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

Splett 2006.

Methods Included as outcome evaluation and process evaluation
Study design: clustered parallel‐group design, randomised at the school level
Setting: K‐8 schools in Minneapolis, Minnesota, USA
Period: in 2000 and 2001, the HLAI was implemented in schools and was tested for effectiveness; in 2001 and 2002, the HLAI was expanded to all K‐8 schools
Participants Eligible sample frame: not reported; however 700 students with asthma were required in each group to detect a positive change in attendance
Randomised: 916 in intervention schools and 645 in control schools
Completed (intervention): not reported
Inclusion criteria: not reported
Exclusion criteria: not reported
Baseline characteristics
Age of children: not reported
Ethnicity: 66% were African American, 6% were Hispanic, 5% were American‐Indian, and 20% were white
Socio‐economic status: 73% of participants were eligible for free or reduced price lunches
Gender: males represented 58% of participants
Asthma status: not reported
Interventions Intervention: in participating schools, licensed school nurses, licensed practical nurses, and health service assistants received coaching and reinforcement by asthma resource nurses. Clinics also received training on NIH guidelines and guidance on implementing standards of care for asthma. Study authors reported: "staff followed 'Core Components of Asthma Management in the School Health Office' (Core Components), including case identification, nursing care procedures, care coordination, emergency care, and student education, to provide more systematic and consistent care to students with asthma and improve communication with school staff, parents, and health care providers", although further details of the student education component were not provided
Control: usual care
Intensity: not reported
Instructor: school nurse
Theoretical framework: not reported
Parental engagement: not reported
Child satisfaction: not reported
Timing of intervention in school day: not reported
Outcomes Extractable outcomes were collected for:
Absence from school
Unplanned visit to hospital or GP due to asthma symptoms
Core processes evaluated (child level): no information (other outcomes considered around sustainability)
Notes This study conducted an ecological analysis
Process evaluation category: stand‐alone, named section (2 papers)
Breadth and depth: neither broad nor deep
Voice of children given prominence: not featured
Funding source: Member Organisations of the Healthy Learners Board, Controlling Asthma in American Cities Grant
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study authors reported: "A random sequence of treatment codes, stratified by school system, was generated using the SAS System (Version 9.1, Cary, North Carolina) by the statistician"
Allocation concealment (selection bias) Low risk Centrally allocated: study authors reported: "A random sequence of treatment codes, stratified by school system, was generated using the SAS System (Version 9.1, Cary, North Carolina) by the statistician"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No measures were described as implemented around blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No measures were described as implemented around blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No direct reports describe attrition
Selective reporting (reporting bias) Low risk No evidence of selective reporting was found
Other bias Unclear risk Missingness ‐ low risk ‐ all those who were followed up submitted information
Baseline imbalance ‐ low risk ‐ no evidence of baseline imbalances between intervention and control groups
Risk of contamination ‐ high ‐ children were the unit of randomisation; potential was present for children with different treatment allocations to share materials/information, etc
Transparent and clearly stated aims Low risk Study aims were clearly stated
Explicit theories underpinning and/or literature review High risk No theoretical framework or supporting literature was provided
Transparent and clearly stated methods and tools Low risk Methods and tools were clearly stated
Selective reporting High risk A focus group is mentioned in the DuPlessis paper, but whether this occurred before or after or during the intervention is not clear. In addition, relevant results were not presented
Harmful effects High risk Very broad study; harmful effects were not directly considered
Population and sample described well High risk Some information is missing, including age of participants
Continuous evaluation Low risk Process evaluation data were apparently collected throughout
Evaluation participation equity and sampling High risk No information was collected from nurses
Design and methods overall approach Unclear risk Some core elements are missing
Tools and methods of data collection reliable/credible Low risk Based on administrative records ‐ straightforward constructs
Tools and methods of data analysis reliable/credible Unclear risk Lack of age data makes it difficult to interpret some outcomes, although the models include controls for age
Performance bias/neutrality/credibility/conformability Low risk As based on administrative records, little reason was provided to assign anything but low risk of bias
Reliability of findings and recommendations Unclear risk Reliability of findings was compromised by the K‐12 age group
Transferability of findings High risk Details are lacking, and standardisation introduced difficulties related to transferability ‐ particularly the wide age range
Overall risk of bias of process evaluation High risk Details around the ages of children and other key factors that could influence outcomes are lacking