Improving comparative effectiveness research through electronic health records continuity cohorts

通过电子健康记录连续性队列改进比较有效性研究

基本信息

批准号：
9365420
负责人：
JOSHUA K LIN
金额：
$ 34.11万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-01 至 2021-08-31
项目状态：
已结题

项目摘要

Title: Improving comparative effectiveness research through electronic health records continuity cohorts PI: Joshua Lin, MD, MPH Abstract (about 30 lines) Epidemiologic analyses of health care data can provide critical evidence on the effectiveness and safety of therapeutics in the routine care setting since clinical trials often exclude frail and older patients who are the primary consumers of most medications. Electronic health record (EHR) databases contain rich clinical information vital for many comparative effectiveness studies and have been increasingly used for drug research. There are currently more than 50 EHR-based research networks in the US. It is thus critical to understand how we can conduct valid comparative clinical studies with EHR data. However, other than few highly integrated plans, most US EHR systems do not have comprehensive capture of medical encounters across the care continuum and may miss substantial amounts of information. Exposures, co-morbidities, and health outcomes that are recorded at a clinic or hospital outside of a given EHR system are "invisible" to the investigator, increasing misclassification or complete omission of essential variables. While such issues are pervasive, no prior study has ever quantified the magnitude of resultant bias and how to remedy the situation if linkage of more information is not feasible. To address this knowledge gap, we have combined longitudinal claims data from Medicare with EHR patient data from a large multi-center health care system as a `gold standard' setup where the claims data comprehensively capture medical information across care settings and provider systems and EHR provides necessary clinical data. We will (1) use these `gold standard' data to identify `EHR continuity cohorts' for whom the EHR system captures a high proportion of all encounters and evaluate whether misclassification/omission of a list of essential variables in the comparative effectiveness research is substantially reduced within vs outside of the EHR continuity cohort; (2) develop strategies to identify the EHR continuity cohort based on a set of proxy indicators available in typical EHR databases and validate the candidate prediction rules internally in a sample within the given EHR and externally using a second EHR system that is also linked to Medicare claims data; (3) assess research validity and generalizability in the EHR continuity cohorts in several empirical studies; and (4) Develop structured recommendation on how to conduct comparative effectiveness research using high-validity EHR continuity cohorts in an EHR system without linked claims data and make our program public available to facilitate future research using EHR-based research networks.

标题：通过电子健康记录改进比较有效性研究连续性队列 PI：Joshua Lin，医学博士、公共卫生硕士摘要（约30行）医疗保健数据的流行病学分析可以提供有关有效性和安全性的关键证据常规护理环境中的治疗方法，因为临床试验通常排除体弱和老年患者，他们是大多数药物的主要消费者。电子健康记录 (EHR) 数据库包含丰富的临床信息这些信息对于许多比较有效性研究至关重要，并且已越来越多地用于药物研究。目前美国有超过 50 个基于 EHR 的研究网络。因此，了解如何我们可以利用 EHR 数据进行有效的比较临床研究。然而，除了少数高度集成的计划中，大多数美国 EHR 系统无法全面捕获整个护理过程中的医疗遭遇连续体，可能会丢失大量信息。暴露、合并症和健康结果在给定 EHR 系统之外的诊所或医院记录的信息对于研究者来说是“不可见的”，增加错误分类或完全遗漏基本变量。虽然此类问题普遍存在，但先前的研究已经量化了由此产生的偏见的严重程度，以及如果将以下因素联系起来如何纠正这种情况：更多信息是不可行的。为了解决这一知识差距，我们结合了纵向索赔数据来自 Medicare 的 EHR 患者数据来自大型多中心医疗保健系统，作为“黄金标准”设置索赔数据全面捕获跨护理机构和提供者系统的医疗信息 EHR 提供必要的临床数据。我们将 (1) 使用这些“黄金标准”数据来识别“EHR 连续性” EHR 系统捕获了所有遭遇中很大比例的群体，并评估是否比较有效性研究中错误分类/遗漏了一系列基本变量 EHR 连续性队列内部与外部相比大幅减少； (2) 制定识别 EHR 的策略基于典型 EHR 数据库中可用的一组代理指标的连续性队列，并验证候选预测规则在给定 EHR 内的样本内部以及在外部使用第二个 EHR 还链接到医疗保险索赔数据的系统； (3) 评估 EHR 研究的有效性和普遍性多项实证研究中的连续性队列； (4) 制定关于如何进行的结构化建议在 EHR 系统中使用高有效性 EHR 连续性队列进行比较有效性研究，无需链接索赔数据并使我们的计划公开，以促进使用基于 EHR 的未来研究研究网络。