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Mediators of the Effects on Fatigue of Pragmatic Rehabilitation for CFS

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
J Consult Clin Psychol. 2013 Jun 24. [Epub ahead of print]
Mediators of the Effects on Fatigue of Pragmatic Rehabilitation for Chronic Fatigue Syndrome

Wearden AJ, Emsley R.
Abstract

Objective:

To examine potential mediators of the effect of pragmatic rehabilitation on improvements in fatigue following a randomized controlled trial for patients with chronic fatigue syndrome (CFS/ME) in primary care (IRCTN 74156610).

Method:

Patients fulfilled the Oxford criteria for CFS. Ninety-five patients were randomized to pragmatic rehabilitation and 100 to general practitioner (GP) treatment as usual.

The outcome was the Chalder fatigue scale score (0123 scoring) at end of treatment (20 weeks) and 1-year follow up (70 weeks).

First, the effect of treatment on potential mediators was assessed. Then fatigue was regressed on significant mediators, treatment allocation, and baseline measures of fatigue and significant mediators.

Results:

Reduction in limiting activities at 20 weeks mediated the positive effect of pragmatic rehabilitation on fatigue at 70 weeks (mediated effect size = -2.64, SE = 0.81, p = .001, proportion of effect mediated = 82.0%).

Reduction in catastrophizing at 20 weeks mediated the positive effect of pragmatic rehabilitation on fatigue at 70 weeks (mediated effect size = -1.39, SE = 0.61, p = .023, proportion of effect mediated = 43.2%).

Reductions in 70-week measures of fear avoidance, embarrassment avoidance, limiting activities, and all-or-nothing behavior all mediated improvement in fatigue at 70 weeks, although the causal direction of these cross-sectional effects cannot be determined.

There were no between-group differences on measures of exercise capacity (a timed step test).

Conclusions:

Improvements in fatigue following pragmatic rehabilitation are related to changes in behavioral responses to and beliefs about fatigue.

(PsycINFO Database Record (c) 2013 APA, all rights reserved).
 

Firestormm

Senior Member
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Location
Cornwall England
Can anyone explain the above in simple terms for me please? I don't mean by way of an obvious explanation - but more one relating to terminology used and how the results have been assessed. Thanks in advance :)
 
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15,786
Can anyone explain the above in simple terms for me please? I don't mean by way of an obvious explanation - but more one relating to terminology used and how the results have been assessed. Thanks in advance :)
I think they're looking to see what is associated with the improvement in ability to answer fatigue questionnaires, based on other self-reported measurements.

I don't have access to the full article, and I doubt it would be worthwhile to read. The only outcome measurement is "fatigue" on a dodgy questionnaire, and the treatments are aimed at self-denial of fatigue. One thing they're doing right (in the abstract at least) is that they're only claiming association, not cause and effect. And it's also not making any claims about "recovery", just "improvements".

But their basic premises are incorrect (that "fatigue" is particularly relevant, that subjective measurement is sufficient, and that CFS is purely psychological) so there's not going to be any useful outcome from it. They're doing their research properly perhaps, if those premises were proven, but they haven't bothered to look at the basis of their assumptions. So they're basically building a nice house on a pile of loose gravel.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Firestormm, I don't understand this study either, especially because it seems to be related to the failed FINE Trial (same lead author, and same therapy). The FINE Trial found 'Pragmatic Rehabilitation' to be unhelpful for CFS patients at follow up. So I don't know why they are putting further effort into a failed trial.

Perhaps their conclusion unwittingly explains why their therapy was mildly helpful during the therapy, in the short term, before it failed:
"Improvements in fatigue following pragmatic rehabilitation are related to changes in behavioral responses to and beliefs about fatigue."

