OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis

Ruth Dobson*, Matthew Craner, Ed Waddingham, Aleisha Miller, Ana Cavey, Stewart Webb, Cheryl Hemingway, Jeremy Hobart, Nikos Evangelou, Neil Scolding, David Rog, Richard Nicholas, Monica Marta, Camilla Blain, Carolyn Anne Young, Helen L. Ford, Paul M. Matthews

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

9 Downloads (Pure)

Abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec>
Original languageEnglish
Number of pages0
JournalBMJ Open
Volume11
Issue number11
Early online date25 Nov 2021
DOIs
Publication statusPublished - 25 Nov 2021

Fingerprint

Dive into the research topics of 'OPTIMISE: MS study protocol: a pragmatic, prospective observational study to address the need for, and challenges with, real world pharmacovigilance in multiple sclerosis'. Together they form a unique fingerprint.

Cite this