Enrollment into critical care clinical trials is often hampered by the need to rely on surrogate decision-makers. To identify potential interventions facilitating enrollment into critical care clinical trials, a better understanding of surrogate decision-making for critical care clinical trial enrollment is needed. What are the barriers and facilitators of critical care trial enrollment? What are surrogate decision-makers’ perspectives on proposed interventions to facilitate trial enrollment? We conducted semistructured interviews with 20 surrogate decision-makers of critically ill patients receiving mechanical ventilation. The interviews were recorded and transcribed verbatim, and analyzed for themes using an inductive approach. Thematic analysis confirmed previous research showing that trust in the system, assessing the risks and benefits of trial participation, the desire to help others, and building medical knowledge as important motivating factors for trial enrollment. Two previously undescribed concerns among surrogate decision-makers of critically ill patients were identified, including the potential to interfere with clinical treatment decisions and negative sentiment about placebos. Surrogates viewed public recognition and charitable donations for participation as favorable potential interventions to encourage trial enrollment. However, participants viewed direct financial incentives and prioritizing research participants during medical rounds negatively. This study confirms and extends previous findings that health system trust, study risks and benefits, altruism, knowledge generation, interference with clinical care, and placebos are key concerns and barriers for surrogate decision-makers to enroll patients in critical care trials. Future studies are needed to evaluate if charitable giving on the patient’s behalf and public recognition are effective strategies to promote enrollment into critical care trials.

中文翻译：

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临床试验中为危重患者提供同意的代理人的障碍和促进因素：一项定性研究


重症监护临床试验的入组往往因需要依赖代理决策者而受到阻碍。为了确定促进重症监护临床试验入组的潜在干预措施，需要更好地了解重症监护临床试验入组的替代决策。重症监护试验入组的障碍和促进因素是什么？代理决策者对促进试验注册的拟议干预措施有何看法？我们对 20 名接受机械通气的危重患者的代理决策者进行了半结构化访谈。采访被逐字记录和转录，并使用归纳法分析主题。主题分析证实了之前的研究表明，对系统的信任、评估参与试验的风险和收益、帮助他人的愿望以及建立医学知识是试验入组的重要激励因素。危重患者的代理决策者发现了两个先前未描述的担忧，包括可能干扰临床治疗决策和对安慰剂的负面情绪。代理人将公众认可和参与慈善捐赠视为鼓励试验注册的有利潜在干预措施。然而，参与者对直接经济激励和在医疗查房期间优先考虑研究参与者持负面态度。这项研究证实并扩展了之前的研究结果，即卫生系统信任、研究风险和收益、利他主义、知识生成、对临床护理的干扰和安慰剂是代理决策者将患者纳入重症监护试验的关键问题和障碍。 未来的研究需要评估代表患者的慈善捐赠和公众认可是否是促进重症监护试验入组的有效策略。