UK Health Research Authority defends PACE. Answer to MP's question, February 2019.

Barry said:
Does a similar argument also apply to GET? What solid evidence was there that encouraging people to repeatedly ignore their bodies' natural safety warnings was in fact safe, especially when the underlying physical problem was only assumed to be deconditioning. The PACE paper tacitly acknowledged that the true disease mechanism was not understood with any real certainty. As per my post #95.
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The argument is similar for GET but may not be quite so watertight. For GET the therapist can simply say that they think the patient may improve if they give exercise a try. CBT is different in that it explicitly takes the position that the patient has incorrect beliefs that need to be changed by education, and that education may involve 'cognitive strategies' which effectively means using persuasion techniques as in brainwashing.
 
dave30th said:
The recovery criteria were also not mentioned. So was that tantamount to allowing them to drop them as secondary outcomes? They have described their recovery paper as a "secondary analysis," as if it were a secondary analysis of an existing data set--not a report of secondary outcomes form a clinical trial. Perhaps they can argue that allows them to make up any post-hoc criteria because they had gotten approval to drop them as secondary outcomes by the publication of the SAP?
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The step test and the Borg scale were also missing from the stats plan.

My belief is they justified the post hoc recovery criteria without approval because they dropped the formal recovery secondary outcomes from the stats plan (but I don't think there was a new protocol). So yes.

I also think they (or the statisticians) may have accessed blinded data earlier so they could prepare summaries for one committee. So they may have dropped these with a guess as to the results. I think the stats plan says something around this.
 
Jonathan Edwards said:
The argument is similar for GET but may not be quite so watertight. For GET the therapist can simply say that they think the patient may improve if they give exercise a try. CBT is different in that it explicitly takes the position that the patient has incorrect beliefs that need to be changed by education, and that education may involve 'cognitive strategies' which effectively means using persuasion techniques as in brainwashing.
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I guess that's why the clinics tend to use CBT and GET in combination. I still don't really understand why they didn't do that in PACE. Was it a professional face-off between White's GET and Sharpe's CBT?
 
Lucibee said:
I guess that's why the clinics tend to use CBT and GET in combination. I still don't really understand why they didn't do that in PACE. Was it a professional face-off between White's GET and Sharpe's CBT?
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I think FINE did? It was more of a hodge-podge that didn't explicitly mention CBT or GET but basically seems to amount to some combination of the two.

Anyway, part of GET is convincing the patient to push through and ignore their symptoms so conversion therapy / CBT is pretty much implicitly used. It's not as if there's a precise protocol about what they are anyway, the treatments were made-up to maximize some placebo response, not provide any actual therapeutic effect.
 
Michiel Tack said:
Its in the published protocol (2007), under competing interests.

EDIT: can't find it in the 226 pages version that Adrian and Lucibee shared
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I believe that the version I had was obtained by a FoI. I think I got it form @Tom Kindlon but not sure.

The published version came later and is a summary and not the full protocol. They say
"This paper should not be used as the protocol for executing the study, and is not the complete protocol considered to be ethically satisfactory by the relevant MREC, having been subject to shortening and revision to enhance communication for publication."
 
Lucibee said:
I guess that's why the clinics tend to use CBT and GET in combination. I still don't really understand why they didn't do that in PACE. Was it a professional face-off between White's GET and Sharpe's CBT?
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I always thought is was between Wessely and Chadler at Kings and White at QMUL but I assumed that there needed to be a political compromise to say each of the favoured methods were equally effective.
 
Lucibee said:
I guess that's why the clinics tend to use CBT and GET in combination. I still don't really understand why they didn't do that in PACE. Was it a professional face-off between White's GET and Sharpe's CBT?
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Comparing GET with CBT was actually a good scientific idea. Although they drew on the same theory and were both 'active test' treatments they were methodologically separable and so could act as plausible controls for each other. The problem is that they gave the same result so neither had power to provide evidence of efficacy of the other.

