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White & QMUL praising PACE's value and impact for a research assessment

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13,774
http://webcache.googleusercontent.com/search?q=cache:ya-oQep9QR8J:results.ref.ac.uk/(S(1x5usno2sjtyyfwoj2a5u0g5))/DownloadFile/ImpactCaseStudy/pdf?caseStudyId=18135 &cd=3&hl=en&ct=clnk&gl=uk

Nothing that important.

I pulled out about 25% of it for people who only want a taster, but it's not that long.

White (with Fulcher, an exercise physiologist) designed graded
exercise therapy (GET), based on the existing literature (Richard Edwards had already published
an open study of exercise for “effort syndrome”).

This work has been successfully replicated four times; systematic reviews and meta-analyses of
these studies have confirmed the efficacy of GET for CFS. White went on to show (unexpectedly)
that the effect of GET on global improvement was not mediated by a physical training effect [2], a
finding since replicated by others. However, increased exercise tolerance, measured objectively,
was mediated by increased fitness after GET [3]. This suggested that GET works as much as a
behavioural graded exposure therapy as a physical training programme; something that was
incorporated into later designs of GET trials.

In spite of this scientific support, several surveys by patient organisations claimed that GET was
often damaging, and that “pacing” (living within the limits of the illness) was most helpful. White
therefore approached a patient charity, Action for ME, who agreed to help him design and
implement an RCT to compare specialist medical care (SMC) alone against such care
supplemented by either adaptive pacing therapy (APT), GET or cognitive behaviour therapy (CBT),
the last of which had also been shown to be effective and was recommended by NICE
(www.pacetrial.org) [4].

22% of patients in the trial recovered their health after either of these treatments, compared to 7%
following SMC alone [6].

Why the contorted 'recovered their health' rather than 'recovered'? Anyone want to guess? The phrasing is repeated later too.

The P2P Evidence Review was critical of the PACE trial's recovery paper, and this commentary pointed out a number of problems with it too: http://link.springer.com/article/10.1007/s11136-014-0819-0

Maybe people are starting to see through the BS.

In a nutshell, gradually doing more is better for CFS than staying within limits
imposed by the illness. Consequent research includes an NIHR-funded RCT of guided self-help
using GET for patients with CFS (White is the PI). The Cochrane Collaboration have a systematic
review update of GET for CFS in review, and an individual patient data meta-analysis is due for
submission this year (White is a co-author).

4a: Informed and affirmed NICE guidelines for CFS and ME

As a major recommendation within its guidelines, NICE recommends: “Cognitive behavioural
therapy and/or graded exercise 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.”
(page 30) [7]. There
have been no trials of GET in severe CFS/ME. However, partly because of an open study
conducted at Queen Mary, showing that GET helps severely disabled patients (Essame CS et al.
Journal of Chronic Fatigue Syndrome 1998; 4: 51-60), NICE recommend an activity management
programme for such patients that “draws on the principles of CBT and GET.” Since publication of
the PACE trial in 2011, NICE have publicly affirmed their recommendation of GET (and CBT) [8].

4b: Graded exercise therapy has been adopted as a standard treatment for CFS in the UK

The British Association for Chronic Fatigue Syndrome/ME (BACME) “champions evidence-based
approaches to the treatment of CFS/ME”
and represents clinicians of NHS specialist services in
the UK [9]. BACME welcomed the findings of the PACE trial saying: “The PACE trial ... provides
convincing evidence that GET and CBT are safe and effective therapies and should be widely
available for patients with CFS/ME.”

BACME is supported by the National Outcomes Database [9], which holds clinical assessment and
outcome data on ~9,000 NHS patients, to allow benchmarking of effectiveness. Crawley and
colleagues compared patient outcomes across six of the largest NHS services against outcomes
after both CBT and GET in the PACE trial. Three of the services used GET; three used activity
management incorporating the principles of GET. Symptomatic improvement was similar to that
achieved after GET provided within the PACE trial [10]. However, the mean improvement in
physical disability was about a quarter of the size achieved by GET in the trial, which may be partly
explained by the fidelity of the intervention not always being optimal when implemented outside a
trial setting. One obvious difference is that some services deliver interventions in a group setting,
rather than individually as in the trial [10].

