Efficacy of therapist-delivered transdiagnostic CBT for patients with persistent physical symptoms in secondary care: an RCT, 2021, Chalder et al

I like that he makes the point that continuing to fund this type of research by the usual suspects is all money down the loo (although he words it differently).

If only we could get through to the funders of crap that money wasted does not provide the benefits they imagine.

 

Except, perhaps it does.

I'm sure some of the money is invested with all good intentions but I'm equally sure that some of it is an investment made to make savings on other budgets within healthcare or to attract more funding to certain areas, like IAPT for example.

 

Trial By Error: Quartet of Trials Reveals Limitations of CBT for “Medically Unexplained Symptoms”

"A year ago, I wrote a post about how the biopsychosocial ideological brigades had completed a trifecta of major studies that investigated cognitive behavior therapy for a variety of so-called “medically unexplained symptoms” (MUS). As a group, the studies demonstrated the overall ineffectiveness of CBT as a treatment for this category of disorders—despite herculean efforts to spin the results the other way. MUS is usually defined to include chronic fatigue syndrome, irritable bowel syndrome, fibromyalgia, functional neurological disorders, and other conditions for which pathophysiological mechanisms have not been identified.

These three trials were: the PACE trial for chronic fatigue syndrome, which also tested graded exercise therapy; the ACTIB trial for irritable bowel syndrome; and the CODES trial for psychogenic non-epileptic seizures, a form of functional neurological disorder also called dissociative seizures. Now a fourth major trial can be added to the group. PRINCE Secondary is a recently published study of CBT to treat so-called “persistent physical symptoms” (PPS), another term for MUS. I blogged last month about how the investigators tried to present the trial as a success despite null results for the primary outcome."

https://www.virology.ws/2021/07/03/...ns-of-cbt-for-medically-unexplained-symptoms/

 

This contrasts with the trials to see if vaccines caused autism. There came a point where it was said that this had been tested over and over and no evidence for it found. Rightly, the patient societies demanded that the money be spent on what actually was causing autism.

Since it was a group of patients who were insisting on more trials the establishment was happy to stop.

For us, unfortunately, it is the establishment that are pushing pointless trials and claiming all the money so the science is overruled and we are condemned for making the same point.

 

What this shows more than anything is that they don't even trust their own results. They know it's not valid research, it doesn't tell us anything about anything. So they simply dismiss their own negative results, an easy thing to do since they know none of this matters. They're selling a product and it's boom time for the industry, they get paid whatever they do so they might as well keep pretending.

 

"King’s College London, which touted the findings in a press release, has licensed the web-based CBT program to a private company. The company has received approval to market the program in the US and UK. --"*
So they get public funding [Department of Work and Pensions funded PACE and the Department of Health and Social Care funds NIHR**] to do the crap research, then they get patents and sell licences to use the crap treatment*. With a bit of "luck" (well for them at least) the UK Government will then roll out the crap treatment and they gets lots more money - what's not to like! Check out @Jonathan Edwards comments re NIHR here***. I really have no knowledge/insight but it looks like NIHR may be a convenient vehicle to fund politically acceptable/welcome research.

*https://www.virology.ws/2021/07/03/...ns-of-cbt-for-medically-unexplained-symptoms/
**https://www.nihr.ac.uk/about-us/wha...ment of Health and,aid from the UK government.

https://www.s4me.info/threads/in-pr...-individuals-the-tlc-study.21210/#post-353743

 

The NICE review, of it's guidance re ME/CFS, recently categorised the evidence from unblinded trials, with no objective outcome indicators*. as "low" - grateful if someone could provide a reference. In a sense that is a line in the sand i.e. if NIHR fund a ME/CFS trial which is unblinded, and has no objective outcome indicators*, then they are funding research which has no public benefit i.e. since the trial will not provide data which can be relied upon - as a basic to identify intervention which may help people with ME/CFS ---

I'm no expert on the system but I've recall advice from someone with more knowledge - if they don't respond to this then we will make life difficult for them - until they do what we want.

One option would be to ask a Parliamentary Question -
Recently NICE reviewed the evidence from trials in ME/CFS which were unblinded, and used subjective outcomes (typically questionnaires), as "low". Therefore, these trials cannot be used to identify treatment options. These trials were funded using public money i.e. by the Department of Work and Pensions [PACE] and the Department of Health and Social Care [funds NIHR**]. What steps are being taken by DWP and DHSC that research funded by their Department is not of "low" quality - as identified by the recent NICE review?

You could also ask a "repeat" question e.g. each month "ask Minister for details of research funded by his Department** in the last month re ME/CFS and whether that research was unblinded, and used subjective outcome indicators, i.e. was of low quality as highlighted by NICE"?

