Data Infrastructure for Post-Marketing Comparative Effectiveness Studies

描述（由申请人提供）：本申请涉及广泛挑战领域（05）：比较有效性研究和特定挑战主题05-AG-101*：上市后比较有效性研究的数据基础设施。迫切需要数据基础设施来进行药物和其他治疗剂的批准后比较有效性研究。研究人员建议利用他们以前的工作和建立的数据资源，通过扩展他们目前的1999-2005年数据库的五个大型医疗补助计划（加州，佛罗里达，纽约，俄亥俄州，和宾夕法尼亚州）到2007年（总人口60万受益人），并获得和链接数据从医疗保险部分A，B，和D在这些国家的双重登记。这将允许研究医疗补助受益人，包括那些共同参加医疗保险，残疾人和养老院居民。这些新链接的数据可以通过与美国国立卫生研究院、美国食品药品监督管理局和三个主要的国家研究网络的研究合作，作为比较有效性研究的国家资源：美国国立卫生研究院赞助的临床和转化科学奖联盟，医疗质量和研究机构（AHRQ）资助的治疗学教育和研究中心（CERT），和AHRQ资助的发展证据，为有效性决策提供信息（DECIDE）网络。此外，为了证明这个新扩展的数据库的实用性，研究人员建议使用这些新链接的数据进行药物利用和比较有效性研究。具体而言，研究人员将通过确定最频繁分配的治疗类，按处方量和成本，为疗养院居民和疗养院非居民，仅医疗补助和医疗补助-医疗保险受益人，来表征医疗补助登记者的整体药物使用情况。然后，为了证明这种新的数据资源在比较有效性研究中的效用，他们将比较新开始使用袢利尿剂和新开始使用噻嗪类利尿剂的患者中初始补充和监测钾的不同策略在预防1）全因死亡和2）心源性猝死/室性心律失常方面的有效性。 公共卫生相关性：本研究将为开展上市后比较有效性研究提供重要的永久性国家数据资源。此外，它还将为典型代表性不足的人群提供重要的药物利用数据，并解决接受利尿剂的患者中监测和补充血清钾的策略的比较有效性。通过汇编医疗补助和医疗保险健康保险索赔（包括D部分）的大型纵向和当前数据资源，该项目将创建一个重要的，永久的国家数据基础设施，用于进行上市后比较有效性研究，从而为临床医生和患者提供选择替代疗法或方法的证据基础。为了证明这一基础设施的效用，该项目将检查医疗补助注册者的药物利用情况，包括那些也参加医疗保险的人，并评估利尿剂使用者中钾的补充和监测的不同策略，以预防1）全因死亡和2）心源性猝死和室性心律失常，这两者都是对患者，临床医生和政策制定者重要的严重后果。

DESCRIPTION (provided by applicant): This application addresses broad challenge area (05): Comparative Effectiveness Research and specific challenge topic 05-AG-101*: Data Infrastructure for Post-Marketing Comparative Effectiveness Studies. Data infrastructure is badly needed to conduct post-approval comparative effectiveness studies of drugs and other therapeutic agents. The investigators propose to leverage their previous work and established data resources by extending their current 1999-2005 database of five large Medicaid programs (California, Florida, New York, Ohio, and Pennsylvania) through 2007 (a total ever-enrolled population of 60 million beneficiaries), and obtaining and linking data from Medicare Parts A, B, and D on dual enrollees in those states. This will allow the study of Medicaid beneficiaries, including those co-enrolled in Medicare, the disabled, and nursing home residents. These newly linked data can serve as a national resource for comparative effectiveness research via research collaborations with the National Institutes of Health, the Food and Drug Administration, and three major national research networks: the National Institutes of Health-sponsored Clinical and Translational Science Award Consortium, the Agency for Healthcare Quality and Research (AHRQ)- funded Centers for Education and Research on Therapeutics (CERTs), and the AHRQ-funded Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network. Further, to demonstrate the utility of this newly extended database, the investigators propose to perform drug utilization and comparative effectiveness research using these newly linked data. Specifically, the investigators will characterize overall medication use in Medicaid enrollees by identifying the most frequently dispensed therapeutic classes, both by prescription volume and by cost, for nursing home residents and nursing home non-residents, in Medicaid-only and Medicaid-Medicare beneficiaries. Then, to demonstrate the utility of this novel data resource for comparative effectiveness research, they will compare the effectiveness of different strategies for initial supplementation and monitoring of potassium in patients newly starting loop diuretics and those newly starting thiazide diuretics with regard to preventing 1) all-cause death and 2) sudden cardiac death / ventricular arrhythmia. PUBLIC HEALTH RELEVANCE: This study will result in an important, permanent, national data resource for conducting post-marketing comparative effectiveness studies. In addition, it will provide important drug utilization data for typically underrepresented populations, and address the comparative effectiveness of strategies for monitoring and supplementing serum potassium in patients receiving diuretics. By compiling a very large, longitudinal, and current data resource of Medicaid and Medicare health insurance claims (including Part D), this project will create an important, permanent, national data infrastructure for conducting post-marketing comparative effectiveness studies, thereby providing clinicians and patients with an evidence base for selecting among alternative therapies or approaches. To demonstrate the utility of this infrastructure, this project will examine drug utilization in Medicaid enrollees, including those also enrolled in Medicare, and evaluate differing strategies for supplementation and monitoring of potassium among diuretic users in preventing 1) all-cause death and 2) sudden cardiac death and ventricular arrhythmia, which are both serious outcomes of importance to patients, clinicians, and policy makers.