Kessler 2018.

Study characteristics
Methods	Study design: a multi centre, open‐label randomised controlled trial in four European countries Duration: 52 weeks (follow‐up period originally set at two years but changed via a protocol amendment) Setting: secondary care
Participants	Population: 319 adults recruited from 33 centres across France, Germany, Italy, and Spain Baseline characteristics: mean age 66.9 years, male: 69.6%, 94.1% in GOLD III/IV, FEV1 (% predicted): 37.1 (12.4), FEV/FVC ratio: 44.7 (11.3), pack years: 52 (27), current smokers: 21.3% Inclusion criteria: at least 35 years old, FEV1/FVC ratio <= 70%, FEV1 50% of predicted value, smoking history of at least 10 pack‐years, at least one serious exacerbation in the last year Exclusion criteria: survival expectation < 6 months, unable to speak or read local language, cognitive/psychiatric disease, continuous treatment of >10 mg prednisolone per day or equivalent for more than 6 weeks, living in a nursing home
Interventions	Measurements were taken at baseline and 12 months: Treatment arms: Multi‐component home‐based COPD disease management Usual care (COPD education, care, and follow‐up as per investigational centre routine practice)
Outcomes	Healthcare utilisation (number of unplanned all‐cause hospitalisation days, number of unplanned all‐cause hospitalisation in acute care wards for COPD exacerbations) Exacerbations Physical activity (6MWD) BODE index and its separate components Anxiety and depression (HADS) Quality of life (SGRQ) Adverse and serious adverse events Mortality
Notes	Funding: Air Liquide Healthcare Other identifiers: COMET, 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 supervised by the study sponsor.
Allocation concealment (selection bias)	Unclear risk	No further information provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study, neither study investigators nor patients were blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study neither study investigators nor patients were blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition in the intervention arm was 12.7% (20/157), while it was 21% (34/162) in the control arm.
Selective reporting (reporting bias)	Low risk	The outcomes were reported according to the protocol.
Other bias	Low risk	None found.