PACE Trial and PACE Trial Protocol

[Bob]

Well, Malcolm Hooper can't be expected to transform the situation single-handedly anyway.
It takes the involvement of our whole community to make just small incremental changes over time.
So if his work helps us in some way, then that can only be good news.
And his involvement seems to have helped to bring government attention to the PACE Trial.
The Lords parliamentary debate might help to bring some wider attention to the limitations of the PACE Trial.
I'm not expecting much from it, but it might get the government to focus on the subject for a short while, and even research it, because they might have to answer parliamentary questions, on record.
It might also get some of the information about the PACE Trial on public record because the parliamentary debate will be recorded in Hansard, and the government might even be forced to acknowledge some of PACE Trial's shortcomings on record.

 

[Graham]

Have you seen the Countess of Mar's notes for meeting with BIS officials, in response to incorrect information that she was given as "Parliamentary Answers"? It's good stuff. She is certainly working so hard on our behalf. (The document is a pdf download.)

 

[Firestormm]

Yes. That was what we were discussing Graham.

Bob - I haven't studied this 'Update' from Hooper (maybe I should as I seem to recall some past statements have proven factually incorrect) but you are of course right, although in regard to the PACE Trial I genuinely think the 'community' has been rather proactive in voicing some genuine concerns particularly when it came to factual inaccuracies in the paper itself (as well as claims made and opinions expressed etc.).

Threads like this one are evidence of that I think (not to mention Dolphin and Esther's work on it all of course). Indeed (perhaps) one might say that because of the 'community' pressure little has actually come of the PACE nonsense in practice.

I do recall very clearly how much of a damp squib this appeared to be when it was published in terms of NICE's acceptance. What was a massive build-up accompanied by a splurge of media coverage and then.... zilch.

If memory serves NICE had very little to say other than 'We are reviewing the Guidelines in 2013'. Then again I suppose you could argue they didn't alter what was said about CBT/GET in the existing notes. Which reminds me... a meeting on Tuesday and I must study G53 in preparation (Doh!).

I think if a more professional debate in the House of Lords (or Commons preferably) or even better with NICE were made ahead of the review next year - then you might get somewhere. Not sure what action NICE would take though either way. I mean - again if memory serves - this Trial was initiated with regards to safety wasn't it? To determine if what was being recommended by NICE was indeed safe and fit for purpose?

Therefore a defence of that might be a good idea to pursue I guess i.e. that these THERAPIES () have not been tested on severely affected patients, cannot therefore be considered 'safe for all' etc. etc. etc.

Hooper's stuff did take on some or the original brief I recall but not all of it. I'd perhaps begin with that and leave all the 'He said, she said (or didn't say)' stuff out of any serious debate.

Just me 'umble opine Guv. And no offence Prof. Each to his own I suppose. Proof of the pudding.... and all that jazz.

Night all

Edit:

Just remembered. You seen the MEA pre-Review survey on these THERAPIES?

'...We expect the results will influence the next review of the NICE Guideline on ME/CFS treatments, which is due to be announced next year. We’ll include the results in our submission to the review which may lead NICE (the National Institute for Health and Clinical Excellence) to come up with new guidance to doctors.
You may remember that the first NICE guidelines on ME/CFS, issued in 2007, were a huge disappointment to many in the ME UK population because Pacing was not a recommended therapy and no therapies were recommended for severe sufferers. Doctors have to follow NICE guidelines in giving advice to their patients and so you can see why your help in influencing a review is vital.
And the evidence we gather from people who have tried out these therapies may be helpful to medical researchers when they apply for funding for new studies into these approaches. As yet there has been no substantive research carried out into Pacing...'

http://www.meassociation.org.uk/?p=11824

 

[user9876]

And despite PACE the MRC have felt the need to pump even more (though not half as much) money into ME to try and find more effective treatments.

Those in Government want to get us back to work. 'We' want to get back to work. The PACE Trial and it's 'treatments' promised this - and it FAILED miserably. FACT.

