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  • 标题:Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
  • 本地全文:下载
  • 作者:Sheila Sprague ; Taryn Scott ; Shannon Dodds
  • 期刊名称:Trials
  • 印刷版ISSN:1745-6215
  • 电子版ISSN:1745-6215
  • 出版年度:2020
  • 卷号:21
  • 期号:1
  • 页码:1-12
  • DOI:10.1186/s13063-020-04611-9
  • 出版社:BioMed Central
  • 摘要:Background: In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. Methods: The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (AqueousPREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics.
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