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Table 1 Schedule of assessments – child/parent/carer

From: 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

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
  1. AI associate investigator, AMS Aboriginal Medical Service, GP general practitioner, NP nurse practitioner, RO research officer
  2. aBracketed day/week numbers in the Post-randomisation column above represent acceptable time ranges.
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Trials

ISSN: 1745-6215