon rank sum test was used to compare central tendencies related to patient and volunteer characteristics. Patients and volunteers agreed on their preference rankings, with highest preference given to infection (median TTO = 1.0) and thrombosis (median TTO = 0.97). Lowest preference was assigned to radiation proctitis (median TTO = 0.87) and gastrointestinal fistula formation (median TTO = 0.83). Utility scores for the majority of health states were not significantly associated with age, race, parity, patient or volunteer status, history of abnormal Pap smear, stage of cervical cancer diagnosis, or personal experience of a serious treatment-related AE. This study helps establish preferences and quality-of-life utility scores for health states related to toxicities from surgery, radiation, and chemotherapy for gynecologic cancer treatment. Such information can be used to inform medical decision making/counseling and may be applied to future comparative effectiveness models in which radical surgery and/or chemoradiation are considered.

Authors
Jewell, EL; Smrtka, M; Broadwater, G; Valea, F; Davis, DM; Nolte, KC; Valea, R; Myers, ER; Havrilesky, LJ
MLA Citation
Jewell, EL, Smrtka, M, Broadwater, G, Valea, F, Davis, DM, Nolte, KC, Valea, R, Myers, ER, and Havrilesky, LJ. "Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 23.6 (July 1, 2013): 1158-1166.
Source
scopus
Published In
International Journal of Gynecological Cancer
Volume
23
Issue
6
Publish Date
2013
Start Page
1158
End Page
1166

Oral contraceptive pills as primary prevention for ovarian cancer: a systematic review and meta-analysis.

OBJECTIVE: To estimate the overall reduction in ovarian cancer risk associated with the use of oral contraceptive pills (OCPs) and whether reduction in risk is affected by specifics of OCP use, such as formulation or duration of use. DATA SOURCES: We searched PubMed, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for studies published from January 1990 to June 2012, with primary analysis of studies published since January 2000. METHODS OF STUDY SELECTION: We reviewed 6,476 citations. We included English-language controlled studies with human participants reporting a quantitative association between exposure to OCPs (in which the explicit or implicit indication for OCP use was prevention of pregnancy or ovarian cancer) compared with no use of OCPs. Two investigators independently reviewed the title and abstract and full-text of articles for inclusion or exclusion decision; discordant decisions were resolved by team review and consensus. TABULATION, INTEGRATION, AND RESULTS: Fifty-five studies met inclusion criteria. A random-effects meta-analysis of 24 case-control and cohort studies showed significant reduction in ovarian cancer incidence in ever-users compared with never-users (odds ratio 0.73, 95% confidence interval 0.66-0.81). There was a significant duration-response relationship, with reduction in incidence of more than 50% among women using OCPs for 10 or more years. The lifetime reduction in ovarian cancer attributable to the use of OCPs is approximately 0.54% for a number-needed-to-treat of approximately 185 for a use period of 5 years. CONCLUSION: Significant duration-dependent reductions in ovarian cancer incidence in the general population are associated with OCP use.

Authors
Havrilesky, LJ; Moorman, PG; Lowery, WJ; Gierisch, JM; Coeytaux, RR; Urrutia, RP; Dinan, M; McBroom, AJ; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Havrilesky, LJ, Moorman, PG, Lowery, WJ, Gierisch, JM, Coeytaux, RR, Urrutia, RP, Dinan, M, McBroom, AJ, Hasselblad, V, Sanders, GD, and Myers, ER. "Oral contraceptive pills as primary prevention for ovarian cancer: a systematic review and meta-analysis." Obstet Gynecol 122.1 (July 2013): 139-147. (Review)
PMID
23743450
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
122
Issue
1
Publish Date
2013
Start Page
139
End Page
147
DOI
10.1097/AOG.0b013e318291c235

Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers.

OBJECTIVE: Our goals were to (1) define a set of descriptive health states related to adverse events (AEs) associated with gynecologic cancer treatment with radical surgery and chemoradiation and (2) derive a set of quality of life-related utility scores corresponding to these health states. METHODS: We developed a list of health states for grade 3/4 AEs related to gynecologic cancer treatment. Using the visual analog scale score and time trade-off (TTO) methods, valuation of each health state was obtained through interviews of 60 volunteers (15 cervical cancer survivors treated with surgery and/or chemoradiation and 45 women without a cancer diagnosis). Health states were ranked by mean/median TTO scores. Wilcoxon rank sum test was used to compare central tendencies related to patient and volunteer characteristics. RESULTS: Patients and volunteers agreed on their preference rankings, with highest preference given to infection (median TTO = 1.0) and thrombosis (median TTO = 0.97). Lowest preference was assigned to radiation proctitis (median TTO = 0.87) and gastrointestinal fistula formation (median TTO = 0.83). Utility scores for the majority of health states were not significantly associated with age, race, parity, patient or volunteer status, history of abnormal Pap smear, stage of cervical cancer diagnosis, or personal experience of a serious treatment-related AE. CONCLUSIONS: This study helps establish preferences and quality-of-life utility scores for health states related to toxicities from surgery, radiation, and chemotherapy for gynecologic cancer treatment. Such information can be used to inform medical decision making/counseling and may be applied to future comparative effectiveness models in which radical surgery and/or chemoradiation are considered.

Authors
Jewell, EL; Smrtka, M; Broadwater, G; Valea, F; Davis, DM; Nolte, KC; Valea, R; Myers, ER; Havrilesky, LJ
MLA Citation
Jewell, EL, Smrtka, M, Broadwater, G, Valea, F, Davis, DM, Nolte, KC, Valea, R, Myers, ER, and Havrilesky, LJ. "Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers." Int J Gynecol Cancer 23.6 (July 2013): 1158-1166.
PMID
23792609
Source
pubmed
Published In
International Journal of Gynecological Cancer
Volume
23
Issue
6
Publish Date
2013
Start Page
1158
End Page
1166
DOI
10.1097/IGC.0b013e318299e2a6

Age-specific occurrence of HPV16- and HPV18-related cervical cancer.

The age-specific occurrence of cervical cancer related to human papillomavirus (HPV) genotypes HPV16 and HPV18, the two targeted by current HPV vaccines, is not well described. We therefore used data from two large, tissue-based HPV genotyping studies of cervical cancer, one conducted in New Mexico (n = 744) and an International study restricted to cancers (n = 1,729) from Europe, North America, and Australia to represent those regions with widely available cervical cancer screening facilities. HPV results were categorized as HPV16- or HPV18-positive (HPV16/18) versus other HPV genotype. We observed a decreasing proportion of HPV16/18-positive cancers with increasing age in the International study (Ptrend < 0.001) and New Mexico study (Ptrend < 0.001). There was no heterogeneity in the relationship between age of diagnosis and the proportion of HPV16/18-positive cancers between studies (P = 0.8). Combining results from the two studies (n = 2,473), the percentages of HPV16/18-positive cases were 77.0% [95% confidence interval (CI): 75.1%-78.9%] for women less than 65 years old and 62.7% [95% confidence interval (CI): 58.4%-66.9%] for women aged 65 and older (P < 0.001). In women who are under the age of 25 and have been vaccinated before becoming sexually active, the cervical cancer incidence is expected to be approximately 3.5 per million by 2020. HPV vaccination against HPV16/18 may have a greater impact on cervical cancers in women under 65 than in women aged 65 and older. These data will inform the age-specific impact of HPV vaccination and its integration with cervical cancer screening activities.

Authors
de Sanjose, S; Wheeler, CM; Quint, WGV; Hunt, WC; Joste, NE; Alemany, L; Xavier Bosch, F; Retrospective International Survey and HPV Time Trends Study Group, ; Myers, ER; Castle, PE
MLA Citation
de Sanjose, S, Wheeler, CM, Quint, WGV, Hunt, WC, Joste, NE, Alemany, L, Xavier Bosch, F, Retrospective International Survey and HPV Time Trends Study Group, , Myers, ER, and Castle, PE. "Age-specific occurrence of HPV16- and HPV18-related cervical cancer." Cancer Epidemiol Biomarkers Prev 22.7 (July 2013): 1313-1318.
PMID
23632816
Source
pubmed
Published In
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
Volume
22
Issue
7
Publish Date
2013
Start Page
1313
End Page
1318
DOI
10.1158/1055-9965.EPI-13-0053

Oral contraceptive use for the primary prevention of ovarian cancer.

To estimate the overall balance of harms and benefits from the potential use of oral contraceptives (OCs) for the primary prevention of ovarian cancerWe searched PubMed®, Embase®, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for English-language studies published from January 1990 to June 2012 that evaluated the potential benefits (reduction in ovarian, colorectal, and endometrial cancers) and harms (increase in breast and cervical cancer, and vascular complications) of OC use.Two investigators screened each abstract and full-text article for inclusion; the investigators abstracted data, and they performed quality ratings, applicability ratings, and evidence grading. Random-effects models were used to compute summary estimates of effects. A simulation model was used to estimate the effects of OC use on the overall balance of benefits and harms.We reviewed 55 studies relevant to ovarian cancer outcomes, 66 relevant to other cancers, and 50 relevant to vascular events. Ovarian cancer incidence was significantly reduced in OC users (OR [odds ratio], 0.73; 95% CI [confidence interval], 0.66 to 0.81), with greater reductions seen with longer duration of use. Breast cancer incidence was slightly but significantly increased in OC users (OR, 1.08; 95% CI, 1.00 to 1.17), with a significant reduction in risk as time since last use increased. The risk of cervical cancer was significantly increased in women with persistent human papillomavirus infection who used OCs, but heterogeneity prevented a formal meta-analysis. Incidences of both colorectal cancer (OR, 0.86; 95% CI, 0.79 to 0.95) and endometrial cancer (OR, 0.57; 95% CI, 0.43 to 0.76) were significantly reduced by OC use. The risk of vascular events was increased in current OC users compared with nonusers, although the increase in myocardial infarction was not statistically significant. The overall strength of evidence for ovarian cancer prevention was moderate to low, primarily because of the lack of randomized trials and inconsistent reporting of important characteristics of use, such as duration. The simulation model predicted that the combined increase in risk of breast and cervical cancers and vascular events was likely to be equivalent to or greater than the decreased risk in ovarian cancer, although the harm/benefit ratio was much more favorable when protection against endometrial and colorectal cancers was added, resulting in net gains in life expectancy of approximately 1 month.There is insufficient evidence to recommend for or against the use of OCs solely for the primary prevention of ovarian cancer. Although the net effects of the current patterns of OC use likely result in increased life expectancy when other noncontraceptive benefits are included, the harm/benefit ratio for ovarian cancer prevention alone is uncertain, particularly when the potential quality-of-life impact of breast cancer and vascular events are considered.

Authors
Havrilesky, LJ; Gierisch, JM; Moorman, PG; Coeytaux, RR; Urrutia, RP; Lowery, WJ; Dinan, M; McBroom, AJ; Wing, L; Musty, MD; Lallinger, KR; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Havrilesky, LJ, Gierisch, JM, Moorman, PG, Coeytaux, RR, Urrutia, RP, Lowery, WJ, Dinan, M, McBroom, AJ, Wing, L, Musty, MD, Lallinger, KR, Hasselblad, V, Sanders, GD, and Myers, ER. "Oral contraceptive use for the primary prevention of ovarian cancer." Evidence report/technology assessment 212 (June 2013): 1-514.
PMID
24423062
Source
epmc
Published In
Evidence report/technology assessment
Issue
212
Publish Date
2013
Start Page
1
End Page
514

Perinatal implications of motor vehicle accident trauma during pregnancy: identifying populations at risk.

OBJECTIVE: The purpose of this study was to examine the association between restraint use, race, and perinatal outcome after motor vehicle accidents (MVAs) during pregnancy. STUDY DESIGN: The Duke Trauma Registry and medical records were searched for information on pregnant women at >14 weeks' gestation who were involved in an MVA and who received care through the Emergency Department and the Obstetric Units. Between January 1994 and December 31, 2010, 126 women were identified. Variables that were collected included type of trauma, gestational age at presentation, and delivery outcomes. A prognostic study was performed that evaluated the associations between maternal demographics, details of the accident that included restraint use, and maternal treatment that was related to the accident in relationship to perinatal outcome. RESULTS: There was no difference in the mean age or median gravidity or parity by race among pregnant women who were cared for after an MVA. There was no difference in mean age or racial distribution between women who were restrained compared with women who were unrestrained; unrestrained women were more likely to be nulliparous. Unrestrained women were more likely to require nonobstetric surgery that was related to the trauma. The overall rate of placental abruption was 6%. There were 6 intrauterine fetal deaths, 3 each in the unrestrained (25%) and restrained groups (3.5%; P = .018). Airbags deployed in 17 accidents. Among the 7 women with placenta abruption, 4 women (57%) experienced air bag deployment. CONCLUSION: Lack of restraint use during pregnancy is associated with an increased risk of fetal death.

Authors
Luley, T; Fitzpatrick, CB; Grotegut, CA; Hocker, MB; Myers, ER; Brown, HL
MLA Citation
Luley, T, Fitzpatrick, CB, Grotegut, CA, Hocker, MB, Myers, ER, and Brown, HL. "Perinatal implications of motor vehicle accident trauma during pregnancy: identifying populations at risk." Am J Obstet Gynecol 208.6 (June 2013): 466.e1-466.e5.
PMID
23439323
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
208
Issue
6
Publish Date
2013
Start Page
466.e1
End Page
466.e5
DOI
10.1016/j.ajog.2013.02.032

Cost-effectiveness of BRCA1 and BRCA2 mutation testing to target PARP inhibitor use in platinum-sensitive recurrent ovarian cancer.

OBJECTIVES: (1) To determine whether use of a PARP inhibitor or (2) BRCA1/2 mutation testing followed by a PARP inhibitor for test positives is potentially cost-effective for maintenance treatment of platinum-sensitive recurrent high-grade serous ovarian cancer. METHODS: A modified Markov decision analysis compared 3 strategies: (1) observe; (2) olaparib to progression; (3) BRCA1/2 mutation testing; treat mutation carriers with olaparib to progression. Progression-free survival and rates of adverse events were derived from a phase 2 randomized trial. Key assumptions are as follows: (1) 14% of patients harbor a BRCA1/2 mutation; (2) progression-free survival of individuals treated with olaparib is improved for BCRA1/2 carriers compared with noncarriers (estimated hazard ratio, approximately 0.4). Costs derived from national data were assigned to treatments, adverse events, and BRCA1/2 test. Monte Carlo probabilistic sensitivity analysis was performed. RESULTS: Global olaparib was the most effective strategy, followed by BRCA1/2 testing and no olaparib. BRCA1/2 testing had an incremental cost-effectiveness ratio (ICER) of $193,442 per progression-free year of life saved (PF-YLS) compared to no olaparib, whereas global olaparib had an ICER of $234,128 per PF-YLS compared to BRCA1/2 testing. At a 52% lower-than-baseline olaparib cost estimate of $3000 per month, BRCA1/2 testing became potentially cost-effective compared with observation, with an ICER of $100,000 per PF-YLS. When strategy (1) was removed from the analysis, BRCA1/2 testing was the preferred strategy. CONCLUSIONS: The use of maintenance olaparib in women with high-grade serous ovarian cancer is not cost-effective regardless of whether BRCA1/2 testing is used to direct treatment. However, BRCA1/2 testing is a preferred strategy compared to global maintenance olaparib alone.

Authors
Secord, AA; Barnett, JC; Ledermann, JA; Peterson, BL; Myers, ER; Havrilesky, LJ
MLA Citation
Secord, AA, Barnett, JC, Ledermann, JA, Peterson, BL, Myers, ER, and Havrilesky, LJ. "Cost-effectiveness of BRCA1 and BRCA2 mutation testing to target PARP inhibitor use in platinum-sensitive recurrent ovarian cancer." Int J Gynecol Cancer 23.5 (June 2013): 846-852.
PMID
23666017
Source
pubmed
Published In
International Journal of Gynecological Cancer
Volume
23
Issue
5
Publish Date
2013
Start Page
846
End Page
852
DOI
10.1097/IGC.0b013e31829527bd

How Obamacare Will Impact Reproductive Health

Authors
Brezina, PR; Shah, AA; Myers, ER; Huang, A; DeCherney, AH
MLA Citation
Brezina, PR, Shah, AA, Myers, ER, Huang, A, and DeCherney, AH. "How Obamacare Will Impact Reproductive Health." SEMINARS IN REPRODUCTIVE MEDICINE 31.3 (May 2013): 189-197.
PMID
23609149
Source
wos-lite
Published In
Seminars in Reproductive Medicine
Volume
31
Issue
3
Publish Date
2013
Start Page
189
End Page
197
DOI
10.1055/s-0033-1336599

Screening for cervical cancer: a modeling study for the US Preventive Services Task Force.

OBJECTIVE: This study addresses the following 3 questions posed by the US Preventive Services Task Force: (1) at what age should screening for cervical cancer begin; (2) at what age should screening for cervical cancer end; and (3) how do the benefits and potential harms of screening strategies that use human papillomavirus DNA testing in conjunction with cytology (cotesting) compare with those strategies that use cytology only? MATERIALS AND METHODS: A Markov model was updated and used to quantify clinical outcomes (i.e., colposcopies, cancers, and life expectancy) associated with different screening strategies. RESULTS: Screening in the teenaged years is associated with a high number of colposcopies (harms), small differences in cancers detected and, as a result, small gains in life expectancy (benefits). Screening women beginning in the early 20s provides a reasonable balance of the harms and benefits of screening. Among women who have been screened according to the current recommendations for cervical cancer (beginning at age 21 years and conducted every 3 years with cytology), screening beyond 65 years is associated with small additional gains in life expectancy but large increases in colposcopies. For cotesting, a strategy of cytology only conducted every 3 years, followed by cotesting conducted every 5 years (for women ≥30 years), is associated with fewer colposcopies and greater gains in life expectancy compared with screening with cytology only conducted every 3 years. CONCLUSIONS: The results of this modeling study support current US Preventive Services Task Force recommendations for cervical cancer screening.

Authors
Kulasingam, SL; Havrilesky, LJ; Ghebre, R; Myers, ER
MLA Citation
Kulasingam, SL, Havrilesky, LJ, Ghebre, R, and Myers, ER. "Screening for cervical cancer: a modeling study for the US Preventive Services Task Force." J Low Genit Tract Dis 17.2 (April 2013): 193-202.
PMID
23519288
Source
pubmed
Published In
Journal of Lower Genital Tract Disease
Volume
17
Issue
2
Publish Date
2013
Start Page
193
End Page
202
DOI
10.1097/LGT.0b013e3182616241

Comparison of characteristics of fibroids in African American and white women undergoing premenopausal hysterectomy.

OBJECTIVE: To compare pathologic characteristics and epidemiologic risk factors for uterine fibroids in African American and white women undergoing hysterectomy. DESIGN: Cross-sectional analysis of women undergoing premenopausal hysterectomy. SETTING: Two university-associated hospitals in North Carolina. PATIENT(S): African American (n = 225) and white women (n = 135) with fibroid diagnosis. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Data were obtained from an in-person interview and abstracted from operative and pathologic reports. Analysis of variance and multiple linear regression models were used to identify characteristics associated with higher uterine weight, greater number of fibroids, and size of the largest fibroid. RESULT(S): African American women had substantially more fibroids (9.9 vs. 4.5) with a concomitant higher mean uterine weight (477 vs. 267 g). Although African American women had a higher prevalence of established risk factors for fibroids, such as high body mass index (BMI) and hypertension, these factors were not associated with larger uteri or more numerous fibroids. In multiple linear regression models, the only factors statistically significantly associated with higher uterine weight, larger fibroids, and more numerous fibroids were race and nulligravidity. CONCLUSION(S): The presentation of fibroids as measured by uterine size or number of fibroids is more severe in African American women compared with white women. The differences in presentation cannot be explained by racial differences in the prevalence of known risk factors. Additional research is needed on environmental and genetic factors that may increase the risk for fibroids.

Authors
Moorman, PG; Leppert, P; Myers, ER; Wang, F
MLA Citation
Moorman, PG, Leppert, P, Myers, ER, and Wang, F. "Comparison of characteristics of fibroids in African American and white women undergoing premenopausal hysterectomy." Fertil Steril 99.3 (March 1, 2013): 768-776.e1.
PMID
23199610
Source
pubmed
Published In
Fertility and Sterility
Volume
99
Issue
3
Publish Date
2013
Start Page
768
End Page
776.e1
DOI
10.1016/j.fertnstert.2012.10.039

Computer modeling informs study design: vaginal estrogen to prevent mesh erosion after different routes of prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Many clinicians use perioperative vaginal estrogen therapy (estradiol, E(2)) to diminish the risk of mesh erosion after prolapse surgery, though supporting evidence is limited. We assessed the feasibility of a factorial randomized trial comparing mesh erosion rates after vaginal mesh prolapse surgery (VM) versus minimally invasive sacral colpopexy (MISC), with or without adjunct vaginal estrogen therapy. METHODS: A Markov state transition model simulated the probability of 2-year outcomes of visceral injury, mesh erosion, and reoperation after four possible prolapse therapies: VM or MISC, each with or without estrogen therapy (E(2)). We used pooled estimates from a systematic review to generate probability distributions for the following outcomes after each procedure: visceral injury, postoperative mesh erosion, and reoperation for either recurrent prolapse or mesh erosion. Assuming different assumptions for E(2) efficacies (50 and 75 % reduction in erosion rates), Monte Carlo simulations estimated outcomes rates, which were then used to generate sample size estimates for a four-arm factorial trial. RESULTS: While E(2) reduced the risk of mesh erosion for both VM and MISC, absolute reduction was small. Assuming 75 % efficacy, E(2) decreased the risk of mesh erosion for VM from 7.8 to 2.0 % and for MISC from 2.0 to 0.5 %. Total sample sizes ranged from 448 to 1,620, depending on power and E(2) efficacy. CONCLUSIONS: The required sample size for a trial to determine which therapy results in the lowest erosion rates would be prohibitively large. Because this remains an important clinical issue, further study design strategies could include composite outcomes, cost-effectiveness, or value of information analysis.

Authors
Weidner, AC; Wu, JM; Kawasaki, A; Myers, ER
MLA Citation
Weidner, AC, Wu, JM, Kawasaki, A, and Myers, ER. "Computer modeling informs study design: vaginal estrogen to prevent mesh erosion after different routes of prolapse surgery." Int Urogynecol J 24.3 (March 2013): 441-445.
PMID
22801937
Source
pubmed
Published In
International Urogynecology Journal
Volume
24
Issue
3
Publish Date
2013
Start Page
441
End Page
445
DOI
10.1007/s00192-012-1877-x

How much is another randomized trial of lymph node dissection in endometrial cancer worth? A value of information analysis

Objective. This study aimed to assess the value of a randomized controlled trial (RCT) of lymph node dissection (LND) at the time of hysterectomy for high-risk subsets of women with endometrial cancer. Methods. A modified Markov decision model compared routine LND to no LND for women with grade 3 or grades 2-3 endometrial cancer. Inputs were modeled as distributions for Monte Carlo probabilistic sensitivity and value of information (VOI) analyses. Survival without LND was modeled from Surveillance, Epidemiology and End Results program data. A hazard ratio (HR) describing survival in the high-risk group undergoing LND (estimate 0.9, 95% CI 0.6-1.1), adverse event rates, probability and type of adjuvant therapy were modeled from published RCTs. Costs were obtained from national reimbursement data. VOI estimated the value of reducing uncertainty regarding the survival benefit of LND. Results. For grade 3, LND had an incremental cost-effectiveness ratio of $40,183/quality-adjusted life year (QALY) compared to no LND. Acceptability curves revealed considerable uncertainty, with an expected value of perfect information of $4,195 per patient at societal willingness to pay of $50,000/QALY. The estimated value of partial perfect information regarding the HR was $3,702 per patient. Assuming 8,000 individuals annually with grade 3 endometrial cancer in the US, the upper limit of VOI for the HR was $29.6 million annually. For grades 2 and 3 combined, analysis revealed a much lower likelihood of finding LND cost-effective. Conclusion. A clinical trial defining the survival effect of LND in women with grade 3 endometrial cancer is a worthwhile use of resources. © 2013 Elsevier Inc. All rights reserved.

Authors
Havrilesky, LJ; Chino, JP; Myers, ER
MLA Citation
Havrilesky, LJ, Chino, JP, and Myers, ER. "How much is another randomized trial of lymph node dissection in endometrial cancer worth? A value of information analysis." Gynecologic Oncology 131.1 (2013): 140-146.
Source
scival
Published In
Gynecologic Oncology
Volume
131
Issue
1
Publish Date
2013
Start Page
140
End Page
146
DOI
10.1016/j.ygyno.2013.06.025

Cost effectiveness of alternative strategies for incorporating bevacizumab into the primary treatment of ovarian cancer

BACKGROUND The objective of this study was to evaluate the comparative effectiveness of strategies that incorporated bevacizumab into the primary platinum-based treatment of ovarian cancer: 1) no bevacizumab; 2) concurrent and maintenance bevacizumab for all; 3) bevacizumab for suboptimally debulked stage III and stage IV disease (high-risk cohort); and the evaluation of an alternative exploratory strategy of 4) directed bevacizumab therapy based on a predictive test for bevacizumab responsiveness. METHODS A modified Markov state transition model with a 3-year time horizon that simulated publically available International Collaboration on Ovarian Neoplasms (ICON7) trial outcomes was used to evaluate the cost effectiveness of each strategy. Costs and adverse events were incorporated. An alternative strategy was used to model the impact on overall survival of a genetic-based predictive test. A Monte Carlo simulation simultaneously accounted for uncertainty in key parameters. RESULTS The incorporation of bevacizumab for high-risk patients had an incremental cost-effectiveness ratio of 168,000 per quality-adjusted life-year (QALY) saved compared with chemotherapy alone and dominated a strategy of giving bevacizumab to all patients with ovarian cancer. Monte Carlo simulation acceptability curves indicated that, at a willingness-to-pay threshold of 200,000 per QALY, the treatment of high-risk women with bevacizumab was the strategy of choice in 84% of simulations. A predictive test had an incremental cost-effectiveness ratio of 129,000 per QALY compared with chemotherapy alone and dominated other bevacizumab treatment strategies. CONCLUSIONS The selective treatment of women with suboptimal and/or stage IV ovarian cancer was a more cost-effective use of bevacizumab than universal treatment but still did not fall within the limits of common willingness-to-pay thresholds. Continued investigation of potentially cost-effective strategies, such as a predictive test, is necessary to optimize the use of this expensive treatment. Cancer 2013;119:3653-3661. © 2013 American Cancer Society.

Authors
Barnett, JC; Secord, AA; Cohn, DE; II, CAL; Myers, ER; Havrilesky, LJ
MLA Citation
Barnett, JC, Secord, AA, Cohn, DE, II, CAL, Myers, ER, and Havrilesky, LJ. "Cost effectiveness of alternative strategies for incorporating bevacizumab into the primary treatment of ovarian cancer." Cancer 119.20 (2013): 3653-3661.
Source
scival
Published In
Cancer
Volume
119
Issue
20
Publish Date
2013
Start Page
3653
End Page
3661
DOI
10.1002/cncr.28283

Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women

Purpose: Human papillomavirus (HPV) is the causative agent of cervical cancer. Black women are disproportionally diagnosed and have higher mortality from cervical cancer in the United States. Here we describe the prophylactic efficacy and safety of a quadrivalent HPV-6/11/16/18 vaccine in black women. Methods: A total of 700 black women from Latin America, Europe, and North America (aged 16-24 years) received the vaccine or placebo in one of two studies. Analyses focused on the efficacy and safety of the vaccine. Results: Baseline rates of Chlamydia trachomatis infection and history of past pregnancy were more than twice as high in black women compared with the non-black women who were enrolled in these trials. HPV-6/11/16 or 18 DNA was detected in 18% of black women versus 14.6% in non-black women at day 1. For black women, vaccine efficacy against disease caused by HPV-6/11/16/18 was 100% for cervical intraepithelial neoplasia (0 vs. 15 cases; 95% confidence interval, 64.5%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia and condylomata acuminata (0 vs. 17 cases; 95% confidence interval, 69.3%-100%). There were no serious vaccine-related adverse experiences. A similar proportion of pregnancies resulted in live births (75.8% vaccine; 72.7% placebo) and fetal loss (24.2% vaccine; 27.3% placebo). Conclusions: Prophylactic quadrivalent HPV-6/11/16/18 vaccination of young black women demonstrated high efficacy, safety, and tolerability. HPV vaccination has the potential to reduce cervical cancer-related health disparities both in the United States and around the world. © 2013 Society for Adolescent Health and Medicine. All rights reserved.

Authors
Clark, LR; Myers, ER; Huh, W; Joura, EA; Paavonen, J; Perez, G; James, MK; Sings, HL; Haupt, RM; Saah, AJ; Garner, EIO
MLA Citation
Clark, LR, Myers, ER, Huh, W, Joura, EA, Paavonen, J, Perez, G, James, MK, Sings, HL, Haupt, RM, Saah, AJ, and Garner, EIO. "Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women." Journal of Adolescent Health 52.3 (2013): 322-329.
Source
scival
Published In
Journal of Adolescent Health
Volume
52
Issue
3
Publish Date
2013
Start Page
322
End Page
329
DOI
10.1016/j.jadohealth.2012.07.003

Comparison of characteristics of fibroids in African American and white women undergoing premenopausal hysterectomy

Objective: To compare pathologic characteristics and epidemiologic risk factors for uterine fibroids in African American and white women undergoing hysterectomy. Design: Cross-sectional analysis of women undergoing premenopausal hysterectomy. Setting: Two university-associated hospitals in North Carolina. Patient(s): African American (n = 225) and white women (n = 135) with fibroid diagnosis. Intervention(s): None. Main Outcome Measure(s): Data were obtained from an in-person interview and abstracted from operative and pathologic reports. Analysis of variance and multiple linear regression models were used to identify characteristics associated with higher uterine weight, greater number of fibroids, and size of the largest fibroid. Result(s): African American women had substantially more fibroids (9.9 vs. 4.5) with a concomitant higher mean uterine weight (477 vs. 267 g). Although African American women had a higher prevalence of established risk factors for fibroids, such as high body mass index (BMI) and hypertension, these factors were not associated with larger uteri or more numerous fibroids. In multiple linear regression models, the only factors statistically significantly associated with higher uterine weight, larger fibroids, and more numerous fibroids were race and nulligravidity. Conclusion(s): The presentation of fibroids as measured by uterine size or number of fibroids is more severe in African American women compared with white women. The differences in presentation cannot be explained by racial differences in the prevalence of known risk factors. Additional research is needed on environmental and genetic factors that may increase the risk for fibroids. ©2013 by American Society for Reproductive Medicine.

Authors
Moorman, PG; Leppert, P; Myers, ER; Wang, F
MLA Citation
Moorman, PG, Leppert, P, Myers, ER, and Wang, F. "Comparison of characteristics of fibroids in African American and white women undergoing premenopausal hysterectomy." Fertility and Sterility 99.3 (2013): 768-776.e1.
Source
scival
Published In
Fertility and Sterility
Volume
99
Issue
3
Publish Date
2013
Start Page
768
End Page
776.e1
DOI
10.1016/j.fertnstert.2012.10.039

Perinatal implications of motor vehicle accident trauma during pregnancy: Identifying populations at risk

Objective: The purpose of this study was to examine the association between restraint use, race, and perinatal outcome after motor vehicle accidents (MVAs) during pregnancy. Study Design: The Duke Trauma Registry and medical records were searched for information on pregnant women at >14 weeks' gestation who were involved in an MVA and who received care through the Emergency Department and the Obstetric Units. Between January 1994 and December 31, 2010, 126 women were identified. Variables that were collected included type of trauma, gestational age at presentation, and delivery outcomes. A prognostic study was performed that evaluated the associations between maternal demographics, details of the accident that included restraint use, and maternal treatment that was related to the accident in relationship to perinatal outcome. Results: There was no difference in the mean age or median gravidity or parity by race among pregnant women who were cared for after an MVA. There was no difference in mean age or racial distribution between women who were restrained compared with women who were unrestrained; unrestrained women were more likely to be nulliparous. Unrestrained women were more likely to require nonobstetric surgery that was related to the trauma. The overall rate of placental abruption was 6%. There were 6 intrauterine fetal deaths, 3 each in the unrestrained (25%) and restrained groups (3.5%; P =.018). Airbags deployed in 17 accidents. Among the 7 women with placenta abruption, 4 women (57%) experienced air bag deployment. Conclusion: Lack of restraint use during pregnancy is associated with an increased risk of fetal death. © 2013 Mosby, Inc.

Authors
Luley, T; Fitzpatrick, CB; Grotegut, CA; Hocker, MB; Myers, ER; Brown, HL
MLA Citation
Luley, T, Fitzpatrick, CB, Grotegut, CA, Hocker, MB, Myers, ER, and Brown, HL. "Perinatal implications of motor vehicle accident trauma during pregnancy: Identifying populations at risk." American Journal of Obstetrics and Gynecology 208.6 (2013): 466.e1-466.e5.
Source
scival
Published In
American Journal of Obstetrics & Gynecology
Volume
208
Issue
6
Publish Date
2013
Start Page
466.e1
End Page
466.e5
DOI
10.1016/j.ajog.2013.02.032

Oral contraceptive pills as primary prevention for ovarian cancer: A systematic review and meta-analysis

OBJECTIVE:: To estimate the overall reduction in ovarian cancer risk associated with the use of oral contraceptive pills (OCPs) and whether reduction in risk is affected by specifics of OCP use, such as formulation or duration of use. DATA SOURCES:: We searched PubMed, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov for studies published from January 1990 to June 2012, with primary analysis of studies published since January 2000. METHODS OF STUDY SELECTION:: We reviewed 6,476 citations. We included English-language controlled studies with human participants reporting a quantitative association between exposure to OCPs (in which the explicit or implicit indication for OCP use was prevention of pregnancy or ovarian cancer) compared with no use of OCPs. Two investigators independently reviewed the title and abstract and full-text of articles for inclusion or exclusion decision; discordant decisions were resolved by team review and consensus. TABULATION, INTEGRATION, AND RESULTS:: Fifty-five studies met inclusion criteria. A random-effects meta-analysis of 24 case-control and cohort studies showed significant reduction in ovarian cancer incidence in ever-users compared with never-users (odds ratio 0.73, 95% confidence interval 0.66-0.81). There was a significant duration-response relationship, with reduction in incidence of more than 50% among women using OCPs for 10 or more years. The lifetime reduction in ovarian cancer attributable to the use of OCPs is approximately 0.54% for a number-needed-to-treat of approximately 185 for a use period of 5 years. CONCLUSION:: Significant duration-dependent reductions in ovarian cancer incidence in the general population are associated with OCP use. © 2013 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins.

Authors
Havrilesky, LJ; Moorman, PG; Lowery, WJ; Gierisch, JM; Coeytaux, RR; Urrutia, RP; Dinan, M; McBroom, AJ; Hasselblad, V; Sanders, GD; Myers, ER
MLA Citation
Havrilesky, LJ, Moorman, PG, Lowery, WJ, Gierisch, JM, Coeytaux, RR, Urrutia, RP, Dinan, M, McBroom, AJ, Hasselblad, V, Sanders, GD, and Myers, ER. "Oral contraceptive pills as primary prevention for ovarian cancer: A systematic review and meta-analysis." Obstetrics and Gynecology 122.1 (2013): 139-147.
Source
scival
Published In
Obstetrics & Gynecology (Elsevier)
Volume
122
Issue
1
Publish Date
2013
Start Page
139
End Page
147
DOI
10.1097/AOG.0b013e318291c235

A branching process model of ovarian cancer.

Ovarian cancer is usually diagnosed at an advanced stage, rendering the possibility of cure unlikely. To date, no cost-effective screening test has proven effective for reducing mortality. To estimate the window of opportunity for ovarian cancer screening, we develop a branching process model for ovarian cancer growth and progression accounting for three cell populations: Primary (cells in the ovary or fallopian tube), Peritoneal (viable cells in peritoneal fluid), and Metastatic (cells implanted on other intra-abdominal surfaces). Growth and migration parameters were chosen to match results of clinical studies. Using these values, our model predicts a window of opportunity of 2.9 years, indicating that one would have to screen at least every other year to be effective. The model can be used to inform future efforts in designing improved screening and treatment strategies.

Authors
Danesh, K; Durrett, R; Havrilesky, LJ; Myers, E
MLA Citation
Danesh, K, Durrett, R, Havrilesky, LJ, and Myers, E. "A branching process model of ovarian cancer." J Theor Biol 314 (December 7, 2012): 10-15.
PMID
22959913
Source
pubmed
Published In
Journal of Theoretical Biology
Volume
314
Publish Date
2012
Start Page
10
End Page
15
DOI
10.1016/j.jtbi.2012.08.025

How Should "Negative" Laboratory Developed Test Results for Human Papillomavirus Be Verified? Reply

Authors
Myers, ER; Castle, PE; Saslow, D
MLA Citation
Myers, ER, Castle, PE, and Saslow, D. "How Should "Negative" Laboratory Developed Test Results for Human Papillomavirus Be Verified? Reply." AMERICAN JOURNAL OF CLINICAL PATHOLOGY 138.4 (October 2012): 620-622.
Source
wos-lite
Published In
American Journal of Clinical Pathology
Volume
138
Issue
4
Publish Date
2012
Start Page
620
End Page
622

Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treatment of ischemic heart disease: Future research needs prioritization.

BACKGROUND: A recent review evaluated the comparative effectiveness of angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor blockers (ARBs) in patients with or at high risk for stable ischemic heart disease (IHD). The prioritization of future research needs has customarily been an informal process that is not responsive to the needs of all relevant stakeholders. METHODS: As part of the Agency for Healthcare Research and Quality Effective Healthcare Program, the Duke Evidence-Based Practice Center engaged a diverse stakeholder group in 3 exercises designed to prioritize future research needs pertaining to the comparative effectiveness of ACE-I/ARB in patients with stable IHD. RESULTS: Our stakeholders prioritized the following areas of research pertaining to the comparative effectiveness of ACE-I/ARB in stable IHD: (1) strategies to enhance greater evidence-based use, (2) impact of adherence on effectiveness or harms, (3) impact of comorbidities on effectiveness or harms, (4) medication impact on patient quality of life, (5) impact of demographic differences on effectiveness or harms, and (6) medication impact on incidence of new diagnoses. This project also yielded suggestions regarding potential study designs to address these future research needs. CONCLUSIONS: Our stakeholders prioritized research designed to facilitate (1) tailored ACE-I/ARB treatment based on individual patient characteristics and (2) implementation of ACE-I/ARB use among patients most likely to benefit. With respect to suggested study designs, it was felt that analysis of existing data would sufficiently address many of the top-tier future research needs (FRNs).

Authors
Crowley, MJ; Powers, BJ; Myers, ER; McBroom, AJ; Sanders, GD
MLA Citation
Crowley, MJ, Powers, BJ, Myers, ER, McBroom, AJ, and Sanders, GD. "Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treatment of ischemic heart disease: Future research needs prioritization." Am Heart J 163.5 (May 2012): 777-782.e8. (Review)
PMID
22607854
Source
pubmed
Published In
American Heart Journal
Volume
163
Issue
5
Publish Date
2012
Start Page
777
End Page
782.e8
DOI
10.1016/j.ahj.2012.02.016

Cost-effectiveness of combination versus sequential docetaxel and carboplatin for the treatment of platinum-sensitive, recurrent ovarian cancer.

BACKGROUND: In a randomized controlled trial (RCT) of patients with recurrent, platinum-sensitive ovarian cancer, the combination weekly docetaxel and carboplatin was associated a with progression-free survival (PFS) of 13.7 months compared with 8.4 months for sequential, single-agent docetaxel followed by carboplatin. The objective of the current study was to construct a cost-utility model to compare these 2 regimens with the incorporation of prospectively collected quality-of-life (QoL) data. METHODS: An RCT of concurrent docetaxel and carboplatin (cDC) versus docetaxel followed by carboplatin (sequential docetaxel and carboplatin [sDC]) was the basis for a Markov decision model, and the primary effectiveness outcome was PFS. Costs were estimated using US dollars based on Medicare reimbursements for chemotherapy regimens, bone marrow support, and management of adverse events. QoL data obtained using the Functional Assessment of Cancer Therapy-General questionnaire were converted to utilities. Costs and incremental cost-effectiveness ratios (ICERs) were reported in US dollars per quality-adjusted life year (QALY). Extensive 1-way sensitivity analyses and a Monte Carlo probabilistic sensitivity analysis were performed. RESULTS: The least expensive strategy was sDC, which cost an average of $20,381, compared with cDC, which cost an average of $25,122. cDC had an ICER of $25,239 per QALY compared with sDC. cDC remained cost-effective, with an ICER <$50,000 per QALY, over a range of costs and estimates. In Monte Carlo sensitivity analysis using a $50,000 per QALY willingness-to-pay threshold, cDC was either dominant or cost-effective with an ICER <$50,000 per QALY in 83% of simulations. CONCLUSIONS: Combined weekly cDC appeared to be cost-effective compared with sDC as treatment strategy for patients with platinum-sensitive ovarian cancer, even when accounting for slightly lower QoL during treatment.

Authors
Havrilesky, LJ; Pokrzywinski, R; Revicki, D; Higgins, RV; Nycum, LR; Kohler, MF; Berchuck, A; Myers, ER; Secord, AA
MLA Citation
Havrilesky, LJ, Pokrzywinski, R, Revicki, D, Higgins, RV, Nycum, LR, Kohler, MF, Berchuck, A, Myers, ER, and Secord, AA. "Cost-effectiveness of combination versus sequential docetaxel and carboplatin for the treatment of platinum-sensitive, recurrent ovarian cancer." Cancer 118.2 (January 15, 2012): 386-391.
PMID
21598242
Source
pubmed
Published In
Cancer
Volume
118
Issue
2
Publish Date
2012
Start Page
386
End Page
391
DOI
10.1002/cncr.26199

High throughput, cell type-specific analysis of key proteins in human endometrial biopsies of women from fertile and infertile couples

Background Although histological dating of endometrial biopsies provides little help for prediction or diagnosis of infertility, analysis of individual endometrial proteins, proteomic profiling and transcriptome analysis have suggested several biomarkers with altered expression arising from intrinsic abnormalities, inadequate stimulation by or in response to gonadal steroids or altered function due to systemic disorders. The objective of this study was to delineate the developmental dynamics of potentially important proteins in the secretory phase of the menstrual cycle, utilizing a collection of endometrial biopsies from women of fertile (n 89) and infertile (n 89) couples.Methods AND RESULTSProgesterone receptor-B (PGR-B), leukemia inhibitory factor, glycodelin/progestagen-associated endometrial protein (PAEP), homeobox A10, heparin-binding EGF-like growth factor, calcitonin and chemokine ligand 14 (CXCL14) were measured using a high-throughput, quantitative immunohistochemical method. Significant cyclic and tissue-specific regulation was documented for each protein, as well as their dysregulation in women of infertile couples. Infertile patients demonstrated a delay early in the secretory phase in the decline of PGR-B (P < 0.05) and premature mid-secretory increases in PAEP (P < 0.05) and CXCL14 (P < 0.05), suggesting that the implantation interval could be closing early. Correlation analysis identified potential interactions among certain proteins that were disrupted by infertility. Conclusions This approach overcomes the limitations of a small sample number. Protein expression and localization provided important insights into the potential roles of these proteins in normal and pathological development of the endometrium that is not attainable from transcriptome analysis, establishing a basis for biomarker, diagnostic and targeted drug development for women with infertility. © 2012 The Author.

Authors
Leach, RE; Jessmon, P; Coutifaris, C; Kruger, M; Myers, ER; Ali-Fehmi, R; Carson, SA; Legro, RS; Schlaff, WD; Carr, BR; Steinkampf, MP; Silva, S; Leppert, PC; Giudice, L; Diamond, MP; Armant, DR
MLA Citation
Leach, RE, Jessmon, P, Coutifaris, C, Kruger, M, Myers, ER, Ali-Fehmi, R, Carson, SA, Legro, RS, Schlaff, WD, Carr, BR, Steinkampf, MP, Silva, S, Leppert, PC, Giudice, L, Diamond, MP, and Armant, DR. "High throughput, cell type-specific analysis of key proteins in human endometrial biopsies of women from fertile and infertile couples." Human Reproduction 27.3 (2012): 814-828.
PMID
22215622
Source
scival
Published In
Human Reproduction
Volume
27
Issue
3
Publish Date
2012
Start Page
814
End Page
828
DOI
10.1093/humrep/der436

American cancer society, american society for colposcopy and cervical pathology, and american society for clinical pathology screening guidelines for the prevention and early detection of cervical cancer

An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from six working groups, and a recent symposium co-sponsored by the ACS, American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP), which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (e.g., management of screen positives and screening interval for screen negatives) of women after screening, age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16/18 infections. © 2012, American Society for Colposcopy and Cervical Pathology.

Authors
Saslow, D; Solomon, D; Lawson, HW; Killackey, M; Kulasingam, SL; Cain, JM; Garcia, FAR; Moriarty, AT; Waxman, AG; Wilbur, DC; Wentzensen, N; Downs, LS; Spitzer, M; Moscicki, A-B; Franco, EL; Stoler, MH; Schiffman, M; Castle, PE; Myers, ER
MLA Citation
Saslow, D, Solomon, D, Lawson, HW, Killackey, M, Kulasingam, SL, Cain, JM, Garcia, FAR, Moriarty, AT, Waxman, AG, Wilbur, DC, Wentzensen, N, Downs, LS, Spitzer, M, Moscicki, A-B, Franco, EL, Stoler, MH, Schiffman, M, Castle, PE, and Myers, ER. "American cancer society, american society for colposcopy and cervical pathology, and american society for clinical pathology screening guidelines for the prevention and early detection of cervical cancer." Journal of Lower Genital Tract Disease 16.3 (2012): 175-204.
PMID
22418039
Source
scival
Published In
Journal of Lower Genital Tract Disease
Volume
16
Issue
3
Publish Date
2012
Start Page
175
End Page
204
DOI
10.1097/LGT.0b013e31824ca9d5

Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome

Authors
Diamond, MP; Kruger, M; Santoro, N; Zhang, H; Casson, P; Schlaff, W; Coutifaris, C; Brzyski, R; Christman, G; Carr, BR; McGovern, PG; Cataldo, NA; Steinkampf, MP; Gosman, GG; Nestler, JE; Carson, S; Myers, EE; Eisenberg, E; Legro, RS
MLA Citation
Diamond, MP, Kruger, M, Santoro, N, Zhang, H, Casson, P, Schlaff, W, Coutifaris, C, Brzyski, R, Christman, G, Carr, BR, McGovern, PG, Cataldo, NA, Steinkampf, MP, Gosman, GG, Nestler, JE, Carson, S, Myers, EE, Eisenberg, E, and Legro, RS. "Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome." Obstetrical and Gynecological Survey 67.9 (2012): 548-549.
Source
scival
Published In
Obstetrical and Gynecological Survey
Volume
67
Issue
9
Publish Date
2012
Start Page
548
End Page
549
DOI
10.1097/01.ogx.0000421452.19985.8f

High prevalence of cervical squamous intraepithelial lesions in women on antiretroviral therapy in Cameroon: Is targeted screening feasible?

