Faculty of Pharmaceutical Sciences, University of British Columbia (UBC), Vancouver, Canada.
UBC Collaboration for Outcomes Research and Evaluation, Vancouver, Canada.
Adv Ther. 2024 Jun;41(6):2352-2366. doi: 10.1007/s12325-024-02859-0. Epub 2024 Apr 24.
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.
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.
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%).
The Delphi-based taxonomy identified five criteria for the beneficial effects of OAC switching, aiding in characterizing real-world OAC switching.
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。
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。
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%）。
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。
