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.