Jones 1995.
Methods | DESIGN: Randomised Controlled Trial. Stratified by centre in blocks of six. METHOD OF RANDOMISATION: the word "random" stated ; method not described. METHOD OF ALLOCATION CONCEALMENT: not described. OUTCOME ASSESSOR BLINDING: not clear ‐ "data rendered anonymous" before analysis. WITHDRAWAL/DROPOUTS: not described. | |
Participants | Eligible: not stated Randomised: 127 Completed: 72 (Intervention self management 33; planned visits 39) Age: self managed : mean 30.4 yrs SD 11.5 yrs planned visits: mean 28.6 SD 7 yrs. Sex: Male / Female Self managed 14/19 planned visits 12/26. Asthma Diagnosis: Doctor's diagnosis Recruitment: General practices Diseases Included: Not specified Major exclusions: Those on regular oral steroids and those who were regularly conducting home PEF monitoring. Baseline: FEV1: % predicted: self management 85.1 (SD 20.8), planned visits 80.2 (SD19.9) PEF: % predicted: self management 88.2 (SD 15.4), planned visits 86.8 (SD 13.7) Exacerbations | |
Interventions | Setting: General Practice Type: Optimal self management: education, peak flow self monitoring, regular review and an individualised written action plan based on peak flow enabling self adjustment of medications in the event of worsening asthma. Control: regular review and kept a daily diary for morbidity and bronchodilator use for outcomes. Duration: 5 study visits (duration not stated) over a 26 week period | |
Outcomes | Lung Function ‐ % predicted, Use of rescue medication, quality of life, days off work, wheeze (frequency, severity), nocturnal asthma, oral corticosteroid use, cough, shortness of breath, disrupted days. | |
Notes | Jadad Score = 4 Oral corticosteroids was given for 2 weeks to optimise lung function in both groups during baseline. Drop outs were more likely to be younger and male with lower initial FVC values then the completers. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | Information not available |