Bruzzese 2006.

Methods	Cluster randomized controlled trial with 12 and 24 month follow‐up. Schools and families enrolled in May 1998 (wave 1) and September 1999 (wave 2). Collaborating partners Lead agency: Local Education Authority Strategic involvement (policy making and service planning): Primary health care, health promotion, Local Education Authority Commissioning (implementing strategy taking account of resources available): Local Education Authority Operational (providing services directly): Primary health care, health promotion, Local Education Authority Set in United States of America.
Participants	591 students in kindergarten to grade 5 (307 in intervention schools, 284 in control schools), mean age at baseline 7.8 years, and their caregivers, from 44 schools (out of 650 schools meeting eligibility criteria of >50% of students receiving free lunch and >67% being ethnic minorities) from all 5 boroughs of New York City. Males 57.8% (intervention), 59.4% (controls). Eligible families (those with a child diagnosed with asthma and symptoms of persistent asthma) were enrolled through telephone call. Identified from case‐detection forms, returned to school by approximately 27%  of all caregivers. Schools were paired by size and borough and randomly assigned in each pair to either intervention or control school.  Families were enrolled in 2 waves and data collection lasted 2 years for each wave. Wave 1 data collection started for 24 schools in May 1998 and wave 2 in 20 schools began September 1999.
Interventions	Preventive care networks for each intervention school were established between school staff, health professionals and families of students with asthma. Each school health team included a full time school nurse, school physician 2 days per month, public health assistant 2‐3 days per week, schoolteacher or administrator, and a parent. Columbia University staff led a three day training workshop for the school health teams and an additional single training session was run for teachers on asthma and their role in helping children manage asthma in school. Workshops on preventative therapy, communication, patient education strategies and medication plans were run for children?s primary care providers (PCPs) using PACE (Physician Asthma Care Education) programme. School nurses and physicians worked with families to assess children's asthma severity and healthcare needs. They sent sample treatment plans to the students' PCPs based on each student's asthma severity and encouraged caregivers and PCPs to develop asthma management plans in line with National Heart, Lung and Blood Institute criteria. School health team nurses conveyed instructions from the management plans to teachers and also arranged referral for medical care if needed. They delivered this intervention in full for 2 years and continued to give ad hoc support for a further year.
Outcomes	Outcomes were measured at 12 month (n= 472) and 24 month (n=368) follow‐up. Primary outcomes Asthma symptoms (number of days with symptoms in past 2 weeks and past 6 months, number of nights woken in past 2 weeks and past 6 months). Limitations due to asthma (number of days restricted activity in past 2 weeks and past 6 months), number of days absent from school as reported by parents in past 2 weeks. School absences for all reasons measured using school records Paediatric Asthma Caregiver's Quality of Life (PACQLQ). Secondary outcomes Health care utilization (number of urgent visits to clinician in past 12 months, number of Emergency Department visits in past 12 months, number of hospitalisations in past 12 months).
Notes	No power calculation was reported. Only 25% of PCPs completed PACE training and only 10% returned treatment plans to school and these were often inconsistent with NHBLI treatment guidelines. Substantial support will be needed to replicate intervention. Overall risk of bias was high.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	No description of allocation method.
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding but outcome was judged to not be influenced. Pg 309
Incomplete outcome data (attrition bias) All outcomes	High risk	Data only provided for 368/591 participants (62%) at 24 months.
Selective reporting (reporting bias)	Unclear risk	No protocol available to compare intended with reported outcome measures.
Other bias	Unclear risk	Unclear how participants were selected.
Randomisation adequately described/protected?	Unclear risk	No description of randomisation method. Pages 307 and 308
Protection against contamination?	High risk	Unrelated to this study, New York City Department Of Health and Mental Hygiene provided Open Airways for Schools (OAS)  programme for 3rd‐5th grade students with asthma, including those in control group. Approximately half the sample met the age criteria to receive OAS and intervention and control group participation levels were comparable.
Follow‐up rate adequate?	Low risk	Rate >60% and balanced across both arms.
Reliable primary outcome measure?	Low risk	After 6 months, intervention group had significantly fewer asthma symptoms but after 2 years, only difference was fewer hospitalisations in past 12 months.
Groups measured at baseline?	Low risk	Groups approximately balanced
Appropriate choice of controls (CBA studies only)?	Unclear risk	Not applicable
Contemporaneous data collection (CBA studies only)?	Unclear risk	Not applicable
IS THE STUDY AT LOW RISK OF BIAS?	High risk	OVERALL RISK OF BIAS WAS HIGH