A bias correction method in meta-analysis of randomized clinical trials with no adjustments for zero-inflated outcomes

dc.creatorZhou, Zhengyang
dc.creatorXie, Minge
dc.creatorHuh, David
dc.creatorMun, Eun-Young
dc.creator.orcid0000-0002-1820-615X (Mun, Eun-Young)
dc.date.accessioned2022-10-14T14:32:31Z
dc.date.available2022-10-14T14:32:31Z
dc.date.issued2021-09-03
dc.description.abstractMany clinical endpoint measures, such as the number of standard drinks consumed per week or the number of days that patients stayed in the hospital, are count data with excessive zeros. However, the zero-inflated nature of such outcomes is sometimes ignored in analyses of clinical trials. This leads to biased estimates of study-level intervention effect and, consequently, a biased estimate of the overall intervention effect in a meta-analysis. The current study proposes a novel statistical approach, the Zero-inflation Bias Correction (ZIBC) method, that can account for the bias introduced when using the Poisson regression model, despite a high rate of inflated zeros in the outcome distribution of a randomized clinical trial. This correction method only requires summary information from individual studies to correct intervention effect estimates as if they were appropriately estimated using the zero-inflated Poisson regression model, thus it is attractive for meta-analysis when individual participant-level data are not available in some studies. Simulation studies and real data analyses showed that the ZIBC method performed well in correcting zero-inflation bias in most situations.
dc.description.sponsorshipThis work was supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) grants R01 AA019511, K02 AA028630 and the National Science Foundation (NSF) grants DMS1737857, 1812048, 2015373 and 2027855. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAAA, the National Institutes of Health, or the NSF.
dc.identifier.citationZhou, Z., Xie, M., Huh, D., & Mun, E. Y. (2021). A bias correction method in meta-analysis of randomized clinical trials with no adjustments for zero-inflated outcomes. Statistics in medicine, 40(26), 5894-5909. https://doi.org/10.1002/sim.9161
dc.identifier.issn1097-0258
dc.identifier.issue26
dc.identifier.urihttps://hdl.handle.net/20.500.12503/31854
dc.identifier.volume40
dc.publisherJohn Wiley & Sons, Inc.
dc.relation.urihttps://doi.org/10.1002/sim.9161
dc.rights.holder© 2021 The Authors.
dc.rights.licenseAttribution-NonCommercial 4.0 International (CC BY-NC 4.0)
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.sourceStatistics in Medicine
dc.subjectaggregate data
dc.subjectindividual participant data
dc.subjectmeta-analysis
dc.subjectrandomized clinical trial
dc.subjectzero-inflated outcome
dc.subject.meshBias
dc.subject.meshComputer Simulation
dc.subject.meshHumans
dc.subject.meshModels, Statistical
dc.subject.meshPoisson Distribution
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshResearch Design
dc.titleA bias correction method in meta-analysis of randomized clinical trials with no adjustments for zero-inflated outcomes
dc.typeArticle
dc.type.materialtext

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