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

I am struggling now, so I cant find your comments about past/moving forward/baggage & your concerns about how contructive input on the toolkit might be here, in order to quote them, but i just wanted to say that I can well imagine that you may have come on here, seen a load of comments about Dr Gladwell and I imagine it may have seemed like it was just a negative, derogatory pile on, & thats regrettable, & for my part in that i apologise & will edit my original post accordingly.

I respect you want to move forward without the baggage of past history, and that as a PwME & a carer of one too you will be all too aware of it, but sadly, we are so many of us traumatised by that history & what is still going on, its a bombardment that seems unending, decade after decade. Things have not changed at ground level and we are still suffering greatly & being regularly derided, ridiculed & abused as a result of it, so context just cant be ignored or stepped out of so easily, we are human beings.

But i think if you read the links Trish provided, and for example, our discussions around the NICE draft & others, you will see that S4 is very capable of giving constructive feedback & i hope it will be a useful collaboration. But of course i recognise you are ill too and have caring responsibilities & will not be able to read everything.

All that is to say i hope you wont be put off by initial concerns. The forum is hot on not allowing personal attacks, but of course our familiarity with each other gives us a sense of the tone of the post that will be different when read by someone who doesnt know us, particularly when the persons work being discussed is their own or of a colleague/friend. We would do well to remember that i will certainly try.

I likely wont be able to engage again for a while as i used all my budget on thinking & typing now, but i do wish you well with the project & hope to chat again as it moves forward.

 

The issue for many here wi11 be that the NHS ME/CFS specia1ists services are not aimed at peop1e with 1ong term or moderate-severe ME. Most are very time 1imited and are on1y accessib1e to peop1e with mi1d and/or new1y diagnosed ME/CFS. Therefore they do not have any c1inicians who can c1aim to be 'specia1ists' in the condition. This is discussed e1sewhere on the forum, I think @Jonathan Edwards has made many va1uab1e comments on this issue.

 

Hi @sarahtyson,

I am afraid that you explanation of the use of 'gold standards' makes me heart sink a little further.

Yes, I spent my career developing and working with outcome measures in RA. My 'fine and dandy' way led me to major progress in understanding the disease and devising new therapies - through listening without reference to recipes. I was aware of an industry of people sitting on committees trying to devise 'gold standards' but they made no impact on routine clinical care. What matters remains what bothers the individual. Surely, 'patient-centred care' should focus on the individual, not a questionnaire. But I may have misunderstood the aims.

I did devise specific measures, but always targeted in the context of a specific treatment or whatever. Generic measures are always suboptimal. And the additional problem I see for ME is that since we do not know anything about mechanism and have no useful treatments it is hard to see a motivation for asking more than how the person is getting on. I am sure it is worth assessing mobility problems systematically but presumably there is an up to date version of the ADL assessment that applies.

I am really just unclear how you would identify standardised questions and in particular how you would show that those particular questions were useful to ask. It might seem obvious that they are, but it seemed obvious to Trudie Chalder that CBT would work. I don't get how you validate this. Repeatability is useful but secondary. What might be useful for service review may well not actually be any use to patients. And patient reported outcomes are a pretty dodgy way to do service review, as we have seen from IAPT.

I can imagine that you can achieve something very useful here - just passing on what has been learnt by experience in terms of picking up problems that patients may not themselves raise for whatever reason. But as a clinical scientist I would stuff 'gold standards' in the waste bin. They mostly reflect the lowest common denominator of professional committee nerds.

I guess what I would find helpful in understanding the project would be specific examples of candidate 'tools'.

 

This is key. I really hope the study will acknowledge that the vast majority of the patient base is effectively shut out of NHS specialist services. I'm 47 years into my illness, disabled enough to qualify for supported housing, benefits, and an NHS-prescribed wheelchair, and I've never seen a specialist. It's hard to imagine this would happen if I'd spent decades with a different disabling illness.

If that quality of listening were used by NHS ME services, a lot might be learned about how the condition develops in the first couple of years, what people's biggest concerns and challenges are, and to what extent learning to adapt helps. However, if no-one sees the long term patients because they assume (wrongly, by the way) they have nothing to offer them, some of the learning may never happen and we risk still being here in 20 years' time.

Hear hear.

 

I apologise if my concerns expressed (Not with yourself but with Bristol Service etc and BACME historically.. ) gave rise to any suggestion to you of unjustified criticism or caused you offence.
I will justify my concerns by referring to Trish' s comments which were clearly articulated.
Suffice to say after 25 years of battling on ME matters, both as a carer for 2 at home plus as a Local Authority employee for some 45 years involved wirh vulnerable CYP with ME and CFS for half that time, as a mum treated as an FII parent in the 1990's/ 2000, I have seen many with the best intentions, (professionals charities, alternative fatigue suppport groups and professional organisations) unwittingly and unintentionally, do enormous harm.
I have been involved in Service Development and co production in the East region for 20 years. With some degree of success to date.

