Bruzzese 2004.
Methods |
Included as process evaluation and outcome evaluation Intervention study design: randomised controlled trial with the child selected as the unit of allocation Setting: children were recruited from 2 inner city public high schools Period: not reported |
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Participants |
Eligible sample frame: 65 students were eligible; 45 were randomised to intervention or control group Randomised: 45 students were randomised: 23 to the intervention group and 22 to the delayed‐treatment control group across the 2 schools Completed (intervention): 100% of children in the intervention group received workshop 1; 91% received workshop 2; 61% of children in the intervention group received workshop 3, as time did not permit a make‐up session Inclusion criteria: students with persistent asthma symptoms, at least 3 days a week or 3 nights a month Exclusion criteria: not reported Baseline characteristics Age of children: students in 9th and 10th grades Ethnicity: not reported Socio‐economic status: not reported Gender: not reported Asthma status: asthmatic students only |
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Interventions |
School type: high school Intervention description: Open Airways for Schools, academic detailing Control description: usual care/nothing Theoretical framework: self‐regulation theory Intervention: students received the ASMA programme, in which students were taught how to manage their asthma to prevent symptoms and improve quality of life. One goal of ASMA is to help students incorporate asthma management strategies into their self‐identity. Continued medical education was also offered to students' medical providers Intensity: intervention was delivered over an 8‐week period, comprising 3 workshops spaced 2 to 3 weeks apart Instructor: intervention was delivered by a trained health educator Parental engagement: not reported Child satisfaction: most students found the sessions helpful; however a third confirmed that they may or may not participate again Timing of intervention in school day: every attempt was made to meet with students during their free time |
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Outcomes |
Extractable outcomes were collected for: none Core processes/outcomes evaluated (child level): attrition, adherence |
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Notes |
Process evaluation category: stand‐alone Breadth and depth: neither broad nor deep Voice of children given prominence: sufficient coverage Funding source: Speakers' fund for public health |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only detail provided was that students were randomly assigned to treatment or control groups |
Allocation concealment (selection bias) | Unclear risk | No details were provided except that students were randomly assigned to treatment or control groups |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Methods used for blinding were not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Methods used for blinding were not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Low levels of post‐test outcomes collected: 14 students who attended group workshop #3 ‐ 64% of all treatment students ‐ completed an evaluation of the programme |
Selective reporting (reporting bias) | Unclear risk | No data from the control group were presented. The procedure followed for control group students is unclear |
Other bias | Unclear risk | Baseline data were not reported, so we are unable to determine if any imbalances existed at baseline |
Transparent and clearly stated aims | Low risk | Study aims were clearly stated |
Explicit theories underpinning and/or literature review | Low risk | Theory guiding the intervention was provided as self‐regulation theory |
Transparent and clearly stated methods and tools | High risk | Tools used for data collection were inferred, as opposed to being stated |
Selective reporting | Unclear risk | Outcomes that study authors intended to measure are unclear; therefore we are unable to say whether evidence shows selective reporting |
Harmful effects | High risk | No provision was made for harmful effects |
Population and sample described well | Unclear risk | Some aspects of the sample were described in sufficient detail; however no information was provided on ethnicity, SES, or asthma severity among participants |
Continuous evaluation | High risk | Study authors did not capture the people who dropped out |
Evaluation participation equity and sampling | Unclear risk | Not reported by study authors |
Design and methods overall approach | Unclear risk | Little information was given about the methods used |
Tools and methods of data collection reliable/credible | High risk | Small sample size suggests that different approaches to analysis and collection should have been used |
Tools and methods of data analysis reliable/credible | High risk | Small sample size suggests that different approaches to analysis and collection should have been used |
Performance bias/neutrality/credibility/conformability | Unclear risk | Not reported by study authors |
Reliability of findings and recommendations | Unclear risk | Not reported by study authors |
Transferability of findings | Unclear risk | Some of the lessons learnt around time‐tabling were transferable; however study authors did not assess transferability |
Overall risk of bias of process evaluation | High risk | Points around sampling and absence of continuous evaluation contribute to high risk of bias |