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. 2023 Nov 14;2023(11):CD013303. doi: 10.1002/14651858.CD013303.pub2

Poureslami 2016b.

Study characteristics
Methods Study design: RCT, 4 arms
Geographic location: Vancouver, Canada
Ethical approval: yes
Recruitment setting: outpatient respiratory clinics
Method of recruitment: collaborating physicians identified and referred potential candidates, bilingual facilitators contacted candidates
Length of follow‐up: 3 months*
Dropouts: no dropouts
A priori calculation of effect size/power?: yes
*Inconsistencies between text and figure 1; according to figure 1 follow‐ups should have been conducted at 3, 6 and 9 months after intervention. Quote: "All outcomes were measured at baseline, then at 4 weeks and 3 months after intervention (...) Data were collected over a 4‐month period through 3 in‐person assessments. The baseline assessment preceded the intervention; the post‐intervention assessment occurred immediately following the intervention (4 weeks after baseline); a follow‐up assessment occurred 3 months following intervention."
Participants Description: Chinese immigrants with chronic obstructive pulmonary disease (COPD)
Health topic
  • All participants had diagnosed COPD by spirometry


Inclusion criteria
  • Confirmed COPD diagnosis by spirometry, being symptomatic, an immigrant to Canada within past 20 years, residing in Vancouver, speaking Mandarin or Cantonese


Exclusion criteria
  • Self‐reported patients, persons < 21 years old, persons who live in a nursing home, unwilling to participate in the study


Intervention groups
  • Group 1: clinical knowledge video (22 randomised and analysed)

  • Group 2: narrative, community video (26 randomised and analysed)

  • Group 3: clinical and community video (29 randomised and analysed)

  • Group 4: pictorial pamphlet (14 randomised and analysed)


Note: according to figure 1, 29 participants watched the clinical video (vs 22 according to the text and to table 1) and 22 participants watched both videos (vs 29 according to text and to table 1). We used the numbers displayed in the text and in table 1, assuming that the numbers displayed in figure 1 might be wrong.
PROGRESS‐Plus
Place of residence: urban, Canada
Time living in host country: participants had immigrated to Canada within the past 12 years
Race/ethnicity: Chinese
Gender:
  • 21.9% female (applies to the entire study population)


Note: not reported per arm
Education: 46.2% low education, 53.8% high education
Age (years), median; distribution: 75; 40.7% ≤ 75, 59.3% > 75
Health literacy (baseline)
Not measured
Interventions Theoretical framework: theories of health literacy
Comparison 1: audio‐/visual education without personal feedback versus written information on the same topic
Intervention: clinical, knowledge video, narrative community video or both (groups 1, 2 and 3)*
Description: participants watched either a physician‐led, knowledge video (group 1), a narrative, community video (group 2) related to COPD management. The researchers used the same content to develop the lay videos and the clinical videos in the 2 languages. In the last scene of both videos, an experienced respiratory educator from the same language group as the participants demonstrated the correct use of different inhalers. The “clinician video” was a 20‐minute physician‐led video, providing clinical information about COPD symptoms and self‐management strategies. In the “lay video,” peer patients role‐played a scenario offering opinions and narratives about COPD self‐management in a 12‐minute video clip. 2 lay videos with similar content in Mandarin and Cantonese languages were developed.
  • Intervention provider: not applicable

  • Delivery method/mode: 1 individual video session (2 videos: 1 physician‐led, factual knowledge video and 1 peer‐led (role‐played) video

  • Language of delivery: language concordant

  • Format: standard

  • Setting/location: clinic or home

  • Consumer involvement: culturally and linguistically adapted through involvement of members from the community of interest


Comparator
Description: easy‐to‐understand pictorial self‐management pamphlet at grade 5 literacy level using the same content from the active intervention in a printed format, translated and back‐translated in Cantonese and Mandarin.
Comparison 2: culturally and literacy adapted audio‐/visual education without personal feedback versus another culturally and literacy adapted audio‐/visual education without personal feedback
Intervention: narrative, community video (group 2)
Description: participants watched the narrative, community video (see description above)
Comparator: physician‐led, knowledge video (group 1)
Description: participants watched the physician‐led, knowledge video (see description above)
*From this study, we have formed two comparisons: firstly, we combined group 1, 2 and 3 to create a single‐pairwise comparison with group 4 reporting the results in comparison 6 'culturally and literacy adapted audio‐/visual education without personal feedback versus written information on the same topic'. Secondly, we compared the results of group 1 with those of group 2, reporting them in comparison 7 'culturally and literacy adapted audio‐/visual education without personal feedback versus another culturally and literacy adapted audio‐/visual education without personal feedback'.
Outcomes Outcomes assessed in the study: COPD knowledge**, inhaler technique, understanding of pulmonary rehabilitation procedure*, understanding of steps to manage COPD, self‐efficacy for COPD self‐management
Outcomes considered in this review
  • Health literacy

