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Weinfurt, Kevin Phillip

Overview:

Kevin P. Weinfurt, PhD, is a professor in psychiatry and behavioral sciences at the Duke University School of Medicine. He holds a secondary appointment as a professor of psychology and neuroscience. He is co-director of the Clinical Research Training Program (Masters degree offered through the School of Medicine).

Dr. Weinfurt conducts research on measuring patient-reported outcomes, medical decision making, and bioethics. In addition to conducting research, Dr. Weinfurt has taught undergraduate courses in introductory psychology, judgment and decision making, the psychology of medical decision making; and graduate courses in multivariate statistics and patient-reported outcomes research.


Areas of Expertise: Bioethics, Health Measurement, Health Services Research, and Health Behavior

Positions:

Professor in Population Health Sciences

Population Health Sciences
School of Medicine

Professor in Psychiatry and Behavioral Sciences

Psychiatry & Behavioral Sciences, Translational Neuroscience
School of Medicine

Professor in the Department of Psychology and Neuroscience

Psychology and Neuroscience
Trinity College of Arts & Sciences

Associate of the Duke Initiative for Science & Society

Duke Science & Society
Institutes and Provost's Academic Units

Membership of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Member in the Duke Clinical Research Institute

Duke Clinical Research Institute
School of Medicine

Education:

Ph.D. 1997

Ph.D. — Georgetown University

News:

Grants:

Duke CTSA (KL2)

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
May 02, 2018
End Date
April 30, 2023

Duke CTSA (TL1)

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
May 02, 2018
End Date
April 30, 2023

NIH Health Care Systems Research Collaboratory - Coordinating Center

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co-Principal Investigator
Start Date
September 15, 2017
End Date
August 31, 2022

Dissemination and Implementation Science in Cardiovascular Outcomes (DISCO)

Administered By
Basic Science Departments
AwardedBy
National Institutes of Health
Role
Faculty Member
Start Date
September 01, 2017
End Date
June 30, 2022

Urinary Stone Disease Research Network: Scientific Data Research Center

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 01, 2016
End Date
August 31, 2021

Advancing the Measurement and Classification of Lower Urinary Tract Dysfunction

Administered By
Obstetrics and Gynecology, Urogynecology
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 30, 2012
End Date
May 31, 2019

Health Care Systems Research Collaboratory - Coordinating Center

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
PD/PI
Start Date
September 30, 2012
End Date
August 31, 2018

Duke CTSA (UL1)

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 26, 2013
End Date
July 31, 2018

Duke KURe Program

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

Stopping Tyrosine Kinase Inhibitors in CML Patients (Stop-TKIs)

Administered By
Medicine, Hematologic Malignancies and Cellular Therapy
AwardedBy
Medical College of Wisconsin
Role
Co-Principal Investigator
Start Date
September 19, 2014
End Date
August 31, 2017

Health Care Systems Research Collaboratory -Empirical Ethics Supplement

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 30, 2012
End Date
August 31, 2017

ENHANCING THE BIOBANKING INFORMED CONSENT PROCESS TO IMPROVE COMPREHENSION

Administered By
Basic Science Departments
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
August 14, 2012
End Date
June 19, 2017

Symptoms of Lower Urinary Tract Dysfunction Research Network (U01) Supplement

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 30, 2012
End Date
May 31, 2017

Li Lin support from MCW

Administered By
Duke Clinical Research Institute
AwardedBy
Medical College of Wisconsin
Role
Principal Investigator
Start Date
October 01, 2015
End Date
September 30, 2016

Validating and Extending the PROMIS Sexual Function Measure for Clinical Research

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 30, 2009
End Date
July 31, 2015

PREMIS: Preventive Misconception in HIV Prevention Trials

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
July 01, 2010
End Date
April 30, 2014

Assessing the Use and Understanding of Certificates of Confidentiality

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
May 28, 2010
End Date
February 28, 2013

CTSA UL

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Investigator
Start Date
September 30, 2006
End Date
September 01, 2012

Understanding Patient Expectations of Treatment Outcomes

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
June 08, 2009
End Date
November 30, 2011

PROMIS

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 28, 2004
End Date
September 29, 2009

Mammography Pain in Breast Cancer Survivors

Administered By
Psychiatry & Behavioral Sciences, Behavioral Medicine
AwardedBy
National Institutes of Health
Role
Co-Sponsor
Start Date
September 04, 2006
End Date
September 03, 2009

ACTION EQOL STUDY

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 30, 2002
End Date
December 31, 2008

CSP 442 - #1416

Administered By
Duke Clinical Research Institute
AwardedBy
Department of Veterans Affairs
Role
Fiscal Specialist
Start Date
April 25, 2000
End Date
March 31, 2005
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Publications:

Design and rationale for the life after stopping tyrosine kinase inhibitors (LAST) study, a prospective, single-group longitudinal study in patients with chronic myeloid leukemia.

Treatment of chronic myeloid leukemia with a tyrosine kinase inhibitor (TKI) offers significant improvements over previous treatments in terms of survival and toxicity yet nevertheless is associated with reduced health-related quality of life and very high cost. Several small studies from Europe and Australia suggested that discontinuing TKIs with regular monitoring was safe.The Life After Stopping TKIs (LAST) study is a large, U.S.-based study that aims to improve the evidence for clinical decision making regarding TKI discontinuation with monitoring in patients with chronic myeloid leukemia who have a deep molecular response to TKI therapy. The LAST study is a non-randomized, prospective, single-group longitudinal study of 173 patients. The co-primary objectives are to determine the proportion of patients who develop molecular recurrence (> 0.1% BCR-ABLIS) after discontinuing one of four TKIs (imatinib, dasatinib, nilotinib, or bosutinib) and to compare the patient-reported health status of patients before and after stopping TKIs. Outcomes are assessed at baseline and throughout the 36-month study follow-up period with a central laboratory used for blood samples. All samples with undetectable BCR-ABL are also examined using digital polymerase chain reaction, which is a more sensitive nanofluidic polymerase chain reaction system.Because of their high cost and side effects, discontinuation of TKIs for patients with chronic myeloid leukemia who have a deep molecular response to TKI therapy is a promising approach to treatment. The LAST study is the largest U.S.-based TKI discontinuation study. It is the first to allow participation from patients on any of 4 first- and second-generation TKIs, includes a robust approach to measurement of clinical and patient-reported outcomes, and is using digital polymerase chain reaction to explore better prediction of safe discontinuation.This study was registered prospectively on October 21, 2014 and assigned trial number NCT02269267 .

Authors
Atallah, E; Schiffer, CA; Weinfurt, KP; Zhang, M-J; Radich, JP; Oehler, VG; Pinilla-Ibarz, J; Deininger, MWN; Lin, L; Larson, RA; Mauro, MJ; Moore, JO; Ritchie, EK; Shah, NP; Silver, RT; Wadleigh, M; Cortes, J; Thompson, J; Guhl, J; Horowitz, MM; Flynn, KE
MLA Citation
Atallah, E, Schiffer, CA, Weinfurt, KP, Zhang, M-J, Radich, JP, Oehler, VG, Pinilla-Ibarz, J, Deininger, MWN, Lin, L, Larson, RA, Mauro, MJ, Moore, JO, Ritchie, EK, Shah, NP, Silver, RT, Wadleigh, M, Cortes, J, Thompson, J, Guhl, J, Horowitz, MM, and Flynn, KE. "Design and rationale for the life after stopping tyrosine kinase inhibitors (LAST) study, a prospective, single-group longitudinal study in patients with chronic myeloid leukemia." BMC cancer 18.1 (April 2, 2018): 359-.
PMID
29609532
Source
epmc
Published In
BMC Cancer
Volume
18
Issue
1
Publish Date
2018
Start Page
359
DOI
10.1186/s12885-018-4273-1

Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study.

We described and compared the frequency and type of lower urinary tract symptoms reported by men and women at the time that they were recruited from urology and urogynecology clinics into the Symptoms of Lower Urinary Tract Dysfunction Research Network multicenter, prospective, observational cohort study.At 6 research sites treatment seeking men and women were enrolled who reported any lower urinary tract symptoms at a frequency more than rarely during the last month on the LUTS (Lower Urinary Tract Symptoms) Tool. At baseline the study participants underwent a standardized clinical evaluation and completed validated questionnaires. Urological tests were performed, including pelvic/rectal examination, post-void residual urine measurement and urinalysis.A total of 545 women and 519 men were enrolled in the study. Mean ± SD age was 58.8 ± 14.1 years. At baseline nocturia, frequency and a sensation of incomplete emptying were similar in men and women but men experienced more voiding symptoms (90% vs 85%, p = 0.007) and women reported more urgency (85% vs 66%, p <0.001). Women also reported more of any type of urinary incontinence than men (82% vs 51% p <0.001), which was mixed incontinence in 57%. Only 1% of men reported stress incontinence but they had other urinary incontinence, including post-void dribbling in 44% and urgency incontinence in 46%. Older participants had higher odds of reporting symptoms of nocturia and urgency.In this large, treatment seeking cohort of men and women lower urinary tract symptoms varied widely by gender and age. Men reported more voiding symptoms and nonstress or urgency urinary incontinence while women reported more incontinence overall and urgency. Older participants had greater odds of urgency and nocturia.

Authors
Cameron, AP; Lewicky-Gaupp, C; Smith, AR; Helfand, BT; Gore, JL; Clemens, JQ; Yang, CC; Siddiqui, NY; Lai, HH; Griffith, JW; Andreev, VP; Liu, G; Weinfurt, K; Amundsen, CL; Bradley, CS; Kusek, JW; Kirkali, Z; Symptoms of Lower Urinary Tract Dysfunction Research Network Study Group,
MLA Citation
Cameron, AP, Lewicky-Gaupp, C, Smith, AR, Helfand, BT, Gore, JL, Clemens, JQ, Yang, CC, Siddiqui, NY, Lai, HH, Griffith, JW, Andreev, VP, Liu, G, Weinfurt, K, Amundsen, CL, Bradley, CS, Kusek, JW, Kirkali, Z, and Symptoms of Lower Urinary Tract Dysfunction Research Network Study Group, . "Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study." The Journal of urology 199.4 (April 2018): 1023-1031.
PMID
29111381
Source
epmc
Published In
The Journal of Urology
Volume
199
Issue
4
Publish Date
2018
Start Page
1023
End Page
1031
DOI
10.1016/j.juro.2017.10.035

Inflammatory Bowel Diseases Can Adversely Impact Domains of Sexual Function Such as Satisfaction with Sex Life.

Aspects of sexual health, which can be adversely affected by chronic disease, have been inadequately explored in inflammatory bowel disease (IBD).We evaluated patient-reported interest in sexual activity and satisfaction with sex life in a large cohort of IBD patients.We conducted a cross-sectional study within the Crohn's and Colitis Foundation Partners Internet cohort. Sequential participants completed a 6-question supplemental online survey to examine sexual interest and satisfaction using the Patient-Reported Outcome Measurement Information System® (PROMIS®) Sexual Function and Satisfaction measures. One-sample t tests were used to compare interest and satisfaction scores to general population norms.Among 2569 individuals, 1639 had Crohn's disease (CD), 930 had ulcerative colitis (UC) or indeterminate colitis, and 71% were women. Mean PROMIS scores for sexual interest were comparable to the general US population in men (CD: 49 and UC: 48 vs. population mean 50) and women (CD: 41 and UC: 40 vs. population mean 42). However, sexual satisfaction scores were lower than the US population in men (CD: 48 and UC: 48 vs. 51) and women (CD: 47 and UC: 46 vs. 49), p < 0.01 for both. Older age, disease activity, depression, anxiety, and pain were associated with lower interest and satisfaction and lowered IBD-specific quality of life.IBD patients in a large online survey had similar levels of sexual interest but decreased sexual satisfaction compared to the general population. Exploring these sexual health domains during clinical encounters can aid in improving IBD quality of life.

Authors
Eluri, S; Cross, RK; Martin, C; Weinfurt, KP; Flynn, KE; Long, MD; Chen, W; Anton, K; Sandler, RS; Kappelman, MD
MLA Citation
Eluri, S, Cross, RK, Martin, C, Weinfurt, KP, Flynn, KE, Long, MD, Chen, W, Anton, K, Sandler, RS, and Kappelman, MD. "Inflammatory Bowel Diseases Can Adversely Impact Domains of Sexual Function Such as Satisfaction with Sex Life." Digestive diseases and sciences (March 21, 2018).
PMID
29564672
Source
epmc
Published In
Digestive Diseases and Sciences
Publish Date
2018
DOI
10.1007/s10620-018-5021-8

Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study.

The primary objective of this study was to evaluate reasons for seeking care among men and women with lower urinary tract symptoms.Participants were recruited from urology and urogynecology clinics, and the community. The sample was enriched with persons expected to have abnormal or diminished bladder sensations (eg participants with lower back surgery and participants 65 years old or older). Interviews were performed in person beginning with an open-ended assessment of urinary symptoms and associated bother followed by more directed questions, including reasons for seeking or not seeking treatment. We also examined the relationship between symptom frequency and bother using the LUTS (Lower Urinary Tract Symptoms) Tool.A total of 88 participants, including 38 men and 50 women, with a mean ± SD age of 52.2 ± 14.3 years provided information about urinary symptoms, including a range of quality of life consequences and coping behaviors. They sought treatment mostly because of new, continuing or bothersome symptoms. Factors associated with not seeking treatment included low symptom severity and concerns about the costs vs the benefits of treatment (eg side effects of medication). Symptom frequency and bother were associated with each other across symptoms assessed by the LUTS Tool.In this large qualitative study we obtained useful insights into the impact of lower urinary tract symptoms from the perspective of the person with the symptoms. Removing barriers and misconceptions about the treatment of lower urinary tract symptoms may increase the number of people who seek clinical care and improve the clinical course of men and women who experience lower urinary tract symptoms.

Authors
Griffith, JW; Messersmith, EE; Gillespie, BW; Wiseman, JB; Flynn, KE; Kirkali, Z; Kusek, JW; Bavendam, T; Cella, D; Kreder, KJ; Nero, JJ; Corona, ME; Bradley, CS; Kenton, KS; Helfand, BT; Merion, RM; Weinfurt, KP; LURN Study Group,
MLA Citation
Griffith, JW, Messersmith, EE, Gillespie, BW, Wiseman, JB, Flynn, KE, Kirkali, Z, Kusek, JW, Bavendam, T, Cella, D, Kreder, KJ, Nero, JJ, Corona, ME, Bradley, CS, Kenton, KS, Helfand, BT, Merion, RM, Weinfurt, KP, and LURN Study Group, . "Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study." The Journal of urology 199.2 (February 2018): 528-535.
PMID
28734864
Source
epmc
Published In
The Journal of Urology
Volume
199
Issue
2
Publish Date
2018
Start Page
528
End Page
535
DOI
10.1016/j.juro.2017.07.067

Reframing Consent for Clinical Research: A Function-Based Approach.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals.

Authors
Dickert, NW; Eyal, N; Goldkind, SF; Grady, C; Joffe, S; Lo, B; Miller, FG; Pentz, RD; Silbergleit, R; Weinfurt, KP; Wendler, D; Kim, SYH
MLA Citation
Dickert, NW, Eyal, N, Goldkind, SF, Grady, C, Joffe, S, Lo, B, Miller, FG, Pentz, RD, Silbergleit, R, Weinfurt, KP, Wendler, D, and Kim, SYH. "Reframing Consent for Clinical Research: A Function-Based Approach." The American journal of bioethics : AJOB 17.12 (December 2017): 3-11.
PMID
29148951
Source
epmc
Published In
American Journal of Bioethics
Volume
17
Issue
12
Publish Date
2017
Start Page
3
End Page
11
DOI
10.1080/15265161.2017.1388448

Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices.

For pragmatic clinical research comparing commonly used treatments, questions exist about if and how to notify participants about it and secure their authorization for participation.To determine how patients react when they seek clinical care and encounter one of several different pragmatic clinical research studies.In an online survey using a between-subjects experimental design, respondents read and responded to 1 of 24 hypothetical research scenarios reflecting different types of studies and approaches to notification and authorization (eg, general notification, oral consent, written consent).English-speaking US adults 18 years and older.Willingness to participate in the hypothetical study, acceptability of the notification and authorization approach, understanding of the study, perceptions of benefit/harm, trust, and perception of amount of study information received.Willingness to participate did not differ by notification and authorization approach. Some (21%-36%) of the patients randomized to general notification with an explicit opt-out provision were not aware they would be enrolled by default. Acceptability was greatest for and similar among notification and authorization approaches that actively engaged the patient (eg, oral or written consent) and lower for approaches with less engagement (eg, general notification). Problems of understanding were found among 20%-55% of respondents, depending on the particular scenario. Most respondents (77%-94%) felt that participation in the hypothetical study posed no risks of harm to their health or privacy.Current attitudes about notification and authorization approaches and difficulties understanding pragmatic clinical research pose significant challenges for pragmatic research. Data from this study provide a starting point to developing solutions to these surprisingly complex issues.

Authors
Weinfurt, KP; Bollinger, JM; Brelsford, KM; Bresciani, M; Lampron, Z; Lin, L; Topazian, RJ; Sugarman, J
MLA Citation
Weinfurt, KP, Bollinger, JM, Brelsford, KM, Bresciani, M, Lampron, Z, Lin, L, Topazian, RJ, and Sugarman, J. "Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices." Medical care 55.11 (November 2017): 970-978.
PMID
28650924
Source
epmc
Published In
Medical Care
Volume
55
Issue
11
Publish Date
2017
Start Page
970
End Page
978
DOI
10.1097/mlr.0000000000000762

Patients' Conceptions of Terms Related to Sexual Interest, Desire, and Arousal.

Measurement of sexual function typically uses self-report, which, to work as intended, must use language that is understood consistently by diverse respondents. Commonly used measures employ multiple terms, primarily (sexual) interest, desire, and arousal, that might not be understood in the same way by laypeople and professionals.To inform self-reported measurement efforts for research and clinical settings by examining how US men and women recruited from a health care setting understand and interpret different terms.We conducted 10 focus groups in Durham, NC (N = 57). Discussions were audio-recorded and transcribed, and the content of the discussions was systematically analyzed in 2 phases of coding by the research team, facilitated by Nvivo qualitative analysis software (QSR International, Doncaster, VIC, Australia).Patient focus group discussions about the meanings and connotations of multiple terms related to sexual function, especially interest, desire, and arousal.5 groups included male participants and 5 included female participants. Participants characterized (sexual) interest as a cognitive phenomenon and a situational response to a specific person. Similarly, they characterized (sexual) desire as a situational person-specific experience with some support for it as a cognitive phenomenon but more support for it as a physical phenomenon. In contrast, participants characterized sexual arousal as a physical phenomenon occurring in response to physical or visual stimulation and not related to a specific person.These results can help us understand how laypeople are using and responding to these terms when they are used in clinical and research settings.Patient participants in these groups were diverse in age, gender, sexual orientation, and health, with the potential to voice diverse perspectives on sexual functioning; however, the sample was limited to a single city in the southeastern United States.The meanings of interest, desire, and arousal were defined, compared, and contrasted in the context of patient focus groups. Qualitative coding showed that interest was considered the most "cognitive," arousal the most "physical," and desire somewhere in between. DeLamater JD, Weinfurt KP, Flynn KE. Patients' Conceptions of Terms Related to Sexual Interest, Desire, and Arousal. J Sex Med 2017;14:1327-1335.

Authors
DeLamater, JD; Weinfurt, KP; Flynn, KE
MLA Citation
DeLamater, JD, Weinfurt, KP, and Flynn, KE. "Patients' Conceptions of Terms Related to Sexual Interest, Desire, and Arousal." The journal of sexual medicine 14.11 (November 2017): 1327-1335.
PMID
29017897
Source
epmc
Published In
The Journal of Sexual Medicine
Volume
14
Issue
11
Publish Date
2017
Start Page
1327
End Page
1335
DOI
10.1016/j.jsxm.2017.09.009

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Authors
Weinfurt, KP; Hernandez, AF; Coronado, GD; DeBar, LL; Dember, LM; Green, BB; Heagerty, PJ; Huang, SS; James, KT; Jarvik, JG; Larson, EB; Mor, V; Platt, R; Rosenthal, GE; Septimus, EJ; Simon, GE; Staman, KL; Sugarman, J; Vazquez, M; Zatzick, D; Curtis, LH
MLA Citation
Weinfurt, KP, Hernandez, AF, Coronado, GD, DeBar, LL, Dember, LM, Green, BB, Heagerty, PJ, Huang, SS, James, KT, Jarvik, JG, Larson, EB, Mor, V, Platt, R, Rosenthal, GE, Septimus, EJ, Simon, GE, Staman, KL, Sugarman, J, Vazquez, M, Zatzick, D, and Curtis, LH. "Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory." BMC medical research methodology 17.1 (September 18, 2017): 144-.
PMID
28923013
Source
epmc
Published In
BMC Medical Research Methodology
Volume
17
Issue
1
Publish Date
2017
Start Page
144
DOI
10.1186/s12874-017-0420-7

Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention.

To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension.We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that topic.Consistent with our first hypothesis, comprehension among those who received the simplified form was not inferior to that among those who received the traditional form. Contrary to expectations, receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group. The review/retest procedure significantly improved quiz scores in every combination of consent form and education level. Although improved, comprehension remained a challenge in the lowest-education group. Higher quiz scores were significantly associated with willingness to participate.Ensuring consent comprehension remains a challenge, but simplified forms have virtues independent of their impact on understanding. A review/retest intervention may have a significant effect, but assessing comprehension raises complex questions about setting thresholds for understanding and consequences of not meeting them.Genet Med advance online publication 13 October 2016.

Authors
Beskow, LM; Lin, L; Dombeck, CB; Gao, E; Weinfurt, KP
MLA Citation
Beskow, LM, Lin, L, Dombeck, CB, Gao, E, and Weinfurt, KP. "Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention." Genetics in medicine : official journal of the American College of Medical Genetics 19.5 (May 2017): 505-512.
PMID
27735922
Source
epmc
Published In
Genetics in Medicine
Volume
19
Issue
5
Publish Date
2017
Start Page
505
End Page
512
DOI
10.1038/gim.2016.157

Assessment of vulvar discomfort with sexual activity among women in the United States.

Multidimensional self-report measures of sexual function for women do not include the assessment of vulvar discomfort, limiting our understanding of its prevalence. In an effort to improve the measurement of patient-reported health, the National Institutes of Health funded the creation of the Patient Reported Outcomes Measurement Information System (PROMIS). This included the development of the PROMIS Sexual Function and Satisfaction measure, and version 2.0 of the Sexual Function and Satisfaction measure included 2 scales to measure vulvar discomfort with sexual activity.The objectives of the study were to describe the development of 2 self-reported measures of vulvar discomfort with sexual activity, describe the relationships between these scales and scales for lubrication and vaginal discomfort, and report the prevalence of vulvar discomfort with sexual activity in a large, nationally representative sample of US women.We followed PROMIS measure development standards, including qualitative development work with patients and clinicians and psychometric evaluation of candidate items based on item response theory, in a probability sample of 1686 English-speaking US adult women. We tested 16 candidate items on vulvar discomfort. We present descriptive statistics for these items, correlation coefficients among the vulvar and vaginal scales, and mean PROMIS scores with 95% confidence intervals separately by menopausal status for the 1046 women who reported sexual activity in the past 30 days.Based on the psychometric evaluation of the candidate items, we created 2 separate 4 item scales, one to measure labial discomfort and pain and one to measure clitoral discomfort and pain. Additional items not included in the scales assess pain quality, numbness, and bleeding. The correlations between the lubrication, vaginal discomfort, and the 2 vulvar discomfort measures ranged from 0.46 to 0.77, suggesting that these measures represent related yet distinct concepts. In our nationally representative sample, 1 in 5 US women endorsed some degree of vulvar discomfort with sexual activity in the past 30 days. Menopausal status was associated with lower lubrication and higher vaginal discomfort but not with vulvar discomfort.The PROMIS Vulvar Discomfort with Sexual Activity-Labial and Vulvar Discomfort with Sexual Activity-Clitoral scales are publicly available for use in research and clinical settings. There is limited overlap between vulvar discomfort and lubrication or vaginal discomfort. The importance of measuring vulvar discomfort as part of a comprehensive assessment of sexual function is underscored by its prevalence.

Authors
Flynn, KE; Carter, J; Lin, L; Lindau, ST; Jeffery, DD; Reese, JB; Schlosser, BJ; Weinfurt, KP
MLA Citation
Flynn, KE, Carter, J, Lin, L, Lindau, ST, Jeffery, DD, Reese, JB, Schlosser, BJ, and Weinfurt, KP. "Assessment of vulvar discomfort with sexual activity among women in the United States." American journal of obstetrics and gynecology 216.4 (April 2017): 391.e1-391.e8.
PMID
27988269
Source
epmc
Published In
American Journal of Obstetrics & Gynecology
Volume
216
Issue
4
Publish Date
2017
Start Page
391.e1
End Page
391.e8
DOI
10.1016/j.ajog.2016.12.006

Sexual function and satisfaction among heterosexual and sexual minority U.S. adults: A cross-sectional survey.

Despite known health disparities for sexual minorities, few studies have described sexual function by sexual orientation using a robust approach to measurement of sexual function. We compared recent sexual function and satisfaction by sexual orientation among English-speaking US adults.Cross-sectional surveys were administered by KnowledgePanel® (GfK), an online panel that uses address-based probability sampling and is representative of the civilian, noninstitutionalized US population. Data were collected in 2013 from the general population (n = 3314, 35% response rate) and in 2014 from self-identified lesbian, gay, and bisexual adults (n = 1011, 50% response rate). Sexual function and satisfaction were measured using the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction measure version 2.0 (PROMIS SexFS v2). The PROMIS SexFS v2 is a comprehensive, customizable measurement system with evidence for validity in diverse populations. A score of 50 (SD 10) on each domain corresponds to the average for US adults sexually active in the past 30 days. We adjusted all statistics for the complex sample designs and report differences within each sex where the 95% CIs do not overlap, corresponding to p<0.01. Among US men who reported any sexual activity in the past 30 days, there were no differences in erectile function or orgasm-ability. Compared to heterosexual men, sexual minority men reported higher oral dryness and lower orgasm-pleasure and satisfaction. Compared to heterosexual men, gay men reported lower interest, higher anal discomfort and higher oral discomfort. Among sexually active women, there were no differences in the domains of vulvar discomfort-clitoral, orgasm-pleasure, or satisfaction. Compared to heterosexual women, sexual minority women reported higher oral dryness. Lesbian women reported lower vaginal discomfort than other women; lesbian women reported higher lubrication and orgasm-ability than heterosexual women. Bisexual women reported higher interest, higher vulvar discomfort-labial and higher anal discomfort than other women, as well as higher oral discomfort compared to heterosexual women.Recent sexual function and satisfaction differed by sexual orientation among US adults. Sexual minority men and women had decrements in domains of sexual function that have not traditionally been included in multi-dimensional self-report measures. Clinicians should make themselves aware of their patients' sexual concerns and recognize that sexual minority patients may be more vulnerable to certain sexual difficulties than heterosexual patients.

Authors
Flynn, KE; Lin, L; Weinfurt, KP
MLA Citation
Flynn, KE, Lin, L, and Weinfurt, KP. "Sexual function and satisfaction among heterosexual and sexual minority U.S. adults: A cross-sectional survey." PloS one 12.4 (January 2017): e0174981-.
Website
http://hdl.handle.net/10161/14245
PMID
28403193
Source
epmc
Published In
PloS one
Volume
12
Issue
4
Publish Date
2017
Start Page
e0174981
DOI
10.1371/journal.pone.0174981

Sexual Satisfaction and the Importance of Sexual Health to Quality of Life Throughout the Life Course of U.S. Adults.

Discussions about sexual health are uncommon in clinical encounters, despite the sexual dysfunction associated with many common health conditions. Understanding of the importance of sexual health and sexual satisfaction in U.S. adults is limited.To provide epidemiologic data on the importance of sexual health for quality of life and people's satisfaction with their sex lives and to examine how each is associated with demographic and health factors.Data are from a cross-sectional self-report questionnaire from a sample of 3,515 English-speaking U.S. adults recruited from an online panel that uses address-based probability sampling.We report ratings of importance of sexual health to quality of life (single item with five-point response) and the Patient-Reported Outcomes Measurement Information System Satisfaction With Sex Life score (five items, each with five-point responses, scores centered on the U.S. mean).High importance of sexual health to quality of life was reported by 62.2% of men (95% CI = 59.4-65.0) and 42.8% of women (95% CI = 39.6-46.1, P < .001). Importance of sexual health varied by sex, age, sexual activity status, and general self-rated health. For the 55% of men and 45% of women who reported sexual activity in the previous 30 days, satisfaction with sex life differed by sex, age, race-ethnicity (among men only), and health. Men and women in excellent health had significantly higher satisfaction than participants in fair or poor health. Women with hypertension reported significantly lower satisfaction (especially younger women), as did men with depression or anxiety (especially younger men).In this large study of U.S. adults' ratings of the importance of sexual health and satisfaction with sex life, sexual health was a highly important aspect of quality of life for many participants, including participants in poor health. Moreover, participants in poorer health reported lower sexual satisfaction. Accordingly, sexual health should be a routine part of clinicians' assessments of their patients. Health care systems that state a commitment to improving patients' overall health must have resources in place to address sexual concerns. These resources should be available for all patients across the lifespan.

Authors
Flynn, KE; Lin, L; Bruner, DW; Cyranowski, JM; Hahn, EA; Jeffery, DD; Reese, JB; Reeve, BB; Shelby, RA; Weinfurt, KP
MLA Citation
Flynn, KE, Lin, L, Bruner, DW, Cyranowski, JM, Hahn, EA, Jeffery, DD, Reese, JB, Reeve, BB, Shelby, RA, and Weinfurt, KP. "Sexual Satisfaction and the Importance of Sexual Health to Quality of Life Throughout the Life Course of U.S. Adults." The journal of sexual medicine 13.11 (November 2016): 1642-1650.
PMID
27671968
Source
epmc
Published In
The Journal of Sexual Medicine
Volume
13
Issue
11
Publish Date
2016
Start Page
1642
End Page
1650
DOI
10.1016/j.jsxm.2016.08.011

The Need to Improve Care and Research on Sexual Functioning in Cardiology.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "The Need to Improve Care and Research on Sexual Functioning in Cardiology." JAMA cardiology 1.7 (October 2016): 765-766.
PMID
27579794
Source
epmc
Published In
JAMA Cardiology
Volume
1
Issue
7
Publish Date
2016
Start Page
765
End Page
766
DOI
10.1001/jamacardio.2016.2436

Physicians' perspectives regarding pragmatic clinical trials.

Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians' perspectives related to PCTs.In-depth semistructured interviews with 20 physicians in the USA.Although physicians are generally willing to participate in PCTs, their support is predicated on several factors including expected benefits, minimization of time and workflow burdens and physician engagement. Physicians communicated a desire to respect patients' rights and interests while maintaining a high level of care.Future work is needed to systematically assess the impact of PCTs on clinicians in meeting their ethical obligations to patients and the burdens clinicians are willing to accept in exchange for potential benefits.

