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. 2021 Apr 19;2021(4):CD013246. doi: 10.1002/14651858.CD013246.pub2

Koff 2009.

Study characteristics
Methods Study design: single‐centre, open‐label, parallel randomised controlled trial in the USA
Duration: 13 weeks
Setting: secondary care
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)
Interventions Measurements taken at baseline and at a 3‐month follow‐up
Treatment arms:
  • Integration of self‐management education with proactive remote disease monitoring

  • Usual care (continuation of treatment regimen prescribed by health provider)

Outcomes
  • Quality of life (SGRQ)

  • Hospitalisation utilisation (emergency department visits, hospitalisations)

  • Exacerbations

  • Equipment satisfaction

Notes Funding: University of Colorado Hospital
Other identifiers: 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 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