Background: Cervical cancer is the most common cancer in women in low-income countries. Although cervical cancer incidence and mortality is higher in HIV-positive women, resource limitations restrict the implementation of systematic screening programs in these women. We explored the potential for targeted screening by assessing the prevalence, severity and predictors of cervical squamous intra-epithelial lesions (SILs) in HIV-positive women in Cameroon. Methods and findings: We conducted a cross-sectional study of women on antiretroviral therapy in Cameroon. Socio-demographic, behavioral, and clinical information was obtained from eligible women. Cervical exfoliated cells were then collected, a conventional cytology performed and epithelial lesions classified according to the Bethesda 2001 system. A total of 282 women, aged 19-68 years, were enrolled in this study. The median CD4 count was 179 cells/microliter (interquartile range: 100-271). SILs were detected in 43.5% of the 276 women with satisfactory samples: including atypical squamous cells of unknown significance (ASCUS) 0.7%, low-grade SIL (LSIL) 25.0%, atypical squamous cells, cannot exclude high grade lesions (ASC-H) 14.5%, and high-grade SIL (HSIL) 3.3%. None of the demographic or clinical characteristics considered significantly predicted the presence of any SILs or the presence of severe lesions requiring colposcopy. Conclusion: The prevalence of SIL in women on antiretroviral therapy in Cameroon was high underscoring the need for screening and care in this population. In the absence of any accurate demographic or clinical predictor of SIL, targeted screening does not seem feasible. Alternative affordable screening options need to be explored. © 2011 Elsevier Ltd.

Authors
Atashili, J; Adimora, AA; Ndumbe, PM; Ikomey, GM; Rinas, AC; Myers, E; Eron, J; Smith, JS; Miller, WC
MLA Citation
Atashili, J, Adimora, AA, Ndumbe, PM, Ikomey, GM, Rinas, AC, Myers, E, Eron, J, Smith, JS, and Miller, WC. "High prevalence of cervical squamous intraepithelial lesions in women on antiretroviral therapy in Cameroon: Is targeted screening feasible?." Cancer Epidemiology 36.3 (2012): 263-269.
PMID
22047636
Source
scival
Published In
Cancer Epidemiology: the international journal of cancer epidemiology, detection and prevention
Volume
36
Issue
3
Publish Date
2012
Start Page
263
End Page
269
DOI
10.1016/j.canep.2011.10.003

Altering hirsutism through ovulation induction in women with polycystic ovary syndrome

Objective: Many women with polycystic ovary syndrome (PCOS) experience infertility and hirsutism and often seek treatment for both concurrently. We investigated whether women who ovulate in response to treatment with clomiphene citrate, metformin, or both would have greater improvement in hirsutism compared with those who did not ovulate. Methods: This is a secondary analysis evaluating the change in Ferriman-Gallwey score for the hirsute women (n=505 [80.7%]) from the Pregnancy in Polycystic Ovary Syndrome I study. This was a prospective, randomized, doubled-blind trial of 626 women with PCOS and infertility recruited from 12 university sites. They were treated with clomiphene citrate, metformin, or both (combination) for up to six cycles, and hirsutism evaluators were blinded to group assignment. Results: There was a significant decrease in the Ferriman-Gallwey score between baseline and completion of the study in each of the three individual groups (clomiphene citrate, P=.024; metformin, P=.005; combination, P<.001). There was no significant difference in the degree to which the hirsutism score changed when comparing the three groups (P=.44). The change in hirsutism was not associated with the duration of treatment or with the presence or absence of ovulation. Conclusion: In infertile hirsute women with PCOS, treatment with clomiphene citrate, metformin, or both for up to six cycles does not alter hirsutism. Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00068861. © 2012 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins.

Authors
Roth, LW; Huang, H; Legro, RS; Diamond, MP; Coutifaris, C; Carson, SA; Steinkampf, MP; Carr, BR; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Myers, ER; Zhang, H; Schlaff, WD
MLA Citation
Roth, LW, Huang, H, Legro, RS, Diamond, MP, Coutifaris, C, Carson, SA, Steinkampf, MP, Carr, BR, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Myers, ER, Zhang, H, and Schlaff, WD. "Altering hirsutism through ovulation induction in women with polycystic ovary syndrome." Obstetrics and Gynecology 119.6 (2012): 1151-1156.
PMID
22617579
Source
scival
Published In
Obstetrics & Gynecology (Elsevier)
Volume
119
Issue
6
Publish Date
2012
Start Page
1151
End Page
1156
DOI
10.1097/AOG.0b013e31825618fb

American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer

An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from 6 working groups, and a recent symposium cosponsored by the ACS, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology, which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (eg, the management of screen positives and screening intervals for screen negatives) of women after screening, the age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections. CA Cancer J Clin 2012. © 2012 American Cancer Society. Copyright © 2012 American Cancer Society, Inc.

Authors
Saslow, D; Solomon, D; Lawson, HW; Killackey, M; Kulasingam, SL; Cain, J; Garcia, FAR; Moriarty, AT; Waxman, AG; Wilbur, DC; Wentzensen, N; Jr, LSD; Spitzer, M; Moscicki, A-B; Franco, EL; Stoler, MH; Schiffman, M; Castle, PE; Myers, ER
MLA Citation
Saslow, D, Solomon, D, Lawson, HW, Killackey, M, Kulasingam, SL, Cain, J, Garcia, FAR, Moriarty, AT, Waxman, AG, Wilbur, DC, Wentzensen, N, Jr, LSD, Spitzer, M, Moscicki, A-B, Franco, EL, Stoler, MH, Schiffman, M, Castle, PE, and Myers, ER. "American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer." CA Cancer Journal for Clinicians 62.3 (2012): 147-172.
PMID
22422631
Source
scival
Published In
Ca: A Cancer Journal for Clinicians
Volume
62
Issue
3
Publish Date
2012
Start Page
147
End Page
172
DOI
10.3322/caac.21139

American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer

An update to the American Cancer Society (ACS) guideline regarding screening for the early detection of cervical precancerous lesions and cancer is presented. The guidelines are based on a systematic evidence review, contributions from 6 working groups, and a recent symposium cosponsored by the ACS, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology, which was attended by 25 organizations. The new screening recommendations address age-appropriate screening strategies, including the use of cytology and high-risk human papillomavirus (HPV) testing, follow-up (eg, the management of screen positives and screening intervals for screen negatives) of women after screening, the age at which to exit screening, future considerations regarding HPV testing alone as a primary screening approach, and screening strategies for women vaccinated against HPV16 and HPV18 infections. Cervical cancer screening has successfully decreased cervical cancer incidence and mortality. The American Cancer Society (ACS) guideline for the early detection of cervical cancer was last reviewed and updated in 2002; for the first time, those recommendations incorporated human papillomavirus (HPV) DNA testing.1 Since that time, numerous studies have been published that support changes to recommended age-appropriate screening as well as the management of abnormal screening results, as summarized in Table 1. Copyright© by the American Society for Clinical Pathology.

Authors
Saslow, D; Solomon, D; Lawson, HW; Killackey, M; Kulasingam, SL; Cain, J; Garcia, FAR; Moriarty, AT; Waxman, AG; Wilbur, DC; Wentzensen, N; Jr, LSD; Spitzer, M; Moscicki, A-B; Franco, EL; Stoler, MH; Schiffman, M; Castle, PE; Myers, ER
MLA Citation
Saslow, D, Solomon, D, Lawson, HW, Killackey, M, Kulasingam, SL, Cain, J, Garcia, FAR, Moriarty, AT, Waxman, AG, Wilbur, DC, Wentzensen, N, Jr, LSD, Spitzer, M, Moscicki, A-B, Franco, EL, Stoler, MH, Schiffman, M, Castle, PE, and Myers, ER. "American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer." American Journal of Clinical Pathology 137.4 (2012): 516-542.
PMID
22431528
Source
scival
Published In
American Journal of Clinical Pathology
Volume
137
Issue
4
Publish Date
2012
Start Page
516
End Page
542
DOI
10.1309/AJCPTGD94EVRSJCG

Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome

OBJECTIVE:: To estimate whether progestin-induced endometrial shedding, before ovulation induction with clomiphene citrate, metformin, or a combination of both, affects ovulation, conception, and live birth rates in women with polycystic ovary syndrome (PCOS). METHODS:: A secondary analysis of the data from 626 women with PCOS from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network trial was performed. Women had been randomized to up to six cycles of clomiphene citrate alone, metformin alone, or clomiphene citrate plus metformin. Women were assessed for occurrence of ovulation, conception, and live birth in relation to prior bleeding episodes (after either ovulation or exogenous progestin-induced withdrawal bleed). RESULTS:: Although ovulation rates were higher in cycles preceded by spontaneous endometrial shedding than after anovulatory cycles (with or without prior progestin withdrawal), both conception and live birth rates were significantly higher after anovulatory cycles without progestin-induced withdrawal bleeding (live births per cycle: spontaneous menses 2.2%; anovulatory with progestin withdrawal 1.6%; anovulatory without progestin withdrawal 5.3%; P<.001). The difference was more marked when rate was calculated per ovulation (live births per ovulation: spontaneous menses 3.0%; anovulatory with progestin withdrawal 5.4%; anovulatory without progestin withdrawal 19.7%; P<.001). CONCLUSION:: Conception and live birth rates are lower in women with PCOS after a spontaneous menses or progestin-induced withdrawal bleeding as compared with anovulatory cycles without progestin withdrawal. The common clinical practice of inducing endometrial shedding with progestin before ovarian stimulation may have an adverse effect on rates of conception and live birth in anovulatory women with PCOS. Copyright © 2012 American College of Obstetricians and Gynecologists.

Authors
Diamond, MP; Kruger, M; Santoro, N; Zhang, H; Casson, P; Schlaff, W; Coutifaris, C; Brzyski, R; Christman, G; Carr, BR; McGovern, PG; Cataldo, NA; Steinkampf, MP; Gosman, GG; Nestler, JE; Carson, S; Myers, EE; Eisenberg, E; Legro, RS
MLA Citation
Diamond, MP, Kruger, M, Santoro, N, Zhang, H, Casson, P, Schlaff, W, Coutifaris, C, Brzyski, R, Christman, G, Carr, BR, McGovern, PG, Cataldo, NA, Steinkampf, MP, Gosman, GG, Nestler, JE, Carson, S, Myers, EE, Eisenberg, E, and Legro, RS. "Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome." Obstetrics and Gynecology 119.5 (2012): 902-908.
PMID
22525900
Source
scival
Published In
Obstetrics & Gynecology (Elsevier)
Volume
119
Issue
5
Publish Date
2012
Start Page
902
End Page
908
DOI
10.1097/AOG.0b013e31824da35c

Clinical Trial Experience With Prophylactic Human Papillomavirus 6/11/16/18 Vaccine in Young Black Women

Purpose: Human papillomavirus (HPV) is the causative agent of cervical cancer. Black women are disproportionally diagnosed and have higher mortality from cervical cancer in the United States. Here we describe the prophylactic efficacy and safety of a quadrivalent HPV-6/11/16/18 vaccine in black women. Methods: A total of 700 black women from Latin America, Europe, and North America (aged 16-24 years) received the vaccine or placebo in one of two studies. Analyses focused on the efficacy and safety of the vaccine. Results: Baseline rates of Chlamydia trachomatis infection and history of past pregnancy were more than twice as high in black women compared with the non-black women who were enrolled in these trials. HPV-6/11/16 or 18 DNA was detected in 18% of black women versus 14.6% in non-black women at day 1. For black women, vaccine efficacy against disease caused by HPV-6/11/16/18 was 100% for cervical intraepithelial neoplasia (0 vs. 15 cases; 95% confidence interval, 64.5%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia and condylomata acuminata (0 vs. 17 cases; 95% confidence interval, 69.3%-100%). There were no serious vaccine-related adverse experiences. A similar proportion of pregnancies resulted in live births (75.8% vaccine; 72.7% placebo) and fetal loss (24.2% vaccine; 27.3% placebo). Conclusions: Prophylactic quadrivalent HPV-6/11/16/18 vaccination of young black women demonstrated high efficacy, safety, and tolerability. HPV vaccination has the potential to reduce cervical cancer-related health disparities both in the United States and around the world. © 2012 Society for Adolescent Health and Medicine.

Authors
Clark, LR; Myers, ER; Huh, W; Joura, EA; Paavonen, J; Perez, G; James, MK; Sings, HL; Haupt, RM; Saah, AJ; al, E
MLA Citation
Clark, LR, Myers, ER, Huh, W, Joura, EA, Paavonen, J, Perez, G, James, MK, Sings, HL, Haupt, RM, Saah, AJ, and al, E. "Clinical Trial Experience With Prophylactic Human Papillomavirus 6/11/16/18 Vaccine in Young Black Women." Journal of Adolescent Health (2012).
PMID
23299013
Source
scival
Published In
Journal of Adolescent Health
Publish Date
2012
DOI
10.1016/j.jadohealth.2012.07.003

Age trends in the prevalence of cervical squamous intraepithelial lesions among HIV-positive women in Cameroon: A cross-sectional study

Background: Cervical squamous intra-epithelial lesions (SIL) are more frequent in HIV-positive women overall. However the appropriate age at which to begin and end cervical cancer screening for early detection of lesions in HIV-positive women is not clear. We assessed the age-specific prevalence of any SIL and SIL requiring colposcopy in HIV-positive women in Cameroon. Methods. We enrolled, interviewed and conducted conventional cervical cytology in 282 women, aged 19-68 years, initiating antiretroviral therapy in three clinics in Cameroon. In bivariable analyses, the crude relationship between age and the presence of lesions was assessed using locally weighted regression (LOWESS) methods. In multivariate analyses, generalized linear models with prevalence as the outcome, an identity link and a binomial distribution, were used to estimate prevalence differences. Bias analyses were conducted to assess the potential effect of inaccuracies in cytology. Results: SIL were detected in 43.5% of the 276 women with satisfactory samples, 17.8% of whom had ASC-H/HSIL. On average, women aged 26 to 59 tended to have a slightly higher prevalence of any SIL than other women (Prevalence difference PD: 6.5%; 95%CI: -11.4, 24.4%). This PD was a function of CD4 count (heterogeneity test p-value =0.09): amongst patients with CD4 counts less than 200cells/uL, the prevalence was higher in patients aged 26-59, while there was essentially no difference amongst women with CD4 counts greater than 200 cells/uL. ASC-H/HSIL were present in women as young as 19 and as old as 62. Overall the prevalence of ASC-H/HSIL increased by 0.7% (95%CI: -3.8%, 5.1%) per decade increase in age. Conclusion: Both severe and less severe lesions were prevalent at all ages suggesting little utility of age-targeted screening among HIV-positive women. Nevertheless, the long-term evolution of these lesions needs to be assessed in prospective studies. © 2012 Atashili et al.; licensee BioMed Central Ltd.

Authors
Atashili, J; Miller, WC; Smith, JS; Ndumbe, PM; Ikomey, GM; Eron, J; Rinas, AC; Myers, E; Adimora, AA
MLA Citation
Atashili, J, Miller, WC, Smith, JS, Ndumbe, PM, Ikomey, GM, Eron, J, Rinas, AC, Myers, E, and Adimora, AA. "Age trends in the prevalence of cervical squamous intraepithelial lesions among HIV-positive women in Cameroon: A cross-sectional study." BMC Research Notes 5 (2012).
PMID
23106940
Source
scival
Published In
BMC Research Notes
Volume
5
Publish Date
2012
DOI
10.1186/1756-0500-5-590

In reply

Authors
Myers, E; Castle, P; Saslow, D
MLA Citation
Myers, E, Castle, P, and Saslow, D. "In reply." Journal of Lower Genital Tract Disease 16.4 (2012): 483-485.
Source
scival
Published In
Journal of Lower Genital Tract Disease
Volume
16
Issue
4
Publish Date
2012
Start Page
483
End Page
485
DOI
10.1097/LGT.0b013e31825c041c

Effect of hysterectomy with ovarian preservation on ovarian function.

OBJECTIVE: To prospectively estimate the risk for earlier ovarian failure among women undergoing hysterectomy with ovarian preservation, as compared with women of similar age without hysterectomy. METHODS: A prospective cohort study was conducted among women aged 30 to 47 years undergoing hysterectomy without bilateral oophorectomy (n=406) and women with intact uteri (n=465). Blood samples and questionnaire data were obtained at baseline and annually for up to 5 years. Hazard ratios (HR) for ovarian failure, defined as follicle-stimulating hormone levels 40 international units/L or higher, were calculated using Cox proportional hazards models. RESULTS: Ovarian failure occurred among 60 of the women with hysterectomy and 46 of the women in the control group. Women undergoing hysterectomy were at nearly a twofold increased risk for ovarian failure as compared with women with intact uteri (HR 1.92, 95% confidence interval [CI] 1.29-2.86). The proportional hazards model further estimated that 14.8% of women with hysterectomies experienced ovarian failure after 4 years of follow-up compared with 8.0% of the women in the control group. Risk for ovarian failure was greater for women who had a unilateral oophorectomy along with their hysterectomy (HR 2.93, 95% CI 1.57-5.49), but also it was significantly increased for women who retained both ovaries (HR 1.74, 95% CI 1.14-2.65). CONCLUSION: Increased risk of earlier ovarian failure is a possible consequence of premenopausal hysterectomy. Although it is unresolved whether it is the surgery itself or the underlying condition leading to hysterectomy that is the cause of earlier ovarian failure, physicians and patients should take into account this possible sequela when considering options for treatment of benign conditions of the uterus. LEVEL OF EVIDENCE: II.

Authors
Moorman, PG; Myers, ER; Schildkraut, JM; Iversen, ES; Wang, F; Warren, N
MLA Citation
Moorman, PG, Myers, ER, Schildkraut, JM, Iversen, ES, Wang, F, and Warren, N. "Effect of hysterectomy with ovarian preservation on ovarian function." Obstet Gynecol 118.6 (December 2011): 1271-1279.
PMID
22067716
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
118
Issue
6
Publish Date
2011
Start Page
1271
End Page
1279
DOI
10.1097/AOG.0b013e318236fd12

Preoperative screening strategies for bacterial vaginosis prior to elective hysterectomy: a cost comparison study.

OBJECTIVE: The purpose of this study is to compare costs of 3 strategies for women undergoing hysterectomy: (1) test all patients for bacterial vaginosis; treat if positive; (2) treat all patients for bacterial vaginosis; (3) neither test nor treat patients for bacterial vaginosis. For comparison purposes, a fourth strategy is examined: (4) no surgical site infection prophylaxis or bacterial vaginosis treatment. STUDY DESIGN: A cost minimization model was created using estimates obtained from the published literature, Medicare reimbursement data, and wholesale drug costs. RESULTS: In the base case, the optimal strategy was to treat all patients for bacterial vaginosis, with a cuff infection rate of 4.0% and mean cost of $593. The "test all patients for bacterial vaginosis; treat if positive" strategy was also inexpensive, with a mean cost of $623 and 4.2% cuff infection rate. "Neither test nor treat patients for bacterial vaginosis" and "no surgical site infection prophylaxis or bacterial vaginosis treatment" were more expensive and less effective than other strategies. CONCLUSION: This model suggests that consideration should be given to adding metronidazole to standard surgical site infection prophylaxis before hysterectomy.

Authors
McElligott, KA; Havrilesky, LJ; Myers, ER
MLA Citation
McElligott, KA, Havrilesky, LJ, and Myers, ER. "Preoperative screening strategies for bacterial vaginosis prior to elective hysterectomy: a cost comparison study." Am J Obstet Gynecol 205.5 (November 2011): 500.e1-500.e7.
PMID
21944221
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
205
Issue
5
Publish Date
2011
Start Page
500.e1
End Page
500.e7
DOI
10.1016/j.ajog.2011.07.012

Cost comparison of strategies for the management of venous thromboembolic event risk following laparotomy for ovarian cancer.

OBJECTIVE: To evaluate the costs and effectiveness of thromboprophylaxis strategies following laparotomy for ovarian cancer. METHODS: We constructed a decision model to evaluate six strategies for management of postoperative venous thromboembolism (VTE) risk: (1) no thromboprophylaxis; (2) inpatient sequential compression device (SCD); (3) inpatient unfractionated heparin (UFH) 5000 units TID; (4) inpatient low molecular weight heparin (LMWH) 40 mg daily; (5) UFH 5000 units TID×1 month; (6) LMWH 40 mg daily×1 month. Rates of VTE, heparin-induced thrombocytopenia, and significant bleeding for each strategy were obtained from published literature. Costs were based on institutional charges or obtained from the Agency for Healthcare Research and Quality Nationwide Inpatient Sample database for 2008 and average wholesale pricing. Sensitivity analyses were performed to account for uncertainty in estimates. RESULTS: In the base case, UFH×1 month was the least expensive (mean cost $1611) and most effective (VTE risk 1.9%) strategy. LMWH×1 month was equally effective but more expensive ($2197). Inpatient UFH, inpatient LMWH, and SCDs were less effective and more expensive than UFH×1 month. In the sensitivity analysis, cost rankings remained unchanged unless the baseline probability of VTE was assumed <6.5%, the cost of VTE treatment was <$20,000, or the cost of bleeding was >$4500. LMWH×1 month became least expensive when cost was decreased 38%. CONCLUSION: Based on current evidence, extended prophylaxis with UFH is the least expensive and most effective strategy to prevent postoperative VTE following laparotomy for ovarian cancer.

Authors
Teoh, D; Berchuck, A; Alvarez Secord, A; Lee, PS; Lowery, WJ; Sfakianos, GP; Valea, FA; Myers, ER; Havrilesky, LJ
MLA Citation
Teoh, D, Berchuck, A, Alvarez Secord, A, Lee, PS, Lowery, WJ, Sfakianos, GP, Valea, FA, Myers, ER, and Havrilesky, LJ. "Cost comparison of strategies for the management of venous thromboembolic event risk following laparotomy for ovarian cancer." Gynecol Oncol 122.3 (September 2011): 467-472.
PMID
21752434
Source
pubmed
Published In
Gynecologic Oncology
Volume
122
Issue
3
Publish Date
2011
Start Page
467
End Page
472
DOI
10.1016/j.ygyno.2011.06.014

Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050.

OBJECTIVE: We sought to estimate the number of women who will undergo inpatient and outpatient surgery for stress urinary incontinence (SUI) or pelvic organ prolapse (POP) in the United States from 2010 through 2050. STUDY DESIGN: Using the 2007 Nationwide Inpatient Sample and the 2006 National Survey of Ambulatory Surgery, we calculated the rates for inpatient and outpatient SUI and POP surgery. We applied the surgery rates to the US Census Bureau population projections from 2010 through 2050. RESULTS: The total number of women who will undergo SUI surgery will increase 47.2% from 210,700 in 2010 to 310,050 in 2050. Similarly, the total number of women who will have surgery for prolapse will increase from 166,000 in 2010 to 245,970 in 2050. CONCLUSION: If the surgery rates for pelvic floor disorders remain unchanged, the number of surgeries for urinary incontinence and POP will increase substantially over the next 40 years.

Authors
Wu, JM; Kawasaki, A; Hundley, AF; Dieter, AA; Myers, ER; Sung, VW
MLA Citation
Wu, JM, Kawasaki, A, Hundley, AF, Dieter, AA, Myers, ER, and Sung, VW. "Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050." Am J Obstet Gynecol 205.3 (September 2011): 230.e1-230.e5.
PMID
21600549
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
205
Issue
3
Publish Date
2011
Start Page
230.e1
End Page
230.e5
DOI
10.1016/j.ajog.2011.03.046

Reported symptoms before and one year after hysterectomy in African American and white women.

PURPOSE: Although African American women are more likely than white women to undergo hysterectomy, there are few data describing their symptoms before and after surgery. This report compares reported symptoms in white and African American women before and 1-year after having a hysterectomy with at least one ovary retained. METHODS: Using data from a prospective cohort study, we compared self-reported symptoms at baseline and 1-year follow-up among 382 women undergoing hysterectomy without bilateral oophorectomy (197 African American and 185 white) and 448 controls (199 African American and 249 white). Symptoms were assessed using an 11-item scale with questions on somatic, psychologic, and urogenital symptoms. RESULTS: Women undergoing hysterectomy had more severe symptom scores before surgery than controls, but no significant racial differences were found. At follow-up, total scores for women with hysterectomies were comparable to those of control women, but some differences were observed within individual domains. Urogenital scores were worse for women with hysterectomies for both African American and white women. African American women with hysterectomies had better scores in the psychologic domain than either controls or white women with hysterectomies. CONCLUSIONS: African American women, despite having such characteristics as larger uterine weight and lower hemoglobin that might suggest they would have more severe symptoms, had scores that were no worse than white women both before and after hysterectomy.

Authors
Moorman, PG; Schildkraut, JM; Myers, ER; Wang, F
MLA Citation
Moorman, PG, Schildkraut, JM, Myers, ER, and Wang, F. "Reported symptoms before and one year after hysterectomy in African American and white women." J Womens Health (Larchmt) 20.7 (July 2011): 1035-1042.
PMID
21671769
Source
pubmed
Published In
Journal of Women's Health
Volume
20
Issue
7
Publish Date
2011
Start Page
1035
End Page
1042
DOI
10.1089/jwh.2010.2543

Utility scores and treatment preferences for clinical early-stage cervical cancer.

OBJECTIVES: To determine utility scores for health states relevant to the treatment of early-stage, high-risk cervical cancer. METHODS: Seven descriptive health states incorporating the physical and emotional aspects of medical treatment, recovery, and prognosis were developed. Forty-five female volunteers valuated each health state using the visual analogue score (VAS) and time trade off (TTO) methods. Treatment options were ranked by mean and median TTO scores. The 95% confidence intervals were calculated to determine the statistical significance of ranking preferences. The Wilcoxon rank-sum test was used to compare central tendencies related to age, race, parity, and subject history of abnormal cervical cytology. RESULTS: VAS and TTO scores were highly correlated. Volunteers ranked minimally invasive radical hysterectomy with low-risk features as most preferred (mean TTO = 0.96; median TTO = 1.00) and aborted radical hysterectomy followed by chemoradiation as least preferred (mean TTO = 0.69; median TTO = 0.83). Health states that included radical surgery were ranked higher than those that included chemoradiation, either in the adjuvant or primary setting. When survival was comparable, volunteers rated radical hysterectomy with high-risk pathology followed by adjuvant chemoradiation (mean TTO = 0.78; median TTO = 0.92; 95% CI: 0.69-0.87) similarly to chemoradiation alone (mean TTO = 0.76; median TTO 0.90; 95% CI: 0.66-0.86; p = NS). Utility scores for the majority of health states were not significantly associated with age, race, parity, or subject history of abnormal cervical cytology. CONCLUSION: Subjects consistently preferred surgical excision to treat early-stage, high-risk cervical cancer and chose a minimally invasive approach. Such utility scores can be used to incorporate quality-of-life effects into comparative-effectiveness models for cervical cancer.

Authors
Jewell, EL; Smrtka, M; Broadwater, G; Valea, F; Davis, DM; Nolte, KC; Valea, R; Myers, ER; Samsa, G; Havrilesky, LJ
MLA Citation
Jewell, EL, Smrtka, M, Broadwater, G, Valea, F, Davis, DM, Nolte, KC, Valea, R, Myers, ER, Samsa, G, and Havrilesky, LJ. "Utility scores and treatment preferences for clinical early-stage cervical cancer." Value Health 14.4 (June 2011): 582-586.
PMID
21669383
Source
pubmed
Published In
Value in Health
Volume
14
Issue
4
Publish Date
2011
Start Page
582
End Page
586
DOI
10.1016/j.jval.2010.11.017

Influence of timing of seasonal influenza vaccination on effectiveness and cost-effectiveness in pregnancy.

The purpose of this review was to estimate the impact of timing of seasonal influenza vaccination during pregnancy on health and economic outcomes. Cost-effectiveness analysis with a dynamic model of the US population of pregnant women and infants who were <6 months incorporated seasonal variation in influenza incidence. Compared with no vaccination, seasonal influenza vaccination in pregnancy costs $70,089 per quality-adjusted life year. Most of the benefit for infants was limited to those whose mothers were vaccinated within the first 4 weeks of vaccine availability. Once all women who were pregnant at the time of vaccine availability were vaccinated, vaccination of newly pregnant women had benefits for mothers but not infants. Delay of vaccination beyond November reduced both effectiveness and cost-effectiveness. The greatest population benefit from seasonal influenza vaccination in pregnancy was realized if pregnant women were vaccinated as soon as possible after trivalent inactivated influenza vaccine became available. Efforts to increase vaccine rates should be concentrated early in the influenza season.

Authors
Myers, ER; Misurski, DA; Swamy, GK
MLA Citation
Myers, ER, Misurski, DA, and Swamy, GK. "Influence of timing of seasonal influenza vaccination on effectiveness and cost-effectiveness in pregnancy." Am J Obstet Gynecol 204.6 Suppl 1 (June 2011): S128-S140. (Review)
PMID
21640230
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
204
Issue
6 Suppl 1
Publish Date
2011
Start Page
S128
End Page
S140
DOI
10.1016/j.ajog.2011.04.009

Development of an ovarian cancer screening decision model that incorporates disease heterogeneity: implications for potential mortality reduction.

BACKGROUND: Pathologic and genetic data suggest that epithelial ovarian cancer may consist of indolent and aggressive phenotypes. The objective of the current study was to estimate the impact of a 2-phenotype paradigm of epithelial ovarian cancer on the mortality reduction achievable using available screening technologies. METHODS: The authors modified a Markov model of ovarian cancer natural history (the 1-phenotype model) to incorporate aggressive and indolent phenotypes (the 2-phenotype model) based on histopathologic criteria. Stage distribution, incidence, and mortality were calibrated to data from the Surveillance, Epidemiology, and End Results Program of the US National Cancer Institute. For validation, a Monte Carlo microsimulation (1000,000 events) of the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) multimodality prevalence screen was performed. Mortality reduction and positive predictive value (PPV) were estimated for annual screening. RESULTS: In validation against UKCTOCS data, the model-predicted percentage of screen-detected cancers diagnosed at stage I and II was 41% compared with 47% (UKCTOCS data), and the model-predicted PPV of screening was 27% compared with 35% (UKCTOCS data). The model-estimated PPV of a strategy of annual population-based screening in the United States at ages 50 to 85 years was 14%. The mortality reduction using annual postmenopausal screening was 14.7% (1-phenotype model) and 10.9% (2-phenotype model). Mortality reduction was lower with the 2-phenotype model than with the 1-phenotype model regardless of screening frequency or test sensitivity; 68% of cancer deaths are accounted for by the aggressive phenotype. CONCLUSIONS: The current analysis suggested that reductions in ovarian cancer mortality using available screening technologies on an annual basis are likely to be modest. A model that incorporated 2 clinical phenotypes of ovarian carcinoma into its natural history predicted an even smaller potential reduction in mortality because of the more frequent diagnosis of indolent cancers at early stages.

Authors
Havrilesky, LJ; Sanders, GD; Kulasingam, S; Chino, JP; Berchuck, A; Marks, JR; Myers, ER
MLA Citation
Havrilesky, LJ, Sanders, GD, Kulasingam, S, Chino, JP, Berchuck, A, Marks, JR, and Myers, ER. "Development of an ovarian cancer screening decision model that incorporates disease heterogeneity: implications for potential mortality reduction." Cancer 117.3 (February 1, 2011): 545-553.
PMID
21254049
Source
pubmed
Published In
Cancer
Volume
117
Issue
3
Publish Date
2011
Start Page
545
End Page
553
DOI
10.1002/cncr.25624

Smoking prevalence in early pregnancy: comparison of self-report and anonymous urine cotinine testing.

OBJECTIVE: Societal pressures against smoking during pregnancy may lead to a reduction in disclosure of smoking status. The objective of this study was to compare prevalence of smoking at prenatal intake by self-report with anonymous biochemical validation. METHODS: Women receiving care at the Duke Obstetrics Clinic from February 2005 through January 2006 were eligible for evaluation. Self-reported smoking and urine samples were obtained anonymously at prenatal intake. The NicCheck™ I semi-quantitative dipstick was used to detect urinary nicotine, cotinine, and 3-hydroxycotinine. The difference, with 95% confidence interval, between the proportions of smokers by self-report and urine testing was calculated for (1) high-positive vs. low-positive and negative results combined and (2) any positive vs. negative results. RESULTS: Among 297 subjects, self-reported smoking was 18.2 vs. 14.8% for low-positive and negative results combined with an absolute difference of 3.4%, [-2.9%, 9.6%]. When comparing self-report with any positive result (43.1%), the absolute difference was 24.9%, [17.4%, 32.1%]. CONCLUSIONS: Our findings suggest that most pregnant women disclose their smoking and many nonsmokers may have significant second-hand exposure. Universal urinary cotinine screening of pregnant women could aid in appropriately counseling women about second-hand exposure as well as monitoring women at high risk for adverse pregnancy outcomes.

Authors
Swamy, GK; Reddick, KLB; Brouwer, RJN; Pollak, KI; Myers, ER
MLA Citation
Swamy, GK, Reddick, KLB, Brouwer, RJN, Pollak, KI, and Myers, ER. "Smoking prevalence in early pregnancy: comparison of self-report and anonymous urine cotinine testing." J Matern Fetal Neonatal Med 24.1 (January 2011): 86-90.
PMID
20384470
Source
pubmed
Published In
Journal of Maternal-Fetal and Neonatal Medicine (Informa)
Volume
24
Issue
1
Publish Date
2011
Start Page
86
End Page
90
DOI
10.3109/14767051003758887

Adverse birth outcomes among nulliparous vs. multiparous women

Objectives. Previous studies indicate that nulliparous women (i.e., women having no previous births) are at higher risk for adverse birth outcomes than multiparous women (i.e., women having had at least one previous birth). We examined whether part of the difference in adverse outcome rates is attributable to nulliparous women with poor pregnancy outcomes being less likely (through choice or fecundity differences) to have a subsequent live birth within the same Objectives. Previous studies indicate that nulliparous women (i.e., women having no previous births) are at higher risk for adverse birth outcomes than multiparous women (i.e., women having had at least one previous birth). We examined whether part of the difference in adverse outcome rates is attributable to nulliparous women with poor pregnancy outcomes being less likely (through choice or fecundity differencesbirth (PTB). Results. Among nulliparous women who were not linked to a second birth, maternal age-adjusted rates of multiple adverse outcomes were all statistically higher compared with rates for linked women. These results also held in race/ ethnicity-specific analyses. Simulations found that the relative risk of PTB associated with a history of PTB was underestimated if some women who would have been at risk for PTB did not experience a second birth. Conclusions. The observed differences in rates of adverse outcomes between nulliparous and multiparous women are partly attributable to higher-risk women not having a subsequent live birth, either by choice or due to fecundity differences. © 2011 Association of Schools of Public Health.

Authors
Miranda, ML; Edwards, SE; Myers, ER
MLA Citation
Miranda, ML, Edwards, SE, and Myers, ER. "Adverse birth outcomes among nulliparous vs. multiparous women." Public Health Reports 126.6 (2011): 797-805.
PMID
22043095
Source
scival
Published In
Public health reports (Washington, D.C. : 1974)
Volume
126
Issue
6
Publish Date
2011
Start Page
797
End Page
805

Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome

Context: Nonalcoholic fatty liver disease is common to insulin-resistant states such as polycystic ovary syndrome (PCOS). Metformin (MET) is often used to treat PCOS but information is limited as to its effects on liver function. Objective:Wesought to determine the effects of MET on serum hepatic parameters in PCOS patients. Design: This was a secondary analysis of a randomized, doubled-blind trial from 2002-2004. Setting: This multi-center clinical trial was conducted in academic centers. Patients: Six hundred twenty-six infertile women with PCOS with serum liver function parameters less than twice the upper limit of normal were included. Interventions: Clomiphene citrate (n = 209), MET (n = 208), or combined (n = 209) were given for up to 6 months. Main Outcome Measure: The percent change from baseline in renal and liver function betweenand within-treatment arms was assessed. Results: Renal function improved in all treatment arms with significant decreases in serum blood urea nitrogen levels (range, -14.7 to -21.3%) as well as creatinine (-4.2 to -6.9%). There were similar decreases in liver transaminase levels in the clomiphene citrate and combined arms (-10% in bilirubin, -9 to -11% in transaminases) without significant changes in the MET arm. When categorizing baseline bilirubin, aspartate aminotransferase, and alanine aminotransferase into tertiles, there were significant within-treatment arm differences between the tertiles with the highest tertile having the largest decrease from baseline regardless of treatment arm. Conclusion: Women with PCOS can safely use metformin and clomiphene even in the setting of mildly abnormal liver function parameters, and both result in improved renal function. Copyright © 2011 by The Endocrine Society.

Authors
Aubuchon, M; Kunselman, AR; Schlaff, WD; Diamond, MP; Coutifaris, C; Carson, SA; Steinkampf, MP; Carr, BR; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Myers, ER; Legro, RS
MLA Citation
Aubuchon, M, Kunselman, AR, Schlaff, WD, Diamond, MP, Coutifaris, C, Carson, SA, Steinkampf, MP, Carr, BR, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Myers, ER, and Legro, RS. "Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome." Journal of Clinical Endocrinology and Metabolism 96.10 (2011): E1645-E1649.
PMID
21832111
Source
scival
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
96
Issue
10
Publish Date
2011
Start Page
E1645
End Page
E1649
DOI
10.1210/jc.2011-1093

Leiomyoma-related hospitalization and surgery: Prevalence and predicted growth based on population trends

Objective: To estimate leiomyoma-related inpatient care in the United States for 2007 with predictions for the ensuing 40 years. Study Design: We used the 2007 Nationwide Inpatient Sample to estimate hospitalizations and inpatient surgeries for uterine leiomyoma in US women 15 to 54 years. We used the US Census Bureau population projections to predict leiomyoma-related inpatient care through 2050. Results: In 2007, 355,135 women were hospitalized for leiomyoma (rate = 42 per 10,000 women-years). Black women had increased rates of hospitalization, hysterectomy, and myomectomy (relative risk, 3.5, 2.4, 6.8, respectively) compared with white women. Leiomyoma-related hospitalizations are predicted to increase 23% (to 437,874) between 2007 and 2050, with 20% and 31% increases in leiomyoma-related hysterectomies and myomectomies. Conclusion: Leiomyoma-related inpatient care and major surgery remains substantial despite advances in less invasive treatment options. Given population growth, the projected burden of leiomyoma-related inpatient care will increase significantly by 2050, differentially impacting black vs white women. © 2011 Mosby, Inc.

Authors
Wechter, ME; Stewart, EA; Myers, ER; Kho, RM; Wu, JM
MLA Citation
Wechter, ME, Stewart, EA, Myers, ER, Kho, RM, and Wu, JM. "Leiomyoma-related hospitalization and surgery: Prevalence and predicted growth based on population trends." American Journal of Obstetrics and Gynecology 205.5 (2011): 492.e1-492.e5.
PMID
22035951
Source
scival
Published In
American Journal of Obstetrics & Gynecology
Volume
205
Issue
5
Publish Date
2011
Start Page
492.e1
End Page
492.e5
DOI
10.1016/j.ajog.2011.07.008

End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age

Background:Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.Methods:We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.Results:Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.Conclusions:The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type. © 2011 Cancer Research UK All rights reserved.

Authors
Castellsagué, X; Mũoz, N; Pitisuttithum, P; Ferris, D; Monsonego, J; Ault, K; Luna, J; Myers, E; Mallary, S; Bautista, OM; Bryan, J; Vuocolo, S; Haupt, RM; Saah, A
MLA Citation
Castellsagué, X, Mũoz, N, Pitisuttithum, P, Ferris, D, Monsonego, J, Ault, K, Luna, J, Myers, E, Mallary, S, Bautista, OM, Bryan, J, Vuocolo, S, Haupt, RM, and Saah, A. "End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age." British Journal of Cancer 105.1 (2011): 28-37.
PMID
21629249
Source
scival
Published In
British Journal of Cancer
Volume
105
Issue
1
Publish Date
2011
Start Page
28
End Page
37
DOI
10.1038/bjc.2011.185

Potential impact of antiretroviral therapy and screening on cervical cancer mortality in HIV-positive women in sub-Saharan Africa: A simulation

Background: Despite having high cervical cancer incidence and mortality rates, screening for cervical precancerous lesions remains infrequent in sub-Saharan Africa. The need to screen HIV-positive women because of the higher prevalence and faster progression of cervical precancerous lesions may be heightened by the increased access to highly-active antiretroviral therapy (HAART). Policymakers need quantitative data on the effect of HAART and screening to better allocate limited resources. Our aim was to quantify the potential effect of these interventions on cervical cancer mortality. Methods and Findings: We constructed a Markov state-transition model of a cohort of HIV-positive women in Cameroon. Published data on the prevalence, progression and regression of lesions as well as mortality rates from HIV, cervical cancer and other causes were incorporated into the model. We examined the potential impact, on cumulative cervical cancer mortality, of four possible scenarios: no HAART and no screening (NHNS), HAART and no screening (HNS), HAART and screening once on HAART initiation (HSHI), and HAART and screening once at age 35 (HS35). Our model projected that, compared to NHNS, lifetime cumulative cervical cancer mortality approximately doubled with HNS. It will require 262 women being screened at HAART initiation to prevent one cervical cancer death amongst women on HAART. The magnitudes of these effects were most sensitive to the rate of progression of precancerous lesions. Conclusions: Screening, even when done once, has the potential of reducing cervical cancer mortality among HIV-positive women in Africa. The most feasible and cost-effective screening strategy needs to be determined in each setting. © 2011 Atashili et al.

Authors
Atashili, J; Smith, JS; Adimora, AA; Eron, J; Miller, WC; Myers, E
MLA Citation
Atashili, J, Smith, JS, Adimora, AA, Eron, J, Miller, WC, and Myers, E. "Potential impact of antiretroviral therapy and screening on cervical cancer mortality in HIV-positive women in sub-Saharan Africa: A simulation." PLoS ONE 6.4 (2011).
PMID
21483701
Source
scival
Published In
PloS one
Volume
6
Issue
4
Publish Date
2011
DOI
10.1371/journal.pone.0018527

Projecting the need for gynecologic oncologists for the next 40 years.

OBJECTIVE: To estimate the ratio of gynecologic cancer cases to practicing gynecologic oncologists in the United States over the next 40 years. METHODS: Using population projections from the U.S. Census Bureau and incidence and mortality rates from Surveillance, Epidemiology and End Results surveys, we estimated the annual number of new gynecologic cancer cases through 2050; the effects of human papillomavirus (HPV) vaccination was included in cervical cancer estimates. The number of practicing gynecologic oncologists was projected through 2050 using data from the 2005 Society of Gynecologic Oncologists Practice Survey, current Society of Gynecologic Oncologists membership information, American Board of Obstetrics and Gynecology and Gynecologic Oncology oral examination results, and mortality estimates from U.S. life tables. Projected time in practice was sex-dependent based on Society of Gynecologic Oncologists Practice Survey. For sensitivity analyses, we varied annual number and sex distribution of fellowship graduates, HPV vaccination coverage rates, and future incidence of overweight and obesity. RESULTS: At constant training rates, the annual number of new cancer cases per practicing gynecologic oncologist will rise from 112 in 2010 to 133 in 2050, a 19% increase. If the annual number of fellowship graduates increases by 25%, the ratio of cancer cases per gynecologic oncologist will decrease to 106, a 5% decrease. Projections are more sensitive to changes in physician demographics than to changes in HPV vaccination coverage rates. CONCLUSION: The gynecologic cancer caseload of practicing gynecologic oncologists will increase by almost 20% over the next 40 years at constant training rates. Changes in the projected sex distribution of fellowship graduates and their time in practice affect these projections.

Authors
Wallace, AH; Havrilesky, LJ; Valea, FA; Barnett, JC; Berchuck, A; Myers, ER
MLA Citation
Wallace, AH, Havrilesky, LJ, Valea, FA, Barnett, JC, Berchuck, A, and Myers, ER. "Projecting the need for gynecologic oncologists for the next 40 years." Obstet Gynecol 116.6 (December 2010): 1366-1372.
PMID
21099604
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
116
Issue
6
Publish Date
2010
Start Page
1366
End Page
1372
DOI
10.1097/AOG.0b013e3181fc3a22

Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial.

OBJECTIVE: To investigate the relationship among intercourse compliance, ovulation, and the occurrence of pregnancy in the Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (RMNPPCOS) Trial. DESIGN: Post hoc data analysis of subjects in the Reproductive Medicine Network PPCOS Trial. SETTING: Academic medical centers. INTERVENTION(S): None. PATIENT(S): Six hundred twenty-six infertile women with polycystic ovary syndrome with a mean age of 28.1+/-4 years and mean body mass index of 35.2+/-8.7 kg/m2. MAIN OUTCOME MEASURE(S): Intercourse compliance, ovulation, and pregnancy. RESULT(S): Data on 2925 cycles were included in the analysis, of which 1340 were ovulatory cycles and 1585 were nonovulatory cycles. The rates of intercourse compliance in the PPCOS trial were similar across all treatment groups at all cycles except cycle 4. Among cycles with known ovulation status, 81.2% of patients were compliant with intercourse instructions. Patients were more intercourse compliant in those cycles during which ovulation occurred (83.2% vs. 79.4%). With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles. CONCLUSION(S): Intercourse compliance was not associated with the occurrence of pregnancy in ovulatory cycles in the PPCOS Trial. The occurrence of ovulation still remains a critical predictor for the occurrence of pregnancy.

Authors
Pagidas, K; Carson, SA; McGovern, PG; Barnhart, HX; Myers, ER; Legro, RS; Diamond, MP; Carr, BR; Schlaff, WD; Coutifaris, C; Steinkampf, MP; Cataldo, NA; Nestler, JE; Gosman, G; Giudice, LC; National Institute of Child Health and Human Development-Reproductive Medicine Network,
MLA Citation
Pagidas, K, Carson, SA, McGovern, PG, Barnhart, HX, Myers, ER, Legro, RS, Diamond, MP, Carr, BR, Schlaff, WD, Coutifaris, C, Steinkampf, MP, Cataldo, NA, Nestler, JE, Gosman, G, Giudice, LC, and National Institute of Child Health and Human Development-Reproductive Medicine Network, . "Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial." Fertil Steril 94.4 (September 2010): 1444-1446.
PMID
19540477
Source
pubmed
Published In
Fertility and Sterility
Volume
94
Issue
4
Publish Date
2010
Start Page
1444
End Page
1446
DOI
10.1016/j.fertnstert.2009.05.047

Body mass index and intercourse compliance.

OBJECTIVE: To investigate the relationship between body mass index and intercourse compliance in the Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (RMN PPCOS) Trial. DESIGN: Post hoc data analysis of subjects in the RMN PPCOS Trial. SETTING: Academic medical centers. INTERVENTION(S): None. PATIENT(S): Six hundred twenty-six infertile women with polycystic ovary syndrome (PCOS) with a mean age of 28.1+/-4 years and mean body mass index (BMI) of 35.2+/-8.7 kg/m2. MAIN OUTCOME MEASURE(S): Intercourse compliance and BMI. RESULT(S): Overall, body mass index was not associated with increased intercourse compliance. However, although patients with BMI>or=35 were less likely to ovulate than patients with BMI<35, they tend to be more compliant with intercourse frequency in ovulatory cycles than patients with BMI<35. CONCLUSION(S): BMI was not associated with intercourse compliance or noncompliance. An elevated BMI in infertile women with PCOS is not associated with poor intercourse compliance.

Authors
Pagidas, K; Carson, SA; McGovern, PG; Barnhart, HX; Myers, ER; Legro, RS; Diamond, MP; Carr, BR; Schlaff, WD; Coutifaris, C; Steinkampf, MP; Cataldo, NA; Nestler, JE; Gosman, G; Giudice, LC; National Institute of Child Health and Human Development-Reproductive Medicine Network,
MLA Citation
Pagidas, K, Carson, SA, McGovern, PG, Barnhart, HX, Myers, ER, Legro, RS, Diamond, MP, Carr, BR, Schlaff, WD, Coutifaris, C, Steinkampf, MP, Cataldo, NA, Nestler, JE, Gosman, G, Giudice, LC, and National Institute of Child Health and Human Development-Reproductive Medicine Network, . "Body mass index and intercourse compliance." Fertil Steril 94.4 (September 2010): 1447-1450.
PMID
19540480
Source
pubmed
Published In
Fertility and Sterility
Volume
94
Issue
4
Publish Date
2010
Start Page
1447
End Page
1450
DOI
10.1016/j.fertnstert.2009.05.048

Cost comparison among robotic, laparoscopic, and open hysterectomy for endometrial cancer.

