Discussion in 'Latest ME/CFS Research' started by AndyPR, Jul 13, 2017.
Excellent and congrats @Keith Geraghty Look forward to reading - and using for advocacy - your work.
This is excellent news, and good on you @Keith Geraghty.
An aspect I would find very interesting, if your trial could address it, would be the extreme disconnect between perceived and actual physical function, given as trials so far have relied on perceived physical function as primary outcome measures. The FOI-released PACE data clearly shows that the two differ wildly (the SF-36 PF sub-scale versus - an at least approximate - actual PF in the 6mwt), and how absurd it is to presume perceived PF to be even a remotely good indication of actual PF. And when I say "differ wildly" I mean both: 1) Complete lack of determinism across participants, and 2) Very disproportionate for many individuals.
Congratulations @Keith Geraghty and thank you to ME Association, this is well spent money.
Are you referring to that graph someone made a while ago? Was that you?
Yes it was.
Correction: No it wasn't.
If you posted it here, it would be persuasive.
It was a series of posts, so I'll go have a look.
It would be very important that someone else independently checked my analysis of course.
Following on from my post 9 above, I think these may be the graphs @A.B. is thinking of (Edit: no they were not as it turns out), which I originally posted in:-
Reproduced here for convenience:-
EDIT: Not sure how to get the graphs from that post to just show up here, rather than links that have to be clicked.
I've been doing some homework on the PACE FOI-released data, regarding perceived Vs actual physical function, and being as GETSET shares the same issues, I'll post some charts here, four of them in all. Click on a chart to magnify it.
View attachment 22324
View attachment 22325
View attachment 22326
View attachment 22327
The charts show % improvement, not absolute improvement. So someone who did 10m at baseline and 15 at 52 weeks shows 50% improvement, same as someone who did 100m at baseline and 150 at 52 weeks.
The charts are all about comparing a person's perceived percentage physical function improvement Vs actual % physical function improvement.
Remember PACE interprets a "50% increase from baseline in SF-36 sub-scale score as a positive outcome".
Each table, within each trial arm, show participants (X axis) from the lowest % increase in actual physical function, through to the highest % increase in actual physical function.
For each participant, their perceived physical function % improvement is shown, as well as their actual % physical function improvement.
The Y axis is % improvement. Negative values mean % PF decreased at 52 weeks compared to baseline. 0% means no change between baseline and 52 weeks.
Perceived PF is as per the SF-36 PF sub-scale, and actual PF as per the 6 min walk test.
In the data there are some participants who rated their PF at 0% at baseline, which gives divide-by-zero if trying to gauge % increase. I have got around this by treating their baseline as 1%, which still shows the expected sharp spike in % change, but keeps the values finite. I didn't want to exclude these participants, because they are a good indication of the disconnect between perceived and actual % PF improvement.
There were quite a lot of drop-outs in the PACE data, with NULL results. These are excluded from the charts.
Edit: Having read @Snow Leopard 's posts and thought about them a little, I agree that the 6mwt itself is likely not wholly objective. But I think that just means if there were results for a wholly objective measure, it would just show an even bigger disconnect between the subjective (SF-36 PF) versus the objective.
Actually I was thinking of this. I had it saved on my desktop actually. If there was a clear correlation between these two measures, most of the points should be distributed along a line from the top left corner to the bottom right corner.
Bear in mind this is comparing (more or less) actual physical function (x axis) against perceived fatigue, not perceived physical function. But I suspect the disconnect looks much the same.
Also following on from my post 9 above:-
Original post reproduced here:-
Bearing in mind PACE set the bar for improvement at a 50% increase in perceived physical function (as per the SF-36 PF sub-scale), if you look at the highlighted figures below extracted from the FOI-released PACE trial data, you can see that with the bar at 50% improvement, the number of participants who perceived their physical function to have improved >= 50% at 52 weeks compared to baseline, was much higher than the 6 minute walking test indicated.
View attachment 22387
Interestingly if you increase the bar to 100% improvement, the disparity between perceived and actual PF for numbers of CBT and GET participants becomes increasingly disproportionate, albeit the numbers for actual PF are getting statistically small by then (and are less than for APT or SMC):-
View attachment 22388
With the rider that, as @Snow Leopard indicated, the 6mwt is itself unlikely to be wholly objective either.
ME Association trustees have approved a new research grant that will critically examine the theoretical basis that underlies the use of Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET) in ME/CFS.
