Table 5.
Comparison of outcomes between study groups in the modified per-protocol population
|
ENO Breathe (n=40) |
Usual care (n=42) |
Regression coefficient (95% CI) | p value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Follow-up | Change | Baseline | Follow-up | Change | ||||
| RAND SF-36 scores | |||||||||
| RAND SF-36 MHC score | 30·88 (10·41) | 35·11 (12·00) | 4·22 (6·83) | 36·23 (7·78) | 36·63 (8·82) | 0·40 (5·17) | 3·50 (0·72 to 6·27) | 0·014 | |
| RAND SF-36 PHC score | 32·97 (7·41) | 35·02 (9·30) | 2·05 (6·23) | 33·83 (6·74) | 35·40 (8·23) | 1·56 (5·06) | 0·45 (−2·06 to 2·95) | 0·72 | |
| SF-36 physical function | 46·25 (22·32) | 51·25 (25·13) | 5·00 (12·96) | 45·24 (20·78) | 50·24 (22·44) | 5·00 (12·00) | 0·06 (−5·44 to 5·55) | 0·98 | |
| SF-36 role limitation, physical | 8·75 (19·24) | 15·63 (30·32) | 6·88 (29·41) | 9·52 (16·52) | 17·26 (28·42) | 7·74 (27·32) | −1·18 (−13·30 to 10·95) | 0·85 | |
| SF-36 pain | 53·10 (24·52) | 58·70 (24·26) | 5·60 (24·93) | 56·45 (24·70) | 56·64 (23·56) | 0·19 (21·24) | 3·84 (−5·04 to 12·72) | 0·39 | |
| SF36 general health | 40·88 (18·92) | 42·45 (20·20) | 1·57 (12·19) | 44·62 (16·88) | 45·98 (19·35) | 1·36 (13·06) | −0·30 (−5·82 to 5·21) | 0·91 | |
| SF-36 energy | 22·38 (16·76) | 29·38 (21·10) | 7·00 (17·35) | 22·38 (14·99) | 24·00 (16·47) | 1·62 (11·28) | 5·38 (−0·88 to 11·64) | 0·091 | |
| SF-36 role limitation, emotional | 41·67 (40·47) | 50·00 (44·66) | 8·33 (38·30) | 61·11 (44·73) | 58·73 (40·86) | −2·38 (46·21) | 1·09 (−15·67 to 17·85) | 0·90 | |
| SF-36 emotional wellbeing | 54·50 (20·91) | 59·70 (23·14) | 5·20 (13·01) | 65·52 (14·99) | 65·71 (16·72) | 0·19 (10·22) | 4·00 (−1·35 to 9·35) | 0·14 | |
| SF-36 social functioning | 33·75 (25·03) | 44·06 (28·59) | 10·31 (21·54) | 45·83 (26·29) | 47·32 (26·41) | 1·49 (19·17) | 5·91 (−2·91 to 14·73) | 0·19 | |
| SF-6D | 0·57 (0·09) | 0·60 (0·08) | 0·03 (0·05) | 0·57 (0·09) | 0·60 (0·08) | 0·01 (0·06) | 0·01 (−0·01 to 0·03) | 0·33 | |
| CAT score | 20·13 (7·02) | 15·85 (6·85) | −4·28 (5·33) | 17·52 (5·69) | 16·60 (5·96) | −0·93 (4·28) | −2·61 (−4·64 to −0·59) | 0·012 | |
| Anxiety (GAD-7 score) | 8·43 (5·40) | 6·95 (5·60) | −1·48 (2·62) | 5·62 (4·17) | 6·24 (4·64) | 0·62 (3·63) | −1·68 (−3·10 to −0·25) | 0·022 | |
| Dyspnoea-12 total score | 14·40 to (6·90) | 10·40 (7·19) | −4·00 (4·51) | 14·48 (7·26) | 12·43 (6·72) | −2·05 (5·53) | −1·97 (−4·04 to 0·09) | 0·061 | |
| Dyspnoea-12 affective | 5·33 (3·68) | 3·45 (3·34) | −1·88 (2·87) | 4·57 (3·23) | 4·10 (3·24) | −0·48 (2·76) | −1·11 (−2·22 to −0·01) | 0·049 | |
| Dyspnoea-12 physical | 9·07 (3·78) | 6·95 (4·28) | −2·13 (2·52) | 9·90 (4·47) | 8·33 (3·97) | −1·57 (3·39) | −0·78 (−2·01 to 0·46) | 0·22 | |
| VAS breathlessness rest | 22·63 (20·78) | 20·10 (20·83) | −2·52 (16·75) | 23·00 (20·77) | 19·10 (18·57) | −3·90 (12·95) | 1·26 (−4·70 to 7·23) | 0·67 | |
| VAS breathlessness walking | 33·08 (22·25) | 25·77 (22·04) | −7·30 (19·64) | 37·79 (23·24) | 31·60 (21·05) | −6·19 (14·71) | −2·72 (−9·59 to 4·16) | 0·43 | |
| VAS breathlessness stairs | 52·67 (24·59) | 40·50 (24·42) | −12·18 (22·98) | 56·02 (25·42) | 51·02 (24·94) | −5·00 (19·77) | −8·44 (−16·95 to 0·07) | 0·052 | |
| VAS breathlessness running | 76·60 (27·79) | 65·92 (29·80) | −10·68 (24·64) | 82·48 (18·16) | 80·62 (20·73) | −1·86 (13·95) | −10·37 (−18·81 to −1·93) | 0·017 | |
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.