Table 3.
Comparison of outcomes between study groups in the intention-to-treat population
|
ENO Breathe (n=58) |
Usual care (n=71) |
Regression coefficient (95% CI) | p value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=74) | Follow-up (n=58) | Change (n=58) | Baseline (n= 76) | Follow-up (n=71) | Change (n=71) | ||||
| RAND SF-36 scores | |||||||||
| RAND SF-36 MHC score | 30·89 (10·20) | 34·40 (11·97) | 3·56 (7·22) | 33·21 (9·83) | 34·17 (10·37) | 0·78 (6·63) | 2·42 (0·03 to 4·80) | 0·047 | |
| RAND SF-36 PHC score | 31·77 (7·44) | 34·02 (9·39) | 1·73 (5·79) | 32·18 (7·41) | 33·30 (8·51) | 1·14 (5·27) | 0·60 (−1·33 to 2·52) | 0·54 | |
| SF-36 physical function | 41·55 (22·71) | 48·10 (26·17) | 4·05 (13·72) | 42·76 (23·42) | 46·41 (23·61) | 4·37 (14·56) | −0·08 (−4·99 to 4·82) | 0·97 | |
| SF-36 role limitation, physical | 8·78 (21·67) | 14·22 (29·66) | 5·60 (26·92) | 8·22 (18·88) | 14·79 (27·57) | 6·34 (26·63) | −0·67 (−9·70 to 8·36) | 0·88 | |
| SF-36 pain | 47·82 (25·12) | 55·95 (24·48) | 6·41 (21·95) | 50·58 (25·51) | 50·58 (23·51) | −0·18 (20·01) | 6·11 (−0·34 to 12·57) | 0·063 | |
| SF-36 general health | 40·57 (19·49) | 40·97 (20·59) | 0·03 (12·17) | 40·89 (17·45) | 41·01 (20·71) | 0·30 (13·95) | −0·23 (−4·79 to 4·32) | 0·92 | |
| SF-36 energy | 22·03 (17·69) | 27·59 (21·40) | 5·26 (16·26) | 20·26 (16·12) | 22·93 (16·90) | 2·08 (12·23) | 3·50 (−1·32 to 8·32) | 0·15 | |
| SF-36 role limitation, emotional | 43·24 (42·28) | 45·40 (44·02) | 1·15 (38·98) | 51·76 (45·67) | 47·89 (43·18) | −3·29 (45·83) | 1·08 (−12·03 to 14·19) | 0·87 | |
| SF-36 emotional wellbeing | 54·65 (19·92) | 58·76 (23·41) | 5·03 (14·21) | 59·05 (19·23) | 60·28 (19·52) | 0·39 (12·38) | 3·65 (−0·91 to 8·22) | 0·12 | |
| SF-36 social functioning | 33·28 (24·59) | 44·40 (26·82) | 10·56 (22·56) | 41·15 (26·41) | 44·37 (26·29) | 3·84 (19·30) | 4·75 (−2·13 to 11·63) | 0·17 | |
| SF-6D | 0·56 (0·09) | 0·59 (0·09) | 0·02 (0·06) | 0·58 (0·10) | 0·59 (0·09) | 0·01 (0·06) | 0·01 (−0·01 to 0·03) | 0·16 | |
| CAT score | 21·30 (7·18) | 17·43 (7·95) | −2·88 (5·84) | 19·34 (6·60) | 17·76 (7·15) | −1·41 (4·61) | −1·25 (−3·02 to 0·52) | 0·17 | |
| Anxiety (GAD-7 score) | 8·57 (5·54) | 7·29 (5·81) | −1·14 (2·99) | 7·38 (5·54) | 7·34 (5·37) | −0·03 (4·02) | −1·03 (−2·21 to 0·14) | 0·085 | |
| Dyspnoea-12 total score | 16·08 (7·25) | 12·05 (7·88) | −3·10 (5·29) | 15·83 (7·86) | 13·41 (7·43) | −2·46 (5·67) | −0·82 (−2·64 to 1·00) | 0·38 | |
| Dyspnoea-12 affective | 5·88 (3·78) | 3·98 (3·56) | −1·55 (3·21) | 5·42 (3·90) | 4·70 (3·72) | −0·73 (3·14) | −0·78 (−1·76 to 0·20) | 0·12 | |
| Dyspnoea-12 physical | 10·20 (4·14) | 8·07 (4·79) | −1·55 (3·20) | 10·41 (4·65) | 8·70 (4·23) | −1·73 (3·29) | −0·02 (−1·10 to 1·06) | 0·97 | |
| VAS breathlessness rest | 23·32 (20·73) | 26·55 (24·71) | 3·12 (20·24) | 26·67 (22·41) | 23·41 (23·33) | −3·00 (19·08) | 5·23 (−1·29 to 11·75) | 0·12 | |
| VAS breathlessness walking | 38·51 (23·88) | 30·21 (24·66) | −5·91 (21·06) | 41·07 (26·78) | 35·49 (25·26) | −4·08 (18·02) | −2·86 (−9·20 to 3·49) | 0·38 | |
| VAS breathlessness stairs | 60·18 (24·12) | 47·57 (28·21) | −11·07 (23·20) | 59·09 (26·96) | 52·66 (26·50) | −5·92 (21·06) | −5·13 (−12·33 to 2·06) | 0·16 | |
| VAS breathlessness running | 83·53 (23·19) | 71·47 (28·12) | −10·03 (22·59) | 81·71 (24·62) | 81·48 (22·22) | 0·70 (19·92) | −10·48 (−17·23 to −3·73) | 0·0026 | |
Data are mean (SD). CAT=chronic obstructive pulmonary disease assessment test. ENO=English National Opera. GAD-7=generalised anxiety disorder-7 questionnaire. MHC=mental health composite. PHC=physical health composite. RAND SF-36=RAND 36-item short form survey instrument. SF-6D=short form-6D. VAS=visual analogue scale.