Characteristic | Non-inferiority trials (N = 13) | Superiority trials (N = 82) | ||
---|---|---|---|---|
n | %b | n | %b | |
Methods | ||||
 Expected magnitude of difference identified explicitly as the MCIDc | 2 | 15.4 | 2 | 2.4 |
 Justification for MCIDa | ||||
  Clinical relevance | 1 | 50.0 | 1 | 50.0 |
  Methodological | 1 | 50.0 | 1 | 50.0 |
 Delta value | ||||
Stated as an absolute difference | 13 | 100.0 | 78 | 95.1 |
 Margin (median, IQR) | − 0.10 | − 0.10,0.10 | 0.12 | 0.10, 0.17 |
 Time-to-event | 12 | 92.3 | 69 | 88.5 |
 Dichotomous outcome | 1 | 7.7 | 9 | 11.5 |
 Stated as relative difference | 0 | 0.0 | 7 | 8.5 |
  Margin (median, IQR) | N/A | 0.63 | 0.60, 2.50 | |
  Time-to-event | N/A | 6 | 85.7 | |
  Dichotomous outcome | N/A | 1 | 14.3 | |
  Stated as a percentage and ratio | 0 | 0.0 | 4 | 4.9 |
 Anticipated control value stated | 10 | 76.9 | 63 | 76.8 |
 Assumptions in the control group | 6 | 46.2 | 12 | 14.6 |
 Stated | ||||
  Results from previous trial or systematic review | 5 | 83.3 | 11 | 91.7 |
  Based on clinical expertise | 1 | 16.7 | 1 | 8.3 |
 Type 1 error (α value) | ||||
 Stated | 10 | 76.9 | 52 | 63.4 |
  0.20 | 0 | 0.0 | 1 | 1.9 |
  0.10 | 2 | 20.0 | 2 | 3.8 |
  0.05 | 8 | 80.0 | 49 | 94.2 |
 Sides | ||||
 Stated | 12 | 92.3 | 40 | 48.8 |
  One-sided | 10 | 83.3 | 29 | 72.5 |
  Two-sided | 2 | 16.7 | 11 | 27.5 |
 Type 2 error (1 − β value) | ||||
 Stated | 12 | 92.3 | 81 | 98.8 |
   < 80% | 2 | 16.7 | 7 | 8.6 |
  80 to 85% | 6 | 50.0 | 58 | 71.6 |
  85 to 90% | 1 | 8.3 | 7 | 8.6 |
   ≥ 90% | 3 | 25.0 | 9 | 11.1 |
Results | ||||
 Statistical significance of primary outcome reported via p value | 13 | 100.0 | 66 | 80.5 |
 Confidence intervals/standard error for primary outcome reported | 12 | 92.3 | 52 | 63.4 |
 Treatment effect stated | 6 | 46.2 | 6 | 7.3 |
Discussion (and/or Results) | ||||
 Clinical importance of primary outcome discussed | 10 | 76.9 | 11 | 13.4 |