Scholars@Duke
Kevin Phillip Weinfurt

Kevin Phillip Weinfurt

James B. Duke Distinguished Professor of Population Health Sciences
Population Health Sciences
kevin.weinfurt@duke.edu
Box 104023 Med Ctr, Durham, NC 27710
215 Morris Street, Durham, NC 27705
Manage Profile
Embed Profile Data

Selected Publications

Expectations of preventative benefits and risk behaviors in a randomized trial evaluating oral HIV preexposure prophylaxis candidates.

Journal Article AIDS Care · August 2024 When participants enrolled in an HIV prevention trial hold a preventive misconception (PM) - expectations that experimental interventions will confer protection from HIV infection - they may engage in behaviors that increase their risk of acquiring HIV. Th ... Full text Link to item Cite

Structural Changes in Brain White Matter Tracts Associated With Overactive Bladder Revealed by Diffusion Tensor Magnetic Resonance Imaging: Findings From a Symptoms of Lower Urinary Tract Dysfunction Research Network Cross-Sectional Case-Control Study.

Journal Article J Urol · August 2024 PURPOSE: Our objective was to investigate structural changes in brain white matter tracts using diffusion tensor imaging (DTI) in patients with overactive bladder (OAB). MATERIALS AND METHODS: Treatment-seeking OAB patients and matched controls enrolled in ... Full text Link to item Cite

Facets of physical function assessed by patient-reported outcome measures in oncology research.

Journal Article Qual Life Res · July 2024 PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and clas ... Full text Open Access Link to item Cite

What facets of physical function are most important to adults diagnosed with cancer?

Journal Article Qual Life Res · July 2024 PURPOSE: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or ... Full text Link to item Cite

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

Journal Article J Gen Intern Med · May 2024 In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities levera ... Full text Open Access Link to item Cite

Evaluating Recall Periods for Patient-Reported Outcome Measures: A Systematic Review of Quantitative Methods.

Journal Article Value Health · April 2024 OBJECTIVES: The current guidance for selection of recall periods recommends considering the design of the study, nature of the condition, patient's burden and ability to recall, and intent of the outcome measure. Empirical study of the accuracy of recall p ... Full text Link to item Cite

Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements

Journal Article Learning Health Systems · January 1, 2024 Introduction: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspec ... Full text Cite

Prognostic Discordance Among Parents and Physicians Caring for Infants with Neurologic Conditions.

Journal Article J Pediatr · December 2023 OBJECTIVE: To determine the frequency, degree, and nature of prognostic discordance between parents and physicians caring for infants with neurologic conditions. STUDY DESIGN: In this observational cohort study, we enrolled parents and physicians caring fo ... Full text Link to item Cite

Contralateral Prophylactic Mastectomy Decision-Making: The Partners' Perspective.

Journal Article Ann Surg Oncol · October 2023 BACKGROUND: The rate of contralateral prophylactic mastectomy (CPM) continues to rise despite no improvement in survival, an increased risk of surgical complications, and negative effects on quality of life. This study explored the experiences of the partn ... Full text Link to item Cite

Investigating Potential Gender-Based Differential Item Functioning for Items in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitations Domain

Conference Applied Research in Quality of Life · August 1, 2023 Women with heart failure report worse health-related quality of life on average, than men. This may result from actual differences in care or differing interpretations of and responses to survey questions. We investigated potential gender-based differentia ... Full text Cite

Risk Factors for Increased Stent-associated Symptoms Following Ureteroscopy for Urinary Stones: Results From STENTS.

Journal Article J Urol · May 2023 PURPOSE: The STudy to Enhance uNderstanding of sTent-associated Symptoms sought to identify risk factors for pain and urinary symptoms, as well as how these symptoms interfere with daily activities after ureteroscopy for stone treatment. MATERIALS AND METH ... Full text Link to item Cite

Investigating gender-based differential item functioning on the Kansas City Cardiomyopathy Questionnaire (KCCQ) using qualitative content analysis.

Journal Article Qual Life Res · March 2023 PURPOSE: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KC ... Full text Link to item Cite

Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity.

Journal Article Contemp Clin Trials · March 2023 BACKGROUND: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention ... Full text Link to item Cite

Moving From Idealism to Realism With Data Sharing.

Journal Article Annals of internal medicine · March 2023 Full text Cite

Expectations of preventative benefits and risk behaviors in a randomized trial evaluating oral HIV preexposure prophylaxis candidates.

Journal Article AIDS Care · August 2024 When participants enrolled in an HIV prevention trial hold a preventive misconception (PM) - expectations that experimental interventions will confer protection from HIV infection - they may engage in behaviors that increase their risk of acquiring HIV. Th ... Full text Link to item Cite

Structural Changes in Brain White Matter Tracts Associated With Overactive Bladder Revealed by Diffusion Tensor Magnetic Resonance Imaging: Findings From a Symptoms of Lower Urinary Tract Dysfunction Research Network Cross-Sectional Case-Control Study.

Journal Article J Urol · August 2024 PURPOSE: Our objective was to investigate structural changes in brain white matter tracts using diffusion tensor imaging (DTI) in patients with overactive bladder (OAB). MATERIALS AND METHODS: Treatment-seeking OAB patients and matched controls enrolled in ... Full text Link to item Cite

Facets of physical function assessed by patient-reported outcome measures in oncology research.

Journal Article Qual Life Res · July 2024 PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and clas ... Full text Open Access Link to item Cite

What facets of physical function are most important to adults diagnosed with cancer?

Journal Article Qual Life Res · July 2024 PURPOSE: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or ... Full text Link to item Cite

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

Journal Article J Gen Intern Med · May 2024 In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities levera ... Full text Open Access Link to item Cite

Evaluating Recall Periods for Patient-Reported Outcome Measures: A Systematic Review of Quantitative Methods.

