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A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials.
Trials ( IF 2.5 ) Pub Date : 2020-01-10 , DOI: 10.1186/s13063-019-3991-2
Kris McGill 1 , Catherine M Sackley 2 , Jon Godwin 3 , Jodie McGarry 3 , Marian C Brady 1
Affiliation  

INTRODUCTION Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke rehabilitation RCTs has not been explored. AIMS AND OBJECTIVES To explore recruitment efficiency and the trial features associated with efficient recruitment to stroke rehabilitation RCTs. METHODS A systematic review of stroke rehabilitation RCTs published between 2005 and 2015 identified in a search of the Cochrane Stroke Group (CSG) Trials Register from 35 electronic databases (e.g. Medline, CINAHL; EMBASE), clinical trial registers, and hand-searching. Inclusion criteria are stroke rehabilitation intervention, delivered by a member of the rehabilitation team, and clinically relevant environment. We extracted data on recruitment efficiency and trial features. RESULTS We screened 12,939 titles, 1270 abstracts and 788 full texts, before extracting data from 512 included RCTs (n = 28,804 stroke survivor participants). This is the largest systematic review of recruitment to date. A third of stroke survivors screened consented to participate (median 34% (IQR 14-61), on average sites recruited 1.5 participants per site per month (IQR 0.71-3.22), and one in twenty (6% (IQR 0-13) dropped out during the RCT. Almost half (48%) of those screened in the community were recruited compared to hospital settings (27%). Similarly, almost half (47%) those screened at least 6 months after stroke participated, compared to 23% of stroke survivors screened within a month of stroke. When one recruiter screened multiple sites, a median of one stroke survivor was recruited every 2 months compared to more than two per month when there was a dedicated recruiter per site. RCT recruitment was significantly faster per site, with fewer dropouts, for trials conducted in Asia (almost three stroke survivors monthly; 2% dropout) compared to European trials (approximately one stroke survivor monthly; 7% dropout). CONCLUSIONS One third of stroke survivors screened were randomised to rehabilitation RCTs at a rate of between one and two per month, per site. One in twenty did not complete the trial. Our findings will inform recruitment plans of future stroke rehabilitation RCTs. Limited reporting of recruitment details restricted the subgroup analysis performed. TRIAL REGISTRATION Prospective Register of Systematic Reviews, registration number CRD42016033067.

中文翻译:

对中风康复随机对照试验招募效率的系统评价。

简介未能达到其招募目标的随机对照试验(RCT)可能增加研究浪费。急性中风随机对照试验存在明显的招募问题。尚未研究招募中风康复RCT的效率。目的和目的探讨中风康复RCT的招募效率和与有效招募相关的试验特征。方法对2005年至2015年发布的中风康复RCT进行系统回顾,从35个电子数据库(例如Medline,CINAHL,EMBASE),临床试验注册和手工搜索中检索Cochrane中风组(CSG)试验注册资料。纳入标准为中风康复干预措施,由康复小组成员提供,并具有临床相关环境。我们提取了有关招聘效率和试用功能的数据。结果我们筛选了12,939个标题,1270个摘要和788篇全文,然后从512个包括在内的RCT(n = 28,804名卒中幸存者参与者)中提取了数据。这是迄今为止规模最大的招聘系统评价。筛选出三分之一的卒中幸存者同意参加(中位数34%(IQR 14-61),平均每个站点每月每个站点招募1.5名参与者(IQR 0.71-3.22),二十个参与者中的一个(6%(IQR 0-13))在RCT中退出了社区,筛查了社区中筛查的人的将近一半(48%),而医院是27%;而卒中后至少6个月筛查的筛查的人中的近一半(47%)则是23在中风后一个月内接受过筛查的中风幸存者的百分比。当一名招聘人员对多个地点进行筛查时,每2个月招募一名中风幸存者的中位数,而每个站点有专门的招募者,则每个月要招募两名以上。与欧洲的试验(每月大约一名卒中幸存者; 7%辍学)相比,在亚洲进行的试验(每月近三名卒中幸存者; 2%辍学),每个站点的RCT招募明显更快,辍学更少。结论筛选出的中风幸存者中有三分之一被随机分配到康复RCT中,每个部位每月接受一两次。十分之一的人没有完成审判。我们的发现将为将来的中风康复RCT的招聘计划提供信息。招聘细节的报告有限,限制了所进行的亚组分析。试用注册系统评价预期注册者,注册号CRD42016033067。
更新日期:2020-01-11
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