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Dinan, Michaela Ann

Overview:

Areas of expertise: Health Services Research and Health Policy

Positions:

Assistant Professor in Population Health Sciences

Population Health Sciences
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Membership in the Duke Clinical Research Institute

Duke Clinical Research Institute
School of Medicine

Education:

B.S. 2003

B.S. — University of Virginia

Ph.D. 2011

Ph.D. — University of North Carolina at Chapel Hill

News:

Grants:

Bladder Cancer in Older Adults - Treatment and Outcomes

Administered By
Duke Clinical Research Institute
AwardedBy
AstraZeneca Pharmaceuticals, LP
Role
Co Investigator
Start Date
September 08, 2016
End Date
December 31, 2017

Thyrogen Utilization Patterns in the Treatment of Thyroid Cancer

Administered By
Duke Clinical Research Institute
AwardedBy
Genzyme Corporation
Role
Principal Investigator
Start Date
June 30, 2015
End Date
June 30, 2017

National Utilization Patterns of Oncotype DX in Early Stage Breast Cancer

Administered By
Duke Clinical Research Institute
AwardedBy
Agency for Healthcare Research and Quality
Role
Principal Investigator
Start Date
August 01, 2013
End Date
July 31, 2015

Cardiac Imaging

Administered By
Duke Clinical Research Institute
AwardedBy
BC Cancer Research Centre
Role
Principal Investigator
Start Date
July 01, 2014
End Date
January 31, 2015
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Publications:

Trends in hospital-physician integration in medical oncology.

Hospitals have rapidly acquired medical oncology practices in recent years. Experts disagree as to whether these trends are related to oncology-specific market factors or reflect a general trend of hospital-physician integration. The objective of this study was to compare the prevalence, geographic variation, and trends in physicians billing from hospital outpatient departments in medical oncology with other specialties.Retrospective analysis of Medicare claims data for 2012 and 2013.We calculated the proportion of physicians and practitioners in the 15 highest-volume specialties who billed the majority of evaluation and management visits from hospital outpatient departments in each year, nationally and by state.We included 338,998 and 352,321 providers in 2012 and 2013, respectively, of whom 9715 and 9969 were medical oncologists. Among the 15 specialties examined, medical oncology had the highest proportion of hospital outpatient department billing in 2012 and 2013 (35.0% and 38.3%, respectively). Medical oncology also experienced the greatest absolute change (3.3%) between the years, followed by thoracic surgery (2.4%) and cardiology (2.0%). There was marked state-level variation, with the proportion of medical oncologists based in hospital outpatient departments ranging from 0% in Nevada to 100% in Idaho.Hospital-physician integration has been more pronounced in medical oncology than in other high-volume specialties and is increasing at a faster rate. Policy makers should take these findings into consideration, particularly with respect to recent proposals that may continue to fuel these trends.

Authors
Clough, JD; Dinan, MA; Schulman, KA
MLA Citation
Clough, JD, Dinan, MA, and Schulman, KA. "Trends in hospital-physician integration in medical oncology." The American journal of managed care 23.10 (October 2017): 624-627.
PMID
29087634
Source
epmc
Published In
American Journal of Managed Care
Volume
23
Issue
10
Publish Date
2017
Start Page
624
End Page
627

Algorithms for prediction of the Oncotype DX recurrence score using clinicopathologic data: a review and comparison using an independent dataset.

Given the potential savings in cost and resource utilization, several algorithms have been proposed to predict Oncotype DX recurrence score (ODX RS) using commonly acquired histopathologic variables. Although it is promising, additional independent validation of these surrogate markers is needed prior to guide the patient management.In this retrospective study, we analyzed 305 patients with invasive breast cancer at our institution who had ODX RS available. We selected five equations that provide a surrogate measure of ODX as previously published by Klein et al. (Magee equations 1-3), Gage et al., and Tang et al. All equations used estrogen receptor status and progesterone receptor status along with different combinations of grade, proliferation indices (Ki-67, mitotic rate), HER2 status, and tumor size.Of all surrogate scores tested, the Magee equation 2 provided the highest correlation with ODX both with regard to raw score (Pearson's correlation coefficient = 0.66 95% CI 0.59-0.72) and categorical correlation (Cohen's kappa = 0.43, 95% CI 0.33-0.53). Although Magee equation 2 provided a way to reliably identify high-risk disease by assigning 95% of the patients with high ODX RS to either the intermediate- or high-risk group, it was unable to reliably identify the potential for patients to have intermediate- or high-risk disease by ODX (66% of such patients identified).Although commonly available surrogates for ODX appear to predict high-risk ODX RS, they are unable to reliably rule out the presence of patients with intermediate-risk disease by ODX. Given the potential benefit of adjuvant chemotherapy in women with intermediate-risk disease by ODX, current surrogates are unable to safely substitute for ODX. Characterizing the true recurrence risk in patients with intermediate-risk disease by ODX is critical to the clinical adoption of current surrogate markers and is an area of ongoing clinical trials.

Authors
Harowicz, MR; Robinson, TJ; Dinan, MA; Saha, A; Marks, JR; Marcom, PK; Mazurowski, MA
MLA Citation
Harowicz, MR, Robinson, TJ, Dinan, MA, Saha, A, Marks, JR, Marcom, PK, and Mazurowski, MA. "Algorithms for prediction of the Oncotype DX recurrence score using clinicopathologic data: a review and comparison using an independent dataset." Breast cancer research and treatment 162.1 (February 2017): 1-10. (Review)
PMID
28064383
Source
epmc
Published In
Breast Cancer Research and Treatment
Volume
162
Issue
1
Publish Date
2017
Start Page
1
End Page
10
DOI
10.1007/s10549-016-4093-4

PS01.61: Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now (REVOLUTION): Registry Study in Progress: Topic: Medical Oncology.

Authors
Kim, E; Dinan, M; Islam, KM; Fernandes, A; Schwartzberg, L; Croft, E; Brahmer, J; Mansfield, A; Hyslop, T; Burke, L; Crawford, J
MLA Citation
Kim, E, Dinan, M, Islam, KM, Fernandes, A, Schwartzberg, L, Croft, E, Brahmer, J, Mansfield, A, Hyslop, T, Burke, L, and Crawford, J. "PS01.61: Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now (REVOLUTION): Registry Study in Progress: Topic: Medical Oncology." Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 11.11S (November 2016): S308-S309.
PMID
27969528
Source
epmc
Published In
Journal of Thoracic Oncology
Volume
11
Issue
11S
Publish Date
2016
Start Page
S308
End Page
S309
DOI
10.1016/j.jtho.2016.09.096

How Many Lymph Nodes Are Enough? Assessing the Adequacy of Lymph Node Yield for Papillary Thyroid Cancer.

Patients who undergo surgery for papillary thyroid cancer with only a limited lymph node examination are thought to be at risk for potentially harboring occult disease. However, this risk has not been objectively quantified and may have implications for subsequent management and surveillance.Data from the National Cancer Database (1998 to 2012) were used to characterize the distribution of nodal positivity of adult patients diagnosed with localized ≥ 1-cm papillary thyroid cancer who underwent thyroidectomy with one or more lymph nodes (LNs) examined. A β-binomial distribution was used to estimate the probability of occult nodal disease as a function of total number of LNs examined and pathologic tumor stage.A total of 78,724 patients met study criteria; 38,653 patients had node-positive disease. The probability of falsely identifying a patient as node negative was estimated to be 53% for patients with a single node examined and decreased to less than 10% when more than six LNs were examined. To rule out occult nodal disease with 90% confidence, six, nine, and 18 nodes would need to be examined for patients with T1b, T2, and T3 disease, respectively. Sensitivity analyses limited to patients likely undergoing prophylactic central neck dissection resulted in three, four, and eight nodes needed to provide comparable adequacy of LN evaluation.To our knowledge, our study provides the first empirically based estimates of occult nodal disease risk in patients after surgery for papillary thyroid cancer as a function of primary tumor stage and number of LNs examined. Our estimates provide an objective guideline for evaluating adequacy of LN yield for surgeons and pathologists in the treatment of papillary thyroid cancer, and especially intermediate-risk disease, for which use of adjuvant radioactive iodine and surveillance intensity are not currently standardized.

Authors
Robinson, TJ; Thomas, S; Dinan, MA; Roman, S; Sosa, JA; Hyslop, T
MLA Citation
Robinson, TJ, Thomas, S, Dinan, MA, Roman, S, Sosa, JA, and Hyslop, T. "How Many Lymph Nodes Are Enough? Assessing the Adequacy of Lymph Node Yield for Papillary Thyroid Cancer." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 34.28 (October 2016): 3434-3439.
PMID
27528716
Source
epmc
Published In
Journal of Clinical Oncology
Volume
34
Issue
28
Publish Date
2016
Start Page
3434
End Page
3439
DOI
10.1200/jco.2016.67.6437

Knowledge of pathologically versus clinically negative lymph nodes is associated with reduced use of radioactive iodine post-thyroidectomy for low-risk papillary thyroid cancer.

Cervical lymph node metastases are common in papillary thyroid cancer (PTC). Clinically negative lymph nodes confer uncertainty about true lymph node status, potentially prompting empiric postoperative radioactive iodine (RAI) administration even in low-risk patients. We examined the association of clinically (cN0) versus pathologically negative (pN0) lymph nodes with utilization of RAI for low-risk PTC. Using the National Cancer Database 1998-2011, adults with PTC who underwent total thyroidectomy for Stage I/II tumors 1-4 cm were evaluated for receipt of RAI based on cN0 versus pN0 status. Cut-point analysis was conducted to determine the number of pN0 nodes associated with the greatest decrease in the odds of receipt of RAI. Survival models and multivariate analyses predicting RAI use were conducted separately for all patients and patients <45 years. 64,980 patients met study criteria; 39,778 (61.2 %) were cN0 versus 25,202 (38.8 %) pN0. Patients with pN0 nodes were more likely to have negative surgical margins and multifocal disease (all p < 0.001). The mean negative nodes reported in surgical pathology specimens was 4; ≥5 pathologically negative lymph nodes provided the best cut-point associated with reduced RAI administration (OR 0.91, CI 0.85-0.97). After multivariable adjustment, pN0 patients with ≥5 nodes examined were less likely to receive RAI compared to cN0 patients across all ages (OR 0.89, p < 0.001) and for patients aged <45 years (0R 0.86, p = 0.001). Patients with <5 pN0 nodes did not differ in RAI use compared to cN0 controls. Unadjusted survival was improved for pN0 versus cN0 patients across all ages (p < 0.001), but not for patients <45 years (p = 0.11); adjusted survival for all ages did not differ (p = 0.13). Pathological confirmation of negative lymph nodes in patients with PTC appears to influence the decision to administer postoperative RAI if ≥5 negative lymph nodes are removed. It is possible that fewer excised lymph nodes may be viewed by clinicians as incidentally resected and thus may suboptimally represent the true nodal status of the central neck. Further research is warranted to determine if there is an optimal number of lymph nodes that should be resected to standardize pathological diagnosis.

Authors
Ruel, E; Thomas, S; Dinan, MA; Perkins, JM; Roman, SA; Sosa, JA
MLA Citation
Ruel, E, Thomas, S, Dinan, MA, Perkins, JM, Roman, SA, and Sosa, JA. "Knowledge of pathologically versus clinically negative lymph nodes is associated with reduced use of radioactive iodine post-thyroidectomy for low-risk papillary thyroid cancer." Endocrine 52.3 (June 2016): 579-586.
PMID
26708045
Source
epmc
Published In
Endocrine
Volume
52
Issue
3
Publish Date
2016
Start Page
579
End Page
586
DOI
10.1007/s12020-015-0826-0

Patient-Centered Communication for Discussing Oncotype DX Testing.

Oncotype DX testing (ODX), a tumor gene expression test, may improve breast cancer care, however, communicating results remains challenging. We identified patient-centered communication strategies/gaps for discussing ODX results. We applied a patient-centered communication framework to analyze qualitative interviews with oncologists about how they communicate about ODX with patients, using template analysis in Atlas.ti. Overall, providers discussed four patient-centered communication domains: exchanging information, assessing uncertainty, making decisions and cross-cutting themes. Providers did not report discussing emotional aspects of managing uncertainty, assessing decision-making preferences, and evaluating decisions. A patient-centered approach may be a model for communicating about tumor gene expression tests.

Authors
Roberts, MC; Bryson, A; Weinberger, M; Dusetzina, SB; Dinan, MA; Reeder-Hayes, KE; Wheeler, SB
MLA Citation
Roberts, MC, Bryson, A, Weinberger, M, Dusetzina, SB, Dinan, MA, Reeder-Hayes, KE, and Wheeler, SB. "Patient-Centered Communication for Discussing Oncotype DX Testing." Cancer investigation 34.5 (May 2016): 205-212.
PMID
27124287
Source
epmc
Published In
Cancer Investigation (Informa)
Volume
34
Issue
5
Publish Date
2016
Start Page
205
End Page
212
DOI
10.3109/07357907.2016.1172637

Otolaryngology utilization of speech-language pathology services for voice disorders.

