Table 4.
Secondary outcomes based on clinical assessment, functional health status (OM8-30) and health-related quality-of-life (PedsQL and HUI3) scores over time and by treatment group
|
Baseline (n=380) |
5 weeks (n=363) |
6 months (n=340) |
12 months (n=332) |
Treatment effect |
Treatment × time effect (p value) | |||
|---|---|---|---|---|---|---|---|---|
| Adjusted* odds ratio (95% CI) or adjusted* difference in means (95% CI) | p value | |||||||
| Outcome† | ||||||||
| Audiometry resolution | ||||||||
| Oral steroid | .. | 73/183 (40%) | 105/174 (60%) | 118/170 (69%) | 1·42 (0·91 to 2·21) | 0·12 | 0·98 | |
| Placebo | .. | 59/180 (33%) | 86/166 (52%) | 99/162 (61%) | .. | .. | .. | |
| Tympanometry resolution (defined as moving from type B to C) | ||||||||
| Oral steroid | .. | 7/182 (4%) | 26/152 (17%) | 31/159 (19%) | 0·51 (0·20 to 1·30) | 0·156 | 0·0066 | |
| Placebo | .. | 13/178 (7%) | 17/147 (12%) | 9/144 (6%) | .. | .. | .. | |
| Otoscopy findings | ||||||||
| Perforation present in at least one ear | ||||||||
| Oral steroid | 2/192 (1%) | 0/171 (0%) | 6/155 (4%) | 6/151 (4%) | 0·78 (0·37 to 1·66) | 0·52 | 0·62 | |
| Placebo | 2/184 (1%) | 2/169 (1%) | 9/152 (6%) | 7/134 (5%) | .. | .. | .. | |
| Presence of a middle ear effusion in at least one ear | ||||||||
| Oral steroid | 192/192 (100%) | 150/172 (87%) | 90/154 (59%) | 80/151 (53%) | 0·70‡ (0·35 to 1·39) | 0·31 | 0·95 | |
| Placebo | 183/184 (99%) | 152/168 (91%) | 96/151 (64%) | 80/138 (58%) | .. | .. | .. | |
| Bubbles present behind the ear drum in at least one ear | ||||||||
| Oral steroid | 25/190 (13%) | 23/169 (14%) | 13/152 (9%) | 8/149 (5%) | 1·57 (0·76 to 3·26) | 0·22 | 0·17 | |
| Placebo | 23/183 (13%) | 15/164 (9%) | 19/147 (13%) | 4/135 (3%) | .. | .. | .. | |
| Operations for ventilation tubes | ||||||||
| Oral steroid | .. | NA§ | 39/173 (23%) | 23/172 (13%) | 1·10 (0·64 to 1·89) | 0·738 | 0·76 | |
| Placebo | .. | NA§ | 38/170 (22%) | 23/162 (14%) | .. | .. | .. | |
| Mean OM8-30 scores¶(SD) | ||||||||
| Total OM8-30 score | ||||||||
| Oral steroid | 0·60 (1·03) | 0·49 (1·11) | −0·14 (1·19) | −0·22 (1·18) | 0·05 (−0·12 to 0·22) | 0·54 | 0·30 | |
| Placebo | 0·47 (1·04) | 0·33 (1·08) | −0·13 (1·13) | −0·29 (1·20) | .. | .. | .. | |
| Infection-related physical health facet | ||||||||
| Oral steroid | −0·17 (0·99) | −0·30 (1·00) | −0·68 (0·95) | −0·57 (1·04) | 0·04 (−0·12 to 0·20) | 0·67 | 0·59 | |
| Placebo | −0·31 (1·03) | −0·44 (0·98) | −0·67 (0·90) | −0·69 (0·90) | .. | .. | .. | |
| General development impact facet | ||||||||
| Oral steroid | 0·48 (1·20) | 0·58 (1·18) | 0·43 (1·18) | 0·25 (1·16) | 0·08 (−0·07 to 0·23) | 0·31 | 0·29 | |
| Placebo | 0·52 (1·24) | 0·54 (1·24) | 0·44 (1·19) | 0·29 (1·19) | .. | .. | .. | |
| Reported hearing difficulties facet | ||||||||
| Oral steroid | 0·87 (0·82) | 0·67 (0·87) | 0·06 (0·99) | −0·04 (0·99) | 0·03 (−0·13 to 0·20) | 0·69 | 0·89 | |
| Placebo | 0·74 (0·78) | 0·58 (0·88) | 0·04 (0·88) | −0·05 (0·91) | .. | .. | .. | |
| HUI3 score=1 indicating perfect health (%)‖ | ||||||||
| Oral steroid | 22 (13·4%) | 37 (22·6%) | 52 (33·5%) | 51 (34·0%) | 1·23 (0·66 to 2·27) | 0·51 | 0·79 | |
| Placebo | 22 (13·8%) | 33 (21·3%) | 49 (32·2%) | 44 (31·0%) | .. | .. | .. | |
| Median PedsQL score**(IQR) | ||||||||
| Total PedsQL score | ||||||||
| Oral steroid | 84·8 (73·8 to 92·7) | 84·5 (72·4 to 91·7) | 82·6 (72·6 to 94·6) | 86·9 (75·0 to 95·2) | −85·11†† (−420·65 to 50·44) | 0·62 | 0·48 | |
