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. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

Walker 2018.

Study characteristics
Methods Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in Spain, United Kingdom, Slovenia, Estonia, and Sweden
Duration: 39 weeks
Setting: clinics, hospitals, and community health services
Participants Population: 312 adults recruited from 6 sites in 5 countries (United Kingdom 75, Sweden 63, Estonia 80, Spain 61, Slovenia 33)
Baseline characteristics: % Male: 66 RM and 65 UC, Mean age: 71 RM and 71 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: Mean depression PHQ‐9 score RM 6.27 (5.69) and UC 5.97 (5.79), Baseline medications: not reported, FEV₁ (% mean): RM 49.4 and UC 50.4, FVC (% mean): RM 73.8 and UC 75.8, FEV₁/FVC (% mean): RM 0.53 and UC 0.53, Current smokers (n): not reported, GOLD stage: RM: I (3%), II (47%), III (36%), IV (15%) and UC: I (2%), II (48%), III (39%), IV (11%), COPD exacerbations last 12 months: 1 exacerbation: RM 63 (41%) and UC 59 (37%); More than 1 exacerbation: RM 91 (59%) and UC 99 (63%), Hospitalisations in past 12 months: RM 64 (42%) and UC 65 (41%)
Inclusion criteria: GOLD grade II or higher, exacerbations or hospitalisation or both in the last year, comorbidities such as CHF, SDB, smoking pack‐years > 10 years, able to provide written consent, able to use TM equipment at home, reliable mobile phone coverage at home, > 60 years
Exclusion criteria: any condition likely to put patient at risk, significant visual or mental condition, planned long‐time absence from home
Interventions Measurements taken at baseline, every 2 months (CAT, PHQ‐9, MLHFQ), every 3 months (EQ‐5D, exacerbations, medication use, use of GP), and at end of study
Treatment arms
  1. CHROMED remote monitoring platform

  2. Control group

Outcomes Primary outcomes: time to first hospitalisation, quality of life (change in EQ‐5D utility index score)
Secondary outcomes: moderate exacerbation rate, hospitalisation, CAT, PHQ‐9, MLHFQ questionnaires, cost utility analysis
Notes Funding: European commission grant
Other identifier: NCT01960907
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Concealed computer‐generated randomisation with 4‐element block design stratified by centre was used
Allocation concealment (selection bias) Unclear risk Randomisation sequence was concealed, but it is unclear how allocation was concealed
Blinding of participants and personnel (performance bias)
All outcomes High risk Trial was open‐label
Blinding of outcome assessment (detection bias)
All outcomes High risk Trial was open‐label
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition was similar in TM (29%) and control groups (22%)
Selective reporting (reporting bias) Low risk Outcomes were reported as planned. Study authors were contacted about time to first hospitalisation to see if they could provide HR and 95% CI, which they provided on request. Trial was registered at clnicaltrials.gov
Other bias Low risk None