Introducing a core dataset for real-world data in multiple sclerosis registries and cohorts: Recommendations from a global task force
Tina Parciak, Lotte Geys, Anne Helme, Ingrid van der Mei, Jan Hillert, Hollie Schmidt, Amber Salter, Magd Zakaria, Rod Middleton, Alexander Stahmann, Maria Pamela Dobay, Elena H. Martínez‐Lapiscina, Pietro Iaffaldano, Kelly Plueschke, Juan Ignacio Rojas, Meritxell Sabidó, Melinda Magyari, Anneke van der Walt, Francis Arickx, Gıancarlo Comı, Liesbet M. Peeters
Abstract
BACKGROUND: As of September 2022, there was no globally recommended set of core data elements for use in multiple sclerosis (MS) healthcare and research. As a result, data harmonisation across observational data sources and scientific collaboration is limited. OBJECTIVES: To define and agree upon a core dataset for real-world data (RWD) in MS from observational registries and cohorts. METHODS: A three-phase process approach was conducted combining a landscaping exercise with dedicated discussions within a global multi-stakeholder task force consisting of 20 experts in the field of MS and its RWD to define the Core Dataset. RESULTS: A core dataset for MS consisting of 44 variables in eight categories was translated into a data dictionary that has been published and disseminated for emerging and existing registries and cohorts to use. Categories include variables on demographics and comorbidities (patient-specific data), disease history, disease status, relapses, magnetic resonance imaging (MRI) and treatment data (disease-specific data). CONCLUSION: The MS Data Alliance Core Dataset guides emerging registries in their dataset definitions and speeds up and supports harmonisation across registries and initiatives. The straight-forward, time-efficient process using a dedicated global multi-stakeholder task force has proven to be effective to define a concise core dataset.