To examine the utilization of speech-language pathology (SLP) services by otolaryngology for outpatients with laryngeal/voice disorders.Retrospective analysis of a large, national, administrative US claims database.The study population included patients with a laryngeal/voice disorder based on International Classification of Diseases, Ninth Revision, Clinical Modification codes from January 1, 2004 to December 31, 2008, seen by an otolaryngologist as an outpatient, and 12 months of follow-up. Data were collected on SLP evaluation and treatment and patient factors including age, gender, geographic region, employment status, initial laryngeal diagnosis, and laryngeal diagnosis change over 12 months. Multivariable logistic regression analysis was used to investigate factors associated with receipt of SLP evaluation and treatment.There were 91,898 unique patients who met study criteria. A total of 4,485 (4.9%) patients had an SLP evaluation, of whom 2,216 (49.4%) had at least one voice therapy session. Patient age, gender, geographic region, and laryngeal diagnosis were associated with increased likelihood of receiving SLP services. Patients whose final laryngeal diagnosis changed from their initial diagnosis had greater odds of having an SLP evaluation (odds ratio = 1.18, 95% confidence interval = 1.06-1.31) compared to patients without laryngeal diagnosis change.SLP evaluation and treatment occurred in a minority of laryngeal/voice-disordered patients. Further study is needed to assess the impact of SLP services on the healthcare utilization of patients with laryngeal/voice disorders.2C.

Authors
Cohen, SM; Dinan, MA; Kim, J; Roy, N
MLA Citation
Cohen, SM, Dinan, MA, Kim, J, and Roy, N. "Otolaryngology utilization of speech-language pathology services for voice disorders." The Laryngoscope 126.4 (April 2016): 906-912.
PMID
26308555
Source
epmc
Published In
The Laryngoscope
Volume
126
Issue
4
Publish Date
2016
Start Page
906
End Page
912
DOI
10.1002/lary.25574

Resource Use in the Last Year of Life Among Patients Who Died With Versus of Prostate Cancer.

We conducted a retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data of men with prostate cancer. Among 34,727 patients, those who died of their prostate cancer had more hospice and outpatient use, less inpatient and intensive care unit use, and lower overall costs. Efforts to shift care toward the outpatient setting might provide more efficient and judicious care for patients during the end of life.Prostate cancer poses a significant financial burden in the United States. However, most men with prostate cancer will die from noncancer causes. Concerns about increased resource utilization at the end of life have not been appropriately examined in this context.We conducted a retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data of men who were diagnosed with and died of, as opposed to with, prostate cancer between 2000 and 2007. Within these 2 populations, we compared changes in the use of medical interventions, hospice, and overall health care costs to Medicare in the last year of life.Among 34,727 patients, those who died of prostate cancer had lower costs ($43,572 vs. $45,830; P < .001), largely because of lower mean inpatient costs ($20,769 vs. $29,851) and fewer hospitalizations (1.8 vs. 2.1), inpatient days (12.2 vs. 15.7), intensive care unit (ICU) days (1.4 vs. 3.4), and skilled nursing facility days (11.7 vs. 14.7; P < .001 for all). Outpatient and hospice costs were significantly greater among patients who died of prostate cancer, as was use of chemotherapy and androgen deprivation therapy. Patients who died of prostate cancer had approximately 12% lower costs than patients who died from other causes in adjusted analyses (fold-change, 0.88; 95% confidence interval [CI], 0.85-0.92). The single strongest predictor of increased costs at the end of life was receipt of multiple invasive procedures (fold increase in costs, 2.39; 95% CI, 2.22-2.58).Patients who died of prostate cancer rather than from other causes had more hospice and outpatient use, less inpatient and ICU use, and lower overall costs. Efforts to shift care toward outpatient settings might provide more efficient and judicious care for patients during the end of life.

Authors
Dinan, MA; Li, Y; Zhang, Y; Stewart, SB; Curtis, LH; George, DJ; Reed, SD
MLA Citation
Dinan, MA, Li, Y, Zhang, Y, Stewart, SB, Curtis, LH, George, DJ, and Reed, SD. "Resource Use in the Last Year of Life Among Patients Who Died With Versus of Prostate Cancer." Clinical genitourinary cancer 14.1 (February 2016): 28-37.e2.
PMID
26382223
Source
epmc
Published In
Clinical genitourinary cancer
Volume
14
Issue
1
Publish Date
2016
Start Page
28
End Page
37.e2
DOI
10.1016/j.clgc.2015.07.006

Racial Variation in the Uptake of Oncotype DX Testing for Early-Stage Breast Cancer.

Oncotype DX (ODX) is a tumor gene-profiling test that aids in adjuvant chemotherapy decision-making. ODX has the potential to improve quality of care; however, if not equally accessible across racial groups, disparities in cancer care quality may persist or worsen. We examined racial disparities in ODX testing uptake.We used data from the Carolina Breast Cancer Study, phase III, a longitudinal, population-based study of 2,998 North Carolina women who received a diagnosis of breast cancer between 2008 and 2014. Our primary analysis used modified Poisson regression to determine the association between race and whether ODX testing was ordered among two strata: node-negative and node-positive breast cancer.A total of 1,468 women with estrogen receptor-positive, human epidermal growth factor receptor-2-negative, stage I or II breast cancer met inclusion criteria. Black patients had higher-grade and larger tumors, more comorbidities, younger age at diagnosis, and lower socioeconomic status than non-black women. Overall, 42% of women had ODX test results in their pathology reports. Compared with those who did not receive ODX testing, women who received ODX testing tended to be younger and have medium tumor size and grade. Our regression analyses indicated no racial disparities in ODX uptake among node-negative patients. However, racial differences were detected among node-positive patients, with black patients being 46% less likely to receive ODX testing than non-black women (adjusted relative risk, 0.54; 95% CI, 0.35 to 0.84; P = .006).We did not find racial disparities in ODX testing for node-negative patients for whom ODX testing is guideline recommended and widely covered by insurers. However, our findings suggest that a newer, non-guideline-concordant application of ODX testing for node-positive breast cancer was accessed less by black women than by non-black women, reflecting more guideline concordant care among black women.

Authors
Roberts, MC; Weinberger, M; Dusetzina, SB; Dinan, MA; Reeder-Hayes, KE; Carey, LA; Troester, MA; Wheeler, SB
MLA Citation
Roberts, MC, Weinberger, M, Dusetzina, SB, Dinan, MA, Reeder-Hayes, KE, Carey, LA, Troester, MA, and Wheeler, SB. "Racial Variation in the Uptake of Oncotype DX Testing for Early-Stage Breast Cancer." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 34.2 (January 2016): 130-138.
PMID
26598755
Source
epmc
Published In
Journal of Clinical Oncology
Volume
34
Issue
2
Publish Date
2016
Start Page
130
End Page
138
DOI
10.1200/jco.2015.63.2489

ONCOLOGISTS' BARRIERS AND FACILITATORS FOR ONCOTYPE DX USE: QUALITATIVE STUDY.

Oncotype DX (ODX), a tumor gene profiling test, has been incorporated into clinical guidelines to aid in adjuvant chemotherapy decision making for early-stage, hormone receptor positive breast cancer patients. Despite United States (U.S.) guidelines, less than half of eligible women receive testing. Reasons for low usage are unclear: Our objective was to better understand U.S. oncologists' ODX uptake and how they use ODX during adjuvant chemotherapy decision making.We conducted semi-structured, ~30-minute phone interviews with medical and surgical oncologists in one U.S. State using purposive sampling. Oncologists were included if they saw greater than or equal to five breast cancer patients per week. Recruitment ended upon thematic saturation. Interviews were recorded, transcribed, and double-coded using template analysis.During analysis, themes emerged across three domains. First, organizational factors (i.e., departmental structure, ODX marketing, and medical/insurance guidelines) influenced ease of ODX use. Second, oncologists referenced the influence of interpersonal factors (e.g., normative beliefs and peer use of ODX) over their own practices and recommendations. Third, intrapersonal factors (e.g., oncologist attitudes, perceived barriers, and research gaps) were discussed: although oncologists largely held positive attitudes about ODX, they reported challenges with interpreting intermediate scores for treatment decisions and explaining test results to patients. Finally, oncologists identified several research gaps.As more tumor gene profiling tests are incorporated into cancer care for treatment decision making, it is important to understand their use in clinical practice. This study identified multi-level factors that influence ODX uptake into clinical practice, providing insights into facilitators and modifiable barriers that can be leveraged for improving ODX uptake to aid treatment decision making.

Authors
Roberts, MC; Bryson, A; Weinberger, M; Dusetzina, SB; Dinan, MA; Reeder-Hayes, K; Wheeler, SB
MLA Citation
Roberts, MC, Bryson, A, Weinberger, M, Dusetzina, SB, Dinan, MA, Reeder-Hayes, K, and Wheeler, SB. "ONCOLOGISTS' BARRIERS AND FACILITATORS FOR ONCOTYPE DX USE: QUALITATIVE STUDY." International journal of technology assessment in health care 32.5 (January 2016): 355-361.
PMID
27958190
Source
epmc
Published In
International Journal of Technology Assessment in Health Care
Volume
32
Issue
5
Publish Date
2016
Start Page
355
End Page
361
DOI
10.1017/s026646231600060x

Longitudinal Trends in Costs of Palliative Radiation for Metastatic Prostate Cancer.

In recent years, palliative treatment of prostate cancer metastases has been characterized by the use of more complex radiation treatment, despite a lack of evidence demonstrating a clinical benefit of these technologies in the palliative setting. The impact of adoption of these technologies on the costs of palliative radiation treatment in patients with metastatic prostate cancer remains poorly understood in the general patient population.The study was a retrospective analysis of Surveillance, Epidemiology and End Results (SEER) Medicare data of men aged 66 and older who died from metastatic prostate cancer between 2000 and 2007 and received radiation therapy for bony metastases in the last year of life. Direct costs were obtained from Medicare carrier and outpatient facility payments for all radiation treatment claims and adjusted to 2008 dollars.A total of 1705 men met study inclusion criteria. Total Medicare payments for radiation therapy for bony metastases in the last year of life increased by 44.4% from an average of $2,763 in 2000 to $3,989 in 2007, with the proportion of all payments accrued within hospital-based settings increasing from 48% to 57%. Complexity of radiation therapy techniques over the same period was characterized by use of less simple (30.1% to 23.3%) and more complex (59.9% versus 66.7%) radiation therapy. From 2000-2003 to 2004-2007, the use of shorter treatment courses (≤5 fractions) decreased from 22% to 14%, and the use of single fraction treatment courses decreased by half (6.3% to 2.9%; P≤.001).Between 2000 and 2007, palliative radiation therapy for bony prostate cancer metastases was characterized by the use of more advanced treatment technologies and prolonged radiation treatment courses. Further research investigating barriers to cost-effective palliation is warranted.

Authors
Robinson, TJ; Dinan, MA; Li, Y; Lee, WR; Reed, SD
MLA Citation
Robinson, TJ, Dinan, MA, Li, Y, Lee, WR, and Reed, SD. "Longitudinal Trends in Costs of Palliative Radiation for Metastatic Prostate Cancer." November 2015.
PMID
26241733
Source
epmc
Published In
Journal of Palliative Medicine
Volume
18
Issue
11
Publish Date
2015
Start Page
933
End Page
939
DOI
10.1089/jpm.2015.0171

Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009.

Guidelines recommend consideration of chemotherapy for most patients with early-stage, estrogen receptor-positive, invasive breast cancer in the absence of additional prognostic information. The 21-gene recurrence score (RS) assay has been shown in limited academic settings to reduce physician recommendations for adjuvant chemotherapy. Associations between the adoption of the assay and receipt of chemotherapy in the general population have not been examined.To examine whether adoption of the RS assay in a nationally representative sample of patients with early-stage breast cancer was associated with use of chemotherapy.Retrospective cohort study of Medicare beneficiaries who received a diagnosis of incident breast cancer between 2005 and 2009 using Surveillance, Epidemiology, and End Results data set with linked Medicare claims.Receipt of chemotherapy within 12 months after diagnosis.A total of 44,044 patients had low-risk (24.0%), intermediate-risk (51.3%), or high-risk disease (24.6%, lymph node positive) as defined by National Comprehensive Cancer Network (NCCN) guidelines and met the study criteria. We observed no overall association between receipt of the RS assay and chemotherapy (odds ratio [OR], 1.03 [99% CI, 0.88-1.19]). In multivariable analysis, there was a significant interaction between NCCN risk and use of the RS assay, with assay use associated with lower chemotherapy use in high-risk patients (OR, 0.36 [99% CI, 0.26-0.50]) and greater chemotherapy use in low-risk patients (OR, 3.71 [99% CI, 2.30-5.98]), compared with no receipt of the assay (P=.006 for the overall interaction). Results were similar in prespecified subgroup analyses of patients 70 years and younger, with the exception of a shift toward lower chemotherapy use during 2008 (OR, 0.90 [99% CI, 0.77-.1.05]; P=.09) and 2009 (OR, 0.81 [99% CI, 0.66-0.99]; P=.007). In unadjusted analyses, overall chemotherapy use decreased over time in patients 70 years or younger with high-risk disease and those receiving the assay.The impact of the adoption of the RS assay on receipt of chemotherapy was strongly population dependent and was associated with relatively lower chemotherapy use in groups with high-risk disease and relatively higher chemotherapy use in patients with low-risk disease. Overall use of chemotherapy decreased during the study period in patients who were most likely to receive chemotherapy.

