Table 2.
Baseline characteristics of randomised children by treatment group
| Placebo group (n=187) | Oral steroid group (n=193) | ||
|---|---|---|---|
| Child demographics | |||
| Mean age at recruitment (years) | 5·08 (1·60) | 5·30 (1·60) | |
| 2–5 years | 133 (71%) | 131 (68%) | |
| 6–8 years | 54 (29%) | 62 (32%) | |
| Boys | 102 (55%) | 109 (57%) | |
| Girls | 85 (45%) | 84 (43%) | |
| Townsend deprivation quintile* | |||
| 1 | 32 (17%) | 25 (13%) | |
| 2 | 16 (9%) | 23 (12%) | |
| 3 | 48 (26%) | 45 (23%) | |
| 4 | 46 (25%) | 48 (25%) | |
| 5 | 45 (24%) | 52 (27%) | |
| Ethnicity | |||
| White | 134 (83%) | 143 (82%) | |
| Mixed or multiple ethnic | 10 (6%) | 10 (5%) | |
| Asian or Asian British | 13 (8%) | 18 (10%) | |
| Black or African or Caribbean or Black British | 3 (2%) | 3 (2%) | |
| Other ethnic | 2 (1%) | 0 (0%) | |
| Data missing | 25 | 19 | |
| Season randomised | |||
| Spring (March–May) | 64 (34%) | 70 (36%) | |
| Summer (June–Aug) | 32 (17%) | 33 (17%) | |
| Autumn (September–November) | 31 (17%) | 34 (18%) | |
| Winter (December–February) | 60 (32%) | 56 (29%) | |
| Height measured | 62 (33%) | 74 (38%) | |
| Mean height (cm) | 112·22 (11·34) | 115·08 (10·59) | |
| Weight measured | 70 (37%) | 75 (39%) | |
| Mean weight (kg) | 20·24 (5·49) | 21·77 (5·95) | |
| Body-mass index | 60 (32%) | 69 (36%) | |
| Median body-mass index (kg/m2) | 18·5 (16·4–23·1) | 21·0 (18·7–24·6) | |
| Relation of carer to child | |||
| Mother | 159 (86%) | 171 (89%) | |
| Father | 24 (13%) | 20 (10%) | |
| Other | 3 (2%) | 2 (1%) | |
| Data missing | 1 | 0 | |
| Medical history of children | |||
| First episode of otitis media with effusion | 135 (72%) | 128 (66%) | |
| Length of time had problems due to this episode | |||
| <6 months | 26 (14%) | 19 (10%) | |
| 6 months to <9 months | 28 (15%) | 22 (12%) | |
| 9 months to <12 months | 18 (10%) | 20 (10%) | |
| 12 months or more | 115 (61%) | 131 (68%) | |
| Data missing | 0 | 1 | |
| Previous ventilation tubes (grommet surgery) | 19 (10%) | 14 (7%) | |
| On waiting list for ventilation tubes | 52 (28%) | 55 (29%) | |
| Fitted with hearing aids | 31 (17%) | 27 (14%) | |
| Frequency of use | |||
| Not at all | 5 (16%) | 2 (7%) | |
| Occasionally | 2 (6%) | 2 (7%) | |
| Most of the time | 8 (26%) | 15 (56%) | |
| All the time | 16 (52%) | 8 (30%) | |
| Previous tonsillectomy | 8 (4%) | 9 (5%) | |
| Previous adenoidectomy | 8 (4%) | 8 (4%) | |
| Family history of otitis media with effusion | |||
| Has a brother or sister? | 147 (79%) | 156 (81%) | |
| If yes, at least one currently has or has had otitis media with effusion | 34 (23%) | 44 (28%) | |
| Data missing | 1 | 1 | |
| Atopy | |||
| None | 131 (70%) | 125 (65%) | |
| At least one | 56 (30%) | 68 (35%) | |
| Asthma | 22 (12%) | 21 (11%) | |
| Eczema | 41 (22%) | 41 (22%) | |
| Hay fever | 16 (9%) | 21 (11%) | |
| Data missing | 0 | 3 | |
| Medications | |||
| Presently using medication regularly longer than 1 week | 25 (13%) | 32 (17%) | |
