Burgess 2007.

Methods	Design: parallel‐group randomised controlled trial; blinding not stated Duration: 13 weeks Setting: private and public paediatric respiratory clinics. Australia Trial registration: not reported
Participants	Population: 47 children with asthma randomised to receive a 'Funhaler' (n = 26) or a control spacer (n = 21) Age: 18 months to 7 years; mean age in the Funhaler group 3.4 years and in the control group 3.8 years Baseline asthma severity: intervention group: mean frequency of wheeze (5‐point scale) = 1.9; number with exacerbation in previous month = 8; mean fluticasone dose (mg/d) = 166. Control group: mean frequency of wheeze (5‐point scale) = 1.9; number with exacerbation in previous month = 3; mean fluticasone dose (mg/d) = 193 Inclusion criteria: children with diagnosis of asthma, 18 months to 7 years of age, taking preventive asthma medication on a daily basis Exclusion criteria: not reported Percentage withdrawn: 8% from the intervention arm and 5% from the control arm Other allowed medication: not reported
Interventions	Intervention summary: small‐volume spacer that incorporates an incentive toy (spinning disk and whistle) that is driven by the child’s expired breath (the 'Funhaler') Control summary: a control spacer (Aerochamber Plus) Complex intervention: no
Outcomes	Outcomes measured: adherence, symptoms (from a 'symptoms questionnaire'), exacerbations (defined as the child having received a course of prednisolone initiated by the parent in response to an escalation of symptoms requiring regular reliever medication more than 4th‐hourly for 24 hours as per asthma management plan or prescription of prednisolone by the child’s primary care physician) Adherence calculation: Adherence was evaluated as a percentage of prescribed doses registered by the Smartinhaler between midnight and midday and between midday and midnight for morning and evening doses, respectively, or at any time during the day for once‐daily dosing
Notes	Type of publication: single peer‐reviewed full‐text journal article Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"All subjects were then randomized to either the FunHaler or a control spacer using a minimization computer program (Minim) with equal weighting for age, sex and level of maternal education"
Allocation concealment (selection bias)	Unclear risk	No details
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants or personnel described. Although primary outcome ‐ adherence ‐ was measured by an electronic counter, other outcomes (such as symptoms) may be subject to performance bias
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessors described. Main outcome ‐ adherence ‐ objectively measured, but other outcomes (such as symptoms) subject to detection bias, as the unblinded parent is the outcome assessor
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition low and balanced (< 10% in both arms) and all drop‐outs accounted for
Selective reporting (reporting bias)	Unclear risk	No prospective trial registration identified; symptoms measured but not reported numerically so could not be included in meta‐analysis. Other outcomes reported appropriately
Other bias	Low risk	None noted