Division of Population Health Sciences, University of Dundee, Dundee, UK.
BMJ Open. 2013 Feb 7;3(2). doi: 10.1136/bmjopen-2012-002360. Print 2013.
This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review.
To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation.
Systematic review.
The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied.
Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility.
45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36; two studies, 4833 participants). However, the effect of many other strategies is less clear, including the use of video to provide trial information and interventions aimed at recruiters.
There are promising strategies for increasing recruitment to trials, but some methods, such as open-trial designs and opt-out strategies, must be considered carefully as their use may also present methodological or ethical challenges. Questions remain as to the applicability of results originating from hypothetical trials, including those relating to the use of monetary incentives, and there is a clear knowledge gap with regard to effective strategies aimed at recruiters.
本文是 Cochrane 系统评价数据库 2010 年第 4 期发表的 Cochrane 综述的精简版，文献号为 MR000013 DOI：10.1002/14651858.MR000013.pub5（有关详细信息，请访问 www.thecochranelibrary.com）。随着新证据的出现以及反馈意见，Cochrane 综述会定期更新，应查阅 Cochrane 系统评价数据库以获取该综述的最新版本。
确定旨在提高随机对照试验招募效果的干预措施，并量化其对试验参与的影响。
系统评价。
Cochrane 方法学评价组的 Cochrane 图书馆专业注册库、MEDLINE、EMBASE、ERIC、科学引文索引、社会科学引文索引、C2-SPECTR、国家研究注册处和 PubMed。大多数检索截至 2010 年；未对语言进行限制。
随机和半随机对照试验，包括针对假设性研究的试验。排除了保留策略研究、评估提高问卷回复率的方法以及评估为临床医生提供激励措施的使用效果的研究。研究人群包括任何潜在的试验参与者（如患者、临床医生和公众），或负责试验招募的个人或群体（如临床医生、研究人员和招募地点）。两位作者独立筛选出符合条件的研究。
纳入了 45 项试验，涉及超过 43000 名参与者。一些干预措施在提高招募效果方面是有效的：给未回复者打电话提醒（RR 1.66，95%CI 1.03 至 2.46；两项研究，1058 名参与者）、使用默认选择（即不要求参与者选择是否参加，除非明确表示不参加）而不是默认排除（即要求参与者选择参加）的方法来联系潜在参与者（RR 1.39，95%CI 1.06 至 1.84；一项研究，152 名参与者）和采用开放设计，使参与者知道他们在试验中接受的是哪种治疗（RR 1.22，95%CI 1.09 至 1.36；两项研究，4833 名参与者）。然而，许多其他策略的效果不太明确，包括使用视频提供试验信息和针对招募者的干预措施。
有一些很有前景的方法可用于提高试验的招募效果，但一些方法，如开放性试验设计和默认选择策略，因其可能带来方法学或伦理学方面的挑战，必须慎重考虑。关于源自假设性试验的结果的适用性问题仍存在疑问，包括与使用金钱激励措施相关的问题，而且对于针对招募者的有效策略，目前明显存在知识空白。
