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

[Ash]

Hi Ash

Im trying to understand where you are coming from.

Are you?

 

[Hutan]

Bearing in mind that CFS clinics use stuff like Chalder questionnaire HADs etc having a product that can be used to move them away from that will be better. I don’t claim this is an ideal solution but having a framework that actually focusses on the symptoms pwme experience, how ME impacts on their lives, and attempts to cover PEM is better than the status quo. It’s like the NICE guidelines, an incremental improvement.

In the absence of a biomedical breakthrough incremental change has value.

I'm not sure this has net value though. It might be better than the Chalder questionnaire, but, when we say, this still isn't great, we want objective measures of activity and gait and reaction times in order to assess any interventions and to gather useful data on disease course, we'll get told 'oh, this was very carefully developed by a team including a person with ME/CFS, and there was a lot of consultation with people with ME/CFS.

I register your cynicism about our collaboration with PwME (I don’t use the phrase patients, as few of us are patients) and clinicians, and probably most other things too. All I can do it assure you that this project is led by people with ME, delivered by PwME, and informed by PwME at every stage. The advisory groups have contributed to every stage of the project and their input, plus that of the participants who have given their feedback has been invaluable in shaping the running of the project and the PROMS that will be the final outputs. I realise there will always be people who prefer to sneer, and deride any efforts to improve things, but webvare giving it our best shot.

We'll get told 'We've spent research money on it, we've put so much effort into it, so we need to try to bed it down in the clinics and make it a success...'

And the prospect of any real progress, progress that could also be useful elsewhere in the world, gets kicked down the road.

A tool that is highly open to interpretation, and therefore open to influence by clinicians who want to prove that their 'rehabilitation' efforts have been useful, will be used to make 'rehabilitation' efforts appear more useful than they are. Scarce health funding will continue to be wasted on efforts that don't make a significant positive difference.

Why do you consider goal setting and treatment planning ominous? They are the cornerstones of rehabilitation.

Because, in the context of ME/CFS, they are largely a waste of money and patient effort. What treatment? There is no useful treatment. People with ME/CFS can largely work out how to pace, provided there are supports that allow them to choose to not work/not attend school and, if necessary, get help with tasks of daily living. But, it isn't a magically and mathematically precise thing. We've had plenty of discussions here, and it is clear that pacing is mostly muddling through, trying to do what has to be done while minimising the incidence of PEM, based on previous experience.

Here in New Zealand, we have no ME/CFS clinics to speak of, in fact almost no ME/CFS specialist clinicians. People with ME/CFS look online for information about pacing, they may attend meetings run by patient support groups. I honestly don't think people with ME/CFS here are worse off than people with ME/CFS in the UK. I have not got any sense of that from the discussions here on the forum. Actually, we have been mostly protected from clinicians who incorrectly imagine that they can help, and so have probably been better off.

People with 'mild' ME, have short lived PEM. When I'm having a good spell, my PEM lasts minutes or a couple of hours. Fatigability isn't a term I have come across before in this context. How do you define it? How does it differ from PEM? ?

Fatiguability is mentioned in the literature and it is discussed on the forum. I am astonished if it isn't well known among ME/CFS professionals.
To give an example, my arms will get very heavy and not work so well when I am hanging out the washing, when they didn't before I got ME/CFS, and in fact they don't usually even now. Sometimes, I need to make a conscious effort to walk up a couple of steps up to the back door, I can feel the thigh muscles straining with the effort, when they don't usually. When that happens, I know I have overdone things, and need to rest. To me, that isn't PEM though. As Trish says, PEM is a crash, it is when I can't do anything but lie in my bed and wait for it to pass.

Do really you think that HCPs should not document the patients’ problems, or record their assessments, treatments or outcomes?

What treatments? Pacing is not a treatment. Of course assessments and outcomes are useful, but objective ones will be most useful and least subject to manipulation. Assessment and outcomes are much worse than useless if they are misleading.

But how do you work out that providing information that enables professionals to better understand what an individual is going through disadvantageous?

When the information doesn't enable professionals to better understand, but instead serves only to confirm what they want to hear.

