Table 7.
Clinical outcomes (0–24 months)
| Outcome (range) |
0–24 months |
0–18–24 months |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| N | 0 months | 24 months | T-test: 0–24 month difference* | SRM | ANOVA | ||||
| Mean (SD) | Mean (SD) | Mean (95% CI) | T-value | P-value | N | P-value | |||
| Average Asthma severity (0–10) | 57 | 5.21 (2.23) | 2.47 (2.44) | 2.74 (1.99–3.48) | 7379 | <0.001 | 0.98 | 52 | <0.001 |
| Symptom score (0–10) | 58 | 5.21 (1.93) | 2.70 (2.20) | 2.51 (1.89–3.14) | 8061 | <0.001 | 1.06 | 53 | <0.001 |
| Asthma symptoms (1–4) | <0.001 | ||||||||
| • Cough | 38 | 3.13 (0.88) | 2.16 (1.10) | 0.97 (0.51–1.44) | 4217 | <0.001 | 0.68 | 33 | <0.001 |
| • Dyspnea | 36 | 2.86 (0.93) | 2.08 (1.05) | 0.78 (0.42–1.13) | 4466 | <0.001 | 0.74 | 32 | <0.001 |
| • Exertion-induced symptoms | 36 | 3.03 (0.94) | 2.17 (1.03) | 0.86 (0.46–1.26) | 4398 | <0.001 | 0.73 | 31 | <0.001 |
| • Frequency of asthma attacks | 37 | 2.27 (1.22) | 1.76 (1.14) | 0.51 (0.06–0.97) | 2285 | 0.028 | 0.38 | 32 | <0.001 |
| • Awakening from asthma | 37 | 2.22 (1.11) | 1.49 (0.87) | 0.73 (0.40–1.06) | 4483 | <0.001 | 0.74 | 32 | <0.001 |
| AQLQ (1–7) | |||||||||
| • Overall score | 22 | 4.26 (1.09) | 5.53 (1.32) | 1.27 (0.74–1.80) | 4977 | <0.001 | 1.06 | 18 | <0.001 |
| • Activity limitations | 20 | 3.94 (1.00) | 5.43 (1.35) | 1.49 (0.92–2.07) | 5410 | <0.001 | 1.21 | 18 | <0.001 |
| • Symptoms | 22 | 4.13 (1.36) | 5.41 (1.47) | 1.28 (0.65–1.91) | 4240 | <0.001 | 0.90 | 18 | <0.001 |
| • Emotional function | 22 | 4.63 (1.29) | 5.67 (1.68) | 1.03 (0.47–1.60) | 3818 | 0.001 | 0.81 | 18 | 0.001 |
| • Exposure to environmental stimuli | 20 | 4.52 (1.40) | 5.66 (1.22) | 1.14 (0.43–1.86) | 3349 | 0.003 | 0.75 | 17 | <0.001 |
| KINDL Asthma module (0–100) | 15 | 80.11 (10.36) | 90.25 (8.95) | 10.14 (1.92–18.35) | 2647 | 0.019 | 0.68 | 14 | 0.013 |
| KINDL Total score (0–100) | 12 | 67.82 (11.22) | 72.13 (13.68) | 4.31 (−3.65–12.27) | 1192 | 0.258 | 0.34 | 12 | 0.390 |
| SF-36 Physical Component summary | 33 | 44.88 (9.94) | 49.68 (9.30) | 4.80 (2.37–7.23) | 4022 | <0.001 | 0.70 | 27 | 0.015 |
| SF-36 Mental Component summary | 33 | 43.51 (11.60) | 45.87 (10.94) | 2.36 (−1.37 to 6.09) | 1287 | 0.207 | 0.22 | 31 | 0.001 |
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, Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents; N, asthma symptoms; SD, standard deviation; SRM, standardized response mean effect size (minimal, <0.20; small, 0.20–0.49; medium, 0.50–0.79; large, ≥0.80).