Burns Karen E A, Prats Clara Juando, Maione Maria, Lanceta Mary, Zubrinich Celia, Jeffs Lianne, Smith Orla M
1 Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
2 Division of Critical Care Medicine, and.
Ann Am Thorac Soc. 2017 Feb;14(2):238-245. doi: 10.1513/AnnalsATS.201606-425OC.
Recruitment in critical care research differs from other contexts in important ways: patients lack decision-making capacity, uncertainty exists regarding patient prognosis, and critical illnesses are often associated with appreciable morbidity and mortality.
We aimed to describe the experiences of surrogate decision makers (SDMs) in being approached for consent for critically ill patients to participate in research.
A multicenter, qualitative study involving semistructured interviews with 26 SDMs, who provided or declined surrogate consent for research participation, at 5 Canadian centers nested within a multicenter observational study of research recruitment practices. Transcripts were reviewed by three qualitative researchers, and data were analyzed using grounded theory and a narrative critical analysis.
SDMs were guided by an overarching desire for the patient to live. Surrogate research decision-making involved three sequential stages: (1) being approached; (2) reflecting on participation; and (3) making a decision. In stage 1, SDMs identified factors (their expectations, how they were approached, the attributes of the person approaching, and study risks and benefits) that characterized their consent encounter and affirmed a preference to be approached in person. If SDMs perceived the risk of participation to be too high or felt patients may not benefit from participation, they did not contemplate further. In stage 2, SDMs who knew the patient's wishes or had a deeper understanding of research prioritized the patient's wishes and the perceived benefits of participation. Without this information, SDMs prioritized obtaining more and better care for the patient, considered what was in their mutual best interests, and valued healthcare professional's knowledge. Trust in healthcare professionals was essential to proceeding further. In stage 3, SDMs considered six factors in rendering decisions.
SDMs engaged in three sequential stages and considered six factors in making surrogate decisions for research participation. Surrogates' assessments of the risks and benefits of participation and their trust in healthcare professionals were critical factors in research decision-making. By conceptualizing surrogate decision-making for research in stages, future research can develop and test procedures to enhance the surrogate research decision-making process.
重症监护研究中的招募工作在重要方面与其他情况不同：患者缺乏决策能力，患者预后存在不确定性，并且危重病往往伴随着明显的发病率和死亡率。
我们旨在描述替代决策者（SDM）在被征求同意重症患者参与研究时的经历。
一项多中心定性研究，涉及对26名SDM进行半结构化访谈，这些SDM在一项关于研究招募实践的多中心观察性研究中的5个加拿大中心，为研究参与提供或拒绝替代同意。三名定性研究人员对访谈记录进行了审查，并使用扎根理论和叙事性批判性分析对数据进行了分析。
SDM以患者生存的总体愿望为指导。替代研究决策包括三个连续阶段：（1）被征求意见；（2）思考参与；（3）做出决定。在第一阶段，SDM确定了表征其同意过程的因素（他们的期望、被征求意见的方式、征求意见者的属性以及研究的风险和益处），并确认倾向于亲自被征求意见。如果SDM认为参与风险过高或觉得患者可能无法从参与中受益，他们就不会进一步考虑。在第二阶段，了解患者意愿或对研究有更深入理解的SDM将患者的意愿和感知到的参与益处放在首位。没有这些信息时，SDM将为患者获得更多更好的护理放在首位，考虑什么符合他们的共同最大利益，并重视医疗保健专业人员的知识。对医疗保健专业人员的信任对于进一步推进至关重要。在第三阶段，SDM在做出决定时考虑了六个因素。
SDM在为研究参与做出替代决策时经历了三个连续阶段，并考虑了六个因素。替代者对参与风险和益处的评估以及他们对医疗保健专业人员的信任是研究决策中的关键因素。通过分阶段对研究替代决策进行概念化，未来的研究可以开发和测试程序，以加强替代研究决策过程。