Authors
Topazian, R; Bollinger, J; Weinfurt, KP; Dvoskin, R; Mathews, D; Brelsford, K; DeCamp, M; Sugarman, J
MLA Citation
Topazian, R, Bollinger, J, Weinfurt, KP, Dvoskin, R, Mathews, D, Brelsford, K, DeCamp, M, and Sugarman, J. "Physicians' perspectives regarding pragmatic clinical trials." Journal of comparative effectiveness research 5.5 (August 2016): 499-506.
PMID
27417953
Source
epmc
Published In
Journal of Comparative Effectiveness Research
Volume
5
Issue
5
Publish Date
2016
Start Page
499
End Page
506
DOI
10.2217/cer-2016-0024

Symptoms of Lower Urinary Tract Dysfunction Research Network.

To address gaps in understanding and treating lower urinary tract symptoms, the NIDDK created the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). The goals of LURN are to work collaboratively to 1) identify and explain the important subtypes of lower urinary tract symptoms; 2) improve the measurement of patient experiences of lower urinary tract symptoms; 3) disseminate novel findings to researchers, clinicians and patients; and 4) generate data, research tools and biological samples for future studies.As a first step in understanding subtypes of lower urinary tract symptoms, LURN will focus on disorders of urinary sensation (eg urgency) and their causes. These are being examined with respect to patient experience, organism or systemic factors, genitourinary organs and tissues, and cellular/molecular factors. This is being achieved via an observational cohort study that is currently enrolling patients with lower urinary tract symptoms (target number 1,000) and that will extensively characterize patients with lower urinary tract symptoms. Future studies embedded within the observational cohort study will focus on neuroimaging and sensory testing, biomarkers and organ based factors. To advance the science of measurement of lower urinary tract symptoms, LURN is also developing and evaluating a comprehensive set of self-report questions to provide more granular assessments of lower urinary tract symptoms.LURN has taken its first steps by developing a framework for studying lower urinary tract symptom subtypes.In developing this framework, LURN is choosing an initial domain on which to focus (sensory experiences), and creating and executing protocols designed to improve measurement of self-reported symptoms and identify patient subtypes.

Authors
Yang, CC; Weinfurt, KP; Merion, RM; Kirkali, Z; LURN Study Group,
MLA Citation
Yang, CC, Weinfurt, KP, Merion, RM, Kirkali, Z, and LURN Study Group, . "Symptoms of Lower Urinary Tract Dysfunction Research Network." The Journal of urology 196.1 (July 2016): 146-152.
PMID
26784646
Source
epmc
Published In
The Journal of Urology
Volume
196
Issue
1
Publish Date
2016
Start Page
146
End Page
152
DOI
10.1016/j.juro.2016.01.007

PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions.

To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations.Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model.The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions.The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions.

Authors
Cook, KF; Jensen, SE; Schalet, BD; Beaumont, JL; Amtmann, D; Czajkowski, S; Dewalt, DA; Fries, JF; Pilkonis, PA; Reeve, BB; Stone, AA; Weinfurt, KP; Cella, D
MLA Citation
Cook, KF, Jensen, SE, Schalet, BD, Beaumont, JL, Amtmann, D, Czajkowski, S, Dewalt, DA, Fries, JF, Pilkonis, PA, Reeve, BB, Stone, AA, Weinfurt, KP, and Cella, D. "PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions." Journal of clinical epidemiology 73 (May 2016): 89-102.
PMID
26952842
Source
epmc
Published In
Journal of Clinical Epidemiology
Volume
73
Publish Date
2016
Start Page
89
End Page
102
DOI
10.1016/j.jclinepi.2015.08.038

Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials.

We describe our use of cognitive interviews in developing a measure of "preventive misconception" to demonstrate the importance of this approach to researchers developing surveys in empirical bioethics. The preventive misconception involves research participants' false beliefs about a prevention trial, including beliefs that the interventions being tested will certainly be effective.We developed and refined a measure of the preventive misconception using qualitative interviews that focused on cognitive testing of proposed survey items with HIV prevention trial participants.Two main problems emerged during initial interviews. First, the phrase "reduce your risk," used to elicit beliefs about risk reduction from the use of study medications, was interpreted as relating to a reduction of risky behaviors. Second, the phrase "participating in this study," intended to elicit beliefs about trial group assignment, was interpreted as relating to personal behavior changes associated with study participation. Additional interviews using a revised measure were no longer problematic in these ways, and participants felt the response options were appropriate for conveying their answers.These findings underscore the importance of cognitive testing in developing surveys for empirical bioethics.

Authors
Sugarman, J; Seils, DM; Watson-Ormond, JK; Weinfurt, KP
MLA Citation
Sugarman, J, Seils, DM, Watson-Ormond, JK, and Weinfurt, KP. "Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials." AJOB empirical bioethics 7.1 (January 2016): 17-23.
PMID
27747258
Source
epmc
Published In
Ajob Empirical Bioethics
Volume
7
Issue
1
Publish Date
2016
Start Page
17
End Page
23
DOI
10.1080/23294515.2015.1037967

Patients' Views Concerning Research on Medical Practices: Implications for Consent.

Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients' views and opinions regarding a variety of different types of research on usual medical practices, especially notification and authorization for them.We conducted twelve focus groups with adults in five U.S. cities-six focus groups addressing CER ("CER groups") and six groups addressing research involving hospital operations and clinician interventions ("Operations groups"). Participants discussed hypothetical research studies and potential methods of notifying patients and obtaining their authorization to participate. Group discussions were recorded, transcribed, and coded to identify patients' views related to research on standard medical practice.A total of ninety six people participated. Twelve key themes emerged from participants' discussions of the hypothetical research studies; these themes were then grouped into four general categories: clinical care; notification and authorization; communication; and conduct and design of research. The desire to be actively notified and asked was more prominent with regard to CER studies than with regard to Operations studies.Our data suggest that effective policy and guidance will involve balancing different patients' interests and potentially different sets of interests for different types of research studies on usual medical practices.

Authors
Weinfurt, KP; Bollinger, JM; Brelsford, KM; Crayton, TJ; Topazian, RJ; Kass, NE; Beskow, LM; Sugarman, J
MLA Citation
Weinfurt, KP, Bollinger, JM, Brelsford, KM, Crayton, TJ, Topazian, RJ, Kass, NE, Beskow, LM, and Sugarman, J. "Patients' Views Concerning Research on Medical Practices: Implications for Consent." AJOB empirical bioethics 7.2 (January 2016): 76-91.
PMID
27800531
Source
epmc
Published In
Ajob Empirical Bioethics
Volume
7
Issue
2
Publish Date
2016
Start Page
76
End Page
91
DOI
10.1080/23294515.2015.1117536

Reliability and construct validity of PROMIS® measures for patients with heart failure who undergo heart transplant.

To evaluate the reliability and construct validity of measures from the Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) for patients with heart failure before and after heart transplantation.We assessed reliability of the PROMIS short forms using Cronbach's alpha and the average marginal reliability. To assess the construct validity of PROMIS computerized adaptive tests and short-form measures, we calculated Pearson product moment correlations between PROMIS measures of physical function, fatigue, depression, and social function and existing PRO measures of similar domains (i.e., convergent validity) as well as different domains (i.e., discriminate validity) in patients with heart failure awaiting heart transplant. We evaluated the responsiveness of these measures to change after heart transplant using effect sizes.Forty-eight patients were included in the analyses. Across the many domains examined, correlations between conceptually similar domains were larger than correlations between different domains of health, demonstrating construct validity. Health status improved substantially after heart transplant (standardized effect sizes, 0.63-1.24), demonstrating the responsiveness of the PROMIS measures. Scores from the computerized adaptive tests and the short forms were similar.This study provides evidence for the reliability and construct validity (including responsiveness to change) of four PROMIS domains in patients with heart failure before and after heart transplant. PROMIS measures are a reasonable choice in this context and will facilitate comparisons across studies and health conditions.

Authors
Flynn, KE; Dew, MA; Lin, L; Fawzy, M; Graham, FL; Hahn, EA; Hays, RD; Kormos, RL; Liu, H; McNulty, M; Weinfurt, KP
MLA Citation
Flynn, KE, Dew, MA, Lin, L, Fawzy, M, Graham, FL, Hahn, EA, Hays, RD, Kormos, RL, Liu, H, McNulty, M, and Weinfurt, KP. "Reliability and construct validity of PROMIS® measures for patients with heart failure who undergo heart transplant." Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 24.11 (November 2015): 2591-2599.
PMID
26038213
Source
epmc
Published In
Quality of Life Research
Volume
24
Issue
11
Publish Date
2015
Start Page
2591
End Page
2599
DOI
10.1007/s11136-015-1010-y

Development and Validation of a Single-Item Screener for Self-Reporting Sexual Problems in U.S. Adults.

Brief self-assessment of sexual problems in a clinical context has the potential to improve care for patients through the ability to track trends in sexual problems over time and facilitate patient-provider communication about this important topic. However, instruments designed for research are typically too long to be practical in clinical practice.To develop and validate a single-item self-report clinical screener that would capture common sexual problems and concerns for men and women.We created three candidate screener items, refined them through cognitive interviews, and administered them to a large sample. We compared the prevalence of responses to each item and explored the discrepancies between items. We evaluated the construct validity of the items by comparing them to scores on the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction (PROMIS® SexFS) measure.Local patients participated in two rounds of cognitive interviews (n = 7 and n = 11). A probability-based random sample of U.S. adults comprised the item-testing sample (n = 3517).The items were as follows: 1) a yes/no item on any sexual problems or concerns ("general screener"), 2) a yes/no item on problems experienced for 3 months or more during the past 12 months, with a list of examples ("long list screener"), and 3) an item identical to the long list screener except that examples appeared individually as response options and respondents could check all that applied ("checklist screener").All of the screeners tested showed evidence for basic validity and had minimal missing data. Percentages of women and men endorsing the screeners were 10 % and 15 % (general); 20 % and 17 % (long list); and 38 % and 30 % (checklist), respectively. Participants who endorsed the screeners had lower function compared to those who did not endorse them.We recommend the checklist screener for its specificity and ability to identify specific problems associated with decreased sexual function.

Authors
Flynn, KE; Lindau, ST; Lin, L; Reese, JB; Jeffery, DD; Carter, J; Baron, SR; Abramsohn, E; Weinfurt, KP
MLA Citation
Flynn, KE, Lindau, ST, Lin, L, Reese, JB, Jeffery, DD, Carter, J, Baron, SR, Abramsohn, E, and Weinfurt, KP. "Development and Validation of a Single-Item Screener for Self-Reporting Sexual Problems in U.S. Adults." Journal of general internal medicine 30.10 (October 2015): 1468-1475.
PMID
25893421
Source
epmc
Published In
Journal of General Internal Medicine
Volume
30
Issue
10
Publish Date
2015
Start Page
1468
End Page
1475
DOI
10.1007/s11606-015-3333-3

Use of altered informed consent in pragmatic clinical research.

There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests.

Authors
McKinney, RE; Beskow, LM; Ford, DE; Lantos, JD; McCall, J; Patrick-Lake, B; Pletcher, MJ; Rath, B; Schmidt, H; Weinfurt, K
MLA Citation
McKinney, RE, Beskow, LM, Ford, DE, Lantos, JD, McCall, J, Patrick-Lake, B, Pletcher, MJ, Rath, B, Schmidt, H, and Weinfurt, K. "Use of altered informed consent in pragmatic clinical research." Clinical trials (London, England) 12.5 (October 2015): 494-502.
PMID
26374677
Source
epmc
Published In
Clinical Trials
Volume
12
Issue
5
Publish Date
2015
Start Page
494
End Page
502
DOI
10.1177/1740774515597688

Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0.

The Patient-Reported Outcomes Measurement Information System (PROMIS)(®) Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations.The aim of this study was to describe the development of the SexFS v2.0 and present preliminary evidence for its validity.Development built on version 1.0, plus additional review of extant items, discussions with 15 clinical experts, 11 patient focus groups (including individuals with diabetes, heart disease, anxiety, depression, and/or are lesbian, gay, bisexual, or aged 65 or older), 48 cognitive interviews, and psychometric evaluation in a random sample of U.S. adults plus an oversample for specific sexual problems (2281 men, 1686 women). We examined differential item functioning (DIF) by gender and sexual activity. We examined convergent and known-groups validity.The final set of domains includes 11 scored scales (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction), and six nonscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Domains from version 1.0 were reevaluated and improved. Domains considered applicable across gender and sexual activity status, namely interest, orgasm, and satisfaction, were found to have significant DIF. We identified subsets of items in each domain that provided consistent measurement across these important respondent groups. Convergent and known-groups validity was supported.The SexFS version 2.0 has several improvements and enhancements over version 1.0 and other extant measures, including expanded evidence for validity, scores centered around norms for sexually active U.S. adults, new domains, and a final set of items applicable for both men and women and those sexually active with a partner and without. The SexFS is customizable, allowing users to select relevant domains and items for their study.

Authors
Weinfurt, KP; Lin, L; Bruner, DW; Cyranowski, JM; Dombeck, CB; Hahn, EA; Jeffery, DD; Luecht, RM; Magasi, S; Porter, LS; Reese, JB; Reeve, BB; Shelby, RA; Smith, AW; Willse, JT; Flynn, KE
MLA Citation
Weinfurt, KP, Lin, L, Bruner, DW, Cyranowski, JM, Dombeck, CB, Hahn, EA, Jeffery, DD, Luecht, RM, Magasi, S, Porter, LS, Reese, JB, Reeve, BB, Shelby, RA, Smith, AW, Willse, JT, and Flynn, KE. "Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0." The journal of sexual medicine 12.9 (September 7, 2015): 1961-1974.
PMID
26346418
Source
epmc
Published In
The Journal of Sexual Medicine
Volume
12
Issue
9
Publish Date
2015
Start Page
1961
End Page
1974
DOI
10.1111/jsm.12966

Informed consent for biobanking: consensus-based guidelines for adequate comprehension.

Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent.We conducted a Delphi process to define "adequate comprehension" in the context of biobanking consent. The process involved an iterative series of three online surveys of a diverse panel of 51 experts, including genome scientists, biobank managers, ethics and policy experts, and community and participant representatives. We sought consensus (>70% agreement) concerning what specific details participants should know about 16 biobank consent topics.Consensus was achieved for 15 of the 16 consent topics. The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act.Our Delphi process was successful in identifying a concise set of key points that prospective participants must grasp to provide valid consent for biobanking. Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes, as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension.Genet Med 17 3, 226-233.

Authors
Beskow, LM; Dombeck, CB; Thompson, CP; Watson-Ormond, JK; Weinfurt, KP
MLA Citation
Beskow, LM, Dombeck, CB, Thompson, CP, Watson-Ormond, JK, and Weinfurt, KP. "Informed consent for biobanking: consensus-based guidelines for adequate comprehension." Genetics in medicine : official journal of the American College of Medical Genetics 17.3 (March 2015): 226-233.
PMID
25144889
Source
epmc
Published In
Genetics in Medicine
Volume
17
Issue
3
Publish Date
2015
Start Page
226
End Page
233
DOI
10.1038/gim.2014.102

Patient preferences in advanced or recurrent ovarian cancer.

The objective of this study was to elucidate relative preferences of women with ovarian cancer for symptoms, treatment-related side effects, and progression-free survival (PFS) relevant to choosing a treatment regimen.Women with advanced or recurrent ovarian cancer participated in a survey that included 3 methods to measure patient preferences (ratings, rankings, and a discrete-choice experiment) for 7 attributes: mode of administration, visit frequency, peripheral neuropathy, nausea and vomiting, fatigue, abdominal discomfort, and PFS. Participants were asked to choose between 2 unlabeled treatment scenarios that were characterized using the 7 attributes. Each participant completed 12 choice questions in which attribute levels were assigned according to an experimental design and a fixed-choice question representing 2 chemotherapy regimens for ovarian cancer.In total, 95 women completed the survey. Participants' ratings and rankings revealed greater concern and importance for PFS than for any other attribute (P < .0001 for all). The discrete-choice experiment revealed that the relative odds that a participant would choose a scenario with 18 months, 21 months, and 24 months of PFS versus 15 months of PFS were 1.5 (P = .01), 3.4 (P < .001), and 7.5 (P < .001), respectively. However, participants' choices indicated that they were willing to accept a shorter PFS to avoid severe side effects: 6.7 months to reduce nausea and vomiting from severe to mild, 5.0 months to reduce neuropathy from severe to mild, and 3.7 months to reduce abdominal symptoms from severe to moderate.PFS is the predominant driver of patient preferences for chemotherapy regimens. However, women in the current study were willing to trade significant PFS time for reductions in treatment-related toxicity.

Authors
Havrilesky, LJ; Alvarez Secord, A; Ehrisman, JA; Berchuck, A; Valea, FA; Lee, PS; Gaillard, SL; Samsa, GP; Cella, D; Weinfurt, KP; Abernethy, AP; Reed, SD
MLA Citation
Havrilesky, LJ, Alvarez Secord, A, Ehrisman, JA, Berchuck, A, Valea, FA, Lee, PS, Gaillard, SL, Samsa, GP, Cella, D, Weinfurt, KP, Abernethy, AP, and Reed, SD. "Patient preferences in advanced or recurrent ovarian cancer." Cancer 120.23 (December 2014): 3651-3659.
PMID
25091693
Source
epmc
Published In
Cancer
Volume
120
Issue
23
Publish Date
2014
Start Page
3651
End Page
3659
DOI
10.1002/cncr.28940

Improving patients' understanding of terms and phrases commonly used in self-reported measures of sexual function.

There is a significant gap in research regarding the readability and comprehension of existing sexual function measures. Patient-reported outcome measures may use terms not well understood by respondents with low literacy.This study aims to test comprehension of words and phrases typically used in sexual function measures to improve validity for all individuals, including those with low literacy.We recruited 20 men and 28 women for cognitive interviews on version 2.0 of the Patient-Reported Outcome Measurement Information System(®) (PROMIS(®) ) Sexual Function and Satisfaction measures. We assessed participants' reading level using the word reading subtest of the Wide Range Achievement Test. Sixteen participants were classified as having low literacy.In the first round of cognitive interviews, each survey item was reviewed by five or more people, at least two of whom had lower than a ninth-grade reading level (low literacy). Patient feedback was incorporated into a revised version of the items. In the second round of interviews, an additional three or more people (at least one with low literacy) reviewed each revised item.Participants with low literacy had difficulty comprehending terms such as aroused, orgasm, erection, ejaculation, incontinence, and vaginal penetration. Women across a range of literacy levels had difficulty with clinical terms like labia and clitoris. We modified unclear terms to include parenthetical descriptors or slang equivalents, which generally improved comprehension.Common words and phrases used across measures of self-reported sexual function are not universally understood. Researchers should appreciate these misunderstandings as a potential source of error in studies using self-reported measures of sexual function. This study also provides evidence for the importance of including individuals with low literacy in cognitive pretesting during the measure development.

Authors
Alexander, AM; Flynn, KE; Hahn, EA; Jeffery, DD; Keefe, FJ; Reeve, BB; Schultz, W; Reese, JB; Shelby, RA; Weinfurt, KP
MLA Citation
Alexander, AM, Flynn, KE, Hahn, EA, Jeffery, DD, Keefe, FJ, Reeve, BB, Schultz, W, Reese, JB, Shelby, RA, and Weinfurt, KP. "Improving patients' understanding of terms and phrases commonly used in self-reported measures of sexual function." The journal of sexual medicine 11.8 (August 2014): 1991-1998.
PMID
24902984
Source
epmc
Published In
The Journal of Sexual Medicine
Volume
11
Issue
8
Publish Date
2014
Start Page
1991
End Page
1998
DOI
10.1111/jsm.12599

Community consultation for prehospital research: experiences of study coordinators and principal investigators.

OBJECTIVE: To assess principal investigators' and study coordinators' views and experiences regarding community consultation in a multicenter trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings. METHODS: Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included 1) perceived goals of community consultation, 2) experiences with and views of community consultation methods used, 3) interactions with IRB regarding community consultation, and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data. RESULTS: Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median = 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings. CONCLUSIONS: Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.

Authors
Dickert, NW; Govindarajan, P; Harney, D; Silbergleit, R; Sugarman, J; Weinfurt, KP; Pentz, RD
MLA Citation
Dickert, NW, Govindarajan, P, Harney, D, Silbergleit, R, Sugarman, J, Weinfurt, KP, and Pentz, RD. "Community consultation for prehospital research: experiences of study coordinators and principal investigators." Prehosp Emerg Care 18.2 (April 2014): 274-281.
PMID
24401134
Source
pubmed
Published In
Prehospital Emergency Care (Elsevier)
Volume
18
Issue
2
Publish Date
2014
Start Page
274
End Page
281
DOI
10.3109/10903127.2013.856503

Impact of cardiovascular events on change in quality of life and utilities in patients after myocardial infarction: a VALIANT study (valsartan in acute myocardial infarction).

OBJECTIVES: The objective of this study was to determine the impact of nonfatal cardiovascular (CV) events on changes in health-related quality of life (HRQL). BACKGROUND: There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors of myocardial infarction (MI). METHODS: The VALIANT (Valsartan In Acute Myocardial Infarction) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher (scale measuring heart failure severity post-MI ranging from class I to IV) and/or reduced ejection fraction. The HRQL substudy included 2,556 (17.4%) patients who completed the EQ-5D with 5 questions, with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale (VAS) ranging from 0 (worst) to 100 (best) imaginable health state. EQ-5D was administered at baseline and 6, 12, 20, and 24 months. The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events. Patients who died before the next EQ-5D assessment were excluded. RESULTS: Over a 2-year period, 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment. Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event (VAS 61.0 ± 19 vs 68.2 ± 18 [p < 0.001] and US-based utility score 0.76 ± 0.22 vs 0.83 ± 0.17 [p < 0.001]). These patients with CV events experienced a trajectory-adjusted 6.6 point decrease (p < 0.001) in VAS scores and a 0.07 decrease (p < 0.001) in utility score after the nonfatal CV event. CONCLUSIONS: MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory, suggesting that generic instruments can be responsive to nonfatal events. Reduction in nonfatal CV events may affect longitudinal changes in HRQL.

Authors
Lewis, EF; Li, Y; Pfeffer, MA; Solomon, SD; Weinfurt, KP; Velazquez, EJ; Califf, RM; Rouleau, J-L; Kober, L; White, HD; Schulman, KA; Reed, SD
MLA Citation
Lewis, EF, Li, Y, Pfeffer, MA, Solomon, SD, Weinfurt, KP, Velazquez, EJ, Califf, RM, Rouleau, J-L, Kober, L, White, HD, Schulman, KA, and Reed, SD. "Impact of cardiovascular events on change in quality of life and utilities in patients after myocardial infarction: a VALIANT study (valsartan in acute myocardial infarction)." JACC. Heart failure 2.2 (April 2014): 159-165.
PMID
24720924
Source
epmc
Published In
JACC: Heart Failure
Volume
2
Issue
2
Publish Date
2014
Start Page
159
End Page
165
DOI
10.1016/j.jchf.2013.12.003

Accuracy of 30-day recall for components of sexual function and the moderating effects of gender and mood.

INTRODUCTION: Despite the ubiquity of 1-month recall periods for measures of sexual function, there is limited evidence for how well recalled responses correspond to individuals' actual daily experiences. AIM: To characterize the correspondence between daily sexual experiences and 1-month recall of those experiences. METHODS: Following a baseline assessment of sexual functioning, health, and demographic characteristics, 202 adults from the general population (101 women, 101 men) were recruited to complete daily assessments of their sexual function online for 30 days and a single recall measure of sexual function at day 30. MAIN OUTCOME MEASURES: At the baseline and 30-day follow-ups, participants answered items asking about sexual satisfaction, sexual activities, interest, interfering factors, orgasm, sexual functioning, and use of therapeutic aids during the previous 30 days. Participants also completed a measure of positive and negative affect at follow-up. The main outcome measures were agreement between the daily and 1-month recall versions of the sexual function items. RESULTS: Accuracy of recall varied depending on the item and on the gender and mood of the respondent. Recall was better (low bias and higher correlations) for sexual activities, vaginal discomfort, erectile function, and more frequently used therapeutic aids. Recall was poorer for interest, affectionate behaviors (e.g., kissing), and orgasm-related items. Men more than women overestimated frequency of interest and masturbation. Concurrent mood was related to over- or underreporting for six items addressing the frequency of masturbation and vaginal intercourse, erectile function, and orgasm. CONCLUSIONS: A 1-month recall period seems acceptable for many aspects of sexual function in this population, but recall for some items was poor. Researchers should be aware that concurrent mood can have a powerful biasing effect on reports of sexual function.

Authors
Weinfurt, KP; Lin, L; Dombeck, CB; Broderick, JE; Snyder, DC; Williams, MS; Fawzy, MR; Flynn, KE
MLA Citation
Weinfurt, KP, Lin, L, Dombeck, CB, Broderick, JE, Snyder, DC, Williams, MS, Fawzy, MR, and Flynn, KE. "Accuracy of 30-day recall for components of sexual function and the moderating effects of gender and mood." J Sex Med 11.3 (March 2014): 678-696.
PMID
23802907
Source
pubmed
Published In
The Journal of Sexual Medicine
Volume
11
Issue
3
Publish Date
2014
Start Page
678
End Page
696
DOI
10.1111/jsm.12225

Consulting communities when patients cannot consent: A multicenter study of community consultation for research in emergency settings

OBJECTIVES:: To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study. DESIGN:: A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury. SETTING:: Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent. SUBJECTS:: Adult participants in community consultation events. INTERVENTIONS:: Community consultation efforts at participating sites. MEASUREMENTS AND MAIN RESULTS:: Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive consultation participants (77% vs 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs 45%) but less likely to recall potential risks (56% vs 69%). CONCLUSIONS:: Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed consent acceptance among different interactive consultation events. These findings have important implications for institutional review board and investigators conducting exception from informed consent research and for community engagement efforts in research more generally. © 2013 by the Society of Critical Care Medicine and Lippincott.

Authors
Dickert, NW; Mah, VA; Biros, MH; Harney, DM; Silbergleit, R; Sugarman, J; Veledar, E; Weinfurt, KP; Wright, DW; Pentz, RD
MLA Citation
Dickert, NW, Mah, VA, Biros, MH, Harney, DM, Silbergleit, R, Sugarman, J, Veledar, E, Weinfurt, KP, Wright, DW, and Pentz, RD. "Consulting communities when patients cannot consent: A multicenter study of community consultation for research in emergency settings." Critical Care Medicine 42.2 (February 1, 2014): 272-280.
Source
scopus
Published In
Critical Care Medicine
Volume
42
Issue
2
Publish Date
2014
Start Page
272
End Page
280
DOI
10.1097/CCM.0b013e3182a27759

Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings.

OBJECTIVES: To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study. DESIGN: A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury. SETTING: Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent. SUBJECTS: Adult participants in community consultation events. INTERVENTIONS: Community consultation efforts at participating sites. MEASUREMENTS AND MAIN RESULTS: Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive consultation participants (77% vs 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs 45%) but less likely to recall potential risks (56% vs 69%). CONCLUSIONS: Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed consent acceptance among different interactive consultation events. These findings have important implications for institutional review board and investigators conducting exception from informed consent research and for community engagement efforts in research more generally.

Authors
Dickert, NW; Mah, VA; Biros, MH; Harney, DM; Silbergleit, R; Sugarman, J; Veledar, E; Weinfurt, KP; Wright, DW; Pentz, RD
MLA Citation
Dickert, NW, Mah, VA, Biros, MH, Harney, DM, Silbergleit, R, Sugarman, J, Veledar, E, Weinfurt, KP, Wright, DW, and Pentz, RD. "Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings." Crit Care Med 42.2 (February 2014): 272-280.
PMID
24145834
Source
pubmed
Published In
Critical Care Medicine
Volume
42
Issue
2
Publish Date
2014
Start Page
272
End Page
280
DOI
10.1097/CCM.0b013e3182a27759

Accuracy of 30-Day Recall for Components of Sexual Function and the Moderating Effects of Gender and Mood

Introduction: Despite the ubiquity of 1-month recall periods for measures of sexual function, there is limited evidence for how well recalled responses correspond to individuals' actual daily experiences. Aim: To characterize the correspondence between daily sexual experiences and 1-month recall of those experiences. Methods: Following a baseline assessment of sexual functioning, health, and demographic characteristics, 202 adults from the general population (101 women, 101 men) were recruited to complete daily assessments of their sexual function online for 30 days and a single recall measure of sexual function at day 30. Main Outcome Measures: At the baseline and 30-day follow-ups, participants answered items asking about sexual satisfaction, sexual activities, interest, interfering factors, orgasm, sexual functioning, and use of therapeutic aids during the previous 30 days. Participants also completed a measure of positive and negative affect at follow-up. The main outcome measures were agreement between the daily and 1-month recall versions of the sexual function items. Results: Accuracy of recall varied depending on the item and on the gender and mood of the respondent. Recall was better (low bias and higher correlations) for sexual activities, vaginal discomfort, erectile function, and more frequently used therapeutic aids. Recall was poorer for interest, affectionate behaviors (e.g., kissing), and orgasm-related items. Men more than women overestimated frequency of interest and masturbation. Concurrent mood was related to over- or underreporting for six items addressing the frequency of masturbation and vaginal intercourse, erectile function, and orgasm. Conclusions: A 1-month recall period seems acceptable for many aspects of sexual function in this population, but recall for some items was poor. Researchers should be aware that concurrent mood can have a powerful biasing effect on reports of sexual function. © 2013 International Society for Sexual Medicine.

Authors
Weinfurt, KP; Lin, L; Dombeck, CB; Broderick, JE; Snyder, DC; Williams, MS; Fawzy, MR; Flynn, KE
MLA Citation
Weinfurt, KP, Lin, L, Dombeck, CB, Broderick, JE, Snyder, DC, Williams, MS, Fawzy, MR, and Flynn, KE. "Accuracy of 30-Day Recall for Components of Sexual Function and the Moderating Effects of Gender and Mood." Journal of Sexual Medicine 11.3 (January 1, 2014): 678-696.
Source
scopus
Published In
The Journal of Sexual Medicine
Volume
11
Issue
3
Publish Date
2014
Start Page
678
End Page
696
DOI
10.1111/jsm.12225

Improving patients' understanding of terms and phrases commonly used in self-reported measures of sexual function

Introduction: There is a significant gap in research regarding the readability and comprehension of existing sexual function measures. Patient-reported outcome measures may use terms not well understood by respondents with low literacy. Aim: This study aims to test comprehension of words and phrases typically used in sexual function measures to improve validity for all individuals, including those with low literacy. Methods: We recruited 20 men and 28 women for cognitive interviews on version 2.0 of the Patient-Reported Outcome Measurement Information System ® (PROMIS ® ) Sexual Function and Satisfaction measures. We assessed participants' reading level using the word reading subtest of the Wide Range Achievement Test. Sixteen participants were classified as having low literacy. Main Outcome Measures: In the first round of cognitive interviews, each survey item was reviewed by five or more people, at least two of whom had lower than a ninth-grade reading level (low literacy). Patient feedback was incorporated into a revised version of the items. In the second round of interviews, an additional three or more people (at least one with low literacy) reviewed each revised item. Results: Participants with low literacy had difficulty comprehending terms such as aroused, orgasm, erection, ejaculation, incontinence, and vaginal penetration. Women across a range of literacy levels had difficulty with clinical terms like labia and clitoris. We modified unclear terms to include parenthetical descriptors or slang equivalents, which generally improved comprehension. Conclusions: Common words and phrases used across measures of self-reported sexual function are not universally understood. Researchers should appreciate these misunderstandings as a potential source of error in studies using self-reported measures of sexual function. This study also provides evidence for the importance of including individuals with low literacy in cognitive pretesting during the measure development. Alexander AM, Flynn KE, Hahn EA, Jeffery DD, Keefe FJ, Reeve BB, Schultz W, Reese JB, Shelby RA, and Weinfurt KP. Improving patients' understanding of terms and phrases commonly used in self-reported measures of sexual function. J Sex Med 2014;11:1991-1998. © 2014 International Society for Sexual Medicine.

