PACE Trial and PACE Trial Protocol

[Bob]

The PACE Trial provided evidence that 5 sessions of SMC is more effective than 14 sessions of GET or CBT, so then why don't they just roll out SMC for the entire ME patient community.
SMC is more effective than psychological interventions, and it would save the NHS money.
And if they provided 10 sessions of SMC, then it might be even more effective than SMC+GET or SMC+CBT, and still save money!

I wonder why we haven't heard about the wonders of SMC from the authors of the study, but only the wonders of CBT and GET, which were less effective!

 

[wdb]

This is a very interesting paper and hugely important I think. It looks to me like Wessely's own data indicates that placebo response alone in CFS trials is typically 15.4%23.7%
Does this not mean that in this context the PACE trials 15% response above no treatment is completely meaningless.

The Placebo Response in the Treatment of Chronic Fatigue Syndrome: A Systematic Review and Meta-Analysis

Hyong Jin Cho, MD, Matthew Hotopf, PhD and Simon Wessely, MD

From the Section of General Hospital Psychiatry, Institute of Psychiatry, Kings College London, United Kingdom.

Address correspondence and reprint requests to Dr. Hyong Jin Cho, Section of General Hospital Psychiatry, Institute of Psychiatry, Kings College London, P. O. Box 62, Weston Education Centre, 10 Cutcombe Road, London SE5 9RJ, United Kingdom.

Objective: The placebo response is conventionally asserted to be high in chronic fatigue syndrome (CFS) because of the latters subjective nature and obscure pathogenesis, but no systematic review of placebo responses has been undertaken. We report such a study. Patient expectation is known to be important in the placebo response. It is also known that CFS patients attending specialist clinics often have strong physical attributions regarding causation and hence skepticism about psychological or psychiatric interventions. If so, the placebo response in CFS may be influenced by the type of intervention according to its perceived rationale. We aimed to estimate the summary placebo response in clinical trials of CFS and to determine whether intervention type influences the placebo response in CFS.

Methods: We searched Medline, Embase, Cochrane Library, PsychInfo, and the references of the identified articles, and contacted experts for controlled trials (randomized or nonrandomized) of any intervention on CFS patients reporting the placebo response as a clinical improvement in physical or general outcomes. Data were extracted from the articles and validity assessment conducted by one reviewer and checked by a second. Meta-analysis and metaregression were performed.

Results: The pooled placebo response was 19.6% (95% confidence interval, 15.423.7), lower than predicted and lower than in some other medical conditions. The meta-regression revealed that intervention type significantly contributed to the heterogeneity of placebo response (p = .03).

Conclusion: In contrast with the conventional wisdom, the placebo response in CFS is low. Psychological-psychiatric interventions were shown to have a lower placebo response, perhaps linked to patient expectations.

 

[Dolphin]

There is some excellent info and analysis being done on this thread, some very important issues and points being raised. But fitting all this into letters, or even a full article or two, is going to be difficult. Needs some thought about how to collate it, and use it effectively (and legitimately).

We do need to maintain the momentum, but I would suggest at a somewhat more sustainable pace than recently.

You'll be pleased to hear that I doubt I'll be adding that many more observations. Am going to be moving on but will keep an eye on this thread, etc.

If anyone can work on a wiki or collate the info, that's great.

 

[Dolphin]

This is a very interesting paper and hugely important I think. It looks to me like Wessely's own data indicates that placebo response alone in CFS trials is typically 15.4%23.7%
Does this not mean that in this context the PACE trials 15% response above no treatment is completely meaningless.

The Placebo Response in the Treatment of Chronic Fatigue Syndrome: A Systematic Review and Meta-Analysis

Hyong Jin Cho, MD, Matthew Hotopf, PhD and Simon Wessely, MD

From the Section of General Hospital Psychiatry, Institute of Psychiatry, Kings College London, United Kingdom.

Address correspondence and reprint requests to Dr. Hyong Jin Cho, Section of General Hospital Psychiatry, Institute of Psychiatry, Kings College London, P. O. Box 62, Weston Education Centre, 10 Cutcombe Road, London SE5 9RJ, United Kingdom.

Objective: The placebo response is conventionally asserted to be high in chronic fatigue syndrome (CFS) because of the latters subjective nature and obscure pathogenesis, but no systematic review of placebo responses has been undertaken. We report such a study. Patient expectation is known to be important in the placebo response. It is also known that CFS patients attending specialist clinics often have strong physical attributions regarding causation and hence skepticism about psychological or psychiatric interventions. If so, the placebo response in CFS may be influenced by the type of intervention according to its perceived rationale. We aimed to estimate the summary placebo response in clinical trials of CFS and to determine whether intervention type influences the placebo response in CFS.