I assume part of the role of the MRC is to do the precompetitive research for the medical and phama industries. There is an argument that they have let the economy down here not just by keeping people from work but also by investing in the wrong things hence not allowing the phama industry to develop cures which would sell to millions world wide. With the patents that Fluge and Mella have filed they are in a position to make a lot of money. I assume Ampligen also has a huge potential if approved by the FDA. Nothing in the UK though.

 

[Graham]

Sorry Firestorm and others. For some reason I must have been stuck on an earlier page, and missed all this discussion. It's down to brainfog, senility or just confusion with the new website. And as the new website is beautifully structured, it doesn't leave many options, does it?

Let's do the timewarp again?

 

[Graham]

Bob I'm still not happy with the notion of standard medical care - the usual - heart, lungs, basic blood tests for infections, any specifics eg hypothyroidism etc. The notion of medical care lends some legitimacy to the other psyche mumbo jumbo however they use it. How clever to bring it in and 10% to improve only - well they might be right if the Docs (and we know it) do not understand the illness in the first place. Sort of hey we are in with Docs (not the four in my family who know they don't know but watch all developing medical research in order to try to treat effectively, what to look for/special tests the most important).

Sorry Enid, but as you may gather, I've been stuck on earlier pages, so lost touch with the discussion!

As far as I could make out, all SMC offered was advice on pain control, sleep, offering antidepressants in some cases and information about the illness in general terms (see below), but the majority of the doctors giving SMC were psychiatrists – only a few were GPs. It may sound weird to think that this could result in improvements – surely a standard GP should offer this? But that isn't so in my experience. In my case, my GP never offered anything for pain control or help with sleeping patterns: I came across what worked for me by accident about 7 years later, and just getting a regular night's sleep (even not a refreshing one) improved my levels. I know of quite a few who have had their GPs waiting for suggestions from the specialist before doing anything, and often the specialist only saw them for ten to fifteen minutes, mostly going over the history, then passed them on to support staff (for CBT/GET or pep talks) and didn't send any advice back on medication.

I guess that the doctors offering SMC assumed that each patient had been assessed as having ME (or was it CFS, or even CF?), and so did not feel the need to carry out blood tests etc., because I didn't come across any mention of things like that.

This is from the protocol: "SSMC will involve a minimum of three visits after randomisation, or more if clinically indicated (such as overseeing benefit/adverse effects of a prescribed medication). Allowed interventions include explaining the diagnosis, education about the illness, standardised advice on activity management ... and prescription of syptomatice medications, such as antidepressants and hypnotics, as clinically indicated."

 

[biophile]

Overall I think Hooper does more good than harm and I really appreciate his efforts. When was the last time any popular ME/CFS doctor or researcher published anything critical of the PACE Trial or did anything remotely significant on the issue? I agree with others that his writing can be too long, too padded with peripheral points, too focused on motives, and could be toned down in a few places for certain audiences. I don't have the capacity to investigate every claim he makes, I don't agree with everything he says, and occasionally I've spotted something which seems inaccurate. However, even if only a proportion of his points are both correct and important, that is still a big deal considering how the prevailing attitude is that the PACE Trial was utterly unbiased/flawless while the critics have said nothing of value whatsoever.

A genuine investigation would go through each point made, concede the ones which are accurate and significant, then reject the rest with a provided explanation. The Lancet examined Hooper's complaint to them and rejected the entire document as a groundless diatribe. That includes points which people on this forum believe are genuine and crucial. I doubt that an ideal critique to the Lancet would have made much difference anyway. The Lancet will bizarrely not even publish corrections for easily verifiable errors, although perhaps the editors have taken it personally and publishing a correction would be an admission of error.

I think the supposed damage caused by the perception of Hooper's "ranting" is overstated. Just about everything we say is already perceived as ranting if it does not follow the party line. We were literally expected to welcome the PACE results with open arms, anything less is basically misinterpreted as irrational recalcitrance. Obviously it could be argued that further ranting does not help, but it is not like the super-polite and carefully-worded letters to the editor (Lancet) were interpreted in a much more positive light than Hooper's complaint. van der Meer and Lloyd even claimed in a journal publication that these letters were unscientific personal attacks.