It seems that they managed to change 'beliefs' about fatigue (hence the short-term improvements to the self-reported outcomes), but not actually improve the illness.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
The study can be summed up in two letters: BS. To clarify: Wesselyite BS.

rehabilitation without proper treatment: BS
Oxford criteria: BS
catastrophizing (a fancy word which re ME means believing that exertion will cause harm): BS
fear avoidance (in this context at least): BS
embarrassment avoidance (?!): BS

By BS I of course mean Bad Science. ;)
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
Now it has been proven that cultured muscle cells from PWME produce lactic acid at 20 times the normal rate, there IS a measurable "fatigue" which can be used - and we can get rid of nasty little nursey's silly scales.:p
 
Messages
13,774
Firestormm, I don't understand this study either, especially because it seems to be related to the failed FINE Trial (same lead author, and same therapy). The FINE Trial found 'Pragmatic Rehabilitation' to be unhelpful for CFS patients at follow up. So I don't know why they are putting further effort into a failed trial.

Perhaps their conclusion unwittingly explains why their therapy was mildly helpful during the therapy, in the short term, before it failed:
"Improvements in fatigue following pragmatic rehabilitation are related to changes in behavioral responses to and beliefs about fatigue."

It seems that they managed to change 'beliefs' about fatigue (hence the short-term improvements to the self-reported outcomes), but not actually improve the illness.

They've done other papers from FINE which gloss over the fact that the treatment was found to be ineffective.

Reality doesn't matter to quacks.

Has anyone seen the full paper? Did they do the same assessment on predictors for the patients who only got usual care, and improved just as much?
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Firestormm, I don't understand this study either, especially because it seems to be related to the failed FINE Trial (same lead author, and same therapy). The FINE Trial found 'Pragmatic Rehabilitation' to be unhelpful for CFS patients at follow up. So I don't know why they are putting further effort into a failed trial.

Perhaps their conclusion unwittingly explains why their therapy was mildly helpful during the therapy, in the short term, before it failed:
"Improvements in fatigue following pragmatic rehabilitation are related to changes in behavioral responses to and beliefs about fatigue."

It seems that they managed to change 'beliefs' about fatigue (hence the short-term improvements to the self-reported outcomes), but not actually improve the illness.

Bit of a bad-one yesterday, sorry didn't reply before now.

[Bold] Is this not then a 'good thing' for them to admit? Do you perhaps think it is a 'good paper' I wonder because it reveals the true nature of improvement.

I mean they may not say it as succinctly in the full paper as you have here: but that's the feeling I got from the above too. I just couldn't get my head around terms such as 'mediated' yesterday.

I mean all we are saying is that if you learn to better manage your condition and your abilities - you can make some small improvements in general function. Depending on the person and on the severity and on one's concerns about how much to do safely - for example - would depend on how much any learned techniques might help.

I like Vals reference to those damned questionnaires too. The questions are so non-specific as to render them pointless in my opinion and it is hard to comprehend how one's answers might be interpreted.

I still think any attention paid to a patient for a period of time will tend to lead that patient to say 'it helped'. But it's the practical nature of that help in relation to specific symptoms perhaps and to function and over what time-frame that is important.

Also the measures are key. I mean we lambasted PACE because whilst their 'end points' were interpreted as 'recovery' they are nothing like how we or anyone else in the real world might interpret recovery.

These interventions are all over the treatment spectrum and yet they never are willing to relate them to benefit dependence or ability to return to and maintain work or indeed lifestyle: at least not in the literature.

Asking the patient if they feel they have recovered as a direct result of any intervention/management technique - would be useful.

I think drugs are viewed in these terms: so why not management strategies too? Not in relation to any pre-intervention 'goals' but overall - and I don't mean in relation to pre-illness function either: a more realistic measure is needed.

I know they like to write with jargon but a little more honesty and realism wouldn't go amiss. I'd rather like them to be honest about what I might realistically expect before I invest the time and effort - know what I mean?
 

biophile

Places I'd rather be.
Messages
8,977
Now it has been proven that cultured muscle cells from PWME produce lactic acid at 20 times the normal rate, there IS a measurable "fatigue" which can be used - and we can get rid of nasty little nursey's silly scales.:p

I had to laugh because of the following (and other similar dubious statements) in bold in the FINE Trial patient manual:

http://www.fine-trial.net/downloads/Patient PR Manual ver9 Apr05.pdf

presumptive claim from the FINE manual said:
#3. Muscle function or behaviour is normal in CFS.