Authors
Alexander, AM; Flynn, KE; Hahn, EA; Jeffery, DD; Keefe, FJ; Reeve, BB; Schultz, W; Reese, JB; Shelby, RA; Weinfurt, KP
MLA Citation
Alexander, AM, Flynn, KE, Hahn, EA, Jeffery, DD, Keefe, FJ, Reeve, BB, Schultz, W, Reese, JB, Shelby, RA, and Weinfurt, KP. "Improving patients' understanding of terms and phrases commonly used in self-reported measures of sexual function." Journal of Sexual Medicine 11.8 (January 1, 2014): 1991-1998.
Source
scopus
Published In
The Journal of Sexual Medicine
Volume
11
Issue
8
Publish Date
2014
Start Page
1991
End Page
1998
DOI
10.1111/jsm.12599

Patient preferences in advanced or recurrent ovarian cancer

© 2014 American Cancer Society. BACKGROUND: The objective of this study was to elucidate relative preferences of women with ovarian cancer for symptoms, treatment-related side effects, and progression-free survival (PFS) relevant to choosing a treatment regimen. METHODS: Women with advanced or recurrent ovarian cancer participated in a survey that included 3 methods to measure patient preferences (ratings, rankings, and a discrete-choice experiment) for 7 attributes: mode of administration, visit frequency, peripheral neuropathy, nausea and vomiting, fatigue, abdominal discomfort, and PFS. Participants were asked to choose between 2 unlabeled treatment scenarios that were characterized using the 7 attributes. Each participant completed 12 choice questions in which attribute levels were assigned according to an experimental design and a fixed-choice question representing 2 chemotherapy regimens for ovarian cancer. RESULTS: In total, 95 women completed the survey. Participants' ratings and rankings revealed greater concern and importance for PFS than for any other attribute (P < .0001 for all). The discrete-choice experiment revealed that the relative odds that a participant would choose a scenario with 18 months, 21 months, and 24 months of PFS versus 15 months of PFS were 1.5 (P5.01), 3.4 (P < .001), and 7.5 (P < .001), respectively. However, participants' choices indicated that they were willing to accept a shorter PFS to avoid severe side effects: 6.7 months to reduce nausea and vomiting from severe to mild, 5.0 months to reduce neuropathy from severe to mild, and 3.7 months to reduce abdominal symptoms from severe to moderate. CONCLUSIONS: PFS is the predominant driver of patient preferences for chemotherapy regimens. However, women in the current study were willing to trade significant PFS time for reductions in treatment-related toxicity.

Authors
Havrilesky, LJ; Secord, AA; Ehrisman, JA; Berchuck, A; Valea, FA; Lee, PS; Gaillard, SL; Samsa, GP; Cella, D; Weinfurt, KP; Abernethy, AP; Reed, SD
MLA Citation
Havrilesky, LJ, Secord, AA, Ehrisman, JA, Berchuck, A, Valea, FA, Lee, PS, Gaillard, SL, Samsa, GP, Cella, D, Weinfurt, KP, Abernethy, AP, and Reed, SD. "Patient preferences in advanced or recurrent ovarian cancer." Cancer 120.23 (January 1, 2014): 3651-3659.
Source
scopus
Published In
Cancer
Volume
120
Issue
23
Publish Date
2014
Start Page
3651
End Page
3659
DOI
10.1002/cncr.28940

An evaluation of mobile health application tools.

BACKGROUND: The rapid growth in the number of mobile health applications could have profound significance in the prevention of disease or in the treatment of patients with chronic disease such as diabetes. OBJECTIVE: The objective of this study was to describe the characteristics of the most common mobile health care applications available in the Apple iTunes marketplace. METHODS: We undertook a descriptive analysis of a sample of applications in the "health and wellness" category of the Apple iTunes Store. We characterized each application in terms of its health factor and primary method of user engagement. The main outcome measures of the analysis were price, health factors, and methods of user engagement. RESULTS: Among the 400 applications that met the inclusion criteria, the mean price of the most frequently downloaded paid applications was US $2.24 (SD $1.30), and the mean price of the most currently available paid applications was US $2.27 (SD $1.60). Fitness/training applications were the most popular (43.5%, 174/400). The next two most common categories were health resource (15.0%, 60/400) and diet/caloric intake (14.3%, 57/400). Applications in the health resource category constituted 5.5% (22/400) of the applications reviewed. Self-monitoring was the most common primary user engagement method (74.8%, 299/400). A total of 20.8% (83/400) of the applications used two or more user engagement approaches, with self-monitoring and progress tracking being the most frequent. CONCLUSIONS: Most of the popular mobile health applications focus on fitness and self-monitoring. The approaches to user engagement utilized by these applications are limited and present an opportunity to improve the effectiveness of the technology.

Authors
Sama, PR; Eapen, ZJ; Weinfurt, KP; Shah, BR; Schulman, KA
MLA Citation
Sama, PR, Eapen, ZJ, Weinfurt, KP, Shah, BR, and Schulman, KA. "An evaluation of mobile health application tools." JMIR mHealth and uHealth 2.2 (January 2014): e19-.
PMID
25099179
Source
epmc
Published In
JMIR mHealth and uHealth
Volume
2
Issue
2
Publish Date
2014
Start Page
e19
DOI
10.2196/mhealth.3088

A comparison of cancer survivors from the PROMIS study selecting telephone versus online questionnaires

Authors
Williams, MS; Snyder, DC; Sloane, R; Levens, J; Flynn, KE; Dombeck, CB; Demark-Wahnefried, W; Weinfurt, KP
MLA Citation
Williams, MS, Snyder, DC, Sloane, R, Levens, J, Flynn, KE, Dombeck, CB, Demark-Wahnefried, W, and Weinfurt, KP. "A comparison of cancer survivors from the PROMIS study selecting telephone versus online questionnaires." Psycho-Oncology 22.11 (November 1, 2013): 2632-2635. (Letter)
Source
scopus
Published In
Psycho-Oncology
Volume
22
Issue
11
Publish Date
2013
Start Page
2632
End Page
2635
DOI
10.1002/pon.3330

A comparison of cancer survivors from the PROMIS study selecting telephone versus online questionnaires.

Authors
Williams, MS; Snyder, DC; Sloane, R; Levens, J; Flynn, KE; Dombeck, CB; Demark-Wahnefried, W; Weinfurt, KP
MLA Citation
Williams, MS, Snyder, DC, Sloane, R, Levens, J, Flynn, KE, Dombeck, CB, Demark-Wahnefried, W, and Weinfurt, KP. "A comparison of cancer survivors from the PROMIS study selecting telephone versus online questionnaires." Psychooncology 22.11 (November 2013): 2632-2635. (Letter)
PMID
23813785
Source
pubmed
Published In
Psycho-Oncology
Volume
22
Issue
11
Publish Date
2013
Start Page
2632
End Page
2635
DOI
10.1002/pon.3330

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.

INTRODUCTION: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. METHODS: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. RESULTS: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. CONCLUSIONS: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.

Authors
Denicoff, AM; McCaskill-Stevens, W; Grubbs, SS; Bruinooge, SS; Comis, RL; Devine, P; Dilts, DM; Duff, ME; Ford, JG; Joffe, S; Schapira, L; Weinfurt, KP; Michaels, M; Raghavan, D; Richmond, ES; Zon, R; Albrecht, TL; Bookman, MA; Dowlati, A; Enos, RA; Fouad, MN; Good, M; Hicks, WJ; Loehrer, PJ; Lyss, AP; Wolff, SN; Wujcik, DM; Meropol, NJ
MLA Citation
Denicoff, AM, McCaskill-Stevens, W, Grubbs, SS, Bruinooge, SS, Comis, RL, Devine, P, Dilts, DM, Duff, ME, Ford, JG, Joffe, S, Schapira, L, Weinfurt, KP, Michaels, M, Raghavan, D, Richmond, ES, Zon, R, Albrecht, TL, Bookman, MA, Dowlati, A, Enos, RA, Fouad, MN, Good, M, Hicks, WJ, Loehrer, PJ, Lyss, AP, Wolff, SN, Wujcik, DM, and Meropol, NJ. "The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations." J Oncol Pract 9.6 (November 2013): 267-276.
PMID
24130252
Source
pubmed
Published In
Journal of Oncology Practice
Volume
9
Issue
6
Publish Date
2013
Start Page
267
End Page
276
DOI
10.1200/JOP.2013.001119

Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial).

Anemia is common in patients with chronic heart failure (HF), with a prevalence ranging from 10% to 56%, and may be a risk factor for poor outcomes. Anemia in HF remains poorly understood, with significant gaps in its impact on health-related quality of life (HRQoL), with most studies in HF being retrospective or from registries. The purpose of this study was to explore the relation of hemoglobin (Hgb) with HRQoL and training-induced changes in HRQoL in a cohort of patients in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Using data from HF-ACTION, a randomized controlled trial of exercise training in patients with HF and low left ventricular ejection fractions, HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and annually up to 4 years. Treatment group effects on HRQoL were estimated using linear mixed models according to the intention-to-treat principle. It was hypothesized that baseline Hgb would be correlated with baseline KCCQ scales and that Hgb would moderate the beneficial effect of exercise training on HRQoL. Hgb level was not significantly correlated with baseline HRQoL. Baseline Hgb did not moderate the beneficial effect of exercise training on KCCQ overall or subscales relative to usual care. In conclusion, in the HF-ACTION cohort, there was no correlation with baseline Hgb and baseline HRQoL as measured by the KCCQ. In addition, the beneficial effects of HRQoL from exercise training were not modulated by baseline Hgb.

Authors
Piña, IL; Lin, L; Weinfurt, KP; Isitt, JJ; Whellan, DJ; Schulman, KA; Flynn, KE; HF-ACTION Investigators,
MLA Citation
Piña, IL, Lin, L, Weinfurt, KP, Isitt, JJ, Whellan, DJ, Schulman, KA, Flynn, KE, and HF-ACTION Investigators, . "Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)." Am J Cardiol 112.7 (October 1, 2013): 971-976.
PMID
23809621
Source
pubmed
Published In
American Journal of Cardiology
Volume
112
Issue
7
Publish Date
2013
Start Page
971
End Page
976
DOI
10.1016/j.amjcard.2013.05.033

Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature.

BACKGROUND: To improve the efficiency of conducting multicenter clinical trials, the Food and Drug Administration, the Office of Human Research Protections, and the Department of Health and Human Services have expressed support for using a centralized institutional review board (IRB) process. However, research institutions differ in their willingness to defer to central IRBs. PURPOSE: We aimed to review and describe peer-reviewed journal articles on the use of central IRBs for multicenter clinical trials in the United States in an effort to inform the policy discussion about central IRBs. METHODS: We used a PubMed search and consulted IRB experts and the bibliographies of other reviews to identify relevant commentaries and empirical studies. RESULTS: Our search identified 33 articles related to the use of central IRBs for multicenter trials in the United States. Of these, 22 were commentary pieces and 11 were empirical studies. LIMITATIONS: Our review was restricted to journal articles about the use of central IRBs for multicenter clinical trials in the United States. CONCLUSIONS: There is limited empirical work on the use of central IRBs for multicenter trials in the United States. Most published studies focused on problems in efficiency associated with redundant local reviews of multicenter studies and the potential benefits of a centralized system. Because the absence of studies on the use of central IRBs may be due to their infrequent use, additional work is needed to generate data on the use of central IRBs and to elucidate and address the concerns that research institutions have about deferring ethical review to a central IRB.

Authors
Check, DK; Weinfurt, KP; Dombeck, CB; Kramer, JM; Flynn, KE
MLA Citation
Check, DK, Weinfurt, KP, Dombeck, CB, Kramer, JM, and Flynn, KE. "Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature." Clin Trials 10.4 (August 2013): 560-567. (Review)
PMID
23666951
Source
pubmed
Published In
Clinical Trials
Volume
10
Issue
4
Publish Date
2013
Start Page
560
End Page
567
DOI
10.1177/1740774513484393

Participants' perspectives on safety monitoring in clinical trials.

BACKGROUND: Minimizing the risk to study participants is an essential requirement of ethical research. Respecting the rights of subjects is also paramount, which includes respecting their autonomy by making available important information about the evolving safety profile of an investigational product as the trial progresses. Little is known about what trial participants understand and expect regarding monitoring and communication of serious adverse events during the conduct of a trial in which they have agreed to participate. PURPOSE: To explore understanding and expectations of potential trial participants concerning monitoring and communication of serious adverse events during a clinical trial. METHODS: A professional moderator led four 90-min, in-person focus groups: two groups with individuals who had never participated in a clinical trial and two groups with people who had. After relevant research terms were defined and existing regulations were explained, discussion focused on how participants expected safety to be monitored and communicated during the conduct of a clinical trial. Group comments were video-recorded and transcribed and then analyzed by the investigators. RESULTS: The 27 racially diverse focus group members were largely unaware of existing safeguards and regulations to manage risk in clinical trials. Many people expressed a desire for increased transparency about serious adverse events during the trial as well as shortened reporting deadlines. Focus group members also spontaneously expressed concerns about potential financial conflicts of interest in monitoring and reporting serious adverse events. LIMITATIONS: This was a single-site, qualitative study and is not meant to establish the prevalence of beliefs. CONCLUSIONS: Potential trial participants have limited understanding and a wide range of expectations about how safety monitoring in clinical trials should be managed and communicated. The overall tenor of opinion suggests unease about participant safety and a desire to have more information conveyed by sponsors to investigators and, in some cases, by investigators to participants. Additional study in other regions and settings may be useful to more broadly explore the range of participants' beliefs and expectations. In the meantime, engaging patient advocates in the design of clinical trials and clearly communicating to trial participants the plan for oversight of their safety may help ease the types of concerns expressed in this study.

Authors
Flynn, KE; Kramer, JM; Dombeck, CB; Weinfurt, KP
MLA Citation
Flynn, KE, Kramer, JM, Dombeck, CB, and Weinfurt, KP. "Participants' perspectives on safety monitoring in clinical trials." Clin Trials 10.4 (August 2013): 552-559.
PMID
23644503
Source
pubmed
Published In
Clinical Trials
Volume
10
Issue
4
Publish Date
2013
Start Page
552
End Page
559
DOI
10.1177/1740774513484394

A Web-based communication aid for patients with cancer: the CONNECT Study.

BACKGROUND: Cancer patients and their oncologists often report differing perceptions of consultation discussions and discordant expectations regarding treatment outcomes. CONNECT, a computer-based communication aid, was developed to improve communication between patients and oncologists. METHODS: CONNECT includes assessment of patient values, goals, and communication preferences; patient communication skills training; and a preconsultation physician summary report. CONNECT was tested in a 3-arm, prospective, randomized clinical trial. Prior to the initial medical oncology consultation, adult patients with advanced cancer were randomized to the following arms: 1) control; 2) CONNECT with physician summary; or 3) CONNECT without physician summary. Outcomes were assessed with postconsultation surveys. RESULTS: Of 743 patients randomized, 629 completed postconsultation surveys. Patients in the intervention arms (versus control) felt that the CONNECT program made treatment decisions easier to reach (P = .003) and helped them to be more satisfied with these decisions (P < .001). In addition, patients in the intervention arms reported higher levels of satisfaction with physician communication format (P = .026) and discussion regarding support services (P = .029) and quality of life concerns (P = .042). The physician summary did not impact outcomes. Patients with higher levels of education and poorer physical functioning experienced greater benefit from CONNECT. CONCLUSIONS: This prospective randomized clinical trial demonstrates that computer-based communication skills training can positively affect patient satisfaction with communication and decision-making. Measurable patient characteristics may be used to identify subgroups most likely to benefit from an intervention such as CONNECT.

Authors
Meropol, NJ; Egleston, BL; Buzaglo, JS; Balshem, A; Benson, AB; Cegala, DJ; Cohen, RB; Collins, M; Diefenbach, MA; Miller, SM; Fleisher, L; Millard, JL; Ross, EA; Schulman, KA; Silver, A; Slater, E; Solarino, N; Sulmasy, DP; Trinastic, J; Weinfurt, KP
MLA Citation
Meropol, NJ, Egleston, BL, Buzaglo, JS, Balshem, A, Benson, AB, Cegala, DJ, Cohen, RB, Collins, M, Diefenbach, MA, Miller, SM, Fleisher, L, Millard, JL, Ross, EA, Schulman, KA, Silver, A, Slater, E, Solarino, N, Sulmasy, DP, Trinastic, J, and Weinfurt, KP. "A Web-based communication aid for patients with cancer: the CONNECT Study." Cancer 119.7 (April 1, 2013): 1437-1445.
PMID
23335150
Source
pubmed
Published In
Cancer
Volume
119
Issue
7
Publish Date
2013
Start Page
1437
End Page
1445
DOI
10.1002/cncr.27874

Construct validity of the PROMIS® sexual function and satisfaction measures in patients with cancer.

BACKGROUND: With data from a diverse sample of patients either in treatment for cancer or post-treatment for cancer, we examine inter-domain and cross-domain correlations among the core domains of the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction measures (PROMIS® SexFS) and the corresponding domains from conceptually-similar measures of sexual function, the International Index of Erectile Function and the Female Sexual Function Index. FINDINGS: Men (N=389) and women (N=430) were recruited from a tumor registry, oncology clinics, and an internet panel. The PROMIS SexFS, International Index of Erectile Function, and Female Sexual Function Index were used to collect participants' self-reported sexual function. The domains shared among the measures include desire/interest in sexual activity, lubrication and vaginal discomfort/pain (women), erectile function (men), orgasm, and satisfaction. We examined correlations among different domains within the same instrument (discriminant validity) and correlations among similar domains measured by different instruments (convergent validity). Correlations demonstrating discriminant validity ranged from 0.38 to 0.73 for men and 0.48 to 0.74 for women, while correlations demonstrating convergent validity ranged from 0.62 to 0.83 for men and 0.71 to 0.92 for women. As expected, correlations demonstrating convergent validity were higher than correlations demonstrating discriminant validity, with one exception (orgasm for men). CONCLUSIONS: Construct validity was supported by convergent and discriminant validity in a diverse sample of patients with cancer. For patients with cancer who may or may not have sexual dysfunction, the PROMIS SexFS measures provide a comprehensive assessment of key domains of sexual function and satisfaction.

Authors
Flynn, KE; Reeve, BB; Lin, L; Cyranowski, JM; Bruner, DW; Weinfurt, KP
MLA Citation
Flynn, KE, Reeve, BB, Lin, L, Cyranowski, JM, Bruner, DW, and Weinfurt, KP. "Construct validity of the PROMIS® sexual function and satisfaction measures in patients with cancer. (Published online)" Health Qual Life Outcomes 11 (March 11, 2013): 40-.
PMID
23497200
Source
pubmed
Published In
Health and Quality of Life Outcomes
Volume
11
Publish Date
2013
Start Page
40
DOI
10.1186/1477-7525-11-40

Patient time costs associated with sensor-augmented insulin pump therapy for type 1 diabetes: results from the STAR 3 randomized trial.

BACKGROUND: Sensor-augmented pump therapy (SAPT) leads to lower glycated hemoglobin levels than multiple daily injections of insulin (MDI) in patients with type 1 diabetes. Patient time and costs associated with SAPT are not known. OBJECTIVE: We compared time spent on diabetes-related care, changes in time, and associated patient time costs between patients randomly assigned to SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a 52-week clinical trial, participants aged 7 to 70 years (n = 483) reported total time per week spent on diabetes-related care. MEASUREMENTS: Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation. RESULTS: At baseline, patients in the MDI group reported spending an average of 4.0 hours per week on diabetes-related care. During the pump initiation period (weeks 1-7), SAPT patients spent 1.9 hours more per week than MDI patients (95% confidence interval [CI], 1.2-2.6). After the initiation period (weeks 8-52), SAPT patients spent 1 hour more per week (95% CI, 0.4-1.7) than MDI patients (i.e., 4.4 v. 3.4 hours); patients in both groups spent progressively less time on diabetes-related care by 1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean time costs per person were $4600 with the SAPT group and $3523 with the MDI group (difference, $1077; 95% CI, $491-$1638). LIMITATIONS: Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities. CONCLUSIONS: Patients receiving SAPT v. MDI spent approximately 2 hours more per week on diabetes-related care during pump initiation and 1 hour more per week thereafter, resulting in higher patient time costs.

Authors
Kamble, S; Weinfurt, KP; Schulman, KA; Reed, SD
MLA Citation
Kamble, S, Weinfurt, KP, Schulman, KA, and Reed, SD. "Patient time costs associated with sensor-augmented insulin pump therapy for type 1 diabetes: results from the STAR 3 randomized trial." Med Decis Making 33.2 (February 2013): 215-224.
PMID
23128579
Source
pubmed
Published In
Medical Decision Making
Volume
33
Issue
2
Publish Date
2013
Start Page
215
End Page
224
DOI
10.1177/0272989X12464824

Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer.

INTRODUCTION: We describe the development and validation of the Patient-Reported Outcomes Measurement Information System(®) Sexual Function and Satisfaction (PROMIS(®) SexFS; National Institutes of Health) measures, version 1.0, for cancer populations. AIM: To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS Network. METHODS: Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient-reported outcome measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item-response theory and evaluated for reliability and validity. MAIN OUTCOME MEASURES: The PROMIS SexFS measures, version 1.0, include 81 items in 11 domains: Interest in Sexual Activity, Lubrication, Vaginal Discomfort, Erectile Function, Global Satisfaction with Sex Life, Orgasm, Anal Discomfort, Therapeutic Aids, Sexual Activities, Interfering Factors, and Screener Questions. RESULTS: In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different) and convergent validity (strong correlations between scores on PROMIS and scores on conceptually similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (interclass correlations from two administrations of the instrument, 1 month apart). CONCLUSIONS: The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study.

Authors
Flynn, KE; Lin, L; Cyranowski, JM; Reeve, BB; Reese, JB; Jeffery, DD; Smith, AW; Porter, LS; Dombeck, CB; Bruner, DW; Keefe, FJ; Weinfurt, KP
MLA Citation
Flynn, KE, Lin, L, Cyranowski, JM, Reeve, BB, Reese, JB, Jeffery, DD, Smith, AW, Porter, LS, Dombeck, CB, Bruner, DW, Keefe, FJ, and Weinfurt, KP. "Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer." J Sex Med 10 Suppl 1 (February 2013): 43-52.
PMID
23387911
Source
pubmed
Published In
The Journal of Sexual Medicine
Volume
10 Suppl 1
Publish Date
2013
Start Page
43
End Page
52
DOI
10.1111/j.1743-6109.2012.02995.x

Talking with patients about dying.

Authors
Weinfurt, KP; Kim, SY; Meropol, NJ
MLA Citation
Weinfurt, KP, Kim, SY, and Meropol, NJ. "Talking with patients about dying." N Engl J Med 368.5 (January 31, 2013): 479-. (Letter)
PMID
23363508
Source
pubmed
Published In
The New England journal of medicine
Volume
368
Issue
5
Publish Date
2013
Start Page
479
DOI
10.1056/NEJMc1214249#SA1

Using central IRBs for multicenter clinical trials in the United States.

Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation's capacity to efficiently conduct the large number of high-quality trials.

Authors
Flynn, KE; Hahn, CL; Kramer, JM; Check, DK; Dombeck, CB; Bang, S; Perlmutter, J; Khin-Maung-Gyi, FA; Weinfurt, KP
MLA Citation
Flynn, KE, Hahn, CL, Kramer, JM, Check, DK, Dombeck, CB, Bang, S, Perlmutter, J, Khin-Maung-Gyi, FA, and Weinfurt, KP. "Using central IRBs for multicenter clinical trials in the United States." PLoS One 8.1 (2013): e54999-.
PMID
23383026
Source
pubmed
Published In
PloS one
Volume
8
Issue
1
Publish Date
2013
Start Page
e54999
DOI
10.1371/journal.pone.0054999

Understanding What Participants in Empirical Bioethical Studies Mean: Historical Cautions From William James and Ludwig Wittgenstein

Methods from psychology are informing much empirical research in bioethics by helping to understand the thoughts, feelings, and beliefs of people as they relate to a variety of bioethical issues. This can lead to improvements in practice or policy only if the subjective mental states under study have been characterized accurately. In this article, I describe two cautions from the history of psychology concerning the accurate characterization of mental states that have significant implications for how we elicit and interpret data in empirical bioethical studies. Both make reference to tendencies of mind that can be difficult to combat and that are the cause of other more specific methodological errors. The first historical caution, William James's "psychologist's fallacy," warns against substituting the ethicist/researcher's point of view with that of the person under study. Failure to appreciate this essentially egocentric bias can result in asking people to report on things (e.g., probability of benefit from an experimental therapy) that are not a part of the person's experience in the same way they are a part of the researcher's worldview. The responses the person provides in such cases do not provide good information about his or her experience and so cannot be used to guide sound policy. The second historical caution is Wittgenstein's discursive perspective, which urges us to interpret the meaning of things said by a person in a research study by examining the function each utterance serves for the person. For example, one should avoid assuming that people respond to queries about understanding by simply describing their understanding. Instead, research participants might provide responses to achieve other goals, such as establishing a desired attitude in themselves. I suggest that both cautions can be addressed through careful qualitative investigation at the beginning of a research project. © 2013 Copyright Taylor and Francis Group, LLC.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Understanding What Participants in Empirical Bioethical Studies Mean: Historical Cautions From William James and Ludwig Wittgenstein." AJOB Primary Research 4.3 (2013): 49-54.
Source
scival
Published In
American Journal of Bioethics Primary Research
Volume
4
Issue
3
Publish Date
2013
Start Page
49
End Page
54
DOI
10.1080/21507716.2013.807893

Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)

Anemia is common in patients with chronic heart failure (HF), with a prevalence ranging from 10% to 56%, and may be a risk factor for poor outcomes. Anemia in HF remains poorly understood, with significant gaps in its impact on health-related quality of life (HRQoL), with most studies in HF being retrospective or from registries. The purpose of this study was to explore the relation of hemoglobin (Hgb) with HRQoL and training-induced changes in HRQoL in a cohort of patients in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Using data from HF-ACTION, a randomized controlled trial of exercise training in patients with HF and low left ventricular ejection fractions, HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and annually up to 4 years. Treatment group effects on HRQoL were estimated using linear mixed models according to the intention-to-treat principle. It was hypothesized that baseline Hgb would be correlated with baseline KCCQ scales and that Hgb would moderate the beneficial effect of exercise training on HRQoL. Hgb level was not significantly correlated with baseline HRQoL. Baseline Hgb did not moderate the beneficial effect of exercise training on KCCQ overall or subscales relative to usual care. In conclusion, in the HF-ACTION cohort, there was no correlation with baseline Hgb and baseline HRQoL as measured by the KCCQ. In addition, the beneficial effects of HRQoL from exercise training were not modulated by baseline Hgb. © 2013 Elsevier Inc. All rights reserved.

Authors
Piña, IL; Lin, L; Weinfurt, KP; Isitt, JJ; Whellan, DJ; Schulman, KA; Flynn, KE
MLA Citation
Piña, IL, Lin, L, Weinfurt, KP, Isitt, JJ, Whellan, DJ, Schulman, KA, and Flynn, KE. "Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)." American Journal of Cardiology 112.7 (2013): 971-976.
Source
scival
Published In
The American Journal of Cardiology
Volume
112
Issue
7
Publish Date
2013
Start Page
971
End Page
976
DOI
10.1016/j.amjcard.2013.05.033

Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question?

PURPOSE: To determine whether patients' expectations of benefit in early-phase oncology trials depend on how patients are queried and to explore whether expectations are associated with patient characteristics. PATIENTS AND METHODS: Participants were 171 patients in phase I or II oncology trials in the United States. After providing informed consent for a trial but before receiving the investigational therapy, participants answered questions about expectations of benefit. We randomly assigned participants to one of three groups corresponding to three queries about expectations: frequency type, belief type, or both. Main outcomes were differences in expectations by question type and the extent to which expectations were associated with demographic characteristics, numeracy, dispositional optimism, religiousness/spirituality, understanding of research, and other measures. RESULTS: The belief-type group had a higher mean expectation of benefit (64.4 of 100) than the combination group (51.6; P = .01) and the frequency-type group (43.1; P < .001). Mean expectations in the combination and frequency groups were not significantly different (P = .06). Belief-type expectations were associated with a preference for nonquantitative information (r = -0.19; 95% CI, -0.19 to -0.36), knowledge about research (r = -0.21; 95% CI, -0.38 to -0.03), dispositional optimism (r = 0.20; 95% CI, 0.01 to 0.37), and spirituality (r = 0.22; 95% CI, 0.03 to 0.38). Frequency-type expectations were associated with knowledge about clinical research (r = -0.27; 95% CI, -0.27 to -0.51). CONCLUSION: In early-phase oncology trials, patients' reported expectations of benefit differed according to how patients were queried and were associated with patient characteristics. These findings have implications for how informed consent is obtained and assessed.

Authors
Weinfurt, KP; Seils, DM; Lin, L; Sulmasy, DP; Astrow, AB; Hurwitz, HI; Cohen, RB; Meropol, NJ
MLA Citation
Weinfurt, KP, Seils, DM, Lin, L, Sulmasy, DP, Astrow, AB, Hurwitz, HI, Cohen, RB, and Meropol, NJ. "Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question?." J Clin Oncol 30.35 (December 10, 2012): 4396-4400.
PMID
23091107
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
30
Issue
35
Publish Date
2012
Start Page
4396
End Page
4400
DOI
10.1200/JCO.2011.40.6587

Patient experiences with communication about sex during and after treatment for cancer.