The information from a PROM is used, along with the rest of the assessment to identify the patients’ main symptoms, impairments, activity limitations, and in conjunction with the patient, decide their priorities and goals and devise a treatment plan. That is the point and process of clinical assessment. The effect of the treatment plan needs to be evaluated and monitored – to see if it working and thus whether to continue to whether to change tack. And monitoring is needed to check how the effects of any treatment, and the patients’ status in terms of the effects of their illness is going over the longer term. I fail to see in what way it is manipulative or exploitative, let alone a con or swindle. It is, in fact, the way in which clinical practice for chronic disabling conditions works the world over, and a professional requirement to do so, professionals would be struck off it they didn’t do it.

Again, what treatment, for the treatment plan?

Suggesting that what rehabilitation professionals do is going to achieve anything much more positive than what is achieved by ensuring that people have financial support to allow them to live while reducing work hours (perhaps to zero), a caring GP, links to useful information about pacing and the contact details for online and in-person support groups, and assistance with the tasks of daily living as needed is, for the most part, a con. There is no evidence that suggests otherwise.

The challenge we face is to to find some wording, or format that accommodates as many people's understanding and preferences as possible. They are many, and varied, and quite often contradictory. To date, it has been a bigger issue than for the previous study (which focussed on people's symptoms). Hopefully as more feedback comes in, the way forward will become clearer.

I know the MEA has funded this work, and there are contractual obligations to complete it. I know the the people involved are trying hard, and are working in good faith. But, the concept of it is fundamentally flawed. It's a waste of effort. Subjective assessments of function in ME/CFS are too unreliable, too subject to wishful thinking and misinterpretation and manipulation. The best outcome would be for the people involved to understand this, stop the project, and report that objective outcomes need to be developed.

 

[Amw66]

I'm not sure this has net value though. It might be better than the Chalder questionnaire, but, when we say, this still isn't great, we want objective measures of activity and gait and reaction times in order to assess any interventions and to gather useful data on disease course, we'll get told 'oh, this was very carefully developed by a team including a person with ME/CFS, and there was a lot of consultation with people with ME/CFS.


We'll get told 'We've spent research money on it, we've put so much effort into it, so we need to try to bed it down in the clinics and make it a success...'

And the prospect of any real progress, progress that could also be useful elsewhere in the world, gets kicked down the road.

A tool that is highly open to interpretation, and therefore open to influence by clinicians who want to prove that their 'rehabilitation' efforts have been useful, will be used to make 'rehabilitation' efforts appear more useful than they are. Scarce health funding will continue to be wasted on efforts that don't make a significant positive difference.


Because, in the context of ME/CFS, they are largely a waste of money and patient effort. What treatment? There is no useful treatment. People with ME/CFS can largely work out how to pace, provided there are supports that allow them to choose to not work/not attend school and, if necessary, get help with tasks of daily living. But, it isn't a magically and mathematically precise thing. We've had plenty of discussions here, and it is clear that pacing is mostly muddling through, trying to do what has to be done while minimising the incidence of PEM, based on previous experience.

Here in New Zealand, we have no ME/CFS clinics to speak of, in fact almost no ME/CFS specialist clinicians. People with ME/CFS look online for information about pacing, they may attend meetings run by patient support groups. I honestly don't think people with ME/CFS here are worse off than people with ME/CFS in the UK. I have not got any sense of that from the discussions here on the forum. Actually, we have been mostly protected from clinicians who incorrectly imagine that they can help, and so have probably been better off.



Fatiguability is mentioned in the literature and it is discussed on the forum. I am astonished if it isn't well known among ME/CFS professionals.
To give an example, my arms will get very heavy and not work so well when I am hanging out the washing, when they didn't before I got ME/CFS, and in fact they don't usually even now. Sometimes, I need to make a conscious effort to walk up a couple of steps up to the back door, I can feel the thigh muscles straining with the effort, when they don't usually. When that happens, I know I have overdone things, and need to rest. To me, that isn't PEM though. As Trish says, PEM is a crash, it is when I can't do anything but lie in my bed and wait for it to pass.



