Enhancing the informed consent process for critical care research: Strategies from a thromboprophylaxis trial
Enhancing the informed consent process for critical care research: Strategies from a thromboprophylaxis trial
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DOI：
10.1016/j.iccn.2013.04.006
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发表时间：
2013-12-01
影响因子：
5.3
通讯作者：
Cook, Deborah J.
中科院分区：
文献类型：
--
作者：
Smith, Orla M.;McDonald, Ellen;Cook, Deborah J.
背景：重症患者缺乏参与研究的决策能力。同意招收这些患者的研究通常是从替代decisionmakers.Objective：目前的策略，可以优化过程中获得知情同意的替代决策者参与危重患者的试验。我们使用的例子，从肝素血栓预防在重症监护室（CITMT，clinicaltrials.gov NCT 00182143）的随机试验。方法：3764例患者随机，知情同意率为82%，90%的同意书是从替代决策者。北美研究协调员参加了三次会议，讨论入组问题：（1）试验启动（2006年1月）;（2）接近试验结束（2010年1月）;（3）出版后（2011年4月）。数据来自幻灯片演示文稿，现场笔记从分组和全体会议讨论，然后分析inductives.Results：我们得出了三个阶段的知情同意过程：（1）准备的同意遭遇;（2）同意遭遇;和（3）后续行动的同意遭遇。每个阶段都有具体的战略：第一阶段（四项战略）;第二阶段（六项战略）;第三阶段（三项战略）。结论：我们确定了13种策略，可以改善从替代决策者获得知情同意的过程，并可推广到其他环境和研究。(C)2013作者由爱思唯尔有限公司出版。保留所有权利。
Background: Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers.Objective: To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143).Methods: 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively.Results: We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). Conclusion: We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. (C) 2013 The Authors. Published by Elsevier Ltd. All rights reserved.