Fig. 1.

Overview and schedule of enrolment, data collection, and assessments (SPIRIT Figure). ¹Baseline data includes age, gender, medical history, day-care attendance, vaccination status, exposure to tobacco smoke, family composition, and items discussed by general practitioner (GP) during acute otitis media (AOM) consultation. ²Symptoms include earache (on Wong-Baker Faces Scale rating), ear discharge, fever, runny nose, cough, disturbed sleep, diarrhoea, obstipation, vomiting, decreased fluid intake, abdominal pain, and rash. ³Medication use includes specification of type of medication, dosing frequency, actual dosage given, over-the-counter medication, (delayed) antibiotic prescription. ⁴Productivity loss is captured as composite of number of days absence from work (parent) or day-care (child), number of hours a nanny was required, and costs of nanny employment. ⁵Adverse events include gastrointestinal complaints, as well as serious adverse events such as renal failure, gastrointestinal bleeding, and hypersensitivity reactions. ⁶GP re-consultation includes out-of-hours consultation and referral to secondary care (i.e. emergency room visits, hospital admissions, and surgical procedures). PCC primary care centre