Minozzi Silvia, Gonzalez-Lorenzo Marien, Cinquini Michela, Berardinelli Daniela, Cagnazzo Celeste, Ciardullo Stefano, De Nardi Paola, Gammone Mariarosaria, Iovino Paolo, Lando Alex, Rissone Marco, Simeone Giovanni, Stracuzzi Marta, Venezia Giovanna, Moja Lorenzo, Costantino Giorgio
Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Laboratorio di Metodologia delle revisioni sistematiche e produzione di Linee Guida, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
J Clin Epidemiol. 2022 Dec;152:47-55. doi: 10.1016/j.jclinepi.2022.09.003. Epub 2022 Sep 23.
To assess whether the use of the revised Cochrane risk of bias tool for randomized trials (RoB2) in systematic reviews (SRs) adheres to RoB2 guidance.
We searched MEDLINE, Embase, Cochrane Library from 2019 to May 2021 to identify SRs using RoB2. We analyzed methods and results sections to see whether risk of bias was assessed at outcome measure level and applied to primary outcomes of the SR as per RoB2 guidance. The relation between SR characteristics and adequacy of RoB2 use was examined by logistic regression analysis.
Two hundred-eight SRs were included. We could assess adherence in 137 SRs as 12 declared using RoB2 but actually used RoB1 and 59 did not report the number of primary outcomes. The tool usage was adherent in 69.3% SRs. Considering SRs with multiple primary outcomes, adherence dropped to 28.8%. We found a positive association between RoB2 guidance adherence and the methodological quality of the reviews assessed by AMSTAR2 (p-for-trend 0.007). Multivariable regression analysis suggested journal impact factor [first quartile vs. other quartiles] was associated with RoB2 adherence (OR 0.34; 95% CI: 0.16-0.72).
Many SRs did not adhere to RoB2 guidance as they applied the tool at the study level rather than at the outcome measure level. Lack of adherence was more likely among low and very low quality reviews.
评估在系统评价（SRs）中使用修订后的随机试验Cochrane偏倚风险工具（RoB2）是否符合RoB2指南。
我们检索了2019年至2021年5月的MEDLINE、Embase、Cochrane图书馆，以识别使用RoB2的SRs。我们分析了方法和结果部分，以查看是否在结局测量水平评估了偏倚风险，并根据RoB2指南将其应用于SRs的主要结局。通过逻辑回归分析检查SR特征与RoB2使用充分性之间的关系。
纳入了208项SRs。我们可以评估137项SRs的依从性，因为有12项声明使用RoB2但实际使用了RoB1，59项未报告主要结局的数量。该工具的使用率在69.3%的SRs中是符合要求的。考虑到有多个主要结局的SRs，依从性降至28.8%。我们发现RoB2指南依从性与通过AMSTAR2评估的综述的方法学质量之间存在正相关（趋势p值为0.007）。多变量回归分析表明期刊影响因子[第一四分位数与其他四分位数]与RoB2依从性相关（OR 0.34；95%CI：0.16-0.72）。
许多SRs未遵循RoB2指南，因为它们是在研究水平而非结局测量水平应用该工具。在低质量和极低质量的综述中，不依从的可能性更大。
