Monitoring treatment harm in [ME/CFS]: A freedom-of-information study of National Health Service specialist, 2019, McPhee et al

For example, one clinic responded to our request for harm data by stating:

This data is not available. This is making an assumption that treatments we provide are harmful. If any treatment is contraindicated we would not provide it.​
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Their lack of data gathering shows a presumption that the treatment cannot possibly be harmful, as is evident in the self-reinforcing circular logic. If you refuse to gather evidence of harms, then there will be no evidence of harms.
 
Adrian said:
One point behind this paper is that for years a response to patient reports of harm with GET and other treatments was the line that it only happens when the treatment is not done correctly. What this paper shows is that the clinics in the UK (who are the ones who should be doing the treatment correctly) don't look to understand or record harm and that patients are not warned about the potential for harm which may affect reporting.

So the claims made that if GET is done properly cannot be justified in terms of there is a lack of evidence of data collection to support such views.
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There is always the risk of harm from any treatment, and to deny it even as a possibility is deeply revealing in itself. If you go for a pre-op assessment, you get given all manner of bumph on the possible harms and their probabilities. Same on pretty much every medicine leaflet you can ever have. I would really like to hear these folk trying to argue in a court of law how it is OK to not have any infrastructure for recognising and recording harms, because they know harms are impossible, hence there is no need for such a mechanism. Try and make that fly.
 
Lucibee said:
Please don't mistake my data pedantry for any kind of criticism of the paper itself.
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Not at all, @Lucibee ! There's never a chance of that. Like me, you want to get to grips with the data (and like me, you would have been going bananas at their answers!). Always pleased to help if I can. My problem is that I often focus so much on the answer that I forget to "soften" it with more casual chat.
 
Barry said:
There is always the risk of harm from any treatment
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I think what baffles me is that they have confidence that a treatment or therapy is strong enough to treat or ever cure ME, and yet believe it is gentle enough to leave no harm, whereas in reality, it is hard to devise something that actually cures or helps things, but it is so very much easier to cause harm.
 
@Andy, what a way to run health care!

Mediocre accountability at best. Looks like a government gravy train. It would be interesting to see what is reported, and a cost analysis of these clinics. Given the fact we know GET/CBT may cause harm, and the low recovery rate of 5 percent, the cost for these clinics versus their effectiveness would likely be miles apart, as they are with the PACE trial. Nice work if you can get it!
 
Graham said:
I think what baffles me is that they have confidence that a treatment or therapy is strong enough to treat or ever cure ME, and yet believe it is gentle enough to leave no harm, whereas in reality, it is hard to devise something that actually cures or helps things, but it is so very much easier to cause harm.
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One of the things I like about this paper is how the clinics have tacitly admitted, probably without realising it, that they fly in the face of real scientific practice - claiming there is no need to record harms because no harms due to treatment are possible. That alone exposes how amateurish it all is, and how divorced from the rest of medical practice. It's an amazing shambles really.
 
Yes, @Barry, the downsides of medicines and treatments are often provided to patients. One instance where they are not is when a practitioner wishes to gloss over less favourable methods, outcomes etc.

It is the norm to carefully provide the downsides of treatments. These clinics' practise of not recording harms, and the NHS not requiring this reporting is a glaring example of patient mistreatment. It shows the entire structure does not care if pwME are harmed in treatment.
 
It is however, sadly not unusual for harms to not be reported, nor required, in other areas of medicine, I believe. Or if they are officially required, it may be understood that this is not a request or regulation with any force behind it. For example the birth control product Essure (sp?) that has harmed numerous women. Health Canada had a report of only one harm.
 
Graham said:
This was one of the hardest pieces of information to sort out. We did ask for follow-up after the treatment had finished, but it seemed as though many clinics took the last session of treatment with a "So how do you think it is going?" enquiry as a follow-up. That is my personal interpretation of the responses!

I don't think that many (perhaps one?) clinics carried out any form of follow-up that (a) left a gap between the last treatment and the follow-up, (b) asked questions that could be compared with baseline responses, (c) were asked by folk other than those who actually carried out the treatments, and (d) were capable of being put together and analyzed.

Believe me, it was a struggle to decide what many of them were actually reporting, which is why I keep emphasizing that some of these statements are just my personal impressions, trying to give you a realistic picture, but warning you against making clear-cut statements to that effect.
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Words just simply fail. I wonder if this sort of approach to data has been applied in other diseases? If this is done as a matter of course such as Diabetes, Cancer, Ms or Asthma then this would, starkly show how inadequate patient safety is taken. How can anyone give informed consent on this sort of information?
 
