A general thread on the PACE trial!

[Lou B Lou]

The CEO of AFME at the time (Chris Clarke) sold PACE to the members as a study on pacing. I'm sure AFME did one of their endless polls, that one asked what the members wanted research on. Many members wanted research on pacing. When the content of the PACE Trial was questioned, that it was a study on CBT and GET, Chris Clarke said that was the only way they could get a study on pacing. AFME ran an article in their magazine 'Interaction' (2002/3/4?) that said (I paraphrase) 'Hooray Hooray, we have a study on pacing'. I have the Interaction copy somewhere or other in the chaos of my flat.

 

[Lou B Lou]

Early criticism of PACE included that it used the Oxford Criteria for participant selection.

 

[Evergreen]

The CEO of AFME at the time (Chris Clarke) sold PACE to the members as a study on pacing. I'm sure AFME did one of their endless polls asking what the members wanted research on. Many members wanted research on pacing. When the content of the PACE Trial was questioned, that it was a study on CBT and GET, Chris Clarke said that was the only way they could get a study on pacing. AFME ran an article in their magazine 'Interaction', 2003/4) that said (I paraphrase) 'Hooray Hooray, we have a study on pacing'. I have the Interaction copy somewhere or other in the chaos of my flat.

Here's one of those surveys, published in the October 2002 edition of InterAction (issue 42), after the Medical Research Council asked for research priorities from patient organisations, following the CFS/ME Working Group report to the CMO published in Jan 2002:



What patients got was PACE.

 

[Evergreen]

Interesting how AfME interpreted that table, especially the fifth bullet point:


It looks, to me, like (some at) AfME had their own priorities.

 

[JemPD]

They were specifically claiming to be studying the group of people who have ME.

Actually, they weren't...
after PACE was released, one of the authors (pretty sure it was Sharpe but it could have been White) on twitter said that PACE was a study into CFS only & results could not be extrapolated for ME .

I dont have a link but i am certain thats the case as much was made of it at the time & i can 'see' the tweet in my mind's eye. I didnt save it as i knew it was irrelevant bandying of words, but they definitely did say that, or words to that effect, i dont have energy to look but i'd bet theres in image of it here on S4 somewhere

 

[DigitalDrifter]

The term ME had always been ambiguous and confusing, with a variety of interpretations.

See: https://www.s4me.info/threads/who-hijacked-me.28199/

At the moment patients who experience damage from exercise don't have an accurate diagnosis, they are illness misfits. It's what my currant signature means, ME to medical professionals does not mean (and never meant) damage from exercise.

 

[rvallee]

But by Boolean algebra, if ME is the intersection of several symptoms, one of which is fatigue, then it will describe a subset of the set of people with fatigue.

But in real life it's more complicated than that. It's almost impossible to work this out in criteria, but many of us, like me, did not have chronic fatigue for many months or years while we had PEM and many of the other symptoms. There was fatigue, sure, but it was a distant and relatively ignorable thing.

I've seen many with LC report the same. For months they didn't have any of that crushing fatigue. They had some, but they would report no to having chronic fatigue, it just didn't describe their problem well. And then it hit. It creates all sorts of problems when seen in a broader perspective. For example I had what I would properly consider mild chronic fatigue in my teens. Only fatigue, nothing else, and it was possible to push through, I had a mostly normal life with plenty of sports and activities, although sometimes I'd sleep 12-15h per day. It had nothing to do whatsoever with the illness I later developed and have had for 16 years.

So by usual criteria and definition alone, shmaybe, but really it's a lot more complicated than that, and ME, CFS or ME/CFS, however it's defined, can't be contained fully within a chronic fatigue umbrella. It's a big overlap, but from such a high-level definition, MS overlaps almost as strongly. That's the problem with common non-specific symptoms, they're basically found in almost all illnesses to a varying degree.

