A general thread on the PACE trial!

Somebody has asked me for information on where the PACE Trial investigators dismiss concerns about the poor results on the employment measure in the trial.

I found this:
https://meassociation.org.uk/2013/0...ournal-of-psychological-medicine-august-2013/
Economic data, such as sickness benefits and employment status, have already been published by McCrone et al. (2012). However, recovery from illness is a health status, not an economic one, and plenty of working people are unwell (Oortwijn et al. 2011), while well people do not necessarily work. Some of our participants were either past the age of retirement or were not in paid employment when they fell ill. In addition, follow-up at 6 months after the end of therapy may be too short a period to affect either benefits or employment. We therefore disagree with Shepherd (2013) that such outcomes constitute a usefulcomponent of recovery in the PACE trial.

But there was another excuse somewhere where they claim that a poor economic situation in the UK could explain the results [even though the trial took place over several years so this seems very questionable: if there was a sudden downturn, that would only affect a relatively small percentage of participants while longer longer downturn would also affect the baseline scores also].

Can anyone find the source or alternatively come up with phrases that might help an Internet search. Thanks.

@Esther12 @dave30th
 
This from McCrone?

3. The study has been criticised because there very limited impacts on employment. While reductions in lost employment would have been welcome we do have to ask whether this is the success indicator by which interventions should be judged. Is it really being suggested that gaining employment should be the primary aim of a successful intervention? After a long spell out of work this may be very difficult especially in the current economic environment. Reducing symptoms and improving quality of life are surely important outcomes and building up capacity and confidence to work again is likely to take time.
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https://journals.plos.org/plosone/a...notation/81bb33be-7b60-45f3-b467-efe29ced1bde
 
Esther12 said:
This from McCrone?

3. The study has been criticised because there very limited impacts on employment. While reductions in lost employment would have been welcome we do have to ask whether this is the success indicator by which interventions should be judged. Is it really being suggested that gaining employment should be the primary aim of a successful intervention? After a long spell out of work this may be very difficult especially in the current economic environment. Reducing symptoms and improving quality of life are surely important outcomes and building up capacity and confidence to work again is likely to take time.
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https://journals.plos.org/plosone/a...notation/81bb33be-7b60-45f3-b467-efe29ced1bde
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Peter Denton White, the chief principal investigator in the PACE Trial, in his capacity as a chief medical officer of a re-insurance company, denied a disability insurance claim around the time of this trial https://www.s4me.info/threads/how-p...fs-such-as-the-pace-trial-investigators.8066/ saying what the individual needed was more CBT/GET. That is just one we have on record: I wouldn’t be surprised if he hasn’t denied hundreds if not thousands over the many (20-30?) years he has held the position given the sort of views he is on record as saying.
 
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I was just reading this 2020 ICO PACE judgement: https://ico.org.uk/media/action-weve-taken/decision-notices/2020/2618033/fs50867390.pdf

It seems KCL is using the 'ongoing research' argument to avoid releasing PACE data, and they provide some details of it here:

17. In this case the complainant has argued that there has not been any
research conducted on PACE at KCL for some years.
18. KCL has confirmed that it has checked with the principal investigator at
KCL who has confirmed that the research programme is very much still
ongoing.
19. As KCL has confirmed that the programme of research is ongoing this
criteria can be met.

Intention to publish a report of the research

20. The Commissioner’s guidance explains that:
“The exemption requires that the research programme must be
‘continuing with a view to the publication... of a report of the research
(whether or not including a statement of that information)’.
21. KCL has said it is doing an analysis of moderators/predictors of outcome
as well as exploring clusters and how this affects outcome. The data is
currently being analysed so KCL does not have a draft paper yet. KCL also
has a PhD submission which it will use as the basis for further papers.
22. In this case KCL has confirmed that the research programme is
currently in the process of writing the papers, which may take longer
than anticipated due to the coronavirus pandemic.
23. It has confirmed that when complete, there is an intention for papers
to be published. The principal investigator has confirmed that KCL will
itself be publishing the papers
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0. Finally KCL said that the ethics committee that oversees this study has
explicitly stated that information should not be released. While KCL is
not bound by this directive when considering disclosure under the
FOIA, it does enter into its considerations. While the information
requested may not in itself directly identify individuals within the
dataset, combining it with information previously disclosed under the
FOIA by collaborating organisations increases the likelihood that an
individual could be identified despite steps taken to try and avoid such
an outcome. Accordingly, KCL considers the chance of an individual
being identified to be more than remote (this is why it has also applied
section 40(2) (Personal information) FOIA to this information)
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Some of their claims on cost seem a bit of a stretch compared to what I've heard from statisticians and those involved in data management:

46. In terms of providing a copy of the information requested at parts 1 and
7 of the request, KCL said that this would be extremely difficult and
expensive to do. It said it would have to employ a statistician with the
necessary skillset to extract the requested information from the raw
dataset.
47. This would involve running a recruitment campaign (writing a business
case and applying for management approval for the post; writing a job
description/person specification; writing a job advert; reviewing,
shortlisting and interviewing applicants etc).
48. The successful candidate (presuming KCL manage to find someone as
this would not be a particularly attractive role) would then need several
days to get acquainted with the data and to put it into the right format.
KCL estimated this would take two weeks’ work at the very least.
49. Initially KCL said that the only staff member who has the expertise
required to work on this data is not funded for data management
purposes. This staff member is expected to do her own research leading
directly to the production of publications. However subsequently KCL
clarified that, the principal investigator had confirmed that the member
of staff previously referred to as having “the expertise required to work
on this data” would not be able to provide the economic data under (1)
and (7) as she does not have the expertise to extract this from the raw
dataset – an economist would be required. The economist previously
attached to the study is no longer at KCL.
50. The complainant has disputed that an economist would be required to
extract the information.
51. Given KCL’s position is that it would be required to find an external
individual with relevant expertise to extract the requested information
from the raw data and then even once a suitable individual were found
they would need to become acquainted with the data, this is going to
create a time and cost implication to enable KCL to be in a position to be
able to comply with the request. This individual would then need to
begin work to locate, retrieve and extract the data which KCL has
estimated is approximately two weeks work. Even if this were reduced
down to 2 or 3 days this would exceed the cost limit. The Commissioner
is therefore satisfied that to comply with parts 1 and 7 of the request
would exceed the cost limit under section 12 FOIA
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I wonder if this old judgement could be related to those academics trying to access this data a while back?
 
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Esther12 said:
It seems KCL is using the 'ongoing research' argument to avoid releasing PACE data
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But doesn't this contradict another foi where they said they should release the data, but couldn't because no-one knew how to access it anymore due to retirements... If they are still writing papers, then someone must be able to access the data.
I'm sorry i forget which foi this related, but i think this is worth taking and using to get them to release whatever was not allowed before on the premise they clearly can still access the data.
@JohnTheJack
 
But doesn't this contradict another foi where they said they should release the data, but couldn't because no-one knew how to access it anymore due to retirements... If they are still writing papers, then someone must be able to access the data.
I'm sorry i forget which foi this related, but i think this is worth taking and using to get them to release whatever was not allowed before on the premise they clearly can still access the data.
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I think that was the request to QMUL that @dave30th discusses here:
At some point in the FOI appeal process, according to the ICO decision, QMUL changed its rationale for not providing the requested data. The new argument was not that data were exempt but that they were essentially not available. With Professor White gone, argued the university, no one on staff knew enough about the trial to figure out how to access requested data. QMUL also cited an earlier ICO determination that public agencies should not have to hire staff just to respond to FOI requests.
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I think what many of us would like to see, short of the dataset being made public, is an independent reanalysis. Given that Fiona Watt has stated that the data is available via a platform called "Vivli" and that access requests are considered by a panel at the Wellcome Trust (independent of the PACE authors) - that would seem to be the way forward, although it would be a mammoth undertaking. Is there a suitably experienced PI, a medical statistician, etc, who would attempt such a project?
 
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Nightsong said:
I think that was the request to QMUL that @dave30th discusses here:

I think what many of us would like to see, short of the dataset being made public, is an independent reanalysis. Given that Fiona Watt has stated that the data is available via a platform called "Vivli" and that access requests are considered by a panel at the Wellcome Trust (independent of the PACE authors) - that would seem to be the way forward, although it would be a mammoth undertaking. Is there a suitably experienced PI, a medical statistician, etc, who would attempt such a project?
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Nightsong said:
I think that was the request to QMUL that @dave30th discusses here:

I think what many of us would like to see, short of the dataset being made public, is an independent reanalysis. Given that Fiona Watt has stated that the data is available via a platform called "Vivli" and that access requests are considered by a panel at the Wellcome Trust (independent of the PACE authors) - that would seem to be the way forward, although it would be a mammoth undertaking. Is there a suitably experienced PI, a medical statistician, etc, who would attempt such a project?
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I am aware of at least two researchers who made a request and were denied. The PACE authors appear to have a veto, the availability of the data on this platform is a sham so they can pretend they are making it available while being able to block all meaningful access.

