Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome, 2021, White & Etherington

[Trish]

Thanks for posting the full document, I have skimmed it but have run out of energy for a proper read. All I can say is their arguments are ridiculous and it's not science, it's a polemic.

 

[dave30th]

The Journal of Psychosomatic Research is already dealing with the previous White paper, which misreported the follow-up to GETSET. Now they are allowing him to publish another piece of crap. The journal is obviously having an identity crisis. The current and previous two editors have categorically stated that subjective outcomes are fraught with bias when blinding is weak. But the journal's advisory board has White, Sharpe, Fink, Rosmalen and others who see no problem and specialize in unblinded studies relying on subjective outcomes. Either these studies are valid, per the auhors, or they do not provide authoritative and actionable evidence because of bias, per the journal editors. Both can't be true. The journal is in an untenable position.

 

[Jonathan Edwards]

Never heard of him but I suspect this says it all:

Current President of the Faculty of Sport and Exercise Medicine UK and Master’s degree in Sports Medicine"

(The conflict of interest being income for rehab.)

 

[Hutan]

Armed Forces, as the Director of Defence Rehabilitation and Defence Consultant Advisor in Rheumatology, Rehabilitation and Sport and Exercise Medicine, NHS England as National Clinical Director for Rehabilitation and Clinical Director at the Defence Rehabilitation Centre, Headley Court

Thankfully, my fantastic GP at HMS Excellent, and the team at DMRC (Defence Medical Rehabilitation Centre) Stanford Hall, identified the underlying cause of my relapse. With medication, treatment and a rehabilitation programme, I am now looking at a full-time return to work in the summer.

It seems unlikely to me @Hilda Bastian, that it is a coincidence that the only person with ME/CFS on the Cochrane exercise review writing team, someone who has not previously expressed any interest or shown any expertise in evaluating GET trials, has publicly expressed her thanks to the team at a Defence Medical Rehabilitation Centre, and is reliant on the Navy's goodwill as she deals with a relapse. This is not the way to make patients feel that the review process is safe from manipulation and will arrive at a scientific truth.

The issue of the composition of the Cochrane Exercise review writing team is discussed further on this thread:Independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS (2020), led by Hilda Bastian

 

[Hilda Bastian]

It seems unlikely to me @Hilda Bastian, that it is a coincidence that the only person with ME/CFS on the Cochrane exercise review writing team, someone who has not previously expressed any interest or shown any expertise in evaluating GET trials, has publicly expressed her thanks to the team at a Defence Medical Rehabilitation Centre, and is reliant on the Navy's goodwill as she deals with a relapse. This is not the way to make patients feel that the review process is safe from manipulation and will arrive at a scientific truth.

The issue of the composition of the Cochrane Exercise review writing team is discussed further on this thread:Independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS (2020), led by Hilda Bastian

To be fair, Kay Hallsworth is no longer in the Navy: her bio statement begins with "was". (I disagree with the characterization generally - one of the criteria for consideration was "A history of interest in research on ME/CFS".)

 

[DokaGirl]

The authors themselves now seem rather unenthusiastic or unsure about GET for ME: "GET is probably safe..." Not a ringing endorsement. (my bolding)

Also more participants in the GET arm dropped out from trial follow up....doesn't appear to bolster the profile for this "therapy".

GET for ME; what's the point for patients and their families if the goals of recovery, or at least significant improvement aren't met? Return to work or school? Are these ever measured or reported on? If memory serves success in these areas falls far short, if even measured or reported on. I guess results based goals are not important. Research funding continues in spite of this. GET for ME for its own sake.

 

[DokaGirl]

GET for ME is "probably safe", looks like a retreat. CYA. In case of what...?

 

[DokaGirl]

Wonder why the BPS Movement travels in the same groove over and over and over again.

 

[Barry]

White of QMC how did they do this then if the data is all lost in a filing cabinet in a cellar somewhere and there’s no one available to search it out

Maybe resubmission of the FOI request is needed, given they have clearly managed to overcome their primary obstacle to fulfilling it.

