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

I looks stranger and stranger. These authors are likely to be fully aware of the timing and circumstances of the resignations. Personal and professional integrity is at stake here.

 

Just like "duty" of candor.

Words have no power. Enforcing them does. It's people who give power to words, by acting on them. Refusing to act on them is also a way of acting on them, as it is here, the refusal to apply standards is a choice, deliberate actions.

Without enforcement, everything is an honor code, and not everyone is honorable, especially when they stand to benefit from being dishonest, even more so when they have approval from their immediate culture.

 

It is incredibly naughty because those clinicians cannot speak for themselves, for all we know they could have thought it had been too soft on BPS. And I'm very sure that if the biomed side had inferred in the way these guys have then BPS would have noted that fact.

Putting words in the mouths of people who cannot speak which suggest something that the physical evidence notes did not happen based on timing - how is a professional allowed to get away with that without repercussions to their career? Yet the Chinese whispers and happy to pass it on makes it systemic.

Not a good look of either 'we don't check our facts before we spout it out' or 'we tell lies and help spread them so we are all on the same page' as a profession really is it, but everyone who re-uttered it is responsible for doing that.

 

Perhaps we should start labelling it as fools-gold-standard.

A diversion about fool's gold has been moved here

 

My letter has now been published: https://link.springer.com/article/10.1007/s11606-022-07715-x

I hope it raises some eyebrows.

 

Robert Saunders (aka McMullen) on Twitter:

"My letter on ME/CFS in the Journal of General Internal Medicine in response to Sharpe et al: https://t.co/0SR2aawqRc The history of how GET & CBT have been promoted, prescribed & researched is alarming. Sadly, these mistakes are now affecting people with #LongCovid. 1/“ / Twitter

Robert Saunders (aka McMullen) on Twitter:

"In response, the authors point out that 3 clinicians resigned from the NICE guideline committee before publication. This is true but misleading. NICE’s minutes state: “The whole guideline was agreed by the committee … before there were resignations." https://t.co/8f6Ogwigrj 2/ https://t.co/aUmjZ512Pd / Twitter

Robert Saunders (aka McMullen) on Twitter:

"It should also be noted that an FOI revealed that a representative of one the Royal Colleges privately texted the NICE chief executive before the guideline was published to try to persuade her tamper with the independent evidence review: https://t.co/3lcB94K8Ag 3/ https://t.co/McuhANHiui / Twitter

https://twitter.com/user/status/1544442322691178504


Thank you to the forum member who provided a transcript of that text message:

"There is a way. You go ahead with the recommendations but hold back with the evidence. You take over the evidence and correct the errors of fact. You over rule the committee to ensure that the evidence documents are now accurate. So you correct the mistakes. And publish the evidence when you can. Ok there is now a disconnect between the evidence abd the recommendations. But well, you are doing what the committee want but to those who look under the bonnet it's clear that the committee made they decisions not supported by evidence. Which is totally true they didn't. But the patient groups may not care too much because they have what they wanted. And your reputation for fairness and competence remains intact. It's messy. The committee will scream but all that does is draw more attention to the fact that they got it wrong. So Perhaos they won't. But the 135 week thing was their idea. They refused to admit it was indefensible. . And also went abd did the direct opposite with the Powell trial. And you have to conclude that although the committee continues to insist on their own

"diagnostic criteria actually they can keep their views if they want but they have to accept that as there is no good evidence for indirectness on that basis ,and that the evidence in so much as it exists points the other way, the trials are regraded to reflect this. NICE is neutral on this. You stay honest. The researchers at least know they are not incompetent patient hating charlatans. The guidelines are as they are but it woukd mean they won't have the cachet and status of the full NICE quality approval stamp. They are what they - opinion based.

"That's the best I can do !
After all. You have said you will correct errors of fact. The 135 week thing is an error of fact. The fact is that is totally daft and would never happen in any other review. And indeed the committee stupidly know this because they correctly did not use the last recorded outcome on Powell for exactly the reasons that they shouldn't have used the 135 week on pace."

"Finally. I am very very sorry !!!!you and paul have been dealt a crap hand. Not your fault."

Source:

https://domsalisbury.github.io/mecfs/nice-mecfs-guideline-pause/

Edit:
If anyone could add here a short explanation why the "The 135 week thing" was not an error of fact but why the person is so angry about it, that would be great.

