2.1 Return to normal hearing, randomised by child (long‐term) |
1 |
391 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.94, 1.03] |
2.2 Mean final hearing threshold, randomised by child (short‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.3 Mean final hearing threshold (air conduction), randomised by child (medium‐term) |
2 |
351 |
Mean Difference (IV, Random, 95% CI) |
‐1.89 [‐7.32, 3.54] |
2.4 Mean final hearing threshold (air‐bone gap), randomised by child, analysed by ear (medium‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Totals not selected |
2.4.1 Adjusted for non‐independence of within‐individual measurements, assuming ICC of 0.5 |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Totals not selected |
2.5 Mean final hearing threshold, randomised by child (long‐term) |
3 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.5.1 Assumed correlation coefficient for Paradise 2007 (left and right ear data combined) of 0.5 |
3 |
633 |
Mean Difference (IV, Random, 95% CI) |
0.36 [‐0.41, 1.13] |
2.6 Hearing in noise test, randomised by child (long‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.6.1 Competing noise from the front (dB) |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
0.20 [‐0.13, 0.53] |
2.6.2 Competing noise from the right (dB) |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐0.54, 0.54] |
2.6.3 Competing noise from the left (dB) |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
0.40 [‐0.10, 0.90] |
2.7 Change in hearing threshold from baseline, randomised by child (medium‐term) |
1 |
176 |
Mean Difference (IV, Random, 95% CI) |
‐4.60 [‐8.57, ‐0.63] |
2.8 Adjusted mean difference in hearing improvement, randomised by child (medium term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
1.60 [‐0.62, 3.82] |
2.9 Adverse event: persistent perforation, randomised by child (medium‐term) |
1 |
161 |
Risk Difference (M‐H, Random, 95% CI) |
0.00 [‐0.03, 0.03] |
2.10 Adverse event: persistent perforation, randomised by child (long‐term) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Totals not selected |
2.10.1 Adjusted for non‐independence of within‐individual measurements: ICC 0.5 |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Totals not selected |
2.11 Presence/persistence of OME, randomised by child, measured by otoscopy (medium‐term) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.11.1 Adjusted for non‐independence of within‐individual measurements, assuming ICC of 0.5 |
1 |
113 |
Risk Ratio (M‐H, Random, 95% CI) |
0.39 [0.09, 1.72] |
2.12 Presence/persistence of OME, randomised by child, measured by tympanometry (medium‐term) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.13 Presence/persistence of OME, mean percentage of days, randomised by child (medium‐term) |
1 |
316 |
Mean Difference (IV, Random, 95% CI) |
‐0.19 [‐0.23, ‐0.15] |
2.14 Presence/persistence of OME, randomised by child (long‐term) |
3 |
584 |
Risk Ratio (M‐H, Random, 95% CI) |
1.21 [0.84, 1.74] |
2.15 Presence/persistence of OME, adjusted OR, randomised by child (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
0.99 [0.35, 2.83] |
2.16 Adverse event: tympanosclerosis (long‐term) |
1 |
375 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.33, 2.55] |
2.16.1 Adjusted for non‐independence of within‐individual measurements: ICC 0.5 |
1 |
375 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.33, 2.55] |
2.17 Adverse event: fibrosis (long‐term) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.17.1 Adjusted for non‐independence of within‐individual measurements: ICC 0.5 |
1 |
375 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.10, 3.60] |
2.18 Adverse event: segmental atrophy (long‐term) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Totals not selected |
2.18.1 Adjusted for non‐independence of within‐individual measurements. Assumed ICC 0.5 |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Totals not selected |
2.19 Adverse event: retraction pocket with other abnormality (long‐term) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.19.1 Adjusted for non‐independence of within‐individual measurements; assumed ICC 0.5 |
1 |
374 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.06, 14.41] |
2.20 Receptive language development, Reynell test, randomised by child (medium‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.31 [‐0.03, 0.65] |
2.21 Receptive language development, Reynell test, adjusted MD (medium‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.39 [0.04, 0.74] |
2.22 Receptive language, Reynell test, randomised by child (long‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.26 [‐0.08, 0.60] |
