Treatment Effect in Earlier Trials of Patients With Chronic Medical Conditions: A Meta-Epidemiologic Study

Mayo Clinic Proceedings
Fares AlahdabZhen Wang

Abstract

To determine whether the early trials in chronic medical conditions demonstrate an effect size that is larger than that in subsequent trials. We identified randomized controlled trials (RCTs) evaluating a drug or device in patients with chronic medical conditions through meta-analyses (MAs) published between January 1, 2007, and June 23, 2015, in the 10 general medical journals with highest impact factor. We estimated the prevalence of having the largest effect size or heterogeneity in the first 2 published trials. We evaluated the association of the exaggerated early effect with several a priori hypothesized explanatory variables. We included 70 MAs that had included a total of 930 trials (average of 13 [range, 5-48] RCTs per MA) with average follow-up of 24 (range, 1-168) months. The prevalence of the exaggerated early effect (ie, proportion of MAs with largest effect or heterogeneity in the first 2 trials) was 37%. These early trials had an effect size that was on average 2.67 times larger than the overall pooled effect size (ratio of relative effects, 2.67; 95% CI, 2.12-3.37). The presence of exaggerated effect was not significantly associated with trial size; number of events; length of follow-up; intervention duration; nu...Continue Reading

Citations

May 23, 2020·Experimental Physiology·Peter Cahusac
Apr 23, 2020·Journal of General Internal Medicine·Zhen WangMohammad Hassan Murad
Oct 23, 2020·International Endodontic Journal·V NagendrababuP M H Dummer
Aug 18, 2018·Pediatrics·Wade HarrisonShawn L Ralston

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