MSer-defined relapses. Time to relook at fatigue and cognitive relapses. #MSBlog #MSResearch
Perrin Ross et al. Assessing relapse in multiple sclerosis questionnaire: results of a pilot study. Mult Scler Int. 2013;2013:470476.
Background: There is need for a brief but comprehensive objective assessment tool to help clinicians evaluate relapse symptoms in MSers and their impact on daily functioning, as well as response to treatment.
Objective: The 2-part Assessing Relapse in Multiple Sclerosis (ARMS) questionnaire was developed to achieve these aims.
Method: Part 1 consists of 7 questions that evaluate relapse symptoms, impact on activities of daily living (ADL), overall functioning, and response to treatment for previous relapses. Part 2 consists of 7 questions that evaluate treatment response in terms of symptom relief, functioning, and tolerability. The ARMS questionnaire has been evaluated in 103 MSers.
Results: The most commonly reported relapse symptoms were numbness/tingling (67%), fatigue (58%), and leg/foot weakness (55%). Over half of MSers reported that ADL or overall functioning were affected very much (47%) or severely (11%) by relapses. Prescribed treatments for relapses included intravenous and/or oral corticosteroids (87%) and adrenocorticotropic hormone (13%). Nearly half of MSers reported that their symptoms were very much (33%) or completely resolved (16%) following treatment. The most commonly reported adverse events were sleep disturbance (45%), mood changes (33%), weight gain (29%), and increased appetite (26%).
Conclusion: Systematic assessment of relapses and response to relapse treatment may help clinicians to optimize outcomes for MSers.
“One of the biggest problems in MS is defining a relapse objectively. This study defines a PROM (patient-related outcome measure) to do that. Can MSers make the call on whether or not they have had a relapse? The regulators won’t like that. At present relapses have to have objective clinical signs last more than 24 hours in the absence of a fever. The problem with this definition is that it needs a baseline EDSS and it also then relies on the EDSS being sensitive enough to pick up change. This is a problem as it misses our many relapses that cause symptoms that don’t impact on the EDSS, e.g. pain and fatigue. Close to 50% of relapses in clinical trials don’t fulfill the so called protocol definition of a relapse. This cause problems as MSers don’t feel comfortable with their neurologists telling them that they haven’t had a relapse. I think it is time we moved away from physician-related to MSer-related outcomes in clinical trials and clinical practice. What do you think?”
“It is interesting to see how prominent fatigue is when MSers have relapses. May be we should re-open the debate about can we define fatigue- or cognitive relapses? I am sure we can we simply need to acknowledge that they occur.”