Chow Ryan, Huang Eileen, Fu Sarah, Kim Eileen, Li Sophie, Sodhi Jasmine, Tulandi Togas, Cobey Kelly D, Bacal Vanessa, Chen Innie
Faculty of Medicine, University of Ottawa, Ottawa, Canada.
Faculty of Biology, University of Ottawa, Ottawa, Canada.
Womens Health Rep (New Rochelle). 2022 Sep 20;3(1):795-802. doi: 10.1089/whr.2021.0141. eCollection 2022.
The objective of this study was to evaluate the extent, type, and severity of spin in randomized controlled trials (RCTs) in obstetrics and gynecology.
The top five highest impact journals in obstetrics and gynecology were systematically searched for RCTs with non-significant primary outcomes published between January 1, 2019, and December 31, 2020.
Study selection and data extraction assessment were conducted independently and in duplicate. The extent, type, and severity of spin was identified and reported with previously established methodology, and risk of bias was assessed with the Cochrane Risk-of-Bias 2 Tool independently and in duplicate. Fisher's exact tests were used to evaluate the association between study characteristics, risk of bias, and spin.
We identified 1475 publications, of which 59 met our inclusion criteria. Articles evaluated interventions in obstetrics ( = 37, 63%) and gynecology ( = 22, 37%). Spin was not detected in 28 (47%) of the articles: Three (5%) had one, 10 (17%) had two, and 18 (31%) had greater than two occurrences of spin. Compared with articles where no spin was detected, spin was associated with the Cochrane Risk-of-Bias domain pertaining to missing data ( < 0.05). No association was observed with the journal, funding source, number of authors, types of interventions, and whether the study involved gynecology or obstetrics.
Spin was detected in nearly half of 1:1 parallel two-arm RCTs in obstetrics and gynecology, highlighting the need for caution in the interpretation of RCT findings, particularly when the primary outcome is nonsignificant.
本研究的目的是评估妇产科随机对照试验（RCT）中结果扭曲的程度、类型和严重程度。
系统检索了妇产科影响最大的前五本期刊，以查找2019年1月1日至2020年12月31日期间发表的主要结局无统计学意义的RCT。
研究选择和数据提取评估由两人独立进行且重复操作。采用先前建立的方法识别并报告结果扭曲的程度、类型和严重程度，使用Cochrane偏倚风险2工具独立且重复地评估偏倚风险。使用Fisher精确检验评估研究特征、偏倚风险和结果扭曲之间的关联。
我们共识别出1475篇出版物，其中59篇符合纳入标准。文章评估了产科（n = 37，63%）和妇科（n = 22，37%）的干预措施。28篇（47%）文章未检测到结果扭曲：3篇（5%）有1次，10篇（17%）有2次，18篇（31%）有超过2次结果扭曲情况。与未检测到结果扭曲的文章相比，结果扭曲与Cochrane偏倚风险中与缺失数据相关的领域有关（P < 0.05）。未观察到与期刊、资金来源、作者数量、干预类型以及研究涉及妇科还是产科之间存在关联。
在妇产科1:1平行双臂RCT中，近一半检测到结果扭曲，这凸显了解释RCT结果时需谨慎，尤其是当主要结局无统计学意义时。
