Active surveillance for adverse events: The experience of the vaccine safety datalink project

Pediatrics

Volumn 127, Issue SUPPL. 1, 2011, Pages

  Yih, W Katherine ^a   Kulldorff, Martin ^a   Fireman, Bruce H ^b   Shui, Irene M ^a   Lewis, Edwin M ^c   Klein, Nicola P ^c   Baggs, James ^d   Weintraub, Eric S ^d   Belongia, Edward A ^e   Naleway, Allison ^f   Gee, Julianne ^d   Platt, Richard ^a   Lieu, Tracy A ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b DIVISION OF RESEARCH   (United States)

^c KAISER PERMANENTE   (United States)

^d CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^e MARSHFIELD CLINIC   (United States)

^f CENTER FOR HEALTH RESEARCH   (United States)

Author keywords

Epidemiologic methods; Statistics; Surveillance; Vaccines

Indexed keywords

CHICKENPOX MEASLES MUMPS RUBELLA VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; MENINGOCOCCUS VACCINE; ROTAVIRUS VACCINE; WART VIRUS VACCINE;

ADOLESCENT; ADULT; APPENDICITIS; ARTHRITIS; ARTICLE; ATAXIA; ATTRIBUTABLE RISK; BELL PALSY; BRAIN DISEASE; CHICKENPOX; CHILD; CONTROLLED STUDY; CRANIAL NEUROPATHY; DIPHTHERIA; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; ENCEPHALITIS; FEMALE; GASTROINTESTINAL HEMORRHAGE; GRAM NEGATIVE SEPSIS; GUILLAIN BARRE SYNDROME; HEALTH CARE ORGANIZATION; HUMAN; INFANT; INFORMATION PROCESSING; INTUSSUSCEPTION; MAJOR CLINICAL STUDY; MALE; MEASLES; MEDICAL INFORMATICS; MENINGITIS; MENINGOCOCCOSIS; MUMPS; PAPILLOMAVIRUS INFECTION; PARALYSIS; PERTUSSIS; PRESCHOOL CHILD; PRIORITY JOURNAL; ROTAVIRUS INFECTION; RUBELLA; SCHOOL CHILD; SEIZURE; STROKE; SYNCOPE; TETANUS; THROMBOCYTOPENIA; UNITED STATES; VACCINATION; VENOUS THROMBOEMBOLISM;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGE FACTORS; CHILD; CHILD, PRESCHOOL; CROSS-SECTIONAL STUDIES; DATABASE MANAGEMENT SYSTEMS; FEMALE; HUMANS; INCIDENCE; INFANT; MALE; MULTIVARIATE ANALYSIS; RISK ASSESSMENT; VACCINATION; VACCINES; YOUNG ADULT;

EID: 79955514152     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2010-1722I     Document Type: Article

References (24)

1. Institute of Medicine, Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: Institute of Medicine; 2006
2. McClellan M. Drug safety reform at the FDA: pendulum swing or systematic improvement? N Engl J Med. 2007;356(17):1700-1702
3. Hennessy S, Strom BL. PDUFA reauthorization: drug safety's golden moment of opportunity? N Engl J Med. 2007;356(17):1703-1704
4. Davis RL, Kolczak M, Lewis E, et al. Active surveillance of vaccine safety: a system to detect early signs of adverse events. Epidemiology. 2005;16(3):336-341 (Pubitemid 40590071)
5. Lieu TA, Kulldorff M, Davis RL, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007;45(10 suppl 2):S89-S95
6. Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics. 2011;127(3 suppl):S45-S53
7. Yih WK, Nordin JD, Kulldorff M, et al. An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (TdaP) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink. Vaccine. 2009;27(32):4257-4262
8. Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices. Update: recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding administration of combination MMRV vaccine. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260
9. Belongia EA, Irving S, Shui IM, et al; Vaccine Safety Datalink Investigation Group. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent rotavirus vaccine. Pediatr Infect Dis J. 2010;29(1):1-5
10. Greene SK, Kulldorff M, Lewis EM, et al. Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. Am J Epidemiol. 2010;171(2):177-188
11. Kulldorff M, Davis RL, Kolczak M, Lewis E, Lieu T, Platt R. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Seq Anal. 2011;30(1):58-78
12. Wald A. Sequential tests of statistical hypotheses. Ann Math Stat. 1945;16(2):117-186
13. Li L, Kulldorff M. A conditional maximized sequential probability ratio test for pharmacovigilance. Stat Med. 2010;29(2):284-295
14. Lewis E, Fireman B, Klein NP, Baxter R. Exact sequential analysis for vaccine safety surveillance. Presented at the NFID 12th Annual Conference on Vaccine Research. Baltimore, MD: April, 2009
15. SaTScan v7.0: software for the spatial and space-time scan statistics. Available at: www.satscan.org. Accessed September 22, 2009
16. Kulldorff M. Sequential statistical methods for prospective post-marketing safety surveillance. In: Strom BL, Hennessy S, Kimmel SE, eds. Pharmacoepidemiology. 5th ed. Oxford, England: Wiley; 2011:In press
17. Klein NP, Fireman B, Yih WK, et al; Vaccine Safety Datalink. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics. 2010;126(1). Available at: www.pediatrics.org/cgi/content/ full/126/1/e1
18. Sejvar JJ, Kohl KS, Bilynsky R, et al; Brighton Collaboration Encephalitis Working Group. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5771-5792
19. France EK, Glanz J, Xu S, et al; Vaccine Safety Datalink Team. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics. 2008;121(3). Available at: www.pediatrics.org/cgi/content/ full/121/3/e687
20. Centers for Disease Control and Prevention. Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine - United States, June 2005-September 2006 [published correction appears in MMWR Morb Mortal Wkly Rep. 2006;55(43):1177]. MMWR Morb Mortal Wkly Rep. 2006;55(41):1120-1124
21. Brown JS, Moore KM, Braun MM, et al. Active influenza vaccine safety surveillance: potential within a healthcare claims environment. Med Care. 2009;47(12):1251-1257
22. Bohlke K, Davis RL, DeStefano F, Marcy SM, Braun MM, Thompson RS; Vaccine Safety Datalink Team. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization. J Allergy Clin Immunol. 2004;113(3):536-542 (Pubitemid 38338961)
23. Shui IM, Shi P, Dutta-Linn MM, et al; Vaccine Safety Datalink Research Team. Predictive value of seizure ICD-9 codes for vaccine safety research. Vaccine. 2009;27(39):5307-5312
24. Platt R, Wilson M, Chan KA, Benner JS, Marchibroda J, McClellan M. The new Sentinel Network: improving the evidence of medical-product safety. N Engl J Med. 2009;361(7):645-647