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

The COvid-19 scale is a general overall measure. It may be useful to show overall change over time to measure outcome and useful for service evaluation and development, also reporting treatment outcome but lacks the detail we seek which will (probably) cover symptomology, activity, needs, Possibly mood and sleep as separate scales to symptomology, patients' needs and patient experience/satisfaction. The statistical approach is the same as that used in the C19 measure but the content will be very different

Thank you for confirming Sarah, it is interesting to just help try and get my head around/picture it. The more I think about it and try and do so the more complex I realise it all is for you :)
 
Im not disagreeing that the prospect of using 'wearables' to measure activity in everyday life is very appealing, which is why I have spent about 20 years trying to do so in both clinical trials and clinical practice. To cut a very long story short, in my experience there are none available that have the level of approval to use in the health care setting (the MRHA in the UK); produce the quality of data needed for use as an outcome or clinical measure; and/or is accessible and compatible with NHS or university IT systems; cover the parameters that are important to sufficient numbers/ breadth of patients to be useful as a clinical measure; reliable/feasible and acceptable for all patients to use; are of a suitable cost; quick and easy to collect, download and interpret the data at a service level. etc etc etc etc.

I know that many pwME use technologies to monitor and better understand their condition, I do myself. But one does not have to spend very long on discussion groups about them to realise there is huge variety in what people use and how they use them. They can be very useful for individuals to use (although there are also many reports of pwME not finding them useful in the same forums) but there is a huge difference between something being used for a individual level and at a service level.

As an aside, I am about submit a paper with Physios4ME about our study looking at the feasibility of assessing physiological measures during everyday activities (as a possible alternative to 2day CPET), I can't go into details until published but we (unsurprisingly) found many abnormalities indicating a disordered physiological responce to activity but the responses were highly varied, so the choice of what to measure, when, how and when is much more complicated and variable than one would hope. There would need to be much more investigation to work out how to match up the parameter, the technology, the extent to which activity (during measurement) needs to be standardised, and interpretation. I do hope that this work will be done and that we will have a physiological biomarker one day, but in the meantime I am getting on with work that can /will make a difference to practice and pwME in much shorter time frame. It would be preferable, rather imperative, for technology to be used to measure/monitor activity if the suitable technology was available, but it isn't. If it were available, it would be used mainly as an outcome measure, which as I have explained earlier is only one small part of clinical assessment. Q'aires are actually much more useful to specify the nature and severity of patients' problems, identify needs and priorities. This is the sort of information that is needed to develop goals, formulate treatment plans, assess outcome and patient satisfaction, and develop and evaluate services.

Will we be asking whether pwME monitor their condition? Possibly, it may come up in the needs assessment.
I know q'aires can be time consuming to complete, which is why feasibility and acceptability is one of the top issues we will be addressing. The PROMS will be designed to be as quick easy as possible to complete.
No there isn't scope to include wearables/'technology' is this project as it is not part of the aim/objectives/research question, requires a different method and resources I do not have access to.


I'm really glad that you've been involved in this and bring that on-the-ground experience. I find/think the work towards developing physiological measures in a home environment one of the most important things in making sure we get to the bottom of the condition, but imagine it isn't 'the easy way/road' to do research so am watching all of this with interest for what is learned from it both in data but also the insight it provides on what is possible or tricky things to watch out for with different methods etc.

I imagine that there are lots of catches and issues that you can only anticipate from being there and trying to deal with them at the time, so it is such important work which should represent quite a big move forward in innovation and I hope that more will be funded to keep this developing.
 
I agree comp1ete1y with the need for objective data. However, the rea1ity in Eng1and is that these ME/CFS services are not fit for purpose so there's no chance that they wi11 be interested in measuring objective outcomes. So it's not I don't agree with you @Hutan, just I'm cynica1 about the who1e project of service eva1uation when the funding is dire and what these services offer is ad hoc across various areas of the UK (service 1eve1 is not determined at nationa1 1eve1, but a11 the services are time 1imited and most don't accept any patient who can't trave1 and engage in their 'set activities').
Bravo Jonathan... you echo my thoughts entirely. So what is happening, where is the DHSC NICE GRIP development going?

