Developing scalable algorithms to incorporate unstructured electronic health records for causal inference based on real-world data

项目总结/摘要 美国医疗保健系统的日常运作产生了大量的电子存储数据， 在受控研究环境之外的环境中提供患者护理。的 利用这些数据为未来的治疗选择提供信息，并改善患者护理和所有患者的结局 病人在生成数据的系统中的作用得到了广泛的认可。考虑到 常规护理数据和涵盖数百万患者的丰富电子医疗数据库， 加强对这些数据分析的严谨性。我们小组以前已经开发了一种分析方法， 在分析常规护理数据库时减少偏倚，这在50多个经验性数据库中已被证明是有效的。 对一系列主题和数据源进行研究。然而，这种方法目前无法纳入 记录在电子健康记录中的自由文本信息，如临床笔记和报告。这 限制使得大量丰富的患者信息未被充分利用于临床研究。因此，我们的目标是 调整和完善一套已建立的计算机化自然语言处理算法，可以识别和 从电子健康记录的临床记录和报告中提取有用的信息，并将其纳入 在我们经过验证的平衡不同对照组背景风险的分析方法中， 以确保在比较不同的治疗方案时进行公平的评价。为了测试这个新集成的， 增强的方法，我们将实施和适应它在模拟研究中，我们可以评估和改进 这些新的分析方法的性能在一个可控的，但现实的方式。此外，我们将评估 我们的新方法在8项比较内科或外科治疗的实际研究中的表现， 与患者高度相关。为了确保最高水平的数据完整性和质量，我们将多个 2007年至2016年的医疗保健利用（索赔）数据库，包括3个电子健康记录系统， 包括马萨诸塞州、北卡罗来纳州和德克萨斯州各一个。这些数据将允许测试我们新的 在各种护理提供系统和数据环境中的综合方法，这将是非常翔实的 我们的产品在现实世界中的应用。

Project Summary/Abstract The routine operation of the US Healthcare system produces an abundance of electronically-stored data that captures the care of patients as it is provided in settings outside of controlled research environments. The potential for utilizing these data to inform future treatment choices and improve patient care and outcomes of all patients in the very system that generates the data is widely acknowledged. Given these key properties of the routine-care data and the abundance of electronic healthcare databases covering millions of patients, it is critical to strengthen the rigor of analyses of such data. Our group has previously developed an analytic approach to reduce bias when analyzing routine-care databases, which has proven effective in more than 50 empirical research studies across a range of topics and data sources. However, this approach currently cannot incorporate free-text information that is recorded in electronic health records, such as clinical notes and reports. This limitation has left a large amount of rich patient information underutilized for clinical research. We thus aim to adapt and refine a set of established computerized natural language processing algorithms that can identify and extract useful information from the clinical notes and reports in electronic health records and incorporate them into our validated analytical approach for balancing background risks of different comparison groups, a key step to ensure fair evaluation when comparing different therapeutic options. To test this newly integrated and augmented approach, we will implement and adapt it in simulation studies where we can evaluate and improve the performance of these new analytic methods in a controlled but realistic fashion. In addition, we will assess the performance of our new approach in 8 practical studies comparing medical or surgical treatments that are highly relevant to patients. To ensure highest level of data completeness and quality, we have linked multiple healthcare utilization (claims) databases, spanning from 2007 to 2016, with 3 electronic health records systems, including one each in Massachusetts, North Carolina, and Texas. This data will allow testing of our newly integrated approach in a variety of care delivery systems and data environments, which will be very informative for the application of our products in the real-world settings.