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 often ignored in analyses, which leads to biased estimates 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 zeros in the outcome distribution for randomized clinical trials. This correction method utilizes summary information from individual studies to correct intervention effect estimates as if they were appropriately estimated in zero-inflated Poisson regression models. Simulation studies and real data analyses show that the ZIBC method has good performance in correcting zero-inflation bias in many situations. This method provides a methodological solution in improving the accuracy of meta-analysis results, which is important to evidence-based medicine