OBJECTIVE: We studied patients' experiences with oncology providers regarding communication about sexual issues during and after treatment for cancer. METHODS: During development of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) Sexual Function measure, we collected focus group and survey data on communication with oncology professionals about sexual problems. We conducted 16 focus groups with patients and survivors (n = 109) and analyzed the discussions for major themes, including experiences discussing sex during oncology visits. During testing of the PROMIS Sexual Function measure, we assessed experiences discussing sexual problems with oncology professionals (n = 819) and measured bivariate associations between asking for information from clinicians and sexual function and satisfaction with sex life. RESULTS: Most patients and survivors (74%) thought that discussions with oncology professionals about sexual problems were important, but whether they had ever received information about sexual function from a provider varied by cancer type (23% lung, 29% breast, 39% colorectal, and 79% prostate). Those who had asked an oncology professional about sexual problems had significantly greater interest in sexual activity as well as more sexual dysfunction. CONCLUSIONS: Sexual problems are a widespread concern among patients and survivors, but there is much variation in experiences of communication about sexual issues, and many patients do not receive the information they need from their oncology providers. There are large differences in sexual function between patients who do and do not ask providers about sexual problems. Sexual health has yet to be fully integrated into oncology care, even for cancers involving sex organs.

Authors
Flynn, KE; Reese, JB; Jeffery, DD; Abernethy, AP; Lin, L; Shelby, RA; Porter, LS; Dombeck, CB; Weinfurt, KP
MLA Citation
Flynn, KE, Reese, JB, Jeffery, DD, Abernethy, AP, Lin, L, Shelby, RA, Porter, LS, Dombeck, CB, and Weinfurt, KP. "Patient experiences with communication about sex during and after treatment for cancer." Psychooncology 21.6 (June 2012): 594-601.
PMID
21394821
Source
pubmed
Published In
Psycho-Oncology
Volume
21
Issue
6
Publish Date
2012
Start Page
594
End Page
601
DOI
10.1002/pon.1947

Predictors of primary care physicians' self-reported intention to conduct suicide risk assessments.

Primary care physicians play a significant role in depression care, suicide assessment, and suicide prevention. However, little is known about what factors relate to and predict quality of depression care (assessment, diagnosis, and treatment), including suicide assessment. The authors explored the extent to which select patient and physician factors increase the probability of one element of quality of care: namely, intention to conduct suicide assessment. Data were collected from 404 randomly selected primary care physicians after their interaction with CD-ROM vignettes of actors portraying major depression with moderate levels of severity. The authors examined which patient factors and physician factors increase the likelihood of physicians' intention to conduct a suicide assessment. Data from the study revealed that physician-participants inquired about suicide 36% of the time. A random effects logistic model indicated that several factors were predictive of physicians' intention to conduct a suicide assessment: patient's comorbidity status (odds ratio (OR) = 0.61; 95% confidence interval (CI) = 0.37-1.00), physicians' age (OR = 0.67; 95% CI = 0.49-0.92), physicians' race (OR = 1.84; 95% CI = 1.08-3.13), and how depressed the physician perceived the virtual patient to be (OR = 0.58; 95% CI = 0.39-0.87). A substantial number of primary care physicians in this study indicated they would not assess for suicide, even though most physicians perceived the virtual patient to be depressed or very depressed. Further study is needed to establish factors that may be modified and targeted to increase the likelihood of physicians' providing one element of quality of care--suicide assessment--for depressed patients.

Authors
Hooper, LM; Epstein, SA; Weinfurt, KP; DeCoster, J; Qu, L; Hannah, NJ
MLA Citation
Hooper, LM, Epstein, SA, Weinfurt, KP, DeCoster, J, Qu, L, and Hannah, NJ. "Predictors of primary care physicians' self-reported intention to conduct suicide risk assessments." J Behav Health Serv Res 39.2 (April 2012): 103-115.
PMID
22218814
Source
pubmed
Published In
The Journal of Behavioral Health Services & Research
Volume
39
Issue
2
Publish Date
2012
Start Page
103
End Page
115
DOI
10.1007/s11414-011-9268-5

Prospective study of factors predicting adherence to surveillance mammography in women treated for breast cancer.

PURPOSE: This prospective study examined the factors that predicted sustained adherence to surveillance mammography in women treated for breast cancer. METHODS: Breast cancer survivors (N = 204) who were undergoing surveillance mammography completed questionnaires assessing mammography-related anticipatory anxiety, persistent breast pain, mammography pain, and catastrophic thoughts about mammography pain. Adherence to mammography in the following year was assessed. RESULTS: In the year after study entry, 84.8% of women (n = 173) returned for a subsequent mammogram. Unadjusted associations showed that younger age, shorter period of time since surgery, and having upper extremity lymphedema were associated with lower mammography adherence. Forty percent of women reported moderate to high levels of mammography pain (score of ≥ 5 on a 0 to 10 scale). Although mammography pain was not associated with adherence, higher levels of mammography-related anxiety and pain catastrophizing were associated with not returning for a mammogram (P < .05). The impact of anxiety on mammography use was mediated by pain catastrophizing (indirect effect, P < .05). CONCLUSION: Findings suggest that women who are younger, closer to the time of surgery, or have upper extremity lymphedema may be less likely to undergo repeated mammograms. It may be important for health professionals to remind selected patients directly that some women avoid repeat mammography and to re-emphasize the value of mammography for women with a history of breast cancer. Teaching women behavioral techniques (eg, redirecting attention) or providing medication for reducing anxiety could be considered for women with high levels of anxiety or catastrophic thoughts related to mammography.

Authors
Shelby, RA; Scipio, CD; Somers, TJ; Soo, MS; Weinfurt, KP; Keefe, FJ
MLA Citation
Shelby, RA, Scipio, CD, Somers, TJ, Soo, MS, Weinfurt, KP, and Keefe, FJ. "Prospective study of factors predicting adherence to surveillance mammography in women treated for breast cancer." J Clin Oncol 30.8 (March 10, 2012): 813-819.
PMID
22331949
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
30
Issue
8
Publish Date
2012
Start Page
813
End Page
819
DOI
10.1200/JCO.2010.34.4333

Relationships between changes in patient-reported health status and functional capacity in outpatients with heart failure.

BACKGROUND: Heart failure trials use a variety of measures of functional capacity and quality of life. Lack of formal assessments of the relationships between changes in multiple aspects of patient-reported health status and measures of functional capacity over time limits the ability to compare results across studies. METHODS: Using data from HF-ACTION (N = 2331), we used the Pearson correlation coefficients and predicted change scores from linear mixed-effects modeling to demonstrate the associations between changes in patient-reported health status measured with the EQ-5D visual analog scale and the Kansas City Cardiomyopathy Questionnaire (KCCQ) and changes in peak VO(2) and 6-minute walk distance at 3 and 12 months. We examined a 5-point change in KCCQ within individuals to provide a framework for interpreting changes in these measures. RESULTS: After adjustment for baseline characteristics, correlations between changes in the visual analog scale and changes in peak VO(2) and 6-minute walk distance ranged from 0.13 to 0.28, and correlations between changes in the KCCQ overall and subscale scores and changes in peak VO(2) and 6-minute walk distance ranged from 0.18 to 0.34. A 5-point change in KCCQ was associated with a 2.50-mL kg(-1) min(-1) change in peak VO(2) (95% CI 2.21-2.86) and a 112-m change in 6-minute walk distance (95% CI 96-134). CONCLUSIONS: Changes in patient-reported health status are not highly correlated with changes in functional capacity. Our findings generally support the current practice of considering a 5-point change in the KCCQ within individuals to be clinically meaningful.

Authors
Flynn, KE; Lin, L; Moe, GW; Howlett, JG; Fine, LJ; Spertus, JA; McConnell, TR; Piña, IL; Weinfurt, KP
MLA Citation
Flynn, KE, Lin, L, Moe, GW, Howlett, JG, Fine, LJ, Spertus, JA, McConnell, TR, Piña, IL, and Weinfurt, KP. "Relationships between changes in patient-reported health status and functional capacity in outpatients with heart failure." Am Heart J 163.1 (January 2012): 88-94.e3.
PMID
22172441
Source
pubmed
Published In
American Heart Journal
Volume
163
Issue
1
Publish Date
2012
Start Page
88
End Page
94.e3
DOI
10.1016/j.ahj.2011.09.027

Institutional review boards' use and understanding of certificates of confidentiality.

Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants' privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public's health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders' views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions' use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or 'unsure'. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an 'extra layer' of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants' confidentiality, and the need for further empirical investigation of Certificates' effect on researchers and research participants.

Authors
Beskow, LM; Check, DK; Namey, EE; Dame, LA; Lin, L; Cooper, A; Weinfurt, KP; Wolf, LE
MLA Citation
Beskow, LM, Check, DK, Namey, EE, Dame, LA, Lin, L, Cooper, A, Weinfurt, KP, and Wolf, LE. "Institutional review boards' use and understanding of certificates of confidentiality." PLoS One 7.9 (2012): e44050-.
PMID
22962599
Source
pubmed
Published In
PloS one
Volume
7
Issue
9
Publish Date
2012
Start Page
e44050
DOI
10.1371/journal.pone.0044050

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Authors
Eisenstein, EL; Diener, LW; Nahm, M; Weinfurt, KP
MLA Citation
Eisenstein, EL, Diener, LW, Nahm, M, and Weinfurt, KP. "Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study." J Med Syst 35.6 (December 2011): 1521-1530.
PMID
20703765
Source
pubmed
Published In
Journal of Medical Systems
Volume
35
Issue
6
Publish Date
2011
Start Page
1521
End Page
1530
DOI
10.1007/s10916-010-9429-8

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; 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." Med Care 49.4 (April 2011): 415-419. (Review)
PMID
21368680
Source
pubmed
Published In
Medical Care
Volume
49
Issue
4
Publish Date
2011
Start Page
415
End Page
419
DOI
10.1097/MLR.0b013e3182064aa2

Sexual functioning along the cancer continuum: focus group results from the Patient-Reported Outcomes Measurement Information System (PROMIS®).

OBJECTIVE: Cancer and treatments for cancer affect specific aspects of sexual functioning and intimacy; however, limited qualitative work has been done in diverse cancer populations. As part of an effort to improve measurement of self-reported sexual functioning, we explored the scope and importance of sexual functioning and intimacy to patients across cancer sites and along the continuum of care. METHODS: We conducted 16 diagnosis- and sex-specific focus groups with patients recruited from the Duke University tumor registry and oncology/hematology clinics (N=109). A trained note taker produced field notes summarizing the discussions. An independent auditor verified field notes against written transcripts. The content of the discussions was analyzed for major themes by two independent coders. RESULTS: Across all cancers, the most commonly discussed cancer- or treatment-related effects on sexual functioning and intimacy were fatigue, treatment-related hair loss, weight gain and organ loss or scarring. Additional barriers were unique to particular diagnoses, such as shortness of breath in lung cancer, gastrointestinal problems in colorectal cancers and incontinence in prostate cancer. Sexual functioning and intimacy were considered important to quality of life. While most effects of cancer were considered negative, many participants identified improvements to intimacy after cancer. CONCLUSION: Overall evaluations of satisfaction with sex life did not always correspond to specific aspects of functioning (e.g. erectile dysfunction), presenting a challenge to researchers aiming to measure sexual functioning as an outcome. Health-care providers should not assume that level of sexual impairment determines sexual satisfaction and should explore cancer patients' sexual concerns directly.

Authors
Flynn, KE; Jeffery, DD; Keefe, FJ; Porter, LS; Shelby, RA; Fawzy, MR; Gosselin, TK; Reeve, BB; Weinfurt, KP
MLA Citation
Flynn, KE, Jeffery, DD, Keefe, FJ, Porter, LS, Shelby, RA, Fawzy, MR, Gosselin, TK, Reeve, BB, and Weinfurt, KP. "Sexual functioning along the cancer continuum: focus group results from the Patient-Reported Outcomes Measurement Information System (PROMIS®)." Psychooncology 20.4 (April 2011): 378-386.
PMID
20878833
Source
pubmed
Published In
Psycho-Oncology
Volume
20
Issue
4
Publish Date
2011
Start Page
378
End Page
386
DOI
10.1002/pon.1738

Describing depression: congruence between patient experiences and clinical assessments.

OBJECTIVES: Efforts to describe depression have relied on top-down methods in which theory and clinical experience define depression but may not reflect the individuals' experiences with depression. We assessed the degree of overlap between academic descriptions of depression and patient-reported symptoms as conceptualized in the Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)). By extension, this work assesses the degree of overlap between current clinical descriptions of depression and patient-reported symptoms. DESIGN: In this content analysis study, four focus groups were conducted across two sites to elicit symptoms and the experience of depression from depressed and medically ill patients. METHODS: Depressed and medically ill patients were asked to describe symptoms that characterize depression. Data were transcribed and then coded using an a priori list of 43 facets of depression derived from extant depression measures. RESULTS: Participants described 93% of the symptoms from the a priori list, supporting the validity of current depression measures. Interpersonal difficulties were underscored as was anger. In general, results from the focus groups did not require the generation of new items for depression and supported the content validity of the PROMIS hierarchical framework and item pool created originally. CONCLUSIONS: This work supports the validity of current depression assessment, but suggests further investigation of interpersonal functioning and anger may add to the depth and breadth of depression assessment.

Authors
Kelly, MAR; Morse, JQ; Stover, A; Hofkens, T; Huisman, E; Shulman, S; Eisen, SV; Becker, SJ; Weinfurt, K; Boland, E; Pilkonis, PA
MLA Citation
Kelly, MAR, Morse, JQ, Stover, A, Hofkens, T, Huisman, E, Shulman, S, Eisen, SV, Becker, SJ, Weinfurt, K, Boland, E, and Pilkonis, PA. "Describing depression: congruence between patient experiences and clinical assessments." Br J Clin Psychol 50.1 (March 2011): 46-66.
PMID
21332520
Source
pubmed
Published In
British Journal of Clinical Psychology
Volume
50
Issue
1
Publish Date
2011
Start Page
46
End Page
66
DOI
10.1348/014466510X493926

Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research.

Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

Authors
Glickman, SW; Ndubuizu, A; Weinfurt, KP; Hamilton, CD; Glickman, LT; Schulman, KA; Cairns, CB
MLA Citation
Glickman, SW, Ndubuizu, A, Weinfurt, KP, Hamilton, CD, Glickman, LT, Schulman, KA, and Cairns, CB. "Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research." Acad Med 86.3 (March 2011): 389-393.
PMID
21248607
Source
pubmed
Published In
Academic Medicine
Volume
86
Issue
3
Publish Date
2011
Start Page
389
End Page
393
DOI
10.1097/ACM.0b013e318208289a

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

Predictors of Primary Care Physicians' Self-reported Intention to Conduct Suicide Risk Assessments

Primary care physicians play a significant role in depression care, suicide assessment, and suicide prevention. However, little is known about what factors relate to and predict quality of depression care (assessment, diagnosis, and treatment), including suicide assessment. The authors explored the extent to which select patient and physician factors increase the probability of one element of quality of care: namely, intention to conduct suicide assessment. Data were collected from 404 randomly selected primary care physicians after their interaction with CD-ROM vignettes of actors portraying major depression with moderate levels of severity. The authors examined which patient factors and physician factors increase the likelihood of physicians' intention to conduct a suicide assessment. Data from the study revealed that physician-participants inquired about suicide 36% of the time. A random effects logistic model indicated that several factors were predictive of physicians' intention to conduct a suicide assessment: patient's comorbidity status (odds ratio (OR) = 0.61; 95% confidence interval (CI) = 0.37-1.00), physicians' age (OR = 0.67; 95% CI = 0.49-0.92), physicians' race (OR = 1.84; 95% CI = 1.08-3.13), and how depressed the physician perceived the virtual patient to be (OR = 0.58; 95% CI = 0.39-0.87). A substantial number of primary care physicians in this study indicated they would not assess for suicide, even though most physicians perceived the virtual patient to be depressed or very depressed. Further study is needed to establish factors that may be modified and targeted to increase the likelihood of physicians' providing one element of quality of care-suicide assessment-for depressed patients. © 2011 National Council for Community Behavioral Healthcare.

Authors
Hooper, LM; Epstein, SA; Weinfurt, KP; DeCoster, J; Qu, L; Hannah, NJ
MLA Citation
Hooper, LM, Epstein, SA, Weinfurt, KP, DeCoster, J, Qu, L, and Hannah, NJ. "Predictors of Primary Care Physicians' Self-reported Intention to Conduct Suicide Risk Assessments." Journal of Behavioral Health Services and Research (2011): 1-13.
Source
scival
Published In
The Journal of Behavioral Health Services & Research
Publish Date
2011
Start Page
1
End Page
13
DOI
10.1007/s11414-011-9268-5

The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.

OBJECTIVES: Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items. STUDY DESIGN AND SETTING: Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census. RESULTS: Using item-response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental, and social health, along with a 10-item Global Health Scale. Short forms from each bank were developed and compared with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures. CONCLUSION: PROMIS item banks and their short forms provide evidence that they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations.

Authors
Cella, D; Riley, W; Stone, A; Rothrock, N; Reeve, B; Yount, S; Amtmann, D; Bode, R; Buysse, D; Choi, S; Cook, K; Devellis, R; DeWalt, D; Fries, JF; Gershon, R; Hahn, EA; Lai, J-S; Pilkonis, P; Revicki, D; Rose, M; Weinfurt, K; Hays, R; PROMIS Cooperative Group,
MLA Citation
Cella, D, Riley, W, Stone, A, Rothrock, N, Reeve, B, Yount, S, Amtmann, D, Bode, R, Buysse, D, Choi, S, Cook, K, Devellis, R, DeWalt, D, Fries, JF, Gershon, R, Hahn, EA, Lai, J-S, Pilkonis, P, Revicki, D, Rose, M, Weinfurt, K, Hays, R, and PROMIS Cooperative Group, . "The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008." J Clin Epidemiol 63.11 (November 2010): 1179-1194.
PMID
20685078
Source
pubmed
Published In
Journal of Clinical Epidemiology
Volume
63
Issue
11
Publish Date
2010
Start Page
1179
End Page
1194
DOI
10.1016/j.jclinepi.2010.04.011

Developing a simplified consent form for biobanking.

BACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

Authors
Beskow, LM; Friedman, JY; Hardy, NC; Lin, L; Weinfurt, KP
MLA Citation
Beskow, LM, Friedman, JY, Hardy, NC, Lin, L, and Weinfurt, KP. "Developing a simplified consent form for biobanking. (Published online)" PLoS One 5.10 (October 8, 2010): e13302-.
Website
http://hdl.handle.net/10161/4577
PMID
20949049
Source
pubmed
Published In
PloS one
Volume
5
Issue
10
Publish Date
2010
Start Page
e13302
DOI
10.1371/journal.pone.0013302

Sleep-wake functioning along the cancer continuum: focus group results from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)).

OBJECTIVE: Cancer and its treatments disturb sleep-wake functioning; however, there is little information available on the characteristics and consequences of sleep problems associated with cancer. As part of an effort to improve measurement of sleep-wake functioning, we explored the scope of difficulties with sleep in a diverse group of patients diagnosed with cancer. METHODS: We conducted 10 focus groups with patients recruited from the Duke University tumor registry and oncology/hematology clinics. Separate groups were held with patients scheduled to begin or currently undergoing treatment for breast, prostate, lung, colorectal, hematological, and other cancer types and with patients who were in posttreatment follow-up. The content of the focus group discussions was transcribed and analyzed for major themes by independent coders. RESULTS: Participants not only reported causes of sleep disturbance common in other populations, such as pain and restless legs, but they also reported causes that may be unique to cancer populations, including abnormal dreams, anxiety about cancer diagnosis and recurrence, night sweats, and problems with sleep positioning. Many participants felt that sleep problems reduced their productivity, concentration, social interactions, and overall quality of life. Many also shared beliefs about the increased importance of sleep when fighting cancer. CONCLUSIONS: The findings underscore the need for interventions that minimize the negative impact of cancer and its treatments on sleep. This study will inform efforts now underway to develop a patient-reported measure of sleep-wake functioning that reflects the breadth of concepts considered important by patients with cancer.

Authors
Flynn, KE; Shelby, RA; Mitchell, SA; Fawzy, MR; Hardy, NC; Husain, AM; Keefe, FJ; Krystal, AD; Porter, LS; Reeve, BB; Weinfurt, KP
MLA Citation
Flynn, KE, Shelby, RA, Mitchell, SA, Fawzy, MR, Hardy, NC, Husain, AM, Keefe, FJ, Krystal, AD, Porter, LS, Reeve, BB, and Weinfurt, KP. "Sleep-wake functioning along the cancer continuum: focus group results from the Patient-Reported Outcomes Measurement Information System (PROMIS(®))." Psychooncology 19.10 (October 2010): 1086-1093.
PMID
20013938
Source
pubmed
Published In
Psycho-Oncology
Volume
19
Issue
10
Publish Date
2010
Start Page
1086
End Page
1093
DOI
10.1002/pon.1664

Commentary: Per capita payments in clinical trials: reasonable costs versus bounty hunting.

Paying more for clinical research than the cost of doing the work may create a conflict of interest that could lead to overzealous recruitment, putting participants and scientific integrity at risk. Thus, although various policies prohibit "finder's fees" simply for recruiting patients, paying the actual costs for research is permissible. Whereas industry-sponsored research routinely pays for the costs of each patient enrolled, the line between reasonable and excessive costs merits more attention. In academic medical centers (AMCs), institutional review boards and conflict of interest committees usually are not involved in reviewing research budgets to determine whether per capita payments are excessive. Also, the costs for clinical services in research are not standardized. Instead, budgets are negotiated both internally, among departments within research institutions, and externally, between researchers and sponsors. Sometimes, rates paid by sponsors exceed what researchers usually receive or are actually paid for particular services, generating a surplus. Nevertheless, the authors see only limited cause for concern because, at the AMCs with which the authors are familiar, any monetary surplus generally remains within the research enterprise to cover unanticipated budget shortfalls or to support research staff in the future during lean times. In addition, the surplus from research budgets is not shared directly with individual investigators. However, further investigation is needed to determine whether practices outside AMCs pose greater concerns.

Authors
Hall, MA; Friedman, JY; King, NMP; Weinfurt, KP; Schulman, KA; Sugarman, J
MLA Citation
Hall, MA, Friedman, JY, King, NMP, Weinfurt, KP, Schulman, KA, and Sugarman, J. "Commentary: Per capita payments in clinical trials: reasonable costs versus bounty hunting." Acad Med 85.10 (October 2010): 1554-1556.
PMID
20881671
Source
pubmed
Published In
Academic Medicine
Volume
85
Issue
10
Publish Date
2010
Start Page
1554
End Page
1556
DOI
10.1097/ACM.0b013e3181ef9cc6

Simplifying informed consent for biorepositories: stakeholder perspectives.

PURPOSE: Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. METHODS: We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. RESULTS: On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. CONCLUSION: The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

Authors
Beskow, LM; Friedman, JY; Hardy, NC; Lin, L; Weinfurt, KP
MLA Citation
Beskow, LM, Friedman, JY, Hardy, NC, Lin, L, and Weinfurt, KP. "Simplifying informed consent for biorepositories: stakeholder perspectives." Genet Med 12.9 (September 2010): 567-572.
PMID
20697289
Source
pubmed
Published In
Genetics in Medicine
Volume
12
Issue
9
Publish Date
2010
Start Page
567
End Page
572
DOI
10.1097/GIM.0b013e3181ead64d

The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.

BACKGROUND: Patients' estimates of their chances of therapeutic benefit from participation in early phase trials greatly exceed historical data. Ethicists worry that this therapeutic misestimation undermines the validity of informed consent. METHODS: The authors interviewed 45 patients enrolled in phase 1 or 2 oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. They used a phenomenological, qualitative approach with 1 primary coder to identify emergent themes, verified by 2 independent coders. RESULTS: Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27 of 45 participants used 1 of these words. Three major themes emerged: 1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; 2) fighting cancer as a battle; and 3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P=.04). CONCLUSIONS: Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early phase clinical trials.

Authors
Sulmasy, DP; Astrow, AB; He, MK; Seils, DM; Meropol, NJ; Micco, E; Weinfurt, KP
MLA Citation
Sulmasy, DP, Astrow, AB, He, MK, Seils, DM, Meropol, NJ, Micco, E, and Weinfurt, KP. "The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials." Cancer 116.15 (August 1, 2010): 3702-3711.
PMID
20564120
Source
pubmed
Published In
Cancer
Volume
116
Issue
15
Publish Date
2010
Start Page
3702
End Page
3711
DOI
10.1002/cncr.25201

Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings.

BACKGROUND: Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings. OBJECTIVE: To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings. DESIGN, SETTING, AND PARTICIPANTS: Survey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007. MEASUREMENTS AND MAIN RESULTS: Response rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P < 0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P < 0.001). CONCLUSIONS: Nonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.

Authors
Weinfurt, KP; Hall, MA; Hardy, NC; Friedman, JY; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, Hardy, NC, Friedman, JY, Schulman, KA, and Sugarman, J. "Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings." J Gen Intern Med 25.5 (May 2010): 460-464.
PMID
20186498
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
25
Issue
5
Publish Date
2010
Start Page
460
End Page
464
DOI
10.1007/s11606-010-1264-6

Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.

BACKGROUND: Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial. METHODS AND RESULTS: We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001). CONCLUSIONS: Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

Authors
Fortune-Greeley, AK; Hardy, NC; Lin, L; Friedman, JY; Lawlor, JS; Muhlbaier, LH; Hall, MA; Schulman, KA; Sugarman, J; Weinfurt, KP
MLA Citation
Fortune-Greeley, AK, Hardy, NC, Lin, L, Friedman, JY, Lawlor, JS, Muhlbaier, LH, Hall, MA, Schulman, KA, Sugarman, J, and Weinfurt, KP. "Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research." Circ Cardiovasc Qual Outcomes 3.2 (March 2010): 151-158.
PMID
20233979
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
3
Issue
2
Publish Date
2010
Start Page
151
End Page
158
DOI
10.1161/CIRCOUTCOMES.109.849273

Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure.

BACKGROUND: Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure. METHODS: Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak VO(2), 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions. RESULTS: The KCCQ was correlated with peak VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II. CONCLUSIONS: These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.

Authors
Flynn, KE; Lin, L; Ellis, SJ; Russell, SD; Spertus, JA; Whellan, DJ; Piña, IL; Fine, LJ; Schulman, KA; Weinfurt, KP; HF-ACTION Investigators,
MLA Citation
Flynn, KE, Lin, L, Ellis, SJ, Russell, SD, Spertus, JA, Whellan, DJ, Piña, IL, Fine, LJ, Schulman, KA, Weinfurt, KP, and HF-ACTION Investigators, . "Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure." Am Heart J 158.4 Suppl (October 2009): S64-S71.
PMID
19782791
Source
pubmed
Published In
American Heart Journal
Volume
158
Issue
4 Suppl
Publish Date
2009
Start Page
S64
End Page
S71
DOI
10.1016/j.ahj.2009.07.010

Using cognitive interviews to evaluate items for measuring sexual functioning across cancer populations: improvements and remaining challenges.

PURPOSE: One goal of the Patient-Reported Outcomes Measurement Information System (PROMIS) is to develop a measure of sexual functioning that broadens the definition of sexual activity and incorporates items that reflect constructs identified as important by patients with cancer. We describe how cognitive interviews improved the quality of the items and discuss remaining challenges to assessing sexual functioning in research with cancer populations. METHODS: We conducted 39 cognitive interviews of patients with cancer and survivors on the topic of sexual experience. Each of the 83 candidate items was seen by 5-24 participants. Participants included both men and women and varied by cancer type, treatment trajectory, race, and literacy level. Significantly revised items were retested in subsequent interviews. RESULTS: Cognitive interviews provided useful feedback about the relevance, sensitivity, appropriateness, and clarity of the items. Participants identified broad terms (e.g., "sex life") to assess sexual experience and exposed the challenges of measuring sexual functioning consistently, considering both adjusted and unadjusted sexual experiences. CONCLUSIONS: Cognitive interviews were critical for item refinement in the development of the PROMIS measure of sexual function. Efforts are underway to validate the measure in larger cancer populations.

Authors
Fortune-Greeley, AK; Flynn, KE; Jeffery, DD; Williams, MS; Keefe, FJ; Reeve, BB; Willis, GB; Weinfurt, KP; PROMIS Sexual Function Domain Committee,
MLA Citation
Fortune-Greeley, AK, Flynn, KE, Jeffery, DD, Williams, MS, Keefe, FJ, Reeve, BB, Willis, GB, Weinfurt, KP, and PROMIS Sexual Function Domain Committee, . "Using cognitive interviews to evaluate items for measuring sexual functioning across cancer populations: improvements and remaining challenges." Qual Life Res 18.8 (October 2009): 1085-1093.
PMID
19672697
Source
pubmed
Published In
Quality of Life Research
Volume
18
Issue
8
Publish Date
2009
Start Page
1085
End Page
1093
DOI
10.1007/s11136-009-9523-x

Disclosure of financial relationships to participants in clinical research.

Authors
Weinfurt, KP; Hall, MA; King, NMP; Friedman, JY; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, King, NMP, Friedman, JY, Schulman, KA, and Sugarman, J. "Disclosure of financial relationships to participants in clinical research." N Engl J Med 361.9 (August 27, 2009): 916-921.
PMID
19710491
Source
pubmed
Published In
The New England journal of medicine
Volume
361
Issue
9
Publish Date
2009
Start Page
916
End Page
921
DOI
10.1056/NEJMsb0902598

Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial.

CONTEXT: Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent. OBJECTIVE: To test the effects of exercise training on health status among patients with heart failure. DESIGN, SETTING, AND PATIENTS: Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007. INTERVENTIONS: Usual care plus aerobic exercise training (n = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). Randomization was stratified by heart failure etiology, which was a covariate in all models. MAIN OUTCOME MEASURES: Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle. RESULTS: Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean, 5.21; 95% confidence interval, 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval, 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval, 0.84 to 3.01) in the exercise training group was statistically significant (P < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected. CONCLUSIONS: Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00047437.

Authors
Flynn, KE; Piña, IL; Whellan, DJ; Lin, L; Blumenthal, JA; Ellis, SJ; Fine, LJ; Howlett, JG; Keteyian, SJ; Kitzman, DW; Kraus, WE; Miller, NH; Schulman, KA; Spertus, JA; O'Connor, CM; Weinfurt, KP; HF-ACTION Investigators,
MLA Citation
Flynn, KE, Piña, IL, Whellan, DJ, Lin, L, Blumenthal, JA, Ellis, SJ, Fine, LJ, Howlett, JG, Keteyian, SJ, Kitzman, DW, Kraus, WE, Miller, NH, Schulman, KA, Spertus, JA, O'Connor, CM, Weinfurt, KP, and HF-ACTION Investigators, . "Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial." JAMA 301.14 (April 8, 2009): 1451-1459.
PMID
19351942
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
301
Issue
14
Publish Date
2009
Start Page
1451
End Page
1459
DOI
10.1001/jama.2009.457

Initial report of the cancer Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function committee: review of sexual function measures and domains used in oncology.

