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基于属性的房颤患者口服抗凝药物转换获益分类法的制定与应用:一项德尔菲研究。

Development and Application of an Attribute-Based Taxonomy on the Benefits of Oral Anticoagulant Switching in Atrial Fibrillation: A Delphi Study.

机构信息

Faculty of Pharmaceutical Sciences, University of British Columbia (UBC), Vancouver, Canada.

UBC Collaboration for Outcomes Research and Evaluation, Vancouver, Canada.

出版信息

Adv Ther. 2024 Jun;41(6):2352-2366. doi: 10.1007/s12325-024-02859-0. Epub 2024 Apr 24.

Abstract

INTRODUCTION

Patients with atrial fibrillation (AF) often switch between oral anticoagulants (OACs). It can be hard to know why a patient has switched outside of a clinical setting. Medication attribute comparisons can suggest benefits. Consensus on terms and definitions is required for inferring OAC switch benefits. The objectives of the study were to generate consensus on a taxonomy of the potential benefits of OAC switching in patients with AF and apply the taxonomy to real-world data.

METHODS

Nine expert clinicians (seven clinical pharmacists, two cardiologists) with at least 3 years of clinical and research experience in AF participated in a Delphi process. The experts rated and commented on a proposed taxonomy on the potential benefits of OAC switching. After each Delphi round, ratings were analyzed with the RAND Corporation/University of California, Los Angeles (RAND/UCLA) appropriateness method. Median ratings, disagreement index, and comments were used to modify the taxonomy. The resulting taxonomy from the Delphi process was applied to a cohort of patients with AF who switched OACs in a population-based administrative health dataset from 1996 to 2019 in British Columbia, Canada.

RESULTS

The taxonomy was finalized in two Delphi rounds, reaching consensus on five switch benefit categories: safety, effectiveness, convenience, economic considerations, and drug interactions. Safety benefit (a switch that could lower the risk of adverse drug events) had three subcategories: major bleeding, intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding. Effectiveness benefit had four subcategories: stroke and systemic embolism (SSE), ischemic stroke, myocardial infarction (MI), and all-cause mortality. Real-world OAC switches revealed that more OAC switches had convenience (72.6%) and drug interaction (63.0%) benefits compared to effectiveness (SSE 22.0%, ischemic stroke 11.1%, MI 3.1%, all-cause mortality 10.1%), safety (major bleeding 24.3%, GI bleeding 10.6%, ICH 48.5%), and economic benefits (12.1%).

CONCLUSIONS

The Delphi-based taxonomy identified five criteria for the beneficial effects of OAC switching, aiding in characterizing real-world OAC switching.

摘要

简介

患有心房颤动(AF)的患者经常在口服抗凝剂(OAC)之间切换。在临床环境之外,很难知道患者为什么要切换药物。药物属性比较可以提示益处。为了推断 OAC 转换的益处,需要就术语和定义达成共识。本研究的目的是就 AF 患者 OAC 转换的潜在益处生成分类法,并将该分类法应用于真实世界数据。

方法

9 名具有至少 3 年 AF 临床和研究经验的专家临床医生(7 名临床药师,2 名心脏病专家)参与了 Delphi 流程。专家们对 OAC 转换潜在益处的分类法进行了评分和评论。在每个 Delphi 回合之后,使用 RAND 公司/加利福尼亚大学洛杉矶分校(RAND/UCLA)适宜性方法分析评分。中位数评分、分歧指数和评论用于修改分类法。Delphi 流程产生的分类法应用于 1996 年至 2019 年在加拿大不列颠哥伦比亚省基于人群的行政健康数据集的 AF 患者队列,这些患者转换了 OAC。

结果

该分类法在两轮 Delphi 中最终确定,就五个转换益处类别达成共识:安全性、有效性、便利性、经济考虑因素和药物相互作用。安全性益处(可降低不良药物事件风险的转换)有三个亚类:大出血、颅内出血(ICH)和胃肠道(GI)出血。有效性益处有四个亚类:中风和全身性栓塞(SSE)、缺血性中风、心肌梗死(MI)和全因死亡率。真实世界的 OAC 转换显示,便利性(72.6%)和药物相互作用(63.0%)的 OAC 转换益处多于有效性(SSE 22.0%、缺血性中风 11.1%、MI 3.1%、全因死亡率 10.1%)、安全性(大出血 24.3%、GI 出血 10.6%、ICH 48.5%)和经济益处(12.1%)。

结论

基于 Delphi 的分类法确定了 OAC 转换的有益效果的五个标准,有助于描述真实世界的 OAC 转换。

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