UK NHS Online Clinic for August is CFS/ME & Fibromyalgia

[WillowJ]

I wanted to point out that the clinic closes today, and there's a "thank you" thread in the "adult medical" forum at http://www.talkhealthpartnership.com/forum/viewtopic.php?f=493&t=4819, which really does seem to be the best place for it

Anyhow, quite a few people have added their "thanks" already, and I think it would be great if PR members who have been posting there take a moment to do so as well.

good idea! I came too late to post there, but I think it's great that people took the time to do this.

 

[WillowJ]

gosh it was a little as well - its like their views are embedded in stone..

I think these are archived (although ours has a forum url instead of a clinic url, so not sure they are treating it the same as the others?) so the information there might be available to others who might have a less settled opinion

 

[Valentijn]

I think these are archived (although ours has a forum url instead of a clinic url, so not sure they are treating it the same as the others?) so the information there might be available to others who might have a less settled opinion

It looks like all of the past clinics still use forums, with the entire forum/clinic locked to new posts.

 

[Firestormm]

The locked forums - the Q&A - will apparently be linked to from NHS Choices. I can't actually see where this might occur; although there is a 'community' tab here. Maybe that's where the link will occur? Hadn't actually noticed the clinical trials tab before but then I rarely check NHS Choices. Anyway, this is where I heard the archived questions and answers will reappear. So watch this space I suppose

 

[Bob]

I just re-read the PACE trial authors' comment again, and I almost fell off my chair in disbelief!:
"...we believe that the patient is the best judge of how unwell they are."

What the hell is a 'false illness belief' then!!!

I can't believe that they've got the audacity to say it.


I just checked the PACE trial protocol, and the study was designed to test the hypothesis that CFS symptoms are caused/propagated by 'unhelpful illness beliefs', (aka 'false illness beliefs'):

"We do not know the mechanisms of successful treatment
for CFS/ME. Do illness beliefs or focusing of attention on
symptoms (symptom focusing) need to be changed for
CBT to be effective? Or do CBT and GET both work by
improving tolerance to activity?"

"CBT will be based on the illness model of fear avoidance,
used in the three positive trials of CBT [18,25,26]. There
are three essential elements: (a) Assessment of illness
beliefs and coping strategies, (b) structuring of daily rest,
sleep and activity, to establish a stable baseline of general
activities, with a graduated return to normal activity, (c)
collaborative challenging of unhelpful beliefs about
symptoms and activity. Both therapists and participants
will receive separate manuals."

So, if the trial was designed to test a hypothesis that CFS symptoms are caused/propagated by 'unhelpful beliefs' about symptoms and activity, then surely subjective interpretations of illness need to be tested against objective measures of illness, to test the hypothesis. Otherwise you can't know if the therapies have changed the beliefs and the actual illness/disability, or if they have changed some interpretations of the illness but without changing the actual illness or disability.

For example, if the patient 'believes' that their symptoms have improved, but you don't trust their 'beliefs', and their objectively measured outcomes haven't improved, then where does that leave the hypothesis? (Answer = it disproves it!) How have they tested their hypothesis if they haven't actually interpreted the objective outcomes?

If, when CFS/ME patients are very ill, the patients are the "best judge of how unwell they are" (as the authors claim) then on what basis is CBT prescribed? Why are they testing the patients' illness beliefs?



References.

Comment by the PACE trial principal authors:
Professor PD White, Professor M Sharpe, Professor T Chadler.
August 2013
http://www.talkhealthpartnership.com/forum/viewtopic.php?f=451&t=4800

PACE Trial - Published Protocol:
Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy
Peter D White, Michael C Sharpe, Trudie Chalder, Julia C DeCesare, Rebecca Walwyn and the PACE trial group
8 March 2007
BMC Neurology 2007, 7:6
doi:10.1186/1471-2377-7-6
http://www.biomedcentral.com/1471-2377/7/6

 

[Esther12]

That was before they'd been successfully treated Bob!

I just read the comment on safety measures in the Bavinton section, and thought that was a pretty good response to some of Bavinton's claims. She never replied to the thread though.

