Henry 2004.
Methods |
Included as outcome evaluation and process evaluation Study design: clustered parallel‐group design Setting: secondary schools in Newcastle, New South Wales, Australia Period: baseline data were collected between February and March 1993. Follow‐up data were collected between August and October 1993. Follow‐up questionnaires were sent to the heads of participating schools in 1999 Process evaluation methods: descriptive/bivariate |
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Participants |
Eligible sample frame: 33 schools were eligible for participation, with a total of 4475 year 8 students, 23% of whom had current asthma. In total, 76.7% of all eligible students and 82.7% of students recruited into th initial phase contributed to data analysis Randomised: not reported Completed (intervention): not reported Inclusion criteria: not reported Exclusion criteria: not reported Baseline characteristics Age of children: year 8 students were eligible; adolescents aged 13 to 14 years were targeted Ethnicity: numbers were not reported; however schools included a predominantly Caucasian population Socio‐economic status: not reported. Gender: males represented 52.4% of intervention students with matched data and 52.9% of control adolescents Asthma status: not reported |
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Interventions |
Intervention: intervention schools received a 3‐lesson package about asthma designed to be taught within the Personal Development/Health/Physical Education (PD/ H/PE) strand of the school curriculum. Each school was invited to send a delegate to learn the curriculum and was provided with the Living With Asthma teaching kit Control: usual care Intensity: 3 lessons; however the duration of these lessons was not reported Instructor: in some schools, teachers who attended the training seminar delivered the lessons; in other schools, teachers trained their colleagues Theoretical framework: not reported Parental engagement: not reported Child satisfaction: not reported Timing of intervention in school day: taught within the Personal Development/Health/Physical Education strand of the school curriculum |
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Outcomes |
Core processes evaluated (child level): adherence (long‐term) Extractable outcomes were collected for: Health‐related quality of life (HRQoL) |
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Notes |
Process evaluation category: integrated Breadth and depth: depth ‐ not breadth Voice of children given prominence: featured but not sufficiently Funding source: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Method of stratification is unclear: schools were randomised to control or intervention, with an attempt to obtain similar demographic mixes in the 2 groups |
Allocation concealment (selection bias) | Unclear risk | Not addressed by study authors |
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 | Unclear risk | Attrition data for asthmatic children were not provided in full |
Selective reporting (reporting bias) | Low risk | All data were reported by study authors |
Other bias | Unclear risk | Missingness ‐ unclear risk ‐ missing data are apparent with no explanation provided Baseline imbalance ‐ unclear risk ‐ this was not addressed by study authors Risk of contamination ‐ low ‐ risk of contamination was low due to the study design |
Transparent and clearly stated aims | Low risk | Study aims were clearly stated |
Explicit theories underpinning and/or literature review | High risk | No theoretical framework and very little supporting literature were provided |
Transparent and clearly stated methods and tools | Low risk | Study aims were clearly stated |
Selective reporting | Unclear risk | Medium bias ‐ problems with linking surveys were experienced (pre‐post intervention) |
Harmful effects | Unclear risk | How this was addressed is unclear. In particular, this might not have been beneficial for many children |
Population and sample described well | High risk | Level of baseline imbalance was not reported |
Continuous evaluation | Unclear risk | Pre‐post assessment data were used for the majority, but an element of continuous evaluation was included in the school policy analysis |
Evaluation participation equity and sampling | Unclear risk | Moderate evidence shows that the voice of children was reflected adequately |
Design and methods overall approach | Low risk | Design and methods were appropriate for this study |
Tools and methods of data collection reliable/credible | Low risk | Data collection tools used were credible and reliable |
Tools and methods of data analysis reliable/credible | Low risk | Analysis of quantitative data was reliable |
Performance bias/neutrality/credibility/conformability | Unclear risk | No evidence shows how confidentiality was maintained |
Reliability of findings and recommendations | Unclear risk | Level of baseline imbalance is unclear |
Transferability of findings | Unclear risk | Transferability was not assessed by study authors |
Overall risk of bias of process evaluation | Unclear risk | Some aspects of study design and study characteristics were not explained fully |