期刊
JOURNAL OF CLINICAL EPIDEMIOLOGY
卷 68, 期 6, 页码 716-723出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2014.10.006
关键词
CONSORT statement; Reporting; Cluster randomized trial; Sample size; Intracluster correlation coefficient; Statistical methods
资金
- Medical Research Council [I031857]
- MRC [MC_UU_12023/21, MC_UU_12023/29] Funding Source: UKRI
- Medical Research Council [MC_UU_12023/21, MC_UU_12023/29, 1031857] Funding Source: researchfish
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. (C) 2015 The Authors. Published by Elsevier Inc.
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