Journal Article Value Health · April 2024 OBJECTIVES: The current guidance for selection of recall periods recommends considering the design of the study, nature of the condition, patient's burden and ability to recall, and intent of the outcome measure. Empirical study of the accuracy of recall p ... Full text Link to item Cite

Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements

Journal Article Learning Health Systems · January 1, 2024 Introduction: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspec ... Full text Cite

Prognostic Discordance Among Parents and Physicians Caring for Infants with Neurologic Conditions.

Journal Article J Pediatr · December 2023 OBJECTIVE: To determine the frequency, degree, and nature of prognostic discordance between parents and physicians caring for infants with neurologic conditions. STUDY DESIGN: In this observational cohort study, we enrolled parents and physicians caring fo ... Full text Link to item Cite

Contralateral Prophylactic Mastectomy Decision-Making: The Partners' Perspective.

Journal Article Ann Surg Oncol · October 2023 BACKGROUND: The rate of contralateral prophylactic mastectomy (CPM) continues to rise despite no improvement in survival, an increased risk of surgical complications, and negative effects on quality of life. This study explored the experiences of the partn ... Full text Link to item Cite

Investigating Potential Gender-Based Differential Item Functioning for Items in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitations Domain

Conference Applied Research in Quality of Life · August 1, 2023 Women with heart failure report worse health-related quality of life on average, than men. This may result from actual differences in care or differing interpretations of and responses to survey questions. We investigated potential gender-based differentia ... Full text Cite

Risk Factors for Increased Stent-associated Symptoms Following Ureteroscopy for Urinary Stones: Results From STENTS.

Journal Article J Urol · May 2023 PURPOSE: The STudy to Enhance uNderstanding of sTent-associated Symptoms sought to identify risk factors for pain and urinary symptoms, as well as how these symptoms interfere with daily activities after ureteroscopy for stone treatment. MATERIALS AND METH ... Full text Link to item Cite

Investigating gender-based differential item functioning on the Kansas City Cardiomyopathy Questionnaire (KCCQ) using qualitative content analysis.

Journal Article Qual Life Res · March 2023 PURPOSE: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KC ... Full text Link to item Cite

Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity.

Journal Article Contemp Clin Trials · March 2023 BACKGROUND: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention ... Full text Link to item Cite

Moving From Idealism to Realism With Data Sharing.

Journal Article Annals of internal medicine · March 2023 Full text Cite

Do PRO Measures Function the Same Way for all Individuals With Heart Failure?

Journal Article J Card Fail · February 2023 Women diagnosed with heart failure report worse quality of life than men on patient-reported outcome (PRO) measures. An inherent assumption of PRO measures in heart failure is that women and men interpret questions about quality of life the same way. If th ... Full text Link to item Cite

Psychometric evaluation of the Swedish version of the PROMIS Sexual Function and Satisfaction Measures in clinical and nonclinical young adult populations.

Journal Article Sex Med · February 2023 BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) Sexual Function and Satisfaction (SexFS) version 2.0 measurement tool was developed to assess sexual functioning and satisfaction in the general population regardless of hea ... Full text Link to item Cite

Advancing workforce diversity by leveraging the Clinical and Translational Science Awards (CTSA) program.

Journal Article J Clin Transl Sci · 2023 Clinical trials continue to disproportionately underrepresent people of color. Increasing representation of diverse backgrounds among clinical research personnel has the potential to yield greater representation in clinical trials and more efficacious medi ... Full text Link to item Cite

Ethics challenges in sharing data from pragmatic clinical trials.

Journal Article Clin Trials · December 2022 Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges r ... Full text Link to item Cite

Patient- and physician-reported pain after tyrosine kinase inhibitor discontinuation among patients with chronic myeloid leukemia.

Journal Article Haematologica · November 1, 2022 For patients with optimally treated chronic myeloid leukemia (CML), discontinuation of tyrosine kinase inhibitor (TKI) therapy can lead to treatment-free remission. In previous trials, TKI discontinuation has been associated with increased musculoskeletal ... Full text Link to item Cite

Comparing clinical bladder diaries and recalled patient reports for measuring lower urinary tract symptoms in the symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

Journal Article Neurourol Urodyn · November 2022 PURPOSE: Bladder diaries are a key source of information about lower urinary tract symptoms (LUTS); however, many patients do not complete them as instructed. Questionnaire-based patient-reported outcome measures (PROMs) are another option for reporting LU ... Full text Link to item Cite

Characterizing the Language Used to Discuss Death in Family Meetings for Critically Ill Infants.

Journal Article JAMA Netw Open · October 3, 2022 IMPORTANCE: Communication during conversations about death is critical; however, little is known about the language clinicians and families use to discuss death. OBJECTIVE: To characterize (1) the way death is discussed in family meetings between parents o ... Full text Link to item Cite

AUGS-PERFORM: A New Patient-Reported Outcome Measure to Assess Quality of Prolapse Care.

Journal Article Female Pelvic Med Reconstr Surg · August 2022 UNLABELLED: Patient-reported outcomes (PRO) are important for measuring quality of care, particularly for interventions aimed at improving symptom bother such as procedures for pelvic organ prolapse. We aimed to create a concise yet comprehensive PRO measu ... Full text Link to item Cite

Novel Questionnaires for Assessing Signs and Symptoms of Eosinophilic Esophagitis in Children.

Journal Article J Allergy Clin Immunol Pract · July 2022 BACKGROUND: Pediatric patients with eosinophilic esophagitis (EoE) experience heterogeneous symptoms and the patient's age may preclude reliable self-report of symptoms. OBJECTIVE: The goal of this study was to develop a patient-reported outcome and an obs ... Full text Link to item Cite

Decisional Satisfaction, Regret, and Conflict Among Parents of Infants with Neurologic Conditions.

Journal Article J Pediatr · June 2022 OBJECTIVE: To characterize decisional satisfaction, regret, and conflict among parents of critically ill infants with neurologic conditions. STUDY DESIGN: In this prospective cohort study, we enrolled parents of infants with neurologic conditions in the in ... Full text Link to item Cite

The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.

