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

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
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
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
Outcomes Core processes evaluated (child level): adherence (long‐term)
Extractable outcomes were collected for:
Health‐related quality of life (HRQoL)
Notes Process evaluation category: integrated
Breadth and depth: depth ‐ not breadth
Voice of children given prominence: featured but not sufficiently
Funding source: not reported
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