Data Infrastructure for Post-Marketing Comparative Effectiveness Studies

描述（由申请人提供）：本申请涉及广泛的挑战领域（05）：比较有效性研究和具体的挑战主题05- ag -101*：上市后比较有效性研究的数据基础设施。数据基础设施是进行药物和其他治疗药物批准后比较有效性研究的迫切需要。研究人员建议利用他们之前的工作和已建立的数据资源，将他们目前1999-2005年的五个大型医疗补助计划（加利福尼亚、佛罗里达、纽约、俄亥俄和宾夕法尼亚）数据库扩展到2007年（总共有6000万受益人），并从这些州的双重参保者的医疗保险a、B和D部分获取和链接数据。这将允许对医疗补助受益人进行研究，包括那些共同参加医疗保险的人、残疾人和养老院的居民。通过与国立卫生研究院、食品和药物管理局以及三个主要的国家研究网络的研究合作，这些新关联的数据可作为比较有效性研究的国家资源：美国国立卫生研究院资助的临床和转化科学奖联盟，医疗质量和研究局（AHRQ）资助的治疗学教育和研究中心（CERTs），以及AHRQ资助的关于有效性决策的发展证据（DEcIDE）网络。此外，为了证明这个新扩展数据库的效用，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。具体来说，调查人员将通过确定疗养院居民和非疗养院居民、纯医疗补助和医疗补助-医疗保险受益人最常用的治疗类别，确定医疗补助参保者的总体药物使用情况，包括处方量和成本。然后，为了证明这一新的数据资源在比较有效性研究中的实用性，他们将比较不同策略的初始补充和监测钾对新开始使用利尿剂和新开始使用噻嗪类利尿剂的患者在预防1)全因死亡和2)心源性猝死/室性心律失常方面的有效性。

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.