What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies
What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies
复制标题
DOI：
10.1186/1745-6215-7-9
复制
发表时间：
2006-04-07
期刊：
影响因子：
2.5
通讯作者：
Snowdon, Claire
中科院分区：
文献类型：
--
作者：
McDonald, Alison M.;Knight, Rosemary C.;Snowdon, Claire
背景：多中心随机对照试验(RCT)的一个常见问题是招募往往比预期的慢或困难，许多试验未能在最初设想的时间尺度和资金范围内达到计划的样本量。这项研究的目的是在由两个公共机构：英国医学研究理事会(MRC)和卫生技术评估(HTA)计划资助的多中心试验队列中，探索可能与招募良好和不良招募相关的因素。方法：从这两个资助机构持有的行政数据库中确定试验队列。1994年至2002年间招募参与者的114项试验符合纳入标准。试验小组向资助者提交的完整科学申请和随后的试验报告提供了主要数据来源。结果：不到1/3(31%)的试验达到了最初的招募目标，一半(53%)的试验获得延期。实现目标的比例似乎没有随着时间的推移而改善。在47次(41%)试验中，总体招募延迟，在77次(63%)试验中发现早期招募问题。审判特点和征聘成功之间的相互关系是复杂的。为了增加招聘，采取了多种策略，但其成功与否无法评估。结论：招聘问题复杂且具有挑战性。队列中的许多试验都遇到了招募困难。审判往往需要较长的招聘期(有时由额外资金支持)。虽然这是一个持续令人关切的问题，但成功解决审判问题可能比仅仅征聘更重要。
Background: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme.Methods: The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate.Results: Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed.Conclusion: Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.