Methods: We searched Medline, Embase, Cochrane Library, PsychInfo, and the references of the identified articles, and contacted experts for controlled trials (randomized or nonrandomized) of any intervention on CFS patients reporting the placebo response as a clinical improvement in physical or general outcomes. Data were extracted from the articles and validity assessment conducted by one reviewer and checked by a second. Meta-analysis and metaregression were performed.

Results: The pooled placebo response was 19.6% (95% confidence interval, 15.423.7), lower than predicted and lower than in some other medical conditions. The meta-regression revealed that intervention type significantly contributed to the heterogeneity of placebo response (p = .03).

Conclusion: In contrast with the conventional wisdom, the placebo response in CFS is low. Psychological-psychiatric interventions were shown to have a lower placebo response, perhaps linked to patient expectations.

I was thinking about this before but not sure if the SMC group can be called a placebo group (although maybe it's even less).

Anyway, the point that was rolling around in my head was that 45% of the SMC group "improved" by the criteria they chose (which I think were too loose) which is much higher than the average "placebo response/effect" - what I was wondering was to try to quote this study to show that 45% is too high a figure and suggests the definition of improvement was too minimal to be meaningful. However, perhaps there are easier ways of making this point.

 

[wdb]

I was thinking about this before but not sure if the SMC group can be called a placebo group (although maybe it's even less).

The way I see it is that all of the interventions must contribute both placebo and therapeutic effects.

Take the GET SF-36 scores

36.7 is the baseline score
50.8 = baseline + SMC placebo + SMC therapeutic
57.7 = baseline + SMC placebo + SMC therapeutic + GET placebo + GET therapeutic

 

[Dolphin]

PACE Isn't For ME - Complete List of Participating Blogs

I just got this.

I'm afraid I won't have time to look at the blogs but maybe other people will look at one or more.

If you're not on Facebook, the links would hopefully work if you knock off the Facebook bit right up till the part of the URL that has a .com in it (not the .com beside Facebook).

ME/CFS Blogger Army: PACE isn't for ME " sent you a message on Facebook

Subject: PACE Isn't For ME - Complete List of Participating Blogs

PACE Isn't for ME's aim was to launch accurate information on PACE into cyberspace and counteract all the recent 'space junk' produced by vested-interest groups aligned with the lead researchers of the trial. The campaign relied on bloggers posting about PACE (and ME/CFS) and on those blogs being shared, viewed and commented on.

Although PACE Isn't for ME has come to a close, there is still a way you can help. Below is a list of the participating blogs - if you would visit each one in turn and leave a comment, this will help raise the blog's profile on Google, which in turn will increase its public visibility.

There is also another way you can help. By entering Google http://www.facebook.com/l/4a3e1mtKIY0UIcq2zHvfIm4bsMQ/www.google.com and typing PACE into the search window you will be presented with the top ranking PACE articles. Find the ones that have published positive and accurate information and leave a comment. In future, you might want to consider not leaving a comment when you read a negative 'blog' article. Visiting and commenting on some of the obvious attention-seeking blogs (ie those that bate sufferers with a view to increasing hits), only raises their profile, which we want to avoid. Commenting on online news media sites is a good thing, especially if the information they provide is inaccurate. It's a good opportunity to put the record straight and your comment is likely to be read by a larger audience.

If you enjoyed participating in XMRV Bloggerama Day and PACE Isn't for ME consider joining the newly created blog ring ME/CFS Blogger Nation. This will be an ongoing initiative aimed at growing a dedicated network and community of patient writers.

PACE trial: vague criteria and poor assessment
http://www.facebook.com/l/4a3e1TI_K...11/02/pace-trial-vague-criteria-and-poor.html

Advocacy Groups run alongside Liberal Democrat MP Ian Swales Blaze a Trail through the Political Arena
http://www.facebook.com/l/4a3e1oSaC...acy-groups-blaze-a-trail-through-politics.php

PACE Trial - A Strong Smell of Fish
http://www.facebook.com/l/4a3e1j-tl.../2011/02/pace-trial-strong-smell-of-fish.html

Rocky Works Hard: a Good News/Bad News Story Inspired by the PACE Trial
http://www.facebook.com/l/4a3e1w9VK...11/02/rocky-works-hard-good-newsbad-news.html

