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

Poureslami 2016.

Study characteristics
Methods Study design: single‐centre, single‐blinded, parallel randomised controlled trial in Canada.
Duration: 13 weeks
Setting: secondary care
Participants Population: 91 adults recruited from outpatient respiratory clinics in British Columbia
Baseline characteristics: mean age 67 years, male: 62%, current smokers (n): 40/91, > 50% had a FEV1 predicted between 30‐50%, concomitant medications: LAA (55/91), ICS (12/91), SABD (76/91), LABA (9/91), ICS + LABA (79/91), other medication (17/91), COPD severity: mild to very severe COPD, exacerbations in the last 12 months: NR, ethnicity: Mandarin or Cantonese but residing in Canada, cognitive function: NR
Inclusion criteria: diagnosis of COPD, mandarin/Cantonese speaking, immigrated to Canada in the past 15 years from China or Hong Kong
Exclusion criteria: self‐reported patients, age < 21 years, nursing home resident, unwilling to participate in study
Interventions Measurements taken at baseline, followed by single exposure to intervention, then a follow‐up at 3 months.
Treatment arms:
  • Clinician‐led video (clinical information about symptoms and self‐management strategies)

  • Peer‐led (lay) video (self‐management strategies and opinions)

  • Clinician‐led video and peer‐led (lay) video (information about symptoms and self‐management strategies)

  • Usual care (self‐management strategies delivered in a pamphlet)

Outcomes
  • Impact on health behaviours (inhaler technique, understanding of pulmonary rehabilitation, understanding steps to manage COPD)

  • Self‐efficacy (prepared to manage exacerbation, perception of being informed about COPD, remaining calm when facing a COPD worsening, ability to achieve goals in managing COPD, ability to self‐manage symptoms)

Notes Funding: Canadian Institutes of Health Research
Other identifiers: NCT01474707
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Reported as randomised, no further information about the process
Allocation concealment (selection bias) Unclear risk No further information
Blinding of participants and personnel (performance bias)
All outcomes High risk Reported as single blind (participant) on trial registry website but blinding is not mentioned in the publication. Personnel are likely to be aware of the intervention that they are delivering.
Blinding of outcome assessment (detection bias)
All outcomes High risk Data collectors and the data analyst were blinded throughout the study, however, for subjective outcomes such as self‐efficacy, this is going to be high risk of bias because it is a self‐reported outcome
Incomplete outcome data (attrition bias)
All outcomes Low risk No participants withdrew, or were lost to follow‐up
Selective reporting (reporting bias) Low risk All outcomes were reported as planned in the registered protocol
Other bias Low risk None identified