Table 1.
Summary of data collected at each data collection timepoint
| Baseline evaluation |
Follow-up period |
|||
|---|---|---|---|---|
| 5 weeks | 6 months | 12 months | ||
| Demographics | Clinic visit | .. | .. | .. |
| Medical history | Clinic visit | .. | .. | .. |
| Audiometry | Clinic visit | Clinic visit | Clinic visit | Clinic visit |
| Tympanometry | Clinic visit | Clinic visit | Clinic visit | Clinic visit |
| Otoscopy | Clinic visit | Clinic visit | Clinic visit | Clinic visit |
| Medication use | .. | Parent diary | − | .. |
| Insertion of ventilation tubes | .. | Clinic visit | Clinic visit | Clinic visit |
| Daily symptoms | .. | Parent diary | .. | .. |
| Adverse effects | .. | Parent diary | .. | .. |
| Resource use | .. | Parent diary | Clinic visit | Clinic visit |
| Functional health status (HUI3, OM8-30 {Timmerman, 2008 #26}) | Clinic visit | Clinic visit | Clinic visit | Clinic visit |
| Health related quality of life (PedsQL) | Clinic visit | Clinic visit | Clinic visit | Clinic visit |
| Serious adverse events | As required | As required | .. | .. |
| Withdrawals | As required | As required | As required | As required |
HUI3=Health Utilities Index Mark 3. OM8-30=Otitis Media questionnaire. PedsQL= Pediatric Quality of Life Inventory.