I wish you well with your research.

I hope the outcome will consolidate the mechanism for wider effective service delivery which is so desperately needed.

However, there will be no proper services if the government, DHSC NHS and most importantly NHS England, fail to acknowledge this fact and starve the newly created ICS system, not even 1 year old of funding, but even worse it would appear, ignore NICE and GRIP recommendations by imposing a 30% CUT in available existing funding .....
* with no uplift due to Inflationary pressures faced by ICSs.

We are fortunate within our ICS (SNEE) to have exceptional support and commitment from our NHS Transformation and Commissioning Team.

We have ME and CFS embedded in the new ICS 5 year Forward Plan as one of our local princuple clinical priorities, about to go to NHS England in June.

When AfME FOI on service plans post NICE is delivered to APPG AGM this week, it will be interesting to see how many other local ICSs have done the same?

Hello Sarah

Hello Sarah,

I am really sorry that it would appear that I did not express myself at all clearly.
I was not mortified at your work or your aspiration, but by the wider implications, matters and various disappointments we have had surrounding truely acceptable service provision - that have been endured by patients and families for over 2 decades.
Concerns have existed (and continue to flare up with BACME for us coproducers) ie aspects of the last November Conference and it's workships - together with practioners with a rehabilitation bent to ME Service delivery, I am sorry to say.

I am willing to private message you rather than air specific concerns in public?
Dialogue with you about the toolkit may be useful as we progress our SNEE ICS Eastern region post NICE new service spec which will soon in 2023 we hope, go out to tender?
My wider concerns and observations I will post against Trish's excellent posting.

 

I apologise if the concerns expressed (not with yourself but with Bristol Service etc and PG/ BACME historically.. ) gave rise to any upset to you or of a feeling of unjustified criticism. I did not mean to cause you any offence.

I will justify my concerns by referring to Trish' s comments (which echo mine) and which she clearly referenced and articulated.

Person experiences as a carer and a professional

Suffice to say after 25 years of battling on ME matters, both as a carer for 2 at home plus as a Local Authority employee for some 45 years involved with vulnerable CYP with ME and CFS for half that time,.... as a mum treated as an FII parent in the 1990's/ 2000, ....I have seen many, often with the best possible intentions, (professionals charities, alternative generalised 'fatigue' support groups and professional organisations) unwittingly and unintentionally, do enormous harm.

Our local service development

I have been involved in Service Development and co production in the Eastern region for 20 years. With some degree of success to date. Forgive my cynicism and scepticism over the toolkit research announcement, which I will now outline.

I wish you well with your research which is required within the new approach to matters within the NHS.

I hope the outcome will consolidate the mechanism for wider effective service delivery which is so desperately needed.

However my/our experiences over recent years ( articulated well on S4ME), suggest insurmount reluctance on the part of Government and arms length organisations entrusted since 2012 with Commissioning.

There will be no proper services if the government, DHSC NHS and most importantly NHS England, fail to acknowledge this need and facts as follows;

* and starve the newly created ICS system, not even 1 year old of funding,
*but even worse it would appear, ignore NICE and GRIP- (so hard fought for) with the decision and recommendation of imposing a 30% CUT in available existing ICS funding .....

*with no uplift due to Inflationary pressures faced by ICSs.

We are fortunate within our ICS (SNEE) to have exceptional support and commitment from our NHS Transformation and Commissioning Team.


We have ME and CFS embedded in the new ICS 5 year Forward Plan as one of our local principle clinical priorities, about to go to NHS England in June.


When AfME FOI on service plans post NICE is delivered to APPG AGM this week, it will be interesting to see how many other local ICSs have done the same?

We have worked so hard for 2 decades and now face the stark reality of our and national ME service situation.

Yes we need a toolkit but mostly, we need a proper funding stream within Specialised Services Commissioning, another tier NHS E have washed their hands off and offloaded to ICSs.....

Our local commissioning team opinion, entrusted with a businss case analysis, suggests an adequate toolkit could be secured for a low figure than £90,000, especially in the light of deficits for general funding for service development.
Money is so tight. It would be sad to have a 'gold standard' toolkit but totally inadequate spread of national services to use it!

 

Both posts typo edited. Replying on a mobile phone is difficult!

 

I am all in favour of seeing people regularly long term. And that must surely translate into providing help through experience. But I just unclear as to how you turn that into a 'toolkit' using 'PROMs'.

I guess my gut feeling is that it is better for patients to be seen by people who realise nobody yet knows the best thing to do rather than by people encouraged to think that is known.

