Title Randomized (1a) |
40 |
0.80 (±0.40) |
0–1 |
Structured Abstract (1b) |
49 |
0.98 (±0.14) |
0–1 |
Background (2a) |
50 |
2.04 (±0.20) |
2–3 |
Objectives (2b) |
50 |
1.44 (±0.61) |
1–3 |
Trial Design (3a) |
49 |
1.48 (±0.95) |
0–5 |
Changes to Trial Design (3b) |
4 |
0.20 (±0.70) |
0–3 |
Eligibility Criteria (4a) |
49 |
3.20 (±1.56) |
0–8 |
Data Collection Setting (4b) |
40 |
0.96 (±0.60) |
0–2 |
Interventions (5) |
50 |
5.40 (±3.17) |
1–15 |
Outcomes (6a) |
50 |
13.22 (±7.24) |
3–38 |
Changes to Outcomes (6b) |
5 |
0.12 (±0.39) |
0–2 |
Sample Size Determination (7a) |
46 |
2.26 (±1.65) |
0–8 |
Interim Analyses/ Stopping Guidelines
(7b) |
11 |
0.42 (±1.01) |
0–5 |
Sequence Generation (8a) |
38 |
0.86 (±0.61) |
0–3 |
Randomization Type (8b) |
39 |
1.00 (±0.70) |
0–3 |
Allocation Concealment (9) |
19 |
0.44 (±0.64) |
0–3 |
Randomization Implementation (10) |
30 |
1.14 (±1.51) |
0–8 |
Blinding (11a) |
40 |
1.18 (±1.38) |
0–9 |
Similarity of Interventions (11b) |
15 |
0.36 (±0.60) |
0–2 |
Statistical Methods for Outcomes (12a) |
50 |
5.44 (±2.60) |
1–13 |
Statistical Methods for Other Analyses
(12b) |
29 |
1.44 (±1.67) |
0–6 |
Participant Flow (13a) |
45 |
2.52 (±1.39) |
0–6 |
Participant Loss/Exclusion (13b) |
43 |
2.32 (±1.65) |
0–7 |
Periods of Recruitment/ Follow-Up (14a) |
42 |
1.04 (±0.67) |
0–3 |
Trial Stopping (14b) |
6 |
0.18 (±0.63) |
0–4 |
Baseline Data (15) |
50 |
3.80 (±2.24) |
1–12 |
Numbers Analyzed (16) |
47 |
2.06 (±1.43) |
0–7 |
Outcome Results (17a) |
50 |
14.38 (±8.89) |
2–48 |
Binary Outcome Results (17b) |
32 |
3.94 (±5.59) |
0–26 |
Ancillary Analyses (18) |
37 |
4.50 (±4.46) |
0–16 |
Harms (19) |
45 |
3.88 (±3.90) |
0–17 |
Limitations (20) |
44 |
4.16 (±2.97) |
0–11 |
Generalizability (21) |
29 |
0.88 (±0.98) |
0–4 |
Interpretation (22) |
50 |
13.00 (±6.74) |
3–40 |
Registration (23) |
45 |
1.20 (±0.61) |
0–2 |
Protocol Access (24) |
7 |
0.16 (±0.42) |
0–2 |
Funding (25) |
50 |
2.52 (±1.82) |
1–10 |