Table 1.
Assessment | Screening/Randomisation | Post-randomisationa | |||||
---|---|---|---|---|---|---|---|
Performed by | Day 0 | Day 3 | Day 7 | Day 14 | Week 7 | 3 months | |
(Days 2 − 4) | (Days 5 − 10) | (Days 11 − -17) | (Weeks 6 − 8) | (no window) | |||
Clinical assessment | GP/NP | X | X | ||||
Temperature | GP/NP/Health service RO or AI | X | X | ||||
Tympanometry | GP/NP/AMS Health service RO or/AMS AI | X | X | X | |||
Digital video-otoscopy | GP/NP/Health service RO or AI | X | X | X | |||
Health history and socio-demographics | Health service RO/AI | X | |||||
Symptoms questionnaire | AMS Health service RO/AMS AI | X | X | X | X | ||
Progress questions | AMS Health service RO/AMS AI | X | X | X | X | ||
Serious adverse events/severe study- related adverse events | AMS Health service RO/AMS AI | X | X | X | X | ||
Review Parent/Carer/Child Diary -symptom assessment using AOM-Faces Scale | AMS Health service RO/AMS AI | X | X | X | |||
Medical record review | Medical record reviewer | X |
AI associate investigator, AMS Aboriginal Medical Service, GP general practitioner, NP nurse practitioner, RO research officer
aBracketed day/week numbers in the Post-randomisation column above represent acceptable time ranges.