METHODS: Using the Short Form of Depression, Anxiety and Stress Scale (DASS21) questionnaire, we aimed (1) to measure the psychological states of hemodialysis (HD) or peritoneal dialysis (PD) subjects from 15 sites, (2) to compare DASS21 scores between HD and PD, and (3) to identify the associated demographic and medical factors of better psychological states.
RESULTS: A total of 1,332 were eligible for analysis. Stress (48%) recorded the highest negative emotional states, followed by depression (37%) and anxiety (20%). By multivariate analysis, normal body mass index weight status, religion and absence of coronary artery disease were associated with lower score for depression, anxiety and stress, respectively. Tertiary education was associated with the lowest score in depression and anxiety, whereas HD had a lower score in stress than PD. A younger age was associated with worse DASS21 score of anxiety and stress.
CONCLUSIONS: Obesity, religion and coronary artery disease were significantly associated with all 3 symptoms of depression, anxiety and stress. Older age has a protective effect on anxiety and stress. Further study is needed to evaluate the relationship between these significant factors and each psychological state.
OBJECTIVE: To determine efficacy and safety of PDA10 in treating renal anaemia in haemodialysis patients, in comparison to the originator epoetin-α, Eprex®.
METHODS: A phase 3, multicentre, multi-national, double-blind, randomised, active-controlled and parallel group study conducted over 40 weeks in Malaysia and Korea. End stage kidney disease patients undergoing regular haemodialysis who were on erythropoietin treatment were recruited. The study has 3 phases, which included a 12-week titration phase, followed by 28-week double-blind treatment phase and 24-week open-label extension phase.
RESULTS: The PDA10 and Eprex® were shown to be therapeutically equivalent (p
METHODS: A 17-item questionnaire was developed to assess nutrition practices and administered to dialysis managers of 150 HD centers, identified through the National Renal Registry. Nutritional outcomes of 4362 patients enabled crosscutting comparisons as per dietitian accessibility and center sector.
RESULTS: Dedicated dietitian (18%) and visiting/shared dietitian (14.7%) service availability was limited, with greatest accessibility at government centers (82.4%) > non-governmental organization (NGO) centers (26.7%) > private centers (15.1%). Nutritional monitoring varied across HD centers as per albumin (100%) > normalized protein catabolic rate (32.7%) > body mass index (BMI, 30.7%) > dietary intake (6.0%). Both sector and dietitian accessibility was not associated with achieving albumin ≥40 g/L. However, NGO centers were 36% more likely (p = 0.030) to achieve pre-dialysis serum creatinine ≥884 μmol/L compared to government centers, whilst centers with dedicated dietitian service were 29% less likely (p = 0.017) to achieve pre-dialysis serum creatinine ≥884 μmol/L. In terms of BMI, private centers were 32% more likely (p = 0.022) to achieve BMI ≥ 25.0 kg/m2 compared to government centers. Private centers were 62% less likely (p
Methods: We conducted a cross-sectional study to evaluate the diagnostic performance of four POCT brands at 12 sites in Malaysia. We assessed the sensitivity and specificity of the POCTs for the detection of HBsAg and anti-HCV in a finger-stick capillary or venepuncture whole-blood samples compared with test results from lab-based enzyme immunoassay (EIA) or chemi-luminescence immunoassay (CLIA) assay as the reference standard. We also conducted a cross-sectional study on 30 to 139 serum specimen panel to evaluate the diagnostic performance of a low-cost in-house Applied Biosystem®TaqMan real-time polymerase chain reaction (PCR) assay (ABS) for the detection of HCV RNA and HBV DNA, compare with Roche Cobas® Ampliprep/TaqMan assay (COBAS).
Results: Between March and December 2017, we enroll 295 participants for the evaluation of POCT for HBsAg and another 307 participants for POCT anti-HCV evaluation. Three of the four POCT brands dropped out of evaluation early on account of sub-optimal sensitivity. The sensitivity of the remaining POCT for HBsAg was 95.2%and specificity 100%, while the POCT for anti-HCV has a sensitivity of 98.1% and specificity 100%.Hepatitis B virus dioxyribo nucleic acid and HCV RNA concentrations detected by the ABS were systematically higher than those measured by COBAS (mean bias +0.10 and +0.17 log10 IU/mL respectively). The 95% limits of agreement between the two assays are -1.28 to 1.47 log10 IU/mL for HBV DNA and -0.41 to 0.75 log10 IU/mL for HCV RNA.
Conclusion: We found adequate evidence for the diagnostic validity of a low-cost POCT for anti-HCV and HBsAg, as well as for an in-house nucleic acid tests (NAT), to provide support for their broader use in our Hepatitis screening and treatment campaign.
Abbreviations: ABS: Applied Biosystem®TaqMan real-time PCR assay, CI: Confidence interval, CLD: Chronic liver disease, CLIA: Chemi-luminescence immunoassay, COBAS: Roche Cobas® Ampliprep/ TaqMan assay, DAA: Direct Acting Anti-Viral drugs, EIA: Enzyme immunoassay, HBV: Hepatitis B virus, HCV: Hepatitis C virus, HFPM: Hepatitis Free Pahang Malaysia, LOA: Limits of agreement, LOD: Limit of detection, MOH: Ministry of Health, Malaysia, NAT: Nucleic Acid Tests, POCT: Point of Care Tests, SD: Standard deviation, WHO: World Health OrganizationHow to cite this article: Radzi AHM, Tan SS, Mohamed R, Jaya F, Senamjit K, Aun AC, Kutty GA, Wong HS, Abdullah R, Seman MR, Mahtab MA, Morad Z, Lim TO. Hepatitis Screening and Treatment Campaign in Malaysia-Validation of Low-cost Point of Care Screening Tests and Nucleic Acid Tests for Hepatitis B and C. Euroasian J Hepatogastroenterol, 2018;8(2):101-107.
METHOD: Secondary data from a cross-sectional survey was utilized. HRQOL was assessed for 379 HD patients using the generic Short Form 36 (SF-36) and disease-specific Kidney-Disease Quality of Life-36 (KDQOL-36). Malnutrition was indicated by malnutrition inflammation score (MIS) ≥ 5, and presence of protein-energy wasting (PEW). The individual nutritional parameters included the domains of physical status, serum biomarkers, and dietary intake. Multivariate associations were assessed using the general linear model.
RESULTS: MIS ≥ 5 was negatively associated with SF-36 scores of physical functioning (MIS
DESIGN: This multicenter, parallel group, randomized controlled trial involved 363 prevalent CAPD patients from 8 centers. The primary endpoint was peritonitis rate; secondary endpoints were technique failure and technical problems encountered. The duration of the evaluation was 1 year.
RESULTS: The risk of peritonitis on Carex varied between the centers. We found a significant treatment-center interaction effect (likelihood ratio test: p = 0.03). The incidence rate ratio (IRR) of peritonitis on Carex as compared with Ultra ranged from 0.4 to 7.2. In two centers, Carex was inferior to Ultra with regard to peritonitis; but, in five centers, the results were inconclusive. Equivalence was not demonstrated in any center. The overall rate of peritonitis in the Carex group was twice that in the Ultra group [IRR: 2.18; 95% confidence interval (CI): 1.51 to 3.14]. Technique failure and technical problems were more common with the Carex system. Technique failure rate at 1 year was 44% in the Carex group and 22% in the Ultra group.
CONCLUSIONS: Equivalence between the Carex disconnect system and the Ultra disconnect system could not be demonstrated. The risk of peritonitis on Carex varied significantly between centers.