Authors
Dinan, MA; Mi, X; Reed, SD; Lyman, GH; Curtis, LH
MLA Citation
Dinan, MA, Mi, X, Reed, SD, Lyman, GH, and Curtis, LH. "Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009." JAMA oncology 1.8 (November 2015): 1098-1109.
PMID
26313372
Source
epmc
Published In
JAMA oncology
Volume
1
Issue
8
Publish Date
2015
Start Page
1098
End Page
1109
DOI
10.1001/jamaoncol.2015.2722

Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients.

To describe national practice patterns regarding utilization of minimally invasive pancreaticoduodenectomy (MIPD) and compare short-term outcomes with those following open pancreaticoduodenectomy for cancer.There is increasing interest in use of MIPD; however, published data are limited to single institutional experiences.Adult patients undergoing pancreaticoduodenectomy were identified from the National Cancer Database, 2010-2011. Descriptive statistics and multivariable modeling were employed to characterize use of MIPD (laparoscopic or robotic) and compare short-term outcomes to those following open pancreaticoduodenectomy.A total of 7061 patients underwent pancreaticoduodenectomy: 983 had MIPD and 6078 had open procedures. The use of MIPD increased by 45% (179 cases) from 2010 to 2011. The majority of hospitals (92%) performing MIPD were low volume (≤ 10 cases/2 years). Factors independently associated with undergoing MIPD included fewer comorbidities, treatment at an academic institution, and a neuroendocrine tumor diagnosis (all P < 0.01). The unadjusted 30-day mortality rate was 5.1% for MIPD versus 3.1% after open surgery. For patients with adenocarcinoma, there were no differences between MIPD and open pancreaticoduodenectomy after multivariable adjustment in number of lymph nodes removed, rate of positive surgical margins, length of stay, or readmissions. However, 30-day mortality was higher for patients undergoing MIPD versus open surgery (odds ratio = 1.87, confidence interval: 1.25-2.80, P = 0.002).While there is increasing interest in employing MIPD for adenocarcinoma, its use is associated with increased 30-day mortality. The majority of hospitals performing MIPD were low volume. These results may suggest that MIPD is a complex procedure for which comprehensive protocols outlining criteria for implementation might be warranted to optimize patient safety.

Authors
Adam, MA; Choudhury, K; Dinan, MA; Reed, SD; Scheri, RP; Blazer, DG; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Choudhury, K, Dinan, MA, Reed, SD, Scheri, RP, Blazer, DG, Roman, SA, and Sosa, JA. "Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients." Annals of surgery 262.2 (August 2015): 372-377.
PMID
26158612
Source
epmc
Published In
Annals of Surgery
Volume
262
Issue
2
Publish Date
2015
Start Page
372
End Page
377
DOI
10.1097/sla.0000000000001055

Racial variation in adjuvant chemotherapy initiation among breast cancer patients receiving oncotype DX testing.

It is unknown whether racial differences exist in adjuvant chemotherapy initiation among women with similar oncotype DX (ODX) risk scores. We examined whether adjuvant chemotherapy initiation varied by race. Data come from the Phase III, Carolina Breast Cancer Study, a longitudinal, population-based study of North Carolina women diagnosed with breast cancer between 2008 and 2014. We used modified Poisson regression and report adjusted relative risk (aRR) and 95% confidence intervals (95%CI) to estimate the association between race and adjuvant chemotherapy initiation across ODX risk groups among women who received the test (n = 541). Among women who underwent ODX testing, 54.2, 37.5, and 8.3% of women had tumors classified as low-, intermediate-, and high-risk groups, respectively. We observed no racial variation in adjuvant chemotherapy initiation. Increasing ODX risk score (aRR = 1.39, 95%CI = 1.22, 1.58) and being married (aRR = 2.92, 95%CI = 1.12, 7.60) were independently associated with an increased likelihood of adjuvant chemotherapy in the low-risk group. Among women in the intermediate-risk group, ODX risk score (aRR = 1.15, 95%CI = 1.11, 1.20), younger age (aRR = 1.95, 95%CI = 1.35, 2.81), larger tumor size (aRR = 1.70, 95%CI = 1.22, 2.35), and higher income were independently associated with increased likelihood of adjuvant chemotherapy initiation. No racial differences were found in adjuvant chemotherapy initiation among women receiving ODX testing. As treatment decision-making becomes increasingly targeted with the use of genetic technologies, these results provide evidence that test results may drive treatment in a similar way across racial subgroups.

Authors
Roberts, MC; Weinberger, M; Dusetzina, SB; Dinan, MA; Reeder-Hayes, KE; Troester, MA; Carey, LA; Wheeler, SB
MLA Citation
Roberts, MC, Weinberger, M, Dusetzina, SB, Dinan, MA, Reeder-Hayes, KE, Troester, MA, Carey, LA, and Wheeler, SB. "Racial variation in adjuvant chemotherapy initiation among breast cancer patients receiving oncotype DX testing." Breast cancer research and treatment 153.1 (August 2015): 191-200.
PMID
26216535
Source
epmc
Published In
Breast Cancer Research and Treatment
Volume
153
Issue
1
Publish Date
2015
Start Page
191
End Page
200
DOI
10.1007/s10549-015-3518-9

Presence and Number of Lymph Node Metastases Are Associated With Compromised Survival for Patients Younger Than Age 45 Years With Papillary Thyroid Cancer.

PURPOSE: Cervical lymph node metastases are recognized as a prognostic indicator only in patients age 45 years or older with papillary thyroid cancer (PTC); patients younger than age 45 years are perceived to have low-risk disease. The current American Joint Committee on Cancer staging for PTC in patients younger than age 45 years does not include cervical lymph node metastases. Our objective was to test the hypothesis that the presence and number of cervical lymph node metastases have an adverse impact on overall survival (OS) in patients younger than age 45 years with PTC. PATIENTS AND METHODS: Adult patients younger than age 45 years undergoing surgery for stage I PTC (no distant metastases) were identified from the National Cancer Data Base (NCDB; 1998-2006) and from SEER 1988-2006 data. Multivariable models were used to examine the association of OS with the presence of lymph node metastases and number of metastatic nodes. RESULTS: In all, 47,902 patients in NCDB (11,740 with and 36,162 without nodal metastases) and 21,855 in the SEER database (5,188 with and 16,667 without nodal metastases) were included. After adjustment, OS was compromised for patients with nodal metastases compared with patients who did not have them (NCDB: hazard ratio (HR), 1.32; 95% CI, 1.04 to 1.67; P = .021; SEER: HR, 1.29; 95% CI, 1.08 to 1.56; P = .006). After adjustment, increasing number of metastatic lymph nodes was associated with decreasing OS up to six metastatic nodes (HR, 1.12; 95% CI, 1.01 to 1.25; P = .03), after which more positive nodes conferred no additional mortality risk (HR, 0.99; 95% CI, 0.99 to 1.05; P = .75). CONCLUSION: Our results suggest that cervical lymph node metastases are associated with compromised survival in young patients, warranting consideration of revised American Joint Committee on Cancer staging. A change point of six or fewer metastatic lymph nodes seems to carry prognostic significance, thus advocating for rigorous preoperative screening for nodal metastases.

Authors
Adam, MA; Pura, J; Goffredo, P; Dinan, MA; Reed, SD; Scheri, RP; Hyslop, T; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Goffredo, P, Dinan, MA, Reed, SD, Scheri, RP, Hyslop, T, Roman, SA, and Sosa, JA. "Presence and Number of Lymph Node Metastases Are Associated With Compromised Survival for Patients Younger Than Age 45 Years With Papillary Thyroid Cancer." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 33.21 (July 2015): 2370-2375.
PMID
26077238
Source
epmc
Published In
Journal of Clinical Oncology
Volume
33
Issue
21
Publish Date
2015
Start Page
2370
End Page
2375
DOI
10.1200/jco.2014.59.8391

Initial Trends in the Use of the 21-Gene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009.

In 2006, the Centers for Medicare & Medicaid Services approved coverage for the use of the 21-gene recurrence score (RS) assay in women with early-stage, estrogen receptor-positive, node-negative breast cancers to help guide recommendations for adjuvant chemotherapy. Use of the assay in community settings has not been previously examined in a nationally representative sample of patients.To examine trends in the use of the RS assay in routine clinical practice in a nationally representative sample of women with breast cancer.Retrospective observational study of Medicare beneficiaries diagnosed with incident breast cancer between 2005 and 2009, as recorded in a Surveillance, Epidemiology, and End Results data set with linked Medicare claims through 2010.Demographic and clinical variables associated with the use of the assay.A total of 70,802 patients met the study criteria. Use of the RS assay increased from 1.1% in 2005 to 10.1% in 2009 (P < .001). The majority of tests (60.9%) occurred in patients with National Comprehensive Cancer Network-defined intermediate-risk disease (ie, estrogen receptor-positive, node-negative tumors >1 cm). Most patients with other than intermediate-risk disease had borderline indications for testing, including T1b (47.5%) or N1 (26.8%) disease. Testing was associated with younger age, fewer comorbid conditions, higher-grade disease, and being married. Among patients younger than 70 years with intermediate-risk disease, testing rates increased from 7.7% in 2005 to 38.8% in 2009 (P < .001). In multivariable analysis, testing was modestly higher in Northeast than in Western registries (odds ratio, 1.83; 95% CI, 1.49-2.26) but was otherwise not associated with region, local census tract demographic characteristics, black race, location in an urban area, or tumor histologic characteristics.The RS assay was adopted quickly in clinical practice after the Medicare coverage decision in 2006, and use appears to be consistent with guidelines and equitable across geographic and racial groups. Factors influencing adoption of the assay and its impact on adjuvant chemotherapy use in clinical practice remain important areas of study.

Authors
Dinan, MA; Mi, X; Reed, SD; Hirsch, BR; Lyman, GH; Curtis, LH
MLA Citation
Dinan, MA, Mi, X, Reed, SD, Hirsch, BR, Lyman, GH, and Curtis, LH. "Initial Trends in the Use of the 21-Gene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009." JAMA oncology 1.2 (May 2015): 158-166.
PMID
26181015
Source
epmc
Published In
JAMA oncology
Volume
1
Issue
2
Publish Date
2015
Start Page
158
End Page
166
DOI
10.1001/jamaoncol.2015.43

Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer.

Papillary thyroid cancer (PTC) is the most common endocrine malignancy. The long-term prognosis is generally excellent. Due to a paucity of data, debate exists regarding the benefit of adjuvant radioactive iodine therapy (RAI) for intermediate-risk patients.The objective of the study was to examine the impact of RAI on overall survival in intermediate-risk PTC patients.Adult patients with intermediate-risk PTC who underwent total thyroidectomy with/without RAI in the National Cancer Database, 1998-2006, participated in the study.Intermediate-risk patients, as defined by American Thyroid Association risk and American Joint Commission on Cancer disease stage T3, N0, M0 or Mx, and T1-3, N1, M0, or Mx were included in the study. Patients with aggressive variants and multiple primaries were excluded.Overall survival (OS) for patients treated with and without RAI using univariate and multivariate regression analyses was measured.A total of 21 870 patients were included; 15 418 (70.5%) received RAI and 6452 (29.5%) did not. Mean follow-up was 6 years, with the longest follow-up of 14 years. In an unadjusted analysis, RAI was associated with improved OS in all patients (P < .001) as well as in a subgroup analysis among patients younger than 45 years (n = 12 612, P = .002) and 65 years old and older (median OS 140 vs 128 mo, n = 2122, P = .008). After a multivariate adjustment for demographic and clinical factors, RAI was associated with a 29% reduction in the risk of death, with a hazard risk 0.71 (95% confidence interval 0.62-0.82, P < .001). For age younger than 45 years, RAI was associated with a 36% reduction in risk of death, with a hazard risk 0.64 (95% confidence interval 0.45- 0.92, P = .016).This is the first nationally representative study of intermediate-risk PTC patients and RAI therapy demonstrating an association of RAI with improved overall survival. We recommend that this patient group should be considered for RAI therapy.

Authors
Ruel, E; Thomas, S; Dinan, M; Perkins, JM; Roman, SA; Sosa, JA
MLA Citation
Ruel, E, Thomas, S, Dinan, M, Perkins, JM, Roman, SA, and Sosa, JA. "Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer." The Journal of Clinical Endocrinology and Metabolism 100.4 (April 2015): 1529-1536.
PMID
25642591
Source
epmc
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
100
Issue
4
Publish Date
2015
Start Page
1529
End Page
1536
DOI
10.1210/jc.2014-4332

Patterns of use and cost for inappropriate radioactive iodine treatment for thyroid cancer in the United States: use and misuse.

