• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

PACE trial: Lancet Psychiatry paper on long term follow - correspondence

worldbackwards

Senior Member
Messages
2,051
Given that they keep citing the additional treatments as rationale for ignoring the lack of differences between groups, it would be good if someone could pin them down on the fact that those who had additional CBT/GET didn't drag up the results.

What really annoys me about the response is this bit:
The marked antipathy of some toward this study, apparent in the correspondence and elsewhere, is perhaps related in part to the view, expressed by Shepherd, that the findings support “a simplistic and flawed model of psychosocial causation”. They do not.
No they don't. But, given that the next time Sharpe et al give a lecture or briefing on the subject they will claim said causation and quote PACE as exhibit A, it's a highly disingenuous position. It can hardly be said that the concerns surrounding this paper regarding it's ideological underpinnings are misplaced or somehow nothing to do with the authors.
 

Kati

Patient in training
Messages
5,497
Given that they keep citing the additional treatments as rationale for ignoring the lack of differences between groups, it would be good if someone could pin them down on the fact that those who had additional CBT/GET didn't drag up the results.

What really annoys me about the response is this bit:

No they don't. But, given that the next time Sharpe et al give a lecture or briefing on the subject they will claim said causation and quote PACE as exhibit A, it's a highly disingenuous position. It can hardly be said that the concerns surrounding this paper regarding it's ideological underpinnings are misplaced or somehow nothing to do with the authors.
Very vexatious.
 

Tom Kindlon

Senior Member
Messages
1,734
PACE Trial authors' response very misleading: whether APT/SMC-only groups got CBT/GET or not made no difference.
PACE over2.png

(Figure prepared by @Simon )
 
Messages
5,238
Location
Sofa, UK
I think some of Coyne's and Twisk's points are devastating; unanswered and unanswerable. They seem very carefully chosen. Although some of them may require too much technical knowledge of PACE for the casual reader to draw much from the exchange, any academic following the references and checking the numbers would have to see how damaging these points are to the trial's credibility.

I think Shepherd vs the PACE cabal drew the usual ping-pong response from PACE; as usual they managed to wriggle around and put just enough doubt in the mind of the intelligent but uninformed neutral reader to leave them still undecided on whether Shepherd's critique was fair. Taking Shepherd's comments alongside the serious and unanswered technical points from Coyne and Twisk, though, the PACE authors begin to look isolated, and Shepherd's rather more accessible points seem like they might be worth taking that little bit more seriously. And I daresay there may be more critique to come, and the sense of isolation may grow...:D
 

charles shepherd

Senior Member
Messages
2,239
So am I missing something... what is happening regarding the release of the data?

This is correspondence relating to the paper in Lancet Psychiatry that reported on long term follow up of PACE trial participants

Nothing to do with release of PACE trial data

That is still being debated and resisted……..
 

Tom Kindlon

Senior Member
Messages
1,734
Also the authors refer to Crawley et al (2013).

They do, however, offer practical hope of useful improvement, a finding reinforced from the routine monitoring of the outcomes of the many patients who attend clinics that offer these and similar treatments.6

The results in this were actually quite poor (remember no control group). The no-individualised therapy SMC-only group in the PACE Trial had better improvements in self-reported physical functioning then the results seen in the clinics as reported by Crawley et al. (2013).

QJM.2013 Jun;106(6):555-65. doi: 10.1093/qjmed/hct061. Epub 2013 Mar 28.
3 comments on PubPeer
Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database.
Crawley E1,Collin SM,White PD,Rimes K,Sterne JA,May MT;CFS/MENationalOutcomesDatabase.
Author information
Erratum in

  • QJM. 2013 Jun;106(6):567.
Abstract
BACKGROUND:
Chronic fatigue syndrome(CFS) is relatively common and disabling. Over 8000 patients attend adult services each year, yet little is known about the outcome of patients attending NHS services.
AIM:
Investigate the outcome of patients with CFS and what factors predict outcome.
DESIGN:
Longitudinal patient cohort.
METHODS:
We used data from six CFS/ME (myalgic encephalomyelitis) specialist services to measure changes in fatigue (Chalder Fatigue Scale), physical function (SF-36), anxiety and depression (Hospital Anxiety and Depression Scale) and pain (visual analogue pain rating scale) between clinical assessment and 8-20 months of follow-up. We used multivariable linear regression to investigate baseline factors associated with outcomes at follow-up.
RESULTS:
Baseline data obtained at clinical assessment were available for 1643 patients, of whom 834 (51%) had complete follow-up data. There were improvements in fatigue[mean difference from assessment to outcome: -6.8; 95% confidence interval (CI) -7.4 to -6.2; P < 0.001]; physical function (4.4; 95% CI 3.0-5.8; P < 0.001), anxiety (-0.6; 95% CI -0.9 to -0.3; P < 0.001), depression (-1.6; 95% CI -1.9 to -1.4; P < 0.001) and pain (-5.3; 95% CI -7.0 to -3.6; P < 0.001). Worse fatigue, physical function and pain at clinical assessment predicted a worse outcome for fatigue at follow-up. Older age, increased pain and physical function at assessment were associated with poorer physical function at follow-up.
CONCLUSION:
Patients who attend NHS specialist CFS/ME services can expect similar improvements in fatigue, anxiety and depression to participants receiving cognitive behavioural therapy and graded exercise therapy in a recent trial, but are likely to experience less improvement in physical function. Outcomes were predicted by fatigue, disability and pain at assessment.
 