The explanations and expectations in the manual are clearly out of touch with reality. The overall attitude was that there is nothing major or non-functional from preventing patients rehabilitating back to health. I have not read this latest paper yet, but the main results paper showed that the benefits of pragmatic rehabilitation on average were so small and transient as to be basically worthless in the real world. Yet papers keep being published which suggest substantial success worth reporting. Talk of significant "mediators" (*cough* cross-sectional associations which cannot determine direction of causation) at this point sounds similar to what happens when impressive looking numbers are multiplied by zero.

That said, perhaps some people did benefit slightly, due to a limited amount of decent advice embedded in the program, but not because the "cognitive behavioural model of chronic fatigue syndrome" has much explanatory power. Have the researchers ever once just admitted that they could be fundamentally wrong about their model, instead of ongoing attempts to justify the failures (or less than expected results) and the millions they spent on it? Re questionnaires, it would not surprise me at all if most of the CBT/GET-related "evidence base" turns out to be based on methodological artifacts.

Wearden et al said:
There were no between-group differences on measures of exercise capacity (a timed step test).

Thanks for taking over 3 years to publish important hypothesis-busting data?
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
I mean all we are saying is that if you learn to better manage your condition and your abilities - you can make some small improvements in general function. Depending on the person and on the severity and on one's concerns about how much to do safely - for example - would depend on how much any learned techniques might help.

I can't disagree with any of that. But the BIG problem is that the hypothesis on which this study, and the PACE study, are based is false, and therefore what patients learn in the course of such 'therapies' is wrong. They are told that they are wrong to believe that exertion will make them ill. They are regarded as 'catastrophizing' if they have such beliefs, i.e. they are imagining, wrongly, that exertion will be catastrophic for them. So patients are being made to unlearn the effective strategies that have often taken years to start to master (and I don't think we ever completely master them due to our urges to do too much and due to life getting in the way).

The 'therapists' are doing the equivalent of telling a child that it is safe to put their hand in the fire, and that their learned belief that it will burn them is wrong.

I mean we lambasted PACE because whilst their 'end points' were interpreted as 'recovery' they are nothing like how we or anyone else in the real world might interpret recovery.

That's one of a multitude of reasons why PACE was BS.

Asking the patient if they feel they have recovered as a direct result of any intervention/management technique - would be useful.

I think drugs are viewed in these terms: so why not management strategies too? Not in relation to any pre-intervention 'goals' but overall - and I don't mean in relation to pre-illness function either: a more realistic measure is needed.

Drug studies measure success largely by means of physiological measurements, such as whether a cancer has shrunk, whether a heart rhythm has stabilised, whether blood pressure has come down, whether a skin condition has cleared up. There is sometimes an element of patient perception, but that is not usually the main criterion for measuring efficacy, unless we are talking about drugs for psychiatric conditions. PACE did not use objective measurements to assess efficacy.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Bob said:
It seems that they managed to change 'beliefs' about fatigue (hence the short-term improvements to the self-reported outcomes), but not actually improve the illness.

Is this not then a 'good thing' for them to admit? Do you perhaps think it is a 'good paper' I wonder because it reveals the true nature of improvement.

My point was that, considering the background of the authors, they probably belief that CFS/ME is 'perpetuated' by maladaptive cognition & behaviour. (i.e. the usual psycho-social model of illness.)

So they think that changing the patient's beliefs about their symptoms will cure the illness.
Well, it blatantly failed to make any difference to the actual illness in this study.

Instead, what it did was to change how patients filled in their questionnaires, temporarily.
This isn't surprising if you set out to brainwash a patient that they are not really ill, but they are misinterpreting their symptoms.
For a short while, a patient may change the way they report their symptoms, just as they have been trained to, but over the long-term, the patient will forget this mind-training, and will answer the questions honestly again.

This effect is demonstrated in the difference between self-reported fatigue questionnaires and objectively measured physical function.
This is the reason that psycho-social research rarely includes objective measures of disability, or if they do, they don't report the results.

It's known as 'response bias' whereby patients self-report their symptoms differently as a result of external influences.
A similar effect is seen for homoeopathy. It's the placebo effect. A patients' expectations are raised, and their interpretation of their symptoms subtly change as a result of altered expectations, as a result of external influence. They may feel better for a while, but the actual disease process remains.

