Box 1. The WATCH trial.
AOM, pain
SECONDARY, RECRUITMENT
WATCH was a study of whether watchful waiting is non-inferior to immediate antibiotics for AOM in Aboriginal and Torres Strait Islander children attending urban or regional Aboriginal Medical Services for their primary care [Aboriginal and Torres Strait Islander primary health care services were research partners in the WATCH trial. Research officers (ROs) from the local communities are employed to undertake recruitment and data collection. Children attending the services for any reason underwent ear screening and, if subsequently found to have AOM, participation was invited. GPs made the diagnosis of AOM and decided on eligibility for the study. Parents or carers provided written informed consent for their child to participate. The primary outcome in the trial was clinical resolution of AOM at day 7, determined by GP assessment based on otoscopy, tympanometry and symptoms. The GP answered the question of “Has the Child’s index AOM resolved?” choosing between ‘Yes/no/don’t know’. Time to resolution of AOM symptoms is a secondary outcome.The scales were employed concurrently in face to face study visits at days 0 and 7 and by phone at days 3 and 14. Trained research officers (ROs) administered the AOM-SOS verbally to parents/carers at each visit. Several other symptom items were incorporated in the study questionnaire, including ear pain and runny nose (