From the Rehabilitation Sciences Institute (R.A., J.U.), University of Toronto; Toronto Rehabilitation Institute-University Health Network (R.A., D.J., C.J.D., G.R., J.U., A.H.H., A.M.); Department of Physical Therapy (C.J.D., A.M.), University of Toronto; School of Physical Therapy (J.U.), Faculty of Health Sciences, Western University, London; and Evaluative Clinical Sciences (A.M.), Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, ON, Canada.
Neurology. 2021 Mar 30;96(13):617-626. doi: 10.1212/WNL.0000000000011660. Epub 2021 Feb 10.
To determine the publication rate of motor-rehabilitation trials poststroke and the consistency between registry records and their corresponding main publications in trial design, primary objectives and outcomes, eligibility criteria, and sample size.
We searched 18 clinical trial registries to identify randomized controlled trials of motor-based stroke rehabilitation registered after July 2005 and completed before April 2017. Eligible trials included adults with stroke, with at least one outcome measure related to motor function. Information in the registry records was compared with that of their main publications, if any.
Three hundred twenty-three trials met our eligibility criteria; we were unable to find a peer-reviewed publication reporting the main findings for 46% (150/323) of these. Of the 169 trials with peer-reviewed articles published in English, 141 (83%) were consistent with the registry record in trial design, 100 (59%) were consistent in primary objectives, 71 (42%) were consistent in primary outcomes, 28 (17%) were consistent in eligibility criteria, and 74 (44%) were consistent in sample size.
Approximately half of motor-based stroke rehabilitation trials were not published, even more than 3 years after the end of the trial. When main publications were found, they substantially deviated from information in the registry record. These findings highlight the importance of trial registries for identifying unpublished stroke rehabilitation trials and of searching trial registries when conducting systematic reviews and meta-analysis to help ensure that reviews are unbiased.
确定卒中后运动康复试验的发表率,以及注册记录与其在试验设计、主要目标和结果、纳入标准和样本量方面的主要出版物之间的一致性。
我们搜索了 18 个临床试验注册机构,以确定 2005 年 7 月以后注册并于 2017 年 4 月前完成的基于运动的卒中康复的随机对照试验。符合条件的试验包括成年卒中患者,至少有一项与运动功能相关的结局测量指标。如果有主要出版物,我们将比较注册记录中的信息与其主要出版物中的信息。
323 项试验符合我们的纳入标准;我们无法找到同行评审的出版物来报告其中 46%(150/323)的主要发现。在 169 项以英文发表同行评审文章的试验中,141 项(83%)在试验设计方面与注册记录一致,100 项(59%)在主要目标方面一致,71 项(42%)在主要结局方面一致,28 项(17%)在纳入标准方面一致,74 项(44%)在样本量方面一致。
大约一半的基于运动的卒中康复试验没有发表,即使在试验结束后 3 年以上也是如此。当发现主要出版物时,它们与注册记录中的信息有很大的差异。这些发现强调了临床试验注册机构在识别未发表的卒中康复试验以及在进行系统评价和荟萃分析时搜索临床试验注册机构的重要性,以帮助确保评价是无偏倚的。