Slow boat to China comes to mind!
 
ME Association email newsletter:

We need people with ME/CFS to help with a research study!

The ME Association is funding a study led by Prof Sarah Tyson of University of Manchester (who has ME/CFS) to develop a clinical assessment toolkit for use by ME/CFS specialist services.


The research will be completed in collaboration with people with ME and clinicians who work in ME/CFS specialist services. It will use gold-standard techniques to develop a range of patient-reported outcome measures (PROMs).


Prof Tyson’s work with other long-term disabling conditions has shown that using these types of assessment can help to evaluate and monitor the nature and severity of symptoms, activity levels, identify patient need (which forms the basis of goal setting and treatment planning), and monitor progress. There will also be a patient satisfaction measure that will contribute to service development.



To achieve this, the PROMs need to be carefully developed to ensure they cover the full range of symptoms and disabilities that are found in people with ME, are easy to use, and produce accurate and useful information.


Read more about the research study




PwME Advisory Group


In the first stage of the project, we want to establish a People with ME Advisory Group.


Members will act as a sounding board to develop the content and format of the PROMs to ensure they include questions that are relevant and important, and that any instructions are easy to understand and complete.


The Group will meet and share their views virtually by email, group video meetings or individual meetings by video or phone, according to the task and member’s preferences. The meetings will be spread across several months and we hope to begin them later this summer.


To join the Group you must have a diagnosis of ME/CFS and be over the age of 18. We want to include a range of experiences. If you are interested please complete a short form that will allow Prof Tyson to select members.


The closing date for applications is 30 June 2023

Prof Tyson will review all applications and will let successful candidates know early next month. We hope the first Group meeting will occur later in July.


Please complete the application form
 
The link for PAG application form now says they have had enough responses and they have closed the process

so it is positive there has been a good response but they have closed it two weeks early. I hope there aren’t people spending precious energy working on applications who don’t know the process has been cut short.
 
I've replied to the MEA newsletter email with this:
Dear ME Association,

I received this notification yesterday that the closing date for applications for the PAG for this MEA funded research is 30th June. This was the first I had heard of the application process being opened.

I now understand that applications are closed with a message that they have sufficient applicants. I would like to politely request that this be reconsidered immediately and applications reopened, as there will be good applicants working on their applications in good faith who have now been shut out of the process.

I would be grateful if you could let me know that you have received this email and acted on it.

With best wishes,Trish Davis
 
I have just looked back over this thread and re read the initial MEA article that did have a link to 'take part' but didn't make it clear what taking part meant. I guess I wrongly assumed more info on a PAG or some other form of 'taking part' would be forthcoming later. That link now also says they have enough applicants.

The email newsletter received yesterday that gives more information on the PAG indicated clearly that applications are open would and close on June 30th. I assumed that was an accurate invitation to apply to join the PAG. I don't remember anywhere it saying applications would close earlier if sufficient applications had been received.

I did apply in time, but nearly decided to leave it for a couple of days before making a decision. I know someone else who took a few hours longer to consider, but found they were too late.
 
I have just looked back over this thread and re read the initial MEA article that did have a link to 'take part' but didn't make it clear what taking part meant. I guess I wrongly assumed more info on a PAG or some other form of 'taking part' would be forthcoming later. That link now also says they have enough applicants.

The email newsletter received yesterday that gives more information on the PAG indicated clearly that applications are open would and close on June 30th. I assumed that was an accurate invitation to apply to join the PAG. I don't remember anywhere it saying applications would close earlier if sufficient applications had been received.

I did apply in time, but nearly decided to leave it for a couple of days before making a decision. I know someone else who took a few hours longer to consider, but found they were too late.