Funny to have them acting like BACME's support is impressive.

4d: Graded exercise therapy is included in guidelines for treatment of CFS internationally
Guidelines published in other countries recommend GET. For example:

• In USA, the Mayo Clinic states: “The most effective treatment for chronic fatigue syndrome

appears to be a two-pronged approach that combines psychological counseling with a
gentle exercise program.
” [12]

• Also in USA, the Centers for Disease Control recommend GET; specifically White’s clinical

website: “The GET Guide 2008 by Chronic Fatigue Syndrome/ME Service at St.
Bartholomew's Hospital can be helpful in structuring your graded exercise plan.
” [13]

• Australian clinical guidelines for ME/CFS recommend GET “unless severely affected” [14]
• The Norwegian Knowledge Centre for Health Services, commissioned by their

government, concluded: “Cognitive behavioural therapy and graded exercise therapy is
likely to be effective for people with chronic fatigue syndrome.
” [15]

4c: Engagement with ‘lay epidemiology’ and improving public understanding of science
This research succeeded in spite of considerable opposition from activists. Some people in the
CFS/ME community have developed a ‘lay epidemiology’ comprising purely organic explanations
and hypotheses for the condition, and view psychological hypotheses as dismissive of patients’
‘real’ experiences. A vocal minority has actively opposed any research into this condition with a
psychological component and has even sought to sabotage such studies [16]. Pressure from such
activists (including threats of violence) has led some researchers to pull out of researching CFS
altogether. The approach taken at Queen Mary, as described in Section 2, has been to seek

dialogue with patients, carers and the lay public, engage with their concerns, try to understand their

explanations and seek as far as possible to work with them rather than against them.

CFS is so controversial that the House of Lords held a debate about the PACE trial in February
2013 [17]. One peer was critical, but seven others supported the trial. Baroness Northover replied
for the Government, and later wrote to White: “PACE was an example of a well conducted, robust
research study. It is with thanks to you and your team that we now have some very good evidence
that CBT and GET are moderately effective when provided alongside specialist medical care.” [18]
As part of a public relations policy to disseminate the PACE trial results, The Science Media Centre
hosted a press conference for the main paper [19]. This led to positive, world-wide coverage,
including almost all UK national newspapers as well as the New York Times, Wall Street Journal,
Sky, BBC, and ITV, and radio stations in the UK, USA and Australia.

Ho-ho-ho-ho-ho-ho.

6. White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC. Recovery from chronic fatigue
syndrome after treatments given in the PACE trial. Psychological Medicine, 2013, 1-9. (Three
times more patients recover their health after either GET or CBT than alternatives.)
 
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13,774
Looks like Barts was using the same phrasing already. I think we've already discussed this quote before:

What outcomes can I expect from the CFS/ME service?
We have found that three-quarters of our patients with CFS/ME significantly improve or recover with treatment in our clinic. Research has suggested that a quarter recover their health and a further half significantly improve. For some people recovery may not necessarily mean a return to their previous lifestyle, if this contributed to them becoming ill in the first place.

Some patients may not improve whilst in our service, but we would expect to help them to cope better with their illness and manage symptoms more effectively. Some patients may find other approaches to managing their ill health more helpful than those we provide here.
 
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Min

Guest
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Location
UK
We have found that three-quarters of our patients with CFS/ME significantly improve or recover with treatment in our clinic.

I do wonder how many patients with actual myalgic encephalomyelitis are daft enough to go anywhere near these harmful clinics for more than one visit, and what the patients they do see are suffering from.

The patients they boast have recovered appear to have mild depression that does respond to CBT and GET, and not M.E. which does not. Both are very real illnesses but also very different.

Surely their interpretation of their clinics' recovery rate is likely to be as surreal as their interpretation of the PACE results?
 

