BBC: Chronic fatigue trial results 'not robust', new study says

Skycloud

Skycloud

Senior Member (Voting Rights)
http://www.bbc.co.uk/news/health-43490335

Fresh analysis of a controversial study, which recommended exercise and psychological therapy for people with chronic fatigue syndrome, suggests their impact is more modest than first thought.

The PACE trial found the treatments to be "moderately effective", leading to recovery in a fifth of patients.

But this new analysis finds "no long-term benefits at all".
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Very short, but clear presentation of the new paper's findings. Comment from Carolyn Wilshire, The ME Association and Dr Jon Stone

Sharpe Chalder and Goldsmith are given the last word.

What I expected from the BBC, and better than we've had in the past.

I like "Goalposts 'moved'" as a subheading.

edit - grammar and spelling
 
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Eagles said:
The study has now made it onto the SMC website -

Reanalysis of the PACE trial

http://www.sciencemediacentre.org/reanalysis-of-the-pace-trial/
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SMC said:
One goal of trial registries is to avoid the selective reporting of trial results which can lead to exaggerated or false claims about the effectiveness of treatments. However, it is worth noting the PACE trial was planned at a time when trial registration was in its infancy and the problems with selective reporting were less well known.
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[My bold]

I suspect that is a huge fudge. I cannot imagine that all the trial methodology strategies that people like @Jonathan Edwards have been clarifying for us here, have only just been understood in the last decade or so! Although much of it has been enlightening to me in recent times, for those involved in clinical trials it must have been bread and butter for a long time. And in any case, it is still a tacit admission PACE got it wrong.

Funny how the SMC always seems to take a particular stance :rolleyes:. Though they do seem to be very much on the back foot here :).
 
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SMC said:
However, it is worth noting the PACE trial was planned at a time when trial registration was in its infancy and the problems with selective reporting were less well known.
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Spin. Spin. Twirl.
They can't be serious? Pull the other one! The problems of selective reporting was why databases of trial protocols were set up in the first place.

The changes were not well justified hence the constant criticism.

Besides, when people make mistakes, they should admit it and apologise, not continue to contort and defer criticism.

Why do they not want to bridge the gap with the community and make amends?

SMC said:
There are points of the original PACE protocol that were either inconsistent or open to interpretation. The authors in this paper seem to have selected the most extreme analysis to make their point: for example by making adjustment for 6 comparisons where 3 or 5 comparisons are also described, and focusing on 52 week data only.
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More spin. How is the protocol specified measures "extreme analysis"?

SMC said:
The authors have made little attempt to uncover the reasons for protocol deviations in the PACE trial or the point at which they were made; trialists could have been invited to comment.
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Those trialists have had years to tell us when and why. We have been asking since the original publication and they continue to ignore us.

SMC said:
In fact, CBT and exercise therapies have been investigated in several other studies, and these have been reviewed in Cochrane reviews. The latest such Cochrane review (of exercise therapies, from 2017) includes eight studies other than PACE, and does come to positive conclusions about some aspects of effectiveness of exercise therapies.
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Yes, and strangely enough the other studies often suffer from the same problems - deviations from protocol and more importantly: no blinding and either lack of objective measures (actigraphy, neuropsychological testing, employment outcomes) or lack of change on these measures. All this means is this evidence is merely suggestive and not at all conclusive as it is not the gold-standard double-blinded or unblinded study with strong (hard to bias) objective outcomes.
 
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Adrian said:
CONSORT says they are required to give reasons but the reasons they gave were along the lines of "we felt like it".
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Simon Wessely gave the game away when he more or less said they had changed the outcomes so that the results "would be consistent with earlier trials".

This is bad science by definition.

We can deduce the story - the group allocation is still blinded, but they can still look at the data for the patients who have completed the initial trial and realise that change is minimal patients are still severely ill. So they decide to water down the thresholds before the allocation is unblinded. The timeline of the protocol changes bares this out - they had five years worth of data, which could be viewed, albeit with group allocation still blinded before they decided to change their outcome measures.

(PACE): statistical analysis plan
https://www.ncbi.nlm.nih.gov/pubmed/24225069

Timeline

"First participant was randomised on 18 March 2005"
"Date of Last Randomisation: 28 November 2008"
"planned analyses that were approved by the Trial Steering Committee in May 2010"

Notes:
"The anchoring date for visits and assessments is randomisation; thus 24 weeks refers to 24 weeks from randomisation."
Patients were followed up at around 52 weeks after allocation.

The Lancet study said:
As with any therapy trial, participants, therapists, and doctors could not be masked to treatment allocation and it was also impractical to mask research assessors. The primary outcomes were rated by participants themselves. The statistician undertaking the analysis of primary outcomes was masked to treatment allocation.
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065633/
 
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anyone tried a Google search on PACE trial recently............:)

eta:
https://www.belfasttelegraph.co.uk/...onic-fatigue-study-not-reliable-36733161.html
http://www.thisismoney.co.uk/wires/...dings-chronic-fatigue-study-not-reliable.html
http://www.stroudnewsandjournal.co...._of_chronic_fatigue_study____not_reliable___/

Voices from the Shadows shared David Tuller's post.
9 hrs ·
A sane counter-point to the SMC's devious manipulations and lies. Many thanks to all those involved in writing this.


David Tuller
14 hrs ·
I am honored to be included as a co-author on this study that debunks the PACE "improvement" and "recovery" findings, as well as the bogus "follow-up" study. If science worked as it should, this paper would be the end of the bogus CBT/GET paradigm and the increasingly desperate efforts of the CBT/GET ideological brigades to save their careers. Unfortunately, science is broken in this domain of investigation. Hopefully that will change in the near future.
 
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