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so it was designed in order to show hypofrac is non-inferior? I wouldn't be bothered with this if it weren't for the fact that the hypofrac arm is numerically worse, regardless of how squishy the endpoint is. Sure, we can say not ss, but that's because the trial was designed to not allow for that.My thoughts are that QOL endpoints are difficult to study. SDN is not the place to provide a complete answer but the issue is how does one define a clinically meaningful difference in a QOL endpoint also considered as "minimally important difference (MID)".
There are (at least) two ways.
One relies on simple statistics and generally uses 0.5 of a standard deviation (0.5SD) as a MID (this is what GU003 used).
The other is "anchoring" which is more complicated and involves patient focus groups where patients have a distribution of scores and they are asked to rate themselves-is Joe worse off than Bob...more expensive and time consuming.
The paper attached describes some of the problems with studying QOL as endpoints
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