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

Farmer 2017.

Study characteristics
Methods Study design: multi centre, open‐label, parallel randomised controlled trial in the UK
Duration: 52 weeks
Setting: secondary care, primary care, community services
Participants Population: 166 adults recruited from respiratory hospital outpatient clinics and primary care
Baseline characteristics: male: 62% IG and 61% CG, mean age: 69.8 IG and 69.8 CG, median number of COPD medication: 5 IG and 5 CG, FEV1 (% predicted): 47.4 IG and 50.1 CG, ex‐smoker: 79% IG and 76% CG, current smoker: 20.9% IG and 23.3% CG, severe or very severe COPD: 63% IG and 59% CG
Inclusion criteria: COPD diagnosis, FEV1 post bronchodilation < 80% and predicted FEV/FVC ratio < 0.70, smoking > 10 pack years, MRC dyspnoea >= 2, registered with a GP and had a COPD exacerbation in the last 12 months or referred to PR
Exclusion criteria: other significant lung disease, chronic heart failure, life expectancy < 3 months, cognitive impairment, no Internet‐enabled mobile phone network
Interventions Measurements were taken at baseline and 12 months follow‐up.
Treatment arms:
  • Internet‐linked, tablet computer‐based system of monitoring and self‐management support (EDGE)

  • Standard care included the same information as the intervention group, but were not given any equipment for monitoring symptoms

Outcomes
  • Quality of life (SGRQ, ED‐5D‐5L)

  • Hospital utilisation (people requiring admissions)

  • Anxiety and depression (SCL‐10)

  • Exacerbations

  • Adverse and severe adverse events

Notes Funding: Wellcome Trust and Department of Health
Other identifiers: ISRCTN40367841
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer programme (Sortiton V1.2) was used to randomise participants.
Allocation concealment (selection bias) Unclear risk It is unclear whether the allocation was concealed or not.
Blinding of participants and personnel (performance bias)
All outcomes High risk Neither the study investigators or patients were blinded.
Blinding of outcome assessment (detection bias)
All outcomes High risk Open‐label study
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition was similar in each treatment group, with 15.5% lost to follow‐up in the intervention arm and 14.3% lost to follow‐up from the control arm.
Selective reporting (reporting bias) Low risk Outcomes were reported as planned.
Other bias Low risk None detected.