Bavinton did have (or at least, started with) plenty of cheery and misguided confidence, and it seems that she's off spreading that around the NHS:

NE practitioners join Graded Exercise Therapy training course

by CFS/ME Northern Clinical Network on August 19, 2013

Jessica Bavinton provides an update from the first part of a GET training course with CFS/ME specialists in the North East.
We recently returned from a training course we provided to NHS employees in the north East of England. Over the course of 2 days, the course, led by Jessica Bavinton, provided NHS staff from across several different disciplines, including Physiotherapy, Occupational Therapy and Psychology, the opportunity to gain an insight into the concept of Graded Exercise Therapy, and its use in practise.
The course attendees also had the opportunity to gain valuable learnings by speaking via video conference directly to a past patient of Jessica’s who had previously suffered from Chronic Fatigue Syndrome, and who’s life has been turned around by the implementation of a Graded Exercise Therapy programme. Many of those attending the course had little or no previous experience with Graded Exercise Therapy, and the majority commented at the end of the course how confident they were to immediately start implementing some of the concepts and theories they’d learned on the course.
Confidence levels in the use of Graded Exercise Therapy went from an average of 4.6 out of 10 before the course started to 8 out of 10 by the end of the course! A further day of training is scheduled for November 2013, where all the course attendees will return to share and discuss their experiences and findings with the use of Graded Exercise Therapy in their work since their two days of training.
Contact Jessica and Vitality 360 via http://vitality360.co.uk.

http://www.talkhealthpartnership.com/online_clinics/clinic.php

Great news.

 

[Purple]

Bob Well, clearly patients are not to be trusted if they say they are unwell as that is irrational but they are perfectly trustworthy and rational when they say they are better! (ETA: this post is tongue in cheek, in case it could be misinterpreted.)

 

[Bob]

Bavinton did have (or at least, started with) plenty of cheery and misguided confidence, and it seems that she's off spreading that around the NHS...

I hadn't seen that before. How depressing.

 

[Bob]

These are quotes by Jessica Bavinton, taken from the following thread:
http://www.talkhealthpartnership.com/forum/viewtopic.php?f=490&t=4841&p=14198

The short answer is yes, both CBT and GET have been shown to improve physical functioning.

Clinical experience also very much supports that conclusion as well: someone I'm working with is just achieved their 5K run after starting their programme at a 5min walk... many people are currently returning to work, another still is walking her children to school for the first time in 2 years....I heard recently from someone who was severely affected who had just been on a dance holiday - the list goes on, this is supported very much clinically - these results are why I love my work and why I choose to work in this area.

Science is constantly evolving, as is the evidence base. GET isn't a 'miracle cure', and doesn't work for everyone - there is still much more to understand about this, and if there are any more effective treatments in future then I will support them, too. However, GET and CBT are the best we currently have and help most people to feel better and do more: a significant minority even recover after these programmes.

I don't think that Jessica Bavinton is a doctor. I think she's a physiotherapist.

But I'm wondering if it is legal to promote therapies misleadingly, in medical terms?

 

[biophile]

In their recent response on the NHS online clinic, White et al issued the following position statement on safety:
http://www.talkhealthpartnership.com/online_clinics/PACE_TRIAL_info.php

In order to carefully examine whether any of these treatments made patients worse, we measured six safety outcomes. Serious adverse events, serious adverse reactions to treatment, and non-serious adverse events were judged independently by experienced CFS doctors. We also noted both the numbers of patients who withdrew from treatment because of feeling worse, those dissatisfied with their treatment, as well as those who reported feeling “much” or “very much worse”. There were no significant differences in any of these safety measures across the four treatment arms, with the one exception that more patients who had received specialist medical care alone, with no added therapy, were more dissatisfied with their treatment. We think this all means that these treatments are as safe as each other. Because the proportions thought to have had a serious adverse reaction to a treatment were 2% or less in all treatment groups, we think this means that all these treatments, including GET, are safe. Improvements in post-exertional malaise, after GET in particular, add to this reassurance.

Their claim that "there were no significant differences in any of these safety measures across the four treatment arms" (except dissatisfaction with SMC) is false and does not exactly help the ongoing suspicions of spin.

I attempted to address this in a post which described their definition of serious adverse events (SAEs) and pointed out there were indeed a statistically significant higher number of SAEs for GET even according to their own 2011 Lancet paper but that it was trial assessors (after being unblinded to allocation) which had consciously decided these SAEs were somehow unrelated to GET. I also explained how PACE have not adequately addressed the non-serious adverse events/reactions, nor non-serious deterioration when defined by the exact opposite of their definition for improvement in fatigue and physical function, although I have doubts about the usefulness of this latter data if it will be for 6 months after therapy which may be enough time for participants to recover from such non-serious deterioration.

http://www.talkhealthpartnership.com/forum/viewtopic.php?f=451&t=4827&p=14076#p14076

 

[biophile]

A few people on the clinic forum made a very important point which deserves repeating here. Amidst the routine downplaying of adverse effects from GET as just a result of "insensitive delivery", the question was asked:

[What is being done in the NHS to assure that patients are not given "insensitive delivery" of CBT/GET in the first place, particularly when numerous anecdotes suggests that this problem is relatively common and would not be acceptable for other conditions treated in the NHS?]