Tilly said:
Words just simply fail. I wonder if this sort of approach to data has been applied in other diseases? If this is done as a matter of course such as Diabetes, Cancer, Ms or Asthma then this would, starkly show how inadequate patient safety is taken. How can anyone give informed consent on this sort of information?
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I don't think that in my cancer treatment and in particular chemo and rads that I did give a proper informed consent or had all the harms explained or had any of the harms recorded. It was very much a conveyor belt NHS clinic.

The big difference is that I no longer have cancer (or at least the last one..) and things like recovery and survival rates are well documented.

With GET and CBT there is no evidence that these are curative at all. There are still NHS clinics that claim this in face to face interviews which I can see from new member comments on other forums.

We only have the PACE and FINE trails to judges these types of approach on and they weren't shown to be helpful particularly there.

The clinics though offering these products are in a win/win situation. A never ending supply of new, hopeful and desperate people. A cartel atmosphere which restricts choice to 2 or 3 "treatments" and no comeback at the end when patients drop out and leave the clinics because they are worse or it doesn't help.

With cancer I was going through treatments that had a high degree of success and could examine papers to support this, with GET in particular we have a high degree of failure and the possibility of ending up worse at the end.

That's a huge risk for patients and I can't see any other common conditions where this also occurs.
 
Seems so bizarre that a bunch of whinging feeble minded bodily oversensitive people who are in need of re educating and exercise therapy because they have become so decondtioned wouldn't report back on the very nature of their sensitivities when being coeocrced into changing their warped behavioural patterns.
 
I am worried that exercise may make me worse

You may be worried that any increase in exercise or physical activity could make your condition worse. Be reassured – research has shown that a guided, gradual increase in exercise can help people who suffer from CFS/ME without causing ill effects.
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This didn't make it to the final paper text, but is publicly available on the Cambridgeshire and Peterborough Foundation Trust website

https://www.cpft.nhs.uk/PDF/Miscellaneous/How to Exercise with CFS Booklet May 2017.pdf
 
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Tom Kindlon said:
This didn't make it to the final paper text, but is publicly available on the Cambridgeshire and Peterborough Foundation Trust website

https://www.cpft.nhs.uk/PDF/Miscellaneous/How to Exercise with CFS Booklet May 2017.pdf
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The premise of those statements is that in GET is some secret ingredient based on specialist knowledge, which is not the case. This is a common trope, basically a No True Scotsman fallacy, that only real GET done by certified professionals, blessed by the PACE bishops, should work, even though most accounts of harm were done in that context and that consistency cannot be guaranteed anyway.

I don't know how to expose that, but it's a key point. It lends some hidden magical element to an otherwise perfectly ordinary exercise program. This is so much like Uri Geller's excuses when his "magic" didn't work under observation, that there was some element that he normally requires that was missing, mostly the act of believing it works (and hidden sleights-of-hand, obviously). It's all make-believe but it's promoted because there are enough who suspend disbelief or simply don't care one way or another as long as it seems real.

As far as I can tell, GET is a typical reconditioning program that tries to reach a 10% increase per week. That's about it despite there being ample evidence that deconditioning plays no role in ME other than as a consequence for the most severe bedbound patients, perhaps 10% or less. There is nothing special about it. The idea that there is some carefully-tuned process involved is ridiculous. I expect that we would find as much a wide variety of ideas within that program as we would find in Feng-Shui.

It's absurd that so much energy should be spent on debunking nonsense but it seems necessary, typical asymmetry of bullshit and all. There are claims to some superior knowledge that are in fact based in complete ignorance and they apparently have to be exposed in order to move forward, the very pores of the emperor's ass have to be described in such painful detail in order to make the point that there is no gilded garment of any kind.
 
rvallee said:
As far as I can tell, GET is a typical reconditioning program that tries to reach a 10% increase per week.
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Their oft-cited claim that GET is safe provided it is administered properly, totally misses a massively important fact - no one, them especially, knows how to do it 'properly' for someone with ME, so cannot be safe - there is no way. The assertion rests on the premise they back off activity levels soon enough, so things do not go wrong. But they, of all people, are least qualified to recognise when activity needs to back off, because what works for deconditioning most assuredly does not work for ME. Moreover, GET is much about not listening to your body, and much more about doing the 10% thing. Whereas the crucially important warning signs for ME are very much about listening to your body, and far less evident to an outsider ... unless they actually happen to listen to the pwME.
 
Sorry that I missed answering these: I'm slowing down!

