Performance of the Brighton Collaboration case definition for hypotonic-hyporesponsive episode (HHE) on reported collapse reactions following infant vaccinations in the Netherlands

被引:8
作者
Vermeer-de Bondt, Patricia E. [1 ]
Dzaferagic, Aida [1 ]
David, Silke [1 ]
van der Maas, Nicoline A. T. [1 ]
机构
[1] RIVM Natl Inst Publ Hlth & Environm, Natl Vaccinat Programme, Ctr Infect Dis Control, NL-3720 BA Bilthoven, Netherlands
关键词
case definition; collapse reaction; adverse event following immunisation;
D O I
10.1016/j.vaccine.2006.07.008
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
We reviewed collapse (sudden onset of pallor, limpness and hyporesponsiveness) following the first infant (DPTP + Hib) vaccination reported to the enhanced passive surveillance system of the Netherlands in 1994-2003. All 1303 reports identified by the current RIVM (National Institute for Public Health and Environment) case definition were captured by the Brighton Collaboration (BC) case definition, with in 17 (1.3%) reports insufficient information. Over the years the proportion of the highest level of diagnostic certainty (level 1) increased due to more complete data from 70% to over 90%. We checked the BC case definition also on a sample of cases (with pallor or hyporesponsiveness) not meeting RIVM's case definition for collapse at the time. Sixty out of 200 cases were captured by BC but again rejected by RIVM. The sensitivity BC levels 2 and 3 appeared too high. We recommend a more restrict case definition by the Brighton Collaboration with certain exclusion criteria to make it more specific. Furthermore a change in the specifications for levels 2 and 3 will increase specificity and accommodate for the loss of sensitivity. (c) 2006 Elsevier Ltd. All rights reserved.
引用
收藏
页码:7066 / 7070
页数:5
相关论文
共 16 条
  • [1] The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI)
    Bonhoeffer, J
    Kohl, K
    Chen, R
    Duclos, P
    Heijbel, H
    Heininger, U
    Jefferson, T
    Loupi, E
    [J]. VACCINE, 2002, 21 (3-4) : 298 - 302
  • [2] Hypotonic-Hyporesponsive Episode (HHE) as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation
    Bonhoeffer, J
    Gold, MS
    Heijbel, H
    Vermeer, P
    Blumberg, D
    Braun, M
    de Souza-Brito, G
    Davis, RL
    Halperin, S
    Heininger, U
    Khuri-Bulos, N
    Menkes, J
    Nokleby, H
    [J]. VACCINE, 2004, 22 (5-6) : 563 - 568
  • [3] Report of a US Public Health Service Workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization
    Braun, MM
    Terracciano, G
    Salive, ME
    Blumberg, DA
    Vermeer-de Bondt, PE
    Heijbel, H
    Evans, G
    Patriarca, PA
    Ellenberg, SS
    [J]. PEDIATRICS, 1998, 102 (05)
  • [4] CODY CL, 1981, PEDIATRICS, V68, P650
  • [5] Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998
    DuVernoy, TS
    Braun, MM
    [J]. PEDIATRICS, 2000, 106 (04) : art. no. - e52
  • [6] Hypotonic-hyporesponsive episodes following pertussis vaccination - A cause for concern?
    Gold, MS
    [J]. DRUG SAFETY, 2002, 25 (02) : 85 - 90
  • [7] Gold R, 1997, Can Commun Dis Rep, V23, P73
  • [8] HANNIK CA, 1979, PERTUSSIS VACCINE EX, P79
  • [9] Heijbel H, 1997, DEV BIOL STAND, V89, P101
  • [10] Howson CP, 1991, ADVERSE EFFECTS PERT