Bignall 2015.
Methods |
Included as process evaluation Intervention study design: randomised controlled trial Unit of allocation: child Process evaluation methods: descriptive/bivariate (quantitative), descriptive (qualitative) |
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Participants |
Setting: single high school in a midwestern city in the USA Age of children: 12 to 17 years (mean age, 15.47 years) Child characteristics (BME/SES): African American Asthma status: asthmatic only Intervention recipients: children |
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Interventions |
School type: high school Intervention description: 2 short instructional sessions for children on relaxation/breathing retraining techniques. Participants completed 2 in‐person visits spaced 1 month apart and were given a copy of the script and a CD with breathing retraining techniques to help them practise at home Control description: participants in the control group received 30 minutes of standard asthma education Theoretical framework: no specific framework was named (although supporting literature around breathing exercises was provided) |
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Outcomes | Core processes evaluated (child level): attrition, dosage, adherence | |
Notes |
Process evaluation category: named section(s) on processes included Breadth and depth: neither broad nor deep Voice of children given prominence: featured but not sufficiently Note: not included as outcome evaluation because control received asthma education Funding source: not reported |
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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 | High risk | No named theoretical framework was presented |
Transparent and clearly stated methods and tools | Unclear risk | Although methods and tools were clearly described, it is unclear who delivered the intervention. However, tools used and the content of interviews were well described |
Selective reporting | Unclear risk | Interviews may have been underreported |
Harmful effects | High risk | Not much scope for harmful effects, such as impact of disruption of the intervention, to be studied |
Population and sample described well | Low risk | The most relevant characteristics of the sample were captured |
Continuous evaluation | Low risk | Data were collected before and after the intervention |
Evaluation participation equity and sampling | High risk | Only child‐level data were collected |
Design and methods overall approach | Low risk | Two sets of data were provided |
Tools and methods of data collection reliable/credible | Unclear risk | Difficult to establish whether these were reliable, as they were interviews |
Tools and methods of data analysis reliable/credible | Unclear risk | Analysis of quantitative data was comprehensive. However, treatment/analysis of qualitative data was unclear |
Performance bias/neutrality/credibility/conformability | High risk | Because of the way in which qualitative interviews were conducted, risk of performance bias was increased |
Reliability of findings and recommendations | High risk | Study included a small sample, and target numbers for the study were not achieved. Presentation of qualitative data was limited |
Transferability of findings | High risk | Study authors did consider transferability of findings; however analysis of qualitative data was absent |
Overall risk of bias of process evaluation | High risk | Some data were collected well; however treatment of qualitative data reveals high risk of bias |