Sink 2020.

Study characteristics
Methods	Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in the United States Duration: 34 weeks Setting: primary care clinic
Participants	Population: 168 adults recruited from 2 hospitals in Missouri Baseline characteristics: % Male: 35 RM and 38 UC, Mean age: 59.8 RM and 61.9 UC, % White: 29 RM and 28 UC, % African: 66 RM and 65 UC, % LTOT: % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM 0.65 and UC 0.63, FVC (% mean): not reported, FEV₁/FVC (% mean): RM 0.64 and UC 0.61, Current smokers (n): RM 41 and UC 32, GOLD stage: mild (22%), moderate (54%), severe (17%) very severe (7%), COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: COPD diagnosis, > 18 years of age, consent to provide telephone number to receive text or voice messages, able to complete enrolment process, able to understand voice calls in English Exclusion criteria: intending to move away from clinic during the study period
Interventions	Measurements taken at baseline, daily or twice a week, and at end of study Treatment arms EpxCOPD system via automated telephone call or text Usual care
Outcomes	Primary outcomes: time to hospitalisation Secondary outcomes: engagement with Epharmix Telemed System
Notes	Funding: none Other identifier: NCT03002311
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation was performed using the Excel random number generator function in a 1:1 ratio. Randomisation was carried out by independent researchers. 17 participants in the control group were included without randomisation
Allocation concealment (selection bias)	Unclear risk	No further information provided
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	High risk	Although similar withdrawals, percentage of withdrawals was > 20% in each arm
Selective reporting (reporting bias)	Low risk	Trial was registered at the trials registry, but this publication seems to be just about COPD subgroups, so not all outcomes have been reported in the publication
Other bias	High risk	17 people were included in the trial, even though they were not assigned to 1 of the residents at the time of enrolment because these patients had been seen in previous years by resident physicians who had graduated at the time of the study. They were included in the control group without randomisation, so 68/85 were randomised in the control group. FEV₁/FVC was different between randomised and non‐randomised participants in the control group