Casas 2006.
Study characteristics | ||
Methods |
Study design: multi‐centre, single‐blinded, parallel individual randomised controlled trial in Spain and Belgium Duration: 52 weeks Setting: tertiary care hospitals |
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Participants |
Population: 155 adults recruited from 2 tertiary hospitals, Hospital Clinic Barcelona and University Hospital Gathuisberg, UZ‐Leuven Baseline characteristics: % Male: 77 IC and 88 UC, Mean age: 70 IC and 72 UC, % White: not reported, % African: not reported, % LTOT: 25 IC and 23 UC, % Home oxygen: not reported, % Anxiety or depression: IC 8.5 and UC 8.2, Baseline medications: influenza and pneumococcal vaccination, FEV₁ (% mean): IC 43 and UC 41, FVC (% mean): IC 64 and UC 63, FEV₁/FVC (% mean): IC 48 and UC 48, Current smokers (n): IC 21 and UC 19, GOLD stage: not reported, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: IC: 1.0 ± 1.3 and UC 0.6 ± 1.2 Inclusion criteria: COPD patients discharged from hospital from previous episode of exacerbation requiring hospitalisation for > 48 hours Exclusion criteria: not living in healthcare area, severe comorbidity (lung cancer, extremely severe neurological/cardiovascular condition), admitted to nursing home, unable to participate because not literate or no phone access at home |
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Interventions |
Run‐in: during hospitalisation, 2 hours before discharge, participants received a 2‐hour comprehensive education on disease and disease management; at Barcelona only, participant received 1 visit 72 hours after discharge; in Leuven, general practitioners made regular planned home visits Treatment arms
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Outcomes |
Primary outcomes: re‐hospitalisation rate during follow‐up Secondary outcomes: not reported |
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Notes |
Funding: CHRONIC project (IST‐1999/12158) from European Union Other identifier: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was achieved by using computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Participants were blindly allocated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open study design; neither study investigators nor patients were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No further information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar percentage of withdrawals in each group: 74% intervention and 80% usual care patients at end of follow‐up; majority of dropouts due to death/palliative care |
Selective reporting (reporting bias) | Unclear risk | No registry information found; unclear whether outcomes reported as planned |
Other bias | Low risk | None |