Authors
Goffredo, P; Thomas, SM; Dinan, MA; Perkins, JM; Roman, SA; Sosa, JA
MLA Citation
Goffredo, P, Thomas, SM, Dinan, MA, Perkins, JM, Roman, SA, and Sosa, JA. "Patterns of use and cost for inappropriate radioactive iodine treatment for thyroid cancer in the United States: use and misuse." JAMA internal medicine 175.4 (April 2015): 638-640.
PMID
25686394
Source
epmc
Published In
JAMA Internal Medicine
Volume
175
Issue
4
Publish Date
2015
Start Page
638
End Page
640
DOI
10.1001/jamainternmed.2014.8020

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

Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years.

Papillary thyroid cancer (PTC) patients <45 years old are considered to have an excellent prognosis; however, current guidelines recommend total thyroidectomy for PTC tumors >1.0 cm, regardless of age.Our objective was to examine the impact of extent of surgery on overall survival (OS) in patients <45 years old with stage I PTC of 1.1 to 4.0 cm.Adult patients <45 years of age undergoing surgery for stage I PTC were identified from the National Cancer Data Base (NCDB, 1998-2006) and the Surveillance, Epidemiology, and End RESULTS dataset (SEER, 1988-2006).Multivariable modeling was used to compare OS for patients undergoing total thyroidectomy vs lobectomy.In total, 29 522 patients in NCDB (3151 lobectomy, 26 371 total thyroidectomy) and 13 510 in SEER (1379 lobectomy, 12 131 total thyroidectomy) were included. Compared with patients undergoing lobectomy, patients having total thyroidectomy more often had extrathyroidal and lymph node disease. At 14 years, unadjusted OS was equivalent between total thyroidectomy and lobectomy in both databases. After adjustment, OS was similar for total thyroidectomy compared with lobectomy across all patients with tumors of 1.1 to 4.0 cm (NCDB: hazard ratio = 1.45 [confidence interval = 0.88-2.51], P = 0.19; SEER: 0.95 (0.70-1.29), P = 0.75) and when stratified by tumor size: 1.1 to 2.0 cm (NCDB: 1.12 [0.50-2.51], P = 0.78; SEER: 0.95 [0.56-1.62], P = 0.86) and 2.1 to 4.0 cm (NCDB: 1.93 [0.88-4.23], P = 0.10; SEER: 0.94 [0.60-1.49], P = 0.80).After adjusting for patient and clinical characteristics, total thyroidectomy compared with thyroid lobectomy was not associated with improved survival for patients <45 years of age with stage I PTC of 1.1 to 4.0 cm. Additional clinical and pathologic factors should be considered when choosing extent of resection.

Authors
Adam, MA; Pura, J; Goffredo, P; Dinan, MA; Hyslop, T; Reed, SD; Scheri, RP; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Goffredo, P, Dinan, MA, Hyslop, T, Reed, SD, Scheri, RP, Roman, SA, and Sosa, JA. "Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years." The Journal of Clinical Endocrinology and Metabolism 100.1 (January 2015): 115-121.
PMID
25337927
Source
epmc
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
100
Issue
1
Publish Date
2015
Start Page
115
End Page
121
DOI
10.1210/jc.2014-3039

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

Management of chemotherapy-induced neutropenia: measuring quality, cost, and value.

Treatment-associated neutropenia continues to represent the most common dose-limiting toxicity of cancer chemotherapy. It often leads to fever and infection, prompting hospitalization and occasionally resulting in serious morbidity, and even mortality, despite modern broad-spectrum antibiotic treatment and supportive care. Neutropenia and its complications may also lead to chemotherapy dose reductions, treatment delays, or early treatment termination, compromising disease control and the potential for cure. NCCN Clinical Practice Guidelines in Oncology recommend administration of primary prophylaxis with a myeloid growth factor in patients receiving regimens associated with a high risk for febrile neutropenia, and consideration of prophylaxis in patients receiving lower-risk regimens who have other risk factors that might place them at higher risk for febrile neutropenia. Although these agents have been shown to be effective and safe in numerous randomized controlled trials, they are expensive and contribute significantly to increasing health care costs. Regulatory agencies and guideline organizations do not currently address the issue of cost. However, with the relentless increase in health care use and current efforts to reform health care, it has become increasingly important to assess both the cost and the net benefit of interventions related to an episode of care in order to compare the overall value of therapeutic options. This article defines and discusses the intersection of quality, costs, and value in the context of prophylactic myeloid growth factor use in patients with cancer receiving myelosuppressive chemotherapy.

Authors
Dinan, MA; Hirsch, BR; Lyman, GH
MLA Citation
Dinan, MA, Hirsch, BR, and Lyman, GH. "Management of chemotherapy-induced neutropenia: measuring quality, cost, and value." Journal of the National Comprehensive Cancer Network : JNCCN 13.1 (January 2015): e1-e7. (Review)
PMID
25583775
Source
epmc
Published In
Journal of the National Comprehensive Cancer Network : JNCCN
Volume
13
Issue
1
Publish Date
2015
Start Page
e1
End Page
e7
DOI
10.6004/jnccn.2015.0014

Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years

© 2015 by the Endocrine Society.Context: Papillary thyroid cancer (PTC) patients <45 years old are considered to have an excellent prognosis; however, current guidelines recommend total thyroidectomy for PTC tumors 1.0 cm, regardless of age. Objective: Our objective was to examine the impact of extent of surgery on overall survival (OS) in patients <45 years old with stage I PTC of 1.1 to 4.0 cm. Design, Setting, and Patients: Adult patients <45 years of age undergoing surgery for stage I PTC were identified from the National Cancer Data Base (NCDB, 1998-2006) and the Surveillance, Epidemiology, and End Results dataset (SEER, 1988-2006). Main Outcome Measure: Multivariable modeling was used to compare OS for patients undergoing total thyroidectomy vs lobectomy. Results: In total, 29 522 patients in NCDB (3151 lobectomy, 26 371 total thyroidectomy) and 13 510 in SEER (1379 lobectomy, 12 131 total thyroidectomy) were included. Compared with patients undergoing lobectomy, patients having total thyroidectomy more often had extrathyroidal and lymph node disease. At 14 years, unadjusted OS was equivalent between total thyroidectomy and lobectomy in both databases. After adjustment, OS was similar for total thyroidectomy compared with lobectomy across all patients with tumors of 1.1 to 4.0 cm (NCDB: hazard ratio = 1.45 [confidence interval = 0.88-2.51], P = 0.19; SEER: 0.95 (0.70 -1.29), P = 0.75) and when stratified by tumor size: 1.1 to 2.0 cm (NCDB: 1.12 [0.50 -2.51], P=0.78; SEER: 0.95 [0.56 -1.62], P=0.86) and 2.1 to 4.0 cm (NCDB: 1.93 [0.88-4.23], P = 0.10; SEER: 0.94 [0.60 -1.49], P = 0.80). Conclusions: After adjusting for patient and clinical characteristics, total thyroidectomy compared with thyroid lobectomy was not associated with improved survival for patients <45 years of age with stage I PTC of 1.1 to 4.0 cm. Additional clinical and pathologic factors should be considered when choosing extent of resection.

Authors
Adam, MA; Pura, J; Goffredo, P; Dinan, MA; Hyslop, T; Reed, SD; Scheri, RP; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Goffredo, P, Dinan, MA, Hyslop, T, Reed, SD, Scheri, RP, Roman, SA, and Sosa, JA. "Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years." Journal of Clinical Endocrinology and Metabolism 100.1 (2015): 115-121.
Source
scival
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
100
Issue
1
Publish Date
2015
Start Page
115
End Page
121
DOI
10.1210/jc.20143039

Exploring variation in care: alternative conceptual models.

Authors
Dinan, MA; Schulman, KA
MLA Citation
Dinan, MA, and Schulman, KA. "Exploring variation in care: alternative conceptual models." Annals of internal medicine 161.11 (December 2014): 835-836.
PMID
25437412
Source
epmc
Published In
Annals of internal medicine
Volume
161
Issue
11
Publish Date
2014
Start Page
835
End Page
836
DOI
10.7326/m14-2382

Robotic thyroidectomy for cancer in the US: patterns of use and short-term outcomes.

We describe nationally representative patterns of utilization and short-term outcomes from robotic versus open thyroidectomy for thyroid cancer.Descriptive statistics and multivariable analysis were used to analyze patterns of use of robotic thyroidectomy from the National Cancer Database (2010-2011). Short-term outcomes were compared between patients undergoing robotic versus open thyroidectomy, while adjusting for confounders.A total of 68,393 patients with thyroid cancer underwent thyroidectomy; 225 had robotic surgery and 57,729 underwent open surgery. Robotic thyroid surgery use increased by 30 % from 2010 to 2011 (p = 0.08). Robotic cases were reported from 93 centers, with 89 centers performing <10 robotic cases. Compared with the open group, the robotic group was younger (51 vs. 47 years; p < 0.01) and included more Asian patients (4 vs. 8 %; p = 0.006) and privately-insured patients (68 vs. 77 %; p = 0.01). Tumor size was similar between patients undergoing robotic versus open surgery. Total thyroidectomy was performed less frequently in the robotic group (67 vs. 84 % open; p < 0.0001). Patients were relatively more likely to undergo robotic surgery if they were female (odds ratio [OR] 1.6; p = 0.04), younger (OR 0.8/10 years; p < 0.0001), or underwent lobectomy (OR 2.4; p < 0.0001). In adjusted multivariable analysis, there were no differences in the number of lymph nodes removed or length of stay between groups; however, there was a non-significant increase in the incidence of positive margins with robotic thyroidectomy.Use of robotic thyroidectomy for thyroid cancer is limited to a few institutions, with short-term outcomes that are comparable to open surgery. Multi-institutional studies should be undertaken to compare thyroidectomy-specific complications and long-term outcomes.

Authors
Adam, MA; Speicher, P; Pura, J; Dinan, MA; Reed, SD; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Speicher, P, Pura, J, Dinan, MA, Reed, SD, Roman, SA, and Sosa, JA. "Robotic thyroidectomy for cancer in the US: patterns of use and short-term outcomes." Annals of surgical oncology 21.12 (November 2014): 3859-3864.
PMID
24934584
Source
epmc
Published In
Annals of Surgical Oncology
Volume
21
Issue
12
Publish Date
2014
Start Page
3859
End Page
3864
DOI
10.1245/s10434-014-3838-8

Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States.

Nonfunctional pancreatic neuroendocrine tumors (PNETs) ≤2 cm have uncertain malignant potential, and optimal treatment remains unclear. Objectives of this study were to better understand their malignant potential, determine whether extent of surgery or lymph node dissection is associated with overall survival (OS), and identify other factors associated with OS.Patients with nonfunctional PNETs ≤2 cm were identified from the National Cancer Data Base (1998 to 2011). Descriptive statistics were used for patient characteristics and surgical resection patterns. Five-year OS was estimated using Kaplan-Meier analyses across extent of surgery and compared using the log-rank test. Cox proportional regression modeling was used to test the association between survival and extent of surgery.A total of 1854 patients with nonfunctional PNETs ≤2 cm were included. From 1998 to 2011, these tumors increased three-fold as a proportion of all PNETs. Among tumors ≤0.5 cm, 33 % presented with regional lymph node metastases and 11 % with distant metastases. Five-year OS for patients not undergoing surgery was 27.6 % vs. 83.0 % for partial pancreatectomy, 72.3 % for pancreaticoduodenectomy, and 86.0 % for total pancreatectomy (p < 0.01). Multivariate analysis demonstrated no difference in OS based on type of surgery or the addition of regional lymphadenectomy (p = 0.16). Younger age and later year of diagnosis were independently associated with improved survival.Small nonfunctional PNETs represent an increasing proportion of all PNETs and have a significant risk of malignancy. Survival is improving over time despite older age at diagnosis. Type of surgical resection and the addition of lymph node resection were not associated with OS.

Authors
Gratian, L; Pura, J; Dinan, M; Roman, S; Reed, S; Sosa, JA
MLA Citation
Gratian, L, Pura, J, Dinan, M, Roman, S, Reed, S, and Sosa, JA. "Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States." Annals of surgical oncology 21.11 (October 2014): 3515-3521.
PMID
24841347
Source
epmc
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3515
End Page
3521
DOI
10.1245/s10434-014-3769-4

Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States.