Of course that discussion is basically impossible for the most part, very few people are aware of this, and even fewer would think it makes sense, especially with having made everything about fatigue, and then with the odd decision that fatigue is mostly psychiatric, which makes zero sense. But making sense isn't high on the list of priorities for natural phenomena. What matters for a theoretical model that explains the whole is to make sense of the data, however little sense they seem to make. And from that the intersection is a lot more complicated than a simple general set and subset.

 

[DigitalDrifter]

one of the authors (pretty sure it was Sharpe but it could have been White) upon twitter said that PACE was a study into CFS only & results could not be exteminemolated for ME .

They're happy to let everybody conflate the two concepts. I've never seen them mention in their research the harm of conflating ME with idiopathic chronic fatigue. Sharpe said in the intro of the PACE trial that some researchers think ME and CFS are separate illnesses.

 

[JemPD]

They're happy to let everybody conflate the two concepts. I've never seen them mention in their research the harm of conflating ME with idiopathic chronic fatigue. Sharpe said in the intro of the PACE trial that some researchers think ME and CFS are separate illnesses.

yes DD i know that, of course they are happy to let people conflate the 2!.... except when it suits them not to.
And in this case, when they were trying to play semantics & weedle out of things, either he or White did say that (or words to that effect, on twitter, because i remember it being shouted about a lot at the time, its a lot of yrs ago now.

I wont press the point further, because without an image of the tweet in question, i cant prove it, but it was defintiely said. But he wasnt saying it in any way that would have been helpful for us.

 

[bobbler]

I’ve always thought the timing of the PACE protocol changes need to be seen in the context of the earlier-finishing FINE trial.

The protocols for the FINE and PACE trials had the same criterion for improvement on the SF36PF scale (having agreed to swap protocols in a May 2003 TMG meeting). The FINE protocol confirms using the 11-point Chalder questionnaire, but does not specify what will count as improvement on that scale.

This table, from Wilshire et al 2018 (full reference below) shows the switch in criteria for improvement on the SF36PF and CFQ that was made between protocol and publication of the PACE trial ie 2007 vs 2011:
View attachment 21781


From: Wilshire CE, Kindlon T, Courtney R, Matthees A, Tuller D, Geraghty K, Levin B. Rethinking the treatment of chronic fatigue syndrome-a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT. BMC Psychol. 2018 Mar 22;6(1):6. doi: 10.1186/s40359-018-0218-3. PMID: 29562932; PMCID: PMC5863477.

On 29th April 2009, the PACE statistical analysis plan is discussed at a TSC meeting, but there is no mention of changing the criteria for improvement at this point.
On 13th May 2009 the FINE trial results were presented to the FINE TMC.
On 17 June 2009 the FINE trial results were presented to the PACE TMG.

The FINE trial results as published in 2010:
View attachment 21782

From: Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group. Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial. BMJ. 2010 Apr 23;340:c1777. doi: 10.1136/bmj.c1777. PMID: 20418251; PMCID: PMC2859122.

The FINE trial summarised their findings as follows:


On 4 November 2009, less than 5 months after the FINE results were presented to the PACE TMG, TMG meeting minutes note changes to the analysis plan:



White et al. describe the change in 2015 in BJPsych Bull. 2015 Feb; 39(1): 24–27:

Wow, you can see where their move towards 'fatigue' being their big thing they realised they could 'own' and make as lowest common denominator / black box as possible over the years as a 'school' basing its papers on manifestos and a focus on lobbying to ever weaken methodology 'robustness' (if there is anything left by now) developed from.

The Crawley et al (2013) paper which included White and took place in clinics around the same time as PACE basically found that there was no effect on physical function, but could eke some claim short-term from the CFQ with a recommendation that the answer is 'new PROMS' ie change the measures.

And there he is even earlier weasel-wording why he didn't want to 'combine' anything because he knew it didn't work for physical function. But maybe if they separated them they could wangle something out of the most ambiguous subjective fatigue one. And they'd have had some inkling on the objective measures and drop-outs by the sounds I guess too.

