Ethics and Collateral Findings in Pragmatic Clinical Trials

Morain, Stephanie R.; Weinfurt, Kevin P.; Bollinger, Juli; Geller, Gail; Mathews, Debra J. H.; Sugarman, Jeremy

doi:10.1080/15265161.2020.1689031

Cited by 17 publications

(18 citation statements)

References 47 publications

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“…For example, participants might react differently to a PCT-CF related to a false-positive rate of a test. 4,15 Furthermore, during the focus group discussions, we frequently had to remind participants of the differences between PCTs and experimental trials of new therapeutics. While we took time to address misunderstandings, we cannot be sure that participants understood and kept in mind the important distinctions between PCTs and experimental trials.…”

Section: Limitationsmentioning

confidence: 99%

“…3 One issue that has not received much attention is the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in a PCT that is unrelated to the primary research question(s) but may have implications for patients, clinicians, and health systems from whom or within which the research data were collected. 4 For example, a PCT aimed at increasing uptake of cardiac care guidelines identified patients with diagnoses that increased their risk for a cardiac event based on insurance claims data, but for whom documentation that the diagnosis was communicated was lacking. 5 Furthermore, because PCTs straddle the research-clinical care boundary, there are conflicting opinions as to who is ultimately responsible for managing PCT-CFs.…”

Section: Introductionmentioning

confidence: 99%

“…5 Furthermore, because PCTs straddle the research-clinical care boundary, there are conflicting opinions as to who is ultimately responsible for managing PCT-CFs. 4 Regardless of who has responsibility, when a decision has been made to disclose PCT-CFs to patients, the actual disclosure will undoubtedly involve clinicians. For example, clinicians may be called upon to directly report these findings to their patients.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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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 pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems. OBJECTIVE: We sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided. DESIGN: Prospective, qualitative focus group study. PARTICIPANTS: Focus groups were conducted in Baltimore, MD; Houston, TX; and Seattle, WA (overall N = 66), during July and August 2019. APPROACH: All groups discussed a hypothetical scenario involving the detection of a PCT-CF of contraindicated medications. Participants were asked about their reactions to the PCT-CF and issues related to its disclosure. KEY RESULTS: Reactions to learning about the PCT-CF were mixed, ranging from fear of a significant health problem, anger that the contraindicated medications had gone unnoticed and/or for being included in research without their permission, to gratitude for the information. Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. Many wanted their treating clinician to be informed of the PCT-CF so that they would be prepared to answer patients' questions and to discuss treatment options. CONCLUSIONS: The detection of PCT-CFs is likely to increase with further expansion of PCTs. As such, clinicians will undoubtedly become involved in the management of PCT-CFs. Our data illustrate some of the challenges clinicians may face when their patients are informed of a PCT-CF and the need to develop guidance for disclosing PCT-CFs in ways that align with patients' preferences and values.

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Section: Limitationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…2 One issue relates to what we have coined "pragmatic clinical trial collateral findings" (PCT-CFs)-findings, discovered intentionally or unintentionally, that may have implications for patients' health but were not generated to address the trial's primary research question. 5 For example, in a pragmatic clinical trial comparing the effectiveness of 2 medications for hypertension, researchers collecting data from the electronic health record might discover that a patient appeared to be taking 2 contraindicated medications.…”

Section: Introductionmentioning

confidence: 99%

“…The first step was a conceptual analysis of ethical issues associated with PCT-CFs. 5 The second step was a qualitative study of the perspectives of stakeholders in pragmatic clinical trials, including principal investigators and health care system leaders. 6 The third step was a qualitative study of the views of the general public on the disclosure of PCT-CFs.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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 findings to patients. OBJECTIVES: To determine how reactions to a letter communicating collateral findings relate to who signed the letter, the type of finding, or whether the letter specified that the finding arose from a pragmatic clinical trial. RESEARCH DESIGN: Web-based survey experiment using a between-subjects design in which respondents were randomly assigned within education strata to view and respond to 1 of 16 hypothetical scenarios. SUBJECTS: Adults recruited from an online panel constructed from a probability sample of US-based postal addresses. MEASURES: The primary outcomes were the action the respondent would take next (i.e., contact a doctor immediately or something else) and the respondent's emotional reactions (i.e., all positive, all negative, mixed, or none). RESULTS: A total of 4080 respondents had analyzable data. Although some effects were statistically significant (P < .05), none exceeded a prespecified threshold for policy relevance (15 or more percentage points). Ratings of letter clarity and level of understanding were lower for letters that included a description of the clinical trial. CONCLUSIONS: Signatory and level of detail about collateral findings did not substantially affect people's intentions to take the recommended action of contacting their doctor. Deciding whether to include a description of the pragmatic clinical trial requires a trade-off between transparency and more difficulty understanding the contents of the letter.

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Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials

Morain¹,

Kraft²,

Wilfond³

et al. 2022

Hastings Center Report

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Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)—particularly those that may alter or waive informed consent—remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.

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Ethics and Collateral Findings in Pragmatic Clinical Trials

Cited by 17 publications

References 47 publications

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

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

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

Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials

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