Evidence based care for people with chronic fatigue syndrome and myalgic encephalomyelitis, 2021, Sharpe, Chalder & White

It seems they're deliberately mischaracterising the critical arguments as usual.

The use of patient-reported outcomes to judge effectiveness has been much debated as a source of bias. In the absence of any established objective test or ‘biomarker’ for CFS/ME, the condition is defined almost solely by patient report.1,2,3 It is therefore both appropriate and necessary to determine the outcome of treatment for CFS/ME by asking patients about the same symptoms and associated disability that were used to make the diagnosis, using standardised and validated patient-reported outcome measures (PROMs).
Click to expand...

This is nonsense. We're not talking about "biomarkers", we're talking about objective measures of functioning. If there are no objective measures of functioning then those PROMs all lack construct validity.
 
Thanks @Sly Saint !


Snow Leopard said:
It seems they're deliberately mischaracterising the critical arguments as usual.



This is nonsense. We're not talking about "biomarkers", we're talking about objective measures of functioning. If there are no objective measures of functioning then those PROMs all lack construct validity.
Click to expand...

It's the trick they've used from the earliest times, talking about unknown aetiology and/or lack of single biomarker like it means "no physical abnormalities that indicate illness can be found".

(Another trick is that you can't find treatable disease, the added adjective can make it technically true, but it is brought like there isn't anything to be found. At some point Wessely and Sharpe even argued that attributing the aetiology of ME/CFS to a virus was useless, a disadvantage even, because "It is common knowledge that viruses cannot be treated (Helman, 1978) and thus, this view of aetiology, implicit in the label of 'post-viral fatigue', carries no information about how the sufferer can recover." Yes, when you're done blinking you may want to read that sentence again.)
 
Last edited:
the paper said:
"Rehabilitation, including CBT and GET, for CFS/ME assumes that disability and symptoms, once established, are at least in part maintained by factors that are reversible. The reversible factors include psychological and behavioural factors, such as the patients’ worries about their symptoms and how they cope with them, as well as by associated physiological changes."
Click to expand...

They know that people can read right?
In 1992 Sharpe was very clear that patients had "muscle wasting, changes in cardiovascular response to exertion, depressed mood, postural hypotension and impaired thermoregulation." , which he calls an effect of inactivity, continuing that "These effects can be reversed with gradual increases in activity, although this will commonly result in a transient, and physiologically understandable, exacerbation of symptoms, particularly muscle pain."

So those vague "associated physiological changes" that are tacked on at the back there like they are an afterthough, instead of the main course that they have been throughout, include changes in cardiovascular response to exertion and postural hypotension.

Also, no elaboration on the "thorough assessment" like I had expected from the abstract. Are we supposed to forget that they spent 30 years discouraging physical examination and urging GP's to gatekeep access to it?




I think it's time to settle on the sofa with a mug of tea and a marker.
 
Last edited:
chrisb said:
These dates may be relevant
  • Received 07 August 2020

  • Accepted 01 October 2021

  • Published 17 November 2021
Click to expand...
So here's a possible timetable (invented by me):

July/August 2020 - they get whispers from their spies on the Guideline committee that CBT/GET as treatments are going, and that the evidence review has trashed their PACE research.

7th August - paper submitted to the journal with the intention of publication in 2021 as soon as possible after the final guideline is published.

10th November 2020 - the draft guideline is published, confirming CBT/GET have gone.

November/December 2020 - they contribute to submissions to the draft consultation, believing their arguments will persuade the NICE committee they got it wrong, and no doubt network among colleagues from other organisations to make sure there's as much support as possible for their views.

4th August 2021 - the embargoed guideline is sent to stakeholders, with intended publication date 18th August

4th to 18th August - they do their best to get NICE to withdraw the guideline, including participating in the statement from RC's saying they won't implement the guideline, and probably by private communications with senior people at NICE. Their main aim to defend their reputations by getting the evidence review of PACE overturned, and the guideline rewritten to include GET/CBT or withdrawn.

18th August to 18th October - during the pause they continue to push for withdrawal of the guideline and redoing the evidence review.

1st October - they still hope the guideline will be withdrawn, or at least the evidence review altered to preserve their reputations. They give the go ahead to publish this article as soon as possible after the guideline is published.

29th October. The guideline is published.

17th November This article is published.
 
Well, hello:

After arguing (as far as I can tell with my mush brain atm very lamely, with use of....the PACE trial o_O) that trial results that use the Oxford criteria and others that do not require PEM are still applicable to ME/CFS, it says

the paper said:
Any reviews of the literature, which conclude there is insufficient evidence for rehabilitative therapies after excluding such trials, are therefore misleading.
Click to expand...
with a reference that according to the list was last accessed March 24, 2021.

Which is after Appendix G was sent along with the draft, 5 days before the NICE guideline was delayed, and 5 weeks before the final guideline was originally due to be published.

edited to add, if it wasn't directly clear, that I think this sentence, or quite possibly this whole section, was added with the expected near-publication of Appendix G in mind.


@InitialConditions
 
Last edited:
The use of patient-reported outcomes to judge effectiveness has been much debated as a source of bias. In the absence of any established objective test or ‘biomarker’ for CFS/ME, the condition is defined almost solely by patient report.
Click to expand...
And where did that definition originate from?
It is therefore both appropriate and necessary to determine the outcome of treatment for CFS/ME by asking patients about the same symptoms and associated disability that were used to make the diagnosis, using standardised and validated patient-reported outcome measures (PROMs).
Click to expand...
Standardised and validated? Validated with the same level of scientific rigour as the trials that rely on them I suspect. Zilch in other words.