 

[Barry]

I think there is an inherent bias within the CGI scale, given that someone could feel noticeably worse (and thereby of clinical significance), albeit not much worse. In which case their likely choice is going to be 5 on the scale, minimally worse, and thereby allows these analyses to consider out of scope for considering as deterioration.

 

[Hoopoe]

That's not a bias in the CGI scale. That's how the authors chose to define evidence of harm, most likely because that allowed them to find no evidence of harm.

 

[Barry]

It is very clear the main objective of this paper is to impact the NICE guideline review, given how it comments strongly on the implications of the current draft guideline being ratified.

 

[Barry]

That's not a bias in the CGI scale. That's how the authors chose to define evidence of harm, most likely because that allowed them to find no evidence of harm.

Which therefore still means the scale induces bias.

 

[Barry]

Any medical treatment can cause harm if delivered at either the wrong dose or frequency. But we do not ban a treatment on that basis. GET should be tailored to the individual and guided by professionals who are expert in the delivery of graded exercise therapy with the aim of empowering the individual to take control of their own exercise plan and recovery. Rather than banning an effective treatment, which is probably safe when appropriately prescribed, NICE might describe effective and safe GET, as they did in 2007, and making recommendations both for further research into GET and the provision of training and supervision for this treatment.

If they are so confident of how right they are, then put their money where their mouth is and release the rest of the PACE data; they clearly should have nothing to fear by doing so. And they have demonstrated they still have the resources available to be able to do that.

 

[Mithriel]

What about the drug for arthritis that was banned because less than a hundred people worldwide were badly affected?

I cannot believe that GET is not banned on the basis of the number of people who claim they were harmed. It would be a simple matter to check that people were house or bed bound

 

[rvallee]

Maybe resubmission of the FOI request is needed, given they have clearly managed to overcome their primary obstacle to fulfilling it.

With an added "why did you mislead the tribunal?" and a note to the tribunal whether they care about such things, perhaps?

This was an official response. It has clearly been revealed as BS. Does making false official statements to a tribunal matter in medical research and ethics? Doesn't appear to be the case. But the original FOI request was either clearly responded with a lie, or they felt no need to go back on it if and when White's health improved enough for him to be able to fulfil such a simple request, one that was already taken care of as part of the research protocol, confirmed by the official notes.

 

[Hutan]

To be fair, Kay Hallsworth is no longer in the Navy: her bio statement begins with "was". (I disagree with the characterization generally - one of the criteria for consideration was "A history of interest in research on ME/CFS".)

Just noting, for the sake of completeness here, that we established on the Cochrane Exercise review thread that Kay has had permanent role with the Association of Royal Navy Officers since Feb 2021. Further discussion about that, and the extent to which the criterion of 'a history of interest in research on ME/CFS' has been met is on that thread.

 

[Sean]

GET should be tailored to the individual and guided by professionals who are expert in the delivery of graded exercise therapy with the aim of empowering the individual to take control of their own exercise plan and recovery.

There is that whole patients are deluded morons who need to be guided by experts in how to get out of bed and wipe their own arse routine they have been flogging for decades. The story never changes.

 

[Barry]

GET should be tailored to the individual and guided by professionals who are expert in the delivery of graded exercise therapy with the aim of empowering the individual to take control of their own exercise plan and recovery.

There is that whole patients are deluded morons who need to be guided by experts in how to get out of bed and wipe their own arse routine they have been flogging for decades. The story never changes.

[my bold]

Whilst still including the BS spin clause that it's all the patient's own fault if they still end up in a mess.

 

[Adrian]

We undertook meta-analyses of three outcomes: Self-ratings of Clinical Global Impression (CGI) change scores of 6 or 7 (“much worse” or “very much worse”), numbers of participants withdrawing from treatments, and numbers of participants dropping out of trial follow up. We provide risk ratios (95% confidence intervals (CI)), comparing GET with control interventions.

My first question to them would be if they are looking for deteriation then why choose a scale that they use as a secondary outcome in studies rather than the ones that were used as primary outcomes - given their record is this careful outcome selection. Also (and perhaps this is as I've only looked at the abstract) they don't seem to define a time scale over which the meaurements are taken.

Then there are all the caveats around compliance to treatment and activity substitution that would normally be raised.

And no look at the reasons for withdrawl