Pedone 2013.
Study characteristics | ||
Methods |
Study design: single‐centre, open‐label, parallel block and stratified randomised controlled trial in Italy Duration: 39 weeks Setting: university pulmonary medicine outpatient clinic |
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Participants |
Population: 99 adults recruited from 1 university pulmonary medicine outpatient facility, in Rome, Italy Baseline characteristics: % Male: 72 RM and 63 UC, Mean age: 74.1 RM and 75.4 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM 52.5 and UC 55.4, FVC (% mean): RM 78.8 and UC 78.5, FEV₁/FVC (% mean): not reported, Current smokers (n): not reported, GOLD stage: II/III, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: COPD GOLD II and III Exclusion criteria: cognitive impairment preventing use of experimental intervention |
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Interventions | Measurements were taken at baseline and daily Treatment arms
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Outcomes |
Primary outcomes: number of exacerbations, number of hospitalisations Secondary outcomes: not reported |
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Notes |
Funding: Lazio Region through FILAS Other identifier: NCT01481506 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated number list was used to randomise participants |
Allocation concealment (selection bias) | Unclear risk | No further information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial was open‐label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was open‐label |
Incomplete outcome data (attrition bias) All outcomes | High risk | No participants in usual care group dropped out, whereas 11/50 in RM group did (22%) |
Selective reporting (reporting bias) | Low risk | Study authors reported outcomes as planned in trials registry, but SDs for length of stay were incomplete. Contacted study authors, who provided data for SDs. Trial was registered |
Other bias | Low risk | None |