Sean

Senior Member
Messages
7,378
has suggested

For some people recovery may not necessarily

Some patients may not improve whilst in our service,

Some patients may find other approaches to managing their ill health more helpful than those we provide here.

Weasel words, leaving a hole big enough to sail a fleet of aircraft carriers through.

:p:p:p
 

Dolphin

Senior Member
Messages
17,567
@Maxwhd on Twitter who unearths all sorts of interesting stuff posted this on Twitter today: http://twitdoc.com/3SXO

I've attached the file

Impact case study (REF3b)
Institution: Queen Mary University of London (QMUL)
Unit of Assessment: A2 (Public Health, Health Services Research and Primary Care)
Title of case study: Chronic fatigue syndrome

1. Summary of the impact

Chronic fatigue syndrome (CFS) is a disorder of unknown cause affecting 1% of people.

Studies by Queen Mary researchers between 1993 and 2012 helped to characterise and demystify CFS and,in a series of randomised trials, showed that graded exercise therapy (GET) was effective and cost-effective, especially when costs to the patient and society were included.

For impacts, GET was [a] recommended in NICE guidance; offered as standard therapy in most UK centres managing CFS; [c] recommended and used internationally.

The lead researchers have worked hard to build a dialogue with patient groups, including working with them to co-design the most recent trial, thereby increasing the chance of acceptance of findings by people affected by CFS.

(I don't have the time/energy to copy the whole text in as some words are being combined - maybe somebody else can?)
 

Attachments

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In the Sharpe document they cite this as evidence of the value of their work:

Impact on the economy

CFS costs the NHS £14K per annum per patient and the annual cost to the UK economy is up to
£3.5B [3.2]. It is clear that enormous savings can be made by effective management of this
condition.

A Dutch study suggested that up to 3.6% of the workforce suffers from CFS. The UoE research
has led to national changes in the occupational management of individuals with medically
unexplained symptoms, demonstrating effective strategies to reduce absence from work (e.g.,
NHS/Royal College of Physicians Guidance [5.9]).

...

5.9 NHS Plus. Occupational Aspects of the Management of Chronic Fatigue Syndrome: a
National Guideline (2006).

http://www.anhops.com/docs/92_8_273539_CFSyndrome_full_review.pdf. [Evidence that the

research has altered guidelines for occupational management. N.B. These remain the current
guidelines from 2008–present.]

I started a thread on that ages back:

http://forums.phoenixrising.me/inde...-with-data-from-pace-in-2011-still-not.23157/

This is from the review:

Review Date: 2011
...

Key findings of the review:
• Cognitive behavioural therapy and graded exercise therapy have been shown to be effective in restoring the ability to work in those who are currently absent from work
A large multicentre RCT, PACE is currently under way in the UK, comparing standardised specialist medical care with CBT, GET and pacing. PACE will include work outcomes.

Strangely, the review has not been updated since PACE showed that CBT and GET led to no improvements in employment data.

Their claims of positive impact here seem to be built on spin and BS. I wonder who is responsible for that?

Also, the Sharpe document above says:

Management of individuals with medically unexplained symptoms
From 2006–2010, the Edinburgh team conducted a randomised controlled trial of guided self-help
for medically unexplained symptoms at NHS neurology clinics in Edinburgh and Glasgow. The
guided self-help was superior to the comparator treatment (odds ratio=2.36, p=0.02; number
needed to treat=8), with efficacy maintained at 6 months follow-up [3.4].

In 2011, Sharpe and
colleagues published the first definitive randomised controlled study (n=641) showing superior
efficacy of cognitive behaviour therapy (CBT) for CFS compared with specialist care alone (rating
scale score difference=3.4, p=0.0001), and inefficacy of the very widely recommended (at the time)
intervention of ‘pacing’ at 52 weeks follow-up (the Pacing, graded Activity and Cognitive behaviour
therapy: a randomised Evaluation (PACE) trial) [5.5].

