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

[sarahtyson]

Could you give examples?

I don't get why you need psychometric measurement tools for monitoring patients with ME/CFS.

I think a smart symptoms/ activity diary could be helpful if doesn't need too much time to fill in?

Also with regard to wearables, I agree they have to be validated / adjusted for ME/CFS, but there has been so much progress in the development of them -- why not prioritize adjustment / validation of wearables instead of psychometrics?

Psychometrics refers to the study of the quality of the data obtained. All measurement tools need work to establish that the data they produce is relevant, accurate and reliable. When it comes to implementation in practice/daily life then consideration of their feasibility and acceptability are needed to be credible. I totes recognise that very few measurement tools of any description have completed this rigorous development and evaluation, which isxwhy we wanted to do things properly from the start.

 

[sarahtyson]

Hi Sarah,

Nice to see you here and thanks for contributing and telling us about your background and experiences.

Just so that I can contextualise this could you confirm what 'field' you are coming from when you are mentioning that this is better for 'offering effective services'.

I think knowing 'which services' the focus is perhaps helps to note here, as I assume these will be the measure of those? and their 'effectiveness' etc


I say this because many of us think in terms of medical care, and clinics being monitoring the condition and their health medically as well as potentially other forms of adjustment/support

It might be useful to somewhat 'itemise' which specific bits within this such PROMS aim to cover/measure? And are these things that e.g. a clinic would use to demonstrate 'usefulness' or 'where the money has gone', or are they more akin to the old-style satisfaction or improvement/recovery usage of such data?

I'm not sure there will be a convenient pigeonhole in which to shove me. I'm a physio by background, my main research area has been in stroke and neuro rehabilitation, but I have also worked in other chronic disabling conditions as a methodologist. I generally describe my research approach as a pragmatic mixed methods clinical trialist. Which means I am not attached to any methodological approach. I use whatever methods/designs are needed to best answer the clinical research question. These include rcts, other trial and quantitative methods, movement science, qualitative approaches, epidemiology, systematic reviews and meta-analyses, psychometrics, service evaluations and a little bit of implementation science. One of my main 'lines of enquiry' is/was on the development and implementation of clinical assessment tools. Other top topics are assistive rehabilitation technology; organisation of rehabilitation services and movement science (particularly balance and gait) in neurological conditions.

 

[Shadrach Loom]

I'm not sure there will be a convenient pigeonhole in which to shove me. I'm a physio by background, my main research area has been in stroke and neuro rehabilitation, but I have also worked in other chronic disabling conditions as a methodologist. I generally describe my research approach as a pragmatic mixed methods clinical trialist. Which means I am not attached to any methodological approach. I use whatever methods/designs are needed to best answer the clinical research question. These include rcts, other trial and quantitative methods, movement science, qualitative approaches, epidemiology, systematic reviews and meta-analyses, psychometrics, service evaluations and a little bit of implementation science. One of my main 'lines of enquiry' is/was on the development and implementation of clinical assessment tools. Other top topics are assistive rehabilitation technology; organisation of rehabilitation services and movement science (particularly balance and gait) in neurological conditions.

You might find the gait thread of interest, alongside the other ones that MSEsperanza flagged.

https://www.s4me.info/threads/gait-in-me-cfs.32055/

 

[sarahtyson]

really? the wording implies these 'gold standard' techniques are already known... they arent, at least not by Peter Gladwell, or anyone at Bristol from the reports i heard, or Bacme, although I'm willing to bet he & the rest of BACME believe they know exactly what they are.... and therein lies the problem

Edited to add: Am happy to discover I am wrong, but i'll believe it when i see it

As you may have seen from my replies to other posts, the gold standard approach to developing clinical assessment tools is very well known, and has been widely used for years. Obviously not known here or used by people who developed previous ME assessments but there is a world of research outside the ME bubble. My experience of working with Pete on this grant is that he is knowledgeable about these methods and aware of the many dilemmas and uncertainties. He is very far from believing he knows what is needed but is curious and motivated to find out. I am wondering whether the people who are posting the derogatory comments about him have actually met him.

 

[sarahtyson]

Just came across this paper by Gladwell and a couple of others, not overly encouraging.

https://www.tandfonline.com/doi/pdf/10.1080/21641846.2023.2175579

Apparently I have not been using the reply function effectively so some of my replies are disconnected from the original post and you may not have spotted it.
I'm curious why you find this paper "not overly encouraging ". It highlights the mismatch between pwMEs needs/priorities/concerns and the content of current measures. It makes the case for co-produced patient-centred new tools. What's not to like?

 

[sarahtyson]

If you mean Isle of Man, I think they are mentioned in the context of having a combined ME/CFS and LC service, unlike in some other places where services, if they exist, are separate.

