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

When it comes to assessing the services, I wonder if there are any useful models in other NHS clinics where there are few or no curative or disease-modifying treatment options?

I'm thinking of the lipoedema clinic I visited. For most patients in the early stages it was a diagnose-and-discharge model, but all the same I couldn't have felt more supported or listened to. I saw a consultant, a registrar, and a specialist nurse, all of whom made different contributions, and it was made clear that I was welcome to self-refer back any time I needed advice about progression or new symptoms.

ME patients need more input than that because there's a much bigger impact on their ability to work, study, and parent than in uncomplicated lipoedema. All the same, they'd give their eye teeth for access to that sort of expertise, compassion, and honesty.

 

As ever Trish, a masterful response. Very helpful. Thanks. B

 

I couldn't find any because I can't remember or figure out how to search for it, but over the last few years I've seen several long haulers who had pre-illness daily steps count from a smart watch/actimeter and compared to the period they were ill the difference is extreme, you can see the precipitous drop that marks a clear change. I saw many and of course I can't find a single one but we're talking about a 90%+ drop, impossible to miss and does not need to be statistically massaged in any way to show.

And I've seen the opposite, people who had been ill for months or longer and whose condition improved, and you can see the dramatic change in daily steps count, from tiny blips to sustained activity. Of course actimetry data is relevant here, there is no question about that.

As you say, not showing much change from trials only tells us that those treatments are useless, because the data reflect the change when it's there. And we are being played yet again with the recent Knoop trial where they, again, covered up the bad actimetry data, which they would have massively hyped had it been positive. I don't think anyone can seriously argue against that.

And although that's usually not measured, I'd also add pace velocity to it. I used to walk fast everywhere, long fast strides. The difference in speed is dramatic. I not only walk a lot less, I walk so much slower and that is also change that does not need any statistical massaging, it's a huge drop.

We don't just need more data, we also need better data, more substantial, more precise and with way more depth. That's beyond the scope here but it always shocks me how superficial the data we get from most studies is. That can't come from questionnaires.

 

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

 

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.

 

thank you

 

I’m sorry I haven’t read your comment in full yet (but looking forward to doing so when I have a moment where I’m better set up to make the most of it

I did get a moment of inspiration on the actimeter bit as reading through that part of your comment (eg PACE) that one thing worth adding into the debate now is the fact that the tech is here and so commonly used by most non-pwme people that it is almost going to have to be addressed on basis of people will do it anyway but advice on the more misleading stuff etc vs ignoring elephant in room I imagine is the ‘state of play’ position

A total side note to a maybe more specific debate on that topic (actimeters of the type measuring 24-7) I worry about privacy, intrusiveness and controlling behaviour/advice ie how it is done when judging someone’s day which might be dictated by their illness and what they prioritise has in the past had the potential for ‘shoulds’ and diaries and the like to give me the willies someone might try and timetable my whole life. And the understanding eg on PEM and rest vs the old sleep hygiene presumptions doesn’t seem to have been fully cleared down with the paradigm change (which it should have but seems to for many have been seen as ‘just applies to exercise’). So if you had someone overly keen on sleep hygiene then demanding that data it would be scary.

ADDED PARA: Or even just the many who prefer to go 'behavioural' and think micro-managing a pwme, rather than supporting to 'live as well as can' ie respectfully as someone with a debilitating energy-limited condition (in a world where all isn't controllable) is what they should be doing as a job/profession. In those hands having data downloads of someone's most intimate body data has all sorts of worrying potential (for people who see someone not getting better as the person's fault for somehow not controlling their body because they still incorrectly/deludedly think their behavioural treatment can cure such things, or worse 'x is only ill because they don't go to bed early enough' type attitude, I hate to think of the possibilities if got into employer Occupational Health or benefits type arenas etc).

There are ways round all of this of course /third ways in that people with these things on their phones, wrists etc might well use these to inform their answers on questionnaires anyway - as some have said above to check out their curiosity that they might feel better.

so I’ve no genius answers here re specific scales, just musings on this re task ahead vs context and how such things might be implicitly working their way in anyway and there being downsides if managed wrongly that protocols could actually warn against. So really starting to see the potential benefit of this discussion/thinking process of what clinics might/do do etc

 

the aim of the project is not to assess services, it is to work with pwME and clinicians to develop good quality tools to do so.

