Pinnock 2013.

Study characteristics
Methods	Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in the United Kingdom Duration: 52 weeks Setting: primary care
Participants	Population: 256 adults randomised from 96 primary care practices Baseline characteristics: % Male: 41 RM and 49 UC, Mean age: 69.4 RM and 68.4 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: HADS: RM 9.8 (5.2) and UC 9.6 (4.6), Depression: RM 8.9 (4.4) and UC 8.2 (4.1), Baseline medications: not reported, FEV₁ (% mean): RM 44 and UC 40, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 37 and UC 30, GOLD stage: Mild/moderate: RM 46 and UC 42, Severe: RM 45 and UC 42, Very severe: RM 37 and UC 44, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: RM 2.3 (2.1) and UC 2.5 (2.6) Inclusion criteria: patient registered with GP practice in Lothian and admitted to 1 of 3 acute hospitals with a primary diagnosis of COPD exacerbation in the last 12 months Exclusion criteria: other significant lung disease, unable to consent, unable to use the intervention, other significant medical or social reasons at GP discretion
Interventions	Measurements taken at baseline and at 3, 6, 9, and 12 months Treatment arms Touchscreen telemonitor used to send secure data about COPD vitals and symptoms by remote server to UK health services Education on living with COPD and exacerbation management
Outcomes	Primary outcomes: time to first hospital admission with exacerbation of COPD Secondary outcomes: frequency of admissions, time to first hospitalisation due to COPD exacerbation, number of deaths, number and duration of admissions (all cause), number of exacerbations, SGRQ, HADS, self‐efficacy scale SECD6, number and duration of contacts with community services, LINQ, MARS
Notes	Funding: Chief Scientist Office, NHS Applied Research Programme Grant Other identifier: ISRCTN96634935
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised in a stratified approach according to clinical service providing COPD care, and were centrally randomised 1:1 via randomised blocks of 2 or 4. All eligible participants will be randomised by randomised blocks of varying size, stratified by the service that will providing clinical care (i.e. Edinburgh Respiratory Physiotherapy Service, Mid‐Lothian Chronic Disease Nursing Team) to control or intervention. This will be managed by the telephone randomisation service of the Edinburgh Clinical Trials Unit, which will generate the randomisation sequence
Allocation concealment (selection bias)	High risk	"It is not possible to blind clinicians or patients to allocation thus potentially introducing bias in subsequent care"
Blinding of participants and personnel (performance bias) All outcomes	High risk	"It is not possible to blind clinicians or patients to allocation thus potentially introducing bias in subsequent care"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Trial administrators entering data were blind to allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Similar numbers of participants in each group did not complete questionnaires at endpoint: 23/128 in RM group, 28/128 in control group
Selective reporting (reporting bias)	Low risk	Study authors reported outcomes as planned; their protocol was registered at ISRCTN Registry
Other bias	Low risk	None