Soriano 2018.

Study characteristics
Methods	Study design: multi‐centre, open‐label, parallel block randomised controlled trial in Spain Duration: 52 weeks Setting: hospitals and primary care centres
Participants	Population: 229 adults recruited from 5 Madrid hospitals Baseline characteristics: % Male: 78.3 RM and 82.5 UC, Mean age: 71.5 RM and 71.3 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: 100 RM and 100 UC, % Anxiety or depression: RM Goldberg anxiety 1.5 ± 2.3 and Goldberg depression 2.5 ± 2.4 and UC Goldberg anxiety 1.8 ± 2.5 and Goldberg depression 2.9 ± 2.5, Baseline medication: LABA (98%), LAMA (98%), ICS (94%), SAA (57%), PDE4 inhibitor (16%), theophylline (14%), oral steroid (4%), b2‐adrenergic receptor agonists (5%), FEV₁ (% mean): RM 34.2 and UC 32.2, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): not reported, GOLD stage: stable and severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: RM 2.0 ± 1.3 and UC 2.0 ± 1.2 Inclusion criteria: 50 to 90 years of age, COPD diagnosis (GesEPOC criteria), FEV₁ < 50%, 2+ moderate/severe exacerbations per year, clinically stable, home O₂ therapy, signed informed consent Exclusion criteria: unable to understand TM programme, < 12 months' life expectancy, terminal heart failure, advanced renal insufficiency/dialysis, residential hospice or institutionalised, MM test score < 24 (dementia), recommended as not complying with treatment/monitoring required by lung disease, failure to complete inclusion criteria
Interventions	Run‐in: initial home visit to install equipment and train patient or caregiver and 4 days of physiological measurements Treatment arms Telemonitoring intervention Routine clinical practice
Outcomes	Primary outcomes: severe exacerbations resulting in emergency department visit or hospitalisation Secondary outcomes: quality of life, costs, patient/clinician satisfaction
Notes	Funding: Fundación Teófilo Hernando, Universidad Autónoma de Madrid, with support of Linde Healthcare Other identifier: NCT02499068
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Reported as randomised (block randomisation), no further information, contacted study author
Allocation concealment (selection bias)	High risk	Open‐label study
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Similar attrition in both groups, with 28/115 in TM group and 32/114 in RCP group
Selective reporting (reporting bias)	Low risk	Outcomes were reported as planned; trial was registered at clinicaltrials.gov
Other bias	Low risk	None