Table 3.
Ordered OR of GADS Improvement on the 7-Point Likert Scale at Week 4
| GADS Response at Week 4, n (%) | Number of PRO Responsesa at Week 4 | ||||||
|---|---|---|---|---|---|---|---|
| No CII at Week 4 (n=1100) | CII at Week 4 (N=1210) | 0 (n=407) | 1 (n=693) | 2 (n=579) | 3 (n=433) | 4 (n=198) | |
| Much Better | 17 (2) | 85 (7) | 2 (<1) | 15 (2) | 17 (3) | 31 (7) | 37 (19) |
| Better | 68 (6) | 308 (25) | 9 (2) | 59 (9) | 107 (18) | 121 (28) | 80 (40) |
| Slightly Better | 332 (30) | 562 (46) | 83 (20) | 249 (36) | 264 (46) | 225 (52) | 73 (37) |
| No Change | 509 (46) | 215 (18) | 213 (52) | 296 (43) | 158 (27) | 50 (12) | 7 (4) |
| Slightly Worse | 140 (13) | 37 (3) | 74 (18) | 66 (10) | 31 (5) | 5 (1) | 1 (<1) |
| Worse | 28 (3) | 3 (<1) | 21 (5) | 7 (1) | 2 (<1) | 1 (<1) | 0 |
| Much Worse | 6 (<1) | 0 | 5 (1) | 1 (<1) | 0 | 0 | 0 |
| OR of better responseb vs no CII (95% CI) | – | 5.56 (4.69, 6.58); p<0.001 | – | – | – | – | – |
| OR of better responseb vs 0 PRO responses (95% CI) | – | – | – | 2.91 (2.30, 3.69); p<0.001 | 6.67 (5.18, 8.61); p<0.001 | 15.96 (12.07, 21.10); p<0.001 | 42.07 (29.58, 59.83); p<0.001 |
Notes: aA PRO response was defined as meeting the MCID for SAC-TDI, E-RS, CAT or SGRQ scores; bImprovement in GADS was defined as a patient reporting a GADS response of Slightly Better, Better or Much Better at Week 4.
Abbreviations: CAT, COPD Assessment Test; CI, confidence interval; CII, clinically important improvement; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms:COPD; GADS, Global Assessment of Disease Severity; MCID, minimal clinically important difference; OR, odds ratio; PRO, patient-reported outcome; SAC-TDI, self-administered computerized-Transition Dyspnea Index; SGRQ, St George’s Respiratory Questionnaire.