What have the Isle of Man got to do with it? Well ..... Juan Corlett is the Chair of the Isle of Man ME Support. Over many years, IoM ME Support have been working with Manx Care (the IoM health service) to develop a ME service for the IoM. Pragmatically, long-covid has recently been added in to the mix becuase, you know the pandemic. They have developed constructive, collaborative working relationships with all parties, drawn on best practice, and applied the NICE Guidelines to produce an exemplar service. I know Juan through a family friend who is a relative of Juan's. Conversations between us, and then members of Manx Care were the catalyst for this project. Juan is a co-applicant because of his personal experience of ME, exceptional leadership and managerial skills, and experience and know-how of wo

 

[Trish]

Hi Sarah, as I explained, some of us have examined in detail some of Dr Gladwell's and others from his clinic's recent writings about ME/CFS.

I think it's unfair to dismiss these as derogatory comments by people who haven't met him. Perhaps it would help you to understand where I'm coming from if you read the links I gave in a previous post.

Of course I haven’t met him as I'm housebound and don't live in the catchment area of his clinic. Does this mean I can't have valid concerns about his written work on ME/CFS and work by people he has worked with in his clinic?

I am happy to accept your reassurance that he's a thoroughly decent person who works hard and has appropriate skills to work on this project.

 

[sarahtyson]

Link to the letter written by @sarahtyson and @dave30th:
A new paradigm is needed to explain long COVID, Saunders et al 2023


It would be great if you could use the members here as a resource to get feedback on draft toolkits and training materials before things are finalised.

That was the plan, although given the tone of some posts I'm a tad concerned about how constructive any feedback will be, but nothing ventured nothing gained.

This would best be addressed by @rvallee . You’ve quoted my weak pun in reply to his post, thus tagging me rather than him.

Soz, apparently I haven't been using reply function correctly. I assumed all the quotes and brackets were formatting glitches, we live and learn

 

[Shadrach Loom]

Soz, apparently I haven't been using reply function correctly. I assumed all the quotes and brackets were formatting glitches, we live and learn

Xenforo (the forum software) is great if you’ve been using it since the turn of the century, and if your primary device is a steam-powered affair with a mouse and a keyboard. It’s nowhere near as intuitive or mobile-friendly as modern social platforms, though, and everyone has a learning curve with it. I hope you stick around.

 

[Hutan]

There have been lots of instances where institutions that don't understand ME/CFS and related diseases put up their own "pet" patients, who they know will not be challenging. People are just being cautious, on the basis of past experience. BACME has certainly been problematic in the past.

Im not sure who are institutions to which you refer but, I read this post out to my family. The thought of me being anybody's 'pet patient" or that I will not "be challenging" has raised a giggle, so thank you. I realise there is a lot of baggage for everyone whenever ME is mentioned. You probably wont be surprised to know that some BACME members also have historical concerns, war wounds and cynicisms. Tbh I'm not terribly interested in the history, my focus (and the rest of the team) is to work constructively with all parties to develop and improve services and thus pwME's experiences. The times have changes, it is time to move forward.

You misunderstood my comment; perhaps that was my fault. I was not suggesting that you are the "pet" patient. It was a reference to some researchers with a track record in ME/CFS and similar conditions who have validated harmful work with a carefully selected patient advisory group.

 

[Hutan]

I think any assessment of how much physical activity a person can do must include measurement of actual movement, not just questionnnares. Sure it's may not be a linear measure of illness severity, but neither is any questionnaire. Why not develop a measure that combines both?

I agree. It is absolutely imperative that any assessment of people with ME/CFS that is being developed in 2023 involves wearable technologies/actimetry and real time symptom logging. Surveys are time consuming and very subject to manipulation and poor memory. Will you be asking people with ME/CFS how they are monitoring their illness? If you do, I am sure that you will find that many people are using technology to do that. @SNT Gatchaman, perhaps you have a comment on this.

We desperately need some measures in the assessment toolkit (and in research) to be as objective as they can be. If you do get a strong message from people with ME/CFS that wearable technology should be part of the assessment tools, is there scope within your project to investigate these? Or are the only outcomes that are possible surveys?

I am wondering whether the people who are posting the derogatory comments about him have actually met him.

You can report any post that you feel is a personal attack on you or others by clicking on the 'contact moderators' button of the offending post. We aim to ensure discussion is focussed on substance rather than personal characteristics.

 

[Solstice]

Can't partake in the discussion atm, but thanks for engaging here @sarahtyson , means a lot.

 

[Simbindi]

I don't get why you need psychometric measurement tools for monitoring patients with ME/CFS.

This is my immediate thought too.

 

[Trish]

That was the plan, although given the tone of some posts I'm a tad concerned about how constructive any feedback will be, but nothing ventured nothing gained.