2.23 Receptive language: Reynell test, long‐term, adjusted MD |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.17 [‐0.21, 0.55] |
2.24 Receptive language: WOLD adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
1.58 [0.59, 4.24] |
2.25 Receptive language, mean difference (months) in improvement in Reynell test score (equivalent age‐real age): medium‐term |
1 |
|
Mean Difference (IV, Random, 95% CI) |
1.01 [‐0.14, 2.16] |
2.26 Receptive language, adjusted mean difference (months) in improvement in Reynell test score (equivalent age ‐ real age): medium‐term |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.71 [‐0.28, 1.70] |
2.27 Expressive language development: Reynell test (medium‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.38 [‐0.00, 0.76] |
2.28 Expressive language development: Reynell test, medium‐term, adjusted MD |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.42 [0.02, 0.82] |
2.29 Expressive language development: Reynell test (long‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.31 [‐0.07, 0.69] |
2.30 Expressive language development: Reynell test, long‐term, adjusted MD |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.14 [‐0.28, 0.56] |
2.31 Expressive language: WOLD adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
2.10 [0.78, 5.65] |
2.32 Expressive language, MD (months) in improvement in Schlichting test score (equivalent age‐real age): medium‐term |
1 |
|
Mean Difference (IV, Random, 95% CI) |
‐0.53 [‐2.19, 1.13] |
2.33 Expressive language, adjusted mean difference (months) in improvement in Schlichting test score (equivalent age‐real age): medium‐term |
1 |
|
Mean Difference (IV, Random, 95% CI) |
0.96 [‐0.43, 2.35] |
2.34 Non‐word repetition total score, adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
1.69 [0.64, 4.47] |
2.35 Reading, WORD test, adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
Subtotals only |
2.36 Spelling, ALSPAC test, adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
0.90 [0.33, 2.45] |
2.37 Phoneme deletion, adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
0.84 [0.32, 2.20] |
2.38 Cognitive development: Griffiths practical reasoning (medium‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
2.40 [‐3.78, 8.58] |
2.39 Cognitive development: IQ (WISC‐III UK short form) adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
Totals not selected |
2.40 Behaviour, Richman score (medium‐term) |
1 |
150 |
Mean Difference (IV, Random, 95% CI) |
‐0.65 [‐1.85, 0.55] |
2.41 Behaviour, Richman score, dichotomised (medium‐term) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
0.63 [0.42, 0.96] |
2.42 Behaviour, Richman score, adjusted OR (medium‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
1.16 [0.27, 4.90] |
2.43 Behaviour, Richman score (long‐term) |
1 |
123 |
Mean Difference (IV, Random, 95% CI) |
0.90 [‐0.27, 2.07] |
2.44 Behaviour, Richman score, dichotomised (long‐term) |
1 |
123 |
Risk Ratio (M‐H, Random, 95% CI) |
1.22 [0.62, 2.40] |
2.45 Behaviour: SDQ teacher report, total, adjusted OR (long‐term) |
1 |
|
Odds Ratio (IV, Random, 95% CI) |
2.05 [0.62, 6.74] |
2.46 Parent‐child interaction: Erickson child scale (medium‐term) |
1 |
165 |
Mean Difference (IV, Random, 95% CI) |
‐0.34 [‐0.56, ‐0.12] |
2.47 Parent‐child interaction: Erickson parent scale (medium‐term) |
1 |
165 |
Mean Difference (IV, Random, 95% CI) |
‐0.42 [‐0.67, ‐0.17] |
2.48 Generic health‐related quality of life: TAIQOL (medium‐term) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
2.48.1 Vitality |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐1.95, 1.75] |
2.48.2 Appetite |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.40 [‐3.77, 4.57] |
2.48.3 Communication |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.30 [‐5.11, 5.71] |
2.48.4 Motoric |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.00 [‐2.51, 2.51] |
2.48.5 Social |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.00 [‐2.49, 2.49] |
2.48.6 Anxiety |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.30 [‐3.04, 3.64] |
2.48.7 Aggression |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.30 [‐5.82, 6.42] |
2.48.8 Eating |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐1.63, 1.43] |
2.48.9 Sleeping |
1 |
165 |
Mean Difference (IV, Fixed, 95% CI) |
0.00 [‐5.70, 5.70] |
2.49 Parental stress, Parental Stress Index, short form (long‐term) |
1 |
383 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐4.12, 4.12] |
2.50 Literacy (long‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.50.1 Woodcock Reading Mastery Tests: Word Identification subtest |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐3.28, 1.28] |
2.50.2 Woodcock Reading Mastery Tests: Word Attack subtest |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐3.68, 1.68] |
