Pichichero 1987.
Study characteristics | ||
Methods | Open randomised controlled trial over 27 months | |
Participants | 114 children with sore throat (suspected GABHS) were included who presented to 1 private paediatric practice in New York State, USA. Of these 114 children, 55 were randomised to delayed antibiotics and 59 were randomised to immediate antibiotics. Age: of the 55 children randomised to delayed antibiotics, the average age was 7.8 years (SD 2.3); of the 59 children randomised to immediate antibiotics, it was 7.5 years (SD 2.6) Sex: not reported Exclusion criteria included hypersensitivity to penicillin, receipt of antibiotics in preceding 7 days, acute illness in preceding 7 days, GABHS infection in the preceding month and concurrent treatment with an antibiotic other than penicillin |
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Interventions | Children were randomised to delayed antibiotics (48‐hour delay) versus immediate antibiotics. Children in each group received penicillin V 250 mg 3 times a day for 10 days. | |
Outcomes |
Primary outcomes: fever, duration of fever, malaise Secondary outcomes: reconsultation rates, vomiting Outcomes were measured using a symptom diary and reassessment at the paediatrician's office 3 days after child's initial enrolment |
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Notes | This study was funded by the Robert Wood Johnson Foundation, Eli Lilly and Company, and Elmwood Paediatric Research fund. We approached the authors for their study data, but they did not provide this information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers |
Allocation concealment (selection bias) | High risk | Allocation concealment measures were not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participant and doctor blinded, but there was no description of outcome assessor blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants dropped out |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | High risk | Funded by philanthropic organisation and Eli Lilly |