What do people think of SF-36?

Thanks. I would much prefer objective measures. but does the research group understand the prolem of using subjective outcomes in non-blinded trials?

 

Well I do, Adrian does, and I suspect some others do, but it hasn't been discussed directly.

 

Same. But I have a feeling that to get funding these days it's almost obligatory, in an unwritten sort of way, to include some patient-reported outcomes to prove you are taking patients seriously. Never mind if it makes sense or not in the context of a particular study design. Or that it would be much better to properly include e-patients in designing the study from the start.

So the trick is to ensure that in any non-blinded study subjective outcomes are a) the least bad possible and b) relegated to secondary status with the primary outcome always being an objective one.

Used that way a subjective outcome can still be useful. It strengthens the objective findings if both point in the same direction and would hopefully encourage an extra round of critical thinking should the outcomes point in opposite directions.

 

I know you and Adrian do, but unless the research group absolutely locks in subjective outcome measures to use only in blinded trials, I think the sf-36 is not a suitable measure. We'll just end up down the same rabbit hole as before.

 

The working group was convened by the government, as I understand it. I am merely one member. However, I have suggested that interested members might want to look at relevant S4ME threads.

I intend to take a very hard line if it comes to recommendations that might be misguided in the way you suggest! But this is a democracy.

(Adrian, of course, as a co-chair, may wield more power than me.)

The point has been made that actimetry is not immune to bias in unblinded studies because PWME may do more to please the researcher. I think that underlines the importance of measuring activity over a long enough period for that to be as impractical as possible.

 

Thank you, I’m glad the issue will be clearly raised.

Like many others, I’ve achieved that short term gain under the encouragement of a therapist, which ended in long term loss.

 

If the measure is to be used to check the outcome in a trial I think the questions are not sensitive enough to give a meaningful result.

Limited a lot, limited a little, not limited at all are the only options. We need treatments that take us from completely unable to limited a lot which would open up life in a wonderful way!

They are ambiguous terms anyway and would be answered differently by different people. Let's face it most people can't get their heads round how little we can do. Even people with less severe ME don't understand how bad it can be, why would they?Conversely, it is easy for us to forget how much other people can do.

Most people with ME are limited a lot but a useful treatment may not move us to limited a little so seem like a failure when it could be very useful.

 

But it is likely that your gains would have been registered as a success in a clinical trial and left your therapist with the impression that it was very effective.

 

It doesn't seem like anybody has mentioned the Karnofsky Performance Status questionnaire. Of all the questionnaires that the Solve ME/CFS patient registry uses, it's the only one that has felt at all relevant to my day to day functional capacity. It asks questions about function and how much of that function you can do, i.e. can you walk around, and if so, how much? Can you be out of bed? If so, for how long? Maybe it's more relevant because I'm severely affected?

I can't seem to find the questions with a quick Google search. And on my Solve patient portal, it only shows three questions asked with that questionnaire: are you able to carry on with your normal work or activities (problematic to be sure...what does normal mean?), are you ambulatory more than 50% of the time, and to what degree are you not able to walk around by yourself (in which case I selected the answer "In a bed or chair more than 90% of waking hours but not completely bedridden").

However, I could have sworn there were more questions than that...But I'm too tired to bother researching any further. Just throwing that questionnaire out there as another option.

 

Asking someone with ME/CFS if they ‘can’ do something is like asking someone if they ‘can’ jump out a window at the fourth floor.

Technically you can do it, but it wouldn’t be good for your health.

 

FUNCAP is the best of them that I know of. I do still have some issues with it however.
1. There is a crush effect at the bottom of the scale between can not do and this will impact for 6 days or more, that doesn't really account for risk and the fluctation of available energy.
2. At the top there is little to distinguish between can do just fine and rarely has an effect, the distinction here is slight and tough to see in practice.
3. If you are pacing successfully the options of can do but with impact questions immediately get hard pushed to can not do or you have to predict how long the PEM impact is.

So I think it does a better job at diagnosing PEM for those unaware of it than it does as a tracker of function for people who already understand PEM. It will have a tendency to produce lower scores of function for those now pacing successfully. Its still the best one I have seen for assessing function and it maps fairly well to the mild/moderate/severe/vsevere severities but its got these niggles for knowledge verses not that can cause issues and especially at the edges of mild or very severe.

 

I don’t like SF 36 10 physical function questions but for completely different reasons. I score in normal healthy human ranges (and won’t vary over time for me) so these 10 questions wouldn’t tell you anything at all about me.

I do like a couple of the SF 36 questions related to energy and pep— like “Do you feel full of pep”?

I will score low on the pep scale.

 

FUNCAP does include questions related to cognitive function, but I don’t see any general questions about energy level or pep.

 

I had to look it up to check the meaning. I'm familiar with it, but only in the verb form "pep up", meaning to liven up. Even that's so dated that I'm not sure young people would know it.

Never heard "full of pep" before, it sounds a bit pornographic!

Yep, I agree. One of the snags I hit was that I score from mild to severe, depending on which section it is. The aggregated score across all domains comes out reasonably accurately, but I think the individual scores should be used rather than the single number—they may give a better picture of each individual's impairments.

 

‘Pep’ in the urban dictionary

https://www.urbandictionary.com/define.php?term=pep

Chalder really wants us on amphetamines haha