Rethink, 89 Albert Embankment, London SE1 7TP, UK.
BMC Med Res Methodol. 2011 May 19;11:73. doi: 10.1186/1471-2288-11-73.
The pragmatic randomised controlled trial is widely regarded as the gold standard method for evaluating the effectiveness of health care interventions. Successful conduct of trials and generalisation of findings depends upon efficient recruitment of representative samples, which often requires the collaboration of 'gatekeepers' who mediate access to potential participants. Effective negotiation of gatekeeping is thus vital to process and outcomes of trials and the quality of evidence. Whilst relevant literature contains discussion of the problems of recruitment and gatekeeping, little is known about how recruitment can be optimised and factors leading to successful recruitment.
As practised researchers with first-hand experience of gatekeeping, we were aware that some researchers recruit more effectively than others and curious about the ingredients of success. With the goal of developing practical guidance, we conducted a series of workshops with 19 expert researchers to investigate and map successful recruitment. Workshops were digitally recorded and transcribed. Analysis of discussion supported modelling of effective recruitment as a process involving three phases, each comprising two key tasks. Successful negotiation of set-up, alliance, and exchange require judicious deployment of interpersonal skills in an appropriately assertive manner. Researcher flexibility and credibility are vital for success, such that a foundation for rapprochement between the worlds of research and practice is established.Our model provides a framework to support design and implementation of recruitment activities and will enable trouble shooting and support recruitment, supervision and training of effective researchers. This, in turn will support delivery of trials on time and on budget, maximising return on investment in the production of evidence.
Pragmatic trials are central to development of evidence based health care but often failure to recruit the necessary sample in a timely manner means many fail or require costly extensions. Gatekeeping is implicated in this. Drawing on the knowledge of 19 expert researchers, we argue that successful researchers are resourceful and personable, judiciously deploying interpersonal skills and expertise to engage with gatekeepers and establish a shared objective. We propose that understanding recruitment as a phased process can enhance design and conduct of trials, supporting completion on time, on budget.
实用随机对照试验被广泛认为是评估医疗干预措施有效性的金标准方法。试验的成功进行和结果的推广取决于对代表性样本的有效招募,这通常需要“把关人”的合作,他们可以为潜在参与者提供便利。因此,有效地协商“把关人”对于试验的过程和结果以及证据的质量至关重要。虽然相关文献中讨论了招募和“把关人”的问题,但对于如何优化招募以及导致成功招募的因素知之甚少。
作为有第一手“把关人”经验的实践研究人员,我们意识到有些研究人员比其他人更有效地招募参与者,并且对成功的因素感到好奇。为了制定实用指南,我们与 19 名专家研究人员进行了一系列研讨会,以调查和描绘成功的招募情况。研讨会进行了数字记录和转录。对讨论的分析支持了将有效招募建模为一个涉及三个阶段的过程,每个阶段都由两个关键任务组成。成功协商设置、联盟和交流需要明智地以适当的自信方式运用人际交往技巧。研究人员的灵活性和信誉对于成功至关重要,因为这为研究和实践之间的和解奠定了基础。我们的模型为设计和实施招募活动提供了一个框架,并将支持解决问题以及招募、监督和培训有效的研究人员。这反过来又将支持按时、按预算完成试验,最大限度地提高证据产生的投资回报。
实用试验是循证医疗保健的核心,但由于未能及时招募到所需的样本,许多试验失败或需要昂贵的扩展。“把关人”是导致这种情况的原因之一。借鉴 19 名专家研究人员的知识,我们认为成功的研究人员足智多谋且善解人意,他们明智地运用人际交往技巧和专业知识与“把关人”合作,并建立共同的目标。我们提出,将招募理解为一个分阶段的过程可以增强试验的设计和进行,支持按时、按预算完成。