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

Mosnaim 2011.

Methods Included as outcome evaluation
Study design: clustered parallel‐group RCT
Setting: elementary schools in Chicago
Period: not reported
Participants Eligible sample frame: not reported
Randomised: 344 pupils within the youth group (275 in the intervention group and 69 in the control group) and 192 within the teen group (141 in the intervention group and 51 in the control group) participated. 25 youth classes (19 intervention groups and 6 control groups) and 16 teen classes (11 intervention group and 5 control groups) from 26 schools participated
Completed (intervention): not reported
Inclusion criteria: not reported
Exclusion criteria: not reported
Baseline characteristics
Age of children: youths and teens 5 to 15 years old. Median age was 10 for the youth group and 13 for the treatment group
Ethnicity: 65.5% in the youth intervention group were African American; 11.6% were Hispanic; and 22.3% were other. In the teen intervention group, 85.1% were African American, 7.1% were Hispanic, and 7.1% were other
Socio‐economic status: not reported, but study author described participants as predominantly low income
Gender: females represented 43% of participants. In the youth intervention group, 41.5% were female; in the teen intervention group, 48.2% were female
Asthma status: not reported
Interventions Intervention: certified asthma educators provided 1‐to‐1 training on spacer technique, peak flow meter use, and use of an asthma action plan. The teen programme also addressed tobacco avoidance, asthma‐related peer pressure, and asthma self‐management skills
Control: usual care
Intensity: four 45‐minute sessions conducted in school on 4 consecutive days
Instructor: certified asthma educators
Theoretical framework: not reported
Parental engagement: not reported
Child satisfaction: not reported
Timing of intervention in school day: not explicitly reported, but sessions were scheduled at times with the least impact on instruction, as determined by each school
Outcomes Extractable outcomes were collected for: None
Notes Considered for process evaluation: study did not include the core components of a process evaluation
Funding source: Abbott Laboratories Unrestricted Grant
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Potential breach of randomisation schedule through systematic bias in selection of schools for the control group: "The allocation scheme first determined whether an eligible school could accommodate the intervention schedule. Those that could not were automatically assigned to the control group, whereas those that could were subject to the 3:1 randomisation scheme"
Allocation concealment (selection bias) High risk Potential breach of randomisation schedule through systematic bias in selection of schools for the control group: "The allocation scheme first determined whether an eligible school could accommodate the intervention schedule. Those that could not were automatically assigned to the control group, whereas those that could were subject to the 3:1 randomisation scheme"
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 Relatively low levels of missing data; study authors state that this had no impact on the outcome: "Approximately 15% of the participants overall were missing posttest scores (39 youth and 44 teen participants). Based on feedback from our trained educators as to the source of the absenteeism, we concluded that these missing data were missing at random and did not merit use of data imputation methods"
Selective reporting (reporting bias) Low risk No evidence of indicators measured but not reported. However, indicators that were not included in our protocol were collected
Other bias Unclear risk Missingness ‐ unclear risk ‐ missing data but no imputation strategy ‐ study authors stated that it was not necessary to implement imputation strategies
Baseline imbalance ‐ unclear risk ‐ some ethnic and gender differences at baseline but impact on outcomes unclear; no differences in asthma knowledge at baseline
Risk of contamination ‐ low ‐ unit of randomisation was the school, lowering the risk of contamination
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