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 |
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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 |
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Interventions | Measurements made at baseline and 3 months Treatment arms
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Outcomes |
Primary outcomes: quality of life measured by SGRQ Secondary outcomes: healthcare costs, COPD exacerbations, equipment satisfaction |
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Notes |
Funding: University of Colorado Hospital Other identifier:NCT01044927 |
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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 |