A guidance was developed to identify participants with missing outcome data in randomized controlled trials
Kahale, Lara A; Guyatt, Gordon H; Agoritsas, Thomas; Briel, Matthias; Busse, Jason W; Carrasco-Labra, Alonso; Khamis, Assem M; Zhang, Yuqing; Hooft, Lotty; Scholten, Rob J P M; Akl, Elie A
(2019) Journal of Clinical Epidemiology, volume 115, pp. 55 - 63
(Article)
Abstract
BACKGROUND AND OBJECTIVES: In order for authors of systematic reviews to address missing data in randomized controlled trials (RCTs), they need to first identify the number of trial participants with missing data. The objective of this study was to provide guidance for authors of systematic reviews on how to identify
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participants with missing outcome data in reports of RCTs. METHODS: Guidance statements were informed by a review of studies addressing the topic of missing data and an iterative process of feedback and refinement, through meetings involving experts in health research methodology and authors of systematic reviews. RESULTS: The proposed guidance includes (1) definitions of key terms, (2) 19 categories of participants described in RCT reports and who might have missing data, and (3) a flowchart on how to judge the outcome data missingness for each category. The judgment of missingness relies on how trial authors report on the categories and handle them in their analyses. Practically, for their primary analysis, systematic review authors should choose how to identify participants with missing outcome data (i.e., use either "definitely missing data" or "total possible missing data"), then select a method for handling missing data in meta-analysis. Sensitivity analyses should be undertaken to explore consistency with competing options for classifying patients as having missing data. CONCLUSION: Adopting the proposed guidance will help promote transparency and consistency regarding how missing data are managed in systematic reviews.
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Keywords: Guidance, Meta-analysis, Missing data, Randomized controlled trials, Risk of bias, Systematic reviews, Epidemiology, Journal Article
ISSN: 0895-4356
Publisher: Elsevier USA
Note: Funding Information: Funding: This paper is part of a project on addressing missing trial participant data in systematic reviews funded by the Cochrane Methods Innovation Fund. The funder was not involved in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. The researchers are independent from the funder and had full access to all the data. Funding: This paper is part of a project on addressing missing trial participant data in systematic reviews funded by the Cochrane Methods Innovation Fund. The funder was not involved in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. The researchers are independent from the funder and had full access to all the data. Conflicts of interest: All authors have completed the ICMJE uniform disclosure form and declare no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years. They declare being involved in previous publications making recommendations on the topic missing data. Authors' contributions: L.A.K. G.H.G. and E.A.A. contributed to the conception and design of the article, data analysis, interpretation of data, and drafting the article. T.A. M.B. J.W.B. A.C.-L. A.M.K. Y.Z. L.H. and R.J.P.M.S. contributed to the critical revision of the article for important intellectual content. All authors reviewed and approved the final version. Funding: This paper is part of a project on addressing missing trial participant data in systematic reviews funded by the Cochrane Methods Innovation Fund. The funder was not involved in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. The researchers are independent from the funder and had full access to all the data. Conflicts of interest: All authors have completed the ICMJE uniform disclosure form and declare no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years. They declare being involved in previous publications making recommendations on the topic missing data. Publisher Copyright: © 2019 Elsevier Inc.
(Peer reviewed)