Rasmussen 2005.
Methods | Randomised controlled trial with one intervention arm and 2 control arms | |
Participants | Patients: This study was set in Copenhagen, Denmark. In 2001, a random sample of subjects was sent a questionnaire to diagnose asthma. A power calculation was performed. Letters were posted until 300 adults aged 18 to 45 had been diagnosed with asthma on the basis of a combination of respiratory symptoms and at least one objective measurement (i.e. hyperresponsiveness to methacholine or peak expiratory flow variability) | |
Interventions | Intervention: This group were given electronic diary, an asthma action plan and a decision support system for the physician. Patients were given a Peak Flow Meter and taught how to fill in a daily diary and respond to the computer’s advice. Physicians gave instructions via e‐mail or telephone to the participant. Control 1. Specialist care: The specialists taught the patients how to adjust their medication on the basis of a peak flow meter and written action plan Control 2: GP: The GP group were asked to contact their GP and pass on a letter describing the study and giving the test results. GPs in Copenhagen had been sent a circular about asthma and GINA guidelines in the past. |
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Outcomes | Outcomes: 1. Quality of Life as assessed by AQLQ 2. Other questionnaire based outcomes: asthma self‐care, smoking, education, salary, sick leave and hospitalisations. Respiratory symptoms current medication, compliance and adverse reactions. 3. Lung function as carried out at baseline and 6 months and airway responsiveness with methacholine |
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Notes | The selection of participants was unusual as they came directly from the community and not from previous diagnosis by a physician or GP as in most other studies. This has the benefit of standardised diagnosis and avoids under‐diagnosis which may be a problem in the general population, however it may have implications when synthesising results from other studies. Participants in all 3 groups had to cover the costs of the medication prescribed, this may have been a problem for some patients and caused a bias. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | “Patients were randomised consecutively” |
Allocation concealment (selection bias) | Low risk | “sealed envelope technique” |
Blinding (performance bias and detection bias) All outcomes | High risk | Impossible to blind participants and no evidence of attempts to blind outcome assessors or data analysers |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of the 300 patients randomised, 253 patiens completed both the screening and follow‐up visits. |
Selective reporting (reporting bias) | High risk | Not all of the results from the questionnaires above are reported |
Other bias | High risk | See notes above |