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改善临床试验受试者招募与留存的干预措施:一项评估当前实践及未来优先事项的调查与研讨会

Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities.

作者信息

Bower Peter, Brueton Valerie, Gamble Carrol, Treweek Shaun, Smith Catrin Tudur, Young Bridget, Williamson Paula

机构信息

National Institute for Health Research School for Primary Care Research, North West Hub for Trials Methodology Research, University of Manchester, Oxford Road, Manchester M13 9PL, UK.

出版信息

Trials. 2014 Oct 16;15:399. doi: 10.1186/1745-6215-15-399.

Abstract

BACKGROUND

Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions.

METHODS

In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions.

RESULTS

Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives.

CONCLUSIONS

Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.

摘要

背景

尽管在基础设施方面投入巨大,但许多试验在招募和留住参与者方面仍面临挑战。我们认为,在招募和留住参与者干预措施的开发和测试方面关注不足。

方法

在本文中,我们总结了关于改善招募和留住参与者的干预措施的现有综述。我们报告了来自英国临床试验单位的调查数据,以表明这些单位用于鼓励招募和留住参与者的干预措施范围。我们展示了最近一次研讨会参与者的观点以及一份用于评估的招募干预措施优先清单(由研讨会参与者投票确定)。我们还讨论了有关招募干预措施测试的更广泛问题。

结果

用于鼓励招募和留住参与者的方法分为:患者联系、患者便利、对招募人员的支持、监测与系统、激励措施、设计、资源和人为因素。受访者认为值得研究的干预措施分为三类:培训现场工作人员、与患者沟通和激励措施。

结论

临床试验和其他高质量研究仍在投入大量资源,但招募仍然是一项重大挑战。需要采用创新方法来开发、测试和实施招募干预措施。

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