SO there was a heck of a lot of research all at the same time from different angles, albeit it was messing with research design to claim effects, all coming up with the same issue - that there really (just as we see nowadays) was nothing even short-term 'of use' coming from any of their 'help' [and at the same time of course they didn't really note drop outs they got to not include, or really have to talk about harms or do yellow cards like drugs or other areas of medicine would].

Basically, if you can exhaust enough really ill people to drop out then you can eke some claim from just 2 points being forced on a subjective chalder fatigue self-report scale as soon as a treatment that effectively hammered participants to 'play down your symptoms, don't whinge, state the positive' and loads of newsletters telling them 'everyone else recovered' was the sum total?

.. and of course whatever you do start dropping anything objective as a measure of disability, even anything subjective that is physical function.

So they must surely have known they were basically brainwashing people into potentially making their actual physical condition and function worse longer term because it did nothing for the underlying condition?

Yes I can see why the only logical positions would be to go from signing off something with a proper method to a huge loss of faith / feeling of it being in bad faith when such intentions start becoming obvious?

 

[Adam pwme]

Does anyone have a copy of this? Or a scan.

ME Association.
MEA calls for PACE trial to be scrapped. ME Essential, July 2004: 91: 3–4

thanks

 

[Kalliope]

YouTuber and behavioural scientist Pete Judo has done a video debunking the PACE trial. It includes clips with David Tuller and walks through the main problematic aspects with the trial. He also contacts Professor White and gets an answer where White dismisses all critique.

ETA: His descriptions of ME and PEM are not very accurate, but he gets the main aspects with the PACE trial and this video will hopefully bring the story to a wider audience.

 

[rvallee]

YouTuber and behavioural scientist Pete Judo has done a video debunking the PACE trial. It includes clips with David Tuller and walks through the main problematic aspects with the trial. He also contacts Professor White and gets an answer where White dismisses all critique.



ETA: His descriptions of ME and PEM are not very accurate, but he gets the main aspects with the PACE trial and this video will hopefully bring the story to a wider audience.

That was really good. A few issues with PEM being about exercise rather than exertion, but otherwise the tone and content were excellent. Peter White's excuses are just mediocre and look terrible after this exposition of the problems with the study. What a bunch of charlatans.

He speaks very fast so don't forget that Youtube has a function to slow down playback

 

[NelliePledge]

Does anyone have a copy of this? Or a scan.

ME Association.
MEA calls for PACE trial to be scrapped. ME Essential, July 2004: 91: 3–4

thanks

Bumping @Adam pwme s request

 

[dave30th]

That was really good. A few issues with PEM being about exercise rather than exertion, but otherwise the tone and content were excellent.

I thought the same. It's already got close to 5,000 views and he just put it up earlier today.

 

[sneyz]

https://twitter.com/user/status/1788209660740186178

 

[bobbler]

I thought the same. It's already got close to 5,000 views and he just put it up earlier today.

Agreed. And it has just reminded me watching this (I think the last line about CBT, plus the bit about Chalder's misuse/misunderstanding of the term 'normal') that we need to begin requiring that it is underlined that just because Nice NG206 didn't throw out all CBT does NOT mean that it didn't throw out, and underline that included anything along similar lines, CFS-CBT ie anything that was based on the idea of false beliefs or deconditioning being behind ME/CFS.

THAT is being utterly flouted by BACME and what is written in the NHS website currently.

It is one thing saying that if someone wanted to avail themselves of other CBT for other conditions because they had grief or comorbidities then those types of real CBT were 'OK', and another thing twisting that trust imbued on them to use that distinction correctly to take advantage and claim that CBT could address 'symptoms' of the condition and ergo infer it would be a 'treatment'. Which is exactly what I suggest BACME and the King's college lot are trying to do.

SO I do think we need a campaign or pushback to say that needs to be banned. rewording 'false beliefs' to 'caused by being stressed' and still pushing 'think differently' is an outrageous distortion.

