Simon M
Senior Member (Voting Rights)
Thanks. I would much prefer objective measures. but does the research group understand the prolem of using subjective outcomes in non-blinded trials?
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What do people think of SF-36?
- Thread starter Jonathan Edwards
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- graham's videos sf-36
Jonathan Edwards
Senior Member (Voting Rights)
Well I do, Adrian does, and I suspect some others do, but it hasn't been discussed directly.
Ravn
Senior Member (Voting Rights)
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.
Simon M
Senior Member (Voting Rights)
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.
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Jonathan Edwards
Senior Member (Voting Rights)
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.
Mithriel
Senior Member (Voting Rights)
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.
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.
Michelle
Senior Member (Voting Rights)
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.
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.
My comment on the SF36 Physical function, copied from another thread:
The SF36 is very susceptible to priming i.e. a change in your frame of reference for people with ME/CFS. I think Graham's excellent video about the issue with a subjective outcome used SF36 Physical function as the example.
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SF36 Physical Function has 10 questions with questions like
Does your health now limit you in these activities. If so, how much?
Limited a lot/ Limited a little/ No, not limited at all (Scoring: 0, 5, 10)
3. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
4. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
5. Lifting or carrying groceries
6. Climbing several flights of stairs
7. Climbing one flight of stairs
8. Bending, kneeling, or stooping
9. Walking more than a mile
10. Walking several blocks
11. Walking one block
12. Bathing or dressing yourself
You can see how hard those questions are to answer. Do you answer for times when you are ok, or do you take into account the times when you have PEM? Anyone who gets occasional PEM that causes them to spend time in bed could theoretically answer at least 'limited a little' to all of the questions. If you did that, you would have a score of 50. If you felt that you would also struggle all the time with vigorous activities, climbing several flights of stairs and walking more than a mile, you would have a score of 35. I think someone could have mild ME/CFS and score 35 with that approach.
And then there is the issue of repeatability and detail. Perhaps you can play golf today without problem, but could you then do it tomorrow? Perhaps you can lift your groceries from the trolley to the car, but can you carry them? How far can you carry them? Are the groceries the fortnightly shop for a family of five, or the weekly shop for a household of one? Do you regard choosing to only shower twice a week rather than daily as 'limited a lot' or 'limited a little'?
I have answered the SF36 myself, and I did not take into account the time when I have PEM, and instead answered for a good day.
The SF36 is very susceptible to priming i.e. a change in your frame of reference for people with ME/CFS. I think Graham's excellent video about the issue with a subjective outcome used SF36 Physical function as the example.
...
SF36 Physical Function has 10 questions with questions like
Does your health now limit you in these activities. If so, how much?
Limited a lot/ Limited a little/ No, not limited at all (Scoring: 0, 5, 10)
3. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
4. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
5. Lifting or carrying groceries
6. Climbing several flights of stairs
7. Climbing one flight of stairs
8. Bending, kneeling, or stooping
9. Walking more than a mile
10. Walking several blocks
11. Walking one block
12. Bathing or dressing yourself
You can see how hard those questions are to answer. Do you answer for times when you are ok, or do you take into account the times when you have PEM? Anyone who gets occasional PEM that causes them to spend time in bed could theoretically answer at least 'limited a little' to all of the questions. If you did that, you would have a score of 50. If you felt that you would also struggle all the time with vigorous activities, climbing several flights of stairs and walking more than a mile, you would have a score of 35. I think someone could have mild ME/CFS and score 35 with that approach.
And then there is the issue of repeatability and detail. Perhaps you can play golf today without problem, but could you then do it tomorrow? Perhaps you can lift your groceries from the trolley to the car, but can you carry them? How far can you carry them? Are the groceries the fortnightly shop for a family of five, or the weekly shop for a household of one? Do you regard choosing to only shower twice a week rather than daily as 'limited a lot' or 'limited a little'?
I have answered the SF36 myself, and I did not take into account the time when I have PEM, and instead answered for a good day.
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BrightCandle
Senior Member (Voting Rights)
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.
Kitty
Senior Member (Voting Rights)
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.
I see that as a bonus, not a snag. FUNCAP is designed so the individual section scores provide useful information.
Chestnut tree
Senior Member (Voting Rights)
‘Pep’ in the urban dictionary
https://www.urbandictionary.com/define.php?term=pep
Chalder really wants us on amphetamines haha
Could someone increase their score on the SF-36 by 50 points on the 100 point scale just by reframing how they answer? For example, if you were asked to answer thinking about your worst times over the last month, and then later asked to answer on what you could do right now, ignoring consequences.
I could, very easily.
I could, very easily.