Wilson 2001.
Methods | STUDY DESIGN: Parallel design, controlled trial
LOCATION, NUMBER OF CENTRES: 1 ‐ USA Valley Children's Hospital, California
DURATION OF STUDY: 12 months No blinding of outcomes from assessors |
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Participants | N SCREENED: 867 families contacted N RANDOMISED: 87 (44 intervention, 43 control) N COMPLETED: 60 (intervention: 32 of 44 attended all 3 sessions, 2 x 2 sessions, 5 x 1 session, 5 x 0 sessions) M = 44 F = 43 MEAN AGE: 7.2 intervention, 7.5 control BASELINE DETAILS: family demographics, asthma hx, current symptoms, activity limitations, environmental triggers, medications, detailed smoking hx (what, how much, degree of exposure, limitations to smoking around the child) INCLUSION CRITERIA: 3 to 12 years, seen for urgent asthma visit in ED/urgent clinic (PedsPlus) and/or hospital in past 12 months, Medicaid eligible, exposed to ETS, spoke English/Spanish EXCLUSION: Not stated | |
Interventions | EDUCATION GROUP: Counselling to parents in home where children were exposed to environmental tobacco smoke. 3 behaviourally based education sessions on effects of smoking on asthma & strategies to quit/reduce ETS exposure. Examination/asthma hx & PFT review by pulmonologist. Medications altered to reach national guidelines. Urine cotinine at baseline & 12 months. Pre & post‐bronchodilator PFT at baseline & 12 months. Setting: Clinic CONTROL GROUP: Examination/asthma hx & PFT review by pulmonologist. Medications altered to reach national guidelines. Urine cotinine at baseline & 12 months. Pre & post‐bronchodilator PFT at baseline & 12 months. Basic verbal information about asthma. TRETAMENT PERIOD: 5 weeks (3 sessions) FOLLOW‐UP PERIOD: 12 months |
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Outcomes | Emergency/urgent health care utilisation for asthma, ETS exposure by CCR (urine cotinine/creatinine ratio) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomisation in blocks of 4 |
Allocation concealment? | Unclear risk | Information not available |
Incomplete outcome data addressed? All outcomes | Low risk | All participants passively observed through their medical records for hospital contact outcomes |
In all studies numbers refer to intervention and control groups, respectively; ARP = asthma risk profile; ATS ‐ American Thoracic Society; ED ‐ Emergency Department; ETS: Envinronmental tobacco smoke; GP ‐ General Practitioner; HMO ‐ Health Maintenance Organisation; hx = history; ITT = intention‐to‐treat; PEF ‐ Peak Expiratory Flow; PCP = primary care provider; QOL = quality of life; RCT ‐ Randomised Controlled Trial; SD ‐ Standard Deviation; SE ‐ Standard Error