Levy 2006.

Methods	Included as outcome evaluation and process evaluation Intervention study design: cluster parallel‐group RCT with schools selected as unit of randomisation, based on a stratified design according to school characteristics Setting: 14 elementary schools in Memphis, Tennessee, USA, school district participated in the study Period: study was conducted over 2 school years between 1999 and 2001
Participants	Eligible sample frame: see below Randomised (based on year 1): 14 schools randomised. In 8 treatment group schools, 115 students participated, and in 6 usual care schools, 128 students participated. This represented a consent rate of 48% for both groups of students, whose parents reported asthma on the student's registration form Completed (intervention) (based on year 1): in the treatment group, 90 (78.3%) parents completed both pre‐ and post‐test surveys; in the usual care group, 72 (56.3%) parents participated in post‐test surveys Inclusion criteria: children 6 to 10 years of age with a diagnosis of asthma reported on school health forms and whose parents provided consent (see above) Exclusion criteria: not reported Baseline characteristics Age of children: 6 to 10 years of age; further breakdown not provided Ethnicity (based on year 1): 97% of children in the treatment group and 99% of children in the control group were African American Socio‐economic status: (based on year 1): 81% of students in the treatment group and 85% in the control group were in receipt of TennCare health insurance (a state‐specific version of Medicare) Gender (based on year 1): treatment: 58% male, 42% female; control: 57% male, 53% female Asthma status: not reported directly
Interventions	Intervention: the intervention consisted of the following: "(1) education (delivery of the Open Airways curriculum to students in a weekly group setting at school), (2) weekly monitoring of students' health status (following up on absences and symptoms with students, families, and teachers), and (3) coordination of care (contacting students, family members, school personnel, and medical providers to facilitate disease management and mitigate environmental triggers at school and at home)" The intervention aimed to introduce the following principles of self‐management: "(1) periodic physiologic assessment and monitoring of asthma symptoms, (2) appropriate use of medications, (3) patient education, and (4) control of factors contributing to asthma severity" Control: usual care Intensity: weekly group sessions and weekly individual sessions; "nurse case managers met with students weekly from October through May to teach and coach students on asthma knowledge and treatment techniques" Instructor: school‐based nurses Theoretical framework: not directly reported Parental engagement: difficulties reported; low levels of consent and high levels of attrition at post‐test survey Child satisfaction: not reported Timing of intervention: during school day; exact time unclear
Outcomes	Extractable outcomes were collected for: Exacerbations leading to hospital admission Asthma symptoms leading to emergency hospital visits Withdrawal Core processes outcomes evaluated (child level): attrition
Notes	Notes for outcome evaluation: only data for year 1 used, as year 2 data not collected through randomised study design Additional measures of process evaluation quality Process evaluation category: integrated Breadth and depth: breadth ‐ not depth Voice of children given prominence: not featured Funding source: Tennessee Department of Health
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information on method of randomisation was provided
Allocation concealment (selection bias)	High risk	Study author description suggests that allocation concealment was broken: "although schools were matched on demographic variables, a greater number of schools were randomised to intervention status than usual care because of staffing considerations and the school district's request for intervention in as many schools as possible"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Some measures were taken to ensure blinding of personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Clear that blinding was implemented for several outcomes based on study author's description of staff being blinded to students' experimental condition in dealing with abstracted medical data from computerised hospital records
Incomplete outcome data (attrition bias) All outcomes	High risk	Study authors reported a differential loss to follow‐up: "there was a 24% loss in follow‐up with intervention parents and a 44% dropout rate with usual care parents"
Selective reporting (reporting bias)	High risk	High risk, as study authors tended to report in passing or incompletely outcomes that were not significantly different
Other bias	Unclear risk	Missingness ‐ high risk ‐ evidence shows substantial missing data, as study authors described that "in the usual care parent group, only 72 of the possible 128 parents participated in the posttest surveys, and considerable data were missing". How this affected outcomes is unclear Baseline imbalance ‐ low risk ‐ no evidence shows a baseline imbalance in the characteristics of children Risk of contamination ‐ low ‐ randomisation took place by school, thereby lowering the risk of contamination
Transparent and clearly stated aims	Unclear risk	Medium bias ‐ aims were inferred
Explicit theories underpinning and/or literature review	High risk	No theory and not much literature were provided
Transparent and clearly stated methods and tools	Unclear risk	These data were not clearly reported by study authors
Selective reporting	High risk	Some outcomes were not fully reported (outcomes as opposed to processes)
Harmful effects	Low risk	Study authors did consider harmful effects and paid attention to harmful processes or implementation problems
Population and sample described well	Unclear risk	Medium bias ‐ some conflation between year 1 and year 2 populations is evident
Continuous evaluation	Unclear risk	Medium bias ‐ pre‐post for most of the process evaluation
Evaluation participation equity and sampling	High risk	No input from children or teachers and no satisfaction data were reported
Design and methods overall approach	Unclear risk	Data were collected at multiple time points and from different sources; but they were not very well reported
Tools and methods of data collection reliable/credible	Unclear risk	Lack of transparency surrounds some aspects, so it is difficult to categorise this risk of bias appropriately
Tools and methods of data analysis reliable/credible	High risk	Lack of disaggregated data and the bivariate nature of the data mean that this study is likely at high risk of bias
Performance bias/neutrality/credibility/conformability	Low risk	Study authors attempted to introduce rigour and provided a full outline of the caveats. Staff who were blinded to students' experimental condition abstracted medical data from computerised hospital records
Reliability of findings and recommendations	Low risk	How conclusions were reached based on the data is clear
Transferability of findings	Low risk	Study findings are transferable to the wider population
Overall risk of bias of process evaluation	Unclear risk	Bivariate nature of this study makes it have high risk of bias