Comparison of methodological components between registered records and subsequent publications of RCTs
| Items | Records n=115 (%) | Publication n=136 (%) | Inconsistency rate (%) |
|---|---|---|---|
| Sample size | 114 (99.1%) | 136 (100%) | 17.6% |
| Generation of allocation sequence | 3 (2.6%) | 80 (58.8%) | 66.7% |
| Allocation concealment | 0 (0.0%) | 61 (44.9%) | NA |
| Participant blinded | 43 (37.4%) | 66 (48.5%) | 17.7% |
| Practitioner blinded | 18 (15.7%) | 31 (22.8%) | 11.1% |
| Outcome assessor blinded | 30 (26.1%) | 54 (39.7%) | 37.5% |
| Primary outcome | 62 (53.9%) | 114 (83.8%) | 29.2% |
| Secondary outcome | 52 (45.2%) | 96 (70.6%) | 34.4% |
| Safety | 28 (24.4%) | 58 (42.7%) | 28.6% |
NA: not available; RCTs, randomised clinical trials.