Bias correction of risk estimates in vaccine safety studies with rare adverse events using a self-controlled case series design

American Journal of Epidemiology

Volumn 178, Issue 12, 2013, Pages 1750-1759

  Zeng, Chan ^a   Newcomer, Sophia R ^a   Glanz, Jason M ^a   Shoup, Jo Ann ^a   Daley, Matthew F ^a   Hambidge, Simon J ^a,b   Xu, Stanley ^a  

^a Kaiser Permanente Colorado   (United States)

^b DENVER HEALTH MEDICAL CENTER   (United States)

Author keywords

Bias correction; Penalized maximum likelihood; Rare events; Self controlled case series; Simulation study; Vaccine safety

Indexed keywords

VACCINE;

CORRECTION; DISEASE INCIDENCE; MAXIMUM LIKELIHOOD ANALYSIS; NUMERICAL MODEL; REGRESSION ANALYSIS; RISK ASSESSMENT; SAMPLING BIAS; VACCINATION; VACCINE;

ADVERSE DRUG REACTION; ARTICLE; CASE CONTROL STUDY; CASE STUDY; CONTROLLED STUDY; CORDEIRO ETHOD; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; HUMAN; HYPOTENSION; INTERMETHOD COMPARISON; LOGISTIC REGRESSION ANALYSIS; MAXIMUM LIKELIHOOD METHOD; MCCULLAGH METHOD; OBSERVATIONAL METHOD; RISK ASSESSMENT; SAMPLE SIZE; SELF CONTROLLED CASE SERIES METHOD; SEPSIS; SIMULATION; STATISTICAL ANALYSIS; STATISTICAL MODEL; STUDY DESIGN;

BIAS CORRECTION; PENALIZED MAXIMUM LIKELIHOOD; RARE EVENTS; SELF-CONTROLLED CASE SERIES; SIMULATION STUDY; VACCINE SAFETY;

BIAS (EPIDEMIOLOGY); CASE-CONTROL STUDIES; COMPUTER SIMULATION; HUMANS; INCIDENCE; MODELS, THEORETICAL; RESEARCH DESIGN; RISK ASSESSMENT; VACCINES;

EID: 84890725571     PISSN: 00029262     EISSN: 14766256     Source Type: Journal    
DOI: 10.1093/aje/kwt211     Document Type: Article

References (30)

1. Farrington CP. Relative incidence estimation from case series for vaccine safety evaluation. Biometrics. 1995;51(1): 228-235.
2. Farrington CP, Nash J, Miller E. Case series analysis of adverse reactions to vaccines: a comparative evaluation. Am J Epidemiol. 1996;143(11):1165-1173.
3. Dalrymple LS, Mohammed SM, Mu Y, et al. Risk of cardiovascular events after infection-related hospitalizations in older patients on dialysis. Clin J Am Soc Nephrol. 2011;6(7): 1708-1713.
4. Douglas IJ, Smeeth L. Exposure to antipsychotics and risk of stroke: self controlled case series study. BMJ. 2008; 337(7670):616-618.
5. Douglas IJ, Evans SJ, Pocock S, et al. The risk of fractures associated with thiazolidinediones: a self-controlled caseseries study. PLoS Med. 2009;6(9):e1000154.
6. Gribbin J, Hubbard R, Gladman J, et al. Risk of falls associated with antihypertensive medication: self-controlled case series. Pharmacoepidemiol Drug Saf. 2011;20(8): 879-884.
7. Pariente A, Fourrier-Reglat A, Ducruet T, et al. Antipsychotic use and myocardial infarction in older patients with treated dementia. JAMA Intern Med. 2012;172(8):648-653.
8. Ramsay EN, Roughead EE, Ewald B, et al. A self-controlled case series to assess the effectiveness of beta blockers for heart failure in reducing hospitalisations in the elderly. BMC Med Res Methodol. 2011;11:106.
9. Glanz JM, McClure DL, Xu S, et al. Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. J Clin Epidemiol. 2006;59(8): 808-818.
10. Musonda P, Hocine MN, Whitaker HJ, et al. Self-controlled case series analyses: small-sample performance. Comput Stat Data Anal. 2008;52(4):1942-1957.
11. Greenland S. Small-sample bias and corrections for conditional maximum-likelihood odds-ratio estimators. Biostatistics. 2000;1(1):113-122.
12. Heinze G, Puhr R. Bias-reduced and separation-proof conditional logistic regression with small or sparse data sets. Stat Med. 2010;29(7-8):770-777.
13. Sun JX, Sinha S, Wang S, et al. Bias reduction in conditional logistic regression. Stat Med. 2011;30(4):348-355.
14. Firth D. Bias reduction of maximum likelihood estimates. Biometrika. 1993;80(1):27-38.
15. Cordeiro GM, McCullagh P. Bias correction in generalized linear models. J R Stat Soc Series B Stat Methodol. 1991; 53(3):629-643.
16. Whitaker HJ, Farrington PC, Spiessens B, et al. Tutorial in biostatistics: the self-controlled case series method. Stat Med. 2006;25(10):1768-1797.
17. Stata Corp LP. Stata Statistical Software, Release 12. College Station, TX: Stata Corp LP; 2011.
18. SAS Institute Inc. SAS, Version 9.2. Cary, NC: SAS Institute Inc; 2008.
19. Heinze G, Schemper M. A solution to the problem of separation in logistic regression. Stat Med. 2002;21(16): 2409-2419.
20. Heinze G. A comparative investigation of methods for logistic regression with separated or nearly separated data. Stat Med. 2006;25(24):4216-4226.
21. Heinze G, Schemper M. A solution to the problem of monotone likelihood in Cox regression. Biometrics. 2001; 57(1):114-119.
22. Ibrahim JG, Laud PW. On Bayesian analysis of generalized linear models using Jeffreys's prior. J Am Stat Assoc. 1991; 86(416):981-986.
23. Xu S, Gargiullo P, Mullooly J, et al. Fitting parametric and semi-parametric conditional Poisson regression models with Cox's partial likelihood in self-controlled case series and matched cohort studies. J Data Sci. 2010;8:349-360.
24. Ward KN, Bryant NJ, Andrews NJ, et al. Risk of serious neurologic disease after immunization of young children in Britain and Ireland. Pediatrics. 2007;120(2):314-321.
25. Gwini SM, Coupland CAC, Siriwardena AN. The effect of influenza vaccination on risk of acute myocardial infarction: self-controlled case-series study. Vaccine. 2011;29(6): 1145-1149.
26. France EK, Glanz J, Xu S, et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics. 2008;121(3): e687-e692.
27. Glanz J, France E, Xu S, et al. A population-based, multisite cohort study of the predictors of chronic idiopathic thrombocytopenic purpura in children. Pediatrics. 2008; 121(3):e506-e512.
28. O'Leary ST, Glanz JM, McClure DL, et al. The risk of immune thrombocytopenic purpura after vaccination in children and adolescents. Pediatrics. 2012;129(2): 248-255.
29. Taylor B, Miller E, Farrington CP, et al. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet. 1999;353(9169):2026-2029.
30. Glanz JM, Newcomer SR, Hambidge SJ, et al. Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the Vaccine Safety Datalink. Arch Pediatr Adolesc Med. 2011;165(8):749-755.