Is malnutrition a determining factor of health-related quality of life in hemodialysis patients? A cross-sectional design examining relationships with a comprehensive assessment of nutritional status.

PURPOSE: To identify relationships between health-related quality of life (HRQOL) and nutritional status in hemodialysis (HD) patients. 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 < 5 = 73.4 ± 8.0 SE vs MIS ≥ 5 = 64.6 ± 7.7 SE, P < 0.001), role-limitation-physical (MIS < 5 = 65.3 ± 14.3 SE vs MIS ≥ 5 = 52.9 ± 14.0 SE, P = 0.006), general health (MIS < 5 = 53.7 ± 7.5 SE vs MIS ≥ 5 = 47.0 ± 7.1 SE, P = 0.003), and PCS-36 (MIS < 5 = 40.5 ± 3.3 SE vs MIS ≥ 5 = 35.9 ± 3.1 SE, P < 0.001); and KDQOL-36 score of symptoms/problems (MIS < 5 = 78.9 ± 5.6 SE vs MIS ≥ 5 = 74.8 ± 5.4 SE, P = 0.022), but not with PEW by any tool. Of individual nutritional parameters, underweight (68.1 ± 5.4 SE, P = 0.031), normal weight (63.8 ± 2.8 SE, P = 0.023), and overweight (64.3 ± 2.9 SE, P = 0.003) patients had significantly higher physical functioning scores compared to obese patients (44.8 ± 5.5 SE). Serum albumin levels were positively associated with physical functioning (P = 0.041) score. HGS was also positively associated with physical functioning (P = 0.036), and vitality (P = 0.041) scores. Greater dietary phosphorus intakes were significantly associated with lower scores for role limitation-physical (P = 0.008), bodily pain (P = 0.043), and PCS-36 (P = 0.024). CONCLUSION: Malnutrition diagnosis by MIS, but not PEW, indicated associations with HRQOL in HD patients. Individual nutritional parameters that related to higher HRQOL were BMI < 30 kg/m2, better dietary phosphorus control, greater muscle strength and higher visceral protein pool.

A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure.

BACKGROUND: Erythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage. Biosimilar epoetin is a potential cost-effective alternative to originator for optimal renal anaemia management. 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 < 0.0001) with mean absolute change in haemoglobin from baseline of - 0.176 (± 0.91) g/dl and - 0.118 (± 1.114) g/dl, respectively. Weekly dose change was 10.01 IU/kg/week in PDA10 group and 10.30 IU/kg/week in Eprex® group, which has no significant difference. There were no significant differences in the safety profile between PDA10 and Eprex® groups. CONCLUSION: This study has confirmed the therapeutic equivalence between PDA10 and Eprex® in terms of efficacy, dosage requirement and safety profile in haemodialysis patients with renal anaemia. TRIAL REGISTRATION: The study was registered with the National Medical Research Register ( NMRR-13-400-16313 ). This study has been registered retrospectively with Clinical Research Information Service ( CRiS ), Republic of Korea on 25 March 2021.

The state of nutrition care in outpatient hemodialysis settings in Malaysia: a nationwide survey.

BACKGROUND: This study aimed to assess the situational capacity for nutrition care delivery in the outpatient hemodialysis (HD) setting in Malaysia by evaluating dietitian accessibility, nutrition practices and patients' outcomes. 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 <  0.001) while NGO centers were 56% less likely (p <  0.001) to achieve serum phosphorus control compared to government centers. Patients from centers with a shared/visiting dietitian had 35% lower probability (p <  0.001) to achieve serum phosphorus levels below 1.78 mmol/L compared to centers without access to a dietitian. CONCLUSIONS: There were clear discrepancies in nutritional care in Malaysian HD centers. Changes in stakeholder policy are required to ensure that dietitian service is available in Malaysian HD centers.

Funding renal replacement therapy in southeast Asia: building public-private partnerships in Singapore, Malaysia, Thailand, and Indonesia.

The provision of renal replacement therapy (RRT) in developing economies is limited by lack of financial and other resources. There are no national reimbursement policies for RRT in many countries in Asia. The Southeast Asia countries of Singapore, Malaysia, Thailand, and Indonesia have adopted a strategy of encouraging public-private partnerships to increase the RRT rates in their respective countries. The private organizations include both for-profit and philanthropic bodies. The latter raise funds from ordinary citizens, corporations, and faith-based groups, as well as receive subsidies from the government to support RRT for patients in need. The kidney foundations of these countries play a leadership role in this public-private partnership. Many of the private organizations that support RRT are providers of treatment in addition to offering financial assistance to patients, with hemodialysis being the most frequently supported modality. Public-private partnership in funding RRT is sustainable over the long term with proper organization and facilitated by support from the government.

