Persaud 1996.
Methods |
Included as outcome evaluation Study design: parallel‐group design with children selected as the unit of randomisation Setting: study was conducted in Galveston, Texas, USA, across children in 10 schools Period: the intervention was conducted between September and December 1992 |
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Participants |
Eligible sample frame: 60 pupils found to be eligible; 43 were contacted and 36 agreed to participate Randomised: 36 children were randomised, with 18 each selected into intervention and control arms Completed (intervention): no students were described as having dropped out Inclusion criteria: children 8 to 12 years of age with a diagnosis of asthma (several prior episodes of airway obstruction, clinical response to bronchodilator, and absence of other pulmonary disease) Exclusion criteria: no additional exclusion criteria provided Baseline characteristics Age of children: mean age, 10.2 years Ethnicity: 69% of children were African American Socio‐economic status: 69% of children were from families in receipt of Medicaid Gender: 64% of children were male Asthma status: 44% of children had mild asthma, 50% had moderately severe asthma, and 6% had severe asthma |
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Interventions |
Intervention: study authors described that "intervention subjects received individualized, weekly, 20‐min education sessions with the school nurse for 8 weeks. Each child had a personal peak flow meter in the school health office to use during teaching sessions. At each visit, the school nurse reviewed the asthma diary with the student and discussed progress, symptoms, and ability to take appropriate measures to control asthma. At each visit, the child demonstrated proper use of inhaled medications and the peak flow meter. The school nurses recorded each student's weekly progress on a checklist in the teaching manual" Control: usual care Intensity: target asthmatic students received 3 lessons from peer leaders (year 11 students) Instructor: school nurses Theoretical framework: no overarching theory named Parental engagement: not reported Child satisfaction: not reported Timing of intervention in school day: not reported |
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Outcomes |
Extractable outcomes were collected for: Emergency department visits Absences from school |
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Notes |
Considered for process evaluation: study did not include the core components of a process evaluation, and process data were collected with the use of structured tools Funding source: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No further information beyond this: students within each school were randomly assigned to intervention or control groups |
Allocation concealment (selection bias) | Unclear risk | No further information beyond this: students within each school were randomly assigned to intervention or control groups |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All primary care providers were blinded as to assignment to treatment or control groups; primary care providers collected most of these data |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All primary care providers were blinded as to assignment to treatment or control groups; primary care providers collected most of these data |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition was reported among the 36 children |
Selective reporting (reporting bias) | Low risk | Selective reporting was evident and outcomes were extracted |
Other bias | Unclear risk | Missingness ‐ low risk ‐ no apparent missing data Baseline imbalance ‐ unclear risk ‐ control group had lived with asthma for longer, which could inflate the impact of the intervention Risk of contamination ‐ high ‐ students were randomised within schools; this could lead to contamination across groups |
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 |