Messages
13,774
Just thought I'd pull out my favorite bit. While we've been rather spoilt by Coyne's campaigning, and having @Keith Laws join the forum, three months ago I'd have been over-the-moon to hear that they'd had a letter in the Lancet Psych saying:

Lastly, the PACE investigators have previously complained inThe Lancet Psychiatryof “the apparent campaign to bring the robust findings of the trial into question”.5We think the further scrutiny that the follow-up study has brought casts further doubt on whether there ever were “robust findings”. The investigators should get more accustomed to rigorous post-publication peer review, which is not a campaign, but a reality of the 21st century.

As a sign to those reading the Lancet Psych that concerns about the PACE trial don't just stem from patients/patient advocates being too stupid to appreciate all the good work being done for them, that's pretty great.
 

Large Donner

Senior Member
Messages
866
How rather ironic that the PACE proponents are challenging the scientific veracity of a survey yet their £5 million trial failed to meet, to any degree, anything that could be described as the scientific method.

This is one case where a supposed scientific study can be deemed more of a survey than an actual survey and definitely more bias. At least the survey was actual patients responses and not some engineering exercise of information bias mining. On top of that the survey did not have objective measures that they decided to drop in the reporting stage wheras the PACE trial did.

If the best defense they can put up for the PACE trial is "we used the Oxford Criteria so we know what people had as opposed to the ME Association survey", they are basically admitting that even if people did have improvement (which seems not to be the case) there is no way they can relate that to "we find these results to apply however one defines ME or CFS".

They cannot have their cake and eat it by saying Oxford Criteria, which has been called upon to be retired, produces a more worthy result in a trial than a survey by a patient organisation which by their own claim logic would be a larger cross section of cohorts at the same time as knowing that their chosen criteria is the weakest definition.
 
Last edited:

chipmunk1

Senior Member
Messages
765
The authors argued: “In so far as the need to seek additional treatment is a marker of continuing illness, these findings support the superiority of CBT and GET as treatments for chronic fatigue syndrome”.

part of the CBT/GET treatment is probably tellling the patient NOT to seek additional treatment.
 

chipmunk1

Senior Member
Messages
765
Although this finding might mean that all PACE treatments have similar long-term outcomes, we cannot draw this conclusion. This is because, as explained in the Article,2 the follow-up study was not, as suggested by Coyne and Laws, a continuation of the trial (with or without crossover), but rather a naturalistic follow-up after trial completion. During this follow-up period, more than half of participants originally allocated to standard medical care alone and to APT sought at least some treatment with CBT or GET. Consequently, the long-term outcome in these participants is not of standard medical care alone or APT alone, but of these therapies supplemented in many cases by CBT or GET.

So they are admitting that their follow up data is worthless?

The control group got a "hidden" CBT boost?
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
tbh, my main response is: the 500 word limit makes it really difficult to have a proper debate in Lancet Psych. A shame the PACE researchers didn't want to go through with the Mental Elf thing.

If I was reading that without prior knowledge, I don't think that I'd be able to conclude much from the exchange.

Would have been nice to have had some more critical letters in to cover more issues, but can understand people who wrote last time not bothering after PACE's last response. Thanks to all those who did write in. All letter raised important points, and I think that having Coyne and Laws write should also be really helpful for encouraging people to at least consider whether concerns' about PACE might have some merit.

Nothing new from the PACE crew.
Just read the all the letters - thanks to all who wrote, and it was particularly pleasing to see a robust critique from prominent academics in @Keith Laws and James Coyne.

But I agree with Esther12 that someone new to the debate might not be able to conclude much. The authors reply was sophisticated: it made numerous statements that were true without addressing the heart of the matters raised by the critics.

eg
the authors said:
While recovery for all participants receiving these treatments has never been claimed, a mean improvement of approximately 20 points on the medical outcomes study short-form 36 (SF-36) physical functioning scale from trial entry is, contrary to Frank Twisk's comments about the lack of treatment effect, clearly clinically meaningful.
Which of course ignores the fact this gain was from baseline, not compared with the control groups. The advantage of CBT/GET was only around 8 points at the end of the trial (a self-report measure in an unblinded trial) and there was no advantage at long-term follow-up, which is actually what this correspondence is all about.

eg
the authors said:
The statistical analysis accounted for missing data using linear mixed effects models and made the missing-at-random assumption. These are widely accepted approaches, given that missing data assumptions cannot be properly tested;
Since when was 'widely acccepted' an acceptable scientific riposte to criticism?
 

Keela Too

Sally Burch
Messages
900
Location
N.Ireland
This is correspondence relating to the paper in Lancet Psychiatry that reported on long term follow up of PACE trial participants

Nothing to do with release of PACE trial data

That is still being debated and resisted……..

Ah thank you. I had it in my head that yesterday was a significant day in that story too. Excellent that these 3 rebuttal letters were published in The Lancet.

I'm looking forward to hearing James Coyne speak in Belfast in Feb.