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. 2019 Jan 28;2019(1):CD011651. doi: 10.1002/14651858.CD011651.pub2

McGhan 2003.

Methods Included as outcome evaluation
Study design: clustered parallel‐group RCT, with schools selected as the unit of randomisation
Setting: 18 elementary schools in Edmonton, Canada
Period: dates on which study was conducted ‐ intervention and subsequent data collection ‐ are not clear (post‐test data collection took place 9 months after the intervention)
Participants Eligible sample frame: eligibility based on school and parent assent and asthma status ‐ 162 children found to be eligible across 18 schools
Randomised: 162 pupils were randomised at the school level: 76 to the treatment group and 86 to the control group
Completed (intervention): 136 pupils completed the trial
Inclusion criteria: Study authors stated: "the target population was children with asthma ages 7–12 years; however, other ages were included if the parent and child were interested in participating. Criteria for selection included: (1) a diagnosis of asthma by a physician, (2) informed consent from the parent/guardian, (3) ability to speak English, and (4) no previous participation in RAP"
Exclusion criteria: no additional exclusion criteria described
Baseline characteristics
Age of children: wide age range, with children 5 to 13 years old participating (most were 8 to 10 years of age)
Ethnicity: approximately 77.8% of children were white
Socio‐economic status: unclear
Gender: approximately 59.2% of participants were male
Asthma status: approximately 66.6% of children were deemed to have mild asthma, and 6.3% were deemed to have severe asthma
Interventions Intervention: involved testing the effectiveness of "Roaring Adventures of Puff" (RAP). Study authors describe that "using the 30 page manual, the instructors taught six 60‐minute sessions: (1) getting to know each other, goal setting, use of a peak flow meter, diary monitoring; (2) trigger identification, control and avoidance, basic pathophysiology; (3) medications and proper use of inhalers; (4) symptom recognition and action plan; (5) lifestyle, exercise, managing an asthma episode; and (6) sharing this information with teachers and parents. Parents and teachers in the intervention schools were invited to participate in a RAP parent/teacher asthma awareness event at the school"
Control: not clearly stated (usual care)
Intensity: asthmatic students received 6*60‐minute lessons
Instructor: nursing and pharmacy students were asked to be RAP instructors
Theoretical framework: social cognitive theory
Parental engagement: it was intended that parents would be involved, although parent and teacher attendance ranged from 10% to 80%
Child satisfaction: not reported
Timing of intervention in school day: not reported
Outcomes Outcomes were extracted for:
Asthma symptoms leading to emergency hospital visits
Parent‐reported absence from school
Unplanned GP or hospital visit due to asthma
Experience of daytime and night‐time symptoms
Withdrawal
Notes Considered for process evaluation: did not meet the definition of a process evaluation
Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk This is not addressed by study authors, who describe: "the study compared children with asthma in randomly assigned intervention schools with those
 in control schools"
Allocation concealment (selection bias) Unclear risk This is not addressed by study authors, who describe: "the study compared children with asthma in randomly assigned intervention schools with those
 in control schools"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not addressed by study authors
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not addressed by study authors
Incomplete outcome data (attrition bias) 
 All outcomes High risk Twenty‐six families (16%) dropped out of the study; indications show that children who dropped out had substantially different characteristics from children who remained engaged: "the dropouts were significantly less likely to have reported seasonal asthma and unscheduled doctor visits in the last year"
Selective reporting (reporting bias) Unclear risk No evidence shows selective reporting
Other bias Unclear risk Missingness ‐ unclear risk ‐ information on missing data was not provided in detail
Baseline imbalance ‐ high risk ‐ the intervention group was more likely to have received previous education on asthma, which is likely to have influenced response to the intervention
Risk of contamination ‐ low ‐ unit of randomisation was schools
Transparent and clearly stated aims Unclear risk N/A
Explicit theories underpinning and/or literature review Unclear risk N/A
Transparent and clearly stated methods and tools Unclear risk N/A
Selective reporting Unclear risk N/A
Harmful effects Unclear risk N/A
Population and sample described well Unclear risk N/A
Continuous evaluation Unclear risk N/A
Evaluation participation equity and sampling Unclear risk N/A
Design and methods overall approach Unclear risk N/A
Tools and methods of data collection reliable/credible Unclear risk N/A
Tools and methods of data analysis reliable/credible Unclear risk N/A
Performance bias/neutrality/credibility/conformability Unclear risk N/A
Reliability of findings and recommendations Unclear risk N/A
Transferability of findings Unclear risk N/A
Overall risk of bias of process evaluation Unclear risk N/A