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

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)
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
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)
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
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