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. 2018 Aug 22;2018(8):CD001955. doi: 10.1002/14651858.CD001955.pub4

Garbutt 2013.

Methods Randomised double‐blind controlled trial
Participants Study period: 26 October 2009 to 16 April 2010 and 6 September 2010 to 29 April 2011
Setting: 10 offices of primary care practitioners in St Louis, MO, USA
Inclusion criteria: children aged 1 to 8 years with croup symptoms for ≤ 48 hours and a clinical diagnosis of mild or moderate croup at an office visit, based on symptoms in the past 24 to 36 hours
Exclusion criteria: diagnosis of severe croup or impending respiratory failure; prior treatment with epinephrine or oral corticosteroids for this croup episode; symptoms or signs suggesting other cause of stridor; chronic respiratory disease including asthma; known contraindication to steroid use; parent not in the same household as the child in the subsequent 4 days, could not participate in telephone interviews, or was not English speaking
Baseline demographics (N = 87):
proportion male: treatment: 61%; comparator: 68%
mean (SD) age in years: treatment: 2.67 (1.43); comparator: 3.11 (1.58)
mean (SD) Westley croup score: treatment : 0.4 (0.7); comparator: 0.6 (0.8)
mean (SD) Telephone Outpatient Score: treatment: 2.2 (0.9); comparator: 2.0 (0.9)
Interventions Treatment (N = 41): single 2 mg/kg (maximum 60 mg/day) dose of oral prednisolone once per day for 3 days
Comparator (N = 46): single 0.60 mg/kg (maximum 18 mg) dose of oral dexamethasone, followed by 2 days of placebo comparable in appearance, smell, and taste
Outcomes Additional health care for croup within 11 days of randomisation
Notes Funding source: National Center for Research Resources (National Institutes of Health); National Institutes of Health Roadmap for Medical Research
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomized blocks were used to assign subjects to treatment groups, with randomization stratified by site. Computer generated random numbers determined how the two treatments were allocated"
Allocation concealment (selection bias) Low risk Quote: "Study drug packages were prepared offsite by the pharmacist" "The pharmacist... packaged the bottles in a sealed opaque envelope" "For allocation concealment, the drug formulation ensured the volume of the weight‐based dose was equivalent for each medication."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The pharmacist... packaged the bottles in a sealed opaque envelope" "comparable in appearance, smell and taste" "patients, parents, PCPs, and study team members were blinded to treatment assignments"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The pharmacist... packaged the bottles in a sealed opaque envelope" "comparable in appearance, smell and taste" "patients, parents, PCPs, and study team members were blinded to treatment assignments"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: intention‐to‐treat analysis used. Losses to follow‐up on days 1, 2, 3, 4, and 11 were 7%, 9%, 9%, 3%, and 2% (non‐cumulative). Participation in follow‐up interviews was balanced between groups.
Selective reporting (reporting bias) Low risk Comment: no deviations from protocol detected.
Other bias Low risk Comment: no other sources of bias identified.
Overall risk of bias 
 All outcomes Low risk Comment: all domains judged as low risk.