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Real-world Performance of Meta-analysis Methods for Double-Zero-Event Studies with Dichotomous Outcomes Using the Cochrane Database of Systematic Reviews.

ABSTRACT: BACKGROUND:Meta-analysis combines multiple independent studies, which can increase power and provide better estimates. However, it is unclear how best to deal with studies with zero events; such studies are also known as double-zero-event studies (DZS). Several statistical methods have been proposed, but the agreement among different approaches has not been systematically assessed using real-world published systematic reviews. METHODS:The agreement of five commonly used methods (i.e., the inverse-variance, Mantel-Haenszel, Peto, Bayesian, and exact methods) was assessed using the Cohen's ? coefficients using 368 meta-analyses with rare events selected from the Cochrane Database of Systematic Reviews. Three continuity corrections, including the correction of a constant 0.5, the treatment arm continuity correction (TACC), and the empirical (EMP) correction, were used to handle DZS when applying inverse-variance and Mantel-Haenszel methods. RESULTS:When the proportion of DZS studies was lower than 50% in a meta-analysis, different methods had moderately high agreement. However, when this proportion was increased to be over 50%, the agreement among the methods decreased to different extents. For the Bayesian, exact, and Peto methods and the inverse-variance and Mantel-Haenszel methods using the EMP correction, their agreement coefficients with the inverse-variance and Mantel-Haenszel methods using a constant 0.5 and TACC decreased from larger than 0.70 to smaller than 0.30. In contrast, the agreement coefficients only decreased slightly among the Bayesian, exact, and Peto methods and the inverse-variance and Mantel-Haenszel methods using the EMP correction. CONCLUSIONS:To utilize all available information and reduce research waste and avoid overestimating the effect, meta-analysts should incorporate DZS, rather than simply removing them. The Peto and other conventional methods with continuity correction should be avoided when the proportion of DZS is extremely high. The exact and Bayesian methods are highly recommended, except when none of the included studies have an event in one or both treatment arms.

SUBMITTER: Ren Y

PROVIDER: S-EPMC6544742 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Real-world Performance of Meta-analysis Methods for Double-Zero-Event Studies with Dichotomous Outcomes Using the Cochrane Database of Systematic Reviews.

Ren Yanan Y Lin Lifeng L Lian Qinshu Q Zou Hui H Chu Haitao H

Journal of general internal medicine 20190318 6

<h4>Background</h4>Meta-analysis combines multiple independent studies, which can increase power and provide better estimates. However, it is unclear how best to deal with studies with zero events; such studies are also known as double-zero-event studies (DZS). Several statistical methods have been proposed, but the agreement among different approaches has not been systematically assessed using real-world published systematic reviews.<h4>Methods</h4>The agreement of five commonly used methods (i ...[more]

PMID: 30887438

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Project description:BackgroundPrevious research on data extraction methods in systematic reviews has focused on single aspects of the process. We aimed to provide a deeper insight into these methods by analysing a current sample of reviews.MethodsWe included systematic reviews of health interventions in humans published in English. We analysed 75 Cochrane reviews from May and June 2020 and a random sample of non-Cochrane reviews published in the same period and retrieved from Medline. We linked reviews with protocols and study registrations. We collected information on preparing, piloting, and performing data extraction and on use of software to assist review conduct (automation tools). Data were extracted by one author, with 20% extracted in duplicate. Data were analysed descriptively.ResultsOf the 152 included reviews, 77 reported use of a standardized extraction form (51%); 42 provided information on the type of form used (28%); 24 on piloting (16%); 58 on what data was collected (38%); 133 on the extraction method (88%); 107 on resolving disagreements (70%); 103 on methods to obtain additional data or information (68%); 52 on procedures to avoid data errors (34%); and 47 on methods to deal with multiple study reports (31%). Items were more frequently reported in Cochrane than non-Cochrane reviews. The data extraction form used was published in 10 reviews (7%). Use of software was rarely reported except for statistical analysis software and use of RevMan and GRADEpro GDT in Cochrane reviews. Covidence was the most frequent automation tool used: 18 reviews used it for study selection (12%) and 9 for data extraction (6%).ConclusionsReporting of data extraction methods in systematic reviews is limited, especially in non-Cochrane reviews. This includes core items of data extraction such as methods used to manage disagreements. Few reviews currently use software to assist data extraction and review conduct. Our results can serve as a baseline to assess the uptake of such tools in future analyses.

Project description:BackgroundTigecycline has broad-spectrum anti-bacterial activity and often used for critically ill patients with complicated infections. Only a few clinical studies have reported the coagulation disorder induced by tigecycline. The aim of this study was to investigate the association between tigecycline and coagulation dysfunction using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodData from January 2005 to December 2020 in FAERS were retrieved. We investigated the clinical characteristics of the coagulation dysfunction events and conducted disproportionality analysis by using reporting odds ratios (ROR) to compare tigecycline with the full database and other antibiotics.ResultsThe total number of reports of coagulation dysfunction related to tigecycline as the primary suspect drug was 223. The median time to event of the coagulation dysfunction events was 10 (interquartile range [IQR] 6.75-13) days. 80.72% coagulation-related adverse events appeared within the first 14 days since the initiation of tigecycline administration. The overall ROR (95% CI) for coagulation-related adverse events was 3.55 (3.08, 4.09). The RORs (95% CI) for thrombocytopenia, hypofibrinogenaemia, coagulopathy, activated partial thromboplastin time prolonged, international normalized ratio increased, prothrombin time prolonged were 8.21 (6.34, 10.62), 705.41 (526.81, 944.54), 30.67 (21.92, 42.92), 42.98 (24.85, 74.31), 4.67 (2.51, 8.71), and 27.99 (15.01, 52.19), respectively. In analyses stratified on comparing tigecycline to vancomycin and daptomycin, significant coagulation dysfunction signals were found with the RORs (95% CI) 2.74 (2.34, 3.22) and 3.08 (2.57, 3.70).ConclusionsWe found a strong signal of high frequency of reporting coagulation dysfunction in tigecycline. Health professionals should be aware of the potential coagulation disorders risk and monitor coagulation parameters during anti-bacterial therapy with tigecycline, particularly the need to monitor fibrinogen levels.

Dataset Information

Real-world Performance of Meta-analysis Methods for Double-Zero-Event Studies with Dichotomous Outcomes Using the Cochrane Database of Systematic Reviews.

Publications

Real-world Performance of Meta-analysis Methods for Double-Zero-Event Studies with Dichotomous Outcomes Using the Cochrane Database of Systematic Reviews.

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