TableĀ 2.
CONSORT number | Point | Overall adherence, n (%) | Medical adherence, n (%) | Surgical adherence, n (%) |
---|---|---|---|---|
1a | Title and abstract | 46 (85) | 17 (77) | 29 (91) |
1b | 7 (13)* | 7 (32) | 0 | |
2a | Background and objectives | 54 (100) | 22 (100) | 32 (100) |
2b | 54 (100) | 22 (100) | 32 (100) | |
3a | Trial design | 22 (41) | 14 (64) | 8 (25) |
3b | 54 (100) | 22 (100) | 32 (100) | |
4a | Participants | 54 (100) | 22 (100) | 32 (100) |
4b | 13 (24)* | 7 (32) | 6 (19) | |
5 | Interventions | 48 (89) | 19 (86) | 29 (91) |
5a | 39 (72) | 20 (91) | 19 (59) | |
5b | 50 (93) | 20 (91) | 30 (94) | |
5c | 7 (13)* | 6 (27) | 1 (3) | |
6a | Outcomes | 48 (89) | 22 (100) | 26 (81) |
6b | 54 (100) | 22 (100) | 32 (100) | |
7a | Sample size | 3 (6)* | 2 (9) | 1 (3) |
7b | 52 (96) | 22 (100) | 30 (94) | |
8a | Randomisation sequence generation | 30 (56) | 12 (55) | 18 (56) |
8b | 9 (17)* | 2 (9) | 7 (22) | |
9 | Allocation concealment mechanism | 28 (52) | 17 (77) | 11 (34) |
10 | Randomisation implementation | 18 (33) | 13 (59) | 5 (16) |
11a | Blinding | 29 (54) | 16 (73) | 13 (41) |
11b | 30 (56) | 16 (73) | 14 (44) | |
12a | Statistical methods | 54 (100) | 22 (100) | 32 (100) |
12b | 2 (4)* | 0 | 2 (6) | |
13a | Participant flow | 0* | 0 | 0 |
13b | 51 (94) | 22 (100) | 29 (91) | |
New | Implementation of intervention | 38 (70) | 12 (55) | 26 (81) |
14a | Recruitment | 48 (89) | 22 (100) | 26 (81) |
14b | 51 (94) | 22 (100) | 29 (91) | |
15a | Baseline data | 52 (96) | 22 (100) | 30 (94) |
15b | 0* | 0 | 0 | |
16 | Numbers analysed | 52 (96) | 22 (100) | 30 (94) |
17a | Outcomes and estimation | 21 (39) | 18 (82) | 3 (9) |
17b | 15 (28)* | 14 (64) | 1 (3) | |
18 | Ancillary analyses | 42 (78) | 20 (91) | 22 (29) |
19 | Harms | 51 (94) | 21 (95) | 30 (94) |
20 | Limitations | 35 (65) | 19 (86) | 16 (50) |
21 | Generalisability | 24 (44) | 14 (64) | 10 (31) |
22 | Interpretation | 51 (94) | 22 (100) | 29 (91) |
23 | Registration | 49 (91) | 22 (100) | 27 (84) |
24 | Protocol | 25 (46) | 18 (82) | 7 (22) |
25 | Funding | 40 (74) | 22 (100) | 18 (56) |
Headings in italics are covered within the CONSORT-NPT extension. Non-italics are exclusive to CONSORT 2010 statement. Further details available in online supplementary appendix S3.