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GETSET (white) in Lancet 22/06/17

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13,774
Thought this probably deserved a new thread:

Lancet article: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32589-2/fulltext

Lancet commentry: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30577-9/fulltext

Science Media Centre coverage:

June 22, 2017
expert reaction to study on guided self-help graded exercise therapy as a treatment for chronic fatigue syndrome (CFS)


Researchers publishing in The Lancet present their findings from a randomised controlled trial they conducted to test the efficacy and safety of graded exercise delivered as guided self-help, for the treatment of chronic fatigue syndrome.



Dr Jon Stone, Consultant Neurologist and Honorary Reader in Neurology, Western General Hospital, Edinburgh, said:

“The GETSET trial is a helpful addition to the evidence base for treatment of CFS which is a common and disabling condition.

“What this shows, for the first time, is that it is possible for relatively time-limited guided self-help based on a graded exercise model to make a modest positive difference overall to a group of patients with CFS over a short time window (12 weeks).

“Importantly, the trial addresses concerns that graded exercise may be harmful in CFS by showing that deterioration was no more common in the group allocated the intervention.

“In absolute terms, around 1 in 6 patients noticed a positive change overall compared to 1 in 20 patients not receiving the intervention and nearly all the secondary outcome measures were also positive.

“The trial has been well conducted but it is important to note that the long term outcome of this intervention is not yet known and that data at 12 months is yet to be published.

“This is likely to be a treatment option that is helpful for some but not all patients with CFS. Clinicians should not assume that just directing patients to a booklet is sufficient. These patient had up to 90 minutes of input from experienced physiotherapists over four sessions which is likely to have been an important part of the treatment effect.

“It’s encouraging that this effect was also achieved through technologies such as skype which help patients who find it difficult to travel to appointments.

“The study also offers encouragement for managing fatigue in a range of other conditions such as multiple sclerosis and Parkinson’s disease where this approach may also be useful for some patients

“Studies like this should encourage the NHS to invest in relatively low tech interventions which may have a significant impact on disability and distress.”


Dr David Henderson Slater, Consultant in Neurological Disability & Rehabilitation Medicine and Honorary Senior Clinical Lecturer, Nuffield Orthopaedic Centre NHS Trust, said:

“The results of this positive study will probably not be surprising to clinicians who have worked with patients suffering from CFS/ME. It is encouraging that there is further evidence that graded exercise is an effective treatment leading to clinical improvements. The evidence is that the participants who received the graded exercise self-help programme benefitted from the input of the physiotherapist advising on the graded exercise either face to face, by Skype, or by telephone. Given the difficulty some patients with CFS/ME may have in getting to hospital appointments, and the limited nature of NHS resources, this suggests that future treatments involving consultation and discussion by Skype or telephone should extend the reach of limited therapy resources and enable more patients to benefit from this treatment approach.”



Prof. Allan House, Professor of Liaison Psychiatry, University of Leeds, said:

“It is well established that physical inactivity and sedentary behaviour are bad for you, and that physical activity can have health benefits in conditions as diverse as coronary heart disease, rheumatoid arthritis and prostate cancer. It is therefore reasonable to start with an assumption that in most health problems, a sensible gradual increase in physical activity is likely to beneficial unless there is evidence to the contrary.

“In chronic fatigue syndrome there is already evidence to support this supposition of the benefit of physical activity, from for example the PACE trial. In the present study, the researchers ask whether a version of graded activity could be effective if it is largely self-managed – based upon a self-help guide with light touch help in using it.

“The study was generally well-designed, with (importantly) its protocol published in advance of conduct of the trial itself. In a group of patients with chronic fatigue syndrome who were perhaps not as severely affected as some can be, about a third made important improvements compared with 1 in 7 of those in the comparison group. On its own this trial wouldn’t be definitive, but against the background of what we know more generally about the benefits of activity for physical and mental health, including the health of people with chronic fatigue syndrome, this is further evidence of the usefulness of carefully managed increase in activity.

“Perhaps more important were the trial’s findings about harm – because so many sufferers from chronic fatigue worry about harmful effects from doing too much. About a quarter of patients in the trial reported worsening of their physical health over the three months of the trial but there was no evidence of severe untoward events at all, and no evidence that those practising graded activity did worse than those in the comparison group.

“We can be confident that responsibly managed graded activity is safe in chronic fatigue syndrome, and that for some sufferers at least, it can lead to significant improvements in their health.”



Dr Simon Day, Statistician, Clinical Trials Consulting & Training Limited, said:

“This is an important question and a randomised controlled trial is probably the best way to try to answer it. But any trial like this has limitations.

