Table 4.
Overview of the impact of core outcome domains on the odds ratio (OR) for achieving primary endpoint per trial
| Univariate meta-regression analysis based on trials reporting primary endpoint | Univariate meta-regression analysis based on trials reporting all four domains significantly affecting primary endpoint** (k = 15) | Multivariable meta-regression analysis based on trials reporting all four domains significantly affecting primary endpoint** (k = 15) | |||||
|---|---|---|---|---|---|---|---|
| Domain | k | OR (95% CI) | P value | OR (95% CI) | P value | OR (95% CI) | P value |
| Overall* | 39 | 3.26 (2.58, 4.13) | < 0.001 | 3.72 (2.92, 4.74) | < 0.001 | ||
| PF | 31 | 2.79 (1.58, 4.90) | 0.001 | 3.9 (1.67, 9.15) | 0.005 | 0.56 (0.27, 1.16) | 0.105 |
| Pain | 27 | 2.11 (1.45, 3.06) | < 0.001 | 5.6 (2.4, 13.15) | 0.001 | 5.19 (2.28, 11.77) | 0.001 |
| SM | 31 | 1.20 (0.94, 1.5) | 0.142 | 2.25 (1.27, 3.99) | 0.009 | 1.03 (0.64, 1.68) | 0.883 |
| SS | 22 | 1.29 (0.81, 2.06) | 0.268 | 1.88 (0.62, 1.56) | 0.227 | – | – |
| PGA | 20 | 2.15 (1.41, 3.30) | 0.001 | 2.58 (1.53, 4.34) | 0.002 | 1.87 (1.14, 3.07) | 0.018 |
| PJ/E | 10 | 8.14 (0.36, 186.27) | 0.161 | 16.99 (0.00, 3687 | 0.403 | – | – |
| APR | 23 | 1.68 (1.05, 2.68) | 0.031 | 1.61 (0.99, 2.63) | 0.054 | 0.86 (0.58, 1.29) | 0.381 |
| SR | – | – | – | – | – | – | – |
| Fatigue | 4 | 2.59 (0.00, 1360) | 0.581 | – | – | – | – |
*Based on trials reporting primary outcome; PF physical function, SM spinal mobility, SS spinal stiffness, APR acute phase reactants, SR spine radiographs
**PF, Pain, PGA, APR