Baren 2001.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: North America, single centre. DURATION OF STUDY: 8 weeks COMPLIANCE: Not assessed CONFOUNDERS: Even distribution between groups in terms of baseline lung function, age, sex and maintenance therapies. |
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Participants | N SCREENED: 197 N RANDOMISED: 192 N COMPLETED: 178 M = 64/F = 128 MEAN AGE: 31 BASELINE DETAILS: Ethnicity: Asian: 7; Black: 146; Hispanic: 3; White: 18; Insurance: Government/HMO: 40%; Government/military: 4%; HMO: 22%; Private: 22%; None: 13%. PEFR: 246 l/min; respiratory rate: 21.3; Inhaler use in previous 24 hrs (puffs): 4.7 INCLUSION CRITERIA: Aged between 16‐46 years; attendance at emergency department with symptoms of acute asthma EXCLUSION: Admission to hospital; unable to speak English; unwilling/unable to provide informed consent |
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Interventions | Education group: On discharge, participants were provided with a pack containing oral steroids, transportation vouchers to attend a primary care follow up; asthma information card; written instructions on use of vouchers and medication. Attempts made to contact all intervention group participants to remind them to attend a primary care follow up. Control group: Participants discharged with short course of oral steroids; further instructions and medication at discretion of discharging physician FOLLOW‐UP PERIOD: Participants were followed up for two months. |
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Outcomes | Scheduled attendance at primary care physician/clinic; relapse (re‐presentation at ED within 21 days of discharge); withdrawal/loss to follow‐up. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block randomisation schedule |
Allocation concealment (selection bias) | Low risk | Prepared by third party. 'Study packages were prepared and sealed by 2 investigators not involved in patient enrolment.' |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Study participants aware of treatment group assignment. Information on study outcome assessor blinding not available. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Differential loss to follow‐up. 11/93 in control group withdrew versus 3/94 in intervention group. |
Selective reporting (reporting bias) | Unclear risk | Could not determine this reliably |
Other bias | Low risk | No other sources of bias could be identified. |