“The trial is described as ‘pragmatic’ – but it is not clear what the authors mean by that. In particular, this is not a trial of all patients diagnosed with chronic fatigue syndrome; it is a trial of all such patients who are interested to take part in such a trial. Note, in contrast, the results of trials of pharmaceutical interventions are generally assumed to apply to all patients who would meet the inclusion criteria, not just those with the enthusiasm to take part in a trial. The results of this trial, therefore, might not be as positive if GES (Graded Exercise Self-help) +SMC (Specialist Medical Care) were introduced more routinely.

“The trial is not, and cannot be, blinded – but the obvious inability to blind the trial does not negate the possible biases that may be introduced in an unblinded study. This is particularly so as the endpoints are self-reported by the patients (who knew which ‘treatment’ they were getting). The authors state, ‘Primary outcomes were self-reported by participants, thus preventing observer bias’ and also ‘all outcomes were self-rated, which might lead to bias by expectation…’.

“The authors rightly identify some other limitations of their trial. The lack of standardisation of SMC is an inevitable problem, but lack of recording and reporting of its content is unfortunate. For me, the biggest unanswered question (which the authors do recognise) is the very limited number of health-care professionals involved and, hence, the extent to which the findings might apply more broadly if GES+SMC were administered by other healthcare professionals. In trials of pharmaceutical interventions, it is usually assumed that the pharmacological effect will be independent of the treating physician, but in trials of this nature (and, for example, trials in surgery) the outcome is likely to be highly dependent on the skills of the health-care professionals delivering the intervention.”



Prof. Chris Ponting, Chair of Medical Bioinformatics and Principal Investigator at the MRC Human Genetics Unit, Institute of Genetics and Molecular Medicine, University of Edinburgh, said:

“The beneficial effect was for fewer than 1 in 5 individuals, for an unblinded trial, and there was no consideration of long-term benefit or otherwise. The study could also have exploited actometers that would have more accurately measured participant activity.”


Prof. Trudie Chalder, Professor of Cognitive Behavioural Psychotherapy, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, said:

“This study contributes to a body of evidence that graded exercise can help to improve functioning and reduce fatigue in people with chronic fatigue syndrome. It replicates the finding that graded exercise if tackled in a measured way is safe. This non pharmacological intervention for CFS can be delivered to patients in their own home which gives patients flexibility. Although it doesn’t help all patients it can undoubtedly help some.”


* ‘Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial’ by Clark et al. published in The Lancet on Thursday 22 June.


All our previous output on this subject can be seen at this weblink: http://www.sciencemediacentre.org/?s=%22CFS%22&cat


Declared interests

Dr Jon Stone: I am a neurologist with an interest in self-help, guided self-help and physiotherapy for a range of conditions seen in neurology, especially functional disorders.

I have published studies of physio interventions and have applied for funding for a multicentre trial of a physiotherapy intervention

I run a free website www.neurosymptoms.org for patients with functional disorders in neurology.

Dr Simon Day: Dr Day works as a paid consultant to the pharmaceutical industry. He has also received research and/or travel grants from the Medical Research Council, the European Commission and the National Institutes of Health.

Prof. Chris Ponting: “I am funded by the MRC and by the Wellcome Trust.”

Prof. Trudie Chalder: TC has authored self-help books on fatigue and collaborates with Peter White on a number of research projects.

None others received.

http://www.sciencemediacentre.org/e...a-treatment-for-chronic-fatigue-syndrome-cfs/

Exercise can help chronic fatigue syndrome, study shows
22 June 2017 • 11:30pm
Increasing exercise each day can help patients with Chronic Fatigue System to feel less tired and feel better, a new study suggests.

Scientists at Queen Mary University of London placed 200 people on a 12 week programme in which they were either encouraged by a physiotherapist to walk a little more each or given a programme of medical care including medication for depression, pain and insomnia.

After four months the mean fatigue score of the exercise group was four points lower than in the control group, on a scale of 100, which researchers said was a moderate but significant impact. Physical function was also six points higher.

One in five of the group who had exercised also reported feeling ‘much better’ or ‘very much better.’

<img src="/content/dam/property/Spark/churchill-retirement-living/mature-couple-walking-along-the-beach-small_trans_NvBQzQNjv4Bqeo_i_u9APj8RuoebjoAHt0k9u7HhRJvuo-ZLenGRumA.jpg" alt="Gradually increasing walking each day could help reduce fatigue" width="320" height="200" class="responsive-image--fallback"/>
mature-couple-walking-along-the-beach-large_trans_NvBQzQNjv4Bqeo_i_u9APj8RuoebjoAHt0k9u7HhRJvuo-ZLenGRumA.jpg

Gradually increasing walking each day could help reduce fatigue
Lead author Dr Lucy Clark said: “We found that a self-help approach to a graded exercise programme, guided by a therapist, was safe and also helped to reduce fatigue for some people with chronic fatigue syndrome, suggesting that it might be useful as an initial treatment for patients to help manage symptoms of chronic fatigue syndrome.