Prescription of exercise should be treated like a drug, more so due to the post-exertional symptomatology of ME/CFS. I think someone pointed out that legally in the UK it must be? I am not sure how many serious adverse events are required for a drug to be regarded as risky, but I do recall that Nefazodone was banned in several countries because the incidence of severe liver damage was approximately 1 in every 250,000 to 300,000 patient-years.

Of course, benefits and risks must be considered together, and there are numerous similar dugs available, whereas for ME/CFS the treatment options are much more limited. Drugs also have non-serious adverse effects which are much more common, but PACE did not really report on these adequately or thoroughly.

In a large study on the incidence and preventability of adverse drug events among older persons in the ambulatory setting (a population more likely to have adverse effects than middle aged people), the overall rate of adverse drug events was about 5 per 100 person-years (of which 38% were categorized as serious, life-threatening, or fatal). The authors concluded that "adverse drug events are common and often preventable among older persons in the ambulatory clinical setting" ( http://www.ncbi.nlm.nih.gov/pubmed/12622580 ).

In the PACE Trial, the number of severe adverse events for SMC was 4.4 (95% CI 1.8-9.0) per 100 person-years for SMC vs 10.6 (95% CI 6.2-17.0) per 100 person-years for GET. However, although these rates appear to be higher than in the above mentioned drug study, in the 2011 Lancet paper White et al used the terms "uncommon" and "rare".

PACE was a best case scenario, before not only considering the efficacy-effectiveness gap between RCTs and routine clinical practice, but also considering that without proper measures in place, the number of adverse effects as a result of CBT/GET could be much higher in the NHS. Furthermore, patients and researchers may have different ideas of what constitutes a significant adverse effect, particularly when researchers are testing their own pet treatments in order to resolve the controversy that has arisen over issues relating to adverse effects!

CBT/GET proponents generally believe that exercise is essentially harmless because the main explanation for post-exertional symptoms is "deconditioning" and perceived effort etc. In reality however, the deconditioning hypothesis is basically discredited and never could adequately explain the characteristics of post-exertional symptoms.

 

[lastgasp]

Thanks to everyone who asked incisive questions and made informed comments on that appalling clinic site, both there and here. Would have done something myself but been too sick recently without doing myself a mischief in the short (and sour) time it was open.

Re the legality of Bavington's promoting I'm sure she's covered by enough loopholes and woolly altruisms. Much of what OTs and social services do more than ever seems to be in cost-saving rehabilitation, they have their own research and evidence base and a lot of it is flaky, just google "re-ablement" or "reablement". My local council's been accused of severely spinning their miraculous social work outcomes in a way that sounds oddly familiar. I've never seen OTs as being all that helpful, ME is too much of a "sickness" for their style, and Bavington epitomises that to a T (I believe she's also got a book out on "fatigue", feel free to give it a review on amazon!)

All our "services" will continue to be inappropriate crap until we have disease modifying treatments to lift us out of the disregard-and-deride dustbin.

 

[user9876]

Re the legality of Bavington's promoting I'm sure she's covered by enough loopholes and woolly altruisms. Much of what OTs and social services do more than ever seems to be in cost-saving rehabilitation, they have their own research and evidence base and a lot of it is flaky, just google "re-ablement" or "reablement". My local council's been accused of severely spinning their miraculous social work outcomes in a way that sounds oddly familiar. I've never seen OTs as being all that helpful, ME is too much of a "sickness" for their style, and Bavington epitomises that to a T (I believe she's also got a book out on "fatigue", feel free to give it a review on amazon!)

All our "services" will continue to be inappropriate crap until we have disease modifying treatments to lift us out of the disregard-and-deride dustbin.

If she is selling direct to patients then she probably gets into far more problems as exclusion clauses can and often are ignored by the courts. I'm assuming complaints would come under trade descriptions and possibly product safety legislation (but she would provide a service so that might not cover it). There are exclusions where you can demonstrate that reasonable precautions are being taken which is why pointing out safety issues to her is possibly important.