What chances do we have when pro-CBT/GET professionals are allowed to publish lies against us but everything we say is dismissed regardless of the argument's validity?

Horton personally derided the entire community's attempts at critiquing the PACE Trial, not just Hooper's. News media presented critique in the same league as hatred, extremism, and criminal behaviour. Reader comments on news articles rarely distinguished rants from quality critique, many people were even disgusted at the fact that we challenged the PACE results at all. Over at the Bad Science forum, Hooper was generally regarded as a ranting dullard, but so was just about every other critic, polite and concise or otherwise.

As Bob points out: "Well, Malcolm Hooper can't be expected to transform the situation single-handedly anyway. It takes the involvement of our whole community to make just small incremental changes over time. So if his work helps us in some way, then that can only be good news. And his involvement seems to have helped to bring government attention to the PACE Trial."

Hooper was the only one who wrote any sort of comprehensive critique shortly after publication of the PACE paper. This would have been no easy task and was probably rushed given the urgency of the situation. Look how long it is taking us to do it! It took PACE about a decade to organize and conduct and publish the PACE Trial (with more coming), it will probably take us the rest of this decade to deconstruct it and take appropriate action. The PACE Trial goes beyond scientific issues, it is a political issue too, and Hooper offers more than scientific criticism. To borrow a phrase from Australian politics, Hooper is also attempting to "keep the bastards honest" by taking it up with the relevant officials or assisting others to do so. He may be getting stonewalled most of the time, but he is persisting and the recent development sounds positive.

 

[ukxmrv]

Professor Hooper doesn't have access to a huge body of helpers and that includes not having a PR person. It's just him and a few like minded ME patients and doctors.

We need to be realistic in what we expect from him. For the past few years I believe that his wife has been unwell so that's an added stress on him.

My feeling is that we need to treat Professor Hooper like a "national treasure". If we can help polish things then offer to help. If we know of a PR firm that can work pro-bono then put them in touch. If we think that the campaign should be run in a different way offer to do it.

It's not that he should be beyond criticism of course, just that he's working with few resources and could do with some more. If we want his output to change we need to offer ideas that he can actually do.

 

[Sean]

Hooper has done some good work, and I am grateful to him for it. We owe him a lot.

But his work is not really for citing directly in formal debates.

Use his stuff as a good informal additional summary, analysis, commentary, etc, of other more formal work.

 

[Enid]

Graham - your post at 1806 - many thanks, just as I suspected. The psychiatric naming of ME/CFS took root many years ago (well ever since the Royal Free really). My own unfortunate "run in" with their creeping monopoly in the disease was one presented in Accident and Emergency (picked up collapsed in the street) and following a huddle by three very junior Docs who had a "new idea" - it's all in your mind, imposed a psychiatrist. That was about 12 years ago. I don't need to tell what was going on at the time - encephalitis, passings out and all the rest. At least my baffled GP who seemed to be trying to persuade herself I wasn't bonkers allowed Neurontin (which I took to epileptic levels) provided some aid at that time. It seems no-one in the practice (didn't fit into their training) had ever heard of anyway and despite the obvious symptoms - glands up and down, serious GI issues, breathing and heart problems and blackouts, and a clinical fatigue (not CFS) - seemed wrapped in some disbelief. A Neurologist eventually found brain etc abnormalties, agreed in principle ME thought viral in origin but could not aid. A battle all the way and made even more difficult when unable to speak even. I think what I'm trying to say is that the "how to make a disease disappear" club need removal so this disease is returned to real medicine, and medics provided with the guidance they currently lack - what to screen for specifically (pathogens), restoration of some belief in the patient, and education. And no CBT nor GET would have aided at any stage (PACE). Antidepressants and hypnotics either. (Hypnotics a trance state ? - luckily escaped that one, but basic blood tests carried out revealed nothing. Subsequently when questioning the nurse about specific named pathogens I was told "only if asked for" so not included in my original blood test it seems).

