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临床试验的招募率与特定的操作程序和临床医生的特征有关。

Recruitment rate for a clinical trial was associated with particular operational procedures and clinician characteristics.

机构信息

Musculoskeletal Division, The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Rd, Camperdown, NSW 2050, Australia.

Musculoskeletal Division, The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Rd, Camperdown, NSW 2050, Australia.

出版信息

J Clin Epidemiol. 2014 Feb;67(2):169-75. doi: 10.1016/j.jclinepi.2013.08.007. Epub 2013 Oct 31.

Abstract

OBJECTIVES

Expenditure on research has grown substantially; however, a major challenge for conducting successful clinical research is the efficient recruitment of participants. We investigated factors influencing the rate at which general practitioners (GPs) recruit participants to a randomized controlled trial.

STUDY DESIGN AND SETTING

We used data on 363 GPs recruiting participants for a randomized controlled trial of low back pain. Multivariate negative binomial regression was used to determine associations of characteristics of the GP and study operational aspects with the recruitment rate.

RESULTS

GPs recruited 1,195 participants at a rate of 0.013 participants/day. GPs located in a high socioeconomic area recruited at half the rate as those located in a low socioeconomic area [incident rate ratio (IRR), 0.52; 95% confidence interval (CI): 0.37, 0.74]. A follow-up within 2 weeks of training the GP and a higher number of face-to-face visits were operational procedures associated with a higher rate of recruitment (IRR, 2.15; 95% CI: 1.58, 2.94 and IRR, 1.17; 95% CI: 1.11, 1.24, respectively). Other contacts made with a GP were not associated with recruitment.

CONCLUSION

The results suggested that the type of operational procedures used in clinical trial recruitment strategies are important aspects to consider. The ability to predict which GPs will recruit based on GP characteristics seems limited.

摘要

目的

研究支出大幅增长;然而,成功开展临床研究的一个主要挑战是高效招募参与者。我们调查了影响全科医生(GP)招募参与者参与随机对照试验的因素。

研究设计和地点

我们使用了 363 名 GP 招募参与者参与腰痛随机对照试验的数据。采用多变量负二项回归分析确定 GP 特征和研究操作方面与招募率的关联。

结果

GP 以每天 0.013 名参与者的速度招募了 1195 名参与者。位于高社会经济地区的 GP 的招募率是位于低社会经济地区的 GP 的一半[发病率比(IRR),0.52;95%置信区间(CI):0.37,0.74]。培训 GP 后 2 周内进行随访和增加面对面访问是与更高招募率相关的操作程序(IRR,2.15;95%CI:1.58,2.94 和 IRR,1.17;95%CI:1.11,1.24)。与 GP 进行的其他接触与招募无关。

结论

结果表明,临床试验招募策略中使用的操作程序类型是需要考虑的重要方面。根据 GP 特征预测哪些 GP 将进行招募的能力似乎有限。

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