CBT & GET: The Studies, the Science and the Pseudoscience
http://www.facebook.com/l/4a3e1KbEj....com/2011/02/cbt-get-studies-science-and.html

PACE Tripesorry I mean Trial
http://www.facebook.com/l/4a3e1inx7...com/2011/02/18/pace-tripe-sorry-i-mean-trial/

The PACE Trial: This is not a good day for people with ME/CFS
http://www.facebook.com/l/4a3e19dLU...this-is-not-a-good-day-for-people-with-mecfs/

Not Exactly Medical Journalism
http://www.facebook.com/l/4a3e1UM9U...php/2011/02/13/not-exactly-medical-journalism

Fighting the PACE
http://www.facebook.com/l/4a3e1xfSwUiedcKUJ8M1K4LtpvQ/nopostergirl.com/2011/02/23/fighting-the-pace/

PACE Trial Results are Out: ME is Caused by an Oncogenic Virus
http://www.facebook.com/l/4a3e10b-e.../pace-trial-results-are-out-me-is-caused.html

PACE Trial: What's fear got to do with it?
http://www.facebook.com/l/4a3e1VHS7...02/19/pace-trial-whats-fear-got-to-do-with-it

Keep on blogging!

 

[Dolphin]

It even perfectly explains why the subgroups did not show significant difference - because all we are looking at is change in perception, there is no significant therapeutic effect beyond placebo in any of the groups.

I don't think it even proves that patients changed their perceptions. Strictly logically speaking, all they can claim is that patients changed their own reports of their own behaviour (ie they changed their test taking behaviour), with no objective independent evidence to confirm any actual change in behaviour beyond the subjective test scoring process, and some good evidence to refute it.

Patients changed their response to being asked questions by psychs (and maybe authority figures in general), who had been heavily conditioning the patients to change their subjective response in exactly that very limited and non-therapeutic way.

Which is not the same as patients genuinely changing their perceptions, let alone that leading to improved overall health.

Circularity methinks.

Good points from both of you, I think.

If I remember correctly, there were studies in the early 2000s (I think one or more of them involved Ridsdale) which asked patients what there beliefs were about what caused the illness (e.g. believe it was physical, caused by a virus, etc.) and for some of them, this didn't change even though the patients appeared to improved (based on the questionnaire results).

In the PACE Trial, they are supposed to look at what are the mediators/how does the treatment work (although I don't think they'll look at some of the things Sean asked).

For example, one of the questionnaires is the following:

A6.15 Exercise and Activity Scale

Please indicate how much you agree with the following statements by ticking the
appropriate box. (Please tick one only per line)

Beliefs

Strongly Disagree

Disagree

Neither

Agree

Strongly Agree

I should avoid exercise when tired

Doing less helps fatigue

Exercise is harmful

I should avoid physical activity

They answered this at:
- baseline
- 12 weeks
- 24 weeks
- 52 weeks

Also:

A6132 Symptom Interpretation Questionnaire

Please indicate how much you agree or disagree with the following statements about your
current symptoms by ticking the appropriate box. (Please tick only one box per line)

Views about your symptoms

Strongly Disagree

Disagree

Neither

Agree

Strongly Agree

I am afraid that I will make
my symptoms worse if
exercise

My symptoms would be
relieved if I were to exercise

Avoiding unnecessary
activities is the safest thing
I can do to prevent my
symptoms from worsening

The severity of my
symptoms must mean there
is something serious going
on in my body

Even though I experience
symptoms, I don't think they
are actually harming me

When I experience
symptoms, my body is
telling me that there is
something seriously wrong.

Physical activity makes' my
symptoms worse

Doing less helps symptoms

Symptoms are a signal that I
am damaging myself

I am afraid I will have more
symptoms if I am not careful

I should avoid exercise when
I have symptoms

1 worry that I may become I
permanently bedridden
because of my symptoms

I think that if my symptoms
get too severe they may
never decrease

If I push myself too hard I will
collapse

My illness is awful and I feel
that it overwhelms me

If I overdo things it will cause
a major relapse

I will never feel right again

When I experience
symptoms, I think about
them constantly


I worry when I am
experiencing symptoms

When I am experiencing
symptoms it is difficult for me
to think of anything else

I think a great deal about my
symptoms

My symptoms are always at
the back of my mind

I spend a lot of time thinking
about my illness

I am embarrassed about my
symptoms

I worry that people will think
badly of me because of my
symptoms

The embarrassing nature of
my symptoms prevents me.
from doing things . '