Journal Article Trials · May 21, 2022 BACKGROUND: The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high ... Full text Link to item Cite

Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.

Journal Article J Gen Intern Med · May 2022 BACKGROUND: Collateral findings in pragmatic clinical trials are findings that may have implications for patients' health but were not generated to address a trial's primary research questions. It is uncertain how best to communicate these collateral findi ... Full text Link to item Cite

Extension and Evaluation of the PROMIS Sexual Function and Satisfaction Measures for Use in Adults Living With Multiple Sclerosis.

Journal Article J Sex Med · May 2022 BACKGROUND: Sexual dysfunction is a common symptom of multiple sclerosis (MS). Clinically meaningful and psychometrically sound measures of sexual function validated in people with MS are necessary to identify people with MS who experience problems with se ... Full text Link to item Cite

Extension and Evaluation of the PROMIS Sexual Function and Satisfaction Measures for Use in Adults Living with Multiple Sclerosis.

Journal Article J Sex Med · May 1, 2022 BACKGROUND: Sexual dysfunction is a common symptom of multiple sclerosis (MS). Clinically meaningful and psychometrically sound measures of sexual function validated in people with MS are necessary to identify people with MS who experience problems with se ... Full text Link to item Cite

A web-based personalized decision support tool for patients diagnosed with ductal carcinoma in situ: development, content evaluation, and usability testing.

Conference Breast Cancer Res Treat · April 2022 PURPOSE: Patients diagnosed with ductal carcinoma in situ (DCIS) face trade-offs when deciding among different treatments, including surgery, radiation, and endocrine therapy. A less chosen option is active monitoring. While evidence from clinical trials i ... Full text Link to item Cite

Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test.

Journal Article Clin Trials · April 2022 BACKGROUND: Clinical trials that evaluate new medical products often use clinical outcome assessments to measure how patients feel or function. Determining the evidentiary support needed for clinical outcome assessments is challenging but necessary to ensu ... Full text Link to item Cite

Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

Journal Article Contemp Clin Trials · April 2022 Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW- ... Full text Link to item Cite

Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.

Journal Article Contemp Clin Trials · February 2022 BACKGROUND: Ethical responsibilities for monitoring and responding to signals of behavioral and mental health risk (such as suicidal ideation, opioid use disorder, or depression) in general clinical research have been described; however, pragmatic clinical ... Full text Link to item Cite

Patient-Reported Functional Outcomes in Patients With Chronic Myeloid Leukemia After Stopping Tyrosine Kinase Inhibitors.

Journal Article J Natl Cancer Inst · January 11, 2022 Treatment-free remission (TFR) is a goal for patients with chronic myeloid leukemia (CML). Functional outcomes after discontinuing tyrosine kinase inhibitor (TKI) treatment have not been described. Patient-Reported Outcomes Measurement Information System ( ... Full text Link to item Cite

Leave me out: Patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence.

Journal Article Medicine (Baltimore) · December 23, 2021 Opt-out procedures are sometimes used instead of standard consent practices to enable patients to exercise their autonomous preferences regarding research participation while reducing patient and researcher burden. However, little is known about the charac ... Full text Link to item Cite

Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research.

Journal Article Healthc (Amst) · December 2021 While the embedded nature of pragmatic clinical trials (PCTs) can improve the efficiency and relevance of research for multiple stakeholders, embedding research into ongoing clinical care can also involve ethical and regulatory challenges. An emergent chal ... Full text Link to item Cite

Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.

Journal Article Clin Trials · December 2021 Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this article, we examine a set of issues related to incentives and o ... Full text Link to item Cite

Stakeholder perspectives regarding pragmatic clinical trial collateral findings

Journal Article Learning Health Systems · October 1, 2021 Context: Pragmatic clinical trials (PCTs), which are becoming widespread since they are relatively inexpensive and offer important benefits for healthcare decision-making, can also present practical, ethical, and legal challenges. One such challenge involv ... Full text Cite

Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer.

Journal Article J Sex Med · October 2021 BACKGROUND: Tools for diagnosing sexual dysfunction and for tracking outcomes of interest include clinician interviews, physical exam, and patient self-report. Limited work has described relationships among these three sources of information regarding fema ... Full text Link to item Cite

Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer.

Journal Article J Sex Med · October 1, 2021 BACKGROUND: Tools for diagnosing sexual dysfunction and for tracking outcomes of interest include clinician interviews, physical exam, and patient self-report. Limited work has described relationships among these three sources of information regarding fema ... Full text Link to item Cite

Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials.

Journal Article Health Qual Life Outcomes · June 13, 2021 OBJECTIVES: There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. METHODS: Stakeholders from academia, industry, non-profits, insu ... Full text Link to item Cite

Study to Enhance Understanding of Stent-Associated Symptoms: Rationale and Study Design.

Journal Article J Endourol · June 2021 Background: Ureteral stents are commonly employed after ureteroscopy to treat urinary stone disease, but the devices impose a substantial burden of stent-associated symptoms (SAS), including pain and urinary side effects. The NIDDK (National Institute of D ... Full text Link to item Cite

Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.

Journal Article Am J Kidney Dis · June 2021 RATIONALE & OBJECTIVE: Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake. STUDY DESIGN: We describe the rationale ... Full text Open Access Link to item Cite

Constructing arguments for the interpretation and use of patient-reported outcome measures in research: an application of modern validity theory.

Journal Article Qual Life Res · June 2021 The past 100 years have witnessed an evolution of the meaning of validity and validation within the fields of education and psychology. Validity was once viewed as a property of tests and scales, but is now viewed as the extent to which theory and evidence ... Full text Link to item Cite

Views of Normal Bladder Function Among Women Experiencing Lower Urinary Tract Symptoms.

