Rapid learning during a public health emergency: COVID-19 related medication treatment patterns in Medicare

摘要/摘要 医疗实践不断发展，大量资源被分配给发展医疗 创新和加强新的和现有的治疗方法的临床证据。在大多数情况下，新的证据 食品和药物管理局(FDA)的支持批准证明了新疗法的有效性；在 如果获得批准，现有治疗方法的新证据可能会显示它们无效或不安全。理解 从a的角度来看，新的临床证据是否以及如何整合到实践中是至关重要的) 改善患者的安全和健康结果；b)解决获得和 使用；c)设计方案和政策，鼓励使用高价值、有效的治疗方法，减少遗弃 有效和有害的治疗；d)通过将有限的保健预算分配给 它们最有效的利用。 新冠肺炎大流行为研究证据扩散到实践中提供了一个独特的机会 观察医生对快速变化的信息的采用和取消采用行为 在新冠肺炎背景下继续使用常见药物的潜在治疗方法和风险。这项建议 在我们先前关于减少有害或无效医疗做法的工作的基础上，通过引入其他 可能与采用和停用药物的比率和时间相关的因素 治疗。我们将检查与以下相关的一组有针对性的药物的处方填写和基于声明的使用 新冠肺炎使用联邦医疗保险报销服务(FFS)参与者的数据。新冠肺炎特别有 受影响的老年人、残疾人和慢性病患者，其中许多人面临着更高的严重发病率风险 以及疾病的死亡率，可能是由于在大流行期间得不到医疗护理。我们 将调查新冠肺炎相关药物的处方如何回应国家级药品政策，FDA的安全性 通信，以及新冠肺炎对医疗体系的压力。我们将评估患者的耐心程度 特征(例如，种族和族裔、年龄和主要并存)，以及医生和医疗实践 组织特征与这些处方模式相关。 三个深入的新冠肺炎案例研究将评估与以下相关的治疗方法的采用和停用 在公众注意力密切协调的背景下，较低质量的证据和更快的周转 每一次开发和印刷前的生物医学手稿都在大众媒体上进行了详细的讨论。 探讨在高不确定性和高负担的背景下采用和不采用治疗方法 疾病的流行将为信息质量在医生决策中的作用提供重要的见解 制作。此外，这些案例将使我们能够探索国家层面监管的有效性 治疗。特别是，羟氯喹在一些州受到了监管，以回应人们对 将有足够的药物供使用该药物的人治疗非新冠肺炎疾病。

SUMMARY/ABSTRACT Medical practice is continuously evolving, with substantial resources allocated to developing medical innovations and enhancing clinical evidence on new and existing treatments. In most cases, new evidence supporting approval by the Food and Drug Administration (FDA) demonstrates efficacy of new treatments; after approval, new evidence for existing treatments may show them to be ineffective or unsafe. Understanding whether and how new clinical evidence is integrated into practice is critical from the perspectives of a) improving patient safety and health outcomes; b) addressing racial and socioeconomic equity in access and use; c) designing programs and policies to encourage use of high value, effective treatments and abandon less effective and harmful treatments; d) containing health care costs by allocating limited health care budgets to their most effective use. The COVID-19 pandemic provides a unique opportunity to study the diffusion of evidence into practice by observing adoption and de-adoption behavior of physicians in response to rapidly changing information about potential treatments and risks of continued use of common drugs in the context of COVID-19. This proposal builds on our prior work on de-adoption of harmful or ineffective medical practices by introducing additional factors that could be associated with the rates and timing of adoption and de-adoption of pharmaceutical treatments. We will examine prescription fills and claims-based use of a targeted set of drugs related to COVID-19 using data from Medicare claims for Fee-for-Service (FFS) enrollees. COVID-19 has particularly affected older adults and the disabled and chronically ill, many of whom face increased risk of severe morbidity and mortality from the disease, and potentially from lack of access to medical care during the pandemic. We will investigate how prescribing of COVID-19-related drugs responds to state-level drug policies, FDA safety communications, and COVID-19 pressures on the healthcare system. We will assess how patient characteristics (e.g., race and ethnicity, age, and key comorbidities), as well as physician and medical practice organization characteristics are associated with these prescribing patterns. Three in-depth COVID-19 case studies will assess uptake and de-adoption of treatments associated with lower quality evidence and more rapid turnaround in a context where public attention is closely attuned to every development and pre-print biomedical manuscripts are discussed at length in the popular press. Exploring adoption and de-adoption of treatments in a context of high uncertainty and high burden and prevalence of disease will provide important insights into the role of information quality in physician decision making. In addition, these cases will allow us to explore the effectiveness of state-level regulation of treatments. In particular, hydroxychloroquine was regulated in some states in response to fears that not enough would be available for people using the drug to treat non-COVID-19 conditions.