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 |