What treatments? Pacing is not a treatment. Of course assessments and outcomes are useful, but objective ones will be most useful and least subject to manipulation. Assessment and outcomes are much worse than useless if they are misleading.



When the information doesn't enable professionals to better understand, but instead serves only to confirm what they want to hear.


Again, what treatment, for the treatment plan?

Suggesting that what rehabilitation professionals do is going to achieve anything much more positive than what is achieved by ensuring that people have financial support to allow them to live while reducing work hours (perhaps to zero), a caring GP, links to useful information about pacing and the contact details for online and in-person support groups, and assistance with the tasks of daily living as needed is, for the most part, a con. There is no evidence that suggests otherwise.



I know the MEA has funded this work, and there are contractual obligations to complete it. I know the the people involved are trying hard, and are working in good faith. But, the concept of it is fundamentally flawed. It's a waste of effort. Subjective assessments of function in ME/CFS are too unreliable, too subject to wishful thinking and misinterpretation and manipulation. The best outcome would be for the people involved to understand this, stop the project, and report that objective outcomes need to be developed.

This

 

[Amw66]

NG 206 . Care and support plan , managing symptoms .
Not a treatment plan - this terminology is obsolete.

I haven't looked at the questionnaire . I'm a carer and could not accurately respond . Some form.of assessment tool which is an accurate reflection of the impacts of this illness and doesn't suffer from the inbuilt ceiling effects of others is sorely needed , and I hope that something positive, specific enough and accurate can come of this .

However from the thread this looks like it's trying to be something for everyone , and that never works out well You can't keep everyone happy all the time and in trying to do so you may end up with a toolkit that lacks tools, or has the wrong tools.

My daughter is borderline moderate/ severe and we are acutely aware it would not take much to tip into severe.
Whilst there are event triggered crashes , cumulative effects ( from all types of input ) are insidious , more difficult to track , less acknowledged, and probably drive more PEM episodes ( I would vouch generally not just in my family). Is this not widely known within HCP circles ?

PEM is not simply symptom exacerbation - this is misinformation which belittles it's effect . It's not a simple ramping up ( even with bells on), pwME commonly report additional " PEM only " symptoms and these may differ between physically induced or cognitively induced PEM. That this is not acknowledged at this stage for a potential toolkit is worrying.

Life simply gets in the way - a support and care plan should seek to reduce life's impacts as has been mentioned by others - this is not treatment, but the provision of the kind of support that reduces social burdens - aids, accommodation ,financial support . .....

There is too much of a gulf between mild and severe to have a single accurate PROM and my usual gripe is that nothing is designed to reflect the experiences of severely affected - when looking at mild ME , it could be a different condition. It is so rarely understood. You could argue that even the mild/ moderate border is a significantly different animal from simply mild manifestation .

There needs to be objective definitions - effects are a further limiting in function , the only way to gauge this is by having some nuance as to extent / range of functional impact as well as symptoms / subjective descriptions .

Out of interest , what do PROMS lookalike for other progressive degenerative conditions ( as this is the reality for a not insignificant number ) MS?

 

[Jonathan Edwards]

Out of interest , what do PROMS look like for other progressive degenerative conditions ( as this is the reality for a not insignificant number ) MS?

Interesting question. I Googled MS and PROMS and got this hit first.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9326853/

It looks as if they don't work!

 

[NelliePledge]

I don't understand, 'very severe ME' is included. It is covered in level 5. If you feel it isn't covered, please could you suggest what should be included and how? We have deliberately removed the labels as, not unreasonably, people whose life had been turned upside down get fed up with being told their illness was mild.
People with 'mild' ME, have short lived PEM. When I'm having a good spell, my PEM lasts minutes or a couple of hours. Fatigability isn't a term I have come across before in this context. How do you define it? How does it differ from PEM? ?
I take your point that the the impact of 'small' activities can have a cumulative effect, others have made hte same point. How would you word a question about it? What would be ask? And how would you word the responses?

Yes I saw that very severe is included in the description of the person completing the questionnaire’s overall level of ME, I’m one of those who had undiagnosed “mild” ME/cFS for years until it worsened to current Moderate and I got diagnosed. I will have to go back through on my iPad to see what I was referring to as I don’t have a copy of the questions. It may be that I had misunderstood something.

