Enhanced Data to Accelerate Complex Patient Comparative Effectiveness Research

描述（由申请人提供）：我们的前提是易于使用的数据产品将加速有意义的比较有效性研究（CER）。索赔数据极难使用，需要丰富的经验才能最适当地将这些数据汇总到患者水平。还需要专业知识来创建有意义的变量，如治疗，协变量和索赔数据的终点。我们建议开发和传播一个大型的易于使用的分析文件和预编码的算法套件，以研究复杂的心血管疾病（CVD）患者的二级预防策略的比较有效性。对CVD实践指南的依从性随着年龄的增长而下降，这可能是由于对最年长的老年人和患有多种合并症的人的各种二级预防策略的有效性的不确定性。爱荷华大学老年人治疗学教育和研究中心的这项合作（lowa CERT）和海盗计算系统和服务，Inc（Buccaneer）建议使用医疗保险慢性疾病仓库（CCW）作为我们的主要输入来源，以创建一个由180万名患有AMI或中风的医疗保险受益人组成的纵向队列。TIA于2007年进行，并随访至2008年，以评估复发事件、并发症和死亡。大样本确保了检验二级预防策略在具有复杂病情的优先亚组（例如80岁以上的糖尿病患者）中的相对有效性的能力。至少2个SAS（r）分析数据文件将包含同一CVD队列的不同详细程度和汇总。从CCW中的50多个原始索赔、药物事件和人口统计学（入组）数据文件中，我们将处理这些文件，以便随着时间的推移和在所有护理环境中加入我们队列中每个受益人的信息。分析文件将包括：1）患者级汇总数据文件，其汇总了每个受益人在护理环境中接受的护理，并且我们将从该文件创建2）汇总治疗和结果数据文件，以允许快速查询和报告（例如，用于可行性分析和初步数据分析）。创建数据产品的代码和算法预计将简化未来CER研究的新临床人群中未来数据产品的开发。联邦CERT和CTSA网络是传播有关数据产品信息的自然通信资产。我们将在一个研究项目中测试数据产品，该研究项目的重点是他汀类药物在患有多种合并症的老年患者中的有效性和安全性的不确定性。 公共卫生相关性：心血管疾病（CVD）是导致死亡的主要原因，其中超过80%发生在565岁的人群中，但没有积极遵循循证指南，合并症的影响尚不清楚。我们将开发一种易于使用的数据产品，用于对180万名医疗保险心脏病发作和中风患者进行比较有效性研究，并通过爱荷华州老年人治疗学教育和研究中心与临床和转化科学研究所之间的合作支持其使用。

DESCRIPTION (provided by applicant): It is our premise that easy to use data products will accelerate meaningful comparative effectiveness research (CER). Claims data are extremely difficult to use, requiring extensive experience to most appropriately aggregate these data to the patient level. Specialized expertise is also required to create meaningful variables such as treatments, covariates, and endpoints from claims data. We propose to develop and disseminate a large easy to use suite of analytical files and pre-coded algorithms to study comparative effectiveness of secondary prevention strategies among complex patients with cardiovascular disease (CVD). Adherence to CVD practice guidelines declines with age and this may be explained by uncertainty over the effectiveness of various secondary prevention strategies for the oldest old and those with multiple comorbidities. This collaboration of the University of lowa Older Adults Center for Education and Research on Therapeutics (lowa CERT) and Buccaneer Computing Systems & Services, Inc (Buccaneer) proposes to use the Medicare Chronic Condition Warehouse (CCW) as our major input source to create a longitudinal cohort of 1.8 million Medicare beneficiaries admitted with AMI or stroke/TIA in 2007 and followed through 2008 for recurrent events, complications and death. The large sample ensures power to test comparative effectiveness of secondary prevention strategies in priority subgroups with complex conditions, e.g. people over 80 years old with diabetes. At least 2 SAS(r) analytic data files will contain different levels of detail and aggregation for the same CVD cohort. From the more than fifty raw claims, drug event, and demographic (enrollment) data files in CCW, we will process the files to join the information for each beneficiary in our cohort over time and across all care settings. The analytical files will consist of: 1) patient-level aggregated data file(s) that summarize across care settings the care received by each beneficiary, and from this file we will create 2) summary treatment and outcome data files, to allow for rapid querying and reporting (e.g., for feasibility analyses and preliminary data analysis).The code and algorithms to create the data product are expected to streamline the development of future data products in new clinical populations for future CER studies. The federal CERT and CTSA networks are natural communication assets to disseminate information about the data product. We will test the data product in a research project focused on the uncertainty around statin effectiveness and safety in the aging patient with multiple comorbidities. PUBLIC HEALTH RELEVANCE: Cardiovascular disease (CVD) is the leading cause of death and over 80% of this is in people age 565, yet evidence-based guidelines are not aggressively followed, with the effect of co-morbidities not known. We will develop an easy to use data product for comparative effectiveness studies of 1.8 million Medicare heart attack and stroke patients and support its use through a collaboration between the lowa Older Adults Center for Education and Research on Therapeutics and the Institute for Clinical and Translational Science.