OBJECTIVE: To use decision modeling to compare the costs associated with robotic, laparoscopic, and open hysterectomy for the treatment of endometrial cancer. METHODS: Three separate models were used, each with sensitivity analysis: 1) a societal perspective model, which included inpatient hospital costs, robotic expenses, and lost wages and caregiver costs; 2) a hospital perspective plus robot costs model, which was identical to the societal perspective model but excluded lost wages and caregiver costs; and 3) a hospital perspective without robot costs model, which was identical to the hospital perspective plus robot costs model except that it excluded initial cost of the robot. RESULTS: The societal perspective model predicted laparoscopy ($10,128) as the least expensive approach followed by robotic and ($11,476) and open hysterectomy ($12,847). Societal perspective model sensitivity analyses predicted robotic hysterectomy to be least expensive when robotic disposable equipment cost less than $1,046 per case (baseline cost $2,394). In the hospital perspective plus robot costs model, laparoscopy was least expensive ($6,581) followed by open ($7,009) and robotic hysterectomy ($8,770); however, if hospital stay after open surgery was less than 2.9 days, open hysterectomy was least expensive. In the hospital perspective without robot costs model, laparoscopy remained least expensive, but robotic surgery became least expensive if the cost of robotic disposable equipment was reduced to less than $1,496 per case. CONCLUSION: Laparoscopy is the least expensive surgical approach for the treatment of endometrial cancer. Robotic is less costly than abdominal hysterectomy when the societal costs associated with recovery time are accounted for and is most economically attractive if disposable equipment costs can be minimized. LEVEL OF EVIDENCE: III.

Authors
Barnett, JC; Judd, JP; Wu, JM; Scales, CD; Myers, ER; Havrilesky, LJ
MLA Citation
Barnett, JC, Judd, JP, Wu, JM, Scales, CD, Myers, ER, and Havrilesky, LJ. "Cost comparison among robotic, laparoscopic, and open hysterectomy for endometrial cancer." Obstet Gynecol 116.3 (September 2010): 685-693.
PMID
20733453
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
116
Issue
3
Publish Date
2010
Start Page
685
End Page
693
DOI
10.1097/AOG.0b013e3181ee6e4d

Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer.

OBJECTIVE: We sought to estimate mean costs of chemotherapy treatment for recurrent ovarian cancer with or without use of a chemoresponse assay. STUDY DESIGN: We estimated mean costs for 3 groups: (1) assay assisted: 75 women who received oncologist's choice of chemotherapy following chemoresponse testing (65% adherence to test results), (2) assay adherent: modeled group assuming 100% adherence to assay results, and (3) empiric: modeled from market share data on most frequently utilized chemotherapy regimens. Cost estimates were based on commercial claims database reimbursements. RESULTS: The most common chemotherapy regimens used were topotecan, doxorubicin, and carboplatin/paclitaxel. Mean chemotherapy costs for 6 cycles were $48,758 (empiric), $33,187 (assay assisted), and $23,986 (assay adherent). The cost savings related to the assay were associated with a shift from higher- to lower-cost chemotherapy regimens and lower use of supportive drugs such as hematopoiesis-stimulating agents. CONCLUSION: Assay-assisted chemotherapy for recurrent ovarian cancer may result in reduced costs compared to empiric therapy.

Authors
Havrilesky, LJ; Krivak, TC; Mucenski, JW; Myers, ER
MLA Citation
Havrilesky, LJ, Krivak, TC, Mucenski, JW, and Myers, ER. "Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer." Am J Obstet Gynecol 203.2 (August 2010): 160.e1-160.e7.
PMID
20417480
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
203
Issue
2
Publish Date
2010
Start Page
160.e1
End Page
160.e7
DOI
10.1016/j.ajog.2010.02.054

Optimal timing of implantable cardioverter-defibrillator implantation after myocardial infarction: a decision analysis.

BACKGROUND: The optimal timing of implantable cardioverter defibrillator (ICD) placement for the primary prevention of sudden cardiac death after myocardial infarction (MI) remains unknown. METHODS AND RESULTS: We developed a Markov model to investigate the optimal timing of ICD implantation after MI (no ICD, ICD at 60 days, 6 months, and 1 year) in patients who meet current guidelines. Estimates of arrhythmic death (baseline risk 6%, range 1-20% per year), nonarrhythmic death, and ICD efficacy were based upon MADIT-II and other contemporary post-MI clinical trials. We used both deterministic and stochastic modeling processes in our analysis. After 10 years follow-up, the baseline probability of survival was higher in those treated with ICD implantation versus not (42% vs 30%, P < 0.001). Survival was highest with ICD implantation at 60 days versus 6 months versus 1 year: 42.4%, 42.3%, and 42.0% (P = 0.0028). ICD implantation at 60 days provided a mean incremental survival of 0.28 months and 0.84 months per patient (compared with implantation at 6 months and 1 year). In sensitivity analyses, patients' competing risk for nonarrhythmic death was the primary determinant of benefit from ICD implantation. Overall, ICD implantation at 60 days resulted in the greatest life expectancy over a wide range of plausible nonarrhythmic and arrhythmic death rates. CONCLUSIONS: The benefits of early ICD implantation are modest when compared with delayed implantation at 6 months/1 year. Our results suggest that making sure a patient receives an ICD, when appropriate, may be more important than the timing of the implantation procedure.

Authors
Piccini, JP; Al-Khatib, SM; Myers, ER; Anstrom, KJ; Buxton, AE; Peterson, ED; Sanders, GD
MLA Citation
Piccini, JP, Al-Khatib, SM, Myers, ER, Anstrom, KJ, Buxton, AE, Peterson, ED, and Sanders, GD. "Optimal timing of implantable cardioverter-defibrillator implantation after myocardial infarction: a decision analysis." J Cardiovasc Electrophysiol 21.7 (July 2010): 791-798.
PMID
20132397
Source
pubmed
Published In
Journal of Cardiovascular Electrophysiology
Volume
21
Issue
7
Publish Date
2010
Start Page
791
End Page
798
DOI
10.1111/j.1540-8167.2009.01696.x

Total Testosterone Assays in Polycystic Ovary Syndrome: Is There a Gold Standard?.

Authors
Legro, RS; Schlaff, WD; Diamond, MP; Coutifaris, C; Casson, PR; Brzyski, RJ; Christman, GM; Trussell, JC; Krawetz, SA; Snyder, PJ; Ohl, D; Carson, SA; Steinkampf, MP; Carr, BR; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Myers, ER; Santoro, N; Eisenberg, E; Zhang, M; Zhang, H
MLA Citation
Legro, RS, Schlaff, WD, Diamond, MP, Coutifaris, C, Casson, PR, Brzyski, RJ, Christman, GM, Trussell, JC, Krawetz, SA, Snyder, PJ, Ohl, D, Carson, SA, Steinkampf, MP, Carr, BR, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Myers, ER, Santoro, N, Eisenberg, E, Zhang, M, and Zhang, H. "Total Testosterone Assays in Polycystic Ovary Syndrome: Is There a Gold Standard?." June 2010.
Source
wos-lite
Published In
Endocrine reviews
Volume
31
Issue
3
Publish Date
2010

Fertility patients' views about frozen embryo disposition: results of a multi-institutional U.S. survey.

OBJECTIVE: To describe fertility patients' preferences for disposition of cryopreserved embryos and determine factors important to these preferences. DESIGN: Cross-sectional survey conducted between June 2006 and July 2007. SETTING: Nine geographically diverse U.S. fertility clinics. PATIENT(S): 1020 fertility patients with cryopreserved embryos. INTERVENTION(S): Self-administered questionnaire. MAIN OUTCOME MEASURE(S): Likelihood of selecting each of five conventional embryo disposition options: store for reproduction, thaw and discard, donate to another couple, freeze indefinitely, and donate for research; likelihood of selecting each of two alternative options identified in previous research: placement of embryos in the woman's body at an infertile time, or a disposal ceremony; importance of each of 26 considerations to disposition decisions; and views on the embryo's moral status. RESULT(S): We found that 54% of respondents with cryopreserved embryos were very likely to use them for reproduction, 21% were very likely to donate for research, 7% or fewer were very likely to choose any other option. Respondents who ascribed high importance to concerns about the health or well-being of the embryo, fetus, or future child were more likely to thaw and discard embryos or freeze them indefinitely. CONCLUSION(S): Fertility patients frequently prefer disposition options that are not available to them or find the available options unacceptable. Restructuring and standardizing the informed consent process and ensuring availability of all disposition options may benefit patients, facilitate disposition decisions, and address problems of long-term storage.

Authors
Lyerly, AD; Steinhauser, K; Voils, C; Namey, E; Alexander, C; Bankowski, B; Cook-Deegan, R; Dodson, WC; Gates, E; Jungheim, ES; McGovern, PG; Myers, ER; Osborn, B; Schlaff, W; Sugarman, J; Tulsky, JA; Walmer, D; Faden, RR; Wallach, E
MLA Citation
Lyerly, AD, Steinhauser, K, Voils, C, Namey, E, Alexander, C, Bankowski, B, Cook-Deegan, R, Dodson, WC, Gates, E, Jungheim, ES, McGovern, PG, Myers, ER, Osborn, B, Schlaff, W, Sugarman, J, Tulsky, JA, Walmer, D, Faden, RR, and Wallach, E. "Fertility patients' views about frozen embryo disposition: results of a multi-institutional U.S. survey." Fertil Steril 93.2 (February 2010): 499-509.
PMID
19061998
Source
pubmed
Published In
Fertility and Sterility
Volume
93
Issue
2
Publish Date
2010
Start Page
499
End Page
509
DOI
10.1016/j.fertnstert.2008.10.015

Predictors of pregnancy in women with polycystic ovary syndrome

Authors
Rausch, ME; Legro, RS; Barnhart, HX; Schlaff, WD; Carr, BR; Diamond, MP; Carson, SA; Steinkampf, MP; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Giudice, LC; Leppert, PC; Myers, ER; Coutifaris, C
MLA Citation
Rausch, ME, Legro, RS, Barnhart, HX, Schlaff, WD, Carr, BR, Diamond, MP, Carson, SA, Steinkampf, MP, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Giudice, LC, Leppert, PC, Myers, ER, and Coutifaris, C. "Predictors of pregnancy in women with polycystic ovary syndrome." Obstetrical and Gynecological Survey 65.1 (2010): 30-32.
Source
scival
Published In
Obstetrical and Gynecological Survey
Volume
65
Issue
1
Publish Date
2010
Start Page
30
End Page
32
DOI
10.1097/01.ogx.0000367515.48912.b1

Total testosterone assays in women with polycystic ovary syndrome: Precision and correlation with hirsutism

Context: There is no standardized assay of testosterone in women. Liquid chromatography mass spectrometry (LC/MS) has been proposed as the preferable assay by an Endocrine Society Position Statement. Objective: The aim was to compare assay results from a direct RIA with two LC/MS. Design and Setting: We conducted a blinded laboratory study including masked duplicate samples at three laboratories - two academic (University of Virginia, RIA; and Mayo Clinic, LC/MS) and one commercial (Quest, LC/MS). Participants and Interventions: Baseline testosterone levels from 596 women with PCOS who participated in a large, multicenter, randomized controlled infertility trial performed at academic health centers in the United States were run by varying assays, and results were compared. Main Outcome Measure: We measured assay precision and correlation and baseline Ferriman-Gallwey hirsutism scores. Results: Median testosterone levels were highest with RIA. The correlations between the blinded samples that were run in duplicate were comparable. The correlation coefficient (CC) between LC/MS at Quest and Mayo was 0.83 [95% confidence interval (CI), 0.80-0.85], between RIA and LC/MS at Mayo was 0.79 (95% CI, 0.76-0.82), and between RIA and LC/MS at Quest was 0.67 (95% CI, 0.63-0.72). Interassay variation was highest at the lower levels of total testosterone (≤50 ng/dl). The CC for Quest LC/MS was significantly different from those derived from the other assays. We found similar correlations between total testosterone levels and hirsutism score with the RIA (CC = 0.24), LC/MS at Mayo (CC = 0.15), or Quest (CC = 0.17). Conclusions: A testosterone RIA is comparable to LC/MS assays. There is significant variability between LC/MS assays and poor precision with all assays at low testosterone levels. Copyright © 2010 by The Endocrine Society.

Authors
Legro, RS; Schlaff, WD; Diamond, MP; Coutifaris, C; Casson, PR; Brzyski, RG; Christman, GM; Trussell, JC; Krawetz, SA; Snyder, PJ; Ohl, D; Carson, SA; Steinkampf, MP; Carr, BR; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Myers, ER; Santoro, N; Eisenberg, E; Zhang, M; Zhang, H
MLA Citation
Legro, RS, Schlaff, WD, Diamond, MP, Coutifaris, C, Casson, PR, Brzyski, RG, Christman, GM, Trussell, JC, Krawetz, SA, Snyder, PJ, Ohl, D, Carson, SA, Steinkampf, MP, Carr, BR, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Myers, ER, Santoro, N, Eisenberg, E, Zhang, M, and Zhang, H. "Total testosterone assays in women with polycystic ovary syndrome: Precision and correlation with hirsutism." Journal of Clinical Endocrinology and Metabolism 95.12 (2010): 5305-5313.
PMID
20826578
Source
scival
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
95
Issue
12
Publish Date
2010
Start Page
5305
End Page
5313
DOI
10.1210/jc.2010-1123

Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trial

Objectives: To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design: Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months' follow-up. Setting: Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants: 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy. Intervention: Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6. Main outcome measures: Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied. Results: In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma. Conclusions: Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up. Trial registrations: NCT00092521 and NCT00092534.

Authors
Dillner, J; Kjaer, SK; Wheeler, CM; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; García, P; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Lehtinen, M; Steben, M; Bosch, FX; Joura, EA; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, JT; Maansson, R; Lu, S; Vuocolo, S; Hesley, TM; Barr, E; Haupt, R
MLA Citation
Dillner, J, Kjaer, SK, Wheeler, CM, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Lehtinen, M, Steben, M, Bosch, FX, Joura, EA, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, JT, Maansson, R, Lu, S, Vuocolo, S, Hesley, TM, Barr, E, and Haupt, R. "Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trial." BMJ (Online) 341.7766 (2010): 239--.
PMID
20647284
Source
scival
Published In
BMJ
Volume
341
Issue
7766
Publish Date
2010
Start Page
239-
DOI
10.1136/bmj.c3493

Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women

Background The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were "negative to 14 HPV types" and in a mixed population of HPV-exposed and-unexposed women (intention-to-treat group).MethodsThis analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk.ResultsThe average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95% confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7% reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95% CI = 0.04 to 0.16), genital warts (62.0% reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95% CI = 0.58 to 0.87), Pap abnormalities (11.3% reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95% CI = 0.74 to 1.90), and cervical definitive therapy (23.0% reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95% CI = 0.35 to 0.83), irrespective of causal HPV type.ConclusionsHigh-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.

Authors
Munoz, N; Kjaer, SK; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Wheeler, CM; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; Garcia, PJ; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Steben, M; Bosch, FX; Dillner, J; Huh, WK; Joura, EA; Kurman, RJ; Majewski, S; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, JT; Lupinacci, LC; Giacoletti, KED; Sings, HL; James, MK; Hesley, TM; Barr, E; Haupt, RM
MLA Citation
Munoz, N, Kjaer, SK, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Wheeler, CM, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, Garcia, PJ, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Steben, M, Bosch, FX, Dillner, J, Huh, WK, Joura, EA, Kurman, RJ, Majewski, S, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, JT, Lupinacci, LC, Giacoletti, KED, Sings, HL, James, MK, Hesley, TM, Barr, E, and Haupt, RM. "Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women." Journal of the National Cancer Institute 102.5 (2010): 325-339.
PMID
20139221
Source
scival
Published In
Journal of the National Cancer Institute
Volume
102
Issue
5
Publish Date
2010
Start Page
325
End Page
339
DOI
10.1093/jnci/djp534

Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples

Objective.: Estimate the accuracy and cost-effectiveness of cervical cancer screening strategies based on high-risk human papillomavirus (HPV) DNA testing of self-collected vaginal samples. Materials and methods.: A subset of 1,665 women (age range, 18-50 y) participating in a cervical cancer screening study were screened by liquid-based cytology and by high-risk HPV DNA testing of both self-collected vaginal swab samples and clinician-collected cervical samples. Women with positive/abnormal screening test results and a subset of women with negative screening test results were triaged to colposcopy. On the basis of individual and combined test results, 5 screening strategies were defined. Estimates of sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or worse were calculated, and a Markov model was used to estimate the incremental cost-effectiveness ratios for each strategy. Results.: Compared with cytology-based screening, high-risk HPV DNA testing of self-collected vaginal samples was more sensitive (68%, 95% CI = 58%-78% vs 85%, 95% CI = 76%-94%) but less specific (89%, 95% CI = 86%-91% vs 73%, 95% CI = 67%-79%). A strategy of high-risk HPV DNA testing of self-collected vaginal samples followed by cytology triage of HPV-positive women was comparably sensitive (75%, 95% CI = 64%-86%) and specific (88%, 95% CI = 85%-92%) to cytology-based screening. In-home self-collection for high-risk HPV DNA detection followed by in-clinic cytology triage had a slightly lower lifetime cost and a slightly higher quality-adjusted life year (QALY) expectancy than did cytology-based screening (incremental cost-effectiveness ratio of triennial screening compared with no screening was $9,871/QALY and $12,878/QALY, respectively). Conclusions.: Triennial screening by high-risk HPV DNA testing of in-home, self-collected vaginal samples followed by in-clinic cytology triage was cost-effective. © 2010 American Society for Colposcopy and Cervical Pathology.

Authors
Balasubramanian, A; Kulasingam, SL; Baer, A; Hughes, JP; Myers, ER; Mao, C; Kiviat, NB; Koutsky, LA
MLA Citation
Balasubramanian, A, Kulasingam, SL, Baer, A, Hughes, JP, Myers, ER, Mao, C, Kiviat, NB, and Koutsky, LA. "Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples." Journal of Lower Genital Tract Disease 14.3 (2010): 185-195.
PMID
20592553
Source
scival
Published In
Journal of Lower Genital Tract Disease
Volume
14
Issue
3
Publish Date
2010
Start Page
185
End Page
195
DOI
10.1097/LGT.0b013e3181cd6d36

Cost-effectiveness of sacral neuromodulation versus intravesical botulinum A toxin for treatment of refractory urge incontinence.

PURPOSE: We determined the cost-effectiveness of sacral neuromodulation vs intravesical botulinum toxin A for the treatment of refractory urge incontinence. MATERIALS AND METHODS: We developed a Markov decision model using a societal perspective to compare costs (2008 U.S. dollars) and effectiveness (quality adjusted life-years) of sacral nerve stimulation and botulinum toxin A. Our primary outcome was the incremental cost-effectiveness ratio, which was defined as (sacral nerve stimulation cost - botulinum toxin A cost)/(sacral nerve stimulation quality adjusted life-year - botulinum toxin A quality adjusted life-year). Sensitivity analyses were performed to assess the impact of varying efficacy, costs and adverse event rates over the range of reported values. RESULTS: In the base case scenario sacral nerve stimulation was more expensive ($15,743 vs $4,392) and more effective (1.73 vs 1.63 quality adjusted life-years) than botulinum toxin A during a 2-year period. The incremental cost-effectiveness ratio was $116,427 per quality adjusted life-year. Using conventional incremental cost-effectiveness ratio thresholds of $50,000 and $100,000 per quality adjusted life-year, sacral nerve stimulation was not cost-effective. In sensitivity analyses intravesical botulinum generally remained cost-effective. CONCLUSIONS: During a 2-year period botulinum toxin A was cost-effective compared to sacral neuromodulation for the treatment of refractory urge incontinence. Additional data regarding time to failure after botulinum toxin A injections, long-term efficacy with repeat botulinum toxin A injections and long-term complications with both therapies will be helpful for future cost-effectiveness studies.

Authors
Siddiqui, NY; Amundsen, CL; Visco, AG; Myers, ER; Wu, JM
MLA Citation
Siddiqui, NY, Amundsen, CL, Visco, AG, Myers, ER, and Wu, JM. "Cost-effectiveness of sacral neuromodulation versus intravesical botulinum A toxin for treatment of refractory urge incontinence." J Urol 182.6 (December 2009): 2799-2804.
PMID
19837427
Source
pubmed
Published In
The Journal of Urology
Volume
182
Issue
6
Publish Date
2009
Start Page
2799
End Page
2804
DOI
10.1016/j.juro.2009.08.031

Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050.

OBJECTIVES: To estimate the number of women who will have symptomatic pelvic floor disorders in the United States from 2010 to 2050. METHODS: We used population projections from the U.S. Census Bureau from 2010 to 2050 and published age-specific prevalence estimates for bothersome, symptomatic pelvic floor disorders (urinary incontinence [UI], fecal incontinence, and pelvic organ prolapse [POP]) from the 2005 National Health and Nutrition Examination Survey. We abstracted data regarding the number of women aged 20 years or older in 20-year age groups. We assumed that the age-specific prevalences for these disorders and the population distribution of risk factors remained unchanged thru 2050. We also conducted sensitivity analyses that varied both the prevalence estimates and the population projections. RESULTS: The number of American women with at least one pelvic floor disorder will increase from 28.1 million in 2010 to 43.8 million in 2050. During this time period, the number of women with UI will increase 55% from 18.3 million to 28.4 million. For fecal incontinence, the number of affected women will increase 59% from 10.6 to 16.8 million, and the number of women with POP will increase 46% from 3.3 to 4.9 million. The highest projections for 2050 estimate that 58.2 million women will have at least one pelvic floor disorder, with 41.3 million with UI, 25.3 million with fecal incontinence, and 9.2 million with POP. CONCLUSION: The prevalence of pelvic floor disorders will increase substantially given the changing demographics in the United States. This increase has important implications for public health and the field of gynecology. LEVEL OF EVIDENCE: III.

Authors
Wu, JM; Hundley, AF; Fulton, RG; Myers, ER
MLA Citation
Wu, JM, Hundley, AF, Fulton, RG, and Myers, ER. "Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050." Obstet Gynecol 114.6 (December 2009): 1278-1283.
PMID
19935030
Source
pubmed
Published In
Obstetrics and Gynecology
Volume
114
Issue
6
Publish Date
2009
Start Page
1278
End Page
1283
DOI
10.1097/AOG.0b013e3181c2ce96

Human papillomavirus testing with Pap triage for cervical cancer prevention in Canada: a cost-effectiveness analysis.

BACKGROUND: Recently published results from a large randomized trial (Canadian Cervical Cancer Screening Trial study group) suggest that human papillomavirus testing followed by Pap smear-based triage for human papillomavirus positive women may be an effective way to screen women for cervical cancer. We determined the potential cost-effectiveness of including human papillomavirus tests for cervical cancer screening for Canada and three provinces: Alberta, Newfoundland and Ontario. METHODS: We developed four Markov decision models using data from relevant Canadian and provincial studies and databases. The models were used to determine the number of false positive test results, cancers, lifetime costs and life-expectancy for 27 different screening strategies that varied by age to begin screening (18 or 25 years), screening interval (one, two, three, or five years) and whether the currently recommended strategy (screening every year from age 18 until 21 and then every three years afterwards with conventional Paps) was conducted prior to age 25. Strategies were compared using incremental cost-effectiveness ratios. RESULTS: Screening strategies beginning at age 18 were associated with a substantial increase in the number of false-positive test results but only small differences in the number of cancers compared to the same strategy conducted beginning at age 25. Strategies of human papillomavirus testing first, followed by triage with Pap smears were associated with lower costs and greater increases in life-expectancy than the currently recommended screening strategy in Canada. CONCLUSION: A strategy of human papillomavirus testing beginning at age 25, with Pap triage for women with positive human papillomavirus results may be more effective at reducing cervical cancer at a lower cost than the current recommended strategy for screening in Canada.

Authors
Kulasingam, SL; Rajan, R; St Pierre, Y; Atwood, CV; Myers, ER; Franco, EL
MLA Citation
Kulasingam, SL, Rajan, R, St Pierre, Y, Atwood, CV, Myers, ER, and Franco, EL. "Human papillomavirus testing with Pap triage for cervical cancer prevention in Canada: a cost-effectiveness analysis. (Published online)" BMC Med 7 (November 9, 2009): 69-.
PMID
19900264
Source
pubmed
Published In
BMC Medicine
Volume
7
Publish Date
2009
Start Page
69
DOI
10.1186/1741-7015-7-69

A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (Types 6/11/16/18) vaccine against high-grade cervical and external genital lesions.

Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

Authors
Kjaer, SK; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Wheeler, CM; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; García, P; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Lehtinen, M; Steben, M; Bosch, FX; Dillner, J; Joura, EA; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, J; Maansson, R; Lu, S; Vuocolo, S; Hesley, TM; Saah, A; Barr, E; Haupt, RM
MLA Citation
Kjaer, SK, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Wheeler, CM, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Lehtinen, M, Steben, M, Bosch, FX, Dillner, J, Joura, EA, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Maansson, R, Lu, S, Vuocolo, S, Hesley, TM, Saah, A, Barr, E, and Haupt, RM. "A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (Types 6/11/16/18) vaccine against high-grade cervical and external genital lesions." Cancer Prev Res (Phila) 2.10 (October 2009): 868-878.
PMID
19789295
Source
pubmed
Published In
Cancer Prevention Research
Volume
2
Issue
10
Publish Date
2009
Start Page
868
End Page
878
DOI
10.1158/1940-6207.CAPR-09-0031

Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection.

OBJECTIVE: In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL/SILGARD) clinical program, 73% of women aged 16-26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. Of the remaining women, 15% of had evidence of past infection with one or more vaccine HPV types (seropositive and DNA negative) at the time of enrollment. Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical and external anogenital disease related to the same vaccine HPV type which had previously been cleared. Vaccine tolerability in this previously infected population was also assessed. METHODS: 18,174 women were enrolled into 3 clinical studies. The data presented comprise a subset of these subjects (n = 2,617) who were HPV seropositive and DNA negative at enrollment (for >or=1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6 (without knowledge of baseline HPV status). Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing, and collection of cervicovaginal and external genital specimens. Analyses of efficacy were carried out in a population stratified by HPV serology and HPV DNA status at enrollment. RESULTS: Subjects were followed for an average of 40 months. Seven subjects in the placebo group developed cervical disease, and eight subjects developed external genital disease related to a vaccine HPV type they had previously encountered. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrolment. CONCLUSIONS: These results suggest that natural HPV infection-elicited antibodies may not provide complete protection over time, however the immune response to the HPV 6/11/16/18 vaccine appears to prevent reinfection or reactivation of disease with vaccine HPV types. Vaccine-related adverse experiences were higher among subjects receiving vaccine, mostly due to increased injection site adverse experiences.

Authors
Olsson, S-E; Kjaer, SK; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Wheeler, CM; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; García, P; Ault, KA; Garland, SM; Leodolter, S; Tang, GWK; Ferris, DG; Paavonen, J; Lehtinen, M; Steben, M; Bosch, FX; Dillner, J; Joura, EA; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, J; Maansson, R; Vuocolo, S; Hesley, TM; Saah, A; Barr, E; Haupt, RM
MLA Citation
Olsson, S-E, Kjaer, SK, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Wheeler, CM, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Tang, GWK, Ferris, DG, Paavonen, J, Lehtinen, M, Steben, M, Bosch, FX, Dillner, J, Joura, EA, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Maansson, R, Vuocolo, S, Hesley, TM, Saah, A, Barr, E, and Haupt, RM. "Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection." Hum Vaccin 5.10 (October 2009): 696-704.
PMID
19855170
Source
pubmed
Published In
Human vaccines
Volume
5
Issue
10
Publish Date
2009
Start Page
696
End Page
704

Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial.

OBJECTIVE: The purpose of this study was to determine the contribution of randomization to nicotine replacement therapy (NRT), sociodemographic and psychosocial factors, and pregnancy and medical history to serious perinatal adverse events among pregnant smokers. STUDY DESIGN: We performed a retrospective review of all medical records for participants in the Baby Steps Trial. Data that were abstracted from 157 records were combined with baseline characteristics for logistic regression modeling of serious adverse events and adjusted for covariates. RESULTS: Serious adverse events occurred in 17% (9/52 pregnancies) and 31% (33/105 pregnancies) of participants in the control and NRT arms, respectively. Black race, adverse pregnancy history, and use of analgesic medication during pregnancy were significant predictors (P = .02, .04, and .01, respectively). Remaining covariates, which included randomization to NRT, were not statistically significant. CONCLUSION: Although race, poor pregnancy history, and use of analgesics were associated with serious adverse events, randomization to NRT during pregnancy was not a significant factor. Further research is needed to examine the safety of analgesic medications during pregnancy.

Authors
Swamy, GK; Roelands, JJ; Peterson, BL; Fish, LJ; Oncken, CA; Pletsch, PK; Myers, ER; Whitecar, PW; Pollak, KI
MLA Citation
Swamy, GK, Roelands, JJ, Peterson, BL, Fish, LJ, Oncken, CA, Pletsch, PK, Myers, ER, Whitecar, PW, and Pollak, KI. "Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial." Am J Obstet Gynecol 201.4 (October 2009): 354.e1-354.e7.
PMID
19664750
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
201
Issue
4
Publish Date
2009
Start Page
354.e1
End Page
354.e7
DOI
10.1016/j.ajog.2009.06.006

Predictors of pregnancy in women with polycystic ovary syndrome.

CONTEXT: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. The selection of first-line therapies for ovulation induction is empiric. OBJECTIVE: The aim of the study was to develop a clinically useful predictive model of live birth with varying ovulation induction methods. DESIGN, SETTING, AND PARTICIPANTS: We built four prognostic models from a large multicenter randomized controlled infertility trial of 626 women with PCOS performed at academic health centers in the United States to predict success of ovulation, conception, pregnancy, and live birth, evaluating the influence of patients' baseline characteristics. INTERVENTIONS: Ovulation was induced with clomiphene, metformin, or the combination of both for up to six cycles or conception. MAIN OUTCOME MEASURE: The primary outcome of the trial was the rate of live births. RESULTS: Baseline free androgen index, baseline proinsulin level, interaction of treatment arm with body mass index, and duration of attempting conception were significant predictors in all four models. History of a prior loss predicted ovulation and conception, but not pregnancy or live birth. A modified Ferriman Gallwey hirsutism score of less than 8 was predictive of conception, pregnancy, and live birth (although it did not predict ovulation success). Age was a divergent predictor based on outcome; age greater than 34 predicted ovulation, whereas age less than 35 was a predictive factor for a successful pregnancy and live birth. Smoking history had no predictive value. CONCLUSIONS: A live birth prediction chart developed from basic clinical parameters (body mass index, age, hirsutism score, and duration of attempting conception) may help physicians counsel and select infertility treatments for women with PCOS.

Authors
Rausch, ME; Legro, RS; Barnhart, HX; Schlaff, WD; Carr, BR; Diamond, MP; Carson, SA; Steinkampf, MP; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Giudice, LC; Leppert, PC; Myers, ER; Coutifaris, C; Reproductive Medicine Network,
MLA Citation
Rausch, ME, Legro, RS, Barnhart, HX, Schlaff, WD, Carr, BR, Diamond, MP, Carson, SA, Steinkampf, MP, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Giudice, LC, Leppert, PC, Myers, ER, Coutifaris, C, and Reproductive Medicine Network, . "Predictors of pregnancy in women with polycystic ovary syndrome." J Clin Endocrinol Metab 94.9 (September 2009): 3458-3466.
PMID
19509098
Source
pubmed
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
94
Issue
9
Publish Date
2009
Start Page
3458
End Page
3466
DOI
10.1210/jc.2009-0545

The impact of human papillomavirus vaccination on cervical cancer prevention efforts.

OBJECTIVES: To review concepts, information, obstacles, and approaches to cervical cancer screening and prevention as vaccination against human papillomavirus (HPV) types 16 and 18 is adopted. METHODS: Expert forum, conducted September 12-13, 2008, hosted by the Society of Gynecologic Oncologists, including 56 experts in cervical cancer and titled Future Strategies of Cervical Cancer Prevention: What Do We Need to Do Now to Prepare? RESULTS: The current approach to cervical cancer screening in the U.S. is limited by its opportunistic nature. If given to women before exposure, a vaccine against HPV 16,18 can decrease cervical cancer risk by up to 70%. The impact on abnormal cytology and cervical intraepithelial neoplasia (CIN) will be less but still substantial. As the prevalence of high-grade CIN falls, fewer women with positive screening tests will have truly preinvasive disease. To minimize harm from false positive tests in women who are at low risk for cancer because of early vaccination, later initiation of and longer intervals between screenings are ideal. However, the vaccine is less effective when administered after first intercourse, and delivering and documenting HPV vaccination to girls at optimal ages may prove difficult. CONCLUSIONS: Until population-based data on the performance of cytology, HPV testing, and alternate screening or triage interventions become available, modifying current screening guidelines is premature. Current recommendations to initiate screening as late as age 21 and to screen less often than annually are appropriate for young women known to have been vaccinated before first intercourse.

Authors
Massad, LS; Einstein, M; Myers, E; Wheeler, CM; Wentzensen, N; Solomon, D
MLA Citation
Massad, LS, Einstein, M, Myers, E, Wheeler, CM, Wentzensen, N, and Solomon, D. "The impact of human papillomavirus vaccination on cervical cancer prevention efforts." Gynecol Oncol 114.2 (August 2009): 360-364. (Review)
PMID
19410282
Source
pubmed
Published In
Gynecologic Oncology
Volume
114
Issue
2
Publish Date
2009
Start Page
360
End Page
364
DOI
10.1016/j.ygyno.2009.04.005

Complications of hysterectomy in women with von Willebrand disease.

Case reports and small case series suggest that women with von Willebrand disease (VWD) are at a very high risk of bleeding complications with hysterectomy. As the procedure may be beneficial to women who suffer from heavy menstrual bleeding and have completed childbearing, an understanding of the true risks involved is essential for appropriate decision making. To estimate the incidence of bleeding and other complications in women with VWD who undergo hysterectomy. The United States Nationwide Inpatient Sample (NIS) from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality for the years 1988-2004 was queried for all hysterectomies for non-malignant conditions. Data were analysed based on the NIS sampling design. Bivariate analyses were used to examine the differences between women with and without VWD. Multivariate analysis was used to adjust for potential confounders among women who underwent hysterectomy for heavy menstrual bleeding. 545 of the 1 358 133 hysterectomies were to women with VWD. Women with VWD were significantly more likely to experience intraoperative and postoperative bleeding (2.75% vs. 0.89%, P < 0.001) and require transfusion (7.34% vs. 2.13%, P < 0.001) than women without VWD. One woman with VWD died. While the risk of bleeding complications from hysterectomy in women with VWD is smaller than previously reported, women with VWD did experience significantly more bleeding complications than women without VWD. Nonetheless, for women who have completed childbearing, the risks of hysterectomy may be acceptable.

Authors
James, AH; Myers, ER; Cook, C; Pietrobon, R
MLA Citation
James, AH, Myers, ER, Cook, C, and Pietrobon, R. "Complications of hysterectomy in women with von Willebrand disease." Haemophilia 15.4 (July 2009): 926-931.
PMID
19473420
Source
pubmed
Published In
Haemophilia
Volume
15
Issue
4
Publish Date
2009
Start Page
926
End Page
931
DOI
10.1111/j.1365-2516.2009.02022.x

Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial.

BACKGROUND: Although the peak incidence of human papillomavirus (HPV) infection occurs in most populations within 5-10 years of first sexual experience, all women remain at risk for acquisition of HPV infections. We tested the safety, immunogenicity, and efficacy of the quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like-particle vaccine in women aged 24-45 years. METHODS: Women aged 24-45 years with no history of genital warts or cervical disease were enrolled from community health centres, academic health centres, and primary health-care providers into an ongoing multicentre, parallel, randomised, placebo-controlled, double-blind study. Participants were allocated by computer-generated schedule to receive quadrivalent HPV vaccine (n=1911) or placebo (n=1908) at day 1, and months 2 and 6. All study site investigators and personnel, study participants, monitors, and central laboratory personnel were blinded to treatment allocation. Coprimary efficacy endpoints were 6 months' or more duration of infection and cervical and external genital disease due to HPV 6, 11, 16, 18; and due to HPV 16 and 18 alone. Primary efficacy analyses were done in a per-protocol population, but intention-to-treat analyses were also undertaken. This study is registered with ClinicalTrials.gov, number NCT00090220. FINDINGS: 1910 women received at least one dose of vaccine and 1907 at least one dose of placebo. In the per-protocol population, efficacy against the first coprimary endpoint (disease or infection related to HPV 6, 11, 16, and 18) was 90.5% (95% CI 73.7-97.5, four of 1615 cases in the vaccine group vs 41/1607 in the placebo group) and 83.1% (50.6-95.8, four of 1601 cases vs 23/1579 cases) against the second coprimary endpoint (disease or infection related to HPV 16 and 18 alone). In the intention-to-treat population, efficacy against the first coprimary endpoint was 30.9% (95% CI 11.1-46.5, 108/1886 cases vs 154/1883 cases) and against the second coprimary endpoint was 22.6% (-2.9 to 41.9, 90/1886 cases vs 115/1883 cases), since infection and disease were present at baseline. We recorded no vaccine-related serious adverse events. INTERPRETATION: The quadrivalent HPV vaccine is efficacious in women aged 24-45 years not infected with the relevant HPV types at enrolment. FUNDING: Merck (USA).

Authors
Muñoz, N; Manalastas, R; Pitisuttithum, P; Tresukosol, D; Monsonego, J; Ault, K; Clavel, C; Luna, J; Myers, E; Hood, S; Bautista, O; Bryan, J; Taddeo, FJ; Esser, MT; Vuocolo, S; Haupt, RM; Barr, E; Saah, A
MLA Citation
Muñoz, N, Manalastas, R, Pitisuttithum, P, Tresukosol, D, Monsonego, J, Ault, K, Clavel, C, Luna, J, Myers, E, Hood, S, Bautista, O, Bryan, J, Taddeo, FJ, Esser, MT, Vuocolo, S, Haupt, RM, Barr, E, and Saah, A. "Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial." Lancet 373.9679 (June 6, 2009): 1949-1957.
PMID
19493565
Source
pubmed
Published In
The Lancet
Volume
373
Issue
9679
Publish Date
2009
Start Page
1949
End Page
1957
DOI
10.1016/S0140-6736(09)60691-7

Cost-effectiveness analysis of annual screening strategies for endometrial cancer.

OBJECTIVE: The objective of the study was to determine the cost-effectiveness of annual screening tests for endometrial cancer. STUDY DESIGN: Markov state transition model of the natural history of endometrial cancer used as the design for the study. Incidence was modeled for the general population and high risk groups (obese, body mass index [BMI] of >or= 30 kg/m(2); tamoxifen users). Strategies evaluated were no screening, annual endometrial biopsy, annual endovaginal ultrasound, and annual serum screening. Serum screening was based on a recently described biomarker panel (sensitivity of 0.98, specificity of 0.98). RESULTS: In the general population model, no screening was least expensive, whereas annual serum screening age at 50-75 years had incremental cost-effectiveness ratio (ICER) of $60,363 per year of life saved (YLS) compared with no screening. In a high-risk population (obesity, BMI of >or= 30 kg/m(2)), annual serum screening at age 45-80 years had ICER of $41,226 per YLS compared with no screening. Annual endometrial biopsy and annual transvaginal ultrasound were dominated. CONCLUSION: Annual serum screening for endometrial cancer has the potential to be cost effective when applied to high-risk populations.

Authors
Havrilesky, LJ; Maxwell, GL; Myers, ER
MLA Citation
Havrilesky, LJ, Maxwell, GL, and Myers, ER. "Cost-effectiveness analysis of annual screening strategies for endometrial cancer." Am J Obstet Gynecol 200.6 (June 2009): 640.e1-640.e8.
PMID
19380121
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
200
Issue
6
Publish Date
2009
Start Page
640.e1
End Page
640.e8
DOI
10.1016/j.ajog.2009.02.022

Determination of quality of life-related utilities for health states relevant to ovarian cancer diagnosis and treatment.

OBJECTIVES: (1) To define a set of health state descriptions related to screening, diagnosis, prognosis, and toxicities relevant to ovarian cancer; (2) To derive a set of quality of life-related utilities to be used for cost-effectiveness analyses. METHODS: A comprehensive list of health states was developed to represent the experiences of diagnostic testing for ovarian cancer, natural history of ovarian cancer (e.g., newly diagnosed early stage ovarian cancer, recurrent progressive ovarian cancer) and the most common chemotherapy-related toxicities (e.g. alopecia, peripheral neuropathy, pain, neutropenia, fatigue). Valuation of each health state was obtained through individual interviews of 13 ovarian cancer patients and 37 female members of the general public. Interviews employed visual analog score (VAS) and time trade off (TTO) methods of health state valuation. RESULTS: Mean TTO-derived utilities were higher than VAS-derived utilities by 0.118 U (p<0.0001). Mean VAS-derived utilities for screening tests were 0.83 and 0.81 for true negative blood test and ultrasound; 0.79 and 0.78 for false negative blood test and ultrasound, respectively. Patients and volunteers generally agreed in their preference ranking of chemotherapy-associated states, with lowest rankings being given to febrile neutropenia, grades 3-4 fatigue, and grades 3-4 nausea/vomiting. For 55% of chemotherapy-associated health states, the average utility assigned was higher for patients than for volunteers. CONCLUSIONS: This study establishes societal preferences for a number of health states related to screening, diagnosis and treatment of ovarian cancer that can be used for assessing the cost-effectiveness of different ovarian cancer screening and treatment regimens.

Authors
Havrilesky, LJ; Broadwater, G; Davis, DM; Nolte, KC; Barnett, JC; Myers, ER; Kulasingam, S
MLA Citation
Havrilesky, LJ, Broadwater, G, Davis, DM, Nolte, KC, Barnett, JC, Myers, ER, and Kulasingam, S. "Determination of quality of life-related utilities for health states relevant to ovarian cancer diagnosis and treatment." Gynecol Oncol 113.2 (May 2009): 216-220.
PMID
19217148
Source
pubmed
Published In
Gynecologic Oncology
Volume
113
Issue
2
Publish Date
2009
Start Page
216
End Page
220
DOI
10.1016/j.ygyno.2008.12.026

Adherence to nicotine replacement therapy among pregnant smokers.

INTRODUCTION: This secondary analysis examined the association between adherence to nicotine replacement therapy (NRT) and smoking cessation among pregnant smokers enrolled in Baby Steps, an open-label randomized controlled trial testing cognitive-behavioral therapy (CBT) versus CBT plus NRT. METHOD: The analysis included only women who received NRT for whom we had complete data (N = 104). Data came from daily calendars created from recordings of counseling sessions and from telephone surveys at baseline and 38 weeks gestation. RESULTS: Overall, 29% of the 104 women used NRT for the recommended 6 weeks and 41% used NRT as directed in the first 48 hr after a quit attempt. Ordinal logistic regression modeling indicated that using NRT as directed in the first 48 hr and having made a previous quit attempt were the strongest predictors of longer NRT use. Univariate analyses suggested that primigravid women and women who used NRT longer were more likely to report quitting at 38 weeks gestation. DISCUSSION: Findings indicated that adherence to NRT is low among pregnant smokers, but adherence was a predictor of cessation. Future trials should emphasize adherence, particularly more days on NRT, to promote cessation during pregnancy.

Authors
Fish, LJ; Peterson, BL; Namenek Brouwer, RJ; Lyna, P; Oncken, CA; Swamy, GK; Myers, ER; Pletsch, PK; Pollak, KI
MLA Citation
Fish, LJ, Peterson, BL, Namenek Brouwer, RJ, Lyna, P, Oncken, CA, Swamy, GK, Myers, ER, Pletsch, PK, and Pollak, KI. "Adherence to nicotine replacement therapy among pregnant smokers." Nicotine Tob Res 11.5 (May 2009): 514-518.
PMID
19351783
Source
pubmed
Published In
Nicotine and Tobacco Research (OUP)
Volume
11
Issue
5
Publish Date
2009
Start Page
514
End Page
518
DOI
10.1093/ntr/ntp032

A prospective study of weight gain after premenopausal hysterectomy.

PURPOSE: Many women who have had hysterectomies have the perception that they gained weight after surgery that cannot be attributed to changes in diet or physical activity. The purpose of this analysis was to assess weight gain in premenopausal women in the first year after hysterectomy compared with a control group of women with intact uteri and ovaries. METHODS: As part of a prospective cohort study designed to assess the risk for ovarian failure after premenopausal hysterectomy, weight was measured at baseline and 1-year follow-up in 236 women undergoing hysterectomy and 392 control women. Changes in measured weight and reported weight were assessed. Unconditional logistic regression analyses were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for weight gains of >10 pounds. RESULTS: Women with hysterectomies weighed more and had a higher mean body mass index (BMI) than control women at baseline. Mean weight gain was 1.36 kg ( approximately 3 pounds) for women with hysterectomies vs. 0.61 kg ( approximately 1.3 pounds) for control women (p = 0.07). Weight gain of >10 pounds occurred in 23% of women with hysterectomies compared with 15% of control women (multivariable OR = 1.61, 95% CI 1.04 = 2.48). CONCLUSIONS: Women undergoing hysterectomies appear to be at higher risk for weight gain in the first year after surgery. Heavier women and women who have had weight fluctuations throughout adulthood may be at greater risk for postsurgical weight gain, suggesting that lifestyle interventions to maintain or lose weight may be particularly helpful for these women in the months following hysterectomy.

Authors
Moorman, PG; Schildkraut, JM; Iversen, ES; Myers, ER; Gradison, M; Warren-White, N; Wang, F
MLA Citation
Moorman, PG, Schildkraut, JM, Iversen, ES, Myers, ER, Gradison, M, Warren-White, N, and Wang, F. "A prospective study of weight gain after premenopausal hysterectomy." J Womens Health (Larchmt) 18.5 (May 2009): 699-708.
PMID
19445617
Source
pubmed
Published In
Journal of Women's Health
Volume
18
Issue
5
Publish Date
2009
Start Page
699
End Page
708
DOI
10.1089/jwh.2008.1019

Cost-effectiveness of botulinum toxin a versus anticholinergic medications for idiopathic urge incontinence.

PURPOSE: We assessed the cost-effectiveness of botulinum toxin A injection compared to anticholinergic medications for the treatment of idiopathic urge incontinence. MATERIALS AND METHODS: A Markov decision analysis model was developed to compare the costs in 2008 U. S. dollars and effectiveness in quality adjusted life-years of botulinum toxin A injection and anticholinergic medications. The analysis was conducted from a societal perspective with a 2-year time frame using 3-month cycles. The primary outcome was the incremental cost-effectiveness ratio, defined as the difference in cost (botulinum toxin A cost--anticholinergic cost) divided by the difference in effectiveness (botulinum toxin A quality adjusted life-years--anticholinergic quality adjusted life-years). RESULTS: While the botulinum strategy was more expensive ($4,392 vs $2,563) it was also more effective (1.63 vs 1.50 quality adjusted life-years) compared to the anticholinergic regimen. The calculated incremental cost-effectiveness ratio was $14,377 per quality adjusted life-year, meaning that botulinum toxin A cost $14,377 per quality adjusted life-year gained. A strategy is often considered cost-effective when the incremental cost-effectiveness ratio is less than $50,000 per quality adjusted life-year. Given this definition botulinum toxin A is cost-effective compared to anticholinergics. To determine if there are situations in which anticholinergics would become cost-effective we performed sensitivity analyses. Anticholinergics become cost-effective if compliance exceeds 75% (33% in the base case) and if the botulinum toxin A procedure cost exceeds $3,875 ($1,690 in the base case). For the remainder of the sensitivity analyses botulinum toxin A remained cost-effective. CONCLUSIONS: Botulinum toxin A injection was cost-effective compared to anticholinergic medications for the treatment of refractory urge incontinence. Anticholinergics become cost-effective if patients are highly compliant with medications or if the botulinum procedure costs increase substantially.

