Reports from participants in GET and CBT trials

Inara said:
It could be possible that I can use these testimonials in court. I'm collecting lots of stuff, you never know if it can be useful.
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Absolutely. Sometimes even if you gather mostly anecdotal information, then a golden nugget of hard evidence might turn up that would otherwise have never been volunteered or discovered. I'm sure that many investigations brought to a successful conclusion, end up accumulating vast amounts of inadmissible evidence, but without which the admissible evidence would never have been captured along with it.
 
Just quoting previous post:

JaimeS said:
ME Association did a giant survey on GET and CBT as a whole. I believe there were some narratives about PACE there.

You can also check the STOP GET website -- they were collecting patient reports, and I'm pretty sure some of them were PACE.

I think it will be easier to get negative reports of treatments that arose from the trial than negative reports from the trial itself.
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I realise this is a thread about reports of adverse effects in the PACE trial but I am trying to get my head around the wider context.

If this was a drug treatment it would not matter if there were no adverse reports from a trial. If there were significant adverse reports from usage where the person delivered the treatment was reasonably thinking it was the treatment tried in a successful trial then the drug would be withdrawn.

Much of the problem here stems from the fact that the analogy with drug trials breaks down because we are in the strange situation that for therapist-delivered treatments, (and even more weirdly for treatments involving operations or radioactive substances), because these are 'procedures' or 'devices', there is no requirement for licensing approval. So there is no such thing as a 'black box' warning attached to a license - there is no license.

That means that assessment of adverse events has to follow quite different rules for therapist-delivered treatments. And it only makes sense if those rules weigh up positive and negative effects in similar terms. There is concern that there is no objective or systematic evidence for adverse effects of GET. However, there is of course no objective evidence of benefit and although PACE gives systematic evidence of apparent subjective benefit the quality of evidence is poor. Moreover, it is standard to take an asymmetric view in which non-systematic evidence of harm overrides systematic evidence of benefit. A few cases of harm outweigh average benefit.

More specifically, the only evidence of benefit from PACE is an indication that patients' beliefs about their health status have become more positive. (There is no evidence of improvement in disability.) The only rationale for using CBT and GET is that they may achieve this result, on the assumption that it feeds through to reduced disability. In these terms we have clear evidence, even from a few reports, that in some cases GET is followed by a very significant reinforcement of negative beliefs about health status. (Irrespective of whether or not we think those beliefs are realistic. And note that even Sharpe denies that any of these beliefs are 'false'.) So, in direct and simple terms there is evidence of harm on the only measure that can be used in this context - whether the treatment seems to have done the only thing it can be expected to do, or the opposite.
 
Jonathan Edwards said:
More specifically, the only evidence of benefit from PACE is an indication that patients' beliefs about their health status have become more positive.
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To be nitpicking, although patients' ratings of their health status improved, there's no evidence that their ratings reflected their beliefs. The ratings may simply have reflected what they felt pressured to say, given everything they'd been told about how effective the treatments were and the implications that 'good people' - those who tried hard - would recover.

Huge social pressure to respond positively there, no matter how bad the patients felt.
 
Jonathan Edwards said:
Much of the problem here stems from the fact that the analogy with drug trials breaks down because we are in the strange situation that for therapist-delivered treatments, (and even more weirdly for treatments involving operations or radioactive substances), because these are 'procedures' or 'devices', there is no requirement for licensing approval. So there is no such thing as a 'black box' warning attached to a license - there is no license.
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Yet another thing that needs changing in medicine.

Is anyone campaigning for it?

If not, maybe this is a campaign that our community could begin.

It seems to me that ME is at the centre of a perfect storm of medical crap - the rush to assume that poorly understood illnesses are 'all in the mind', the low quality of psychiatric trials, the irresponsibility of institutions when faced with bad trials, the absence of anyone to take charge of dealing with 'new' diseases, and this - no system for dealing with harms from psychosocial interventions.
 
Jonathan Edwards said:
So, in direct and simple terms there is evidence of harm on the only measure that can be used in this context - whether the treatment seems to have done the only thing it can be expected to do, or the opposite.
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That's when patients are informed that their belief to have been harmed is incorrect. It is assumed that patients are not sick, and that exercise cannot do real harm, so whatever the patient is reporting cannot be correct, and must be a hysterical misinterpretation of ordinary postexercise tiredness and muscle soreness.