The excuse of not being able to access the data is also a lie. It was a large trial, they had more than enough funding to do this and it was discussed in the minutes. We also know they know how to make the data available because they sent it to the other platform. Peter White isn't even retired and that's not a valid excuse anyway for such a large investment, the best excuse they can come up with is that they are inept and dishonest.

Massive consciousness of guilt playing out here, no one works this hard, and this ineptly, to hide data unless it's bad for them.
 
rvallee said:
Peter White isn't even retired
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Hasn’t Prof White, since his supposed retirement and the refusal of the FOI request on the grounds of no staff left who are able to access the data, been listed as the lead researcher in the current PACE follow up?

[added - not found an up to date confirmation that Prof White is still heading up the ten year follow up, though he was listed as the main contact in Jan 2017, see ‘PACE 10 year follow-up: feasibility study’ https://www.hra.nhs.uk/planning-and...ies/pace-10-year-follow-up-feasibility-study/ and @dave30th blogged on this issue in 2018 see https://www.virology.ws/2018/02/13/...d-foi-nature-and-cochrane-the-pineapple-fund/ ]
 
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Esther12 said:
I was just reading this 2020 ICO PACE judgement: https://ico.org.uk/media/action-weve-taken/decision-notices/2020/2618033/fs50867390.pdf

It seems KCL is using the 'ongoing research' argument to avoid releasing PACE data, and they provide some details of it here:





Some of their claims on cost seem a bit of a stretch compared to what I've heard from statisticians and those involved in data management:



I wonder if this old judgement could be related to those academics trying to access this data a while back?
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That was one of my requests. I haven't been well enough to appeal but will try this year. It's timed out but I am going to ask if the tribunal will hear it because I have had Covid (twice) and been unwell.

I started that request years ago and have already been through one appeal for it.
 
Moved posts

Jonathan Edwards said:
I think it is probably fair to say the 2007 review was influenced by the PACE trial. By then PACE was under way and the results had been reliably arranged. The NICE committee was very likely informed that these results were going according to plan, even if recruitment was annoyingly slow. And since in 2011 the result came out very nicely in print the guidelines were informed by that in 2012 - because they would have had to change if the results had mysteriously gone the wrong way.
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In 2007, NICE 'chose' to process guideline, for the first time. It originally I remember came out under "muskosckeletal" disorders... until we complained, and that was changed. Under musko skeletals it could/wouldhave been"Waddled"...

Here is my history lesson for the day-

(Professor Gordon Waddell was an orthopaedic surgeon with a particular interest in back pain and pain-associated disability.... and was a BSP advocate...'he won the prestigious Volvo award for back pain for his biopsychosocial model of low back disability. This new theoretical framework proved to be a focus for a fundamental change leading to the current approach to the clinical management'.He also made a major contribution to the development of occupational health around the world. He also undertook a series of major policy reviews commissioned primarily by the UK Government (Department for Work and Pensions), appraising the evidence of the impact of work on health....Gordon released the management of musculoskeletal disorders from primary orthopaedic management and his biopsychosocial model has underpinned the development of modern pain management, the identification/management of yellow flags, and psychologically informed practice.)



Also , under the NHS Health & Work programme of Occupational Health advice- (my absolute favourite hobby horse) - we had the genesis of NICE Guidance CG35 and PACE Trial- yes folks it is still top of the Google listing.

'NHS Health at Work promotes best clinical practice. We are committed to providing consistent, high quality health at work services to all NHS staff.'

https://www.nhshealthatwork.co.uk/chronic-fatigue.asp

'Information for healthcare professionals, employers and employees providing the current evidence on managing and supporting employees with chronic fatigue syndrome.

