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 |
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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 |
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Interventions |
Run‐in: 5 consecutive days (mornings) of clinical and symptom observations reported by participant prior to study for trending Treatment arms
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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 |
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Notes |
Funding: European Centre for Connected Health Other identifier: none |
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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 |