Fatiguability- others have commented about this. I would say when doing a task or activity when you start to get that feeling that physical or cognitive energy is draining. You stop and rest (if that is an option) and then a few minutes or a couple of hours later you are ok to complete the task. Sometimes I won’t get PEM kicking in after that. Usually I would. PEM for me involves insomnia or at least severely delayed sleep, ramping up of pain, cognitive issues, flu like symptoms.

I will have a think about cumulative activity question.

 

[Lou B Lou]

PEM/PENE is typically delayed. I may be exhausted with exacerbated symptoms from doing an activity, but the full force of PEM descends the following day or the day after and the next. Any activity attempted while in PEM makes the PEM effect much worse and delays any return to my original level of functioning before the PEM. It's not unusual to be seriously knocked out for weeks or months with PEM, not for minutes, hours or days.


Edit
@sarahtyson

 

[NelliePledge]

I'm not sure this has net value though. It might be better than the Chalder questionnaire, but, when we say, this still isn't great, we want objective measures of activity and gait and reaction times in order to assess any interventions and to gather useful data on disease course, we'll get told 'oh, this was very carefully developed by a team including a person with ME/CFS, and there was a lot of consultation with people with ME/CFS.

if it was down to me objective measurements would definitely be addressed. I guess I was being pragmatic focusing on the product in front of me and the prospect of moving on from the status quo.

 

[Kitty]

It's not unusual to be seriously knocked out for weeks or months with PEM, not for minutes, hours or days.

This. I'm not severely ill, but I've never experienced PEM that only lasts minutes or a couple of hours. I find it worrying that something so transient is described as PEM, as it suggests a fundamental lack of understanding of what is arguably the defining phenomenon of ME.

I quite understand what @sarahtyson means about clinical notes and so on, but if I were being managed on an ongoing basis by a health professional, I would expect a much more general assessment:

How are you feeling, compared with the last appointment?

What's your general function like – better, worse, or the same?

Is there anything that might help?

Is there anything that's worrying you?

These are the kind of questions we go through at consultant reviews for other conditions. They're deliberately non-specific, as everyone's illness, life situation, and personal priorities are different. They allow me to focus on whatever is most important at the time, and the doctor to check for signs of progression or improvement; they also capture a record of the broad trajectory of my illness. If there are major changes or the doctor sees something worrying, a further appointment can be arranged to look at them in more depth.

I don't really understand why the management of ME would be different, or require a questionnaire that's so detailed and specific that it's never going to work for everyone (and actually risks working for no one).

 

[Hutan]

I would expect a much more general assessment:

How are you feeling, compared with the last appointment?

What's your general function like – better, worse, or the same?

Is there anything that might help?

Is there anything that's worrying you?

Yes, this.

Interesting question. I Googled MS and PROMS and got this hit first.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9326853/
It looks as if they don't work!

That's a very interesting paper. I'll make a thread for it. Thread here.

 

[Ash]

@Hutan the link doesn’t work for me?

 

[Amw66]

Link doesn't work for me, but can access thread from main page

 

[Hutan]

Sorry, fixed now

 

[Trish]

I have just sent the following feedback by email to Sarah Tyson:

Dear Sarah and team,

Thank you for the opportunity to respond to your second ME/CFS questionnaire, the PASS scale. I have submitted my attempt to fill it in and said in the comment box at the end that I would send my comment by email, so here it is. I have already noted some concerns about it on the Science for ME forum (I am Trish on the forum).

First, some positives. I can see a lot of thought has gone into PASS, and care has been taken to make the language understandable to patients. There is a logical progression of questions designed to elicit detailed data points from patients, and superficially PASS is something some patients may not find too intellectually taxing to fill in. I also appreciate the ability to do it in stages and to go back to check for mistakes, and the offer of a paper version.

