| Methods |
DESIGN: Randomised Trial of Two Interventions
METHOD OF RANDOMISATION: Random numbers after stratification for age, gender, and number already in each group.
MEANS OF ALLOCATION CONCEALMENT‐ not stated.
OUTCOME ASSESSOR BLINDING ‐ not stated.
WITHDRAWAL/DROPOUTS ‐ all subjects accounted for. |
| Participants |
Eligible: 380
Randomised: 172
Completed: 134 (Intervention 73, Control 61)
Age: mean: PFM 37.3 yrs , Symptoms 35.5 yrs
Range: eligible range 16 to 70 yrs
Sex: PFM: Male / Female ‐ 40%/60%
Symptoms 38%/62%
Asthma Diagnosis: ATS
Recruitment: Inpatients & outpatients
Diseases Included:
Major exclusions: Previous life threatening asthma, previous or current action plan, pregnancy, poor perception of bronchoconstriction(histamine challenge), baseline FEV1 <1.5L
Baseline:
FEV1:
PEF: mean(SD) % predicted PFM: 75.8(18), Symptoms 75.6(18)
Exacerbations: |
| Interventions |
Setting: Inpatients & outpatients
Type: Two optimal self management interventions:
(1) education in use of written action plans, monthly telephone contact for reinforcement and data collection and ongoing education, self monitoring of PEF. Seen by specialist on entry to study and commenced on inhaled corticosteroids
(2) same as intervention 1 but symptom self monitoring
Duration: Initial intervention duration not stated. Monthly telephone call for 12 months. months |
| Outcomes |
Hospitalisation, ER visits, FEV1, days off work or school, PD20 histamine, severity self‐rating. |
| Notes |
Jadad Score: 5 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
