Lewis 2010.
Study characteristics | ||
Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in the United Kingdom Duration: 26 weeks Setting: general hospital |
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Participants |
Population: 40 adults recruited from a general hospital in Wales, UK Baseline characteristics: % Male: 50 RM and 50 UC, Mean age: 70 RM and 73 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: RM: HADSA: 5.6 ± 3.5, HADSD 6.3 ± 3.5 and UC: HADSA: 6.3 ± 3.5, HADSD 5.9 ± 2.8, Baseline medications: not reported, FEV₁ (% mean): RM 38 and UC 40, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 1 and UC 1, GOLD stage: moderate/severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: RM: 0 (0, 1.0) and UC: 0 (0, 0.8) Inclusion criteria: COPD (GOLD stage moderate/severe), completed 12 to 18 sessions of PR programme, maximal respiratory medication, standard telephone line installed at home, willing to have TM equipment installed at home, willing to provide consent Exclusion criteria: chronic asthma and ILD, went to < 12 sessions of PR programme, not living at home |
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Interventions |
Run‐in: measurements were taken at baseline, 4 weeks, 25 weeks, 30 weeks, and 52 weeks Treatment arms
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Outcomes |
Primary outcomes: SGRQ Secondary outcomes: EQ‐5D, HADS, mortality, patient satisfaction |
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Notes |
Funding: EU grant Other identifier: ISRCTN 41424840 Other: study was planned for 26 weeks, but usual care continued for 52 weeks |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer programme was used to generate random numbers into 2 groups |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes were used to conceal randomisation sequence |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It would not be possible to blind participants to the intervention. Clinical staff (hospital doctors and general practitioners) were not aware of telemonitoring allocation; however, it is unclear whether Chronic Disease Management Team was aware of allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3 withdrawals (including 2 deaths) occurred in the RM group (15%); unclear how many deaths/withdrawals occurred in SC group |
Selective reporting (reporting bias) | High risk | Data reported as medians and IQRs; means given for hospitalisations, but no SDs. Trial was registered |
Other bias | Low risk | None |