Generating consistent longitudinal real-world data to support research: lessons from physical therapists.
Generating consistent longitudinal real-world data to support research: lessons from physical therapists.
复制标题
DOI：
10.1002/acr2.11465
复制
发表时间：
2022-09
影响因子：
3.4
通讯作者：
Franklin, Patricia D
中科院分区：
文献类型：
--
作者：
Oatis, Carol A;Konnyu, Kristin J;Franklin, Patricia D
使用真实世界数据 (RWD) 的研究人员希望为临床有效性研究 (CER) 和以患者为中心的结果研究 (PCOR) 问题提供答案。然而，这些结果的可靠性和有效性取决于数据的完整性和一致性。由于 RWD 并不是以研究为主要目标而产生的，因此它们的常规临床干预记录不完整且不一致。 RWD 的两个最常见来源是临床医生记录的数据和存储在电子健康记录 (EHR) 中的卫生系统使用数据以及管理数据。 RWD 的两种来源均可在卫生系统内轻松获得或汇总在区域数据库中，例如 PCORNet 或行政索赔数据。 EHR 数据质量尤其受到数据结构和文档不一致以及跨时间和设置的碎片化的影响。例如，初级保健医生的 EHR 中没有系统记录处方补充或物理治疗 (PT) 干预措施。在风湿病实践中，使用美国风湿病学会风湿病信息学系统有效性登记的类风湿关节炎质量测量的表现根据所采用的具体 EHR 的不同而有所不同 (1)。在慢性病时代，当跨环境的 EHR 中包含系统且全面的干预措施临床记录时，现有数据的丰富性以及由这些数据驱动的研究价值将得到增强。 EHR 是现实世界 CER 和 PCOR 应用的主要数据源，但当临床记录不一致、不完整且可能存在偏见时，可能会成为偏差来源 (2)。 EHR 数据缺失是由于临床医生在记录内容、记录时间或患者在多个卫生系统或社区提供者接受护理方面不一致。人类决策决定了 EHR 中数据元素的内容和定义（或不决定），因此导致干预和结果数据不完整 (3)。因此，使用当今的 EHR 及其临床数据进行的研究存在有效性风险，原因有两个主要因素：1）护理过程中临床干预和结果记录不一致；2）缺乏跨时间和地点的临床记录整合。全膝关节 (TKR) 和髋关节置换手术后，PT 提供者通常不隶属于进行手术的医疗系统。因此，他们的文件并不存在于患者的外科 EHR 中。此外，尽管 PT 办公室 EHR 记录了就诊时间和时长，但很少有 PT EHR 记录了 PT 干预的全部内容（即特定的 PT 组成部分）；它们的强度、频率和进展；或 PT 的“剂量”。因此，由于缺乏完整、一致的 PT 数据来探索 PT 护理的最佳实践，CER 使用真实世界的证据受到阻碍。这是一个特别成问题的问题，因为 TKR 是当今美国最常见和最昂贵的手术之一，并且 TKR 后的 PT 实践存在很大差异，这是有据可查的 (4, 5)。最近，COVID-19 疫情引入了新的 TKR 期间实践模式，EHR 指出尚未准备对其进行评估。当今 RWD 中的不完整数据无法生成 PT 干预内容和剂量以及 TKR 后护理模式变化的最佳实践 (6, 7)。能否提高 RWD 的质量以服务于研究并最终服务于最佳实践？作为临床医生可以生成一致且标准化的临床数据以提高常规患者护理过程中的数据质量的概念证明，我们与 PT 临床医生和专家合作生成了一个基于网络的综合系统......
Researchers using real-world data (RWD) hope to generate answers to clinical effectiveness research (CER) and patientcentered outcomes research (PCOR) questions. However, reliability and validity of these results are dependent on data completeness and consistency. Because RWD are not generated with research as the primary goal, they suffer from incomplete and inconsistent documentation of routine clinical interventions. The two most common sources of RWD are clinician-documented and health system use data stored in electronic health records (EHRs) and administrative data, respectively. Both sources of RWD are readily available within health systems or aggregated in regional databases, such as PCORNet or administrative claims data. EHR data quality, in particular, suffers from inconsistent data structure and documentation as well as fragmentation across time and settings. For example, prescription refills or physical therapy (PT) interventions are not systematically documented in the primary care physician’s EHR. In rheumatology practices, performance on rheumatoid arthritis quality measures using the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness registry varies according to the specific EHR employed (1). In an era of chronic disease, the richness of existing data and the value to research driven by these data will be enhanced when systematic and comprehensive clinical documentation of interventions is included in the EHR across settings. The EHR is the primary data source for real-world CER and PCOR applications but can be a source of bias when clinical documentation is inconsistent, incomplete, and potentially biased (2). Missing EHR data result from clinician inconsistencies in what and when to document or when patients receive care across multiple health systems or from community-based providers. Human decisions determine content and definition of the data elements (or not) in the EHR, hence contributing to incomplete intervention and outcome data (3). Thus, research using today’s EHR, and its clinical data, risks validity because of two major factors: 1) inconsistent clinical intervention and outcome documentation in the course of care and 2) lack of integration of clinical documentation across time and place. Following total knee (TKR) and hip replacement surgeries, PT providers are commonly not affiliated with the health system where the surgery was performed. Thus, their documentation does not reside in the patient’s surgical EHR. Further, although PT office EHRs capture visit time and length, few PT EHRs capture the full content of the PT interventions (ie, specific PT components); their intensity, frequency, and progression; or the “dose” of PT. Thus, CER using real-world evidence is stymied by the lack of complete, consistent PT data to explore best practices in PT care. This is particularly problematic because TKR is one of the most common and costly procedures in the United States today, and wide variation in PT practice after TKR is well documented (4, 5). More recently, the COVID-19 epidemic introduced new peri-TKR practice patterns that EHR notes are not prepared to evaluate. The incomplete data in today’s RWD cannot generate best practice for content and dosage of PT interventions and changes in care patterns post TKR (6, 7). Can the quality of RWD be improved to serve research and, ultimately, best practice? As proof of concept that clinicians can generate consistent and standardized clinical data to enhance data quality in the course of routine patient care, we collaborated with PT clinicians and experts to generate a web-based comprehensive system to …