2.50.3 Woodcock Reading Mastery Tests: Passage Comprehension subtest |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐3.38, 1.38] |
2.50.4 Oral reading fluency test: Children in grade 3 |
1 |
74 |
Mean Difference (IV, Random, 95% CI) |
‐9.00 [‐26.58, 8.58] |
2.50.5 Oral reading fluency test: Children in grade 4 |
1 |
184 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐10.70, 10.70] |
2.50.6 Oral reading fluency test: Children in grade 5 |
1 |
105 |
Mean Difference (IV, Random, 95% CI) |
‐5.00 [‐18.98, 8.98] |
2.50.7 Oral reading fluency test: Children in grade 6 |
1 |
21 |
Mean Difference (IV, Random, 95% CI) |
6.00 [‐27.42, 39.42] |
2.50.8 Woodcock–Johnson III Tests of Achievement: Spelling subtest |
1 |
390 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐3.89, 1.89] |
2.50.9 Woodcock–Johnson III Tests of Achievement: Writing Samples subtest |
1 |
387 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐3.89, 1.89] |
2.51 Phonological awareness (long‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.51.1 Comprehensive Test of Phonological Processing: Elision subtest |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
‐0.10 [‐0.91, 0.71] |
2.51.2 Comprehensive Test of Phonological Processing: Rapid Letter Naming subtest |
1 |
389 |
Mean Difference (IV, Random, 95% CI) |
‐0.30 [‐0.79, 0.19] |
2.52 Attention, impulsivity and psychosocial function, long‐term (1): disruptive behaviour disorders, child behaviour and impairment rating |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.52.1 Disruptive Behavior Disorders Rating Scale: Inattention factor: Parent's rating |
1 |
390 |
Mean Difference (IV, Random, 95% CI) |
0.05 [‐0.08, 0.18] |
2.52.2 Disruptive Behavior Disorders Rating Scale: Inattention factor: Teacher's rating |
1 |
382 |
Mean Difference (IV, Random, 95% CI) |
0.04 [‐0.11, 0.19] |
2.52.3 Disruptive Behavior Disorders Rating Scale: Impulsivity and overactivity factor: Parent's rating |
1 |
390 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.01, 0.21] |
2.52.4 Disruptive Behavior Disorders Rating Scale: Impulsivity and overactivity factor: Teacher's rating |
1 |
382 |
Mean Difference (IV, Random, 95% CI) |
0.08 [‐0.04, 0.20] |
2.52.5 Disruptive Behavior Disorders Rating Scale: Oppositional defiant factor: Parent's rating |
1 |
390 |
Mean Difference (IV, Random, 95% CI) |
0.05 [‐0.06, 0.16] |
2.52.6 Disruptive Behavior Disorders Rating Scale: Oppositional defiant factor: Teacher's rating |
1 |
382 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐0.11, 0.11] |
2.52.7 Child Behavior Checklist: Total Problems score, parent’s rating |
1 |
390 |
Mean Difference (IV, Random, 95% CI) |
2.00 [‐0.38, 4.38] |
2.52.8 Child Behavior Checklist: Total Problems score, teacher’s rating |
1 |
380 |
Mean Difference (IV, Random, 95% CI) |
2.00 [‐0.21, 4.21] |
2.52.9 Impairment Rating Scales: Overall functioning, parent’s rating |
1 |
390 |
Mean Difference (IV, Random, 95% CI) |
0.14 [‐0.13, 0.41] |
2.52.10 Impairment Rating Scales: Overall functioning, teacher’s rating |
1 |
382 |
Mean Difference (IV, Random, 95% CI) |
0.26 [‐0.18, 0.70] |
2.53 Attention, impulsivity and psychosocial function, long‐term (2): social skills |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.53.1 Attention, impulsivity and psychosocial function: Social Skills Rating System: parent version |
1 |
388 |
Mean Difference (IV, Random, 95% CI) |
‐2.00 [‐5.68, 1.68] |
2.53.2 Attention, impulsivity and psychosocial function: Social Skills Rating System: teacher version |
1 |
370 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐3.65, 1.65] |
2.54 Attention, impulsivity and psychosocial function, long‐term: Visual and auditory continuous performance |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.54.1 Visual Continuous Performance Test: Inattention |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
0.20 [‐2.66, 3.06] |
2.54.2 Visual Continuous Performance Test: Impulsivity |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
0.60 [‐2.58, 3.78] |
2.54.3 Auditory Continuous Performance Test: Inattention |
1 |
308 |
Mean Difference (IV, Random, 95% CI) |
‐0.30 [‐2.00, 1.40] |
2.54.4 Auditory Continuous Performance Test: Impulsivity |
1 |
307 |
Mean Difference (IV, Random, 95% CI) |
‐0.90 [‐3.26, 1.46] |
2.55 Intelligence and academic achievement (long‐term) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.55.1 Wechsler Abbreviated Scale of Intelligence |
1 |
391 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐2.68, 2.68] |
2.55.2 Calculation subtest of the Woodcock–Johnson III Tests of Achievement |
1 |
389 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐2.58, 2.58] |