Gundler Christopher, Gottfried Karl, Wiederhold Alexander Johannes, Ataian Maximilian, Wurlitzer Marcus, Gewehr Jan Erik, Ückert Frank
Institute for Applied Medical Informatics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Research Data Facility, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Interact J Med Res. 2024 Oct 1;13:e51563. doi: 10.2196/51563.
Clinical routine data derived from university hospitals hold immense value for health-related research on large cohorts. However, using secondary data for hypothesis testing necessitates adherence to scientific, legal (such as the General Data Protection Regulation, federal and state protection legislations), technical, and administrative requirements. This process is intricate, time-consuming, and susceptible to errors.
This study aims to develop a platform that enables clinicians to use current real-world data for testing research and evaluate advantages and limitations at a large university medical center (542,944 patients in 2022).
We identified requirements from clinical practitioners, conceptualized and implemented a platform based on the existing components, and assessed its applicability in clinical reality quantitatively and qualitatively.
The proposed platform was established at the University Medical Center Hamburg-Eppendorf and made 639 forms encompassing 10,629 data elements accessible to all resident scientists and clinicians. Every day, the number of patients rises, and parts of their electronic health records are made accessible through the platform. Qualitatively, we were able to conduct a retrospective analysis of Parkinson disease over 777 patients, where we provide additional evidence for a significantly higher proportion of action tremors in patients with rest tremors (340/777, 43.8%) compared with those without rest tremors (255/777, 32.8%), as determined by a chi-square test (P<.001). Quantitatively, our findings demonstrate increased user engagement within the last 90 days, underscoring clinicians' increasing adoption of the platform in their regular research activities. Notably, the platform facilitated the retrieval of clinical data from 600,000 patients, emphasizing its substantial added value.
This study demonstrates the feasibility of simplifying the use of clinical data to enhance exploration and sustainability in scientific research. The proposed platform emerges as a potential technological and legal framework for other medical centers, providing them with the means to unlock untapped potential within their routine data.
来自大学医院的临床常规数据对大规模队列的健康相关研究具有巨大价值。然而，使用二次数据进行假设检验需要遵守科学、法律（如《通用数据保护条例》、联邦和州保护立法）、技术和管理要求。这个过程复杂、耗时且容易出错。
本研究旨在开发一个平台，使临床医生能够使用当前的真实世界数据进行研究测试，并在一家大型大学医学中心（2022年有542,944名患者）评估其优缺点。
我们确定了临床医生的需求，基于现有组件进行概念化并实施了一个平台，并对其在临床实际中的适用性进行了定量和定性评估。
所提议的平台在汉堡-埃彭多夫大学医学中心建立，使所有住院科学家和临床医生都能访问包含10,629个数据元素的639份表格。每天患者数量都在增加，他们的部分电子健康记录可通过该平台获取。定性方面，我们能够对777例帕金森病患者进行回顾性分析，通过卡方检验（P<.001），我们发现与无静止性震颤的患者（255/777，32.8%）相比，有静止性震颤的患者中动作性震颤的比例显著更高（340/777，43.8%），我们为此提供了额外证据。定量方面，我们的研究结果表明在过去90天内用户参与度有所提高，这突出了临床医生在其常规研究活动中对该平台的采用率不断增加。值得注意的是，该平台促进了从600,000名患者中检索临床数据，强调了其巨大的附加值。
本研究证明了简化临床数据使用以加强科研探索和可持续性的可行性。所提议的平台成为其他医学中心潜在的技术和法律框架，为它们提供了挖掘其常规数据中未开发潜力的手段。
