Kokubu 2000.
Methods |
Study design: 6‐month parallel RCT Setting: 17 tertiary care hospitals in Japan |
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Participants |
Population: 75 participants were randomised to home telemonitoring (37) or to control (38) Baseline characteristics Mean age (SD): monitoring 49.9 (15.6); control 47.3 (13.6) % male: monitoring 37.5; control 44.1 Participants had a mean duration of asthma of around 17 years, ICS mean dose of 1000 mcg/d and 6 ER visits in past year Inclusion criteria: patients with asthma who were treated with sufficient inhaled steroid therapy and were admitted to emergency department more than 3 times in past year Exclusion criteria: COPD, chronic heart failure |
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Interventions |
Intervention: telemedicine system to monitor airway status at home for participants with poorly controlled asthma, whereby a nurse provides instructions to individuals via telephone to help them manage exacerbation under the supervision of their physicians. Participants measured their PEF twice daily and sent this information to the nurse via the system. Participants inhaled the corticosteroid when PEF was ≥ 80%. When inhaled B2‐stimuli with the best PEF was between 60% and 80%, and when PEF did not recover up to 80%, participants were instructed to inhale an increased dosage of corticosteroids or to take oral corticosteroids. When the best PEF was < 60%, participants were instructed to visit their physicians Control: conventional asthma therapy including twice‐daily measurement of PEF, which was recorded in a diary and was not shared |
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Outcomes | Hospitalisation, night and daytime ED visits, compliance with PEF measurements and medications, PEFR, QoL | |
Notes | Funding: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but details of how the sequence was generated not described |
Allocation concealment (selection bias) | Low risk | Randomisation was done by telephone to the registration centre |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | It would not have been possible to hide allocation from participants and personnel, but it is unlikely that this would have introduced bias for objective outcomes (e.g. number of people having exacerbations) |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Subjective outcomes such as quality of life and symptom scales filled in by participants or personnel may have been subject to performance bias |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was open label (from translator), and no information suggests outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 people in the intervention group (13.5%) and 4 people in the control group (10.5%) did not complete the trial. These people were not included in the analyses, but dropout was fairly low and balanced, so was not thought to pose significant risk of bias |
Selective reporting (reporting bias) | High risk | Translator stated that some numerical data were underreported and were "not usable for meta‐analysis" |
Other bias | Low risk | None noted |