 

If I understood properly, Adam @adambeyoncelowe explained it very well in his review on Fiona Fox' book:[*]

"[...] in PACE and other trials, any gains seemed to disappear at long-term follow-up. By two years, there was no difference between those who undertook costly GET or CBT and those who got nothing.

"This means that any initial 'improvements' recorded on surveys, perhaps due to placebo or expectation, vanished.

"The triallists in PACE said this is because they contaminated the trial arms (i.e., patients in the control arms clamoured for CBT and GET, so they let everyone have those treatments) which adds two more problems: again, it was sloppy, and made the results harder to interpret; but also, it confirms that there was bias in how the treatment arms and control arms were presented to patients, making it clear that there was higher expectation for CBT and GET."

"The trial was therefore subject to all kinds of biases which likely influenced the results."

And more about the resignations from the NICE committee etc:

And of course there was also the roundtable, moderated by Dame Carol Black:

I think Adam's conclusion about Fiona Fox's misleading take on the NICE committee also applies to the article by Chalder, Sharpe and Wessely, as well as to Lancet commentary they reference (perhaps no surprise that authors of the latter have a history of co-working with the authors of the former) :

Why it is so hard for those people to realize, to quote Robert Saunders' comment, that...

"it would be a far greater disservice to patients to prescribe ineffective and potentially harmful therapies than to tell them the truth."

If some people still object to the work done by the NICE guideline committee, they also object to all those members who left the committee after they had signed off on the new guideline, they also object to the view that the roundtable was a success, and I think this also implies that they even object to the the round table's moderator Dame Carol Black.

The Round table minutes are available on the NICE guidelines website:

https://www.nice.org.uk/guidance/ng206/history

Direct link to the minutes:
https://www.nice.org.uk/guidance/ng206/documents/minutes-31

Direct link to the presentation:
https://www.nice.org.uk/guidance/ng206/documents/workshop-notes-4


[*] In her book, Fiona Fox misrepresented the bmj's speculations about the resignations -- basically a quote by Paul Garner (referenced as source in the mentioned Lancet commentary by Flottorp et al) -- as if they had reported them as factual news. Fiona Fox: "the media reported that three members of the committee had resigned because they felt unable to sign up the final guideline".

(Edited to add some links.)

 

The Scottish Government has also just stated that clinicians' refusal to accept the new NICE guidelines is symptomatic of the general disbelief patients experience when dealing with clinicians.

So we need to start bringing that up too. It is clearly a continuation of their gaslighting.

 

I doubt most readers will -- Tacks' and Saunders' comments aren't even referenced in their response.

But I hope someone will request the editors and authors to reference the comments and also to correct some crass misrepresentations, not only of the comments by Tack but also of other sources they reference. They also made misleading implications in their response to Saunders.

Three points I'm aware of:

1) The combination of relying on subjective outcomes alone in unblinded trials:

Chalder, White and Sharpe write:

"Tack is concerned about the use of patient-reported outcome measures (PROMS) in trials of CBT and GET for patients with CFS/ME. On the contrary, we think that PROMS are essential for illnesses that are defined entirely by patient report."

Of course, Tack is only concerned about relying solely on subjective outcomes in trials that cant' be blinded. Yet Chalder et al. imply that Tack doesn't validate PROMS in other than these particular settings.

Chalder, White and Sharpe also write:

"Furthermore, any response bias from the use of such measures has been reported to be minimal.3 "

They reference the MetaBlind study [*] to back up their claim.

There has been some critique of that study. [**]. Yet that "any response bias from the use of such measures has been reported to be minimal" is not even what the MetaBlind authors claim -- they say it's only a possibility. They conclude their findings could also reflect...

"meta-epidemiological study limitations, such as residual confounding or imprecision".

The authors of the MetaBlind study also say: "At this stage, replication of this study is suggested and blinding should remain a methodological safeguard in trials."


2) Measuring trial participants' expectations before the start of treatments isn't sufficient to negate bias in PROMS

Chalder, White and Sharpe also misrepresent Tacks' rebuttal of their misrepresentation of the rebuttal of the risk of bias in PROMS in the PACE trial:

Tack wrote:

"In contrast to what Sharpe and colleagues claim, measuring the expectations of patients before the trial begins, does not address how therapists might have influenced symptom reporting during the trial."