We all know about PACE, but I also commented on the MUS study here: http://forums.phoenixrising.me/inde...genic-symptoms-a-randomized-controlled.22910/

The control group was just usual care, and there was no significant difference between groups for their primary outcome at six months.

"with efficacy maintained at 6 months follow-up" is another example of weasel words.

I quoted from the google cache version, as it was easier to copy and paste:

http://webcache.googleusercontent.c...f?caseStudyId=23887+&cd=1&hl=en&ct=clnk&gl=uk
 
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A.B.

Senior Member
Messages
3,780
When they use the acronym MUS I think "Parturient montes, nascetur ridiculus mus".

It's a circus. The clowns think they can change reality by redefining it. It would even be funny if it weren't so tragic at the same time.
 
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13,774
@maxwhd tweeted out this related to the QMUL submission:

Government and national policymaking. Of 22 academics in this submission, 14 have been represented on national-level policymaking and related groups in 2008-13 including NICE guidelines (Robson, Bhui, Khan), NICE implementation groups (Khan, Greenhalgh, Russell), NHS RightCare (Khan), Department of Health and Public Health England (Cardiovascular Risk: Robson, Pandemic Flu: Greenhalgh, Mental Health: Bhui), Medicines and Healthcare Devices Regulatory Agency (Greenhalgh); select committees (Mental Health:Bhui) and advising a wide range of other government departments and groups including the Airports Commission (Clark); Ministry of Defence Advisory Group on Chronic Fatigue in the Military (White), Department for Environment, Food and Rural Affairs (Stansfeld), Department of Work and Pensions (Stansfeld) and Working Group on High Speed Train link (Stansfeld).

4. Relationship to case studies
Our three case studies (on chronic fatigue, cross-cultural mental health and cardiovascular risk) illustrate four key elements of our ‘life cycle’ approach to research impact. First, the research was clinically led by academics who held NHS appointments and sought to explore questions emerging in practice; they were opinion leaders in their clinical field hence their colleagues were aware of their work, followed it as it unfolded and took notice of the findings. Second, there was strong patient and public involvement that began at the design stage in all cases so as to maximise relevance and acceptability of findings to users. Third, lead researchers were members of, or advisors to, key policymaking groups including NICE, Department of Health, Scottish Chief Scientist’s Office and Parliamentary Reviews. Finally, proactive engagement of lay media ensured that the messages being put out by the press on these potentially controversial topics were clear, accurate and targeted appropriately.

http://t.co/KnDQADGvQZ
 
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13,774
He also posted a link to the Richard Morriss submission:

http://t.co/EGSveuEkGv


Effectiveness of reattribution training

In order to provide a framework for GPs to tackle these issues through the use of a structured approach to increase confidence, a psychosocial approach called reattribution was adapted for a broader group of patients with MUS. Reattribution refers to an intensive structured consultation delivered by a GP, which aims to provide a psychological explanation to patients with somatised mental disorder.

To explore the potential advantages of reattribution within a clinical setting, a randomised controlled trial (‘Training family practitioners in reattribution to manage patients with Medically Unexplained Symptoms: MUST- see section 3 for details) was conducted2. The trial compared reattribution with treatment as usual in 16 GP practices with 74 GPs and 141 MUS patients to explore feasibility. A six hour training package was developed and adapted for use by GPs to deliver reattribution to patients with MUS. Morriss and colleagues developed training materials and practice-based delivery of such training by mental health facilitators to improve both the recognition and management of such patients. Findings showed that such practice-based training improved doctor-patient communication and highlighted a number of attitudinal, practical and organisational issues that needed to be addressed e.g. that patients needed GPs to demonstrate to them that they would take any new symptoms seriously in terms of physical disease rather than assume them to be psychologically created.