 

[Esther12]

(not to mention Dolphin and Esther's work on it all of course)

Thanks Fire, but I'm afraid I've been putting far less work in than many others recently!

re Hooper: I agree with those who emphasise the work he's put in, and it does seem that he's one of the few people who has some sense of moral imperative with regards to CFS, but there is a danger of allowing emotional feelings of gratitude to create a sense of loyalty which leads to us turning a blind eye to failings in his work. I can also feel something like: "I do so little, should I really criticise those who have put so much more work in to this?" - but I think that this is an unhelpful attitude - the more criticism and debate we have the better imo. Admittedly, social and political movements which are able to bring about real change often don't seem to share my commitment to relentless adversarial discussions, so I could be trying to lead us down a blind alley on this one.

re PACE and the DWP:

I went through Aylward's pamphlet on Models of Disability in this thread: http://forums.phoenixrising.me/inde...cial-model-paper-from-2004.17783/#post-270979

(Perhaps I should have started a new thread for it?)

The Biopsychosocial approach to medicine is a major driving force in the recent UK benefit reforms, which are currently pushing lots of ill and disabled people in to poverty, and saving the Government lots of money.

One of the quotes I pulled out was this:

The major limitation of the biopsychosocial approach has been the lack of simple
clinical tools to assess psychosocial issues and simple, practical interventions to address
them (Kendall et al 1997, Borkan et al 2002, Kendall & Burton 2009). After more than
30 years, and despite agreement on the importance of psychosocial factors, there is
relatively little empirical evidence for effective biopsychosocial interventions at an individual
level. The challenge is to develop simple, practical, biopsychosocial messages for
routine practice, and the evidence base for their effectiveness.28

This lack of evidence is rather important.

PACE is the only piece of medical research which the DWP has funded, and I think that it's important to see it in the context of recent benefits reforms, and a desire for evidence to support a BPS model of disability which could be used as an excuse to shift responsibility for disability away from society, and back on to the individual.

There is also quite a lot of public cynicism about government and 'expert' claims about the recent benefit reforms, as lots of people know individuals personally affected, and can see the disconnect between the claims being made and reality. If we were able to show the connection with the way in which CFS is being treated in the UK, it could help us overcome people's instinctive deference to the government and 'experts'.

 

[Bob]

I've just checked, and I was right when I said that SMC advised people to avoid extremes of activity:

From the long protocol:
8.1.4 Standardised Specialist Medical Care
SSMC will be given to all participants. This will include visits to the clinic doctor with
general, but not specific advice, regarding activity and rest management, such as advice
to avoid the extremes of exercise and rest, as well as symptomatic pharmacotherapy.

 

[Enid]

I wonder who their "clincal Docs" were - specialists in what exactly ? - any screening for pathogens etc. Advice to avoid extremes of exercise and rest could be quite contrary to the actual aims of the PACE trial. How very confusing .

There were (and mostly still now) no such things as specialists in ME/CFS.

 

[Bob]

Advice to avoid extremes of exercise and rest could be quite contrary to the actual aims of the PACE trial. How very confusing .

Yes, that's what I was thinking, Enid.
I thought that the SMC advice might conflict with the instructions given to the GET group.
But actually, the GET group were instructed to avoid extremes of activity, and only increased their activity levels very carefully and incrementally. It was a very controlled and carefully monitored environment, and if there was a flare up after an incremental increase in activity, then the activity levels would be reduced.

Unfortunately, the media, doctors, and therapists in clinical settings often don't understand this, and think that telling patients to "get out and exercise", or to push themselves to their limits, will be good for them, based on the GET.

