RECRUITMENT/RANDOMISATION At our site some patients receive oseltamivir/corticosteroids as part of usual care, can these patients be randomised?
Without good evidence to guide the use of oseltamivir and steroids, clinical practice varies widely between different countries, hospitals, and clinicians, and so RECOVERY eligibility follows the ‘Uncertainty Principle’.
The protocol allows wide range of patients to join, but we know some clinicians may have strong views on which kinds of patient they are willing to recruit (e.g. some might give steroids to all severe CAP patients, or oseltamivir to all flu patients if symptom onset was less than 48 hours ago).
For each treatment comparison:
- If the responsible clinician is reasonably certain that the treatment should, or should not, be given (or if they feel they must follow local guidelines that specify this) then the patient is not eligible for that treatment comparison
- If the responsible clinician is substantially uncertain about giving the trial treatment (whether or not they would usually give it in their normal practice) and they would be happy to follow a random allocation, the patient is potentially eligible.
This means the kind of patients recruited at each site will vary, but when each comparison ends we will explore which (if any) kinds of patients benefit in prespecified subgroup analyses (e.g. based on severity, symptom duration, immunosuppression).