Feldman William B, Kim Anthony S, Josephson S Andrew, Lowenstein Daniel H, Chiong Winston
From the School of Medicine (W.B.F.), Department of Neurology (A.S.K., S.A.J., D.H.L., W.C.), and Memory and Aging Center (W.C.), University of California, San Francisco.
Neurology. 2016 Apr 19;86(16):1543-51. doi: 10.1212/WNL.0000000000002587. Epub 2016 Mar 23.
There is urgent need for clinical trials of novel interventions to reduce the burden of acute ischemic stroke. A key impediment to such trials is slow recruitment. Since obtaining written informed consent in the setting of acute stroke is especially challenging, some experts have endorsed relaxing the requirement for informed consent by permitting verbal consent or waivers to facilitate recruitment. This systematic review of 36 randomized controlled trials of acute interventions for ischemic stroke assesses whether alternatives to written informed consent are associated with increased recruitment rates. After the exclusion of 2 outlier trials that differed from other trials in conduct and interventions studied, no association was observed on univariable analysis (8.9 participants/month in trials requiring written consent vs 6.1 participants/month in trials with alternatives, p = 0.43) or multivariable analysis (when adjusting for the number of centers, number of countries, and exclusions based on modified Rankin Scale scores). Alternatives to written informed consent in acute stroke trials may enable trial designs that would not be feasible otherwise. However, we did not find evidence that, within traditional trial designs, such alternatives are associated with faster recruitment.
迫切需要开展新型干预措施的临床试验，以减轻急性缺血性中风的负担。此类试验的一个关键障碍是招募速度缓慢。由于在急性中风情况下获得书面知情同意特别具有挑战性，一些专家支持通过允许口头同意或豁免来放宽知情同意的要求，以促进招募。这项对36项缺血性中风急性干预随机对照试验的系统评价，评估了书面知情同意的替代方式是否与更高的招募率相关。在排除2项在实施和研究干预措施方面与其他试验不同的异常试验后，单变量分析未观察到相关性（需要书面同意的试验中每月招募8.9名参与者，采用替代方式的试验中每月招募6.1名参与者，p = 0.43），多变量分析也未观察到相关性（调整中心数量、国家数量以及基于改良Rankin量表评分的排除情况后）。急性中风试验中书面知情同意的替代方式可能会使一些原本不可行的试验设计成为可能。然而，我们没有发现证据表明，在传统试验设计中，此类替代方式与更快的招募速度相关。