I avoid social situations
because I am scared my
symptoms will get out of
control

I am ashamed of my
symptoms

My symptoms have the
potential to make me look
foolish in front of other
people

I stay in bed to control my
symptoms

When I experience
symptoms, I rest

I tend to avoid activities that
make my symptoms worse

I tend to nap during the day
to control my symptoms

Itend to overdo things when I feel energetic

I find myself rushing to get
things done before I crash

I tend toverdo things and . •
then rest up for a while

I tend to do a lot on a good
day and rest on a bad day

They answered this at:
- baseline
- 12 weeks
- 24 weeks
- 52 weeks

Also:

A6.27 Self-efficacy scale

We would like to know how confident you are in doing certain activities. For each of the
following questions, please choose the number that corresponds to your confidence that
you can do the tasks regularly at the present time. (Please tick one box per line)

Not Confident at all Totally Confident
0 1 2 3 4 5 6 7 8 9 10

How confident are you that you can
keep the fatigue caused by your
disease from interfering with the
things you want to do?

How confident are you that you can
keep the physical discomfort or
pain of your disease from
interfering with the things you want
to do?

How confident are you that you can
keep the emotional distress caused
by your disease from interfering
with the things you want to do?

How confident are you that you can
keep any other symptoms or health
problems from interfering with the
things you want to do?

How confident are you that you can do the different tasks and activities
needed to manage your health
condition so as to reduce your need
to see a doctor?

How confident are you that you can
do things other than just taking
medication to reduce how much
your illness affects your everyday

They answered this at:
- baseline
- 12 weeks
- 24 weeks
- 52 weeks

 

[Dolphin]

Don't know if this is of any interest to people or not

Investigating the active ingredients of cognitive behaviour therapy and counselling for patients with chronic fatigue in primary care: developing a new process measure to assess treatment fidelity and predict outcome.

Br J Clin Psychol. 2007 Sep;46(Pt 3):253-72.

Godfrey E, Chalder T, Ridsdale L, Seed P, Ogden J.

Department of Psychology, Institute of Psychiatry, Kings College London, UK. emma.l.godfrey@kcl.ac.uk

Abstract

OBJECTIVES: To develop a brief measure of the therapy process and use it to examine which therapeutic ingredients were associated with outcome in a sample of patients from a randomized controlled trial (RCT) of cognitive behaviour therapy (CBT) versus counselling for patients with chronic fatigue in primary care. It was hypothesized that the two therapies would be clearly distinguishable and that in terms of process variables, the therapeutic alliance would be important in predicting outcome.

DESIGN: The data for this study were collected alongside a RCT in primary care and included audiotaped therapy sessions. These tapes were assessed by two independent raters using a newly devised measure in order to evaluate therapy process and its relationship with outcome.

METHODS: Tapes from 71 patients participating in the RCT were assessed to form the basis of the process analysis. Outcome was self-reported fatigue symptoms at 6 months follow-up. Data reduction was achieved via a principal component analysis (PCA). Factors were entered into a multiple regression analysis to produce a final model of predictors of outcome.

RESULTS: The process measure showed that although the treatments could be distinguished, there was some overlap between them. The key predictor of a good fatigue outcome was emotional processing, including the expression, acknowledgement and acceptance of emotional distress.

CONCLUSION: A new process measure was developed successfully which now warrants further testing. It was able to assess treatment adherence and unpack, and distinguish the common factor which predicted outcome across therapy modalities. The findings lend preliminary support to the view that the specific techniques associated with particular 'brand names' of therapy are not necessarily the 'active ingredients' that help patient's change within the primary care setting. Emotional processing predicted outcome for patients with chronic fatigue and therefore future research might explore this in more depth, in order to understand better how it can be facilitated.

PMID: 17697477

 

[Dolphin]

...patience and keeping your brakes on may be just as important as increasing activity.
Peter White

One has to ask: why? If we are merely suffering from standard deconditioning – which is pretty easy to fix in somebody who does not have any serious physical limitations – then why take it so slowly, why should symptoms take so long to resolve? Really, it is just an excuse for why they get so little improvement from these therapies, even after extended 'treatment'.

Seems like they want it both ways.

I agree.

I have had a number of private discussions over the years about the way the CBT/GET school seems to be slowly and quietly changing their model to incorporate and be more like pacing (as we patients understand & use it), but of course without admitting it. I think they are quite vulnerable on this.

What do others think of that view?

