Table 7.
Mean change in PROMIS SD-SF-8b total score: PGI-S SD and PGI-C SD categories
| Categories | N | Mean change | Median change | 95% CI |
|---|---|---|---|---|
| PGI-S SD | ||||
| Baseline to week 4 | ||||
| All categories | ||||
| Improved 3 points | 6 | – 19.00 | – 20.50 | – 29.09, – 8.91 |
| Improved 2 points | 102 | – 12.25 | – 12.00 | – 13.66, – 10.85 |
| Improved 1 point | 341 | – 6.07 | – 6.00 | – 6.65, – 5.49 |
| No change | 377 | – 1.02 | – 1.00 | – 1.58, – 0.46 |
| Worsened 1 point | 97 | 3.70 | 4.00 | 2.53, 4.88 |
| Worsened 2 points | 9 | 10.56 | 9.00 | 6.58, 14.53 |
| Worsened 3 points | 0 | |||
| Collapsed categories | ||||
| Improved ≥ 2 points (collapsed) | 108 | – 12.63 | – 13.00 | – 14.04, – 11.22 |
| Worsened ≥ 2 points (collapsed) | 9 | 10.56 | 9.00 | 6.58, 14.53 |
| Baseline to week 12 | ||||
| All categories | ||||
| Improved 3 points | 12 | – 18.33 | – 22.00 | – 23.43, – 13.23 |
| Improved 2 points | 120 | – 11.28 | – 11.50 | – 12.51, – 10.04 |
| Improved 1 point | 313 | – 6.30 | – 6.00 | – 6.92, – 5.68 |
| No change | 311 | – 1.17 | – 1.00 | – 1.78, – 0.57 |
| Worsened 1 point | 98 | 3.35 | 3.00 | 2.16, 4.53 |
| Worsened 2 points | 10 | 7.30 | 7.00 | 2.73, 11.87 |
| Worsened 3 points | 0 | |||
| Collapsed categories | ||||
| Improved ≥ 2 points (collapsed) | 132 | – 11.92 | – 12.00 | – 13.16, – 10.67 |
| Worsened ≥ 2 points (collapsed) | 10 | 7.30 | 7.00 | 2.73, 11.87 |
| PGI-C SD | ||||
| Baseline to week 4 | ||||
| All categories | ||||
| Much better | 160 | – 10.98 | – 10.00 | – 12.12, – 9.84 |
| Moderately better | 152 | – 5.93 | – 6.00 | – 6.86, – 4.99 |
| A little better | 265 | – 3.80 | – 4.00 | – 4.51, – 3.09 |
| No change | 291 | 0.33 | 0.00 | – 0.32, 0.98 |
| A little worse | 39 | 2.82 | 4.00 | 0.52, 5.12 |
| Moderately worse | 16 | 3.38 | 4.00 | 0.86, 5.89 |
| Much worse | 8 | 4.63 | 5.00 | 0.09, 9.16 |
| Collapsed categories | ||||
| Much or moderately better | 312 | – 8.52 | – 8.00 | – 9.31, – 7.73 |
| Moderately worse or much worse | 24 | 3.79 | 4.00 | 1.73, 5.85 |
| Improvement | 577 | – 6.35 | – 6.00 | – 6.92, – 5.78 |
| No change | 291 | 0.33 | 0.00 | – 0.32, 0.98 |
| Worsening | 63 | 3.19 | 4.00 | 1.60, 4.78 |
| Baseline to week 12 | ||||
| All categories | ||||
| Much better | 189 | – 9.69 | – 10.00 | – 10.71, – 8.67 |
| Moderately better | 170 | – 5.87 | – 6.00 | – 6.77, – 4.97 |
| A little better | 231 | – 3.59 | – 3.00 | – 4.45, – 2.74 |
| No change | 198 | – 0.56 | 0.00 | – 1.38, 0.26 |
| A little worse | 37 | 3.00 | 2.00 | 1.20, 4.80 |
| Moderately worse | 29 | 4.03 | 4.00 | 1.72, 6.35 |
| Much worse | 8 | 6.63 | 4.50 | 1.90, 11.35 |
| Collapsed categories | ||||
| Much or moderately better | 359 | – 7.88 | – 8.00 | – 8.59, – 7.17 |
| Moderately worse or much worse | 37 | 4.59 | 4.00 | 2.59, 6.60 |
| Improvement | 590 | – 6.20 | – 6.00 | – 6.77, – 5.63 |
| No change | 198 | – 0.56 | 0.00 | – 1.38, 0.26 |
| Worsening | 74 | 3.80 | 3.00 | 2.47, 5.13 |
Bolded categories were used for the triangulation of meaningful change thresholds
CI Confidence interval, PGI-C SD Patient Global Impression of Change Sleep Disturbance, PGI-S SD Patient Global Impression of Severity Sleep Disturbance, PROMIS SD-SF-8b Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b