Mosnaim 2011.
Methods |
Included as outcome evaluation Study design: clustered parallel‐group RCT Setting: elementary schools in Chicago Period: not reported |
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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 |
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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 |
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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 |
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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 |