Authors
Wu, JM; Siddiqui, NY; Amundsen, CL; Myers, ER; Havrilesky, LJ; Visco, AG
MLA Citation
Wu, JM, Siddiqui, NY, Amundsen, CL, Myers, ER, Havrilesky, LJ, and Visco, AG. "Cost-effectiveness of botulinum toxin a versus anticholinergic medications for idiopathic urge incontinence." J Urol 181.5 (May 2009): 2181-2186.
PMID
19296983
Source
pubmed
Published In
The Journal of Urology
Volume
181
Issue
5
Publish Date
2009
Start Page
2181
End Page
2186
DOI
10.1016/j.juro.2009.01.037

The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years.

BACKGROUND: Human papillomavirus (HPV)-6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18-related cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1-3/AIS associated with nonvaccine oncogenic HPV types was evaluated. METHODS: We enrolled 17,622 women aged 16-26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotyping was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of 6 months' duration and CIN1-3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types. RESULTS: Vaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1-3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/33/45/52/58 infection and CIN1-3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2-3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31. CONCLUSIONS: HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for approximately 20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18-related disease, because women may have >1 CIN lesion, each associated with a different HPV type. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.

Authors
Brown, DR; Kjaer, SK; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Wheeler, CM; Perez, G; Koutsky, LA; Tay, EH; Garcia, P; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Steben, M; Bosch, FX; Dillner, J; Joura, EA; Kurman, RJ; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, J; Lupinacci, LC; Giacoletti, KED; Sings, HL; James, M; Hesley, TM; Barr, E
MLA Citation
Brown, DR, Kjaer, SK, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Wheeler, CM, Perez, G, Koutsky, LA, Tay, EH, Garcia, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Steben, M, Bosch, FX, Dillner, J, Joura, EA, Kurman, RJ, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Lupinacci, LC, Giacoletti, KED, Sings, HL, James, M, Hesley, TM, and Barr, E. "The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years." J Infect Dis 199.7 (April 1, 2009): 926-935.
PMID
19236279
Source
pubmed
Published In
Journal of Infectious Diseases
Volume
199
Issue
7
Publish Date
2009
Start Page
926
End Page
935
DOI
10.1086/597307

The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years.

BACKGROUND: We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment. METHODS: Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received 1 dose and returned for follow-up were included. RESULTS: Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant. CONCLUSIONS: These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and -18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.

Authors
Wheeler, CM; Kjaer, SK; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; García, P; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Steben, M; Bosch, FX; Dillner, J; Joura, EA; Kurman, RJ; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, J; Lupinacci, LC; Giacoletti, KED; James, M; Vuocolo, S; Hesley, TM; Barr, E
MLA Citation
Wheeler, CM, Kjaer, SK, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Steben, M, Bosch, FX, Dillner, J, Joura, EA, Kurman, RJ, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Lupinacci, LC, Giacoletti, KED, James, M, Vuocolo, S, Hesley, TM, and Barr, E. "The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years." J Infect Dis 199.7 (April 1, 2009): 936-944.
PMID
19236277
Source
pubmed
Published In
Journal of Infectious Diseases
Volume
199
Issue
7
Publish Date
2009
Start Page
936
End Page
944
DOI
10.1086/597309

Cost effectiveness of a test to detect metastases for endometrial cancer.

OBJECTIVE: To estimate the potential cost-effectiveness of a hypothetical test to screen for lymph node metastases in women with newly diagnosed, apparent early stage endometrial cancer. METHODS: A decision model was constructed to inform a choice between the following strategies: (1) Usual care, in which the probability of undergoing full surgical staging (29%) is based on literature review; (2) Non-invasive diagnostic testing for metastasis (Testing), in which patients with abnormal test results undergo full surgical staging; (3) 100% referral, in which all patients are referred for full surgical staging. Survival was modeled using Surveillance Epidemiology and End Results (SEER) database. Base case diagnostic test characteristic estimates (sensitivity 0.90, specificity 0.90) were varied for sensitivity analysis. Cost of the diagnostic test was set at $500 and varied; costs of treatment for endometrial cancer (surgery, adjuvant therapies, diagnosis of recurrence, salvage therapies and palliative care) were incorporated. RESULTS: Usual care was the least expensive strategy, while Testing was more expensive and more effective, with an incremental cost-effectiveness ratio (ICER) of $18,785 per year of life saved (YLS) compared to Usual care. 100% referral was the most expensive and most effective strategy, with an ICER of $35,358 per YLS compared to Testing. Results are relatively sensitive to variation in test characteristics and the cost of the diagnostic test but insensitive to cost of treatment and probability of adjuvant therapies. Testing remains cost-effective compared to Usual care unless the usual rate of referral to a Gynecologic Oncologist for full staging exceeds 90%. CONCLUSIONS: Given the current low rates of full surgical staging and/or referral to a Gynecologic Oncologist, a diagnostic test to detect nodal metastasis for endometrial cancer has potential to be cost-effective when compared to usual care. Testing is also potentially cost-effective compared to 100% referral at very high test sensitivities and at the lower range of test costs.

Authors
Havrilesky, LJ; Maxwell, GL; Chan, JK; Myers, ER
MLA Citation
Havrilesky, LJ, Maxwell, GL, Chan, JK, and Myers, ER. "Cost effectiveness of a test to detect metastases for endometrial cancer." Gynecol Oncol 112.3 (March 2009): 526-530.
PMID
19100608
Source
pubmed
Published In
Gynecologic Oncology
Volume
112
Issue
3
Publish Date
2009
Start Page
526
End Page
530
DOI
10.1016/j.ygyno.2008.11.017

Cost analysis of ovarian cancer chemotherapy based on the use of a chemoresponse assay

Authors
Havrilesky, LJ; Krivak, TC; Mucenski, JW; Myers, ER
MLA Citation
Havrilesky, LJ, Krivak, TC, Mucenski, JW, and Myers, ER. "Cost analysis of ovarian cancer chemotherapy based on the use of a chemoresponse assay." GYNECOLOGIC ONCOLOGY 112.2 (February 2009): S22-S22.
Source
wos-lite
Published In
Gynecologic Oncology
Volume
112
Issue
2
Publish Date
2009
Start Page
S22
End Page
S22

Reductions in human papillomavirus-disease resource use and costs with quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccination: the FUTURE Study Economic Evaluation.

OBJECTIVE: To examine the short-term impact of quadrivalent human papillomavirus (HPV) (types 6/11/16/18) recombinant vaccination upon HPV disease-related health-care resource utilization and costs among young women. METHODS: We analyzed data from a randomized clinical trial comparing quadrivalent vaccination to placebo, among women (N = 7861) primarily 16 to 23 years of age at enrollment. HPV disease episodes, health-care resource utilization and costs associated with cervical, vaginal, and vulvar precancers, and anogenital warts were analyzed over a period of 2.5 years among women, regardless of baseline HPV status. RESULTS: Overall, there was a 25.9% (P < 0.001) reduction in total HPV disease-related health-care costs among women receiving vaccine versus placebo (absolute reduction $3939 per 100 trial enrollees). We observed similar overall reductions in HPV-disease episodes and resource utilization. There was a statistically significant reduction in HPV 6/11-related disease episode costs of 65.1% ($1837 per 100), and a reduction of 51.4% ($1781 per 100) in HPV 16/18-related episode costs. CONCLUSIONS: Quadrivalent HPV vaccination can reduce HPV disease events, resource use and costs when administered to a broad population of young women 16 to 23 years of age. Prevention of HPV types 6 and 11 yielded similar value in terms of HPV disease cost offsets, compared to protection against HPV 16 and 18, during the years initially after vaccination. Over the short-term, costs of vaccination exceed cost offsets associated with prevention of HPV disease; however, quadrivalent HPV vaccination has previously been shown to be cost-effective in the longer term, when fully accounting for health benefits and cost offsets.

Authors
Insinga, RP; Dasbach, EJ; Allen, SE; Carides, GW; Myers, ER
MLA Citation
Insinga, RP, Dasbach, EJ, Allen, SE, Carides, GW, and Myers, ER. "Reductions in human papillomavirus-disease resource use and costs with quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccination: the FUTURE Study Economic Evaluation." Value Health 11.7 (December 2008): 1022-1032.
PMID
18489503
Source
pubmed
Published In
Value in Health
Volume
11
Issue
7
Publish Date
2008
Start Page
1022
End Page
1032
DOI
10.1111/j.1524-4733.2008.00342.x

Complications of Hysterectomy in Women with Von Willebrand Disease

Authors
James, AH; Myers, ER; Cook, C; Pietrobon, R
MLA Citation
James, AH, Myers, ER, Cook, C, and Pietrobon, R. "Complications of Hysterectomy in Women with Von Willebrand Disease." BLOOD 112.11 (November 16, 2008): 1166-1166.
Source
wos-lite
Published In
Blood
Volume
112
Issue
11
Publish Date
2008
Start Page
1166
End Page
1166

Reducing ovarian cancer mortality through screening: Is it possible, and can we afford it?

OBJECTIVE: Ovarian cancer is a leading cause of cancer-related deaths among women. Given the low prevalence of this disease, the effectiveness of screening strategies has not been established. We wished to estimate the clinical impact and cost-effectiveness of potential screening strategies for ovarian cancer using population-specific data. METHODS: A Markov state transition model to simulate the natural history of ovarian cancer in a cohort of women age 20 to 100. Age-specific incidence and mortality rates were obtained from SEER. Base-case characteristics of a potential screening test were sensitivity 85%, specificity 95%, and cost $50. Outcome measures were mortality reduction, lifetime number of false positive screening tests, positive predictive value, years of life saved (YLS), lifetime costs in US dollars, and incremental cost-effectiveness ratios (ICER, in cost/YLS). RESULTS: Model-predicted lifetime risk of ovarian cancer (1.38%), lifetime risk of death from ovarian cancer (0.95%), and stage distribution (stage I-19%; stage II-7%; stage III, IV, or unstaged - 74%) closely approximated SEER data. Annual screening resulted in 43% reduction in ovarian cancer mortality, with ICER of $73,469/YLS (base case) and $36,025/YLS (high-risk population) compared to no screening. In the base case, the average lifetime number of false positive tests is 1.06. Cost-effectiveness of screening is most sensitive to test frequency, specificity and cost. CONCLUSIONS: Annual screening for ovarian cancer has the potential to be cost effective, particularly in high-risk populations. Clinically acceptable positive predictive values are achieved if specificity exceeds 99%. Mortality reduction above 50% may not be achievable without screening intervals less than 12 months.

Authors
Havrilesky, LJ; Sanders, GD; Kulasingam, S; Myers, ER
MLA Citation
Havrilesky, LJ, Sanders, GD, Kulasingam, S, and Myers, ER. "Reducing ovarian cancer mortality through screening: Is it possible, and can we afford it?." Gynecol Oncol 111.2 (November 2008): 179-187.
PMID
18722004
Source
pubmed
Published In
Gynecologic Oncology
Volume
111
Issue
2
Publish Date
2008
Start Page
179
End Page
187
DOI
10.1016/j.ygyno.2008.07.006

Medication adherence and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome Trial.

We investigated whether poor adherence with metformin tablets may have contributed to the poor success rates seen in the metformin-containing arms of the Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial. Median adherence for both metformin and clomiphene citrate tablets was within acceptable limits and unrelated to ovulation: thus, failure to comply with physician recommendations for metformin dosing was not the reason for low ovulation and pregnancy rates in the PPCOS Trial.

Authors
McGovern, PG; Carson, SA; Barnhart, HX; Myers, ER; Legro, RS; Diamond, MP; Carr, BR; Schlaff, WD; Coutifaris, C; Cataldo, NA; Steinkampf, MP; Nestler, JE; Gosman, G; Leppert, PC; Giudice, LC; National Institute of Child Health and Human Development-Reproductive Medicine Network,
MLA Citation
McGovern, PG, Carson, SA, Barnhart, HX, Myers, ER, Legro, RS, Diamond, MP, Carr, BR, Schlaff, WD, Coutifaris, C, Cataldo, NA, Steinkampf, MP, Nestler, JE, Gosman, G, Leppert, PC, Giudice, LC, and National Institute of Child Health and Human Development-Reproductive Medicine Network, . "Medication adherence and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome Trial." Fertil Steril 90.4 (October 2008): 1283-1286.
PMID
18082737
Source
pubmed
Published In
Fertility and Sterility
Volume
90
Issue
4
Publish Date
2008
Start Page
1283
End Page
1286
DOI
10.1016/j.fertnstert.2007.09.004

Cesarean Delivery on Maternal Request Versus Planned Vaginal Delivery: A Decision Analysis To Identify Important Outcomes and To Prioritize Future Research Directions

Authors
Wu, JM; Visco, AG; Myers, ER
MLA Citation
Wu, JM, Visco, AG, and Myers, ER. "Cesarean Delivery on Maternal Request Versus Planned Vaginal Delivery: A Decision Analysis To Identify Important Outcomes and To Prioritize Future Research Directions." JOURNAL OF WOMENS HEALTH 17.8 (October 2008): 1249-1249.
Source
wos-lite
Published In
Journal of Women's Health
Volume
17
Issue
8
Publish Date
2008
Start Page
1249
End Page
1249

Descriptive evidence that risk profiles for cervical intraepithelial neoplasia 1, 2, and 3 are unique.

OBJECTIVE: This study aimed to estimate if risk factor profiles for histologically confirmed cervical intraepithelial neoplasia (CIN) 2 lesions differ from those for CIN 1 or 3. METHODS: A total of 2,055 women positive for high-risk human papillomavirus, with a minimum of five cervical biopsies, were enrolled in the Shanxi Province Cervical Cancer Screening Study II. We evaluated risk factor profiles for CIN 2 in comparison with CIN 1 and 3. Polytomous logistic regression was used to generate odds ratios and corresponding 95% confidence intervals and to test for differences in odds ratios across histologic grades. RESULTS: The risk for CIN 3 associated with three or more pregnancies and sexual intercourse within 4 months of childbirth was higher than that for CIN 2 (P(difference) = 0.02 and 0.0007, respectively). Significant differences in the associations of age groups with CIN 1 and 2 were observed, such that there were positive associations with CIN 2 but none for CIN 1. There was no difference in the association of number of sexual partners or reported number of abortions between CIN 1 and 2 or between CIN 3 and 2. CONCLUSIONS: In our study, the patterns of risk factor profiles for CIN 1, 2, and 3 were unique. Conventional grouping of CIN 2 with 3 for analysis of risk factors may need revisiting.

Authors
Belinson, S; Smith, JS; Myers, E; Olshan, A; Belinson, J; Pretorius, R; Qiao, Y-L; Hartmann, K
MLA Citation
Belinson, S, Smith, JS, Myers, E, Olshan, A, Belinson, J, Pretorius, R, Qiao, Y-L, and Hartmann, K. "Descriptive evidence that risk profiles for cervical intraepithelial neoplasia 1, 2, and 3 are unique." Cancer Epidemiol Biomarkers Prev 17.9 (September 2008): 2350-2355.
PMID
18768503
Source
pubmed
Published In
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
Volume
17
Issue
9
Publish Date
2008
Start Page
2350
End Page
2355
DOI
10.1158/1055-9965.EPI-08-0004

Extended-release metformin does not reduce the clomiphene citrate dose required to induce ovulation in polycystic ovary syndrome.

CONTEXT: When used for ovulation induction, higher doses of clomiphene may lead to antiestrogenic side effects that reduce fecundity. It has been suggested that metformin in combination with clomiphene can restore ovulation to some clomiphene-resistant anovulators with polycystic ovary syndrome (PCOS). OBJECTIVE: Our objective was to determine if cotreatment with extended-release metformin (metformin XR) can lower the threshold dose of clomiphene needed to induce ovulation in women with PCOS. DESIGN: A secondary analysis of data from the National Institute of Child Health and Human Development Cooperative Multicenter Reproductive Medicine Network prospective, double-blind, placebo-controlled multicenter clinical trial, Pregnancy in Polycystic Ovary Syndrome, was performed. SETTING: Study volunteers at multiple academic medical centers were included. PARTICIPANTS: Women with PCOS and elevated serum testosterone who were randomized to clomiphene alone or with metformin (n = 209 in each group) were included in the study. INTERVENTIONS: Clomiphene citrate, 50 mg daily for 5 d, was increased to 100 and 150 mg in subsequent cycles if ovulation was not achieved; half also received metformin XR, 1000 mg twice daily. Treatment was for up to 30 wk or six cycles, or until first pregnancy. MAIN OUTCOME MEASURES: Ovulation was confirmed by a serum progesterone more than or equal to 5 ng/ml, drawn prospectively every 1-2 wk. RESULTS: The overall prevalence of at least one ovulation after clomiphene was 75 and 83% (P = 0.04) for the clomiphene-only and clomiphene plus metformin groups, respectively. Using available data from 314 ovulators, the frequency distribution of the lowest clomiphene dose (50, 100, or 150 mg daily) resulting in ovulation was indistinguishable between the two treatment groups. CONCLUSION: Metformin XR does not reduce the lowest dose of clomiphene that induces ovulation in women with PCOS.

Authors
Cataldo, NA; Barnhart, HX; Legro, RS; Myers, ER; Schlaff, WD; Carr, BR; Diamond, MP; Carson, SA; Steinkampf, MP; Coutifaris, C; McGovern, PG; Gosman, G; Nestler, JE; Giudice, LC; Reproductive Medicine Network,
MLA Citation
Cataldo, NA, Barnhart, HX, Legro, RS, Myers, ER, Schlaff, WD, Carr, BR, Diamond, MP, Carson, SA, Steinkampf, MP, Coutifaris, C, McGovern, PG, Gosman, G, Nestler, JE, Giudice, LC, and Reproductive Medicine Network, . "Extended-release metformin does not reduce the clomiphene citrate dose required to induce ovulation in polycystic ovary syndrome." J Clin Endocrinol Metab 93.8 (August 2008): 3124-3127.
PMID
18505764
Source
pubmed
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
93
Issue
8
Publish Date
2008
Start Page
3124
End Page
3127
DOI
10.1210/jc.2008-0287

A national study of the complications of lupus in pregnancy.

OBJECTIVE: This study was undertaken to determine the risk of rare complications during pregnancy for women with systemic lupus erythematosus. STUDY DESIGN: By using the Nationwide Inpatient Sample from 2000-2003, we compared maternal and pregnancy complications for all pregnancy-related admissions for women with and without systemic lupus erythematosus. RESULTS: Of more than 16.7 million admissions for childbirth over the 4 years, 13,555 were to women with systemic lupus erythematosus. Maternal mortality was 20-fold higher among women with systemic lupus erythematosus. The risks for thrombosis, infection, thrombocytopenia, and transfusion were each 3- to 7-fold higher for women with systemic lupus erythematosus. Lupus patients also had a higher risk for cesarean sections (odds ratio: 1.7), preterm labor (odds ratio: 2.4), and preeclampsia (odds ratio: 3.0) than other women. Women with systemic lupus erythematosus were more likely to have other medical conditions, including diabetes, hypertension, and thrombophilia, that are associated with adverse pregnancy outcomes. CONCLUSION: Women with systemic lupus erythematosus are at increased risk for serious medical and pregnancy complications during pregnancy.

Authors
Clowse, MEB; Jamison, M; Myers, E; James, AH
MLA Citation
Clowse, MEB, Jamison, M, Myers, E, and James, AH. "A national study of the complications of lupus in pregnancy." Am J Obstet Gynecol 199.2 (August 2008): 127.e1-127.e6.
PMID
18456233
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
199
Issue
2
Publish Date
2008
Start Page
127.e1
End Page
127.e6
DOI
10.1016/j.ajog.2008.03.012

Weight gain after pre-menopausal hysterectomy

Authors
Moorman, PG; Schildkraut, JM; Myers, ER; Iversen, ES; Warren-White, N; Wang, F
MLA Citation
Moorman, PG, Schildkraut, JM, Myers, ER, Iversen, ES, Warren-White, N, and Wang, F. "Weight gain after pre-menopausal hysterectomy." June 1, 2008.
Source
wos-lite
Published In
American Journal of Epidemiology
Volume
167
Issue
11
Publish Date
2008
Start Page
S32
End Page
S32

The current and future role of screening in the era of HPV vaccination.

With the introduction of cervical screening programs, the incidence and mortality of cervical cancer has been drastically reduced. Techniques such as the traditional Papanicolaou test and the newer liquid-based cytology allow for the early detection of cervical abnormalities prior to the development of invasive cervical cancer. As oncogenic human papillomavirus (HPV) infection is necessary for cervical cancer, HPV-DNA testing has also been proposed as a routine screening method for the general population. Screening limitations, such as adherence, test sensitivity and specificity, access, and cost-effectiveness are reflected in current screening guidelines. The development of prophylactic cervical cancer vaccines is a major milestone in cervical cancer prevention. These vaccines protect against the initial infection of certain oncogenic HPV types, and therefore prevent the development of cervical dysplasia, precancerous lesions, and cervical cancer. Considering routine cervical cancer vaccination in adolescent girls, screening guidelines must adapt in order to retain efficient and cost-effective prevention measures. Although the true epidemiological and economic impact of cervical cancer vaccines cannot be immediately realized, mathematical models predict various scenarios in which vaccination, in addition to cervical screening, will be cost-effective and further reduce cervical cancer disease.

Authors
Myers, E; Huh, WK; Wright, JD; Smith, JS
MLA Citation
Myers, E, Huh, WK, Wright, JD, and Smith, JS. "The current and future role of screening in the era of HPV vaccination." Gynecol Oncol 109.2 Suppl (May 2008): S31-S39. (Review)
PMID
18482556
Source
pubmed
Published In
Gynecologic Oncology
Volume
109
Issue
2 Suppl
Publish Date
2008
Start Page
S31
End Page
S39
DOI
10.1016/j.ygyno.2008.02.001

Effectiveness of assisted reproductive technology (ART).

OBJECTIVES: We reviewed the evidence regarding the outcomes of interventions used in ovulation induction, superovulation, and in vitro fertilization (IVF) for the treatment of infertility. Short-term outcomes included pregnancy, live birth, multiple gestation, and complications. Long-term outcomes included pregnancy and post-pregnancy complications for both mothers and infants. DATA SOURCES: MEDLINE and Cochrane Collaboration resources. REVIEW METHODS: We included studies published in English from January 2000 through January 2008. For short-term outcomes, we excluded non-randomized studies and studies where a pregnancy or live birth rate per subject could not be calculated. For long-term outcomes, we excluded studies with fewer than 100 subjects and those without a control group. Articles were abstracted for relevant details, and relative risks or odds ratios, with 95 percent confidence intervals, were calculated for outcomes of interest for each study. RESULTS: We identified 5294 abstracts and (for the three questions discussed in this draft report) reviewed 1210 full-text articles and included 478 articles for abstraction. Approximately 80 percent of the included studies were performed outside the United States. The majority of randomized trials were not designed to detect differences in pregnancy and live birth rates; reporting of delivery rates and obstetric outcomes was unusual. Most did not have sufficient power to detect clinically meaningful differences in live birth rates, and had still lower power to detect differences in less frequent outcomes such as multiple births and complications. Interventions for which there was sufficient evidence to demonstrate improved pregnancy or live birth rates included: (a) administration of clomiphene citrate in women with polycystic ovarian syndrome, (b) metformin plus clomiphene in women who fail to respond to clomiphene alone; (c) ultrasound-guided embryo transfer, and transfer on day 5 post-fertilization, in couples with a good prognosis; and (d) assisted hatching in couples with previous IVF failure. There was insufficient evidence regarding other interventions. Infertility itself is associated with most of the adverse longer-term outcomes. Consistently, infants born after infertility treatments are at risk for complications associated with abnormal implantation or placentation; the degree to which this is due to the underlying infertility, treatment, or both is unclear. Infertility, but not infertility treatment, is associated with an increased risk of breast and ovarian cancer. CONCLUSIONS: Despite the large emotional and economic burden resulting from infertility, there is relatively little high-quality evidence to support the choice of specific interventions. Removing barriers to conducting appropriately designed studies should be a major policy goal.

Authors
Myers, ER; McCrory, DC; Mills, AA; Price, TM; Swamy, GK; Tantibhedhyangkul, J; Wu, JM; Matchar, DB
MLA Citation
Myers, ER, McCrory, DC, Mills, AA, Price, TM, Swamy, GK, Tantibhedhyangkul, J, Wu, JM, and Matchar, DB. "Effectiveness of assisted reproductive technology (ART)." Evid Rep Technol Assess (Full Rep) 167 (May 2008): 1-195. (Review)
PMID
18620469
Source
pubmed
Published In
Evidence report/technology assessment
Issue
167
Publish Date
2008
Start Page
1
End Page
195

The economic impact of HPV vaccines: not just cervical cancer.

Authors
Myers, ER
MLA Citation
Myers, ER. "The economic impact of HPV vaccines: not just cervical cancer." Am J Obstet Gynecol 198.5 (May 2008): 487-488.
PMID
18455522
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
198
Issue
5
Publish Date
2008
Start Page
487
End Page
488
DOI
10.1016/j.ajog.2008.03.056

Ovulatory response to treatment of polycystic ovary syndrome is associated with a polymorphism in the STK11 gene.

CONTEXT: Clomiphene and insulin sensitizers such as metformin are used to induce ovulation in polycystic ovary syndrome (PCOS), but the ovulatory response is variable, and the causes of this variation are poorly understood. OBJECTIVE: Our objective was to identify predictive genetic polymorphisms and other determinants of ovulatory response. DESIGN: This was a substudy of a multicenter randomized clinical trial. SETTING: This study was performed at academic medical centers and their affiliates. PARTICIPANTS: A total of 312 women with PCOS were included in the study. MAIN OUTCOME MEASURES: Historical, biometric, biochemical, and genetic parameters were performed. RESULTS: We found that the C allele of a single nucleotide polymorphism in the STK11 gene (expressed in liver; also known as LKB1) was associated with a significantly decreased chance of ovulation in PCOS women treated with metformin. In an analysis of ovulation per cycle, the adjusted odds ratio (OR) comparing the C/C genotype to the G/G genotype was 0.30 [95% confidence interval (CI) 0.14, 0.66], and the OR for the C/G genotype vs. the G/G genotype was also 0.30 (95% CI 0.14, 0.66). In an analysis of metformin-treated subjects, we found that the percentage of women who ovulated increased with the number of G alleles present: 48% (10 of 21) of C/C women, 67% (32 of 48) of C/G women, and 79% (15 of 19) of G/G women ovulated. We also found that increased frequency of ovulation was associated with lower body mass index (BMI) [adjusted OR of 2.36 (95% CI 1.65, 3.36) and 2.05 (95% CI 1.46, 2.88), respectively, for comparisons of BMI less than 30 vs. BMI equal to or more than 35, BMI 30-34 vs. BMI equal to or more than 35, in the analysis of ovulation per cycle], a lower free androgen index (FAI) [adjusted OR of 1.59 (95% CI 1.17, 2.18) for FAI<10 vs. FAI>or=10], and a shorter duration of attempting conception [adjusted OR of 1.63 (95% CI 1.20, 2.21) for<1.5 vs.>or=1.5 yr]. CONCLUSIONS: We have demonstrated that a polymorphism in STK11, a kinase gene expressed in liver and implicated in metformin action, is associated with ovulatory response to treatment with metformin alone in a prospective randomized trial. The interaction with the effects of changes in modifiable factors (e.g. BMI or FAI) requires further study.

Authors
Legro, RS; Barnhart, HX; Schlaff, WD; Carr, BR; Diamond, MP; Carson, SA; Steinkampf, MP; Coutifaris, C; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Giudice, LC; Ewens, KG; Spielman, RS; Leppert, PC; Myers, ER; Reproductive Medicine Network,
MLA Citation
Legro, RS, Barnhart, HX, Schlaff, WD, Carr, BR, Diamond, MP, Carson, SA, Steinkampf, MP, Coutifaris, C, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Giudice, LC, Ewens, KG, Spielman, RS, Leppert, PC, Myers, ER, and Reproductive Medicine Network, . "Ovulatory response to treatment of polycystic ovary syndrome is associated with a polymorphism in the STK11 gene." J Clin Endocrinol Metab 93.3 (March 2008): 792-800.
PMID
18000088
Source
pubmed
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
93
Issue
3
Publish Date
2008
Start Page
792
End Page
800
DOI
10.1210/jc.2007-1736

Can screening for ovarian cancer achieve mortality reduction and be cost effective?

Authors
Havrilesky, LJ; Kulasingam, S; Sanders, G; Myers, ER
MLA Citation
Havrilesky, LJ, Kulasingam, S, Sanders, G, and Myers, ER. "Can screening for ovarian cancer achieve mortality reduction and be cost effective?." GYNECOLOGIC ONCOLOGY 108.3 (March 2008): S114-S115.
Source
wos-lite
Published In
Gynecologic Oncology
Volume
108
Issue
3
Publish Date
2008
Start Page
S114
End Page
S115

Cost effectiveness of annual screening strategies for endometrial cancer

Authors
Havrilesky, LJ; Maxwell, G; Myers, ER
MLA Citation
Havrilesky, LJ, Maxwell, G, and Myers, ER. "Cost effectiveness of annual screening strategies for endometrial cancer." GYNECOLOGIC ONCOLOGY 108.3 (March 2008): S7-S7.
Source
wos-lite
Published In
Gynecologic Oncology
Volume
108
Issue
3
Publish Date
2008
Start Page
S7
End Page
S7

Adding a quadrivalent human papillomavirus vaccine to the UK cervical cancer screening programme: A cost-effectiveness analysis.

BACKGROUND: We assessed the cost-effectiveness of adding a quadrivalent (6/11/16/18) human papillomavirus (HPV) vaccine to the current screening programme in the UK compared to screening alone. METHODS: A Markov model of the natural history of HPV infection incorporating screening and vaccination was developed. A vaccine that prevents 98% of HPV 6, 11, 16 and 18-associated disease, with a lifetime duration and 85% coverage, in conjunction with current screening was considered. RESULTS: Vaccination with screening, compared to screening alone, was associated with an incremental cost-effectiveness ratio of pound21,059 per quality adjusted life year (QALY) and pound34,687 per life year saved (LYS). More than 400 cases of cervical cancer, 6700 cases of cervical intraepithelial neoplasia and 4750 cases of genital warts could be avoided per 100,000 vaccinated girls. Results were sensitive to assumptions about the need for a booster, the duration of vaccine efficacy and discount rate. CONCLUSION: These analyses suggest that adding a quadrivalent HPV vaccine to current screening in the UK could be a cost-effective method for further reducing the burden of cervical cancer.

Authors
Kulasingam, SL; Benard, S; Barnabas, RV; Largeron, N; Myers, ER
MLA Citation
Kulasingam, SL, Benard, S, Barnabas, RV, Largeron, N, and Myers, ER. "Adding a quadrivalent human papillomavirus vaccine to the UK cervical cancer screening programme: A cost-effectiveness analysis. (Published online)" Cost Eff Resour Alloc 6 (February 15, 2008): 4-.
PMID
18279515
Source
pubmed
Published In
Cost Effectiveness and Resource Allocation
Volume
6
Publish Date
2008
Start Page
4
DOI
10.1186/1478-7547-6-4

Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry.

OBJECTIVE: To assess long-term clinical outcomes of uterine artery embolization across a wide variety of practice settings in a large patient cohort. METHODS: The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization was a 3-year, single-arm, prospective, multi-center longitudinal study of the short- and long-term outcomes of uterine artery embolization for leiomyomata. Two thousand one hundred twelve patients with symptomatic leiomyomata were eligible for long-term follow-up at 27 sites representing a geographically diverse set of practices, including academic centers, community hospitals, and closed-panel health maintenance organizations. At 36 months after treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The primary measures of outcome were the symptom and health-related quality-of-life scores from the Uterine Fibroid Symptom and Quality of Life questionnaire. RESULTS: Mean symptom scores improved 41.41 points (P<.001), and the quality of life scores improved 41.47 points (P<.001), both moving into the normal range for this questionnaire. The improvements were independent of practice setting. During the 3 years of the study, Kaplan-Meier estimates of hysterectomy, myomectomy, or repeat uterine artery embolization were 9.79%, 2.82%, and 1.83% of the patients, respectively. CONCLUSION: Uterine artery embolization results in a durable improvement in quality of life. These results are achievable when the procedure is performed in any experienced community or academic interventional radiology practice. LEVEL OF EVIDENCE: III.

Authors
Goodwin, SC; Spies, JB; Worthington-Kirsch, R; Peterson, E; Pron, G; Li, S; Myers, ER; Fibroid Registry for Outcomes Data (FIBROID) Registry Steering Committee and Core Site Investigators,
MLA Citation
Goodwin, SC, Spies, JB, Worthington-Kirsch, R, Peterson, E, Pron, G, Li, S, Myers, ER, and Fibroid Registry for Outcomes Data (FIBROID) Registry Steering Committee and Core Site Investigators, . "Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry." Obstet Gynecol 111.1 (January 2008): 22-33.
PMID
18165389
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
111
Issue
1
Publish Date
2008
Start Page
22
End Page
33
DOI
10.1097/01.AOG.0000296526.71749.c9

HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers. © 2008 Elsevier Ltd. All rights reserved.

Authors
Joura, EA; Kjaer, SK; Wheeler, CM; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; García, P; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Lehtinen, M; Steben, M; Bosch, X; Dillner, J; Kurman, RJ; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, J; Lupinacci, LC; Giacoletti, KED; Lu, S; Vuocolo, S; Hesley, TM; Haupt, RM; Barr, E
MLA Citation
Joura, EA, Kjaer, SK, Wheeler, CM, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Lehtinen, M, Steben, M, Bosch, X, Dillner, J, Kurman, RJ, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Lupinacci, LC, Giacoletti, KED, Lu, S, Vuocolo, S, Hesley, TM, Haupt, RM, and Barr, E. "HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine." Vaccine 26.52 (2008): 6844-6851.
PMID
18930097
Source
scival
Published In
Vaccine
Volume
26
Issue
52
Publish Date
2008
Start Page
6844
End Page
6851
DOI
10.1016/j.vaccine.2008.09.073

Corrigendum to "The current and future role of screening in the era of HPV vaccination" [Gynecol. Oncol. 109 (2008) S31-S39] (DOI:10.1016/j.ygyno.2008.02.001)

Authors
Myers, E; Huh, WK; Wright, JD; Smith, JS
MLA Citation
Myers, E, Huh, WK, Wright, JD, and Smith, JS. "Corrigendum to "The current and future role of screening in the era of HPV vaccination" [Gynecol. Oncol. 109 (2008) S31-S39] (DOI:10.1016/j.ygyno.2008.02.001)." Gynecologic Oncology 110.2 (2008): 270--.
Source
scival
Published In
Gynecologic Oncology
Volume
110
Issue
2
Publish Date
2008
Start Page
270-
DOI
10.1016/j.ygyno.2008.05.022

Baseline demographic characteristics of subjects enrolled in international quadrivalent HPV (types 6/11/16/18) vaccine clinical trials

Background: In Phase II/III trials, administration of quadrivalent human papillomavirus (HPV) (types 6/11/16/18) L1 virus-like-particle vaccine was highly effective in preventing HPV6/11/16/18-related cervical intraepithelial neoplasia and non-invasive cervical cancer in women aged 16-26 years who were naive to these HPV types at enrollment. However, the makeup and extent of catch-up vaccination programs among young women is unclear, because a proportion of this population will likely already have been exposed to one or more vaccine-HPV-types. Objective: Herein we analyze baseline data from the quadrivalent HPV vaccine clinical trial program to investigate variables which may help shape catch-up vaccine implementation policies. Methods: Female adolescents and young adults aged 16-26 years were randomized into five clinical trials. Baseline data regarding demographics, sexual history, pregnancy history, and other characteristics were collected at enrollment. At the baseline gynecological examination during enrollment, specimens were obtained for Pap testing. Swabs of external genital, lateral vaginal, and cervical sites for HPV polymerase chain reaction (PCR) testing were taken, and serum samples were obtained for HPV serology testing. Regional analyses of data were conducted. Results: Overall, 72% of subjects enrolled worldwide were naïve by both serology and PCR to all four vaccine HPV types. Few subjects were seropositive and/or PCR positive for more than two vaccine-related HPV types. Of all subjects with HSIL at enrollment, 78% were positive to at least one vaccine-related HPV type at enrollment. Regional differences in HPV and STD prevalence were evident. Study limitations included under-representation of women with ≥4 sexual partners and possible underestimation of prior HPV exposure. Conclusions: Our findings demonstrate that sexually active 16-26 year-old women with ≤4 life time sex partners (LSP) in North America, Europe, Latin America, and Asia Pacific are generally naive to most or all types targeted by the quadrivalent HPV6/11/16/18 vaccine and that they are at subsequent risk for infection and disease caused by these types. © 2008 Informa UK Ltd. All rights reserved.

Authors
Paavonen, J; Villa, L; Munoz, N; Perez, G; Kjaer, SK; Paavonen, J; Lehtinen, M; Sigurdsson, K; Hernandez-Avila, M; Iversen, O-E; Garcia, P; Majewski, S; Tay, EH; Bosch, FX; Dillner, J; Olsson, S-E; Ault, K; Brown, D; Ferris, D; Koutsky, L; Kurman, R; Myers, E
MLA Citation
Paavonen, J, Villa, L, Munoz, N, Perez, G, Kjaer, SK, Paavonen, J, Lehtinen, M, Sigurdsson, K, Hernandez-Avila, M, Iversen, O-E, Garcia, P, Majewski, S, Tay, EH, Bosch, FX, Dillner, J, Olsson, S-E, Ault, K, Brown, D, Ferris, D, Koutsky, L, Kurman, R, and Myers, E. "Baseline demographic characteristics of subjects enrolled in international quadrivalent HPV (types 6/11/16/18) vaccine clinical trials." Current Medical Research and Opinion 24.6 (2008): 1623-1634.
PMID
18435868
Source
scival
Published In
Current Medical Research and Opinion
Volume
24
Issue
6
Publish Date
2008
Start Page
1623
End Page
1634
DOI
10.1185/03007990802068151

Primary surgery versus chemoradiation in the treatment of IB2 cervical carcinoma: a cost effectiveness analysis.

OBJECTIVES: To estimate the relative cost-effectiveness of treatments for patients with FIGO stage IB2 cervical cancer and no evidence of metastasis as determined by combination of positron emission tomography/computed tomography (PET/CT). METHODS: A Markov state transition model was constructed to compare two strategies: (1) radical hysterectomy and pelvic lymphadenectomy with tailored adjuvant therapy (RH+TA); (2) primary chemoradiation (CR). Five-year survival estimates for FIGO stage IB2 cervical cancer were obtained from literature. Medicare reimbursement rates and Agency for Healthcare Research and Quality database were used to obtain costs of treatment regimens and grades 3-5 adverse events. Strategies were compared using incremental cost per year of life saved (YLS). Extensive sensitivity analyses were performed. RESULTS: Overall survival estimates were 78.9% for CR; 79.6% for RH+TA. Mean cost for CR at 5 years was $21,403 compared to $27,840 for RH+TA. RH+TA cost $63,689 per additional year of life saved (YLS) compared to CR. Results were most sensitive to survival estimates and the costs associated with high dose rate (HDR) versus low dose rate (LDR) brachytherapy. If 90% of patients with intermediate pathologic risk factors at surgery were assumed to receive adjuvant CR, the ICER of RH+TA rose to $100,000 per YLS compared to CR. CONCLUSIONS: RH+TA is potentially cost effective when compared to CR for patients with stage IB2 cervical cancer without metastatic disease by PET/CT imaging. Key factors in the cost-effectiveness of treatments include physician's expected recommendation of adjuvant therapy, brachytherapy modality employed for primary CR and quality of life related to both treatment and its complications.

Authors
Jewell, EL; Kulasingam, S; Myers, ER; Alvarez Secord, A; Havrilesky, LJ
MLA Citation
Jewell, EL, Kulasingam, S, Myers, ER, Alvarez Secord, A, and Havrilesky, LJ. "Primary surgery versus chemoradiation in the treatment of IB2 cervical carcinoma: a cost effectiveness analysis." Gynecol Oncol 107.3 (December 2007): 532-540.
PMID
17900674
Source
pubmed
Published In
Gynecologic Oncology
Volume
107
Issue
3
Publish Date
2007
Start Page
532
End Page
540
DOI
10.1016/j.ygyno.2007.08.056

Potential effects of decreased cervical cancer screening participation after HPV vaccination: an example from the U.S.

A concern with widespread implementation of HPV vaccination programs is that women may mistakenly decide that they do not need to be screened any longer, and thus be less likely to participate in cervical cancer screening, because they view themselves to be at low-risk of developing cervical cancer. We hypothesized that non-participation in screening among vaccinated young women in the 5 years following vaccination may result in missed CIN 2-3 cases that could progress to cancer. For instance, if 50% fewer women 26-30 years old, who were vaccinated, participate in screening in the United States over a 5 year time horizon, there would be approximately 4 women (per 1000) with missed CIN 2-3. On the other hand, non-participation will reduce the number of false-positive screening test results, as non-participation would avoid approximately 27 false-positive test results, with a decrease in follow-up procedures and costs. These results highlight the importance of educating women to ensure continued screening, as well as the need to consider new approaches to screening in the era of vaccination.

Authors
Kulasingam, SL; Pagliusi, S; Myers, E
MLA Citation
Kulasingam, SL, Pagliusi, S, and Myers, E. "Potential effects of decreased cervical cancer screening participation after HPV vaccination: an example from the U.S." Vaccine 25.48 (November 23, 2007): 8110-8113.
PMID
17961877
Source
pubmed
Published In
Vaccine
Volume
25
Issue
48
Publish Date
2007
Start Page
8110
End Page
8113
DOI
10.1016/j.vaccine.2007.09.035

Management of platinum-sensitive recurrent ovarian cancer: a cost-effectiveness analysis.

OBJECTIVE: We wished to compare the cost-effectiveness of three chemotherapy regimens for treatment of recurrent platinum-sensitive ovarian cancer. METHODS: A Markov decision tree was constructed comparing three chemotherapy regimens: (1) carboplatin alone (C); (2) paclitaxel/carboplatin (PC); (3) gemcitabine/carboplatin (GC). Progression-free survival (PFS) and adverse event rates were estimated from published randomized controlled trials (RCTs). Costs of treatment and adverse events were obtained using Medicare reimbursement data. RESULTS: Estimated mean and median progression-free survival were 8.0 and 6.0 months for C, 10.1 and 7.8 months for PC, 10.5 and 8.4 months for GC, respectively. C was the least expensive strategy, costing $501 per progression-free month (PFM). PC had an incremental cost-effectiveness ratio (ICER) of $1297 per additional PFM ($15,564 per additional progression-free year (PFY)) compared to C. GC had an ICER of $23,199 per additional PFM ($278,388 per additional PFY) compared to PC. Results were insensitive to variation in the rates and costs of toxicities over clinically reasonable ranges. The model was sensitive to changes in PFS estimates. When the PFS of GC was assumed to be equivalent to that of PC, GC was strongly dominated (more expensive and no more effective) by PC due to the additional costs. Adjustment for neurotoxicity-associated quality of life (QoL) did not change rankings of strategies. CONCLUSIONS: PC appears to be relatively cost-effective compared to C for the treatment of recurrent platinum-sensitive ovarian cancer. GC appears to be less cost-effective compared to PC, with an ICER ten times higher.

Authors
Havrilesky, LJ; Secord, AA; Kulasingam, S; Myers, E
MLA Citation
Havrilesky, LJ, Secord, AA, Kulasingam, S, and Myers, E. "Management of platinum-sensitive recurrent ovarian cancer: a cost-effectiveness analysis." Gynecol Oncol 107.2 (November 2007): 211-218.
PMID
17870150
Source
pubmed
Published In
Gynecologic Oncology
Volume
107
Issue
2
Publish Date
2007
Start Page
211
End Page
218
DOI
10.1016/j.ygyno.2007.06.029

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

BACKGROUND: This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation. METHODS: An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum. RESULTS: Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth. CONCLUSIONS: The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.

Authors
Pollak, KI; Oncken, CA; Lipkus, IM; Lyna, P; Swamy, GK; Pletsch, PK; Peterson, BL; Heine, RP; Brouwer, RJN; Fish, L; Myers, ER
MLA Citation
Pollak, KI, Oncken, CA, Lipkus, IM, Lyna, P, Swamy, GK, Pletsch, PK, Peterson, BL, Heine, RP, Brouwer, RJN, Fish, L, and Myers, ER. "Nicotine replacement and behavioral therapy for smoking cessation in pregnancy." Am J Prev Med 33.4 (October 2007): 297-305.
PMID
17888856
Source
pubmed
Published In
American Journal of Preventive Medicine
Volume
33
Issue
4
Publish Date
2007
Start Page
297
End Page
305
DOI
10.1016/j.amepre.2007.05.006

Cost-effectiveness of treatment strategies for cervical infection among women at high risk in Madagascar.

BACKGROUND: According to the national guidelines developed in 2001, a woman at high risk of gonorrhea and chlamydia in Madagascar is treated presumptively at her first sexually transmitted infection clinic visit; risk-based treatment (RB) is subsequently used at 3-month visits. OBJECTIVES: To compare health and economic outcomes for a 2-stage Markov process with the following 3 cervical infection treatment policies at baseline and at 3-month follow-up visit: presumptive treatment (PT), RB, and an interim laboratory/risk-based policy. STUDY DESIGN: Cost-effectiveness analysis was used to compare the 9 treatment strategies. RESULTS: When 3-month incidence of cervical infection is <20%, the national guidelines are less costly and less effective than both RB followed by PT, and PT at both visits. CONCLUSIONS: The national guidelines are a reasonable strategy, especially in the context of resource constraints, relatively low reinfection rates, and local preferences.

Authors
McClamroch, K; Behets, F; Van Damme, K; Rabenja, LN; Myers, E
MLA Citation
McClamroch, K, Behets, F, Van Damme, K, Rabenja, LN, and Myers, E. "Cost-effectiveness of treatment strategies for cervical infection among women at high risk in Madagascar." Sex Transm Dis 34.9 (September 2007): 631-637.
PMID
17308503
Source
pubmed
Published In
Sexually Transmitted Diseases
Volume
34
Issue
9
Publish Date
2007
Start Page
631
End Page
637
DOI
10.1097/01.olq.0000258107.75888.0e

A cost-effectiveness analysis of adding a human papillomavirus vaccine to the Australian National Cervical Cancer Screening Program.

