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

[ME/CFS Skeptic]

Trying to make some promo for the article on twitter. Hope I haven't made a (major) mistake in summarizing it. Here's what I wrote:

1) There’s a new interesting study out by a collaboration of ME/CFS patients and scientists.

They’ve sent Freedom of Information requests to 38 NHS specialist centers for ME/CFS and asked them about their information on harms by rehabilitative therapies such as GET or CBT.

2) The results are striking. Among the ME/CFS clinics surveyed, there was an almost universal absence of criteria for detecting harm, and no clinic reported any harm to have occurred in their patients, despite acknowledging that many dropped out of treatment.

3) No clinic reported telling patients explicitly that they could be worse after therapy than before. They only said that setbacks are possible (but temporary) or that the reported harms of GET are due to the treatment being wrongly executed.

4) So patients getting worse during treatment might think that their decline is due to something else.

The authors suggest this can result in a “misinformation loop”: clinics say GET is safe, patients believe that and do not report harm, clinics think GET is really safe...

5) Or as the authors put it more eloquently: “if clinics presume that treatments are harmless, they will inevitably fail to record harms accurately.”

Another possibility is of course that patients do report harms but that clinics do not use or record this information…

6) The solution the authors propose is a national system for collecting information from patients who think they have been harmed by rehabilitative therapies such as GET, something similar to the Yellow Card Scheme for adverse effects arising from medical drugs or devices.

7) The study was published in The Journal of Health Psychology and can be found here: https://journals.sagepub.com/doi/abs/10.1177/1359105319854532?journalCode=hpqa​

 

[Hoopoe]

The CBT/GET narrative is apparently designed to anticipate and deflect reports of harm.

Presumably its designers created it with the firm conviction that in ME/CFS there is nothing wrong in the body, and that therefore exercise cannot harm.

They offer all sorts of explanations and interpretations for why it cannot be harm. I wonder what sort of event would qualify as actual harm? These clinics seem to think no patient has ever been harmed.

 

[Lucibee]

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.

Absolutely. With you all the way. I'm just trying to get my head around the data.

Please forgive me if this is very wrong, but I've had a play in powerpoint with table 1 [if it is wildly wrong, tell me and I'll delete it straight away - eta: I've marked it as "retracted" bcs I got it wrong!], although if it was that much of a tangled mess from the clinics, maybe I should have tried it in interpretative dance instead

 

[rvallee]

So much for informed consent. Given the rates of harm are consistently found to be around 50%, with a further 25-30% or so who find it useless, reporting zero harm while doing no quality control to speak of is a complete failure. The claims of safety are made without any rigorous process and based more on what they want to be true than actual data.

The discrepancy between their own controlled self-reports and general population self-reports are enormous and need an explanation. They clearly have no clear notion of what deterioration is, a "setback" is their own meaningless language that does not correspond to any reliable indicator and the SF-36 is simply not a valid measure for it.

This amounts more to deceitful reluctant consent than any reliable definition of the concept of genuine informed consent. The self-reports consistently found by patient organizations are just as valid and reliable in evaluating the efficacy and it's clear that there is simply no quality control to speak of.

After more than a decade of implementation, this is simply unacceptable. It never was acceptable to begin with but the onus on patient safety is on the institutions themselves and there is no reliable process in place to report on the safety and efficacy of these pseudoscientific treatments. The only claims to safety and efficacy otherwise come from controversial, biased and selective studies done by people with a clear allegiance to this alternative medicine model. This is not even close to be acceptable.

Is there a possibility of funding a larger study building up on this? It's clear that this system of clinics is acting recklessly and without any oversight, with well-documented evidence of harm that completely contradicts not only their claims but the very premise of their existence.

Great work to all. This is a solid base to work with.

 

[Jonathan Edwards]

This is one of the additional pieces of data I will be raising with NICE at my verbal submission on September 6th.

 

[Graham]

They’ve sent Freedom of Information requests to 38 NHS specialist centers

We sent out a lot more than that. We ended up with 38 that offered rehabilitative treatment and replied: there were two that replied and didn't offer rehabilitative treatment: some did not give us anything because it was farmed out to private contractors.

