Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?

[Ecoclimber]

James C.Coyne
@CoyneoftheRealm
Medical Research Council. MRC policy on data sharing and preservation mrc.ac.uk/research/resea… pic.twitter.com/J5yhkmy7Bi

James C.Coyne
@CoyneoftheRealm
Wellcome Trust. Policy on data management and sharing. wellcome.ac.uk/About-us/Polic… pic.twitter.com/DprBsWFZvo
2:44 PM - 9 Nov 2015

James C.Coyne
@CoyneoftheRealm
.@cochranecollab Supports Access to Data from All Trials community.cochrane.org/organisational… pic.twitter.com/IcUS0WZMq0
2:37 PM - 9 Nov 2015

 

[Woolie]

I was shocked by how they stacked the cards in their favour (although without much result, it turned out):

The treatment manual for pragmatic rehabilitation repeatedly informed participants that the therapy could help them get better—even though the trial itself was designed to test the effectiveness of the therapy. (In the PACE trial, the manuals for the cognitive behavior and graded therapy arms also included many statements promoting the idea that the therapies could successfully treat the illness.)

“This booklet has been written with the help of patients who have made a full recovery from Chronic Fatigue Syndrome,” stated the FINE pragmatic rehabilitation manual on its second page. “Facts and information which were important to them in making this recovery have been included.”...

But:

The supportive listening manual did not similarly promote the idea that “recovery” from the illness was possible. During the sessions, the manual explained, “The listener, your therapist, will provide support and encourage you to find ways to cope by using your own resources to change, manage or adapt to difficulties…She will not tell you what to do, advise, coach or direct you.”

The nurses were given training in the BPS view of MECFS, and it sounds like they truly believed they had the "truth". They simply couldn't fathom why the patients were so critical of this view. In an article Tuller quotes about the trial process, one or the trial supervisors said “Their frustration has reached the point where they sort of boiled over,"... “There is sort of feeling that the patient should be grateful and follow your advice, and in actual fact, what happens is the patient is quite resistant and there is this thing like you know, ‘The bastards don’t want to get better.’” .

 

[Esther12]

I think that FINE went too far with the 'positivity' so led to resentment and disbelief rather than biasing the way patients completed their questionnaires.

I think that we should make more use of FINE as an example of BPS approaches. In a lot of ways, it's simpler than PACE to explain, and their manuals were more forthright in the claims being made to patients.

 

[Tom Kindlon]

I think that FINE went too far with the 'positivity' so led to resentment and disbelief rather than biasing the way patients completed their questionnaires.

I think that we should make more use of FINE as an example of BPS approaches. In a lot of ways, it's simpler than PACE to explain, and their manuals were more forthright in the claims being made to patients.

@Orla in this thread http://forums.phoenixrising.me/inde...liverpool-cf-cfs-clinic-patient-handout.3066/ goes through the Liverpool clinic hand-out on Pragmatic Rehabilitation, the same approach and similar manual to the one used in the trial.

 

[Woolie]

The nurses were given training in the BPS view of MECFS, and it sounds like they truly believed they had the "truth". They simply couldn't fathom why the patients were so critical of this view. In an article Tuller quotes about the trial process, one or the trial supervisors said “Their frustration has reached the point where they sort of boiled over,"... “There is sort of feeling that the patient should be grateful and follow your advice, and in actual fact, what happens is the patient is quite resistant and there is this thing like you know, ‘The bastards don’t want to get better.’” .

To quote my own post , it occurred to me how much this again goes against the statements submitted by Queen Mary Univ. of London, which implied that the majority of patients - at least in the PACE trial - are grateful for and positive about the treatments, and only a "small vocal minority" are critical of CBT/GET and similar approaches.

It seems pretty clear that, at least in the FINE trial, the situation was nothing short of a mutiny. Perhaps in PACE, the therapists learned to lie better, and not say quite so up-front that patients are deluded in their illness beliefs. Still, it makes you wonder, doesn't it?

 

[Esther12]

It seems pretty clear that, at least in the FINE trial, the situation was nothing short of a mutiny. Perhaps in PACE, the therapists learned to lie better, and not say quite so up-front that patients are deluded in their illness beliefs. Still, it makes you wonder, doesn't it?

I vaguely remember some figures for patient satisfaction which weren't that bad (no idea which paper these were from, and could even have imagined it)- (figures for patient satisfaction almost always seem to be high in CFS trials- we have low standards for medicine!)

 

[Tom Kindlon]

I vaguely remember some figures for patient satisfaction which weren't that bad (no idea which paper these were from, and could even have imagined it)- (figures for patient satisfaction almost always seem to be high in CFS trials- we have low standards for medicine!)

From the PACE Trial

Overall, how satisfied are you with the treatment you received?
(Please tick one only)
Very satisfied
Moderately satisfied
Slightly satisfied
Neither
Slightly satisfied
Moderately dissatisfied
Very dissatisfied

At 52 weeks, participants rated satisfaction with treatment received on a 7-point scale, condensed into three categories to aid interpretation (satisfied, neutral, or dissatisfied).

