Robustness Assessments Are Needed to Reduce Bias in Meta-Analyses That Include Zero-Event Randomized Trials

Keus, F.; Wetterslev, J.; Gluud, C.; Gooszen, H. G.; van Laarhoven, C. J. H. M.
March 2009
American Journal of Gastroenterology;Mar2009, Vol. 104 Issue 3, p546
Academic Journal
OBJECTIVES:Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials.METHODS:Five levels of statistical methods are identified for meta-analysis with zero-event trials, leading to numerous data analyses. We used the binary outcomes from our Cochrane review of randomized trials of laparoscopic vs. small-incision cholecystectomy for patients with symptomatic cholecystolithiasis to illustrate the influence of statistical method on inference.RESULTS:In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%–57.9%). There was also considerable variability in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes.CONCLUSIONS:The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event trials.Am J Gastroenterol 2009; 104: 546–551; doi:10.1038/ajg.2008.22


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