UK:ME Association funds research for a new clinical assessment toolkit in NHS ME/CFS specialist services, 2023

I agree that this raises significant questions around informed consent on the PROMS research. Those involved know well enough that if not all potential participants would have been wary if this history had been more clear, then those who witnessed it the first time around would have filled them in.

It feels somewhat sneaky that a paper was published yesterday under a title about the Chalder fatigue scale which was about PROMS and involved Gladwell, and it is only when you look very carefully that you really when it really dates from. And the one from May 2023 having been started according to its ethics statement before 2016. Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with ME/CFS, 2023, Jones, Gladwell | Science for ME (s4me.info)

In fact it looks like that paper was released (with JOnes as the first author listed rather than Gladwell) on almost the same day as the MEA PROMS project in May 2023


OK here we go, I've gone back and looked up the MEA stuff on the study from back in May 2023: ME Association funds research for a new clinical assessment toolkit in NHS ME/CFS specialist services - The ME Association

"The study will also consider whether the toolkit can be applied to people with Long Covid who might be referred to combined NHS ME/CFS and Long Covid specialist services – such as in the Isle of Man – or to NHS Long Covid Clinics – such as in England.

The ME Association is very pleased to announce that a £90,000 research grant has been made for a 12-month study that will enable Professor Sarah Tyson (Manchester), Dr Mike Horton (Leeds), and Dr Peter Gladwell (Bristol), to apply gold-standard techniques and develop patient-reported outcome measures (PROMs) and a clinical assessment toolkit to monitor people with ME/CFS who use NHS specialist services.

The researchers undertook extensive work in preparation of the grant application. Using recent national guidance, they established the concepts to be measured and completed scoping reviews to identify any existing measurement tools. While these revealed that nothing suitable currently existed for ME/CFS several were found that could be developed.

The implementation of effective PROMs in other medical conditions has shown an improved understanding of patient problems, better monitoring, more effective decision-making, and improved communication. To achieve this, PROMs need to be carefully developed to ensure the content covers the full range of symptoms and disabilities, are easy to use, and produce accurate and useful information.

The toolkit will address the assessment needs and research recommendations (for a core outcomes database) identified in the 2021 NICE Clinical Guideline on ME/CFS. It will be produced following consultation with patients and with clinicians to ensure the toolkit can record accurate and reliable data. Then it will be made available to the network of services in England and in Northern Ireland, Scotland, and Wales, when new specialist services are commissioned.

The main outcome from this research will be a clinical toolkit and a greater understanding of patient difficulties, their needs, and satisfaction with service provision, along with a better appreciation of the assessment challenges that clinicians working in specialist services face and how they might be overcome.

Application of the toolkit will be of benefit to patients, to clinicians who are tasked with providing tailored care and support, and to healthcare commissioners who want to review and improve existing service provision – or create new services – that adopts the NICE Guideline recommendations."

 

Agreed. Probably not for this thread, or not until/if well-formed questions we might want to put up etc?

 

Yep.

I remember Sarah saying that it/they would be likely to end up being done by someone anyway, and obviously some might be better than others etc.

I think probably it has given me the idea that it might be worth us all having a peek back through the history on what measures these individuals (White, Gladwell etc) might be keen to avoid including

interesting that it was 11 points difference on the SF-36 they used for recovery marker in the Crawley et al (2013) which included WHite for example. Can we find what the actual data said?

and probably worth trawling what the Jones paper that includes Gladwell and is 'critiquing' the CFQ claims to 'have a problem with' because it seemed to be saying something like 5 measures were fine and the rest had issues.

What were the actual raw data measures on the PACE trial that can relate to physical function - objective and subjective. and what differences did they find?


And yes then probably get a number of these up and public so that the 'cut-offs' are a bit more transparent and what is 'in more' and 'out more' can be compared for coincidences.

It does sharpen my resolve that all questionnaires and measures are necessarily 'situated' and the MEA might need to consider the external validity issue/representativeness of any sample from them/certain ones, whilst the clinic situation is in such a state.

To make sure clinics that effectively put off patients who are ill and do such treatments they are using Krypton factor where those who are ill with PEM can't get to the end and complete the survey have another way that they are going to be measured. Focusing on drop-outs.

On the 'push back' side of things ( @JellyBabyKid ), I don't know enough - just that it is worth comparing given Gladwell is involved and might have brought ideas, imagining what ideas that chime with those past ones might 'look like' to have a looky-see vs this? And has been involved in other areas too where other parts of similar ideas and so on would be logical input.