In terms of training it would depend on her contract with the NHS

 

[MeSci]

I don't think that Jessica Bavinton is a doctor. I think she's a physiotherapist.

But I'm wondering if it is legal to promote therapies misleadingly, in medical terms?

My next-door neighbour is a physiotherapist. Sometimes I think that her ignorance knows no bounds!

Interesting point about illegality. I guess if you are following NICE Guidelines you are in the clear, but if you helped to formulate those guidelines, and have a financial interest in them...

 

[Bob]

I guess if you are following NICE Guidelines you are in the clear...

I'm thinking specifically of when she said:

"...help most people to feel better and do more: a significant minority even recover after these programmes."

I'm not sure if the NICE guidelines say that CBT/GET help "most" people to feel better.
And there definitely isn't evidence to support this claim. (Unless the word 'help' is allowed as a caveat.)

And I'm not sure if the evidence supports the claim that CBT/GET can lead to a recovery.

So I wonder if those claims would be considered misleading.
I would have thought that medical claims have to be quite precise, to avoid being misleading.

 

[Sasha]

Just got this via Co-cure:

Archive now available for the NHS Choices online clinic on ME/CFS and Fibromyalgia | 14-20 August 2013​

by Tony Britton on August 22, 2013​

​

​

This online clinic for ME/CFS and Fibromyalgia, which was organised by TalkHealth for NHS Choices, closed to all new questions on Tuesday (20 August 2013). But the archive of all the questions and answers – covering a wide range of diagnostic and management issues – is still available.​

​

Many thousands of people visited the online clinic in the week it was operational. And it turned out to be one of the most popular online health clinics ever to be run by TalkHealth.​

​

Questions and answers are arranged by forums covering:​

​

Activity management and exercise in adults – 23 topics​

​

Activity management in children – 3 topics​

​

Adult medical and benefits – 157 topics​

​

Children and adolescents medical – 14 topics​

​

Diet – 23 topics​

​

Fibromyalgia – 32 topics​

​

Research, funding and charities – 13 topics​

​

Our medical adviser, Dr Charles Shepherd, was the most prolific expert contributor – posting 216 answers to questions.​

http://www.meassociation.org.uk/?p=16659​

 

[biophile]

It is touchingly warm that Bavinton feels fulfilled with her clinical experiences of commonly rehabilitating people back to health and function, experiences which perhaps should not be disregarded out of hand, but the same story will be told over by countless homeopaths, acupuncturists, spiritual healers, and other alternative medicine practitioners everywhere, who are generally frowned upon by the medical establishment and routinely ridiculed by skeptics.

As stated on skepdic.com, "The whole idea of having double-blind, randomized, placebo-controlled studies is to avoid deluding ourselves." ( http://www.skepdic.com/toothfairyscience.html ). Unsurprisingly, such trials do not exist on CBT/GET for ME/CFS, because of the difficulties involved with adequate masking and placebo equivalent, but expressing the existence of these difficulties does not somehow magically negate the associated methodological problems.

CBT/GET proponents apparently want their therapies to be highly respected as if it is based on almost unimpeachable scientific evidence, but non-blinded trials are frowned upon or even ridiculed in drug research, and the net response rates for CBT/GET are well within the range of a lowered placebo response in CFS patients, a particularly important issue when CBT/GET actively target patients' perceptions about their symptoms, and when trials into these therapies have woefully failed to control for numerous reactivity biases which plague open-label trials.

The limited evidence available from randomized trials suggests that a slim minority (1 in 7 or so depending on the outcome) of broadly-defined CFS patients will self-report at least a modest improvement in fatigue and physical function but not much else, including a range of important measures such as objectively measured physical activity, employment/sickness-related benefits or insurance payouts, six-minute walking test distance, total service usage/costs, and (in at least one study) neuropsychological test performance, etc.

Null results for the more objective measures in non-blinded trials are rather telling too.

If reviews on treatments for CFS disregarded all trials which were not adequately controlled, the "evidence-base" would basically vanish for CBT/GET. In the grand scheme of evaluating clinical evidence, it is second-rate at best and that is being generous. At least the 2011 BMJ Clinical Evidence review admitted that the evidence was generally of "low quality". It is not that such evidence is entirely useless, but that it is being misleadingly promoted beyond its worth.

