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

Seconded, really excellent work.

"patient as the receiver of the clinician's wisdom.

It assumes that clinician input makes a significant difference to disease course and that data, to be effective, has to be held and analysed by the clinician, with information fed back to the patient. However, in a disease where there are no treatments, we believe that the key is to empower the patient to manage their disease.

Members of the project team have assumed that constructive criticisms from patients and clinicians with considerable knowledge and experience, are inferior to their views and have no value."

I really appreciated these points. Very well put.

As though we have no agency or input and that our painfully gained lived experience is irrelevant and of less value than a medical education.

Thank you to all of those who used their valuable spoons on these letters, lets hope they are received in the spirit with which they were produced.

 

I thought the letters were brilliant, thank you for all your hard work!

 

I think you have just misunderstood that the points I have been making are about the complexity of the reality and the fact that there is no simple 'zero option' way out.

Of course not. I have made it very clear that I don't think that.

You are missing the point that the horse has bolted. The diagnosis has been made. Closing the stable door and in the process telling the person they have been conned is unlikely to help if they are quite happy that they have a label and have been given help to continue with their job.

 

Is there a pattern developing here?

These are notes I compiled in 2022 [long read]

• The first UK study to even properly look at outcomes was begun in 2007. It included data from 5 CFS/ME clinics in England covering the period from 2006 – 2010 and was categorized as service evaluation. [1] Published 2013.

Resulting from the Science and Technology Committee inquiry into research integrity and transparency 2019 the MRA (I think it was) was asked to follow up and check that all trials funded had been published.


An update to the “Ethical Approval” section of the paper above was published online on 10 May 2023 [2] This update related to the use of a subset of data forming part of the CFS/ME National Outcomes Database.

“The ‘Ethical Approval’ section of this paper has been updated to read -

The data used in this study was originally collected and collated in the National Outcomes Database for the purposes of evaluation of CFS/ME services. The collection of a subset of CFS/ME patient data as part of the .national CFS/ME collaborative was confirmed to be service evaluation by the North Somerset & Bristol Research Ethics Committee under REC reference 07/Q2006/48, and in a letter dated 29 January 2007 the Chair of the Research Ethics Committee had previously confirmed (a) that it would not be necessary to apply for ethical permission to use the data being collected as part of service evaluation for the national CFS/ME collaborative and (b) that if in future this data were to be used as part of a research project, this would be agreeable.”


The original paper refers to data being collected from 2006 although it did not start until 2007.
​

• Occupational Aspects of Chronic Fatigue Syndrome: A National Guideline 2006 published by the NHS. [don't read this if you are feeling low at the moment, as all the usual players are there and it's a grim read, including the Guidance Lead - BUPA] [3]

This Guideline has White and Sharpe as external assessors to the guideline committee which included the clinical lead in the Bath adult CFS/ME service as it was called, Nickie Catchpool. I think, although I can't find a copy at the moment, that she co-authored with Crawley the first National paediatric guideline for CFS/ME in 2004?​

• Also in 2006 from the University of Bristol the publication of the results of a Randomised Controlled Trial titled "Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme.” [4] All the authors of this study were from Bristol, all specialist in delivering CBT, one being Dr Gladwell of Bristol University. The trial took place between August 2000 to July 2002.

From the published paper:

“The rehabilitation and symptom management approach

There has been a steady increase in the number of services dedicated to the rehabilitation and management of the symptoms associated with CFS. This is, most likely, a result of the success of this approach with other chronic conditions, for example chronic pain. The approach is based on CBT and addresses a range of areas implicated in the biopsychosocial model of disease and disability.”

The stated purpose of the CBT used in this trial was to do two things:

”1. attempted modification of thoughts and beliefs about symptoms and illness

2. attempted modification of behavioural responses to symptoms and illness, such as rest, sleep and activity.”​

“It is common practice to include a structured, incremental exercise programme as an integral part of group CBT for other health conditions such as chronic pain, and we saw no reason to deprive the CBT cohort of this aspect of group CBT.”

In addition to the 3 pages of limitations to the study, the paper also included a page and a half of recommendations for future research. In relation to the PROMs discussion, the following stands out among the many concerns already discussed, as a legitimate concern over the clinical use of the ME/CFS specific PROM.

“The researchers generated a range of recommendations for further research as the study progressed. These include validation of outcome measures, investigation of the mechanism of action of CBT and investigation of prognostic factors for patients participating in CBT-based self-management groups. All of the above factors could be investigated alongside normal clinical practice.”

which they summarize as follows:

1. illness-specific validation of physical outcome measures

2. estimation of the minimal clinically important difference for research outcome measures in CFS/ME

3. qualitative research investigating relevant outcome domains for CBT in CFS/ME

4. investigation of the mechanism of action of CBT, with an aim of improving patient selection

5. research into early management and secondary prevention strategies​

• Also in 2007 the new NICE Guidelines for CFS/ME were published.