Michiel Tack said:
But later on in the paper, the discussion section reads: "No clinic reported telling patients explicitly that they could be worse after therapy than before." If those clinics said in relation to GET/CBT that a relapse may happen, that would be telling patients they could be worse after therapy than before, no?
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It is very difficult to get across just how confusing it was to sort through all the responses. I can give you my broad overview, but I cannot be sure that it is right because someone would need to work through all the stuff and check it. But here it is. We excluded the two clinics that stated that they did not provide rehabilitative therapies. Some centres clearly stated that they did CBT and GET, others wrote that they were included in their treatments, some just stated that they followed NICE guidelines. Some mentioned setbacks, some phrased it in other ways, but all of them spoke in terms of it being a temporary situation: some said it was part of the natural variation of ME, some on doing too much, having to rein back, recover, then carry on, some on not following the scheme correctly. But there were pages, and pages and pages of stuff in their patient booklets. The important part was a failure to suggest that there could be any possible setback due to the actual treatment if it had been carried out correctly by the patient. That meant that patients would be "encouraged" to see any setback as either a natural fluctuation or their own fault. I emphasize though, that that is my personal impression from reading all those booklets. If anyone wants to work through them and check, please let me know. Enclose a certificate from your doctor confirming that you are still in your own mind, and willing to risk the fact that you won't be for much longer.


Milo said:
I suspect that the non-responders are the clinics we want to hear most about.
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No, we got replies from the clinics that I guess you are referring to. There was a lot of confusion around. I gather that there had been and still is a lot of restructuring and reorganization going on.


DokaGirl said:
Does the NHS request/require these clinics report harms? If not, this seems to indicate the NHS does not view pwME as needing protection, as other patients do.
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Not as far as I am aware. If that were so, they would have the summary data and would have to give it to us. There is a general system across the NHS for registering harm (DATRIX?), but unless therapists had some guidance specific to ME, it might be difficult for them to sort out what to do.

I'm not really aware that the NHS requires any such feedback from other sources either: let's face it, it is only recently that they have started to publish pretty crude analyses of surgical success/failure in different hospitals. My impression is that once NICE says jump through this hoop, it's safe, they do.

I'll repeat my disclaimer, that all of this is my opinion. It isn't part of the study, and isn't part of the data we extracted, cross-checked and agreed upon. And someone of my fading years and eyesight may not be that reliable. But then, when I think of the standards that PACE set ....
 
Graham said:
The important part was a failure to suggest that there could be any possible setback due to the actual treatment if it had been carried out correctly by the patient. That meant that patients would be "encouraged" to see any setback as either a natural fluctuation or their own fault.
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I think I remember BPS authors say that reconditioning can result in a temporary increase in symptoms such as muscle soreness. So I assume they acknowledge gradually increasing your exercise level can cause symptom flares or 'setbacks', but that it's seen as a normal part of getting fitter and stronger. The GETSET manual literally said: "Setbacks are a normal part of recovery"

Anyway, thanks for replying Graham. It's really great to have one of the authors of the paper actually answering questions and giving more info. It makes me wonder whether it would be realistic for journals to obligate authors to answer any question asked about their study and methodology as a requirement for getting published. Just a thought.
 
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Graham said:
It is very difficult to get across just how confusing it was to sort through all the responses.
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Just from reading through the document from CPFT that @Tom Kindlon posted gives a small sense of how confusing the information they provide can be. There seems to be a lot of contradiction and hedging, and I was surprised at how little information there was on how to safely increase exercise in a long document that claimed to be explaining just that.
It seems to come down to: Q- "How do I safely increase my exercise?" A - "It depends. Talk to your therapist."
 
The problem is that I'm not an academic: I'm an ex-maths teacher. So when I read through these booklets, their overall tone and style have as much impact on me as the actual wording. It's like working with people: it's not what they say, but how they react/behave and the tone they use that is as important as the words they use. (Which is why I find it harder to communicate in writing or on the phone.)

I'm sure that the overall tone of these booklets is as I have described, but it may be harder to find enough hard evidence. One of my co-authors was not sure that all of the clinics that mentioned setbacks etc. made it clear that they would be temporary in nature, and that is right: it's rather like reading political manifestos – a masterpiece in implying a variety of things to various people without being specific.

This may come across as me wriggling around: I hope not. I'm trying to convey the general tone of the information given to patients: the study itself conveys the factual analysis.
 
Michiel Tack said:
I think I remember BPS authors say that reconditioning can result in a temporary increase in symptoms such as muscle soreness. So I assume they acknowledge gradually increasing your exercise level can cause symptom flares or 'setbacks', but that it's seen as a normal part of getting fitter and stronger.
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They're referring to DOMS and acute muscle soreness, which are indeed a normal function of conditioning and building muscle. The only problem is that these are bugger all like ME's symptoms, and conflating the two is gaslighting bullshit. They're not recognising symptoms or relapses by mentioning that, they're literally telling patients that any decline in function is how their bodies are supposed to work and that there's nothing actually wrong with them.

They wouldn't recognise muscle soreness as a "relapse", a "symptom", or a "harm" because they've decided that we can't tell the difference between normal and abnormal, and any complaints we might make are just hypochondriacal kvetching.
 
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