 

I read this as being about what goals the services should be developing—which would be fine, and appropriate—but like you, I worry when treatment plans are mentioned. There are no treatments, and if we can't be honest about that from the outset, both the clinics and the study are set up to fail.

I don't want to see either fail. I want to see clinics that are prepared to listen and respond to people's needs and priorities, are able to develop expertise over time in partnership with patients, and where it's understood that the most important outcome measure is not causing harm.

 

I was wondering the same thing.

I'm quite skeptical that there are good quality tools to assess services.

 

The NHS ME/CFS service in my area is aimed so1e1y at new patients, there is no 1ong term fo11ow up, much 1ess a service for the most severe. I think this is typica1 in Eng1and at present. At 1east Somerset are honest that a11 they can offer is to he1p patients adjust to 1iving with the condition (this actua11y makes it easier when dea1ing with DWP benefits, as they make it c1ear there are no effective treatments for my ME).

https://bacme.info/services/somerset-cfs-me-service/

I think this questionnaire research needs to be seen in this context, it isn't going to produce anything appropriate for use in c1inica1 tria1s, at 1east not for primary outcomes. Of course that doesn't mean that it won't get misused in future research - think Craw1ey's use of 'service outcomes' for her research papers. Indeed think about IAPTs misuse of the GAD and PHQ sca1es in their service outcome statistics (which was designed into it from its inception*).

*see the fo11owing website for more detai1 the prob1ems with IAPT -

http://www.cbtwatch.com/category/iapt/

 

100% agree on trials. In fact this should be over e.g. 2yrs follow up (and someone should be able to come up with a way it is a 'pattern' downloaded so that privacy issues and blips are ironed out but you can see whether e.g. 6mnths after someone thinking they are doing better they then enter a relapse where their activity pattern is at a 'lower threshold') and used as a yellow-card type requirement for all ME/CFS trials in order that they prove their treatment really isn't making people worse.

The tech is reliable enough to at least be able to use it to show if a certain % are basically declining at 6mnth, 12mnth, and how long this persists for. No claimed effect is 'real' until you've tested whether it is a 'false flag thinking you feel better when you are just pushing your boundaries too much' until you've checked the actual effects 6 and 12months on.

I can understand maybe there might be reliability issues for anything more detailed where you are trying to prove 'improvements' (which is often the focus of researchers behind the studies) but doing it the opposite way I don't think this holds for using this tech and it being at the stage where it can be reliable for checking for harm. Particularly when harm comes in the form of PEM but then relapse which reduces threshold if you are doing it consistently. All is needed is 'averages' checks for this. And it wouldn't mean someone wearing the tech for 2yrs continually if they didn't want to but having designated weeks within this time period. If, like all trials should have, there are controls, then with half-decent power in sample size these checks should be simple to make. Red flag anyone who drops and report how many and by how much.


My next bit is rambly as I've had a terrible week but I've started it off as it covers concerns worth trying to get my head around elucidating on 'context' for the clinics side of things. Bearing in mind e.g. some of these are spin-offs offering e.g. 6 sessions of CBT to mild pwme, who will be looking at keeping their funding for continuing to do that when they see whatever new measures are thrown at them. I'm trying to imagine how such measures will 'drop' or 'overlay' onto the current landscape and culture and what that will actually result in, vs if there is anything clever that can be done where such measures could 'drive' changes to these things and get rid of the 'framing' issues that I think is the mismatch-issue currently between ME/CFS provision vs the condition.

One worry I do have with clinic assessments is the idea that - if these then relate to 'goals' or 'impacts' we are going to have clinics that push people into things which are detrimental to their health in order to tick the box of 'that being the achievement'. I don't trust such situations not resulting in the focus being keeping at school/work at all costs to health - and the short-term focus and short-course focus will also never change because they will all know that doing such things will mean they might get their stats short term but they then wreck people and mean they never work again long-term so certainly won't want to change to a proper medical model of being responsible long term.

I just can't get my head away from the fact that it would be asking those whose career and pay is what they think they do as 'therapies' in the set-up for most of these centres, and we are expecting that having them either doing these assessments or being able to still do their therapies and effectively will 'work to these outputs' won't cause some huge warping of these vs the intented reason for having them. Because clinics will be looking to 'prove improvement' which will necessitate playing the game on the stats I think that it is vital to think about these in that context. I'm almost minded to say clinics should only have their funding linked to 5yr+ outcomes only, in order to cut out the risk associated with short-termism if you imagine how people could get pushed into doing to much which causes detriment longer term.

