A Bayesian Meta-analysis Method for Estimating Risk Difference of Rare Events

ABSTRACT Bayesian meta-analysis has been more frequently utilized for synthesizing safety and efficacy information to support landmark decision-making due to its flexibility of incorporating prior information and availability of computing software. However, when the outcome is binary and the events are rare, where event counts can be zero, conventional meta-analysis methods including Bayesian methods may not work well. Several methods have been proposed to tackle this issue but the prior knowledge of event rate was not utilized to increase precision of risk difference estimates. To better estimate risk differences, we propose a new Bayesian method, Beta prior BInomial model for Risk Differences (B-BIRD), which takes into account the prior information of rare events. B-BIRD is illustrated using a real data set of 48 clinical trials about a type 2 diabetes drug. In simulation studies, it performs well in low event rate settings.

[1]  John E. Hunter,et al.  Methods of Meta-Analysis , 1989 .

[2]  S M Berry Understanding and testing for heterogeneity across 2 x 2 tables: application to meta-analysis. , 1998, Statistics in medicine.

[3]  B. Gersh Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes , 2008 .

[4]  Douglas G Altman,et al.  Bayesian random effects meta‐analysis of trials with binary outcomes: methods for the absolute risk difference and relative risk scales by D. E. Warn, S. G. Thompson and D. J. Spiegelhalter, Statistics in Medicine 2002; 21: 1601–1623 , 2005, Statistics in medicine.

[5]  Alexander J Sutton,et al.  What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. , 2004, Statistics in medicine.

[6]  Bradley P Carlin,et al.  Network meta-analysis of randomized clinical trials: Reporting the proper summaries , 2014, Clinical trials.

[7]  Tianxi Cai,et al.  Meta‐analysis for rare events , 2010, Statistics in medicine.

[8]  Anup Amatya,et al.  Meta-Analysis of Rare Binary Adverse Event Data , 2012, Journal of the American Statistical Association.

[9]  Lisa A. Weissfeld,et al.  An assessment of the use of the continuity correction for sparse data in meta-analysis , 1996 .

[10]  Michael Evans,et al.  Checking for prior-data conflict , 2006 .

[11]  Jonathan J Deeks,et al.  Much ado about nothing: a comparison of the performance of meta‐analytical methods with rare events , 2007, Statistics in medicine.

[12]  Lu Tian,et al.  Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 x 2 tables with all available data but without artificial continuity correction. , 2009, Biostatistics.

[13]  Minge Xie,et al.  Exact Meta-Analysis Approach for Discrete Data and its Application to 2 × 2 Tables With Rare Events , 2014, Journal of the American Statistical Association.

[14]  N. Laird,et al.  Meta-analysis in clinical trials. , 1986, Controlled clinical trials.

[15]  J B Carlin,et al.  Tutorial in biostatistics. Meta-analysis: formulating, evaluating, combining, and reporting by S-L. T. Normand, Statistics in Medicine, 18, 321-359 (1999) , 2000, Statistics in medicine.

[16]  A. Gelman Prior distributions for variance parameters in hierarchical models (comment on article by Browne and Draper) , 2004 .

[17]  J. Carlin Meta-analysis for 2 x 2 tables: a Bayesian approach. , 1992, Statistics in medicine.

[18]  Edna Schechtman,et al.  Odds ratio, relative risk, absolute risk reduction, and the number needed to treat--which of these should we use? , 2002, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[19]  Alex J. Sutton,et al.  Methods for Meta-Analysis in Medical Research , 2000 .

[20]  Dungang Liu,et al.  Meta‐analysis framework for exact inferences with application to the analysis of rare events , 2016, Biometrics.

[21]  K R Abrams,et al.  Bayesian methods in meta-analysis and evidence synthesis. , 2001, Statistical methods in medical research.

[22]  Joseph Beyene,et al.  Inclusion of zero total event trials in meta-analyses maintains analytic consistency and incorporates all available data , 2007, BMC medical research methodology.

[23]  D J Spiegelhalter,et al.  Bayesian approaches to random-effects meta-analysis: a comparative study. , 1995, Statistics in medicine.

[24]  Peter Cummings,et al.  The relative merits of risk ratios and odds ratios. , 2009, Archives of pediatrics & adolescent medicine.