For example, based on GET, the Daily Mail said:
“...scientists have found encouraging people with ME to push themselves to their limits gives the best hope of recovery"

My memory fails me with regards to how much is written about testing 'limits' in the PACE literature.
But Peter White has said the following, which I think was unhelpful:
"They [the results] imply that testing the limits of the illness is more effective than staying within them."
(The EACLPP / European Association for Consultation Liaison Psychiatry and Psychosomatics: Abstracts, oral presentations)

 

[Firestormm]

Quite interesting to reappraise myself of the NICE Guidelines last night/today, Bob. The definition of GET for example, is very much similar to the one you have spoken of above as being said to the 'GET group'. Similarly, the CBT definition was far more 'realistic' than some patient's experiences have been... O hell I wasn't going to do this now but here's the relevant definitions:

NICE Guidelines G53 2007 (review date 2013)

Page 49 CBT

'An evidence-based psychological therapy that is used in many health settings, including cardiac rehabilitation and diabetes management. It is a collaborative treatment approach. When it is used for CFS/ME, the aim is to reduce the levels of symptoms, disability and distress associated with the condition. A course of CBT is usually 12-16 sessions. The use of CBT does not assume or imply that symptoms are psychological or 'made up'.'

Page 50

GET
'An evidence-based approach to CFS/ME that involves physical assessment, mutually negotiated goal-setting and education. The first step is to set a sustainable baseline of physical activity, then the duration of the activity is gradually increased in a planned way that is tailored to the person. This is followed by an increase in intensity, when the person is able, taking into account their preferences and objectives, current activity and sleep patterns, setbacks/relapses and emotional factors. The objective is to improve the person's CFS/ME symptoms and functioning, aiming towards recovery.'

On page 10 it states - in relation to 'Specialist CFS/ME Care' -:

'CBT and/or GET therapy should be offered to people with mild or moderate CFS/ME and provided to those who choose these approaches, because currently these are the interventions for which there is the clearest research evidence of benefit.'

Anyhoo, I have to get back to me reading. Good to hear from you Esther. I'll have a better read of your comment later if I may. Take care.

 

[Enid]

The whole fiasco to me is thoroughly irresponsible however viewed and any allowance made. The pathologies revealed from knowledgeable specific testing (mostly US - absent here) are being treated. PACE held up any hope for any biomedical research by years to "prove" their CBT and GET. The condition fluctuates (over years) and it is quite obvious (like any other illness) it better to move about again WHEN and AS one is able. If the PACE team have been misrepresented by the Press and wider medical community (which they have) it is their responsiblity to rectify. Testing for abnormalties and treating would obviously be better than a "learn to live with it".

(To Bob @ 1814).

 

[Firestormm]

Afore I go...

There's a question that has been flying around in one of the mindfulness-inspired compartments of my brain for some time:

Is there any need to have a particular form of CBT or GET for patients with ME? What I mean is, that I have spoken to several therapists over the years all of whom treat a variety of conditions. What I have not been able to ascertain is if their application differs for ME than say for MS or any other long term condition involving mobility and cognitive debilitation.

Now, I still haven't read those bloody PACE Manuals and I think they do dictate a specific form of intervention (at least that is my impression having followed all the debate), but in practice - in the trenches - do the applications differ markedly and if so in what way?

Would it not save money to combine - for example - all neurological treatment under one roof? I know the Occupational Therapists attached to our ME Service only spend a small proportion of their working week with ME patients, similarly so does the psychologist. I wonder though if their approach is any different really for anyone else with another condition.

Shouldn't our 'specialists' function solely for the purpose of diagnosis, and medical advice in the main? To ensure that the most appropriate drugs are prescribed and then signpost them to relevant and agreed multi-disciplinary practitioners? To warn of the dangers of the condition, to inform, to guide to support - from a medical perspective.

The whole emphasis now - kind of what Esther was saying - is on 'patient responsibility'. They appear to downplay the importance of drug therapy and the involvement of medical clinicians. Once you have a diagnosis (if you can get a correct one speedily) you are directed towards 'management' therapists. Important, yes but only when balanced with medical clinicians with expert knowledge of the condition who ensure you have the necessary drugs and complete the tests etc..

I don't think it is appropriate for a health service to operate whereby a patient must inform a doctor of a drug that is deemed to be most appropriate. It seems the patient is being burdened unduly with responsibility for his/her own care at a time when he/she needs support and help.

