2014 Impact case study - Queen Mary University of London (QMUL) - CFS

Sly Saint

Senior Member (Voting Rights)
Didn't know where to post this or if it has been posted before;

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.

2. Underpinning research
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 then led the first randomised controlled trial (RCT) of GET to show that it was more effective than a non-specific therapy time-control intervention for patients with CFS, whether or not this followed an infection [2].

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].

The PACE trial recruited 640 UK participants from secondary care [4]. Physiotherapists delivered GET, designed to increase exercise duration and then intensity in a gradual and symptom-contingent manner, based on the principles of behavioural graded exposure therapy (www.pacetrial.org).

The primary outcomes of fatigue and physical disability were significantly improved in those who had received either GET or CBT, compared to those who had received either APT or SMC; effect size was moderate (between 0.4 and 0.8) with similar effect sizes for both GET and CBT [4]. The pacing approach of APT was no more effective than SMC.

The patterns of results were similar however CFS or ME were defined, as well as in those with a comorbid depressive illness. Serious adverse events and reactions were uncommon and equally distributed across the four treatment arms. CBT was the most cost-effective, followed by GET [5]. At a societal level both GET and CBT paid for themselves due to reductions in informal social care. 22% of patients in the trial recovered their health after either of these treatments, compared to 7% following SMC alone [6].

White et al concluded that individually delivered CBT and GET were safe, effective and cost-effective when added to SMC, and should be offered to all secondary care patients with CFS, however defined. 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).

The trial was coordinated at Queen Mary and sponsored by them. White (QMUL) was the lead principal investigator (PI), supported by co-PIs Trudie Chalder (KCL) and Michael Sharpe (Oxford). Funding was from Medical Research Council, Department of Health for England, Department for Work and Pensions, and Scottish Chief Scientist’s Office.

4. Details of the impact
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].

4c: Graded exercise therapy has been adopted internationally as a treatment of CFS.

Permission has been granted for both translation into German and the use of the PACE trial GET manuals for a trial in neuromuscular disease, and for use in an Australian trial of rehabilitation for patients with traumatic brain injuries. The PACE trial treatment manuals are free to download from the trial website: www.pacetrial.org/trialinfo. The site was accessed by 6,672 people between June 2012 and 21 August 2013, particularly from the UK, USA, Australia, Germany, and Canada (source – Google Analytics), this monitored period being more than a year after the main results were published [11].

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.


5. Sources to corroborate the impact
7. NICE Guideline 2007 (updated 2011) on Chronic Fatigue Syndrome / Myalgic Encephalomyelitis (CG053). http://guidance.nice.org.uk/CG53/Guidance/pdf/English
8. NICE affirming support of GET. www.nice.org.uk/nicemedia/live/11824/53532/53532.pdf
9. British Association for Chronic fatigue syndrome/ME BACME endorsement of GET www.bacme.info/aboutcfsme/management/get.html and national outcomes database: http://www.bacme.info/nod/
10. Crawley E, Collin SM, White PD, Rimes K, Sterne JAC, May MT. (Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database. Quarterly Journal of Medicine 2013; 106: 555-565. doi:10.1093/qjmed/hct061
11. PACE trial website: www.pacetrial.org
12. Mayo Clinic guideline on CFS www.mayoclinic.com/health/chronic-fatigue-syndrome/DS00395/DSECTION=treatments-and-drugs
13. US Center for Disease Control guideline on CFS www.cdc.gov/cfs/toolkit/get.html
14. See for example Government of South Australia ME/CFS guidelines http://sacfs.asn.au/download/guidelines.pdf
15. Norwegian Knowledge Centre for Health Services rapid review on CFS (English summary): www.kunnskapssenteret.no/Publikasjoner/Behandling+av+kronisk+utmattelsessyndrom+CFSME.12742.cms?language=english&threepage=1
16. Hawkes N. Dangers of research into chronic fatigue syndrome. BMJ 2011; 342: d3780
17. House of Lords debate on PACE, HANSARD 6 February 2013 (see column GC65): www.publications.parliament.uk/pa/ld201213/ldhansrd/text/130206-gc0001.html
18. Letter from Baroness Northover. www.pacetrial.org/docs/Northover.pdf
19. Science Media Centre hosted a press conference on PACE. www.sciencemediacentre.org/cfsme-trial/ & www.sciencemediacentre.org/expert-reaction-to-lancet-study-looking-at-treatments-for-chronic-fatigue-syndromeme-2-2/

https://www.qmul.ac.uk/wolfson/media/wolfson/ref-2014-results/UoA2-chronic_fatigue_syndrome.pdf

We have so much to thank QMUL for
 
We sort of own them thanks - for so kindly assembling this historical document.

I'm saving this one, for when pace/get/cbt is truly devaluated and generally known to be bad science. An impact case study from QMUL themselfs, well summarizing of the widespred impact made by this shenanigans - while everyone looked away.

They can't even claim patients advocates put a negative spin on things, and that it wasn't really like that - they wrote it themselfs.
 
Didn't know where to post this or if it has been posted before;













https://www.qmul.ac.uk/wolfson/media/wolfson/ref-2014-results/UoA2-chronic_fatigue_syndrome.pdf

We have so much to thank QMUL for

This piece should have been titled: Stroking Wessely's ego. I don't think a single sentence is accurate or relevant.

Quite the lie right here:
The lead researchers have worked hard to build a dialogue with patient groups

This "dialogue" can be summed up as a cardboard cutout of Wessely holding a sign that says "YOU'RE WRONG" and another of Sharpe that says "HAVE YOU READ THE PAPER?" and basically blasts at full volume (to make sure we can't get anywhere close to you it) "JUMP ON THE STOP MAT, you lazy malingering type A personality". Then there's a phone number for complaints that is a disconnected line that basically screeches insults at you when you dare calling.

