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

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
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
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
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
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