| Methods |
DESIGN: Randomised Controlled Trial. Stratified by 11 physicians and 3 asthma severity levels. Blocked so that 2 out of 4 in a given stratum were assigned to intervention and control.
METHOD OF RANDOMISATION: Separate randomisation schedule for the 33 strata were prepared in advance. Method of randomisation not stated.
METHOD OF CONCEALMENT: closed envelope technique.
OUTCOME ASSESSOR BLINDING: not stated.
WITDHRAWAL/DROPOUTS: all subjects accounted for. |
| Participants |
Eligible: not stated
Randomised: 267 Intervention 132, Control 135
Completed: 225 Intervention 124, Control 101
Age: <20 yrs Int 1.6%, Cont 5.1%; 20‐39 yrs Int 27.4%, Cont 31.6%; 50‐59 yrs Int 37.1%, Cont 30.6 %; >/= 60 yrs Int 33.9%, Cont 32.7%.
Sex: Male / Female Intervention 39/61 Control 29/71.
Asthma Diagnosis: Doctor's diagnosis.
Recruitment: Regular Clinic Visits
Diseases Excluded: Another pulmonary or severely debilitation disease (e.g. CF, CA, severe rheumatoid arthritis.
Other exclusions: Under 18 years, refusal (5 %)
Baseline:
FEV1: not reported
PEF: not reported
Exacerbations: Intervention Mild 37.1%, Mod 47.6%, Severe 16.3%; Control Mild 38.6%, Moderate 44.6%, Severe 16.8%. |
| Interventions |
Setting: Outpatient clinic
Type: Education, peak flow self monitoring and regular review.
Duration: one hour, one to one session ‐ Subjects were provided information about attack management but not an individualised written action plan. |
| Outcomes |
Skills, Hospitalisations, ER visits, Days off work/school, Compliance, Severity of asthma symptoms, bothered by asthma symptoms, 5 or more days coughing or dyspnoea. |
| Notes |
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