However, these are superficial matters that should be basic to any questionnaire, and not specific to the content of PASS. I’m afraid my honest and constructive advice is that you scrap it and start again from scratch. That may seem harsh, but to me it seems to be so fundamentally flawed that it will inevitably not provide useful information either for a clinician caring for the patient or for data collection in the form of some sort of scoring system, or, importantly, as an outcome measure for research. I will try to set out the main problems below:
________________

Misunderstanding of PEM and conflation with the effects of daily activity

Conflation of

1 daily ‘fatigability’ effects of exertion such as diminishing capacity to continue exertion, increased fatigue and, for some people, increases in other symptoms such as pain, nausea, muscle weakness, cognitive problems, during and after all exertion,

2 What most of us understand to be Post exertional malaise, which is a more major ‘crash’, often delayed after the triggering exertions and lasting at least a day, usually significantly longer, includes major increase in symptoms and major reduction in the pwME’s current ability to function.

See for example the MEA description which also gives the NICE definition of PEM.
https://meassociation.org.uk/medical-matters/items/symptoms-post-exertional-malaise-pem/

It seems from the wording of the questions that PASS is intended to refer to PEM. in that it specifies exertion beyond ‘baseline’, but the options for answers make no sense in the context of PEM by referring for example to effects lasting minutes or hours and happening immediately, and not allowing for any distinction to be made between immediate effects of activity and a full blown ‘crash’ which is my understanding of PEM. For example, in my case, I have immediate effects of increasing symptoms and decreasing capacity to function during and for minutes or hours after every exertion, however small and regardless of the so called ‘baseline’. But if I rest sufficiently between activities, and don’t do too many activities in a day, I can often still do the same level of activity the next day. So to me that’s not PEM.
________________

Assumptions of a baseline being known, and single rather than cumulative exertions triggering PEM

From memory, the whole set of questions was predicated on the patient knowing their baseline so well that they can tell whether a single activity will tip them over the baseline. That assumes the patient is in a stable phase of their illness and also very experienced at pacing and has the support systems set up so they are able to pace effectively. In such circumstances a patient may establish a fairly settled baseline for a time, and may sometimes be able to tell which specific activity triggered a specific bout of PEM.

Many of us, I suspect most, are not in such favourable circumstances. We muddle along, never sure which day’s activities will cumulatively be enough to trigger PEM. Even very careful diary keeping is fraught with complications. Was it the half hour chat on the phone that triggered PEM, or the shower, or the concentrated effort reading a scientific paper, or the noisy roadworks outside? How can we tell? Unless there is a single outstandingly effortful activity, my experience is that PEM is almost always triggered unexpectedly and only when I look back I realise I have cumulatively done too much over the last day or few days. It was only when I started wearing a step and heart rate monitor, combined with a stable period of relatively undemanding life circumstances, that I got some level of control and was able to glimpse what my current baseline might be, and many other patients report similarly.

So my conclusion is that predicating a whole questionnaire on patients knowing both their baseline and which specific activity triggered a crash is bound to leave us guessing and trying to fit the square peg of our PEM episode into the round holes of the questionnaire.

What if the participant has daily symptom exacerbation with fatiguability but is able to pace well enough to not have had an episode of PEM in the last month? How do they fill in PASS ?
__________________

Response shift and the use of terms such as ‘strenuous’, ‘moderate’, ‘minor’, ‘major’.

Throughout the questionnaire types of activities/exertions and effects of activities are generalised using terms such as strenuous, moderate, slight, major, minor etc.

Patients were asked to select which one applied. There was no concrete example of any of these as a reference point. So it was left to the patient to either imagine what the researchers meant by each term, or to choose their benchmark as referring to a healthy person or their current or past severity, and no guarantee that they will remember to use the same benchmark the next time they fill it in.

To illustrate what I mean: When I was healthy, having a shower was a daily activity of no consequence and I would have chosen ‘very slight’ as the exertion expended. When my ME was mild, having a shower was a daily activity that was usually not a problem, though if I washed my hair as well I needed to sit while dressing and drying my hair as I couldn’t stand for long, but I could still do it daily except when crashed and do all my other daily activities, so I would have rated a shower as a slight exertion or if I had recognised its contribution to a cumulative set of activities triggering PEM I might have rated it as moderate. Now that my ME is physically severe, I can only manage a shower about once a week on a good day and need to rest for the rest of the day, so I rate it a strenuous activity. On a bad day it is impossible, so I would rate it very strenuous.

