PACE trial TSC and TMG minutes released

Adrian said:
I think this is where they try to blame action for ME (the patient charity).
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"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."
 
Trish said:
It looks like deliberate deception to me.

1. Agree privately it's not a good outcome measure because the Dutch studies showed it didn't show improvement and that's not the outcome wanted from the trial.
2. Then tell everyone publicly the reason it's not being used as an outcome measure is because it's too much of a burden for patients.
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[My bold]

Which always came across as an incredibly contrived and unconvincing excuse at best.
 
Adrian said:
I think this is where they try to blame action for ME (the patient charity).
Click to expand...
Sly Saint said:
"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."
Click to expand...
Whether that is blame or collusion I'm not quite sure.
 
Trish said:
''The patient charity advising us agreed that this would be sensible''

Just goes to show how under the thumb of White et al AfME were at the time.
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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.
 
Trish said:
''The patient charity advising us agreed that this would be sensible''
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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
 
Last edited:
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.
 
Barry said:
Whether that is blame or collusion I'm not quite sure.
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The PACE PIs always try to deflect or blame others. So with the protocol changes they said they were approved by the TSC which is independent and with the actigraphy they were deflecting to AfME and for the bad results and bad methodology they are now trying to deflect to Cochrane saying they back the results.

It always seems like them having a tactic of not taking responsibility.

In terms of AfME I think they had someone on the trial management committee (not sure though) but did that person report everything back to AfME (the board or the CEO) or did they just act autonomously. Then was that person just in the room when the decision was made, were they active in making it, did they just agree that there was a lot of patient assessment. AfME may not know what happened because they may not have detailed reports from the representative.

My view is I don't trust the PACE PIs when they try to push blame. But those they push blame to need to be careful because it will stick. For example, it looks bad for the TSC that they approved protocol changes.
 
"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."
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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.
 
Sean said:
An instrument deliberately designed to be as unobtrusive as possible, weighing less than 50g (1.75oz), is claimed to be too much of a burden.
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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.
 
Inara said:
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.
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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 :emoji_rolling_eyes:
 
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