| Methods |
DESIGN: Randomised controlled trial stratified according to peak flow ownership.
METHOD OF RANDOMISATION: Randomised ‐ stated. Method not described.
MEANS OF ALLOCATION CONCEALMENT‐ blinded.
OUTCOME ASSESSOR BLINDING ‐ not stated.
WITHDRAWAL/DROPOUTS ‐ all participants accounted for. |
| Participants |
Eligible: 116
Randomised: 58/58
Completed: 56/57
Age: Mean: 40 yrs Range: 19 to 63
Sex: Male / Female 46%/54%
Asthma Diagnosis: Doctors Diagnosis
Recruitment: volunteer community respondents
Diseases Included: Asthma ‐ moderate to severe
Major exclusions: Current smokers or quit in the past 3 months, previous asthma education programme.
Baseline:
FEV1: Intervention n = 56. 16% normal (> or = 80%), 77% mild/moderate (50 to 79%), 7% severe (< 50%). Control n = 57. 10% normal, 78% mild/mod, 12% severe.
PEF: Intervention n = 54. median 58.4, range 35.0 to 77.0. Control n = 26. median 48.3, range 37 to 75.
Exacerbations ‐ not stated. |
| Interventions |
Setting: Hospital Based community service asthma education programme
Type: Education, Self Monitoring of Peak Flow and External Regular Review. (diaries of medications and symptoms were kept by members of both groups for 4 week periods at 3, 6, 9 and 12 months. If control group members owned a PF, they recorded this also. All members of the intervention group recorded PF and were taught in its use and interpretation).
Duration: weekly 2.5 hour group education sessions over 4 weeks (total 10 hrs) |
| Outcomes |
Knowledge, Compliance, scheduled and unscheduled doctor and hospital visits, disrupted days (ie being confined to bed or a chair), Frequency of morning wheeze, nocturnal asthma symptoms, bronchodilator medications, pre‐bronchodilator FEV1/FVC, asthma symptoms diary, PEF. |
| Notes |
|
| 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) |