When considering bias relating to patient reported outcomes, it is absolutely not valid to imply validity of such outcomes simply because diagnosis is made based on patient reporting of their symptoms; it is completely spurious.

We are talking about the bias associated with self reporting of symptoms, not simply the self reporting of symptoms per se. Any bias involved will be heavily influenced by the patient's prevailing situation, and environment, at the time. In the case of patient reported trial outcomes for ME/CFS, the potential for bias is much higher, given all the previously well discussed influences on trial participants, not least of which is trialling interventions where biasing of self reported outcomes is intrinsic to those interventions!

Patients seeking initial diagnosis will not be exposed to such biasing interventions.

So bias relating to self reporting of symptoms, is not simply a function of the self reporting process itself! The issue is that self reporting is highly vulnerable to biasing influences, be they deliberate or unintended. Suggesting the issue of bias is void simply by stating two different uses of self reporting is bogus; it is the vulnerability to bias in the different scenarios that is key, and glibly overlooked (or maybe genuinely not perceived from their blinkered perspective).

It seems a straw man argument.
 
Trish said:
So here's a possible timetable (invented by me):

July/August 2020 - they get whispers from their spies on the Guideline committee that CBT/GET as treatments are going, and that the evidence review has trashed their PACE research.

7th August - paper submitted to the journal with the intention of publication in 2021 as soon as possible after the final guideline is published.

10th November 2020 - the draft guideline is published, confirming CBT/GET have gone.

November/December 2020 - they contribute to submissions to the draft consultation, believing their arguments will persuade the NICE committee they got it wrong, and no doubt network among colleagues from other organisations to make sure there's as much support as possible for their views.

4th August 2021 - the embargoed guideline is sent to stakeholders, with intended publication date 18th August

4th to 18th August - they do their best to get NICE to withdraw the guideline, including participating in the statement from RC's saying they won't implement the guideline, and probably by private communications with senior people at NICE. Their main aim to defend their reputations by getting the evidence review of PACE overturned, and the guideline rewritten to include GET/CBT or withdrawn.

18th August to 18th October - during the pause they continue to push for withdrawal of the guideline and redoing the evidence review.

1st October - they still hope the guideline will be withdrawn, or at least the evidence review altered to preserve their reputations. They give the go ahead to publish this article as soon as possible after the guideline is published.

29th October. The guideline is published.

17th November This article is published.
Click to expand...
They've shot themselves in the foot by publishing this paper though, because despite all the linguistic contortions used they actually point to the PACE trial manuals as explaining how to do GET and CBT safely! But the roundtable event led to the clarification that this is the type of GET that the new guidelines are prohibiting.

Whilst the rehabilitative approaches of CBT and GET were developed separately, they have many similarities. For those seeking information on how to deliver these therapies, the manuals for both therapists and patients that were used in a trial that found them to be safe and effective, are freely available on line.

Their reference for this: White PD, Chalder T, Sharpe M. PACE trial manuals. Available at: https://www.qmul.ac.uk/wolfson/research-projects/current-projects/projects/pace-trial.html. Last accessed July 17th, 2020.
Click to expand...
 
chrisb said:
These dates may be relevant
  • Received 07 August 2020

  • Accepted 01 October 2021

  • Published 17 November 2021
Click to expand...

Oh. I actually missed the 2020 in the first date! A paper does not usually sit with a journal for a year, but the fact that they give the original submission date means that it probably wasn't totally pulled as the authors tried to keep up with developments at NICE. I suspect it may have been an invited paper—these 'Perspective' papers often are.

It was almost certainly timed to coincide with the guideline release, and they've shifted publication accordingly.
 
Last edited:
I think there's always a lag of a few months between submission to journals and publication. At the time this was submitted, publication was supposed to be in March, not August, so submitting the previous August would have seemed reasonable. I suspect the longer delay was requested by the authors to fit with the new guideline publication date.
 
Trish said:
I think there's always a lag of a few months between submission to journals and publication. At the time this was submitted, publication was supposed to be in March, not August, so submitting the previous August would have seemed reasonable. I suspect the longer delay was requested by the authors to fit with the new guideline publication date.
Click to expand...

The expected guideline publication date at the time of submission was 21 April 2021 (announced June 2020). Yes, it can take months and months—and occasionally years—to publish (I've been there myself), but, for a 3-page perspective paper, submitting 8 months prior to the expected guideline publication date is extremely early.
 
Barry said:
In more ways than one I think. They have clearly stated their position, which is totally opposed to the new guideline, and the evidence assessments it is based on. Their arrogance seems to know no limits, and I think it will come back to bite them one of these days.
Click to expand...
I also wonder if this paper will become an indirect way to get BACME members on board with the new NICE guidelines, as the authors are basically claiming that most of the ME/CFS clinics must have been doing GET and CBT wrong and that is the reason patients have reported harm - thereby portraying professional colleagues as incompetent. I think the authors are successfully marginalising themselves from the majority of therapists working in the clinics, who may actually be relieved that the new NICE guidelines allow them to work in a way that patients' views align with.
 
Last edited:
You must log in or register to reply here.
Back
Top Bottom