There is another issue here. Consideration for the severely affected.
This morning I did a literature search on PROMS.

https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2175579
Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome
Bethan Jones
,
Corin Bourne
&
Peter Gladwell

Received 04 Oct 2022, Accepted 19 Jan 2023, Published online: 07 Feb 2023


Danger of suitability and use of PROMs!

Full article: Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome
References NHS clinics following 2007 NICE...!

https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2175579#:~:text=Limitations of this,be quite different.

"Limitations of this study relate to the sampling method.
For example, sampling from an outpatient service will have excluded potential participants who are being impacted by activities they are no longer able to do, because they are not well enough to complete and return the questionnaires, or even access the service in order to have been eligible to complete the questionnaires.

Therefore, patients severely affected by ME/CFS may not have the energy resources to participate and are excluded from research as a result.

We cannot assume that the participants are reflective of the wider population of patients living with ME/CFS who have not accessed the service for other reasons, for example as a result of inequalities of access as a result of protected characteristics such as learning disabilities, and ethnic background.

We also have a limited catchment as a result of being based in England, and the list of impacted activities in different populations around the world could be quite different."
 
I've replied to the MEA newsletter email with this:

it is a fair point re demographics that you want included too: those who are more severe often get implicitly cut out by things like this as even a long-seeming deadline would require a lot of pacing and they’ve a harder to describe situation, those with more experience would also need more time as they have more to write ironically meaning they’d be disadvantaged by early closing, ditto for those who are having to continue to work or have responsibilities above their level of mE who are exactly who need to be included as the reality for most younger people has been that dire situation where pacing is made impossible whilst advice ‘in theory’ might be given to the person because employers and other services aren’t onboard.

I’ve seen early closing happen a few times, including the physios for ME pilot for the home one so it isn’t specific to this and obviously over application is an issue which needs to be flagged so future projects for ME can bear this in mind when designing processes. First come first served doesn’t feel an ideal for getting the best cohort for many things. I don’t know how you’d filter down using other criteria but it would be possible and maybe I’d an ME-sector issue to discuss.

I do think having some ME methods groups ongoing that overarch all projects and charities etc snd just can note these issues, along with issues such as infouencability and exclusion of those more severe being better understood eg in those who just think throwing many long surveys at people to fill out is fine or doing a focus group at pace and timing of well people etc - so lots of really fundamental stuff for it to discuss to ensure the more severe and experienced don’t get paternalists by those more well and in better situations who perhaps would bring the reality such people could of the on-the-ground situation of unsupportive family partners financial situations etc that might be more if the norm than exception gif those with ME.
 
There is another issue here. Consideration for the severely affected.
This morning I did a literature search on PROMS.

https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2175579
Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome
Bethan Jones
,
Corin Bourne
&
Peter Gladwell

Received 04 Oct 2022, Accepted 19 Jan 2023, Published online: 07 Feb 2023


Danger of suitability and use of PROMs!

Full article: Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome
References NHS clinics following 2007 NICE...!

https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2175579#:~:text=Limitations of this,be quite different.

"Limitations of this study relate to the sampling method.
For example, sampling from an outpatient service will have excluded potential participants who are being impacted by activities they are no longer able to do, because they are not well enough to complete and return the questionnaires, or even access the service in order to have been eligible to complete the questionnaires.

Therefore, patients severely affected by ME/CFS may not have the energy resources to participate and are excluded from research as a result.

We cannot assume that the participants are reflective of the wider population of patients living with ME/CFS who have not accessed the service for other reasons, for example as a result of inequalities of access as a result of protected characteristics such as learning disabilities, and ethnic background.

We also have a limited catchment as a result of being based in England, and the list of impacted activities in different populations around the world could be quite different."


