Liu 2011.
Methods |
Study design: 6‐month parallel RCT Setting: outpatient clinics of a teaching hospital in Taiwan |
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Participants |
Population: 120 participants were randomised to remote monitoring (60) or to control (60) Baseline characteristics Mean age (SD): monitoring 50.4 (12.9); control 54.0 (15.7) % male: monitoring 51.2; control 47.8 Inclusion criteria: participants with moderate to severe persistent asthma from outpatient clinics of Chang Gung Memorial Hospital Exclusion criteria: NR |
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Interventions |
Intervention: mobile telephone‐based interactive self care software: electronic diary provided to record participants' daily asthma symptom scores, use of relievers and lung function measures. Management advice was given via GPRS on the basis of uploaded data, in accordance with GINA guidelines. Participants and medical staff reviewed daily, weekly and monthly data on the website. Data were given to physicians to adjust their treatment plan when participants returned to their clinics Control: written asthma diary and action plan. All participants received asthma education, self management plan and standard treatment |
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Outcomes | Quality of life on the SF‐12, episodes of acute exacerbation and medications used for asthma control on return visit, FEV1, FVC, asthma symptom score; numbers of unscheduled clinic visits, emergency department visits and hospitalisations | |
Notes | Funding: NR | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but method used to generate the random sequence not described |
Allocation concealment (selection bias) | Unclear risk | No information regarding allocation concealment |
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 | It would have been possible to blind outcome assessors, but no information suggests this was done |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout was quite high and balanced between groups (28% and 23%). Outcomes are reported for the 43 and 46 participants completing the 6‐month follow‐up, not for the 60 and 60 randomised |
Selective reporting (reporting bias) | Low risk | No mention of trial registration. Outcomes stated in the methods were well reported |
Other bias | Low risk | None noted |