Joseph 2013.
Methods |
Included as process evaluation Intervention study design: parallel‐group randomised controlled trial Unit of allocation: child Process evaluation methods: survey based, including multi‐variate analyses of outcomes |
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Participants |
Setting: 6 high schools in Detroit, Michigan, USA Age of children: mean age, 15.6 years Child characteristics (BME/SES): 98% African American; 74% of children were in receipt of free or reduced price school meals Asthma status: asthmatic only; severity unclear Intervention recipients: children only |
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Interventions |
School type: high school Intervention description: this is an adapted version of a tailored computer programme (Puff City) that was tested in Joseph 2010. Puff City focusses on 3 behaviours: controller medication adherence, keeping an inhaler nearby, and smoking reduction or cessation. This new intervention included new submodules designed to target teens with characteristics shown to be associated with lack of behaviour change in the previous trial, and who exhibited no change after 1 or more sessions. Students were provided 4 sessions in total Control description: controls received 4 sessions of generic asthma education to match the experience of students in the treatment group Theoretical framework: Puff City uses tailoring to apply behavioural theory. Also includes Health Belief Model, Attribution Theory, and motivational interviewing |
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Outcomes | Core processes evaluated (child level): attrition, dosage, adherence | |
Notes |
Process evaluation category: stand‐alone and integrated (2 papers) Breadth and depth: breadth and depth Voice of children given prominence: featured but not sufficiently Note: study is not included as an outcome evaluation because the comparison group received asthma education (this study evaluated the added impact of providing tailored messaging) Funding source: National Institutes of Health; National Heart, Lung, and Blood Institute |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | N/A |
Allocation concealment (selection bias) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | N/A |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | N/A |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | N/A |
Selective reporting (reporting bias) | Unclear risk | N/A |
Other bias | Unclear risk | N/A |
Transparent and clearly stated aims | Low risk | Study aims were clearly stated |
Explicit theories underpinning and/or literature review | Low risk | Behavioural theory informed the intervention |
Transparent and clearly stated methods and tools | High risk | Information collected from caregivers is unclear |
Selective reporting | High risk | Data were collected from caregivers, but study authors did not state what these data included |
Harmful effects | Low risk | Subgroup analyses of the impact of potential risk group were undertaken |
Population and sample described well | Unclear risk | More could have been done to describe caregivers |
Continuous evaluation | Low risk | Pre‐post assignment data were collected |
Evaluation participation equity and sampling | Unclear risk | Data collected are unclear |
Design and methods overall approach | Unclear risk | Data were collected but were not presented; a clear outline of the research design was not presented |
Tools and methods of data collection reliable/credible | High risk | Information collected from caregivers is unclear |
Tools and methods of data analysis reliable/credible | Low risk | Data presented were analysed in a straightforward way |
Performance bias/neutrality/credibility/conformability | Unclear risk | Steps taken to address this are unclear |
Reliability of findings and recommendations | High risk | Very low proportion of eligible students took part, so reliability of study findings was compromised |
Transferability of findings | Unclear risk | Subgroup analyses were conducted; however study authors did not address transferability of findings, and the high level of non‐response does impede data transferability |
Overall risk of bias of process evaluation | High risk | Data collected were not presented clearly; high level of non‐participation impinges on ability to generalise, even to the population in question |