Comparison of epidemiologic methods for active surveillance of vaccine safety

Vaccine

Volumn 26, Issue 26, 2008, Pages 3341-3345

  McClure, David L ^a   Glanz, Jason M ^a,b   Xu, Stanley ^a   Hambidge, Simon J ^a,b,c,d   Mullooly, John P ^e   Baggs, James ^f  

^a KAISER PERMANENTE   (United States)

^b UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^c Children's Hospital Colorado   (United States)

^d DENVER HEALTH   (United States)

^e CENTER FOR HEALTH RESEARCH   (United States)

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

Author keywords

Epidemiology study designs; Post market vaccine safety surveillance; Sequential statistical analysis

Indexed keywords

VACCINE;

ANALYTICAL ERROR; ARTICLE; CASE CONTROL STUDY; CONTROLLED STUDY; DRUG SAFETY; EPIDEMIOLOGICAL DATA; FALSE POSITIVE RESULT; HUMAN; METHODOLOGY; PRIORITY JOURNAL; REGRESSION ANALYSIS; RISK ASSESSMENT; SIMULATION; STATISTICAL MODEL; VACCINATION; VACCINATION REACTION;

ADOLESCENT; CASE-CONTROL STUDIES; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; COMMUNICABLE DISEASE CONTROL; COMPUTER SIMULATION; DRUG EVALUATION; EPIDEMIOLOGIC METHODS; HUMANS; INFANT; POPULATION SURVEILLANCE; SENSITIVITY AND SPECIFICITY; TIME FACTORS; VACCINES;

EID: 44749086997     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.03.074     Document Type: Article

References (22)

1. Lieu T.A., Kulldorff M., Davis R.L., Lewis E.M., Weintraub E., Yih K., et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 45 (2007) S89-S95
2. Chen R.T., Glasser J.W., Rhodes P.H., Davis R.L., Barlow W.E., Thompson R.S., et al. Vaccine Safety Datalink Project: a new tool for improving vaccine safety monitoring in the United States. Pediatrics 99 (1997) 765-773
3. Davis R.L., Kolczak M., Lewis E., Nordin J., Goodman M., Shay D.K., et al. Active surveillance of vaccine safety: a system to detect early signs of adverse events. Epidemiology 16 (2005) 336-341
4. Whitehead J. The design and analysis of sequential clinical trials. Revised 2nd ed. (1997), Wiley Limited, Chichester
5. Wald A. Sequential analysis (1947), Wiley, New York
6. Sonesson C., and Bock D. A review and discussion of prospective statistical surveillance in public health. J Roy Statist Soc A 166 Part 1 (2003) 5-21
7. Brown J.S., Kulldorff M., Chan K.A., Davis R.L., Graham D., Pettus P.T., et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf 16 12 (2007) 1275-1284
8. Glanz J.M., McClure D.L., Xu S., Hambidge S.J., Lee M., Kolczak M.S., et al. Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. J Clin Epidemiol 59 8 (2006) 808-818
9. Whitaker H.J., Farrington C.P., Spiessens B., and Musonda P. Tutorial in biostatistics: the self-controlled case series method. Stat Med 25 10 (2006) 1768-1797
10. Greenland S. Estimation of exposure-specific rates from sparse case-control data. J Chronic Dis 40 12 (1987) 1087-1094
11. Barlow W.E., Davis R.L., Glasser J.W., Rhodes P.H., Thompson R.S., Mullooly J.P., et al. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. N Engl J Med 345 9 (2001) 656-661
12. Vestergaard M., Hviid A., and Madsen K.M. MMR vaccination and febrile seizures evaluation of susceptible subgroups and long-term prognosis. JAMA 292 3 (2004) 351-357
13. Kramarz P., France E.K., Destefano F., Black S.B., Shinefield H., Ward J.I., et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J 20 4 (2001) 410-416
14. Murphy T.V., Gargiullo P.M., Massoudi M.S., Nelson D.B., Jumaan A.O., Okoro C.A., et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 344 8 (2001) 564-572
15. Miller E., Waight P., Farrington C.P., Andrews N., Stowe J., and Taylor B. Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Child 84 3 (2001) 227-229
16. France E.K., Glanz J., Xu S., Hambidge S., Yamasaki K., Black S.B., et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics 121 3 (2008) e687-e692
17. Rosner B. Power and sample size calculations for person-time data. Fundamentals of Biostatistics. 4th ed. (1995), Duxbury, Belmont p. 601-604
18. Wadman M. Experts call for active surveillance of drug safety. Nature 446 7134 (2007) 358-359
19. Fine E.M., and Chen R.T. Confounding in studies of adverse reactions to vaccines. Am J Epidemiol 136 2 (1992) 121-135
20. France E.K., Glanz J.M., Xu S., Davis R.L., Black S.B., Shinefield H.R., et al. Safety of the trivalent inactivated influenza vaccine among children: a population-based study. Arch Pediatr Adolesc Med 158 (2004) 1031-1036
21. Hambidge S.J., Glanz J.M., France E.K., McClure D., Xu S., Yamasaki K., et al. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA 296 (2006) 1990-1997
22. Mullooly J.P. Misclassification model for person-time analysis of automated medical care databases. Am J Epidemiol 144 8 (1996) 782-792