Friday, 19 July 2013

Defining a relapse

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."

4 comments:

  1. Run both physician and self reported figures in trials... It's only capturing more information at first but is clearly useful to know, particularly if there are loads of missed relapses...
    Does this mean that when I read the reduction of relapse rate results from trials I should half them?

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    1. No; the reduction in relapse rate is relative to placebo. What it means is that the relapse rates are higher than those quoted. For example if the per protocol relapse rate is defined as 0.3 per annum the actual relapse rate is typically 0.6 per annum. In other words 50% of relapses don't fulfill the definition of a relapse as defined in the protocol.

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  2. A very welcome post. I've had RRMS for ten years and had huge difficulty sorting out the difference between relapse and 'come and go' symptoms. There can be so much 'little stuff' going on in various parts of your body (at different times and with varying degrees of intensity) that it would take you an hour to describe to a neuro exactly how symptoms are playing out. Then there's the 'cause and effect' lot of symptoms : early on I overdid things on a holiday and the subsequent muscle pain I had was so bad I ended up in the relapse clinic - to be told that it was muscle strain nothing else. If I get stressed or overtired, I start sensory symptoms but so far they've receded once I tackle the tiredness/stress. But are these mini-relapses? Seems to me that the criteria applied are blunt instruments. I'm willing to bet that MSers who have less-than-perfect clinical support just give up on reporting symptoms Unless you have a really good nurse/neuro you'll be brushed aside. (PS - my own care is very good, but friends in other teams are less fortunate).

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    1. You are so right. If I went to my GP each time I had a problem I'd have to go at least three times a week. I have an excellent GP, but I don't always go when I feel ill. I recently had terrible fatigue and other symptoms and didn't seek help until I was desperate. Had a blood test and found I had Low iron. After a course of iron tablets I feel much better. We are lucky when we have a G.P. and Neurologist that care.

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