BACKGROUND: The cost-effectiveness of adding a human papillomavirus (HPV) vaccine to the Australian National Cervical Screening Program compared to screening alone was examined. METHODS: A Markov model of the natural history of HPV infection that incorporates screening and vaccination was developed. A vaccine that prevents 100% of HPV 16/18-associated disease, with a lifetime duration of efficacy and 80% coverage offered through a school program to girls aged 12 years, in conjunction with current screening was compared with screening alone using cost (in Australian dollars) per life-year (LY) saved and quality-adjusted life-year (QALY) saved. Sensitivity analyses included determining the cost-effectiveness of offering a catch-up vaccination program to 14-26-year-olds and accounting for the benefits of herd immunity. RESULTS: Vaccination with screening compared with screening alone was associated with an incremental cost-effectiveness ratio (ICER) of $51 103 per LY and $18 735 per QALY, assuming a cost per vaccine dose of $115. Results were sensitive to assumptions about the duration of vaccine efficacy, including the need for a booster ($68 158 per LY and $24 988 per QALY) to produce lifetime immunity. Accounting for herd immunity resulted in a more attractive ICER ($36 343 per LY and $13 316 per QALY) for girls only. The cost per LY of vaccinating boys and girls was $92 052 and the cost per QALY was $33 644. The cost per LY of implementing a catch-up vaccination program ranged from $45 652 ($16 727 per QALY) for extending vaccination to 14-year-olds to $78 702 ($34 536 per QALY) for 26-year-olds. CONCLUSIONS: These results suggest that adding an HPV vaccine to Australia's current screening regimen is a potentially cost-effective way to reduce cervical cancer and the clinical interventions that are currently associated with its prevention via screening alone.

Authors
Kulasingam, S; Connelly, L; Conway, E; Hocking, JS; Myers, E; Regan, DG; Roder, D; Ross, J; Wain, G
MLA Citation
Kulasingam, S, Connelly, L, Conway, E, Hocking, JS, Myers, E, Regan, DG, Roder, D, Ross, J, and Wain, G. "A cost-effectiveness analysis of adding a human papillomavirus vaccine to the Australian National Cervical Cancer Screening Program." Sex Health 4.3 (September 2007): 165-175.
PMID
17931529
Source
pubmed
Published In
Sexual Health
Volume
4
Issue
3
Publish Date
2007
Start Page
165
End Page
175

Co-treatment with metformin XR does not reduce the threshold dose of clomiphene to induce ovulation in polycystic ovary syndrome: Results from the pregnancy in polycystic ovary syndrome (PPCOS) study.

Authors
Cataldo, NA; Legro, RS; Myers, ER; Barnhart, HX
MLA Citation
Cataldo, NA, Legro, RS, Myers, ER, and Barnhart, HX. "Co-treatment with metformin XR does not reduce the threshold dose of clomiphene to induce ovulation in polycystic ovary syndrome: Results from the pregnancy in polycystic ovary syndrome (PPCOS) study." September 2007.
Source
wos-lite
Published In
Fertility and Sterility
Volume
88
Publish Date
2007
Start Page
S73
End Page
S74
DOI
10.1016/j.fertnstert.2007.07.246

The personal economics of IVF: Impact of time horizon, number of embryos transferred, quality of life, and choice of outcome on cost-effectiveness from the couple's perspective.

Authors
Myers, ER; Poulos, TA; Hagy, AP
MLA Citation
Myers, ER, Poulos, TA, and Hagy, AP. "The personal economics of IVF: Impact of time horizon, number of embryos transferred, quality of life, and choice of outcome on cost-effectiveness from the couple's perspective." September 2007.
Source
wos-lite
Published In
Fertility and Sterility
Volume
88
Publish Date
2007
Start Page
S135
End Page
S135
DOI
10.1016/j.fertnstert.2007.07.433

Cost-effectiveness of adjuvant radiotherapy in intermediate risk endometrial cancer.

OBJECTIVES: Endometrial cancer is the most common gynecologic malignancy in the United States. Adjuvant radiotherapy in patients with intermediate risk disease (stage IB, IC, and occult stage II) is controversial. Despite no proven survival advantage, a significant number of women undergo this treatment annually. The purpose of this study was to compare the estimated health and economic outcomes for adjuvant whole pelvic radiotherapy to no treatment with salvage therapy for recurrence. METHODS: A decision analytic model was created to estimate the costs of adjuvant pelvic radiotherapy versus no adjuvant radiotherapy in patients with intermediate risk endometrial cancer. Data used was gathered from published literature and institutional data on costs. The model incorporates complications, recurrence rates, treatment of recurrence, and survival in each group. RESULTS: In the base case analysis, adjuvant pelvic radiation reduced the recurrence rate by 50%. Cost-effectiveness as measured by cost per recurrence prevented was highly sensitive to the probability of recurrence and the efficacy of adjuvant therapy. In our model the mean costs of Strategy 1 with observation and treatment reserved until the time of recurrence would be $5016. In contrast the mean cost of Strategy 2 which incorporated adjuvant radiotherapy would be $21,159. Cost per recurrence prevented based on the incremental cost-effectiveness is thus $225,215. In the highest risk subgroup, using the upper limit of the 90% confidence limit of efficacy seen in GOG Protocol 99, cost/recurrence prevented was approximately $50,000. Results did not differ when using parameters solely from GOG 99 or PORTEC. CONCLUSIONS: Although adjuvant pelvic radiation does not appear to improve survival for intermediate risk endometrial cancer patients, it does prevent recurrences, at a net positive cost compared to no therapy. Data are not currently available to incorporate quality of life information into cost-effectiveness analyses. Obtaining such data would allow cost/quality-adjusted life year gained to be estimated. This information is necessary to determine if the extra costs of adjuvant radiotherapy in patients with intermediate risk endometrial cancer are acceptable by current health care policy standards.

Authors
Rankins, NC; Secord, AA; Jewell, E; Havrilesky, LJ; Soper, JT; Myers, E
MLA Citation
Rankins, NC, Secord, AA, Jewell, E, Havrilesky, LJ, Soper, JT, and Myers, E. "Cost-effectiveness of adjuvant radiotherapy in intermediate risk endometrial cancer." Gynecol Oncol 106.2 (August 2007): 388-393.
PMID
17509672
Source
pubmed
Published In
Gynecologic Oncology
Volume
106
Issue
2
Publish Date
2007
Start Page
388
End Page
393
DOI
10.1016/j.ygyno.2007.04.015

Abnormal outcomes following cervical cancer screening: event duration and health utility loss.

BACKGROUND: For decision analytic models, little empirical data are available from which to model the amount of time women spend with various cervical cytologic and histologic diagnoses following an abnormal Pap smear or the associated loss in quality-adjusted life-years (QALYs). METHODS: The authors retrospectively examined administrative and cytopathology data for women with abnormal routine cervical smears within the Kaiser Permanente Northwest (Portland, OR) health plan during 1998. Data were examined through the conclusion of follow-up, with final outcomes categorized as cervical intraepithelial neoplasia (CIN) grades 1 to 3 (n = 201) or a false-positive result (n = 722) if no CIN or cancer was detected on follow-up. CIN outcomes were assigned according to the initial grade of dysplasia observed during the care episode in the primary analysis. The number of months spent with various cytologic and histologic diagnoses during the course of follow-up was tabulated, and utility weights were assigned using data from a prior study reporting time tradeoff scores for cervical health states. RESULTS: The average total duration of follow-up was between 18 and 22 months for women with CIN, compared with 10 months for a false-positive Pap smear. The number of months spent with either an abnormal cytologic or histologic diagnosis was greater (P = 0.01) for women with CIN 1 (12.6 months) than CIN 3 (9.2 months), although this relationship was reversed for time spent receiving negative follow-up Pap smears and biopsies to rule out the presence of CIN and cancer. Total QALY losses per episode of care were estimated to be 0.11 for all 3 grades of CIN and 0.04 for a false-positive Pap smear. CONCLUSIONS: The health and psychosocial burdens associated with follow-up for abnormal Pap smears translate into tangible QALY losses in a decision analytic context, with women receiving many months of follow-up and a variety of cytologic and histologic diagnoses over the course of a care episode.

Authors
Insinga, RP; Glass, AG; Myers, ER; Rush, BB
MLA Citation
Insinga, RP, Glass, AG, Myers, ER, and Rush, BB. "Abnormal outcomes following cervical cancer screening: event duration and health utility loss." Med Decis Making 27.4 (July 2007): 414-422.
PMID
17585005
Source
pubmed
Published In
Medical Decision Making
Volume
27
Issue
4
Publish Date
2007
Start Page
414
End Page
422
DOI
10.1177/0272989X07302128

Is Burch colposuspension ever cost-effective compared with tension-free vaginal tape for stress incontinence?

OBJECTIVE: This study was undertaken to evaluate the cost-effectiveness of Burch colposuspension compared with tension-free vaginal tape. STUDY DESIGN: A Markov decision model was developed to compare costs (2005 US dollars) and effectiveness (quality-adjusted life years) of Burch and tension-free vaginal tape for stress urinary incontinence over 10 years from a health care system perspective. After surgery, outcomes included cure, persistent stress urinary incontinence followed by second surgery, and persistent stress urinary incontinence and mesh erosion after tension-free vaginal tape. An incremental cost-effectiveness ratio of less than $50,000 per quality-adjusted life year was considered cost-effective. RESULTS: For the base-case, the Burch strategy cost more than tension-free vaginal tape ($9320 vs $8081), but was slightly more effective (7.260 vs 7.248 quality-adjusted life years). The incremental cost-effectiveness ratio was $98,755 per quality-adjusted life year. The incremental cost-effectiveness ratio was less than $50,000 per quality-adjusted life year when the relative risk of cure after Burch to tension-free vaginal tape was greater than 1.09. CONCLUSION: Burch colposuspension was not cost-effective compared with tension-free vaginal tape. However, if the tension-free vaginal tape failure rate was to increase over time, Burch may become cost-effective.

Authors
Wu, JM; Visco, AG; Weidner, AC; Myers, ER
MLA Citation
Wu, JM, Visco, AG, Weidner, AC, and Myers, ER. "Is Burch colposuspension ever cost-effective compared with tension-free vaginal tape for stress incontinence?." Am J Obstet Gynecol 197.1 (July 2007): 62.e1-62.e5.
PMID
17618760
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
197
Issue
1
Publish Date
2007
Start Page
62.e1
End Page
62.e5
DOI
10.1016/j.ajog.2007.02.039

Treatment of infertility in the polycystic ovary syndrome - Reply

Authors
Legro, RS; Myers, ER; Med, CMR
MLA Citation
Legro, RS, Myers, ER, and Med, CMR. "Treatment of infertility in the polycystic ovary syndrome - Reply." NEW ENGLAND JOURNAL OF MEDICINE 356.19 (May 10, 2007): 2000-2001.
Source
wos-lite
Published In
The New England journal of medicine
Volume
356
Issue
19
Publish Date
2007
Start Page
2000
End Page
2001

Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome.

BACKGROUND: The polycystic ovary syndrome is a common cause of infertility. Clomiphene and insulin sensitizers are used alone and in combination to induce ovulation, but it is unknown whether one approach is superior. METHODS: We randomly assigned 626 infertile women with the polycystic ovary syndrome to receive clomiphene citrate plus placebo, extended-release metformin plus placebo, or a combination of metformin and clomiphene for up to 6 months. Medication was discontinued when pregnancy was confirmed, and subjects were followed until delivery. RESULTS: The live-birth rate was 22.5% (47 of 209 subjects) in the clomiphene group, 7.2% (15 of 208) in the metformin group, and 26.8% (56 of 209) in the combination-therapy group (P<0.001 for metformin vs. both clomiphene and combination therapy; P=0.31 for clomiphene vs. combination therapy). Among pregnancies, the rate of multiple pregnancy was 6.0% in the clomiphene group, 0% in the metformin group, and 3.1% in the combination-therapy group. The rates of first-trimester pregnancy loss did not differ significantly among the groups. However, the conception rate among subjects who ovulated was significantly lower in the metformin group (21.7%) than in either the clomiphene group (39.5%, P=0.002) or the combination-therapy group (46.0%, P<0.001). With the exception of pregnancy complications, adverse-event rates were similar in all groups, though gastrointestinal side effects were more frequent, and vasomotor and ovulatory symptoms less frequent, in the metformin group than in the clomiphene group. CONCLUSIONS: Clomiphene is superior to metformin in achieving live birth in infertile women with the polycystic ovary syndrome, although multiple birth is a complication. (ClinicalTrials.gov number, NCT00068861 [ClinicalTrials.gov].).

Authors
Legro, RS; Barnhart, HX; Schlaff, WD; Carr, BR; Diamond, MP; Carson, SA; Steinkampf, MP; Coutifaris, C; McGovern, PG; Cataldo, NA; Gosman, GG; Nestler, JE; Giudice, LC; Leppert, PC; Myers, ER; Cooperative Multicenter Reproductive Medicine Network,
MLA Citation
Legro, RS, Barnhart, HX, Schlaff, WD, Carr, BR, Diamond, MP, Carson, SA, Steinkampf, MP, Coutifaris, C, McGovern, PG, Cataldo, NA, Gosman, GG, Nestler, JE, Giudice, LC, Leppert, PC, Myers, ER, and Cooperative Multicenter Reproductive Medicine Network, . "Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome." N Engl J Med 356.6 (February 8, 2007): 551-566.
PMID
17287476
Source
pubmed
Published In
The New England journal of medicine
Volume
356
Issue
6
Publish Date
2007
Start Page
551
End Page
566
DOI
10.1056/NEJMoa063971

Utility of screening for other causes of infertility in women with "known" polycystic ovary syndrome.

We investigated the prevalence of abnormal screening results (questionnaire and testing for other causes of oligo-ovulation, male or tubal factor infertility) in a group of 1,313 oligo-ovulatory women (included and excluded subjects) whose condition was screened for inclusion in the Pregnancy in Polycystic Ovary Syndrome trial, a multicenter clinical trial that was conducted at 13 sites in the United States. Other than failure to demonstrate laboratory evidence of hyperandrogenemia, the most common reasons for subject exclusion were persistent oligospermia and tubal factor infertility.

Authors
McGovern, PG; Legro, RS; Myers, ER; Barnhart, HX; Carson, SA; Diamond, MP; Carr, BR; Schlaff, WD; Coutifaris, C; Steinkampf, MP; Nestler, JE; Gosman, G; Leppert, PC; Giudice, LC; National Institutes for Child Health and Human Development-Reproductive Medicine Network,
MLA Citation
McGovern, PG, Legro, RS, Myers, ER, Barnhart, HX, Carson, SA, Diamond, MP, Carr, BR, Schlaff, WD, Coutifaris, C, Steinkampf, MP, Nestler, JE, Gosman, G, Leppert, PC, Giudice, LC, and National Institutes for Child Health and Human Development-Reproductive Medicine Network, . "Utility of screening for other causes of infertility in women with "known" polycystic ovary syndrome." Fertil Steril 87.2 (February 2007): 442-444.
PMID
17141768
Source
pubmed
Published In
Fertility and Sterility
Volume
87
Issue
2
Publish Date
2007
Start Page
442
End Page
444
DOI
10.1016/j.fertnstert.2006.06.050

Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection

Background. A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with ≥1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. Methods. Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. Results. Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). Conclusions. Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening. © 2007 by the Infectious Diseases Society of America.

Authors
Villa, LL; Perez, G; Kjær, SK; Paavonen, J; Lehtinen, M; Muñoz, N; Sigurdsson, K; Hernandez-Avila, M; Iversen, OE; Thoresen, S; García, PJ; Majewski, S; Eng, HT; Bosch, FX; Dillner, J; Olsson, S-E; Ault, KA; Brown, DR; Ferris, DG; Koutsky, LA; Kurman, RJ; Myers, ER; Barr, E; Boslego, J; Bryan, J; Esser, MT; Hesley, TM; Nelson, M; Railkar, R; James, M; Sattler, C; Taddeo, FJ; Thornton, AR; Vuocolo, SC
MLA Citation
Villa, LL, Perez, G, Kjær, SK, Paavonen, J, Lehtinen, M, Muñoz, N, Sigurdsson, K, Hernandez-Avila, M, Iversen, OE, Thoresen, S, García, PJ, Majewski, S, Eng, HT, Bosch, FX, Dillner, J, Olsson, S-E, Ault, KA, Brown, DR, Ferris, DG, Koutsky, LA, Kurman, RJ, Myers, ER, Barr, E, Boslego, J, Bryan, J, Esser, MT, Hesley, TM, Nelson, M, Railkar, R, James, M, Sattler, C, Taddeo, FJ, Thornton, AR, and Vuocolo, SC. "Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection." Journal of Infectious Diseases 196.10 (2007): 1438-1446.
PMID
18008221
Source
scival
Published In
Journal of Infectious Diseases
Volume
196
Issue
10
Publish Date
2007
Start Page
1438
End Page
1446
DOI
10.1086/522864

The authors reply [5]

Authors
Legro, RS; Myers, ER
MLA Citation
Legro, RS, and Myers, ER. "The authors reply [5]." New England Journal of Medicine 356.19 (2007): 2000-2001.
Source
scival
Published In
The New England journal of medicine
Volume
356
Issue
19
Publish Date
2007
Start Page
2000
End Page
2001

Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. Copyright © 2007 Massachusetts Medical Society.

Authors
Villa, LL; Perez, G; Kjaer, SK; Paavonen, J; Lehtinen, M; Muñoz, N; Sigurdsson, K; Hernandez-Avila, M; Skjeldestad, FE; Thoresen, S; García, P; Majewski, S; Dillner, J; Olsson, S-E; Eng, HT; Bosch, FX; Ault, KA; Brown, DR; Ferris, DG; Koutsky, LA; Kurman, RJ; Myers, ER; Barr, E; Boslego, J; Bryan, J; Esser, MT; Gause, CK; Hesley, TM; Lupinacci, LC; Sings, HL; Taddeo, FJ; Thornton, AR
MLA Citation
Villa, LL, Perez, G, Kjaer, SK, Paavonen, J, Lehtinen, M, Muñoz, N, Sigurdsson, K, Hernandez-Avila, M, Skjeldestad, FE, Thoresen, S, García, P, Majewski, S, Dillner, J, Olsson, S-E, Eng, HT, Bosch, FX, Ault, KA, Brown, DR, Ferris, DG, Koutsky, LA, Kurman, RJ, Myers, ER, Barr, E, Boslego, J, Bryan, J, Esser, MT, Gause, CK, Hesley, TM, Lupinacci, LC, Sings, HL, Taddeo, FJ, and Thornton, AR. "Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions." New England Journal of Medicine 356.19 (2007): 1915-1927.
PMID
17494925
Source
scival
Published In
The New England journal of medicine
Volume
356
Issue
19
Publish Date
2007
Start Page
1915
End Page
1927
DOI
10.1056/NEJMoa061741

Response to Letter to the Editor

Authors
Myers, ER
MLA Citation
Myers, ER. "Response to Letter to the Editor." Contraception 75.4 (2007): 323--.
Source
scival
Published In
Contraception
Volume
75
Issue
4
Publish Date
2007
Start Page
323-
DOI
10.1016/j.contraception.2007.01.001

Development of a research agenda for uterine artery embolization: proceedings from a multidisciplinary research consensus panel.

Authors
Spies, JB; Rundback, JH; Ascher, S; Bradley, L; Goodwin, SC; Hovsepian, DM; Myers, ER; Pelage, J-P; Pron, G; Siskin, GP; Stewart, EA; Worthington-Kirsch, R; Hume, KM; Strain, C; Gomolka, B; SIR Foundation,
MLA Citation
Spies, JB, Rundback, JH, Ascher, S, Bradley, L, Goodwin, SC, Hovsepian, DM, Myers, ER, Pelage, J-P, Pron, G, Siskin, GP, Stewart, EA, Worthington-Kirsch, R, Hume, KM, Strain, C, Gomolka, B, and SIR Foundation, . "Development of a research agenda for uterine artery embolization: proceedings from a multidisciplinary research consensus panel." J Vasc Interv Radiol 17.12 (December 2006): 1871-1879.
PMID
17185681
Source
pubmed
Published In
JVIR: Journal of Vascular and Interventional Radiology
Volume
17
Issue
12
Publish Date
2006
Start Page
1871
End Page
1879
DOI
10.1097/01.RVI.0000251151.01365.c1

HPV vaccines: now that they're here, how do we maximize their benefit?

Authors
Myers, ER
MLA Citation
Myers, ER. "HPV vaccines: now that they're here, how do we maximize their benefit?." Contraception 74.4 (October 2006): 277-279.
PMID
16982224
Source
pubmed
Published In
Contraception
Volume
74
Issue
4
Publish Date
2006
Start Page
277
End Page
279
DOI
10.1016/j.contraception.2006.07.001

Health care resource use for uterine fibroid tumors in the United States.

OBJECTIVE: The purpose of this study was to quantify the total direct cost to the US health care system for the management of uterine leiomyomas. STUDY DESIGN: We used Center for Disease Control heath care databases for estimates of inpatient care, ambulatory care, and outpatient care of leiomyomas. With International Classification of Diseases-9 codes for fibroid tumors and fibroid-related conditions, all fibroid-related care was identified in each database. Inpatient and ambulatory surgical cases were stratified by surgical procedure, and outpatient clinical cases were categorized by type of visit and health care provider. With the use of Medicare's RBRVU reimbursement rates for 2000 as a proxy for the cost of physician services and Medicare diagnostic-related group reimbursement as a proxy for facility costs, the total direct cost to the US health care system for the care of fibroid tumors was estimated. RESULTS: Total direct cost to treat uterine fibroid tumors was estimated at 2,151,484,847 dollars. Most of the cost was due to inpatient care, in particular, hysterectomy. CONCLUSION: Uterine fibroid tumors consume a significant amount of health care resources in the United States.

Authors
Flynn, M; Jamison, M; Datta, S; Myers, E
MLA Citation
Flynn, M, Jamison, M, Datta, S, and Myers, E. "Health care resource use for uterine fibroid tumors in the United States." Am J Obstet Gynecol 195.4 (October 2006): 955-964.
PMID
16723104
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
195
Issue
4
Publish Date
2006
Start Page
955
End Page
964
DOI
10.1016/j.ajog.2006.02.020

Genomic tests for ovarian cancer detection and management.

OBJECTIVES: To assess the evidence that the use of genomic tests for ovarian cancer screening, diagnosis, and treatment leads to improved outcomes. DATA SOURCES: PubMed and reference lists of recent reviews. REVIEW METHODS: We evaluated tests for: (a) single gene products; (b) genetic variations affecting risk of ovarian cancer; (c) gene expression; and (d) proteomics. For tests covered in recent evidence reports (cancer antigen 125 [CA-125] and breast cancer genes 1 and 2 [BRCA1/2]), we added studies published subsequent to the reports. We sought evidence on: (a) the analytic performance of tests in clinical laboratories; (b) the sensitivity and specificity of tests in different patient populations; (c) the clinical impact of testing in asymptomatic women, women with suspected ovarian cancer, and women with diagnosed ovarian cancer; (d) the harms of genomic testing; and (e) the impact of direct-to-consumer and direct-to-physician advertising on appropriate use of tests. We also constructed a computer simulation model to test the impact of different assumptions about ovarian cancer natural history on the relative effectiveness of different strategies. RESULTS: There are reasonable data on the clinical laboratory performance of most radioimmunoassays, but the majority of the data on other genomic tests comes from research laboratories. Genomic test sensitivity/specificity estimates are limited by small sample sizes, spectrum bias, and unrealistically large prevalences of ovarian cancer; in particular, estimates of positive predictive values derived from most of the studies are substantially higher than would be expected in most screening or diagnostic settings. We found no evidence relevant to the question of the impact of genomic tests on health outcomes in asymptomatic women. Although there is a relatively large literature on the association of test results and various clinical outcomes, the clinical utility of changing management based on these results has not been evaluated. We found no evidence that genomic tests for ovarian cancer have unique harms beyond those common to other tests for genetic susceptibility or other tests used in screening, diagnosis, and management of ovarian cancer. Studies of a direct-to-consumer campaign for BRCA1/2 testing suggest increased utilization, but the effect on "appropriateness" was unclear. Model simulations suggest that annual screening, even with a highly sensitive test, will not reduce ovarian cancer mortality by more than 50 percent; frequent screening has a very low positive predictive value, even with a highly specific test. CONCLUSIONS: Although research remains promising, adaptation of genomic tests into clinical practice must await appropriately designed and powered studies in relevant clinical settings.

Authors
Myers, ER; Havrilesky, LJ; Kulasingam, SL; Sanders, GD; Cline, KE; Gray, RN; Berchuck, A; McCrory, DC
MLA Citation
Myers, ER, Havrilesky, LJ, Kulasingam, SL, Sanders, GD, Cline, KE, Gray, RN, Berchuck, A, and McCrory, DC. "Genomic tests for ovarian cancer detection and management." Evid Rep Technol Assess (Full Rep) 145 (October 2006): 1-100. (Review)
PMID
17764207
Source
pubmed
Published In
Evidence report/technology assessment
Issue
145
Publish Date
2006
Start Page
1
End Page
100

The Pregnancy in Polycystic Ovary Syndrome study: baseline characteristics of the randomized cohort including racial effects.

OBJECTIVE: To report the baseline characteristics and racial differences in the polycystic ovary syndrome (PCOS) phenotype from a large multicenter clinical trial (PPCOS). DESIGN: Double-blind, randomized trial of three treatment regimens (with extended release metformin or clomiphene citrate). SETTING: Academic medical centers. PATIENT(S): Six hundred twenty-six infertile women with PCOS, aged 18-39 years, with elevated T levels and oligomenorrhea (exclusion of secondary causes), seeking pregnancy, with > or = 1 patent fallopian tube, normal uterine cavity, and a partner with sperm concentration > or = 20 x 10(6)/mL in > or = 1 ejaculate. INTERVENTION(S): Baseline characterization. MAIN OUTCOME MEASURE(S): Historical, biometric, and biochemical measures of PCOS. RESULT(S): There were no significant differences in baseline variables between treatment groups. The overall mean (+/-SD) age of the subjects was 28.1 +/- 4.0 years, and the mean body mass index was 35.2 kg/m2 (+/-8.7). Polycystic ovaries (PCOs) were present in 90.3% of the subjects, and the mean volume of each ovary was 10 cm3 or more. Of the subjects, 7% had ovaries that were discordant for PCO morphology. At baseline, 18.3% of the subjects had an abnormal fasting glucose level (> 100 mg/dL). Asians tended to have a milder phenotype, and whites and African Americans were similar in these measures. CONCLUSION(S): The treatment groups were well matched for baseline parameters, and we have added further information to the PCOS phenotype.

Authors
Legro, RS; Myers, ER; Barnhart, HX; Carson, SA; Diamond, MP; Carr, BR; Schlaff, WD; Coutifaris, C; McGovern, PG; Cataldo, NA; Steinkampf, MP; Nestler, JE; Gosman, G; Guidice, LC; Leppert, PC; Reproductive Medicine Network,
MLA Citation
Legro, RS, Myers, ER, Barnhart, HX, Carson, SA, Diamond, MP, Carr, BR, Schlaff, WD, Coutifaris, C, McGovern, PG, Cataldo, NA, Steinkampf, MP, Nestler, JE, Gosman, G, Guidice, LC, Leppert, PC, and Reproductive Medicine Network, . "The Pregnancy in Polycystic Ovary Syndrome study: baseline characteristics of the randomized cohort including racial effects." Fertil Steril 86.4 (October 2006): 914-933.
PMID
16963034
Source
pubmed
Published In
Fertility and Sterility
Volume
86
Issue
4
Publish Date
2006
Start Page
914
End Page
933
DOI
10.1016/j.fertnstert.2006.03.037

Improvement in live births with clomiphene citrate and metformin, alone and in combination, in infertile women with polycystic ovary syndrome.

Authors
Legro, RS; Myers, ER; Schlaff, WD; Carr, BR; Diamond, MP
MLA Citation
Legro, RS, Myers, ER, Schlaff, WD, Carr, BR, and Diamond, MP. "Improvement in live births with clomiphene citrate and metformin, alone and in combination, in infertile women with polycystic ovary syndrome." September 2006.
Source
wos-lite
Published In
Fertility and Sterility
Volume
86
Publish Date
2006
Start Page
S1
End Page
S1
DOI
10.1016/j.fertnstert.2006.07.004

Chapter 19: Cost-effectiveness of cervical cancer screening.

In the last two decades, computer-based models of cervical cancer screening have been used to evaluate the cost-effectiveness of different secondary prevention policies. Analyses in countries with existing screening programs have focused on identifying the optimal screening interval, ages for starting and stopping screening, and consideration of enhancements to conventional cytology, such as human papillomavirus (HPV)-DNA testing as a triage for equivocal results or as a primary screening test for women over the age of 30. Analyses in resource-poor settings with infrequent or no screening have focused on strategies that enhance the linkage between screening and treatment, consider noncytologic alternatives such as HPV-DNA testing, and target women between the ages of 35 and 45 for screening one, two, or three times per lifetime. Despite differences in methods and assumptions, this paper identifies the qualitative themes that are consistent among studies, and highlights important methodological challenges and high-priority areas for further work.

Authors
Goldie, SJ; Kim, JJ; Myers, E
MLA Citation
Goldie, SJ, Kim, JJ, and Myers, E. "Chapter 19: Cost-effectiveness of cervical cancer screening." Vaccine 24 Suppl 3 (August 31, 2006): S3/164-S3/170. (Review)
PMID
16950004
Source
pubmed
Published In
Vaccine
Volume
24 Suppl 3
Publish Date
2006
Start Page
S3/164
End Page
S3/170
DOI
10.1016/j.vaccine.2006.05.114

Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial.

Improvements in smoking cessation interventions for pregnant smokers are needed. One major step is to examine the potential effectiveness of nicotine replacement therapy (NRT). The potential benefits of providing pregnant women with NRT to help them quit smoking are still unknown; early interventions to test the effectiveness and efficacy are vital to advancing the field. This paper describes recruitment efforts for a multiclinic trial to test the effectiveness of NRT use in addition to behavioral therapy in promoting cessation during pregnancy. The biggest challenge is recruiting sufficient numbers of pregnant women. This paper discusses specific obstacles for recruitment and solutions. Knowing the potential pitfalls to recruiting pregnant women into these trials can lead to better studies and thus improved outcomes.

Authors
Pollak, KI; Oncken, CA; Lipkus, IM; Peterson, BL; Swamy, GK; Pletsch, PK; Lyna, P; Namenek Brouwer, RJ; Fish, LJ; Myers, ER
MLA Citation
Pollak, KI, Oncken, CA, Lipkus, IM, Peterson, BL, Swamy, GK, Pletsch, PK, Lyna, P, Namenek Brouwer, RJ, Fish, LJ, and Myers, ER. "Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial." Nicotine Tob Res 8.4 (August 2006): 547-554.
PMID
16920652
Source
pubmed
Published In
Nicotine and Tobacco Research (OUP)
Volume
8
Issue
4
Publish Date
2006
Start Page
547
End Page
554
DOI
10.1080/14622200600789882

Arterial thromboembolism in pregnancy: A United States population-based study

Authors
James, AH; Jamison, MG; Bushnell, CD; Biswas, MS; Myers, ER
MLA Citation
James, AH, Jamison, MG, Bushnell, CD, Biswas, MS, and Myers, ER. "Arterial thromboembolism in pregnancy: A United States population-based study." JOURNAL OF WOMENS HEALTH 15.6 (July 2006): 688-688.
Source
wos-lite
Published In
Journal of Women's Health
Volume
15
Issue
6
Publish Date
2006
Start Page
688
End Page
688

Cost-effectiveness analysis of liquid-based cytology and human papillomavirus testing in cervical cancer screening.

OBJECTIVE: To compare the outcomes of several cervix cancer screening strategies in a military population using a model that considers both direct and indirect costs of health care. METHODS: A Markov model of the natural history of cervical cancer was used to simulate an age-stratified cohort of 100,000 active duty women in the U.S. Army. Total costs and incremental cost-effectiveness ratios were estimated for different modalities of screening: liquid-based cytology with testing for human papillomavirus (HPV) irrespective of cytologic results compared with liquid-based cytology with HPV detection for cytologic results of atypical cells of undetermined significance (reflex HPV). The costs and outcomes of these screening methods were evaluated separately as well as in combination (liquid-based cytology and reflex HPV before age 30 years and DNA and Pap test every 3 years thereafter). Each of these screening methods was evaluated at 1-, 2-, and 3-year intervals. RESULTS: A screening strategy of liquid-based cytology and reflex HPV every 2 or 3 years is the least costly strategy among active duty women irrespective of age, especially when accounting for time costs associated with screening, diagnosis, and treatment of cervix cancer. A strategy of liquid-based cytology and HPV testing irrespective of cytology results is the most effective strategy; however, it is also the most costly of the strategies tested, even when performed in patients older than 30 years of age. CONCLUSION: In the U.S. Army, cervix cancer screening performed with liquid-based cytology and reflex HPV testing of atypical squamous cells of undetermined significance performed every 2 years is cost-effective, especially when indirect costs are considered.

Authors
Bidus, MA; Maxwell, GL; Kulasingam, S; Rose, GS; Elkas, JC; Chernofsky, M; Myers, ER
MLA Citation
Bidus, MA, Maxwell, GL, Kulasingam, S, Rose, GS, Elkas, JC, Chernofsky, M, and Myers, ER. "Cost-effectiveness analysis of liquid-based cytology and human papillomavirus testing in cervical cancer screening." Obstet Gynecol 107.5 (May 2006): 997-1005.
PMID
16648402
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
107
Issue
5
Publish Date
2006
Start Page
997
End Page
1005
DOI
10.1097/01.AOG.0000210529.70226.0a

Venous thromboembolism during pregnancy and the postpartum period: incidence, risk factors, and mortality.

OBJECTIVE: The purpose of this study was to estimate the incidence, risk factors, and mortality from pregnancy-related venous thromboembolism. STUDY DESIGN: The Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality for the years 2000 to 2001 was queried for all pregnancy-related discharges with a diagnosis of venous thromboembolism. RESULTS: The rate of venous thromboembolism was 1.72 per 1000 deliveries with 1.1 deaths per 100,000. The risk of venous thromboembolism was 38% higher for women ages 35 and older and 64% higher for black women. Other significant risk factors included thrombophilia, lupus, heart disease, sickle cell disease, obesity, fluid and electrolyte imbalance, postpartum infection, and transfusion. The risk factor with the highest odds ratio, 51.8 (38.7-69.2) was thrombophilia. CONCLUSION: The incidence of pregnancy-related venous thromboembolism was higher than generally quoted. Women ages 35 and older, black women, and women with certain medical conditions and obstetric complications appear to be at increased risk.

Authors
James, AH; Jamison, MG; Brancazio, LR; Myers, ER
MLA Citation
James, AH, Jamison, MG, Brancazio, LR, and Myers, ER. "Venous thromboembolism during pregnancy and the postpartum period: incidence, risk factors, and mortality." Am J Obstet Gynecol 194.5 (May 2006): 1311-1315.
PMID
16647915
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
194
Issue
5
Publish Date
2006
Start Page
1311
End Page
1315
DOI
10.1016/j.ajog.2005.11.008

Acupuncture as adjunctive therapy in assisted reproduction: remaining uncertainties.

Two randomized trials provide suggestive evidence that acupuncture might be an effective adjunctive therapy in assisted reproductive technologies, leading to improved pregnancy rates. However, additional research addressing remaining scientific and methodologic issues is needed before routine use of acupuncture can be recommended.

Authors
Myers, ER
MLA Citation
Myers, ER. "Acupuncture as adjunctive therapy in assisted reproduction: remaining uncertainties." Fertil Steril 85.5 (May 2006): 1362-1363.
PMID
16600223
Source
pubmed
Published In
Fertility and Sterility
Volume
85
Issue
5
Publish Date
2006
Start Page
1362
End Page
1363
DOI
10.1016/j.fertnstert.2005.10.062

Acute myocardial infarction in pregnancy: a United States population-based study.

BACKGROUND: The purpose of this study was to determine the incidence, mortality, and risk factors for pregnancy-related acute myocardial infarction in the United States. METHODS AND RESULTS: The Nationwide Inpatient Sample for the years 2000 to 2002 was queried for all pregnancy-related discharges. A total of 859 discharges included a diagnosis of acute myocardial infarction, for a rate of 6.2 (95% confidence interval [CI] 3.0 to 9.4) per 100,000 deliveries. Among these, there were 44 deaths, for a case fatality rate of 5.1%. The odds of acute myocardial infarction were 30-fold higher for women aged 40 years and older than for women <20 years of age. Single independent variables that were statistically and clinically significant, including age, race, and certain medical conditions and obstetric complications, were entered into a multivariable logistic regression model. Hypertension (odds ratio [OR] 21.7, 95% CI 6.8 to 69.1), thrombophilia (OR 25.6, 95% CI 9.2 to 71.2), diabetes mellitus (OR 3.6, 95% CI 1.5 to 8.3), smoking (OR 8.4, 95% CI 5.4 to 12.9), transfusion (OR 5.1, 95% CI 2.0 to 12.7), postpartum infection (OR 3.2, 95% CI 1.2 to 10.1), and age 30 years and older remained as significant risk factors for pregnancy-related acute myocardial infarction. Black race was eliminated as a risk factor in the multivariable analysis, which suggests that the increased incidence among black women is explained by an increased prevalence of other cardiovascular risk factors. CONCLUSIONS: Although acute myocardial infarction is a rare event in women of reproductive age, pregnancy increases the risk 3- to 4-fold. Certain medical conditions and complications of pregnancy increase the risk further and are potentially modifiable risk factors.

Authors
James, AH; Jamison, MG; Biswas, MS; Brancazio, LR; Swamy, GK; Myers, ER
MLA Citation
James, AH, Jamison, MG, Biswas, MS, Brancazio, LR, Swamy, GK, and Myers, ER. "Acute myocardial infarction in pregnancy: a United States population-based study." Circulation 113.12 (March 28, 2006): 1564-1571.
PMID
16534011
Source
pubmed
Published In
Circulation
Volume
113
Issue
12
Publish Date
2006
Start Page
1564
End Page
1571
DOI
10.1161/CIRCULATIONAHA.105.576751

Cost-effectiveness of extending cervical cancer screening intervals among women with prior normal pap tests.

OBJECTIVE: Annual cervical cancer screening in women with many prior normal Pap tests is common despite limited evidence on the cost-effectiveness of this strategy. We estimated the cost-effectiveness of screening women with 3 or more prior normal tests compared with screening those with no prior tests. METHODS: We used a validated cost-effectiveness model in conjunction with data on the prevalence of biopsy-proven cervical neoplasia in women enrolled in the Centers for Disease Control and Prevention National Breast and Cervical Cancer Early Detection Program. Women were grouped according to age at the final Program Pap test (aged < 30, 30-44, 45-59, and 60-65 years) and by screening history (0, 1, 2, and 3+ consecutive prior normal Program tests) to estimate cost per life-year and quality-adjusted life-year associated with annual, biennial, and triennial screening. RESULTS: For women aged 30-44 years with no prior tests, incremental cost-effectiveness ratios ranged from 20,533 US dollars for screening triennially (compared with no further screening) to 331,837 US dollars for screening annually (compared with biennially) per life-year saved. Among same-aged women with 3 or more prior normal Program tests, incremental cost-effectiveness ratios for the same measures ranged from 60,029 US dollars to 709,067 US dollars per life-year saved. Inclusion of the most conservative utility estimates resulted in incremental cost-effectiveness ratios in excess of 100,000 US dollars per quality-adjusted life-year saved associated with annual screening of same-aged women with 3 or more prior normal tests compared with biennial screening. CONCLUSION: As the number of prior normal Pap tests increases, the costs per life-year saved increase substantially. Resources should be prioritized for screening those never or rarely screened women. LEVEL OF EVIDENCE: II-2.

Authors
Kulasingam, SL; Myers, ER; Lawson, HW; McConnell, KJ; Kerlikowske, K; Melnikow, J; Washington, AE; Sawaya, GF
MLA Citation
Kulasingam, SL, Myers, ER, Lawson, HW, McConnell, KJ, Kerlikowske, K, Melnikow, J, Washington, AE, and Sawaya, GF. "Cost-effectiveness of extending cervical cancer screening intervals among women with prior normal pap tests." Obstet Gynecol 107.2 Pt 1 (February 2006): 321-328.
PMID
16449119
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
107
Issue
2 Pt 1
Publish Date
2006
Start Page
321
End Page
328
DOI
10.1097/01.AOG.0000196500.50044.ce

Management of adnexal mass.

OBJECTIVES: To assess diagnostic strategies for distinguishing benign from malignant adnexal masses. DATA SOURCES: MEDLINE(R) and reference lists of recent reviews; discharge data from the Nationwide Inpatient Sample. REVIEW METHODS: The major diagnostic methods evaluated were bimanual pelvic examination, ultrasound (morphology and Doppler velocimetry), MRI, CT, FDG-PET, CA-125, and scoring systems that incorporated multiple clinical, laboratory, and radiologic findings. Meta-analysis using a random-effects model was used to estimate pooled sensitivity and specificity for discriminating benign from malignant. We reviewed evidence for followup strategies for masses considered benign, and for adverse outcomes of diagnostic surgery. We also reviewed published models of the natural history of ovarian cancer and compared the impact of assumptions about natural history on outcomes. RESULTS: The majority of studies did not describe whether patients presented with asymptomatic masses detected through screening or with symptoms. Prevalence of malignant masses in a U.S. postmenopausal screening population was approximately 0.1 percent, while benign masses were found in 0.8 to 1.8 percent of women. Pooled (a) sensitivity and (b) specificity were: bimanual exam (a) 0.45, (b) 0.90; ultrasound morphology scores (a) 0.86 to 0.91, (b) 0.68 to 0.83; Doppler resistive index (a) 0.72, (b) 0.90; pulsatility index (a) 0.80, (b) 0.73; maximum systolic velocity (a) 0.74, (b) 0.81; presence of vessels (a) 0.88, (b) 0.78; combined morphology and Doppler (a) 0.86, (b) 0.91; MRI (a) 0.91, (b) 0.88; CT (a) 0.90, (b) 0.75; FDG-PET (a) 0.67, (b) 0.79; and CA-125 (a) 0.78, (b) 0.78. Both sensitivity and specificity of CA-125 were better in postmenopausal than in premenopausal women. In modeled outcomes, combinations of imaging and CA-125 were both more sensitive and more specific than either alone. Performance of scoring systems in validation studies was consistently worse than in development studies; the highest demonstrated specificity observed was 0.91, with a concurrent sensitivity of 0.74. Evidence on followup strategies was sparse, although one large study provided good evidence for safely following unilocular cysts less than 10 cm in diameter. Overall complication rates in studies of surgically managed adnexal masses were low, but important clinical information was not reported. CONCLUSIONS: All diagnostic modalities showed trade-offs between sensitivity and specificity, but the available literature does not provide sufficient detail on relevant characteristics of study populations to allow confident estimation of the results of alternative diagnostic strategies. Although modeling studies may prove useful in evaluating diagnostic algorithms, further work is needed to explore the implications of uncertainty about the natural history of ovarian cancer.

Authors
Myers, ER; Bastian, LA; Havrilesky, LJ; Kulasingam, SL; Terplan, MS; Cline, KE; Gray, RN; McCrory, DC
MLA Citation
Myers, ER, Bastian, LA, Havrilesky, LJ, Kulasingam, SL, Terplan, MS, Cline, KE, Gray, RN, and McCrory, DC. "Management of adnexal mass." Evid Rep Technol Assess (Full Rep) 130 (February 2006): 1-145. (Review)
PMID
17854238
Source
pubmed
Published In
Evidence report/technology assessment
Issue
130
Publish Date
2006
Start Page
1
End Page
145

Pregnancy in polycystic ovary syndrome (PPCOS) baseline characteristics: Effect of race and ethnicity on the PCOS phenotype.

Authors
Legro, RS; Myers, ER; Barnhart, HX; Carson, SA; Diamond, MP; Carr, BA; Schlaff, WD; Coutifaris, C; McGovern, PG; Cataldo, NA; Steinkampf, MP; Nestler, JE; Gosman, G; Giudice, LC; Leppert, PC
MLA Citation
Legro, RS, Myers, ER, Barnhart, HX, Carson, SA, Diamond, MP, Carr, BA, Schlaff, WD, Coutifaris, C, McGovern, PG, Cataldo, NA, Steinkampf, MP, Nestler, JE, Gosman, G, Giudice, LC, and Leppert, PC. "Pregnancy in polycystic ovary syndrome (PPCOS) baseline characteristics: Effect of race and ethnicity on the PCOS phenotype." February 2006.
Source
wos-lite
Published In
Journal of the Society for Gynecologic Investigation (Elsevier)
Volume
13
Issue
2
Publish Date
2006
Start Page
268A
End Page
269A

Pregnancy in polycystic ovary syndrome (PPCOS): Study design and baseline characteristics of the randomized cohort.

Authors
Legro, RS; Myers, ER; Barnhart, HX; Carson, SA; Diamond, MP; Carr, BA; Schlaff, WD; Coutifaris, C; McGovern, PG; Cataldo, NA; Steinkampf, MP; Nestler, JE; Gosman, G; Giudice, LC; Leppert, PC
MLA Citation
Legro, RS, Myers, ER, Barnhart, HX, Carson, SA, Diamond, MP, Carr, BA, Schlaff, WD, Coutifaris, C, McGovern, PG, Cataldo, NA, Steinkampf, MP, Nestler, JE, Gosman, G, Giudice, LC, and Leppert, PC. "Pregnancy in polycystic ovary syndrome (PPCOS): Study design and baseline characteristics of the randomized cohort." February 2006.
Source
wos-lite
Published In
Journal of the Society for Gynecologic Investigation (Elsevier)
Volume
13
Issue
2
Publish Date
2006
Start Page
269A
End Page
269A

Cost-effectiveness analysis based on the atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion Triage Study (ALTS).

BACKGROUND: The ALTS (atypical squamous cells of undetermined significance [ASCUS] and low-grade squamous intraepithelial lesion [LSIL] Triage Study) suggests that, for women diagnosed with ASCUS, human papillomavirus (HPV) DNA testing followed by referral to colposcopy of only those women with oncogenic HPV (i.e., HPV DNA testing) is as effective at detecting cervical intraepithelial neoplasia (CIN) 3 or cancer (CIN3+) as referring all women with ASCUS for immediate colposcopy. We conducted a cost-effectiveness analysis of the ALTS trial to determine whether HPV DNA testing is a cost-effective alternative to immediate colposcopy or conservative management with up to three cytology examinations. METHODS: Data from the ALTS trial were used in conjunction with medical care costs in a short-term decision model. The model compared the incremental costs per case of CIN3+ detected as measured by the incremental cost-effectiveness ratio (ICER) for the following management strategies for women with ASCUS: immediate colposcopy, HPV DNA testing, and conservative management with up to three cytology examinations. RESULTS: The least costly and least sensitive strategy was conservative management with one repeat cytology examination using a threshold of high-grade squamous intraepithelial lesion (HSIL) for referral to colposcopy. Compared with this strategy, triage to colposcopy based on a positive HPV DNA test result had an ICER of 3517 dollars per case of CIN3+ detected. Immediate colposcopy and conservative management with up to three repeat cytology visits detected fewer cases of CIN3+ and were more costly than HPV DNA testing. Immediate colposcopy became cost-effective at 20,370 dollars compared with HPV DNA testing only if colposcopy and biopsy were assumed to be 100% sensitive. CONCLUSIONS: HPV DNA testing is an economically viable strategy for triage of ASCUS cytology. The less than perfect sensitivity of colposcopy and biopsy needs to be accounted for in future clinical guidelines and policy analyses.

