Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Department of Critical Care Medicine, Alberta Health Services & University of Calgary, Calgary, AB, Canada.
Can J Anaesth. 2022 Apr;69(4):513-526. doi: 10.1007/s12630-021-02176-y. Epub 2021 Dec 14.
Our primary objective was to describe consent models used in Canadian-led adult and pediatric intensive care unit (ICU/PICU) randomized controlled trials (RCTs). Our secondary objectives were to determine the consent rate of ICU/PICU RCTs that did and did not use an alternate consent model to describe consent procedures.
Using scoping review methodology, we searched MEDLINE, Embase, and CENTRAL databases (from 1998 to June 2019) for trials published in English or French. We included Canadian-led RCTs that reported on the effects of an intervention on ICU/PICU patients or their families. Two independent reviewers assessed eligibility, abstracted data, and achieved consensus.
We identified 48 RCTs of 17,558 patients. Included RCTs had ethics approval to use prior informed consent (43/48; 90%), deferred consent (13/48; 27%), waived consent (5/48; 10%), and verbal consent (1/48; 2%) models. Fifteen RCTs (15/48; 31%) had ethics approval to use more than one consent model. Twice as many trials used alternate consent between 2010 and 2019 (13/19) than between 2000 and 2009 (6/19). The consent rate for RCTs using only prior informed consent ranged from 54 to 91% (ICU) and 43 to 94% (PICU) and from 78 to 100% (ICU) and 74 to 87% (PICU) in trials using an alternate/hybrid consent model.
Alternate consent models were used in the minority of Canadian-led ICU/PICU RCTs but have been used more frequently over the last decade. This suggests that Canadian ethics boards and research communities are becoming more accepting of alternate consent models in ICU/PICU trials.
我们的主要目标是描述加拿大主导的成人和儿科重症监护病房（ICU/PICU）随机对照试验（RCT）中使用的同意模式。我们的次要目标是确定使用替代同意模式和未使用替代同意模式描述同意程序的 ICU/PICU RCT 的同意率。
使用范围综述方法，我们检索了 MEDLINE、Embase 和 CENTRAL 数据库（1998 年至 2019 年 6 月），以获取发表在英语或法语中的试验。我们纳入了报告干预对 ICU/PICU 患者或其家属影响的加拿大主导的 RCT。两名独立审查员评估了合格性、提取数据并达成共识。
我们确定了 48 项涉及 17558 名患者的 RCT。纳入的 RCT 均获得了使用事先知情同意（43/48；90%）、延迟同意（13/48；27%）、豁免同意（5/48；10%）和口头同意（1/48；2%）模型的伦理批准。15 项 RCT（15/48；31%）获得了使用多种同意模型的伦理批准。2010 年至 2019 年期间，使用替代同意的 RCT 数量是 2000 年至 2009 年期间的两倍（13/19）。仅使用事先知情同意的 RCT 的同意率范围为 54%至 91%（ICU）和 43%至 94%（PICU），而使用替代/混合同意模型的 RCT 的同意率范围为 78%至 100%（ICU）和 74%至 87%（PICU）。
替代同意模式仅在少数加拿大主导的 ICU/PICU RCT 中使用，但在过去十年中使用频率有所增加。这表明加拿大伦理委员会和研究界越来越接受 ICU/PICU 试验中的替代同意模式。
