Building an evidence base for management of severe ME (including sleep management)

BruceInOz said:
This is a very important point. The two domains (physical and cognitive) are definitely coupled so if you only measure one you will not get the true picture.
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Yes, I think measuring activity needs to be done in a sophisticated way and as part of a larger package of assessments.

When it comes to analysing progress with different plans it is probably not essential to predefine primary outcome measures in the way usually done for trials. If plans are theory neutral cherry picking is less of an issue. I see the situation as a bit more like a dose response study where you pick the dose that looks best all round on whatever evidence you have, because nobody is biased to one dose or another. ~That does mean genuine impartiality in the set up though and that means not making use of professionals with preformed ideas!
 
My takeaway from this thread and from my own experience is there should be no plan on a pwME, especially not on severe pwME, and so no trial with such an aim, at this point of time where information about what might improve and worsen is unclear/uncollected/ambiguous. As a first step, I think, what might be elucidating is observation alone, in case of severe ME help according to their instructions, like everyday-life behavior (via objective measures like number of times that the house was left, step counting, sleep oatterns etc) and state of health (which would be subjective) - this is what NIH is doing and the Solve Biobank with their App (yes?). It's certainly not wrong to do more trials outside of the US. If a clear pattern showed (e.g. pwME seem to do better with .... pwME don't get worse but also not better with... you name it ....), then this would be a justification to run a trial with a "plan" which will take a closer look at that.
 
strategist said:
I think this thread demostrates that patients already have opinions on sleep. That suggests they would give biased answers in a clinicial trial of sleep advice. Maybe the bias is well founded because patients are right that the usual advice given is not helpful, maybe it is not.
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There are certainly risks, although my assumption would be that plans would be tried out on people newly ill who had not yet developed their own plan.

If plans are cross stratified, to include say four aspects of 'advice' then each subject would not specifically associate their grand plan with any one proposal they agreed or disagreed with. That would not solve the problem entirely but it would help.
 
Inara said:
If a clear pattern showed (e.g. pwME seem to do better with .... pwME don't get worse but also not better with... you name it ....), then this would be a justification to run a trial with a "plan" which will take a closer look at that.
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But you cannot get a clear pattern of what helps unless you instigate some form of help. And you cannot tell if that is what makes a difference without a controlled experiment. Otherwise we follow the BPS approach - guess what is helping on the basis of no controlled evidence.

What to me is the elephant in the room is that almost certainly professionals are giving all sorts of advice to patients, including severe patients, without any evidence base. At least we ought to be testing what is currently advised in order to be able to show that it is no use if it is not.
 
Jonathan Edwards said:
There are certainly risks, although my assumption would be that plans would be tried out on people newly ill who had not yet developed their own plan.

If plans are cross stratified, to include say four aspects of 'advice' then each subject would not specifically associate their grand plan with any one proposal they agreed or disagreed with. That would not solve the problem entirely but it would help.
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Could you include two sleep studies at the beginning and at the end (one at each time point before exertion, the second at each time point after exertion)?

That way, you could objectively assess sleep quality at beginning and end to see if anything has changed. You could use wearables throughout the trial to track sleep duration and quality too, so that you could cross-reference this with subjective reports.

The wearables could also track activity, which will help us see if that actually is a helpful measure of functional capacity.
 
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Nobody have stated that ME is a sleep disorder as someone here said. But that non-restorative sleep is a cardinal symptom should not be controversial or is it? I don’t think we can give general advice on sleeping, when knowing that’s what’s supposed to be natural sleep cycle is not working at all. Some sleep in cycles of 2x4, some sleep on the day and it doesn’t make a difference night and so on.


I myself don’t know what to do next. For years I tried the same time on and off, just after the intuitively logic idea that trying to keep a natural cycle no matter how bad you probably would increase the chance of a good night of restorative sleep. That doesn’t work at all. Maybe in for trying the 2x4 hours!

Sleep is difficult. I think the only good general advice that really can be given, is the winding down before going to bed. Giving good advice on pacing and trying to avoid-minimize PEM is easier. The problem for the ones severe is that you reach kind of a tipping-point where you kind of never ever is out of PEM-state.
 
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Jonathan Edwards said:
What to me is the elephant in the room is that almost certainly professionals are giving all sorts of advice to patients, including severe patients, without any evidence base.
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It recently occurred to me that the suggestion that some clinics may withdraw the diagnosis of CFS and substitute Pervasive Refusal Syndrome, or whatever thy call it these days, specifically so as not to be bound by NICE guidelines on treatment of CFS, and thus potentially avoid one cause of action should patients turn litigious. They then give themselves greater freedom to experiment with even more inappropriate "treatment".
 
I think it would be good to test the things many patients agree are helpful based on their own experience (but which are not the things everyone "knows" to be helpful for chronic illness, like exercise or sleep hygiene).

For example paying attention to sound and light sensitivity, or orthostatic stress. Outside of this patient community hardly anyone considers these important. That they are considered important could be because they are specifically helpful for ME/CFS.

Increasing salt consumption is likely to be genuinely helpful because I ate a lot of salt out of instinct, well before I ever read about it being a treatment for OI.
 
lansbergen said:
I have never seen a child or a animal that does less than possible.
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I actually think the situation for children who are ill is quite different.

An adult who is unwell is aware of a need to protect their capabilities. A child has no sense of responsibility for their own capacity in that way. So an adult with arthritis struggles to maintain the range of motion of their joints by stretching them. A child sits still to avoid discomfort. And I think this is a major factor in the fact that adult arthritis only produces fixed immobility of joints in a small proportion but in children it is much higher.

There is also the problem that parents may feel they should keep a child comfortable and take them out in a buggy rather than them walk. Parents need to be told that movement is essential for long term joint function. I think this issue with arthritis may have had a significant impact on the management of ME in children. The critical question is what is the right approach for ME. I don't think we know. I suspect some children with ME develop Achilles contractures. But that does not mean that they should be pushing exercise. It just means that either they or someone else should be putting their ankles through full range every day.
 
Most patients, when they first get sick, have a bias towards trying to carry on despite the illness. They then painfully learn that they must reduce their activity levels.

That's why I think that reducing activity levels is genuinely helpful. It is not what patients initially want or believe in, but despite that, they eventually begin to believe it.

Let's test the advice that patients should give themselves permission to rest, simplify their life and to reduce activity levels. This goes against the established wisdom and what society generally expects of patients but it could be genuinely useful if given early enough in the illness. Maybe everyone who is at risk of possibly developing ME/CFS should be given this advice.
 
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Jonathan Edwards said:
I think this issue with arthritis may have had a significant impact on the management of ME in children. The critical question is what is the right approach for ME. I don't think we know. I suspect some children with ME develop Achilles contractures. But that does not mean that they should be pushing exercise. It just means that either they or someone else should be putting their ankles through full range every day.
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Children want to be active. They will move whenever they can. Most likely out of sight of the people that want them to rest.
 
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