Abstract：
This report introduces a Brighton Collaboration (BC) case definition for autoimmune hepatitis (AIH), which has been classified as a priority adverse event of special interest (AESI), as there were possible cases seen following COVID-19 vaccination. The case definition was developed by a group of subject matter and BC process experts to facilitate safety data comparability across pre- and post-licensure clinical trials, as well as pharmacovigilance activities in multiple settings with diverse resources and healthcare access. The usual BC case definition development process was followed in an expedited manner, and took two months to complete, including finalising the manuscript for publication, instead of the usual 1 year development time. It includes a systematic review of the literature and an expert consensus to define levels of diagnostic certainty for AIH, and provides specific guidelines for data collection and analysis. Histology, serological and biochemical tests and exclusion of alternate diagnosis were considered necessary to define the levels of certainty (definitive, probable and possible). AEFI reports of suspected AIH were independently classified by the WG members to test its useability and these classifications were used to finalise the case definition. The document underwent peer review by external AIH experts and a Reference Group of vaccine safety stakeholders in high-, low- and middle-income countries to ensure case definition useability, applicability, and scientific integrity. The expedited process can be replicated for development of other standardised case definitions for priority AESIs for endemics and epidemics. While applicable to cases reported following immunisation, the case definition is independent of lapsed time following vaccination and, as such, can also be used to determine background incidence for vaccinated and unvaccinated control groups in studies of causal association. While use of this case definition is also appropriate for the study of safety of other products including drugs, it is not meant to guide clinical case management.
摘要：
本报告介绍了自身免疫性肝炎（AIH）的布莱顿合作（BC）病例定义，已被归类为特别关注的优先不良事件（AESI），因为在接种COVID-19疫苗后可能出现病例。病例定义由一组主题和BC过程专家制定，以促进许可前和许可后临床试验的安全性数据可比性。以及在具有不同资源和医疗保健访问的多种环境中的药物警戒活动。通常的BC病例定义开发过程是以加快的方式进行的，花了两个月才完成,包括完成手稿的出版，而不是通常的1年开发时间。它包括对文献的系统回顾和专家共识，以定义AIH的诊断确定性水平，并为数据收集和分析提供具体指导。组织学,血清学和生化测试以及排除替代诊断被认为是确定确定性水平所必需的(最终，可能的和可能的)。工作组成员对可疑AIH的AEFI报告进行了独立分类，以测试其可用性，并使用这些分类来最终确定病例定义。该文件经过了外部AIH专家和疫苗安全利益相关者参考小组的同行评审，低收入和中等收入国家确保案例定义的可用性，适用性,和科学诚信。可以复制加速过程，以开发针对地方病和流行病的优先AESI的其他标准化病例定义。虽然适用于免疫接种后报告的病例，病例定义与疫苗接种后的时间无关，因此，在因果关系研究中，也可用于确定接种疫苗和未接种疫苗的对照组的背景发生率。虽然使用此案例定义也适用于研究其他产品包括药物的安全性，这并不意味着指导临床病例管理。