This is so important and I have real bee in my bonnet about the severe being properly included with design of research and patient input focusing on being doable for them and not the other way around as there are accessibility issues. Services need to be built in the more severe and experienced not the luckier (situation-wise) and milder or who’ve less to contend with (e.g. issues of finance, employers, other support) so design needs to focus on getting the right people into the design process, in order that when and should those get worse or have such issues it is there or anticipated or understood rather than a service that can only deal with 'non-complex' when that really hardly exists long-term. It is all tickety boo often with supporters or situations until people actually need to ask for adjustments or say no to something or situation changes and that disability actually means you can't just pretend-norm with a smile on your face then go home and crash - and if services don't know that things get severe and worse then we'll still end up having the over-optimistic and brave-faced don't worry everyone else comes first stuff because patients won't realise how important it is they avoid a decline.

This is an issue with many groups yoo where milder members do not even realise they paternalism by having barriers to participation and when someone struggles with their speaking might finish their sentence or listen less making assumptions for them rather than realising how precious such little insights from the horses mouth are and how you need to put effort into hearing.

there is nothing fir severe currently which is ridiculous for a medical disease and means those who are milder have their treatment in a loop because no one who is worse is seen so people think mild is as bad as it gets and don’t understand the very difference disease ME is when you are over threshold and worsened vs in fortunate situations when mild. We will never be believed of the illness not minimised if pwme don’t get behind those who are severe being helped to have places on these things rather than wanting the voice themselves not realising they need those who are worse to show ‘this is what happens if mild/moderate get over exerted and asjustments etc don’t happen’
 
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There is another issue here. Consideration for the severely affected.
This morning I did a literature search on PROMS.

https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2175579
Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome
Bethan Jones
,
Corin Bourne
&
Peter Gladwell

Received 04 Oct 2022, Accepted 19 Jan 2023, Published online: 07 Feb 2023


Danger of suitability and use of PROMs!

Full article: Evaluating the ability of patient reported outcome measures to represent the functional limitation of people living with myalgic encephalomyelitis/chronic fatigue syndrome
References NHS clinics following 2007 NICE...!

https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2175579#:~:text=Limitations of this,be quite different.

"Limitations of this study relate to the sampling method.
For example, sampling from an outpatient service will have excluded potential participants who are being impacted by activities they are no longer able to do, because they are not well enough to complete and return the questionnaires, or even access the service in order to have been eligible to complete the questionnaires.

Therefore, patients severely affected by ME/CFS may not have the energy resources to participate and are excluded from research as a result.

We cannot assume that the participants are reflective of the wider population of patients living with ME/CFS who have not accessed the service for other reasons, for example as a result of inequalities of access as a result of protected characteristics such as learning disabilities, and ethnic background.

We also have a limited catchment as a result of being based in England, and the list of impacted activities in different populations around the world could be quite different."


Yes forms like this often have tables collecting info on these characteristics for monitoring of minorities of equality and yet no standard exists for the condition itself
 
ME Association email newsletter:

We need people with ME/CFS to help with a research study!

The ME Association is funding a study led by Prof Sarah Tyson of University of Manchester (who has ME/CFS) to develop a clinical assessment toolkit for use by ME/CFS specialist services.


The research will be completed in collaboration with people with ME and clinicians who work in ME/CFS specialist services. It will use gold-standard techniques to develop a range of patient-reported outcome measures (PROMs).


Prof Tyson’s work with other long-term disabling conditions has shown that using these types of assessment can help to evaluate and monitor the nature and severity of symptoms, activity levels, identify patient need (which forms the basis of goal setting and treatment planning), and monitor progress. There will also be a patient satisfaction measure that will contribute to service development.



To achieve this, the PROMs need to be carefully developed to ensure they cover the full range of symptoms and disabilities that are found in people with ME, are easy to use, and produce accurate and useful information.


Read more about the research study




PwME Advisory Group


In the first stage of the project, we want to establish a People with ME Advisory Group.


Members will act as a sounding board to develop the content and format of the PROMs to ensure they include questions that are relevant and important, and that any instructions are easy to understand and complete.


The Group will meet and share their views virtually by email, group video meetings or individual meetings by video or phone, according to the task and member’s preferences. The meetings will be spread across several months and we hope to begin them later this summer.


