Table 2. Required Sample Sizes for a Hypothetical New Trial of the Same Design, Using the Observed Effect Sizes from the Present Trial as the Basis of the Sample Size Calculation.
Primary Outcome of New Trial |
Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Expected Between-groups standard-score difference | Required sample size to detect this difference | Expected Between-groups standard-score difference | Required sample size to detect this difference | Expected Between-groups standard-score difference | Required sample size to detect this difference | Expected Between-groups standard-score difference | Required sample size to detect this difference | Expected Between-groups standard-score difference | Required sample size to detect this difference | ||
WOMAC Pain Subscale | 0.02 | 106870 | -0.37 | 236 | -0.44 | 164 | -0.38 | 222 | -0.26 | 476 | |
WOMAC Physical Function Subscale | -0.08 | 4874 | -0.41 | 188 | -0.45 | 158 | -0.42 | 184 | -0.33 | 298 | |
WOMAC Stiffness Subscale | -0.21 | 748 | -0.52 | 122 | -0.54 | 108 | -0.54 | 112 | -0.43 | 176 | |
Number of RM Pills Taken/day | -0.08 | 4362 | -0.33 | 290 | -0.31 | 332 | -0.25 | 496 | -0.24 | 550 | |
Composite 1: WOMAC pain & number of RM pills | -0.01 | 196818 | -0.41 | 190 | -0.45 | 162 | -0.39 | 214 | -0.29 | 364 | |
Composite 2: WOMAC Pain, Stiffness, & Function | -0.09 | 3780 | -0.44 | 164 | -0.49 | 134 | -0.45 | 156 | -0.34 | 270 | |
Composite 3: WOMAC P, S, F, & number of RM pills | -0.09 | 3600 | -0.46 | 154 | -0.49 | 132 | -0.47 | 146 | -0.35 | 260 |
Sample sizes are calculated for a hypothetical new trial with an expected between-groups standard deviation of 1, power of 0.8, and alpha level of 0.05, in all cases.