Asfari Hadyl, Souvignet Julien, Lillo-Le Louët Agnès, Trombert Béatrice, Jaulent Marie-Christine, Bousquet Cédric
UMR_S 1142, Inserm, LIMICS, Sorbonne universités, UPMC université Paris 06, 75006 Paris, France; Service de santé publique et d'information médicale, hôpital nord, centre hospitalier universitaire de Saint-Etienne, 42270 Saint-Etienne, France.
UMR_S 1142, Inserm, LIMICS, Sorbonne universités, UPMC université Paris 06, 75006 Paris, France; Service de santé publique et d'information médicale, hôpital nord, centre hospitalier universitaire de Saint-Etienne, 42270 Saint-Etienne, France.
Therapie. 2016 Dec;71(6):541-552. doi: 10.1016/j.therap.2016.06.003. Epub 2016 Jul 21.
To propose an alternative approach for building custom groupings of terms that complements the usual approach based on both hierarchical method (selection of reference groupings in medical dictionary for regulatory activities [MedDRA]) and/or textual method (string search), for case reports extraction from a pharmacovigilance database in response to a safety problem. Here we take cardiac valve fibrosis as an example.
The list of terms obtained by an automated approach, based on querying ontology of adverse drug reactions (OntoADR), a knowledge base defining MedDRA terms through relationships with systematized nomenclature of medicine-clinical terms (SNOMED CT) concepts, was compared with the reference list consisting of 53 preferred terms obtained by hierarchical and textual method. Two queries were performed on OntoADR by using a dedicated software: OntoADR query tools. Both queries excluded congenital diseases, and included a procedure or an auscultation method performed on cardiac valve structures. Query 1 also considered MedDRA terms related to fibrosis, narrowing or calcification of heart valves, and query 2 MedDRA terms described according to one of these four SNOMED CT terms: "Insufficiency", "Valvular sclerosis", "Heart valve calcification" or "Heart valve stenosis".
The reference grouping consisted of 53 MedDRA preferred terms. Our automated method achieved recall of 79% and precision of 100% for query 1 privileging morphological abnormalities, and recall of 100% and precision of 96% for query 2 privileging functional abnormalities.
An alternative approach to MedDRA reference groupings for building custom groupings is feasible for cardiac valve fibrosis. OntoADR is still in development. Its application to other adverse reactions would require significant work for a knowledge engineer to define every MedDRA term, but such definitions could then be queried as many times as necessary by pharmacovigilance professionals.
提出一种构建术语自定义分组的替代方法，以补充基于层次方法（在用于监管活动的医学词典 [MedDRA] 中选择参考分组）和/或文本方法（字符串搜索）的常用方法，用于从药物警戒数据库中提取病例报告以应对安全问题。在此，我们以心脏瓣膜纤维化为例。
将基于查询药物不良反应本体（OntoADR）自动获取的术语列表与通过层次和文本方法获得的由53个首选术语组成的参考列表进行比较。OntoADR是一个通过与医学临床术语系统命名法（SNOMED CT）概念的关系来定义MedDRA术语的知识库。使用专用软件OntoADR查询工具在OntoADR上执行了两个查询。两个查询均排除先天性疾病，并包括对心脏瓣膜结构进行的一项操作或一种听诊方法。查询1还考虑了与心脏瓣膜纤维化、狭窄或钙化相关的MedDRA术语，查询2考虑了根据以下四个SNOMED CT术语之一描述的MedDRA术语：“功能不全”、“瓣膜硬化”、“心脏瓣膜钙化”或“心脏瓣膜狭窄”。
参考分组由53个MedDRA首选术语组成。对于优先考虑形态异常的查询1，我们的自动方法召回率为79%，精确率为100%；对于优先考虑功能异常的查询2，召回率为100%，精确率为96%。
对于心脏瓣膜纤维化，构建自定义分组的MedDRA参考分组的替代方法是可行的。OntoADR仍在开发中。将其应用于其他不良反应将需要知识工程师进行大量工作来定义每个MedDRA术语，但之后药物警戒专业人员可以根据需要多次查询这些定义。
