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

Lee 2011.

Methods Included as process evaluation
Intervention study design: quasi‐experimental single‐group intervention examining change pre‐post intervention
Unit of allocation: N/A
Process evaluation methods: qualitative and quantitative data collection; descriptive/bivariate, thematic/grounded theory, narrative data analysis
Participants Setting: selected schools (67 schools) in Cleveland Metropolitan School District
Age of children: 8 to 11 years old
Child characteristics (BME/SES): no information
Asthma status: asthmatic only
Intervention recipients: children only
Interventions School type: primary/elementary
Intervention description: Open Airways for Schools (also testing the feasibility of undergraduate nursing students as instructors). The study author described that "the curriculum consists of six 40‐minute group lessons held during the school day. These lessons use group discussion, stories, role‐playing, and games to help the children understand more about asthma and to engage them more in the empowerment of managing their disease. The topics that are included in the program are basic information about asthma, recognizing and managing asthma symptoms, using medication, avoiding asthma triggers, getting enough exercise, and doing well in school. Each lesson focuses on one of the above topics with a review of previous information for enforcement of the skills and knowledge learned. The overall goals of the program are to (a) improve asthma self‐management skills, (b) decrease asthma emergencies, (c) raise awareness among parents/guardians, and (d) promote broader asthma management coordination among physicians, parents, and schools"
Control description: N/A
Theoretical framework: functional context approach
Outcomes Core processes evaluated (child level): explored some indicators of adherence
Notes Process evaluation category: integrated within outcome evaluation
Breadth and depth: neither broad nor deep
Voice of children given prominence: featured but not sufficiently
Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk N/A
Allocation concealment (selection bias) Unclear risk N/A
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk N/A
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk N/A
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk N/A
Selective reporting (reporting bias) Unclear risk N/A
Other bias Unclear risk N/A
Transparent and clearly stated aims Low risk Study aims were clearly stated
Explicit theories underpinning and/or literature review Low risk Functional context approach guided development of the intervention
Transparent and clearly stated methods and tools Unclear risk In terms of the outcome evaluation and information collected from children, lack of transparency surrounds the sample frame and tools
Selective reporting High risk Many instruments were not presented
Harmful effects Unclear risk Some elements that could be negative were included, but nothing from the children is included
Population and sample described well High risk Not much information was included on participants, and some details of the children were not described. More information was provided about the schools themselves
Continuous evaluation Unclear risk Pre‐post assessment, but post hoc only for nurses
Evaluation participation equity and sampling Unclear risk Nothing from the teachers was reported
Design and methods overall approach High risk Structured data about implementation ‐ e.g. attrition, adherence ‐ are insufficient
Tools and methods of data collection reliable/credible High risk Lack of transparency is evident among the methods used to assess child outcomes
Tools and methods of data analysis reliable/credible High risk Quantitative data were not analysed fully ‐ e.g. lack of subgroup analyses
Performance bias/neutrality/credibility/conformability High risk How aspects around neutrality were addressed is unclear
Reliability of findings and recommendations High risk Study design did not support the research question ‐ results from different instructors were not compared
Transferability of findings High risk Generalisability was not explicitly considered in enough detail
Overall risk of bias of process evaluation High risk Study has several limitations, including reporting bias and lack of transparency