SO it would be interesting to hear what he might be feeding in elsewhere? Some of that might be relevant for a different page to prevent the thread from getting overwhelmed ?? but also whilst collecting bits of info helpful to have some thread that is more like a data silo type one rather than other areas that necessarily has the comments - @Trish apologies if I'm overstepping the mark here, tired and brain trying to think of productive next things ?

And @Maat
it was @Dolphin who posted the CFQ paper

 

They're not. That's crucial in sustaining the model, because if people knew the risks of engaging with these programmes, they wouldn't touch them with ten-foot pole.

It's presumably the reason an entire branch of the industry has sprung up to discredit those who've been harmed.

 

I agree - and I think on the basis that there were a few key, and persistent - or one could say pernicious (given how many and such an extended time period) - issues that came up with making research useless as it was such low quality in the assessment of it in that area for the NIce guideline, then it is worth annotating what these were.

Off top of my head I can think of:

- indirectness of measure
- not having PEM (which I think is one we need to check closely given the PASS one)
- longitudinal measures/time to follow up being too short

Such a lot of wasted research money and time for pwme when you look through them all and realise they were all without use therefore, and future ones having the same errors would ... I don't know the words.

I haven't looked into this/these with that pair of eyes on, and it is probably useful for anyone who did the survey and might have a copy to provide more info too?

It would seem if something as a new measure was said to 'come from a need identified in that guideline' (and thereby that process) it wouldn't be unreasonable to assume that these issues were being heeded to ensure the same errors were not being repeated.

As we all know with research there is a major issue with GOGO - garbage in garbage out for things like databases and you are correct that discussion will also need to cover this 'situated' nature of it.


You never know, this could all be 'in hand' as checks to not repeat mistakes etc but it might give us a bit of reassurance - plus also make sure we are all looking on top of all the details here ?

 

Agreed on the new paper published.

There it is right there:

"The toolkit will address the assessment needs and research recommendations (for a core outcomes database) identified in the 2021 NICE Clinical Guideline on ME/CFS. It will be produced following consultation with patients and with clinicians to ensure the toolkit can record accurate and reliable data. Then it will be made available to the network of services in England and in Northern Ireland, Scotland, and Wales, when new specialist services are commissioned." [my bold on the 'new']

They all seem to be re-positioning themselves (bearing in mind the implementation and delivery report delay) to have everything in place to deliver the same activity stuff as before once the plan is published.

Maybe we need a report issued by the Govt on the results of responses received under the consultation for the implementation and delivery plan on the results from the consultation process on the implementation plan as delivery plan is now 4 months late. Here is an example of where they did this in connection with the call for evidence prior to launching the Womens' Health Strategy. A copy of that report which informed the new strategy can be downloaded here. Women's Health Strategy: Call for Evidence - GOV.UK (www.gov.uk)

Look at Table 8 on page 27 of the report I think. The right-hand column starts with mental health an pain, and is then followed by all other disabilities raised in alphabetical order.






Guess who prepared the report?

 

It is interesting reading through the MEA news item on this - where it mentions LC potentially, or at least more specifically clinics like the Isle of Man where it seems they suggest there is a specific LC service or joint one.

I don't know much about them but they seem a bit more sensibly wary from early on vs what happened with ME peeps. DO they have a s4LC equivalent anywhere that might have got ahead of us on this?

And if this might be looking to proliferate into that, have they been contacted and the consent issues there and so on? Or would they proliferate it on the basis of psychometrics from ME - only data?

 

Rehabilitation is defined by WHO as:

Rehabilitation is defined as “a set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment”.


Rehabilitation (who.int)

 

The whole thing appears to have been a decades-long academic exercise. There's almost nothing in the publications about trying to find out what patients need or want. The entire focus is on measuring outcomes, and the sole objective is sustaining further study of measuring outcomes.

 

I know exactly what you mean. Plus there are a lot of get out of jail free cards someone can tell themselves even if they were to see someone clearly more ill if they are really hooked into certain mindsets.

 

Thanks @Dolphin

A quote on the forum somewhere recently, fits very well to this situation.

'Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing ever happened.’ Sir Winston Churchill.

There is less talk in research papers about 'recovery' and increasing amounts of reference to 'rehabilitation' and improved functionality.