Journal Article Urology · April 2021 OBJECTIVE: To explore the perspectives of normal bladder function among women with lower urinary tract symptoms. METHODS: This was a secondary analysis of qualitative data from structured interviews with 50 adult women with lower urinary tract symptoms. A ... Full text Link to item Cite

Assessment of Outcomes After Stopping Tyrosine Kinase Inhibitors Among Patients With Chronic Myeloid Leukemia: A Nonrandomized Clinical Trial.

Journal Article JAMA Oncol · January 1, 2021 IMPORTANCE: Tyrosine kinase inhibitors (TKIs) have been associated with improved survival of patients with chronic myeloid leukemia (CML) but are also associated with adverse effects, especially fatigue and diarrhea. Discontinuation of TKIs is safe and is ... Full text Link to item Cite

Generalizing From Qualitative Data as a Moral Activity: An Example From Regulatory Decision Making for Medical Products

Journal Article Qualitative Psychology · January 1, 2021 The generalizability of quality research is discussed in terms of the generalizing actions of scientists and policymakers. Using decision making in regulatory drug trials as a case study, I illustrate how questions of generalizability arise when specifying ... Full text Cite

Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study.

Journal Article J Gen Intern Med · December 2020 BACKGROUND: Pragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of ... Full text Link to item Cite

Relationship of symptom severity and bother in individuals seeking care for lower urinary tract symptoms.

Journal Article Neurourol Urodyn · November 2020 AIMS: Bother attributed to lower urinary tract symptoms (LUTS) drives care-seeking and treatment aggressiveness. The longitudinal relationship of LUTS severity and bother in a care-seeking cohort, however, is not well understood. We aim to conduct a longit ... Full text Link to item Cite

Applying patient-reported outcome methodology to capture patient-reported health data: Report from an NIH Collaboratory roundtable.

Journal Article Healthc (Amst) · September 2020 Patient-reported health data provide information for pragmatic clinical trials that may not be readily available from electronic health records or administrative claims data. In this report, we present key considerations for collecting patient-reported hea ... Full text Link to item Cite

Patient demographic and psychosocial characteristics associated with 30-day recall of self-reported lower urinary tract symptoms.

Journal Article Neurourol Urodyn · September 2020 AIMS: Measurement of self-reported lower urinary tract symptoms (LUTS) typically uses a recall period, for example, "In the past 30 days…." Compared to averaged daily reports, 30-day recall is generally unbiased, but recall bias varies by item. We examined ... Full text Link to item Cite

Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

Journal Article Ethics Hum Res · September 2020 The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study tea ... Full text Link to item Cite

A Model to Be Emulated.

Journal Article Am J Bioeth · June 2020 Full text Link to item Cite

Vanquishing false idols, then and now

Journal Article Science · March 20, 2020 Francis Bacon's 400-year-old list of scientific foibles holds lessons for modern scientists ... Full text Cite

A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10.

Journal Article J Urol · January 2020 PURPOSE: Lower urinary tract symptoms are common in men and women. Members of the LURN (Lower Urinary Tract Dysfunction Research Network) sought to create a brief, clinically relevant tool to improve existing measurements of lower urinary tract symptoms in ... Full text Link to item Cite

Ethics and Collateral Findings in Pragmatic Clinical Trials.

Journal Article Am J Bioeth · January 2020 Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves ... Full text Link to item Cite

Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States.

Journal Article Clin Trials · December 2019 BACKGROUND: The need for more and better evidence to inform clinical decision making among all stakeholders has fueled calls for creating learning healthcare systems. The successful realization of a learning healthcare system seems to assume that various p ... Full text Link to item Cite

Viewing assessments of patient-reported heath status as conversations: Implications for developing and evaluating patient-reported outcome measures.

Journal Article Qual Life Res · December 2019 Patient-reported outcome measures (PROMs) are frequently used in research to reflect the patient's perspective. In this commentary, I argue that further improvements can be made in how we develop and evaluate PROMs by viewing assessment as a type of conver ... Full text Link to item Cite

Patient-Reported Outcome Results from the U.S. Life after Stopping TKIs (LAST) Study in Patients with Chronic Myeloid Leukemia

Conference Blood · November 13, 2019 Background: Treatment of chronic myeloid leukemia (CML) with a tyrosine kinase inhibitor (TKI) offers significant improvements over previous treatments in terms of survival and toxicity yet has been associated with reduced health-related quality of ... Full text Cite

Sexual Orientation and Patient-Provider Communication About Sexual Problems or Concerns Among US Adults.

Journal Article J Gen Intern Med · November 2019 BACKGROUND: Limited patient-provider communication about sexual health is a crucial barrier to patients receiving treatment for sexual problems, and little is known about how patient sexual orientation is associated with patient-provider communication abou ... Full text Link to item Cite

Can 7 or 30-Day Recall Questions Capture Self-Reported Lower Urinary Tract Symptoms Accurately?

Journal Article J Urol · October 2019 PURPOSE: Self-reported measurement tools often provide a recall period, eg "In the past 7 days…" For lower urinary tract symptoms the concordance of end of day (daily) reports with 7 and 30-day recalled reports is unknown to our knowledge. We evaluated how ... Full text Link to item Cite

Patient Characteristics Associated with More Bother from Lower Urinary Tract Symptoms.

Journal Article J Urol · September 2019 PURPOSE: Some patients continue to have bothersome lower urinary tract symptoms despite treatment. We examined characteristics associated with bother from lower urinary tract symptoms in a prospective cohort. MATERIALS AND METHODS: In this 1-year prospecti ... Full text Link to item Cite

A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire.

Journal Article Neurourol Urodyn · August 2019 AIMS: To develop a representative, self-report assessment of lower urinary tract symptoms (LUTS) for men and women, the symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29). METHODS: Women and men seeking treatment for ... Full text Link to item Cite

Sexual Dysfunction and Reproductive Concerns in Young Men Diagnosed With Testicular Cancer: An Observational Study.

