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增加随机试验的入组人数:随机对照试验综述

Increasing recruitment to randomised trials: a review of randomised controlled trials.

作者信息

Watson Judith M, Torgerson David J

机构信息

York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.

出版信息

BMC Med Res Methodol. 2006 Jul 19;6:34. doi: 10.1186/1471-2288-6-34.

Abstract

BACKGROUND

Poor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective.

METHODS

We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies) were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors.

RESULTS

We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive.

CONCLUSION

Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

摘要

背景

随机对照试验(RCT)的受试者招募不佳是一个普遍且重要的问题。鉴于受试者招募不佳是随机试验开展过程中的一个重要问题,因此开展了一项关于招募方法的对照试验的系统评价,以确定有效的策略。

方法

我们检索了Cochrane图书馆1996年至2004年底的试验注册库。我们还检索了2004年的《科学引文索引》。通过个人所知补充了其他试验。纳入的研究必须采用随机分配,且参与者必须被分配到不同的招募方法以进行“真正的”随机试验。将参与者随机分配到“模拟”试验的研究以及招募到非随机研究(如病例对照研究)的试验被排除。两位作者提取了关于研究设计、干预和对照以及招募患者数量的信息。

结果

我们确定了14篇描述20种不同干预措施的论文。有效的干预措施包括:电话提醒;问卷纳入;金钱激励;采用“开放”而非安慰剂设计;以及使试验材料具有文化敏感性。

结论

很少有试验对改善试验招募的干预措施进行测试。迫切需要更多关于招募策略的随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db03/1559709/8a2493da44e1/1471-2288-6-34-1.jpg

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本文引用的文献

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Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials.
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