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. 2021 Apr 19;2021(4):CD013246. doi: 10.1002/14651858.CD013246.pub2

Chan 2016.

Study characteristics
Methods Study design: single‐centre, single‐blinded, parallel randomised controlled trial in Taiwan.
Duration: 13 weeks
Setting: secondary care
Participants Population: 71 adults recruited from National Taiwan University Hospital.
Baseline characteristics: mean age 72 years, male: 83%, current smokers (n): 9/71, FEV1 (% predicted): 59, concomitant medications: not reported
Inclusion criteria: diagnosis confirmed by pulmonary function FEV1/FVC <0.70, able to speak Mandarin or Taiwanese; body temperature <38, resting pulse 60‐100 beats per minute, resting respiratory rate <30 breaths per minute
Exclusion criteria: lack of lung function test data, impaired cognitive function, difficulties in communicating, acute/serious conditions that may affect study response (e.g. terminal cancer, major organ failure, TB)
Interventions Measurements were taken before intervention, immediately after intervention, and at 1 month and 3 months after discharge
Treatment arms:
  • Face‐to‐face PLB training (administered by research nurse)

  • Tablet computer used to teach PLB, respiratory re‐training skills and standard basic knowledge about COPD management

Outcomes
  • Impact on health behaviours (correct breathing technique)

  • Self‐efficacy (PRAISE)

  • Quality of life (CAT)

  • Patient satisfaction

  • Mortality

Notes Funding: Ministry of Science and Technology Department of Taiwan
Other identifiers: NCT01931267
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was achieved by a computer programme to generate a set of 6 random numbers
Allocation concealment (selection bias) Low risk Allocation was concealed in envelopes
Blinding of participants and personnel (performance bias)
All outcomes High risk Due to nature of the treatment, it would not be possible to blind participants or personnel
Blinding of outcome assessment (detection bias)
All outcomes High risk A research assistant who was the outcome assessor was blinded to group allocation. Hovever, for self‐reported scales (self‐efficacy and quality of life) this domain is likely to be high risk of bias because the participants are reporting their own outcomes
Incomplete outcome data (attrition bias)
All outcomes Low risk There was a similar rate of attrition in both treatment groups (22% in each group)
Selective reporting (reporting bias) Unclear risk The authors referred to NIH website for trial registration, but it was not easy to find on the website as the title was not the same as reported in the publication. The outcomes reported in the protocol are fewer than reported in the publication. Also, it was unclear for some outcomes when the time point for results were reported
Other bias Low risk None identified