We've heard at the German ME/CFS conference from the Norwegian researchers, Fluge and Mella, about how they have successfully used Fitbits. The published a paper on it last year:
Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients, 2022, Rekeland et al
They are planning to use Fitbits to track resting heart rate and steps per day as objective outcomes in intervention trials. There is no reason why ME/CFS intervention trials can't use objective outcomes; funders, advocacy groups, everyone who can, should not be accepting ME/CFS trials that don't have objective trials measured over a usefully long duration. It's not tenable for people to claim that the technology is not at a state where this is possible - it is both effective and affordable.
Similarly, for clinic evaluations, there must be objective outcomes of patient wellbeing included in the outcomes monitored. It is entirely possible.
I think there should also be monitoring of outcomes related to work and school - but having those as short term outcomes for clinic evaluation could be counter productive. People often need to reduce work hours when they first become ill. I'm not sure how work and school outcomes could safely be part of a clinic evaluation. Possibly they might work if they are 3 year followup measures, but the dropout rate might make the data unusable. Perhaps a combination of the 3 year followup and the dropout rate would work - and would provide an incentive for clinics to keep in contact with patients. We have seen clinics push people through a CBT course to fix their beliefs and then wave goodbye, with the clinicians happy that the subjective evaluation forms tell them that they have done a great job.
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?
