METHODS AND ANALYSIS: Initially, during Phase I of the study, the serum level of IL-1β, IL-6 and TNF-α; ERP changes in the EEG and fecal microbiota content will be compared between 120 AUD patients and 120 healthy controls. Subsequently in Phase II of the study, 120 AUD patients will be randomized by stratified permuted block randomization into the probiotic, ACT and placebo groups in a 1:1:1 ratio. Participants in the probiotic and placebo groups will be administered one sachet per day of Lactobacillus spp. probiotic and placebo, respectively for 12 weeks. While those in the ACT group will receive one session per week of ACT for 8 weeks. Outcome measures will be administered at four timepoints, such as t0 = baseline assessment prior to intervention, t1 = 8 weeks after intervention began, t2 = 12 weeks after intervention and t3 = 24 weeks after intervention. Primary outcomes are the degrees of alcohol craving, alcohol withdrawal during abstinence and AUD. Secondary outcomes to be assessed are the severity of co-morbid depression and anxiety symptoms; the serum levels of IL-1β, IL-6 and TNF-α; changes in ERP and fecal microbiota content.
TRIAL REGISTRATION NUMBER: NCT05830708 (ClinicalTrials.gov). Registered on April 25, 2023.
METHODS: The Malay version was translated by two independent translators who were well versed in both languages. We carried out a cross-sectional study collecting data between June 2017 and March 2018 in the pre-operative Eye Clinic of Hospital Melaka with 224 respondents (mean age 66.8 years) and another 204 respondents (mean age 64.3 years) participating in the English version and Malay version of the Questionnaire respectively. Methods used to validate the standard questionnaire included the use of construct validity via factor analysis and the deployment of reliability test through assessment of internal consistency via Cronbach's alpha.
RESULTS: We observed both English and Bahasa Malaysia versions to have high reliability with Cronbach's alpha values of 0.90 and above in factors on difficulty with activities and responses to vision problems. Exploratory factor analysis performed revealed that the three-factor model fits the data well for the English version of the questionnaire - difficulty with activities (23.81 % of variance), responses to vision problem (22.22 % of variance) and general health and vision (14.68 % of variance). The Bahasa Malaysia version of the questionnaire produced three factors with two of the factors resembling the factors from the original version of the questionnaire - difficulty with activities (24.3 % of variance) and responses to vision problem (23.7 % of variance). Item response theory analysis revealed that these factors for both English and Bahasa Malaysia versions comprised of adequately fitted items.
CONCLUSION: The present study observed that both the English and Bahasa Malaysia versions of the NEI VFQ-25 have comparable construct validity to the original American version. With high validity and reliability, the tool shall be able to provide health care providers the assessment of impact due to cataract and other ophthalmic conditions on the vision-related quality of life of ophthalmic patients.