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

McDowell 2015.

Study characteristics
Methods Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in Ireland
Duration: 26 weeks
Setting: specialist respiratory service
Participants Population: 110 adults recruited from a specialist respiratory service in Northern Ireland
Baseline characteristics: % Male: 41.8 RM and 45.5 UC, Mean age: 69.8 RM and 70.2 UC, % White: not reported, % African: not reported, % LTOT: 27.3 RM and 25.5 UC, % Home oxygen: not reported, % Anxiety or depression: RM: HADSA: 8.3 (5.2); HADSD: 6.8 (3.8) UC: HADSA: 7.9 (4.3); HADSD: 7.9 (3.9), Baseline medications: flu vaccine, FEV₁ (% mean): RM 45.5 and UC 43.4, FVC (% mean): RM 71.7 and UC 70.4, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 21 and UC 18, GOLD stage: II/III, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: RM: 0.82 (0.9) and UC: 1.05 (0.9)
Inclusion criteria: COPD diagnosis GOLD II or III, at least 2 of ED admissions, hospital admissions, or emergency GP contacts in last year before the study
Exclusion criteria: other respiratory disease, cognitively impaired/unable to learn about telemonitoring intervention
Interventions Run‐in: 5 consecutive days (mornings) of clinical and symptom observations reported by participant prior to study for trending
Treatment arms
  1. Telemonitoring intervention plus usual care

  2. Usual care

Outcomes Primary outcomes: health‐related quality of life: SGRQ‐C
Secondary outcomes: EQ‐5D, HADSA HADSD, health care utilisation, number of exacerbations, satisfaction, cost‐effectiveness
Notes Funding: European Centre for Connected Health
Other identifier: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer‐generated randomisation procedure was used to generate the sequence, which was prepared by a researcher who was not involved in the trial
Allocation concealment (selection bias) Low risk Randomisation sequence was concealed in sequentially numbered envelopes and was consecutively opened on receipt of informed consent from the patient
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel were not blinded to treatment
Blinding of outcome assessment (detection bias)
All outcomes High risk Primary outcome assessors were not blinded to treatment allocation
Incomplete outcome data (attrition bias)
All outcomes Low risk Similar rates of attrition in each group; however, more withdrawals from trial in the RM group than in the usual care group
Selective reporting (reporting bias) Unclear risk Unclear whether trial was registered; therefore, unclear if all outcomes were reported as planned
Other bias Low risk None