OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis
Ana Cavey,
Ruth Dobson,
Camilla Blain,
Richard Nicholas,
Jeremy Hobart,
David Rog,
Monica Marta,
Cheryl Hemingway,
Nikos Evangelou,
Matthew Craner,
Paul M Matthews,
Neil Scolding,
Helen L Ford,
Stewart Webb,
Ed Waddingham,
Aleisha Miller,
Carolyn Anne Young
Affiliations
Ana Cavey
Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK
Ruth Dobson
Preventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK
Camilla Blain
Department of Neurology, St Georges University Hospitals NHS Foundation Trust, London, UK
Richard Nicholas
Imperial College Healthcare NHS Trust, London, UK
Jeremy Hobart
University Hospitals Plymouth NHS Trust, Plymouth, UK
David Rog
Department of Neurology, Salford Royal NHS Foundation Trust, Salford, UK
Monica Marta
Department of Neurology, Southend Hospital, Westcliff-on-Sea, UK
Cheryl Hemingway
Great Ormond Street Hospital for Children, London, UK
Nikos Evangelou
Nottingham University Hospitals NHS Trust, Nottingham, UK
Matthew Craner
Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Paul M Matthews
Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK
Neil Scolding
Department of Neurology, Southmead Hospital NHS Trust, Bristol, UK
Helen L Ford
Centre for Neurosciences, Leeds General Infirmary, Leeds, UK
Stewart Webb
Queen Elizabeth University Hospital, Glasgow, UK
Ed Waddingham
Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK
Aleisha Miller
Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK
Introduction The power of ‘real world’ data to improve our understanding of the clinical aspects of multiple sclerosis (MS) is starting to be realised. Disease modifying therapy (DMT) use across the UK is driven by national prescribing guidelines. As such, the UK provides an ideal country in which to gather MS outcomes data. A rigorously conducted observational study with a focus on pharmacovigilance has the potential to provide important data to inform clinicians and patients while testing the reliability of estimates from pivotal trials when applied to patients in the UK.Methods and analysis The primary aim of this study is to characterise the incidence and compare the risk of serious adverse events in people with MS treated with DMTs. The OPTIMISE:MS database enables electronic data capture and secure data transfer. Selected clinical data, clinical histories and patient-reported outcomes are collected in a harmonised fashion across sites at the time of routine clinical visits. The first patient was recruited to the study on 24 May 2019. As of January 2021, 1615 individuals have baseline data recorded; follow-up data are being captured and will be reported in due course.Ethics and dissemination This study has ethical permission (London City and East; Ref 19/LO/0064). Potential concerns around data storage and sharing are mitigated by the separation of identifiable data from all other clinical data, and limiting access to any identifiable data. The results of this study will be disseminated via publication. Participants provide consent for anonymised data to be shared for further research use, further enhancing the value of the study.