However, in these psycho-social models of illness, the proponents are still claiming that they affect the course of the illness. (i.e. that they can cure ME, as in the PACE trial in which patients were reported to have 'recovered' when in fact there was no indication of recovery at all.)

Another mediator of response bias, is social pressure to please your therapists, who persistently tell you that you are behaving well if you report improved symptoms, and who might implicitly suggest that you've been a disappointment if you report worsening symptoms, and may even explicitly say that you are not behaving properly if you report worsening symptoms.

The best type of clinical trial will include a control group which offers the patients the same type of expectations as the treatment group, in terms of illness outcomes, and the same changes in perception. (i.e. a placebo control group.)
For example, a control group for a clinical trial based on psychological interventions could include a positive-thinking course alongside a course that is aimed specifically at ME patients that helps them in various ways to cope with symptoms, to cope with their lives, and to feel more positive about themselves.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Darn, I can't help myself, I keep thinking of duck jokes.

images
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
...

The best type of clinical trial will include a control group which offers the patients the same type of expectations as the treatment group, in terms of illness outcomes, and the same changes in perception.
For example, a control group for a clinical trial based on psychological interventions could include a positive-thinking course alongside a course that is aimed specifically at ME patients that helps them in various ways to cope with symptoms, to cope with their lives, and to feel more positive about themselves.

Thanks Bob. Bit obsessed now with the Monumental News on the other thread; but how about a trial in which one of the other groups being observed comprises patients with another chronic condition? Would that not 'expose' the nature of the therapy perhaps i.e. it is not a fix? I haven't seen it done like this - comparisons might have been read by me at some point - but not two diseases and a normal cohort - under similar/same conditions.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Thanks Bob. Bit obsessed now with the Monumental News on the other thread; but how about a trial in which one of the other groups being observed comprises patients with another chronic condition? Would that not 'expose' the nature of the therapy perhaps i.e. it is not a fix? I haven't seen it done like this - comparisons might have been read by me at some point - but not two diseases and a normal cohort - under similar/same conditions.

Yes, that would be helpful. That's a good point. If an MS patient group were included, for example. I think it's been said on this forum that the effects of CBT and GET, for ME/CFS patients, are no different to expected placebo effects. But I don't think I've read up on the details of placebo effects yet.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
My point was that, considering the background of the authors, they probably belief that CFS/ME is 'perpetuated' by maladaptive cognition & behaviour. (i.e. the usual psycho-social model of illness.)

So they think that changing the patient's beliefs about their symptoms will cure the illness.
Well, it blatantly failed to make any difference to the actual illness in this study.

Instead, what it did was to change how patients filled in their questionnaires temporarily.
This isn't surprising if you set out to brainwash a patient that they are not really ill, but they are misinterpreting their symptoms.
For a short while, a patient may change the way they report their symptoms, just as they have been trained to, but over the long-term, the patient will forget this mind-training, and will answer the questions honestly again.

This effect is demonstrated in the difference between self-reported fatigue questionnaires and objectively measured physical function.
This is the reason that psycho-social research rarely includes objectively measures of disability, or if they do, they don't report the results.

It's known as 'response bias' whereby patient's self-report their symptoms differently as a result of external influences.
A similar effect is seen for homoeopathy. It's the placebo effect. A patients' expectations are raised, and their interpretation of their symptoms subtly change as a result of altered expectations, as a result of external influence. They may feel better for a while, but the actual disease process remains.

However, in these psycho-social models of illness, the proponents are still claiming that they affect the course of the illness.

Another mediator of response bias, is social pressure to please your therapists, who persistently tell you that you are behaving well if you report improved symptoms, and who might implicitly suggest that you've been a disappointment if you report worsening symptoms, and may even explicitly say that you are not behaving properly if you report worsening symptoms.

The best type of clinical trial will include a control group which offers the patients the same type of expectations as the treatment group, in terms of illness outcomes, and the same changes in perception.
For example, a control group for a clinical trial based on psychological interventions could include a positive-thinking course alongside a course that is aimed specifically at ME patients that helps them in various ways to cope with symptoms, to cope with their lives, and to feel more positive about themselves.

