A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program

American Journal of Epidemiology
Meghan A BakerMichael D Nguyen

Abstract

The Postlicensure Rapid Immunization Safety Monitoring Program, the vaccination safety monitoring component of the US Food and Drug Administration's Mini-Sentinel project, is currently the largest cohort in the US general population for vaccine safety surveillance. We developed a study design selection framework to provide a roadmap and description of methods that may be utilized to evaluate potential associations between vaccines and health outcomes of interest in the Postlicensure Rapid Immunization Safety Monitoring Program and other systems using administrative data. The strengths and weaknesses of designs for vaccine safety monitoring, including the cohort design, the case-centered design, the risk interval design, the case-control design, the self-controlled risk interval design, the self-controlled case series method, and the case-crossover design, are described and summarized in tabular form. A structured decision table is provided to aid in planning of future vaccine safety monitoring activities, and the data components comprising the structured decision table are delineated. The study design selection framework provides a starting point for planning vaccine safety evaluations using claims-based data sources.

References

Jul 15, 1992·American Journal of Epidemiology·P E Fine, R T Chen
May 1, 1995·Epidemiology·S Suissa
Jun 4, 1999·American Journal of Epidemiology·M SalasB H Stricker
Feb 24, 2001·The New England Journal of Medicine·T V MurphyUNKNOWN Rotavirus Intussusception Investigation Team
Nov 3, 2004·Archives of Pediatrics & Adolescent Medicine·Eric K FranceRobert Chen
Oct 13, 2005·Statistics in Medicine·Heather J WhitakerPatrick Musonda
Dec 22, 2005·International Journal of Epidemiology·Lisa A JacksonNoel S Weiss
Jul 11, 2006·Journal of Clinical Epidemiology·Jason M GlanzEric K France
Mar 4, 2008·Pediatrics·Eric K FranceUNKNOWN Vaccine Safety Datalink Team
May 24, 2008·Biostatistics·C Paddy FarringtonMounia N Hocine
Jul 25, 2009·American Journal of Epidemiology·Bruce FiremanRoger Baxter
Jan 25, 2012·Pharmacoepidemiology and Drug Safety·Lesley H CurtisJeffrey S Brown
Jan 25, 2012·Pharmacoepidemiology and Drug Safety·Joshua J GagneSebastian Schneeweiss
Feb 10, 2012·JAMA : the Journal of the American Medical Association·Irene M ShuiEric Weintraub
Mar 14, 2012·American Journal of Epidemiology·Ali Rowhani-RahbarRoger Baxter
Dec 25, 2012·Obstetrics and Gynecology·Stephanie A IrvingUNKNOWN Vaccine Safety Datalink
Jan 16, 2014·The New England Journal of Medicine·W Katherine YihMichael Nguyen

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Citations

Dec 20, 2015·American Journal of Epidemiology·Meghan A Baker, Bruce H Fireman
Oct 28, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hélène ThéophileAntoine Pariente
Dec 21, 2017·American Journal of Respiratory and Critical Care Medicine·Andrea S GershonPeter Selby
Oct 5, 2018·Biometrical Journal. Biometrische Zeitschrift·Heather J WhitakerC Paddy Farrington
Nov 18, 2018·Tropical Medicine & International Health : TM & IH·Virginia Kagure WachiraMaria Regina Fernandes de Oliveira
Mar 12, 2019·Annals of Internal Medicine·Sebastian SchneeweissShirley V Wang
Jun 23, 2020·Annals of Internal Medicine·Elisabeth M HesseJonathan Duffy
Sep 3, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Roger BaxterNicola P Klein
Mar 31, 2016·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Roger BaxterNicola P Klein
Feb 27, 2021·Pharmacoepidemiology and Drug Safety·Katherine M DuszynskiNicole L Pratt
Mar 15, 2021·Pharmacoepidemiology and Drug Safety·Suzanne M CadaretteJesper Hallas

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