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招募社区居住的中风幸存者参与临床试验的问题:AMBULATE 试验。

Issues in recruiting community-dwelling stroke survivors to clinical trials: the AMBULATE trial.

机构信息

Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, PO Box 170 Lidcombe NSW 1825, Australia.

出版信息

Contemp Clin Trials. 2010 Jul;31(4):289-92. doi: 10.1016/j.cct.2010.04.003. Epub 2010 May 8.

DOI:10.1016/j.cct.2010.04.003
PMID:20435166
Abstract

BACKGROUND

Recruitment to clinical trials is often slow and difficult, with a growing body of research examining this issue. However there is very little work related to stroke.

AIMS

The aim of this study was to examine the success and efficiency of recruitment of community-dwelling stroke survivors over the first two years of a clinical trial aiming to improve community ambulation.

METHOD

Recruitment strategies fell into 2 broad categories: (i) advertisement (such as newspaper advertising and media releases), and (ii) referral (via hospital and community physiotherapists, a stroke liaison officer and other researchers). Records were kept of the number of people who were screened, were eligible and were recruited for each strategy.

RESULTS

The recruitment target of 60 in the first two years was not met. 111 stroke survivors were screened and 57 were recruited (i.e., a recruitment rate of 51%). The most successful strategy was referral via hospital-based physiotherapists (47% of recruited participants) and the least successful were media release and local newspaper advertising. The referral strategies were all more efficient than any of the advertisement strategies.

CONCLUSIONS

In general, recruitment was inefficient and costly in terms of human resources. Given that stroke research is underfunded, it is important to find efficient ways of recruiting stroke survivors to clinical trials. An Australian national database similar to other disease-specific data bases (such as the National Cancer Database) is under development. In the interim, recruiting for several clinical trials at once may increase efficiency.

摘要

背景

临床试验的招募通常缓慢而困难,越来越多的研究关注这一问题。然而,与中风相关的研究却很少。

目的

本研究旨在检查一项旨在改善社区活动能力的临床试验中,在头两年内招募社区居住的中风幸存者的成功率和效率。

方法

招募策略分为两类:(i)广告(如报纸广告和媒体发布),和(ii)转介(通过医院和社区物理治疗师、中风联络官和其他研究人员)。记录了每种策略的筛选人数、合格人数和招募人数。

结果

前两年的招募目标 60 人没有达到。共筛选了 111 名中风幸存者,其中 57 名符合条件并被招募(即招募率为 51%)。最成功的策略是通过医院的物理治疗师转介(招募的参与者中有 47%来自该策略),而最不成功的策略是媒体发布和当地报纸广告。转介策略都比任何广告策略都更有效率。

结论

总体而言,招募在人力资源方面效率低下且成本高昂。鉴于中风研究资金不足,找到有效的方法招募中风幸存者参加临床试验非常重要。一个类似于其他疾病特定数据库(如国家癌症数据库)的澳大利亚国家数据库正在开发中。在此期间,同时招募多个临床试验可能会提高效率。

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