    • Competences (inhaler use technique)

    • Understand (understanding pulmonary rehabilitation procedure)

  • Self‐efficacy (self‐efficacy for COPD self‐management)


*Prioritised outcome in category 'health literacy ‐ understand', as it was unclear how 'understanding of steps to manage COPD was assessed'
**Authors state that "some questions of BRISTOL COPD Knowledge Questionnaire [BCKQ]" (knowledge and actions needed to prevent or treat COPD exacerbation) were used, but the results are not reported.
Methods of assessing outcomes
Trained bilingual facilitators assessed outcomes face‐to‐face.
  • Inhaler use technique: measured in 2 steps, i.e. (1) participants' ability to correctly use an inhaler and (2) to differentiate between different inhalers (reliever or preventer therapy), participants received a pass/fail score; participants demonstrated correct use and had to describe each step, 1 point for appropriate use per step, validated checklist, direct observation through 2 community facilitators, 0 to 10, higher score is better

  • Understanding of pulmonary rehabilitation procedure: based on Canadian Thoracic Society COPD assessment guidelines, the team developed a text passage and participants were asked to answer related questions in the checklist to determine their grasp of pulmonary rehabilitation procedures; responses were scored correct = 1 or incorrect = 0, higher score is better

  • Self‐efficacy for COPD self‐management: validated COPD Self‐Efficacy Scale, short version, 5 items, 5‐point Likert scale to rate from 1 (not at all confident) to 5 (totally confident), higher score is better


Language of assessment: Cantonese, Mandarin
Translation procedure: professional translators translated the written materials and provided back‐translation. In addition, translations were reviewed and commented by COPD patients during initial focus groups.
Reliability/validity: for self‐efficacy, a validated tool was used.
Timing of outcome assessment: baseline, short‐term (at 4 weeks after randomisation; results not reported) and medium‐term (at 3‐month follow‐up)
Health literacy Definition: not reported
Health literacy components addressed by the intervention
Prerequisites and tools
  • Knowledge

  • Motivation


Steps of information processing
  • Understand

  • Appraise

  • Apply


Health domain: health care
Notes Trial ID: NCT01474707
Funding: funding was provided by an operating grant from CIHR.
Additional notes: data were extracted from study report and from information collected at clinicaltrials.gov. Authors were contacted and asked for additional information (e.g. with regard to the knowledge assessments) but without success.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Block randomization was applied to assign patients into the study groups, including three experimental groups and one control group. Because of our previous knowledge regarding the re‐effectiveness of educational pamphlets on disease management, we applied an unequal randomization approach to deliberately assign more participants in intervention groups. Our aim was to ensure enrolling adequate numbers of participants in the intervention groups to detect the effect of educational interventions on attainment of self‐management skills. It is a helpful approach, particularly when a 2:1 ratio is employed, and we managed our random allocation close to a 2:1 ratio for each intervention/control pairing."
Allocation concealment (selection bias) Unclear risk No statement on concealment of allocation.
Blinding of participants and personnel (performance bias)
All outcomes High risk "Data collection was conducted by trained bilingual facilitators, blinded throughout the study, as was the data analyst."
Personnel were blinded throughout the study. However, due to the nature of the study, participants were most likely aware of the intervention to which they were allocated. This might have affected the results of subjectively measured outcomes.
Blinding of outcome assessment (detection bias)
subjective outcome measures High risk "Data collection was conducted by trained bilingual facilitators, blinded throughout the study, as was the data analyst. An identical questionnaire was used in the three different assessments."
Outcome assessors were blinded. However, self‐efficacy was measured subjectively with the use of repeated questionnaires.
Blinding of outcome assessment (detection bias)
objective outcome measures Low risk No blinding of participants but understanding of pulmonary rehabilitation procedures was objectively measured and inhaler technique acquisition was assessed objectively by two blinded outcome assessors by means of a checklist indicating a low risk of bias.
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropouts, therefore the risk of bias is low.
Selective reporting (reporting bias) High risk "Given the lack of an existing COPD self‐management questionnaire in Chinese language, the study assessment tool also included some questions developed by the research team using the Bristol COPD Knowledge Questionnaire regarding disease‐related knowledge and actions needed to prevent or treat a COPD exacerbation."
The results on knowledge were not reported.