Adrenocortical carcinoma (ACC) is a rare, aggressive disease with no apparent change in treatment or survival in the United States over the past two decades. Our objective was to determine whether treatment patterns or clinical outcomes vary by hospital case volume.Patients with ACC were identified from the National Cancer Database (1998-2011). High-volume centers (HVCs) were defined by a case load of ≥4 cases of primary adrenal malignancy annually, which corresponded to the 90th percentile. All other facilities were considered low-volume centers (LVCs).A total of 2,765 ACC patients were treated across 1,046 facilities. Compared to patients treated at LVCs, patients treated at HVCs were younger (50 vs. 54 years), with larger tumors (11.2 vs. 10.5 cm), and underwent higher rates of surgery (78.8 vs. 73.4 %), radical resection (17.3 vs. 13.9 %), regional lymph node evaluation (23.2 vs. 18.8 %), and chemotherapy including mitotane (43.8 vs. 31.0 %, all p < 0.05).There were no significant differences in median length of stay (5 vs. 5 days), 30-day readmission rates (4.0 % for HVCs vs. 3.9 % for LVCs), or 30-day postoperative mortality rates (1.9 % for HVCs vs. 3.7 % for LVCs). Median overall survival was 2.0 years for HVCs and 1.9 years for LVCs, p = 0.53. After adjusting for patient and tumor characteristics, overall survival did not differ significantly between patients treated at HVCs versus LVCs [HR = 0.89 (95 % confidence interval 0.70, 1.12)].Treatment at HVCs was associated with more aggressive surgical resection and chemotherapy use. Prognosis remained poor despite more aggressive treatment.

Authors
Gratian, L; Pura, J; Dinan, M; Reed, S; Scheri, R; Roman, S; Sosa, JA
MLA Citation
Gratian, L, Pura, J, Dinan, M, Reed, S, Scheri, R, Roman, S, and Sosa, JA. "Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States." Annals of surgical oncology 21.11 (October 2014): 3509-3514.
PMID
25069860
Source
epmc
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3509
End Page
3514
DOI
10.1245/s10434-014-3931-z

Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients.

To examine the association between the extent of surgery and overall survival in a large contemporary cohort of patients with papillary thyroid cancer (PTC).Guidelines recommend total thyroidectomy for PTC tumors >1 cm, based on older data demonstrating an overall survival advantage for total thyroidectomy over lobectomy.Adult patients with PTC tumors 1.0-4.0 cm undergoing thyroidectomy in the National Cancer Database, 1998-2006, were included. Cox proportional hazards models were applied to measure the association between the extent of surgery and overall survival while adjusting for patient demographic and clinical factors, including comorbidities, extrathyroidal extension, multifocality, nodal and distant metastases, and radioactive iodine treatment.Among 61,775 PTC patients, 54,926 underwent total thyroidectomy and 6849 lobectomy. Compared with lobectomy, patients undergoing total thyroidectomy had more nodal (7% vs 27%), extrathyroidal (5% vs 16%), and multifocal disease (29% vs 44%) (all Ps < 0.001). Median follow-up was 82 months (range, 60-179 months). After multivariable adjustment, overall survival was similar in patients undergoing total thyroidectomy versus lobectomy for tumors 1.0-4.0 cm [hazard ratio (HR) = 0.96; 95% confidence interval (CI), 0.84-1.09); P = 0.54] and when stratified by tumor size: 1.0-2.0 cm [HR = 1.05; 95% CI, 0.88-1.26; P = 0.61] and 2.1-4.0 cm [HR = 0.89; 95% CI, 0.73-1.07; P = 0.21]. Older age, male sex, black race, lower income, tumor size, and presence of nodal or distant metastases were independently associated with compromised survival (P < 0.0001).Current guidelines suggest total thyroidectomy for PTC tumors >1 cm. However, we did not observe a survival advantage associated with total thyroidectomy compared with lobectomy. These findings call into question whether tumor size should be an absolute indication for total thyroidectomy.

Authors
Adam, MA; Pura, J; Gu, L; Dinan, MA; Tyler, DS; Reed, SD; Scheri, R; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Gu, L, Dinan, MA, Tyler, DS, Reed, SD, Scheri, R, Roman, SA, and Sosa, JA. "Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients." Annals of surgery 260.4 (October 2014): 601-605.
PMID
25203876
Source
epmc
Published In
Annals of Surgery
Volume
260
Issue
4
Publish Date
2014
Start Page
601
End Page
605
DOI
10.1097/sla.0000000000000925

Redistribution of health care costs after the adoption of positron emission tomography among medicare beneficiaries with non-small-cell lung cancer, 1998-2005.

INTRODUCTION: Treatment patterns and cost implications of increased positron emission tomography imaging use since Medicare approval in 1998 are not well understood. We examined rates of surgery, radiotherapy, and chemotherapy and inpatient and total health care costs between 1998 and 2005 among Medicare beneficiaries with non-small-cell lung cancer. METHODS: Patients in this retrospective cohort study were 51,374 Medicare beneficiaries diagnosed with non-small-cell lung cancer between 1996 and 2005. The main outcome measures were receipt of surgical resection, radiotherapy, and chemotherapy and inpatient and total health care costs within 1 year of diagnosis. RESULTS: Between 1996-1997 and 2004-2005, the proportion of patients undergoing surgical resection decreased from 29% to 25%, the proportion receiving radiation therapy decreased from 49% to 43%, and inpatient costs decreased from $28,900 to $26,900. The proportion of patients receiving chemotherapy increased from 25% to 40% and total costs increased from $47,300 to $52,200 (p < 0.001 for all comparisons). Changes in use and costs remained after adjustment for shifting demographic characteristics during the study period. CONCLUSIONS: Adoption of positron emission tomography between 1998 and 2005 was accompanied by decreases in rates of surgery and radiotherapy and in short-term inpatient costs among Medicare beneficiaries with non-small-cell lung cancer, although there was an increase in chemotherapy and overall costs.

Authors
Dinan, MA; Curtis, LH; Carpenter, WR; Biddle, AK; Abernethy, AP; Patz, EF; Schulman, KA; Weinberger, M
MLA Citation
Dinan, MA, Curtis, LH, Carpenter, WR, Biddle, AK, Abernethy, AP, Patz, EF, Schulman, KA, and Weinberger, M. "Redistribution of health care costs after the adoption of positron emission tomography among medicare beneficiaries with non-small-cell lung cancer, 1998-2005." Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 9.4 (April 2014): 512-518.
PMID
24736074
Source
epmc
Published In
Journal of Thoracic Oncology
Volume
9
Issue
4
Publish Date
2014
Start Page
512
End Page
518
DOI
10.1097/jto.0000000000000102

Robotic Thyroidectomy for Cancer in the US: Patterns of Use and Short-Term Outcomes

© 2014, Society of Surgical Oncology. Background: We describe nationally representative patterns of utilization and short-term outcomes from robotic versus open thyroidectomy for thyroid cancer. Methods: Descriptive statistics and multivariable analysis were used to analyze patterns of use of robotic thyroidectomy from the National Cancer Database (2010–2011). Short-term outcomes were compared between patients undergoing robotic versus open thyroidectomy, while adjusting for confounders. Results: A total of 68,393 patients with thyroid cancer underwent thyroidectomy; 225 had robotic surgery and 57,729 underwent open surgery. Robotic thyroid surgery use increased by 30 % from 2010 to 2011 (p = 0.08). Robotic cases were reported from 93 centers, with 89 centers performing < 10 robotic cases. Compared with the open group, the robotic group was younger (51 vs. 47 years; p  <  0.01) and included more Asian patients (4 vs. 8 %; p = 0.006) and privately-insured patients (68 vs. 77 %; p = 0.01). Tumor size was similar between patients undergoing robotic versus open surgery. Total thyroidectomy was performed less frequently in the robotic group (67 vs. 84 % open; p  <  0.0001). Patients were relatively more likely to undergo robotic surgery if they were female (odds ratio [OR] 1.6; p = 0.04), younger (OR 0.8/10 years; p  <  0.0001), or underwent lobectomy (OR 2.4; p  <  0.0001). In adjusted multivariable analysis, there were no differences in the number of lymph nodes removed or length of stay between groups; however, there was a non-significant increase in the incidence of positive margins with robotic thyroidectomy. Conclusions: Use of robotic thyroidectomy for thyroid cancer is limited to a few institutions, with short-term outcomes that are comparable to open surgery. Multi-institutional studies should be undertaken to compare thyroidectomy-specific complications and long-term outcomes.

Authors
Abdelgadir Adam, M; Speicher, P; Pura, J; Dinan, MA; Reed, SD; Roman, SA; Sosa, JA
MLA Citation
Abdelgadir Adam, M, Speicher, P, Pura, J, Dinan, MA, Reed, SD, Roman, SA, and Sosa, JA. "Robotic Thyroidectomy for Cancer in the US: Patterns of Use and Short-Term Outcomes." Annals of Surgical Oncology 21.12 (January 1, 2014): 3859-3864.
Source
scopus
Published In
Annals of Surgical Oncology
Volume
21
Issue
12
Publish Date
2014
Start Page
3859
End Page
3864
DOI
10.1245/s10434-014-3838-8

Diagnosis change in voice-disordered patients evaluated by primary care and/or otolaryngology: a longitudinal study.

OBJECTIVE: Accurate diagnosis of a voice disorder is an essential first step toward its appropriate treatment. We examined differences in laryngeal diagnosis over time in outpatients evaluated by primary care physicians (PCPs) and/or otolaryngologists. STUDY DESIGN AND SETTING: Retrospective analysis of data from a large, national administrative US claims database. SUBJECTS AND METHODS: Patients with laryngeal disorders based on International Classification of Diseases, Ninth Revision, Clinical Modification codes from January 1, 2004, to December 31, 2008, with at least 2 outpatient visits by a PCP and/or otolaryngologist and continuously enrolled for 12 months were included. The initial and final laryngeal diagnoses were tabulated. RESULTS: Of approximately 55 million individuals, 29,501 met inclusion criteria. More than half the patients in the PCP to otolaryngology group and one-third of the otolaryngology to otolaryngology group had different laryngeal diagnoses over time. Three-fourths of patients with an initial acute laryngitis diagnosis in the PCP to otolaryngology group and half of the otolaryngology to otolaryngology group had a different final laryngeal diagnosis. Of patients with a final laryngeal cancer diagnosis, one-fourth of the otolaryngology to otolaryngology group had an initial diagnosis of nonspecific dysphonia, and one-fifth of the PCP to otolaryngology group had an initial diagnosis of acute laryngitis. CONCLUSION: Differential diagnosis of voice disorders often evolves over time. The impact on treatment and health care utilization are important areas of future study.

Authors
Cohen, SM; Dinan, MA; Roy, N; Kim, J; Courey, M
MLA Citation
Cohen, SM, Dinan, MA, Roy, N, Kim, J, and Courey, M. "Diagnosis change in voice-disordered patients evaluated by primary care and/or otolaryngology: a longitudinal study." Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery 150.1 (January 2014): 95-102.
PMID
24264568
Source
epmc
Published In
Otolaryngology - Head and Neck Surgery
Volume
150
Issue
1
Publish Date
2014
Start Page
95
End Page
102
DOI
10.1177/0194599813512982

Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States

BACKGROUND: Nonfunctional pancreatic neuroendocrine tumors (PNETs) ≤2 cm have uncertain malignant potential, and optimal treatment remains unclear. Objectives of this study were to better understand their malignant potential, determine whether extent of surgery or lymph node dissection is associated with overall survival (OS), and identify other factors associated with OS.METHODS: Patients with nonfunctional PNETs ≤2 cm were identified from the National Cancer Data Base (1998 to 2011). Descriptive statistics were used for patient characteristics and surgical resection patterns. Five-year OS was estimated using Kaplan-Meier analyses across extent of surgery and compared using the log-rank test. Cox proportional regression modeling was used to test the association between survival and extent of surgery.RESULTS: A total of 1854 patients with nonfunctional PNETs ≤2 cm were included. From 1998 to 2011, these tumors increased three-fold as a proportion of all PNETs. Among tumors ≤0.5 cm, 33 % presented with regional lymph node metastases and 11 % with distant metastases. Five-year OS for patients not undergoing surgery was 27.6 % vs. 83.0 % for partial pancreatectomy, 72.3 % for pancreaticoduodenectomy, and 86.0 % for total pancreatectomy (p < 0.01). Multivariate analysis demonstrated no difference in OS based on type of surgery or the addition of regional lymphadenectomy (p = 0.16). Younger age and later year of diagnosis were independently associated with improved survival.CONCLUSIONS: Small nonfunctional PNETs represent an increasing proportion of all PNETs and have a significant risk of malignancy. Survival is improving over time despite older age at diagnosis. Type of surgical resection and the addition of lymph node resection were not associated with OS.

