Howell 2005.
Methods |
Included as outcome evaluation and process evaluation Study design: clustered parallel‐group design with schools selected as the unit of randomisation Setting: 4 elementary schools in Syracuse City, New York, USA Period: conducted December 2003 to January 2004; subsequent data collected through September 2004 Process evaluation methods: descriptive/bivariate |
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Participants |
Eligible sample frame: 40 families found to be eligible and 30 consented, with 5 others unable to participate before randomisation Randomised: 25 families (children and caregiver), with 16 selected into the intervention group and 9 into the control group Completed (intervention): no reports of permanent attrition Inclusion criteria: target child was between 8 and 11 years of age and was in third to fifth grade with a diagnosis of asthma and prescribed daily medications for asthma as reported by nurse and/or parent Exclusion criteria: coexisting chronic illness that required daily medication (e.g. insulin‐dependent diabetes) Baseline characteristics Age of children: mean age, 9 years 7 months; range, 8 to 11 years Ethnicity: 75% of children were African American Socio‐economic status: unclear Gender: 63% male Asthma status: all children had a record of asthma, although study authors did not describe asthma severity |
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Interventions |
School type: primary/elementary Intervention description: children in the intervention condition received four 30‐minute sessions on the "Quest for the Code" computer game at their school. The computer game included modules on Lung Physiology; Symptom Recognition; Trigger Recognition; Peak Flow Meter Usage; Appropriate Use of Long‐Term and Reliever Medication; Correct Usage of Common Asthma Medication; and Effect of Asthma Medications on Lungs. The child's primary caregiver participated in a medication routine interview in the home and received a 1‐time home visit at which a medication routine plan was developed Control description: usual care/no additional intervention Theoretical framework: learning theory principles and behaviour modification |
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Outcomes | Core processes evaluated (child level): attrition, dosage, adherence | |
Notes |
Process evaluation category: named section Breadth and depth: neither broad nor deep Voice of children given prominence: the voice of children was featured but not sufficiently Funding source: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information not given: this study was a pretest, intervention, post‐test, follow‐up (PPF) RCT with random assignment based on school site |
Allocation concealment (selection bias) | High risk | Information not given; few students were randomised and concealment may have been breached |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not addressed in the study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not addressed in the study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low risk ‐ low levels of attrition are reported in the study |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | High risk | Missingness ‐ high risk ‐ small sample and evidence of missingness for some indicators
Baseline imbalance ‐ high risk ‐ described in the introduction as imbalanced Risk of contamination ‐ low ‐ randomisation occurred at a school level |
Transparent and clearly stated aims | Low risk | Study aims were clearly stated |
Explicit theories underpinning and/or literature review | Low risk | Intervention was informed by learning theory principles and behaviour modification |
Transparent and clearly stated methods and tools | Low risk | Study included a broad‐ranging description of tools implemented at different time points |
Selective reporting | Unclear risk | Some statements from parents are impenetrable; other statements describe kids enjoying the intervention but are not entirely clear on how this feedback was obtained |
Harmful effects | Unclear risk | Study methods do not highlight the possibility of negative effects |
Population and sample described well | Unclear risk | Only basic demographic information was included |
Continuous evaluation | Low risk | Not continuous; however 3 time points were considered |
Evaluation participation equity and sampling | Unclear risk | Information was collected from parents and children only |
Design and methods overall approach | Low risk | This was an RCT but with dedicated attention to feasibility |
Tools and methods of data collection reliable/credible | Low risk | Validated measures were used |
Tools and methods of data analysis reliable/credible | Unclear risk | Small study sample precludes usefulness of confounding data |
Performance bias/neutrality/credibility/conformability | Unclear risk | Process was limited |
Reliability of findings and recommendations | Low risk | How the data relate to study findings is clear |
Transferability of findings | Unclear risk | Study sample was too small, so transferability is limited |
Overall risk of bias of process evaluation | Unclear risk | Small sample compromises much of the information provided in this study |