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) |
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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 |
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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 |
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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 |
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Notes |
Considered for process evaluation: did not meet the definition of a process evaluation Funding source: not reported |
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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 |