@article{273a1733dc784608a4234595aec3a149,
title = "A bias correction method in meta-analysis of randomized clinical trials with no adjustments for zero-inflated outcomes",
abstract = "Many 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.",
keywords = "aggregate data, individual participant data, meta-analysis, randomized clinical trial, zero-inflated outcome",
author = "Zhengyang Zhou and Minge Xie and David Huh and Mun, {Eun Young}",
note = "Funding Information: information National Institute on Alcohol Abuse and Alcoholism, R01 AA019511; K02 AA028630; National Science Foundation, DMS1737857; DMS1812048; DMS2015373; DMS2027855This 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. Funding Information: This 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. Funding Information: National Institute on Alcohol Abuse and Alcoholism, R01 AA019511; K02 AA028630; National Science Foundation, DMS1737857; DMS1812048; DMS2015373; DMS2027855 Funding information Publisher Copyright: {\textcopyright} 2021 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.",
year = "2021",
month = nov,
day = "20",
doi = "10.1002/sim.9161",
language = "English",
volume = "40",
pages = "5894--5909",
journal = "Statistics in Medicine",
issn = "0277-6715",
publisher = "John Wiley and Sons Ltd",
number = "26",
}