Online workshop: Clinical Trial Design in People with ME/CFS, 4th June 2024

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

 

Well that was useful (not)
I tried to open one of the documents and got an access denied response.

 

That was Sarah Tyson as part of her talk commenting about how unreliable some individuals find wearables, presumably from a few people she's spoken to. I don't recall the audience making any such comments. Can you point to it?

 

Thanks, so the chair says 'a number of comments in the chat saying they were finding wearables 'incredibly unreliable, not recordiing accurately what they were doing, things like that.'
So not lots of people, just 'a number of people' and the chair's quick glance through a few people responding in the chat.
I take that as unreliable evidence, just a few random people agreeing with what ST already said.
Hardly the basis for ST to dismiss so comprehensively any use of wearables.
Also ST says she herself uses HR monitoring to help with pacing, as lots of people do and have done for decades along with step monitoring.
Her justification here seemed to be that they are not yet proven as research outcome measures, yet she kept asserting that her PROMs are intended for clinical care, not for trials. She can't have it both ways. Her PROMs are not yet proven as outcome measures either, and definitely no more reliable, let alone objective.

 

What is required is that they are reasonably accurate at recording changes and trends for the individual. It is the variations that seem most important here, though the absolute values do matter as well.