[For other things, neutral meant the three middle ones but that's not spelled out hereP

No satisfaction figures in main FINE Trial paper. Can't remember whether covered in any of the other papers.

 

[SOC]

From the PACE Trial

Overall, how satisfied are you with the treatment you received?
(Please tick one only)
Very satisfied
Moderately satisfied
Slightly satisfied
Neither
Slightly satisfied
Moderately dissatisfied
Very dissatisfied

At 52 weeks, participants rated satisfaction with treatment received on a 7-point scale, condensed into three categories to aid interpretation (satisfied, neutral, or dissatisfied).

[For other things, neutral meant the three middle ones but that's not spelled out hereP
View attachment 13591

No satisfaction figures in main FINE Trial paper. Can't remember whether covered in any of the other papers.

Is it not true that SMC actually means Got No ME Treatment (GNOME Treatment )? It was just what one ordinarily gets from a GP in the UK, right? So who's freakin' surprised people were not satisfied with that? "Oh, yeah, I'm really happy I'm dreadfully sick and got no treatment." At least the people in the other arms got some sense that the therapists were trying to help them. That should automatically lead to a difference in satisfaction with "treatment".

These satisfaction ratings remind me of the Faculty Evaluations I used to see back in the day. Truth is, unless a student is really pissed off, they rarely rate a teacher Poor. You have to be really awful to get more than one or two Poor ratings. It's like grade inflation. A 'C' these days isn't really a sign your work in the course was necessarily average. Teachers don't like to give D's and F's unless the work was so very poor that they have no choice. Bell curves be hanged.

It seems to be the nature of most people to be unwilling to be highly critical of a teacher/therapist/authority figure in ratings questionnaires. Maybe it's an empathy thing -- they don't want to be mean and hurt the ratee's feelings. Or maybe they're afraid at some level that they'll be identified and don't want to be seen as a bad student/patient. The PACE designers as faculty themselves, and psychologists to boot, had to know about this effect and used it to their advantage. Only in the case where there wasn't a clear therapist (SMC) were the patients willing to express their dissatisfaction -- there was no face associated with the treatment.

I'd love to see the actual breakdown of the satisfaction scores. If most of them were Slightly Satisfied, I'd call that an artefact of ratings questionnaire answering behavior. If most patients claimed to be Very Satisfied, then I'd believe they were actually happy with treatment.

Based on what we've heard from PACE participants in the time since, do we really believe that less than 5% of the patients were actually dissatisfied? I have to admit that I don't know what to think....

 

[Woolie]

@SOC, all good arguments. But on the face of it, there's not much positive evidence of widespread dissatisfaction in PACE trial. Not that would really counter Queen Mary's claims.

 

[Sean]

I was shocked by how they stacked the cards in their favour (although without much result, it turned out)

Yep, even with about as favourable a set-up as they could possibly wish for, they still came up with diddly squat.

 

[Sasha]

Does anyone seriously believe that people capable of a ninety minute session were that severely affected? I can't do much more than a half hour now and I used to be far worse.

I couldn't do ninety minutes but I score zero on that SF-36 physical function scale (it runs from 0-100 and trial entry was what, 70 or below?). I can imagine someone at that upper end being able to talk at home for 90 minutes if they saved up their energy beforehand. I can have a conversation for an hour on a good day, resting before and after and having a day in between.

It would be interesting to know the distribution of scores on their scale.

 

[worldbackwards]

Do we have any of this kind of detailed patient/ therapist commentary for PACE?

 

[user9876]

The nurses were given training in the BPS view of MECFS, and it sounds like they truly believed they had the "truth". They simply couldn't fathom why the patients were so critical of this view. In an article Tuller quotes about the trial process, one or the trial supervisors said “Their frustration has reached the point where they sort of boiled over,"... “There is sort of feeling that the patient should be grateful and follow your advice, and in actual fact, what happens is the patient is quite resistant and there is this thing like you know, ‘The bastards don’t want to get better.’” .

I wonder if the nurses were more direct in repeating what they had been told than therapists would be. Hence there was perhaps more conflict between them and the patients and less of a bias (hence the small difference between pace and fine results).

 

[user9876]

@SOC, all good arguments. But on the face of it, there's not much positive evidence of widespread dissatisfaction in PACE trial. Not that would really counter Queen Mary's claims.

I think it is also important when the questions were answered. Was it in their offices when the therapist was there. Was it before or after sessions or later by post. I'm pretty sure there is a paper somewhere saying with the sf36 scale you get different results when done at home or at the office where a consultation is happening.

 

[K22]

I think the severe would have a much stronger sense of being really physically unwell & disabled with real limits, possibly cased by previous harm, which would have made explanations such as disturbed circadian rhythm and deconditionng just seem wholly inadequate and nowhere near as reversible as assumed, so i am not surprised those inexperienced nurses encountered great resistance. The severe try all the time to "expand their envelope" but many, especially long termers, just cannot or very much, something i am not sure that others appreciate.

