Tonéatti Christine, Saïdi Yacine, Meiffrédy Vincent, Tangre Philippe, Harel Marine, Eliette Véronique, Dormont Jean, Pierre Aboulker Jean
INSERM (Institut National de la Santé et de la Recherche Médicale), Service Commun 10, 16 Avenue Paul Vaillant Couturier, 94807 Villejuif, France.
Contemp Clin Trials. 2006 Feb;27(1):13-22. doi: 10.1016/j.cct.2005.09.009. Epub 2005 Nov 8.
To assess the feasibility of coding with MedDRA, the Medical Dictionary for Regulatory Activities, not only serious adverse events required for notification but also all other events usually reported in HIV clinical trials. To develop an approach for MedDRA implementation within an institutional research unit that contributes to an efficient, concise and reproducible event coding. To evaluate the impact of the maintenance and the versioning of this new medical terminology.
MedDRA versions 3.0 and 5.0 were used for coding hundreds of events reported through two HIV clinical trials. The implementation of MedDRA consisted in the setup of a training program, guidelines to clinical investigators, coding rules and medical validation process. MedDRA version 6.1 was applied to the coding made with the MedDRA version 5.0 in order to identify the assignments affected by the new version and to determine the impact of versioning.
Coding with MedDRA all types of events in HIV clinical trials was feasible even though coders experienced some difficulties due mainly to the lack of precision in the investigator verbatim and the high specificity and sensitivity of MedDRA. The addition of appropriate tools to support the use of MedDRA improved significantly the coding of all types of events in HIV clinical trials. The impact of MedDRA versioning was limited and did not result in significant issues. The global implementation process of MedDRA required important resources in terms of qualified personnel, organisation and maintenance.
Guidelines for investigators, coding rules and medical validation appeared to be mandatory for a successful implementation of MedDRA. The use of MedDRA, with the addition of the mentioned support tools, should ensure coding consistency and facilitate the clinical and tolerance analyses and meta-analyses in clinical trials.
评估使用《医学监管活动词典》（MedDRA）进行编码的可行性，不仅要对通知所需的严重不良事件进行编码，还要对HIV临床试验中通常报告的所有其他事件进行编码。制定一种在机构研究单位内实施MedDRA的方法，以促进高效、简洁且可重复的事件编码。评估这种新医学术语的维护和版本控制的影响。
使用MedDRA 3.0版和5.0版对通过两项HIV临床试验报告的数百个事件进行编码。MedDRA的实施包括设置培训计划、给临床研究人员的指南、编码规则和医学验证过程。将MedDRA 6.1版应用于用MedDRA 5.0版进行的编码，以识别受新版本影响的赋值，并确定版本控制的影响。
在HIV临床试验中对所有类型的事件使用MedDRA进行编码是可行的，尽管编码人员遇到了一些困难，主要原因是研究者逐字记录缺乏精确性以及MedDRA的高特异性和敏感性。添加适当的工具来支持MedDRA的使用显著改善了HIV临床试验中所有类型事件的编码。MedDRA版本控制的影响有限，未导致重大问题。MedDRA的全球实施过程在合格人员、组织和维护方面需要大量资源。
对于MedDRA的成功实施，研究者指南、编码规则和医学验证似乎是必不可少的。使用MedDRA并添加上述支持工具应能确保编码的一致性，并便于临床试验中的临床和耐受性分析以及荟萃分析。
