Patterson 2005.
Methods |
Included as outcome evaluation Study design: clustered parallel‐group design, with schools as the unit of randomisation Setting: primary schools in Belfast, Northern Ireland Period: participating schools entered the trial between September 2002 and September 2003. Preliminary assessment through to follow‐up assessment took 31 weeks |
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Participants |
Eligible sample frame: 102 eligible children in intervention schools and 126 eligible children in control schools Randomised: 84 eligible children in intervention schools and 92 eligible children in control schools Completed (intervention): 99 children in intervention schools and 92 children in control schools Inclusion criteria: children were eligible if they were between 7 and 11 years of age and had received a diagnosis of asthma Exclusion criteria: not reported Baseline characteristics Age of children: mean age, 9.01 years in the intervention group and 8.99 years in the control group Ethnicity: not reported Socio‐economic status: 32% of children in the intervention group and 22% of children in the control group were eligible for free school meals Gender: males represented 45% of the intervention group and 58% of the control group Asthma status: not reported |
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Interventions |
Intervention: each session began with brief reinforcement of previous training and ended with session feedback. The SCAMP club workbook used during sessions was given to children at prize giving, along with the child‐held asthma care pathway record and action plan Control: control group received the same intervention after a 16‐week interval Intensity: weekly sessions for 8 weeks Instructor: school nurse and a health visitor Theoretical framework: study was informed by the Predisposing, Reinforcing, and Enabling Causes in Educational Diagnosis and Evaluation (PRECEDE) model Parental engagement: not reported Child satisfaction: not reported Timing of intervention in school day: intervention was designed to be delivered at lunchtime |
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Outcomes |
Extractable outcomes were collected for: Days of restricted activity Lung function Health‐related quality of life Withdrawal |
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Notes |
Considered for process evaluation: study did not contain core components of a process evaluation Funding source: South and East Belfast Health and Social Services Trust, Primary Care and Development Fund, Eastern Health and Social Services Board, Department of Child Health, Queen's University Belfast |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | In each pair, the toss of a coin was used to randomise schools to immediate or delayed intervention |
Allocation concealment (selection bias) | Unclear risk | Given that allocation was done within pairs of schools, allocation concealment might have been breached |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not addressed by study authors |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not addressed by study authors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Very low levels of attrition (2/83 in the intervention group) |
Selective reporting (reporting bias) | Low risk | No indication that outcomes were collected and not reported upon |
Other bias | Low risk | Missingness ‐ low risk ‐ no missing data among those who did not drop out Baseline imbalance ‐ unclear risk ‐ some differences are apparent; not clear if these differences would significantly alter response to the intervention Risk of contamination ‐ low ‐ schools were the unit of randomisation |
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 |