And those left who still do proper psychology and use CBT that is designed for the specific issue at hand with real models that work, like eg phobias, should be absolutely outraged and sayign something about these people who have trashed the reputation and usage of that term. They don't have the research behind it that makes it CBT, they just use it like some bang something together based on your beliefs in a day course done by a workplace telling people how they should think.

It isn't anything good for mental health, nevermind 'symptoms'. It is just taking advantage of vulnerable people and funding given that was supposed to go towards real staff who wanted to actually do things they checked would and did actually help. Not the callous disregard we see so prevalent in those who have the pretend 'good intentions' and at the same time utterly refuse to ever look into (or hear about) harms - which means they certainly don't have good intentions other than for themselves as far as I'm concerned.

 

[Maat]

Regarding the Youtube video today explaining the problems with the PACE trial - Trudie Chalder certainly isn't stupid.

Below are snapshots of the timeline I'm just trying to finish from the first part of 2015, just before David Tuller published his first triology of 'Trial by Error' and the whole of 2019. The timeline covers 67 years of this illness.

2015

14 January 2015

Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial (thelancet.com)

Note that therapies are now being referred to as Rehabilitation in the paper title but still ‘treatment’ in the body of the research paper.

“Interpretation

Our main finding was that fear avoidance beliefs were the strongest mediator for both CBT and GET. Changes in both beliefs and behaviour mediated the effects of both CBT and GET, but more so for GET. The results support a treatment model in which both beliefs and behaviour play a part in perpetuating fatigue and disability in chronic fatigue syndrome.

Funding

UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions, National Institute for Health Research (NIHR), NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust, and Institute of Psychiatry, Psychology, and Neuroscience, King’s College London.”

“Declaration of interests

PDW has done voluntary and paid consultancy work for the UK government and a reinsurance company. TC has received royalties from Sheldon Press and Constable and Robinson. MS has done voluntary and paid consultancy work for the UK government, has done consultancy work for an insurance company, and has received royalties from Oxford University Press. KAG and ARP declare no competing interests.”


[But Note:]


“The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.”

ME Research UK Slams Lancet Psychiatry Report (theargusreport.com)​

Chronic fatigue syndrome sufferers 'can benefit from exercise' | The Independent | The Independent 2015

Chronic fatigue victims 'suffer fear of exercise' and are anxious activities could aggravate the condition | Daily Mail Online 2015​

In this article in 2015 a quote from Dr Trudie Chalder of King’s College, one of the PACE trial authors is quoted as saying:​

ME: fear of exercise exacerbates chronic fatigue syndrome, say researchers (telegraph.co.uk)


“Professor Chalder said it was wrong to think of sufferers as lazy.

“They tend to be the opposite,” she said: “Sufferers of ME tend to be conscientious and hard-working and there is quite a lot of evidence that they are not lazy.”


This clearly demonstrates a reference to ‘yuppie ‘flu’ burnout with severity due to personality type D

February 2015

The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial - PMC (nih.gov)

Note disclosure of interests in relation to the Lobbying Act 2014

11 March 2015

Montgomery v. Lanarkshire Healthboard heard on appeal to the UK Supreme Court

Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) - The Supreme Court


21 October 2015

The Trial by Error series by David Tuller, DrPH, a senior fellow in public health and journalism at UC Berkeley’s Center for Global Public Health, which is part of the School of Public Health. beginning with this one:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study | Virology Blog

2019

7 January 2019

The NHS Long Term Plan was launched by Simon Stevens, the Chief Executive of NHS England, and the Prime Minister, at Alder Hey Children’s Hospital in Liverpool.

NHS Long Term Plan

Data saves lives: reshaping health and social care with data - GOV.UK (www.gov.uk)

Yet, the estimated prevalence figure for the UK of 250,000 of people affected by ME/CFS is the same one which has been used for over a decade. The author of this timeline has been ill almost 16 years and that’s the only official estimate ever quoted.

