(130) Linkage of German Healthcare Administrative Claims and The MSDS 3D Registry for Enhancing Real-World Evidence Capabilities in Multiple Sclerosis

Publication Number: 1175

Background: The Expanded Disability Status Scale (EDSS) is a standard measure of disability in multiple sclerosis (MS). However, its limited availability in most electronic health records or administrative claims databases significantly hinders the prospects of real-world evidence studies in MS.

Objectives: To develop a linked database that combines the potentials of claims and registry data in MS, supplementing disease severity indicators such as the EDSS.

Methods: We developed a retrospective linked database using the German AOK PLUS statutory health insurance fund and Multiple Sclerosis Management System 3D (MSDS 3D) registry from the Center of Clinical Neuroscience Dresden (ZKN). While AOK PLUS provides a record of all inpatient and outpatient diagnoses, treatment history, and healthcare resource use and costs, it lacks data on disease severity including EDSS. In contrast, ZKN holds a record of clinical factors such as MS clinical history and performance, including EDSS and functional system sub-scores. We recruited patients in MSDS 3D who were insured by AOK PLUS and had at least one EDSS assessment between 01/10/2015 and 30/06/2019. After obtaining informed consent, AOK PLUS received a list of pseudonymized registry IDs and insurance IDs. Using the insurance number, which was later excluded, the registry ID was mapped to a claims ID creating a linked dataset.

Results: Overall, 100 patients with at least one EDSS score in MSDS 3D were linked, and a cumulative 620 scores were available across all patients in the inclusion period (mean 6.2). Date of initial MS diagnosis was available for 93 patients, whereas MS type was specified for all 100. At first EDSS assessment, functional system sub-scores were available for most patients: brainstem, pyramidal, cerebellar, sensory, bowel/bladder, and cerebral (99.0%), visual (98.0%), and ambulation (97.0%). Challenges during linkage included delays in patient recruitment and uneven distribution of EDSS scores in the sample, with 78.6% of all scores ranging from 1.5 to 4 and 2.3% from 7 to 10.

Conclusions: A linked database combining claims and registry outcomes can provide complementary data to improve the capacity of real-world studies in MS, including the investigation of disease severity and progression, comparative effectiveness, and claims data-based proxy validation.