I suspect that as much as anything, with pacing and standard care as necessary comparator arms it would have seemed nice to have at least two arms involving treatments that would corroborate the pet theory. But I suspect that it at least crossed their minds that the two would look good as plausible 'sham' comparators.
 
Thanks to @Michiel Tack for making me look at the Protocol again.

From this section (in tweet below), I can only presume that no-one has ever been harmed or made worse if they received treatment from one of the PACE authors, manual authors, or anyone properly trained by them...



There are also some factual inaccuracies here. Patient surveys cannot possibly say that "APT helps many patients and does not cause harm" because APT does not exist as a therapy.
 
Adrian said:
I believe that the version I had was obtained by a FoI. I think I got it form @Tom Kindlon but not sure.

The published version came later and is a summary and not the full protocol. They say
"This paper should not be used as the protocol for executing the study, and is not the complete protocol considered to be ethically satisfactory by the relevant MREC, having been subject to shortening and revision to enhance communication for publication."
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Yes, I'm almost positive it was obtained using a Freedom of Information request, but not one I made:
https://www.mediafire.com/file/7a4uenbw241cdnc/PACE_Trial_Protocol_searchable.pdf/file
 
Lucibee said:
Patient surveys cannot possibly say that "APT helps many patients and does not cause harm" because APT does not exist as a therapy.
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That one is a doozy. How is it OK to just make stuff up like that? When such obviously false claims are brushed off, how can any part of the judgment be considered credible? Using the same word but making up a whole new definition is not something serious people do.
 
dave30th said:
yes, and here's the issue with that. At the time, there were no prevailing UK requirements that these links be disclosed--the HRA is right about that.
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MRC Guidelines for Good Clinical Practice in Clinical Trials (1998)
5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs.

5.4.2 Whenever possible, all participants, or their representative(s), must give their consent to participate in the trial on the basis of appropriate information and with adequate time to consider this information and with adequate time to consider this information and ask questions.
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Lucibee said:
I guess that's why the clinics tend to use CBT and GET in combination. I still don't really understand why they didn't do that in PACE. Was it a professional face-off between White's GET and Sharpe's CBT?
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It makes you wonder though, in principle, if they treat different things, the effect should stack. We know it doesn't as the crossover shows no effect (crossover was uncontrolled in PACE trial, but still no effect).
 
MRC Guidelines for Good Clinical Practice in Clinical Trials (1998)
5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs.

That's very interesting--hadn't seen that. I guess one would have to check the 1998 version of Helsinki. It got updated in early 2000s I think.
 
MRC Guidelines for Good Clinical Practice in Clinical Trials (1998)
5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs.
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Unfortunately, Guidelines for Good Clinical Practice ≠ Legal Requirement
 
dave30th said:
MRC Guidelines for Good Clinical Practice in Clinical Trials (1998)
5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs.

That's very interesting--hadn't seen that. I guess one would have to check the 1998 version of Helsinki. It got updated in early 2000s I think.
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Declaration of Helsinki (2004)

13. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.
 
JohnTheJack said:
institutional affiliations of the researcher
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I wonder how a company that exists "to carry on business associated with the establishment and promotion of a system of health based on a BPS model" would rate as far as institutional affiliation? Or being a chief medical officer for an insurer advising on mental health exemptions for this disease.

I'm sure this would be fine with regulators if some researchers for a drug trial were directors in a company that aimed "to carry on business associated with the establishment and promotion of" said drug. Totally clears the researchers, thank you!

As for potential risks, assurances that it cannot be harmful are absolutely not based in evidence and are wildly contradicted by patient reports and surveys. But I guess as long as no one publishes peer-reviewed research showing that, which would never get ethical approval, thousands of people all over the world are just... confused?

It's never really ever been explained why there are so many testimonies of harm, in contradiction with the work of researchers who assure harm cannot occur and who won't release their data for independent analysis. Total coincidence, I'm sure.
 
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