MATERIALS AND METHODS: Standard and systematic procedures were adopted to translate the original English version of the Perceived Stress Scale-10 questionnaire into Sinhalese. Consecutive sampling was employed to recruit the Type 2 Diabetes mellitus (T2DM) sample (n = 321), and a convenient sampling was used to recruit the Age and Sex matched Healthy Controls (ASMHC) (n = 101) and the Healthy Community Controls (HCC) groups (n = 75). Cronbach alpha was used to assess internal consistency and reliability was determined using test-retest method utilizing Spearman's correlation coefficient. Sensitivity was evaluated by comparing the mean scores of the Sinhalese Perceived Stress Scale (S-PSS-10) and Sinhalese Patient Health Questionnaire (S-PHQ-9) scores. Post-hoc comparisons were done using Bonferroni's method. Mean scores were compared between the T2DM, ASMHC, and HCC groups using the independent t-test. Explanatory Factor Analysis (EFA) was conducted using the principal component and Varimax rotation while the Confirmatory Factor Analysis (CFA) was performed to assess the goodness-of-fit of the factor structure extracted from the EFA. Concurrent validity was assessed using the Pearson correlation between the S-PSS-10 and Patient Health Questionnaire measured by S-PHQ-9 (p p
METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).
RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).
CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.