We don't tone police, though we do have rules against personal attacks. If you think a post goes too far, please do use the contact moderators button at the bottom of the post.

I think it may help you to see posts in the context of people who have spent years, sometimes decades, missing out on their hopes and dreams, some stuggling even to stay fed and housed, and being gaslighted by a wide range of clinicians and wider society. It's natural and I hope forgivable that sometimes this spills over into comments, or someone get the wrong end of the stick and a comment may seem out of place, or is having a bad day and get the tone of a post wrong - we're all human.

Please don't let this put you off interacting here. We all have the same aim of contributing to better research and support for pwME. Lots of members have valuable insights to contribute and want to participate in research, maybe best to just step around posts that don't seem to you to be in that spirit.

[crossposted with Hutan - as you can see, we're both forum moderators]

 

[Hutan]

Also it is overly simplistic to assume the relationships between pathology; impairment and activity are linear (although I can fully see the attraction of the idea) - in ME or any other complex, multi-faceted disabling condition. So even when we do find a biomarker or physiological marker, and monitor how they change, that will not directly relate to changes in what one is able to do or how one feels. Sorry.

No need to apologise. You aren't responsible for what biomarkers can or can't do. In terms of how my illness affects me, which is what I think your project is concerned with, restrictions on activity and a requirement to spend more time lying down than healthy people do is a substantial part of that. If you ask me how much time I spent lying down, or how active I was, over the last week, I will have difficulty telling you. And I have better things to do with my limited activity time than trying to remember, not least because wearable technology can do that job.

See for example this site; it was on the first page of a google search. It's probably not the best; I'm sure there are lots of companies out there offering similar things. This company's products can report body position, for example, as well as various sorts of activity. It says it's for clinical research and remote monitoring of patients.

Empatica, an MIT spin-off, is a pioneer in offering continuous, passive, and unobtrusive monitoring for patients with neurological conditions.
We build software and algorithms to advance understanding of human behavior through wearable sensors. Our technology empowers thousands of patients, clinicians, and researchers with real-time human insight, driven by physiological and behavioral biomarkers.

I realise there is a lot of baggage for everyone whenever ME is mentioned. You probably wont be surprised to know that some BACME members also have historical concerns, war wounds and cynicisms.

I am sure that there are some people associated with BACME who have felt discomfort when BACME guidance for clinical care has been criticised for increasing stigma, for its lack of evidence and logic and for its capacity to cause harm. It's not reasonable to imply that that discomfort is in any way equivalent to the harm that BACME has caused to people with ME/CFS, even up until very recent times, or that people with ME/CFS should have empathy with the hurt feelings of the people who wrote that very poor material. Hopefully that's not what you meant. Hopefully those particular authors have moved on to other things.

I hope that you will stick around, and read some of the links that members have put in posts. Some good objective assessment tools could make a big difference.

 

[josepdelafuente]

Good to have you here @sarahtyson

 

[MEMarge]

Hi @sarahtyson, so pleased that you are on here and that your experience of working with Peter are so positive.

I will repond more when I have time.

 

[SNT Gatchaman]

Will you be asking people with ME/CFS how they are monitoring their illness? If you do, I am sure that you will find that many people are using technology to do that. @SNT Gatchaman, perhaps you have a comment on this.

Thanks @Hutan and Hi @sarahtyson. I'm an (increasingly less!) new patient at just over 2 years. Presumed long COVID -> ME, essentially housebound but able to work half-time from home. I have found wearable technologies helpful to assist pacing. I appreciate the informed comment on the lack of linearity between objective markers of function and subjective dis/cap-ability and symptoms. I don't know how to judge my stabilisation and symptom reduction against the contributions of effective pacing and any partial recovery in whatever the biological pathophysiology is.

Having the device monitoring me in the background is good vs the active effort of, say, a diary. Over the day my resting, average and max HRs are monitored, with an alert if unfavourable. HRV is interesting to observe but I'm not sure it matches usefully for me. By the time it's particularly low I would already feel the physiological 'jitteriness' and note the tachycardia.

Step count, distance and active energy monitoring are low-hanging fruit for staying within my energy envelope. They would be unhelpful for the bedbound person, but suit my situation. Overnight pulse oximetry via the watch has also shown interesting changes over my time. Initially I would apparently have significant overnight desats, but this no longer seems to happen for the last four-six months, last time I assessed (I'll re-check this again).

The other interesting facet of the wearable technology (latest iPhone and Apple Watch in my case) is the walking speed and gait assessment. If you do enough steps it will estimate your projected 6MW: presumably via stride length and walking speed, but also double-support time and some other mobility parameters. I expect this is fairly crude compared to research tools, but the phone's co-processor (gyrometer, accelerometer) might give useful data for a cohort over time, and while not cheap, it's available at scale.