You could also ask NIHR a monthly FOI request to detail any studies funded re ME/CFS including the amount of money granted and the methodology to be used in the study - particularly whether it was blinded or unblinded and what outcome indicators are used to evaluate the study.

NIHR might get the hint i.e. any unblinded studies, with subjective outcome indicators, are likely to be scrutinised/controversial --- Parliamentary Questions - questions from officials in the Department [what the --- are you up to - we've told you before - the Minister is concerned - reports on social media ---].
Think @Graham may have been trying to link up with other groups experiencing similar problems --- maybe the Long covid folks would join in challenging the gravy train for researchers doing research which is of low quality and has no benefit for people who have the illness - think I noticed someone with Long covid, on last weeks Independent Sage YouTube, talking about poor quality research.

*objective outcome indicators might e.g. be actimetry (activity) monitors - they were used by Fluge/Mella in the Rituximab study
**https://www.nihr.ac.uk/about-us/wha...ment of Health and,aid from the UK government.

@MEMarge
@Kitty
@Graham

 

One of my pet projects was to get both the NEC and the NIHR to be more transparent etc, but I'll say more when I'm back home and my eyes have been done. Please remind me.

 

I think you mean MRC, rather than NEC, @ Graham. Do Hope your cataracts get done next week and the following week.

Do hope that you are backhome soon.

 

Thanks @MEMarge !

It's getting hard to hit the right keys on my Amazon Fire, then autocorrect takes over!

 

David and I have submitted a short commentary on the study. Not sure if it will get published, therefore we have also posted it as a preprint on OSF: https://osf.io/86bkz/

 

Yes, it was great to work with Michiel on this.

 

absolutely. many people will look at the conclusion of the abstract as their main take-away. It's really disgraceful and demonstrates pretty terrible peer review processes

 

Weird that there are "truth in advertising" laws in many countries but in research it's perfectly allowed and no one objects to that. Well, other than us anyway. There's really a need for plain neutral language that simply rejects any spin or speculative interpretation. Or at least for standards to be enforced, hyping secondary results is not allowed and yet it's the bulk of EBM wherever psychology creeps into medicine. Even "zero tolerance policies" are just mere suggestions in some cases.

The advertising industry is better regulated than medical research. Ugh. What a mess.

 

It's very easy for someone o be pretty careful in writing a paper to disclose everything, including null results on a primary outcome, while casting and interpreting things in their favor. It can be hard to characterize that sort of presentation as hiding things because they have included them, even if to dismiss them or not dwell on them.

But a study simply cannot have an abstract whose conclusion completely ignores the null results of the primary outcome. That is
categorically unacceptable. That kind of framing suggests an intention to mislead, or at least a reckless disregard for the likelihood of misleading. And in this case the framing is, of course, misleading. So rather than focusing on the whole paper, it sometimes seems strategic to focus on the abstract and especially the conclusion and then document how the language does not accurately reflect the findings.

 

So the title of this paper includes ...

[my bold]

Yet the primary outcome measure, the Work and Social Adjustment Scale (WSAS), is clearly targeted at assessing people's mental state. Every single question begins with "Because of the way I feel, ...", meaning that the trial's primary outcome is based on the huge - and insulting - presumption* that people's physical limitations are due to the way they feel, and not down to any physical limitations. How the hell do you answer those questions, if you know for sure that your physical symptoms are nothing to do with the way you feel! I think this is why there was no significant change found for this primary outcome.

This is not the same as the other questionnaires, which are sensitive to how CBT skews people's perceptions of their symptoms management. The WSAS is sensitive to the relationship between people's physical capabilities and their feelings; and this trial showed CBT had no significant effect there. Indeed any change at all might well have just picked up any depressive, etc., tendencies in a few participants, because I'm sure CBT and the WSAS would be much more favourable for a cohort of patients primarily suffering from clinical depression.

Also the WSAS says "0 indicates no impairment at all and 8 indicates severe impairment", yet every question can only be answered with values from 1 to 8 ...? Unless it is just a bug on this web page: https://www.psychologyrooms.com/free-assessments/wsas/

* And yes, I do fully appreciate this presumption is what it is all about with these people, but it is just so baldly done! The prove over and over again, to themselves and everyone else, how wrong they are, whilst refusing to accept or realise the fact.

 

Trial By Error: Tack and I Write to Psych Medicine; Struthers Writes to Medical Research Council

"I have written a letter to the journal with Michiel Tack, an ME/CFS patient who comments incisively about research on his blog, ME/CFS Skeptic. In addition being submitted as correspondence, the letter has also been posted on a pre-print server. Most pre-print servers have functioned as venues for research, not for correspondence—but posting the letter seemed like a good idea."

https://www.virology.ws/2021/07/24/...struthers-writes-to-medical-research-council/