• In terms of treatment outcomes this study titled “Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database” involving Crawley and White [5] published in 28 Mar 2013 using the same subset from the CFS/ME National Outcomes Database showed no improvement in physical functioning. This study involved data from 6 treatment centres. This longitudinal study ran from 1 January 2005 to 31 December 2009.

This also ran concurrently with the PACE trial, indeed one of the authors in the Treatment Outcome trial published in 2013, 2 years after the PACE trial results were published in February 2011 was Peter White, Principal Investigator of the PACE trial.

This study also had to be updated for the same ethics reason relating to data use as the previous study mentioned above. There was one correction and one update:

24 May 2013 Correction to methods, results, Tables 3 and 5 and discussion. [6]

3 May 2020 Update to Ethical Approval section of the paper as above.[7] ​

Neither of the longitudinal studys showed improvement in physical function nor employment outcomes This is despite following 2007 NICE Guidance as to the use of CBT and GET as per PACE.

Is it possible that they are simply repeating the cycle from 2002?

• In a paper published 19 Jan 2023 titled “Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome [8] comes 23 years after Dr Gladwell first raised a similar question in this paper.

This time only two of the authors are from Bristol (including Dr Peter Gladwell) and one is from Birmingham.

This, of course, is now two years after the revised guidelines were published in October 2021. However, the study was completed in 2016, and is therefore affected by the GDPR legislation. For that reason the data is no longer available.

That being said, the results paper was clearly not written up until 2022 as is evidence by the more recent references in it. This may have been one of the outcomes from the Science and Technology hearing in 2019 covering the substantial issue that many results of research papers from grants were not being published - transparency.​

A direct linkage from 2000 to 2024 can be made and all the significant events that have detrimentally impacted the patient community involving White, Sharpe, Chalder and Crawley on the much debated question of subjective outcome measures such as these in questionnaires being combined with non objective outcome measures in research.

ALL three pieces of research were in progress at the same time as the PACE trial!

All their questionnaires are out of date because of the new Guidelines and lack of evidence on work and physical function outcome measures.

It seems to me very apparent that White’s indirect involvement in any new clinical PROMs is a feasibility, especially following their objection to the Revised NICE Guidelines and will be used in further research attempting to prop up the PACE trial results - with patient collaboration!

Alternatively, I could just be paranoid, but then I was treated in Bath under both Occupational and NICE guidelines, and activity management and cbt.

Is this one of the reasons the Delivery Plan has not been published yet - so they can include a new PROMS?




[1] The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database | BMC Health Services Research | Full Text (biomedcentral.com)

[2] Correction: The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database - PMC (nih.gov)

[3] Occupational Aspects of the Management of Chronic Fatigue Syndrome: a National Guideline (nhshealthatwork.co.uk)

[4] Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme (nihr.ac.uk)

[5] Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database - PMC (nih.gov)

[6] Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database - PMC (nih.gov)

[7] Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database - PMC (nih.gov)

[8]Full article: Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome (tandfonline.com)

 

I don't think the PROMS project is part of the Delivery Plan. I may be wrong but what I have seen from the working group does not suggest that to me.
It shouldn't be.

 

I am not missing that point at all but there is substantial potential for harm with all sorts of policies and the way they are carried out (like my family member permanently disabled) and we don't actually have any evidence about which is the better one because there are no trials. My point is that there is no zero option with no harms to compare with in real life. Check out Hannah and her fridge on the FND thread!

 

Not keeping up (as usual) had to Google "PROMs" - from the ME Association announcement of the study -
"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"*
Sorry, but "gold-standard techniques" based solely on "patient-reported outcome measures (PROMs)" - non sequitur? Basically you give up at that point - did ME Association miss the PACE debacle?


*
https://meassociation.org.uk/2023/0...nt-toolkit-in-nhs-me-cfs-specialist-services/

 

Sarah Tyson explained what the gold-standard techniques were earlier in the thread.I think they’re applying the gold to the outcome measurement methods.

 

So just for clarity, @FMMM1, they're electroplating a measure of imaginary outcomes.

 

Questionnaires with gold leaf ....

 

Yea the gold is the ME Association funding --- shouldn't take too long to produce substandard work --- quid's in!

 

We have had a reply from the MEA to the letters from the S4ME committee
Open letters to the UK ME Association trustees about a research project developing PROMs, led by Sarah Tyson

 

The reply is worrying.
How can they still have faith in Sarah Tyson after what she said here? It makes no sense.

 

ME Association/Neil:

"Professor Tyson and ourselves are making sure that all the comments from your members will be looked at carefully."


It's Professor Tyson's Comments that the MEA should be looking at carefully.


Edit add:
Does the MEA find it acceptable to fund a project by a professional who is on public record insulting, denigrating and gaslighting ME patients by repeating some of the worst and most damaging jibes devised and used by the BPS Lobby as weapons against us?

 

It seems people at MEA have learnt nothing at all.
And have no understanding of the simple, clear, cogent arguments raised by members here.
They seem to have missed the point that the problem for PWME has not been what flavour of theory someone wants to promote but primarily bad methodology. Thie toolkit has nothing to do with designing trials suitable for changing clinical practice. To use it would be bad methodology.