They have truly invented a form of medicine where the patient is completely irrelevant. It's quite a sight to behold, of the morbid fascination type.
 
Not to mention the fact that Wessely in a possibly unguarded moment on twitter opined that he was regretful that he had not listened to patients more carefully at the beginning.

I don't have the ability to spend the time relocating that tweet. Perhaps someone else knows where to find it.
 
There was loads of spin and hype from UK universities looking to take creadit for how much they've helped CFS patients in REF2014... looks like 2021 is going to be terrible too: https://www.s4me.info/threads/matth...teria-for-assessing-research-in-ref2021.3170/

Will they even have any data for this? By their own admission no one is actually monitoring anything. They're still pointing to decade+-old research as evidence because they know they can get away with not doing any follow-up. So by then they'll just likely continue pointing to the, by now mostly two decades-old, research as evidence that it works if you believe in it.

I haven't seen any movement on this so far: asking them where is the damn data. Because they deliberately avoid recording any. NHS point to the clinics saying they are responsible for the follow-up and the clinics don't do any of this. They just point to the cherry-picked research and say that's good enough.

It would definitely look very bad if they had to show evidence, but so far have avoided this problem entirely and we can't make them. They can definitely get away with this. They already have managed for over a decade without having to show any evidence or even pretend to be monitoring outcomes.
 

They indeed have handed each other shiny awards and very good tenured positions. Wessely is a knight and will likely be a lord. The psychosocial ideology is expanding. Very good achievements. As long as you don't bother looking at the catastrophic outcomes for patients it's been very good for the researchers' careers.
 
Three of these were used in this paper:

Investigator bias and the PACE trial
Steven Lubet

Abstract
The PACE investigators reject Geraghty’s suggestion that the cognitive behavior therapy/graded exercise therapy trial could have been better left to researchers with no stake in the theories under study. The potential sources and standards for determining researcher bias are considered, concluding that the PACE investigators “impartiality might reasonably be questioned.”

https://journals.sagepub.com/doi/10.1177/1359105317697324
 
The PACE investigators reject Geraghty’s suggestion that the cognitive behavior therapy/graded exercise therapy trial could have been better left to researchers with no stake in the theories under study.

Uh, uh. That's not how any of this works. It's a valid issue, it can't just be "rejected" as irrelevant. They have built their entire career and their employment and reputation depend on this research holding up, which explains the length to which they went to cheat their way to a positive result and make outlandish claims that their own research doesn't back up.

They are only conducting unblinded trials with self-reported outcomes that depend on extensive interactions with patients throughout the entire study, giving them information that they then used to move the goalposts to give themselves a better outcome. This is a problem precisely because of the methodology they choose and they have precedent adapting their research by peeking at the data and cheating with it.

With hindsight, this will be incredibly damning. Of course their bias influenced everything they did and caused significant issues. Arguing that this can simply be rejected because whatever is unethical and unprofessional.

And since politics have clearly played an outsized role in this, it's fitting to quote from All the presidentpsychiatrist's men: "the truth is, these are not very bright guys, and things got out of hand".
 
Somebody who was reading this thread noticed the entry for Kings College London and thought it might be worth highlighting the figure given for the PACE Trial e.g. on Twitter.

As there seem to be conflicting figures given by different sources, I'm not sure I'll do it myself.

L6bU4vox.jpg
 
Somebody who was reading this thread noticed the entry for Kings College London and thought it might be worth highlighting the figure given for the PACE Trial e.g. on Twitter.

As there seem to be conflicting figures given by different sources, I'm not sure I'll do it myself.

View attachment 5084

I knew I'd seen that figure somewhere! Likely to be of interest to @AR68 too.
 
Feigning self-deprecation is just something he does every now and again.

Don't disagree. Although since writing that I have been thinking that the true meaning behind the comment as I recall it was that he was sorry for the BPS cause. If he had taken the serious ME cases seriously I think he believes he could have mitigated the blow-back that the BPS crowd has experienced from seriously ill people who will not be shut up/silenced. If he had split them off early the fatigue narrative could go on unencumbered. As it is now we have put a dent in their timeline for ruling the illness world with their 'solution'.

It then becomes another prime example of how he says something that on the face of it sounds apologetic and can be interpreted as directed toward the patients but is actually self-pity.
 
Feigning self-deprecation is just something he does every now and again.
Yes, with some people this is a strategy to convince how open and honest they 'obviously' are; it's human nature to warm to someone who does this, and to be more trusting of them. Con-artists are supremely good at it for instance. If someone apparently "opens up" about their oh-so-human failings, most people are much less likely to believe them capable of engaging in darker misdirections.
 
I feel like Wessely was starting to try to find a cautious retreat, acknowledging that maybe he was a bit too dismissive of patients' concerns. Then there was an indication Cochrane might withdraw their exercise review, and that led to them decided that they wanted more of their smearing of patients' concerns.
 
where did he say this?

There was this, but it is not entirely clear.
www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60802-2/fulltext

With hindsight he admits “I could have been more diplomatic. I wasn’t thinking about the language I used or its impact. I was just keen to get into print.” He understands why patients would prefer to be told they’ve acquired a virus. Nowadays, he reckons, he can make a better fist of handling controversy.

EDIT to include quote and to add this

Sometimes when one looks back, one gets a sense of “why on earth did I do that?”. But not in this case. Yes, one would do some things a little differently. And yes, my writing style has improved over twenty years. But overall, I think that we (and like all medical research, it most definitely was a “we”) achieved quite a lot for the benefit of medicine and patients.
www.simonwessely.com/index.php/cfs-personal-story/


He appears to think that the problem may have been one of form, not substance. I am not sure many would agree.
 
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