 

Thank you for engaging on the forum and getting involved in this @sarahtyson. Apologies if I missed anything in this thread, since I haven't read it in its totality.

I assume this is the FDA guidance you refer to: https://www.fda.gov/media/77832/download

Something which this guidance is very clear on, which seems to have been ignored by virtually everyone that conducts research on PROMS in ME/CFS, is that "content validity" is the most important measurement property of a PROM. Content validity is measured, essentially, by talking to patients to see if the PROM actually measures what it's supposed to measure, and to see if it measures what is important to them.

I don't think a single study on content validity (a proper one at least) has been done for any of the major PROMS used in ME/CFS. The statistical approach is nice, but what's most important is that the PROM actually measures what it's supposed to measure, and the only effective way to do that is by asking and talking to patients (by thoroughly interviewing them about the PROM, essentially). Will you be doing that?

 

The prob1em with any 'PROM' aimed at use in the current NHS ME/CFS c1inics is that the patient popu1ation attending or being 'served' by these c1inics is not at a11 representative of the who1e of the ME popu1ation. It is a service that is specifica11y targeted at the most mi1d and the new1y diagnosed patients, and many of those referred won't even meet the stricter criteria for diagnosis of the new NICE guide1ines (especia11y as more and more 'specia1ist' c1inics now inc1ude pain and 'fatigue' patients).

I'd 1ike more c1arification on what the purpose of any new 'PROM' sca1e is designed to measure. If it's primary use is to 'measure' the outcomes of these existing, time 1imited c1inics (which can on1y focus on he1ping new patients manage their condition - there are no effective treatments for ME), then it wi11 be of 1itt1e use for any future c1inica1 tria1s for actua1 ME/CFS treatments. This prob1em sti11 app1ies even if a wider popu1ation is used in the initia1 deve1opment of such an 'outcome' sca1e.

Current1y these c1inics discharge a11 their ME/CFS patients regard1ess of any 'outcomes', often after on1y 4-6 'treatment' sessions. At most I think they offer 12 months of monitoring, most much 1ess. What I fear is that this focus on 'improving' the 'PROMS' in these c1inics wi11 mask and detract from the fact that the majority of ME patients in the UK are not even served by any specia1ist NHS c1inic. Imagine if MS and Parkinson patients were discharged from specia1ist services (to the ether, not even proper GP care or monitoring) when they are chronica11y and severe1y i11 (or in many cases, not even e1igib1e for the initia1 time 1imited service because their condition is 'too severe').

It a11 seems 1ike smoke and mirrors. I'm sorry if I appear so cynica1, but I've been i11 since I was 17 after g1andu1ar fever, f1uctuating between severe, moderate and severe since my mid 20s - for over 30 years. My NHS care for my ME is non existent, my GP has no understanding of it. I've had to discharge myse1f from inpatient hospita1 treatment (for an infection, not ME) because 2 nights on a ward was causing me to veer into the borders of very severe ME. I cannot access secondary hea1thcare for other non ME conditions because of the barriers the NHS throws up. The rea1ity of 1iving with 1ong term ME in the UK is horrendous. I wou1dn't have known any of this rea1ity in the first 12 months of my ME.

 

Due to limitation or resources, both financial and experts, available to run a comprehensive MDT, it has been suggested in the draft spec that any new service run by our ICS will be primarily targeted at most vulnerable extreme need - CYP plus Moderate/ Severely Affected.

Unless NHS England/DHSC cough up some funding, which seems unlikely atm.. ?

I believe that this approach will be a first service delivery approach in this respect?

As for the DHSC NICE Implimentation Report.....?...

Well the delay/silence speaks volumes.....

 

Well put

 

@sarahtyson I too want to welcome you to the forum. While we can be a pedantic, curmudgeonly bunch, we're all about the science at the end of the day--which is what it sounds like you're all about too!

While wearables are not perfect or purely objective, they certainly can provide valuable data. On the other end of the price spectrum from @SNT Gatchaman's Apple Watch, I've been using a humble $20 tri-axis pedometer clipped to my underwear for about 10 years now. Not only does it tell me how much I'm moving, but also, in a way, how I'm moving since the sicker I am, the more I shuffle. Shuffled steps often do not get picked up on the pedometer. Which, sure, that means it's not accurately measuring each step. But when my step counts start taking a nose dive, it's clear that something is wrong. When I had my Great Crash of Autumn 2020, my step counts began dropping in August from my usual 500 steps a day down to 350, then by the end of September to 250 and by mid October it was in the double and even single digits. This was really handy info to share with my GP to underscore just how bad my functional capacity was. This was all the more useful as I had begun having an increase in symptoms in May 2020 but was still able to maintain my normal step count/functional capacity even if I was a bit more miserable while doing so. When my step counts went south in the autumn, it was all the more significant. It wasn't just a subjective feeling; something was making it hard for me to move.

