对COVID-19治疗指南中托珠单抗实施情况的用药评估:因果推论法。

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Pavel Goriacko, Ari Moskowitz, Nadia Ferguson, Saira Khalique, Una Hopkins, Nicholas Quinn, Mark Sinnett, Eran Bellin
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引用次数: 0

摘要

免责声明:为了加快文章的出版速度,AJHP在接受稿件后会尽快在网上发布。被录用的稿件已经过同行评审和校对,但在进行技术格式化和作者校对之前会在网上发布。这些稿件并非最终记录版本,将在稍后时间以最终文章(按 AJHP 格式排版并由作者校对)取代。目的:在医疗系统的处方集中引入新药时,通常不会评估其对当地患者群体的临床影响。随着电子健康记录(EHR)数据的日益普及和药物流行病学方法的不断进步,医疗机构有机会监控药物的实施过程并评估其在当地临床环境中的临床效果。在本研究中,我们采用了新颖的因果推断方法来评估针对2019年冠状病毒病(COVID-19)重症患者引入托珠单抗治疗的处方政策的效果:我们利用一家大型医疗中心收治的患者的电子病历数据进行了用药评估,这些数据来自于认可使用托珠单抗治疗COVID-19的处方集政策实施前后的6个月。采用差异分析法评估了替西利珠单抗对28天全因死亡率的影响,将不符合条件的患者作为非等效对照组,并在目标试验仿真框架指导下进行了匹配分析。评估的安全性终点包括继发性感染和肝酶升高的发生率。我们的研究结果以临床试验、一项观察性研究和一项荟萃分析为基准:结果:修改指南后,69%的合格患者使用了托珠单抗。将托珠单抗纳入指南后,28 天死亡率的绝对风险降低了 3.1%(几率比 0.86;预防 1 例死亡的治疗需求数 32),而使用该药物后,死亡率的绝对风险又降低了 8.6%(几率比 0.65;预防 1 例死亡的治疗需求数 12)。这些发现与已发表文献的估计结果一致,但差异分析的效果估计值不精确:结论:通过新的因果推论方法评估处方管理决策,可提供有价值的临床效果估计值,并有可能优化新药对人群结果的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Medication use evaluation of tocilizumab implementation in COVID-19 treatment guidelines: A causal inference approach.

Purpose: Introduction of new medications to health-system formularies is often not accompanied by assessments of their clinical impact on the local patient population. The growing availability of electronic health record (EHR) data and advancements in pharmacoepidemiology methods offer institutions the opportunity to monitor the medication implementation process and assess clinical effectiveness in the local clinical context. In this study, we applied novel causal inference methods to evaluate the effects of a formulary policy introducing tocilizumab therapy for critically ill patients with coronavirus disease 2019 (COVID-19).

Methods: We conducted a medication use evaluation utilizing EHR data from patients admitted to a large medical center during the 6 months before and after implementation of a formulary policy endorsing the use of tocilizumab for treatment of COVID-19. The impact of tocilizumab on 28-day all-cause mortality was assessed using a difference-in-differences analysis, with ineligible patients serving as a nonequivalent control group, and a matched analysis guided by a target trial emulation framework. Safety endpoints assessed included the incidence of secondary infections and liver enzyme elevations. Our findings were benchmarked against clinical trials, an observational study, and a meta-analysis.

Results: Following guideline modification, tocilizumab was administered to 69% of eligible patients. This implementation was associated with a 3.1% absolute risk reduction in 28-day mortality (odds ratio, 0.86; number needed to treat to prevent one death, 32) attributable to the inclusion of tocilizumab in the guidelines and an additional 8.6% absolute risk reduction (odds ratio, 0.65; number needed to treat to prevent one death, 12) linked to its administration. These findings were consistent with estimates from published literature, although the effect estimates from the difference-in-differences analysis exhibited imprecision.

Conclusion: Evaluating formulary management decisions through novel causal inference approaches offers valuable estimates of clinical effectiveness and the potential to optimize the impact of new medications on population outcomes.

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来源期刊
CiteScore
2.90
自引率
18.50%
发文量
341
审稿时长
3-8 weeks
期刊介绍: The American Journal of Health-System Pharmacy (AJHP) is the official publication of the American Society of Health-System Pharmacists (ASHP). It publishes peer-reviewed scientific papers on contemporary drug therapy and pharmacy practice innovations in hospitals and health systems. With a circulation of more than 43,000, AJHP is the most widely recognized and respected clinical pharmacy journal in the world.
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