Kintner 2009.
Methods |
Included as outcome evaluation Study design: clustered parallel‐group design, with schools selected as the unit of randomisation Setting: 5 schools in a south‐central Michigan school district Period: dates from recruitment to data collection spanned from September 2006 to June 2007 |
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Participants |
Eligible sample frame: 85 pupils found to be eligible Randomised: 66 pupils randomised at the school level: 38 to treatment group and 28 to control group Completed (intervention): 59 pupils completed the trial (7 dropped out of the intervention group) Inclusion criteria: student eligibility criteria included (a) diagnosis of asthma, (b) availability to participate in scheduled classes or make‐up sessions, and (c) verbal and written assent to participate Exclusion criteria: student's expressed unwillingness to participate, lack of consent from parent or legal guardian Baseline characteristics Age of children: 9 to 12 years of age, with mean age, approximately 10.5 years Ethnicity: 32% African American; 15% mixed race; 11% other; 3% Hispanic Socio‐economic status: unclear: mean score > 50 on Nam‐Powers Socioeconomic Status Scale Gender: overall, 52% of participants were male Asthma status: unclear: mean score on the Severity of Illness Scale was > 5.8 for intervention and control groups |
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Interventions |
Intervention: study evaluated the SHARP programme (Staying Healthy ‐ Asthma Responsible and Prepared). Study authors describe that 'the SHARP programme was integrated into the schools as a teaching module. Students met for 50‐minute sessions delivered once a week for 10 weeks from January through March. Students worked through the 100‐page SHARP workbook, which was designed to be colourful, entertaining, educational, and developmentally appropriate, as well as diverse with regards to gender, race, and culture. The programme was incorporated into the existing curriculum as an elective course through inclusion of spelling words, math problems, reading and writing assignments, discussions, demonstrations, and hands‐on learning activities from biology, psychology, and sociology. To support SHARP students, caregivers and others participated in a 3‐hour information sharing programme Control: not clearly stated (usual care) Intensity: targeted asthmatic students received 10 sessions in total Instructor: unclear (potentially teachers, although not clear) Theoretical framework: a lifespan development perspective guided this study and served as the framework for development of the Acceptance of Asthma Model. Cognitive, behavioural, and psychosocial needs of students with asthma were addressed to foster acceptance of asthma by increasing long‐term responsibility for maintaining and promoting health, and for preventing complications Parental engagement: caregivers were involved, but level of engagement is unclear Child satisfaction: not reported Timing of intervention in school day: integrated into class time |
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Outcomes |
Extractable outcomes were collected for: Health‐related quality of life (study authors described participation in activities as a measure of quality of life) Withdrawal |
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Notes | Considered as a process evaluation but did not include the core components of a process evaluation, with process data collected via use of structured tools Funding source: National Institutes of Health and Staying Healthy – Asthma Responsible and Prepared, National Institute of Nursing Research (Primary); National Heart, Lung, and Blood Institute; National Institute of Allergy & Infectious Diseases; National Institute of Child Health & Human Development |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was computer‐generated following Time 1 data collection |
Allocation concealment (selection bias) | Unclear risk | Unclear; few schools were allocated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Interveners and participants were not blinded to randomisation after schools were designated to treatment and control groups |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluators were instructed to not assume or ask the randomisation status of participants. Participants were requested to not disclose randomisation status to evaluators |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Relatively low levels of attrition; baseline characteristics of those who dropped out of the intervention group did not differ from characteristics of those who completed post‐intervention assessment |
Selective reporting (reporting bias) | Unclear risk | A large body of data was collected; data were aggregated into various scores, hindering their interpretation and use within meta‐analyses |
Other bias | Low risk | Missingness ‐ low risk ‐ baseline characteristics of those who dropped out of the intervention group did not differ from characteristics of those who completed post‐intervention assessment
Baseline imbalance ‐ low risk ‐ baseline group imbalance was addressed by adjusting for baseline values of outcomes in the analyses 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 |