They may be changing it a bit. At the same time, this trial and the manuals have forced them to say what GET, CBT and APT are and are not.

Also, the manuals are now out in the open so can be quoted from. In the past, we generally didn't have the manuals.

Here are a few quotes I sent to highlighted earlier today to somebody in an E-mail so thought I'd re-use. There would be other interesting ones also:

A quote from the GET therapist manual:

“Planned physical activity and not symptoms are used to determine what the participant does.”

Some quotes:

Although it can be difficult to encourage maintenance of exercise despite an increase in symptoms, participants usually are able to understand the reasoning behind this and are often pleased they were able to maintain activity during this time. It is important to explain that although they have an increase in difficult symptoms, ‘hurt does not equal harm’ (as you would do with somebody with chronic low back pain).

[..]

It is helpful to explain the theory behind maintaining exercise during a setback to participants BEFORE they have a setback if possible, as while they are symptomatic it
may be more difficult to encourage.

APT
Theoretical Model

The assumptions of simple pacing are that it is beneficial to stabilise activity and to
balance rest with activity. An analogy of balancing the energy “account” to avoid
overdrawing it is often used. Symptoms are regarded as warning signs to be “listened to”.

It is assumed that the symptoms reflect a pathological disturbance, which is not reversed by undertaking increases in activity. Rather the assumption is that ignoring fatigue and other symptoms risks activity induced exacerbations of the illness and consequently impeding natural recovery, whereas good pacing will maximize the chance of natural recovery and hence improve function in the long term. Activity is therefore planned so as to balance activity and rest. The aim is to do what can be done on the one hand, within the limits set by the illness, but to limit activity related exacerbations of symptoms on the other.

CBT
Theoretical Model

The model emphasises the importance of the participant’s understanding of their illness
and their interpretation of symptoms. For example, they may interpret symptoms as a
warning sign to reduce activity. Fear of symptoms and consequent avoidance of activity
associated with symptoms is central. This model also acknowledges that the participant’s beliefs and behaviours are influenced by available information and attitudes of families and friends and that these may also need to be addressed. The model assumes that physiological (fatigue), cognitive (fear of engaging in activity) and behavioural responses (avoidance of activity), are linked. Therefore by modifying one response it is anticipated that changes occur in the other responses. For example, increasing activity (behaviour) may gradually reduce the fear (cognitions) that activity leads to worsening of symptoms

Theoretical model

GET assumes that CFS/ME is perpetuated by deconditioning (lack of fitness), reduced
physical strength and altered perception of effort consequent upon reduced physical
activity. A normal process of adaptive change in the body is assumed to occur as a
consequence of rest or a reduction in physical functioning, i.e. weakening of muscles,
reduction in fitness, ('use it or lose it') and altered perception of effort. Activity can then produce symptoms as a result of these negative changes, as the body is attempting a physical activity beyond its current capacity. These changes are thought to be reversible, and thus improving fitness and physical functioning will alter perception of effort, enable the body to gain fitness and strength, leading to a reduction in symptoms and an increase in activity capacity ('use it and gain it'). Preliminary research suggests that reduced symptoms arise from simply doing a GET programme, rather than necessarily getting fitter, whereas improved function is related to getting fitter and stronger. Participants are encouraged to see symptoms as temporary and reversible, as a result of their current physical weakness, and not as signs of progressive pathology. A mild and transient increase in symptoms is explained as a normal response to an increase in physical activity.

There may be other mechanisms involved in the success of GET apart from reversing
deconditioning, including elements of habituation, and positive effects of re-engagement
with important activities. GET has also been shown to improve sleep, cognition, and
mood; factors that are also likely to perpetuate the condition, although these are not
directly addressed by the treatment.

---

GET is not APT

In contrast to APT, it is important that the “envelope theory” of pacing is not adhered to. APT is underpinned by an organic disease model, which encourages a person to stay
within the limitations set by their illness, and being directed by their symptoms as guides
to what they can do. The rationale behind APT involves the ability of the body to heal itself by not provoking symptoms. In significant contrast, GET encourages the participant to stretch the limits of physical capacity in order to improve them.

A main difference between APT and GET is that GET plans for incremental increases in
activity while APT does not.

 

[Dolphin]

This is another study investigating how CBT may get its changes (to questionnaires)

Full free text at: http://www.iacfsme.org/LinkClick.aspx?link=436&tabid=437

HOW VALID IS THE MODEL BEHIND COGNITIVE BEHAVIOR THERAPY FOR CHRONIC FATIGUE SYNDROME? AN EVALUATION OF THE ADDITIONAL DATA FROM THE TRIAL BY PRINS ET AL.

