Velsor‐Friedrich 2005.

Methods	Included as outcome evaluation Study design: clustered parallel‐group design with schools selected as the unit of randomisation Setting: 4 inner city elementary schools in the USA Period: dates on which study was conducted ‐ intervention and subsequent data collection ‐ are not clear. Outcomes were collected from children immediately after they participated in the school‐based asthma intervention programme (2 weeks) and at 5 and 12 months
Participants	Eligible sample frame: 73 met inclusion criteria guidelines and were enrolled in the study Randomised: 73 pupils were randomised at the school level, although distribution between groups is unclear Completed (intervention): a total of 52 students were included in the final analysis: 28 students in the treatment group and 24 in the control group Inclusion criteria: children for whom a physician had diagnosed asthma, or who had demonstrated asthma‐related symptoms and frequent asthma‐related emergency department visits or hospital admissions Exclusion criteria: no additional exclusion criteria Baseline characteristics Age of children: mean age of children in the treatment group was 10.2 years; mean age of children in the control group was 9.9 years Ethnicity: all children were African American Socio‐economic status: unclear Gender: the sample of completers was evenly split in terms of sex: 26 females and 26 males Asthma status: children who received a diagnosis were 8 to 13 years old (mean age, 10 years of age)
Interventions	Intervention: 2‐part intervention First part consisted of Open Airways for School (OAS) as described by study authors: "the purposes of the Open Airways Program are to: (a) empower children with asthma by teaching them how to prevent asthma episodes and emergencies; and (b) to help schools control asthma by creating partnerships in asthma care with school personnel, school nurses, physicians, and families. The program consists of six 45‐minute sessions offered once per week in which small groups of children learn new asthma management skills. The session topics include: (a) basic information about asthma; (b) how to recognize and respond to asthma symptoms; (c) using asthma medication and deciding when to seek help; (d) how to keep physically active; (e) identifying and controlling triggers to minimize asthma symptoms; and (f) handling problems related to asthma and school. The curriculum incorporates an interactive teaching approach utilizing group discussion, stories, games, and role‐play to promote children's active involvement in the learning process" Second part of the intervention consisted of nurse practitioner visits, which consisted of the following: "5 monthly visits with the NP at the school‐based health clinic. These follow‐up visits were initiated after the students completed the asthma educational program. During the visits, the nurse assessed the student's asthma health, including auscultation of breath sounds, assessment of current medication use and availability, and history of symptoms, visits to the emergency department, and hospitalizations. Students were asked to demonstrate skills such as medication administration and peak flow meter techniques. The nurse included age‐appropriate asthma education information (from the Open Airways curriculum) as deemed necessary to reinforce and/or increase asthma knowledge" Control: wait‐list control; the control group received the intervention after evaluation Intensity: 6 group‐based lessons plus individual nurse practitioner session Instructor: principal Investigator for the first part, and nurse practitioner for the second part Theoretical framework: Orem's Self‐Care Deficit Theory of Nursing served as the guiding framework for this study Parental engagement: not reported Child satisfaction: not reported Timing of intervention in school day: unclear
Outcomes	Extractable outcomes were collected for: Emergency department visits Daytime and night‐time symptoms Lung function
Notes	Considered as a process evaluation, but study did not seek to address process evaluation/implementation research questions and did not include sufficient process data Funding source: National Institute of Nursing Research, Loyola University Research Award, Respironics Corporation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Unclear ‐ not described in the study: the 4 schools were randomly assigned to treatment or comparison groups
Allocation concealment (selection bias)	High risk	Not described in the study but potentially high, given the low number of randomised schools and study authors' description of study design
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not addressed by study authors
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not addressed by study authors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low risk posed by attrition ‐ only 3 students dropped out
Selective reporting (reporting bias)	Unclear risk	Unclear ‐ some data have high levels of variance
Other bias	Unclear risk	Missingness ‐ unclear risk ‐ not addressed by study authors Baseline imbalance ‐ low risk ‐ not described by study authors as problematic Risk of contamination ‐ low ‐ schools (low number) 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

AAP: Asthma Action Plan.

ACT: Asthma Control Test.

ASMA: Asthma Self‐Management for Adolescents.

BME: black and minority ethnicity.

CNS: clinical nurse specialist.

CST: Corticosteroids.

ED: emergency department.

GP: general practitioner.

HLAI: Health Learners Asthma Initiative.

HPM: Health Promotion Model.

HRQoL: health‐related quality of life.

ICAN: I Can Control Asthma and Nutrition Now.

ISACC: International Study of Asthma and Allergies in Childhood.

N/A: not applicable.

NAEPP: National Asthma Education and Prevention Program.

NHLBI: National Heart, Lung, and Blood Institute.

OAS: Open Airways for Schools.

PBP: Power Breathing Program.

PD/H/PE: personal development/health/physical education.

PI: principal investigator.

PPF: pre‐test/post‐test/follow‐up.

PRECEDE: Predisposing, Reinforcing, and Enabling Causes in Educational Diagnosis and Evaluation.

RAP: Roaring Adventures of Puff.

RCT: randomised controlled trial.

SCDT: self‐care deficit theory.

SES: socio‐economic status.

SHARP: Staying Healthy ‐ Asthma Responsible & Prepared.

Triple A: Adolescent Asthma Action.