| Asthma (β-agonist or corticosteroid inhaler, corticosteroid inhaler in combination) | 20 | 23 | |
| Leukotriene receptor antagonists | 1 | 2 | |
| Antihistamine | 4 | 2 | |
| Nasal steroids | 3 | 1 | |
| Antibiotics | 0 | 0 | |
| Pain relief (ibuprofen, paracetamol) | 2 | 2 | |
| Other | 8 | 17 | |
| Antibiotics for an ear infection in last month | 13 (7%) | 19 (10%) | |
| Data missing | 0 | 1 | |
| Smoking in house (>5 h a week) | 56 (30%) | 51 (26%) | |
| Audiometry | |||
| Method of audiometry | |||
| PTA | 94 (50%) | 108 (56%) | |
| Ear-specific VRA | 3 (2%) | 2 (1%) | |
| Ear-specific play audiometry | 61 (33%) | 61 (32%) | |
| Soundfield VRA | 17 (9%) | 16 (8%) | |
| Soundfield performance/play audiometry | 12 (6%) | 6 (3%) | |
| Mean dB HL that is audible | |||
| PTA, ear-specific VRA/play audiometry† | |||
| Right ear | 37·07 (7·49) | 35·94 (8·59) | |
| Left ear | 37·39 (8·00) | 35·89 (8·83) | |
| Best hearing ear | 34·24 (7·21) | 32·69 (8·21) | |
| Worst hearing ear | 40·22 (7·10) | 39·25 (7·94) | |
| Average of the two ears | 37·23 (6·53) | 35·97 (7·51) | |
| Soundfield mean dB HL‡ | 41·13 (8·12) | 38·35 (9·30) | |
| Overall dB HL (average of the two ears and soundfield) | 37·83 (6·93) | 36·25 (7·74) | |
| Degree of hearing loss (dB HL range), based on overall dB HL | |||
| Slight (16–25) | 8 (4%) | 13 (7%) | |
| Mild (26–40) | 116 (62%) | 134 (69%) | |
| Moderate (41–55) | 63 (34%) | 44 (23%) | |
| Moderate to severe (56–70) | 0 (0%) | 2 (1%) | |
| Severe (71–90) | 0 (0) | 0 (0) | |
| Profound (>90) | 0 (0) | 0 (0) | |
| Tympanometry | |||
| Tympanometry done | 187 (100%) | 192 (99%) | |
| Right ear | |||
| Type B (flat) | 181 (97%) | 184 (97%) | |
| Type C (retracted or negative) | 6 (3%) | 6 (3%) | |
| Data missing | 0 | 3 | |
| Left ear | |||
| Type B (flat) | 181 (98%) | 182 (96%) | |
| Type C (retracted or negative) | 4 (2%) | 8 (4%) | |
| Data missing | 1 | 1 | |
| No type B ears | 1 (1%) | 3 (2%) | |
| One type B ear | 8 (4%) | 10 (5%) | |
| Two type B ears | 177 (95%) | 178 (93%) | |
| Otoscopy: right ear | |||
| Visualise the tympanic membrane: right ear | 180 (96%) | 192 (99%) | |
| Perforation present§ | 0 | 0 | |
| Appearance suggests presence of middle ear effusion§ | 180 (100%) | 190 (99%) | |
| Bubbles behind the ear drum§ | 20 (11%) | 22 (11%) | |
| Otoscopy: left ear | |||
| Visualise the tympanic membrane: left ear | 178 (95%) | 189 (98%) | |
| Perforation present§ | 2 (1%) | 2 (1%) | |
| Appearance suggests presence of middle ear effusion§ | 177 (99%) | 187 (99%) | |
| Bubbles behind the ear drum§ | 20 (11%) | 19 (10%) | |
Data are n (%), mean (SD), or median (IQR), unless otherwise stated. PTA=pure tone audiometry. VRA=visual reinforcement audiometry. dB=decibels. HL=hearing levels.
*
1=least deprived. 5=most deprived.
†
n=158 in the placebo group, n=171 in the oral steroid group.
‡
n=29 in the placebo group, n=22 in the oral steroid group.
§
If the tympanic membrane is visible.