Wang Mei, Jin Yanling, Hu Zheng Jing, Thabane Alex, Dennis Brittany, Gajic-Veljanoski Olga, Paul James, Thabane Lehana
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
Father Sean O'Sullivan Research Institute, St Joseph's Healthcare, Hamilton, ON, Canada.
Contemp Clin Trials Commun. 2017 Aug 18;8:1-10. doi: 10.1016/j.conctc.2017.08.009. eCollection 2017 Dec.
The stepped wedge trial (SWT) design is a type of the randomized clinical trial (RCT) design in which clusters or individuals are randomly and sequentially crossed over from control to intervention over a number of time periods. Trials using SWT design have become increasingly popular in medical, behavioral and social sciences research. Therefore, complete and transparent reporting of these studies is crucial. In particular, the quality of the abstracts of their reports is important because these may be the only accessible sources for their results.
The aims of this survey were to evaluate the reporting quality of SWT abstracts and to identify factors contributing to better reporting quality.
We performed literature searches to identify relevant articles in English published from November 1987 to October 2016 in the following electronic databases: Medline, Embase, Web of Science, CINAHL, and PsycINFO. At least two reviewers examined the quality of abstract reporting using the 17-item CONSORT (CONsolidated Standards Of Reporting Trials) Extension for Abstracts tool. Poisson regression models for incidence rate ratio (IRR) were used to identify factors associated with reporting quality (e.g., CONSORT endorsement, the number of authors, abstract format).
A total of 92 eligible articles were identified. Only 6 from the 17 items were reported in more than 80% of the articles (e.g., the statement of conclusions, contact details for the corresponding author). In the multivariable analysis, the year of publication since 2008 (IRR: 1.16; 95% confidence interval (CI): 1.02, 1.33), journal endorsement of the CONSORT Statement (IRR: 1.15; 95% CI: 1.01, 1.31), and multiple authorship (IRR 1.13, 95% CI: 1.01, 1.27) were significantly associated with better reporting quality.
The quality of reporting of SWT abstracts was suboptimal, although there have been some significant improvements since 2008. Endorsement of the CONSORT Statement by journals is an essential element of improvement strategies. Also, multiple authorship is significantly associated with better quality of abstract reporting.
阶梯楔形试验（SWT）设计是随机临床试验（RCT）设计的一种类型，其中群组或个体在多个时间段内从对照随机且依次交叉至干预组。采用SWT设计的试验在医学、行为学和社会科学研究中越来越普遍。因此，完整且透明地报告这些研究至关重要。特别是，其报告摘要的质量很重要，因为这些可能是获取其研究结果的唯一途径。
本调查旨在评估SWT摘要的报告质量，并确定有助于提高报告质量的因素。
我们进行文献检索，以识别1987年11月至2016年10月期间在以下电子数据库中发表的英文相关文章：医学文献数据库（Medline）、荷兰医学文摘数据库（Embase）、科学引文索引（Web of Science）、护理学与健康领域数据库（CINAHL）和心理学文摘数据库（PsycINFO）。至少两名评审员使用17项CONSORT（统一报告试验标准）摘要扩展工具检查摘要报告的质量。使用发病率比（IRR）的泊松回归模型来识别与报告质量相关的因素（例如，CONSORT认可、作者数量、摘要格式）。
共识别出92篇符合条件的文章。在17项条目中，只有6项在超过80%的文章中被报告（例如，结论陈述、通讯作者的联系方式）。在多变量分析中，2008年以来的发表年份（IRR：1.16；95%置信区间（CI）：1.02，1.33）、期刊对CONSORT声明的认可（IRR：1.15；95%CI：1.01，1.31）以及多位作者（IRR 1.13，95%CI：1.01，1.27）与更好的报告质量显著相关。
SWT摘要的报告质量欠佳，尽管自2008年以来已有一些显著改进。期刊对CONSORT声明的认可是改进策略的一个关键要素。此外，多位作者与更好的摘要报告质量显著相关。
