急性心肌梗死患者对研究入组同意的看法。

Acute cardiac care Pub Date : 2015-03-01 Epub Date: 2015-01-02 DOI:10.3109/17482941.2014.994642
Neal W Dickert, Alexandra E Fehr, Alex Llanos, Victoria M Scicluna, Habib Samady
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引用次数: 23

摘要

目的:本研究的目的是提高对st段抬高型心肌梗死(STEMI)患者在临床试验入组时知情同意的理解。背景:由于时间限制、症状严重程度和潜在的认知障碍,STEMI研究对知情同意提出了挑战。方法:一项访谈研究嵌入STEMI缺血后适应程序的临床试验中。我们使用了一种互动的、结构化的面试指南。结果:进行了20次访谈(初始程序后中位1.5天)。只有11/20(55%)的人最初记得被要求参加试验。对研究细节和研究过程的理解有限;例如,许多患者认为他们的决定主要是临床的,或者研究干预显然是优越的。患者描述了他们做出决定的能力的限制,包括疼痛、不适、缺乏时间和压力。然而,患者通常认为他们能够在陈述时做出决定,并希望成为主要决策者;很少有人支持家庭或医生的替代决策。结论:本研究表明患者认识到理解的障碍,但重视同意的要素。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。
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Patients' views of consent for research enrollment during acute myocardial infarction.

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.

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