Patients' views of consent for research enrollment during acute myocardial infarction.
Patients' views of consent for research enrollment during acute myocardial infarction.
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DOI：
10.3109/17482941.2014.994642
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发表时间：
2015-03-01
期刊：
影响因子：
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通讯作者：
Samady, Habib
中科院分区：
文献类型：
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作者：
Dickert, Neal W;Fehr, Alexandra E;Samady, Habib
目的：本研究的目的是提高对ST段抬高型心肌梗死（STEMI）患者知情同意临床试验入组的认识。背景：由于时间限制、症状严重程度和潜在的认知功能障碍，STEMI研究对知情同意提出了挑战。一个互动的，结构化的采访guides.Results：进行了20次采访（平均1.5天后，初步程序）。只有11/20（55%）最初记得被要求参加试验。对研究细节和研究过程的理解是有限的;例如，许多患者认为他们的决定主要是临床的，或者研究干预明显具有上级优势。患者描述了他们做出决定的能力的局限性，包括疼痛，不适，缺乏时间和压力。然而，患者普遍认为，他们能够在演示文稿中作出决定，并希望成为主要的决策者;很少支持代理决策的家庭或医生。结论：这项研究表明，患者认识到的障碍，理解，但价值的同意要素。需要进一步的研究来开发满足患者目标的方法，同时认识到这种情况固有的局限性。
OBJECTIVE: The goal of this study was to improve understanding of patients' perspectives of informed consent for clinical trial enrollment during ST-elevation myocardial infarction (STEMI).BACKGROUND: STEMI research poses challenges regarding informed consent due to time constraints, symptom severity, and potential cognitive impairment.METHODS: An interview study was embedded within a clinical trial of an ischemic post-conditioning procedure for STEMI. An interactive, structured interview guide was used.RESULTS: Twenty interviews were conducted (median 1.5 days after initial procedure). Only 11/20 (55%) initially remembered being asked to participate in a trial. Comprehension of study details and the research process was limited; for example, many patients believed their decision was primarily clinical or that the study intervention was clearly superior. Patients described limitations regarding their ability to make a decision, including pain, discomfort, lack of time, and stress. However, patients generally felt they were able to make a decision at presentation and wanted to be the primary decision maker; few supported surrogate decision-making by family or physicians.CONCLUSIONS: This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients' goals while recognizing the limitations inherent to this context.