In view of the amount of data collected on it is inconceivable that a more accurate projection of prevalence is not possible. How are ICBs supposed to fund local services if they are unable to justify that expenditure with knowledge of how many patients affected it is required to provide health services for, and what services such patients could be expected to be in need of?

But then, it's easy to conclude that if the various institutions have the belief that if the illness, and in particular, the increasing severity of it, is due to patient personality type D, or failure to comply with 'treatment' it's the patient's own fault now isn't it. It certainly explains the utter contempt with which we are treated.


24 January 2019

Appropriate ME Treatment - Hansard - UK Parliament

MergedFile (actionforme.org.uk) Briefing for debate​

More should be done to raise awareness of Myalgic Encephalomyelitis, says MP | 31 January 2019 - The ME Association


11 Feb 2019

Living hell or yuppie flu? The confusing fog of chronic fatigue syndrome (telegraph.co.uk) [paywalled]


Yuppie flu (1980s reference to ‘burnout’) CFS/ME reference in Telegraph article 14 Jan 2015 Trudie Chalder obliquely references ‘burnout’ in this statement:


“Professor Chalder said it was wrong to think of sufferers as lazy.


“They tend to be the opposite,” she said: “Sufferers of ME tend to be conscientious and hard-working and there is quite a lot of evidence that they are not lazy.”


This clearly demonstrates a reference to ‘yuppie ‘flu’ burnout with severity due to personality type D


13 March 2019

Sick and tired: Online activists are silencing us, scientists say (reuters.com)


Article includes a reference to a drop-off of research from 2015.


The Tribunal confirmed the first order to release the partial trial data for a second time on appeal by QMUL in April 2016.


4 May 2019

'My daughter, 21, who died weighing five-and-a-half stone, had ME on her death certificate – yet some still say it's not real' (inews.co.uk) Interview with Merryn Croft’s mother as the second anniversary of her death approached.


23 May 2019

Three ME patients reveal the accusations they have endured | Daily Mail Online


7 September 2019

Physical activity guidelines: disabled adults - GOV.UK (www.gov.uk)


There is no research evidence published on the site to support its claims contained in this infographic. Unlike, in the Physical Activity guidelines: disabled children and young people referred below in 2022, where a rapid review was undertaken.


17 September 2019

First WHO World Patient Safety Day World Patient Safety Day campaign (who.int)


“World Patient Safety Day calls for global solidarity and concerted action by all countries and international partners to improve patient safety.

The Day brings together patients, families, caregivers, communities, health workers, health care leaders and policy-makers to show their commitment to patient safety.

The resolution WHA 72.6 ‘Global action on patient safety’ recognizes patient safety as a global health priority and endorses the establishment of World Patient Safety Day to be observed annually on 17 September.”


2 October 2019

Cochrane Review

Exercise therapy for chronic fatigue syndrome - Larun, L - 2019 | Cochrane Library

Information on the review confirming again that it was edited by the Cochrane Common Mental Disorders Group. This page also records the complaint handling history of a complaint raised by Robert Courtney in 2018. Insert details of Robert

Exercise therapy for chronic fatigue syndrome - Larun, L - 2019 | Cochrane Library

The complaint be continued by the international Science for ME forum and details of this can be found here

 

[Robert 1973]

It was also a complete bust, showed no positive results, and yet still formed the basis for a NHS module on CFS.

As far as I recall the previous NICE guideline did not recommend GET for severe ME/CFS. My understanding was that was on the basis of the null result for FINE. So in the that sense FINE was useful.

 

[Robert 1973]

It feels irrelevant for PACE since the big issues are around bad methodology rather than who it applied to.

Yes, but only because there was no reliable evidence of efficacy – ie no significant improvement in objective measures. If PACE had provided reliable evidence that CBT or GET improved fitness, employment status etc. (which I think many people anticipated) then it would have been relevant to highlight the fact that positive results from a trial of interventions for people with chronic fatigue without PEM do not tell us anything about their efficacy or safely for people with PEM.