For this report, the authors described the initial activities of the Cancer Patient-Reported Outcomes Measurement Information System (PROMIS)-Sexual Function domain group, which is part of the National Institutes of Health Roadmap Initiative to develop brief questionnaires or individually tailored assessments of quality-of-life domains. Presented are a literature review of sexual function measures used in cancer populations and descriptions of the domains found in those measures. By using a consensus-driven approach, an electronic bibliographic search was conducted for articles that were published from 1991 to 2007, and 486 articles were identified for in-depth review. In total, 257 articles reported the administration of a psychometrically evaluated sexual function measure to individuals who were diagnosed with cancer. Apart from the University of California-Los Angeles Prostate Cancer Index, the International Index of Erectile Function, and the Female Sexual Function Index, the 31 identified measures have not been tested widely in cancer populations. Most measures were multidimensional and included domains related to the sexual response cycle and to general sexual satisfaction. The current review supports the need for a flexible, psychometrically robust measure of sexual function for use in oncology settings and strongly justifies the development of the PROMIS-Sexual Function instrument. When the PROMIS-Sexual Function instrument is available publicly, cancer clinicians and researchers will have another measure with which to assess patient-reported sexual function outcomes in addition to the few legacy measures that were identified through this review.

Authors
Jeffery, DD; Tzeng, JP; Keefe, FJ; Porter, LS; Hahn, EA; Flynn, KE; Reeve, BB; Weinfurt, KP
MLA Citation
Jeffery, DD, Tzeng, JP, Keefe, FJ, Porter, LS, Hahn, EA, Flynn, KE, Reeve, BB, and Weinfurt, KP. "Initial report of the cancer Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function committee: review of sexual function measures and domains used in oncology." Cancer 115.6 (March 15, 2009): 1142-1153. (Review)
PMID
19195044
Source
pubmed
Published In
Cancer
Volume
115
Issue
6
Publish Date
2009
Start Page
1142
End Page
1153
DOI
10.1002/cncr.24134

Decision making and quality of life in the treatment of cancer: a review.

INTRODUCTION: Complexity in decision making for cancer treatment arises from many factors. When considering how to treat patients, physicians prioritize factors such as stage of disease, patient age, and comorbid illnesses. However, physicians must balance these priorities with the patient's preferences, quality of life, social responsibilities, and fear of uncertainty. Although these factors are important, physicians are often unable to effectively judge their patients' preferences. Patients are often unable to fully understand their prognoses and the treatment intent. DISCUSSION: These differences influence how patients and physicians make treatment-related decisions. Partially due to these differences, patients are initially more likely than their physicians to accept greater risk for lesser benefit from treatment. As time progresses and as they experience treatment, a patient's preference changes, yet little is known about this process since few studies have examined it in a prospective longitudinal manner. We present an overview of the literature related to patient and physician decision making and quality of life in patients with advanced cancer, and we propose approaches to future decision-making models in cancer treatment.

Authors
Zafar, SY; Alexander, SC; Weinfurt, KP; Schulman, KA; Abernethy, AP
MLA Citation
Zafar, SY, Alexander, SC, Weinfurt, KP, Schulman, KA, and Abernethy, AP. "Decision making and quality of life in the treatment of cancer: a review." Support Care Cancer 17.2 (February 2009): 117-127. (Review)
PMID
18802727
Source
pubmed
Published In
Supportive Care in Cancer
Volume
17
Issue
2
Publish Date
2009
Start Page
117
End Page
127
DOI
10.1007/s00520-008-0505-2

Community hospital oversight of clinical investigators' financial relationships.

Authors
Hall, MA; Weinfurt, KP; Lawlor, JS; Friedman, JY; Schulman, KA; Sugarman, J
MLA Citation
Hall, MA, Weinfurt, KP, Lawlor, JS, Friedman, JY, Schulman, KA, and Sugarman, J. "Community hospital oversight of clinical investigators' financial relationships." IRB 31.1 (January 2009): 7-13.
PMID
19241734
Source
pubmed
Published In
IRB
Volume
31
Issue
1
Publish Date
2009
Start Page
7
End Page
13

Cancer patient preferences for quality and length of life.

BACKGROUND: Optimal patient decision making requires integration of patient values, goals, and preferences with information received from the physician. In the case of a life-threatening illness such as cancer, the weights placed on quality of life (QOL) and length of life (LOL) represent critical values. The objective of the current study was to describe cancer patient values regarding QOL and LOL and explore associations with communication preferences. METHODS: Patients with advanced cancer completed a computer-based survey before the initial consultation with a medical oncologist. Assessments included sociodemographics, physical and mental health state, values regarding quality and length of life, communication preferences, and cancer-related distress. RESULTS: Among 459 patients with advanced cancer, 55% placed equal valued on QOL and LOL, 27% preferred QOL, and 18% preferred LOL. Patients with a QOL preference had lower levels of cancer-related distress (P < .001). A QOL preference was also associated with older age (P = .001), male sex (P = .003), and higher educational level (P = .062). Patients who preferred LOL over QOL desired a more supportive and less pessimistic communication style from their oncologists. CONCLUSIONS: These data indicate that a values preference for LOL versus QOL may be simply measured, and is associated with wishes regarding the nature of oncologist communication. Awareness of these values during the clinical encounter could improve decision making by influencing the style and content of the communication between oncologists and their patients.

Authors
Meropol, NJ; Egleston, BL; Buzaglo, JS; Benson, AB; Cegala, DJ; Diefenbach, MA; Fleisher, L; Miller, SM; Sulmasy, DP; Weinfurt, KP; CONNECT Study Research Group,
MLA Citation
Meropol, NJ, Egleston, BL, Buzaglo, JS, Benson, AB, Cegala, DJ, Diefenbach, MA, Fleisher, L, Miller, SM, Sulmasy, DP, Weinfurt, KP, and CONNECT Study Research Group, . "Cancer patient preferences for quality and length of life." Cancer 113.12 (December 15, 2008): 3459-3466.
PMID
18988231
Source
pubmed
Published In
Cancer
Volume
113
Issue
12
Publish Date
2008
Start Page
3459
End Page
3466
DOI
10.1002/cncr.23968

Primary care physicians' evaluation and treatment of depression: Results of an experimental study using video vignettes.

Little is known about how patient and primary care physician characteristics are associated with quality of depression care. The authors conducted structured interviews of 404 randomly selected primary care physicians after their interaction with CD-ROM vignettes of actors portraying depressed patients. Vignettes varied along the dimensions of medical comorbidity, attributions regarding the cause of depression, style, race/ethnicity, and gender. Results show that physicians showed wide variation in treatment decisions; for example, most did not inquire about suicidal ideation, and most did not state that they would inform the patient that there can be a delay before an antidepressant is therapeutic. Several physician characteristics were significantly associated with management decisions. Notably, physician age was inversely correlated with a number of quality-of-care measures. In conclusion, quality of care varies among primary care physicians and appears to be associated with physician characteristics to a greater extent than patient characteristics.

Authors
Epstein, SA; Hooper, LM; Weinfurt, KP; DePuy, V; Cooper, LA; Harless, WG; Tracy, CM
MLA Citation
Epstein, SA, Hooper, LM, Weinfurt, KP, DePuy, V, Cooper, LA, Harless, WG, and Tracy, CM. "Primary care physicians' evaluation and treatment of depression: Results of an experimental study using video vignettes." Med Care Res Rev 65.6 (December 2008): 674-695.
PMID
18832109
Source
pubmed
Published In
Medical Care Research and Review
Volume
65
Issue
6
Publish Date
2008
Start Page
674
End Page
695
DOI
10.1177/1077558708320987

Improving health care efficiency and quality using tablet personal computers to collect research-quality, patient-reported data.

OBJECTIVE: To determine whether e/Tablets (wireless tablet computers used in community oncology clinics to collect review of systems information at point of care) are feasible, acceptable, and valid for collecting research-quality data in academic oncology. DATA/SETTING: Primary/Duke Breast Cancer Clinic. DESIGN: Pilot study enrolling sample of 66 breast cancer patients. METHODS: Data were collected using paper- and e/Tablet-based surveys: Functional Assessment of Cancer Therapy General, Functional Assessment of Cancer Therapy-Breast, MD Anderson Symptom Inventory, Functional Assessment of Chronic Illness Therapy (FACIT), Self-Efficacy; and two questionnaires: feasibility, satisfaction. PRINCIPAL FINDINGS: Patients supported e/Tablets as: easy to read (94 percent), easy to respond to (98 percent), comfortable weight (87 percent). Generally, electronic responses validly reflected responses provided by standard paper data collection on nearly all subscales tested. CONCLUSIONS: e/Tablets offer a valid, feasible, acceptable method for collecting research-quality, patient-reported outcomes data in outpatient academic oncology.

Authors
Abernethy, AP; Herndon, JE; Wheeler, JL; Patwardhan, M; Shaw, H; Lyerly, HK; Weinfurt, K
MLA Citation
Abernethy, AP, Herndon, JE, Wheeler, JL, Patwardhan, M, Shaw, H, Lyerly, HK, and Weinfurt, K. "Improving health care efficiency and quality using tablet personal computers to collect research-quality, patient-reported data." Health Serv Res 43.6 (December 2008): 1975-1991.
PMID
18761678
Source
pubmed
Published In
Health Services Research
Volume
43
Issue
6
Publish Date
2008
Start Page
1975
End Page
1991
DOI
10.1111/j.1475-6773.2008.00887.x

Virtual standardized patients: an interactive method to examine variation in depression care among primary care physicians.

BACKGROUND: Some primary care physicians provide less than optimal care for depression (Kessler et al., Journal of the American Medical Association 291, 2581-90, 2004). However, the literature is not unanimous on the best method to use in order to investigate this variation in care. To capture variations in physician behaviour and decision making in primary care settings, 32 interactive CD-ROM vignettes were constructed and tested. AIM AND METHOD: The primary aim of this methods-focused paper was to review the extent to which our study method - an interactive CD-ROM patient vignette methodology - was effective in capturing variation in physician behaviour. Specifically, we examined the following questions: (a) Did the interactive CD-ROM technology work? (b) Did we create believable virtual patients? (c) Did the research protocol enable interviews (data collection) to be completed as planned? (d) To what extent was the targeted study sample size achieved? and (e) Did the study interview protocol generate valid and reliable quantitative data and rich, credible qualitative data? FINDINGS: Among a sample of 404 randomly selected primary care physicians, our voice-activated interactive methodology appeared to be effective. Specifically, our methodology - combining interactive virtual patient vignette technology, experimental design, and expansive open-ended interview protocol - generated valid explanations for variations in primary care physician practice patterns related to depression care.

Authors
Hooper, LM; Weinfurt, KP; Cooper, LA; Mensh, J; Harless, W; Kuhajda, MC; Epstein, SA
MLA Citation
Hooper, LM, Weinfurt, KP, Cooper, LA, Mensh, J, Harless, W, Kuhajda, MC, and Epstein, SA. "Virtual standardized patients: an interactive method to examine variation in depression care among primary care physicians." Prim Health Care Res Dev 9.4 (October 1, 2008): 257-268.
PMID
20463864
Source
pubmed
Published In
Primary Health Care Research and Development
Volume
9
Issue
4
Publish Date
2008
Start Page
257
End Page
268
DOI
10.1017/S1463423608000820

Effects of disclosing financial interests on participation in medical research: a randomized vignette trial.

BACKGROUND: Little is known about the effects of investigators' financial disclosures on potential research participants. METHODS: We conducted a vignette trial in which 470 participants in a telephone survey were randomly assigned to receive a simulated informed consent document that contained 1 of 2 financial disclosures (per capita payments to the research institution or equity ownership by the investigator) or no disclosure. The main outcome measures were trust in medical research and willingness to participate in a hypothetical clinical trial. RESULTS: Participants in the equity group reported less willingness to participate than participants in the per capita payments group (P = .01) and the no disclosure group (P = .03). Trust in the investigator was highest in the per capita payments group and lowest in the equity group (P < .001). Trust among participants who received no disclosure was also greater than trust among participants in the equity group (P = .04) but did not differ significantly from trust among participants in the per capita payments group (P = .15). Participants in the equity group made 3 times as many negative comments as participants in the per capita payments group; and 10 participants in the equity group spontaneously said they would not participate in the hypothetical trial because of the financial interest, compared with only 1 such participant from the other groups. CONCLUSIONS: Although investigators' financial disclosures in research do not substantially affect willingness to participate, potential research participants are more troubled by equity interests than by per capita payments.

Authors
Weinfurt, KP; Hall, MA; Friedman, JY; Hardy, C; Fortune-Greeley, AK; Lawlor, JS; Allsbrook, JS; Lin, L; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, Friedman, JY, Hardy, C, Fortune-Greeley, AK, Lawlor, JS, Allsbrook, JS, Lin, L, Schulman, KA, and Sugarman, J. "Effects of disclosing financial interests on participation in medical research: a randomized vignette trial." Am Heart J 156.4 (October 2008): 689-697.
PMID
18946893
Source
pubmed
Published In
American Heart Journal
Volume
156
Issue
4
Publish Date
2008
Start Page
689
End Page
697

Decisional conflict among patients who accept or decline participation in phase I oncology studies.

WE COMPARED DECISIONAL CONFLICT among adults with advanced cancer who had accepted or declined participation in phase I cancer clinical trials. Respondents completed a 121-item questionnaire that included the Decisional Conflict Scale (DCS), which was designed to measure uncertainty in making health decisions. We used standardized effect sizes to compare the DCS scores of accepters (n = 250) and decliners (n = 65). Accepters had lower decisional conflict than decliners overall (d = 0.42; 95% confidence interval, 0.17--0.68) and on all subscales. Whether greater decisional conflict among decliners represents suboptimal decision-making and is reason for bioethical concern depends on how the results are interpreted. We offer three scenarios to explain the differences and describe opportunities for future empirical work.

Authors
Flynn, KE; Weinfurt, KP; Seils, DM; Lin, L; Burnett, CB; Schulman, KA; Meropol, NJ
MLA Citation
Flynn, KE, Weinfurt, KP, Seils, DM, Lin, L, Burnett, CB, Schulman, KA, and Meropol, NJ. "Decisional conflict among patients who accept or decline participation in phase I oncology studies." J Empir Res Hum Res Ethics 3.3 (September 2008): 69-77.
PMID
19122780
Source
pubmed
Published In
Journal of Empirical Research on Human Research Ethics
Volume
3
Issue
3
Publish Date
2008
Start Page
69
End Page
77
DOI
10.1525/jer.2008.3.3.69

Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.

BACKGROUND: Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit. METHODS: Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions. RESULTS: Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P=0:02). The most common justifications involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower ( < 50%) expectations (n = 3 [27%]). CONCLUSIONS: The wording of questions about likelihood of benefit shapes the expectations that patients express. Patients who express high expectations may not do so to communicate understanding but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding.

Authors
Weinfurt, KP; Seils, DM; Tzeng, JP; Compton, KL; Sulmasy, DP; Astrow, AB; Solarino, NA; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Seils, DM, Tzeng, JP, Compton, KL, Sulmasy, DP, Astrow, AB, Solarino, NA, Schulman, KA, and Meropol, NJ. "Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent." Med Decis Making 28.4 (July 2008): 575-581.
PMID
18378940
Source
pubmed
Published In
Medical Decision Making
Volume
28
Issue
4
Publish Date
2008
Start Page
575
End Page
581
DOI
10.1177/0272989X08315242

Using health communication best practices to develop a web-based provider-patient communication aid: the CONNECT study.

OBJECTIVE: Although there is broad consensus that careful content vetting and user testing is important in the development of technology-based educational interventions, often these steps are overlooked. This paper highlights the development of a theory-guided, web-based communication aid (CONNECT), designed to facilitate treatment decision-making among patients with advanced cancer. METHODS: The communication aid included an on-line survey, patient skills training module and an automated physician report. Development steps included: (1) evidence-based content development; (2) usability testing; (3) pilot testing; and (4) patient utilization and satisfaction. RESULTS: Usability testing identified some confusing directions and navigation for the on-line survey and validated the relevance of the "patient testimonials" in the skills module. Preliminary satisfaction from the implementation of the communication aid showed that 66% found the survey length reasonable and 70% found it helpful in talking with the physician. Seventy percent reported the skills module helpful and about half found it affected the consultation. CONCLUSION: Designing patient education interventions for translation into practice requires the integration of health communication best practice including user feedback along the developmental process. PRACTICE IMPLICATIONS: This developmental process can be translated to a broad array of community-based patient and provider educational interventions.

Authors
Fleisher, L; Buzaglo, J; Collins, M; Millard, J; Miller, SM; Egleston, BL; Solarino, N; Trinastic, J; Cegala, DJ; Benson, AB; Schulman, KA; Weinfurt, KP; Sulmasy, D; Diefenbach, MA; Meropol, NJ
MLA Citation
Fleisher, L, Buzaglo, J, Collins, M, Millard, J, Miller, SM, Egleston, BL, Solarino, N, Trinastic, J, Cegala, DJ, Benson, AB, Schulman, KA, Weinfurt, KP, Sulmasy, D, Diefenbach, MA, and Meropol, NJ. "Using health communication best practices to develop a web-based provider-patient communication aid: the CONNECT study." Patient Educ Couns 71.3 (June 2008): 378-387.
PMID
18417312
Source
pubmed
Published In
Patient Education and Counseling
Volume
71
Issue
3
Publish Date
2008
Start Page
378
End Page
387
DOI
10.1016/j.pec.2008.02.017

Effects of disclosing financial interests on attitudes toward clinical research.

BACKGROUND: The effects of disclosing financial interests to potential research participants are not well understood. OBJECTIVE: To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research. DESIGN AND PARTICIPANTS: 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. MEASUREMENTS: 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. RESULTS: 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. CONCLUSIONS: 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." J Gen Intern Med 23.6 (June 2008): 860-866.
PMID
18386101
Source
pubmed
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

Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research.

STUDY OBJECTIVE: Emergency department (ED) -based clinical research has the potential to include patient populations that are typically underrepresented in clinical research. The objective of this study is to assess how emergency clinical care and research processes, informed consent, and patient demographic factors (age, sex, and ethnicity/race) affect enrollment and consent in clinical research in the ED. METHODS: This was an analysis of prospectively collected data of all patients (aged 2 to 101 years) eligible for one of 7 clinical research studies from February 2005 to April 2007 in an academic ED. We measured rates of enrollment and consent in the clinical studies. RESULTS: One thousand two hundred two of the 4418 patients screened for participation in 7 clinical studies were clinically eligible for enrollment. Of the 868 patients who were able to provide a voluntary decision regarding consent, 639 (73.6%) agreed to participate; an overall enrollment rate of 53.2%. The mean age of patients enrolled was 51.8 years (range 3 to 98 years). Black patients (49.2% enrollment) and Latino patients (18.4% enrollment) were less likely to be enrolled in comparison with white patients (58.3% enrollment) (adjusted odds ratio [OR] of enrollment for blacks=0.64; 95% confidence interval [CI] 0.50 to 0.82; adjusted OR of enrollment for Latinos=0.16; 95% CI 0.08 to 0.33). Enrollment rates were lower among pediatric (40.0%) and geriatric patients (49.1%) in comparison with adult patients ages 18 to 64 years (55.5%) (adjusted OR of enrollment for pediatric patients=0.70, 95% CI 0.34 to 1.43; adjusted OR of enrollment for geriatric patients=0.69, 95% CI 0.53 to 0.90). Unique issues contributing to underenrollment included challenges in consent among pediatric and elderly patients, language issues in Latino patients, reduced voluntary consent rates among black patients, and perhaps underuse of minimal risk waivers. CONCLUSION: In a large academic ED, minority, pediatric, and geriatric patients were less likely to be enrolled in acute care clinical research studies than middle-aged whites. Enrollment and consent strategies designed to enhance research participation in these important patient populations may be necessary to address disparities in the development and application of evidence-based emergency and acute care.

Authors
Glickman, SW; Anstrom, KJ; Lin, L; Chandra, A; Laskowitz, DT; Woods, CW; Freeman, DH; Kraft, M; Beskow, LM; Weinfurt, KP; Schulman, KA; Cairns, CB
MLA Citation
Glickman, SW, Anstrom, KJ, Lin, L, Chandra, A, Laskowitz, DT, Woods, CW, Freeman, DH, Kraft, M, Beskow, LM, Weinfurt, KP, Schulman, KA, and Cairns, CB. "Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research." Ann Emerg Med 51.6 (June 2008): 775-780.e3.
PMID
18191297
Source
pubmed
Published In
Annals of Emergency Medicine
Volume
51
Issue
6
Publish Date
2008
Start Page
775
End Page
780.e3
DOI
10.1016/j.annemergmed.2007.11.002

The patient reported outcomes measurement information system—Cancer (PROMIS-Ca): Cancer-specific application of a generic fatigue measure

Authors
Cella, D; Lai, J; Garcia, SF; Reeve, BB; Weinfurt, KP; George, J; Stone, A
MLA Citation
Cella, D, Lai, J, Garcia, SF, Reeve, BB, Weinfurt, KP, George, J, and Stone, A. "The patient reported outcomes measurement information system—Cancer (PROMIS-Ca): Cancer-specific application of a generic fatigue measure." Journal of Clinical Oncology 26.15_suppl (May 20, 2008): 6537-6537.
Source
crossref
Published In
Journal of Clinical Oncology
Volume
26
Issue
15_suppl
Publish Date
2008
Start Page
6537
End Page
6537
DOI
10.1200/jco.2008.26.15_suppl.6537

Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

BACKGROUND: Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. CONCLUSIONS/SIGNIFICANCE: In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.

Authors
Weinfurt, KP; Seils, DM; Tzeng, JP; Lin, L; Schulman, KA; Califf, RM
MLA Citation
Weinfurt, KP, Seils, DM, Tzeng, JP, Lin, L, Schulman, KA, and Califf, RM. "Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. (Published online)" PLoS One 3.5 (May 7, 2008): e2128-.
Website
http://hdl.handle.net/10161/4492
PMID
18461146
Source
pubmed
Published In
PloS one
Volume
3
Issue
5
Publish Date
2008
Start Page
e2128
DOI
10.1371/journal.pone.0002128

Varieties of uncertainty and the validity of informed consent.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Varieties of uncertainty and the validity of informed consent." Clin Trials 5.6 (2008): 624-625.
PMID
19029211
Source
pubmed
Published In
Clinical Trials
Volume
5
Issue
6
Publish Date
2008
Start Page
624
End Page
625
DOI
10.1177/1740774508098690

Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions.

BACKGROUND: Item response theory (IRT) promises more sensitive and efficient measurement of patient-reported outcomes (PROs) than traditional approaches; however, the selection and use of PRO measures from IRT-based item banks differ from current methods of using PRO measures. PURPOSE: To anticipate barriers to the adoption of IRT item banks into clinical trials. METHODS: We conducted semistructured telephone or in-person interviews with 42 clinical researchers who published results from clinical trials in the Journal of the American Medical Association, the New England Journal of Medicine, or other leading clinical journals from July 2005 through May 2006. Interviews included a brief tutorial on IRT item banks. RESULTS: After the tutorial, 39 of 42 participants understood the novel products available from an IRT item bank, namely customized short forms and computerized adaptive testing. Most participants (38/42) thought that item banks could be useful in their clinical trials, but they mentioned several potential barriers to adoption, including economic and logistical constraints, concerns about whether item banks are better than current PRO measures, concerns about how to convince study personnel or statisticians to use item banks, concerns about FDA or sponsor acceptance, and the lack of availability of item banks validated in specific disease populations. LIMITATIONS: Selection bias might have led to more positive responses to the concept of item banks in clinical trials. CONCLUSIONS: Clinical investigators are open to a new method of PRO measurement offered in IRT item banks, but bank developers must address investigator and stakeholder concerns before widespread adoption can be expected.

Authors
Flynn, KE; Dombeck, CB; DeWitt, EM; Schulman, KA; Weinfurt, KP
MLA Citation
Flynn, KE, Dombeck, CB, DeWitt, EM, Schulman, KA, and Weinfurt, KP. "Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions." Clin Trials 5.6 (2008): 575-586.
PMID
19029206
Source
pubmed
Published In
Clinical Trials
Volume
5
Issue
6
Publish Date
2008
Start Page
575
End Page
586
DOI
10.1177/1740774508098414

Change in health-related quality of life following non-fatal cardiovascular events in post-myocardial infarction patients

Authors
Lewis, EF; Li, Y; Pfeffer, MA; Solomon, SD; Weinfurt, KP; Velazquez, EJ; Califf, R; White, HD; Rouleau, JL; Schulman, KA; Reed, SD
MLA Citation
Lewis, EF, Li, Y, Pfeffer, MA, Solomon, SD, Weinfurt, KP, Velazquez, EJ, Califf, R, White, HD, Rouleau, JL, Schulman, KA, and Reed, SD. "Change in health-related quality of life following non-fatal cardiovascular events in post-myocardial infarction patients." VALUE IN HEALTH 11.3 (2008): A205-A206.
Source
wos-lite
Published In
Value in Health
Volume
11
Issue
3
Publish Date
2008
Start Page
A205
End Page
A206
DOI
10.1016/S1098-3015(10)70652-5

Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative.

Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

Authors
Garcia, SF; Cella, D; Clauser, SB; Flynn, KE; Lad, T; Lai, J-S; Reeve, BB; Smith, AW; Stone, AA; Weinfurt, K
MLA Citation
Garcia, SF, Cella, D, Clauser, SB, Flynn, KE, Lad, T, Lai, J-S, Reeve, BB, Smith, AW, Stone, AA, and Weinfurt, K. "Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative." J Clin Oncol 25.32 (November 10, 2007): 5106-5112. (Review)
PMID
17991929
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
25
Issue
32
Publish Date
2007
Start Page
5106
End Page
5112
DOI
10.1200/JCO.2007.12.2341

Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer.

GOALS OF WORK: Patients with prostate cancer metastasized to bone frequently experience skeletal morbidities as a result of their disease. We sought to quantify the longitudinal effects on patient-reported outcomes of skeletal-related events (SREs) and to ascertain the declines in health-related quality of life (HRQOL) and pain experienced by patients who experienced SREs. MATERIALS AND METHODS: Data are from a clinical trial for the treatment of SREs associated with advanced prostate cancer metastatic to bone. Outcome measures included the Functional Assessment of Cancer Therapy-General (FACT-G) and the Brief Pain Inventory. Among patients who survived 6 months after randomization, patients with no SREs in the initial 6 months after randomization were matched via propensity scores with those experiencing one or more SREs. Similarly, patients with one SRE were matched with a subset of patients with two or more SREs. MAIN RESULTS: Patients with SREs in the initial period had significantly worse survival and HRQOL than those with no SREs. Significant differences were found between the pain differences, FACT-G total scores, and FACT-G physical, emotional, and functional subscales. Comparisons of patients with single vs multiple SREs showed similar patterns. CONCLUSIONS: The presence of SREs is significantly associated with worse survival and poorer HRQOL in this patient population. Increasing SRE intensity shows a pattern of increasingly decreased survival and poorer HRQOL.

Authors
DePuy, V; Anstrom, KJ; Castel, LD; Schulman, KA; Weinfurt, KP; Saad, F
MLA Citation
DePuy, V, Anstrom, KJ, Castel, LD, Schulman, KA, Weinfurt, KP, and Saad, F. "Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer." Support Care Cancer 15.7 (July 2007): 869-876.
PMID
17262196
Source
pubmed
Published In
Supportive Care in Cancer
Volume
15
Issue
7
Publish Date
2007
Start Page
869
End Page
876
DOI
10.1007/s00520-006-0203-x

Use and perceptions of clinical practice guidelines by internal medicine physicians.

The authors sought to explore the use and perceptions of clinical practice guidelines among internal medicine physicians. Through a Web-based survey, 201 board-certified internal medicine physicians rated their opinions on several statements using 7-point Likert scales. Most respondents (74.7%) felt that guidelines were suitable for at least half of their patients, although a failure to take comorbid conditions into account was a frequently cited barrier. For patients with cardiovascular disease, there was no difference between individual internists' perceptions of their own compliance with guidelines and their estimates of cardiologists' compliance (P = .14). A large majority of respondents (70.7%) believed that guideline committee member participation in industry-funded research introduces bias into guideline content (median [interquartile range], 5 [4-6]). Although most respondents felt that measuring physicians against guideline-based performance measures encourages evidence-based medicine (76.5%), opinions were split as to whether this practice distracts from patient care or compromises physician autonomy.

Authors
Shea, AM; DePuy, V; Allen, JM; Weinfurt, KP
MLA Citation
Shea, AM, DePuy, V, Allen, JM, and Weinfurt, KP. "Use and perceptions of clinical practice guidelines by internal medicine physicians." Am J Med Qual 22.3 (May 2007): 170-176.
PMID
17485558
Source
pubmed
Published In
American Journal of Medical Quality
Volume
22
Issue
3
Publish Date
2007
Start Page
170
End Page
176
DOI
10.1177/1062860607300291

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

Authors
Revicki, DA; Gnanasakthy, A; Weinfurt, K
MLA Citation
Revicki, DA, Gnanasakthy, A, and Weinfurt, K. "Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier." Qual Life Res 16.4 (May 2007): 717-723.
PMID
17268927
Source
pubmed
Published In
Quality of Life Research
Volume
16
Issue
4
Publish Date
2007
Start Page
717
End Page
723
DOI
10.1007/s11136-006-9153-5

Value of high-cost cancer care: a behavioral science perspective.

Concerns about the high costs of cancer care have led to a renewed interest in understanding how patients value the outcomes of care. Psychologists, economists, and others have highlighted some of the ways in which patients and caregivers perceive and make treatment decisions. Prospect theory is the predominant framework for understanding decisions made in situations where the outcomes of each choice are uncertain. Prospect theory assumes that a patient values the outcomes of care not in absolute terms, such as years of life saved, but as deviations from the patient's point of reference. This article discusses some of the implications of this notion, along with discussing differences among people in their reference points. These and other considerations from the psychology of decision making help to clarify why some patients might be inclined to seek expensive or risky treatments in the hopes of achieving benefits that others might consider not worthwhile. An appreciation of these psychological issues might improve the quality of debates concerning the rising costs of cancer care.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Value of high-cost cancer care: a behavioral science perspective." J Clin Oncol 25.2 (January 10, 2007): 223-227. (Review)
PMID
17210944
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
25
Issue
2
Publish Date
2007
Start Page
223
End Page
227
DOI
10.1200/JCO.2006.08.9029

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
pubmed
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." Clin Trials 4.3 (2007): 272-278.
PMID
17715256
Source
pubmed
Published In
Clinical Trials
Volume
4
Issue
3
Publish Date
2007
Start Page
272
End Page
278
DOI
10.1177/1740774507079239

Measuring trust in medical researchers.

BACKGROUND: Concern is widespread that the public's and participants' trust in medical research is threatened, but few empirical measures of research trust exist. This project aims to enable more rigorous study of researcher trust by developing and testing appropriate survey measures. METHODS: Survey items were developed based on a conceptual model of the primary domains of researcher trust (safety, fidelity, honesty, global trust). Pilot testing was conducted on a regional convenience sample of adults (n = 124). Exploratory factor analyses of the data were performed, and an item selection procedure reduced the number of survey questions. A final set of 12 items was validated, and a 4-item short version of the researcher trust scale was selected and tested in a national web-based survey of asthma and diabetes patients (n = 3623). Further factor analysis and validation were performed on this larger sample. RESULTS: Both the full and short scales have a single-factor structure with acceptable internal reliability (alphas of 0.87 [12 items] and 0.72 [4 items]). Trust in physician researchers and trust in medical researchers generally were found not to be separate constructs. In the national sample, the short scale was positively associated with better health status, prior participation in medical research, and willingness to participate in a hypothetical medical research study, and negatively associated with African-American race and higher education. CONCLUSIONS: Trust in medical researchers is a measurable single-factor construct including trust in safety, researcher fidelity, and honesty. This new scale provides an empirical tool for informing the ethics and public policy of medical research.

