Ghiani Marco, Zhuleku Evi, Dillenseger Anja, Maywald Ulf, Fuchs Andreas, Wilke Thomas, Ziemssen Tjalf
Institut für Pharmakoökonomie und Arzneimittellogistik e.V. (IPAM e.V.), 23966 Wismar, Germany.
Cytel Inc., 10785 Berlin, Germany.
J Clin Med. 2023 Feb 10;12(4):1441. doi: 10.3390/jcm12041441.
Real-world evidence in multiple sclerosis (MS) is limited by the availability of data elements in individual real-world datasets. We introduce a novel, growing database which links administrative claims and medical records from an MS patient management system, allowing for the complete capture of patient profiles. Using the AOK PLUS sickness fund and the Multiple Sclerosis Documentation System MSDS from the Center of Clinical Neuroscience (ZKN) in Germany, a linked MS-specific database was developed (MSDS-AOK PLUS). Patients treated at ZKN and insured by AOK PLUS were recruited and asked for informed consent. For linkage, insurance IDs were mapped to registry IDs. After the deletion of insurance IDs, an anonymized dataset was provided to a university-affiliate, IPAM e.V., for further research applications. The dataset combines a complete record of patient diagnoses, treatment, healthcare resource use, and costs (AOK PLUS), with detailed clinical parameters including functional performance and patient-reported outcomes (MSDS). The dataset currently captures 500 patients; however, is actively expanding. To demonstrate its potential, we present a use case describing characteristics, treatment, resource use, and costs of a patient subsample. By linking administrative claims to clinical information in medical charts, the novel MSDS-AOK PLUS database can increase the quality and scope of real-world studies in MS.
多发性硬化症（MS）的真实世界证据受到各个真实世界数据集中数据元素可用性的限制。我们引入了一个新颖且不断增长的数据库，该数据库将来自MS患者管理系统的行政索赔数据和医疗记录相链接，从而能够完整获取患者档案。利用德国AOK PLUS疾病基金以及临床神经科学中心（ZKN）的多发性硬化症文档系统（MSDS），开发了一个特定于MS的链接数据库（MSDS - AOK PLUS）。招募了在ZKN接受治疗并由AOK PLUS承保的患者，并征求他们的知情同意。为了进行链接，将保险ID映射到注册ID。在删除保险ID后，将一个匿名数据集提供给一家大学附属机构IPAM e.V.，用于进一步的研究应用。该数据集结合了患者诊断、治疗、医疗资源使用和费用的完整记录（AOK PLUS），以及包括功能表现和患者报告结局在内的详细临床参数（MSDS）。该数据集目前涵盖500名患者；然而，其规模正在积极扩大。为了展示其潜力，我们呈现了一个用例，描述了一个患者子样本的特征、治疗、资源使用和费用情况。通过将行政索赔与病历中的临床信息相链接，新颖的MSDS - AOK PLUS数据库可以提高MS真实世界研究的质量和范围。
