Bolton 1991.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: North America, Two sites (urban and suburban emergency departments) DURATION OF STUDY: 12 months. COMPLIANCE: 41% participants randomised to intervention did not attend any of the educational classes. CONFOUNDERS: Slightly higher ER visits for asthma in control group in 6 months prior to study |
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Participants | N SCREENED: 537 N RANDOMISED: 241 N COMPLETED: 185/241 M = 122 (82/241)/F = 119 (159/241) MEAN AGE: 37 years BASELINE DETAILS: 13% of sample had been admitted at initial ED visit; Ethnicity: white: 34% (31%); ED visit at inner‐city site: 64%; < 13 years education: 57%; 13‐14 years of education: 32%; > 14 years of education: 11%. Insurance coverage: 93%. INCLUSION CRITERIA: 18‐70 years; Attendance at ED with acute asthma episode. EXCLUSION: Language/psychiatric barrier |
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Interventions |
Education group Invitation to attend three small group educational sessions with trained nurse. Participants were reminded of importance of compliance with maintenance therapy, importance of self‐care. Interactive dialogue with emphasis on problem‐solving skills was also undertaken. Education aimed to change behaviour and to teach them about their asthma. Participants received instruction in breathing exercises; practiced inhalation techniques, and received smoking cessation advice if necessary. Those who missed their class received educational material by post. Control group Usual follow up. FOLLOW‐UP PERIOD: 12 months. |
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Outcomes | Attendance at emergency department; cost; withdrawal. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Block randomisation (randomly chosen block size: 4, 6 or 8) stratified by site |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Study participants were aware as to group assignment. 'The follow‐up telephone interviewers were blinded to the patients' group memberships.' |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data reported for 224/241 participants at 12 months. 185 participants completed the study. |
Selective reporting (reporting bias) | Unclear risk | Could not determine this reliably |
Other bias | Low risk | No other sources of bias could be identified. |