Thabane Alex, Dennis Brittany B, Gajic-Veljanoski Olga, Paul James, Thabane Lehana
Life Sciences Program, Queen's University, Kingston, ON, Canada; Department of Anesthesia, McMaster University Hamilton ON.
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; St. George's University of London, London England, UK.
Clin Epidemiol. 2016 Jul 8;8:261-6. doi: 10.2147/CLEP.S103098. eCollection 2016.
Stepped wedge design (SWD) is a cluster randomized controlled trial (RCT) design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge.
The objectives of this review are: 1) to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2) to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3) to assess the reporting of sample size details in SWD trial reports or protocols; 4) to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5) to assess the consistency between the trial registration information and final SWD trial reports; and 6) to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports. We will also explore factors that are associated with the completeness of reporting.
We will search MEDLINE, EMBASE, Web of Science, CINAHL, and PsycINFO for all randomized controlled trials utilizing SWD. Details from eligible papers will be extracted in duplicate. Demographic statistics obtained from the data extraction will be analyzed to answer the primary objectives pertaining to the reporting quality of several aspects of a published paper, as well as to explore possible temporal trends and consistency between abstracts, trial registration information, and final published articles.
Findings from this review will establish the reporting quality of SWD trials and inform academics and clinicians on their completeness and consistency. Results of this review will influence future trials and improve the overall quality and reporting of SWD trials.
阶梯楔形设计（SWD）是一种整群随机对照试验（RCT）设计，它在不同时间点依次对所有群组实施干预。作为一种相对较新的设计方法，其报告质量尚未得到探究，本综述旨在填补这一知识空白。
本综述的目的如下：1）根据CONSORT指南或整群RCT的CONSORT扩展版评估SWD试验报告的质量；2）使用摘要的CONSORT扩展版评估SWD试验摘要报告的完整性；3）评估SWD试验报告或方案中样本量细节的报告情况；4）根据SPIRIT指南评估SWD试验方案报告的完整性；5）评估试验注册信息与最终SWD试验报告之间的一致性；6）评估SWD试验报告摘要与正文所报告内容的一致性。我们还将探究与报告完整性相关的因素。
我们将在MEDLINE、EMBASE、科学网、CINAHL和PsycINFO中检索所有采用SWD的随机对照试验。符合条件的论文细节将由两人独立提取。对从数据提取中获得的人口统计学统计数据进行分析，以回答与已发表论文几个方面的报告质量相关的主要问题，同时探究摘要、试验注册信息和最终发表文章之间可能的时间趋势和一致性。
本综述的结果将确定SWD试验的报告质量，并为学者和临床医生提供有关其完整性和一致性的信息。本综述的结果将影响未来的试验，并提高SWD试验的整体质量和报告水平。
