在随机对照临床试验中使用基层医疗人群集群时的招募问题:爬山还是推巨石上山?

Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?

作者信息

Hoddinott Pat, Britten Jane, Harrild Kirsten, Godden David J

机构信息

Centre For Rural Health, University of Aberdeen, The Green House, Beechwood Business Park North, Inverness IV2 3BL, Scotland, UK.

出版信息

Contemp Clin Trials. 2007 May;28(3):232-41. doi: 10.1016/j.cct.2006.08.004. Epub 2006 Aug 11.

Abstract

Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level.

摘要

用于健康促进、教育、公共卫生或组织变革干预措施的整群随机对照试验越来越普遍,以便为循证政策提供依据。然而,关于基层医疗人群群组招募策略的已发表方法学证据很少。在本文中,我们讨论了选择对哪些人群群组进行随机分组如何影响基层医疗招募的实际操作。我们描述了通过招募基层医疗组织参与一项全国随机对照试验所积累的经验而制定的策略,该试验旨在为怀孕和哺乳期母亲提供社区母乳喂养小组的政策,即“群组母乳喂养”(BIG)试验。我们提出一种迭代的定性招募方法;收集招募过程中产生的数据,识别主题并运用持续比较分析法。这有助于制定成功的招募策略,并且与招募个体参与随机对照试验时常用的标准化方法形成对比。在英国,招募基层医疗人群群组参与试验目前是一场艰苦的战斗。这是一个复杂的过程,运用定性方法为试验设计和招募策略提供信息会从中受益。如果卫生服务管理者致力于在国家层面支持经过同行评审、获得资助且经伦理委员会批准的研究,招募工作可能会更顺利。

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