Excellent points well made! :)
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
A brief take on this paper, based on the abstract only

Mediation is about HOW a treatment works eg in this study they are claiming that that pragmatic rehabilitation (independent variable) improves fatigue (dependent variable) by the meditating effect of behaviours/beliefs. Wikipedia diagram:
Mediation.jpg


So in this study, pragmatic rehabilitation 'changes' beliefs/behaviours, and it's those changes in beliefs and behaviours that lead to the improvement inf fatigue.

First off, they only have a very small effect to go on, an approx 2-point change in the Chalder Fatigue scale (0-33) at 70 weeks (there was no chance using the 0-11 bimodal scoring originally specified). And there was no change in function, either according the the SF36 score, and "There were no between-group differences on measures of exercise capacity (a timed step test)." Which means this is a lot of fuss about not a great deal.

Second, there has to be a time sequence ie therapy starts, meditator changes THEN outcome (fatigue) changes. Consequently, this 'result' is wrong, since mediation can't be shown:
Reductions in 70-week measures of fear avoidance, embarrassment avoidance, limiting activities, and all-or-nothing behavior all mediated improvement in fatigue at 70 weeks, although the causal direction of these cross-sectional effects cannot be determined. [ie no mediation can be shown, they could equally argue changes in fatigue mediate change in embarrassment avoidance etc, and be equally wrong]

The reduction in limiting acitivites could just be a marker of improvement generally, not specific to the therapy, in which case it says' signs of improvement at 20 weeks mediated fatigue improvement at 70 weeks'.
Reduction in limiting activities at 20 weeks mediated the positive effect of pragmatic rehabilitation on fatigue at 70 weeks (mediated effect size = -2.64, SE = 0.81, p = .001, proportion of effect mediated = 82.0%).

Note the change in catastrophizing, a more obvious psychological factor, had a smaller effect than the reduction in activities above:
Reduction in catastrophizing at 20 weeks mediated the positive effect of pragmatic rehabilitation on fatigue at 70 weeks (mediated effect size = -1.39, SE = 0.61, p = .023, proportion of effect mediated = 43.2%).

Another issue is whether or not these results would generalise to other patients. One approach would have been to randomly split the sample in two, and see if the same pattern of mediation was seen in both. Perhaps they did - I haven't seen the full text which appears to be paywalled despite being publicly funded :(
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
The issue with papers is often in the detail, especially unpublished results if any. Abstracts can be misleading. We could be giving this paper unjustified criticism, or it could be that the details will give us even more ammunition and we are not being critical enough. Details, details .... data, data.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
For anyone not familiar with the FINE trial, it demonstrated that 'pragmatic rehabilitation' (which included 'elements' of CBT and GET) was ineffective at follow-up...

The Fine Trial.
Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial.
Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group.
BMJ. 2010 Apr 23;340:c1777.
doi: 10.1136/bmj.c1777.
http://www.bmj.com/content/340/bmj.c1777
http://www.ncbi.nlm.nih.gov/pubmed/20418251

FINE Trial study protocol:
Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol.
AJ Wearden, L Riste, C Dowrick, C Chew-Graham, RP Bentall, RK Morriss, S Peters, G Dunn, G Richardson, K Lovell and P Powell
doi:10.1186/1741-7015-4-9
http://www.biomedcentral.com/1741-7015/4/9

In the protocol, 'pragmatic rehabilitation' is described (for example) using the following phrases:

"[CFS is] often maintained by illness beliefs that lead to exercise avoidance."

"The essential feature of the treatment is the provision of a detailed explanation for patients' symptoms, couched in terms of the physiological dysregulation model, from which flows the rationale for a graded return to activity."

"The explanations for various symptoms of CFS/ME highlight the interaction between psychological and biological factors."

"Having taken control of their symptoms through a programme of graded activity, normalisation of sleep patterns, and simple anxiety and stress-reducing procedures, patients are better able to consider the role of psychological and social factors in their condition."
 
Messages
13,774
The issue with papers is often in the detail, especially unpublished results if any. Abstracts can be misleading. We could be giving this paper unjustified criticism, or it could be that the details will give us even more ammunition and we are not being critical enough. Details, details .... data, data.

Yeah - I want to see the full paper on this before really commenting, but given some of the other FINE follow up papers, I'm not expecting much.