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 |
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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 |
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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 |
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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 |
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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 |