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

Gerald 2009.

Methods Included as outcome evaluation
Study design: parallel‐group design, with a 2‐group randomised longitudinal design, randomised by the child
Setting: USA
Period: baseline data collection occurred from October 2005 to December 2006. Children were randomised in January 2006. The study comprised a longitudinal design with 15‐month follow‐up. Follow‐up data were collected from January 2006 to December 2006
Participants Eligible sample frame: 290 children were randomised
Randomised: 290 children were randomised ‐ 145 in each arm
Completed (intervention): 240 (83%)
Inclusion criteria: children were eligible if they had physician‐diagnosed persistent asthma requiring daily controller medication, they attended one of the 36 participating schools, and they were able to use a dry powder inhaler and a peak flow meter
Exclusion criteria: not reported
Baseline characteristics
Age of children: mean age, 11.0 years
Ethnicity: 91% black ethnicity
Socio‐economic status: not reported.
Gender: 57% male; 43% female in total
Asthma status: mixed levels of severity ‐ 15% mild persistent asthma, 79% moderate persistent asthma, 6% severe persistent asthma
Interventions Intervention: children were given 20 minutes of asthma education, including discussion about avoidance of triggers. Children in the supervised therapy group also received supervision from study staff each day on the use of inhaled corticosteroids. If a child was observed using the inhaler incorrectly, staff provided education with the aid of a placebo inhaler
Control: usual care
Intensity: a single education session for 20 minutes; multiple supervisions for the intervention group
Instructor: study personnel
Theoretical framework: not reported
Parental engagement: not reported
Child satisfaction: not reported
Timing of intervention in school day: not reported
Outcomes Extractable outcomes were collected for:
Parent‐reported absence from school
Lung function
Use of reliever therapies
Withdrawal
Notes This paper did not provide much detail; however the study was previously reported in a separate paper (Gerald 2009)
Considered for process evaluation: implementation data were not considered to have been collected via structured or recognised tools
Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study authors reported: "a random sequence of treatment codes, stratified by school system, was generated using the SAS System (Version 9.1, Cary, North Carolina) by the statistician"
Allocation concealment (selection bias) Low risk Centrally generated: study authors reported: "a random sequence of treatment codes, stratified by school system, was generated using the SAS System (Version 9.1, Cary, North Carolina) by the statistician"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No measures were described as implemented around blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No measures were described as implemented around blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Study authors described: "79.3% completion rate in the control group and 86% completion rate in the intervention group. Reasons and details provided"
Selective reporting (reporting bias) Unclear risk No evidence shows selective reporting
Other bias Unclear risk Missingness ‐ low risk ‐ all those who were followed up submitted information
 Baseline imbalance ‐ low risk ‐ no significant differences between groups were found in baseline demographic characteristics or asthma symptom
 Risk of contamination ‐ high ‐ children were the unit of randomisation; children with different treatment allocations were present in the same school
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