Full guidelines (2006)
Healthcare professionals leaflet (2008)
Employers leaflet (2008)
Employees leaflet (2008)
External assessors

Professor Michael Sharpe
Professor of Psychological Medicine and Symptoms Research, School of Molecular and Clinical Medicine,University of Edinburgh
Professor Peter White Professor of Psychological Medicine,Wolfson Institute of Preventative Medicine(School of Medicine and Dentistry),Queen Mary’s University of LondonGuideline Development Group members

Dr William Bruce-Jones General Adult and Liaison Psychiatrist, Avon and WiltshireMental Health Partnership NHSTrust
Nikie Catchpool Occupational Advanced PractitionerT herapist,Bath and Wiltshire CFS/ME Service,Royal National Hospital forRheumatic DiseasesNHS Foundation Trust, Bath

Professor Trudie ChalderProfessor of Cognitive Behavioura lPsychotherapy,Institute of Psychiatry, at theMaudsley, King’s College, LondonGuideline Development Group3Occupational Aspects of the Management of Chronic Fatigue SyndromeCOI CFSyndrome txt 1 22/9/06 11:22

Chris ClarkChief Executive, Action for ME(until March 2006), AfME,3rd Floor, Canningford House,38 Victoria Street, Bristol BS1 6BY

Sharon HynesHead of Human Resources and Training, BUPA Wellness, London

Dr Meirion Llewelyn Consultant Physician, Infectious Diseases/General Medicine, Royal Gwent Hospital, Newport, Gwent
Dr Jon Poole Consultant Occupational Physician,Dudley NHS Primary Care Trust,Dudley, West Midlands
Suzanne Roche Research Assistant, South London and Maudsley NHS Trust, London
Gael Somerville Occupational Health Nurse, BritishBroadcasting Corporation, London
Bella Stensnas Research Assistant, South London and Maudsley NHS Trust, London

Conflicts of interest:none declare

So there we have it! I have been trying for nearly 20 years to get this taken down (and have not succeeded) as the Faculty of Occupational Medicine is still on the case...
IN 2018 I asked Mark Baker about it at the Guideline Review engagement meeting as it was /is STILL referenced in the latest NICE review material!

 
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Preceding the above 'Information for healthcare professionals, employers and employees providing the current evidence on managing and supporting employees with chronic fatigue syndrome.

Full guidelines (2006)


From 2004 (and the origins of the NHS Health& Work stuff) of course there was the 'National Role Out of ME Clinics Programme" where Barts applied, 2005? and were awarded funding to empire build!


History
'The Chronic Fatigue Service in Hackney and is one of the largest such services in the UK.

Formerly based at St Bartholomew’s Hospital, the Chronic Fatigue Service is provided jointly by East London Foundation Trust and Barts Health NHS Trust.

The service celebrated its 25th anniversary in 2009.'


http://news.bbc.co.uk/1/hi/health/6120514.stm

Luckily, 38-year-old Samantha was referred to a new service at Barts Hospital, London, designed to help people with chronic fatigue syndrome (CFS) or ME (myalgic encephalomyelitis) build their recovery.

"They worked with me on a graded programme. I would start doing a few minutes of exercise and then when I had mastered that I could do 10 minutes. It was a 20% increment each time. I also had cognitive behaviour therapy.

"Now I am at the point where I am doing a 30 minutes walk and a 20 minute cycle ride.


Dr Maurice Murphy, a specialist in infection and infectious diseases and clinical co-leader of the new service, said: "We have become a dynamic hub of clinical expertise, with a well equipped large team combining physical and psychological medicine and allied professionals.

"In the past there has been a lack of services and scepticism amongst the medical profession of this illness. However this commitment shows that we have moved well beyond that point."

Service

Professor Peter White, an expert in psychological medicine and clinical co-leader, said: "The unique part of this service is that we have combined together to provide a truly integrated service for patients who have a misunderstood yet debilitating illness.

"Through our centre patients and their carers will now be given a proper diagnosis and the chance of recovery."

The CFS and ME Service at Bart's Hospital has been trialled since April 2005 before being officially launched last month.

In the past year it has treated more than 600 patients and expects around 250 new referrals every 12 months. It is one of the largest centres in the UK with over 20 professional staff.

 
I was just thinking about attempts to make the late and dramatic changes to the PACE protocol seem as if they were part of the plan, and thought I'd post this:

12.3 Analysis plan (brief)
A full Analysis Strategy (modelled on that successfully employed within the recently
completed, MRC-funded, trial of Cognitive Behaviour Therapy in Bipolar Affective
Disorder), will be developed, independently of looking at the trial database, and before
undertaking any analysis, about 6 months after the start of randomisation.
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From: PACE trial protocol: Final version 5.0, 01.02.2006

I have this as a searchable pdf.

It's a very trivial point compared to the many more obvious problems with the PACE spin, but it could be of some use to someone to have it noted here.
 
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