@article{3a396e8a4a5642a6a3719e8e7f46fec4,
title = "Patients{\textquoteright} Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey",
abstract = "Background: Collateral findings in pragmatic clinical trials are findings that may have implications for patients{\textquoteright} health but were not generated to address a trial{\textquoteright}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{\textquoteright}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{\textquoteright}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.",
keywords = "bioethics, disclosure, pragmatic clinical trials",
author = "Weinfurt, {Kevin P.} and Bollinger, {Juli M.} and Elizabeth May and Gail Geller and Mathews, {Debra J.H.} and Morain, {Stephanie R.} and Lorrie Schmid and Bloom, {Diane L.} and Jeremy Sugarman",
note = "Funding Information: This work is supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health of the National Institutes of Health under award number U24AT009676-02S2. Funding Information: The authors thank the members of the study{\textquoteright}s external advisory panel: Jeff R. Botkin, MD, MPH, University of Utah; Shawneequa Callier, JD, MA, George Washington University; Judith Carrithers, JD, Advarra; Deborah Collyar, BS, Patient Advocates in Research; Mary H. Cooke, DHA, Johns Hopkins US Family Health Plan and Strategic Military Alliances; Lesley H. Curtis, PhD, Duke University; Sarah Green, MPH, Health Care Systems Research Network; Adrian F. Hernandez, MD, Duke University; Eric B. Larson, MD, MPH, Kaiser Permanente Washington Health Research Institute; Amy McGuire, JD, PhD, Baylor College of Medicine; Pearl O{\textquoteright}Rourke, MD, Partners HealthCare and Harvard Medical School; Bray Patrick-Lake, MFS, Evidation Health; Alan Rubel, JD, PhD, University of Wisconsin-Madison; Lucy Savitz, PhD, MBA, Kaiser Permanente Center for Health Research; and Benjamin S. Wilfond, MD, University of Washington. The authors are grateful to Tammy Reece, MS, PMP, CCRA, and Jill George, BS, CCRA, both of Duke University, for project support and to Damon M. Seils, MA, Duke University, for editorial assistance. Publisher Copyright: {\textcopyright} 2021, Society of General Internal Medicine.",
year = "2022",
month = may,
doi = "10.1007/s11606-021-07087-8",
language = "English (US)",
volume = "37",
pages = "1658--1664",
journal = "Journal of general internal medicine",
issn = "0884-8734",
publisher = "Springer New York",
number = "7",
}