“We are now looking at whether the effects were maintained beyond 12 weeks.

ADVERTISING
“The aim is to progress carefully to improve rather than pushing people too hard and towards a setback.”

CFS affects about seven in 1000 people and is characterised by chronic, disabling fatigue in the absence of an alternative diagnosis.

The self-help exercise programmed involved slowly building up physical activity levels after establishing a daily routine, with the support of a physiotherapist over the phone or Skype.

The research was published in The Lancet.


http://www.telegraph.co.uk/science/...e-syndrome-study-shows/?WT.mc_id=tmg_share_tw
 

Large Donner

Senior Member
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866

So there we have it, thats the current evidence NICE will use to determine that there does not need to be a review of the current treatments because the latest evidence backs up the previous evidence. Job done and perfectly timed publication for the BPS crowd just before the NICE review proposal.

This just sounds like pacing dressed up and presented as GET because they tell you at the beginning of the trial to reduce all activity down way below your current amount then build up gradually. Then at the end of the 12 weeks they say "hey you are doing so much more than 12 weeks ago would you like to agree with me cos I've been so nice to you and concerning over the last 12 weeks, just sign here to rate the course and the facilitator from 1-10.

All they seem to have achieved is to get people back to baseline after first reducing their activity down at the start of the trial. No doubt they don't take into account how many of the activities of daily living where reduced during the trial to accommodate any extra exercise.
 
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Messages
13,774
So there we have it, thats the current evidence NICE will use to determine that there does not need to be a review of the current treatments because the latest evidence backs up the previous evidence. Job done and perfectly timed publication for the BPS crowd just before the NICE review proposal.

Lets not just assume NICE will be keen to use this as a reason to not review their guidelines... we've got plenty of fight in us yet. The battle has just begun!
 

JaimeS

Senior Member
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Location
Silicon Valley, CA
Daniel Clauw should state that he uses GET and CBT to treat fibromyalgia at his practice. It's his bread and butter.

I often wonder how honest you have to be in these papers when declaring conflicts of interest. Of course people who use the therapy support its use -- by definition. But it's still odd that he didn't declare that the use of these therapies are an important part of how he makes his living.
 

Large Donner

Senior Member
Messages
866
Lets not just assume NICE will be keen to use this as a reason to not review their guidelines... we've got plenty of fight in us yet. The battle has just begun!

The problem is can you come up with a single accepted scientific advancement in the treatment for ME since the last NICE review.

Everything that is being studied is still in the pipeline including things like rituximab so I can only see NICE not budging form their current recommendations to be honest.
 
Messages
13,774
The problem is can you come up with a single accepted scientific advancement in the treatment for ME since the last NICE review.

Everything that is being studied is still in the pipeline including things like rituximab so I can only see NICE not budging form their current recommendations to be honest.

But there have been a number of papers challenging the quality of research used to underpine the NICE recommendations. I'm not expecting NICE to discover some new treatment, but we might be able to get them to acknowledge that there is not good evidence to support their recommendations of CBT or GET. Nothing is better than something.
 

Large Donner

Senior Member
Messages
866
But there have been a number of papers challenging the quality of research used to underpine the NICE recommendations. I'm not expecting NICE to discover some new treatment, but we might be able to get them to acknowledge that there is not good evidence to support their recommendations of CBT or GET. Nothing is better than something.

Your problem there is that you are applying too much obvious logic.

Can you really see NICE taking on the Lancet and also their own part they have played over the last numerous years and saying, "hey all this GET and CBT stuff has always been useless and even often harmful, get me a hotline to Theresa May and the DWP.... and who's that guy who runs the retraction blog we need to contact him .......we need to fire Richard Horton and the PACE trial must be retracted."

It stands to reason that if NICE retracts CBT and GET from its recommendations the PACE trial would have to be retracted from the Lancet and NICE would have to answer to PWME for all the wasted years and potential harm they have caused.

The true data from the PACE trial shows that CBT and GET the long standing treatments for ME recommended by NICE do not work and have never worked. NICE would be taking themselves down and I just cant see them doing that, it would just lead to one big cluster fuck and theres no way they will be allowed to do that.
 
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13,774
NICE would be taking themselves down and I just cant see them doing that, it would just lead to one big cluster fuck and theres no way they will be allowed to do that.

I agree with msot of what you say. Odds are against us, but it would be a game changing victory if we could achieve it.

Also, with so many people in medicine talking about the need to listen to patients more, concern about poor quality research, recogntion of how over-treatment can harm... surely there are some people with authority who actually believe what they're saying, and are willing to stand up for what's right. We just need one of these authority figures to flip, and then most of the rest will crumble imo.
 

