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. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Burgess 2007.

Methods Randomized controlled trial
Participants The study location was Australia
26 participants were randomized to the intervention group and 21 participants were randomized to the control group
The inclusion criteria were children diagnosed with asthma, aged 18 months to 7 years, taking preventive asthma medication on a daily basis
Interventions Intervention: FUNHALER
 Patients received a Funhaler for their daily asthma medication. The Funhaler (FH) is a small‐volume spacer that incorporates an incentive toy (spinning disk and whistle) that is driven by the child's expired breath
Control: CONTROL SPACER
 Patients received a standard spacer for administering asthma medication
Outcomes The measures of adherence were collected using a Smartinhaler. Adherence was evaluated as a percentage of prescribed doses registered by the Smartinhaler either between midnight and midday or between midday and midnight for morning and evening doses, respectively, or at any time during the day for once daily dosing.The child was provided with preventive medication loaded into a Smartinhaler. The parent was informed that the Smartinhaler would "count" the number of doses dispensed but that the data would remain confidential. The subjects were reviewed every 4 weeks for 3 months. During each review the parent was provided with a clean spacer and Smartinhaler containing a new canister of medication
The patient outcome was exacerbation of asthma. The subjects were reviewed every 4 weeks for 3 months. During each review the parent completed a symptom questionnaire. An exacerbation of asthma was defined as the child having received a course of prednisolone either initiated by the parent in response to an escalation of symptoms requiring regular reliever medication more than 4th hourly for 24 hours as per their asthma management plan or prescription of prednisolone by the child's primary care physician
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk (pg 737) "All subjects were then randomized to either the FH or a control spacer (Aerochamber Plus; ACP; Trudell Medical International, London, Canada) using a minimization computer program (Minim) with equal weighting for age, sex and level of maternal education."
Allocation concealment (selection bias) Unclear risk No information about allocation concealment is given in the paper. "All subjects were then randomized to either the FH or a control spacer (Aerochamber Plus; ACP; Trudell Medical International, London, Canada) using a minimization computer program (Minim) with equal weighting for age, sex and level of maternal education." (pg 737)
Selective reporting (reporting bias) Low risk The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified
Other bias Low risk None noted
Blinding of outcome assessment (detection bias) 
 Adherence measure Low risk (PRIMARY) SMARTINHALER ‐ Objective measure, unlikely to be biased
Blinding of outcome assessment (detection bias) 
 Patient outcome Unclear risk (PRIMARY) ASTHMA EXACERBATION ‐ No mention of blinding of staff
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) SMARTINHALER ‐ Unlikely that patients/parents were blind
Blinding of participants (performance bias) 
 Patient outcome Unclear risk (PRIMARY) ASTHMA EXACERBATION ‐ self report questionnaire, parents could bias results depending on condition
Blinding of personnel (performance bias) 
 Adherence measure Low risk (PRIMARY) SMARTINHALER ‐ Objective measure, unlikely to be biased
Blinding of personnel (performance bias) 
 Patient outcome Unclear risk (PRIMARY) ASTHMA EXACERBATION ‐ No mention of blinding of key personnel
Incomplete outcome data (attrition bias) 
 Adherence measure Low risk (PRIMARY) SMARTINHALER ‐ Few missing data; does not appear likely to be biased
Incomplete outcome data (attrition bias) 
 Patient outcome Low risk (PRIMARY) ASTHMA EXACERBATION ‐ Limited dropouts, balanced across the groups