Challenges in the implementation of reattribution in a clinical setting were explored through qualitative methods and results showed that barriers included the complexity of patients' problems and patients' judgements about how to manage their presentation of this complexity. Many patients reported not trusting doctors with discussion of emotional aspects of their problems and therefore chose not to present them. Therefore it was concluded that simply improving GP explanation of unexplained symptoms is insufficient to reduce patients' concerns. Rather, GPs need to help patients to make sense of the complex nature of their presenting problems, communicate that attention to psychosocial factors will not preclude vigilance to physical disease and ensure a quality of doctor-patient relationship in which patients can perceive psychosocial enquiry as appropriate3.

In light of this, more recent research funded by the Medical Research Council showed that with training and ongoing supervision, psychological treatment for some MUS patients with specific syndromes such as Chronic Fatigue Syndrome could be delivered by adult specialty general nurses who had received four months’ training, including supervised practice, in each of the supportive listening and rehabilitation interventions4. This streamlined the process and reduced barriers to delivery such as patients not disclosing psychological problems to GPs.

reference 2 is for this trial:

http://bjp.rcpsych.org/content/191/6/536.long

Results With training, the proportion of consultations mostly consistent with reattribution increased (31 v. 2%, P=0.002). Training was associated with decreased quality of life (health thermometer difference –0.9, 95% CI –1.6 to –0.1; P=0.027) with no other effects on patient outcome or health contacts.

Conclusions
Practice-based training in reattribution changed doctor–patient communication without improving outcome of patients with medically unexplained symptoms.

reference 4 is for FINE.

So twice he tested his approaches, and twice they were found to be ineffective. Those were the only controlled trials mentioned.

Better identification of patients with MUS
Previous research highlighted the need for a streamlined process of identification of MUS within general practice. Therefore, Morriss and colleagues conducted Department of Health (Care Services Improvement Partnership, CSIP) funded research investigating streamlined diagnosis of MUS by developing methods for estimating the number of patients suffering with MUS using electronic patient records held by practices5. With additional support of CSIP, Morriss developed a search tool ‘The Nottingham Tool’. This searches a GP Practice Database, to identify a cohort of patients that fulfil the criteria for MUS. This cohort provides an overview to the commissioners, or the practice, about the number of people likely to have a MUS. The tool is designed to generate a list for GPs of patients with possible MUS. The GP can then refine the list to exclude or include patients known to have the condition. Morriss noted that whilst identifying the individual patient is important, it is also important for commissioners of services to have a better understanding of the numbers of people who are likely to have a MU symptom. It is important so that appropriate services can be planned and commissioned6.
As a result of such work on both the organisation of care and the development of The Nottingham Tool to help GPs estimate the care needs of patients in their practice, the National Health Service (NHS) in England extended the provision of specialist psychological care as part of the IAPT programme for such patients. Therefore, in summary, taken as a whole, Morriss’s body of research about MUS has shown how GPs can be taught to deliver better doctor-patient communication, organise care for such patients, estimate the numbers needing care, better identify patients and develop strategies to engage patients in psychological treatment at a time when the NHS in England will be spending nearly £200 million over a 3 year period on such treatment.

So he developed a tool to help them identify those people that they can provide ineffective treatments for?

4. Details of the impact
The key beneficiaries for Morriss’s body of work are GPs, other clinicians (such as psychologists and practice nurses) and patients with MUS through the following mechanisms:
 Successful attainment of government funding for IAPT for MUS
 Changes to general practice training
 Reattribution training taken up by clinicians and researchers internationally based upon Nottingham methods
 Better identification of patients through the development of The Nottingham Tool, an aid to identification of MUS within the clinical and patient community

This formed a major part of the need for increased government funding to address the issue. Based upon more recent work by Morriss6, the government have decided to introduce nurse-delivered and CBT psychological interventions for MUS in primary care. This has resulted in a major training programme to be developed to expand the psychological therapist workforce in order to respond more effectively to the needs to patients with MUS/LTC and co-morbid anxiety and depression.

