PACE trial TSC and TMG minutes released

[Nightsong]

200411404 TMG #11.pdf (p4)

Actigraphy is to be given at baseline only, as a predictor. This is on the basis of research by the Dutch Nijmegen group who found it useful as a predictor (the more passive, the poorer outcome), but not useful for outcome.

20041210 TMG #12.pdf (p3) (similar comments in PDFs either side)

The issue of using actigraphy as an outcome measure was raised. It was noted that the Dutch study by Bleijenberg and colleagues reported that actigraphy was not a good outcome measure since the majority of patients are reasonably active and there is no change in this in spite of improvement in fatigue. However, pervasively passive people at baseline may do worse on CBT and perhaps better on GET.

 

[Nightsong]

There was also this, on actigraphy, from the PACE Trial Identifier document (pp5-6):

Possibly predictive variables (measured at baseline): . . . 3. Pervasive inactivity (measured by actigraphy) has predicted poor response to CBT. [15]

Process variables (measured during therapy and at follow-up): Changes in fitness,34 physical activity (by actigraphy),

Ref 15 is:

15. Priiis JB et al. Cognitive behaviour therapy for chronic fatigue syndrome. Lancet 2001; 357: 841-7

 

[Adam pwme]

Someone has asked me to ask around about the following. They want to make a complaint.
—
When I sent in my initial complaint to get the PACE trial minutes, I cited the discrepancy between the Dutch trials which showed no increase in activity and the PACE trials dropping of this objective requirement from their guidelines. The PACE authors played dumb and said no such requirement was involved in their request for funding. However when the full minutes were released, the PACE authors cited this as a direct reason not to need to include actometer data in their request. You can't have it both ways.
—
I believe from an early email from them what this person wants is for someone to find the relevant parts of the minutes that they can quote.

Lucibee wrote about it here.

PACE trial: Whatever happened to actigraphy?

In my first blog about the PACE trial, I discussed the lack of objective measures, and the bothersome issue of not knowing how much participants actually managed to increase their activity, because…

lucibee.wordpress.com

 

[Evergreen]

I believe from an early email from them what this person wants is for someone to find the relevant parts of the minutes that they can quote.

I dug out relevant parts of the minutes recently for a few posts. (In case the person is unfamiliar with the site, click on "Evergreen" in each quote below to go to the posts and see the quotes):

From TMG minutes #11, 4 Nov 2004:
And TMG minutes #12, 10 Dec 2004:

Happy to be corrected with other sources.

The Trial Management Group Minutes start in June 2002. Unless I missed it, actigraphy doesn't get a mention until meeting #7 in May 2004, when the minutes note [underlining added]:

The next mention is in meeting #10 [underlining added]:

Then in meeting #11, we hear why:
And in meeting #12, we get the clanger:

So whatever was written in the Identifier, according to the Trial Management Group minutes, actigraphy was not a planned outcome measure at any point from 2002.

 

[Evergreen]

Somebody has been over this in a thread in the last few months, possibly Valerie Elliott Smith? There was some divergence of view I think, which would fit with your interpretation above. @dave30th might remember.

I think that was me @Jonathan Edwards!

 

[dave30th]

Somebody has been over this in a thread in the last few months, possibly Valerie Elliott Smith? There was some divergence of view I think, which would fit with your interpretation above. @dave30th might remember.

Esther12 used to be very upon this but has not been around here for a good while.

I definitely miss Esther12's valuable contributions.

 

[Sean]

15. Priiis JB et al. Cognitive behaviour therapy for chronic fatigue syndrome. Lancet 2001; 357: 841-7​

Minor typo correction, in case anybody is doing a search for this study, or citing it: It should be Prins JB,... [link]

 

[Lucibee]

Someone has asked me to ask around about the following. They want to make a complaint.
—
When I sent in my initial complaint to get the PACE trial minutes, I cited the discrepancy between the Dutch trials which showed no increase in activity and the PACE trials dropping of this objective requirement from their guidelines. The PACE authors played dumb and said no such requirement was involved in their request for funding. However when the full minutes were released, the PACE authors cited this as a direct reason not to need to include actometer data in their request. You can't have it both ways.
—
I believe from an early email from them what this person wants is for someone to find the relevant parts of the minutes that they can quote.

I documented them all here: https://lucibee.wordpress.com/2018/05/09/pace-trial-whatever-happened-to-actigraphy/