Recalling what we thought we knew about recall periods: a qualitative descriptive study of how adults diagnosed with cancer use recall periods for patient-reported outcome items about physical function.

Objectives: In cancer studies, assessment of patients' physical function can provide insight into cancer-related symptoms and the side effects of treatment. Physical function can be assessed using patient-reported outcome measures (PROMs), which may or may not include a recall period-the amount of time the questionnaire asks the respondent to think back to answer the questions. More understanding is needed about how patients interpret and respond to items posed with different recall periods, and which recall period they actually use.

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

Purpose: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S.

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

Purpose: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials.

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

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. This can raise ethical concerns about whether those enrolled in the trial understand the nature of participation and their safety. Consequently, we systematically evaluated the prevalence of PM and its association with risk behaviors in a trial examining three candidate regimens for oral HIV pre-exposure prophylaxis in which all participants received at least one antiretroviral agent.

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

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 periods is recommended; however, there is not consensus on how to quantitatively evaluate the consistency of results from patient-reported outcome measures (PROMs) with different recall periods. We conducted a systematic review to describe quantitative methods for evaluating results obtained from PROMs with differing recall periods to lay the groundwork for establishing consensus.

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

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 aspects of PCTs that raise distinct considerations for data sharing, there have been no reports of the experiences of those at the leading edge of data-sharing efforts for PCTs, including how these particular challenges have been navigated.

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

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 leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems.

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

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 for infants with neurologic conditions in advance of a family conference. Parent-physician dyads completed a postconference survey targeting expected neurologic outcomes across 3 domains (motor, speech, and cognition) using a 6-point scale.

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

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 partners of women who undergo CPM.

Methods: This study was part of an investigation into the factors motivating women with early-stage unilateral breast cancer and low genetic risk to opt for contralateral prophylactic mastectomy (CPM).

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

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 health condition and sexual orientation.

Aim: The study aimed to evaluate the psychometric properties of the Swedish version of the PROMIS SexFS measure in clinical and nonclinical populations of young adults (aged <40 years).

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

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 medical interventions by addressing medical mistrust. In 2019, North Carolina Central University (NCCU), a Historically Black College and University with a more than 80% underrepresented student population, established the Clinical Research Sciences Program with support from the Clinical and Translational Science Awards (CTSA) program at neighboring Duke University.

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

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 during the trial, and/or ability to detect meaningful differences in outcomes.

Methods: We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool.

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

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 KCCQ-23 that are important to assess in men and/or women with heart failure (HF).

Methods: Patients ≥ 22 years of age with clinician-diagnosed HF and left ventricular ejection fraction ≤ 40% were recruited from two academic medical centers to participate in semi-structured concept elicitation and cognitive debriefing interviews. Enrollment was stratified by patient-identified gender (half women/half men).

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

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 of critically ill infants and the clinical team and (2) how discussion of death differs between clinicians and family members.

Design, Setting, And Participants: This longitudinal qualitative study took place at a single academic hospital in the southeast US.

Ethics challenges in sharing data from pragmatic clinical trials.

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 related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing.

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

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 measurement tool to assess pelvic organ prolapse care in high-volume clinical environments.

Methods: The relevant concepts to measure prolapse treatment quality were first established through literature review, qualitative interviews, and a patient and provider-driven consensus-building process.

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

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 this is not the case, the risk then becomes that the PRO scores cannot be used for valid comparison or to combine outcomes by subgroups of the population.

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

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 risk of disruption due to the dual impacts on the conduct of both care and research.

Methods: We collected qualitative data using multiple methods to characterize the impact of COVID-19 on the research activities of 14 active pragmatic clinical trials in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory.