I’m analyzing clinical trial data and am hoping to get some advice on analysis sets.
The primary endpoint is intubation for respiratory failure over a fixed time period of observation, with a pre-defined set of criteria for respiratory failure (e.g. one criteria: Recurrent apnoea treated with mask ventilation). Some of the subjects have been intubated for respiratory failure before meeting the strictly defined criteria. How best should this be handled in analysis?
I would be inclined to analyse these cases as having met the primary endpoint in intention-to-treat analysis - other opinions are welcome? I have a few ideas in relation to possible secondary analysis but unsure as to the best approach
-treat these cases as ‘censored’ from the point at which they were intubated
-per protocol analysis with these cases omitted
-a ‘competing risks’ model of some sort
Thanks in advance