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布莱顿协作组织病例定义能否用于提高预防接种不良反应(AEFI)报告的质量?以过敏反应作为案例研究。

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

机构信息

Discipline of Paediatrics, School of Paediatrics and Reproductive Health, University of Adelaide, South Australia, Australia.

出版信息

Vaccine. 2010 Jun 17;28(28):4487-98. doi: 10.1016/j.vaccine.2010.04.041. Epub 2010 Apr 29.

Abstract

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.

摘要

布莱顿协作组织(BC)成立于 2000 年,旨在制定全球认可的疫苗不良反应(AEFI)的标准化病例定义,以及用于收集、分析和呈现监测数据的指南。BC 的一些病例定义较为复杂,这可能限制了它们在上市后疫苗监测中的应用。应用 BC 病例定义的障碍包括对不良事件描述不完整,以及报告者使用不良事件术语不一致。我们采用了 BC 的过敏反应病例定义,并制定了临床检查表和病例定义中使用的术语词汇表。预计这些资源可以由 AEFI 报告者在社区层面使用。如果使用这些资源,可以提高不良事件报告的质量,从而促进在地区和/或国家层面应用 BC 病例定义。

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