B. Stouten 1*, PhD
Ellen M. Goudsmit 2, PhD FBPsS

1. Einsteindreef 67A, Utrecht, The Netherlands

2. University of East London, UK



ABSTRACT

The cognitive behavior therapy (CBT) program studied by Prins et al. is based on a model of chronic fatigue syndrome that posits that fatigue and functional impairment are perpetuated by physical inactivity, somatic attributions, focusing on bodily symptoms and a low sense of control. A recent analysis of the data from three trials based on a model devised by Vercoulen et al. concluded that the effect of CBT on fatigue could not be attributed to a persistent increase in physical activity (They are referring to Wiborg et al. (2010)). We therefore examined the effect of treatment on the remaining three variables in the model using data from one of the trials, available in the public domain. The results from the groups given CBT, Guided Support and treatment as usual revealed that CBT had no significant impact on somatic attributions and focusing on bodily symptoms, and that in line with established guidelines, these two variables were not mediating factors. The only variable in the model showing an effect of CBT was sense of control. We submit that there is now sufficient evidence to warrant a review of CFS guidelines which advocate interventions aimed particularly at increasing physical activity and challenging somatic attributions, and that more flexible programs which address loss of control deserve further consideration and evaluation.

--------------------------------------------------------------------------------

Bulletin of the IACFS/ME. 2010;18(2):82-89. 2010 IACFS/ME

 

[Sean]

Thanks for that, Dolphin. Good stuff as always.

Got any comments on this post?

http://forums.aboutmecfs.org/showth...Trial-Protocol&p=164149&viewfull=1#post164149

 

[Dolphin]

Thanks for that, Dolphin. Good stuff as always.

Got any comments on this post?

http://forums.aboutmecfs.org/showth...Trial-Protocol&p=164149&viewfull=1#post164149

That is an interesting histogram, it puts the trial results into perspective if they are shown compared to the normal population.

This is the kind of diagram, of information vehicle, we need to clearly and quickly present and explain the reality of PACE, the underlying behaviour model of ME/CFS, and the daily difficulties we face. Almost everybody, regardless of their level of technical expertise, can readily understand the basic message of the data when presented like this.

I think that quite a lot of the critical info we are dealing with could be expressed in this way. Maybe just ten hard data based graphics like this will do more legitimate damage to their case than a million eloquent words in any forum (in no small part because the visual media will be able to use it). Even more so if we use their own data and definitions to construct the images.

So, what data to use, and how best to present it?

We probably should include our basic economic data, the immediate financial situation we find our selves in, and the long term consequences (the all too predictable consequences, sigh...).

(Somewhat ironically, the first person to effectively present statistical data in a graphic form was [drum roll]... Florence Nightingale, a pioneering statistician in her day. It's a small world.) [/QUOTE]Here are my thoughts, as requested, for what they are worth.

Graphs could be useful alright.

Although I'm not sure where you/we have in mind; I'm not an expert on correspondence/letters-to-the-editor sections (I have tended to read more full papers) but my impression is that generally one isn't allowed use graphs there unless one is using "new new data" (i.e. data you collected yourself that has never been published anywhere else before).

Writing a full paper critique is possible (a few have been published in the Bulletin of the IACFS/ME) but they take a lot of work.

I am also uneasy about even giving them 80 as "healthy" as I said here:
http://forums.aboutmecfs.org/showth...Trial-Protocol&p=163756&viewfull=1#post163756

Note on the point of using 80 as the threshold: if one have a recovered group that are like normal, it means it is possible the could be derived from the same distribution.
If most of the scores were 80/85 and a few 90+, such a group (which might have a mean in the low 80s or even a bit higher) could still be different from a healthy population with mean of 92/93. So shouldn't be described as a normal group.

 

[Sean]

We do need to maintain the momentum, but I would suggest at a somewhat more sustainable pace than recently.
Sean

You'll be pleased to hear that I doubt I'll be adding that many more observations. Am going to be moving on but will keep an eye on this thread, etc.
Dolphin

Just to be clear, I did not mean that in any critical way. Just sign posting my own limits.

Cheers
S

 

[Sean]

Although I'm not sure where you/we have in mind...

Doesn't necessarily need to be for strictly peer reviewed stuff. Will work just as well for educating doctors we deal with, plus media, family, friends, government agencies, etc.