We should push for an investigation into PACE that involves contacting participants to ask them independently whether they were harmed by PACE or not. Disappearing adverse reactions is all too easy when the illness model involves patients misinterpreting ordinary symtoms as harm, major disease, etc.
 
strategist said:
That's when patients are informed that their belief to have been harmed is incorrect. It is assumed that patients are not sick, and that exercise cannot do real harm, so whatever the patient is reporting cannot be correct, and must be a hysterical misinterpretation of ordinary postexercise tiredness and muscle soreness.
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Yes, but despite the belief not being correct - or for Sharpe just being 'unhelpful' - it is the reason why the person is disabled, so is causing the illness state. If it is causing the illness state it is harmful - otherwise there would be no logic in giving the treatment designed to get rid of these unhelpful beliefs. They cannot have it both ways.
 
What the PACE CBT therapist manual says about setbacks https://www.qmul.ac.uk/wolfson/media/wolfson/current-projects/3.cbt-therapist-manual.pdf

Setbacks can occur at any time. They are a “blip” in the recovery phase and certainly do not mean that CBT has failed. Setbacks are more likely to occur in certain situations, for example if the person has another illness, moves house, has a bereavement, or has a number of deadlines to meet. These “stressful” situations may give rise to increased symptoms and an inability to maintain their programme. At these times, it is important to remind the person that setbacks are only temporary. Encourage them to read the appropriate sections of the manual in order to get back on track again. Setbacks should be viewed as a challenge to be overcome and not a disaster. If a setback occurs after the person’s CBT sessions have ended, then encourage the person to devise a small programme for a few weeks, or until they feel they are managing better.
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1. No acknowledgement that increased activity is probably the most common trigger for aggravation of symptoms.
2. The insistence that setbacks are not an indicator that CBT is problematic.
3. The insistence that patients are recovering despite setbacks.


What the PACE GET therapist manual says https://www.qmul.ac.uk/wolfson/media/wolfson/current-projects/5.get-therapist-manual.pdf

CFS/ME setbacks usually involve an exacerbation of their symptoms, leading to a significantly reduced functional capacity. Participants may describe these as a ‘relapse’, or ‘crash’. People with CFS/ME can usually identify an increase in physical activity which may have attributed towards their setback. Sometimes setbacks also appear to be caused by sleep disturbance, a new active infection or emotional distress. It is normal, and likely, that participants will suffer setbacks throughout the GET programme.
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There you have it, setbacks are a normal part of a GET program.

A central concept of GET is to MAINTAIN exercise as much as possible during a CFS/ME setback. This is to reduce the many negative consequences of rest, and to allow the body to habituate to the increase in activity. If activity and exercise is reduced at this time, the boom/bust cycle continues, and the body is not able to desensitise to the increase in activity: which is, of course, an essential component of a graded increase in exercise and activity.
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No you ******* *****, that's how you prolong and exacerbate the crash.

If the plan has been undertaken carefully, with a low baseline and small increments as planned, it is unlikely to be the exercise programme that is responsible. However, it is important to ascertain whether any components of the GET programme may have contributed towards setbacks, and to adapt the
plan immediately to avoid difficulties.
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In my experience there is a limit to the total amount of exertion that is tollerable over a certain period of time. A slow rate of activity increase just means that this limit will be reached more slowly than with a faster rate of activity increase.
 
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strategist said:
That's when patients are informed that their belief to have been harmed is incorrect. It is assumed that patients are not sick, and that exercise cannot do real harm, so whatever the patient is reporting cannot be correct, and must be a hysterical misinterpretation of ordinary postexercise tiredness and muscle soreness
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There is something called exercise-induced anaphylaxis. Never heard of it until recently. So one really has to dismiss the belief that exercise is always helpful. (Say I - and I am passionate about exercise. :) )
 
strategist said:
3. The insistence that patients are recovering despite setbacks.
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Haha :rofl: recovering despite getting worse - welcome to PACE's World!

Edit: This manual shows they have no knowledge about sports medicine and how to train correctly. An athlete is NEVER told to ignore physical signs that seem uncommon to him. Regeneration and rest are an important part of every training plan. You destroy your success if you train your muscles too much, e.g. during muscle soreness a normal, strenuos unit instead of (active) regeneration. Morons.
 
Jonathan Edwards said:
A few cases of harm outweigh average benefit.
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It's akin to risk analysis, for aircraft, cars, etc, etc. Risk => likelihood of an adverse event x the severity of harm from that event. As soon as the per-event severity gets a bit high, then the risk shoots up even if the event frequency is not that high. You would not need many Jumbo jets to fall out of the sky unexpectedly before they got grounded pending further investigation.
 
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