PACE trial TSC and TMG minutes released

But we don't really know how they were even using actigraphy at baseline. Was there anything in the protocol about that?

 

But if some of that "smallest difference they could possibly report as statistically significant" was due to these patients they are still affecting the trial outcome. And the fact they included people with a different illness and palmed them off as ME, and paid GP to get these patients is important to show.

 

In Feb 2007 they are still discussing the actigraphy analysis strategy. At this point, the protocol had already been submitted for publication.

 

But PACE did say in their protocol that they would use a submaximal 'self-paced step test' (search the protocol for ref #43, which is this Petrella thing):

https://www.ncbi.nlm.nih.gov/pubmed/11380757

 

Ah - OK. I'm making assumptions again. (naughty naughty) I'll see if I can get hold of this.

 

My hairs went up on reading the actigraphy stuff. Not only were they aware of the null results for actigraphy when they dropped it as a PACE outcome, but they were explicitly citing this data as part of their reason for dropping it. Wow.

I think it's important to avoid being too critical about some of the smaller things turning up in these minutes, but this seems like a big find to me.

Maybe now would be a good time to draw attention to some old @Tom Kindlon comments on the PACE trial protocol? He got in there with pre-specified criticisms!: https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments

Specifically:

Would it not be preferable if objective outcome measures were used?
23 May 2007

Another example as to why objective measures would be useful
30 August 2007

CFS intervention studies - lessons can be learned from a previous review
30 August 2007

If CBT for CFS is "to help patients improve activity levels and quality of life", would not actometers be useful for measuring outcomes?
13 November 2007

The relevant part of White's response:

Response to comments on “Protocol for the PACE trial”
28 July 2008

...

"Objective outcome measures

We have used several objective outcome measures; the six minute walking test [1], a test of physical fitness [2], as well as occupational and health economic outcomes [3]. Although we originally planned to use actigraphy as an outcome measure, as well as a baseline measure, we decided that a test that required participants to wear an actometer around their ankle for a week was too great a burden at the end of the trial. We will however test baseline actigraphy as a moderator of outcome. No biological measures were sufficiently well established to justify their use as outcomes in the trial."

Then more from Kindlon:

The dropping of actometers as an outcome measure and other points relating to the outcome measures being used
22 October 2008

Further evidence showing why objective measures are preferable in CFS trials particularly where cognitions could be changed following the intervention
6 March 2009

Discrepancies between momentary fatigue and recalled fatigue can exist
1 July 2009

New paper lists 3 CFS studies where there was no improvement in the actometer readings but an improvement was reported in subjective outcome measures
12 May 2010

 

Can you imagine any other scientific study including patients with a different disease? Study MS and throw in some RA patients, study cancer and throw in some with dibetes to make the numbers up? This is horrifying and was not even declared. It really shows the utter contempt with which they hold pwme.

They refuse to even attempt to understand the disease, I suppose they think it doesn't matter as pwme and pwfm are all the same as both 'conditions' are all in the mind. But rather telling they didn't state the trial was studying both conditions.

Actigraphy won't indicate improvement, so we'd better drop that! My jaw is aching is has dropped so many times hearing all this.

 

Also - it's a bit odd to suggest that actometers aren't suitable outcome measures because patients' activity is already so high at baseline, when CBT and GET both aim to improve activity levels.

Chalder and Wessely have said:

"At the heart of CBT is a behavioural approach to the impairment of activity that is part of the definition of CFS."
http://www.amjmed.com/article/S0002-9343(99)80332-5/pdf

 

Presumably just too much on top of all those marathons they were now running.
Not quite what it says in the minutes.

 

Thanks for unearthing this actigraphy stuff @Lucibee.

A smoking gun indeed, @Sean.

I'm alarmed by their use of the word "useful". This hints at motivation. What was the purpose of the trial? To test whether CBT/GET are effective or to try to prove that they are? To suggest that an objective measure of activity which is likely to yield a null result is not "useful" is a shocking admission.

Rough translation of minutes on actigraphy:

Actigraphy is to be used at baseline as it's a good way of assessing how unwell someone is.
Actigraphy is not to be used as an outcome measure as it is a good way of assessing how unwell someone is (and this is not something we are interested in, unless it supports our hypothesis).

Hard to know whether it is incompetence or a deliberate attempt to design a trial that will produce the result they want. Probably both.


This is starting to feel quite exciting. I’m getting a sense of how Bernstein and Woodward must have felt.

 

I suspect the minutes of the Analysis Strategy Group will have more detail on the "issues" they had with actigraphy.

 

I think you're right.

This just gets weirder and weirder. The quote (linked below) shows that they actually knew that they would not be improving physical activity levels, only perceptions of fatigue, but apparently that didn't matter.

View attachment 2410

 

I've put together a PDF with all the Actigraphy mentions in the minutes.

 

Many thanks @Lucibee, I will put that in my 'notebook'.