Authors
Gratian, L; Pura, J; Dinan, M; Roman, S; Reed, S; Sosa, JAN
MLA Citation
Gratian, L, Pura, J, Dinan, M, Roman, S, Reed, S, and Sosa, JAN. "Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States." Annals of surgical oncology 21.11 (2014): 3515-3521.
Source
scival
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3515
End Page
3521
DOI
10.1245/s10434-014-3769-4

Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States

BACKGROUND: Adrenocortical carcinoma (ACC) is a rare, aggressive disease with no apparent change in treatment or survival in the United States over the past two decades. Our objective was to determine whether treatment patterns or clinical outcomes vary by hospital case volume.METHODS: Patients with ACC were identified from the National Cancer Database (1998-2011). High-volume centers (HVCs) were defined by a case load of ≥4 cases of primary adrenal malignancy annually, which corresponded to the 90th percentile. All other facilities were considered low-volume centers (LVCs).RESULTS: A total of 2,765 ACC patients were treated across 1,046 facilities. Compared to patients treated at LVCs, patients treated at HVCs were younger (50 vs. 54 years), with larger tumors (11.2 vs. 10.5 cm), and underwent higher rates of surgery (78.8 vs. 73.4 %), radical resection (17.3 vs. 13.9 %), regional lymph node evaluation (23.2 vs. 18.8 %), and chemotherapy including mitotane (43.8 vs. 31.0 %, all p < 0.05).There were no significant differences in median length of stay (5 vs. 5 days), 30-day readmission rates (4.0 % for HVCs vs. 3.9 % for LVCs), or 30-day postoperative mortality rates (1.9 % for HVCs vs. 3.7 % for LVCs). Median overall survival was 2.0 years for HVCs and 1.9 years for LVCs, p = 0.53. After adjusting for patient and tumor characteristics, overall survival did not differ significantly between patients treated at HVCs versus LVCs [HR = 0.89 (95 % confidence interval 0.70, 1.12)].CONCLUSIONS: Treatment at HVCs was associated with more aggressive surgical resection and chemotherapy use. Prognosis remained poor despite more aggressive treatment.

Authors
Gratian, L; Pura, J; Dinan, M; Reed, S; Scheri, R; Roman, S; Sosa, JAN
MLA Citation
Gratian, L, Pura, J, Dinan, M, Reed, S, Scheri, R, Roman, S, and Sosa, JAN. "Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States." Annals of surgical oncology 21.11 (2014): 3509-3514.
Source
scival
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3509
End Page
3514
DOI
10.1245/s10434-014-3931-z

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 epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 22.11 (November 2013): 1931-1943. (Review)
PMID
24014598
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
22
Issue
11
Publish Date
2013
Start Page
1931
End Page
1943
DOI
10.1158/1055-9965.epi-13-0298

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." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 31.33 (November 2013): 4188-4198. (Review)
PMID
24145348
Source
epmc
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

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." Obstetrics and gynecology 122.2 Pt 1 (August 2013): 380-389. (Review)
PMID
23969809
Source
epmc
Published In
Obstetrics & Gynecology (Elsevier)
Volume
122
Issue
2 Pt 1
Publish Date
2013
Start Page
380
End Page
389
DOI
10.1097/aog.0b013e3182994c43

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." Obstetrics and gynecology 122.1 (July 2013): 139-147. (Review)
PMID
23743450
Source
epmc
Published In
Obstetrics & Gynecology (Elsevier)
Volume
122
Issue
1
Publish Date
2013
Start Page
139
End Page
147
DOI
10.1097/aog.0b013e318291c235

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. (Review)
PMID
24423062
Source
epmc
Published In
Evidence report/technology assessment
Issue
212
Publish Date
2013
Start Page
1
End Page
514

Variations in use of PET among Medicare beneficiaries with non-small cell lung cancer, 1998-2007.

PURPOSE: To explore demographic and regional factors associated with the use of positron emission tomography (PET) in patients with non-small cell lung cancer (NSCLC) and to determine whether their associations with PET use has changed over time. MATERIALS AND METHODS: The Office of Human Research Ethics at the University of North Carolina and the institutional review board of the Duke University Health System approved (with waiver of informed consent) this retrospective analysis of Surveillance Epidemiology and End Results Medicare data for Medicare beneficiaries given a diagnosis of NSCLC between 1998 and 2007. The primary outcome was change in the number of PET examinations 2 months before to 4 months after diagnosis, examined according to year and sociodemographic subgroup. PET use was compared between demographic and geographic subgroups and between early (1998-2000) and late (2005-2007) cohorts by using χ(2) tests. Factors associated with use of PET during the study period were further examined by using logit and linear probability multivariable regression analyses. RESULTS: The final cohort included 46 544 patients with 46 935 cases of NSCLC. By 2005, more than half of patients underwent one or more PET examinations, regardless of demographic subgroup. In multivariable logistic regression analysis, patients who underwent PET were more likely to be married, nonblack, and younger than 80 years and to live in census tracts with higher education levels or in the Northeast (P < .001 for all). Living within 40 miles of a PET facility was initially associated with undergoing PET (P < .001), but this association disappeared by 2007. Imaging rates increased more rapidly in patients who were nonblack (P ≤ .01), patients who were younger than 81 years (P < .001), and patients who lived in the Northeast and South (P < .001). CONCLUSION: PET imaging among Medicare beneficiaries with NSCLC was initially concentrated among nonblack patients younger than 81 years. Despite widespread adoption among all subgroups, differences within demographic subgroups remained.

Authors
Dinan, MA; Curtis, LH; Carpenter, WR; Biddle, AK; Abernethy, AP; Patz, EF; Schulman, KA; Weinberger, M
MLA Citation
Dinan, MA, Curtis, LH, Carpenter, WR, Biddle, AK, Abernethy, AP, Patz, EF, Schulman, KA, and Weinberger, M. "Variations in use of PET among Medicare beneficiaries with non-small cell lung cancer, 1998-2007." Radiology 267.3 (June 2013): 807-817.
PMID
23418003
Source
epmc
Published In
Radiology
Volume
267
Issue
3
Publish Date
2013
Start Page
807
End Page
817
DOI
10.1148/radiol.12120174

Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer.

PURPOSE: New evidence is available regarding the utility of the 21-gene recurrence score assay in guiding chemotherapy use for node-negative, estrogen receptor-positive breast cancer. We applied this evidence in a decision-analytic model to re-evaluate the cost-effectiveness of the assay. METHODS: We cross-classified patients by clinicopathologic characteristics from the Adjuvant! risk index and by recurrence score risk group. For non-recurrence score-guided treatment, we assumed patients receiving hormonal therapy alone had low-risk characteristics and patients receiving chemotherapy and hormonal therapy had higher-risk characteristics. For recurrence score-guided treatment, we assigned chemotherapy probabilities conditional on recurrence score risk group and clinicopathologic characteristics. RESULTS: An estimated 40.4% of patients in the recurrence score-guided strategy and 47.3% in the non-recurrence score-guided strategy were expected to receive chemotherapy. The incremental gain in quality-adjusted life-years was 0.16 (95% confidence interval, 0.08-0.28) with the recurrence score-guided strategy. Lifetime medical costs to the health system were $2,692 ($1,546-$3,821) higher with the recurrence score-guided strategy, for an incremental cost-effectiveness ratio of $16,677/quality-adjusted life-year ($7,613-$37,219). From a societal perspective, the incremental cost-effectiveness was $10,788/quality-adjusted life-year ($6,840-$30,265). CONCLUSION: The findings provide supportive evidence for the economic value of the 21-gene recurrence score assay in node-negative, estrogen receptor-positive breast cancer.

Authors
Reed, SD; Dinan, MA; Schulman, KA; Lyman, GH
MLA Citation
Reed, SD, Dinan, MA, Schulman, KA, and Lyman, GH. "Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer." Genet Med 15.3 (March 2013): 203-211.
PMID
22975761
Source
pubmed
Published In
Genetics in Medicine
Volume
15
Issue
3
Publish Date
2013
Start Page
203
End Page
211
DOI
10.1038/gim.2012.119

Reply to M.S. Hofman et al.

Authors
Dinan, MA; Carpenter, WR; Patz, EF; Abernethy, AP; Biddle, AK; Schulman, KA; Curtis, LH
MLA Citation
Dinan, MA, Carpenter, WR, Patz, EF, Abernethy, AP, Biddle, AK, Schulman, KA, and Curtis, LH. "Reply to M.S. Hofman et al." J Clin Oncol 31.6 (February 20, 2013): 820-. (Letter)
PMID
23544205
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
31
Issue
6
Publish Date
2013
Start Page
820
DOI
10.1200/JCO.2012.46.7373

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

Stage migration, selection bias, and survival associated with the adoption of positron emission tomography among medicare beneficiaries with non-small-cell lung cancer, 1998-2003.

PURPOSE: Previous studies have linked the use of positron emission tomography (PET) with improved outcomes among patients with non-small-cell lung cancer (NSCLC). However, this association may be confounded by PET-induced stage migration and selection bias. We examined the association between PET use and overall survival among Medicare beneficiaries with NSCLC. PATIENTS AND METHODS: Retrospective analysis of Surveillance, Epidemiology, and End Results (SEER) -Medicare data was used to characterize changes in overall survival, stage-specific survival, and stage distribution among Medicare beneficiaries with NSCLC between 1998 and 2003. RESULTS: A total of 97,007 patients with NSCLC diagnosed between 1998 and 2003 met the study criteria. Two-year and 4-year survival remained unchanged, despite widespread adoption of PET. The proportion of patients staged with advanced disease increased from 44% to 50%. Upstaging of disease was accompanied by stage-specific improved survival, with 2-year survival of stage IV disease increasing from 8% to 11% between 1998 and 2003. PET was more likely to be administered to patients with less advanced disease (stages I through IIIA) and greater overall survival. CONCLUSION: Overall survival among Medicare beneficiaries with NSCLC was unchanged between 1998 and 2003, despite widespread adoption of PET. The association between PET use and increased survival likely reflects an artifact of selection bias and consequent stage migration.

Authors
Dinan, MA; Curtis, LH; Carpenter, WR; Biddle, AK; Abernethy, AP; Patz, EF; Schulman, KA; Weinberger, M
MLA Citation
Dinan, MA, Curtis, LH, Carpenter, WR, Biddle, AK, Abernethy, AP, Patz, EF, Schulman, KA, and Weinberger, M. "Stage migration, selection bias, and survival associated with the adoption of positron emission tomography among medicare beneficiaries with non-small-cell lung cancer, 1998-2003." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 30.22 (August 2012): 2725-2730.
PMID
22753917
Source
epmc
Published In
Journal of Clinical Oncology
Volume
30
Issue
22
Publish Date
2012
Start Page
2725
End Page
2730
DOI
10.1200/jco.2011.40.4392

Changes in initial treatment for prostate cancer among Medicare beneficiaries, 1999-2007.

In the absence of evidence from large clinical trials, optimal therapy for localized prostate cancer remains unclear; however, treatment patterns continue to change. We examined changes in the management of patients with prostate cancer in the Medicare population.We conducted a retrospective claims-based analysis of the use of radiation therapy, surgery, and androgen deprivation therapy in the 12 months after diagnosis of prostate cancer in a nationally representative 5% sample of Medicare claims. Patients were Medicare beneficiaries 67 years or older with incident prostate cancer diagnosed between 1999 and 2007.There were 20,918 incident cases of prostate cancer between 1999 and 2007. The proportion of patients receiving androgen deprivation therapy decreased from 55% to 36%, and the proportion of patients receiving no active therapy increased from 16% to 23%. Intensity-modulated radiation therapy replaced three-dimensional conformal radiation therapy as the most common method of radiation therapy, accounting for 77% of external beam radiotherapy by 2007. Minimally invasive radical prostatectomy began to replace open surgical approaches, being used in 49% of radical prostatectomies by 2007.Between 2002 and 2007, the use of androgen deprivation therapy decreased, open surgical approaches were largely replaced by minimally invasive radical prostatectomy, and intensity-modulated radiation therapy replaced three-dimensional conformal radiation therapy as the predominant method of radiation therapy in the Medicare population. The aging of the population and the increasing use of newer, higher-cost technologies in the treatment of patients with prostate cancer may have important implications for nationwide health care costs.

Authors
Dinan, MA; Robinson, TJ; Zagar, TM; Scales, CD; Curtis, LH; Reed, SD; Lee, WR; Schulman, KA
MLA Citation
Dinan, MA, Robinson, TJ, Zagar, TM, Scales, CD, Curtis, LH, Reed, SD, Lee, WR, and Schulman, KA. "Changes in initial treatment for prostate cancer among Medicare beneficiaries, 1999-2007." International journal of radiation oncology, biology, physics 82.5 (April 2012): e781-e786.
PMID
22331001
Source
epmc
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
82
Issue
5
Publish Date
2012
Start Page
e781
End Page
e786
DOI
10.1016/j.ijrobp.2011.11.024

Resource use, costs, and utility estimates for patients with cystic fibrosis with mild impairment in lung function: analysis of data collected alongside a 48-week multicenter clinical trial.

