Table 5.
Clinical outcomes (0–12 months)
| Outcome (range) |
0–12 months |
0–3–6–12 months |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| N | 0 months | 12 months | T-test: 0–12 month difference* | SRM | ANOVA | ||||
| Mean (SD) | Mean (SD) | Mean (95% CI) | T-value | P-value | N | P-value | |||
| Average asthma severity (0–10) | 66 | 5.35 (2.17) | 2.74 (2.30) | 2.61 (1.90–3.32) | 7320 | <0.001 | 0.90 | 52 | <0.001 |
| Symptom score (0–10) | 64 | 5.32 (2.03) | 3.08 (1.87) | 2.22 (1.61–2.84) | 8454 | <0.001 | 1.07 | 52 | <0.001 |
| Asthma symptoms (1–4) | |||||||||
| • Cough | 40 | 3.10 (0.90) | 2.18 (0.90) | 0.93 (0.60–1.25) | 5721 | <0.001 | 0.90 | 31 | <0.001 |
| • Dyspnea | 39 | 2.90 (0.94) | 1.97 (0.84) | 0.92 (0.56–1.28) | 5196 | <0.001 | 0.83 | 30 | <0.001 |
| • Exertion-induced symptoms | 38 | 3.13 (0.88) | 2.18 (0.80) | 0.95 (0.64–1.25) | 6290 | <0.001 | 1.02 | 27 | <0.001 |
| • Frequency of asthma attacks | 40 | 2.30 (1.18) | 1.53 (0.78) | 0.78 (0.41–1.14) | 4287 | <0.001 | 0.68 | 31 | 0.014 |
| • Awakening from asthma | 39 | 2.26 (1.02) | 1.36 (0.71) | 0.90 (0.58–1.21) | 5791 | <0.001 | 0.93 | 30 | <0.001 |
| AQLQ (1–7) | |||||||||
| • Overall score | 25 | 4.06 (1.07) | 5.50 (1.13) | 1.44 (0.97–1.92) | 6302 | <0.001 | 1.26 | 20 | <0.001 |
| • Activity limitations | 24 | 3.91 (1.08) | 5.32 (1.21) | 1.41 (0.88–1.95) | 5496 | <0.001 | 1.12 | 19 | <0.001 |
| • Symptoms | 25 | 3.91 (1.23) | 5.55 (1.18) | 1.64 (1.06–2.23) | 5763 | <0.001 | 1.15 | 20 | <0.001 |
| • Emotional function | 25 | 4.49 (1.44) | 5.73 (1.17) | 1.24 (0.81–1.67) | 5997 | <0.001 | 1.20 | 20 | <0.001 |
| • Exposure to environmental stimuli | 23 | 4.22 (1.28) | 5.33 (1.58) | 1.10 (0.57–1.63) | 4330 | <0.001 | 0.90 | 18 | <0.001 |
| KINDL Asthma module (0–100) | 16 | 78.75 (9.39) | 93.49 (5.32) | 14.74 (9.70–19.78) | 6234 | <0.001 | 1.56 | 12 | 0.002 |
| KINDL Total score (0–100) | 16 | 67.69 (9.39) | 74.67 (12.16) | 6.98 (2.52–11.44) | 3337 | 0.005 | 0.83 | 12 | 0.037 |
| SF-36 Physical Component summary | 37 | 44.84 (9.44) | 48.17 (8.62) | 3.40 (0.58–6.22) | 2510 | 0.019 | 0.41 | 31 | 0.001 |
| SF-36 Mental Component summary | 37 | 43.48 (11.33) | 50.17 (7.77) | 6.68 (2.91–10.46) | 3590 | 0.001 | 0.59 | 31 | 0.003 |
Notes: AQLQ, and KINDL were analyzed in patients enrolled after March 2001; AQLQ and SF-36 were analyzed in adult patients, KINDL were analyzed in children.
*
Positive differences indicate improvement.
Abbreviations: ANOVA, Repeated measures analysis of variance, testing for within-group change; AQLQ, Asthma Quality of Life Questionnaire; CI, confidence interval; KINDL, KINDL questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents; N, asthma symptoms; SF-36, Short-Form Health Survey (36 items); SRM, standardized response mean effect size (minimal, <0.20; small, 0.20–0.49; medium, 0.50–0.79; large, ≥0.80).