Koff 2009.
Study characteristics | ||
Methods |
Study design: single‐centre, open‐label, parallel randomised controlled trial in the USA Duration: 13 weeks Setting: secondary care |
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Participants |
Population: 40 adults recruited from the University of Colorado Hospital Baseline characteristics: mean age 66 years, male: 48%, smoking history (pack‐years): 53, FEV1 (% predicted): 32, concomitant medications: oxygen therapy (38/40), COPD severity: severe to very severe, exacerbations in the last 12 months: NR, ethnicity: white (90%), black (8%), native American (3%), cognitive function: NR. Current PR: PIC (30%), UC (20%), prior PR: PIC (15%), UC (30%) Inclusion criteria: COPD diagnosis GOLD III/IV, telephone land line Exclusion criteria: treatment for lung cancer, not able to comprehend, non‐English speaker, not able to complete six‐minute walk test (6MWD) |
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Interventions | Measurements taken at baseline and at a 3‐month follow‐up Treatment arms:
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Outcomes |
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Notes |
Funding: University of Colorado Hospital Other identifiers: 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 not described |
Allocation concealment (selection bias) | High risk | Open‐label study |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study.The control group just got usual care, but the intervention group got additional telehealth, so expect more bias in intervention group. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study. Main SGRQ outcome was subjective self‐report outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar attrition in each arm, 5% |
Selective reporting (reporting bias) | High risk | Outcomes were reported as planned, but standard deviations were not provided for SGRQ so they were calculated, or for ED visits and hospitalisations. The number of people who had an exacerbation in the UC group was reported as unknown. Satisfaction outcome is not clear if it is mean or another format |
Other bias | Low risk | None identified |