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多中心随机对照试验中的“外出日”:关于其使用情况的问卷调查及一次外出日对患者招募影响的案例研究

"Away Days" in multicenter randomized controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

作者信息

Jefferson Laura, Cook Liz, Keding Ada, Brealey Stephen, Handoll Helen, Rangan Amar

机构信息

York Trials Unit, Department of Health Sciences, University of York, York, UK.

School of Health and Social Care, Health and Social Care Institute, Teesside University, Middlesbrough, UK.

出版信息

J Evid Based Med. 2016 Feb;9(1):24-31. doi: 10.1111/jebm.12180.

Abstract

OBJECTIVE

"Away Days" (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multicenter randomized controlled trials (RCTs). We explored the use of Away Days in multicenter RCTs and analyzed the effect on patient recruitment in a case study.

METHODS

Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multicenter pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients.

RESULTS

A total of 94 people responded to the survey. The majority (78%), who confirmed had organized an Away Day previously, found them to be useful. This is despite their costs. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites.

CONCLUSIONS

Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multicenter surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design, and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days.

摘要

目的

“外出活动日”(针对试验点工作人员的试验推广和培训活动)是试验者常用的一种成熟方法,用于鼓励研究点参与多中心随机对照试验(RCT)的患者招募工作。我们在一个案例研究中探讨了“外出活动日”在多中心RCT中的应用,并分析了其对患者招募的影响。

方法

2013年6月对英国试验管理者网络的成员进行了调查,以了解他们在RCT中设计和开展“外出活动日”的经验。我们使用了一项多中心实用外科试验的数据,来探讨“外出活动日”对患者筛选和招募的影响。

结果

共有94人回复了调查。大多数(78%)曾组织过“外出活动日”的人认为这些活动是有用的,尽管它们成本较高。然而,从一项外科试验的数据分析中没有证据表明参加“外出活动日”能增加参与试验点筛选或招募的患者数量。

结论

尽管英国负责管理RCT的人员倾向于认为试验“外出活动日”是有益的,但一项多中心外科试验的证据显示,在试验成功的关键指标上并无改善。这表明需要仔细考虑“外出活动日”的目标、设计和开展方式。在RCT中进行更严格的进一步研究,对于评估“外出活动日”的设计和开展将是有价值的。

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