Baseline characteristics of participants, by treatment group
| Characteristic | No. %* | |
|---|---|---|
| Standard care n = 160 | Autoinflation n = 160 | |
| Age, yr, mean ± SD | 5.4 ± 1.04 | 5.4 ± 1.24 |
| Male sex | 83 (51.9) | 84 (52.5) |
| Severity of otitis media with effusion | ||
| No type-B tympanogram | 2 (1.3) | 2 (1.3) |
| Type-B tympanogram, 1 ear | 91 (56.9) | 90 (56.3) |
| Type-B tympanogram, 2 ears | 67 (41.9) | 68 (42.5) |
| Month randomly assigned | ||
| October to March | 107 (66.9) | 107 (66.9) |
| April to September | 53 (33.1) | 53 (33.1) |
| Ethnicity | ||
| White | 144 (90.0) | 152 (95.0) |
| Bangladeshi/Indian | 2 (1.3) | 2 (1.3) |
| Mixed race | 3 (1.9) | 1 (0.6) |
| Other group | 2 (1.3) | 2 (1.3) |
| No information | 9 (5.6) | 3 (1.9) |
| Education level of parent or caregiver | ||
| Attended school to age 16 yr; no certificate or diploma | 11 (6.9) | 6 (3.8) |
| Attended school to age 16 yr; secondary school diploma | 28 (17.5) | 33 (20.6) |
| College or nonuniversity certificate | 56 (35.0) | 63 (39.4) |
| University degree | 37 (23.1) | 31 (19.4) |
| Professional/postgraduate degree or certificate | 17 (10.6) | 22 (13.8) |
| No information | 30 (18.8) | 31 (19.4) |
| Parent-reported child characteristics | ||
| Asthma† | 19 (11.9) | 16 (10.0) |
| Eczema† | 15 (9.5) | 20 (12.5) |
| Hay fever† | 40 (25.0) | 42 (26.3) |
| Antibiotics in previous month† | 12 (7.5) | 21 (13.1) |
| Parent-reported symptoms in the previous 3 mo (children aged 4–6 yr only) | n = 135 | n = 130 |
| A prolonged or bad cold, cough or chest infection | 113 (83.7) | 119 (91.5) |
| Appears to be lip reading† | 27 (20.0) | 27 (20.8) |
| An earache | 74 (54.8) | 77 (59.2) |
| Not doing as well at school as expected† | 32 (23.7) | 39 (30.0) |
| Often mishears what is said | 98 (72.6) | 112 (86.2) |
| Has noises in the ear or is dizzy | 29 (21.5) | 30 (23.1) |
| Hearing loss is suspected by anyone† | 56 (41.5) | 67 (51.5) |
| Snores, blocked nose or poor sleep | 93 (68.9) | 101 (77.7) |
| Says “eh what?” or “pardon” a lot | 107 (79.3) | 114 (87.7) |
| Speech seems behind other children’s | 22 (16.3) | 31 (23.8) |
| Needs the television turned up | 78 (57.8) | 82 (63.1) |
| Any suspected ear problem | 48 (35.6) | 55 (42.3) |
| May be irritable or withdrawn | 43 (31.9) | 38 (29.2) |
| No. of symptoms, median (IQR) | 6 (4–8) | 7 (5–9) |
| OMQ-14 (quality of life)‡ | n = 153 | n = 153 |
| Standardized score (SD) | −0.04 (± 0.95) | 0.07 (± 1.00) |
Note: IQR = interquartile range, SD = standard deviation.
↵* Unless stated otherwise.
↵† Missing data for children in the standard care and autoinflation groups on the following variables: asthma and eczema (n = 9, 4), hay fever and antibiotics in previous month (n = 9, 3), appears to be lip reading (n = 1 in autoinflation), not doing as well at school as expected and hearing loss is suspected by anyone (n = 1 in standard care).
↵‡ Lower scores represent better global ear-related health (range of scores −2.1 to 3.8).