Communicating Results of a Critical Care Trial - A Survey of Participants and Family Members.

BACKGROUND: Research participants have expressed a clear preference for receiving research results. Although researchers have many obligations toward research participants, these do not typically include disclosure of research results. The primary objective of this survey was to describe the opinions of participants or their substitute decision-makers regarding the communication of results from a trial conducted in the intensive care unit. METHODS: A recent international randomized trial of vitamin C versus placebo for sepsis showed harm from vitamin C in the primary analysis. We sent Canadian participants in this trial a letter offering a lay summary of the trial results. If the participant had died or lacked capacity, the letter was sent to their substitute decision-maker. The primary outcome was the proportion of recipients who opted out of receiving the trial summary. Recipients who agreed to receive trial results were invited to complete a survey afterward. Respondents could request to know their treatment assignment; if they did, they were invited to complete the same survey after unblinding. RESULTS: Of 340 potential respondents, 24 (7%) declined to receive trial results (13 participants, 11 substitute decision-makers). Of 316 individuals who received the summary, 139 (44%) completed the survey and, of those, 98 (71%) requested information on treatment assignment. Many did not remember the initial trial (40 out of 93 [43%] participants and 21 out of 31 [68%] substitute decision-makers), but 85% of respondents (118 out of 139) thought that the trial was necessary. The most common views after receiving the trial results were satisfaction (n=52, 37%) and surprise (n=40, 29%). Most respondents stated that researchers should systematically disclose trial results (n=127, 91%) and treatment assignment (n=111, 80%) to participants or substitute decision-makers. CONCLUSIONS: Participants and their substitute decision-makers in a critical care trial who responded to our survey largely favored being informed of trial results, and they expressed understanding of the value of research, even when experimental interventions prove harmful. (Funded by the Lotte and John Hecht Foundation and the Canadian Critical Care Research Coordinators Group.).