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

Koff 2009.

Study characteristics
Methods Study design: single‐centre, open‐label, parallel individual randomised controlled trial in the United States
Duration: 13 weeks
Setting: clinics in a university hospital
Participants Population: 40 adults recruited from COPD clinic and general pulmonary clinic at University of Colorado Hospital, in Aurora, Colorado
Baseline characteristics: % Male: 45 IC and 50 UC, Mean age: 66.6 IC and 65.0 UC, % White: 85 IC and 95 UC, % African: 10 IC and 5 UC, % LTOT: 95 IC and 95 UC, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: flu vaccine, FEV₁ (% mean): IC 33.6 and UC 31.1, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): IC 3 and UC 4, GOLD stage: III/IV, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: IC: 0.55 ± 0.21 and UC: 0.6 ± 0.21
Inclusion criteria: COPD GOLD stage III/IV, phone land line
Exclusion criteria: non‐literate, active treatment for lung cancer, not able to speak English, not able to complete a 6‐minute walk test
Interventions Measurements made at baseline and 3 months
Treatment arms
  1. Proactive integrated care including remote home monitoring using Health Buddy System

  2. Usual care

Outcomes Primary outcomes: quality of life measured by SGRQ
Secondary outcomes: healthcare costs, COPD exacerbations, equipment satisfaction
Notes Funding: University of Colorado Hospital
Other identifier:NCT01044927
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Trial was reported as randomised, but randomisation process was not described
Allocation concealment (selection bias) Low risk Participants chose a "blinded envelope that contained a group indicator"
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of participants or personnel not possible due to nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding of outcome assessors not possible due to nature of intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk Similar attrition in each arm; 5%; those who withdrew were accounted for
Selective reporting (reporting bias) Unclear risk Unclear whether outcomes were reported as planned. Could not find a protocol nor registration at trial website. Number of people who had an exacerbation in the UC group was reported as unknown
Other bias Low risk None