Authordas Nair, Roshan
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AbstractIntroduction: Due to the revised 2017 McDonald diagnostic criteria, many more people undergo lumbar punctures as part of their Multiple Sclerosis (MS) diagnostic journey. This results in discomfort and additional costs. Patients often report they find the lumbar puncture painful, and it can cause unintended complications requiring hospitalisations or time off work to recover. Brain lesions with a central vein, detected with T2* MRI are thought to be characteristic of MS. The Central Vein Sign (CVS) supports the diagnosis of MS when over 40% of eligible MRI lesions have a visible central vein. The authors will present the final results from DECISIve - DiagnosE using the Central veIn SIgn (Clinical Trials reference: NCT04024969) at ECTRIMS 2023. Objectives/Aims: To investigate whether T2* MRI is a more sensitive diagnostic test than lumbar puncture with oligoclonal band examination, in people at first clinical presentation with possible MS.
Method(s): A multicentre prospective single group superiority diagnostic accuracy study. Participants presenting with typical clinically isolated syndrome requiring a lumbar puncture to meet the 2017 McDonald diagnostic criteria for MS were enrolled. Trial participants had an eight-minute T2* MRI scan sequence in addition to their lumbar puncture. The final clinical diagnosis is established after at least 18 months of follow up.
Result(s): Of 113 participants recruited, we were able to include 49 in a preliminary analysis. The sensitivity of the CVS to confirm a diagnosis of MS is 94% and lumbar puncture with oligoclonal band examination is 84% (McNemar test; p=0.453).
Conclusion(s): The DECISIve interim analysis has shown that the sensitivity of the CVS is higher than testing for oligoclonal bands by lumbar puncture for the diagnosis of multiple sclerosis. We expect that the full DECISIve dataset will have sufficient power to confirm whether there is a clinically meaningful difference or not. There is only a single discordant result between CVS with a threshold of 40% and the 'rule of six', suggesting this could be rapidly implemented in clinical practice. Further analysis will include comparing the accuracy, speed, costs, and acceptability of the different tests and aim to establish if most lumbar punctures can be replaced by a slightly longer MRI scan.