Shah 2001.
Methods |
Included as outcome evaluation Study design: clustered parallel‐group design Setting: high schools in Tamworth, rural New South Wales, Australia Period: pupils were recruited in February 1998 and completed the study in October 1998 ‐ 3 months after the intervention was completed |
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Participants |
Eligible sample frame: 325 pupils Randomised: 272 pupils: 148 in the control group and 124 in the intervention group Completed (intervention): 251 pupils; 138 in the control group and 113 in the intervention group Inclusion criteria: not reported Exclusion criteria: not reported Baseline characteristics Age of children: 118 pupils in year 7; 133 pupils in year 10 Ethnicity: not reported Socio‐economic status: not reported Gender: 62% to 68% female in the intervention group; 44% to 48% female in the control group Asthma status: 69% to 80% had received an asthma diagnosis |
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Interventions |
Intervention: the intervention involved a 3‐step approach to educating and empowering students with asthma. In step 1, students learnt how to educate their peers about asthma and its management using games, videos, worksheets, and discussions as teaching tools. In step 2, peer leaders conducted three 45‐mnute health lessons for year 10 classes at school. In step 3, year 10 students developed and presented to year 7 students key messages learnt in the lessons Control: wait‐list control group received usual care during data collection Intensity: in step 1, volunteers from year 11 were trained as asthma peers during a 6‐hour workshop. In step 2, three 45‐minute sessions were taught. No information was recorded on length and intensity in step 3 Instructor: peers Theoretical framework: not reported Parental engagement: not reported Child satisfaction: not reported Timing of intervention in school day: not reported |
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Outcomes |
Extractable outcomes were collected for: Experience of daytime and night‐time symptoms Lung function Health‐related quality of life Withdrawal |
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Notes | School absence data were collected as median values but were not reported in full Funding source: Commonwealth Department of Health and Aged Care and Asthma NSW |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Concealed random allocation was performed by study author (who was not involved in administration of the study), using a random number generator and the closed envelope technique |
Allocation concealment (selection bias) | Low risk | Concealed random allocation was performed by PGG (who was not involved in administration of the study), using a random number generator and the closed envelope technique |
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 | Low risk | Low levels of attrition: 272 participated in baseline testing; matched data at baseline and after the intervention were available for 251 students |
Selective reporting (reporting bias) | Unclear risk | No direct evidence, although median number of days missed was collected and could not be combined in the meta‐analysis |
Other bias | Unclear risk | Missingness ‐ low risk ‐ missing data described as uncommon and occurred owing to misclassification, students changing schools or being absent on the day of testing, or failure to complete the questionnaire Baseline imbalance ‐ unclear risk ‐ differences between groups, although it is unclear if these are significant for the outcome Risk of contamination ‐ low ‐ schools were the unit of randomisation, thereby lowering risk of contamination |
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 |