Large Donner

Senior Member
Messages
866
I agree with msot of what you say. Odds are against us, but it would be a game changing victory if we could achieve it.
Logic.

Also, with so many people in medicine talking about the need to listen to patients more, concern about poor quality research, recogntion of how over-treatment can harm... surely there are some people with authority who actually believe what they're saying, and are willing to stand up for what's right. We just need one of these authority figures to flip, and then most of the rest will crumble imo.

Hope.
 

JaimeS

Senior Member
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Location
Silicon Valley, CA
It stands to reason that if NICE retracts CBT and GET from its recommendations the PACE trial would have to be retracted from the Lancet and NICE would have to answer to PWME for all the wasted years and potential harm they have caused.

Ehhhh if they shift their stance, they'll say "best available information at the time..." "new scientific evidence shows..."

If they're got a head on their shoulders, anyhow.

What I EXPECT of them is that they will prefer any alternative to saying "actually, we have no idea how to help." There is little evidence for new treatments, even if there is abundant evidence of biological abnormalities, and treatment recommendations are what concerns us.

I think the individuals at NICE probably believe recommendations to exercise and think happy thoughts are pretty harmless even if they aren't particularly effective. (Because they're not us, and therefore they don't read about the PACE debacle. One repeated theme I've found on PR is that we wildly underestimate others' ignorance. Important to us =/ important to the rest of the world.)

NICE would be taking themselves down

Whatever they choose won't make or break them with anybody but us. Perhaps they will change their minds, but if they do, it will be a shot heard 'round... the ME/CFS scientific and patient community. ;)

-J
 

Large Donner

Senior Member
Messages
866
@JaimeS

The thing is by admitting, "the best available evidence at the time was" they would have to use the PACE trial as proof that GET and CBT dont work, as we here all know.

If they shift to "the best new evidence is" what else can they use from peer reviewed studies apart from the must be retracted PACE trial, thats how they work at NICE.

They either use the PACE trial to say GET and CBT work or GET and CBT dont work as the PACE trial did not form part of their previous decision to recommenced CBT and GET.

If they say the PACE trial proves CBT and GET dont work then that will have to lead to a retraction of the PACE trial as published in the Lancet.

I just cant see NICE, which is part of the UK establishment, retracting their current recommendations which would have to follow with an obvious retraction from the Lancet of PACE.
 

RogerBlack

Senior Member
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902
“In absolute terms, around 1 in 6 patients noticed a positive change overall compared to 1 in 20 patients not receiving the intervention and nearly all the secondary outcome measures were also positive.".

So, not 1/6, but 1/9 patients noticed a positive change compared to control.
And that positive change was _tiny_, in terms of clinical response and on subjective measures.
 

Dolphin

Senior Member
Messages
17,567
Prof. Allan House, Professor of Liaison Psychiatry, University of Leeds, said:

[..]


“The study was generally well-designed, with (importantly) its protocol published in advance of conduct of the trial itself.
This doesn't look like it is true.

http://www.isrctn.com/ISRCTN22975026

Overall trial start date
16/05/2012

Overall trial end date
01/12/2015

Primary outcome measures
1. SF-36 physical function subscale (SF-36PF) measured at 12 weeks from randomisation

Added 21/07/2015:
2. Chalder fatigue scale measured at 12 weeks and 1 year

Updated 28/02/2017:
2. Chalder Fatigue Scale measured at 12 weeks

Clark LV, McCrone P, Ridge D, et al. Graded exercise therapy guided self-help trial for patients with chronic fatigue syndrome (GETSET): protocol for a randomized controlled trial and interview study. JMIR Res Protoc 2016; 5: e70.

We therefore added a second primary outcome, the CFQ, which is scored as the sum of responses to 11 items related to physical and mental fatigue, each of which is coded 0 for less than usual,” 1 for “no more than usual,” 2 for “more than usual” and 3 for “much more than usual,” where usual is how they felt the last time they were feeling well. This gives us a symptomatic measure of fatigue. The two primary outcome variables are valid and reliable and have been used in previous CFS trials [9,11]. The ethics committee, Research and Development (R & D), and the trial steering and data monitoring committees approved this change (in June 2013) before any outcome data were formally examined. Because of the change from one to two primary outcomes, we reanalyzed our power calculation and plan to recruit more participants (see section on sample size).
 

Large Donner

Senior Member
Messages
866
“In absolute terms, around 1 in 6 patients noticed a positive change overall compared to 1 in 20 patients not receiving the intervention and nearly all the secondary outcome measures were also positive.".

So, not 1/6, but 1/9 patients noticed a positive change compared to control.
And that positive change was _tiny_, in terms of clinical response and on subjective measures.

How do you get to 1/9 from 1/6? What am I missing?