Skip to main content
. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

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
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
Interventions Run‐in: measurements were taken at baseline, 4 weeks, 25 weeks, 30 weeks, and 52 weeks
Treatment arms
  1. Telemonitoring intervention plus standard care

  2. Standard care

Outcomes Primary outcomes: SGRQ
Secondary outcomes: EQ‐5D, HADS, mortality, patient satisfaction
Notes Funding: EU grant
Other identifier: ISRCTN 41424840
Other: study was planned for 26 weeks, but usual care continued for 52 weeks
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