Division of Experimental Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.
Division of General Internal Medicine, University Health Network, Toronto, Ontario, Canada.
J Am Geriatr Soc. 2020 Jul;68(7):1594-1602. doi: 10.1111/jgs.16382. Epub 2020 Mar 6.
Polypharmacy is common in older adults and associated with adverse drug events (ADEs). Several methods have been described in studies to help correlate ADE causation. We performed a narrative review to identify methods for ADE adjudication. We compared their strengths and limitations to assess their applicability to deprescribing studies (of which clinical trials are a subset) and to encourage the use of a standardized method in future studies.
We performed a review of original articles (1946-2019) using the Medline (Ovid) and Cochrane databases. We also conducted a manual reference search of review articles. Abstracts were screened for relevance.
Adjudication methods were compared for advantages and limitations including validity, ease of use, and applicability to clinical trials with deprescribing as the primary intervention.
The search yielded 1881 articles of which 175 articles were included for full-text review. Following in-depth review, 135 were excluded: 79 had no ADE outcome data, 35 were not specific to older adults, 9 were not relevant, 6 were review articles, 5 contained duplicate data, and 1 was not written in French or English. Forty articles remained for analysis, from which we identified 10 unique ADE adjudication methods. No method was developed originally for use in a deprescribing setting.
A standard method to identify ADEs is important to capture the outcome reliably in deprescribing studies. All methods we identified had limitations in terms of capturing adverse events from the withdrawal of medications. Future work should focus on refining adjudication methods for capturing ADEs related not only to medication continuation and new drug starts but also to deprescribing and drug discontinuation. J Am Geriatr Soc 68:1594-1602, 2020.
老年人普遍存在多种药物并用的情况,且与药物不良事件(ADE)有关。已有多项方法用于研究以帮助确定 ADE 的因果关系。我们进行了一项叙述性综述,以确定 ADE 裁决的方法。我们比较了它们的优缺点,以评估其在减药研究(临床试验是其中的一个子集)中的适用性,并鼓励在未来的研究中使用标准化方法。
我们使用 Medline(Ovid)和 Cochrane 数据库对原始文章(1946-2019 年)进行了综述。我们还对综述文章进行了手动参考文献搜索。筛选摘要以确定相关性。
对裁决方法进行了比较,包括其优缺点,包括有效性、易用性以及对作为主要干预措施的减药临床试验的适用性。
检索出 1881 篇文章,其中 175 篇文章进行了全文审查。经过深入审查,排除了 135 篇:79 篇没有 ADE 结果数据,35 篇不是针对老年人的,9 篇不相关,6 篇是综述文章,5 篇包含重复数据,1 篇不是用法语或英语写的。有 40 篇文章被纳入分析,从中我们确定了 10 种独特的 ADE 裁决方法。没有一种方法是专为减药环境而开发的。
在减药研究中,确定 ADE 的标准方法对于可靠地捕捉结果非常重要。我们确定的所有方法在捕捉与停药相关的不良事件方面都存在局限性。未来的工作应侧重于完善裁决方法,不仅要捕捉与药物持续使用和新药开始相关的 ADE,还要捕捉与减药和药物停药相关的 ADE。美国老年医学会杂志 68:1594-1602, 2020。