Hi Whytee …. not sure … the results announcement is so poorly presented its hard to make head nor tail of what is going on.
The flavour I get is that the trial was approached with a very confirmatory bias. Surgery is risky and so you need a big benefit to justify it. That benefit is either shown or not at 26 weeks.
Once that failed the exploratory longer follow-up idea comes into play. But the methods / statistical approach is based around the confirmatory model. Taking a slice in time:
At 6 months sig/ns
At 12 months sig/ns
At 18 months sig/ns
etc
The exploratory approach is to fit a curve to the change over time; is there a trend for improvement over time for the treatment groups. And the more time points you have for this the better; particularly when the N is small.
Hi Whytee …. not sure … the results announcement is so poorly...
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