If CBT/GET proponents did not oversell these therapies at the cost of false hope and risk of adverse experiences, and if these therapies actually yielded higher effect sizes which were clinically significant for a higher proportion of patients and also correlated to other more objective measures, then we could be less critical, but so far it frankly appears that CBT/GET have not really proven themselves to be much more than a modest placebo response akin to a "laboratory artifact".

Arguments of "it just works" and "it is the best we have" etc sound similar to falling into the pragmatic fallacy.

 

[MeSci]

I'm thinking specifically of when she said:

"...help most people to feel better and do more: a significant minority even recover after these programmes."

I'm not sure if the NICE guidelines say that CBT/GET help "most" people to feel better.
And there definitely isn't evidence to support this claim. (Unless the word 'help' is allowed as a caveat.)

And I'm not sure if the evidence supports the claim that CBT/GET can lead to a recovery.

So I wonder if those claims would be considered misleading.
I would have thought that medical claims have to be quite precise, to avoid being misleading.

I'm sure most of us would consider them misleading. But I somehow doubt whether a prosecution would be possible, unless someone was directly promoting a private treatment that they themselves were offering. Even then I doubt whether a prosecution would succeed unless it could be proven that one or more individuals had been seriously harmed, and that the person promoting the treatment could be proven to know this and yet continue to promote and provide the treatment.

If the treatment were being promoted/provided under the NHS or by an government-accredited health provider, and professional misconduct could be proven, something might be done. But would this fit? This is an interesting site about medical harm but I don't know if it provides any pointers.

I am reminded of the recent case in which the UK's Advertising Standards Authority ordered proponents of the Lightning Process to stop making certain claims for it. That may be all that can be done with regard to an unofficial private provider.

But it would be good to get a legal expert to look at it. I have a vague memory that it may have been tried before.

 

[MeSci]

I just re-read the PACE trial authors' comment again, and I almost fell off my chair in disbelief!:
"...we believe that the patient is the best judge of how unwell they are."

What the hell is a 'false illness belief' then!!!

I can't believe that they've got the audacity to say it.


I just checked the PACE trial protocol, and the study was designed to test the hypothesis that CFS symptoms are caused/propagated by 'unhelpful illness beliefs', (aka 'false illness beliefs'):

"We do not know the mechanisms of successful treatment
for CFS/ME. Do illness beliefs or focusing of attention on
symptoms (symptom focusing) need to be changed for
CBT to be effective? Or do CBT and GET both work by
improving tolerance to activity?"

"CBT will be based on the illness model of fear avoidance,
used in the three positive trials of CBT [18,25,26]. There
are three essential elements: (a) Assessment of illness
beliefs and coping strategies, (b) structuring of daily rest,
sleep and activity, to establish a stable baseline of general
activities, with a graduated return to normal activity, (c)
collaborative challenging of unhelpful beliefs about
symptoms and activity. Both therapists and participants
will receive separate manuals."

So, if the trial was designed to test a hypothesis that CFS symptoms are caused/propagated by 'unhelpful beliefs' about symptoms and activity, then surely subjective interpretations of illness need to be tested against objective measures of illness, to test the hypothesis. Otherwise you can't know if the therapies have changed the beliefs and the actual illness/disability, or if they have changed some interpretations of the illness but without changing the actual illness or disability.

For example, if the patient 'believes' that their symptoms have improved, but you don't trust their 'beliefs', and their objectively measured outcomes haven't improved, then where does that leave the hypothesis? (Answer = it disproves it!) How have they tested their hypothesis if they haven't actually interpreted the objective outcomes?

If, when CFS/ME patients are very ill, the patients are the "best judge of how unwell they are" (as the authors claim) then on what basis is CBT prescribed? Why are they testing the patients' illness beliefs?



References.

Comment by the PACE trial principal authors:
Professor PD White, Professor M Sharpe, Professor T Chadler.
August 2013
http://www.talkhealthpartnership.com/forum/viewtopic.php?f=451&t=4800

Published Protocol:
Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy
Peter D White, Michael C Sharpe, Trudie Chalder, Julia C DeCesare, Rebecca Walwyn and the PACE trial group
8 March 2007
BMC Neurology 2007, 7:6
doi:10.1186/1471-2377-7-6
http://www.biomedcentral.com/1471-2377/7/6

It's easy. If the patient's beliefs agree with those of the psychoquacks, they are correct. If they disagree with those of the psychoquacks, they are wrong.