The reason I think this is a circular and repeating pattern is because of this focus on 'rehabilitation' in conjunction with

• Valerie Eliot Smith's enormous research effort, which turned up turned up the info which @Robert 1973 lists in his post containing the screenshot of a letter Wessely wrote in 1993 in this thread Who is Simon Wessely? | Page 34 | Science for ME (s4me.info) , together with

• research papers prior to the CMO report in 2002, from which they resigned and would not sign off. It is there modus operandi

"Great flexibility is essential in treating these patients, each case is different. It is a treatable disorder but its management is deplorable at present, the worse thing to do is to tell them to rest. Rehabilitation is essential, exercise is good for these patients. Prolonged inactivity causes adverse physical and psychological consequences. Most cases can be expected to improve in time.

7. As regards benefits: its important to avoid anything that suggests that disability is permanent, progressive or unchanging. Benefits can often make patients worse. "

It's almost as if the CMO report and PACE trial didn't happen, and we've time-warped back to 2001 at least in terms of what 'rehabilitation; will consist of.

ETA: This new PROMS will give them something they didn't have back then.

 

But Sarah Tyson said he is a “good bloke” who “gets it”.

I think a side-by-side of this PROMS against NICE 2021 guidance will be needed, I feel there will be anomalies. And the horse has long bolted on these PROMS, delivery is due in weeks.

Excellent sleuthing @bobbler and @Maat

 

From the British Society of Physical and Rehabilitation Medicine. In the 'Others' list we are sui generis "thing of its own" "unique" and definitely not in the list of post viral illnesses or other long term conditions with the entry shown as "CFS/ME"


The British Society of Physical & Rehabilitation Medicine | Home (bsprm.org.uk)

 

Side-question
Did PACE ever address sex differences? I only ask because I become very exhausted when I have a period. That’s always been the case, and is for many women I know who might drop a run or gym session, have an early night etc. were we supposed to increase activity during that time? A triple whammy of ME, work and hormones.

I haven’t looked whether there’s a specific thread for this, just thinking aloud. Don’t want to derail the topic.

 

True, but for the future, it is very important to now record the issue of consent; lack of clear impartial information which should have been provided prior to requesting consent, on the potential impact of this reseach, as a 'material risk' which patient's have the right to be informed of. The size of the risk is immaterial.

Consent can be withdrawn at any time. If a patient in the future who suffers harm from treatment which can be traced back to this PROMS (similar to the use of SF36 in PACE) as an outcome measure, they can point to this thread as evidence of what they should have been made aware of. We're just doing what Melvin Ramsay and others did for us. Recording. This thread now satisfies the first part of the burden of proof in a future Montgomery claim.

 

And in some perverse way, Long Covid feeds into this, as it brings even more new patients, making it easier to bury older patients under the guise of focusing only on newer/easier patients. They will not run out of new patients to scam, until maybe decades in the future when/if too many people develop chronic illness, but then the natural cycle of life takes care of that, there's always babies growing up to become newly ill patients.

On the other hand, the Long Covid community quickly smarted up to this, but as time passes, it gets less organized and fragmented, fewer of them even associate their new-onset illness to COVID. So while LC communities protect patients from falling to this, to a point, that's not happening anymore. And of course with brain retraining and other scams requiring patients to evangelize, it gives some of those scams a lot of false hope.

Although it still all doesn't matter, since countries where they do nothing at all have the exact same outcomes, but there is no data to compare to, so the whole scam-or-negligence can just continue indefinitely. And really it's either a scam, some people manage to grab money they don't deserve and simply waste, or nothing/negligence, while you get the exact same outcomes regardless, but the way it's all done no one can tell.

In other words: what a shit show of epic proportions.

But on more related note to a PROM, the main thing that would matter here, if this has to happen, is that any PROM has to rely on a huge difference. None of that "all it takes is for 2 answers to be up by 1" crap. If there's a difference, it has to essentially be a full reversal of disability, a huge difference, far far above the normal minimum clinical significance. This is the only protection that can work here, as it doesn't matter much how bad the PROM is, none have ever achieved that given the, you know, complete lack of any effective treatment.

 

Zero chance of that. See also: Phil Hammond (?), the dude who worked at Crawley's clinic. He was completely oblivious and utterly baffled at hearing it from patients that he himself treated. These people are as completely insulated from the outcomes they create as any aristocracy or politburo has ever been in history.