| Placebo | 82·1 (69·0 to 90·5) | 84·8 (73·8 to 92·7) | 84·5 (75·0 to 90·7) | 85·7 (77·7 to 92·9) | .. | .. | .. | |
| Physical health | ||||||||
| Oral steroid | 90·6 (79·7 to 98·4) | 90·6 (80·5 to 100·0) | 93·8 (77·3 to 100·0) | 93·8 (84·4 to 100·0) | 0·84‡‡ (0·51 to 1·37) | 0·48 | 0·55 | |
| Placebo | 90·6 (78·1 to 100·0) | 90·6 (81·3 to 100·0) | 93·8 (81·3 to 100·0) | 93·8 (85·0 to 100·0) | .. | .. | .. | |
| Emotional functioning | ||||||||
| Oral steroid | 75·0 (55·0 to 85·0) | 75·0 (60·0 to 90·0) | 75·0 (60·0 to 95·0) | 80·0 (65·0 to 100·0) | 2·02§§ (−1·85 to 5·89) | 0·31 | 0·78 | |
| Placebo | 70·0 (60·0 to 85·0) | 75·0 (60·0 to 90·0) | 70·0 (55·0 to 85·0) | 75·0 (60·0 to 90·0) | .. | .. | .. | |
| Social functioning | ||||||||
| Oral steroid | 90·0 (72·5 to 100·0) | 90·0 (73·8 to 100·0) | 90·0 (70·0 to 100·0) | 95·0 (78·8 to 100·0) | 1·20‡‡ (0·75 to 1·92) | 0·44 | 0·85 | |
| Placebo | 90·0 (75·0 to 100·0) | 90·0 (80·0 to 100·0) | 90·0 (80·0 to 100·0) | 95·0 (80·0 to 100·0) | .. | .. | .. | |
| School functioning | ||||||||
| Oral steroid | 70·0 (58·3 to 85·0) | 77·5 (60·0 to 90·0) | 80·0 (66·7 to 90·0) | 80·0 (60·0 to 95·0) | −240·53†† (−718·72 to 237·65) | 0·32 | 0·92 | |
| Placebo | 75·0 (58·3 to 90·0) | 80·0 (65·0 to 91·7) | 83·3 (66·3 to 95·0) | 83·3 (66·7 to 91·7) | .. | .. | .. | |
| Psychological functioning | ||||||||
| Oral steroid | 78·3 (63·4 to 87·1) | 81·2 (67·3 to 90·0) | 79·0 (67·5 to 93·3) | 84·0 (69·8 to 93·6) | 0·71†† (0·26 to 2·00) | 0·51 | 0·58 | |
| Placebo | 78·3 (63·5 to 87·5) | 81·7 (69·2 to 90·0) | 80·0 (70·0 to 90·0) | 82·7 (71·4 to 91·7) | .. | .. | .. | |
Data are n (%), mean (SD), or median (IQR), unless otherwise stated. OM8-30=Otitis Media questionnaire. Baseline: n=193 in oral steroid group, n=187 in placebo group. 5 weeks: n=183 in oral steroid group, n=180 in placebo group. 6 months: n=166 in oral steroid group, n=174 in placebo group. 12 months: n=162 in oral steroid group, n=170 in placebo group. Response rate to PedsQL: baseline, 187/189; 5 weeks, 176/182; 6 months, 158/162; 12 months, 149/154. HUI3=Health Utilities Index Mark 3. PedsQL=Pediatric Quality of Life Inventory.
Adjusted for site, child's age group at recruitment (2–5 years vs 6–8 years), and, where applicable, baseline score. Treatment effect is oral steroids minus placebo averaged across all follow-up timepoints. Adjusted odds ratios (95% CI) shown for outcomes and otoscopy findings, and adjusted difference in means (95% CI) shown for all other data.
Missing data varied by outcome.
Adjusted for site and child's age group at recruitment (2–5 years vs 6–8 years). Model would not converge with baseline measures, which were therefore omitted.
Not applicable (NA) as children were not permitted to have ventilation tubes within the first 5 weeks after randomisation.
Low or more negative OM8-30 scores indicate better quality of life related to otitis media.
High scores indicate better health-related quality of life (maximum 1·00): perfect health (score=1) vs non-perfect health (score <1).
High scores indicate better quality of life (maximum 100).
Squared transformation used on the raw scores. Parameter estimate corresponds to adjusted difference in squared means.
Outcome transformed to binary: perfect health (score=100) vs non-perfect health (score <100). Parameter estimate corresponds to adjusted odds ratio.
No transformation used. Parameter estimate displayed as adjusted difference in means.