Appraisal of the MedDRA conceptual structure for describing and grouping adverse drug reactions
Appraisal of the MedDRA conceptual structure for describing and grouping adverse drug reactions
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DOI：
10.2165/00002018-200528010-00002
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发表时间：
2005-01-01
期刊：
影响因子：
4.2
通讯作者：
Jaulent, MC
中科院分区：
文献类型：
--
作者：
Bousquet, C;Lagier, G;Jaulent, MC
药物警戒自发报告系统中的计算机化查询需要对药物不良反应（ADR）进行可靠且可重现的编码。国际医学用语词典（MedDRA）术语的目的是提供一种国际认可的分类，以便在国家之间有效交流ADR数据。多项研究评价了MedDRA的领域完整性以及编码术语是否与医生对ADR的原始逐字描述一致，MedDRA术语分为5个级别：系统器官分类（SOC）、高级别组术语（HLGT）、高级别术语（HLT）、首选术语（PT）和低级别术语（LLT）。尽管术语可能属于不同的SOC，但PT与同一SOC内的一个以上HLT无关。这种分层属性确保术语在统计研究中不会被计数两次，尽管它不允许对PT进行适当的语义分组。为此，在MedDRA中引入了特殊检索类别（SSC）[从各种SOC中收集的PT]，以将具有相似含义的术语分组。然而，目前只有少数类别可用，并且用于构建这些类别的标准尚未澄清。这项工作的目的是确定MedDRA是否包含对语义相关不良事件进行分组的结构和术语属性，以提高自发报告系统的性能。Rossi Mori将术语系统分为三类：第一代系统，将术语表示为字符串;第二代系统，将术语短语分解为一组更简单的术语;和第三代系统，其提供高级功能以自动检索新术语在分类和组含义集合中的位置-我们应用Cimino的desiderata来表明MedDRA与第三代系统的属性不兼容。因此，没有工具可以帮助在层次结构内自动定位新术语，并且SSC必须手动输入，而不是使用MedDRA文件自动输入。一种解决办法是将MedDRA与第三代系统联系起来。这将允许保留当前的MedDRA结构，以确保最终用户对相同的数据有共同的看法，并为MedDRA增加新的计算属性。
Computerised queries in spontaneous reporting systems for pharmacovigilance require reliable and reproducible coding of adverse drug reactions (ADRs). The aim of the Medical Dictionary for Regulatory Activities (MedDRA) terminology is to provide an internationally approved classification for efficient communication of ADR data between countries. Several studies have evaluated the domain completeness of MedDRA and whether encoded terms are coherent with physicians' original verbatim descriptions of the ADR.MedDRA terms are organised into five levels: system organ class (SOC), high level group terms (HLGTs), high level terms (HLTs), preferred terms (PTs) and low level terms (LLTs). Although terms may belong to different SOCs, no PT is related to more than one HLT within the same SOC. This hierarchical property ensures that terms cannot be counted twice in statistical studies, though it does not allow appropriate semantic grouping of PTs. For this purpose, special search categories (SSCs) [collections of PTs assembled from various SOCs] have been introduced in MedDRA to group terms with similar meanings. However, only a small number of categories are currently available and the criteria used to construct these categories have not been clarified.The objective of this work is to determine whether MedDRA contains the structural and terminological properties to group semantically linked adverse events in order to improve the performance of spontaneous reporting systems.Rossi Mori classifies terminological systems in three categories: first-generation systems, which represent terms as strings; second-generation systems, which dissect terminological phrases into a set of simpler terms; and third-generation systems, which provide advanced features to automatically retrieve the position of new terms in the classification and group sets of meaning-related terms.We applied Cimino's desiderata to show that MedDRA is not compatible with the properties of third-generation systems. Consequently, no tool can help for the automated positioning of new terms inside the hierarchy and SSCs have to be entered manually rather than automatically using the MedDRA files. One solution could be to link MedDRA to a third-generation system. This would allow the current MedDRA structure to be kept to ensure that end users have a common view on the same data and the addition of new computational properties to MedDRA.