Can the Brighton Collaboration case definitions be used to improve the quality of Adverse Event Following Immunization (AEFI) reporting? Anaphylaxis as a case study

被引:35
作者
Gold, Michael S. [1 ]
Gidudu, Jane [2 ]
Erlewyn-Lajeunesse, Mich [3 ]
Law, Barbara [4 ]
机构
[1] Univ Adelaide, Discipline Paediat, Sch Paediat & Reprod Hlth, Adelaide, SA 5005, Australia
[2] Ctr Dis Control & Prevent, Atlanta, GA USA
[3] Southampton Univ Hosp NHS Trust, Southampton, Hants, England
[4] Publ Hlth Agcy Canada, Sci Sect, Immunizat & Resp Infect Div, Ottawa, ON, Canada
关键词
Brighton Collaboration anaphylaxis case definition; Checklists; Immunization safety; Case study; SAFETY DATA; GUIDELINES; COLLECTION;
D O I
10.1016/j.vaccine.2010.04.041
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The Brighton Collaboration (BC) was established in 2000 with the aim of developing globally accepted standardized case definitions for adverse events following immunizations (AEFI) as well as guidelines for the collection, analysis and presentation of surveillance data. Some of the BC case definitions are complex and this may limit their application for use in post-marketing vaccine surveillance. Barriers to the application of the BC case definitions include an incomplete description of an adverse event and inconsistencies in reporter use of adverse event terms. We have taken the BC case definition for anaphylaxis and developed a clinical checklist and glossary of terms used in the case definition. It is anticipated that these resources can be used at a community level by AEFI reporters. If used, these resources could improve the quality of adverse event reports which would facilitate the application of the BC case definition at a regional and/or national level. (C) 2010 Published by Elsevier Ltd.
引用
收藏
页码:4487 / 4498
页数:12
相关论文
共 10 条
[1]   Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies [J].
Bonhoeffer, Jan ;
Bentsi-Enchill, Adwoa ;
Chen, Robert T. ;
Fisher, Margaret C. ;
Gold, Michael S. ;
Hartman, Katharina ;
Heininger, Ulrich ;
Hoet, Bernard ;
Jefferson, Thomas ;
Khuri-Bulos, Najwa ;
Kohl, Katrin S. ;
Marcy, S. Michael ;
Nalin, David ;
Pless, Robert ;
Sanabria-Rojas, Hernan ;
Sleeman, Karen ;
Wise, Robert .
VACCINE, 2009, 27 (16) :2282-2288
[2]   Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems [J].
Bonhoeffer, Jan ;
Bentsi-Enchill, Adwoa ;
Chen, Robert T. ;
Fisher, Margaret C. ;
Gold, Michael S. ;
Hartman, Katharina ;
Heininger, Ulrich ;
Hoet, Bernard ;
Jefferson, Thomas ;
Khuri-Bulos, Najwa ;
Kohl, Katrin ;
Marcy, S. Michael ;
Nalin, David ;
Pless, Robert ;
Sanabria-Rojas, Hernan ;
Sleeman, Karen ;
Se, Robert W. .
VACCINE, 2009, 27 (16) :2289-2297
[3]  
DON M, 2007, PRACTICAL PAEDIAT
[4]   Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003 [J].
Johansson, SGO ;
Bieber, T ;
Dahl, R ;
Friedmann, PS ;
Lanier, BQ ;
Lockey, RF ;
Motala, C ;
Martell, JAO ;
Platts-Mills, TAE ;
Ring, J ;
Thien, F ;
Van Cauwenberge, P ;
Williams, HC .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2004, 113 (05) :832-836
[5]   The development of standardized case definitions and guidelines for adverse events following immunization [J].
Kohl, Katrin S. ;
Gidudu, Jane ;
Bonhoeffer, Jan ;
Braun, M. Miles ;
Buettcher, Michael ;
Chen, Robert T. ;
Drammeh, Bakary ;
Duclos, Philippe ;
Heijbel, Harald ;
Heininger, Ulrich ;
Hummelman, Erik ;
Jefferson, Thomas ;
Keller-Stanislawski, Brigitte ;
Loupi, Elisabeth ;
Marcy, S. Michael .
VACCINE, 2007, 25 (31) :5671-5674
[6]  
MIESCHER PA, 1976, TXB IMMUNOPATHOLOGY
[7]   Anaphylaxis:: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data [J].
Rueggeberg, Jens U. ;
Gold, Michael S. ;
Bayas, Jose-Maria ;
Blum, Michael D. ;
Bonhoeffer, Jan ;
Friedlander, Sheila ;
Brito, Glacus de Souza ;
Heininger, Ulrich ;
Imoukhuede, Babatunde ;
Khamesipour, Ali ;
Erlewyn-Lajeunesse, Michel ;
Martin, Susana ;
Makela, Mika ;
Nell, Patricia ;
Pool, Vitali ;
Simpson, Nick .
VACCINE, 2007, 25 (31) :5675-5684
[8]  
Sampson Hugh A, 2006, J Allergy Clin Immunol, V117, P391, DOI 10.1016/j.jaci.2005.12.1303
[9]   Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): Case definitions and guidelines for collection, analysis, and presentation of immunization safety data [J].
Sejvar, James J. ;
Kohl, Katrin S. ;
Bilynsky, Roman ;
Blumberg, Dean ;
Cvetkovich, Therese ;
Galama, Jochem ;
Gidudu, Jane ;
Katikaneni, Lakshmi ;
Khuri-Bulos, Najwa ;
Oleske, James ;
Tapiainen, Terhi ;
Wiznitzer, Max .
VACCINE, 2007, 25 (31) :5771-5792
[10]  
Simons FER, 2007, J ALLERGY CLIN IMMUN, V120, pS2, DOI [10.1016/j.jaci.2007.05.001, 10.1016/j.jaci.2007.05.016]