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

McGhan 2010.

Methods Included as outcome evaluation
Study design: clustered parallel‐group design
Setting: elementary schools in Edmonton, Canada
Period: not reported
Participants Eligible sample frame: all schools in Edmonton were eligible; an estimated 646 students from the 18 participating schools were eligible
Randomised: 162 pupils from 18 schools: 76 pupils in the intervention group and 86 in the control group
Completed (intervention): 136 pupils: 65 in the intervention group and 71 in the control group
Inclusion criteria: the target population was children 7 to 12 years of age with asthma. Pupils were eligible if they had received a diagnosis of asthma from their doctor and informed consent from their parent/guardian, were able to speak Eglish, and had not previously participated in Roaring Adventures of Puff (RAP)
Exclusion criteria: not reported
Baseline characteristics
Age of children: 5 to 10 years of age; 27.6% in the intervention group and 23.3% in the control group were 5 to 7 years old, and 61.8% in the intervention group and 57% in the control group were 8 to 10 years old
Ethnicity: 81.6% of children in the intervention group and 74.4% of children in the control group were Caucasian
Socio‐economic status: not reported; however 26.8% of children in the intervention group and 36.4% in the control group had a father who achieved education grade 12 or less
Gender: males represented 55.3% of intervention students and 62.8% of control students
Asthma status: mixed levels of severity: 62.7% of intervention children and 66.7% of control children had mild asthma; 29.3% of intervention children and 28.6% of control children had moderate asthma; 8% of intervention children and 4.8% of control children had severe asthma
Interventions Intervention: parents and teachers in intervention schools were invited to participate in a RAP asthma awareness event at school. Parents and children in the intervention schools received information letters to share with their doctors, including suggested guidelines for a written action plan to be used at home and school. Doctors also received a summary letter from the RAP instructor at the end of the programme
Control: usual care
Intensity: six 60‐minute sessions
Instructor: third year nursing and pharmacy students were RAP instructors under the guidance of their supervisor
Theoretical framework: social cognitive theory informed the intervention
Parental engagement: not reported
Child satisfaction: not reported
Timing of intervention in school day: not reported
Outcomes Extractable outcomes were collected for:
Asthma symptoms leading to emergency hospital visit
Parent‐reported absence from school
Unplanned visit to hospital or GP due to asthma symptoms
Experience of daytime and night‐time symptoms
Withdrawal
Notes Considered for process evaluation: did not meet the definition of a process evaluation
Funding source: Alberta Heritage Foundation for Medical Research ‐ Health Research Fund
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Schools were randomly assigned to RAP educational intervention or usual care (control group) via a random numbers table
Allocation concealment (selection bias) Unclear risk Selection of schools is unclear
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 Over one‐quarter of children dropped out; no reasons were provided
Selective reporting (reporting bias) High risk Measures of variance were not presented, hindering extraction of some outcomes
Other bias Unclear risk Missingness ‐ unclear risk ‐ no descriptions of missingness were provided
Baseline imbalance ‐ low risk ‐ no differences between intervention and control arms are apparent
Risk of contamination ‐ low ‐ randomisation at the school level
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
Overall risk of bias of process evaluation Unclear risk N/A