Communication of Results to Participants and their Surrogate Decision Maker: A Case Study of the LOVIT Randomized Controlled Trial

DESCRIPTION OF POSTER

"RATIONALE Existing literature shows that most clinical trial participants who consented to participate want to receive trial results, but this finding may not apply to critical care research where the consent encounter is usually with surrogate decision makers (SDMs). It is also unclear whether the direction of the treatment effect or the patients’ outcomes impact perceptions of the research. In this sub-study of the LOVIT trial (vitamin C vs placebo for sepsis), we evaluated whether Canadian participants and SDMs opted out of receiving the trial results. Secondarily, we characterized participants’ and SDMs’ attitudes towards research, given that vitamin C was associated with worse outcomes. METHODS We sent a letter to LOVIT trial participants or to their SDM if the patients had died or lacked capacity to participate in a survey. The letter informed potential respondents that they would receive a lay summary of the trial results, with a questionnaire. Instructions indicated how they could opt-out if they preferred not to receive the results of LOVIT. The survey could be completed online or returned by mail. The last survey item asked respondents if they wanted to know whether they (or their family member) received vitamin C or placebo. Those who did not refuse were invited to complete the same questionnaire a second time, after having been unblinded. RESULTS We sent letters to 421 potential respondents (281 participants, 140 SDMs), of which 81 were returned because the recipients no longer lived at the available address. Of 340 remaining potential respondents, 24 (7%) declined receiving the trial results (13 participants, 11 SDMs). Of 316 potential respondents who received the first trial summary, 139 (44%) returned a completed questionnaire. In a sensitivity analysis, we report the proportion of potential respondents who opted-out of receiving the trial results relative to the number of individuals who actively responded (24/(24+139)=15%). Of 139 respondents to the first questionnaire, 98 (71%) requested information regarding treatment allocation. Most respondents agreed that researchers should disclose trial results (n=127, 91%) and treatment allocation (n=111, 80%) to participants/SDMs. Most respondents described positive feelings after receiving results and their treatment allocation. In contrast, the number of respondents who reported negative feelings was very small. CONCLUSIONS The majority of participants/SDMs involved in the informed consent process for a randomized trial showing that vitamin C was harmful wanted to receive the trial results. Most also believed that researchers should systematically communicate research results to participants."

Communication of Results to Participants and their Surrogate Decision Maker: A Case Study of the LOVIT Randomized Controlled Trial

DESCRIPTION OF POSTER

"RATIONALE Existing literature shows that most clinical trial participants who consented to participate want to receive trial results, but this finding may not apply to critical care research where the consent encounter is usually with surrogate decision makers (SDMs). It is also unclear whether the direction of the treatment effect or the patients’ outcomes impact perceptions of the research. In this sub-study of the LOVIT trial (vitamin C vs placebo for sepsis), we evaluated whether Canadian participants and SDMs opted out of receiving the trial results. Secondarily, we characterized participants’ and SDMs’ attitudes towards research, given that vitamin C was associated with worse outcomes. METHODS We sent a letter to LOVIT trial participants or to their SDM if the patients had died or lacked capacity to participate in a survey. The letter informed potential respondents that they would receive a lay summary of the trial results, with a questionnaire. Instructions indicated how they could opt-out if they preferred not to receive the results of LOVIT. The survey could be completed online or returned by mail. The last survey item asked respondents if they wanted to know whether they (or their family member) received vitamin C or placebo. Those who did not refuse were invited to complete the same questionnaire a second time, after having been unblinded. RESULTS We sent letters to 421 potential respondents (281 participants, 140 SDMs), of which 81 were returned because the recipients no longer lived at the available address. Of 340 remaining potential respondents, 24 (7%) declined receiving the trial results (13 participants, 11 SDMs). Of 316 potential respondents who received the first trial summary, 139 (44%) returned a completed questionnaire. In a sensitivity analysis, we report the proportion of potential respondents who opted-out of receiving the trial results relative to the number of individuals who actively responded (24/(24+139)=15%). Of 139 respondents to the first questionnaire, 98 (71%) requested information regarding treatment allocation. Most respondents agreed that researchers should disclose trial results (n=127, 91%) and treatment allocation (n=111, 80%) to participants/SDMs. Most respondents described positive feelings after receiving results and their treatment allocation. In contrast, the number of respondents who reported negative feelings was very small. CONCLUSIONS The majority of participants/SDMs involved in the informed consent process for a randomized trial showing that vitamin C was harmful wanted to receive the trial results. Most also believed that researchers should systematically communicate research results to participants."