Bourbeau 2016.

Study characteristics
Methods	Study design: multi‐centre, open‐blinded, parallel individual randomised controlled trial in France, Germany, Italy, and Spain Duration: 52 weeks Setting: 33 investigative centres: 12 in France, 8 in Germany, 6 in Italy, 7 in Spain
Participants	Population: 319 adults recruited from 33 investigative centres in 4 countries (12 centres in France, 8 in Germany, 6 in Italy, 7 in Spain) Baseline characteristics: % Male: 69.4 TH and 69.8 UC, Mean age: 67.3 TH and 66.6 UC, % White: not reported, % African: not reported, % LTOT: 75.8 TH and 72.8 UC, % Home oxygen: not reported, % Anxiety or depression: TH: moderate to severe anxiety 22.8 and moderate to severe depression 77.8, UC: moderate to severe anxiety 30.5 and moderate to severe depression 79.3, Baseline medications: long‐acting anticholinergics, long‐acting beta2‐agonist, long‐acting inhaled corticosteroids, FEV₁ (% mean): TH 37.8 and UC 36.4, FVC (% mean): not reported, FEV₁/FVC (% mean): TH 45.7 and UC 43.7, Current smokers (n): TH 34 and UC 34, GOLD stage III/IV, COPD exacerbations last 12 months: TH: 1.3 ± 0.7 and UC: 1.3 ± 0.8, Hospitalisation in past 12 months: TH: 20 (12.7) and UC: 19 (11.7) Inclusion criteria: COPD patients aged ≥ 35 years with post‐bronchodilator FEV₁/FVC ratio ≤ 70%; FEV₁ < 50% of predicted value; ≥ 10 pack‐year smoking history; at least 1 severe exacerbation in previous year Exclusion criteria: not expected to survive longer than 6 months; unable to read or speak the country language or having cognitive/psychiatric disease; on continuous treatment of > 10 mg per day prednisone or equivalent for longer than 6 weeks; living in a nursing home
Interventions	Run‐in: each patient received multi‐component home‐based disease management or usual management care training and education, and was assessed for respiratory and global health status during a 3‐ to 5‐week run‐in period Treatment arms Home‐based management ("Living Well with COPD" plus TM/e‐health) Routine COPD management
Outcomes	Primary outcomes: number of unscheduled all‐cause hospitalisation days, normalised to 1 year of follow‐up Secondary outcomes: number of COPD exacerbations (mild, moderate, or severe to require hospitalisation and/or death), 6‐minute walk distance (6MWD), BODE, anxiety and depression (HADS), health status using SGRQ‐C
Notes	Funding: Air Liquide Healthcare Other identifier: NCT01241526
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A pre‐specified randomised list was generated prior to the study by a partial minimisation computer algorithm. Participants were randomised via a dedicated interactive voice response system
Allocation concealment (selection bias)	Unclear risk	No further information provided
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	High risk	Open study design; neither study investigators nor outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	20/157 participants in intervention arm did not complete the study, with 34/162 participants in UC arm; 23/34 of this group resulted in deaths compared to 3/157 deaths in intervention arm. Overall attrition in total randomised group was 15%
Selective reporting (reporting bias)	Low risk	Outcomes were reported according to protocol
Other bias	Low risk	None