Journal Article J Sex Med · July 2019 INTRODUCTION: The survival rates for testicular cancer are excellent; still, there is a lack of knowledge regarding important survivorship issues, such as sexual dysfunction and reproductive concerns. AIM: The aim of this study was to investigate the preva ... Full text Link to item Cite

Commentary: Dangerous Disconnections.

Journal Article Camb Q Healthc Ethics · July 2019 Full text Link to item Cite

The Comprehensive Assessment of Self-Reported Urinary Symptoms: A New Tool for Research on Subtypes of Patients with Lower Urinary Tract Symptoms.

Journal Article J Urol · June 2019 PURPOSE: To improve the potential for finding clinically important subtypes of patients with lower urinary tract symptoms we developed the CASUS (Comprehensive Assessment of Self-reported Urinary Symptoms). We used it to present data on the experiences of ... Full text Link to item Cite

PROMIS® Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains.

Journal Article Value Health · May 2019 BACKGROUND: There is a need for valid self-report measures of core health-related quality of life (HRQoL) domains. OBJECTIVE: To derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System® (PR ... Full text Link to item Cite

Exploring Understanding of "Understanding": The Paradigm Case of Biobank Consent Comprehension.

Journal Article Am J Bioeth · May 2019 Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously conve ... Full text Link to item Cite

Reframing the conversation about contralateral prophylactic mastectomy: Preparing women for postsurgical realities.

Conference Psychooncology · February 2019 OBJECTIVE: Women with unilateral, early-stage breast cancer and low genetic risk are increasingly opting for contralateral prophylactic mastectomy (CPM), a concerning trend because CPM offers few clinical benefits while increasing risks of surgical complic ... Full text Link to item Cite

Emergency Consent: Patients' and Surrogates' Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction.

Journal Article J Am Heart Assoc · January 22, 2019 Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods a ... Full text Link to item Cite

Statistical Code for Clinical Research Papers.

Journal Article Ann Intern Med · January 1, 2019 Full text Link to item Cite

Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.

Journal Article AJOB Empir Bioeth · 2019 BACKGROUND: Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospe ... Full text Link to item Cite

Symptom Based Clustering of Women in the LURN Observational Cohort Study.

Journal Article J Urol · December 2018 PURPOSE: Women with lower urinary tract symptoms are often diagnosed based on a predefined symptom complex or a predominant symptom. There are many limitations to this paradigm as often patients present with multiple urinary symptoms which do not perfectly ... Full text Link to item Cite

Oh, the Places We'll Go: Patient-Reported Outcomes and Electronic Health Records.

Journal Article Patient · December 2018 The growing measurement of patient-reported outcomes (PROs) and adoption of electronic health records (EHRs) presents an unprecedented opportunity to improve health care for patients and populations. The integration of PROs into EHRs can promote patient-ce ... Full text Link to item Cite

Sexual dysfunction and reproductive concerns in young women with breast cancer: Type, prevalence, and predictors of problems.

Journal Article Psychooncology · December 2018 OBJECTIVE: A dearth of studies focusing on young women (<40 years) with breast cancer have hampered the understanding of the type, prevalence, and predictors of sexual dysfunction and reproductive concerns in this population. METHODS: Data were collected f ... Full text Link to item Cite

Psychometric Evaluation of PROMIS Sexual Function and Satisfaction Measures in a Longitudinal Population-Based Cohort of Men With Localized Prostate Cancer.

Conference J Sex Med · December 2018 BACKGROUND: There are multiple treatment options for men with localized prostate cancer that provide similar curative efficacy but differ in their impact on sexual functioning. AIM: To evaluate the psychometric properties of the Patient-Reported Outcomes M ... Full text Link to item Cite

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

Journal Article Dig Dis Sci · October 2018 The original version of the article unfortunately contained an error in Results section of Abstract. ... Full text Link to item Cite

Propositions and Pragmatics.

Journal Article Am J Bioeth · September 2018 Full text Link to item Cite

Prevalence and Characteristics of Urinary Incontinence in a Treatment Seeking Male Prospective Cohort: Results from the LURN Study.

Journal Article J Urol · August 2018 PURPOSE: Male urinary incontinence is thought to be infrequent. We sought to describe the prevalence of urinary incontinence in a male treatment seeking cohort enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network). MATERIALS A ... Full text Link to item Cite

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

Journal Article Dig Dis Sci · June 2018 BACKGROUND: Aspects of sexual health, which can be adversely affected by chronic disease, have been inadequately explored in inflammatory bowel disease (IBD). AIMS: We evaluated patient-reported interest in sexual activity and satisfaction with sex life in ... Full text Link to item Cite

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.

Journal Article BMC Cancer · April 2, 2018 BACKGROUND: 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 a ... Full text Link to item Cite

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

Journal Article J Urol · April 2018 PURPOSE: 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 Ne ... Full text Link to item Cite

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

Journal Article J Urol · February 2018 PURPOSE: The primary objective of this study was to evaluate reasons for seeking care among men and women with lower urinary tract symptoms. MATERIALS AND METHODS: Participants were recruited from urology and urogynecology clinics, and the community. The s ... Full text Link to item Cite

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

Journal Article Am J Bioeth · December 2017 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 indi ... Full text Link to item Cite

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

Journal Article Med Care · November 2017 BACKGROUND: 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. OBJECTIVE: To determine how patients react when they seek cli ... Full text Link to item Cite

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

Journal Article J Sex Med · November 2017 BACKGROUND: 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, ... Full text Link to item Cite

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

Journal Article BMC Med Res Methodol · September 18, 2017 BACKGROUND: 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. Th ... Full text Link to item Cite

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

Journal Article Genet Med · May 2017 PURPOSE: To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension. METHODS: We conducted a national online survey in which participants were randomized within four educationa ... Full text Link to item Cite

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

Journal Article Am J Obstet Gynecol · April 2017 BACKGROUND: 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 Nationa ... Full text Link to item Cite

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

Journal Article PLoS One · 2017 BACKGROUND: 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 or ... Full text Open Access Link to item Cite

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

Journal Article J Sex Med · November 2016 INTRODUCTION: 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 limi ... Full text Link to item Cite

Physicians' perspectives regarding pragmatic clinical trials.

