BACKGROUND: Myasthenia gravis (MG) is a rare autoimmune disorder. Several new treatment concepts have emerged in recent years, but access to these treatments varies due to differing national reimbursement regulations, leading to disparities across Europe. This highlights the need for high-quality data collection by stakeholders to establish MG registries. A European MG registry could help bridge the treatment access gap across different countries, offering critical data to support regulatory decisions, foster international collaborations, and enhance clinical and epidemiological research. Several national MG registries already exist or are in development. To avoid duplication and ensure harmonization in data collection, a modified Delphi procedure was implemented to identify essential data elements for inclusion in national registries. RESULTS: Following a literature review, consultations with patient associations and pharmaceutical companies, and input from multiple European MG experts, 100 data elements were identified. Of these, 62 reached consensus for inclusion and classification, while only 1 item was agreed for exclusion. 30 items failed to reach the ≥ 80% agreement threshold and were excluded. Among the 62 accepted items, 21 were classified as mandatory data elements, 32 optional, and 9 items pertained to the informed consent form. CONCLUSIONS: Through a modified Delphi procedure, consensus was successfully achieved. This consensus-based approach represents a crucial step toward harmonizing MG registries across Europe. The resulting dataset will facilitate the sharing of knowledge and enhance European collaborations. Furthermore, the harmonized data may assist in regulatory or reimbursement decisions regarding novel therapies, as well as address treatment access disparities between European countries.

Corporate Member of Freie Universität Berlin and Humboldt Universität Zu Berlin Department of Neurology With Experimental Neurologie Neuroscience Clinical Research Center Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany

Department of Brain and Behavioral Sciences University of Pavia IRCCS Mondino Foundation Pavia Italy

Department of Clinical Medicine University of Bergen Bergen Norway

Department of Human Neurosciences Sapienza University of Rome Rome Italy

Department of Neurology Faculty of Medicine University Hospital Brno Masaryk University Brno Czechia

Department of Neurology Leiden University Medical Center Leiden the Netherlands

Department of Pediatric Neurology Centre for Neuromuscular Disorders C TNBS University Duisburg Essen Essen Germany

Department of Pediatric Neurosciences Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy

Departments of Clinical Neuroscience Karolinska Institutet and Neurology Karolinska University Hospital Stockholm Sweden

ESIEE PARIS School Gustave Eiffel University Paris France

Immunotherapy and Apheresis Departmental Unit Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy

Institute for Research On Cancer and Aging of Nice CNRS INSERM Côte d'Azur University SNPM Hôpital Pasteur 2 30 voie Romaine 06001 Nice CEDEX France

Neuroimmunology and Neuromuscular Diseases Unit Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy

Neurology Department Centro Hospitalar Universitário de Santo António; Unit for Multidisciplinary Research in Biomedicine Instituto de Ciências Biomédicas Abel Salazar Universidade do Porto Porto Portugal

Neuromuscular Diseases Unit Hospital de La Santa Creu 1 Sant Pau Barcelona Spain

Nuffield Department of Clinical Neurosciences University of Oxford John Radcliffe Hospital Level 3 West Wing Headley Way Oxford OX3 9DU UK

Peripheral Nervous System and Muscle Department Reference Center for Neuromuscular Disorders Pasteur 2 Hospital Centre Hospitalier Universitaire de Nice Nice University Hospital SNPM Hôpital Pasteur 2 30 voie Romaine 06001 Nice CEDEX France

Reference Center for Neuromuscular Disorders and ALS Timone University Hospital Aix Marseille University Marseille France

Reference Center for Neuromuscular Disorders Lenval Pediatric Hospitals of Nice University Hospital Nice France

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