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

I think we need to be careful in our criticisms of use of feedback, because we don't know what changes Sarah Tyson's team are making to their PROMs following feedback from the thousands who have completed the questionnaires, people writing to them, and comments from people here and on other social media. We simply don't know if our feedback is being listened to.

Yes, Sarah Tyson has decided to stop interacting here, and the MEA head of Trustees has dismissed our concerns, but he also said the team will continue to read comments here.

As I understand it, the 3 questionnaires sent out so far are, or at least should be, a first stage in a multistage process of development. Once analysed there can be radical changes, including shortening, changes in wording, dividing into sub questionnaires for different severity levels and more.

I am still hoping for the team to have the courage to make radical changes, like making the symptom questionnaire a simple one page list with tick boxes, abandoning the PASS questionnaire that wrongly conflated PEM with symptoms after exertion, and using the already established FUNCAP instead if their poorly designed function questionnaire.

I think they are still due to do one on mental health and one on service satisfaction. These also need to be short tick box lists with space for filling in individual concerns, in my opinion.

I hope, if they do a mood, mental health one, it is very short and asks direct questions such as do you experience anxiety and/or low mood that interferes with your ability to function, and do you want help with your mood or mental health?
They need to avoid the sort of long questionnaires on anxiety and depression that dig in to aspects of mood with prompt sentences most of which are inappropriate for people whose lives have been turned upside down by physical illness.

 

The PACE trial used wearables 20 years ago. They used step monitors for a week at the start and were supposed to use them again at the end, until they chickened out. And the GET group used heart rate monitors during their daily timed exercise session and were told to stay below a certain level for a while and gradually increase duration of activity, then increase intensity of exercise to raise their heart rate to a higher level. And interestingly, the APT group were instucted that they were not allowed to use heart rate monitoring to help with pacing, they had to rely on symptoms and activity diaries.

If I remember correctly, the 2007 NICE guideline recommended heart rate monitoring for GET.

I was unimpressed by Sarah Tyson's confidence in PROMs as more reliable and valid that wearables data in her talk today, which I comment on here:
https://www.s4me.info/threads/onlin...me-cfs-4th-june-2024.38150/page-2#post-536220

 

If the primary goal of therapy is to (genuinely and sustainably) increase patients' overall activity capacity, and it should be (even Wessely and Chalder think so*), then it must be measurable by objective means. That is simply not up for negotiation in my view.

I have yet to see a good argument for not using such means, and relying solely (or even primarily) on subjective measures, patient or clinician reported.

(*"...in the later stages of treatment patients are encouraged to increase their activity (which must ultimately be the aim of any treatment)"

Wessely, David, Butler, & Chalder – 1990

Wessely has also stated that his basic approach for ME/CFS patients is rehabilitative.)

 

Yes.

I really don't understand why the research team on this project don't understand that. Or choose not to understand it.

I found Sarah Tyson's arguments againts wearables in her talk yesterday very weak, mostly based on ancedotes of wearables not recording accurate data, which i dispute, and her own preferences for what is a meaningful outcome.

And I would say it applies equally to service evaluation when there is no effective treatment. The aim is to do all that's possible to support people with symptomatic treatment and provision of aids and care, and to do no harm.

If service evaluation and/or patient care is to assess and track over time patients' disease severity, tnen it must also use both objective and subjective data, not rely solely on PROMs.

I would welcome a service that enabled me to track my disease severity over time, and that information in a clinically useable form be shared with my doctor. But only if it's tracking something that is a meaningful to me measure of my health and function. That would probably include a motion sensor that tracked 'steps' and time upright, HR and HRV possibly, a simple symptom tracker app, and a functional capacity questionnaire such as FUNCAP, preferably all recorded analysed via the same app. and wearable.

I think Visible is getting closest from what I've heard, though I'm disappointed its wearable is only a heart not a motion sensor (have I got that right?). I understand there is research being done on Visible's large data set.

 

I was talking to someone recently who was commenting on various medical recording apps and the very poor security/privacy they seem to have. So this can be a real issue.

Generally, wearables won't have medical certifications but I think with using them along side PROMs we are talking about indicative information for anything clinical rather than as detailed accurate assured info. (but the security questions here worry me as that also raises quality issues).

If such mechanisms are used in research then a good data scientist will have an understanding of dealing with error ranges on incoming data and what can be accurately derived (although any statistician making claims from PROMs doesn't seem to have this type of appreciation).

The other issue is if an app is being used on say peoples smart phones (and this can do a lot of monitoring) then there are difficulties across different hardware and OS platforms which could lead to issues,

 

Health apps I'm aware of all offer a cholce of android or apple. Don't most smartphones use one of other of these?

 

No, we need other ways of taking that into account. There are quick tests that can show cognitive fatigue, I think, which could be useful eg how many of a sequence of digits such as a phone number you can recall after reading them.

 

Of course, especially if worn on the dominant wrist. There are ways to get around this, either by wearing on the waist or thigh, or by taking into account that the wearable is recording arm movements including steps. I find it useful, for example that getting dressed and undressed records as steps, and for me is a physically demanding activity.
I agree, playing the piano is energetic activity, and it's fine that it's recorded.

These quibbles seem so minor compared with the subjectivity of PROMs, but Sarah didn't even mention the problems with PROM subjectivity, as far as I remember, and she has said on this thread, wrongly, that they provide objective data.