United Kingdom 2024: Online workshops on ME/CFS Research

I have watched the first 2 talks.
Sarah Tyson's section on her team's development of PROMs she said she expects the 3 tested so far on symptoms, PEM and function are expected to be useful for clinical trials. She talked a bit about them in general terms about reliability and validity and the need to take onto account that ME is a fluctuating condition, so quite large changes would be needed to show clinical change.
Then physiological measures 2 day CPET - she said "drop in aerobic threshold on the second day equals onset of PEM". She said a bit about the home testing study led by Nicola Clague Baker that found physiological effects of activities in the pwME but not consistent between individuals.
Then wearables which she talked about briefly and very dismissively as unreliable and not validated for ME.

There was a question about FUNCAP which she said is validated, but she is clearly not keen on. She says she found it difficult to fill in and she thinks her team's approach to a function questionnaire is better. She describes the difference as FUNCAP focuses on the consequences of doing activities, whereas her questionnaire focuses on the adaptations people make to decide to do or not do each activity.
 
I watched Caroline Kingdon who talked about her experience of visiting people at home who are participating in the ME Biobank. She was excellent on the need for the clinician to listen and be adaptable to the pwME's needs and limitations when designing and carrying out research. Very good talk.

Ran out of energy to watch the last 2 talks.
 
FUNCAP is Not difficult to fill in it is being used by thousands of people in visible through the app monthly. The view of one person is not a valid basis for ruling something out for potential use in the NHS, inappropriate. A lot of people with ME rely on technology more than the average person. It’s a pity ME Association didn’t link up with the Visible team instead.
 
Trish said:
I have watched the first 2 talks.
Sarah Tyson's section on her team's development of PROMs she said she expects the 3 tested so far on symptoms, PEM and function are expected to be useful for clinical trials. She talked a bit about them in general terms about reliability and validity and the need to take onto account that ME is a fluctuating condition, so quite large changes would be needed to show clinical change.
Then physiological measures 2 day CPET - she said "drop in aerobic threshold on the second day equals onset of PEM". She said a bit about the home testing study led by Nicola Clague Baker that found physiological effects of activities in the pwME but not consistent between individuals.
Then wearables which she talked about briefly and very dismissively as unreliable and not validated for ME.

There was a question about FUNCAP which she said is validated, but she is clearly not keen on. She says she found it difficult to fill in and she thinks her team's approach to a function questionnaire is better. She describes the difference as FUNCAP focuses on the consequences of doing activities, whereas her questionnaire focuses on the adaptations people make to decide to do or not do each activity.
Click to expand...
I thought she’d said here PROMS was NOT to be used for clinical trials

I guess if she found FUNCAP difficult to fill in, she’s speaking on badly of the ME community now?
 
Then wearables which she talked about briefly and very dismissively as unreliable and not validated for ME.

Well then the profession needs get to making them reliable and validated. Because inadequately controlled PROMS are not okay.
 
MrMagoo said:
It’s just an excuse. They’re doing the thing they want to do. They want to do PROMS with paper questionnaires they way they want to, that’s all.
Click to expand...
Given that the patient participation seems backwards engineered , I suspect the bulk of this was done years ago before wearables became more of a thing and it's sat on shelf awaiting funding.
The language and methodology seem pre revised NICE guidelines, but too much sunk cost to change..
 
By email from the workshop organiser Monica Bolton:

Dear attendee,


Many thanks for attending the Clinical Trial Design in People with ME/CFS workshop and we hope that you found it informative.

We said at the workshop that we would make as much of it available as possible.

The link for the workshop material is here:

Clinical Trials Workshop

The folder contains two sub-folders labelled;-

Agenda and Presentations. All these are Microsoft documents, and if you click on any document you will be asked to log into Microsoft. Most people will find it easiest to download each document/power point presentation (right click on the document) and then open on your own machine with your Microsoft or equivalent software.

and

Workshop files. The workshop files includes the video file of the workshop, the vtt file (which adds the closed captions), the audio only file, the chat files and the closed caption text file. We hope to edit the closed caption text file if we have time as one of the speakers had microphone issues. So please check back later, probably over the summer, if you want a clearer version.

We hope to keep this link available for some time. Please feel free to download the files and to distribute the link to anyone you feel may be interested in the workshop.

If you have comments or questions please contact us on

clinical-trial-design@serafina3.me.uk

Yours,

Monica Bolton & Alan Mould
 
The issues with wearables seems to be that because they’re all different in how they measure, and she doesn’t know the “under the hood” calculations they use etc, they’re not reliable and -this is key- therefore those results wouldn’t be fit to use as clinical trial data.

Generating a data set for clinical trial data was the NICE gap this project was to fill, was then not part of this project, then suggested it could be a secondary benefit, I don’t like the way this is inconsistent. Also it will be GiGO data, rubbish in rubbish out. I don’t care for any “clinical trial” using this data as a measure
 
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