Shany 2016.
| Study characteristics | ||
| Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in Sydney, Australia Duration: 52 weeks Setting: hospital‐based respiratory care |
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| Participants |
Population: 42 adults recruited from a hospital‐based respiratory Ambulatory Care Service‐Plus in the suburbs of Sydney Baseline characteristics: % Male: 48 RM and 43 UC, Mean age: 72.1 RM and 74.2 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: RM Anxiety: 7.8 ± 4.7 RM Depression 6.0 ± 3.0 and UC Anxiety: 6.2 ± 4.0 UC Depression 6.4 ± 4.5, Baseline medications: not reported, FEV₁ (% mean): RM 32.1 and UC 39.7, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): not reported, GOLD stage: severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: RM 3.0 ± 2.0 and UC 2.5 ± 0.9 Inclusion criteria: at least 1 hospital admission for COPD exacerbation in preceding year Exclusion criteria: not fluent in English, cognitive impairment, motor deficit, part of another trial, no land line connection at home |
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| Interventions | Measurements taken at baseline and at end of study Treatment arms
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| Outcomes |
Primary outcomes: ED visits, hospital admissions, hospital LOS Secondary outcomes: QOL measures, anxiety and depression, costs for hospital admissions |
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| Notes |
Funding: Department of State and Regional Development of NSW Government, TelemedCare, Australian Research Council, Sydney West Area Health Service, University of NSW Other identifier: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Study authors reported in their additional document that randomisation was performed according to a computerised randomisation programme in which participants were stratified according to how long they had been on the RACS‐plus programme |
| Allocation concealment (selection bias) | Unclear risk | Concealment of the allocation process was not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind patients or personnel because the intervention was delivered differently to each group |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding was reported in the study of outcome assessors. The only blinding that took place involved assessment of the duration of ED presentation and hospitalisation, and COPD categorisation. "The duration of ED presentation and hospital admissions as well as their categorisation as a result of COPD were blinded assessments of the Health Information Records Service in the hospital. This was compared to an independent, un‐blinded search of electronic patient records and discharge diagnoses in the electronic medical record" Comment: mixed |
| Incomplete outcome data (attrition bias) All outcomes | High risk | The percentage of attrition was higher in the intervention group (47%) than in the control group (14%) due to premature termination of the intervention. This occurred because participants were unwell, refused to consent to the intervention, or were in a nursing home |
| Selective reporting (reporting bias) | High risk | Registration of the trial was not found. Study authors reported to measure SGRQ and HADS, but results reported only at baseline, not at end of treatment |
| Other bias | Low risk | None |