Anyone care to comment on what they would consider to be an ideal 'Specialist ME care' service? I wish one of the medical disciplines would simply take ownership. Feel like we are still in limbo although the Guidelines do acknowledge the neurology preference they don't allocate responsibility - I don't suppose they can until something definitive is discovered. Wouldn't hurt though would it? 'Specialist Medical Care' is not what it says on the tin.

 

[Esther12]

Good to hear from you Esther. I'll have a better read of your comment later if I may. Take care.

Don't feel intimidated - only the first sentence was aimed at you, and the rest was more general comments. This thread can fill up with interesting posts so quickly that it's difficult to keep up (I know I have to miss loads).

 

[Dolphin]

Yes, that's what I was thinking, Enid.
I thought that the SMC advice might conflict with the instructions given to the GET group.
But actually, the GET group were instructed to avoid extremes of activity, and only increased their activity levels very carefully and incrementally. It was a very controlled and carefully monitored environment, and if there was a flare up after an incremental increase in activity, then the activity levels would be reduced.

It was relatively controlled alright. But the theory isn't that one "if there was a flare up after an incremental increase in activity, then the activity levels would be reduced." GET is about breaking that link.

e.g. from the GET participant manual http://www.pacetrial.org/docs/get-participant-manual.pdf

What is a setback?

You may be familiar with setbacks: in this context, we are referring to an increase in
symptoms that occurs, usually after an increase in activity or for some other reason, that
significantly affects your ability to undertake activity for as time-limited period. The cause,
severity and duration of setbacks can be variable.

[..]

(their bolding)

Dealing with a CFS/ME setback: what should I do?

During a CFE/ME setback, it is understandable that you might wish to rest and reduce the
amount of activity you do, because you don’t feel well and activity feels much harder than
usual. This may even be a time in which you become concerned that the increase in
symptoms may be causing you damage.

The evidence we have is in fact the opposite: there is no evidence to suggest that an
increase in symptoms is causing you harm. It is certainly uncomfortable and unpleasant,
but not harmful. In fact, there is much evidence to support the alternate view: if you rest too
much, it is the resting that can cause negative changes in the body. Resting and
withdrawing from activity can also make us feel fed up or worried, and this can also make it
harder to continue being active.

The periods of excessive rest can be a time when the body adjusts to the lower level of
activity and weakens: if the body weakens further, it can become more sensitive to activity
and make overall symptoms worse.

Therefore, during a setback it is useful to maintain as much physical activity as you can.
This is to avoid the weakening and tightening of muscles, and the reduction in fitness, which
can occur surprisingly quickly (we can lose 10 % of our muscle strength in just one week of
bed-rest, or even 1% per day).

Therefore, if at all possible, try to keep to your exercise and activity plan, knowing that in
time your body will adjust.

Of course, if you are having a very severe setback, in which your previous level of activity is
leading to distressing or unmanageable symptoms, then reducing activity slightly and
increasing rest might be a temporary solution, as long as you build up again as soon as you
can to your previous level. Building up again should ideally occur within a few days to avoid
the detrimental effects of rest. Reducing activity should be avoided if at all possible.

It can be helpful to use other strategies during a setback, such as muscle relaxation, or
gentle stretches that can relieve discomfort. Warm baths can also help your muscles feel
more comfortable. It is also useful to try to avoid extra sleeping where possible, as this can
make it harder for you to get back into physical activity.

Of course, how many people actually stuck to this is another matter.

 

[Graham]

What is a setback?
You may find occasionally that something unusual happens that restricts your normal activity levels: perhaps a leg has dropped off, or perhaps a harpoon has been lodged in your spine. It is important to realise that these are not as serious as you may think, and you should make every effort to maintain your usual activities, even if, when running, you do tend to fall over. Although we have not actually had ME, we know that if you rest, it will actually do you more harm than good, and probably the other leg will fall off. Remember that you must totally ignore the pain messages that your body is giving you and continue with your planned exercises. These pain messages are not to be trusted.

Now, if you would just like to complete this questionnaire on fatigue levels....

(Do I need to insert an emoticon here to suggest that I'm being just a tad sarky?)

Translation for non-English speakers of English: "tad sarky"="a little sarcastic"