Meta-Analysis of Rare Binary Adverse Event Data

Abstract

We examine the use of fixed-effects and random-effects moment-based meta-analytic methods for analysis of binary adverse event data. Special attention is paid to the case of rare adverse events which are commonly encountered in routine practice. We study estimation of model parameters and between-study heterogeneity. In addition, we examine traditional approaches to hypothesis testing of the average treatment effect and detection of the heterogeneity of treatment effect across studies. We derive three new methods, simple (unweighted) average treatment effect estimator, a new heterogeneity estimator, and a parametric bootstrapping test for heterogeneity. We then study the statistical properties of both the traditional and new methods via simulation. We find that in general, moment-based estimators of combined treatment effects and heterogeneity are biased and the degree of bias is proportional to the rarity of the event under study. The new methods eliminate much, but not all of this bias. The various estimators and hypothesis testing methods are then compared and contrasted using an example dataset on treatment of stable coronary artery disease.

Safety of Pregnancy After Cerebral Venous Thrombosis

“…Among 186 reported pregnancies, 33 resulted in spontaneous abortion, with a calculated overall crude risk of 17.7% (95% CI, [13][14][15][16][17][18][19][20][21][22][23][24]. We found no case-control studies.…”

“…15 Nevertheless, meta-analysis of proportions was also conducted, and it is available in the online-only Data Supplement. A random effect model for pooling proportions was used, with a continuity correction of 0.5.…”

“…ОБЗОРЫ, ЛЕКЦИИ В качестве основного статистического анализа мы решили провести простой обобщенный анализ дан-ных отдельных пациенток, а не мета-анализ пропор-ций, поскольку последний метод может привести к получению неверных результатов из-за небольшо-го количества событий, учитывая его зависимость от асимптотической статистической теории [15]. Тем не менее мета-анализ пропорций также выполнили, и его результаты доступны только в дополнительных данных on-line.…”

Do Metal Post–retained Restorations Result in More Root Fractures than Fiber Post–retained Restorations? A Systematic Review and Meta-analysis

“…Confidence intervals (CIs) were based on the normal approximation and calculated using the number of posts and post years of follow-up. A constant 0.5 continuity correction was used for studies with 0 events (9).…”

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