OBJECTIVES: Transport of ions to generate epithelial rehydration (TIGER)-1 was a randomized trial conducted to evaluate the safety and efficacy of denufosol versus placebo in patients with cystic fibrosis with mild impairment in lung function. The trial met its primary end point at 24 weeks, but a subsequent trial did not show a sustained effect of denufosol at 48 weeks. By using the 48-week data, we characterized resource use, direct medical costs, indirect costs, and utility estimates. METHODS: Data on medications, outpatient and emergency visits, hospital admissions, tests, procedures, and home nursing were captured on study case report forms. Sources for unit costs included the Medicare Physician Fee Schedule, the Nationwide Inpatient Sample, and the Red Book. Health utilities were derived from the Health Utilities Index Mark 2/3. We used multivariable regression to evaluate the impact of baseline covariates on costs. RESULTS: Characteristics of the 352 participants at enrollment included mean age of 14.6 years, history of Pseudomonas aeruginosa colonization in 45.2%, use of dornase alfa in 77.0%, and long-term use of inhaled antibiotics in 37.2%. Over 48 weeks, 22.4% of participants were hospitalized and, on average, participants missed 7.4 days of school or work. Mean total costs (excluding denufosol) were $39,673 (SD $26,842), of which 85% were attributable to medications. Female sex and P. aeruginosa colonization were independently associated with higher costs. CONCLUSIONS: Prospective economic data collection alongside a clinical trial allows for robust estimates of cost of illness. The mean annual cost of care for patients with cystic fibrosis with mild impairment in lung function exceeds $43,000 and is driven by medication costs.

Authors
Dewitt, EM; Grussemeyer, CA; Friedman, JY; Dinan, MA; Lin, L; Schulman, KA; Reed, SD
MLA Citation
Dewitt, EM, Grussemeyer, CA, Friedman, JY, Dinan, MA, Lin, L, Schulman, KA, and Reed, SD. "Resource use, costs, and utility estimates for patients with cystic fibrosis with mild impairment in lung function: analysis of data collected alongside a 48-week multicenter clinical trial." Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 15.2 (March 2012): 277-283.
PMID
22433759
Source
epmc
Published In
Value in Health
Volume
15
Issue
2
Publish Date
2012
Start Page
277
End Page
283
DOI
10.1016/j.jval.2011.11.027

Erratum: Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement

MLA Citation
"Erratum: Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement." American Journal of Hematology 86.10 (October 2011): 903-905.
Source
crossref
Published In
American Journal of Hematology
Volume
86
Issue
10
Publish Date
2011
Start Page
903
End Page
905
DOI
10.1002/ajh.22121

Erratum: Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures

MLA Citation
"Erratum: Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures." American Journal of Hematology 86.10 (October 2011): 906-908.
Source
crossref
Published In
American Journal of Hematology
Volume
86
Issue
10
Publish Date
2011
Start Page
906
End Page
908
DOI
10.1002/ajh.22120

Financial implications of changes in the initial treatment of prostate cancer among Medicare beneficiaries.

6115 Background: The traditional treament approaches for localized prostate cancer have included androgen suppression, watchful waiting, open radical prostatectomy, external beam radiation therapy and interstitial brachytherapy. In the last decade a number of novel treatment options have been developed including minimally invasive radical prostatectomy (MIRP) and intensity-modulated radiation therapy (IMRT).In this study, we examined changes in the treatment of Medicare beneficiaries diagnosed with incident prostate cancer between 1999 and 2007. The primary outcome was utiliziation of radiation, surgery, or androgen suppression therapy in the first 12 months following newly diagnosed prostate cancer by year of incidence.The study sample included 20 399 cases of incident prostate cancer identified between 1999 and 2007. Overall rates of surgery and radiotherapy within the first 12 months of diagnosis remained unchanged across the study period, however the proportion of beneficiaries receiving androgen suppression monotherapy decreased by half, with watchful waiting increasing from 16% to 23% of all beneficiaries. From 2002 to 2007, IMRT replaced 3-D conformal treatment as the most common method of prostate radiotherapy, and was used in two-thirds of all Medicare prostate cancer patients receiving any radiotherapy by 2007. During this same period, minimally invasive radical prostatectomy began to replace open surgical approaches, and was used in half of all radical prostatectomies by 2007.By 2007 IMRT had replaced 3D conformal radiotherapy (3D-CRT) as the predominant method of radiotherapy used in the Medicare prostate cancer population. With Medicare reimbursement for IMRT averaging $48,000 per beneficiary vs $22,000 for 3D-CRT, this trend has significant budgetary implications. The aging of the US population over the next decade will cause the number of men with newly diagnosed prostate cancer to climb. When combined with growth in the use of newer high-cost technologies, Medicare spending for prostate cancer will further accelerate.

Authors
Dinan, MA; Robinson, TJ; Zagar, TM; Scales, CD; Curtis, LH; Reed, SD; Schulman, KA; Lee, WR
MLA Citation
Dinan, MA, Robinson, TJ, Zagar, TM, Scales, CD, Curtis, LH, Reed, SD, Schulman, KA, and Lee, WR. "Financial implications of changes in the initial treatment of prostate cancer among Medicare beneficiaries." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 29.15_suppl (May 2011): 6115-.
PMID
28022527
Source
epmc
Published In
Journal of Clinical Oncology
Volume
29
Issue
15_suppl
Publish Date
2011
Start Page
6115

Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials.

To optimize the use of patient-reported outcomes (PROs) in clinical research, it is first necessary to review the current use of these outcomes in clinical trials to determine under what circumstances they are most useful, and to reveal current limitations.To investigate current patterns of use of PROs in clinical trials.We conducted a systematic literature review of all double-blind, placebo-controlled, randomized clinical trials using one or more PROs as a study outcome from 2004 to 2006. Data were abstracted and analyzed with descriptive statistics and logistic regression to characterize the use of PROs in clinical trials.The 180 clinical trials that met the study inclusion criteria used 173 unique instruments to measure a total of 466 PROs. Most PRO measurements were obtained using relatively few PRO instruments, with one-third of PRO instruments applied in more than 1 trial. In multivariable analysis, tests of statistical significance were more often reported for PROs used as primary trial outcomes. Statistically significant PRO outcomes (P<0.05) were more likely among disease-specific PROs compared with general PROs, PROs with a discussion of minimally important difference, and larger trials.PRO instruments may be improved through efforts to provide centralized electronic administration, cross-validation, and standardized interpretation of clinically relevant outcomes. The majority of PROs used in current clinical trials come from relatively few, commonly used disease-specific PRO instruments within major therapeutic areas.

Authors
Dinan, MA; Compton, KL; Dhillon, JK; Hammill, BG; Dewitt, EM; Weinfurt, KP; Schulman, KA
MLA Citation
Dinan, MA, Compton, KL, Dhillon, JK, Hammill, BG, Dewitt, EM, Weinfurt, KP, and Schulman, KA. "Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials." Medical care 49.4 (April 2011): 415-419. (Review)
PMID
21368680
Source
epmc
Published In
Medical Care
Volume
49
Issue
4
Publish Date
2011
Start Page
415
End Page
419
DOI
10.1097/mlr.0b013e3182064aa2

Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials

BACKGROUND: To optimize the use of patient-reported outcomes (PROs) in clinical research, it is first necessary to review the current use of these outcomes in clinical trials to determine under what circumstances they are most useful, and to reveal current limitations. PURPOSE: To investigate current patterns of use of PROs in clinical trials. RESEARCH DESIGN: We conducted a systematic literature review of all double-blind, placebo-controlled, randomized clinical trials using one or more PROs as a study outcome from 2004 to 2006. Data were abstracted and analyzed with descriptive statistics and logistic regression to characterize the use of PROs in clinical trials. RESULTS: The 180 clinical trials that met the study inclusion criteria used 173 unique instruments to measure a total of 466 PROs. Most PRO measurements were obtained using relatively few PRO instruments, with one-third of PRO instruments applied in more than 1 trial. In multivariable analysis, tests of statistical significance were more often reported for PROs used as primary trial outcomes. Statistically significant PRO outcomes (P < 0.05) were more likely among disease-specific PROs compared with general PROs, PROs with a discussion of minimally important difference, and larger trials. CONCLUSIONS: PRO instruments may be improved through efforts to provide centralized electronic administration, cross-validation, and standardized interpretation of clinically relevant outcomes. The majority of PROs used in current clinical trials come from relatively few, commonly used disease-specific PRO instruments within major therapeutic areas.

Authors
Dinan, MA; Compton, KL; Dhillon, JK; Hammill, BG; de Witt, EM; Weinfurt, KP; Schulman, KA
MLA Citation
Dinan, MA, Compton, KL, Dhillon, JK, Hammill, BG, de Witt, EM, Weinfurt, KP, and Schulman, KA. "Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials (Accepted)." Medical Care (March 1, 2011).
Source
scopus
Published In
Medical Care
Publish Date
2011
DOI
10.1097/MLR.0b013e3182064aa2

Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials

Background: To optimize the use of patient-reported outcomes (PROs) in clinical research, it is first necessary to review the current use of these outcomes in clinical trials to determine under what circumstances they are most useful, and to reveal current limitations. Purpose: To investigate current patterns of use of PROs in clinical trials. Research Design: We conducted a systematic literature review of all double-blind, placebo-controlled, randomized clinical trials using one or more PROs as a study outcome from 2004 to 2006. Data were abstracted and analyzed with descriptive statistics and logistic regression to characterize the use of PROs in clinical trials. Results: The 180 clinical trials that met the study inclusion criteria used 173 unique instruments to measure a total of 466 PROs. Most PRO measurements were obtained using relatively few PRO instruments, with one-third of PRO instruments applied in more than 1 trial. In multivariable analysis, tests of statistical significance were more often reported for PROs used as primary trial outcomes. Statistically significant PRO outcomes (P < 0.05) were more likely among disease-specific PROs compared with general PROs, PROs with a discussion of minimally important difference, and larger trials. Conclusions: PRO instruments may be improved through efforts to provide centralized electronic administration, cross-validation, and standardized interpretation of clinically relevant outcomes. The majority of PROs used in current clinical trials come from relatively few, commonly used disease-specific PRO instruments within major therapeutic areas. Copyright © 2011 by Lippincott Williams & Wilkins.

Authors
Dinan, MA; Compton, KL; Dhillon, JK; Hammill, BG; DeWitt, EM; Weinfurt, KP; Schulman, KA
MLA Citation
Dinan, MA, Compton, KL, Dhillon, JK, Hammill, BG, DeWitt, EM, Weinfurt, KP, and Schulman, KA. "Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials." Medical Care 49.4 (January 1, 2011): 415-419.
Source
scopus
Published In
Medical Care
Volume
49
Issue
4
Publish Date
2011
Start Page
415
End Page
419

Commentary: Personalized health planning and the Patient Protection and Affordable Care Act: an opportunity for academic medicine to lead health care reform.

The Patient Protection and Affordable Care Act of 2010 (PPACA) mandates the exploration of new approaches to coordinated health care delivery--such as patient-centered medical homes, accountable care organizations, and disease management programs--in which reimbursement is aligned with desired outcomes. PPACA does not, however, delineate a standardized approach to improve the delivery process or a specific means to quantify performance for value-based reimbursement; these details are left to administrative agencies to develop and implement. The authors propose that coordinated care can be implemented more effectively and performance quantified more accurately by using personalized health planning, which employs individualized strategic health planning and care relevant to the patient's specific needs. Personalized health plans, developed by providers in collaboration with their patients, quantify patients' health and health risks over time, identify strategies to mitigate risks and/or treat disease, deliver personalized care, engage patients in their care, and measure outcomes. Personalized health planning is a core clinical process that can standardize coordinated care approaches while providing the data needed for performance-based reimbursement. The authors argue that academic health centers have a significant opportunity to lead true health care reform by adopting personalized health planning to coordinate care delivery while conducting the research and education necessary to enable its broad clinical application.

Authors
Dinan, MA; Simmons, LA; Snyderman, R
MLA Citation
Dinan, MA, Simmons, LA, and Snyderman, R. "Commentary: Personalized health planning and the Patient Protection and Affordable Care Act: an opportunity for academic medicine to lead health care reform." Academic medicine : journal of the Association of American Medical Colleges 85.11 (November 2010): 1665-1668.
PMID
20844424
Source
epmc
Published In
Academic Medicine
Volume
85
Issue
11
Publish Date
2010
Start Page
1665
End Page
1668
DOI
10.1097/acm.0b013e3181f4ab3c

Changes in the use and costs of diagnostic imaging among Medicare beneficiaries with cancer, 1999-2006.

Emerging technologies, changing diagnostic and treatment patterns, and changes in Medicare reimbursement are contributing to increasing use of imaging in cancer. Imaging is the fastest growing expense for Medicare but has not been examined among beneficiaries with cancer.To examine changes in the use of imaging and how those changes contribute to the overall cost of cancer care.Analysis of a nationally representative 5% sample of claims from the US Centers for Medicare & Medicaid Services from 1999 through 2008. Patients were Medicare beneficiaries with incident breast cancer, colorectal cancer, leukemia, lung cancer, non-Hodgkin lymphoma, or prostate cancer.Use and cost of imaging by modality, year, and cancer type.There were 100,954 incident cases of breast cancer, colorectal cancer, leukemia, lung cancer, non-Hodgkin lymphoma, and prostate cancer from 1999 through 2006. Significant mean annual increases in imaging use occurred among all cancer types for positron emission tomography (35.9%-53.6%), bone density studies (6.3%-20.0%), echocardiograms (5.0%-7.8%), magnetic resonance imaging (4.4%-11.5%), and ultrasound (0.7%-7.4%). Conventional radiograph rates decreased or stayed the same. As of 2006, beneficiaries with lung cancer and beneficiaries with lymphoma incurred the largest overall imaging costs, exceeding a mean of $3000 per beneficiary within 2 years of diagnosis. By 2005, one-third of beneficiaries with breast cancer underwent bone scans and half of beneficiaries with lung cancer or lymphoma underwent positron emission tomography scans. Mean 2-year imaging costs per beneficiary increased at a rate greater than the increase in mean total costs per beneficiary for all cancer types.Imaging costs among Medicare beneficiaries with cancer increased from 1999 through 2006, outpacing the rate of increase in total costs among Medicare beneficiaries with cancer.

