Data items | Combined | Pre-CONSORT | Post-CONSORT | Odds ratio (95% CI) | p value |
---|---|---|---|---|---|
Title and abstract | |||||
Randomised | 1.0 (37) | 1.0 (13) | 1.0 (24) | Â | 1.0 |
Introduction | |||||
Scientific background | 1.0 (37) | 1.0 (13) | 1.0 (24) | Â | 1.0 |
Eligibility criteria for participants | 1.0 (37) | 1.0 (13) | 1.0 (24) | Â | 1.0 |
Details of Intervention | 1.0 (37) | 1.0 (13) | 1.0 (24) | Â | 1.0 |
Objectives | 1.0 (37) | 1.0 (13) | 1.0 (24) | Â | 1.0 |
Endpoints | 0.89 (33) | 0.77 (10) | 0.96 (23) | 6.9 (0.69; 74.51) | 0.115 |
Sample size | 0.54 (20) | 0.23 (3) | 0.71 (17) | 8.1 (1.70; 38.58) | 0.007 |
Methods of randomization | 0.70 (26) | 0.38 (5) | 0.88 (21) | 11.2 (2.11; 58.37) | 0.003 |
Allocation concealment | 0.57 (21) | 0.38 (5) | 0.67 (16) | 3.2 (1.17; 8.74) | 0.096 |
Implementation of randomization | 0.41 (15) | 0.08 (1) | 0.58 (14) | 16.8 (1.87; 150.73) | 0.003 |
Blinding | 0.65 (24) | 0.31(4) | 0.8 (20) | 11.25 (2.29; 55.35) | 0.0023 |
Statistical methods | 0.89 (33) | 0.69 (9) | 1.0 (24) | Â | 0.011 |
Results | |||||
Participant flow | 0.91 (34) | 0.77 (10) | 1.0 (24) | Â | 0.037 |
Recruitment + follow-up | 0.51 (19) | 0.61 (8) | 0.46 (11) | 0.53 (0.13; 2.10) | 0.895 |
Baseline data | 0.95 (35) | 0.85 (11) | 1.0 (24) | Â | 0.12 |
Intention-to-treat analysis | 0.92 (34) | 0.76 (10) | 1.0 (24) | Â | 0.037 |
Outcome and estimation | 0.95 (35) | 0.85 (11) | 1.0 (24) | Â | 0.12 |
Ancillary analysis | 0.29 (11) | 0.15 (2) | 0.38 (9) | 3.3 (0.59; 18.40) | 0.15 |
Adverse effects | 0.81 (30) | 0.92 (12) | 0.75 (18) | 0.25 (0.03; 2.34) | 0.9 |
Discussion | |||||
Interpretation of results | 0.95 (35) | 0.84 (11) | 1.0 (24) | Â | 0.12 |
Generalizability | 0.86 (32) | 0.69 (9) | 0.96 (23) | 10.22 (1.00; 104.0) | 0.042 |
Overall evidence | 0.95 (35) | 0.85 (11) | 1.0 (24) | Â | 0.12 |