Again, it's not purely objective. I could see how if someone was particularly attached to a specific outcome they might change their behavior to try and get their steps to match that (though this would be hard to do in a longer term study of several weeks or more). It also doesn't measure cognitive effort. Indeed there are days where my cognitive impairment is worse so I'm wandering around my apartment racking up steps because I can't concentrate or remember what I was supposed to be doing--hardly an improvement in functional capacity!

And I would never suggest using it as the sole metric of functional capacity or quality of life. I myself also use hours spent out of bed, what I can do while in bed (being on the computer, crocheting or embroidering, etc.), as well as cognitive tasks like writing--outcomes that matter to me. I've found in the 20 years since I was diagnosed with ME/CFS that few questionnaires ask questions about outcomes that are very meaningful (Karnofsky being the best so far imo).

I'm not sure what sort of actigraphs they used in the studies analyzed in Wiborg et al. but the use of actigraphs in those studies and his review did help to underscore the disconnect between answers to questionnaires about fatigue and actual physical functioning.

At any rate, I really hope our forthrightness hasn't put you off. I think we would all love to work with you to make ME/CFS research as solid as it can be.

 

Oh also I should note that I'm not as concerned necessarily with the term "psychometric." My understanding is that it simply means a way of measuring in psychology. While I've not seen specifically what psychometric tests are being used for this study, the psychometric testing I had when I was applying for disability was very effective at demonstrating cognitive impairment with regard to short-term memory, concentration, and information processing speed.

Some tests are better than others. I have real concerns about, say, the IQ test. Obviously on this forum we're all concerned with tests of subjective states of fatigue like the Chalder Fatigue Scale or the SF-36. But cognitive functioning tests might be really helpful. Though it would only be mild-to-moderately affected patients who would be able to manage such thorough testing, which would limit the generalizability of the findings. I remember the testing I had lasted 5 hours. I would be far too ill to manage that now.

 

I agree, @Michelle, I find it hard to see that they do not at least give a rough idea of major change in a more objective way than asking questions. My wife uses one and it gives [retty reasonable account of activity.

We are no expecting anything to be linear or precise in clinical evaluation. In rheumatoid most measures are rough and ready, but they can work reliably in specific contexts. An ESR is not linear but interpreted cautiously it provides something useful.

The only criticism I have seen in the literature of actometers in ME is that they fail to show a response when testing treatments. That seems likely to be because the treatment didn't do much rather than there being anything wrong with actometry. Actometers will be disappointing if they are being used to show difference that aren't there.

Which really brings things back to the question as to why things are being measured - I am still unclear what these measures are going to be for.

 

I have complete confidence in my smart watch. Long term. I bought an oxygen concentrator in Januaray. The stats are completely different from the previous year.

I can't see how this data helps me apart form confirmation that I feel better.

 

Hello @sarahtyson. It's good to see you here. We don't have enough clinicians and researchers engaging with patients (here or elsewhere), in my opinion. A lot of good science and careful thought goes on on this forum.

I hope this initial discussion isn't too overwhelming for you. Someone above described us as a pedantic curmudgeons, which is probably true! But we really are all working in the interests of patients.

On Peter Gladwell, in a previous role I was privy to some work he was doing with Vikki McGeever on the Dysregulation model—a framework BACME wanted to use to explain and help patients understand their condition. I was quite critical at the time, because the model is not grounded in evidence and so shouldn't be rolled out to clinics. Now, it may well turn out that dysregulation of the immune and nervous systems is at the heart of ME/CFS (there is some evidence to support this), but we don't yet know sufficiently enough about this to invoke a model/framework that explains the illness. It remains a vague hypothesis—a bit like the biopsychosocial model.

However, Peter seemed to be part of a BACME contingent that wanted to move the organisation forward, in a positive sense.

 

Apologies, off topic but find it hard to cope with the fact that a number of forum members much smarter than I and who started or were engaged in related discussions have died or are too sick now so can't engage in a discussion anymore.

Perhaps we could find a way to manage the discussion in a manner that makes it easier to refer to related discussions on other threads?

Also, sorry to have to leave the discussion now as too unwell.

Really hope that you will stick around here @sarahtyson so that we all could learn from each other. I think it would be great if your colleagues Dr Mike Horton and Dr Peter Gladwell could join us, too.

But perhaps all a bit too much anyway now given all the activities and events around ME Awareness day.

 

Thanks for doing this so c1ear1y.

After my experience with IAPT many years ago I decided not to fi11 in any medica1 questionnaire as they have so many prob1ems and can actua11y prevent medica1 professiona1s understanding or recording the very symptoms and changes in my various medica1 conditions that I need them to understand. Just because a questionnaire answer has had a number assigned to it does not make it 'objective evidence'!