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

Antoniades 2012.

Study characteristics
Methods Study design: single‐centre, single‐blinded, parallel individual randomised controlled trial in Australia
Duration: 52 weeks
Setting: tertiary care hospital
Participants Population: 44 adults recruited from a metropolitan tertiary care hospital
Baseline characteristics: % Male: 45 RM + SBP and 45 SBP, Mean age: 68 RM + SBP and 70 SBP, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM + SBP 0.91, SBP 0.66, FVC (% mean): RM + SBP 2.13, SBP 1.98, FEV₁/FVC (% mean): RM + SBP 39.9, SBP 32, Current smokers (n): SBP + RM 0/22 and SBP 6/22, GOLD stage: moderate to severe on COPD criteria, COPD exacerbations lasting 12 months: not reported, Hospitalisations in past 12 months: RM + SBP: 2 (1 to 4) and SBP: 1 (1 to 2)
Inclusion criteria: moderate to severe COPD diagnosed by COPD criteria, at least 1 hospitalisation in previous 12 months, fluent English, able to use keyboard and mouse, willing to use computer in self‐management, ambulant, living independently
Exclusion criteria: significant comorbidities including cancer, renal failure, and cognitive impairment
Interventions Run‐in: initial home training was provided to all participants by a nursing informatics project manager; measurements taken at baseline, 6 months, and 12 months
Treatment arms
  1. In‐home telemonitoring of daily measured physiological variables and recorded electronic diary of symptoms and medication usage via TeleMedCare System

  2. Standard best practice care following guidelines in Australia and New Zealand for clinical care, access to outreach nursing, written action plan, and access to pulmonary rehabilitation

Outcomes Primary outcomes: hospital admissions (COPD‐related or non‐COPD‐related), inpatient bed‐days, quality of life (SF‐36 form and CRDQ form completed at 6 and 12 months)
Secondary outcomes: 6‐minute walk distance (6MWD) measured at baseline and 12 months, adherence to daily monitoring, reproducibility of physiological measurements, patient acceptance of remote monitoring
Notes Funding: Department of Human Services; Victoria, Australia
Other identifier: ACTRN12611000112965
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Reported as randomised; designations were randomly generated and sequentially numbered, but it is unclear how the sequence was generated
Allocation concealment (selection bias) Low risk Patients were randomly allocated to either group, using a set of sequentially numbered, opaque, sealed envelopes containing randomly generated designations
Blinding of participants and personnel (performance bias)
All outcomes High risk Unable to blind patients and personnel due to nature of treatment
Blinding of outcome assessment (detection bias)
All outcomes High risk Assumed that outcome assessors were not blinded because study was open‐label
Incomplete outcome data (attrition bias)
All outcomes High risk 27% vs 9% withdrawals in TM group vs standard best practice group, respectively
Selective reporting (reporting bias) Low risk Outcomes reported as planned; trial registered in Australian registry website
Other bias Low risk None