They only said that setbacks are possible (but temporary)

"setbacks" and "symptoms may worsen temporarily" are separate - please see the Venn diagram (and my correction below).

Please forgive me if this is very wrong

Almost, but you have assumed that the 5 who said that therapy was safe if done properly were separate. Again, going back to the original data, four of them were from the "n=8" overlapping set, and the fifth was separate from the other categories. I did say not to assume anything!

 

[Lucibee]

Almost, but you have assumed that the 5 who said that therapy was safe if done properly were separate. Again, going back to the original data, four of them were from the "n=8" overlapping set, and the fifth was separate from the other categories. I did say not to assume anything!

I had to assume something - it's a wip.
I've also assumed that the "patients are given criteria..." and "controversy/disagreement" subsets are somewhere within the other sets (it would be odd if they weren't).

Is this better?

 

[Graham]

Sorry, that was a hasty posting. Meal time was approaching and I was required!

As the report says at the start, we sent out 57 enquiries. This is my unchecked analysis: two did not claim that they were rehabilitative, so we excluded them: three stated that the clinic no longer exists: four were under reorganization, and were all due to send their patients to a private provider: two others contracted out: one said that the clinic doesn't exist, but another source said it did: the rest failed to respond despite reminders.

It would probably be fairest to say that after discounting the two that stated that they did not undertake rehabilitative therapies, we were left with 38 "responses", some of which were minimal to say the least. (For example, "this data is recorded individually and is not available" as an answer to virtually all of the questions from the same provider that said that we were making an assumption that their therapies were harmful, and if any treatment was contraindicated, they would not provide it.)

(it would be odd if they weren't)

Welcome to the world of the ME clinic FoI responses! The "there is controversy" clinic is in the upper n=4 set (A∩B∩C'), and the "given criteria" clinics – one is in the triple overlap n=4 and the other is in the upper right n=4 set (symptoms may worsen only set).

Hope that helps.

As for it being a wip, I'm too old for such acronyms. I'm a member of the SPA. We needed abbreviations when we sent telegrams or messages in morse. Now we have computers with mind-shattering capacities to handle data, and people communicate in ever-more truncated language!
Yours sincerely
The Grumbling Graham (now to wash up, without grumbling)

 

[ME/CFS Skeptic]

We sent out a lot more than that.

I know, sorry about that. I left that out in an attempt to explain the results in an easily readable summary. I assumed that those interested in response rates and study methodology will go for the full study instead of my tweets about it. Hope that's ok.

"setbacks" and "symptoms may worsen temporarily" are separate

I assumed that the setbacks and relapses mentioned were those that GET manuals usually mention: only temporary and as part of the road to improvement.

I got that impression from reading the manuscript, to be honest. Table I says it provides "Information provided by ME/CFS clinics (N=38) to patients regarding safety and risks of rehabilitative therapies." So if the clinics say that "‘setbacks’ or ‘relapses’ may happen" I assume that's in relation to the safety and risks of rehabilitative therapies, not just something in general. And if those setbacks or relapses are not temporary, that would mean that these clinics say that patients can get worse due to these rehabilitative therapies. 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?

 

[Milo]

Congratulations to all authors including our very own @Graham and @Tom Kindlon for this very valuable work! Thank you for spending time and precious energy in finding out the truth and then publishing it where it matters.

While i didn’t read the paper, i wonder what happens to the clinics that did not provide an answer, because it is my understanding that by law they must provide an answer? I suspect that the non-responders are the clinics we want to hear most about.

 

[DokaGirl]

Thank you to all authors of this important study. What a task to interpret answers!

I wonder what these clinics report to funding bodies - perhaps something like "All good here - everyone improved/recovered and happy."

Obviously, the clinics are told GET/CBT are not harmful, and indeed are healing for ME. Patients indicating harms would, as has been discussed be told it is their fault.

I think many patients might not mention harms experienced, as this confronts the therapists, and indeed the entire superstructure of the NHS which backs up
these therapists and their clinics. Very ill, financially tapped out patients are less likely to raise the fact they have been harmed.

Of course recording harms, may open clinics, and therapists to litigation. Denying they occur is an initial defense.

The clinics do not seem to believe pwME
deserve protection from harms - and
therefore don't seem to look for them, or recategorize them as the patient's fault.

