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

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
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
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
Outcomes Extractable outcomes were collected for:
Emergency department visits
Absences from school
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
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