Meta-analysis of incidence of rare events

Statistical Methods in Medical Research

Volumn 22, Issue 2, 2013, Pages 117-132

  Lane, Peter W ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Adverse event; continuity correction; prediction; rosiglitazone; safety; zero count

Indexed keywords

INSULIN; METFORMIN; PLACEBO; ROSIGLITAZONE; SULFONYLUREA;

ATTRIBUTABLE RISK; BAYES THEOREM; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; DRUG SAFETY; HEART INFARCTION; HUMAN; INCIDENCE; MANTEL HAENSZEL TEST; META ANALYSIS; META ANALYSIS (TOPIC); REVIEW; RISK FACTOR; STATISTICAL ANALYSIS; TREATMENT DURATION;

CARDIOVASCULAR DISEASES; DATA INTERPRETATION, STATISTICAL; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; INCIDENCE; META-ANALYSIS AS TOPIC; MYOCARDIAL INFARCTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK ASSESSMENT; THIAZOLIDINEDIONES;

EID: 84876727681     PISSN: 09622802     EISSN: 14770334     Source Type: Journal    
DOI: 10.1177/0962280211432218     Document Type: Review

References (30)

1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007 ; 356: 2457-2471 (Pubitemid 46919772)
2. Tian L, Cai T, Pfeffer MA, Piankov N, Cremieux P-Y, Wei LJ. 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. Biostatistics. 2009 ; 10: 275-281
3. Friedrich JO, Beyene J and Adhikari NKJ. Rosiglitazone: can meta-analysis accurately estimate excess cardiovascular risk given the available data? Re-analysis of randomized trials using various methodologic approaches. BMC Res Notes 2009; 2: 5, doi: 10.1186/1756-0500-2-5.
4. Birge RT. The calculation of errors by the method of least squares. Phys Rev. 1932 ; 40: 207-227
5. Greenland S, Robins JM. Estimation of common effect parameter from sparse follow up data. Biometrics. 1985 ; 41: 55-68
6. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002 ; 21: 1539-1558 (Pubitemid 34746062)
7. Sutton AJ, Cooper NJ, Lambert PC, Jones DR, Abrams KR, Sweeting MJ. Meta-analysis of rare and adverse event data. Expert Rev Pharmacoecon Outcomes Res. 2002 ; 2: 367-379
8. Cai T, Parast L, Ryan L. Meta-analysis for rare events. Stat Med. 2010 ; 29: 2078-2089
9. Shuster JJ, Jones LS, Salmon DA. Fixed vs random effects meta-analysis in rare event studies: the rosiglitazone link with myocardial infarction and cardiac death. Stat Med. 2007 ; 26: 4375-4385 (Pubitemid 47534685)
10. Whitehead A Meta-analysis of controlled clinical trials. Chichester: Wiley ; 2002 :
11. Agresti A Hoboken. NJ: Wiley ; 2002 :
12. Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta-blockade during and after myocardial infarction: an overview of the randomized trials. Progr Cardiovasc Dis. 1985 ; 27: 335-371 (Pubitemid 15107153)
13. Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med. 2004 ; 23: 1251-1375
14. Greenland S, Salvan A. Bias in the one-step method for pooling study results. Stat Med. 1990 ; 9: 247-252 (Pubitemid 20252733)
15. Bradburn MJ, Deeks JJ, Berlin JA, Localio AR. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Stat Med. 2007 ; 26: 53-77 (Pubitemid 46099417)
16. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Instit. 1959 ; 22: 719-748
17. Deeks JJ and Higgins JPT. Statistical Algorithms in Review Manager 5, http://www.cochrane.org/sites/default/files/uploads/handbook/ Statistical-Methods-in-RevMan5-1.pdf (accessed 7 September 2011).
18. Robbins J, Greenland S, Breslow N. A general estimator for the variance of the Mantel-Haenszel odds ratio. Am J Epidemiol. 1986 ; 124: 719-723 (Pubitemid 17180485)
19. Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions, http://www.cochrane.org/training/cochrane-handbook (accessed 7 September 2011).
20. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med. 2007 ; 147: 578-581 (Pubitemid 351664507)
21. Gart JJ, Zweifel JR. On the bias of various estimators of the logit and its variance with application to quantal assay. Biometrika. 1967 ; 54: 181-187
22. Sankey SS, Weissfeld LA, Fine MJ, Kapoor W. An assessment of the use of the continuity correction for sparse data in meta-analysis. Commun Stat - Simul Comput. 1996 ; 25: 1031-1056 (Pubitemid 126434250)
23. Sweeting MJ, Sutton AJ, Lambert PC. Correction. Stat Med. 2006 ; 25: 2700-2700
24. Blyth CR. On Simpson's paradox and the sure-thing principle. J Am Stat Assoc. 1972 ; 67: 364-366
25. Nissen SE, Wolski K. Rosiglitazone revisited. Arch Intern Med. 2010 ; 170: 1191-1201
26. Lane PW, Nelder JA. Analysis of covariance and standardization as instances of prediction. Biometrics. 1980 ; 38: 613-621
27. Amit O, Heiberger R, Lane PW. Graphical approaches to the analysis of safety data from clinical trials. Pharmaceut Stat. 2008 ; 7: 20-35 (Pubitemid 351385323)
28. Dahabreh IJ. Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone. Clin Trials. 2008 ; 5: 116-120 (Pubitemid 351682521)
29. Mannucci E, Monami M, Di Bari M, Lamanna C, Gori F, Gensini GF, et al. Cardiac safety profile of rosiglitazone: a comprehensive meta-analysis of randomized clinical trials. Int J Cardiol. 2010 ; 143: 135-140
30. Kaul S, Diamond GA. Rosiglitazone and cardiovascular risk: Nissen and Wolski 2010 updated meta-analysis revisited. J Am College Cardiol. 2011 ; 57 (14, Supp 1). E1205 - E1205