Authors
Hall, MA; Camacho, F; Lawlor, JS; Depuy, V; Sugarman, J; Weinfurt, K
MLA Citation
Hall, MA, Camacho, F, Lawlor, JS, Depuy, V, Sugarman, J, and Weinfurt, K. "Measuring trust in medical researchers." Med Care 44.11 (November 2006): 1048-1053.
PMID
17063137
Source
pubmed
Published In
Medical Care
Volume
44
Issue
11
Publish Date
2006
Start Page
1048
End Page
1053
DOI
10.1097/01.mlr.0000228023.37087.cb

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." Account Res 13.4 (October 2006): 325-342.
PMID
17849643
Source
pubmed
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.

BACKGROUND: There is little guidance regarding how to disclose researchers' financial interests to potential research participants. OBJECTIVE: 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. DESIGN AND PARTICIPANTS: 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. APPROACH: 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. RESULTS: 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. CONCLUSIONS: 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." J Gen Intern Med 21.9 (September 2006): 901-906.
PMID
16918732
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
21
Issue
9
Publish Date
2006
Start Page
901
End Page
906
DOI
10.1111/j.1525-1497.2006.00502.x

Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer.

BACKGROUND: Zoledronic acid reduces skeletal-related events associated with prostate cancer and has long-term efficacy in pain outcomes. Findings of treatment group differences in pain early in treatment are less reliable. We used a recently recommended analytic approach to examine the effect of zoledronic acid on pain. MATERIALS AND METHODS: In a trial of zoledronic acid (n = 214) versus placebo (n = 208), we used the Brief Pain Inventory to assess pain at baseline, 3 weeks, 6 weeks and every 6 weeks thereafter for a total of 60 weeks. We used a modified longitudinal rank test to determine whether clinically meaningful changes in pain were related to treatment group. RESULTS: Seventy-six of 214 patients (35.5%) receiving zoledronic acid and 62 of 208 patients (29.8%) receiving placebo completed the 60-week visit (P = 0.22). In all 11 pain assessments, patients receiving zoledronic acid reported more favorable, clinically meaningful changes in pain scores. Overall, patients receiving zoledronic acid had a 33% chance of a favorable response, compared with 25% for patients receiving placebo (P = 0.04; 95% CI 0.5% to 15.6%). CONCLUSIONS: Zoledronic acid was more likely than placebo to be associated with clinically meaningful reductions in pain. Thus, zoledronic acid may help to avert the pain experienced by patients with progressing metastatic disease secondary to prostate cancer.

Authors
Weinfurt, KP; Anstrom, KJ; Castel, LD; Schulman, KA; Saad, F
MLA Citation
Weinfurt, KP, Anstrom, KJ, Castel, LD, Schulman, KA, and Saad, F. "Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer." Ann Oncol 17.6 (June 2006): 986-989.
PMID
16533874
Source
pubmed
Published In
Annals of Oncology
Volume
17
Issue
6
Publish Date
2006
Start Page
986
End Page
989
DOI
10.1093/annonc/mdl041

The effects of disclosing financial conflicts of interest in clinical research: Evidence from a large national survey

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. "The effects of disclosing financial conflicts of interest in clinical research: Evidence from a large national survey." JOURNAL OF GENERAL INTERNAL MEDICINE 21 (April 2006): 142-142.
Source
wos-lite
Published In
Journal of General Internal Medicine
Volume
21
Publish Date
2006
Start Page
142
End Page
142

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

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 (April 2006): 160-160.
Source
wos-lite
Published In
Journal of General Internal Medicine
Volume
21
Publish Date
2006
Start Page
160
End Page
160

What is necessary to support informed decision making regarding financial conflicts of interests 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. "What is necessary to support informed decision making regarding financial conflicts of interests in research?." JOURNAL OF GENERAL INTERNAL MEDICINE 21 (April 2006): 164-164.
Source
wos-lite
Published In
Journal of General Internal Medicine
Volume
21
Publish Date
2006
Start Page
164
End Page
164

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

PURPOSE: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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." Acad Med 81.2 (February 2006): 113-118.
PMID
16436571
Source
pubmed
Published In
Academic Medicine
Volume
81
Issue
2
Publish Date
2006
Start Page
113
End Page
118

Racial differences in health concern.

An understanding of racial differences in risk-related affect may help explain racial differences in health behaviors and outcomes and provide additional opportunities for intervention. In phone interviews with a random community sample of 197 whites, 155 blacks and 163 Latinos, we assessed concern that respondents' health would be hurt by their diet, an inability to exercise, an inability to follow a doctor's recommendations and disease. A multivariate analysis of variance with follow-up profile analysis revealed that whites were less concerned than blacks and Latinos about an inability to follow their doctors' recommendations (ps < 0.01). There were no racial differences in the other health concern variables. Interventions to inform blacks and Latinos about their health risks must strike a balance between creating enough health concern to encourage health behavior but not so much that it interferes with health-promoting behaviors.

Authors
Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Bright, CM; Schulman, KA; Bosworth, HB
MLA Citation
Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Bright, CM, Schulman, KA, and Bosworth, HB. "Racial differences in health concern." J Natl Med Assoc 98.1 (January 2006): 36-42.
PMID
16532976
Source
pubmed
Published In
Journal of the National Medical Association
Volume
98
Issue
1
Publish Date
2006
Start Page
36
End Page
42

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." J Law Med Ethics 34.3 (2006): 581-481.
PMID
17144182
Source
pubmed
Published In
The Journal of Law, Medicine & Ethics
Volume
34
Issue
3
Publish Date
2006
Start Page
581
End Page
481

Can prospect theory explain risk-seeking behavior by terminally ill patients?

Patients with life-threatening conditions sometimes appear to make risky treatment decisions as their condition declines, contradicting the risk-averse behavior predicted by expected utility theory. Prospect theory accommodates such decisions by describing how individuals evaluate outcomes relative to a reference point and how they exhibit risk-seeking behavior over losses relative to that point. The authors show that a patient's reference point for his or her health is a key factor in determining which treatment option the patient selects, and they examine under what circumstances the more risky option is selected. The authors argue that patients' reference points may take time to adjust following a change in diagnosis, with implications for predicting under what circumstances a patient may select experimental or conventional therapies or select no treatment.

Authors
Rasiel, EB; Weinfurt, KP; Schulman, KA
MLA Citation
Rasiel, EB, Weinfurt, KP, and Schulman, KA. "Can prospect theory explain risk-seeking behavior by terminally ill patients?." Med Decis Making 25.6 (November 2005): 609-613.
Website
http://hdl.handle.net/10161/2641
PMID
16282211
Source
pubmed
Published In
Medical Decision Making
Volume
25
Issue
6
Publish Date
2005
Start Page
609
End Page
613
DOI
10.1177/0272989X05282642

Patterns of intimate partner violence: correlates and outcomes.

Battered women experience different constellations of violence and abusive behavior characterized by various combinations of physical violence, sexual violence, psychological abuse, and stalking. The goals of the current study were to determine whether it was possible to identify empirically derived and meaningful patterns of intimate partner violence (IPV) and to examine correlates and outcomes of the IPV patterns. Three IPV patterns were identified using cluster analysis. Pattern 1 was characterized by moderate levels of physical violence, psychological abuse, and stalking but little sexual violence. Pattern 2 was characterized by high levels of physical violence, psychological abuse, and stalking but low levels of sexual violence. Pattern 3 was characterized by high levels of all violence types. IPV Pattern 3 was associated with the highest prevalence of posttraumatic stress disorder and depression, and IPV Pattern 2 had the highest levels of revictimization during the year following recruitment. The clinical and policy implications of the findings are discussed.

Authors
Dutton, MA; Kaltman, S; Goodman, LA; Weinfurt, K; Vankos, N
MLA Citation
Dutton, MA, Kaltman, S, Goodman, LA, Weinfurt, K, and Vankos, N. "Patterns of intimate partner violence: correlates and outcomes." Violence Vict 20.5 (October 2005): 483-497.
PMID
16248486
Source
pubmed
Published In
Violence and victims
Volume
20
Issue
5
Publish Date
2005
Start Page
483
End Page
497

Performance of the Thrombolysis in Myocardial Infarction (TIMI) ST-elevation myocardial infarction risk score in a national cohort of elderly patients.

BACKGROUND: The TIMI ST-elevation myocardial infarction (STEMI) score was developed and validated in a randomized controlled trial population. We sought to assess its accuracy in a community-based cohort of elderly patients hospitalized with STEMI. METHODS: We evaluated the TIMI STEMI score in 47,882 patients aged > or = 65 years hospitalized with STEMI in US hospitals from 1994 to 1996. We assessed TIMI STEMI score discrimination and calibration for 30-day mortality and compared observed and published TIMI mortality rates. RESULTS: The cohort's median TIMI score was 6 (25th-75th percentile 4, 8). Thirty-day mortality rates were higher among patients with higher TIMI scores (TIMI score 2: 4.4% vs TIMI score > 8: 35.6%, P < .0001 for trend). However, the TIMI score provided only modest discrimination (c = 0.67) and calibration (goodness-of-fit P < .0001). Mortality rates for TIMI scores differed between patients who did and did not receive reperfusion therapy (P < .0001 for TIMI score x reperfusion therapy interaction). Thirty-day mortality rates in the cohort were higher than published TIMI estimates (P = .001; eg, TIMI score 2: 4.4% cohort vs 2.2% published rate). CONCLUSIONS: The TIMI score provided modest prognostic discrimination and calibration among elderly patients with STEMI. Our findings highlight the difficulties in applying risk scores developed in randomized controlled trial cohorts to elderly patients.

Authors
Rathore, SS; Weinfurt, KP; Foody, JM; Krumholz, HM
MLA Citation
Rathore, SS, Weinfurt, KP, Foody, JM, and Krumholz, HM. "Performance of the Thrombolysis in Myocardial Infarction (TIMI) ST-elevation myocardial infarction risk score in a national cohort of elderly patients." Am Heart J 150.3 (September 2005): 402-410.
PMID
16169316
Source
pubmed
Published In
American Heart Journal
Volume
150
Issue
3
Publish Date
2005
Start Page
402
End Page
410
DOI
10.1016/j.ahj.2005.03.069

Estimating causal effects in randomized studies with imperfect adherence: Conceptual and statistical foundations

Authors
Anstrom, KJ; Weinfurt, KP; Allen, AS
MLA Citation
Anstrom, KJ, Weinfurt, KP, and Allen, AS. "Estimating causal effects in randomized studies with imperfect adherence: Conceptual and statistical foundations." (August 21, 2005): 453-474. (Chapter)
Source
scopus
Publish Date
2005
Start Page
453
End Page
474
DOI
10.4324/9781410615626

Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT).

BACKGROUND: In a multinational clinical trial, valsartan was statistically not inferior to captopril in reducing mortality and cardiovascular morbidity after myocardial infarction (MI) in patients with signs of heart failure and/or left ventricular dysfunction. We conducted a prospective economic evaluation to compare within-trial resource use, costs, and quality of life in patients receiving valsartan, captopril, or both after MI. METHODS: We assigned country-specific unit costs to resource use data for 14703 patients and measured health-related quality of life in a subset of 4524 patients. We used the nonparametric bootstrap method to compare rates of resource use and costs, and a piecewise linear mixed-effects regression analysis to compare longitudinal measures of quality of life. RESULTS: There were no significant differences in rates of resource use between the valsartan and captopril groups. During an average follow-up of 2 years, total costs for patients receiving valsartan were significantly higher than for patients receiving captopril (USD 14103 vs USD 13038; 95% CI USD 369-USD 1875). The cost differential was caused primarily by the cost of the study medications (USD 1056 for valsartan vs USD 165 for captopril; 95% CI USD 867 to USD 912). Quality of life did not differ significantly between groups. CONCLUSIONS: For most patients at high risk after MI, the availability of generic captopril confers a cost advantage over valsartan because of lower medication costs. The difference will be smaller or nonexistent in settings where brand-name ACE inhibitors are prescribed.

Authors
Reed, SD; Radeva, JI; Weinfurt, KP; McMurray, JJV; Pfeffer, MA; Velazquez, EJ; Allsbrook, JS; Masselink, LE; Sellers, MA; Califf, RM; Schulman, KA; VALIANT Investigators,
MLA Citation
Reed, SD, Radeva, JI, Weinfurt, KP, McMurray, JJV, Pfeffer, MA, Velazquez, EJ, Allsbrook, JS, Masselink, LE, Sellers, MA, Califf, RM, Schulman, KA, and VALIANT Investigators, . "Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT)." Am Heart J 150.2 (August 2005): 323-329.
PMID
16086938
Source
pubmed
Published In
American Heart Journal
Volume
150
Issue
2
Publish Date
2005
Start Page
323
End Page
329
DOI
10.1016/j.ahj.2004.08.037

Perceived discrimination and reported delay of pharmacy prescriptions and medical tests.

BACKGROUND: Access to health care varies according to a person's race and ethnicity. Delaying treatment is one measure of access with important health consequences. OBJECTIVE: Determine whether perceptions of unfair treatment because of race or ethnicity are associated with reported treatment delays, controlling for economic constraints, self-reported health, depression, and demographics. DESIGN: Cross-sectional, observational study. PARTICIPANTS: A randomly selected community sample of 181 blacks, 148 Latinos, and 193 whites in Durham County, NC. MEASUREMENTS: A phone survey conducted in 2002 to assess discrimination, trust in medical care, quality of care, and access to care. Treatment delays were measured by whether or not a person reported delaying or forgoing filling a prescription and delaying or forgoing having a medical test/treatment in the past 12 months. Perceived discrimination was measured as unfair treatment in health care and as racism in local health care institutions. RESULTS: The odds of delaying filling prescriptions were significantly higher (odds ratio (OR)=2.02) for persons who perceived unfair treatment, whereas the odds of delaying tests or treatments were significantly higher (OR=2.42) for persons who thought racism was a problem in health care locally. People with self-reported depression and people who reported not working had greater odds of delaying both types of care. CONCLUSIONS: A prospective cohort study with both personal and macro measures of discrimination, as well as more refined measures of treatment delays, would help us better understand the relationship between perceived discrimination and treatment delays.

Authors
Van Houtven, CH; Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Van Houtven, CH, Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "Perceived discrimination and reported delay of pharmacy prescriptions and medical tests." J Gen Intern Med 20.7 (July 2005): 578-583.
PMID
16050850
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
20
Issue
7
Publish Date
2005
Start Page
578
End Page
583
DOI
10.1111/j.1525-1497.2005.0123.x

Perceived racial/ethnic bias in healthcare in Durham County, North Carolina: a comparison of community and national samples.

BACKGROUND: We sought to compare findings of a national survey of perceptions of racial/ethnic discrimination in healthcare to those of a community survey, with emphasis on the perceptions of Latinos. METHODS: Responses from a national survey were compared to a telephone survey of residents of Durham County, North Carolina. RESULTS: Black respondents in the Durham sample were more likely than those in the national sample to feel that a healthcare provider had treated them with disrespect because of health insurance status (28% vs 14%; P < 0.001). Approximately one third of Durham Latinos and 14% of Latinos in the national sample felt they had been treated with disrespect because of their English-language ability (P < 0.01). Compared to a national sample of white participants, white respondents in Durham were more likely to believe that black persons are worse off in terms of receiving routine medical care (40% vs 27%; P < 0.01) and having health insurance (58% vs 43%; P < 0.01). As compared to their national counterparts, there was a similar trend for how white respondents in Durham perceived how Latinos fared (P < 0.001 for all comparisons). CONCLUSIONS: Overall the perception of bias in healthcare was greater among Durham residents, especially among newly immigrated Latinos, than among their national counterparts.

Authors
Friedman, JY; Anstrom, KJ; Weinfurt, KP; McIntosh, M; Bosworth, HB; Oddone, EZ; Bright, CM; Schulman, KA
MLA Citation
Friedman, JY, Anstrom, KJ, Weinfurt, KP, McIntosh, M, Bosworth, HB, Oddone, EZ, Bright, CM, and Schulman, KA. "Perceived racial/ethnic bias in healthcare in Durham County, North Carolina: a comparison of community and national samples." N C Med J 66.4 (July 2005): 267-275.
PMID
16206530
Source
pubmed
Published In
North Carolina Medical Journal
Volume
66
Issue
4
Publish Date
2005
Start Page
267
End Page
275

The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer.

BACKGROUND: We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. PATIENTS AND METHODS: Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. RESULTS: There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. CONCLUSIONS: SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.

Authors
Weinfurt, KP; Li, Y; Castel, LD; Saad, F; Timbie, JW; Glendenning, GA; Schulman, KA
MLA Citation
Weinfurt, KP, Li, Y, Castel, LD, Saad, F, Timbie, JW, Glendenning, GA, and Schulman, KA. "The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer." Ann Oncol 16.4 (April 2005): 579-584.
PMID
15734776
Source
pubmed
Published In
Annals of Oncology
Volume
16
Issue
4
Publish Date
2005
Start Page
579
End Page
584
DOI
10.1093/annonc/mdi122

Women's resources and use of strategies as risk and protective factors for reabuse over time.

Using a longitudinal and ecological approach, we investigated the relationships between women's material and emotional resources and strategies and their ability to stay safe over time in a sample of 406 help-seeking African American women. The multivariate analysis demonstrated that social support served as a protective factor and resistance strategies as risk factors for reabuse during a 1-year period. It also showed an interaction between social support and history of violence such that for participants who had experienced the most severe violence, social support did not serve as a protective factor; however, for the other participants, those with the least amount of social support had a 65% predicted probability of reabuse during the next year, compared to a 20% predicted probability for women reporting the highest level of social support. Policy and programmatic implications of these findings are discussed.

Authors
Goodman, L; Dutton, MA; Vankos, N; Weinfurt, K
MLA Citation
Goodman, L, Dutton, MA, Vankos, N, and Weinfurt, K. "Women's resources and use of strategies as risk and protective factors for reabuse over time." Violence Against Women 11.3 (March 2005): 311-336.
PMID
16043552
Source
pubmed
Published In
Violence Against Women
Volume
11
Issue
3
Publish Date
2005
Start Page
311
End Page
336
DOI
10.1177/1077801204273297

Experience, Grammar, and the Stuff of Psychology

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Experience, Grammar, and the Stuff of Psychology." Theory & Psychology 15.3 (January 1, 2005): 407-409. (Review)
Source
scopus
Published In
Theory & Psychology
Volume
15
Issue
3
Publish Date
2005
Start Page
407
End Page
409
DOI
10.1177/095935430501500307

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials.

BACKGROUND: There is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials. METHODS: Surveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency-type numeracy was assessed using a multiple-choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in "40% of cases like yours." In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified. RESULTS: The correct frequency-type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief-type answer, "The doctor is 40% confident that the treatment will control my cancer." In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies. CONCLUSIONS: Because the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment.

Authors
Weinfurt, KP; Depuy, V; Castel, LD; Sulmasy, DP; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Depuy, V, Castel, LD, Sulmasy, DP, Schulman, KA, and Meropol, NJ. "Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials." Cancer 103.1 (January 1, 2005): 140-147.
PMID
15534885
Source
pubmed
Published In
Cancer
Volume
103
Issue
1
Publish Date
2005
Start Page
140
End Page
147
DOI
10.1002/cncr.20730

For the patient. Who trusts healthcare institutions? Results from a community-based sample.

Authors
Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "For the patient. Who trusts healthcare institutions? Results from a community-based sample." Ethn Dis 15.1 (2005): 150-.
PMID
15720061
Source
pubmed
Published In
Ethnicity & disease
Volume
15
Issue
1
Publish Date
2005
Start Page
150

Who trusts healthcare institutions? Results from a community-based sample.

OBJECTIVE: The goal of this research was to examine racial differences in trust in various healthcare institutions. METHOD: In telephone interviews, 195 Whites, 183 Blacks, and 171 Latinos from Durham, NC indicated how often they trust various institutions (community doctors, local hospitals, county health department, insurance companies, and state and federal government) to do what is best for patients. RESULTS: In bivariate analyses, trust in various healthcare institutions was associated with race; Whites and Latinos trusted physicians more often than Blacks, and Latinos trusted the health department, insurance companies, and both government entities more often than Whites and Blacks (Ps < .01). In adjusted analyses controlling for marital status, financial status, and education, race was still associated with trust. Whites trusted physicians more often than Blacks, and Latinos trusted insurance companies, the state government, and the federal government more often than Whites and Blacks (Ps < .01). CONCLUSIONS: Racial differences in trust of healthcare institutions vary by institution type. Future studies of trust and interventions designed to improve trust must account for race and target institution differences.

Authors
Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "Who trusts healthcare institutions? Results from a community-based sample." Ethn Dis 15.1 (2005): 97-103.
PMID
15720055
Source
pubmed
Published In
Ethnicity & disease
Volume
15
Issue
1
Publish Date
2005
Start Page
97
End Page
103

An exploration of relative health stock in advanced cancer patients.

OBJECTIVE: The authors sought to empirically test whether relative health stock, a measure of patients' sense of loss in their health due to illness, influences the treatment decisions of patients facing life-threatening conditions. Specifically, they estimated the effect of relative health stock on advanced cancer patients' decisions to participate in phase I clinical trials. METHOD: A multicenter study was conducted to survey 328 advanced cancer patients who were offered the opportunity to participate in phase I trials. The authors asked patients to estimate the probabilities of therapeutic benefits and toxicity, their relative health stock, risk preference, and the importance of quality of life. RESULTS: Controlling for health-related quality of life, an increase in relative health stock by 10 percentage points reduced the odds of choosing to participate in a phase I trial by 16% (odds ratio = 0.84, 95% confidence interval = 0.72, 0.97). CONCLUSION: Relative health stock affects advanced cancer patients' treatment decisions.

Authors
Gaskin, DJ; Weinfurt, KP; Castel, LD; DePuy, V; Li, Y; Balshem, A; Benson, A; Burnett, CB; Corbett, S; Marshall, J; Slater, E; Sulmasy, DP; Van Echo, D; Meropol, NJ; Schulman, KA
MLA Citation
Gaskin, DJ, Weinfurt, KP, Castel, LD, DePuy, V, Li, Y, Balshem, A, Benson, A, Burnett, CB, Corbett, S, Marshall, J, Slater, E, Sulmasy, DP, Van Echo, D, Meropol, NJ, and Schulman, KA. "An exploration of relative health stock in advanced cancer patients." Med Decis Making 24.6 (November 2004): 614-624.
PMID
15534342
Source
pubmed
Published In
Medical Decision Making
Volume
24
Issue
6
Publish Date
2004
Start Page
614
End Page
624
DOI
10.1177/0272989X04271041

Parents' reported preference scores for childhood atopic dermatitis disease states.

BACKGROUND: We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic dermatitis would assign different preferences to the health state scenarios compared with parents who did not have a child with atopic dermatitis. METHODS: Subjects were parents of children aged 3 months to 18 years. The sample was derived from the General Panel, Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris Interactive. Participants rated health scenarios for atopic dermatitis, asthma, and eyeglasses on a visual analog scale, imagining a child was experiencing the described state. RESULTS: A total of 3539 parents completed the survey. Twenty-nine percent had a child with a history of atopic dermatitis. Mean preference scores for atopic dermatitis were as follows: mild, 91 (95% confidence interval [CI], 90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4); moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61 (95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1); asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI, 86.3 to 87.4). CONCLUSIONS: Parents perceive that atopic dermatitis has a negative effect on quality of life that increases with disease severity. Estimates of parents' preferences can provide physicians with insight into the value that parents place on their children's treatment and can be used to evaluate new medical therapies for atopic dermatitis.

Authors
Friedman, JY; Reed, SD; Weinfurt, KP; Kahler, KH; Walter, EB; Schulman, KA
MLA Citation
Friedman, JY, Reed, SD, Weinfurt, KP, Kahler, KH, Walter, EB, and Schulman, KA. "Parents' reported preference scores for childhood atopic dermatitis disease states. (Published online)" BMC Pediatr 4.1 (October 18, 2004): 21-.
PMID
15491500
Source
pubmed
Published In
BMC Pediatrics
Volume
4
Issue
1
Publish Date
2004
Start Page
21
DOI
10.1186/1471-2431-4-21

Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions.

BACKGROUND: Research on individual differences in health-related quality of life (HRQOL) can identify intervention targets and important covariates in analyses of treatment outcomes. OBJECTIVES: The objectives of this study were to describe HRQOL trajectories for women with metastatic breast cancer in a randomized trial of bisphosphonates and to identify characteristics associated with variations in HRQOL. RESEARCH DESIGN: We conducted a prospective quality-of-life study within a randomized, controlled trial. SUBJECTS: We studied women with metastatic breast cancer receiving zoledronic acid or pamidronate disodium to reduce the incidence of skeletal-related events (SREs). MAIN OUTCOME MEASURES: HRQOL was measured at fixed time points during the trial. Individual growth-curve modeling was used to describe longitudinal trajectories and to identify predictors of trajectories. RESULTS: For most domains of HRQOL, the mean trajectory reflected a mild increase, which leveled off later in the trial. Older age and full-time employment were associated with higher baseline HRQOL. Longer time from cancer diagnosis to randomization, lower Eastern Cooperative Oncology Group (ECOG) status (score of 2 ["inactive"]), and a history of SREs were associated with lower baseline HRQOL. Significant differences across geographic regions were observed for all domains. Active ECOG status (score of 0-1) at baseline was predictive of greater increases in all domains of HRQOL except Social/Family Well-Being. Age, geographic region, and time from first bone metastases to randomization were associated with longitudinal changes in some domains. CONCLUSIONS: Women with metastatic breast cancer receiving bisphosphonates for prevention of SREs experienced an overall increase in HRQOL. Variations among women's experiences are explained partly by such characteristics as a history of SREs.

Authors
Weinfurt, KP; Castel, LD; Li, Y; Timbie, JW; Glendenning, GA; Schulman, KA
MLA Citation
Weinfurt, KP, Castel, LD, Li, Y, Timbie, JW, Glendenning, GA, and Schulman, KA. "Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions." Med Care 42.2 (February 2004): 164-175.
PMID
14734954
Source
pubmed
Published In
Medical Care
Volume
42
Issue
2
Publish Date
2004
Start Page
164
End Page
175
DOI
10.1097/01.mlr.0000108746.69256.45

The relationship between perceived barriers to healthcare and self-rated health

The main purpose of the current investigation is to examine the extent to which health care barriers are uniquely associated with individual differences in self-rated health. Self-rated health can be easily assessed and is predictive of mortality, health care use and other health outcomes. In this sample of 586 community residents, the six healthcare barriers examined uniquely accounted for 12% of the variance in self-rated health and demographic variables uniquely accounted for an additional 11% of the variance in self-rated health. In conclusion, healthcare barriers were just as important as age, race, gender, and education when accounting for explained variance in self-rated health. Future studies should consider intervening on health care barriers to improve self appraisals of health and subsequently improve health outcomes.

Authors
Hong, TB; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Hong, TB, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "The relationship between perceived barriers to healthcare and self-rated health." Psychology, Health and Medicine 9.4 (2004): 476-482.
Source
scival
Published In
Psychology, Health and Medicine
Volume
9
Issue
4
Publish Date
2004
Start Page
476
End Page
482
DOI
10.1080/13548500412331298966

Discursive versus information-processing perspectives on a bioethical problem: The case of 'unrealistic' patient expectations

This article discusses an example of how the adoption of different theoretical views of the person can have practical implications for the field of bioethics. Patients who agree to receive new medical treatments with little chance of benefit routinely report strong confidence that they will experience benefit. These 'unrealistic' expectations are interpreted as false beliefs about treatment, and thus as evidence that the informed consent process has failed. This interpretation of patient reports is consistent with an information-processing framework in which the patient is viewed as transmitting information that enjoys an independent existence in the mental machinery of the person. The perspective of discursive psychology, on the other hand, views the patients' reports as activities undertaken to achieve specific aims within particular discursive contexts. It is argued that if bioethicists adopt the discursive perspective, some cases of 'false belief' might not pose a bioethical problem.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Discursive versus information-processing perspectives on a bioethical problem: The case of 'unrealistic' patient expectations." Theory and Psychology 14.2 (2004): 191-203.
Source
scival
Published In
Theory & Psychology
Volume
14
Issue
2
Publish Date
2004
Start Page
191
End Page
203
DOI
10.1177/0959354304042016

Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication.

PURPOSE: To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials. METHODS: Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient's physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations. RESULTS: Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P <.0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P <.0001). CONCLUSION: Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients' stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.

Authors
Meropol, NJ; Weinfurt, KP; Burnett, CB; Balshem, A; Benson, AB; Castel, L; Corbett, S; Diefenbach, M; Gaskin, D; Li, Y; Manne, S; Marshall, J; Rowland, JH; Slater, E; Sulmasy, DP; Van Echo, D; Washington, S; Schulman, KA
MLA Citation
Meropol, NJ, Weinfurt, KP, Burnett, CB, Balshem, A, Benson, AB, Castel, L, Corbett, S, Diefenbach, M, Gaskin, D, Li, Y, Manne, S, Marshall, J, Rowland, JH, Slater, E, Sulmasy, DP, Van Echo, D, Washington, S, and Schulman, KA. "Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication." J Clin Oncol 21.13 (July 1, 2003): 2589-2596.
PMID
12829680
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
21
Issue
13
Publish Date
2003
Start Page
2589
End Page
2596
DOI
10.1200/JCO.2003.10.072

The correlation between patient characteristics and expectations of benefit from Phase I clinical trials.

BACKGROUND: Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials. METHODS: Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data. RESULTS: Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy. CONCLUSIONS: Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.

Authors
Weinfurt, KP; Castel, LD; Li, Y; Sulmasy, DP; Balshem, AM; Benson, AB; Burnett, CB; Gaskin, DJ; Marshall, JL; Slater, EF; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Castel, LD, Li, Y, Sulmasy, DP, Balshem, AM, Benson, AB, Burnett, CB, Gaskin, DJ, Marshall, JL, Slater, EF, Schulman, KA, and Meropol, NJ. "The correlation between patient characteristics and expectations of benefit from Phase I clinical trials." Cancer 98.1 (July 1, 2003): 166-175.
PMID
12833469
Source
pubmed
Published In
Cancer
Volume
98
Issue
1
Publish Date
2003
Start Page
166
End Page
175
DOI
10.1002/cncr.11483

Validity of a simple ST-elevation acute myocardial infarction risk index: are randomized trial prognostic estimates generalizable to elderly patients?

