PACE trial TSC and TMG minutes released

I think maybe you'll need a pantechnicon to move your notebook around soon @Jonathan Edwards!

 

"Actigraphy is a measure of physical activity, measured by a wrist
watch sized accelerometer, worn around the ankle continuously for a
week. Before we started the trial, we were advised that the number
and scope of the outcome measures were too great and that it might
reduce the proportion of participants making it through to the end of
the trial. Actigraphy was the obvious measure to reject because of its
burden in time and effort required by participants. The patient charity
advising us agreed that this would be sensible."

 

[My bold]

Which always came across as an incredibly contrived and unconvincing excuse at best.

 

One of many clinchers it would seem. PACE was no so much a trial as preparation for a sermon.

 

Whether that is blame or collusion I'm not quite sure.

 

I'd love to see some-one from @action4me pipe up and defend their charity on this matter.

Were they colluding, being bowled over by force of the characters involved, or in some other way being coerced into agreeing to dropping the actimeters?

Or perhaps they didn't really agree at all, but the records were contrived to appear that way?

If that was the case, why have AfME not defended their name from this slur? I really cannot see how an actimeter round the ankle could in any way be a burden - even to some-one confined to bed most of the day.

Having to do step tests and questionnaires would seem much more arduous to me!

Edit to try again to tag @Action for M.E.

 

Perhaps we should ask them?

@Action for M.E. did you advise or agree that it would be sensible to ditch the use of actigraphs in the PACE trial because it would be too much a time burden and effort for patients?

Could you provide details of any input you gave on the use of actigraphs in the PACE trial?

Clarification on this matter would be greatly appreciated.

ETA - crossed posts with @Keela Too

 

I remember this questioning of @Action for M.E. from five years ago:

Peter Kemp‎ to Action for M.E.
30 December 2012 ·
2nd request.
Dear AfME, the PACE Trial researchers state: "Actigraphy is a measure of physical activity, measured by a wrist watch sized accelerometer, worn around the ankle continuously for a week. Before we started the trial, we were advised that the number and scope of the outcome measures were too great and that it might reduce the proportion of participants making it through to the end of the trial. Actigraphy was the obvious measure to reject because of its burden in time and effort required by participants. The patient charity advising us agreed that this would be sensible."

I would be very grateful if you would publish the correspondence or describe the context (and post/qualifications of responsible personnel) involved in 'advising' the PACE Trial researchers and agreeing that it 'would be sensible' to cancel actigraphy as an outcome measure.

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Action for M.E. We believe we need to respect the confidential nature of internal documents and/or correspondence between organisations and individuals engaged in research projects in which we are involved. This applies to all such projects, past, present and future. We believe that not to do so would run a significant risk of deterring people from getting involved in research into the cause(s) of and possible treatments for M.E. Action for M.E. will continue to drive and fund bio-medical research into the cause(s) of M.E.
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Peter Kemp Well, excuse me, I'm sure! The PACE Trial authors put this information in the public domain. Somebody at AfME supported the move to cancel actigraphy as an outcome measure. Did they give this approval to change a Registered Controlled Clinical Trial in secret? Were they aware that Knoop had recently demonstrated that actigraphy did not correlate with Fatigue or Physical Function when they supported this change? Did they in fact, know what they were doing? Stop mucking about. This affects ALL your members. Where is your duty to them? This is NOT an issue of confidentiality, though you may wish to make it an issue of cover-up.
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Katharine A Gilchrist Nobody is asking you to disclose personal details of addresses of senders of letters, A4ME. Just the other stuff.
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Paul Watton I think Action for M.E. have a prima facie case to answer but their response (above) is a deliberate attempt to avoid your question Peter. IMO they are failing in their duty to serve those whom they purport to represent and who's money they are eager to receive.

 

I think that if you edit a new tag into an existing post, it doesn't work (I think someone told me that once).

So, @Action for M.E. - please look at this post: https://www.s4me.info/threads/pace-trial-tsc-and-tmg-minutes-released.3150/page-11#post-57880

 

I have just sent an email to Sonya Chowdhury asking her to clarify whether AfME agreed that it would be sensible to drop actigraphy as an outcome measure, and if so why. I also sent a link to this thread.

 

More truthful version (probably):

"Actigraphy is a measure of physical activity, measured by a wrist watch sized accelerometer, worn around the ankle continuously for a week. Before we started the trial, we were advised by the patient charity that the number and scope of the outcome measures were too great and that it might reduce the proportion of participants making it through to the end of the trial. However, we ignored this advice and carried on regardless, until we realised that actigraphy was an obvious measure to reject because it wasn't going to show any benefit of our favoured interventions."

There. Fixed it.

 

Those actometers really are a bit bothersome - so what?! Are we three-year-olds? I have to wear it for one week every three months, also during sleep and showering. I don't like it, but it's no burden. That's just a cheap excuse of the PACE authors.

 

https://twitter.com/user/status/978970727230603264

https://twitter.com/user/status/978989354310713346

https://twitter.com/user/status/978922585395204096

https://twitter.com/user/status/978910116522156032

 

Would all this be interesting for Myhill's complaint to GMC?

 

I'd have thought so. Anyone know if the complaint leads to a real investigation, where further evidence can be submitted, responses can be responded to, etc?

 

They are also used by sleep labs for research and patient wake/sleep tests, i suppose they should stop using them because some patients might not like them. They can replace objective data with subjective data and diagnose patients not based on the best science available, its not like anyone needs easily recordable accurate data in medical research