In 2009, Morriss’s work on reattribution training (cited in research from 2007)1,2 informed the Royal College of Psychiatrists Practical Management Guide for Patients with Physical and Psychological Problems in Primary Caree as well as the practical guidance document for GPs to help manage MUS by encouraging reattribution and reducing GP anxieties about tackling psychological problems with the patient. More recently, in 2012, a NHS Emotional Wellbeing and Physical Health Care Case for Change described Morriss’s findings on symptom reattribution as a successful technique as part of a wider package of care for people with MUSg thus further improving the patient experience.

Looking forward, and as evidence of government acknowledgment of its importance, in 2010 the government decided to increase the funding of IAPT services to £400 million over the next 4 years to fund the expansion of work into further areas including medically unexplained symptoms.

It's a kind-of impressive achievement to have had so much influence and got so much money spent despite being so useless.

Finally, Morriss’s continued work on this topic continues to be cited as important in informing the thinking of health-care decisions, in particular in the domain of mental health. Publications are on-going with new advances being made in 2012 (e.g. Morriss: Role of mental health professionals in the management of functional somatic symptoms in primary care). The chair of Sainsbury Centre for Mental Health commented on these on-going contributions.

‘I have no doubt that your work has advanced national and international knowledge and practice, and continues to do so; I am currently a CCG Governing Body Member, leading on mental health - but I am still asked regularly for advice on this subject, part of my reply usually references your work’.

The British Establishment just seems to be full of frauds writing reports praising one another, and then using these reports as justification for their on-gong authority, without them actually doing anything of value.

Reading these submissions has left me even more cynical about the state of British academia. I didn't think that was possible.
 
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13,774
This looks similar to above, but dxrevsion watch has tweeted out a series of case studies related to CFS that were submitted as a part of this project:

QMUL and White on CFS/PACE: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=18135
KCL, Wessely, Chalder on CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=41185
Edinburgh and Sharpe on MUSW and CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=23887
Oxford and Sharpe on CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=17492
Cumbria and Diane Cox on OT for CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=21476
Nottingham and Richard Morriss on MUS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=28021
 

Cheshire

Senior Member
Messages
1,129
This looks similar to above, but dxrevsion watch has tweeted out a series of case studies related to CFS that were submitted as a part of this project:

QMUL and White on CFS/PACE: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=18135
KCL, Wessely, Chalder on CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=41185
Edinburgh and Sharpe on MUSW and CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=23887
Oxford and Sharpe on CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=17492
Cumbria and Diane Cox on OT for CFS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=21476
Nottingham and Richard Morriss on MUS: http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=28021

http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=23887

By showing the benefits of accurate identification and targeted treatment of chronic fatigue syndrome, UoE research has influenced worldwide medical practice and stimulated public and governmental debate.

The UoE work challenged the once popularly held view that 1. CFS is an organic disorder for which assessment and treatment are inappropriate or ineffectiv

The UoE research has led to changes in national and international guidelines on the management of medically unexplained symptoms and CFS/myalgic encephalomyelitis

http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=18135

Studies by Queen Mary researchers between 1993 and 2012 helped to characterise and demystify CFS and, in a series of randomised trials, showed that graded exercise therapy (GET) was effective and cost-effective, especially when costs to the patient and society were included.

The research studies described here were undertaken from 1993 to 2012 and published from 1995 to 2013. Back in 1993, CFS, sometimes called myalgic encephalomyelitis (ME), was far from an established condition and those who did believe in the condition thought it untreatable. In a series of studies at Queen Mary, Prof White led work that established the separate existence, incidence and prognosis of the syndrome after an infection, and also showed that physical deconditioning predicted it [1]. On that basis, White (with Fulcher, an exercise physiologist) designed graded exercise therapy (GET), based on the existing literature (Richard Edwards had already published an open study of exercise for "effort syndrome").

White went on to show (unexpectedly) that the effect of GET on global improvement was not mediated by a physical training effect [2], a finding since replicated by others. However, increased exercise tolerance, measured objectively, was mediated by increased fitness after GET [3].

This is just full of inaccuracies, contradictions and self-sufficiency...
Didn't find the courage to go on.:depressed: