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

NEJM evidence Pub Date : 2025-10-01 Epub Date: 2025-09-17 DOI:10.1056/EVIDoa2500056
Julie Ménard, Dian Cohen, Marie-Hélène Masse, Neill K J Adhikari, Deborah Cook, Diane Heels-Ansdell, Sheila Sprague, Frédérick D'Aragon, Michelle Kho, François Lamontagne, Annabelle Cumyn
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Abstract

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.).

一项重症监护试验的交流结果——对参与者和家庭成员的调查。
背景:研究参与者已经明确表达了接受研究结果的偏好。尽管研究人员对研究参与者负有许多义务,但这些义务通常不包括披露研究结果。本调查的主要目的是描述参与者或他们的替代决策者对在重症监护病房进行的试验结果交流的意见。方法:最近的一项国际随机试验的维生素C与安慰剂败血症的初步分析显示维生素C的危害。我们给这次试验的加拿大参与者寄了一封信,提供了试验结果的概要。如果参与者已经死亡或缺乏能力,这封信将被发送给他们的替代决策者。主要结果是选择不接受试验摘要的接受者的比例。同意接受试验结果的接受者随后被邀请完成一项调查。被调查者可以要求知道他们的治疗分配;如果他们这样做了,他们会被邀请在解盲后完成同样的调查。结果:340名潜在受访者中,24人(7%)拒绝接受试验结果(13名参与者,11名替代决策者)。在收到摘要的316人中,139人(44%)完成了调查,其中98人(71%)要求提供治疗分配的信息。许多人不记得最初的试验(93名参与者中的40名[43%]和31名替代决策者中的21名[68%]),但85%的受访者(139名中的118名)认为试验是必要的。收到试验结果后最常见的观点是满意(n=52, 37%)和惊讶(n=40, 29%)。大多数受访者表示,研究人员应该系统地向参与者或替代决策者披露试验结果(n= 127,91%)和治疗分配(n= 111,80%)。结论:在一项重症监护试验中,参与者和他们的替代决策者对我们的调查做出了回应,他们很大程度上支持被告知试验结果,并且他们表达了对研究价值的理解,即使实验干预证明是有害的。(由洛特和约翰·赫克特基金会和加拿大重症监护研究协调员小组资助。)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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