Additional Descriptors for Interventional Studies

N-of-1Crossover Parallel Group
Single Group, etc.
Statistical intent (superiority, non-inferiority, equivalence)N/A
Sequence generation (random, non-random)
Allocation method (a, b, c, d, e)
Blinding/Masking (yes/no of each of: participant,
investigator, outcomes assessor, statistician)
Control group type (active, placebo, sham, usual care,
dose comparison, historical)
Study phase (Phase 0, I, I/II, II, II/III, III, IV)