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

总结/摘要 医疗实践不断发展，大量资源被分配用于发展医疗保健。 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， 食品和药物管理局（FDA）的支持批准证明了新治疗的疗效; 一旦获得批准，现有治疗方法的新证据可能表明它们无效或不安全。理解 新的临床证据是否以及如何被整合到实践中是至关重要的，从a） 改善患者安全和健康结果; B）解决获得服务方面的种族和社会经济平等问题， c）制定计划和政策，鼓励使用高价值、有效的治疗方法，减少废弃 d）通过将有限的卫生保健预算分配给 最有效的使用。 COVID-19大流行提供了一个独特的机会，通过以下方式研究证据在实践中的传播 观察医生对快速变化的信息的采用和不采用行为， 在COVID-19背景下继续使用普通药物的潜在治疗和风险。这项建议 在我们先前关于废除有害或无效医疗做法的工作的基础上， 可能与采用和停用药物的速率和时间相关的因素 治疗。我们将检查处方填写和索赔为基础的使用一套有针对性的药物有关， COVID-19使用的数据来自医疗保险索赔的收费服务（FFS）登记者。COVID-19特别是 受影响的老年人、残疾人和慢性病患者，其中许多人面临更高的严重发病风险 和死亡率，并可能由于在大流行期间缺乏医疗保健。我们 将调查COVID-19相关药物的处方如何响应国家级药物政策，FDA安全 通信和COVID-19对医疗系统的压力。我们将评估患者 特性（例如，种族和民族、年龄和主要合并症），以及医生和医疗实践 组织特征与这些处方模式相关联。 三项深入的COVID-19案例研究将评估与以下疾病相关的治疗的接受和停用情况： 在公众注意力密切关注的情况下， 每一个发展和预印生物医学手稿在大众媒体上进行了详细的讨论。 在高度不确定性和高负担的背景下探索采用和停用治疗方法， 疾病的流行将提供重要的见解，信息质量的作用，在医生的决定 制作。此外，这些案例将使我们能够探讨国家一级监管的有效性， 治疗。特别是，一些州对羟氯喹进行了管制，以应对人们的担忧， 将有足够的药物用于治疗非COVID-19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.