Rupp Rüdiger, Jersch Patrick, Schuld Christian, Schweidler Joachim, Benning Nils-Hendrik, Knaup-Gregori Petra, Aach Mirko, Badke Andreas, Hildesheim Andreas, Maier Doris, Weidner Norbert, Saur Marion
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg, Heidelberg, Deutschland.
Institut für Medizinische Informatik, Universitätsklinikum Heidelberg, Heidelberg, Deutschland.
Gesundheitswesen. 2021 Nov;83(S 01):S18-S26. doi: 10.1055/a-1538-6537. Epub 2021 Nov 3.
In Germany, treatment paths for patients with acute spinal cord injury (SCI) differ considerably depending on intrinsic, disease-specific and extrinsic factors. Which of these factors are associated with improved outcome with fewer subsequent complications and inpatient re-admissions is not clear. The German-wide, patient-centered, web-based ParaReg registry will be implemented to improve the long-term quality of patient care and the planning of treatment paths with increased cost-effectiveness.
In the 2017-18 conceptualization phase, the data model of the registry was developed in an iterative process of the ParaReg steering committee together with the extended DMGP board and patient representatives. In ParaReg, routine social and medical data as well as internationally established neurological, functional and participation scores will be documented. The assignment of a unique patient ID allows a lifelong, cross-center documentation of inpatient stays in one of the 27 SCI centers organized in the German-speaking Medical Society for SCI (DMGP). The ParaReg data protection concept and patient information/consent are based on the Open Source Registry for Rare Diseases (OSSE) which were extended by GDPR-relevant aspects.
In the realization phase, which started in 2019, the information technology infrastructure was implemented according to the clinical ID management module of the Technology and Methods Platform for Networked Medical Research (TMF). In parallel, the legal and ethical prerequisites for registry operation under the patronage of the DMGP were created. Recommendations of the working group data protection of the TMF were integrated into ParaReg's data protection concept. Based on the feedback from the alpha test phase with documentation of the hospitalization data of 40 patients, the ergonomics of the electronic case report forms were improved in particular for data entry on mobile devices.
After completion of the monocentric alpha test phase, the multicenter data acquisition was started in 5 DMGP-SCI centers. The sustainability of ParaReg is ensured by the structural and financial support of the DMGP after expiry of the funding by the German Federal Ministry of Education and Research (BMBF).
在德国，急性脊髓损伤（SCI）患者的治疗路径因内在因素、疾病特异性因素和外在因素而有很大差异。目前尚不清楚这些因素中哪些与更好的治疗结果、更少的后续并发症以及住院再入院率相关。将实施全德范围的、以患者为中心的基于网络的ParaReg登记系统，以提高患者护理的长期质量，并规划更具成本效益的治疗路径。
在2017 - 18年的概念化阶段，登记系统的数据模型在ParaReg指导委员会与扩展的德国脊髓损伤医学协会（DMGP）董事会及患者代表的迭代过程中得以开发。在ParaReg中，将记录常规社会和医疗数据以及国际上公认的神经学、功能和参与度评分。分配唯一的患者ID可实现对在德语区脊髓损伤医学协会（DMGP）组织的27个SCI中心之一住院情况的终身跨中心记录。ParaReg的数据保护概念和患者信息/同意书基于罕见病开源登记系统（OSSE），并在与GDPR相关的方面进行了扩展。
在2019年开始的实施阶段，信息技术基础设施根据网络医学研究技术与方法平台（TMF）的临床ID管理模块进行了实施。同时，在DMGP的支持下建立了登记系统运行的法律和伦理前提条件。TMF数据保护工作组的建议被纳入ParaReg的数据保护概念。基于对40例患者住院数据进行记录的alpha测试阶段的反馈，尤其改进了电子病例报告表在移动设备上的数据录入人体工程学设计。
在单中心alpha测试阶段完成后，于5个DMGP - SCI中心开始了多中心数据采集。在德国联邦教育与研究部（BMBF）的资金到期后，DMGP的结构和财政支持确保了ParaReg的可持续性。