It’s the same activity, and I do it with objectively a little less exertion than when well by sitting in the shower and to dry and dress, and I take rests during and after, but I rate it completely differently. So which box do I tick on PASS if I have PEM the day after a shower and it was the most strenuous activity of the day preceding PEM, so for the sake of the questionnaire, I select it as the one to attribute the PEM to? Very slight, slight, moderate, strenuous, or very strenuous? I have no idea. And what if I also tried to read a scientific paper and write a response on the forum (cognitive activity) and had a chat on the phone with a friend (physical act of talking, cognitive, social and possibly emotional) on the same day? How do I select which one triggered my PEM? Do I say it was all of them, or pick one?

And what if that day’s activity doesn’t trigger a full blown episode of PEM the next day, but I am flattened and in more pain etc after it for a few hours? Do I include it in my responses, or not? And what if PEM hits a couple of days later, maybe the shower has added to the cumulative effect of several days’ exertion. I have no idea how that can fit in PASS.

If the questionnaire is to be used as a clinical trial outcome measure, it surely needs to include some benchmarks for what you mean by strenuous, major etc. Otherwise as patients symptoms vary, so their answers will vary, not on objective grounds of being able to do more or less, but on what type of activity they find strenuous. This will lead to response shift, making any kind of scoring system meaningless. Surely you must be aware of this?

I think you are aware of the questionnaire produced by the Norwegian ME Association which is not perfect, but captured my experience much more effectively than PASS. I suggest it could be used as the basis for a complete redesign of PASS.
__________________

Trying to cover all people and purposes in detail in a single questionnaire fails all people and purposes

I think the problems with this stem from trying to satisfy all possibilities in one long questionnaire, and thereby causing confusion rather than eliciting useful information.

Separate sections for ‘all the time’ and ‘PEM’ would help. Different information gathering for diagnosis, clinical care, service monitoring, and for research outcomes are necessary I think. I’m not sure questionnaires are the best mode of data collection for any of them.

If we must have questionnaires they need to relate to real life, not idealised compartmentalised outcomes of single exertions over a mythical baseline that this one implies, and apparently just for the sake of creating something that can be added up to give a numerical score. Life’s not like that for most of us, so the responses we give will not reflect reality. So any scores obtained may satisfy the usual ‘validation’ procedures beloved of PROMS developers, but will not, I contend, actually be a valid measure of anything real.
____________________

Suggested alternatives

Finally, a suggested outline for an alternative version for diagnosis and clinical use:

Fatigability section

1. Do you experience an increase in symptoms during and after activities of normal daily living
   
   
2. Do you find you cannot do as much or as energetic activity as when you were well.
   
   
3. About how many hours a day are you able do activities that involve being upright (standing, or sitting with feet on the floor)
   
   
4. An open question allowing the pwME to list their most troubling daily symptoms and things they can no longer do, or find very difficult

PEM section:

Give a definition of PEM, eg the NICE one then ask whether they have ever experienced it, whether they are able to reduce its frequency and/or severity through pacing and how many episodes in the last year and last month. And then home in on the most recent episode, delay time, duration, whether back to pre PEM level, symptoms functional level before, during and after, and what might have triggered it.


Objective measures

For trial outcome measures and service evaluation I think the answer has to be objective outcomes such as motion sensing/ step monitoring and heart monitoring throughout the trial in conjunction with a symptom app, and cognitive testing.

______________________


Testing a questionnaire like PASS on randomly participating pwME will not necessarily elicit the sort of critiques you need, I suggest. We are all too accustomed to questionnaires that don’t really fit our lived experience and doing our best to do what we think is wanted without complaining to the clinicians involved. If I hadn’t spent the past few years discussing in depth with other patients, clinicians and scientists the mass of questionnaires that are inflicted on us, and reading hundreds of pwME’s experiences of daily life and PEM, I would have very little idea what to say about what works and doesn’t work in a questionnaire. I think it is good that you, Sarah, are willing to engage with us on S4ME and listen to our analysis of your PROMS. I hope you will continue to do so.

I hope my comments and suggestions are helpful.

