Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of multiple sclerosis – yet each data source has its limitations, restricting the questions that can be addressed. Here is our solution.
What are the current limitations of RWD regarding MS?
Observational research in multiple sclerosis (MS) in Europe is generally based on two types of data: claims data or clinical/EMR data. However, there are limitations to both types:
- Claims data often lack clinical detail. “While claims data offer a comprehensive picture of patients’ healthcare resource use and costs, as well as comorbidities, they lack information on disease severity and duration, laboratory results, and important prognostic measures.”
- Clinical/EMR data are often incomplete and lack follow-up. “Data sources such as registries and EMRs, which are richer in terms of documenting patients’ clinical characteristics and disease severity, lack information on the economic burden of the disease and/or the broader comorbidity profile of the patient.”
Ideally, observational databases provide information that combines the strengths of both claims and clinical data; these types of data are usually called linked datasets. So far, these linked datasets are largely unavailable for MS patients in Europe.
How have we overcome these limitations?
Cytel has developed an analytical and legal framework to generate linked data in Germany. This unique linked MS dataset is now available: the GER MSDS-AOK PLUS dataset. It offers unique access to both detailed clinical data such as laboratory/diagnostic data and/or EDSS status and broad claims data covering all GP/specialist and hospital visits of each patient and related HCRU/cost information.
“The MSDS-AOK PLUS linked database presents a unique opportunity in MS, expanding the current landscape and potentials of RWE. By combining the strengths of administrative claims databases and detailed clinical information provided in MS patient charts, MSDS-AOK PLUS offers a more complete picture of the patients’ history and clinical state. The database is actively growing, with the overall purpose of expanding the capabilities of MS research in the real-world.”
Details are available in our recently published article, “Data Resource Profile: The Multiple Sclerosis Documentation System 3D and AOK PLUS Linked Database (MSDS-AOK PLUS),” in the Journal of Clinical Medicine.
This new dataset offers a unique opportunity for observational MS research in Europe; other disease areas will follow. In case of any questions, feel free to contact us:
Read more from Perspectives on Enquiry & Evidence:
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Linked Data Studies: Improving the Way We Do Observational Research in Germany
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