Overall, n (%) N=67 | |
---|---|
Sequence generation | |
Adequate | 57 (85) |
Not clear | 10 (15) |
Inadequate | 0 (0) |
Allocation concealment | |
Adequate | 41 (61) |
Inadequate | 3 (5) |
Not clear | 23 (34) |
Participants blinded | |
Definitely yes | 5 (8) |
Probably yes | 21 (31) |
Probably no | 13 (19) |
Definitely no | 28 (42) |
Caregiver blinded | |
Definitely yes | 5 (8) |
Probably yes | 22 (33) |
Probably no | 13 (19) |
Definitely no | 27 (40) |
Data collector blinded | |
Definitely yes | 3 (5) |
Probably yes | 26 (39) |
Probably no | 13 (19) |
Definitely no | 25 (37) |
Outcome assessor blinded | |
Definitely yes | 34 (51) |
Probably yes | 16 (24) |
Probably no | 7 (10) |
Definitely no | 10 (15) |
Data analyst blinded | |
Definitely yes | 7 (10) |
Probably yes | 3 (5) |
Probably no | 37 (55) |
Definitely no | 20 (30) |
Intention to treat | |
Yes | 38 (57) |
Unclear | 15 (22) |
No | 14 (21) |
Free of selective reporting of | |
outcomes | |
Adequate | 59 (88) |
Not clear | 5 (7) |
Inadequate | 3 (5) |
Stopped early | |
Total | 7 (10) |
For benefit | 2 (3) |
For harm | 1 (2) |
For insufficient accrual | 4 (6) |
Not reported | 0 (0) |
Follow up | |
Mean percentage (range) | 96% (57-100) |