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

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
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
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
Outcomes Extractable outcomes were collected for:
Days of restricted activity
Lung function
Health‐related quality of life
Withdrawal
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
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