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 |
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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 |
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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 |
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Outcomes |
Extractable outcomes were collected for: Parent‐reported absence from school Lung function Use of reliever therapies Withdrawal |
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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 |
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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 |