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

Bruzzese 2011.

Methods Included as outcome evaluation
Intervention study design: randomised controlled trial parallel group
Setting: conducted at 5 participating high schools in New York, USA
Period: study enrolment took place over 4 consecutive school years from 2001 to 2004
Participants Eligible sample frame: 261 pupils found to be eligible
Randomised: 345 students randomised: 175 to intervention group and 170 to control group
Completed (intervention): 139 (79.4%) in the intervention group completed follow‐up, as did 142 (83.5%) in the control group
Inclusion criteria: 9th and 10th graders with moderate to severe persistent asthma who were taking medication prescribed by a medical provider in the last 12 months
Exclusion criteria: none stated
Baseline characteristics
Age of children: mean age, 15.10 years
Ethnicity: 45.5% Hispanic/Latino/a or Hispanic American; 37.7% African American/African or Caribbean American/Caribbean; 11.6% mixed ethnicity; 5.2% other ethnicity
Socio‐economic status: not reported
Gender: 29.6% male; 70.4% female
Asthma status: 68.70% moderate persistent asthma, 31.30% severe persistent asthma. No information on SES
Interventions Intervention: ASMA consisted of 2 components: (I) an 8‐week intensive programme for students, and (ii) academic detailing for adolescents’ medical providers. Student intervention consisted of three 45‐ to 60‐minute group sessions, and individual tailored coaching sessions held at least once per week for 5 weeks. Sessions were delivered by trained health educators during the school day. Students were taught asthma management skills and ways to cope with asthma, and were encouraged to see their medical provider for clinical evaluation and treatment (see Bruzzese 2004 for a full outline of ASMA content)
Control: wait‐list control (usual care)
Intensity: three 45‐ to 60‐minute group sessions for children over 8 weeks and individual tailored coaching sessions once a week for 5 weeks
Instructor: health educators
Theoretical framework: ASMA described as grounded in social cognitive theory
Parental engagement: not reported
Child satisfaction: not reported
Timing: unclear but at some point during the school day
Outcomes Extractable outcomes were collected for:
Exacerbations leading to hospital admission
Asthma symptoms leading to emergency hospital visits
Absence from school
Days of restricted activity
Unplanned GP or hospital visit due to asthma
Experience of daytime and night‐time symptoms
Corticosteroid dosage
Withdrawal
Notes Funding source: National Heart, Lung, and Blood Institute; NYC Speakers' Fund
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study authors reported: "Within each stratum, we randomised students to control or intervention using computerized randomisation lists generated in advance by the data manager who concealed them until randomisation"
Allocation concealment (selection bias) Low risk Randomisation lists were generated in advance by the data manager, who concealed them until randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Interviewers were blind to group assignment. Whether participants were blinded is unclear
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Interviewers were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No differences were noted between the 2 groups ‐ incomplete data were unlikely to affect outcomes
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Low risk Missingness ‐ low risk ‐ appears that more participants who did not drop out submitted their data
Baseline imbalance ‐ low risk ‐ intervention and control groups were relatively evenly matched in characteristics
Risk of contamination ‐ low ‐ informal interviews with control participants regarding their contact with other students in the programme suggest that contamination did not occur
Transparent and clearly stated aims Unclear risk N/A
Explicit theories underpinning and/or literature review Unclear risk N/A
Transparent and clearly stated methods and tools Unclear risk N/A
Selective reporting Unclear risk N/A
Harmful effects Unclear risk N/A
Population and sample described well Unclear risk N/A
Continuous evaluation Unclear risk N/A
Evaluation participation equity and sampling Unclear risk N/A
Design and methods overall approach Unclear risk N/A
Tools and methods of data collection reliable/credible Unclear risk N/A
Tools and methods of data analysis reliable/credible Unclear risk N/A
Performance bias/neutrality/credibility/conformability Unclear risk N/A
Reliability of findings and recommendations Unclear risk N/A
Transferability of findings Unclear risk N/A
Overall risk of bias of process evaluation Unclear risk N/A