A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

Table 1 Schedule of assessments – child/parent/carer

Assessment		Screening/Randomisation	Post-randomisation^a
	Performed by	Day 0	Day 3	Day 7	Day 14	Week 7	3 months
	Performed by	Day 0	(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.

ISSN: 1745-6215