BACKGROUND: Risk-stratification scores derived from randomized clinical trial (RCT) data should be evaluated in community-based populations. A simple risk-stratification index for patients with ST-segment elevation myocardial infarction derived from an RCT population was recently proposed, but it has not been validated in a community-based cohort. METHODS AND RESULTS: We evaluated the simple risk index using data from 49 711 patients > or =65 years of age hospitalized with ST-elevation myocardial infarction. We evaluated the distribution of patients in the 5 simple risk index groups, compared observed and published 30-day mortality rates, and assessed the score's discrimination and calibration. The simple risk index provided poor discrimination (c=0.62) and calibration (goodness of fit P<0.001) for survival at 30 days. Risk score distribution was skewed, because two thirds (66.1%) of all patients were classified in the highest-risk group, whereas fewer than 11.0% were classified in the 3 lowest-risk groups. Thirty-day mortality estimates were lower than those observed in the cohort (risk group 2 to 5: 1.9% to 17.4% versus 5.3% to 27.9%). Risk index discrimination, calibration, score distribution, and mortality estimates were worse among patients who did not receive acute reperfusion therapy than among those who did. CONCLUSIONS: The limited performance of the simple risk index highlights the limitations of applying prognostic models derived in RCT populations to the general population of patients 65 years and older. Prognostic scores must be validated in community-based cohorts before integration into clinical practice.

Authors
Rathore, SS; Weinfurt, KP; Gross, CP; Krumholz, HM
MLA Citation
Rathore, SS, Weinfurt, KP, Gross, CP, and Krumholz, HM. "Validity of a simple ST-elevation acute myocardial infarction risk index: are randomized trial prognostic estimates generalizable to elderly patients?." Circulation 107.6 (February 18, 2003): 811-816.
PMID
12591749
Source
pubmed
Published In
Circulation
Volume
107
Issue
6
Publish Date
2003
Start Page
811
End Page
816

Outcomes research related to patient decision making in oncology.

For outcomes research, what are the implications of seeing the patient as a decision maker? In the current medical environment, greater emphasis is placed on the role played by the patient in clinical decision making. In the past 2 decades, considerable work has been done to identify and measure decision-related outcomes, including knowledge about the treatment options (risks and benefits), satisfaction, anxiety, decisional conflict, and involvement in the decision process. Attempts to improve these decision-related outcomes involve patient decision aids, which convey patient-specific information and sometimes help patients proceed through an explicit decision-making process. These interventions have produced positive results, especially with respect to improving patient knowledge. Future research is needed to understand which aspects of the interventions work and for what types of patients. Research is also needed to better understand the decision making process of patients who do not use decision aids.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Outcomes research related to patient decision making in oncology." Clin Ther 25.2 (February 2003): 671-683. (Review)
PMID
12749521
Source
pubmed
Published In
Clinical Therapeutics
Volume
25
Issue
2
Publish Date
2003
Start Page
671
End Page
683

Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception.

The ethical treatment of cancer patients participating in clinical trials requires that patients are well-informed about the potential benefits and risks associated with participation. When patients enrolled in phase I clinical trials report that their chance of benefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type (e.g., "On average, 5 out of every 100 patients will benefit") can be confused with expressions of uncertainty of the belief type (e.g., "The chance that I will benefit is about 80%"). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subserve multiple speech acts, some of which may be indirect. For example, a patient reporting a high expected benefit may be reporting a belief about the future, reassuring family members, and/or attempting to improve his or her outcome by a public assertion of optimism. These sources of linguistic confusion should be considered in judging whether the patient's reported expectation is grounds for a bioethical concern that there has been a failure in the informed consent process.

Authors
Weinfurt, KP; Sulmasy, DP; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Sulmasy, DP, Schulman, KA, and Meropol, NJ. "Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception." Theor Med Bioeth 24.4 (2003): 329-344.
PMID
14620488
Source
pubmed
Published In
Theoretical Medicine and Bioethics
Volume
24
Issue
4
Publish Date
2003
Start Page
329
End Page
344

The intimate partner violence strategies index. Development and application

Although research has documented the myriad ways that victims of IPV struggle to keep themselves safe, little research has gone the next step to investigate patterns in women's use of strategies, the factors that influence choice of strategies, or which strategies are most effective. One obstacle to conducting such research is the absence of an instrument to measure the nature and extent of battered women's strategic responses to violence across specific domains of strategies. This article describes the development of such an instrument, the Intimate Partner Violence Strategies Index, in the context of a longitudinal study of battered women's experience over time. © 2003 Sage Publications.

Authors
Goodman, L; Dutton, MA; Weinfurt, K; Cook, S
MLA Citation
Goodman, L, Dutton, MA, Weinfurt, K, and Cook, S. "The intimate partner violence strategies index. Development and application." Violence Against Women 9.2 (2003): 163-186.
Source
scival
Published In
Violence Against Women
Volume
9
Issue
2
Publish Date
2003
Start Page
163
End Page
186
DOI
10.1177/1077801202239004

Treatment patterns and costs associated with sessile colorectal polyps.

OBJECTIVES: Because of the paucity of existing literature on treatment and costs associated with sessile lesions, the objectives of this study were to perform a retrospective analysis on patients with sessile polyps to identify patient and polyp characteristics, to determine treatment patterns, and to estimate the cost of treating these patients. METHODS: We conducted a retrospective, observational cohort study of 280 patients who presented to a large teaching hospital between 1997 and 2000 with at least one sessile or broad-based pedunculated colorectal polyp of any size or histology, not including adenocarcinoma greater than stage T1. RESULTS: Mean polyp size was 1.3 cm, and two thirds of polyps were removed in a single procedure. The number of repeat procedures increased with polyp size (Kendall T-b = 0.47; 95% CI = 0.39-0.55). Patients with polyps > or = 2 cm were 5.88 times more likely than patients with smaller polyps to undergo a surgical procedure. Surgical procedures required 88.01 min longer than nonsurgical procedures (95% CI = 74.43-102.42). Mean total cost of treatment was $2,038 (range $153 to $14,838). Open resection ($6,165) was the most costly surgical procedure, and piecemeal polypectomy ($892) was the most costly nonsurgical therapeutic procedure. CONCLUSIONS: One third of polyps required more than one procedure. Surgical procedures accounted for the majority of resource use in this sample. Finally, patients with polyps > or = 2 cm incurred almost half the total costs while accounting for only 22% of the sample. The greatest economic gains could be made by improving efficiency of polyp removal for these patients.

Authors
Onken, JE; Friedman, JY; Subramanian, S; Weinfurt, KP; Reed, SD; Malenbaum, JH; Schmidt, T; Schulman, KA
MLA Citation
Onken, JE, Friedman, JY, Subramanian, S, Weinfurt, KP, Reed, SD, Malenbaum, JH, Schmidt, T, and Schulman, KA. "Treatment patterns and costs associated with sessile colorectal polyps." Am J Gastroenterol 97.11 (November 2002): 2896-2901.
PMID
12425565
Source
pubmed
Published In
The American Journal of Gastroenterology (Elsevier)
Volume
97
Issue
11
Publish Date
2002
Start Page
2896
End Page
2901
DOI
10.1111/j.1572-0241.2002.07058.x

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

BACKGROUND: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards. METHODS: From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials. RESULTS: Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items. CONCLUSIONS: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.

Authors
Schulman, KA; Seils, DM; Timbie, JW; Sugarman, J; Dame, LA; Weinfurt, KP; Mark, DB; Califf, RM
MLA Citation
Schulman, KA, Seils, DM, Timbie, JW, Sugarman, J, Dame, LA, Weinfurt, KP, Mark, DB, and Califf, RM. "A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors." N Engl J Med 347.17 (October 24, 2002): 1335-1341.
PMID
12397192
Source
pubmed
Published In
The New England journal of medicine
Volume
347
Issue
17
Publish Date
2002
Start Page
1335
End Page
1341
DOI
10.1056/NEJMsa020349

Practitioner acceptance of the dofetilide risk-management program.

STUDY OBJECTIVE: To assess the opinions and knowledge retention of practitioners after participation in the dofetilide risk-management program. DESIGN: A 21-item questionnaire. SETTING: A large academic medical center. PARTICIPANTS: One hundred forty-six practitioners were given the questionnaire; 91 (62%) completed it. MEASUREMENTS AND RESULTS: The questionnaire assessed practitioners' opinions of the program and guidelines, preparation time for implementing dofetilide treatment, and retention of facts from the program. Responses were graded on a 5-point Likert scale. Practitioners took a mean of 0.86 +/- 0.44 hours to complete the program; physicians took the least time, pharmacists the most. Practitioners agreed the program was necessary but were undecided about whether the guidelines were easily understood or implemented. Nurses answered one of the two knowledge-retention questions incorrectly significantly more often than physicians or pharmacists. Identification of seven drugs that should not be taken with dofetilide differed significantly (p < 0.0001) across groups (mean accuracy score was 41% for nurses, 80% for pharmacists, and 86% for physicians). CONCLUSION: This risk-management program has been well received by practitioners at our institution. We are gathering data to determine whether the program is effective in reducing inappropriate administration of dofetilide.

Authors
LaPointe, NMA; Kramer, JM; Weinfurt, KP; Califf, RM
MLA Citation
LaPointe, NMA, Kramer, JM, Weinfurt, KP, and Califf, RM. "Practitioner acceptance of the dofetilide risk-management program." Pharmacotherapy 22.8 (August 2002): 1041-1046.
PMID
12173789
Source
pubmed
Published In
Pharmacotherapy
Volume
22
Issue
8
Publish Date
2002
Start Page
1041
End Page
1046

Measuring agreement between patient and proxy responses to multidimensional health-related quality-of-life measures in clinical trials. An application of psychometric profile analysis.

When patients cannot provide responses to health-related quality-of-life (HRQOL) measures in clinical trials, family or friends may be asked to respond. We present a simple, comprehensive method for assessing agreement between patients with head injury and their proxy responders. In contrast to more traditional approaches, this method defines agreement separately for each patient-proxy pair, and compares HRQOL profiles along three dimensions-level, or the average of the ratings; scatter, or the variability in the ratings; and shape, or the ranks of the ratings. We demonstrate this method in the context of a clinical trial of a treatment for traumatic head injury and compare the results to those obtained using traditional analyses. Options for incorporating proxy responses into clinical trial analyses are discussed.

Authors
Weinfurt, KP; Trucco, SM; Willke, RJ; Schulman, KA
MLA Citation
Weinfurt, KP, Trucco, SM, Willke, RJ, and Schulman, KA. "Measuring agreement between patient and proxy responses to multidimensional health-related quality-of-life measures in clinical trials. An application of psychometric profile analysis." J Clin Epidemiol 55.6 (June 2002): 608-618.
PMID
12063103
Source
pubmed
Published In
Journal of Clinical Epidemiology
Volume
55
Issue
6
Publish Date
2002
Start Page
608
End Page
618

Welfare reform and Latinas' use of perinatal health care.

Authors
Seils, DM; Castel, LD; Curtis, LH; Weinfurt, KP
MLA Citation
Seils, DM, Castel, LD, Curtis, LH, and Weinfurt, KP. "Welfare reform and Latinas' use of perinatal health care." Am J Public Health 92.5 (May 2002): 699-700. (Letter)
PMID
11988423
Source
pubmed
Published In
American journal of public health
Volume
92
Issue
5
Publish Date
2002
Start Page
699
End Page
700

Economic evaluation of filgrastim, sargramostim, and sequential sargramostim and filgrastim after myelosuppressive chemotherapy.

Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34(+) cells after myelosuppressive chemotherapy (MC). We sought to compare costs and resource use associated with these regimens. Data were collected prospectively alongside a multicenter, randomized trial of filgrastim, sargramostim, and sequential sargramostim and filgrastim. Direct medical costs were calculated for inpatient and outpatient visits and procedures, including administration of growth factors and MC. We followed 156 patients for 30 days or until initiation of high-dose chemotherapy. The main outcome measures were resource use and costs of inpatient and outpatient visits, platelet and red blood cell transfusions, antibiotic use, and apheresis procedures. Hospital admissions, red blood cell transfusions, and use of i.v. antibiotics were significantly more common in the sargramostim group than in the other treatment arms. In univariate and multivariable analyses, total costs were higher for patients receiving sargramostim alone than for patients in the other groups. Mean costs in multivariable analysis for the filgrastim and sequential sargramostim and filgrastim arms were not significantly different. Filgrastim alone and sequential sargramostim and filgrastim are less costly than sargramostim alone after MC, as well as therapeutically more beneficial.

Authors
Weaver, CH; Buckner, CD; Curtis, LH; Bajwa, K; Weinfurt, KP; Wilson-Relyea, BJ; Schulman, KA
MLA Citation
Weaver, CH, Buckner, CD, Curtis, LH, Bajwa, K, Weinfurt, KP, Wilson-Relyea, BJ, and Schulman, KA. "Economic evaluation of filgrastim, sargramostim, and sequential sargramostim and filgrastim after myelosuppressive chemotherapy." Bone Marrow Transplant 29.2 (January 2002): 159-164.
PMID
11850711
Source
pubmed
Published In
Bone Marrow Transplantation
Volume
29
Issue
2
Publish Date
2002
Start Page
159
End Page
164
DOI
10.1038/sj.bmt.1703341

Welfare reform and Latinas' use of perinatal health care [3] (multiple letters)

Authors
Seils, DM; Castel, LD; Curtis, LH; Weinfurt, KP; Joyce, T; Bauer, T; Minkoff, H; Kaestner, R
MLA Citation
Seils, DM, Castel, LD, Curtis, LH, Weinfurt, KP, Joyce, T, Bauer, T, Minkoff, H, and Kaestner, R. "Welfare reform and Latinas' use of perinatal health care [3] (multiple letters)." American Journal of Public Health 92.5 (2002): 699-700.
Source
scival
Published In
American Journal of Public Health
Volume
92
Issue
5
Publish Date
2002
Start Page
699
End Page
700

Are psychiatrists' characteristics related to how they care for depression in the medically ill? Results from a national case-vignette survey.

The authors' goal was to examine the relationship between psychiatrists' characteristics and their decisions regarding depression care. A national sampling of 278 psychiatrists answered diagnosis and treatment questions for one of four case vignettes with depression and various degrees of medical comorbidity. They also responded to a questionnaire assessing practice and demographic characteristics. Tendency to diagnose major depression was significantly associated with being board certified, being in practice for less time, having a greater percentage of patients with managed care, and having a greater percentage of patients on psychotropic medications. Tendency to recommend an antidepressant was significantly associated with the psychiatrist being male, being less satisfied with practice, and having a greater percentage of patients on psychotropic medications. These findings remained significant even after controlling for case characteristics. Diagnostic and prescribing tendencies of psychiatrists appear to be associated with specific physician characteristics and not simply case characteristics. These findings have implications for further studies of predictors of quality of care.

Authors
Epstein, SA; Gonzales, JJ; Weinfurt, K; Boekeloo, B; Yuan, N; Chase, G
MLA Citation
Epstein, SA, Gonzales, JJ, Weinfurt, K, Boekeloo, B, Yuan, N, and Chase, G. "Are psychiatrists' characteristics related to how they care for depression in the medically ill? Results from a national case-vignette survey." Psychosomatics 42.6 (November 2001): 482-489.
PMID
11815683
Source
pubmed
Published In
Psychosomatics
Volume
42
Issue
6
Publish Date
2001
Start Page
482
End Page
489
DOI
10.1176/appi.psy.42.6.482

The role of reperfusion therapy in paced patients with acute myocardial infarction.

BACKGROUND/OBJECTIVE: Our purpose was to evaluate the effectiveness of reperfusion therapy among elderly paced patients with acute myocardial infarction (MI). Current guidelines make no recommendation for the use of reperfusion therapy among patients who have a paced rhythm during MI. METHODS: We evaluated 1954 Medicare beneficiaries 65 years and older treated for acute MI between 1994 and 1996 who had a paced rhythm for use of reperfusion therapy. Use of reperfusion therapy was evaluated for associations with outcomes by logistic regression and Cox proportional hazards models incorporating propensity score analysis. RESULTS: Reperfusion therapy was used in 171 (8.8%) patients; 70 were treated with primary PTCA and 101 with thrombolytic therapy. Patients who received reperfusion therapy had 30-day mortality rates similar to those who did not receive reperfusion (26.3% vs 25.7%, P =.87). Multivariate adjustment for mortality risk factors and treatment propensity indicated no survival benefit associated with reperfusion therapy at 30 days (relative risk [RR] 1.07, 95% confidence interval [CI] 0.77-1.43) or long-term follow-up (hazard ratio [HR] 0.86, 95% CI 0.68-1.10). Mortality risks varied by type of reperfusion therapy. Patients treated with primary percutaneous transluminal coronary angioplasty were at comparable risk of mortality at 30 days (RR 0.73, 95% CI 0.40-1.23) but at lower risk at long-term follow-up (HR 0.60, 95% CI 0.40-0.88). Mortality risks were unchanged among patients treated with thrombolytics at 30 days (RR 1.32, 95% CI 0.92-1.79) and long-term follow-up (HR 1.08, 95% CI 0.82-1.43). CONCLUSION: We find suggestive evidence that primary percutaneous transluminal coronary angioplasty provides a long-term survival benefit in the treatment of elderly patients with acute MI who have a paced rhythm.

Authors
Rathore, SS; Gersh, BJ; Weinfurt, KP; Oetgen, WJ; Schulman, KA; Solomon, AJ
MLA Citation
Rathore, SS, Gersh, BJ, Weinfurt, KP, Oetgen, WJ, Schulman, KA, and Solomon, AJ. "The role of reperfusion therapy in paced patients with acute myocardial infarction." Am Heart J 142.3 (September 2001): 516-519.
PMID
11526367
Source
pubmed
Published In
American Heart Journal
Volume
142
Issue
3
Publish Date
2001
Start Page
516
End Page
519
DOI
10.1067/mhj.2001.117602

An economic and quality-of-life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation.

BACKGROUND: Immunosuppressive therapy with cyclosporin A has substantially improved clinical outcomes for renal transplantation. Whether basiliximab (a chimeric monoclonal antibody) demonstrates economic and quality-of-life advantages over other induction therapies has not yet been shown. METHODS: A multi-centre open-label clinical trial was conducted among renal transplant recipients in the US, in which patients were randomized into two induction therapy regimens: basiliximab and antithymocyte globulin (ATG) as part of a quadruple immunosuppressive regimen. Medical resources used and a EuroQol visual analogue scale (VAS) rating of quality of life were collected prospectively for the 135 dosed subjects for a period of 1 year post-treatment. We analysed the differences between treatment groups in 1-year costs and 1-year quality-adjusted survival. We also conducted a post hoc analysis of outcomes among the subgroup of patients identified as high risk. RESULTS: A significant difference was observed in first-year post-treatment costs (basiliximab, $45857; ATG, $54729; difference, $8872 (95% CI, $1169 to $16573). The savings from basiliximab can be attributed to the less expensive induction therapy (basiliximab, $2378; ATG, $8670; difference, $6292 (95% CI, $5165 to $7419)) and other savings during the initial hospitalization totalling $2609. One-year quality-adjusted survival was the same in both groups (basiliximab, 81.5; ATG, 81.1; difference, 0.45 (95% CI, -5.9 to 6.8)). The results of the post hoc analysis of the 48 high-risk patients were comparable to the analysis of all patients. CONCLUSIONS: These results demonstrate lower first-year post-treatment costs in renal-transplant recipients receiving basiliximab compared to ATG with no differences in quality-adjusted survival. The results also suggest similar differences among high-risk subjects.

Authors
Polsky, D; Weinfurt, KP; Kaplan, B; Kim, J; Fastenau, J; Schulman, KA
MLA Citation
Polsky, D, Weinfurt, KP, Kaplan, B, Kim, J, Fastenau, J, and Schulman, KA. "An economic and quality-of-life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation." Nephrol Dial Transplant 16.5 (May 2001): 1028-1033.
PMID
11328911
Source
pubmed
Published In
Nephrology Dialysis Transplantation
Volume
16
Issue
5
Publish Date
2001
Start Page
1028
End Page
1033

Treatment of patients with myocardial infarction who present with a paced rhythm.

BACKGROUND: A paced rhythm can mask the electrocardiographic features of an acute myocardial infarction, complicating timely recognition and treatment. OBJECTIVE: To evaluate characteristics, treatment, and outcomes among patients presenting with paced rhythms during myocardial infarction. DESIGN: Retrospective cohort study. SETTING: U.S. acute care hospitals. PATIENTS: 102 249 Medicare beneficiaries at least 65 years of age who were treated for acute myocardial infarction between 1994 and 1996. MEASUREMENTS: Provision of three treatments for acute myocardial infarction (emergent reperfusion, aspirin, and beta-blockers), death at 30 days, and long-term follow-up. RESULTS: 1954 patients (1.9%) presented with paced rhythms during myocardial infarction. These patients were older; were predominantly male; and had higher rates of congestive heart failure, diabetes, and previous infarction. They were significantly less likely to receive emergent reperfusion (relative risk [RR], 0.27 [95% CI, 0.22 to 0.33]), aspirin (RR at admission, 0.91 [CI, 0.88 to 0.94]; RR at discharge, 0.87 [CI, 0.83 to 0.92]), and beta-blockers at admission (RR, 0.89 [CI, 0.82 to 0.96]). In addition, there was a trend toward decreased use of beta-blockers at discharge (RR, 0.91 [CI, 0.76 to 1.06]). Crude mortality rates were higher among patients with paced rhythms than among those without at 30 days (25.8% vs. 21.3%; P = 0.001) and at 1 year (47.1% vs. 36.1%; P = 0.001). Among patients with paced rhythms, risk for death at 30 days decreased after adjustment for illness severity and decreased use of therapy (RR, 1.03 [CI, 0.93 to 1.14]). Patients with paced rhythms remained at additional risk for long-term mortality (hazard ratio, 1.12 [CI, 1.06 to 1.18]). CONCLUSIONS: Patients with paced rhythms were less likely than those without to receive treatment for acute myocardial infarction and had poorer short- and long-term outcomes. However, this mortality risk diminished after adjustment for treatment. This suggests that improved recognition and treatment of myocardial infarction may improve outcomes, particularly in the short term.

Authors
Rathore, SS; Weinfurt, KP; Gersh, BJ; Oetgen, WJ; Schulman, KA; Solomon, AJ
MLA Citation
Rathore, SS, Weinfurt, KP, Gersh, BJ, Oetgen, WJ, Schulman, KA, and Solomon, AJ. "Treatment of patients with myocardial infarction who present with a paced rhythm." Ann Intern Med 134.8 (April 17, 2001): 644-651.
PMID
11304104
Source
pubmed
Published In
Annals of internal medicine
Volume
134
Issue
8
Publish Date
2001
Start Page
644
End Page
651

Culture and social distance: a case study of methodological cautions.

The authors presented, as a case study of methodological challenges in cross-cultural research, E. S. Bogardus's (1925) Social Distance Scale, which requires respondents to indicate the social distance between themselves and others. The meaningfulness of the scale depends on the assumption that respondents believe that the magnitude of social distance increases as one moves through the social categories of family member, friend, neighbor, coworker, and citizen. The authors tested this assumption for English Canadian, French Canadian, Jewish, Indian, Algerian, and Greek participants, all 1st-generation immigrants in Montreal. The participants rated their willingness to associate with members of each of the other ethnic groups in 5 social categories. The percentage of respondents in each sample whose data conformed to the prediction ranged from 63.7% to 98.0%, with English Canadian, French Canadian, and Jewish respondents providing responses most consistent with the predicted pattern. The Indian and Algerian respondents' data were the least consistent with the predicted pattern, especially when rating members of their own ethnic groups.

Authors
Weinfurt, KP; Maghaddam, FM
MLA Citation
Weinfurt, KP, and Maghaddam, FM. "Culture and social distance: a case study of methodological cautions." J Soc Psychol 141.1 (February 2001): 101-110.
PMID
11294145
Source
pubmed
Published In
The Journal of social psychology
Volume
141
Issue
1
Publish Date
2001
Start Page
101
End Page
110
DOI
10.1080/00224540109600526

Acute myocardial infarction complicated by heart block in the elderly: prevalence and outcomes.

BACKGROUND: Although second- and third-degree heart block (HB) are common conduction disorders associated with acute myocardial infarction (MI), patient characteristics and HBs association with outcomes, particularly among the elderly, remain poorly defined. METHODS: We evaluated 106,780 Medicare beneficiaries aged 65 years and older treated for acute MI between January 1994 and February 1996 for development of HB. HB and non-HB patients were compared by univariate analysis, and the influence of HB on outcomes was evaluated by unadjusted and multiple logistic regression. RESULTS: HB was documented in 5048 (4.7%) patients; 1646 presented with HB and 3402 developed HB during hospitalization. HB was more common among patients with inferior infarctions than anterior infarctions (7.3% vs 3.0%, P =.001), particularly the cohort of patients with inferior MI treated with reperfusion therapy (8.3%). HB patients had higher rates of in-hospital mortality (29.6% vs. 17.5% vs. non-HB patients, P =.001). After adjustment for demographic and clinical factors, HB remained an independent predictor of in-hospital mortality (relative risk [RR] 1.41, 95% confidence interval [CI] 1. 34-1.48), but HB had no prognostic significance at 1 year among hospital survivors (RR 0.94, 95% CI 0.88-1.01). Mortality risks varied on the basis of MI location. Both anterior MI (RR 1.46, 95% CI 1.30-1.63) and inferior MI (RR 1.52, 95% CI 1.39-1.66) patients with HB had increased risks of in-hospital mortality. There was a trend toward increased mortality among patients with anterior MI (RR 1.15, 95% CI 0.99-1.32) at 1 year, whereas those with inferior MI were at lower risk (RR 0.83, 95% CI 0.75-0.98). CONCLUSIONS: HB is a common complication of acute MI in elderly patients, particularly among patients with inferior MIs who received reperfusion therapy. HB is independently associated with short-term but not long-term mortality.

Authors
Rathore, SS; Gersh, BJ; Berger, PB; Weinfurt, KP; Oetgen, WJ; Schulman, KA; Solomon, AJ
MLA Citation
Rathore, SS, Gersh, BJ, Berger, PB, Weinfurt, KP, Oetgen, WJ, Schulman, KA, and Solomon, AJ. "Acute myocardial infarction complicated by heart block in the elderly: prevalence and outcomes." Am Heart J 141.1 (January 2001): 47-54.
PMID
11136486
Source
pubmed
Published In
American Heart Journal
Volume
141
Issue
1
Publish Date
2001
Start Page
47
End Page
54
DOI
10.1067/mhj.2001.111259

Time to presentation with acute myocardial infarction in the elderly: associations with race, sex, and socioeconomic characteristics.

BACKGROUND: Although prompt treatment is a cornerstone of the management of acute myocardial infarction (AMI), prior studies have shown that one fourth of AMI patients arrive at the hospital >6 hours after symptom onset. It would be valuable to identify individuals at highest risk for late arrival, but predisposing factors have yet to be fully characterized. METHODS AND RESULTS: Data from the Cooperative Cardiovascular Project, involving Medicare beneficiaries aged >65 years hospitalized between January 1994 and February 1996 with confirmed AMI, were used to identify patients who presented "late" (>/=6 hours after symptom onset). Patient characteristics were tested for associations with late presentation by use of backward stepwise logistic regression. Among 102 339 subjects, 29.4% arrived late. Significant predictors of late arrival (odds ratio, 95% CI) included diabetes (1.11, 1.07 to 1.14) and a history of angina (1.32, 1.28 to 1.35), whereas prior MI (0.82, 0.79 to 0.85), prior angioplasty (0.80, 0.75 to 0.85), prior bypass surgery (0.93, 0.89 to 0.98), and cardiac arrest (0.52, 0.46 to 0. 58) predicted early presentation. Additionally, initial evaluation at an outpatient clinic (2.63, 2.51 to 2.75) and daytime presentation (1.67, 1.59 to 1.72) predicted late arrival. Finally, female sex, black race, and poverty, which were evaluated with an 8-level race-sex-socioeconomic status interaction term, were also risk factors for delay. CONCLUSIONS: Delayed hospital presentation is a common problem among Medicare beneficiaries with AMI. Factors associated with delay include not only clinical and logistical issues but also race, sex, and socioeconomic characteristics. Education efforts designed to hasten AMI treatment should be directed at individuals with risk factors for late arrival.

Authors
Sheifer, SE; Rathore, SS; Gersh, BJ; Weinfurt, KP; Oetgen, WJ; Breall, JA; Schulman, KA
MLA Citation
Sheifer, SE, Rathore, SS, Gersh, BJ, Weinfurt, KP, Oetgen, WJ, Breall, JA, and Schulman, KA. "Time to presentation with acute myocardial infarction in the elderly: associations with race, sex, and socioeconomic characteristics." Circulation 102.14 (October 3, 2000): 1651-1656.
PMID
11015343
Source
pubmed
Published In
Circulation
Volume
102
Issue
14
Publish Date
2000
Start Page
1651
End Page
1656

Race, sex, poverty, and the medical treatment of acute myocardial infarction in the elderly.

BACKGROUND: Race, sex, and poverty are associated with the use of diagnostic cardiac catheterization and coronary revascularization during treatment of acute myocardial infarction (AMI). However, the association of sociodemographic characteristics with the use of less costly, more readily available medical therapies remains poorly characterized. METHODS AND RESULTS: We evaluated 169 079 Medicare beneficiaries >/=65 years of age treated for AMI between January 1994 and February 1996 to determine the association of patient race, sex, and poverty with the use of medical therapy. Multivariable regression models were constructed to evaluate the unadjusted and adjusted influence of sociodemographic characteristics on the use of 2 admission (aspirin, reperfusion) and 2 discharge therapies (aspirin, beta-blockers) indicated during the treatment of AMI. Therapy use varied by patient race, sex, and poverty status. Black patients were less likely to undergo reperfusion (RR 0.84, 95% CI 0. 78, 0.91) or receive aspirin on admission (RR 0.97, 95% CI 0.96, 0. 99) and beta-blockers (RR 0.94, 95% CI 0.88, 1.00) at discharge. Female patients were less likely to receive aspirin on admission (RR 0.98, 95% CI 0.97, 0.99) and discharge (RR 0.98, 95% CI 0.96, 0.99). Poor patients were less likely to receive aspirin (RR 0.97, 95% CI 0. 96, 0.98) or reperfusion (RR 0.97, 95% CI 0.93, 1.00) on admission and aspirin (RR 0.98, 95% CI 0.96, 1.00), or beta-blockers (RR 0.95, 95% CI 0.91, 0.99) on discharge. CONCLUSIONS: Medical therapies are currently underused in the treatment of black, female, and poor patients with AMI.

Authors
Rathore, SS; Berger, AK; Weinfurt, KP; Feinleib, M; Oetgen, WJ; Gersh, BJ; Schulman, KA
MLA Citation
Rathore, SS, Berger, AK, Weinfurt, KP, Feinleib, M, Oetgen, WJ, Gersh, BJ, and Schulman, KA. "Race, sex, poverty, and the medical treatment of acute myocardial infarction in the elderly." Circulation 102.6 (August 8, 2000): 642-648.
PMID
10931804
Source
pubmed
Published In
Circulation
Volume
102
Issue
6
Publish Date
2000
Start Page
642
End Page
648

The effects of patient sex and race on medical students' ratings of quality of life.

