期刊
JOURNAL OF CLINICAL EPIDEMIOLOGY
卷 74, 期 -, 页码 40-50出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2015.11.013
关键词
Cluster-randomized crossover trial; Crossover; Cluster; Sample size; Design; Statistical analysis
资金
- Monash University Graduate Scholarship
- National Health and Medical Research Council of Australia Centre of Research Excellence grant [1035261]
- National Institute for Health Research (NIHR) research methods fellowship [MET-12-16]
- National Health and Medical Research Council (NHMRC) Australian Public Health Fellowship [1072366]
- National Institute for Health Research [MET-12-16-101] Funding Source: researchfish
Objective: To assess the design and statistical methods used in cluster-randomized crossover (CRXO) trials. Study Design and Setting: We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus; and citation searches of CRXO methodological articles were conducted to December 2014. We extracted data on design characteristics and statistical methods for sample size, data analysis, and handling of missing data. Results: Ninety-one trials including 139 end point analyses met the inclusion criteria. Trials had a median of nine clusters [interquartile range (IQR), 4-21] and median cluster-period size of 30 individuals (IQR, 14-77); 58 (69%) trials had two periods, and 27 trials (30%) included the same individuals in all periods. A rationale for the design was reported in only 25 trials (27%). A sample size justification was provided in 53 (58%) trials. Only nine (10%) trials accounted appropriately for the design in their sample size calculation. Ten of the 12 cluster-level analyses used a method that accounted for the clustering and multiple-period aspects of the design. In contrast, only 4 of the 127 individual-level analyses used a potentially appropriate method. Conclusions: There is a need for improved application of appropriate analysis and sample size methods, and reporting, in CRXO trials. (C) 2015 Elsevier Inc. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据