The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement.
Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M AlShammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmario Candore, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Manfred Hauben, Maria Teresa Herdeiro, Olivia Mahaux, Katrin Manlik, François Montastruc, Yoshihiro Noguchi, G Niklas Norén, Roberta Noseda, Igho J Onakpoya, Antoine Pariente, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T H Trinh, Marco Tuccori, Florence van Hunsel, Eugène van Puijenbroek, Emanuel Raschi, Charles Khouri
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引用次数: 0
Abstract
Background and aim: 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.
背景和目的：使用可疑药物不良反应报告进行比例失调分析是药物警戒中检测安全信号最常用的定量方法。然而，在已发表的文章中，对其方法和结果的报道通常较少，现有的指南也没有抓住比例失调分析的具体特点。在此，我们介绍了一项指南（REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]）的制定情况，该指南用于在文章和摘要中报告比例失调分析的结果：我们成立了一个由 34 位来自大学、制药行业和监管机构的国际专家组成的小组，他们在药物警戒、比例失调分析和安全信号评估方面都具有专长。我们分三步制定了核对表：(1) 通过开放文本调查生成第一份项目清单；(2) 通过在线德尔菲法选择并重新表述最重要的项目；(3) 召开最终的在线共识会议：在专家小组成员中，33 名专家对德尔菲法第一轮和第二轮做出了回应，30 名专家对第二轮做出了回应，25 名专家参加了共识会议。总体而言，经过德尔菲法后，与会者保留了针对稿件正文的 60 项建议和针对摘要的 13 项建议。在合并部分项目并召开在线共识会议后，READUS-PV 指南由一份包含 32 项建议的核对表和 4 项建议的核对表组成，前者包含 14 项关于在正文中报告比例失调分析的建议，后者包含 12 项关于摘要的建议：READUS-PV指南将为使用个体病例安全报告数据库进行比例失调分析的作者、编辑、同行评审员和用户提供支持。采用这些指南将使比例失调分析的报告和解释更加透明、全面和准确，并促进与其他证据来源的整合。
期刊介绍：
Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes:
Overviews of contentious or emerging issues.
Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes.
In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area.
Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics.
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