Garmann Tahmineh, Samdal Hilde, Sartori Daniele, Jahanlu David, Andersen Fredrik, Rocca Elena
Faculty of Health Sciences, Institute for Natural Science and Health, Oslo Metropolitan University, Postboks 4, St.Olavs plass, 0130, Oslo, Norway.
Norwegian Medical Product Agency, Oslo, Norway.
Drug Saf. 2025 Jul 1. doi: 10.1007/s40264-025-01573-2.
The Medical Dictionary for Regulatory Activities (MedDRA) is an international standardized medical terminology used to code various types of medical information, including safety reports of suspected adverse reactions to medicines. Quantitative studies have highlighted varying levels of coding inconsistency across MedDRA-relevant platforms, though the possible grounds of such inconsistency remain unclear.
We explored the reasoning and strategies employed by pharmacovigilance officers when coding selected ambiguous adverse events to MedDRA, categorized the types of coding inconsistencies, and explored sources of the inconsistencies.
Pharmacovigilance officers from the Norwegian public health sector were invited to participate in a survey-based, cross-sectional study followed by focus group interviews. The survey consisted of 11 coding tasks, with varying degrees of ambiguity, purposively sampled from the Norwegian pharmacovigilance registry. Participants selected the appropriate MedDRA terms and graded the difficulty level of each task on a scale from 1 (least difficult) to 4 (most difficult). Terms selected by participants were compared with a Standard Term Selection (STS), agreed upon by the authors in consultation with a MedDRA trainer. Inconsistencies with the STS were classified as omission (missing term), substitution (extra term selected in the presence of an omission), and addition (extra term selected and none omitted). In focus groups, participants discussed challenges in the coding tasks and the strategies they used to overcome them. Interview transcripts were analyzed using thematic analysis.
In total, 26 coders (79% of the eligible population) completed the survey. Of the survey answers, 36% were identical to the STS; answers consistent with the STS varied across the specific coding tasks and did not align with the perceived difficulty of the tasks. The most common inconsistency (30% of the survey answers) arose from substituting one of multiple MedDRA terms. Of the survey answers, 18% included omissions without substitutions, and 6% added unnecessary terms to the STS. Eight of the 26 coders (31%) participated in the focus group interviews. Focus group themes revealed that substitutions were explained by difficulties in translating lay language to medical terminology, finding accurate English translations for Norwegian medical terms, and fitting complex descriptions into MedDRA terms. This was explained by themes related to ambiguity-resolution strategies. Themes explaining omissions included strategies for resolving ambiguity, contextual thinking, causal and pharmacological reasoning in the coding process, and information categorization.
Tailored training programs and clear institutional guidelines are needed to target the sources of coding inconsistencies suggested by this study.
《药物监管活动医学词典》（MedDRA）是一种国际标准化医学术语，用于对各类医学信息进行编码，包括药品疑似不良反应的安全报告。定量研究强调了MedDRA相关平台间编码不一致的不同程度，不过这种不一致的可能原因仍不明确。
我们探究了药物警戒官员在将选定的模糊不良事件编码为MedDRA时所采用的推理和策略，对编码不一致的类型进行了分类，并探究了不一致的来源。
邀请挪威公共卫生部门的药物警戒官员参与一项基于调查的横断面研究，随后进行焦点小组访谈。该调查包括11项编码任务，具有不同程度的模糊性，是从挪威药物警戒登记处有目的地抽样选取的。参与者选择适当的MedDRA术语，并将每项任务的难度等级从1（最容易）到4（最难）进行评分。将参与者选择的术语与作者在与MedDRA培训师协商后确定的标准术语选择（STS）进行比较。与STS的不一致被分类为遗漏（缺失术语）、替换（在存在遗漏的情况下选择额外术语）和添加（选择额外术语且无遗漏）。在焦点小组中，参与者讨论了编码任务中的挑战以及他们用来克服这些挑战的策略。使用主题分析法对访谈记录进行分析。
共有26名编码人员（占符合条件人群的79%）完成了调查。在调查答案中，36%与STS一致；与STS一致的答案因具体编码任务而异，且与任务的感知难度不一致。最常见的不一致（占调查答案的30%）是由替换多个MedDRA术语中的一个引起的。在调查答案中，18%包括无替换的遗漏，6%在STS中添加了不必要的术语。26名编码人员中有8名（31%）参加了焦点小组访谈。焦点小组主题显示，替换的原因是将通俗语言翻译成医学术语存在困难、为挪威医学术语找到准确的英文翻译以及将复杂描述纳入MedDRA术语。这可以通过与歧义解决策略相关的主题来解释。解释遗漏的主题包括歧义解决策略、情境思维、编码过程中的因果和药理学推理以及信息分类。
需要制定量身定制的培训计划和明确的机构指南，以针对本研究提出的编码不一致来源。
