ITT baseline | n | Completers baseline | n | Completers 12 months | n | Change over 1 year | n | |
---|---|---|---|---|---|---|---|---|
CCQ-Total | ||||||||
NIV | 3.37±1.2 | 96 | 3.4±1.2 | 48 | 2.9±1.1 | 48 | −0.5 (−0.2 to −0.8) * | 48 |
Controls | 3.31±1.06 | 90 | 3.2±1.0 | 51 | 2.8±1.1 | 51 | −0.5 (−0.8 to −0.1) * | 51 |
Treatment effect | −0.04 (−0.5 to 0.4) | |||||||
MRF-28-Total | ||||||||
NIV | 60.88±23.60 | 99 | 58.3±24.3 | 50 | 51.0±24.8 | 50 | −7.3 (−12.5 to 2.1) * | 50 |
Controls | 60.28±23.89 | 90 | 55.3±24.2 | 51 | 49.4±24.2 | 51 | −5.8 (−10.8 to −0.8)* | 51 |
Treatment effect | −1.5 (−8.6 to 5.7) | |||||||
CRQ-Total | ||||||||
NIV | 3.47±1.10 | 100 | 3.5±1.1 | 50 | 4.2±1.2 | 50 | 0.7 (0.4 to 1.1)* | 50 |
Controls | 3.59±1.08 | 89 | 3.6±1.1 | 50 | 4.4±1.1 | 50 | 0.7 (0.5 to 1.0)* | 50 |
Treatment effect | 0.01 (−0.4 to 0.4) | |||||||
SRI-Total | ||||||||
NIV | 48.14±14.97 | 100 | 47.9±15.1 | 50 | 55.0±15.4 | 50 | 7.0 (3.4 to 10.7)* | 50 |
Controls | 51.33±15.87 | 90 | 53.6±16.9 | 51 | 55.8±16.3 | 51 | 2.2 (−1.2 to 5.6) | 51 |
Treatment effect | 4.8 (−0.1 to 9.7) | |||||||
GARS-Total | ||||||||
NIV | 36.66±7.50 | 100 | 36.3±9.4 | 50 | 34.6± 9.4 | 50 | −1.6 (−3.3 to 0.1) | 50 |
Controls | 36.76±8.54 | 90 | 34.7±8.8 | 51 | 32.7±8.2 | 51 | −2.0 (−4.1 to 0.1) | 51 |
Treatment effect | 0.4 (−2.3 to 3.0) | |||||||
HADS-Total | ||||||||
NIV | 15.88±9.24 | 98 | 15.6±8.8 | 48 | 13.9±8.8 | 48 | −1.7 (−4.0 to 0.6) | 48 |
Controls | 14.48±8.83 | 87 | 13.1±9.1 | 50 | 12.7±9.3 | 50 | −0.4 (−2.2 to 1.3) | 50 |
Treatment effect | −1.3 (−4.1 to 1.6) | |||||||
MRC | ||||||||
NIV | 3.9±1.0 | 98 | 3.8±1.0 | 49 | 3.4±1.4 | 49 | −0.4 (−0.7 to −0.01)* | 49 |
Controls | 3.8±1.0 | 90 | 3.6±1.1 | 51 | 3.3±1.2 | 51 | −0.3 (−0.7 to 0.1) | 51 |
Treatment effect | −0.05 (−0.6 to 0.5) |
Data presented as means (±SD) and mean change (95% CIs).
Scores represent: CCQ and MRF-28↓=HRQL↑; CRQ and SRI↑=HRQL↑; GARS↓=ADL↑; HADS↓=mood↑; MRC↓=dyspnoea↓.
*p<0.05 significant change after 12 months within the group. There was no significant difference in change after 12 months between the groups (treatment effect).
CCQ, Clinical COPD Questionnaire; Controls, standard treatment; CRQ, Chronic Respiratory Questionnaire; GARS; Groningen Activity and Restriction Scale; HADS, Hospital Anxiety and Depression Scale (separate scores for anxiety and depression domain); ITT, intention-to-treat; MRC, Medical Research Council dyspnoea scale; MRF-28, Maugeri Respiratory Failure Questionnaire-28; n, numbers for analysis; NIV, non-invasive positive pressure ventilation; SRI, Severe Respiratory Insufficiency questionnaire.