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. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

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
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
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
  1. Integrated care intervention (comprehensive discharge assessment, education programme on self‐management, individualised action plan, ICT web‐based platform for nurse to access patient or carer and HCP during follow‐up)

  2. Usual care (usual hospital discharge protocol)

Outcomes Primary outcomes: re‐hospitalisation rate during follow‐up
Secondary outcomes: not reported
Notes Funding: CHRONIC project (IST‐1999/12158) from European Union
Other identifier: none
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