 

[biophile]

The deceptive safety net of GET

Papers usually don't receive this level of scrutiny, but this paper is getting mauled. I'd be embarrassed to have my name on it. I'm still working on a reply for other comments but I wanted to post this first. Sean raised the following issue:

[...patience and keeping your brakes on may be just as important as increasing activity. - Peter White]

One has to ask: why? If we are merely suffering from standard deconditioning which is pretty easy to fix in somebody who does not have any serious physical limitations then why take it so slowly, why should symptoms take so long to resolve? Really, it is just an excuse for why they get so little improvement from these therapies, even after extended 'treatment'. Seems like they want it both ways.

Good point, and this prompted me to wonder about another issue, the "safety" of the GET conducted in the PACE trial may have a bizarre twist to it.

From the PACE results paper:

"The aim of treatment was to help the participant gradually return to appropriate physical activities, reverse the deconditioning, and thereby reduce fatigue and disability. Therapeutic strategies consisted of establishment of a baseline of achievable exercise or physical activity, followed by a negotiated, incremental increase in the duration of time spent physically active. Target heart rate ranges were set when necessary to avoid overexertion, which eventually aimed at 30 min of light exercise five times a week. When this rate was achieved, the intensity and aerobic nature of the exercise was gradually increased, with participant feedback and mutual planning. The most commonly chosen exercise was walking. The therapy manual was based on that used in previous trials."

Selected quotes from the GET therapist manual:

"Exercise for the following two weeks negotiated and planned."

"If the participant reports an increase in fatigue as a response to a new level of exercise, they should be encouraged to remain at the same level for an extra week or more. They should be reminded that each new level will initially feel harder until the body adapts: they are doing an activity they have not done for a while. The use of the Borg scale can be particularly helpful at this time, for the participant will be able to see their Borg ratings decrease as they maintain the exercise. They can then increase the exercise when the symptoms or Borg scale decreases."

"A participant who is trying to progress too quickly can be warned that a rapid increase can lead to an accumulative effect and an increase in symptoms. Participants such as this can be encouraged to stabilise at a certain level for a while, e.g. 2-3 weeks, to ensure their body is comfortable before the next incremental increase."

Clearly, there is considerable caution here during GET to prevent relapses, an almost pacing-like caution. I won't discuss the adverse effects, but I noticed an interesting catch: While GET has rather optimistic goals and is aimed at "encouraging" the increase of activity in carefully planned increments if possible, the PACE results paper does not mention how many people in the GET group actually managed to increase their activity (correct?), it is quite possible that most people in the GET group did not. Without actigraphy we may never know for sure, but perhaps the 6 minute walking distance is a smoking gun.

More from the GET therapist manual: "By week 4, most participants will be able to commence aerobic exercise." I find it very unusual that a group of people who on average are allegedly ready for (light) "aerobic exercise" after only 4 weeks of GET with the gradual aim of several sessions a week of moderate exercise, cannot even break the 400m barrier on a single 6 minute walking distance after 52-weeks of GET when healthy people (including sedentary people) are scoring 600-700m! It is possible that improvers are skewing the average, and vice versa for non-improvers. However, we know that the supposed superiority of GET over SMC isn't impressive on average. Was there even a single recovery???

The PACE protocol defined "recovery" as follows:

("Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less [27], (ii) SF-36 physical Function score of 85 or above [47,48], (iii) a CGI score of 1 [45], and (iv) the participant no longer meets Oxford criteria for CFS [2], CDC criteria for CFS [1] or the London criteria for ME [40].)

Rates of fully recovery were not given in the results (correct?), but you can be sure that if there were an impressive rate of "recoveries" the authors would be proudly announcing them.

At this stage it does seem that the GET rationale of deconditioning has been thoroughly discredited or at least massively exaggerated. Some studies have already found deconditioning does not perpetuate CFS. Another pro-GET study reported that GET changed patients' "perceptions" rather than actual fitness levels. Research like that, combined with the unimpressive PACE results and an earlier meta-analysis of actigraphy results which found no increases in activity, may be why biopsychosocialists (like those who wrote the editorial and conducted the meta-analysis) while not admitting a major chunk of their hypothesis has been debunked (fear-avoidance and deconditioning) are now focusing more on "cognitions" and "perceptions" about symptoms. This of course is plagued by another set of problems.

Another point I wish to raise has most probably already been covered by someone else. Putting up with a "tolerable" amount of exacerbation and negotiating with limitations is a fact of living with the disease, as long as one does not push too hard or you pay the price generally in proportion to how much you went overboard. In other words, doing what you can or need to "without leading to unmanageable exercise-related CFS/ME symptoms" (that quoted phrase comes from the PACE manual on GET). The keyword here being "unmanageable".

