Little 2001.

Study characteristics
Methods	Pragmatic randomised controlled trial conducted over an unknown period of time
Participants	315 children aged 6 months to 10 years with AOM were recruited by 42 general practitioners in England, UK. 164 of the 315 children were randomised to delayed antibiotics. Age: of the 164 children in the delayed antibiotics group, 93 were older than 3 years of age; of the 151 children in the immediate antibiotics group, 93 were older than 3 years Sex: not provided Exclusion criteria: children were excluded if they had a pink tympanic membrane only, and otoscopic appearances consistent with otitis media with effusion and chronic suppurative otitis media according to the treating general practitioner. Children were also excluded if they had a serious chronic disease, needed antibiotics for an ear infection in the preceding 2 weeks, had previous complications, or if the child was too unwell for a delay in antibiotics. Children were judged to be too unwell if they had a high fever, were floppy, drowsy and/or not responding to antipyretics.
Interventions	The parents of children in the delayed antibiotics group were advised to use the antibiotics script they had been given if their child had significant otalgia or fever after 72 hours, or if discharge lasted for 10 days or more. Alternatively, children were randomised to immediate antibiotics. The antibiotic prescription was amoxicillin syrup (125 mg in 5 mL) 3 times a day for 1 week in each group unless the child was penicillin allergic. The exact dosage depended on the age of the child. Children who were penicillin allergic were prescribed erythromycin (125 mg in 5 mL) 4 times a day for 1 week in a dose appropriate to their age.
Outcomes	Outcomes were measured using a patient diary Primary outcomes: fever, severity of pain, duration of malaise, antibiotic use, patient satisfaction, further earache at 3 and 12 months Secondary outcomes: absence from school, use of paracetamol
Notes	We approached the study authors for original study data, but they were unable to provide these data. This study was funded by the UK National Health Service.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were randomised to a group"
Allocation concealment (selection bias)	Low risk	Quote: "doctor opened a sealed numbered opaque envelope"
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding undertaken
Incomplete outcome data (attrition bias) All outcomes	Low risk	A comparison of responders versus non‐responders was undertaken. 150 of 164 participants in the delayed antibiotics group had outcome data analysed; 135 of 151 participants in the immediate antibiotics group had outcome data analysed.
Selective reporting (reporting bias)	Low risk	Prespecified outcomes were reported
Other bias	Low risk	Funded by government body