There is of course, no true informed
consent in this clinic system.

And, and @Michiel Tack says, interesting that about 50 percent referred do not have ME. This number still hasn't changed from reports a few years ago. That
is unacceptable. It casts serious doubt on the medical profession's ability to accurately diagnose. And what about treatment lag times, as people with other diseases wait, untreated, to see a ME
specialist.

It is also interesting that some clinics do not have a specialist, and therefore do not
diagnose. All those patients' diagnoses are based on their GP's assessments. Which are only correct about half the time. Yet, all these people might be put through GET/CBT, and not have ME.

Overall, the entire set up seems to be a mish mash, with no respect for pwME, and no meaningful follow up.
Thank you to @Graham, and @Tom Kindlon , and @Brian Hughes.

 

[DokaGirl]

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.

If the NHS does require reporting of harms by these clinics, then the fact zero are reported is very suspicious, and laughable in a black humour kind of way.

 

[DokaGirl]

Further to reporting harms: practitioners may deny the harm, and double down on this. Reporting harms to officials may get nowhere, and may worsen the situation for the patient. Patient safety mechanisms in health care systems may not be effective for patients. It is not surprising that no harms were noted by these clinics.

 

[Andy]

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.

If the NHS does require reporting of harms by these clinics, then the fact zero are reported is very suspicious, and laughable in a black humour kind of way.

I think the answer is no, they don't, because everybody knows that GET and CBT are harmless..

 

[Lucibee]

Welcome to the world of the ME clinic FoI responses! The "there is controversy" clinic is in the upper n=4 set (A∩B∩C'), and the "given criteria" clinics – one is in the triple overlap n=4 and the other is in the upper right n=4 set (symptoms may worsen only set).

Hope that helps.

It does, thank you. Well at least that particular assumption was correct. It means that 18 clinics (about half) provided no standard specific info on safety or risks, or at least didn't provide enough info to make that assessment. Who knows what they actually told clinic attenders individually.

As for it being a wip, I'm too old for such acronyms. I'm a member of the SPA. We needed abbreviations when we sent telegrams or messages in morse. Now we have computers with mind-shattering capacities to handle data, and people communicate in ever-more truncated language!

wip=work in progress - though now my work here is done.

Please don't mistake my data pedantry for any kind of criticism of the paper itself. Any lack of clarity is clearly down to the clinic responses and not what you've done with them. It is really important work and I hope it gets wide coverage in all the right places. Things need to start changing.

 

[rvallee]

I wonder what these clinics report to funding bodies - perhaps something like "All good here - everyone improved/recovered and happy."

When asked, the NHS clearly stated they do not care, that it's up to the clinics and here we see, once more, that they don't care either.

There is no meaningful oversight or monitoring of these clinics. However that may be, this needs to be escalated since it's technically not legal to do that. We've known for a while and it's clear nobody who can do something about it cares but nevertheless, this is highly irregular for the very reason why those rules and regulations were put in place: unaccountability breeds mediocrity, and often follows from it. This is clearly the case here.

 

[ukxmrv]

The people that we need protecting from are ourselves (in their minds).

Our bodies have become "deconditioned or hypersensitive" and need encouragement to build up to overcome this.

Some of us have developed a phobia (they think) so the last thing that they would do is reinforce that phobia by talking about harms.

It's all very simple at the clinics.

 

[rvallee]

I think the answer is no, they don't, because everybody knows that GET and CBT are harmless..

Evidence of which is the complete absence of any official complaints... because there is no official system to make complaints so none are ever recorded.

This is really amounting to the very worst of the kind of system that created the old asylum systems, horrors officially condoned simply because nobody looked and nobody cared to look.

 

[rvallee]

Please don't mistake my data pedantry for any kind of criticism of the paper itself

If not one of us, someone will make those comments and do so in bad faith so this is the way to go.

Being rigorous is a pretty good response to a reckless system of willful disregard for human life.

 

[Amw66]

Evidence of which is the complete absence of any official complaints... because there is no official system to make complaints so none are ever recorded.

This is really amounting to the very worst of the kind of system that created the old asylum systems, horrors officially condoned simply because nobody looked and nobody cared to look.

Kafkaesque