目的:使用可疑药物不良反应报告的不相称性分析是药物警戒中检测安全性信号最常用的定量方法。然而,他们的方法和结果在已发表的文章中通常报道得很差,现有指南没有抓住不相称性分析的具体特征.我们在这里描述了指南的开发(使用PharmacoVigilance[READUS-PV]中的个别病例安全性报告进行drUg安全性信号检测的不相称性分析报告),以报告文章和摘要中的不相称性分析结果。
方法:我们建立了一个由34名来自大学的国际专家组成的小组,制药业,和监管机构,具有药物警戒方面的专业知识,不相称性分析,和安全信号的评估。我们遵循三个步骤来开发清单:(1)开放文本调查以生成第一个项目列表;(2)在线Delphi方法来选择和改写最重要的项目;(3)最终的在线共识会议。
结果:在小组成员中,33名专家对德尔菲第1轮和第30轮至第2轮作出了回应,25名专家参加了共识会议。总的来说,在德尔菲法后,与会者保留了60条关于手稿主体的建议和13条关于摘要的建议。在将一些项目合并在一起和在线共识会议之后,READUS-PV指南包括32条建议的清单,在14个项目中,对于在正文和四个项目中报告不相称性分析,包括12条建议,摘要。
结论:READUS-PV指南将支持作者,编辑,同行评审,和使用个别病例安全报告数据库的不成比例分析的用户。采用这些准则将导致更加透明,全面,以及对不相称性分析的准确报告和解释,促进与其他证据来源的整合。
OBJECTIVE: Disproportionality analyses using
reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual
case safety
reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts.
METHODS: We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting.
RESULTS: Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts.
CONCLUSIONS: The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual
case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.