To join the Group you must have a diagnosis of ME/CFS and be over the age of 18. We want to include a range of experiences. If you are interested please complete a short form that will allow Prof Tyson to select members.


The closing date for applications is 30 June 2023

Prof Tyson will review all applications and will let successful candidates know early next month. We hope the first Group meeting will occur later in July.


Please complete the application form

The form is no longer available. Does anyone have a copy? Trish?
 
No, I didn't keep a copy. It was quite short, asking things like severity level, and what method of communication you can use (zoom, email or phone), and she asked for a general statement of why you want to participate, or something like that.

I have been in touch with @sarahtyson about the early closing of applications and she said she received over 150 in a few hours, so that's why she closed it early. I disagree with that decision, but it's not up to me.
 
I have been in touch with @sarahtyson about the early closing of applications and she said she received over 150 in a few hours, so that's why she closed it early. I disagree with that decision, but it's not up to me.
I suspect this high number is an indication of how bad1y the professiona1s have done so far and how 1itt1e they understand patients with ME/CFS. I'm not sure you wou1d get this c1amouring from patients to participate in this sort of research in other medica1 conditions.
 
I think you're probably right, Simbindi. I just hope the hasty applicants are also good applicants.

It seems to me likely that those with more knowledge and understanding of PROMS and their pitfalls may also be those who gave themselves more than a few hours to consider carefully the wording of their applications, and to discuss with their carers and families the sort of time commitment likely to be required of them in order to make a worthwhile contribution. People who rush applications (including me in this case) aren't necessarily the best applicants.
 

Do we have a thread specifica11y for this question? If not, maybe it wou1d be worth having one separate to this discussion, but that can inform it.

I have copied the NICE research recommendation onto this thread:
Questionnaires - design, validation and use in ME/CFS research - discussion thread

@sarahtyson you might like to read that thread.

I would draw particular attention also to this Norwegian work on a questionnaire:
Norway: Developing a new questionnaire for classifying the level of functioning in pwME/CFS
 
Dear All
I'm afraid it is beyond my technical skills to work out how to reply individually but to explain why we closed applications to the advisory group.... am advisory group usually has 6-12 members and I thought some extras would be helpful as it is likely that not everyone will be able to engage all of the time. So I was planning of recruiting ~20 people. When working with people with other conditions I would expect this to take several weeks. Hence the original closing date. But we got ~150 applications within a few years. So, having checked we have applications covering all the characteristics we wanted to include people with very/severe ME, I closed the applications to prevent more people spending their energy on an application with very little chance of success and my energy demands too. To choose members I propose to pick names from a hat until we have good representation of all the characteristics. I'll be contacting folk over the next couple of weeks
Yes Trish, we have your application and ANO who mentioned Science For ME.
Yes, I've seen the read on the Norwegian measure, which was very helpful and thought provoking.
 
Thank you very much for explaining, @sarahtyson.

I think I was imagining a PAG with a more in depth involvement in the whole research process - ie a smaller group with some relevant expertise beyond their own experience of living with ME/CFS. More like in DecodeME.

It sounds from your description of how you will choose the participants that it's going to be something different but still useful. This isn't a criticism. Getting patients of all severity levels to test and comment on what you design will I'm sure be very valuable.
 
Thank you very much for explaining, @sarahtyson.

I think I was imagining a PAG with a more in depth involvement in the whole research process - ie a smaller group with some relevant expertise beyond their own experience of living with ME/CFS. More like in DecodeME.

It sounds from your description of how you will choose the participants that it's going to be something different but still useful. This isn't a criticism. Getting patients of all severity levels to test and comment on what you design will I'm sure be very valuable.

Trish - we already have a group who are doing this. All of the research team (ie the co-applicants on the grant) except the statistician have personal experience. They work with me to oversee hte whole research process. The aim of the advisory groups is specifically to inform the the development of the tools
 
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