I apologise for the length of this response and any typos. I have no energy left to edit it further.

With best wishes,

Trish Davis

Typo spotted after sending corrected here in red.

 

[Hutan]

That's excellent, Trish. Real life, it's complicated.
Thank you for using so much of your scarce energy to provide that feedback.

That may seem harsh, but to me it seems to be so fundamentally flawed that it will inevitably not provide useful information either for a clinician caring for the patient or for data collection in the form of some sort of scoring system, or, importantly, as an outcome measure for research. I will try to set out the main problems below:

I'd add an additional problem to Trish's summary:

the scope for bias, from the patient and from the clinician
Retrospective evaluations are highly subject to bias. Upon enrolment at a clinic, the patient may want to make sure the clinician knows they have a serious problem and so deserve to be there, and so may lean towards exaggerating the impact of the illness on their life. It's in the clinician's interest too, to ensure that the condition at enrolment is viewed negatively.

After treatment, the patient may really want to believe that things are better. They may not want to upset the clinician, they may want to reward the clinician who has been so nice. If the clinician has said that 'if you do what I suggest, you will feel better', then the patient may want to be seen as compliant and hard working, and so doesn't want to admit that they don't feel better. And the patient probably has made an effort, they have worked hard, and so they think that they should be feeling better.

It's actually quite hard to remember how bad (or good) you felt last week.

Retrospective subjective outcomes measured at one point in time are very subject to bias and manipulation.

I do hope, @sarahtyson, that you will check out the thread on PROMS in MS, linked again here:
The MSIS-29 and SF-36 as outcomes in secondary progressive MS trials, 2022, Strijbis et al
I know that you probably feel that you have to continue with this project now, regardless of the evidence that suggests that it is not worthwhile and almost certainly will harm. I think it would be an act of admirable professionalism to go back to the MEA and say, 'we've looked at the evidence and it's just not ethical for us to continue with this. Objective outcomes are what is most needed'. Could you at least make it very clear that the developed questionnaire should not be used in service evaluations or research?

 

[JemPD]

Amazing job @Trish, i hope they listen.

 

[dratalanta]

Utterly incomprehensible.

“What level of physical activity triggered a worsening of symptoms?” With the options of “no physical activity is possible” and “very little physical activity”?

What on earth is “very little physical activity”?

Rolling over in bed? Using the toilet? Brushing teeth? Showering? Fetching a glass of water? Going for a five minute walk? This survey can’t distinguish between very severe and moderate ME.

If this project is to continue, rewrite it in terms of ADLs. The current phrasing is entirely detached from our lives.

 

[Ravn]

Hi @sarahtyson. Thanks for engaging here in what may feel like quite a robust discussion.

I'm not in the UK so haven't completed the questionnaire. The following comments are based on the patient info and snippets posted here so are necessarily based on limited information. Some general comments first with more specific ones in later posts.

Improved PROMS that accurately document an individual's ME and PEM is something we sorely need which is why I'm spending so much effort on this. It's also important - crucial in fact - that the resulting data can be easily and correctly understood by people who are new to the ME field.

As you'll know, most current tools have a high level of ambiguity. Ambiguous language is the most obvious problem especially when people are not aware of the ambiguities and assume everyone shares their particular interpretation of a term. Most clearly demonstrated in this thread by the many different understandings of PEM, more on this later.

A very common reason for misunderstandings is that we try very hard to express exactly what we mean but fail to take into account how the reader/listener is likely to interpret our words once they've filtered them through their own life experience and prejudices. In the context of ME we're always battling some very deeply ingrained convictions others hold about our illness. There are a number of instances where the language used is playing into established prejudices, I'll mention a few later but you may want to review all your work through this lens. Ideally you would test how people interpret your proposed PROMS not just on a wide range of pwME from outside your own group's circle but also on people liable to hold unhelpful prejudices, be that poorly educated medical professionals or members the general population (which would give you an indication of how future pwME and their carers might interpret the PROMS). I don't know if you have the funding to do this sort of additional qualitative research, I hope you do.

Another large contributor to ambiguity is, I think, due to the current tools mixing functional levels, activity levels and symptom levels in unhelpful ways. It looks to me as though you have tried to address this to a degree in some sections but not all.

