报告和方法学质量的样本量计算在整群随机试验中可以得到改善：一项综述。

Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: a review.

机构信息

Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, UK.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Civic Box 693, Ottawa, Ontario K1Y 4E9, Canada; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.

出版信息

J Clin Epidemiol. 2015 Jun;68(6):716-23. doi: 10.1016/j.jclinepi.2014.10.006. Epub 2014 Dec 15.

DOI:10.1016/j.jclinepi.2014.10.006

PMID:25523375

Abstract

OBJECTIVES

To assess the quality of reporting and accuracy of a priori estimates used in sample size calculations for cluster randomized trials (CRTs).

STUDY DESIGN AND SETTING

We reviewed 300 CRTs published between 2000 and 2008. The prevalence of reporting sample size elements from the 2004 CONSORT recommendations was evaluated and a priori estimates compared with those observed in the trial.

RESULTS

Of the 300 trials, 166 (55%) reported a sample size calculation. Only 36 of 166 (22%) reported all recommended descriptive elements. Elements specific to CRTs were the worst reported: a measure of within-cluster correlation was specified in only 58 of 166 (35%). Only 18 of 166 articles (11%) reported both a priori and observed within-cluster correlation values. Except in two cases, observed within-cluster correlation values were either close to or less than a priori values.

CONCLUSION

Even with the CONSORT extension for cluster randomization, the reporting of sample size elements specific to these trials remains below that necessary for transparent reporting. Journal editors and peer reviewers should implement stricter requirements for authors to follow CONSORT recommendations. Authors should report observed and a priori within-cluster correlation values to enable comparisons between these over a wider range of trials.

摘要

目的

评估群组随机试验（CRT）中样本量计算的报告质量和先验估计的准确性。

研究设计和设置

我们回顾了 2000 年至 2008 年间发表的 300 项 CRT。评估了报告 2004 年 CONSORT 建议中样本量元素的流行率，并将先验估计与试验中观察到的进行了比较。

结果

在 300 项试验中，有 166 项（55%）报告了样本量计算。在 166 项中有 36 项（22%）报告了所有推荐的描述性元素。专门针对 CRT 的元素报告最差：仅在 166 项中的 58 项（35%）中指定了组内相关性的度量。只有 18 篇文章（11%）报告了先验和观察到的组内相关性值。除了两种情况外，观察到的组内相关性值要么接近要么小于先验值。