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
Inclusion criteria
Exclusion criteria
Intervention groups
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:
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.
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
*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.
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
Steps of information processing
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. |