I would read it as a statement that the analysis plan wasn't expected to override and change the protocol which appears to be what happened. As far as I can tell the TSC never approved the final protocol changes just an analysis plan that failed to point them out, When the results were...
In one of the early sets of minutes it seems clear that they will publish in the Lancet because they are asking whether the way they registered to trial is ok for the lancet.
I'm still reading the TSG minutes but its not just the analysis plan they hadn't done for the start of the trial. The database wasn't ready and part way through the first year they were just moving to version 6.
What has really struck me about the minutes is they clearly lack any form of...
George Monboit who is an environmentalist and guardian columnist has written a bit on the SMC
http://www.monbiot.com/2003/12/09/invasion-of-the-entryists/
http://www.monbiot.com/2011/06/13/naming-the-genocide-deniers/
When they were looking to raise the SF36 score acceptable for recruitment the PACE PI's understood just how subjective the questionnaires were. (Just not when used for results)
I agree, I think things should move to the analysis being pre-coded so that as the last data is added to the database then the results tables would be produced.
The PACE people seemed to have trouble 'cleaning data' so applying certain checks on the data can be helpful to detect possible errors.
My interpretation is they dropped it as a secondary outcome in the analysis plan and then later produced an adhoc recovery definition created after the initial paper was published.
They seem more concerned about PR strategies than the analysis plan and I've yet to come across protocol changes...
I seem to remember that the stats analysis plan doesn't raise the issue of protocol change but just introduces them. So this raises the issue of whether the protocol changes were explicitly approved.
I think there was a anti-depressant that caused suicides in teenagers which ran into this type of problem in reporting harms because suicide was seen as part of depression. But in that case evidence was in trial data that was then reexamined.
My argument would be evidence of benefit from such...
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