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

Abstract

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.

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

“…For example, a person might report feeling concerned and then explain their feeling in terms of both being worried about a potential health problem and being angry about their inclusion in a study without their awareness. Our strategy for querying and analyzing these reactions was informed by our prior qualitative work with the public, 1,6 but it is likely that significant aspects of these experiences are not adequately captured in web-based surveys.…”

“…The study team drafted the 16 scenarios and letters based on previous focus group findings. 1 Draft letters were tested and revised on the basis of small-group cognitive interviews with 16 individuals of a variety of ages, genders, and races and ethnicities. Additional changes to the letters were made in response to individual cognitive interviews with a separate sample of 20 participants.…”

“…The study team drafted 16 versions of a survey, each of which began with a scenario and letter describing the finding (see Appendix 1 for example). Common to all survey versions was a series of open-ended, multiple-choice, and closed-ended questions that focused on the following topics regarding the hypothetical scenario and letter 2 : emotional reactions to receiving the letter 5 ; why respondents had these reactions 6 ; questions they had after reading the letter 1 ; what their next steps would be 4 ; perceptions of why they were being sent the letter; and 3 thoughts about the communication itself (Appendix 2). Questions about the communication addressed the amount of information in the letter, how well respondents thought they understood the communication, the clarity of the letter, and the acceptability of receiving the communication by mailed letter rather than other modes.…”

“…6 The third step was a qualitative study of the views of the general public on the disclosure of PCT-CFs. 1 Results of this previous work and input from a multistakeholder advisory panel revealed significant uncertainty about whether and how to communicate PCT-CFs to patients. Specifically, it is unclear who should notify the patient and whether to explain that the PCT-CF was discovered in the context of a pragmatic clinical trial.…”

Finding Out Your Doctor Made a Mistake

“…In this issue of JGIM, Bollinger et al 2 describe a new way of uncovering medical error, doing so in the course of conducting research aimed at quality improvement. Pragmatic clinical trials (PCTs), a methodology that is not really new (the polio trial of the 1950s is perhaps the most famous example), are being more commonly performed once again.…”