Authors
Kulasingam, SL; Kim, JJ; Lawrence, WF; Mandelblatt, JS; Myers, ER; Schiffman, M; Solomon, D; Goldie, SJ; ALTS Group,
MLA Citation
Kulasingam, SL, Kim, JJ, Lawrence, WF, Mandelblatt, JS, Myers, ER, Schiffman, M, Solomon, D, Goldie, SJ, and ALTS Group, . "Cost-effectiveness analysis based on the atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion Triage Study (ALTS)." J Natl Cancer Inst 98.2 (January 18, 2006): 92-100.
PMID
16418511
Source
pubmed
Published In
Journal of the National Cancer Institute
Volume
98
Issue
2
Publish Date
2006
Start Page
92
End Page
100
DOI
10.1093/jnci/djj009

Chapter 19: Cost-effectiveness of cervical cancer screening

In the last two decades, computer-based models of cervical cancer screening have been used to evaluate the cost-effectiveness of different secondary prevention policies. Analyses in countries with existing screening programs have focused on identifying the optimal screening interval, ages for starting and stopping screening, and consideration of enhancements to conventional cytology, such as human papillomavirus (HPV)-DNA testing as a triage for equivocal results or as a primary screening test for women over the age of 30. Analyses in resource-poor settings with infrequent or no screening have focused on strategies that enhance the linkage between screening and treatment, consider noncytologic alternatives such as HPV-DNA testing, and target women between the ages of 35 and 45 for screening one, two, or three times per lifetime. Despite differences in methods and assumptions, this paper identifies the qualitative themes that are consistent among studies, and highlights important methodological challenges and high-priority areas for further work. © 2006 Elsevier Ltd. All rights reserved.

Authors
Goldie, SJ; Kim, JJ; Myers, E
MLA Citation
Goldie, SJ, Kim, JJ, and Myers, E. "Chapter 19: Cost-effectiveness of cervical cancer screening." Vaccine 24.SUPPL. 3 (2006): S164-S170.
Source
scival
Published In
Vaccine
Volume
24
Issue
SUPPL. 3
Publish Date
2006
Start Page
S164
End Page
S170
DOI
10.1016/j.vaccine.2006.05.114

Incidence and risk factors for stroke in pregnancy and the puerperium

Authors
James, AH; Bushnell, CD; Jamison, MG; Myers, ER
MLA Citation
James, AH, Bushnell, CD, Jamison, MG, and Myers, ER. "Incidence and risk factors for stroke in pregnancy and the puerperium." Obstetrical and Gynecological Survey 61.1 (2006): 4-5.
Source
scival
Published In
Obstetrical and Gynecological Survey
Volume
61
Issue
1
Publish Date
2006
Start Page
4
End Page
5
DOI
10.1097/01.ogx.0000193837.87337.d7

Cost-effectiveness of HPV vaccines

Authors
Myers, ER
MLA Citation
Myers, ER. "Cost-effectiveness of HPV vaccines." Emerging Issues on HPV Infections: From Science to Practice (2006): 235-241.
Source
scival
Published In
Emerging Issues on HPV Infections: From Science to Practice
Publish Date
2006
Start Page
235
End Page
241
DOI
10.1159/000092759

The FIBROID Registry: symptom and quality-of-life status 1 year after therapy.

OBJECTIVES: To investigate the change in symptom severity and health-related quality of life among patients treated with uterine artery embolization for leiomyomata. METHODS: Using the Fibroid Registry for Outcomes Data (FIBROID), a multicenter, prospective, voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied changes in symptom status, health-related quality of life, subsequent care, menstrual status, and satisfaction with outcome. Health-related quality-of-life and symptom status were measured using the Uterine Fibroid Symptom and Quality of Life, a leiomyoma-specific questionnaire. Summary statistics were used to describe the data set and multivariate analyses to determine predictors of outcome at 12 months. RESULTS: Of 2,112 eligible patients, follow-up data were obtained on 1,797 (85.1%) at 6 months and 1,701 (80.5%) at 12 months. At 12 months, the mean symptom score had improved from 58.61 to 19.23 (P < .001), whereas 5.47% of patients had no improvement. The mean health-related quality-of-life score improved from 46.95 to 86.68 (P < .001), whereas 5.0% did not improve. In the first year after embolization, hysterectomy was performed in 2.9% of patients, with 3.6% requiring gynecologic interventions by 6 months and an additional 5.9% between 6 and 12 months. Amenorrhea as a result of embolization occurred in 7.3% of patients. Of these, 86% were age 45 or older. Most patients were satisfied with their outcome (82% strongly agree or agree). Predictors of a greater symptom change score include smaller leiomyoma size, submucosal location, and presenting symptom of heavy menstrual bleeding. CONCLUSION: Uterine embolization results in substantial symptom improvement for most patients, with hysterectomy required in only 2.9% of patients in the first 12 months after therapy.

Authors
Spies, JB; Myers, ER; Worthington-Kirsch, R; Mulgund, J; Goodwin, S; Mauro, M; FIBROID Registry Investigators,
MLA Citation
Spies, JB, Myers, ER, Worthington-Kirsch, R, Mulgund, J, Goodwin, S, Mauro, M, and FIBROID Registry Investigators, . "The FIBROID Registry: symptom and quality-of-life status 1 year after therapy." Obstet Gynecol 106.6 (December 2005): 1309-1318.
PMID
16319257
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
106
Issue
6
Publish Date
2005
Start Page
1309
End Page
1318
DOI
10.1097/01.AOG.0000188386.53878.49

Comparison of self-reported smoking status and anonymous urinary cotinine testing in pregnancy

Authors
Bursey-Reddick, K; Swamy, GK; Brouwer, RN; Pollak, KI; Myers, ER; Investigators, BS
MLA Citation
Bursey-Reddick, K, Swamy, GK, Brouwer, RN, Pollak, KI, Myers, ER, and Investigators, BS. "Comparison of self-reported smoking status and anonymous urinary cotinine testing in pregnancy." December 2005.
Source
wos-lite
Published In
American Journal of Obstetrics & Gynecology
Volume
193
Issue
6
Publish Date
2005
Start Page
S107
End Page
S107
DOI
10.1016/j.ajog.2005.10.372

Incidence and risk factors for stroke in pregnancy and the puerperium.

OBJECTIVE: To estimate the incidence, mortality, and risk factors for pregnancy-related stroke in the United States. METHODS: The Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality, for the years 2000-2001 was queried for International Classification of Diseases, 9th Revision, codes for stroke among all pregnancy-related discharges. RESULTS: A total of 2,850 pregnancy-related discharges included a diagnosis of stroke for a rate of 34.2 per 100,000 deliveries. There were 117 deaths or 1.4 per 100,000 deliveries. Twenty-two percent of survivors were discharged to another facility. The risk of stroke increased with age, particularly ages 35 years and older. African-American women were at a higher risk, odds ratio (OR) 1.5 (95% confidence interval [CI] 1.2-1.9). Medical conditions that were strongly associated with stroke included migraine headache, OR 16.9 (CI 9.7-29.5), thrombophilia, OR 16.0 (CI 9.4-27.2), systemic lupus erythematosus, OR 15.2 (CI 7.4-31.2), heart disease, OR 13.2 (CI 10.2-17.0), sickle cell disease, OR 9.1 (CI 3.7-22.2), hypertension, OR 6.1(CI 4.5-8.1) and thrombocytopenia, OR 6.0 (CI 1.5-24.1). Complications of pregnancy that were significant risk factors were postpartum hemorrhage, OR 1.8 (CI 1.2-2.8), preeclampsia and gestational hypertension, OR 4.4 (CI 3.6-5.4), transfusion OR 10.3 (CI 7.1-15.1) and postpartum infection, OR 25.0 (CI 18.3-34.0). CONCLUSION: The incidence, mortality and disability from pregnancy related-stroke are higher than previously reported. African-American women are at an increased risk, as are women aged 35 years and older. Risk factors, not previously reported, include lupus, blood transfusion, and migraine headaches. Specific strategies, not currently employed, may be required to reduce the devastation caused by stroke during pregnancy and the puerperium. LEVEL OF EVIDENCE: II-2.

Authors
James, AH; Bushnell, CD; Jamison, MG; Myers, ER
MLA Citation
James, AH, Bushnell, CD, Jamison, MG, and Myers, ER. "Incidence and risk factors for stroke in pregnancy and the puerperium." Obstet Gynecol 106.3 (September 2005): 509-516.
PMID
16135580
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
106
Issue
3
Publish Date
2005
Start Page
509
End Page
516
DOI
10.1097/01.AOG.0000172428.78411.b0

Prospective data collection of a new procedure by a specialty society: the FIBROID registry.

OBJECTIVE: To describe registry methods and baseline patient demographics from a national sample of women undergoing uterine artery embolization for uterine leiomyomata. METHODS: Interventional radiology practices were recruited to submit data by a secure Web site on women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline data included patient demographics, prior medical, surgical, and obstetrical history, uterine anatomy, and quality-of-life measures. Subsequent data collected included details of the uterine artery embolization procedure and hospital stay and outcomes at 30 days; patients were also offered the opportunity to participate in longer-term follow-up. Characteristics of white and African-American women were compared using t tests, chi(2), or Wilcoxon rank-sum tests as appropriate. RESULTS: As of December 31, 2002, 3,319 uterine artery embolization cases had been entered into the registry by 72 sites; number of patients entered by individual sites ranged from 1 to 514. Of these patients, 95.4% consented to participation in the short-term outcomes registry. Forty-eight percent of patients were African American, and 44.4% were white and non-Hispanic. Heavy menstrual bleeding was the single most bothersome symptom in 64.3% of patients. Compared with white non-Hispanic women, African-American women were significantly younger, more likely to be obese, had larger uteri and more numerous leiomyomata, more severe symptoms, and poorer quality-of-life scores before treatment. CONCLUSION: It is feasible to collect prospective data on new technologies. The FIBROID Registry prospectively collected data on more than 3,000 women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline patient characteristics of this patient population seem to be similar to those of women undergoing other procedures for leiomyomata. LEVEL OF EVIDENCE: III.

Authors
Myers, ER; Goodwin, S; Landow, W; Mauro, M; Peterson, E; Pron, G; Spies, JB; Worthington-Kirsch, R; FIBROID Investigators,
MLA Citation
Myers, ER, Goodwin, S, Landow, W, Mauro, M, Peterson, E, Pron, G, Spies, JB, Worthington-Kirsch, R, and FIBROID Investigators, . "Prospective data collection of a new procedure by a specialty society: the FIBROID registry." Obstet Gynecol 106.1 (July 2005): 44-51.
PMID
15994616
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
106
Issue
1
Publish Date
2005
Start Page
44
End Page
51
DOI
10.1097/01.AOG.0000165827.66541.dd

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.

OBJECTIVE: To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. METHODS: Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. RESULTS: Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. CONCLUSION: Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. LEVEL OF EVIDENCE: II-3.

Authors
Worthington-Kirsch, R; Spies, JB; Myers, ER; Mulgund, J; Mauro, M; Pron, G; Peterson, ED; Goodwin, S; FIBROID Investigators,
MLA Citation
Worthington-Kirsch, R, Spies, JB, Myers, ER, Mulgund, J, Mauro, M, Pron, G, Peterson, ED, Goodwin, S, and FIBROID Investigators, . "The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes." Obstet Gynecol 106.1 (July 2005): 52-59.
PMID
15994617
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
106
Issue
1
Publish Date
2005
Start Page
52
End Page
59
DOI
10.1097/01.AOG.0000165828.68787.a9

Dissemination of Evidence-based Practice Center reports.

The Evidence-based Practice Center (EPC) program within the Agency for Healthcare Research and Quality (AHRQ) provides detailed evidence reports for partner organizations that they can translate into activities that improve patient care. A review of these dissemination activities provides a rich opportunity to understand how to create more successful linkages between best evidence and best practice. On the basis of interviews with EPC directors, AHRQ staff, and representatives of public and private users of EPC reports, we summarize the variety of efforts to disseminate the work of the EPCs. We also identify a case example of a successful dissemination of an EPC report. Experience to date reinforces the importance of creating close ties between researchers and the policymakers, clinicians, and other decision makers who use EPC evidence reports; developing a conceptual framework to guide the process; and establishing the resource foundation for the entire effort.

Authors
Matchar, DB; Westermann-Clark, EV; McCrory, DC; Patwardhan, M; Samsa, G; Kulasingam, S; Myers, E; Sarria-Santamera, A; Lee, A; Gray, R; Liu, K; Agency for Healthcare Research and Quality,
MLA Citation
Matchar, DB, Westermann-Clark, EV, McCrory, DC, Patwardhan, M, Samsa, G, Kulasingam, S, Myers, E, Sarria-Santamera, A, Lee, A, Gray, R, Liu, K, and Agency for Healthcare Research and Quality, . "Dissemination of Evidence-based Practice Center reports." Ann Intern Med 142.12 Pt 2 (June 21, 2005): 1120-1125. (Review)
PMID
15968037
Source
pubmed
Published In
Annals of internal medicine
Volume
142
Issue
12 Pt 2
Publish Date
2005
Start Page
1120
End Page
1125

Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial.

Polycystic ovary syndrome (PCOS) affects approximately 5% of the female population, and is a leading cause of infertility, primarily secondary to anovulation. Clomiphene citrate has been standard therapy for ovulation induction in patients seeking pregnancy, but recent evidence suggests that insulin sensitizing agents such as metformin may also be effective. The National Institute of Child Health and Human Development's Reproductive Medicine Network has begun a randomized, double-blind trial of clomiphene vs. metformin vs. clomiphene plus metformin for the induction of ovulation in patients with PCOS seeking pregnancy, with live birth rate as the primary outcome. Because the available literature was largely limited to surrogate outcomes such as ovulation and pregnancy rates, we created a Markov model to derive estimates of likely live birth rates in each arm. Using these estimates, we then constructed an algorithm that allowed only two formal comparisons between the three arms. First, we assumed that combination therapy would have to be superior to the next best single-agent therapy in order to be preferred, because of complexity, costs, increased side effects, etc. If combination therapy is not superior to the next best single agent, then the only other comparison of interest is between the two single agent therapies. Because the third possible comparison, between the best and worst of the three therapies, is not clinically relevant, it can be eliminated from formal statistical consideration, with subsequent reduction in sample size. Based on the opinion of the Network Steering Committee that a 15% absolute difference in live birth rates would be clinically relevant, our methodology resulted in a sample size of 226 per arm, or a total of 678 subjects. The PPCOS trial should definitively answer the question of the relative efficacy of metformin, clomiphene, and combination therapy in the treatment of infertile women with PCOS.

Authors
Myers, ER; Silva, SG; Hafley, G; Kunselman, AR; Nestler, JE; Legro, RS; National Institute of Child Health and Human Development Reproductive Medicine Network,
MLA Citation
Myers, ER, Silva, SG, Hafley, G, Kunselman, AR, Nestler, JE, Legro, RS, and National Institute of Child Health and Human Development Reproductive Medicine Network, . "Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial." Contemp Clin Trials 26.3 (June 2005): 271-280.
PMID
15911461
Source
pubmed
Published In
Contemporary Clinical Trials
Volume
26
Issue
3
Publish Date
2005
Start Page
271
End Page
280
DOI
10.1016/j.cct.2005.01.006

Endometrial dating - still room for controversy - Reply

Authors
McGovern, PG; Myers, ER; Coutifaris, C
MLA Citation
McGovern, PG, Myers, ER, and Coutifaris, C. "Endometrial dating - still room for controversy - Reply." FERTILITY AND STERILITY 83.6 (June 2005): 1890-1891.
Source
wos-lite
Published In
Fertility and Sterility
Volume
83
Issue
6
Publish Date
2005
Start Page
1890
End Page
1891
DOI
10.1016/j.fertnstert.2005.03.011

FDG-PET for management of cervical and ovarian cancer.

OBJECTIVE: To assess the diagnostic performance of Positron Emission Tomography using fluorodeoxyglucose (FDG-PET) in comparison to conventional imaging modalities in the assessment of patients with cervical and ovarian cancer. METHODS: Studies published between 1966 and 2003 were identified using an OVID search of the MEDLINE database. Inclusion criteria were use of a dedicated scanner, resolution specified, >/=12 human subjects, clinical follow-up >/=6 months or histopathology as reference standard, and sufficient data provided to construct a two-by-two table. Two reviewers independently abstracted data regarding sensitivity and specificity of PET. RESULTS: 25 studies (15 cervical cancer, 10 ovarian cancer) met inclusion criteria for full text review. For cervical cancer, pooled sensitivity and specificity of PET for aortic node metastasis are 0.84 (95% CI 0.68-0.94) and 0.95 (0.89-0.98). Pooled sensitivity and specificity for detection of pelvic node metastasis are: PET, 0.79 (0.65-0.90) and 0.99 (0.96-0.99); MRI, 0.72 (0.53-0.87) and 0.96 (0.92-0.98). Pooled sensitivity for CT is 0.47 (0.21-0.73) (pooled specificity not available). Pooled sensitivity and specificity of PET for recurrent cervical cancer with clinical suspicion are 0.96 (0.87-0.99) and 0.81 (0.58-0.94). For ovarian cancer, pooled sensitivity and specificity to detect recurrence with clinical suspicion are: PET, 0.90 (0.82-0.95) and 0.86 (0.67-0.96); conventional imaging, 0.68 (0.49-0.83) and 0.58 (0.33-0.80); CA-125, 0.81 (0.62-0.92) and 0.83 (0.58-0.96). When conventional imaging and CA-125 are negative, pooled sensitivity and specificity of PET are 0.54 (0.39-0.69) and 0.73 (0.56-0.87), respectively. When CA-125 is rising and conventional imaging is negative, the pooled sensitivity and specificity of PET are 0.96 (0.88-0.99) and 0.80 (0.44-0.97). CONCLUSIONS: There is good evidence that PET is useful for the pre-treatment detection of retroperitoneal nodal metastasis in cervical cancer. There is fair evidence that PET is useful for the detection of recurrent cervical cancer. PET is less useful for the detection of microscopic residual ovarian cancer but has fair sensitivity to detect recurrence in the setting of a rising CA-125 and negative conventional imaging studies. Available studies are limited by low numbers of patients and wide confidence intervals.

Authors
Havrilesky, LJ; Kulasingam, SL; Matchar, DB; Myers, ER
MLA Citation
Havrilesky, LJ, Kulasingam, SL, Matchar, DB, and Myers, ER. "FDG-PET for management of cervical and ovarian cancer." Gynecol Oncol 97.1 (April 2005): 183-191.
PMID
15790456
Source
pubmed
Published In
Gynecologic Oncology
Volume
97
Issue
1
Publish Date
2005
Start Page
183
End Page
191
DOI
10.1016/j.ygyno.2004.12.007

Peripartum stroke: Incidence, mortality, and outcomes

Authors
Bushnell, CD; James, AH; Jamison, M; Myers, ER
MLA Citation
Bushnell, CD, James, AH, Jamison, M, and Myers, ER. "Peripartum stroke: Incidence, mortality, and outcomes." February 2005.
Source
wos-lite
Published In
Stroke
Volume
36
Issue
2
Publish Date
2005
Start Page
430
End Page
430

Dissemination of Evidence-based Practice Center reports

The Evidence-based Practice Center (EPC) program within the Agency for Healthcare Research and Quality (AHRQ) provides detailed evidence reports for partner organizations that they can translate into activities that improve patient care. A review of these dissemination activities provides a rich opportunity to understand how to create more successful linkages between best evidence and best practice. On the basis of interviews with EPC directors, AHRQ staff, and representatives of public and private users of EPC reports, we summarize the variety of efforts to disseminate the work of the EPCs. We also identify a case example of a successful dissemination of an EPC report. Experience to date reinforces the importance of creating close ties between researchers and the policy makers, clinicians, and other decision makers who use EPC evidence reports; developing a conceptual framework to guide the process; and establishing the resource foundation for the entire effort.

Authors
Matchar, DB; Westermann-Clark, EV; McCrory, DC; Patwardhan, M; Samsa, G; Kulasingam, S; Myers, E; Sarria-Santamera, A; Lee, A; Gray, R; Liu, K
MLA Citation
Matchar, DB, Westermann-Clark, EV, McCrory, DC, Patwardhan, M, Samsa, G, Kulasingam, S, Myers, E, Sarria-Santamera, A, Lee, A, Gray, R, and Liu, K. "Dissemination of Evidence-based Practice Center reports." Annals of Internal Medicine 142.12 II (2005): 1120-1125.
Source
scival
Published In
Annals of Internal Medicine
Volume
142
Issue
12 II
Publish Date
2005
Start Page
1120
End Page
1125

Endometrial dating - Still room for controversy [5] (multiple letters)

Authors
Koninckx, P; Brosens, JJ; Brosens, I; McGovern, PG; Myers, ER; Coutifaris, C
MLA Citation
Koninckx, P, Brosens, JJ, Brosens, I, McGovern, PG, Myers, ER, and Coutifaris, C. "Endometrial dating - Still room for controversy [5] (multiple letters)." Fertility and Sterility 83.6 (2005): 1889-1891.
PMID
15950681
Source
scival
Published In
Fertility and Sterility
Volume
83
Issue
6
Publish Date
2005
Start Page
1889
End Page
1891
DOI
10.1016/j.fertnstert.2005.03.010

Levonorgestrel-releasing intrauterine system for menorrhagia cost less than hysterectomy over 5 years

Authors
Hurskainen, R; Teperi, J; Rissanen, P; Aalto, AM; Grenman, S; Kivelä, A; Kajansuu, E; Vuorma, S; Yliskoski, M; Paavonen, J; Myers, ER
MLA Citation
Hurskainen, R, Teperi, J, Rissanen, P, Aalto, AM, Grenman, S, Kivelä, A, Kajansuu, E, Vuorma, S, Yliskoski, M, Paavonen, J, and Myers, ER. "Levonorgestrel-releasing intrauterine system for menorrhagia cost less than hysterectomy over 5 years." Evidence-based Obstetrics and Gynecology 7.1 (2005): 23-24.
Source
scival
Published In
Evidence-based Obstetrics and Gynecology
Volume
7
Issue
1
Publish Date
2005
Start Page
23
End Page
24
DOI
10.1016/j.ebobgyn.2004.12.008

Combined bone morphogenetic protein-2 and -7 gene transfer enhances osteoblastic differentiation and spine fusion in a rodent model.

UNLABELLED: To enhance the osteogenic activity of BMP, combination BMP2 and BMP7 gene transfer was performed. This approach led to a significant increase in osteoblastic differentiation of mesenchymal precursors compared with single BMP gene transfer in vitro. When tested in 78 rats, combination gene transfer enhanced mechanically stable spine fusion and bone formation rate versus single BMP gene transfer. INTRODUCTION: Although clinical bone morphogenetic protein (BMP) therapy is effective, required doses are very high. Previous studies have suggested that the co-expression of two different BMP genes can result in the production of heterodimeric BMPs that may be more potent than homodimers. In this study, combined BMP2 and BMP7 gene transfer was performed to test whether this approach improves osteoblastic differentiation and bone formation compared with single BMP gene transfer. MATERIALS AND METHODS: A producer cell (A549) was co-transfected with adenovirus vectors encoding BMP2 (AdBMP2) and BMP7 (AdBMP7) or, as controls, each vector alone, AdNull (with no transgene) or no virus. Supernatants were compared for their ability to stimulate osteoblastic differentiation of C2C12 myoblasts and MC3T3-E1 pre-osteoblasts. In a rat posterolateral spine fusion model, co-administration of AdBMP2 and AdBMP7 was compared with treatment with each vector alone, AdNull or no virus in 78 rats. The spines were assessed 8 weeks after surgery for radiographic and mechanical fusion, bone formation, and mineralization. RESULTS: BMP2 and BMP7 were co-precipitated from supernatants of cells co-transfected with AdBMP2 and AdBMP7, indicating the presence of BMP2/7 heterodimer. Supernatants of co-transfected cells containing relatively low doses (7-140 ng/ml) of BMPs induced osteocalcin expression and alkaline phosphatase activity in both C2C12 and MC3T3-E1 cells, that were up to 6- and 40-fold higher, respectively, than levels induced by maximal doses (200-1000 ng/ml) of either BMP2 or BMP7 alone. In the spine fusion model, co-administration of AdBMP2 and AdBMP7 resulted in a significantly greater number of mechanically stable fusions and also 2-fold higher mineralization rate and bone volume in the fusion mass versus single BMP gene transfer (p < 0.02, all comparisons). CONCLUSION: Combined BMP2 and BMP7 gene transfer is significantly more effective in inducing osteoblastic differentiation and spine fusion than individual BMP gene transfer.

Authors
Zhu, W; Rawlins, BA; Boachie-Adjei, O; Myers, ER; Arimizu, J; Choi, E; Lieberman, JR; Crystal, RG; Hidaka, C
MLA Citation
Zhu, W, Rawlins, BA, Boachie-Adjei, O, Myers, ER, Arimizu, J, Choi, E, Lieberman, JR, Crystal, RG, and Hidaka, C. "Combined bone morphogenetic protein-2 and -7 gene transfer enhances osteoblastic differentiation and spine fusion in a rodent model." J Bone Miner Res 19.12 (December 2004): 2021-2032.
PMID
15537446
Source
pubmed
Published In
Journal of Bone and Mineral Research
Volume
19
Issue
12
Publish Date
2004
Start Page
2021
End Page
2032
DOI
10.1359/JBMR.040821

Histological dating of timed endometrial biopsy tissue is not related to fertility status.

OBJECTIVE: To assess the ability of histological dating to discriminate between women of fertile and infertile couples. The utility of histological dating of endometrium in the evaluation of infertile couples is uncertain. DESIGN: Prospective multicenter study, with subjects randomly assigned to biopsy timing. Criterion standard for infertility was 12 months of unprotected, regular intercourse without conception and for fertility at least one live birth within 2 years. SETTING: University-based infertility practices. PATIENT(S): Volunteer subjects (847) recruited at 12 clinical sites participating in the National Institutes of Health-funded Reproductive Medicine Network. Inclusion criteria included ages 20-39 years, regular menstrual cycles, and no hormonal treatment or contraceptive use for 1 month before the study. Fertile controls were excluded if they had a history of infertility, recurrent pregnancy loss, or recent breastfeeding. INTERVENTION(S): Subjects underwent daily urinary LH testing. After detection of the LH surge, subjects were randomized to biopsy in the mid (days 21-22) or the late (days 26-27) luteal phase. Pathologists at each site estimated the cycle day based on standard criteria. For the primary analysis, an out-of-phase biopsy was defined as a greater than 2-day delay in the histological maturation of the endometrium. MAIN OUTCOME MEASURE(S): The proportion of out-of-phase biopsies in fertile and infertile women was compared using logistic regression models with age at randomization as a covariate. Comparisons were also made between fertile vs. infertile at the midluteal or late luteal phase time points. RESULT(S): Biopsies were evaluated (301 mid and 318 late; N = 619). Out-of-phase biopsy results poorly discriminated between women from fertile and infertile couples in either the midluteal (fertile: 49.4%, infertile: 43.2%) or late luteal phase (fertile: 35.3%, infertile 23.0%). Results did not substantially differ using alternative definitions of "out-of-phase" or standardized cycle day. CONCLUSION(S): Histological dating of the endometrium does not discriminate between women of fertile and infertile couples and should not be used in the routine evaluation of infertility.

Authors
Coutifaris, C; Myers, ER; Guzick, DS; Diamond, MP; Carson, SA; Legro, RS; McGovern, PG; Schlaff, WD; Carr, BR; Steinkampf, MP; Silva, S; Vogel, DL; Leppert, PC; NICHD National Cooperative Reproductive Medicine Network,
MLA Citation
Coutifaris, C, Myers, ER, Guzick, DS, Diamond, MP, Carson, SA, Legro, RS, McGovern, PG, Schlaff, WD, Carr, BR, Steinkampf, MP, Silva, S, Vogel, DL, Leppert, PC, and NICHD National Cooperative Reproductive Medicine Network, . "Histological dating of timed endometrial biopsy tissue is not related to fertility status." Fertil Steril 82.5 (November 2004): 1264-1272.
PMID
15533340
Source
pubmed
Published In
Fertility and Sterility
Volume
82
Issue
5
Publish Date
2004
Start Page
1264
End Page
1272
DOI
10.1016/j.fertnstert.2004.03.069

Absence of secretory endometrium after false-positive home urine luteinizing hormone testing.

OBJECTIVE: To examine the proportion of cases with proliferative endometrium on biopsies performed after positive home urine LH testing. DESIGN: Multicenter clinical trial of the usefulness of endometrial biopsy in the evaluation of infertility, with women from fertile and infertile couples randomly assigned to midluteal vs. late luteal phase endometrial sampling. SETTING: Twelve clinical sites of the National Institutes of Health/National Institute of Child Health and Human Development-sponsored Reproductive Medicine Network. PATIENT(S): All women in the study had regular menstrual cycles. Fertile volunteers who had delivered a live born infant within the past 2 years without medical intervention were recruited through advertisements at participating sites. Infertile women with regular cycles were recruited from the clinical practices of the sites' physicians. INTERVENTION(S): Interview, informed consent, subject-interpreted home urine LH testing, and endometrial biopsy in either the midluteal or late luteal phase. MAIN OUTCOME MEASURE(S): Proportion of cases with proliferative endometrium on biopsy. RESULT(S): In both fertile and infertile women, more than 7% of endometrial biopsies performed 7-13 days after a positive home urine LH test revealed proliferative endometrium. CONCLUSION(S): Patient interpretation of home urine LH test kits not uncommonly results in false-positive tests. Women planning menstrual cycle testing or procedures related to ovulation may benefit from additional confirmatory testing.

Authors
McGovern, PG; Myers, ER; Silva, S; Coutifaris, C; Carson, SA; Legro, RS; Schlaff, WD; Carr, BR; Steinkampf, MP; Giudice, LC; Leppert, PC; Diamond, MP; NICHD National Cooperative Reproductive Medicine Network,
MLA Citation
McGovern, PG, Myers, ER, Silva, S, Coutifaris, C, Carson, SA, Legro, RS, Schlaff, WD, Carr, BR, Steinkampf, MP, Giudice, LC, Leppert, PC, Diamond, MP, and NICHD National Cooperative Reproductive Medicine Network, . "Absence of secretory endometrium after false-positive home urine luteinizing hormone testing." Fertil Steril 82.5 (November 2004): 1273-1277.
PMID
15533341
Source
pubmed
Published In
Fertility and Sterility
Volume
82
Issue
5
Publish Date
2004
Start Page
1273
End Page
1277
DOI
10.1016/j.fertnstert.2004.03.070

Interobserver and intraobserver variability in the histological dating of the endometrium in fertile and infertile women.

OBJECTIVE: To assess effects of biopsy timing and fertility status on inter- and intraobserver variability in dating of the endometrium. DESIGN: Endometrial biopsy slides randomly selected from a multicenter study testing the utility of biopsy in the diagnosis of infertility were distributed to three gynecologic pathologists, who estimated cycle day using standard criteria. Readers were blinded to the purpose of the study, patient age, fertility status, or timing of biopsy relative to LH surge or next menses. SETTING: Multicenter academic research programs in reproductive medicine. PATIENT(S): Eighty-two women with proven fertility, 83 infertile patients. INTERVENTION(S): Endometrial biopsy during midluteal (days 21-22) or late (days 26-27) luteal phase. MAIN OUTCOME MEASURE(S): Intraclass correlation coefficient (ICC), kappa. RESULT(S): Overall agreement was excellent (ICC 0.88); addition of readings by local pathologists decreased ICC only slightly. In subgroup analyses, ICCs were lowest for infertile women during the midluteal phase (0.65 vs. 0.71 for fertile women in the midluteal phase, and 0.88-0.90 for both groups in the late luteal phase). Intraobserver reliability was excellent (0.9-0.99). Agreement for diagnoses of "out-of-phase" was only moderate, with kappa values between 0.4 and 0.6. CONCLUSION(S): Observer variability in dating the endometrium was greatest in infertile women during the window of implantation.

Authors
Myers, ER; Silva, S; Barnhart, K; Groben, PA; Richardson, MS; Robboy, SJ; Leppert, P; Coutifaris, C; NICHD National Cooperative Reproductive Medicine Network,
MLA Citation
Myers, ER, Silva, S, Barnhart, K, Groben, PA, Richardson, MS, Robboy, SJ, Leppert, P, Coutifaris, C, and NICHD National Cooperative Reproductive Medicine Network, . "Interobserver and intraobserver variability in the histological dating of the endometrium in fertile and infertile women." Fertil Steril 82.5 (November 2004): 1278-1282.
PMID
15533342
Source
pubmed
Published In
Fertility and Sterility
Volume
82
Issue
5
Publish Date
2004
Start Page
1278
End Page
1282
DOI
10.1016/j.fertnstert.2004.04.058

High-dose alendronate uncouples osteoclast and osteoblast function: a study in a rat spine pseudarthrosis model.

The effect of alendronate on osteoclast and osteoblast function was studied in a novel spine pseudarthrosis model in rats. Sixty-three Sprague-Dawley rats were divided into three groups: control group (saline), therapeutic dose group (1 microg/kg/week), and one-log overdose group (10 microg/kg/week). Animals had L4-L5 posterior intertransverse process fusion with limited bone graft and were sacrificed at 2, 4, and 6 weeks. Manual palpation showed no notable differences among groups. Treatment group radiographic scores were equal to or better than control group scores and were higher than the overdose group at 2 and 6 weeks. Qualitatively, limited histologic remodeling and poor osteoclastic and osteoblastic function were noted in the alendronate treated groups. Quantitative histologic analysis showed fewer osteoclasts in the therapeutic and high-dose groups (p < 0.001). The percent osteoblasts per bone surface area was lower in the high-dose group (p < 0.05). The results suggest that the effect of alendronate was dose dependent and animal model dependent and that supranormal doses of alendronate had a deleterious effect on osteoclastic and osteoblastic function in this model.

Authors
Sama, AA; Khan, SN; Myers, ER; Huang, RC; Cammisa, FP; Sandhu, HS; Lane, JM
MLA Citation
Sama, AA, Khan, SN, Myers, ER, Huang, RC, Cammisa, FP, Sandhu, HS, and Lane, JM. "High-dose alendronate uncouples osteoclast and osteoblast function: a study in a rat spine pseudarthrosis model." Clin Orthop Relat Res 425 (August 2004): 135-142.
PMID
15292798
Source
pubmed
Published In
Clinical Orthopaedics and Related Research ®
Issue
425
Publish Date
2004
Start Page
135
End Page
142

Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome?

There are multiple surrogate variables in polycystic ovary syndrome (PCOS), including biometric and biochemical parameters. The number of surrogate variables and their poor validity in relationship to primary clinical end-points pose major problems to conducting a trial in women with PCOS. The aim of this review is to discuss the use of surrogate variables compared with primary clinical end-points in women with PCOS. Arguably the best documented correlation between a surrogate variable and a primary clinical end-point is that between ovulation and pregnancy in women with PCOS. Good correlation has been noted between the increase in ovulation frequency with clomiphene citrate and the chance of pregnancy in women with PCOS. However, ovulation cannot be equated with pregnancy, as a host of other factors may affect the true outcome of interest: a healthy liveborn child. Pregnancy and an improvement in hirsutism are clinical end-points that have been successfully studied in past and ongoing clinical trials in women with PCOS. Many other clinical end-points, such as endometrial cancer and cardiovascular disease, are rare in premenopausal women with PCOS, and may not be suitable as the primary outcome of clinical studies. Future multicentre trials in women with PCOS should focus on primary clinical end-points.

Authors
Legro, RS; Myers, E
MLA Citation
Legro, RS, and Myers, E. "Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome?." Hum Reprod 19.8 (August 2004): 1697-1704. (Review)
PMID
15192061
Source
pubmed
Published In
Human Reproduction
Volume
19
Issue
8
Publish Date
2004
Start Page
1697
End Page
1704
DOI
10.1093/humrep/deh322

Testing for von Willebrand disease in women with menorrhagia: a systematic review.

OBJECTIVE: To review the evidence supporting screening of adult women with menorrhagia for von Willebrand disease. DATA SOURCES: MEDLINE search from January 1,1990, to December 31, 2003, for articles in English, using keywords "menorrhagia," "von Willebrand disease," "diagnosis," and "screening," with a hand-search of bibliographies of identified articles, review of published abstracts, and discussion with experts. METHODS OF STUDY SELECTION: One hundred seven articles meeting search criteria were reviewed. Articles included in the study were those that provided primary data on the prevalence of von Willebrand disease in adult women with menorrhagia, quality of life, surgical complications, and the effectiveness of medical therapy in women with menorrhagia and von Willebrand disease and test characteristics of screening tests for von Willebrand disease. TABULATION, INTEGRATION, AND RESULTS: The reported prevalence of von Willebrand disease in women with menorrhagia ranged from 5-20% in 5 published studies. Comparison of results was limited by small sample sizes and large confidence intervals, as well as differences in the definitions of menorrhagia and von Willebrand disease used in the studies. Although menorrhagia in women with known von Willebrand disease has a substantial impact on quality of life, there are no data suggesting that this impact is substantially greater than that of menorrhagia in women without von Willebrand disease. Data on the risk of surgical bleeding in women with von Willebrand disease are limited, with only 3 studies with a total of 29 patients identified. Data on the effectiveness of specific therapies are also limited; only one controlled trial was identified. Of single tests for screening, one study of the ristocetin cofactor assay had a sensitivity of 79% and specificity of 90%. Studies of a test of platelet adhesion and aggregation resulted in pooled sensitivities of 83-94% and specificities of 80-88%; however, significant heterogeneity was present. CONCLUSION: There are inadequate data to justify routine testing for von Willebrand disease in adult women with menorrhagia outside of the research setting.

Authors
James, A; Matchar, DB; Myers, ER
MLA Citation
James, A, Matchar, DB, and Myers, ER. "Testing for von Willebrand disease in women with menorrhagia: a systematic review." Obstet Gynecol 104.2 (August 2004): 381-388. (Review)
PMID
15292016
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
104
Issue
2
Publish Date
2004
Start Page
381
End Page
388
DOI
10.1097/01.AOG.0000133487.55682.7b

Should older women have antepartum testing to prevent unexplained stillbirth?

OBJECTIVE: Older women are at an increased risk for unexplained stillbirth late in pregnancy. The purpose of this study was to compare 3 strategies for the prevention of unexplained fetal death in women aged 35 years and older. We compared usual care (no antepartum testing or induction before 41 weeks), weekly testing at 37 weeks with induction after a positive test, and no testing with induction at 41 weeks. METHOD: We used a Markov model to quantify the risks and benefits of each strategy in terms of the number of antepartum tests, inductions, and additional cesarean deliveries per fetal death averted. Probability data used in the model were derived from obstetrical databases and the literature. RESULTS: Without a strategy of antepartum surveillance between 37 and 41 weeks, women aged 35 years and older would experience 5.2 unexplained fetal deaths per 1,000 pregnancies. For nulliparous women 35 and older, weekly antepartum testing initiated at 37 weeks would avert 3.9 fetal deaths per 1,000 pregnancies but would require 863 antepartum tests, 71 inductions, and 14 additional cesarean deliveries per fetal death averted. A strategy of no testing but induction at 41 weeks would avert 0.9 fetal deaths per 1,000 pregnancies and require 469 inductions and 219 additional cesareans per fetal death averted. CONCLUSION: A strategy of antepartum testing in older women would reduce the number of unexplained stillbirths at term and would result in fewer inductions and cesareans per fetal death averted than a strategy of no antepartum testing but induction at 41 weeks.

Authors
Fretts, RC; Elkin, EB; Myers, ER; Heffner, LJ
MLA Citation
Fretts, RC, Elkin, EB, Myers, ER, and Heffner, LJ. "Should older women have antepartum testing to prevent unexplained stillbirth?." Obstet Gynecol 104.1 (July 2004): 56-64.
PMID
15229001
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
104
Issue
1
Publish Date
2004
Start Page
56
End Page
64
DOI
10.1097/01.AOG.0000129237.93777.1a

Cost-effectiveness of combination thromboembolism prophylaxis in gynecologic oncology surgery.

OBJECTIVE: To compare the cost-effectiveness of external pneumatic compression devices with and without the addition of low-molecular-weight heparin for the prevention of deep vein thrombosis in high-risk surgical patients with gynecologic cancer. METHODS: A Markov decision analytic model was used to estimate the costs and outcomes associated with the prophylactic use of external pneumatic compression with and without low-molecular-weight heparin in patients undergoing gynecologic surgery. We estimated cost per fatal pulmonary embolus prevented, cost per deep vein thrombus prevented, and cost per life-year saved. Probability estimates for various outcomes and efficacies were obtained from the literature, using data specific for gynecologic surgery patients when available. RESULTS: In the base case scenario, cost-effectiveness estimates for combination prophylaxis varied from 10,091 dollars per life-year saved for a 35-year-old patient with IB cervix cancer patient to 50,181 dollars for a 65-year-old patient with stage IIIC ovarian cancer, costs within the 50,000-65,000 dollars per life-year saved threshold considered to be cost-effective. Combination prophylaxis appeared to be cost-effective in gynecologic oncology patients as long as the risk of perioperative thromboembolism using this method of prevention was less than or equal to 4%. Sensitivity analysis indicated that variation of the marginal cost of low-molecular-weight heparin and the marginal effectiveness to extremes did not change the conclusions of the statistical model. CONCLUSION: The use of combination therapy external pneumatic compression is estimated to be cost-effective for high-risk gynecologic oncology patients undergoing surgery. Clinical trials to determine the efficacy of perioperative combination therapy in gynecologic surgery are justified.

Authors
Dainty, L; Maxwell, GL; Clarke-Pearson, DL; Myers, ER
MLA Citation
Dainty, L, Maxwell, GL, Clarke-Pearson, DL, and Myers, ER. "Cost-effectiveness of combination thromboembolism prophylaxis in gynecologic oncology surgery." Gynecol Oncol 93.2 (May 2004): 366-373.
PMID
15099947
Source
pubmed
Published In
Gynecologic Oncology
Volume
93
Issue
2
Publish Date
2004
Start Page
366
End Page
373
DOI
10.1016/j.ygyno.2004.02.004

Absence of secretory endometrium after false positive home urine luteinizing hormone testing.

Authors
McGovern, PG; Myers, ER; Silva, S; Coutifaris, C; Carson, SA; Legro, RS; Schlaff, WD; Carr, BR; Steinkampf, MP; Giudice, LC; Leppert, PC; Diamond, MP
MLA Citation
McGovern, PG, Myers, ER, Silva, S, Coutifaris, C, Carson, SA, Legro, RS, Schlaff, WD, Carr, BR, Steinkampf, MP, Giudice, LC, Leppert, PC, and Diamond, MP. "Absence of secretory endometrium after false positive home urine luteinizing hormone testing." February 2004.
Source
wos-lite
Published In
Journal of the Society for Gynecologic Investigation (Elsevier)
Volume
11
Issue
2
Publish Date
2004
Start Page
378A
End Page
378A

Screening for bacterial vaginosis to prevent preterm birth: assessing effectiveness and cost-effectiveness.

Authors
Myers, ER
MLA Citation
Myers, ER. "Screening for bacterial vaginosis to prevent preterm birth: assessing effectiveness and cost-effectiveness." Acta Obstet Gynecol Scand 83.1 (January 2004): 2-3.
PMID
14678078
Source
pubmed
Published In
Acta Obstetricia et Gynecologica Scandinavica
Volume
83
Issue
1
Publish Date
2004
Start Page
2
End Page
3

A test can be reproducible but still not useful

Good correlation between pathologists in assigning dates to endometrial biopsy specimens did not translate into good agreement in the dichotomous diagnosis of in-phase or out-of-phase. Design and analysis of reproducibility studies is complex; although alternative approaches are certainly reasonable, we believe it unlikely that they would have changed our fundamental conclusion. © 2004 by American Society for Reproductive Medicine.

Authors
Myers, ER
MLA Citation
Myers, ER. "A test can be reproducible but still not useful." Fertility and Sterility 82.5 (2004): 1299--.
Source
scival
Published In
Fertility and Sterility
Volume
82
Issue
5
Publish Date
2004
Start Page
1299-
DOI
10.1016/j.fertnstert.2004.07.931

Screening every three years, instead of annually, would result in a small increase in risk of cervical cancer

Authors
Sawaya, GF; McConnell, KJ; Kulasingam, SL; Lawson, HW; Kerlikowske, K; Melnikow, J; Lee, NC; Gildengorin, G; Myers, ER; Washington, AE; Franco, EL; Duarte-Franco, EF
MLA Citation
Sawaya, GF, McConnell, KJ, Kulasingam, SL, Lawson, HW, Kerlikowske, K, Melnikow, J, Lee, NC, Gildengorin, G, Myers, ER, Washington, AE, Franco, EL, and Duarte-Franco, EF. "Screening every three years, instead of annually, would result in a small increase in risk of cervical cancer." Evidence-based Obstetrics and Gynecology 6.4 (2004): 204-205.
Source
scival
Published In
Evidence-based Obstetrics and Gynecology
Volume
6
Issue
4
Publish Date
2004
Start Page
204
End Page
205
DOI
10.1016/j.ebobgyn.2004.09.009

Decision science and cervical cancer.

Mathematical modeling is an effective tool for guiding cervical cancer screening, diagnosis, and treatment decisions for patients and policymakers. This article describes the use of mathematical modeling as outlined in five presentations from the Decision Science and Cervical Cancer session of the Second International Conference on Cervical Cancer held at The University of Texas M. D. Anderson Cancer Center, April 11-14, 2002. The authors provide an overview of mathematical modeling, especially decision analysis and cost-effectiveness analysis, and examples of how it can be used for clinical decision making regarding the prevention, diagnosis, and treatment of cervical cancer. Included are applications as well as theory regarding decision science and cervical cancer. Mathematical modeling can answer such questions as the optimal frequency for screening, the optimal age to stop screening, and the optimal way to diagnose cervical cancer. Results from one mathematical model demonstrated that a vaccine against high-risk strains of human papillomavirus was a cost-effective use of resources, and discussion of another model demonstrated the importance of collecting direct non-health care costs and time costs for cost-effectiveness analysis. Research presented indicated that care must be taken when applying the results of population-wide, cost-effectiveness analyses to reduce health disparities. Mathematical modeling can encompass a variety of theoretical and applied issues regarding decision science and cervical cancer. The ultimate objective of using decision-analytic and cost-effectiveness models is to identify ways to improve women's health at an economically reasonable cost.

Authors
Cantor, SB; Fahs, MC; Mandelblatt, JS; Myers, ER; Sanders, GD
MLA Citation
Cantor, SB, Fahs, MC, Mandelblatt, JS, Myers, ER, and Sanders, GD. "Decision science and cervical cancer." Cancer 98.9 Suppl (November 1, 2003): 2003-2008.
PMID
14603536
Source
pubmed
Published In
Cancer
Volume
98
Issue
9 Suppl
Publish Date
2003
Start Page
2003
End Page
2008
DOI
10.1002/cncr.11680

Risk of cervical cancer associated with extending the interval between cervical-cancer screenings.

BACKGROUND: Although contemporary guidelines suggest that the intervals between Papanicolaou tests can be extended to three years among low-risk women with previous negative tests, the excess risk of cervical cancer associated with less frequent than annual screening is uncertain. METHODS: We determined the prevalence of biopsy-proven cervical neoplasia among 938,576 women younger than 65 years of age, stratified according to the number of previous consecutive negative Papanicolaou tests. Using a Markov model that estimates the rate at which dysplasia will progress to cancer, we estimated the risk of cancer within three years after one or more negative Papanicolaou tests, as well as the number of additional Papanicolaou tests and colposcopic examinations that would be required to avert one case of cancer given a particular interval between screenings. RESULTS: Among 31,728 women 30 to 64 years of age who had had three or more consecutive negative tests, the prevalence of biopsy-proven cervical intraepithelial neoplasia of grade 2 was 0.028 percent and the prevalence of grade 3 neoplasia was 0.019 percent; none of the women had invasive cervical cancer. According to our model, the estimated risk of cancer with annual Papanicolaou tests for three years was 2 in 100,000 among women 30 to 44 years of age, 1 in 100,000 among women 45 to 59 years of age, and 1 in 100,000 among women 60 to 64 years of age; these risks would be 5 in 100,000, 2 in 100,000, and 1 in 100,000, respectively, if screening were performed once three years after the last negative test. To avert one additional case of cancer by screening 100,000 women annually for three years rather than once three years after the last negative test, an average of 69,665 additional Papanicolaou tests and 3861 colposcopic examinations would be needed in women 30 to 44 years of age and an average of 209,324 additional Papanicolaou tests and 11,502 colposcopic examinations in women 45 to 59 years of age. CONCLUSIONS: As compared with annual screening for three years, screening performed once three years after the last negative test in women 30 to 64 years of age who have had three or more consecutive negative Papanicolaou tests is associated with an average excess risk of cervical cancer of approximately 3 in 100,000.