Journal Article J Comp Eff Res · August 2016 AIM: Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians' perspectives related to PCTs. METHODS: In-depth semistructured interviews with 20 phy ... Full text Link to item Cite

Symptoms of Lower Urinary Tract Dysfunction Research Network.

Journal Article J Urol · July 2016 PURPOSE: 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 imp ... Full text Link to item Cite

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

Journal Article J Clin Epidemiol · May 2016 OBJECTIVE: 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 popu ... Full text Link to item Cite

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

Journal Article AJOB Empir Bioeth · 2016 BACKGROUND: 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 res ... Full text Link to item Cite

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

Journal Article AJOB Empir Bioeth · 2016 BACKGROUND: 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 wa ... Full text Link to item Cite

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

Journal Article Qual Life Res · November 2015 PURPOSE: 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. METHODS: We assessed reliabilit ... Full text Link to item Cite

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

Journal Article J Gen Intern Med · October 2015 BACKGROUND: 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 to ... Full text Link to item Cite

Use of altered informed consent in pragmatic clinical research.

Journal Article Clin Trials · October 2015 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-ran ... Full text Link to item Cite

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

Journal Article J Sex Med · September 2015 INTRODUCTION: 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 valid ... Full text Link to item Cite

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

Journal Article Genet Med · March 2015 PURPOSE: 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 p ... Full text Link to item Cite

Patient preferences in advanced or recurrent ovarian cancer.

Journal Article Cancer · December 1, 2014 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 advan ... Full text Link to item Cite

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

Journal Article J Sex Med · August 2014 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 aim ... Full text Link to item Cite

An evaluation of mobile health application tools.

Journal Article JMIR Mhealth Uhealth · May 1, 2014 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 desc ... Full text Link to item Cite

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).

Journal Article JACC Heart Fail · April 2014 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 chan ... Full text Link to item Cite

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

Journal Article J Sex Med · March 2014 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 dai ... Full text Link to item Cite

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

Journal Article Crit Care Med · February 2014 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 stu ... Full text Link to item Cite

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

Journal Article Prehosp Emerg Care · 2014 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 resea ... Full text Link to item Cite

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

Journal Article J Oncol Pract · November 2013 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 So ... Full text Link to item Cite

Reasons for sexual inactivity in a US national survey of adults

Journal Article QUALITY OF LIFE RESEARCH · October 1, 2013 Link to item Cite

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

Journal Article Am J Cardiol · October 1, 2013 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 li ... Full text Link to item Cite

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

Journal Article Clin Trials · August 2013 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 inst ... Full text Link to item Cite

Participants' perspectives on safety monitoring in clinical trials.

Journal Article Clin Trials · August 2013 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 evolvin ... Full text Link to item Cite

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

Journal Article AJOB Primary Research · July 1, 2013 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 ... Full text Cite

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

Journal Article Cancer · April 1, 2013 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 b ... Full text Link to item Cite

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

Journal Article Health Qual Life Outcomes · March 11, 2013 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 Syste ... Full text Link to item Cite

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

Journal Article Med Decis Making · February 2013 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 t ... Full text Link to item Cite

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

Journal Article J Sex Med · February 2013 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 ... Full text Link to item Cite

Talking with patients about dying.

Journal Article N Engl J Med · January 31, 2013 Full text Link to item Cite

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

Journal Article PLoS One · 2013 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 c ... Full text Link to item Cite

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

Journal Article J Clin Oncol · December 10, 2012 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 p ... Full text Link to item Cite

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

Journal Article Psychooncology · June 2012 Featured Publication 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(®)) S ... Full text Link to item Cite

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

Journal Article J Behav Health Serv Res · April 2012 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 s ... Full text Link to item Cite

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

Journal Article J Clin Oncol · March 10, 2012 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 questi ... Full text Link to item Cite

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

Journal Article Am Heart J · January 2012 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article PLoS One · 2012 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 ... Full text Open Access Link to item Cite

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

Journal Article J Med Syst · December 2011 Featured Publication 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 forma ... Full text Link to item Cite

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

Journal Article Medical care · April 2011 BackgroundTo 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 ... Full text Cite

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

Journal Article Psychooncology · April 2011 Featured Publication 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 funct ... Full text Link to item Cite

Describing depression: congruence between patient experiences and clinical assessments.

Journal Article Br J Clin Psychol · March 2011 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 descri ... Full text Link to item Cite

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

Journal Article Acad Med · March 2011 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 populati ... Full text Link to item Cite

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

Journal Article J Clin Epidemiol · November 2010 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 Pat ... Full text Link to item Cite

Developing a simplified consent form for biobanking.

Journal Article PLoS One · October 8, 2010 Featured Publication 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 eth ... Full text Open Access Link to item Cite

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

Journal Article Psychooncology · October 2010 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Acad Med · October 2010 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" ... Full text Link to item Cite

Simplifying informed consent for biorepositories: stakeholder perspectives.

Journal Article Genet Med · September 2010 Featured Publication 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 cr ... Full text Link to item Cite

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

Journal Article Cancer · August 1, 2010 Featured Publication 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 a ... Full text Link to item Cite

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

Journal Article J Gen Intern Med · May 2010 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Circ Cardiovasc Qual Outcomes · March 2010 Featured Publication 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 do ... Full text Link to item Cite

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

Journal Article Am Heart J · October 2009 Featured Publication 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 mea ... Full text Link to item Cite

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

Journal Article Qual Life Res · October 2009 Featured Publication 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 ... Full text Link to item Cite

Disclosure of financial relationships to participants in clinical research.

