Walders 2006.

Methods	STUDY DESIGN: Parallel group randomised controlled trial LOCATION, NUMBER OF CENTRES: 1 ‐ USA, Cleveland, Ohio DURATION OF STUDY: 12 months CONCEALMENT OF ALLOCATION: Not clear DESCRIBED AS RANDOMISED: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not stated/not clear TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Permuted block randomisation scheme according to age Outcome assessors blinded
Participants	N SCREENED: Not clear (327 eligible families asked to participate, 216 attended baseline visit) N RANDOMISED: 175 (89 intervention, 86 control) N COMPLETED: 83 of 89 in intervention group M = 126 F = 49 MEAN AGE: 7.3 BASELINE DETAILS: English speaking children, 4 to 12 years, physician diagnosed asthma > 3months INCLUSION CRITERIA: (1) 2 or more emergency department visits for asthma in the past year and/or (2) 1 or more asthma hospitalisations in the past year; and (3) the lack of an asthma treatment plan EXCLUSION CRITERIA: Under specialist care, near fatal asthma, co‐morbid conditions
Interventions	EDUCATION GROUP: WAP, PFM, spacer device, treatment group also 1‐hour education on asthma (pathophysiology, triggers, treatment). Intervention group visit 3 1 week later for problem‐solving session based on ARP (asthma risk profile), access to 24‐hour nurse run helpline Setting: Clinic CONTROL GROUP: WAP, PFM, spacer education in visit 2 TREATMENT PERIOD: Baseline visit ‐ info gathering, 2‐week run‐in period then visit 2 for education/PFM and spacer device training. 3 weeks in total for 3 visits. FOLLOW‐UP PERIOD: 12 months (telephone at 2, 4, 8, 10 months, clinic visit at 6 & 12 months)
Outcomes	Primary ‐ asthma symptom reports; secondary ‐ health care utilisation & QOL
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"Permuted block randomisation scheme according to age"'
Allocation concealment?	Unclear risk	Information not available
Incomplete outcome data addressed? All outcomes	Unclear risk	Described as intention‐to‐treat analysis; explicit description of how this population was defined is not provided