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

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
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
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
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
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