Authors
Dinan, MA; Curtis, LH; Hammill, BG; Patz, EF; Abernethy, AP; Shea, AM; Schulman, KA
MLA Citation
Dinan, MA, Curtis, LH, Hammill, BG, Patz, EF, Abernethy, AP, Shea, AM, and Schulman, KA. "Changes in the use and costs of diagnostic imaging among Medicare beneficiaries with cancer, 1999-2006." JAMA 303.16 (April 2010): 1625-1631.
PMID
20424253
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
303
Issue
16
Publish Date
2010
Start Page
1625
End Page
1631
DOI
10.1001/jama.2010.460

SplicerAV: a tool for mining microarray expression data for changes in RNA processing.

Over the past two decades more than fifty thousand unique clinical and biological samples have been assayed using the Affymetrix HG-U133 and HG-U95 GeneChip microarray platforms. This substantial repository has been used extensively to characterize changes in gene expression between biological samples, but has not been previously mined en masse for changes in mRNA processing. We explored the possibility of using HG-U133 microarray data to identify changes in alternative mRNA processing in several available archival datasets.Data from these and other gene expression microarrays can now be mined for changes in transcript isoform abundance using a program described here, SplicerAV. Using in vivo and in vitro breast cancer microarray datasets, SplicerAV was able to perform both gene and isoform specific expression profiling within the same microarray dataset. Our reanalysis of Affymetrix U133 plus 2.0 data generated by in vitro over-expression of HRAS, E2F3, beta-catenin (CTNNB1), SRC, and MYC identified several hundred oncogene-induced mRNA isoform changes, one of which recognized a previously unknown mechanism of EGFR family activation. Using clinical data, SplicerAV predicted 241 isoform changes between low and high grade breast tumors; with changes enriched among genes coding for guanyl-nucleotide exchange factors, metalloprotease inhibitors, and mRNA processing factors. Isoform changes in 15 genes were associated with aggressive cancer across the three breast cancer datasets.Using SplicerAV, we identified several hundred previously uncharacterized isoform changes induced by in vitro oncogene over-expression and revealed a previously unknown mechanism of EGFR activation in human mammary epithelial cells. We analyzed Affymetrix GeneChip data from over 400 human breast tumors in three independent studies, making this the largest clinical dataset analyzed for en masse changes in alternative mRNA processing. The capacity to detect RNA isoform changes in archival microarray data using SplicerAV allowed us to carry out the first analysis of isoform specific mRNA changes directly associated with cancer survival.

Authors
Robinson, TJ; Dinan, MA; Dewhirst, M; Garcia-Blanco, MA; Pearson, JL
MLA Citation
Robinson, TJ, Dinan, MA, Dewhirst, M, Garcia-Blanco, MA, and Pearson, JL. "SplicerAV: a tool for mining microarray expression data for changes in RNA processing." BMC bioinformatics 11 (February 25, 2010): 108-.
Website
http://hdl.handle.net/10161/4332
PMID
20184770
Source
epmc
Published In
BMC Bioinformatics
Volume
11
Publish Date
2010
Start Page
108
DOI
10.1186/1471-2105-11-108

Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement.

Authors
Kamble, S; Telen, MJ; Dinan, MA; Grussemeyer, CA; Reed, SD
MLA Citation
Kamble, S, Telen, MJ, Dinan, MA, Grussemeyer, CA, and Reed, SD. "Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement." American journal of hematology 85.1 (January 2010): 79-81. (Letter)
PMID
20029954
Source
epmc
Published In
American Journal of Hematology
Volume
85
Issue
1
Publish Date
2010
Start Page
79
End Page
81
DOI
10.1002/ajh.21576

Improving health by taking it personally.

Authors
Snyderman, R; Dinan, MA
MLA Citation
Snyderman, R, and Dinan, MA. "Improving health by taking it personally." JAMA 303.4 (January 2010): 363-364.
PMID
20103762
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
303
Issue
4
Publish Date
2010
Start Page
363
End Page
364
DOI
10.1001/jama.2010.34

Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures.

In this study, we examined differences in inpatient costs, length of stay, and in-hospital mortality between hospitalizations for patients with and without sickle cell disease (SCD) undergoing high-volume surgical procedures. We used Clinical Classification Software (CCS) codes to identify discharges in the 2002-2005 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project for patients who had undergone either cholecystectomy or hip replacement. We limited the non-SCD cohort to hospitals where patients with SCD had undergone the same procedure. We compared inpatient outcomes using summary statistics and generalized linear regression analysis to adjust for patient, hospital, and procedural characteristics. Overall, the median age of surgical patients with SCD was more than three decades less than the median age of patients without SCD undergoing the same procedure. In recognition of the age disparity, we limited the analyses to patients aged 18 to 64 years. Nonetheless, patients with SCD undergoing cholecystectomy or hip replacement were 12.1 and 14.4 years younger, had inpatient stays that were 73% and 82% longer, and incurred costs that were 46% and 40% higher per discharge than patients without SCD, respectively. Inpatient mortality for these procedures was low, approximately 0.6% for cholecystectomy and 0.2% for hip replacement and did not differ significantly between patients with and without SCD. Multivariable regression analyses revealed that higher inpatient costs among patients with SCD were primarily attributable to longer hospital stays. Patients with SCD who underwent cholecystectomy or hip replacement required more health care resources than patients without SCD. Am. J. Hematol. 2009. (c) 2009 Wiley-Liss, Inc.

Authors
Dinan, MA; Chou, C-H; Hammill, BG; Graham, FL; Schulman, KA; Telen, MJ; Reed, SD
MLA Citation
Dinan, MA, Chou, C-H, Hammill, BG, Graham, FL, Schulman, KA, Telen, MJ, and Reed, SD. "Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures." American journal of hematology 84.11 (November 2009): 703-709.
PMID
19787790
Source
epmc
Published In
American Journal of Hematology
Volume
84
Issue
11
Publish Date
2009
Start Page
703
End Page
709
DOI
10.1002/ajh.21520

Effects of disclosing financial interests on attitudes toward clinical research.

The effects of disclosing financial interests to potential research participants are not well understood.To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research.Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements.Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial.Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments.Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.

Authors
Weinfurt, KP; Hall, MA; Dinan, MA; DePuy, V; Friedman, JY; Allsbrook, JS; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, Dinan, MA, DePuy, V, Friedman, JY, Allsbrook, JS, and Sugarman, J. "Effects of disclosing financial interests on attitudes toward clinical research." Journal of general internal medicine 23.6 (June 2008): 860-866.
PMID
18386101
Source
epmc
Published In
Journal of General Internal Medicine
Volume
23
Issue
6
Publish Date
2008
Start Page
860
End Page
866
DOI
10.1007/s11606-008-0590-4

Developing model language for disclosing financial interests to potential clinical research participants.

Authors
Weinfurt, KP; Allsbrook, JS; Friedman, JY; Dinan, MA; Hall, MA; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Allsbrook, JS, Friedman, JY, Dinan, MA, Hall, MA, Schulman, KA, and Sugarman, J. "Developing model language for disclosing financial interests to potential clinical research participants." IRB 29.1 (January 2007): 1-5.
PMID
17364012
Source
epmc
Published In
IRB
Volume
29
Issue
1
Publish Date
2007
Start Page
1
End Page
5

Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants.

BACKGROUND: Disclosing financial interests to potential research participants during the informed consent process is one strategy for managing conflicts of interest. Given that clinical research coordinators are typically charged with administering the informed consent process, it is critical to understand their experiences, attitudes and beliefs regarding the disclosure of financial interests in research. PURPOSE: To understand the role of clinical research coordinators in disclosing financial interests in research, and potential barriers to such disclosures. METHODS: We developed a survey designed to measure clinical research coordinators' awareness of financial interests in clinical research, previous experience with disclosing financial interests, comfort with answering questions about financial interests and barriers to disclosing financial interests to potential research participants. Next we conducted cognitive interviews with 10 clinical research coordinators to assess understandability and content validity and to further refine the survey. We then administered the survey to clinical research coordinators attending the 2006 Global Conference of the Association of Clinical Research Professionals. RESULTS: Among 300 clinical research coordinators who completed the survey, there was a general awareness of financial interests in research. Forty-one percent reported disclosing such financial interests to potential research participants, and 28% reported being asked about them. Greater comfort in responding to questions about financial interests was associated with previous experience with disclosure, previous experience answering questions about financial interests, and greater length of time obtaining informed consent. Respondents indicated that there were barriers to disclosure, including lack of information (76%) and that participants would not understand disclosures (26%). LIMITATIONS: Possible sample bias due to using a convenience sample. CONCLUSIONS: Making information about financial interests in research readily available to clinical research coordinators, as well as providing education and training, should facilitate the disclosure of financial interests in research to potential research participants during the informed consent process.

Authors
Friedman, JY; Sugarman, J; Dhillon, JK; Depuy, V; Pierre, CK; Dinan, MA; Allsbrook, JS; Schulman, KA; Weinfurt, KP
MLA Citation
Friedman, JY, Sugarman, J, Dhillon, JK, Depuy, V, Pierre, CK, Dinan, MA, Allsbrook, JS, Schulman, KA, and Weinfurt, KP. "Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants." Clinical trials (London, England) 4.3 (January 2007): 272-278.
PMID
17715256
Source
epmc
Published In
Clinical Trials
Volume
4
Issue
3
Publish Date
2007
Start Page
272
End Page
278
DOI
10.1177/1740774507079239

Comparison of conflict of interest policies and reported practices in academic medical centers in the United States.

The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.

Authors
Dinan, MA; Weinfurt, KP; Friedman, JY; Allsbrook, JS; Gottlieb, J; Schulman, KA; Hall, MA; Dhillon, JK; Sugarman, J
MLA Citation
Dinan, MA, Weinfurt, KP, Friedman, JY, Allsbrook, JS, Gottlieb, J, Schulman, KA, Hall, MA, Dhillon, JK, and Sugarman, J. "Comparison of conflict of interest policies and reported practices in academic medical centers in the United States." Accountability in research 13.4 (October 2006): 325-342.
PMID
17849643
Source
epmc
Published In
Accountability in Research
Volume
13
Issue
4
Publish Date
2006
Start Page
325
End Page
342
DOI
10.1080/08989620601003414

Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure.

There is little guidance regarding how to disclose researchers' financial interests to potential research participants.To determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement.Sixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer.Focus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis.Participants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know.Financial interests are important to potential research participants, but obstacles to effective disclosure exist.

Authors
Weinfurt, KP; Friedman, JY; Allsbrook, JS; Dinan, MA; Hall, MA; Sugarman, J
MLA Citation
Weinfurt, KP, Friedman, JY, Allsbrook, JS, Dinan, MA, Hall, MA, and Sugarman, J. "Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure." Journal of general internal medicine 21.9 (September 2006): 901-906.
PMID
16918732
Source
epmc
Published In
Journal of General Internal Medicine
Volume
21
Issue
9
Publish Date
2006
Start Page
901
End Page
906
DOI
10.1007/bf02743135

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure.The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure.Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant.Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

Authors
Weinfurt, KP; Dinan, MA; Allsbrook, JS; Friedman, JY; Hall, MA; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Dinan, MA, Allsbrook, JS, Friedman, JY, Hall, MA, Schulman, KA, and Sugarman, J. "Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants." Academic medicine : journal of the Association of American Medical Colleges 81.2 (February 2006): 113-118.
PMID
16436571
Source
epmc
Published In
Academic Medicine
Volume
81
Issue
2
Publish Date
2006
Start Page
113
End Page
118
DOI
10.1097/00001888-200602000-00003

Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators.

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.

Authors
Weinfurt, KP; Friedman, JY; Dinan, MA; Allsbrook, JS; Hall, MA; Dhillon, JK; Sugarman, J
MLA Citation
Weinfurt, KP, Friedman, JY, Dinan, MA, Allsbrook, JS, Hall, MA, Dhillon, JK, and Sugarman, J. "Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators." The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics 34.3 (January 2006): 581-481.
PMID
17144182
Source
epmc
Published In
The Journal of Law, Medicine & Ethics
Volume
34
Issue
3
Publish Date
2006
Start Page
581
End Page
481
DOI
10.1111/j.1748-720x.2006.00072.x
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