I don't know how we make the clinics more meaningful and avoid such risks without that change of making them responsible for long-term outcomes for a condition like ME/CFS because it is a condition that is so open to being played - although I guess if you took people with RA or cancer you could do the same by forcing them to stay at work and increase their activity for 6mnths to get your stats up then not have ownership of that meaning their 2,5,10yr prognosis has been made so much worse by having done so.

I also know that we need to be very careful that any measures which can be gerrymandered 'behaviourally' ie by those who use behavioural/manipulation techniques (I don't think for the record most of them think/realise this is what they are - the old 'good intentions' issue) rather than focusing on health and adjustments to then wait for that to mean there might be objective impacts which show through e.g. people being able to do more or at least not declining, will lead to the same old ‘bully/jolly/reframe the patients thinking about it to be more positive or brave’the patient to perform focus from too many - because I do not see signs of penny-drop nevermind culture change as there has been no proper come to Jesus moment, and the paradigm would require such a level of adjustment.

SO we do have to assume this is how most, who come from the background of that being their job and focus and mindset - to 'jolly the patients to achieve their goals' genuinely see their job and 'help'. And that’s of course what they’ve been hired to do so I say it with no inference that it isn’t - these things are what their job description or bid tender have asked for. They actually can't objectively see what they actually do any more clearly than before because of their own CBT reframed mindset reframing what they do into 'positive twist'. Because I have to say this merely because that has been and is the set-up for most so has to be assumed that will be what they will assume is wanted and 'good' unless someone is giving it a serious programme of change and enforcing it, and whilst some of the more obvious stuff might have been removed or sanitised I don't see the embedded stuff which is really the most problematic getting unpicked.

Which leaves me with a huge dilemma, of understanding the pragmatic need of if someone doesn't do something to at least nudge things to be better done then they will do their own/it will happen anyway, but I also know what isn't liked ends up being ignored often (cherry-picking), and having to think how such things might actually end up being played out in context. If patients are in clinics that offer little treatment and then have goals I can't see their position as effective 'pawns', instead of in the real healthcare system with medics being people with a disease that needs to be managed and a package of support to make surviving and living more possible, changing where such people running the show are reporting KPIs to keep their funding.

I think the reason I'm getting so confused about this and .. I think it is a worthy and needed project because of all these question ... what it actually is - is probably because it lies right at the heart of whether such measures are going to apply to the old system as it is, or be used smartly to bring that system into a new focus. And because I don't know whether there will be other changes that will go alongside it or if we have to imagine this is just a new marking scheme for the same people with the same conditioning - and which one of these two it is presents very different things.

How do we change who and where these things are being measured and what they are reporting into in order to make sure there are more 'outcomes' than either a supply-led service reporting 'work done' (whether it was useful or not we threw 5 mindfulness courses at them) as its achievement or reporting 'satisfaction' or 'change achieved' and the risks there being a focus on pressuring 'performance' behaviour that causes harm over 'step back to step forward'?

Because at the moment these clinics aren't offering anything treatment-wise that changes this description (step back to step forward), but do get funding 'based on therapies' so will be focusing on their own stats in relation to keeping funding for those, and what we really need is the entire type of clinic to change to being proper scientific medical monitoring centres. Is it as simple as the funding following only the monitoring ie stop paying for the 'therapy' and make sure that if it is offered or done these monitoring centres are completely independent of these, to reduce conflict of interest?

 

The last part of this is one of the reasons I think wearables are viable. Yes, of course they're going to vary by brand, operating system, algorithm set, etc.; and yes, it's difficult to know whether they're recording quite the same thing on people with different movement styles and physical abilities.

But they're extremely unlikely to be fatally inaccurate when the same device is used on the same patient throughout. What we need to see is the trend over time, and in some ways it almost doesn't matter what the metric is. Does it show the patient's activity level is greater, lower, or the same? Is it reasonably sustained across several weeks, or does it come in bursts with very long gaps in between?

It would be infinitely more reliable than my memory of it, for sure. You could ask me the same set of questions at three different times on the same day, and it would sound like the answers were for three different people.