During my ups and downs I was interested to see some of this background data: some I've previously posted here and here. I appreciate your points about limited accuracy with wearables though. I'll be interested to follow your further comments on this thread and wish you the best with a successful project.

 

[Hutan]

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.

It sounds as though you already have a very clear idea of the concepts you want to measure @sarahtyson. Maybe it would help make the conversation more productive if you listed the concepts?

Given the aims seem to include producing a top quality clinical assessment toolkit as well as PROMs, it sounds as though there is potentially scope to make use of wearable monitoring technology.

 

[JemPD]

Edited to add: this & my next post took me 2 hrs to write lol so i now see some of my points have been better expressed already by Trish etc, but i havent the strength to go through & edit/requoite

As you may have seen from my replies to other posts, the gold standard approach to developing clinical assessment tools is very well known, and has been widely used for years.

Ohhh! I read the release differently. See my bolding in the following quote...

"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."

i read it as meaning that gold standard techniques were going to be applied to the treatment/monitoring of PwME, & then tools were going to be developed to measure the outcomes for said treatment. Not that the gold standards were going to be applied to the development of the PROMS/toolkit!

So what i thought was happening was that a physio from the Bristol clinic was going to say what the 'gold standard' was for treating/monitoring PwME (from his experience in the clinic) and then an outcome measure was going to be developed to get patient feedback on that.

ie it was going to be yet more of what we've seen before - something which in my vernacular paraphrasing would go something like this ''we have been treating PwME in our clinic for years & we know just how to do it really well (gold standards), so we're going to document that in an official toolkit & we're going to develop some OM (questionnaires etc which are hideously prone to bias) so we can prove how brilliant it is, & then that can be given to all clinicians so everyone is singing from the same hymn sheet."

But i now see that the press release really means that youre going to be
applying 'gold-standard techniques to the development of patient-reported outcome measures'.
Doh! my bad. I misunderstood. Apologies.

And of course as you point out, i dont know much about that. And you clearly do, so i accept & am encouraged by your assurance that tools exist for other conditions which are working well & can be worked with to develop better tools for use with PwME.

I wonder if i am the only one who interpreted the MEA press release that way? Possibly, my congitive function was poor the day i read it.

I should have given the MEA the benefit of the doubt but the whole nightmare & trauma of what has happened over the yrs and the harm that has been done to me has given me a hair trigger. I'll try to be more careful to make sure i understand in future.

So just to clarify my comment about Dr Gladwell/BACME not knowing what the gold standard is but thinking they do....

was about the years of harm done to PwME through clinics while thier clinicians & prominent CBT/GET proponents talk about how they know all about ME/CFS and how to treat it.
Even 'top blokes' can inadvertently do harm (i'm not suggesting that Dr Gladwell himself has done harm, I dont have enough info for that, simply that being a top bloke doesnt mean you cant do harm inadvertently)
- the number of lovely, compassionate well meaning people I met & have communicated with over the yrs, & whose work i have read, who hold to the psychosomatic/deconditioning paradigm of ME, &think it can be reversed with CBT/GET is staggering. And frankly, while i would not want to be derogatory about any of them personally, because i know they would be mortified to think they had harmed anyone & truly believe they are helping, i'm afraid i do feel derogatory about their work, no matter how hard they work or how great they are as people).

And as @Trish commented here

To explain my concerns, I understand he wrote the 2020 AfME guide to pacing,
https://www.actionforme.org.uk/uploads/pdfs/Pacing-for-people-with-me-booklet-Feb-2020.pdf
which we discussed in detail on this thread:
https://www.s4me.info/threads/pacin...oklet-revised-and-updated-january-2020.13320/
As you can see our members had significant concerns about it. My comment about it is here:
https://www.s4me.info/threads/pacin...d-and-updated-january-2020.13320/#post-232201

i was really worried because of what we'd seen before in the AfME stuff.

However

My experience of working with Pete on this grant is that he is knowledgeable about these methods and aware of the many dilemmas and uncertainties. ... He is very far from believing he knows what is needed but is curious and motivated to find out.

(my bolding)Thats great & encouraging.

I am wondering whether the people who are posting the derogatory comments about him have actually met him.

As i said it wasnt intended to be derogatory about Dr Gladwell himself, & it was based on a misunderstanding of the project, but i do see it can easily be read that way. The validity of criticisism/scepticism about a person's work shouldnt be dependant on having met them personally, but i can see my comment came across as personal & a derogatory comment. I apologise, that wasnt my intent. And its a timely reminder of the fact that when i comment here i am not only talking to friends who know me well & can intuit my tone & intent, (which was worried & concerned rather than derisive) but also strangers and the people i might be commenting about. Its easy to forget & i'll try to be more aware in future.