Leathem Claire S, Cupples Margaret E, Byrne Mary C, O'Malley Mary, Houlihan Ailish, Murphy Andrew W, Smith Susan M
Department of General Practice, National University of Ireland, Galway, Ireland.
BMC Med Res Methodol. 2009 Jun 19;9:40. doi: 10.1186/1471-2288-9-40.
Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention.
In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection.
We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention.
Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.
ISRCTN24081411.
在随机对照试验（RCT）中招募并留住患者和医疗服务提供者对于确定干预措施的有效性很重要。然而，未能达到招募目标的情况很常见，而且特定招募策略在一项研究中有效而在另一项研究中无效的原因仍不明确。我们试图描述一项在初级保健多中心RCT中使用的策略，报告研究人员和参与者对其实施的体验，并为未来最大化招募和留住参与者的策略提供参考。
从爱尔兰的三个不同地区总共招募了48家全科诊所和903名患者，参与一项旨在优化冠心病二级预防的干预措施的RCT。招募过程包括给诊所打电话、邮寄信息、走访诊所、识别潜在参与者、邮寄邀请函并获得同意。留住参与者包括患者参加复查并回复问卷，以及诊所协助数据收集。
在18个月的干预期内，我们实现了诊所（100%）和患者（85%）的高留存率。试点工作、对研究背景的了解、参与者站点工作人员和组织对变化的认识、对疑问的快速回应以及对从业者贡献的认可被认为很重要。方案和研究支持方面的微小差异有助于满足从业者和患者多样、复杂且不断变化的个人需求，并鼓励他们留在试验中。研究人员与诊所工作人员之间需要时间来建立的合作关系被认为对招募和留住参与者都至关重要。
按照要求招募并留住足够数量的诊所和患者以提供具有足够效力的研究结果，有助于增强对RCT结果的有效性和可推广性的信心。在不影响试验方案的前提下，在试验中持续动态地监测进展并根据具体情况调整策略，应能实现最大程度的招募和留住参与者。
ISRCTN24081411
