Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization

Vaccine

Volumn 26, Issue 50, 2008, Pages 6349-6360

  Kohl, Katrin S ^a   Magnus, Manya ^b   Ball, Robert ^c   Halsey, Neal ^d,e   Shadomy, Sean ^a   Farley, Thomas A ^f  

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

^b GEORGE WASHINGTON UNIVERSITY   (United States)

^c CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^d JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^e Clinical Immunization Safety Assessment network   (United States)

^f TULANE UNIVERSITY   (United States)

Author keywords

Adverse events following immunization; Case definitions; Evaluation methodology; Fever; Generalized convulsive seizure; Hypotonic hyporesponsive episode; Intussusception; Nodule at injection site; Persistent crying

Indexed keywords

VACCINE;

ARTICLE; BRIGHTON COLLABORATION; CLINICAL FEATURE; CONTROLLED STUDY; CRYING; DIAGNOSTIC ACCURACY; DISEASE CLASSIFICATION; DRUG SURVEILLANCE PROGRAM; FEMALE; FEVER; GRAND MAL SEIZURE; HEALTH CARE ORGANIZATION; HEALTH SURVEY; HUMAN; HYPOTONIC HYPORESPONSIVE EPISODE; IMMUNIZATION; INJECTION SITE NODULE; INTERRATER RELIABILITY; INTUSSUSCEPTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RELIABILITY; SCORING SYSTEM; SENSITIVITY AND SPECIFICITY; SIDE EFFECT; STANDARDIZATION; TREATMENT OUTCOME; UNITED STATES; VACCINATION; VACCINE ADVERSE EVENT REPORTING SYSTEM;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD, PRESCHOOL; COOPERATIVE BEHAVIOR; DATA COLLECTION; FEMALE; FEVER; HUMANS; IMMUNIZATION; IMMUNIZATION PROGRAMS; INTERNATIONALITY; MALE; REPRODUCIBILITY OF RESULTS; SEIZURES; SENSITIVITY AND SPECIFICITY; VACCINES;

EID: 55749103875     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.09.002     Document Type: Article

References (27)

1. Bonhoeffer J., Kohl K., Chen R., Duclos P., Heijbel H., Heininger U., et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine 21 3-4 (2002) 298-302
2. Bonhoeffer J., Kohl K.S., Chen R., Duclos P., Heijbel H., Heininger U., et al. The Brighton Collaboration-enhancing vaccine safety. Vaccine 22 (2004) 2046
3. Bonhoeffer J., Kohl K.S., Chen R.T., Duclos P., Heijbel H., Heininger U., et al. Standardized case definitions of adverse events following immunization (AEFI). Vaccine 22 (2004) 547-550
4. Kohl K.S., Bonhoeffer J., Chen R., Duclos P., Heijbel H., Heininger U., et al. The Brighton Collaboration: enhancing comparability of vaccine safety data. Pharmacoepidemiol Drug Saf 12 (2003) 335-340
5. Kohl K.S., Braun M., Chen R.T., Duclos P., Heijbel H., Heininger U., et al. A proposal for a global standard of case definitions (and guidelines) for adverse events following immunization. Advances in patient safety: from research to implementation (2005), AHRQ Publication pp. 1-4
6. Kohl K.S., Bonhoeffer J., Braun M.M., Buettcher M., Chen R.T., Duclos P., et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 25 (2007) 5671-5674
7. Balinska M.A. What is vaccine advocacy? Proposal for a definition and action. Vaccine 22 (2004) 1335-1342
8. Marcy S.M., Kohl K.S., Ron Dagan R., Nalin D., Blum M., Connell Jones M., et al., The Brighton Collaboration Fever Working Group. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine 22 (2004) 551-556
9. Bonhoeffer J., Menkes J., Gold M.S., de Souza-Brito G., Fisher M.C., Halsey N., et al. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22 (2004) 557-562
10. Bonhoeffer J., Gold M.S., Heijbel H., Vermeer P., Blumberg D., Braun M., et al., The Brighton Collaboration HHE Working Group. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22 (2004) 563-568
11. Bines J.E., Kohl K.S., Forster J., Zanardi L.R., Davis R.L., Hansen J., et al., The Brighton Collaboration Intussusception Working Group. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine 22 (2004) 569-574
12. Rothstein E., Kohl K.S., Ball L., Halperin S.A., Halsey N., Hammer S.J., et al., The Brighton Collaboration Local Reaction Working Group. Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22 (2004) 575-585
13. Bonhoeffer J., Vermeer P., Halperin S., Kempe A., Music S., Shindman J., et al. Persistent crying in infants and children as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 22 (2004) 587-592
14. Buettcher M., Heininger U., Braun M., Bonhoeffer J., Halperin S., Heijbel H., et al. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: case definition and guidelines for data collection, analysis, and presentation. Vaccine 25 (2007) 5875-5881
15. Bines J.E., Liem N.T., Justice F., Son T.N., Carlin J.B., de Campo M., et al. Validation of clinical case definition of acute intussusception in infants in Viet Nam and Australia. Bull World Health Organ 84 (2006) 569-575
16. Ball R., Braun M.M., Moulton L.H., Gale A.D., Rommohan K., Wiznitzer M., et al. Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System. J Clin Epidemiol 55 (2002) 819-824
17. Boudville I.C., Phua K.B., Quak S.H., Lee B.W., Han H.H., Verstraeten T., et al. The epidemiology of paediatric intussusception in Singapore: 1997 to 2004. Ann Acad Med Singapore 35 10 (2006) 674-679
18. Braun M.M., Salive M.E., Blumberg D.A., Vermeer-de Bondt P.E., Heijbel H., Evans G., et al. Report on a US public health service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis vaccination. Pediatrics 102 (1998) e52
19. Buettcher M., Baer G., Bonhoeffer J., Schaad U.B., and Heininger U. Three-year surveillance of intussusception in children in Switzerland. Pediatrics 120 3 (2007) 473-480
20. Plesner A.M. Allergic reactions to Japanese encephalitis vaccine. Immunol Allergy Clin North Am 23 4 (2003) 665-697
21. Tapiainen T., Bar G., Bonhoeffer J., and Heininger U. Evaluation of the Brighton Collaboration case definition of acute intussusception during active surveillance. Vaccine 24 9 (2006) 1483-1487
22. Tapiainen T., and Heininger U. Fever following immunization. Expert Rev Vaccines 4 3 (2005) 419-427
23. Vermeer-de Bondt P.E., Dzaferagic A., David S., and van der Maas N.A. Performance of the Brighton collaboration case definition for hypotonic-hyporesponsive episode (HHE) on reported collapse reactions following infant vaccinations in the Netherlands. Vaccine 24 49-50 (2006) 7066-7070
24. Zenardi L.R., Mootrey G.T., Niu M.T., Wharton M., and the VAERS Working Group. Intussusception among recipients of rotavirus vaccine: reports to the vaccine adverse events reporting system. Pediatrics 107 6 (2001) 1-6
25. Zhou W., Pool V., Iskander J.K., English-Bullard R., Ball R., Wise R.P., et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)-United States, 1991-2001. MMWR Surveill Summ 52 (2003) 1-24
26. Food and Drug Administration. COSTART: coding symbols for thesaurus of adverse reaction terms. 3rd ed. Rockville, MD: Department of Health and Human Services, Food and Drug Administration, Center for Drugs and Biologics; 1989.
27. Food and Drug Administration. 21 CFR Part 600.80. Postmarketing reporting of adverse experiences. Federal Register 1997;62:52252-3.