PURPOSE: Although previous studies have examined race and sex differences in health care, few studies have investigated the possible role of physician bias. We evaluated the influence of race and sex on medical students' perceptions of patients' symptoms to determine if there are differences in these perceptions early in medical training. SUBJECTS AND METHODS: One-hundred sixty-four medical students were randomly assigned to view a video of a black female or white male actor portraying patients with identical symptoms of angina. We evaluated students' perceptions of the actors' health state (based on their assessment of quality of life) using a visual analog scale and a standard rating technique, as well as the type of chest pain diagnosis. RESULTS: Students assigned a lower value (indicating a less desirable health state) to the black woman than to the white man with identical symptoms [visual scale (mean +/- SD): 72 +/- 13 vs 67 +/- 12, P <0.02; standard gamble: 87 +/- 10 vs 80 +/- 15, P < 0.001). Nonminority students reported higher mean values for the white male patient (standard gamble: 89 +/- 8 vs 81 +/- 14 for the black female patient), whereas minority students' assessments did not differ by patient. Male students assigned a slightly lower value to the black female patient (standard gamble: 76 +/- 16 vs 87 +/- 10 for the white male patient). Students were less likely to characterize the black female patient's symptoms as angina (46% vs 74% for the white male patient, P = 0.001). CONCLUSIONS: The way that medical students perceive patient symptoms appears to be affected by nonmedical factors.

Authors
Rathore, SS; Lenert, LA; Weinfurt, KP; Tinoco, A; Taleghani, CK; Harless, W; Schulman, KA
MLA Citation
Rathore, SS, Lenert, LA, Weinfurt, KP, Tinoco, A, Taleghani, CK, Harless, W, and Schulman, KA. "The effects of patient sex and race on medical students' ratings of quality of life." Am J Med 108.7 (May 2000): 561-566.
PMID
10806285
Source
pubmed
Published In
The American Journal of Medicine
Volume
108
Issue
7
Publish Date
2000
Start Page
561
End Page
566

Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients.

BACKGROUND: Although surrogate markers such as CD4 counts and viral burden (HIV-1 RNA) are predictive of AIDS-related disease progression, little is known about the relationship between changes in surrogate markers and health-related quality of life (HRQOL) outcomes. This study investigated how changes in CD4/mm3 and viral burden (RNA copies/mL) are related to changes in HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV-30). METHODS: Subjects were HIV-1-infected patients with CD4 counts <300/mm3 enrolled in a double-blind, randomized clinical trial of delavirdine. As part of the clinical protocol, patients completed the MOS-HIV-30, from which the Physical Health (PHS) and Mental Health (MHS) summary scores were used for analyses. HRQOL and surrogate marker data assessed up to 2 years after randomization were analyzed for a total of 1,112 patients. RESULTS: Individual patients' initial status (intercepts) and rates of change (slopes) over time for log CD4, log RNA, PHS, and MHS were estimated with the use of empirical Bayes. Early response to treatment correlated with HRQOL better for RNA than for CD4. However, the relationship between weekly change and HRQOL was stronger for CD4 than for RNA. CONCLUSIONS: Surrogate markers are significantly associated with HRQOL outcomes. Improvements in HRQOL over time are associated with lower initial viral load and with increases in CD4 counts. Limitations concerning the restricted variability of the change scores are addressed.

Authors
Weinfurt, KP; Willke, RJ; Glick, HA; Freimuth, WW; Schulman, KA
MLA Citation
Weinfurt, KP, Willke, RJ, Glick, HA, Freimuth, WW, and Schulman, KA. "Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients." Med Care 38.4 (April 2000): 404-410.
PMID
10752972
Source
pubmed
Published In
Medical Care
Volume
38
Issue
4
Publish Date
2000
Start Page
404
End Page
410

Sex differences in coronary artery size assessed by intravascular ultrasound.

BACKGROUND: Women have worse outcomes after myocardial infarction and coronary revascularization. The explanations are likely multifactorial but may include smaller coronary artery size. Smaller luminal diameter has been confirmed angiographically; however, because of possible confounding effects of coronary remodeling, angiographically silent atherosclerosis, and body size, it is unclear if there is a true sex influence on arterial size. METHODS: We performed intravascular ultrasound on left main (LM) and proximal left anterior descending (LAD) coronary artery segments that were free of significant atherosclerosis in 50 men and 25 women. Arterial and luminal areas were measured by planimetry and corrected for body surface area. We evaluated associations between sex and coronary dimensions with univariate and then multiple linear regression analyses. RESULTS: Mean uncorrected LM and LAD arterial areas were smaller in women than in men (21.53 vs 26.95 mm(2), P <.001, and 14. 68 vs 19.94 mm(2), P =.002, respectively), as were mean LM and LAD luminal areas (15.94 vs 18.79 mm(2), P =.020, and 10.13 vs 12.71 mm(2), P =.036, respectively). In multivariate models accounting for body surface area and controlling for other factors, sex independently predicted corrected LM and LAD arterial area. In analyses that additionally controlled for plaque area, sex independently predicted corrected LAD luminal area. CONCLUSIONS: LM and LAD arteries are smaller in women, independent of body size. This suggests an intrinsic sex effect on coronary dimensions. Future studies should investigate underlying mechanisms because they may lead to novel therapeutic strategies and improved outcomes for women with coronary artery disease.

Authors
Sheifer, SE; Canos, MR; Weinfurt, KP; Arora, UK; Mendelsohn, FO; Gersh, BJ; Weissman, NJ
MLA Citation
Sheifer, SE, Canos, MR, Weinfurt, KP, Arora, UK, Mendelsohn, FO, Gersh, BJ, and Weissman, NJ. "Sex differences in coronary artery size assessed by intravascular ultrasound." Am Heart J 139.4 (April 2000): 649-653.
PMID
10740147
Source
pubmed
Published In
American Heart Journal
Volume
139
Issue
4
Publish Date
2000
Start Page
649
End Page
653

Acute myocardial infarction complicated by atrial fibrillation in the elderly: prevalence and outcomes.

BACKGROUND: Although atrial fibrillation (AF) is a common complication of acute myocardial infarction (MI), patient characteristics and association with outcomes remain poorly defined in the elderly. METHODS AND RESULTS: We evaluated 106 780 Medicare beneficiaries > or =65 years of age from the Cooperative Cardiovascular Project treated for acute MI between January 1994 and February 1996 to determine the prevalence and prognostic significance of AF complicating acute MI in elderly patients. Patients were categorized on the basis of the presence of AF, and those with AF were further subdivided by time of AF (present on arrival versus developing during hospitalization). AF and non-AF patients were compared by univariate analysis, and logistic regression modeling was used to identify clinical predictors of AF. The influence of AF on outcomes was evaluated by unadjusted Kaplan-Meier survival curves and logistic regression models. AF was documented in 23 565 patients (22. 1%): 11 510 presented with AF and 12,055 developed AF during hospitalization. AF patients were older, had more advanced heart failure, and were more likely to have had a prior MI and undergone coronary revascularization. AF patients had poorer outcomes, including higher in-hospital (25.3% versus 16.0%), 30-day (29.3% versus 19.1%), and 1-year (48.3% versus 32.7%) mortality. AF remained an independent predictor of in-hospital (odds ratio [OR], 1. 21), 30-day (OR, 1.20), and 1-year (OR, 1.34) mortality after multivariate adjustment. Patients developing AF during hospitalization had a worse prognosis than patients who presented with AF. CONCLUSIONS: AF is a common complication of acute MI in elderly patients and independently influences mortality, particularly when it develops during hospitalization.

Authors
Rathore, SS; Berger, AK; Weinfurt, KP; Schulman, KA; Oetgen, WJ; Gersh, BJ; Solomon, AJ
MLA Citation
Rathore, SS, Berger, AK, Weinfurt, KP, Schulman, KA, Oetgen, WJ, Gersh, BJ, and Solomon, AJ. "Acute myocardial infarction complicated by atrial fibrillation in the elderly: prevalence and outcomes." Circulation 101.9 (March 7, 2000): 969-974.
PMID
10704162
Source
pubmed
Published In
Circulation
Volume
101
Issue
9
Publish Date
2000
Start Page
969
End Page
974

Computer Program Exchange

Authors
Cai, L; Weinfurt, KP
MLA Citation
Cai, L, and Weinfurt, KP. "Computer Program Exchange." Applied Psychological Measurement 23.4 (December 1999): 308-308.
Source
crossref
Published In
Applied Psychological Measurement
Volume
23
Issue
4
Publish Date
1999
Start Page
308
End Page
308
DOI
10.1177/01466216990234008

Lying for patients: physician deception of third-party payers.

BACKGROUND: Some physicians may resort to deception to secure third-party payer approval for patient procedures. Related physician attitudes, including willingness to use deception, are not well understood. OBJECTIVE: To determine physician willingness to deceive a third-party payer and physician attitudes toward deception of third-party payers. METHODS: A cross-sectional mailed survey was used to evaluate physician willingness to use deception in 6 vignettes of varying clinical severity: coronary bypass surgery, arterial revascularization, intravenous pain medication and nutrition, screening mammography, emergent psychiatric referral, and cosmetic rhinoplasty. We evaluated 169 board-certified internists randomly selected from 4 high- and 4 low-managed care penetration metropolitan markets nationwide for willingness to use deception in each vignette. RESULTS: Physicians were willing to use deception in the coronary bypass surgery (57.7%), arterial revascularization (56.2%), intravenous pain medication and nutrition (47.5%), screening mammography (34.8%), and emergent psychiatric referral (32.1%) vignettes. There was little willingness to use deception for cosmetic rhinoplasty (2.5%). Rates were highest for physicians practicing in predominantly managed care markets, for clinically severe vignettes, and for physicians spending less time in clinical practice. Physician ratings of the justifiability of deception varied by perspective and vignette. CONCLUSIONS: Many physicians sanction the use of deception to secure third-party payers' approval of medically indicated care. Such deception may reflect a tension between the traditional ethic of patient advocacy and the new ethic of cost control that restricts patient and physician choice in the use of limited resources.

Authors
Freeman, VG; Rathore, SS; Weinfurt, KP; Schulman, KA; Sulmasy, DP
MLA Citation
Freeman, VG, Rathore, SS, Weinfurt, KP, Schulman, KA, and Sulmasy, DP. "Lying for patients: physician deception of third-party payers." Arch Intern Med 159.19 (October 25, 1999): 2263-2270.
PMID
10547165
Source
pubmed
Published In
Archives of internal medicine
Volume
159
Issue
19
Publish Date
1999
Start Page
2263
End Page
2270

Reliability of reports of violent victimization and posttraumatic stress disorder among men and women with serious mental illness.

Although violent victimization is highly prevalent among men and women with serious mental illness (SMI; e.g., schizophrenia, bipolar disorder), future research in this area may be impeded by controversy concerning the ability of individuals with SMI to report traumatic events reliably. This article presents the results of a study exploring the temporal consistency of reports of childhood sexual abuse, adult sexual abuse, and adult physical abuse, as well as current symptoms of posttraumatic stress disorder (PTSD) among 50 people with SMI. Results show that trauma history and PTSD assessments can, for the most part, yield reliable information essential to further research in this area. The study also demonstrates the importance of using a variety of statistical methods to assess the reliability of self-reports of trauma history.

Authors
Goodman, LA; Thompson, KM; Weinfurt, K; Corl, S; Acker, P; Mueser, KT; Rosenberg, SD
MLA Citation
Goodman, LA, Thompson, KM, Weinfurt, K, Corl, S, Acker, P, Mueser, KT, and Rosenberg, SD. "Reliability of reports of violent victimization and posttraumatic stress disorder among men and women with serious mental illness." J Trauma Stress 12.4 (October 1999): 587-599.
PMID
10646178
Source
pubmed
Published In
Journal of Traumatic Stress
Volume
12
Issue
4
Publish Date
1999
Start Page
587
End Page
599
DOI
10.1023/A:1024708916143

ACI-TIPI clinical trial. Acute cardiac ischemia time-insensitive predictive instrument.

Authors
Weinfurt, KP; Rathore, SS; Schulman, KA
MLA Citation
Weinfurt, KP, Rathore, SS, and Schulman, KA. "ACI-TIPI clinical trial. Acute cardiac ischemia time-insensitive predictive instrument." Ann Intern Med 131.6 (September 21, 1999): 476-477. (Letter)
PMID
10498573
Source
pubmed
Published In
Annals of internal medicine
Volume
131
Issue
6
Publish Date
1999
Start Page
476
End Page
477

Towards a composite scoring solution for the Neurobehavioral Functioning Inventory.

Little research has been conducted towards the development and evaluation of a measure of quality of life specific to head/brain injury populations. Accordingly, we examined responses to the Neurobehavioral Functioning Inventory in the context of a clinical trial for head injury patients (n = 655) conducted in 14 countries. To reduce the 66 item scale into a smaller number of composite scales, principal components analysis was conducted. Scales were constructed assessing four categories of symptoms: cognitive deficits, depression, aggression and somatization. The internal reliabilities (alpha coefficient) of the four scales were generally acceptable (range = 0.79-0.92). Scores on all four scales correlated significantly with patient-rated overall quality of life and all but the aggression scale correlated significantly with overall clinical severity. The need for more formal evaluation of this and other disease-specific measures is discussed.

Authors
Weinfurt, KP; Willke, R; Glick, HA; Schulman, KA
MLA Citation
Weinfurt, KP, Willke, R, Glick, HA, and Schulman, KA. "Towards a composite scoring solution for the Neurobehavioral Functioning Inventory." Qual Life Res 8.1-2 (1999): 17-24.
PMID
10457735
Source
pubmed
Published In
Quality of Life Research
Volume
8
Issue
1-2
Publish Date
1999
Start Page
17
End Page
24

ACI-TIPI clinical trial [3] (multiple letters)

Authors
Weinfurt, KP; Rathore, SS; Schulman, KA; Selker, HP; Griffith, JL; Beshansky, JR
MLA Citation
Weinfurt, KP, Rathore, SS, Schulman, KA, Selker, HP, Griffith, JL, and Beshansky, JR. "ACI-TIPI clinical trial [3] (multiple letters)." Annals of Internal Medicine 131.6 (1999): 476-477.
Source
scival
Published In
Annals of internal medicine
Volume
131
Issue
6
Publish Date
1999
Start Page
476
End Page
477

Diagnosing attention deficit disorders with the Behavioral Assessment System for Children and the Child Behavior Checklist: test and construct validity analyses using optimal discriminant classification trees.

The usefulness of the Behavioral Assessment System for Children (BASC) and Child Behavior Checklist (CBCL) Parent scales was examined with respect to (a) differentiating students with attention deficit-hyperactivity disorder (ADHD) from non-ADHD students and (b) discriminating between the predominantly inattentive-type and combined-type ADHD-afflicted students. For both the BASC and the CBCL, a different optimal discriminant classification tree analysis (CTA) model was developed for each of the 2 diagnostic predictions. For distinguishing ADHD students from non-ADHD students, the BASC model was more parsimonious and accurate than the CBCL model. Toward the goal of differentiating between primarily inattentive and combined types, the CBCL's model was superior for predicting primarily inattentive students. The results demonstrate the diagnostic utility of the BASC and CBCL and describe salient behavioral dimensions associated with subtypes of ADHD.

Authors
Ostrander, R; Weinfurt, KP; Yarnold, PR; August, GJ
MLA Citation
Ostrander, R, Weinfurt, KP, Yarnold, PR, and August, GJ. "Diagnosing attention deficit disorders with the Behavioral Assessment System for Children and the Child Behavior Checklist: test and construct validity analyses using optimal discriminant classification trees." J Consult Clin Psychol 66.4 (August 1998): 660-672.
PMID
9735584
Source
pubmed
Published In
Journal of Consulting and Clinical Psychology
Volume
66
Issue
4
Publish Date
1998
Start Page
660
End Page
672

Concepts of human differences: a comparison of American, Japanese, and Chinese children and adolescents.

Concepts of human differences were studied among 5th and 11th graders in the United States (n = 175), Japan (n = 256), and the People's Republic of China (n = 160). Relative to their peers in the other 2 cultures, more American students noted differences in appearance and attractiveness and material resources; more Japanese students noted various physical features, and more Chinese students noted specific behaviors. On the whole, Japanese responses resembled those of the American students more closely than those of the Chinese students. With increasing age, American students reported a larger number, whereas Asian students tended to report a smaller number of distinct categories of human differences. Results are discussed in terms of cultural construals of self and theories of cognitive development.

Authors
Crystal, DS; Watanabe, H; Weinfurt, K; Wu, C
MLA Citation
Crystal, DS, Watanabe, H, Weinfurt, K, and Wu, C. "Concepts of human differences: a comparison of American, Japanese, and Chinese children and adolescents." Dev Psychol 34.4 (July 1998): 714-722.
PMID
9681263
Source
pubmed
Published In
Developmental Psychology
Volume
34
Issue
4
Publish Date
1998
Start Page
714
End Page
722

Computer program exchange SAS/IML modules for producing bootstrapped significance levels

Authors
Cai, L; Weinfurt, KP
MLA Citation
Cai, L, and Weinfurt, KP. "Computer program exchange SAS/IML modules for producing bootstrapped significance levels." Applied Psychological Measurement 22.4 (1998): 394--.
Source
scival
Published In
Applied Psychological Measurement
Volume
22
Issue
4
Publish Date
1998
Start Page
394-

The role of age, family support, and negative cognitions in the prediction of depressive symptoms

Cognitive diathesis-stress models of depression suggest that children with a cognitive vulnerability are more likely to be depressed when confronted with developmentally salient sources of stress. The current study examined developmental changes in the relationship between negative cognitions (cognitive errors) and stressful family characteristics (unsupportive family) in the prediction of depression in young people. Participants (N = 102) were between 7 and 18 years of age and included both outpatient clinic and school-based samples. Hierarchical regression analysis demonstrated a significant 3-way interaction between age, negative cognitions, and family unsupportiveness. With younger children, either higher levels of negative cognitions or a highly unsupportive family were sufficient to predict increases in depression. During the transition between late childhood and early adolescence, negative cognitions and an unsupportive family contributed in an additive fashion to increases in depression. The diathesis-stress model was manifested only in late adolescence with greater family unsupportiveness predicting higher levels of depression most for those adolescents high in negative cognitions. Results are discussed as they relate to developmental changes in self-concept, cognitions, and the salience of the family.

Authors
Ostrander, R; Weinfurt, KP; Nay, WR
MLA Citation
Ostrander, R, Weinfurt, KP, and Nay, WR. "The role of age, family support, and negative cognitions in the prediction of depressive symptoms." School Psychology Review 27.1 (1998): 121-137.
Source
scival
Published In
School Psychology Review
Volume
27
Issue
1
Publish Date
1998
Start Page
121
End Page
137

Perception of friends' use of alcohol, cigarettes, and marijuana among urban schoolchildren: a longitudinal analysis.

Relations between adolescents' substance use and perceptions of their friends' substance use were examined cross-sectionally and longitudinally in a predominantly African-American school district. Fourth- and fifth-grade students were surveyed and tracked for 4 consecutive years. Cross-sectional samples included 3,073, 5,955, 7,701, and 6,616 students in years 1 to 4, respectively; the longitudinal sample included 1,802 students surveyed in every year. Self-reported substance use of friends and classmates also was assessed. Perceived friends' substance use had a stronger association with prior substance use than friends' self-reported substance use in every year. Perceived family use and classmates' self-reported use also made independent contributions to regression models. Longitudinal structural equation analyses indicated that perceived friends' use is more likely to be a product of an adolescent's previous substance use than a precursor of subsequent substance use. The findings contradict prevailing theories on the influence of peers on substance use.

Authors
Iannotti, RJ; Bush, PJ; Weinfurt, KP
MLA Citation
Iannotti, RJ, Bush, PJ, and Weinfurt, KP. "Perception of friends' use of alcohol, cigarettes, and marijuana among urban schoolchildren: a longitudinal analysis." Addict Behav 21.5 (September 1996): 615-632.
PMID
8876761
Source
pubmed
Published In
Addictive Behaviors
Volume
21
Issue
5
Publish Date
1996
Start Page
615
End Page
632

Practice patterns in the diagnosis and treatment of anxiety and depression in the medically ill. A survey of psychiatrists.

By use of a survey that assessed practice patterns and responses to case vignettes of anxiety and depression in the medically ill, 38 psychiatrists were compared with 10 national leaders in consultation-liaison psychiatry. On the case vignettes, percentage agreement with the experts varied significantly by case and by question. Fifty-eight percent of the time the psychiatrists agreed with the experts on whether to order laboratory tests as compared with an 81% agreement level on whether to use psychotherapy. Multiple regression analysis revealed that the best model to predict lower agreement with the experts was years in practice plus percentage of time spent in solo (vs. group) practice (r2 = 0.40). This study extended previous data-based pharmacoepidemiology by assessing multiple aspects of psychiatrists' practice patterns. Psychiatrists who are more distant from training years and more isolated from the current stimulation of colleagues may be particularly appropriate targets for continuing education.

Authors
Epstein, SA; Gonzales, JJ; Onge, JS; Carter-Campbell, J; Weinfurt, K; Leibole, M; Goldberg, RL
MLA Citation
Epstein, SA, Gonzales, JJ, Onge, JS, Carter-Campbell, J, Weinfurt, K, Leibole, M, and Goldberg, RL. "Practice patterns in the diagnosis and treatment of anxiety and depression in the medically ill. A survey of psychiatrists." Psychosomatics 37.4 (July 1996): 356-367.
PMID
8701014
Source
pubmed
Published In
Psychosomatics
Volume
37
Issue
4
Publish Date
1996
Start Page
356
End Page
367
DOI
10.1016/S0033-3182(96)71549-9

Contradictory subject response in longitudinal research.

OBJECTIVE: This study investigated the prevalence of logical and estimation errors in a 4-year longitudinal survey of substance abuse for elementary and junior high school students. Logical errors occur when a subject reports having used a substance on one measurement occasion, but reports never having used the substance on a second measurement occasion. Estimation errors occur when a subject reports a lifetime frequency of use on a later survey that is less than the lifetime frequency of use reported for an earlier survey. METHOD: Substance abuse surveys were completed every year for four years by predominantly black District of Columbia students, beginning when the students were in 4th/5th grade, and ending when they were in 7th/8th grade. (Ns ranged from 5,671 to 6,421). Errors for alcohol, cigarette and marijuana use were calculated for every pair of years. Background characteristics such as demographic and academic performance variables were also assessed for each of the four years. RESULTS: Logical errors decreased for all substances as student got older, whereas estimation errors remained stable. Marijuana had the highest frequency of logical errors in every pair of years except one, and had the lowest frequency of estimation errors. Students who made errors in Years 1-2 were 1.64 times more likely to make errors again in Years 3-4. For some of the years, students who made any kind of error had lower school grades, were judged untrustworthy by their peers and were more likely to be males. CONCLUSIONS: The alarming prevalence of errors should be considered when conducting longitudinal substance abuse research. Several methods of dealing with these errors are reviewed. In most cases, the best a researcher can do is assess the error rates and report them.

Authors
Weinfurt, KP; Bush, PJ
MLA Citation
Weinfurt, KP, and Bush, PJ. "Contradictory subject response in longitudinal research." J Stud Alcohol 57.3 (May 1996): 273-282.
PMID
8709586
Source
pubmed
Published In
Journal of studies on alcohol
Volume
57
Issue
3
Publish Date
1996
Start Page
273
End Page
282

Intensive outpatient adjuvant therapy for breast cancer: results of dose escalation and quality of life.

PURPOSE: A dose-escalation study was conducted to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cyclophosphamide (CY) in combination with granulocyte colony-stimulating factor (G-CSF0 and doxorubicin (DOX) given every 2 weeks for eight cycles as outpatient adjuvant therapy for node-positive breast cancer. A pilot study to assess quality of life (QOL) was performed. PATIENTS AND METHODS: From March 1991 to April 1993, 19 patients were entered. Patients received escalating doses of CY intravenously (i.v.) (1,000 mg/m2, 1,500 mg/m2, 2,000 mg/m2, or 2,500 mg/m2) with DOX 40 mg/m2, G-CSF 10 micrograms/kg/d on days 2 to 12, and mesna, every 2 weeks for eight cycles. QOL was measured by the Profile of Mood States (POMS), the Psychosocial Adjustment to Illness Scale-Self Report (PAIS-SR), and a 27-item QOL scale. RESULTS: The CY dose of 2,500 mg/m2 every 2 weeks elicited toxicities that required dose reductions secondary to a combination of thrombocytopenia, hematuria, and anemia that required transfusion. The dose of 2,000 mg/m2 resulted in an acceptable toxicity profile. Ninety-two percent of cycles at the 2,000-mg/m2 dose were delivered on schedule and 77% without hospitalization. QOL assessments indicated high levels of distress measured by POMS in 47%, poor overall quality of life in 40%, and significant problems with physical symptoms in less than 27% of all patients for any given cycle. CONCLUSION: A dose of CY at 2,000 mg/m2 can be administered every 2 weeks with DOX and G-CSF for eight cycles in the outpatient setting with manageable toxicity. The majority of women described levels of physical symptoms and emotional distress as tolerable during treatment.

Authors
Swain, SM; Rowland, J; Weinfurt, K; Berg, C; Lippman, ME; Walton, L; Egan, E; King, D; Spertus, I; Honig, SF
MLA Citation
Swain, SM, Rowland, J, Weinfurt, K, Berg, C, Lippman, ME, Walton, L, Egan, E, King, D, Spertus, I, and Honig, SF. "Intensive outpatient adjuvant therapy for breast cancer: results of dose escalation and quality of life." J Clin Oncol 14.5 (May 1996): 1565-1572.
PMID
8622073
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
14
Issue
5
Publish Date
1996
Start Page
1565
End Page
1572
DOI
10.1200/JCO.1996.14.5.1565

A SAS Macro for Producing SAS t Test Output When Raw Data are Not Available

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "A SAS Macro for Producing SAS t Test Output When Raw Data are Not Available." Applied Psychological Measurement 20.1 (March 1996): 99-99.
Source
crossref
Published In
Applied Psychological Measurement
Volume
20
Issue
1
Publish Date
1996
Start Page
99
End Page
99
DOI
10.1177/014662169602000109

A SAS Macro for Calculating Positive Predictive Values Across a Range of Base Rates

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "A SAS Macro for Calculating Positive Predictive Values Across a Range of Base Rates." Applied Psychological Measurement 20.1 (March 1996): 100-100.
Source
crossref
Published In
Applied Psychological Measurement
Volume
20
Issue
1
Publish Date
1996
Start Page
100
End Page
100
DOI
10.1177/014662169602000110

Peer Assessment of Early Adolescents Solicited to Participate in Drug Trafficking: A Longitudinal Analysis1

Authors
Weinfurt, KP; Bush, PJ
MLA Citation
Weinfurt, KP, and Bush, PJ. "Peer Assessment of Early Adolescents Solicited to Participate in Drug Trafficking: A Longitudinal Analysis1." Journal of Applied Social Psychology 25.24 (December 1995): 2141-2157.
Source
crossref
Published In
Journal of Applied Social Psychology
Volume
25
Issue
24
Publish Date
1995
Start Page
2141
End Page
2157
DOI
10.1111/j.1559-1816.1995.tb01830.x

INTERGRAPH: A SAS Macro for Interpreting and Graphing Regression Interactions

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "INTERGRAPH: A SAS Macro for Interpreting and Graphing Regression Interactions." Applied Psychological Measurement 18.3 (September 1994): 276-276.
Source
crossref
Published In
Applied Psychological Measurement
Volume
18
Issue
3
Publish Date
1994
Start Page
276
End Page
276
DOI
10.1177/014662169401800307

MacSidak: A SAS Macro That Generates Critical p Values for a Sidak Type I Error Control Procedure

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "MacSidak: A SAS Macro That Generates Critical p Values for a Sidak Type I Error Control Procedure." Applied Psychological Measurement 18.3 (September 1994): 298-298.
Source
crossref
Published In
Applied Psychological Measurement
Volume
18
Issue
3
Publish Date
1994
Start Page
298
End Page
298
DOI
10.1177/014662169401800311

The Factor Structure of the Affect Intensity Measure: In Search of a Measurement Model

Authors
Weinfurt, KP; Bryant, FB; Yarnold, PR
MLA Citation
Weinfurt, KP, Bryant, FB, and Yarnold, PR. "The Factor Structure of the Affect Intensity Measure: In Search of a Measurement Model." Journal of Research in Personality 28.3 (September 1994): 314-331.
Source
crossref
Published In
Journal of Research in Personality
Volume
28
Issue
3
Publish Date
1994
Start Page
314
End Page
331
DOI
10.1006/jrpe.1994.1023

Families versus peers: Developmental influences on drug use from grade 4-5 to grade 7-8

This study examined the relative influence of family and peers on abusable substance use, and whether relative influences on problem behaviors are behavior specific as children move from pre- to early adolescence. In 1988-1989, urban public school students in Grades 4-5 completed a substance abuse survey. The survey was repeated in each of the following 3 years into Grades 7-8; 1,802 students, of whom 91% were black, participated on all four occasions. Data were analyzed using structural equation modeling with cross-validation. Perceived family use was a stronger influence on abusable substance use relative to perceived peer use when the students were younger, whereas perceived peer use had more influence when they were older. Prior use predicted perceived family as well as perceived peer use. Varying direct and indirect pathways predicted licit drug use, illicit drug use, and other problem behaviors in Grades 7 and 8, although perceived peer use predicted all three. The results suggest that the relative shift from the influence of families to peers observed among adolescents is consistent among younger urban children. Drug use predisposes children toward greater perceptions of drug use among families and peers, and relative influences on problem behaviors may vary with the specific behavior. Interventions should begin in elementary school as the influence on students is shifting from family toward peers. © 1994.

Authors
Bush, PJ; Weinfurt, KP; Iannotti, RJ
MLA Citation
Bush, PJ, Weinfurt, KP, and Iannotti, RJ. "Families versus peers: Developmental influences on drug use from grade 4-5 to grade 7-8." Journal of Applied Developmental Psychology 15.3 (1994): 437-456.
Source
scival
Published In
Journal of Applied Developmental Psychology
Volume
15
Issue
3
Publish Date
1994
Start Page
437
End Page
456
DOI
10.1016/0193-3973(94)90041-8

Some uncertainty regarding uncertainty reduction

Tryon (1991a) has proposed the definition of a scientific explanation as an explanation that reduces uncertainty, and relates this to the reduction of statistical variance. Lamiell (1991) criticizes Tryon on several grounds, arguing that the reduction of criterion variance does not yield knowledge of the sort Tryon desires. This paper comments on Tryon's proposal, including his reply (1991b) to Lamiell's criticisms. It is concluded that explanation as uncertainty reduction is a simple recapitulation of the Hempelian model of explanation at the theoretical level, and an erroneous conception of statistical epistemology at the methodological level.

Authors
Weinfurt, KP
MLA Citation
Weinfurt, KP. "Some uncertainty regarding uncertainty reduction." Journal of Theoretical and Philosophical Psychology 14.2 (1994): 193-199.
Source
scival
Published In
Journal of Theoretical and Philosophical Psychology
Volume
14
Issue
2
Publish Date
1994
Start Page
193
End Page
199
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