Authors
Sawaya, GF; McConnell, KJ; Kulasingam, SL; Lawson, HW; Kerlikowske, K; Melnikow, J; Lee, NC; Gildengorin, G; Myers, ER; Washington, AE
MLA Citation
Sawaya, GF, McConnell, KJ, Kulasingam, SL, Lawson, HW, Kerlikowske, K, Melnikow, J, Lee, NC, Gildengorin, G, Myers, ER, and Washington, AE. "Risk of cervical cancer associated with extending the interval between cervical-cancer screenings." N Engl J Med 349.16 (October 16, 2003): 1501-1509.
PMID
14561792
Source
pubmed
Published In
The New England journal of medicine
Volume
349
Issue
16
Publish Date
2003
Start Page
1501
End Page
1509
DOI
10.1056/NEJMoa035419

Potential health and economic impact of adding a human papillomavirus vaccine to screening programs.

CONTEXT: Recently published results suggest that effective vaccines against cervical cancer-associated human papillomavirus (HPV) may become available within the next decade. OBJECTIVE: To examine the potential health and economic effects of an HPV vaccine in a setting of existing screening. DESIGN, SETTING, AND POPULATION: A Markov model was used to estimate the lifetime (age 12-85 years) costs and life expectancy of a hypothetical cohort of women screened for cervical cancer in the United States. Three strategies were compared: (1) vaccination only; (2) conventional cytological screening only; and (3) vaccination followed by screening. Two of the strategies incorporated a vaccine targeted against a defined proportion of high-risk (oncogenic) HPV types. Screening intervals of 1, 2, 3, and 5 years and starting ages for screening of 18, 22, 24, 26, and 30 years were chosen for 2 of the strategies (conventional cytological screening only and vaccination followed by screening). MAIN OUTCOME MEASURES: Incremental cost per life-year gained. RESULTS: Vaccination only or adding vaccination to screening conducted every 3 and 5 years was not cost-effective. However, at more frequent screening intervals, strategies combining vaccination and screening were preferred. Vaccination plus biennial screening delayed until age 24 years had the most attractive cost-effectiveness ratio (44 889 dollars) compared with screening only beginning at age 18 years and conducted every 3 years. However, the strategy of vaccination with annual screening beginning at age 18 years had the largest overall reduction in cancer incidence and mortality at a cost of 236 250 dollars per life-year gained compared with vaccination and annual screening beginning at age 22 years. The cost-effectiveness of vaccination plus delayed screening was highly sensitive to age of vaccination, duration of vaccine efficacy, and cost of vaccination. CONCLUSIONS: Vaccination for HPV in combination with screening can be a cost-effective health intervention, but it depends on maintaining effectiveness during the ages of peak oncogenic HPV incidence. Identifying the optimal age for vaccination should be a top research priority.

Authors
Kulasingam, SL; Myers, ER
MLA Citation
Kulasingam, SL, and Myers, ER. "Potential health and economic impact of adding a human papillomavirus vaccine to screening programs." JAMA 290.6 (August 13, 2003): 781-789.
PMID
12915431
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
290
Issue
6
Publish Date
2003
Start Page
781
End Page
789
DOI
10.1001/jama.290.6.781

The health and economic burden of genital warts in a set of private health plans in the United States.

We estimated the prevalence of and costs associated with genital warts among privately insured individuals from the perspective of a private health plan in the United States. Health care claims data were derived from a sample of 3,664,686 privately insured individuals. The database was limited to cases of disease for which an insurance claim was generated, with costs reflecting inpatient, outpatient, and pharmacy payments from all sources. We identified 5095 cases of genital warts (1.7 cases per 1000 person-years) billed through the health plans during 2000. The prevalences of and health plan costs associated with genital warts were highest among women aged 20-24 years (6.2 cases and $1692 in costs per 1000 person-years) and men aged 25-29 years (5.0 cases and $1717 in costs per 1000 person-years). On average, individual episodes of care for genital warts involved 3.1 physician visits and incurred costs of $436. These are the first age- and sex-specific estimates of the prevalence and cost of genital warts for a US health plan.

Authors
Insinga, RP; Dasbach, EJ; Myers, ER
MLA Citation
Insinga, RP, Dasbach, EJ, and Myers, ER. "The health and economic burden of genital warts in a set of private health plans in the United States." Clin Infect Dis 36.11 (June 1, 2003): 1397-1403.
PMID
12766834
Source
pubmed
Published In
Clinical Infectious Diseases
Volume
36
Issue
11
Publish Date
2003
Start Page
1397
End Page
1403
DOI
10.1086/375074

GnRHa prior to surgery for uterine fibroids has beneficial effects before, during, and after surgery – meta-analysis

MLA Citation
"GnRHa prior to surgery for uterine fibroids has beneficial effects before, during, and after surgery – meta-analysis." Evidence-based Obstetrics & Gynecology 5.2 (June 2003): 74-76.
Source
crossref
Published In
Evidence-based Obstetrics & Gynecology
Volume
5
Issue
2
Publish Date
2003
Start Page
74
End Page
76
DOI
10.1016/S1361-259X(03)00081-3

Effects of race and clinical factors on short-term outcomes of abdominal myomectomy.

OBJECTIVE: To estimate the effects of race and preoperative uterine anatomy on complication rates after myomectomy. METHODS: A total of 239 abdominal myomectomies were performed at Duke University Medical Center from July 1992 through June 1998. Charts were abstracted using standardized forms. We assessed patient characteristics, surgical indications, preoperative hematocrit, and operative findings. Outcomes were defined as any complication, including transfusion. RESULTS: The population (n = 225) was 53% black and 47% white. The mean body mass index was 26. Fourteen percent had comorbidities. Twenty percent required transfusion. Black women were found to be more likely to have uteri with more than four leiomyomata and less likely to have only one leiomyoma (P =.001). Black women were 2.48 times more likely to have a complication (P <.006). Race was no longer a significant predictor for complications (odds ratio [OR] 1.36, 95% confidence interval [CI] 0.56, 3.15) after adjustment for uterine size (OR 1.86, 95% CI 1.3, 2.67), number of leiomyomata (OR 1.83, 95% CI 1.1, 3.14), and comorbidities (OR 2.77, 95% CI 1.1, 7.69). A similar pattern was seen for blood transfusion. CONCLUSION: Black women undergoing myomectomy are more than twice as likely to have in-hospital complication or blood transfusion than white women. This is largely attributable to differences in uterine size and leiomyoma number. Research is needed to explore why black women are more likely to have larger and more numerous leiomyomata at the time of presentation for surgery.

Authors
Roth, TM; Gustilo-Ashby, T; Barber, MD; Myers, ER
MLA Citation
Roth, TM, Gustilo-Ashby, T, Barber, MD, and Myers, ER. "Effects of race and clinical factors on short-term outcomes of abdominal myomectomy." Obstet Gynecol 101.5 Pt 1 (May 2003): 881-884.
PMID
12738144
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
101
Issue
5 Pt 1
Publish Date
2003
Start Page
881
End Page
884

Primary care residents' characteristics and motives for providing differential medical treatment of cervical cancer screening

Background: Cervical cancer screening rates in the United States are sub-optimal. Physician factors likely contribute to these lower rates. Previous studies provide inconclusive evidence about the association between physician characteristics and the likelihood of addressing cervical cancer. This report assesses potential mechanisms that explain why certain providers do not address cervical cancer screening, Methods: One hundred primary care residents from various specialties were asked to indicate the preventive topics they would address with a hypothetical white female in her early 20s, who was portrayed as living a "high risk" lifestyle, and visiting her provider only for acute care reasons. Results: Among the provider characteristics assessed, only residents' ethnicity was associated with the likelihood of and time spent addressing cervical cancer screening. In particular, Asian-American residents were least likely to address cervical cancer, while African-American residents were most likely. A mediation analyses revealed that perceived barriers for addressing cervical cancer accounted for this difference. Conclusions: Study results suggest that there may be cultural factors among health care providers that may account for differential referral and treatment practices. Findings from this study may help identify factors that explain why cervical cancer screening rates are not higher.

Authors
Arredondo, EM; Pollak, KI; Costanzo, P; McNeilly, M; Myers, E
MLA Citation
Arredondo, EM, Pollak, KI, Costanzo, P, McNeilly, M, and Myers, E. "Primary care residents' characteristics and motives for providing differential medical treatment of cervical cancer screening." Journal of the National Medical Association 95.7 (2003): 577-584.
Source
scival
Published In
Journal of the National Medical Association
Volume
95
Issue
7
Publish Date
2003
Start Page
577
End Page
584

GnRHa treatment prior to surgery for uterine fibroids is not cost-effective

Authors
Farquhar, C; Brown, PM; Furness, S; Myers, ER
MLA Citation
Farquhar, C, Brown, PM, Furness, S, and Myers, ER. "GnRHa treatment prior to surgery for uterine fibroids is not cost-effective." Evidence-based Obstetrics and Gynecology 5.2 (2003): 75-76.
Source
scival
Published In
Evidence-based Obstetrics and Gynecology
Volume
5
Issue
2
Publish Date
2003
Start Page
75
End Page
76

Effects of race and clinical factors on short-term outcomes of abdominal myomectomy

OBJECTIVE: To estimate the effects of race and preoperative uterine anatomy on complication rates after myomectomy. METHODS: A total of 239 abdominal myomectomies were performed at Duke University Medical Center from July 1992 through June 1998. Charts were abstracted using standardized forms. We assessed patient characteristics, surgical indications, preoperative hematocrit, and operative findings. Outcomes were defined as any complication, including transfusion. RESULTS: The population (n = 225) was 53% black and 47% white. The mean body mass index was 26. Fourteen percent had comorbidities. Twenty percent required transfusion. Black women were found to be more likely to have uteri with more than four leiomyomata and less likely to have only one leiomyoma (P = .001). Black women were 2.48 times more likely to have a complication (P < .006). Race was no longer a significant predictor for complications (odds ratio [OR] 1.36, 95% confidence interval [CI] 0.56, 3.15) after adjustment for uterine size (OR 1.86, 95% CI 1.3, 2.67), number of leiomyomata (OR 1.83, 95% CI 1.1, 3.14), and comorbidities (OR 2.77, 95% CI 1.1, 7.69). A similar pattern was seen for blood transfusion. CONCLUSION: Black women undergoing myomectomy are more than twice as likely to have in-hospital complication or blood transfusion than white women. This is largely attributable to differences in uterine size and leiomyoma number. Research is needed to explore why black women are more likely to have larger and more numerous leiomyomata at the time of presentation for surgery. © 2003 by The American College of Obstetricians and Gynecologists.

Authors
Roth, TM; Gustilo-Ashby, T; Barber, MD; Myers, ER
MLA Citation
Roth, TM, Gustilo-Ashby, T, Barber, MD, and Myers, ER. "Effects of race and clinical factors on short-term outcomes of abdominal myomectomy." Obstetrics and Gynecology 101.5 (2003): 881-884.
Source
scival
Published In
Obstetrics and Gynecology
Volume
101
Issue
5
Publish Date
2003
Start Page
881
End Page
884
DOI
10.1016/S0029-7844(03)00015-2

Decision Science and Cervical Cancer

Mathematical modeling is an effective tool for guiding cervical cancer screening, diagnosis, and treatment decisions for patients and policymakers. This article describes the use of mathematical modeling as outlined in five presentations from the Decision Science and Cervical Cancer session of the Second International Conference on Cervical Cancer held at The University of Texas M. D. Anderson Cancer Center, April 11-14, 2002. The authors provide an overview of mathematical modeling, especially decision analysis and cost-effectiveness analysis, and examples of how it can be used for clinical decision making regarding the prevention, diagnosis, and treatment of cervical cancer. Included are applications as well as theory regarding decision science and cervical cancer. Mathematical modeling can answer such questions as the optimal frequency for screening, the optimal age to stop screening, and the optimal way to diagnose cervical cancer. Results from one mathematical model demonstrated that a vaccine against high-risk strains of human papillomavirus was a cost-effective use of resources, and discussion of another model demonstrated the importance of collecting direct non-health care costs and time costs for cost-effectiveness analysis. Research presented indicated that care must be taken when applying the results of population-wide, cost-effectiveness analyses to reduce health disparities. Mathematical modeling can encompass a variety of theoretical and applied issues regarding decision science and cervical cancer. The ultimate objective of using decision-analytic and cost-effectiveness models is to identify ways to improve women's health at an economically reasonable cost. © 2003 American Cancer Society.

Authors
Cantor, SB; Fahs, MC; Mandelblatt, JS; Myers, ER; Sanders, GD; Follen, M
MLA Citation
Cantor, SB, Fahs, MC, Mandelblatt, JS, Myers, ER, Sanders, GD, and Follen, M. "Decision Science and Cervical Cancer." Cancer 98.9 SUPPL. (2003): 2003-2008.
Source
scival
Published In
Cancer
Volume
98
Issue
9 SUPPL.
Publish Date
2003
Start Page
2003
End Page
2008

Uterine artery embolization: what more do we need to know?

Authors
Myers, ER
MLA Citation
Myers, ER. "Uterine artery embolization: what more do we need to know?." Obstet Gynecol 100.5 Pt 1 (November 2002): 847-848.
PMID
12423838
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
100
Issue
5 Pt 1
Publish Date
2002
Start Page
847
End Page
848

Costs and effectiveness of alternative strategies for cervical cancer screening in military beneficiaries.

OBJECTIVE: To estimate the potential effects, on costs and outcomes, of changes in sensitivity and specificity associated with new screening methods for cervical cancer in the military. METHODS: A Markov model of the natural history of cervical cancer was created to simulate a cohort of 100,000 military beneficiaries aged 18-85. Probability estimates for various outcomes and the accuracy of screening tests were obtained from the literature. Cost estimates were obtained from military sources where available; otherwise, civilian costs were used. The outcomes and costs of conventional cytology, liquid-based cytology, and liquid-based cytology with human papillomavirus (HPV) triage were compared at 1-, 2-, and 3-year screening frequencies. RESULTS: Marginal reductions in the incidence of cervical cancer from increasing screening sensitivity are greater than reductions in cancer mortality at every screening interval. Incremental improvements in both cancer incidence and mortality are higher at less frequent screening intervals. Increases in the ratio of low- to high-grade lesions result from increasing the sensitivity of the screening test or shortening the screening interval. Both liquid-based cytology and liquid-based cytology with HPV testing are cost effective (less than $50,000 per life-year saved) when performed at 3-year screening intervals. However, neither strategy is cost-effective when performed more frequently than every 3 years. CONCLUSION: Use of a more sensitive cervical cancer screening test increases costs. However, a more sensitive test performed less frequently may be more effective and less expensive than conventional cytology done annually. In the military setting, this has significant implications for both expense reduction and readiness enhancement.

Authors
Maxwell, GL; Carlson, JW; Ochoa, M; Krivak, T; Rose, GS; Myers, ER
MLA Citation
Maxwell, GL, Carlson, JW, Ochoa, M, Krivak, T, Rose, GS, and Myers, ER. "Costs and effectiveness of alternative strategies for cervical cancer screening in military beneficiaries." Obstet Gynecol 100.4 (October 2002): 740-748.
PMID
12383543
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
100
Issue
4
Publish Date
2002
Start Page
740
End Page
748

Early physician experience with laparoscopically assisted vaginal hysterectomy and rates of surgical complications and conversion to laparotomy.

OBJECTIVE: Our purpose was to determine whether the rates of conversion to laparotomy and surgical complication rate decrease with increasing physician experience with laparoscopically assisted vaginal hysterectomies (LAVH) in a large population-based administrative database. STUDY DESIGN: We queried the North Carolina Medical Commission Database for all LAVHs performed in the state from January 1, 1988, through September 30, 1994. Conversion to laparotomy and the surgical complication rate were analyzed by use of logistic regression controlling for patient age, socioeconomic level, academic setting, and indication for surgery. Physician experience was assessed by sequentially assigning case numbers for each LAVH by attending physician. A surgical complication was defined as any International Classification of Disease, 9th Revision, code for intraoperative organ injury, excessive blood loss, blood transfusion, or wound infection. RESULTS: Six hundred two attending physicians performed 3,728 LAVHs during the observation period. The median number of LAVHs performed by each attending physician was 2, range 1-107, mean 6.2 +/- 10.1. The mean age of the patients was 39.4 +/- 9.2 years. The mean number of days hospitalized was 2.8 +/- 1.6. A concurrent bilateral salpingo-oophorectomy was performed in 46.4% of the LAVHs. Only 1% were performed for malignancy. There was one reported death. A total of 10.3% of the patients were from a low socioeconomic level. Nine percent were performed at an academic center. Overall, there was a 21.5% rate of conversion to laparotomy and a 12.1% surgical complication rate. The rate of conversion to laparotomy significantly decreased with increasing physician experience (P <.0001) and retained its significance even after patient age, socioeconomic level, indication for surgery, academic setting, and surgical complication were controlled. However, no decrease in the surgical complication rate was observed with increasing physician experience. CONCLUSION: As the number of LAVHs performed by an individual physician increases, the rate of conversion to laparotomy decreases. However, no significant increase or decrease in the complication rate was observed with increasing operator experience.

Authors
Visco, AG; Barber, MD; Myers, ER
MLA Citation
Visco, AG, Barber, MD, and Myers, ER. "Early physician experience with laparoscopically assisted vaginal hysterectomy and rates of surgical complications and conversion to laparotomy." Am J Obstet Gynecol 187.4 (October 2002): 1008-1012.
PMID
12388997
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
187
Issue
4
Publish Date
2002
Start Page
1008
End Page
1012

Management of uterine leiomyomata: what do we really know?

OBJECTIVE: To systematically review the literature on the surgical and nonsurgical management of uterine leiomyomata. DATA SOURCES: Published literature in English on the management of uterine leiomyomata published from 1975 through 2000 was identified in MEDLINE, CINAHL, CancerLit, EMBASE, HealthSTAR, and the Cochrane Database of Systematic Reviews. Search terms included "leiomyomata," "fibroids," "hysterectomy," and "myomectomy." STUDY SELECTION: Study designs considered included controlled trials, prospective trials with historical controls, prospective or retrospective cohort studies, and series with at least 20 cases. Original research studies or relevant reviews were included if the study population included women with uterine leiomyomata, and data were provided relevant to one or more of nine prespecified research questions. TABULATION, INTEGRATION, AND RESULTS: Inconsistency in reporting of severity of symptoms, uterine anatomy, and response to therapy prevented meaningful comparison of studies in most cases, and prevented performance of meta-analysis in all cases. This was true of both surgical and nonsurgical treatments. CONCLUSION: The available evidence on the management of uterine leiomyomata is of poor quality. Patients, clinicians, and policymakers do not have the data needed to make informed decisions about appropriate treatment. Given the prevalence of this condition and its substantial impact on women's lives, obtaining these data should be a high research priority.

Authors
Myers, ER; Barber, MD; Gustilo-Ashby, T; Couchman, G; Matchar, DB; McCrory, DC
MLA Citation
Myers, ER, Barber, MD, Gustilo-Ashby, T, Couchman, G, Matchar, DB, and McCrory, DC. "Management of uterine leiomyomata: what do we really know?." Obstet Gynecol 100.1 (July 2002): 8-17. (Review)
PMID
12100798
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
100
Issue
1
Publish Date
2002
Start Page
8
End Page
17

Factors associated with patient-recalled smoking cessation advice in a low-income clinic.

It is recommended that providers advise cessation to their patients who smoke. However, patients' reports of cessation advice indicate disparities based on patients' race, gender, age, and smoking level. Providers' reports do not corroborate these disparities. We investigated whether smokers who receive their care in a community health center recalled their providers advising them to quit smoking when their providers documented such advice. We examined 219 patient-provider dyads to assess factors associated with lack of agreement between providers' documentation and patient recall. Patients were asked to recall any provider advice to quit smoking in the post 2 years. After every visit, providers completed a form to record the content of the visit. Most of the patients were African American, married, and uninsured. Sixty-eight percent of the dyads agreed in their documentation/recall. Patient race was the only factor associated with lack of agreement; African-American patients were more likely than white patients to provide discrepant reports. Although this study can not disentangle the racial difference in patient-provider recall/documentation, results may indicate an important area in which health disparities exist. Future studies should address the dynamics of patient-provider communication about smoking cessation, especially in populations that include ethnically diverse patients.

Authors
Pollak, KI; Yarnall, KSH; Rimer, BK; Lipkus, I; Lyna, PR
MLA Citation
Pollak, KI, Yarnall, KSH, Rimer, BK, Lipkus, I, and Lyna, PR. "Factors associated with patient-recalled smoking cessation advice in a low-income clinic." J Natl Med Assoc 94.5 (May 2002): 354-363.
PMID
12069216
Source
pubmed
Published In
Journal of the National Medical Association
Volume
94
Issue
5
Publish Date
2002
Start Page
354
End Page
363

Management of prolonged pregnancy.

Authors
Myers, ER; Blumrick, R; Christian, AL; Santanu Datta, S; Gray, RN; Kolimaga, JT; Livingston, E; Lukes, A; Matchar, DB; McCrory, DC
MLA Citation
Myers, ER, Blumrick, R, Christian, AL, Santanu Datta, S, Gray, RN, Kolimaga, JT, Livingston, E, Lukes, A, Matchar, DB, and McCrory, DC. "Management of prolonged pregnancy." Evidence report/technology assessment (Summary) 53 (March 2002): 1-6.
PMID
12418331
Source
epmc
Published In
Evidence report/technology assessment (Summary)
Issue
53
Publish Date
2002
Start Page
1
End Page
6

Influence of stereotyping in smoking cessation counseling by primary care residents.

This study examined racial differences in primary care residents' rates of addressing smoking cessation. We expected residents to have higher rates of addressing cessation with White female patients as compared with African-American or Hispanic female patients, due, in part, to residents having higher outcome expectancies, self-efficacy, lower barriers, and less reliance on stereotypes. Residents (N = 90) were an average of 31 years old; two-thirds were White internal medicine residents. Residents viewed a video of a lower-middle class White, African-American, or Hispanic female interacting with her physician about stomach pain. Results indicate that residents were very likely to address smoking cessation, regardless of patients' race. Compared to residents assigned to an ethnic minority patient, residents assigned to the White patient were less likely to believe the patient would follow their advice (P < .03) and also perceived more barriers to address smoking cessation (P < .04). Reliance on the stereotype of Whites mediated the racial difference in outcome expectancies. Implications are that residents may be relying on stereotypes when they assess lower-middle class White female patients' receptivity to smoking cessation advice. Future research on the role of stereotyping in medical settings is warranted.

Authors
Pollak, KI; Arredondo, EM; Yarnall, KSH; Lipkus, I; Myers, E; McNeilly, M; Costanzo, P
MLA Citation
Pollak, KI, Arredondo, EM, Yarnall, KSH, Lipkus, I, Myers, E, McNeilly, M, and Costanzo, P. "Influence of stereotyping in smoking cessation counseling by primary care residents." Ethn Dis 12.4 (2002): 578-585.
PMID
12477145
Source
pubmed
Published In
Ethnicity & disease
Volume
12
Issue
4
Publish Date
2002
Start Page
578
End Page
585

Uterine artery embolization: What more do we need to know?

Authors
Myers, ER
MLA Citation
Myers, ER. "Uterine artery embolization: What more do we need to know?." Obstetrics and Gynecology 100.5 (2002): 847-848.
Source
scival
Published In
Obstetrics & Gynecology (Elsevier)
Volume
100
Issue
5
Publish Date
2002
Start Page
847
End Page
848
DOI
10.1016/S0029-7844(02)02346-3

Mathematical models as research tools for HPV disease

Authors
Myers, ER
MLA Citation
Myers, ER. "Mathematical models as research tools for HPV disease." Papillomavirus Report 13.5 (2002): 141-144.
Source
scival
Published In
Papillomavirus Report
Volume
13
Issue
5
Publish Date
2002
Start Page
141
End Page
144

Technologic advances for evaluation of cervical cytology: is newer better?

Among those women who have cervical cancer and have been screened, 14% to 33% of the cases represent failure to detect abnormalities that existed at the time of screening. New technologies intended to improve detection of cytologic abnormalities include liquid-based, thin-layer cytology (ThinPrep, AutoCyte), computerized rescreening (PAPNET), and algorithm-based computer rescreening (AutoPap). This report combines evidence reviews conducted for the U.S. Preventive Services Task Force and the Agency for Healthcare Research and Quality, in which we systematically identified articles on cervical neoplasia, cervical dysplasia, and screening published between January 1966 and March 2001. We note the challenges for improving screening methods, providing an overview of methods for collecting and evaluating cytologic samples, and examining the evidence about the diagnostic performance of new technologies for detecting cervical lesions. Using standard criteria for evaluation of the diagnostic tests, we determined that knowledge about the sensitivity, specificity, and predictive values of new technologies is meager. Only one study of liquid-based cytology used a reference standard of colposcopy, with histology as indicated, to assess participants with normal screening results. Lack of an adequate reference standard is the overwhelming reason that test characteristics cannot be properly assessed or compared. Most publications compare results of screening using the new technology with expert panel review of the cytologic specimen. In that case, the tests are not independent measures and do nothing to relate the screening test findings to the true status of the cervix, making determination of false-negatives, and thus sensitivity, specificity, and negative predictive value, impossible. We did not identify any literature about health outcomes or cost effectiveness of using these tools in a system of screening. For the purposes of guiding decision making about choice of screening tools, the current evidence is inadequate to gauge whether new technologies are "better" than conventional cytology..

Authors
Hartmann, KE; Nanda, K; Hall, S; Myers, E
MLA Citation
Hartmann, KE, Nanda, K, Hall, S, and Myers, E. "Technologic advances for evaluation of cervical cytology: is newer better?." Obstet Gynecol Surv 56.12 (December 2001): 765-774. (Review)
PMID
11753179
Source
pubmed
Published In
Obstetrical and Gynecological Survey
Volume
56
Issue
12
Publish Date
2001
Start Page
765
End Page
774

How do residents prioritize smoking cessation for young "high-risk" women? Factors associated with addressing smoking cessation.

BACKGROUND: Sixty-seven percent of physicians report advising their smoking patients to quit. Primary care residents' priorities for preventive health for a young "high-risk" female are unknown. Factors related to residents addressing smoking also need examining. METHODS: One hundred residents completed a survey about preventive health issues for a woman in her 20s "who leads a high-risk lifestyle." Residents indicated which topics they would address, and the likelihood that they would address each of 12 relevant preventive health topics, their outcome expectancies that the patient would follow their advice on each topic, their confidence that they could address the topic, and perceived barriers for addressing the topic. RESULTS: Residents listed STD prevention most frequently. Drug use and smoking cessation were second and third most frequently listed. Residents who believed that the patient would follow their advice were more likely to list smoking cessation than residents who had lower outcome expectancies for that patient. Higher barriers were negatively related to addressing smoking cessation. CONCLUSIONS: When time is not a barrier, residents are likely to address smoking cessation. Teaching residents how to incorporate this subject into their clinical practice is needed. Raising residents' outcome expectancies may increase their likelihood of addressing smoking cessation.

Authors
Pollak, KI; Arredondo, EM; Yarnall, KS; Lipkus, I; Myers, E; McNeilly, M; Costanzo, P
MLA Citation
Pollak, KI, Arredondo, EM, Yarnall, KS, Lipkus, I, Myers, E, McNeilly, M, and Costanzo, P. "How do residents prioritize smoking cessation for young "high-risk" women? Factors associated with addressing smoking cessation." Prev Med 33.4 (October 2001): 292-299.
PMID
11570833
Source
pubmed
Published In
Preventive Medicine
Volume
33
Issue
4
Publish Date
2001
Start Page
292
End Page
299
DOI
10.1006/pmed.2001.0884

Cost-effectiveness of universal cystoscopy to identify ureteral injury at hysterectomy.

OBJECTIVE: To evaluate the cost-effectiveness of routine cystoscopy at the time of abdominal, vaginal, and laparoscopically assisted vaginal hysterectomy in terms of cost per ureteral injury identified and treated. METHODS: Using a hospital-based perspective, a decision-analysis model was constructed to estimate the outcomes and costs of cystoscopy or no cystoscopy at the time of abdominal hysterectomy. A similar model was constructed for vaginal and laparoscopically assisted vaginal hysterectomy to account for the cost of conversion to laparotomy. Cost estimates were based on estimated costs of Duke University Medical Center and from average Medicare reimbursements for similar Diagnostic Related Groups from the Health Care Financing Administration. The incidence of ureteral injury was obtained from a review of the literature. Sensitivity analyses were performed for the following variables: ureteral injury rate, silent ureteral injury rate, cost of cystoscopy, and cost of therapeutic interventions. We assumed a silent renal death rate of 0%. RESULTS: Routine cystoscopy at abdominal hysterectomy was cost-saving above a threshold ureteral injury rate of 1.5%. At a ureteral injury rate of 0.2%, the marginal increase in the cost of routine intraoperative cystoscopy was $108 per abdominal hysterectomy, with an associated cost of $54,000 per ureteral injury identified. In comparison, at a ureteral injury rate of 2%, routine cystoscopy gave a marginal cost savings of $44 per hysterectomy, with a cost savings of $2200 per ureteral injury identified intraoperatively. At the baseline ureteral injury rate of 0.5%, routine cystoscopy had a marginally increased cost of $83 per hysterectomy, with an incremental cost-effectiveness of $16,600 spent per ureteral injury identified. The model constructed for vaginal hysterectomy and laparoscopically assisted vaginal hysterectomy yielded a threshold ureteral injury rate of 2%, above which routine cystoscopy was cost-saving. In both models, the incidence of ureteral injury and the cost of readmission were the two variables with the greatest influence on cost-effectiveness. CONCLUSION: The cost-effectiveness of routine intraoperative cystoscopy depends on the rate of ureteral injury independent of the route of hysterectomy. If that rate exceeds 1.5% for abdominal hysterectomy and 2% for vaginal or laparoscopically assisted vaginal hysterectomy, then routine cystoscopy is cost-effective.

Authors
Visco, AG; Taber, KH; Weidner, AC; Barber, MD; Myers, ER
MLA Citation
Visco, AG, Taber, KH, Weidner, AC, Barber, MD, and Myers, ER. "Cost-effectiveness of universal cystoscopy to identify ureteral injury at hysterectomy." Obstet Gynecol 97.5 Pt 1 (May 2001): 685-692.
PMID
11339916
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
97
Issue
5 Pt 1
Publish Date
2001
Start Page
685
End Page
692

Cost-effectiveness of universal cystoscopy to identify ureteral injury at hysterectomy

Authors
Visco, AG; Taber, KH; Weidner, AC; Barber, MD; Myers, ER
MLA Citation
Visco, AG, Taber, KH, Weidner, AC, Barber, MD, and Myers, ER. "Cost-effectiveness of universal cystoscopy to identify ureteral injury at hysterectomy." OBSTETRICS AND GYNECOLOGY 97.5 (May 2001): 685-692.
Source
wos-lite
Published In
Obstetrics & Gynecology (Elsevier)
Volume
97
Issue
5
Publish Date
2001
Start Page
685
End Page
692
DOI
10.1016/S0029-7844(01)01193-0

Vaginal mesh erosion after abdominal sacral colpopexy.

OBJECTIVE: Our goal was to compare the prevalence of vaginal mesh erosion between abdominal sacral colpopexy and various sacral colpoperineopexy procedures. STUDY DESIGN: We undertook a retrospective analysis of all sacral colpopexies and colpoperineopexies performed between March 1, 1992, and February 28, 1999. The patients were divided into the following 4 groups: abdominal sacral colpopexy, abdominal sacral colpoperineopexy, and 2 combined vaginal and abdominal colpoperineopexy groups, one with vaginal suture passage and the other with vaginal mesh placement. Survival analysis and Cox proportional hazards models were developed to examine erosion rates and time to erosion between groups. RESULTS: A total of 273 abdominal sacral vault suspensions were performed with the use of permanent synthetic mesh. There were 155 abdominal sacral colpopexies and 88 abdominal sacral colpoperineopexies. Among the 30 combined abdominal-vaginal procedures, 25 had sutures attached to the perineal body and brought into the abdominal field and 5 had mesh placed vaginally and brought into the abdominal field. Overall, mesh erosion was observed in 5.5% (15/273). The prevalence of mesh erosion was 3.2% (5/155) in the abdominal sacral colpopexy group and 4.5% (5/88) in the abdominal sacral colpoperineopexy group (P not significant). The rates of erosion when sutures or mesh was placed vaginally were 16% (4/25) and 40% (2/5), respectively, and were significantly increased in comparison with the rates for abdominal sacral colpopexy (hazard ratio, 5.4; 95% confidence interval, 1.6-18.0; P = .005; vs hazard ratio, 19.7; 95% confidence interval, 3.8-101.5; P < .001). These variables retained their significance after we controlled for other independent variables, including age, concomitant hysterectomy, concomitant posterior repair, and estrogen status. The median time to mesh erosion was 15.6 months for abdominal sacral colpopexy, 12.4 months for abdominal sacral colpoperineopexy, 9.0 months in the suture-only group (P < .005), and 4.1 months in the vaginal mesh group (P < .0001). CONCLUSIONS: The rate of mesh erosion is higher and the time to mesh erosion is shorter with combined vaginal-abdominal sacral colpoperineopexy with vaginal suture and vaginal mesh placement in comparison with abdominal sacral colpopexy.

Authors
Visco, AG; Weidner, AC; Barber, MD; Myers, ER; Cundiff, GW; Bump, RC; Addison, WA
MLA Citation
Visco, AG, Weidner, AC, Barber, MD, Myers, ER, Cundiff, GW, Bump, RC, and Addison, WA. "Vaginal mesh erosion after abdominal sacral colpopexy." Am J Obstet Gynecol 184.3 (February 2001): 297-302.
PMID
11228477
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
184
Issue
3
Publish Date
2001
Start Page
297
End Page
302
DOI
10.1067/mob.2001.109654

Management of uterine fibroids.

Authors
Matchar, DB; Myers, ER; Barber, MW; Couchman, GM; Datta, S; Gray, RN; Gustilo-Ashby, T; Kolimaga, JT; McCrory, DC
MLA Citation
Matchar, DB, Myers, ER, Barber, MW, Couchman, GM, Datta, S, Gray, RN, Gustilo-Ashby, T, Kolimaga, JT, and McCrory, DC. "Management of uterine fibroids." Evid Rep Technol Assess (Summ) 34 (January 2001): 1-6.
PMID
11236283
Source
pubmed
Published In
Evidence report/technology assessment (Summary)
Issue
34
Publish Date
2001
Start Page
1
End Page
6

Which women with stress incontinence require urodynamic evaluation?

OBJECTIVE: This study was undertaken to determine the predictive value of the symptom of stress urinary incontinence and to evaluate the ability of other factors suggested by a published Agency for Health Care Policy and Research guideline for the discrimination of patients unlikely to require urodynamic testing before surgical management. STUDY DESIGN: We evaluated 950 consecutive women without advanced (stage III or IV) pelvic organ prolapse who were referred with symptoms of incontinence. Incontinence was recorded by means of standard forms and was characterized as "any stress loss" (76.4%), "primarily stress loss" (58.9%), "stress loss only" (29.8%), "stress and urge loss" (52.2%), "urge loss only" (13.8%), "constant and stress loss" (1.9%), or "constant loss" (2.3%). Other variables were assessed by means of a standardized history, physical examination (including urethral axis determination and stress test), 1-week urinary diary, and postvoid residual volume measurement. A urodynamic diagnosis of pure genuine stress incontinence was used as the criterion standard. Sensitivity, specificity, and positive and negative predictive values were calculated. Logistic regression models incorporating various combinations of stress loss only, previous prolapse or incontinence surgery, nocturia, voiding frequency, urethral hypermobility, and postvoid residual volume <100 mL (the factors recommended by the Agency for Health Care Policy and Research guidelines), along with age and race as predictors of genuine stress incontinence, were constructed to evaluate the predictive ability of the guideline in a subset of 447 patients for whom data on all variables were available. RESULTS: Of the entire population 480 (50.5%) had pure genuine stress incontinence, 134 (14.1%) had both genuine stress incontinence and detrusor instability, 180 (18.9%) had pure detrusor instability, and 40 (4.2%) had intrinsic sphincter deficiency. Fifty-four (5.7%) had normal study results, and 62 (6.5%) had other nonincontinence diagnoses. Among the subjects with symptoms of stress loss only, 10.8% did not have genuine stress incontinence confirmed on urodynamic examination. Agency for Health Care Policy and Research guideline criteria had excellent discrimination (C statistic of 0.807) compared with the sole criterion of stress urinary incontinence only (C statistic of 0.574), with a positive predictive value of 85.7%. Only 7.8% of subjects met all the criteria, however, and 5.7% of these ultimately had a urodynamic diagnosis of either detrusor instability or normal study result. CONCLUSION: The predictive value of stress symptoms alone was not high enough to serve as the basis for surgical management. Agency for Health Care Policy and Research guidelines improved the predictive value but were applicable to only a small subset of patients referred with urinary incontinence.

Authors
Weidner, AC; Myers, ER; Visco, AG; Cundiff, GW; Bump, RC
MLA Citation
Weidner, AC, Myers, ER, Visco, AG, Cundiff, GW, and Bump, RC. "Which women with stress incontinence require urodynamic evaluation?." Am J Obstet Gynecol 184.2 (January 2001): 20-27.
PMID
11174474
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
184
Issue
2
Publish Date
2001
Start Page
20
End Page
27
DOI
10.1067/mob.2001.108171

The ethics of aggregation and hormone replacement therapy.

The use of aggregated quality of life estimates in the formation of public policy and practice guidelines raises concerns about the moral relevance of variability in values in preferences for health care. This variability may reflect unique and deeply held beliefs that may be lost when averaged with the preferences of other individuals. Feminist moral theories which argue for attention to context and particularity underline the importance of ascertaining the extent to which differences in preferences for health states reveal information which is morally relevant to clinicians and policymakers. To facilitate these considerations, we present an empirical study of preferences for the timing and occurrence of health states associated with hormone replacement therapy (HRT). Sixteen women between the ages of 45 and 55 were enrolled in this pilot study. Their preferences regarding five health states associated with HRT (menopausal symptoms. side effects of HRT, breast cancer, myocardial infarction, and osteoporosis) were assessed in quantitative terms known as utilities. Two standard methods, the visual analog scale (VAS) and the standard gamble (SG), were used to assess utility and time preference (calculated as a discount rate). The wide variability of responses underlines the importance of tailoring health care to individual women's preferences. Policy guidelines which incorporate utility analysis must recognize the normative limitations of aggregated preferences, and the moral relevance of individual conceptions of health.

Authors
Lyerly, AD; Myers, ER; Faden, RR
MLA Citation
Lyerly, AD, Myers, ER, and Faden, RR. "The ethics of aggregation and hormone replacement therapy." Health Care Anal 9.2 (2001): 187-211.
PMID
11561996
Source
pubmed
Published In
Health Care Analysis
Volume
9
Issue
2
Publish Date
2001
Start Page
187
End Page
211
DOI
10.1023/A:1011386320609

Trial of labour after cesarean section was cost-effective if the probability of successful vaginal birth was > 74%

Authors
Myers, E
MLA Citation
Myers, E. "Trial of labour after cesarean section was cost-effective if the probability of successful vaginal birth was > 74%." Evidence-based Obstetrics and Gynecology 3.3 (2001): 120--.
Source
scival
Published In
Evidence-based Obstetrics & Gynecology
Volume
3
Issue
3
Publish Date
2001
Start Page
120-
DOI
10.1054/ebog.2001.0271

Commentary

Authors
Myers, E
MLA Citation
Myers, E. "Commentary." Evidence-based Obstetrics and Gynecology 3.3 (2001): 120-121.
Source
scival
Published In
Evidence-based Obstetrics & Gynecology
Volume
3
Issue
3
Publish Date
2001
Start Page
120
End Page
121
DOI
10.1054/ebog.2001.0271

Preventive health services received by minority women aged 45-64 and the goals of healthy people 2000.

We attempted to evaluate the preventive health services received by minority women aged 45-64 in an underserved region of Boston. We compared two surveys of disease burden and preventive health services to national data sets and the goals of Healthy People 2000. We found that minority women seen both in community health centers and within the community had many cardiovascular risk factors (41-45% had hypertension, 24-29% had cholesterol > 200 mg/dL, and 49-56% had a body mass index of >27.3 kg/m(2)). Women reported that they received low rates of counseling on healthy behaviors but generally received breast and cervical cancer screening. Forty-three percent of women who were interviewed in the community had no health insurance and these women were less likely to have received a Papanicolaou test or mammogram than insured women. Lack of insurance did not predict cancer screening for women already being seen in the community health clinic.

Authors
Fretts, RC; Rodman, G; Gomez-Carrion, Y; Goldberg, R; Sachs, BP; Myers, E; Kessel, B
MLA Citation
Fretts, RC, Rodman, G, Gomez-Carrion, Y, Goldberg, R, Sachs, BP, Myers, E, and Kessel, B. "Preventive health services received by minority women aged 45-64 and the goals of healthy people 2000." Womens Health Issues 10.6 (November 2000): 305-311.
PMID
11077213
Source
pubmed
Published In
Women's Health Issues
Volume
10
Issue
6
Publish Date
2000
Start Page
305
End Page
311

Antepartum or postpartum isoniazid treatment of latent tuberculosis infection.

OBJECTIVE: To compare health outcomes and costs of different strategies for treatment of latent tuberculosis infection in pregnancy. METHODS: Using a Markov decision-analysis model, the following three strategies were evaluated for treatment of latent tuberculosis infection in pregnancy, defined as positive tuberculin skin reaction of 10 mm or greater and negative chest radiograph: no treatment, antepartum isoniazid administration, in which women were given 300 mg of isoniazid with pyridoxine beginning at 20 weeks' gestation for 6 months; and postpartum isoniazid, in which women were given isoniazid and pyridoxine for 6 months after delivery. Sensitivity analyses were performed for a wide range of probability and cost estimates, and considered discount rates. RESULTS: Under base-case assumptions, the fewest cases of tuberculosis within the cohort occurred with antepartum treatment (1400 per 100,000) compared with no treatment (3300 per 100,000) or postpartum treatment (1800 per 100,000). Antepartum treatment resulted in a marginal increase in life expectancy due to the prevented cases of tuberculosis, despite more cases of isoniazid-related hepatitis and deaths, compared with no treatment or postpartum treatment. Antepartum treatment was the least expensive. Only if the case-fatality rate for tuberculosis was tenfold lower than the base-case and the risk of fatal hepatitis tenfold higher did antepartum treatment become the least advantageous strategy. CONCLUSION: Rather than delaying treatment until postpartum, consideration for antepartum treatment of latent tuberculosis during pregnancy should be given. If isoniazid is not administered antepartum, then efforts to improve postpartum compliance should be instituted, as either antepartum or postpartum treatment is better than no treatment.

Authors
Boggess, KA; Myers, ER; Hamilton, CD
MLA Citation
Boggess, KA, Myers, ER, and Hamilton, CD. "Antepartum or postpartum isoniazid treatment of latent tuberculosis infection." Obstet Gynecol 96.5 Pt 1 (November 2000): 757-762.
PMID
11042314
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
96
Issue
5 Pt 1
Publish Date
2000
Start Page
757
End Page
762

Setting the target for a better cervical screening test: characteristics of a cost-effective test for cervical neoplasia screening.

OBJECTIVE: To determine the potential effects on costs and outcomes of changes in sensitivity and specificity with new screening methods for cervical cancer. METHODS: Using a Markov model of the natural history of cervical cancer, we estimated the effects of sensitivity, specificity, and screening frequency on cost-effectiveness. Our estimates of conventional Papanicolaou test sensitivity of 51% and specificity of 97% were obtained from a meta-analysis. We estimated the effect of reducing false-negative rates from 40-90% and increasing false-positive rates by up to 20%, independently and jointly. We varied the marginal cost of improving sensitivity from $0 to $15. RESULTS: When specificity was held constant, increasing sensitivity of the Papanicolaou test increased life expectancy and costs. When sensitivity was held constant, decreasing specificity of the Papanicolaou test increased costs, an effect that was more dramatic at more frequent intervals. Decreased specificity had a substantial effect on cost-effectiveness estimates of improved Papanicolaou test sensitivity. Most of those effects are related to the cost of evaluation and treatment of low-grade lesions. CONCLUSION: Policies or technologies that increased sensitivity of cervical cytologic screening increased overall costs, even if the cost of the technology was identical to that of conventional Papanicolaou smears. These effects appear to be caused by relatively high prevalence of low-grade lesions and are magnified at frequent screening intervals. Efficient cervical cancer screening requires methods with greater ability to detect lesions that are most likely to become cancerous.

Authors
Myers, ER; McCrory, DC; Subramanian, S; McCall, N; Nanda, K; Datta, S; Matchar, DB
MLA Citation
Myers, ER, McCrory, DC, Subramanian, S, McCall, N, Nanda, K, Datta, S, and Matchar, DB. "Setting the target for a better cervical screening test: characteristics of a cost-effective test for cervical neoplasia screening." Obstet Gynecol 96.5 Pt 1 (November 2000): 645-652.
PMID
11042294
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
96
Issue
5 Pt 1
Publish Date
2000
Start Page
645
End Page
652

Improving the sensitivity of cervical cytology: what are the issues?

Authors
Myers, ER
MLA Citation
Myers, ER. "Improving the sensitivity of cervical cytology: what are the issues?." Am J Manag Care 6.7 (July 2000): 838-840.
PMID
11067380
Source
pubmed
Published In
American Journal of Managed Care
Volume
6
Issue
7
Publish Date
2000
Start Page
838
End Page
840

Mathematical model for the natural history of human papillomavirus infection and cervical carcinogenesis.

The authors constructed a Markov model as part of a systematic review of cervical cytology conducted at the Duke University Evidence-based Practice Center (Durham, North Carolina) between October 1997 and September 1998. The model incorporated states for human papillomavirus infection (HPV), low- and high-grade squamous intraepithelial lesions, and cervical cancer stages I-IV to simulate the natural history of HPV infection in a cohort of women from ages 15 to 85 years. The age-specific incidence rate of HPV, and regression and progression rates of HPV and squamous intraepithelial lesions, were obtained from the literature. The effects of varying natural history parameters on cervical cancer incidence were evaluated by using sensitivity analysis. The base-case model resulted in a lifetime cervical cancer risk of 3.67% and a lifetime cervical cancer mortality risk of 1.26%, with a peak incidence of 81/100,000 at age 50 years. Age-specific distributions of precursors were similar to reported data. Lifetime risk of cancer was most sensitive to the incidence of HPV and the probability of rapid HPV progression to high-grade lesions (two- to threefold variations in risk). The model approximates the age-specific incidence of cervical cancer and provides a tool for evaluating the natural history of HPV infection and cervical cancer carcinogenesis as well as the effectiveness and cost-effectiveness of primary and secondary prevention strategies.

