Table 3 Differentiation of justifications (causes) for risk judgments with tests and interpretations
Risk judgment justification basis | Intervention | ||
|---|---|---|---|
Domain I (random sequence generation) | Categorization of supporting comments | Non-surgical | Surgical |
Randomization not described | 5317 (57.0%) | 389 (50.0%) | |
Random number table | 815 (8.7%) | 68 (8.7%) | |
Computerized randomization | 2597 (27.8%) | 253 (32.5%) | |
Mechanical randomization | 326 (3.5%) | 33 (4.2%) | |
Inappropriate randomization | 270 (2.9%) | 35 (4.5%) | |
Domain II (allocation concealment) | Type of allocation concealment | Non-surgical | Surgical |
Central allocation | 506 (5.3%) | 32 (4.1%) | |
Incomplete SNOSE | 1117 (11.8%) | 147 (18.6%) | |
Not described/unclear | 7200 (76.1%) | 525 (66.5%) | |
Open / predictable allocation | 386 (4.1%) | 34 (4.3%) | |
SNOSE | 250 (2.6%) | 51 (6.5%) | |
Domain III + a (blinding of participants and personnel) | Blinding achieved | Non-surgical | Surgical |
Achieved | 1239 (12.1%) | 38 (4.0%) | |
Not done or not possible | 4318 (42.1%) | 414 (43.8%) | |
Probably done | 4709 (45.9%) | 493 (52.2%) | |
Outcome influenced by lack of blinding | Non-surgical | Surgical | |
Influenced | 472 (4.6%) | 21 (2.2%) | |
Unknown | 9340 (91.0%) | 832 (88.0%) | |
Not influenced | 454 (4.4%) | 92 (9.7%) | |
Domain IV + a (blinding of outcome assessors) | Blinding achieved | Non-surgical | Surgical |
Achieved | 1722 (15.7%) | 84 (9.1%) | |
Probably done | 6695 (61.1%) | 609 (65.9%) | |
Not done or not possible | 2540 (23.2%) | 231 (25.0%) | |
Outcome influenced by lack of blinding | Non-surgical | Surgical | |
Influenced | 919 (8.4%) | 31 (3.4%) | |
Unknown | 9045 (82.5%) | 839 (90.8%) | |
Not influenced | 993 (9.1%) | 54 (5.8%) | |