Journal Article N Engl J Med · August 27, 2009 Featured Publication Full text Link to item Cite

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

Journal Article JAMA · April 8, 2009 Featured Publication 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, A ... Full text Link to item Cite

CONFLICT OF INTEREST OVERSIGHT IN NON-ACADEMIC RESEARCH SETTINGS

Conference JOURNAL OF GENERAL INTERNAL MEDICINE · April 1, 2009 Link to item Cite

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.

Journal Article Cancer · March 15, 2009 Featured Publication 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 bri ... Full text Link to item Cite

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

Journal Article Support Care Cancer · February 2009 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 ... Full text Link to item Cite

Cancer patient preferences for quality and length of life.

Journal Article Cancer · December 15, 2008 Featured Publication 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) a ... Full text Link to item Cite

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

Journal Article Med Care Res Rev · December 2008 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 vi ... Full text Link to item Cite

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

Journal Article Health Serv Res · December 2008 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Am Heart J · October 2008 Featured Publication 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 i ... Full text Link to item Cite

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

Journal Article Prim Health Care Res Dev · October 1, 2008 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 investig ... Full text Link to item Cite

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

Journal Article J Empir Res Hum Res Ethics · September 2008 Featured Publication 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 desi ... Full text Link to item Cite

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

Journal Article Patient Educ Couns · June 2008 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-gu ... Full text Link to item Cite

Effects of disclosing financial interests on attitudes toward clinical research.

Journal Article J Gen Intern Med · June 2008 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Ann Emerg Med · June 2008 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 ... Full text Link to item Cite

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

Journal Article J Clin Oncol · May 20, 2008 6537 Background: PROMIS-Ca is a cancer-specific extension of an NIH Roadmap effort to standardize measures of self-reported symptoms (pain; fatigue; anxiety; depression), physical function, and social function ( http://www.nihpromis.org ). PROMIS provides ... Link to item Cite

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

Journal Article PLoS One · May 7, 2008 Featured Publication 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 pu ... Full text Open Access Link to item Cite

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

Journal Article Med Decis Making · 2008 Featured Publication 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 ... Full text Link to item Cite

Varieties of uncertainty and the validity of informed consent.

Journal Article Clin Trials · 2008 Featured Publication Full text Link to item Cite

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

Journal Article Clin Trials · 2008 Featured Publication 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 o ... Full text Link to item Cite

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

Journal Article J Clin Oncol · November 10, 2007 Featured Publication 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 ... Full text Link to item Cite

The sexual function domain of the NIHPROMIS: Preliminary report

Journal Article PSYCHO-ONCOLOGY · September 1, 2007 Link to item Cite

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

Journal Article Support Care Cancer · July 2007 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 ... Full text Link to item Cite

Understanding patient expectations in early-phase clinical trials

Conference JOURNAL OF CLINICAL ONCOLOGY · June 20, 2007 Link to item Cite

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

Journal Article Qual Life Res · May 2007 Featured Publication 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 e ... Full text Link to item Cite

Incorporating item banks into clinical trials: Investigator perceptions

Conference JOURNAL OF GENERAL INTERNAL MEDICINE · April 1, 2007 Link to item Cite

Understanding patient expectations in early-phase clinical oncology trials

Conference JOURNAL OF GENERAL INTERNAL MEDICINE · April 1, 2007 Link to item Cite

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

Journal Article J Clin Oncol · January 10, 2007 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Am J Med Qual · 2007 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Clin Trials · 2007 Featured Publication 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 inf ... Full text Link to item Cite

Measuring trust in medical researchers.

Journal Article Med Care · November 2006 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article J Gen Intern Med · September 2006 Featured Publication 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 under ... Full text Link to item Cite

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

Journal Article Ann Oncol · June 2006 Featured Publication 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 an ... Full text Link to item Cite

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

Journal Article Acad Med · February 2006 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article J Law Med Ethics · 2006 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article Account Res · 2006 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 m ... Full text Link to item Cite

Racial differences in health concern.

Journal Article J Natl Med Assoc · January 2006 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 ... Link to item Cite

Patterns of intimate partner violence: correlates and outcomes.

Journal Article Violence Vict · October 2005 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 ... Link to item Cite

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

Journal Article Am Heart J · September 2005 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 ... Full text Link to item Cite

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

Journal Article Am Heart J · August 2005 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 dysfunc ... Full text Link to item Cite

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

Journal Article J Gen Intern Med · July 2005 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 a ... Full text Link to item Cite

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

Journal Article Ann Oncol · April 2005 Featured Publication 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 we ... Full text Link to item Cite

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

Journal Article Violence Against Women · March 2005 Featured Publication 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 multivariat ... Full text Link to item Cite

Experience, Grammar, and the Stuff of Psychology

Journal Article Theory & Psychology · January 1, 2005 Full text Cite

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

Journal Article Med Decis Making · 2005 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 ... Full text Open Access Link to item Cite

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

Journal Article Cancer · January 1, 2005 Featured Publication 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 cance ... Full text Link to item Cite

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

Journal Article N C Med J · 2005 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 ... Link to item Cite

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

Journal Article Ethn Dis · 2005 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 ... Link to item Cite

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

Journal Article Psychology, Health and Medicine · November 1, 2004 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 c ... Full text Cite

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

Journal Article BMC Pediatr · October 18, 2004 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 ... Full text Link to item Cite

Effect of zoledronic acid on clinically meaningful changes in pain associated with metastatic prostate cancer.

Journal Article J Clin Oncol · July 15, 2004 4680 Background: Zoledronic acid (ZA) has been shown to significantly decrease skeletal-related events (SREs) in patients with prostate cancer by 11% relative to placebo. Trends were seen in pain improvement with ZA vs placebo, but there were no reliable t ... Link to item Cite

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

Journal Article Med Care · February 2004 Featured Publication 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 trajector ... Full text Link to item Cite

In Reply:

Journal Article Journal of Clinical Oncology · February 1, 2004 Full text Cite

An exploration of relative health stock in advanced cancer patients.