Overall my impression is that you're trying to do too many different things with a single questionnaire and it's not always clear to me what the practical value of some sections really is, some seem to be documenting for the sake of documenting. When there is no clarity there's also a greater risk of the tools being used in a manipulative fashion especially if used to evaluate a service provider's work. You could put an introduction to every session along the lines of we're asking these questions because they can help patients/carers/doctors/other to do x, y or z. This would help with formulating clear and to the point questions and it would help the people answering them with interpreting them as intended.

More specifics in the following posts

 

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Baseline activity

You said baseline activity was the preferred term. That may be so but it is highly likely it is 'preferred' simply because of familiarity; it seems to be the term historically favoured by the UK clinics. This history also means that many people will also have internalised the concept that baseline activity is something you first find and then apply GET to. This may not be what you're trying to suggest but that's how many will interpret it. Energy Envelope is by far the preferable choice here.

Here are some thoughts I drafted some time ago for a different thread but didn't get around to posting but they fit just as well here

Baseline is an acceptable shorthand for any symptom load and functional level that is not PEM. The term isn't ideal in that it suggests a precisely ruled line when the reality is more of an inexpertly spun string of wool, fuzzy around the edges, thinner in some places, thicker in others, not quite lying flat and no two section of it exactly alike. But it's still a recognisable single piece of string that is distinguishable from the sections where it got all knotted up into a big tangled ball. It's useful to have a term that contrasts PEM and non-PEM territory even if the borders are fuzzy. We've searched and so far failed to find a better term for this. I guess one could get more technical and say something like 'within the range of the normal fluctuations of my baseline function' but that's getting away from shorthand use.

Baseline referring to activity levels is a different story altogether. In the UK in particular there's the history of baseline being the place where one starts GET. That alone is reason enough to not use baseline to refer to activity levels. There is no need to do so either; we already have a better alternative available and in common use, namely energy envelope. Whilst not ideal either it does work reasonably well to get the main message across, i.e. to stay within your limits. Like with the woollen string analogy it helps to visualise the envelope not as something perfect, like a brand-new crisp white envelope. My envelope is a tattered, crumpled thing I've tried to flatten and smooth with moderate success. So the space inside is larger in some places and more cramped in others and there are some really squeezed sections where some external object is weighing on the envelope. But even though it involves some fumbling about in the dark to get a sense of where the edges are it's still a helpful concept, stay within whatever your current envelope is and you'll be mostly ok, step outside it and there'll be trouble

 

[Ravn]

Severity levels

I like that there are 5 levels rather than the usual 3 or 4.

I also like they're simply called Level 1/2/3/4/5 rather than mild through to (very) severe.

I like that there is less mixing of functional levels, activity levels and symptom levels than in the existing scales and that you have (mostly) stuck to functional levels.

I don't like some of the specific references to things patients 'need' at a given level because those 'needs', while frequent, are not universal but listing them creates an expectation that without them the patient can't be as severe as they say they are.

To illustrate, I'm broadly at level 4 but I don't use a wheelchair because it doesn't matter whether I walk 50m myself or am wheeled about, I'll crash regardless. I've been able to organise myself so I hardly ever have to cover that distance so there's no point in me having a wheelchair.

To illustrate further, years ago during a period of milder ME I was misdiagnosed with MS. There was an astonishing number of people - including a doctor - who questioned that diagnosis on the grounds that I wasn't in a wheelchair. As it turned out they were right about the diagnosis being wrong but their reasoning was faulty and based on wrong expectations.

So categorical phrasing like "needs a wheelchair" are problematic. You could rephrase as "some may need a wheelchair" or "many find a wheelchair increases their mobility"

While I think your severity level descriptions are an improvement on existing ones I'm not clear what purpose these levels serve? I can see they have some use where a brief description is required in advocacy or educational materials but beyond that?

For assessing functional level in a much more informative way for patients and doctors, have you had a look at the FUNCAP? It's pretty good, actually by far the best ME questionnaire out there. IMO it should be adopted widely rather than everyone reinventing the wheel.