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

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
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
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
Outcomes Extractable outcomes were collected for: none
Core processes/outcomes evaluated (child level): attrition, adherence
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
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