Willems 2008.
Methods | Single‐centre, prospective, randomised controlled trial | |
Participants | Maastricht in the Netherlands, 56 children and 53 adults, 42% of the children and 50% of the adults were female. Mean ages: children,11: adults, 46 | |
Interventions | Intervention group used an asthma monitor with modem at home with an asthma nurse as the main caregiver, i.e. a telemonitoring kit based on peak‐flow measurements. There was a baseline visit to the asthma nurse when the patient received education about the telemonitoring protocol. Patients were asked to perform daily PEFR and more often in exacerbations. The nurse could increase and decrease asthma medication and involve a doctor if necessary. Control group received regular outpatient care: 3 to 6‐monthly medical check‐ups by their lung specialist or paediatrician |
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Outcomes | 1. Diary of clinical asthma symptoms (cough, sputum production, shortness of breath and wheezing) 2. Asthma‐related medical consumption (health care utilisation and self‐reported medication use) 3. Feasibility as assessed by ease of recruitment, and by the occurrence of technical and logistic problems 4. Spirometry data ‐ which could be stored and analysed after several weeks as the monitor had a sufficient memory 5. Quality of life: as assessed by questionnaires ‐ European Quality of Life‐5D, Short Form 36, Asthma Quality of Life Questionnaire, Paediatric Asthma Quality of Life Questionnaire and Health Related Quality of Life Measure for Children. If available, children received paediatric versions. 6. Patient satisfaction in the intervention group as assessed by a questionnaire based on the satisfaction questionnaire developed by Finkelstein et al 7. Cost effectiveness from the society perspective: cost in Euros per QALY gained |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomization took place on patient level after stratification by age (ages 7‐18 vs 18 years and older) as regular care differs between these age groups. The asthma nurse used a list of random numbers to allocate the patients to one of the two treatment arms" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants could not be blinded, the nurse practitioner was not blinded to the allocation of the participants as they received monthly transfers of the monitor data, and there was no evidence of outcome assessor blinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 109 patients were randomised, 5 were lost to follow up. There were technical problems and where data transfer was missed the nurse practitioner attempted to contact the patients by telephone however this was not possible in 21% of missed data transfers. At baseline there was 100% compliance with filling in the questionnaires, for subsequent measurements response rate was 85% to 92% for questionnaires and 81% to 90% for diaries. 28% of PEF data transfers from adults and 18% from children were missed |
Selective reporting (reporting bias) | Low risk | No apparent selective reporting |
Other bias | High risk | Smoking was not taken account of, neither was the sex imbalance among the children. The nurse practitioner could only be reached during working hours. |
ACQ = Asthma Control Questionnaire AQLQ = Asthma Quality of Life Questionnaire ATAQ = Asthma Therapy Assessment Questionnaire COPD = chronic obstructive pulmonary disease FEV1 = forced expiratory volume in 1 second MDI = metered dose inhaler PEF = peak expiratory flow PEFM = peak expiratory flow meter PEFR = peak expiratory flow rate SMS = Short Message Service (text) RAST = radioallergosorbent test