Authors
Myers, ER; McCrory, DC; Nanda, K; Bastian, L; Matchar, DB
MLA Citation
Myers, ER, McCrory, DC, Nanda, K, Bastian, L, and Matchar, DB. "Mathematical model for the natural history of human papillomavirus infection and cervical carcinogenesis." Am J Epidemiol 151.12 (June 15, 2000): 1158-1171.
PMID
10905528
Source
pubmed
Published In
American Journal of Epidemiology
Volume
151
Issue
12
Publish Date
2000
Start Page
1158
End Page
1171

Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review.

PURPOSE: To evaluate the accuracy of conventional and new methods of Papanicolaou (Pap) testing when used to detect cervical cancer and its precursors. DATA SOURCES: Systematic search of English-language literature through October 1999 using MEDLINE, EMBASE, other computerized databases, and hand searching. STUDY SELECTION: All studies that compared Pap testing (conventional methods, computer screening or rescreening, or monolayer cytology) with a concurrent reference standard (histologic examination, colposcopy, or cytology). DATA EXTRACTION: Two reviewers independently reviewed selection criteria and completed 2 x 2 tables for each study. DATA SYNTHESIS: 94 studies of the conventional Pap test and three studies of monolayer cytology met inclusion criteria. No studies of computerized screening were included. Data were organized by cytologic and histologic thresholds used to define disease. For conventional Pap tests, estimates of sensitivity and specificity varied greatly in individual studies. Methodologic quality and frequency of histologic abnormalities also varied greatly between studies. In the 12 studies with the least biased estimates, sensitivity ranged from 30% to 87% and specificity ranged from 86% to 100%. CONCLUSIONS: Insufficient high-quality data exist to estimate test operating characteristics of new cytologic methods for cervical screening. Future studies of these technologies should apply adequate reference standards. Most studies of the conventional Pap test are severely biased: The best estimates suggest that it is only moderately accurate and does not achieve concurrently high sensitivity and specificity. Cost-effectiveness models of cervical cancer screening should use more conservative estimates of Pap test sensitivity.

Authors
Nanda, K; McCrory, DC; Myers, ER; Bastian, LA; Hasselblad, V; Hickey, JD; Matchar, DB
MLA Citation
Nanda, K, McCrory, DC, Myers, ER, Bastian, LA, Hasselblad, V, Hickey, JD, and Matchar, DB. "Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review." Ann Intern Med 132.10 (May 16, 2000): 810-819. (Review)
PMID
10819705
Source
pubmed
Published In
Annals of internal medicine
Volume
132
Issue
10
Publish Date
2000
Start Page
810
End Page
819

Cost-effectiveness of deep venous thrombosis prophylaxis in gynecologic oncology surgery.

OBJECTIVE: To estimate the cost-effectiveness of preventive strategies for deep vein thrombosis (DVT) in patients undergoing surgery for gynecologic cancer. METHODS: A model was constructed to estimate the costs and outcomes associated with the use of external pneumatic compression, unfractionated heparin, and low molecular weight heparin in women with cervical, endometrial, and ovarian cancer. We estimated cost per DVT prevented, per fatal pulmonary embolus (PE) prevented, and per life-year saved. Probability estimates for various outcomes and efficacies were obtained from the literature, using data specific for gynecologic patients when available. RESULTS: Cost-effectiveness estimates ranged from $27 per life-year saved for a 55-year-old endometrial cancer patient to $5132 per life-year saved for a 65-year-old with ovarian cancer. Although low molecular weight heparin and unfractionated heparin were cost-effective compared with no prophylaxis, each was less effective than external pneumatic compression in the base case. The results of the analysis were sensitive to assumptions about the relative risk of DVT, the life expectancy of the patient, the costs of future treatment, and the relative effectiveness of the different strategies: If unfractionated heparin or low molecular weight heparin is at least 2-3% more effective than external pneumatic compression, then the incremental cost per life-year of either would be less than $50,000 compared with external pneumatic compression. CONCLUSION: Prophylaxis of DVT is cost-effective in terms of life-years gained even for patients with relatively short life expectancies, such as ovarian cancer patients. External pneumatic compression appears to be the most cost-effective strategy under our baseline assumptions, but further studies in gynecologic cancer are needed to validate our conclusions.

Authors
Maxwell, GL; Myers, ER; Clarke-Pearson, DL
MLA Citation
Maxwell, GL, Myers, ER, and Clarke-Pearson, DL. "Cost-effectiveness of deep venous thrombosis prophylaxis in gynecologic oncology surgery." Obstet Gynecol 95.2 (February 2000): 206-214.
PMID
10674581
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
95
Issue
2
Publish Date
2000
Start Page
206
End Page
214

Effect of augmentation on the mechanics of vertebral wedge fractures.

STUDY DESIGN: The effect of cement augmentation of wedge-fractured vertebral bodies on spine segment compliance was studied in 16 cadaver specimens. OBJECTIVES: 1) To assess the mechanical effects of cement augmentation of vertebral wedge fractures. 2) To determine whether a new reduction/injection procedure has the same mechanical effects as the established direct injection procedure. SUMMARY OF BACKGROUND DATA: Although wedge fractures cause pain and disability in hundreds of thousands of people, few effective treatments are available. Clinical studies have shown that cement augmentation, a new procedure, effectively relieves pain and restores mobility in patients suffering from weak or fractured vertebrae. However, only a few studies have examined the mechanics of vertebral augmentation. METHODS: A wedge fracture was created in the middle vertebra of 16 three-vertebra cadaver spine segments. Neutral and full-load compliance of each fractured spine segment in flexion/extension and lateral bending were assessed by measuring the relative rotation of the vertebral bodies in response to applied moments. Eight of the fractured vertebral bodies were then augmented using direct injection, while the remaining eight fractured vertebral bodies were augmented using a combined reduction/injection procedure. Compliance of the augmented segments was then assessed. RESULTS: Augmentation significantly reduced the neutral compliance (reduction of 25% +/- 23%) (mean +/- standard deviation) and the full-load compliance (reduction of 23% +/- 20%) in flexion/extension (P < 0.005). Augmentation also significantly reduced the neutral compliance (reduction of 34% +/- 20%) and the full-load compliance (reduction of 26% +/- 17%) in lateral bending (P < 0.0001). No significant difference was found between the two procedures for compliance reduction. CONCLUSIONS: Augmentation of wedge fractures using both direct injection and reduction/injection reduces spine segment compliance significantly.

Authors
Wilson, DR; Myers, ER; Mathis, JM; Scribner, RM; Conta, JA; Reiley, MA; Talmadge, KD; Hayes, WC
MLA Citation
Wilson, DR, Myers, ER, Mathis, JM, Scribner, RM, Conta, JA, Reiley, MA, Talmadge, KD, and Hayes, WC. "Effect of augmentation on the mechanics of vertebral wedge fractures." Spine (Phila Pa 1976) 25.2 (January 15, 2000): 158-165.
PMID
10685478
Source
pubmed
Published In
Spine
Volume
25
Issue
2
Publish Date
2000
Start Page
158
End Page
165

Elevated serum CA-125 levels: Hepatitis or ascites? [1] (multiple letters)

Authors
Sevinc, A; Buyukberber, S; Sari, R; Nguyen, HN; Priore, GD; Berchuck, A; Myers, E; Nagourney, RA
MLA Citation
Sevinc, A, Buyukberber, S, Sari, R, Nguyen, HN, Priore, GD, Berchuck, A, Myers, E, and Nagourney, RA. "Elevated serum CA-125 levels: Hepatitis or ascites? [1] (multiple letters)." Gynecologic Oncology 76.1 (2000): 141-143.
PMID
10620461
Source
scival
Published In
Gynecologic Oncology
Volume
76
Issue
1
Publish Date
2000
Start Page
141
End Page
143

Setting the target for a better cervical screening test: Characteristics of a cost-effective test for cervical neoplasia screening

Objective: To determine the potential effects on costs and outcomes of changes in sensitivity and specificity with new screening methods for cervical cancer. Methods: Using a Markov model of the natural history of cervical cancer, we estimated the effects of sensitivity, specificity, and screening frequency on cost-effectiveness. Our estimates of conventional Papanicolaou test sensitivity of 51% and specificity of 97% were obtained from a meta-analysis. We estimated the effect of reducing false-negative rates from 40-90% and increasing false-positive rates by up to 20%, independently and jointly. We varied the marginal cost of improving sensitivity from $0 to $15. Results: When specificity was held constant, increasing sensitivity of the Papanicolaou test increased life expectancy and costs. When sensitivity was held constant, decreasing specificity of the Papanicolaou test increased costs, an effect that was more dramatic at more frequent intervals. Decreased specificity had a substantial effect on cost-effectiveness estimates of improved Papanicolaou test sensitivity. Most of those effects are related to the cost of evaluation and treatment of low-grade lesions. Conclusion: Policies or technologies that increased sensitivity of cervical cytologic screening increased overall costs, even if the cost of the technology was identical to that of conventional Papanicolaou smears. These effects appear to be caused by relatively high prevalence of low-grade lesions and are magnified at frequent screening intervals. Efficient cervical cancer screening requires methods with greater ability to detect lesions that are most likely to become cancerous. (C) 2000 by The American College of Obstetricians and Gynecologists.

Authors
Myers, ER; McCrory, DC; Subramanian, S; McCall, N; Nanda, K; Datta, S; Matchar, DB
MLA Citation
Myers, ER, McCrory, DC, Subramanian, S, McCall, N, Nanda, K, Datta, S, and Matchar, DB. "Setting the target for a better cervical screening test: Characteristics of a cost-effective test for cervical neoplasia screening." Obstetrics and Gynecology 96.5 (2000): 645-652.
Source
scival
Published In
Obstetrics and Gynecology
Volume
96
Issue
5
Publish Date
2000
Start Page
645
End Page
652
DOI
10.1016/S0029-7844(00)00979-0

Universal HIV screening of pregnant women in England would be cost-effective in areas of high prevalence

OBJECTIVE To estimate the cost-effectiveness of a voluntary HIV-screening programme for all pregnant women. DESIGN Cost-effectiveness analysis. Only costs to the National Health Service were considered. SETTING England. INTERVENTION Serological screening for HIV antibodies in pregnant women who arc unaware of being infected. The sensitivity and specificity of the initial test are 100 and 99.9%, respectively, with positive results confirmed with additional tests. Preventative interventions are offered to HIV-positive women. ASSUMPTIONS All women agree to be tested. Uptake of interventions in HIV-positive women: zidovudine 75%, elective cesarean section 40%, emergency cesarean section 15%, formula feeding 95%. Mother-to-child transmission rates: 18% for vaginal delivery- and 10% for cesarean section delivery in the absence of zidovudine treatment, 8 and 6%, respectively, with zidovudine treatment, and 14% for breast feeding. Life expectancy: normal 77 years, child with HIV 7 years. Mother will gain 1 year symptom-free with earlier treatment. Cost assumptions: screening (test £4 plus pre-test counselling) £40, post-test counselling of positive women £50, zidovudine treatment for mother (14 weeks) and baby (6 weeks) £600, vaginal delivery £400, elective cesarean section £1000, emergency cesarean section £1300, formula feeding £800, lifetime health-care costs for a child with HIV £178,300, post-partum treatment of mother £12,300 per year. MAIN OUTCOME MEASURES Net cost (costs of screening and preventative interventions minus costs of averted health care) per life year gained (mother and child). MAIN RESULTS At a prevalence of 15 women unaware of being HIV infected per 10,000 pregnant women, for each HIV-positive women detected, the cost of screening is £26,700, the cost of the extra interventions is £1300 and the cost of care for HIV-infected children is £29,100 less, compared to no screening. The net cost per life year gained is £3300. If the prevalence is lower at 1/10,000, the cost per life year gained increases to £114,000. If pre-test counselling is integrated into routine prenatal care, so that the cost of screening involves only the cost of the test, the cost per life year gained would be £7300 at the lower prevalence and cost saving at the higher prevalence. In London, where the prevalence of unaware HIV-infected pregnant women is 14/10,000, the costs of screening and prevention would equal the costs averted if the cost of screening could be reduced from £40 to £22 per person. CONCLUSION A universal HIV-screening programme for pregnant women would be cost-effective in areas of high prevalence if the pre-test counselling were integrated into routine prenatal care. © 2000 Harcourt Publishers Ltd.

Authors
Myers, ER
MLA Citation
Myers, ER. "Universal HIV screening of pregnant women in England would be cost-effective in areas of high prevalence." Evidence-based Obstetrics and Gynecology 2.1 (2000): 7--.
Source
scival
Published In
Evidence-based Obstetrics & Gynecology
Volume
2
Issue
1
Publish Date
2000
Start Page
7-
DOI
10.1054/ebog.2000.0105

Systemic methotrexate treatment of tubal pregnancy was more costly than laparoscopic salpingostomy

OBJECTIVE To compare the cost of treatment of unruptured tubal pregnancy with systemic methotrexate and laparoscopic salpingostomy. DESIGN Cost-minimization evaluation based on a multicentre, randomized controlled trial. Allocation was blocked and stratified for human chorionic gonadotropin (hCG) level. SETTING Six university hospitals in The Netherlands. SUBJECTS 100 hemodynamically stable women with laparoscopically confirmed, unruptured tubal pregnancies, without fetal heart activity or active bleeding. Mean gestational age was 47 days and median serum hCG was 2075 (range 110-19,500) IU/L. INTERVENTION All women underwent laparoscopy to confirm the tubal pregnancy. 49 women were randomized to undergo laparoscopic salpingostomy immediately, and 51 women to receive systemic methotrexate 1.0 mg/kg i.m., every other day for four doses and folinic acid 0.1 mg/kg orally, on alternate days. Costs were based on actual expenditures, including both direct and indirect costs. MAIN OUTCOME MEASURES Mean cost Cm USS) per patient for treatment with methotrexate or laparoscopic salpingostomy. MAIN RESULTS The mean (range) initial hospital stay was 3.2 (1-12) days in the methotrexate group and 2.5 (2-7) days in the laparoscopy group. Seven women in the methotrexate group and 10 in the laparoscopy group required the alternate treatment. Women in the methotrexate group had more transvaginal sonograms (mean 2.3 vs 1.3), more outpatient visits (mean 8.9 vs 6.9), and more visits to a general practitioner (mean 1.6 vs 1.1). The mean medical cost per patient was S3299 for methotrexate and S2520 for laparoscopy (difference S779, 95% CI S28-2384). Women in the methotrexate group were more likely to require home care and took more days off work (mean 38 vs 28). The mean total cost per patient was S5721 for methotrexate and S4066 for laparoscopy (difference S1655, CI S906-2414). The two treatments had similar total costs in women with an initial hCG level < 1500 IU/L, but methotrexate was much more expensive in women with higher hCG levels. If the laparoscopy were eliminated for the methotrexate group, the medical cost would be S944 less than for laparoscopy, and the total costs would be similar. CONCLUSION Treatment of unruptured tubal pregnancy with systemic methotrexate was more costly than laparoscopic salpingostomy. © 2000 Harcourt Publishers Ltd.

Authors
Myers, ER
MLA Citation
Myers, ER. "Systemic methotrexate treatment of tubal pregnancy was more costly than laparoscopic salpingostomy." Evidence-based Obstetrics and Gynecology 2.3 (2000): 72--.
Source
scival
Published In
Evidence-based Obstetrics & Gynecology
Volume
2
Issue
3
Publish Date
2000
Start Page
72-
DOI
10.1054/ebog.2000.0155

Antepartum or postpartum isoniazid treatment of latent tuberculosis infection

Objective: To compare health outcomes and costs of different strategies for treatment of latent tuberculosis infection in pregnancy. Methods: Using a Markov decision-analysis model, the following three strategies were evaluated for treatment of latent tuberculosis infection in pregnancy, defined as positive tuberculin skin reaction of 10 mm or greater and negative chest radiograph: no treatment, antepartum isoniazid administration, in which women were given 300 mg of isoniazid with pyridoxine beginning at 20 weeks' gestation for 6 months; and postpartum isoniazid, in which women were given isoniazid and pyridoxine for 6 months after delivery. Sensitivity analyses were performed for a wide range of probability and cost estimates, and considered discount rates. Results: Under base-case assumptions, the fewest cases of tuberculosis within the cohort occurred with antepartum treatment (1400 per 100,000) compared with no treatment (3300 per 100,000) or postpartum treatment (1800 per 100,000). Antepartum treatment resulted in a marginal increase in life expectancy due to the prevented cases of tuberculosis, despite more cases of isoniazid-related hepatitis and deaths, compared with no treatment or postpartum treatment. Antepartum treatment was the least expensive. Only if the case-fatality rate for tuberculosis was tenfold lower than the base-case and the risk of fatal hepatitis tenfold higher did antepartum treatment become the least advantageous strategy. Conclusion: Rather than delaying treatment until postpartum, consideration for antepartum treatment of latent tuberculosis during pregnancy should be given. If isoniazid is not administered antepartum, then efforts to improve postpartum compliance should be instituted, as either antepartum or postpartum treatment is better than no treatment. (C) 2000 by The American College of Obstetricians and Gynecologists.

Authors
Boggess, KA; Myers, ER; Hamilton, CD
MLA Citation
Boggess, KA, Myers, ER, and Hamilton, CD. "Antepartum or postpartum isoniazid treatment of latent tuberculosis infection." Obstetrics and Gynecology 96.5 (2000): 757-762.
Source
scival
Published In
Obstetrics & Gynecology (Elsevier)
Volume
96
Issue
5
Publish Date
2000
Start Page
757
End Page
762
DOI
10.1016/S0029-7844(00)01039-5

Risk adjustment for complications of hysterectomy: limitations of routinely collected administrative data.

OBJECTIVE: We sought to determine the utility of routinely collected administrative data for risk adjustment for complications of hysterectomy. STUDY DESIGN: Using abstracted discharge data on 107, 648 women undergoing hysterectomy in North Carolina from 1988 through 1994, we constructed logistic regression models for the prediction of medical and surgical complications incorporating coded demographic, diagnostic, and procedural data. RESULTS: The overall complication rate was 16%, with surgical complications (11.8%) more common than medical complications (6.7%). Hysterectomy type, teaching hospital status, patient age >/=65 years, and insurance status of Medicaid or no insurance were significantly associated with both medical and surgical complication risk, as were procedures performed for cancer or pregnancy complications. Models that incorporated coded comorbidity were better predictors of medical complications (C = 0.714) than surgical complications (C = 0.630). CONCLUSION: Although surgical complications of hysterectomy are more common than medical complications, risk adjustment methods that use routinely collected administrative data are better at predicting medical complications. Ambiguities in coding, misclassification, and uncoded factors such as disease severity limit the utility of administrative data for risk adjustment for hysterectomy complications.

Authors
Myers, ER; Steege, JF
MLA Citation
Myers, ER, and Steege, JF. "Risk adjustment for complications of hysterectomy: limitations of routinely collected administrative data." Am J Obstet Gynecol 181.3 (September 1999): 567-575.
PMID
10486465
Source
pubmed
Published In
American Journal of Obstetrics & Gynecology
Volume
181
Issue
3
Publish Date
1999
Start Page
567
End Page
575

Cost-effectiveness of treatment of early stage endometrial cancer.

OBJECTIVE: The purpose of this study was to determine the average life-years gained and cost per life-year gained in treatment of early endometrial cancer. METHODS: We performed a decision analysis using statistical models for survival after treatment for Stage I endometrial cancer. Estimates for survival probabilities without treatment, with surgery alone, and with surgery and radiation were derived from the literature. Charges and costs of treatment were estimated based on data from our institution. We calculated the average number of life-years gained and the cost per life-year gained of various treatment options based on these estimates. Sensitivity analyses were performed to determine the effect of uncertainty about parameter estimates on the results derived from our model. RESULTS: Based on the assumptions of our model, most of the life-years gained in treatment of early endometrial cancer are attributable to hysterectomy, with a very low associated cost. For the "average" woman with endometrial cancer, about 10 life-years are gained from hysterectomy at a cost of $1000 per life-year gained, whereas adjuvant radiation yields on average 1 year of life gained at $4000 per life-year gained. Both life-years gained and cost are dramatically affected by age at diagnosis and to a lesser extent by histologic grade and comorbid medical conditions. CONCLUSIONS: This analysis suggests that the use of hysterectomy and adjuvant radiation in treatment of early endometrial cancer is a worthwhile use of health care resources. More sophisticated models may help determine the cost-effectiveness of various treatment strategies in specific subgroups of patients.

Authors
Ashih, H; Gustilo-Ashby, T; Myers, ER; Andrews, J; Clarke-Pearson, DL; Berry, D; Berchuck, A
MLA Citation
Ashih, H, Gustilo-Ashby, T, Myers, ER, Andrews, J, Clarke-Pearson, DL, Berry, D, and Berchuck, A. "Cost-effectiveness of treatment of early stage endometrial cancer." Gynecol Oncol 74.2 (August 1999): 208-216.
PMID
10419733
Source
pubmed
Published In
Gynecologic Oncology
Volume
74
Issue
2
Publish Date
1999
Start Page
208
End Page
216
DOI
10.1006/gyno.1999.5427

Evaluation of cervical cytology.

Authors
McCrory, DC; Matchar, DB; Bastian, L; Datta, S; Hasselblad, V; Hickey, J; Myers, E; Nanda, K
MLA Citation
McCrory, DC, Matchar, DB, Bastian, L, Datta, S, Hasselblad, V, Hickey, J, Myers, E, and Nanda, K. "Evaluation of cervical cytology." Evid Rep Technol Assess (Summ) 5 (January 1999): 1-6. (Review)
PMID
11925972
Source
pubmed
Published In
Evidence report/technology assessment (Summary)
Issue
5
Publish Date
1999
Start Page
1
End Page
6

Evaluating new (and old) technologies: The role of economic analysis

As new technologies become available for preventing and treating illness, the costs of health care will inevitably rise. Those who develop, assess, and use new interventions need to become familiar with the methods of economic analysis. Cost-minimization studies compare two or more interventions that have identical outcomes; cost-effectiveness studies measure outcomes in terms of lives saved, years of life gained, and so on; and cost-benefit studies measure both costs and outcomes in economic terms. The perspective (who pays and who experiences the outcomes), the sources of estimates for costs and effectiveness, and the method for accounting for temporal preferences for money and health are all important factors in performing and evaluating economic analysis. When comparing two or more interventions, the incremental cost-effectiveness ratio is almost always more important than the average cost-effectiveness ratio. Study design and implementation are as important for economic analyses as they are for clinical trials; familiarity with these methods will enable gynecologists to better evaluate and implement new technologies and techniques.

Authors
Myers, ER
MLA Citation
Myers, ER. "Evaluating new (and old) technologies: The role of economic analysis." Journal of Gynecologic Techniques 5.2 (1999): 41-43.
Source
scival
Published In
Journal of Gynecologic Techniques
Volume
5
Issue
2
Publish Date
1999
Start Page
41
End Page
43

Cost-effectiveness of mandatory compared with voluntary screening for human immunodeficiency virus in pregnancy.

OBJECTIVE: To determine the cost-effectiveness of mandatory screening for human immunodeficiency virus (HIV) in pregnancy compared with that of voluntary screening under varying assumptions about patient behavior. METHODS: Using a health care system perspective, a decision-analysis model was constructed to estimate the outcomes and costs of the two strategies. Average and incremental cost-effectiveness ratios were calculated for each strategy. Sensitivity analyses were performed to test the effects of different values on the results of the simulation. In particular, we examined the potential effects of changes in patient behavior resulting from mandatory screening on our estimates of cost-effectiveness. RESULTS: At a prevalence of 170 per 100,000, average costs per case prevented were $255,158 and $367,998 for mandatory and voluntary screening, respectively. The incremental cost-effectiveness of mandatory compared with voluntary screening was $29,478. These values decreased as prevalence of HIV increased, or as the estimated lifetime cost of pediatric HIV infection increased: above an estimated cost for pediatric HIV of $129,250, mandatory screening was less expensive and more effective than voluntary screening. Assumptions about patient behavior affected these results: a 40% reduction in zidovudine acceptance in women identified only through mandatory screening increased the incremental cost-effectiveness to $112,434. The impact of behavior increased as the prevalence of HIV increased. CONCLUSION: Mandatory screening will prevent more cases of pediatric AIDS, but at a somewhat higher cost than voluntary screening under baseline assumptions. The cost-effectiveness of mandatory screening will be influenced by patient behavior, especially acceptance of zidovudine treatment among women who would have refused voluntary screening.

Authors
Myers, ER; Thompson, JW; Simpson, K
MLA Citation
Myers, ER, Thompson, JW, and Simpson, K. "Cost-effectiveness of mandatory compared with voluntary screening for human immunodeficiency virus in pregnancy." Obstet Gynecol 91.2 (February 1998): 174-181.
PMID
9469271
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
91
Issue
2
Publish Date
1998
Start Page
174
End Page
181

Cost-effectiveness of the technologies to improve sensitivity of pap smears: Impact of screening step (primary vs. Rescreening) and interval

Authors
Myers, ER; McCrory, D; Subramanian, S; Datta, S; Nanda, K; Bastian, LA; Matchar, DB
MLA Citation
Myers, ER, McCrory, D, Subramanian, S, Datta, S, Nanda, K, Bastian, LA, and Matchar, DB. "Cost-effectiveness of the technologies to improve sensitivity of pap smears: Impact of screening step (primary vs. Rescreening) and interval." MEDICAL DECISION MAKING 18.4 (1998): 460-460.
Source
wos-lite
Published In
Medical Decision Making
Volume
18
Issue
4
Publish Date
1998
Start Page
460
End Page
460

Patient preferences and temporal discounting for health states associated with hormone replacement therapy: A pilot study

Authors
Drapkin, AL; Myers, ER
MLA Citation
Drapkin, AL, and Myers, ER. "Patient preferences and temporal discounting for health states associated with hormone replacement therapy: A pilot study." MEDICAL DECISION MAKING 18.4 (1998): 463-463.
Source
wos-lite
Published In
Medical Decision Making
Volume
18
Issue
4
Publish Date
1998
Start Page
463
End Page
463

Which women with stress urinary incontinence require urodynamic testing prior to surgical management?

Authors
Weidner, AC; Myers, ER; Visco, AG; Cundiff, GW; Bump, RC
MLA Citation
Weidner, AC, Myers, ER, Visco, AG, Cundiff, GW, and Bump, RC. "Which women with stress urinary incontinence require urodynamic testing prior to surgical management?." MEDICAL DECISION MAKING 18.4 (1998): 456-456.
Source
wos-lite
Published In
Medical Decision Making
Volume
18
Issue
4
Publish Date
1998
Start Page
456
End Page
456

Cost-effectiveness of fetal lung maturity testing in preterm labor.

OBJECTIVE: To determine the marginal cost-effectiveness of two strategies for preventing respiratory distress syndrome (RDS) resulting from preterm birth: 1) tocolysis with beta-mimetic agonists and treatment with corticosteroids (TREATALL), and 2) amniocentesis and testing for fetal lung maturity, with treatment based on test results (TESTALL), compared with no treatment. METHODS: We used a Markov decision analytic model to estimate the outcomes of each strategy, from a hospital-based perspective. Probability variables were obtained from the literature, whereas cost variables came from the Beth Israel-Deaconess Medical Center. Sensitivity analysis was performed on all variables. RESULTS: The most cost-effective strategy varied with the probability of RDS. TREATALL was the most cost-effective strategy above a probability of 17% (before 34 weeks' gestation), TESTALL was most cost-effective from 17% to 2% (34-36 weeks), and it was most cost-effective to use no treatment at probabilities less than 2% (after 36 weeks). TREATALL and TESTALL were both cost-saving compared with no treatment at probabilities of RDS above 2%. TREATALL was more highly favored as the costs of RDS and preterm birth increased, whereas TESTALL was more favored as the specificity of the test and the cost of maternal hospitalization increased. CONCLUSION: Although testing for fetal lung maturity is useful in many clinical situations, the cost-effectiveness of such testing in the setting of idiopathic preterm labor from a tertiary medical center perspective depends primarily on the probability and costs of RDS and the costs of non-RDS-related morbidity. At our institution, such testing is cost-effective between 34 and 36 weeks' gestation.

Authors
Myers, ER; Alvarez, JG; Richardson, DK; Ludmir, J
MLA Citation
Myers, ER, Alvarez, JG, Richardson, DK, and Ludmir, J. "Cost-effectiveness of fetal lung maturity testing in preterm labor." Obstet Gynecol 90.5 (November 1997): 824-829.
PMID
9351772
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
90
Issue
5
Publish Date
1997
Start Page
824
End Page
829
DOI
10.1016/S0029-7844(97)00412-2

Prevention of respiratory distress syndrome: cost-effectiveness for managing idiopathic preterm labor

OBJECTIVE: To determine the relative cost-effectiveness of three strategies for preventing respiratory distress syndrome (RDS) resulting from preterm labor and delivery: (1) empiric tocolysis with betamimetic agonists and treatment with corticosteroids (TREATALL), (2) amniocentesis and testing for fetal lung maturity, with treatment based on tests results (TESTALL), and (3) no treatment (TREATNONE). METHODS: We used a Markov decision analytic model to estimate the outcomes of each strategy. We took a health care system perspective and used a one-week time frame. We assumed there were no fetal or maternal indications for delivery, and that the patients were not diabetic. Probability variables were obtained from the literature and included the probability of delivery with preterm labor and of RDS by gestational age, the efficacy of betamimetics and corticosteroids, and the sensitivity and specificity of the test for fetal lung maturity. Cost variables were obtained from the Costs and Payments Department at Beth Israel Hospital and included the costs of amniocentesis, fetal lung maturity tests, betamimetics, corticosteroids, maternal hospital costs, costs associated with RDS and other neonatal costs. Sensitivity analysis was performed on all variables. RESULTS: The most cost-effective strategy varied with the probability of RDS. At probabilities ranging from 65% to 14%, corresponding to gestational ages from 28 to 34 wks, TREATALL was the most cost-effective strategy. TESTALL was most cost-effective from 14% to 1% (34 to 36 wks) and TREATNONE at probabilities less than 1% (>36 wks). TRF.ATALI. was more highly favored as the cost of RDS increased, while TESTAU.was more favored as the specificity of the test increased. CONCLUSION: Although testing for fetal lung maturity is useful in many clinical situations, the cost-effectiveness of such testing in the setting of idiopathic preterm labor appears to be limited to a narrow time frame.

Authors
Myers, ER; Alvarez, JG; Richardson, DK; Ludmir, J
MLA Citation
Myers, ER, Alvarez, JG, Richardson, DK, and Ludmir, J. "Prevention of respiratory distress syndrome: cost-effectiveness for managing idiopathic preterm labor." Acta Diabetologica Latina 176.1 PART II (1997): S43-.
Source
scival
Published In
Acta Diabetologica Latina
Volume
176
Issue
1 PART II
Publish Date
1997
Start Page
S43

Tubal ligation, hysterectomy, and risk of ovarian cancer.

Authors
Myers, ER
MLA Citation
Myers, ER. "Tubal ligation, hysterectomy, and risk of ovarian cancer." JAMA 271.16 (April 27, 1994): 1235-. (Letter)
PMID
8204181
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
271
Issue
16
Publish Date
1994
Start Page
1235

Tubal ligation, hysterectomy, and risk of ovarian cancer.

Authors
Silver, AL
MLA Citation
Silver, AL. "Tubal ligation, hysterectomy, and risk of ovarian cancer." JAMA 271.16 (April 1994): 1235-.
PMID
8151891
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
271
Issue
16
Publish Date
1994
Start Page
1235
DOI
10.1001/jama.271.16.1235b

Preoperative coagulation testing on a gynecologic oncology service.

OBJECTIVE: To determine the prevalence and clinical significance of abnormalities of preoperative coagulation tests in gynecologic oncology patients. METHODS: Three hundred fifty-one patients presenting for inpatient surgical procedures on the gynecologic oncology service at Duke University Medical Center from January 1, 1990 to December 31, 1990, underwent preoperative coagulation testing. Twenty-nine patients had only prothrombin time (PT) and partial thromboplastin time (PTT) measured; the remaining 322 had preoperative measurement of PT, PTT, fibrinogen, and fragment D-dimer. Outcomes assessed were perioperative hemorrhage resulting in death or reoperation, postoperative hematomas, and need for intraoperative and postoperative transfusion. RESULTS: Twelve of 351 patients (3.4%) had abnormally elevated PT or PTT; six of these were attributable to risk factors unrelated to malignancy. One hundred fifty-six of 322 subjects (48.4%) had abnormal levels of fibrinogen, mostly elevations above 360 mg/dL, and 88 of 322 subjects (27.3%) had positive tests for D-dimer. Fifty-seven (17.7%) had both elevated fibrinogen and positive D-dimer. One hundred eighty-eight of 322 subjects had at least one abnormal test result. There were no perioperative deaths or reexplorations because of hemorrhage. There was one postoperative hematoma. The combination of an elevated fibrinogen and a positive D-dimer test was a significant predictor of perioperative transfusion in a logistic regression model incorporating stage, preoperative hematocrit, and age (odds ratio 1.96, 95% confidence interval 1.03-3.76). However, the attributable risk associated with this abnormality was only 7.7% in patients at highest risk of transfusion. CONCLUSION: Although abnormalities in coagulation are common in patients undergoing surgery for gynecologic malignancy, preoperative testing for occult coagulopathy provides little clinically useful information.

Authors
Myers, ER; Clarke-Pearson, DL; Olt, GJ; Soper, JT; Berchuck, A
MLA Citation
Myers, ER, Clarke-Pearson, DL, Olt, GJ, Soper, JT, and Berchuck, A. "Preoperative coagulation testing on a gynecologic oncology service." Obstet Gynecol 83.3 (March 1994): 438-444.
PMID
8127539
Source
pubmed
Published In
Obstetrics & Gynecology (Elsevier)
Volume
83
Issue
3
Publish Date
1994
Start Page
438
End Page
444

Serum progesterone levels following vaginal administration of progesterone during the luteal phase.

We measured serum progesterone (P) levels after administration of 400 mg P vaginal suppositories to women during the luteal phase of the menstrual cycle. Blood samples were obtained before suppository insertion and at five intervals up to 8 hours after insertion. On the first day of treatment with P suppositories, there was a substantial elevation in serum P above baseline after insertion. However, on subsequent days of administration a smaller increment in serum P was observed. In 4 women studied on days 1 and 8 of the same treatment cycle in the luteal phase, a smaller rise in serum P following suppository administration on day 8, compared with day 1, was found. Overall, a highly significant negative correlation between change in serum P from baseline and duration of vaginal suppository treatment was found. This observation does not appear to be related to the achievement of a pharmacokinetic steady state. Possible mechanisms for this observation are discussed.

Authors
Myers, ER; Sondheimer, SJ; Freeman, EW; Strauss, JF; Rickels, K
MLA Citation
Myers, ER, Sondheimer, SJ, Freeman, EW, Strauss, JF, and Rickels, K. "Serum progesterone levels following vaginal administration of progesterone during the luteal phase." Fertil Steril 47.1 (January 1987): 71-75.
PMID
3792576
Source
pubmed
Published In
Fertility and Sterility
Volume
47
Issue
1
Publish Date
1987
Start Page
71
End Page
75

Corrigendum to "The current and future role of screening in the era of HPV vaccination" [Gynecol. Oncol. 109 (2008) S31-S39] (DOI:10.1016/j.ygyno.2008.02.001)

Authors
Myers, E; Huh, WK; Wright, JD; Smith, JS
MLA Citation
Myers, E, Huh, WK, Wright, JD, and Smith, JS. "Corrigendum to "The current and future role of screening in the era of HPV vaccination" [Gynecol. Oncol. 109 (2008) S31-S39] (DOI:10.1016/j.ygyno.2008.02.001)." Gynecologic Oncology.
Source
scival
Published In
Gynecologic Oncology
DOI
10.1016/j.ygyno.2008.05.022
Show More

Research Areas:

  • 3T3 Cells
  • AIDS Serodiagnosis
  • Abruptio Placentae
  • Accidents, Traffic
  • Adenocarcinoma
  • Administration, Intravaginal
  • Administration, Intravesical
  • Administration, Oral
  • Adnexal Diseases
  • African Americans
  • African Continental Ancestry Group
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Air Bags
  • Alberta
  • Alendronate
  • Algorithms
  • Alphapapillomavirus
  • Amniocentesis
  • Analysis of Variance
  • Anemia
  • Angiotensin II Type 1 Receptor Blockers
  • Angiotensin-Converting Enzyme Inhibitors
  • Anonymous Testing
  • Anovulation
  • Anti-Bacterial Agents
  • Anti-HIV Agents
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Viral
  • Anticoagulants
  • Antineoplastic Agents
  • Antineoplastic Combined Chemotherapy Protocols
  • Antitubercular Agents
  • Antiviral Agents
  • BRCA1 Protein
  • BRCA2 Protein
  • Bevacizumab
  • Biomedical Research
  • Birth Certificates
  • Birth Rate
  • Blood Coagulation Tests
  • Body Mass Index
  • Bone Cements
  • Bone Morphogenetic Protein 2
  • Bone Morphogenetic Protein 7
  • Bone Morphogenetic Proteins
  • Botulinum Toxins, Type A
  • Breast Neoplasms
  • CA-125 Antigen
  • Cancer Vaccines
  • Carboplatin
  • Carcinoma, Squamous Cell
  • Case-Control Studies
  • Causality
  • Cell Line, Tumor
  • Cervical Intraepithelial Neoplasia
  • Cervix Uteri
  • Cesarean Section
  • China
  • Choice Behavior
  • Cholinergic Antagonists
  • Chronic Disease
  • Clinical Competence
  • Clinical Laboratory Techniques
  • Clinical Trials as Topic
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Clomiphene
  • Cognition
  • Cognitive Therapy
  • Cohort Studies
  • Coitus
  • Colombia
  • Colposcopy
  • Combined Modality Therapy
  • Community Health Centers
  • Community Networks
  • Comorbidity
  • Comparative Effectiveness Research
  • Compliance
  • Computer Simulation
  • Condylomata Acuminata
  • Confidence Intervals
  • Contact Tracing
  • Continental Population Groups
  • Contraceptives, Oral
  • Contraceptives, Oral, Hormonal
  • Controlled Clinical Trials as Topic
  • Cost Savings
  • Cost effectiveness
  • Cost of Illness
  • Cost-Benefit Analysis
  • Costs and Cost Analysis
  • Cotinine
  • Counseling
  • Cross-Sectional Studies
  • Cystadenocarcinoma, Serous
  • Cystoscopy
  • Cytological Techniques
  • DNA Probes, HPV
  • DNA, Viral
  • Data Collection
  • Death, Sudden, Cardiac
  • Decision Making
  • Decision Support Techniques
  • Decision Trees
  • Delayed-Action Preparations
  • Deoxycytidine
  • Developing Countries
  • Diagnosis, Computer-Assisted
  • Diagnostic Techniques, Obstetrical and Gynecological
  • Diagnostic Tests, Routine
  • Direct Service Costs
  • Disease Management
  • Disease Progression
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Combinations
  • Drug Costs
  • Drug Resistance, Neoplasm
  • Drug Therapy, Combination
  • Early Detection of Cancer
  • Electric Countershock
  • Embolization, Therapeutic
  • Embryo Disposition
  • Embryo Research
  • Embryo Transfer
  • Endometrial Neoplasms
  • Endometrium
  • Equipment Failure
  • Estradiol
  • Estrogen Replacement Therapy
  • Ethics, Medical
  • European Continental Ancestry Group
  • Evidence-Based Medicine
  • False Negative Reactions
  • False Positive Reactions
  • Feasibility Studies
  • Fecal Incontinence
  • Female
  • Female Urogenital Diseases
  • Feminism
  • Fertility
  • Fertility Agents, Female
  • Fertilization in Vitro
  • Fetal Death
  • Fetal Distress
  • Fetal Organ Maturity
  • Fluorodeoxyglucose F18
  • Focus Groups
  • Follicle Stimulating Hormone
  • Follow-Up Studies
  • Forecasting
  • Ganglionic Stimulants
  • Genes, BRCA1
  • Genes, BRCA2
  • Genetic Testing
  • Genital Diseases, Female
  • Genital Neoplasms, Female
  • Gestational Age
  • Glucocorticoids
  • Guidelines as Topic
  • Gynecologic Surgical Procedures
  • Gynecology
  • HIV Infections
  • Health Behavior
  • Health Care Costs
  • Health Care Surveys
  • Health Expenditures
  • Health Planning
  • Health Policy
  • Health Priorities
  • Health Promotion
  • Health Services Research
  • Health Status
  • Health Status Indicators
  • Health Surveys
  • Heparin
  • Heparin, Low-Molecular-Weight
  • Heterozygote
  • Hispanic Americans
  • Hormone Replacement Therapy
  • Hospital Costs
  • Human papillomavirus 11
  • Human papillomavirus 16
  • Human papillomavirus 18
  • Human papillomavirus 6
  • Humans
  • Hypoglycemic Agents
  • Hysterectomy
  • Hysterectomy, Vaginal
  • Hysteroscopy
  • Incidence
  • Infant, Low Birth Weight
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical
  • Infertility
  • Infertility, Female
  • Influenza Vaccines
  • Influenza, Human
  • Information Dissemination
  • Injections, Intralesional
  • Interdisciplinary Communication
  • Internship and Residency
  • Intraoperative Complications
  • Isoniazid
  • Kaplan-Meier Estimate
  • Labor, Induced
  • Laparoscopy
  • Laser Therapy
  • Leiomyoma
  • Leiomyomatosis
  • Length of Stay
  • Life Expectancy
  • Live Birth
  • Logistic Models
  • Lumbar Vertebrae
  • Lumbosacral Plexus
  • Luteal Phase
  • Luteinizing Hormone
  • Lymph Node Excision
  • Lymphatic Metastasis
  • Madagascar
  • Magnetic Resonance Imaging
  • Male
  • Mandatory Testing
  • Markov Chains
  • Mass Screening
  • Mass Vaccination
  • Maternal Mortality
  • Medical Oncology
  • Medical Records
  • Medically Underserved Area
  • Membrane Proteins
  • Menopause
  • Menorrhagia
  • Mental Recall
  • Metformin
  • Metronidazole
  • Mice
  • Microbiological Techniques
  • Middle Aged
  • Minority Groups
  • Models, Biological
  • Models, Economic
  • Models, Statistical
  • Models, Theoretical
  • Monte Carlo Method
  • Morbidity
  • Motivation
  • Motor Vehicles
  • Multicenter Studies as Topic
  • Multivariate Analysis
  • Mutation
  • Myocardial Infarction
  • Myometrium
  • National Health Programs
  • National Institute of Child Health and Human Development (U.S.)
  • Needs Assessment
  • Neoplasm Grading
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Neoplasms
  • Neoplasms, Squamous Cell
  • Neuromuscular Agents
  • New Mexico
  • Newfoundland and Labrador
  • Nicotine
  • Nicotinic Agonists
  • North Carolina
  • Nutrition Surveys
  • Obesity
  • Observer Variation
  • Obstetric Labor Complications
  • Obstetric Labor, Premature
  • Odds Ratio
  • Oncology Service, Hospital
  • Ontario
  • Oocyte Donation
  • Oocyte Retrieval
  • Organizational Objectives
  • Osteoarthritis
  • Osteoclasts
  • Osteogenesis
  • Outcome Assessment (Health Care)
  • Ovarian Neoplasms
  • Ovary
  • Ovulation
  • Ovulation Induction
  • Paclitaxel
  • Papillomaviridae
  • Papillomavirus Infections
  • Papillomavirus Vaccines
  • Parity
  • Patient Acceptance of Health Care
  • Patient Compliance
  • Patient Discharge
  • Patient Education as Topic
  • Patient Participation
  • Patient Preference
  • Patient Satisfaction
  • Patient Selection
  • Patient-Centered Care
  • Pelvic Neoplasms
  • Pelvic Organ Prolapse
  • Peritoneum
  • Phenotype
  • Phthalazines
  • Physician's Practice Patterns
  • Physician-Patient Relations
  • Piperazines
  • Placebos
  • Platinum
  • Poly(ADP-ribose) Polymerases
  • Polycystic Ovary Syndrome
  • Polymethyl Methacrylate
  • Polymorphism, Single Nucleotide
  • Population Dynamics
  • Positron-Emission Tomography
  • Postoperative Complications
  • Postpartum Period
  • Practice Guidelines as Topic
  • Predictive Value of Tests
  • Pregnancy
  • Pregnancy Complications
  • Pregnancy Complications, Cardiovascular
  • Pregnancy Complications, Infectious
  • Pregnancy Outcome
  • Pregnancy Rate
  • Pregnancy, High-Risk
  • Pregnancy, Multiple
  • Pregnancy, Prolonged
  • Pregnant Women
  • Prejudice
  • Premature Birth
  • Premenopause
  • Premenstrual Syndrome
  • Prenatal Care
  • Prenatal Diagnosis
  • Prevalence
  • Preventive Health Services
  • Preventive Medicine
  • Primary Health Care
  • Primary Ovarian Insufficiency
  • Primary Prevention
  • Probability
  • Progesterone
  • Prognosis
  • Program Evaluation
  • Proportional Hazards Models
  • Prospective Studies
  • Prostitution
  • Protein-Serine-Threonine Kinases
  • Pseudarthrosis
  • Public Health
  • Puerperal Disorders
  • Quality Control
  • Quality of Life
  • Quality-Adjusted Life Years
  • Questionnaires
  • ROC Curve
  • Radiology, Interventional
  • Radiopharmaceuticals
  • Randomized Controlled Trials as Topic
  • Rats
  • Rats, Sprague-Dawley
  • Recurrence
  • Reference Values
  • Registries
  • Regression Analysis
  • Reoperation
  • Reproducibility of Results
  • Reproductive History
  • Reproductive Medicine
  • Reproductive Techniques, Assisted
  • Research
  • Research Design
  • Retrospective Studies
  • Risk
  • Risk Assessment
  • Risk Factors
  • Robotics
  • SEER Program
  • Safety
  • Sample Size
  • Seasons
  • Seat Belts
  • Self Concept
  • Self Efficacy
  • Self Report
  • Sensitivity and Specificity
  • Severity of Illness Index
  • Sexually Transmitted Diseases
  • Sickness Impact Profile
  • Single Embryo Transfer
  • Smoking
  • Smoking Cessation
  • Social Perception
  • Societies, Medical
  • Socioeconomic Factors
  • Specimen Handling
  • Sperm Injections, Intracytoplasmic
  • Statistics, Nonparametric
  • Stereotyping
  • Sterilization, Tubal
  • Stress, Psychological
  • Stroke
  • Superovulation
  • Surgical Procedures, Minimally Invasive
  • Survival Rate
  • Taxoids
  • Technology Assessment, Biomedical
  • Thailand
  • Thoracic Vertebrae
  • Thrombocytopenia
  • Thromboembolism
  • Thrombosis
  • Time Factors
  • Tobacco Smoke Pollution
  • Transfection
  • Transforming Growth Factor beta
  • Treatment Failure
  • Treatment Outcome
  • Triage
  • Tumor Markers, Biological
  • Ultrasonography, Doppler
  • Uncertainty
  • United States
  • United States Agency for Healthcare Research and Quality
  • Ureter
  • Urinary Bladder Diseases
  • Urinary Incontinence
  • Urinary Incontinence, Stress
  • Urinary Incontinence, Urge
  • Urodynamics
  • Urogenital Surgical Procedures
  • Uterine Cervical Diseases
  • Uterine Cervical Dysplasia
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Uterine Prolapse
  • Uterus
  • Vaccination
  • Vaginal Smears
  • Venous Thromboembolism
  • Venous Thrombosis
  • Viral Vaccines
  • Virology
  • Vulva
  • Weight Gain
  • Women's Health
  • Women's Health Services
  • Wound Healing
  • Wounds and Injuries
  • Young Adult
  • Zidovudine
  • von Willebrand Diseases