Table 2.
Change in fatigue NRS | Sensitivity | Specificity | Positive predictive value | Negative predictive value | Phi coefficient |
A: NRS—SPIRIT-P1 | |||||
−8 | 0.009 | 0.995 | 0.667 | 0.464 | 0.022 |
−7 | 0.042 | 0.995 | 0.900 | 0.472 | 0.116 |
−6 | 0.111 | 0.995 | 0.960 | 0.491 | 0.218 |
−5 | 0.213 | 0.973 | 0.902 | 0.516 | 0.279 |
−4 | 0.310 | 0.914 | 0.807 | 0.533 | 0.276 |
−3 | 0.454 | 0.828 | 0.754 | 0.566 | 0.300 |
−2 | 0.653 | 0.634 | 0.675 | 0.611 | 0.287 |
−1 | 0.806 | 0.478 | 0.642 | 0.679 | 0.302 |
0 | 0.912 | 0.290 | 0.599 | 0.740 | 0.262 |
B: NRS—SPIRIT-P2 | |||||
−8 | 0.007 | 1.000 | 1.000 | 0.587 | 0.063 |
−7 | 0.062 | 1.000 | 1.000 | 0.601 | 0.192 |
−6 | 0.123 | 1.000 | 1.000 | 0.617 | 0.276 |
−5 | 0.226 | 0.966 | 0.825 | 0.638 | 0.298 |
−4 | 0.342 | 0.937 | 0.794 | 0.668 | 0.359 |
−3 | 0.425 | 0.879 | 0.713 | 0.683 | 0.346 |
−2 | 0.541 | 0.723 | 0.581 | 0.690 | 0.268 |
−1 | 0.678 | 0.490 | 0.485 | 0.682 | 0.168 |
0 | 0.870 | 0.291 | 0.465 | 0.759 | 0.190 |
Receiver operating characteristic analyses suggested –3-point fatigue NRS score improvement is the minimum clinically important difference after 24 weeks.
NRS, numeric rating scale; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.