Levy 2000.
Methods | STUDY DESIGN: Parallel group trial. LOCATION, NUMBER OF CENTRES: UK, two outer‐London general hospitals. DURATION OF STUDY: 6 months. COMPLIANCE: 57% participants had three education sessions (either in person or by telephone); 63% had two sessions and 77% had one session. CONFOUNDERS: Comparable groups at baseline. " | |
Participants | N SCREENED: 865 N RANDOMISED: 211 N COMPLETED: 181 M = 80 F = 131 MEAN AGE: 42 BASELINE DETAILS: PEF 47% predicted (in ED). INCLUSION CRITERIA: Presentation at ED with acute asthma. EXCLUSION: Not reported. | |
Interventions | Education group: 1 hr consultation with specialist nurse two weeks post‐study entry, followed by an additional two consultations of 30 minutes at 6 weekly intervals. Asthma control was assessed, followed by some education on recognising and treating acute asthma. Control group: Usual care. FOLLOW‐UP PERIOD: 6 months. |
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Outcomes | Peak flow; quality of life (as measured by the St George Respiratory Questionnaire); symptom scores; asthma attacks. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated equal blocks of 4 from randomly generated number sequence. |
Allocation concealment (selection bias) | Low risk | 'The nurses had no idea which group the patients would be randomised into, however, once randomised they became aware in order to proceed and invite intervention group patients to attend.' |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants aware as to treatment group assignment. 'An interviewer, blinded to the patients randomisation status, conducted four structured telephone interviews using the St George's Respiratory Questionnaire and an assessment questionnaire...' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for. |
Selective reporting (reporting bias) | Unclear risk | Cannot ascertain this reliably. |
Other bias | Low risk | No other sources of bias could be identified. |