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阶梯式随机临床试验具有连续性招募的特点,这需要新的思路。

Stepped wedge trials with continuous recruitment require new ways of thinking.

机构信息

Centre for Primary Care & Public Health, Queen Mary University of London, London, UK.

MRC Clinical Trials Unit, University College London, London, UK.

出版信息

J Clin Epidemiol. 2019 Dec;116:161-166. doi: 10.1016/j.jclinepi.2019.05.037. Epub 2019 Jun 11.

Abstract

OBJECTIVES

There is substantial variation in the design of stepped wedge trials. Many recruit participants continuously over time, although the methodological literature has tended not to differentiate closely between continuous recruitment and discrete sampling. We argue for a deeper understanding of the special features of stepped wedge trials with continuous recruitment.

STUDY DESIGN AND SETTING

This is a commentary and informal review.

RESULTS

We discuss the scheduling of recruitment and implementation in continuous time and how contamination might be avoided. We also offer some suggestions on reporting and terminology for stepped wedge trials with continuous recruitment and comment on issues for analysis.

CONCLUSION

Repeated cross-section and continuous recruitment stepped wedge trials are not the same thing. More work is needed to develop the theory and practice of stepped wedge designs with continuous recruitment. Thoughtful approaches to design and clarity of reporting are vital.

摘要

目的

阶梯式楔形试验的设计存在很大差异。尽管方法学文献往往没有对连续招募和离散抽样进行严格区分,但许多试验都在持续时间内连续招募参与者。我们主张更深入地了解具有连续招募特点的阶梯式楔形试验的特殊特征。

研究设计和设置

这是一篇评论和非正式回顾。

结果

我们讨论了连续时间内招募和实施的时间表,以及如何避免污染。我们还对具有连续招募的阶梯式楔形试验的报告和术语提出了一些建议,并对分析问题进行了评论。

结论

重复横截面和连续招募的阶梯式楔形试验不是一回事。需要进一步研究和实践具有连续招募的阶梯式楔形试验的理论和实践。精心设计和清晰报告至关重要。

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