Chalder et al write:
"Tack acknowledges that the PACE trial found that patient expectations had no obvious role in determining outcomes..."

That's a crass misrepresentation. Tack highlighted that PACE only measured patient expectations before but not during the trial. So these measures aren't useful to negate a difference in participants' expectations and perception during the trial, when they were exposed to the therapists' expectations and also the suggestive leaflets that accompanied the intervention.


3) The NICE guideline: The whole guideline was agreed by the committee, including the recommendations on graded exercise therapy (GET) before there were resignations

Chalder, White and Sharpe write in response to Saunders:

"Saunders point out that NICE (the UK clinical guideline organisation) downgraded its recommendations for cognitive behaviour therapy (CBT) and graded exercise therapy (GET) in its recently revised guideline.

"However, these recommendations have been strongly disputed. Three clinicians resigned from the NICE guideline committee before publication [...] ”. A commentary published in the Lancet journal was equally critical, stating that “In our view, this guideline denies patients treatments that could help them.”2

There is no evidence for the implication of their statement that the committee members resigned because they didnt' agree , see the NICE minutes:
https://www.nice.org.uk/guidance/ng206/documents/minutes-31

“The whole guideline was agreed by the committee, including the recommendations on graded exercise therapy (GET) before there were resignations.” [my bolding]

The referenced commentary in the Lancet by Flottorp et al [***] is misleading as it also refers to the resignations from the guideline committee as if they committee members didn't agree with the new guideline. Flottorp et al reference a bmj news article [****] with the same misleading implication about the motivation of those who resigned, based on a quote from Paul Garner which was mere speculation.


So at least three obviously misleading arguments by Chalder, Sharpe and White:

1) A misrepresentation of another study's findings and the authors' conclusions (MetaBlind study),

2) A misrepresentation of the rebuttal of the critique of a misrepresentation of their own study findings

3) A reiteration of misleading speculation in an original article (Flottorp's et al in the Lancet editorial about the NICE committee, referencing the equally speculative first coverage by the bmj -- see also Saunders' tweets and my posts here and here.)

It would be great if someone could write to the JGIM about those misrepresentations but also to the Lancet and the bmj [****] where the speculation about the NICE committee appeared first.


References:

Tack, M. Bias in Exercise Trials for ME/CFS: the Importance of Objective Outcomes and Long-term Follow-up. J GEN INTERN MED (2022). https://doi.org/10.1007/s11606-022-07704-0

Saunders, R. Evidence-Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis. J GEN INTERN MED (2022). https://doi.org/10.1007/s11606-022-07715-x -- Twitter thread here.

[*] Moustgaard H, Clayton GL, Jones HE, Boutron I, Jørgensen L, Laursen DRT, Olsen MF, Paludan-Müller A, Ravaud P, Savović J, Sterne JAC, Higgins JPT, Hróbjartsson A. Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study. BMJ. 2020 Jan 21;368:l6802. doi: 10.1136/bmj.l6802. Erratum in: BMJ. 2020 Feb 5;368:m358. PMID: 31964641; PMCID: PMC7190062.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7190062/

[**] Forum thread here https://www.s4me.info/threads/bias-due-to-a-lack-of-blinding-a-discussion.11429/page-2#post-231694 )

[***] Flottorp SA, Brurberg KG, Fink P, Knoop H, Wyller VBB. New NICE guideline on chronic fatigue syndrome: more ideology than science? Lancet. 2022 Feb 12;399(10325):611-613. doi: 10.1016/S0140-6736(22)00183-0.

[****] Torjesen I Exclusive: Four members of NICE's guideline committee on ME/CFS stand down, BMJ. 2021; 3741937, https://www.bmj.com/content/374/bmj.n1937


Edit: Thank you to the forum members who helped me write this post.

 

Gosh I was googling for something else and just came across this paper (hence looking up this thread on s4me to check it was on here)

In hindsight now looking back nearly 3yrs to 2021. This was published less than a month after the new guidelines were finally released. I'm not sure of the timeline involved with submission for the Journal of Internal Medicine and whether they might have been allowed to submit it 'after' any normal deadline if it did have to be in a lot before that to get published.

Boy does it make me think of the phrase 'pre-bunking'..

Also - is it interesting that these 3 have chosen the US market / audience / publication specifically for this, to direct their attention to here?