Neumark 2007.

Methods	Randomised ‐ yes, Internet‐based random number generator Concealment of allocation ‐ unclear; method not described Double‐blind ‐ no, open‐label trial Intention‐to‐treat (ITT) ‐ unclear Loss to follow‐up ‐ reasons described, unclear from which treatment group patients were excluded Design ‐ parallel
Participants	N ‐ 186 children (N = 179 patients were included in analysis; 7 patients were excluded due to non‐compliance with protocol) Age ‐ between 2 and 16 years Setting ‐ general practice: 32 healthcare centres and 72 general practitioners in Sweden Inclusion criteria ‐ acute otitis media (AOM) was based on direct inspection of the eardrum by pneumatic otoscope or preferably an aural microscope. Findings had to include a bulging, red eardrum displaying reduced mobility Exclusion criteria ‐ perforation of the eardrum, chronic ear conditions or impaired hearing, previous adverse reactions to penicillin, concurrent disease that should be treated with antibiotics, recurrent AOM (3 or more AOM episodes during the past 6 months), children with immunosuppressive conditions, genetic disorders and mental disease or retardation Baseline characteristics ‐ balanced
Interventions	Tx ‐ immediate treatment with antibiotics: phenoxymethylpenicillin 25 mg/kg twice daily for 5 days; N = 92 C ‐ expectant observation: no immediate antibiotics; N = 87 The guardians received written information about how to act if the condition did not improve or got worse within 3 days after randomisation Use of additional medication ‐ symptomatic treatment with paracetamol or non‐steroidal anti‐inflammatory drugs (NSAIDs), drugs reducing the swelling of the nasal mucosa (e.g. decongestive nose drops) and nasal steroids were allowed
Outcomes	Primary outcomes ‐ (a) pain at day 0, 1, 2 and 3 to 7; (b) use of analgesics at day 0, 1, 2, 3, 4 to 7; (c) fever > 38 °C at day 0, 1, 2 and 3 to 7; (d) subjective recovery at day 14 and 3 months; (e) perforations at 3 months; (f) serous otitis media at 3 months All participants were asked to complete a symptom diary for 7 days; a nurse telephoned all participants after approximately 14 days to supplement the information in the diary and to register all acute contacts that had occurred during the first week of treatment; the final follow‐up was performed after 3 months to register perforations and serous otitis media
Notes	Open‐label trial comparing immediate antibiotic prescribing versus expectant observation (no prescription provided but advice on what to do if symptoms did not improve or worsened)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Internet‐based random number generator
Allocation concealment (selection bias)	Unclear risk	Method not described
Other bias	Unclear risk	ITT analysis ‐ unclear, baseline characteristics ‐ balanced
Blinding of participants and personnel (performance bias)	Unclear risk	Open‐label trial, outcome assessment not blinded
Incomplete outcome data (attrition bias)	Unclear risk	Patients not included in analysis ‐ N = 7 (4%). Reasons described, unclear from which treatment group patients were excluded