Ryan 2012.
Methods |
Study design: 6‐month parallel RCT Setting: 32 general practices in the UK |
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Participants |
Population: 288 participants were randomised to home telemonitoring (145) or to control (143) Baseline characteristics Mean age (SD): monitoring 46.6 (18); control 51.5 (17.7) % male: monitoring 33.8; control 41.3 Inclusion criteria: patients aged 12 and older who were registered with participating practices, had poorly controlled asthma (defined as score ≥ 1.5 on the ACQ) and had, or were willing to borrow, a compatible mobile phone handset and a contract with a compatible network Exclusion criteria: other lung disease, unable to communicate in English, receiving specialist care for severe/difficult asthma, general practitioner advised against inclusion for major social/clinical problems |
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Interventions |
Intervention: twice‐daily recording and mobile phone‐based transmission of symptoms, drug use and peak flow with immediate feedback prompting action according to an agreed plan Control: paper‐based monitoring. "To ensure that our trial specifically tested the impact of the technology, we opted to provide the paper group with the same clinical care as the intervention group, rather than using (probably less intensive) usual care as a comparator." Both groups also received a 30‐minute education session from the practice nurse before randomisation "The practices’ asthma nurse provided clinical care in accordance with the stepwise approach advocated by the BTS‐SIGN asthma guideline" |
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Outcomes | ACQ, KASE‐AQ, Mini‐AQLQ, costs, adverse events, asthma ED attendances, asthma hospitalisation, acute exacerbation, course of oral steroids, unscheduled healthcare attendances, withdrawal. Measures taken at 6 months after randomisation | |
Notes | Funding Asthma UK (project ID 07/047) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "All consenting participants were stratified by practice and centrally randomised (Health Services Research Unit, University of Aberdeen) to mobile phone or paper based monitoring with a 1:1 allocation with random block sizes of two or four" "All consenting participants were stratified by practice and centrally randomised (Health Services Research Unit, University of Aberdeen) to mobile phone or paper based monitoring with a 1:1 allocation with random block sizes of two or four" |
Allocation concealment (selection bias) | Low risk | "Telephone randomisation ensured concealment until the treatment was assigned" |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "The practice nurse informed the patient of allocation to ensure the researchers were blinded to allocation throughout data collection and analysis" Participants could not be blinded, 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 | Low risk | "Assessment of outcomes was blinded. A researcher blinded to allocation collected primary outcome data at the final trial visit; non‐attendees were sent the questionnaires by post" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Our main analysis was on an intention to treat (ITT) basis. We assumed that participants who did not attend the three or six month assessment had not improved their control and their previous results were therefore carried forward.30 A per protocol analysis was undertaken as a sensitivity analysis" |
Selective reporting (reporting bias) | Low risk | "All analyses were agreed a priori. We did not plan, or undertake, any interim analysis" Registered on clinicaltrials.gov |
Other bias | Low risk | None noted |