Journal Article Med Decis Making · 2004 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 esti ... Full text Link to item Cite

Discursive Versus Information-Processing Perspectives on a Bioethical Problem: The Case of ‘Unrealistic’ Patient Expectations

Journal Article Theory & Psychology · January 1, 2004 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 repo ... Full text Cite

In Reply:

Journal Article Journal of Clinical Oncology · December 15, 2003 Full text Cite

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

Journal Article J Clin Oncol · July 1, 2003 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 treatme ... Full text Link to item Cite

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

Journal Article Cancer · July 1, 2003 Featured Publication 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 f ... Full text Link to item Cite

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

Journal Article Circulation · February 18, 2003 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 ... Full text Link to item Cite

Outcomes research related to patient decision making in oncology.

Journal Article Clin Ther · February 2003 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 wo ... Full text Link to item Cite

The intimate partner violence strategies index. Development and application

Journal Article Violence Against Women · February 1, 2003 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 st ... Full text Cite

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

Journal Article Theor Med Bioeth · 2003 Featured Publication 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 cha ... Full text Link to item Cite

Treatment patterns and costs associated with sessile colorectal polyps.

Journal Article Am J Gastroenterol · November 2002 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 characteri ... Full text Link to item Cite

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

Journal Article N Engl J Med · October 24, 2002 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' ... Full text Link to item Cite

Practitioner acceptance of the dofetilide risk-management program.

Journal Article Pharmacotherapy · August 2002 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 p ... Full text Link to item Cite

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

Journal Article J Clin Epidemiol · June 2002 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article American Journal of Public Health · May 7, 2002 Cite

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

Journal Article Bone Marrow Transplant · January 2002 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 w ... Full text Link to item Cite

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

Journal Article Am Heart J · September 2001 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 h ... Full text Link to item Cite

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

Journal Article Nephrol Dial Transplant · May 2001 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 ... Full text Link to item Cite

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

Journal Article Ann Intern Med · April 17, 2001 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 rhy ... Full text Link to item Cite

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

Journal Article J Soc Psychol · February 2001 Featured Publication 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 t ... Full text Link to item Cite

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

Journal Article Am Heart J · January 2001 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 define ... Full text Link to item Cite

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

Journal Article Psychosomatics · 2001 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 ... Full text Link to item Cite

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

Journal Article Circulation · October 3, 2000 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 in ... Full text Link to item Cite

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

Journal Article Circulation · August 8, 2000 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 ... Full text Link to item Cite

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

Journal Article Am J Med · May 2000 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 t ... Full text Link to item Cite

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

Journal Article Med Care · April 2000 Featured Publication 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 ... Full text Link to item Cite

Sex differences in coronary artery size assessed by intravascular ultrasound.

Journal Article Am Heart J · April 2000 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 ... Full text Link to item Cite

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

Journal Article Circulation · March 7, 2000 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 benef ... Full text Link to item Cite

Reperfusion therapy among paced patients with acute myocardial infarction

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · February 1, 2000 Link to item Cite

Treatment of paced patients with acute myocardial infarction

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · February 1, 2000 Link to item Cite

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

Journal Article Arch Intern Med · October 25, 1999 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 ... Full text Link to item Cite

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

Journal Article J Trauma Stress · October 1999 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 re ... Full text Link to item Cite

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

Journal Article Ann Intern Med · September 21, 1999 Featured Publication Full text Link to item Cite

Computer Program Exchange: An SAS/IML Module for the Johnson-Neyman Procedure

Journal Article Applied Psychological Measurement · January 1, 1999 Full text Cite

Towards a composite scoring solution for the Neurobehavioral Functioning Inventory.

Journal Article Qual Life Res · 1999 Featured Publication 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 clinica ... Full text Link to item Cite

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

Journal Article School Psychology Review · December 1, 1998 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 rel ... Cite

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.

Journal Article J Consult Clin Psychol · August 1998 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 a ... Full text Link to item Cite

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

Journal Article Dev Psychol · July 1998 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 i ... Full text Link to item Cite

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

Journal Article Applied Psychological Measurement · January 1, 1998 Full text Cite

Contradictory subject response in longitudinal research.

Journal Article J Stud Alcohol · May 1996 Featured Publication 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 ... Full text Link to item Cite

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

Journal Article J Clin Oncol · May 1996 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 ... Full text Link to item Cite

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

Journal Article Applied Psychological Measurement · January 1, 1996 Full text Cite

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

Journal Article Applied Psychological Measurement · January 1, 1996 Full text Cite

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

Journal Article Addict Behav · 1996 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 ... Full text Link to item Cite

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

Journal Article Psychosomatics · 1996 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 ... Full text Link to item Cite

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

Journal Article Journal of Applied Social Psychology · January 1, 1995 This study examined differences in peer‐ascribed sociometric ratings of preadolescent and adolescent students who were, versus who were not, solicited to help someone sell crack cocaine 1 year later. The sample consisted of 3, 838 predominantly Black, urba ... Full text Cite

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

Journal Article Journal of Research in Personality · September 1, 1994 Larsen (1984) developed the Affect Intensity Measure (AIM) as a putative measure of a unidimensional construct referred to as affect intensity, or the characteristic strength with which people experience emotions. Using a sample of 673 college undergraduat ... Full text Cite

INTERGRAPH: A SAS Macro for Interpreting and Graphing Regression Interactions

Journal Article Applied Psychological Measurement · January 1, 1994 Full text Cite

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

Journal Article Journal of Applied Developmental Psychology · January 1, 1994 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 ... Full text Cite

Some uncertainty regarding uncertainty reduction

Journal Article Journal of Theoretical and Philosophical Psychology · January 1, 1994 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 c ... Full text Cite