As I understand it, pacing it not about avoiding all exacerbations. PACE has set up a false dichotomy between GET (allegedly as a gentle approach to pushing the boundaries) vs a strawmanned version of pacing (APT avoiding all exacerbations). Avoiding all activity related exacerbation as encouraged by APT is impractical, it is no surprise that PF/SF-36 scores were the worst in the APT group.

 

[Sean]

In other words, doing what you can or need to "without leading to unmanageable exercise-related CFS/ME symptoms"...

Otherwise known as 'pacing'.

And if PACE's version of GET is more like proper pacing, then surely that shows that PACE actually proves that the most successful treatment is, in fact, pacing.

Furthermore, if the PACE version of GET is substantially different from its original formulation (in which somatic symptoms where to be explicitly ignored and pushed through), then their underlying theoretical model is not consistent. (Not that you all need that pointed out to you!)

 

[Dolphin]

I have only been able to read a few posts so forgive me if someone has already said something similar. I had a visit from my Occupational Therapist on the ME team. She has spoken directly to Peter White via the Yahoo site for ME NHS workers. Their is immense disquiet amongst the OT's in the ME teams who deliver the care within the UK about PACE especially the fact that PACE did not test the pacing protocol that they use, but instead used Adaptive pacing which only incoorporates a third of the techniques. She tells me Peter White was adament that PACE results were crystal clear and would direct the way future funding is granted. ME NHS staff are also aware that the patients tested were probably not in the main suffering from ME, but they are, in my opinion, very wary about losing their jobs and are too frightened to speak openly to the press. My OT was the first to critisise the trial via their own website after five days and Peter White answered almost immediately and with forthright language. Intimidation? My OT assured me whatever happened professionals in the front line would not change how they approach this illness (I hope they do but in a positive way!). She knows we are ill and that pacing is only a coping mechanism, she is very frustrated. Peter White is so blinkered and desperate to keep a hold on his powerbase no matter how much suffereing he causes. Keep up the good work you are doing. Got to go, too tired.

Thanks Carol. Sounds exactly like the impression I have of him.

 

[oceanblue]

CBT & GET don't make a 'clinically useful difference'

The redefined primary outcomes were based on comparing the mean scores between SMC and GET/CBT at 52 weeks. And they weren't looking merely for simply significant difference between groups, but used a slightly higher threshold of a clinically useful difference.

A clinically useful difference between the means of
the primary outcomes was defined as 0.5 of the SD of
these measures at baseline, equating to 2 points for
Chalder fatigue questionnaire and 8 points for short
form-36.

However, using 95% confidence intervals, neither CBT nor GET achieved a clinically useful difference in either fatigue or physical function scores, as shown by the Lancet paper's figure 3. Nb to be significant, the confidence intervals for treatment intervals would have to be beyond the targets of +8 (PF) and -2 (fatigue) - and they are not.

So it seems that the PACE trial failed to hit any of it primary outcomes, even though these had been lowered from those in the protocol.

However, the authors nonetheless tried to use these primary outcome differences to argue that CBT/GET were moderately effective:

Mean differences between groups on primary
outcomes almost always exceeded predefined clinically
useful differences for CBT and GET when compared
with [APT and] SMC.

nb the section I italicized completey fails to mention that the difference they did find were not statistically signficant.

 

[Dolphin]

BTW, I think I said to you somewhere that Figure 2 showed there wasn't a different response for subgroups (because of what the authors said). However, somebody elsewhere has happened to point that the "yellow" (what colour is it?) overlap in Figures 2F and 2G is interesting. It'd be good if somebody could get the means and standard deviations out of the authors and then we could do a t-test.

I don't know why I said "yellow" here!!! I meant red versus green and red versus purple-ish.

 

[Dolphin]

The PACE Trial provided evidence that 5 sessions of SMC is more effective than 14 sessions of GET or CBT, so then why don't they just roll out SMC for the entire ME patient community.
SMC is more effective than psychological interventions, and it would save the NHS money.
And if they provided 10 sessions of SMC, then it might be even more effective than SMC+GET or SMC+CBT, and still save money!

I wonder why we haven't heard about the wonders of SMC from the authors of the study, but only the wonders of CBT and GET, which were less effective!

You've lost me. How was it shown that 5 sessions of SMC is more effective than 14 sessions of GET or CBT?