What isn't explored here is the consequences for vulnerable patients of having their loved ones and carers being told they could be cured if they tried and believed, only for that not to happen. I have been under immense family pressure after health professionals insisted i could be rehabilitated to the extent that they considered abandoning me if i wouldn't agree to a program.

I agree with @worldbackwards that 90 minutes is an insane amount of time for the severe to be expected able to participate in sessions, i guess this would at least have saved the bed ridden from this failed BPS experiment. FINE should certainly have been mentioned in the recent CBT/GET hype & indeed any discussion of behavioural treatment and theories on perpetuating factors; its not just the bed ridden who constitute the severe & CBT resistant as Wessesly implied but many of the thousands house or wheelchair confined too.

 

[K22]

Since £1.3m FINE, despite its failure and the level of disability, the MRC has funded or commissioned no severe ME research or research including the severe as far as i know.

 

[Sidereal]

On the FINE trial website, a 2004 presentation about pragmatic rehabilitation explained the illness in somewhat simpler terms, comparing it to “very severe jetlag.”

I suppose they just went too far, trying to convince a bunch of folks with SF-36 PF score of 30 at baseline (equivalent to class III congestive heart failure score) that they were just experiencing a very severe jetlag. I can see how PACE trial participants who are still ambulatory could be made to doubt the organicity of their condition with intense brainwashing. But for FINE trial participants, the brazenness of it all just created a nocebo effect and the trial failed. Hardly any citations of the BMJ paper, almost never mentioned, forgotten.

#JusticeForFINE

 

[Wildcat]

.
The FINE Trial researcher Alison Weardon. The underlining in the abstract is mine.


http://www.ncbi.nlm.nih.gov/pubmed/24058124

J Health Psychol. 2015 Feb;20(2):198-209. doi: 10.1177/1359105313501534. Epub 2013 Sep 20.

Understanding medical students' views of chronic fatigue syndrome: a qualitative study.
Stenhoff AL1, Sadreddini S2, Peters S2, Wearden A2.
Author information
Abstract
Chronic fatigue syndrome receives little attention in the medical curriculum. This study explores UK medical students' knowledge of and attitudes towards chronic fatigue syndrome. Semi-structured interviews (average length 22 minutes) were conducted with 21 participants (7 females and 14 males) in years 3 (n = 4), 4 (n = 11) and 5 (n = 6) of their studies. Inductive thematic analysis taking a realist perspective produced three themes: limited knowledge, influences on attitudes and training needs. Students acquired their knowledge and attitudes largely from informal sources and expressed difficulty understanding chronic fatigue syndrome within a traditional biomedical framework. Incorporating teaching about chronic fatigue syndrome into the medical curriculum within the context of a biopsychosocial understanding of illness could encourage more positive attitudes towards chronic fatigue syndrome.

© The Author(s) 2013.
KEYWORDS:
beliefs; chronic fatigue syndrome; health education; models; qualitative methods
PMID:
24058124
[PubMed - in process]

 

[Tom Kindlon]

What isn't explored here is the consequences for vulnerable patients of having their loved ones and carers being told they could be cured if they tried and believed, only for that not to happen. I have been under immense family pressure after health professionals insisted i could be rehabilitated to the extent that they considered abandoning me if i wouldn't agree to a program.

Very sorry to hear this. These secondary harms from the model don't tend to be acknowledged in the medical literature.

 

[Tom Kindlon]

From Twitter (anyone can see):

Chloë‏@chloemiriam2h2 hours ago
Pretty sure that FINE trial is the treatment that made me relapse & I dropped out & they blamed me for not doing it right
https://twitter.com/chloemiriam/status/664069059017842688

Chloë‏@chloemiriam2h2 hours ago
I recognise a name on it, she was horrible to me.

Edited to add:
I see she also has a longer comment under David's piece:

Chloe•2 hours ago
I'm pretty sure I was treated as part of this trial or similar, same hospital around the same time and the woman who treated me is listed as a 'collaborator'. I was put on a GET programme and I dropped out because I relapsed terribly. I was blamed for 'not doing it right' and my mum had many arguments with them as by this point I could barely move out of bed and she was dealing with the admin side for me. I'm curious as to how many others dropped out and why and if this was factored into the results. I seem to recall it wasn't, I was just classed as non compliant or something but my memory is very hazy. I do know it was the worst relapse I have ever had and I was not given any help afterwards, I was pretty much blamed for 'not doing it right' - I tried everything they said. Ironically id probably be better if I hadn't done it properly. Personal feelings aside the ethics of such research are questionable (I was not treated with any professional courtesy or respect once it became clear I was getting worse) and the methodology especially if people are dropping out because the treatment makes them worse and this is NOT factored into the results . I was given the whole 'deconditiining' explanation too, repeated like a mantra.