The £25,000 grant – over two years – has been given to Dr Keith Geraghty at the University of Manchester and will challenge and review the theoretical basis and clinical application of CBT and GET in the NHS.
Dr Geraghty is an Honorary Research Fellow in Population Health, Health Sciences Research and Primary Care, where his work focuses on ME and CFS.
This new grant will fund an incremental study, in two main phases: phase 1 being a theoretical exploration of the CBT-model of ME/CFS and phase 2 being an empirical study of patients’ experiences of CBT and GET.
Its aim will be to better understand why clinical trials are reporting seemingly different effects than are demonstrated in patient surveys and clinical outcomes.
The hypotheses driving this research are that many of the benefits reported in clinical trials, even where modest, may actually come from factors unrelated to illness belief modification, such as therapy effects, stress management advice, lifestyle advice, the power of suggestion (being asked to think more positively).
The research will also examine whether patients are adequately informed of the rationale for CBT and GET therapies, or are entered into such treatments with strong promotion by physicians and therapists – thus increasing therapy and expectancy effects.
Also, that many false positive cases of ME/CFS may be diagnosed (primarily mental health complaints that mimic the symptoms of ME/CFS – such as fatigue and sleep disturbance), in the absence of careful screening and a proper understanding of the illness. This could mean we are not seeing a true record of outcomes for a ME/CFS population.
Dr Geraghty said: “I am very grateful to the ME Association for their support. I feel a weight of responsibility to patients with the illness, their families and friends.”
“ME/CFS is an illness that devastates the lives of many, and is very poorly understood, so I hope that this work may add to the research base and shed light on this neglected illness.”
“It is important we understand how patients respond to CBT and GET in practice, rather than in clinical trials alone,” he added.
Dr Charles Shepherd, Hon. Medical Adviser to the ME Association, commented:
“We have been working with Dr Geraghty for some time on the preparation of a paper that summarises the results of our ‘patient evidence’ report into the acceptability, efficacy and safety of CBT, GET and Pacing in order to get this research published in a high quality medical journal [below].”
“We have come to know Keith as a very dedicated and questioning researcher who wants to critically analyse the basis for using these two very controversial forms of treatment in ME/CFS. So we are very pleased to be able to announce that the MEA will be funding his academic work for the next two years.”
You can find more of Dr Geraghty’s published work, here. It includes his most recent commentary on the PACE Trial which appeared in the Journal of Health Psychology and launcheda series of similarly critical opinion pieces including from Dr Charles Shepherd.
We will be publishing a full interview with Dr Geraghty in the November issue of ME Essential – the magazine for members of the ME Association
A more complete summary of this new research will be added to the Research section of the website in due course
Nice one MEA
I talk to Keith quite regularly. He works very hard not just writing papers (and dealing with comments from peer reviewers) but also doing a lot of peer review work himself. Such work is unpaid and is time-consuming but it is important that somebody does it well to make sure unjustifiable claims don't get published, or if question marks hang over particular studies, that the papers include the limitations. This has not always been the case in the past in the field possibly because proponents of the CBT/GET model for the illness did a lot of the peer reviewing.
Not sure if this is related to the research hypothesis, but something I would find interesting to know more about:
Let's say, a patient is following a CBT treatment, and reports an increase in symptoms to the therapist.
If I understand the BPS model correctly, there are now two possible conclusions the therapist can draw:
A) The increase in symptoms means the patient has reached his/her limits. The patient is a non-responder to GET and the treatment should be stopped.
B) The increase in symptoms means the patient has been catastrophizing. The patient needs to be reassured and should continue increasing activities.
Now how does the therapist decide if it's A or B? Is there some kind of protocol/guideline for this?
If yes, what does it say? (To me it seems impossible to decide if it's A or B, other than guessing. There is no objective test for this.)
If no, how do they guarantee the kind of CBT they are delivering is the same as the CBT in (other) clinical trials? If the therapist uses a different "threshold" for adverse reactions, this could affect results of the treatment.
Not quite sure I understand your question as you mix CBT with GET. But you might find some answers in the manuals for the two; somewhere on this thread!
Yes, Keith is also playing a very important role in the peer review process of papers relating to ME/CFS that arebeing considered for publication by the medical and scientific journals
As you say, this is normally yet another voluntary task to add to already very full workloads and this can lead to some very poor peer reviews - as I know from personal experience
So this is another reason why the MEA has been very happy to provide some financial assistance to Keith in relation to his academic work at the University of Manchester
Well done MEA!
Thank you, @Keith Geraghty
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