背景:药物警戒的核心动机是检测和预防药物不良反应(ADR),改善药物的风险-收益平衡。然而,ADR的因果关系评估仍然是临床医生面临的主要挑战,用于评估ADR的因果关系评估工具均未被普遍接受。
目的:提供不同因果关系评估工具的最新概述。
方法:我们在MEDLINE进行了电子搜索,EMBASE,还有Cochrane数据库.每个工具的合格性由三个审阅者筛选。然后仔细检查每个符合条件的工具的领域(报告的特定问题集/领域,用于计算ADR的因果关系的可能性),以发现最全面的工具。最后,我们主观地评估了该工具在加拿大的易用性,印度人,匈牙利人,和巴西的临床背景。
结果:检索了21个合格的因果关系评估工具。Naranjo的工具和DeBoer的工具是所有工具中最全面的,每个覆盖10个领域。关于临床环境中的“易用性”,我们判断,许多工具由于其复杂性和/或长度而难以在临床应用.Naranjo的工具,琼斯的工具,Danan和Benichou的工具,Hsu和Stoll的工具似乎是最容易在各种临床环境中实施的工具。
结论:在确定的许多工具中,1981年,Naranjo的量表仍然是最全面、最易于使用的用于进行ADR因果关系评估的量表。即将进行的分析应比较每种ADR工具在临床环境中的性能。
The core motive of pharmacovigilance is the detection and prevention of adverse drug reactions (ADRs), to improve the risk-benefit balance of the drug. However, the causality assessment of ADRs remains a major challenge among clinicians, and none of the available tools of causality assessment used for assessing ADRs have been universally accepted.
To provide an up-to-date overview of the different causality assessment tools.
We conducted electronic searches in MEDLINE, EMBASE, and the Cochrane database. The eligibility of each tool was screened by three reviewers. Each eligible tool was then scrutinized for its domains (the reported specific set of questions/areas used for calculating the likelihood of cause-and-effect relation of an ADR) to discover the most comprehensive tool. Finally, we subjectively assessed the tool\'s ease-of-use in a Canadian, Indian, Hungarian, and Brazilian clinical context.
Twenty-one eligible causality assessment tools were retrieved. Naranjo\'s tool and De Boer\'s tool appeared the most comprehensive among all the tools, covering 10 domains each. Regarding \"ease-of-use\" in a clinical setting, we judged that many tools were hard to implement in a clinical context because of their complexity and/or lengthiness. Naranjo\'s tool, Jones\'s tool, Danan and Benichou\'s tool, and Hsu and Stoll\'s tool appeared to be the easiest to implement into various clinical contexts.
Among the many tools identified, 1981 Naranjo\'s scale remains the most comprehensive and easy to use for performing causality assessment of ADRs. Upcoming analysis should compare the performance of each ADR tool in clinical settings.