Prevalence and risk factors for proteinuria: the National Kidney Foundation of Malaysia Lifecheck Health Screening programme.

AIM: Treatment of chronic kidney disease (CKD) poses a huge burden to the healthcare system. To address the problem, the National Kidney Foundation of Malaysia embarked on a programme to screen for proteinuria and educate the public on CKD. METHODS: The public was invited for health screening and the data collected over a 21 month period was analyzed. RESULTS: In total, 40400 adults from all the states in Malaysia were screened. The screening population had a mean age of 41 years, 30.1% had hypertension and 10.6% had diabetes. Proteinuria was detected in 1.4% and haematuria in 8.9% of the participants. Factors associated with the highest risk for proteinuria were the presence of diabetes (adjusted odds ratio (OR) 2.63 (95% confidence interval (CI) 2.16-3.21)), hypertension (OR 2.49 (95% CI 2.03-3.07)) and cardiac disease (OR 2.05 (95% CI 1.50-2.81)). Other risk factors identified were lower educational level, family history of kidney disease, hypercholesterolaemia, obesity and lack of regular exercise. Chinese had the lowest risk for proteinuria among the races (OR 0.71 (95% CI 0.57-0.87) compared with Malays). The combination of high blood glucose and high blood pressure (BP) substantially increased the risk for proteinuria (OR 38.1 for glucose ≥ 10 mmol/L and systolic BP ≥ 180 mm Hg and OR 47.9 for glucose ≥ 10 mmol/L and diastolic BP ≥ 110 mm Hg). CONCLUSION: The prevalence of proteinuria in Malaysia is similar to other countries. The major risk factors for proteinuria were diabetes, hypertension and cardiac disease. The presence of both high blood pressure and high blood glucose exert a synergistic effect in substantially increasing the risk for proteinuria.

Effectiveness of a Nutritional Mobile Application for Management of Hyperphosphatemia in Patients on Hemodialysis: A Multicenter Open-Label Randomized Clinical Trial.

This study aims to determine the effectiveness of a phosphate mobile app (PMA), MyKidneyDiet-Phosphate Tracker ©2019, on hemodialysis (HD) patients with hyperphosphatemia. A multicenter, open-label, randomized controlled trial design allowed randomization of patients with hyperphosphatemia to either the usual care group (UG; receiving a single dietitian-led session with an education booklet) or the PMA group (PG). Thirty-three patients in each intervention group completed the 12-week study. Post-intervention, serum phosphorus levels were reduced in both groups (PG: −0.25 ± 0.42 mmol/L, p = 0.001; UG: −0.23 ± 0.33 mmol/L, p < 0.001) without any treatment difference (p > 0.05). Patients in both groups increased their phosphate knowledge (PG: 2.18 ± 3.40, p = 0.001; UG: 2.50 ± 4.50, p = 0.003), without any treatment difference (p > 0.05). Dietary phosphorus intake of both groups was reduced (PG: −188.1 ± 161.3 mg/d, p < 0.001; UG: −266.0 ± 193.3 mg/d, p < 0.001), without any treatment difference (p > 0.05). The serum calcium levels of patients in the UG group increased significantly (0.09 ± 0.20 mmol/L, p = 0.013) but not for the PG group (−0.03 ± 0.13 mmol/L, p = 0.386), and the treatment difference was significant (p = 0.007). As per phosphate binder adherence, both groups reported a significant increase in Morisky Medication Adherence Scale scores (PG: 1.1 ± 1.2, p < 0.001; UGa: 0.8 ± 1.5, p = 0.007), without any treatment difference (p > 0.05). HD patients with hyperphosphatemia using the PMA achieved reductions in serum phosphorus levels and dietary phosphorus intakes along with improved phosphate knowledge and phosphate binder adherence that were not significantly different from a one-off dietitian intervention. However, binder dose adjustment with meal phosphate content facilitated by the PMA allowed stability of corrected calcium levels, which was not attained by UC patients whose binder dose was fixed.

Circulating fatty acid profiles are associated with protein energy wasting in maintenance hemodialysis patients: a cross-sectional study.

The metabolic impact of circulating fatty acids (FAs) in patients requiring hemodialysis (HD) is unknown. We investigated the associations between plasma triglyceride (TG) FAs and markers of inflammation, insulin resistance, nutritional status and body composition. Plasma TG-FAs were measured using gas chromatography in 341 patients on HD (age = 55.2 ± 14.0 years and 54.3% males). Cross-sectional associations of TG-FAs with 13 markers were examined using multivariate linear regression adjusted for potential confounders. Higher levels of TG saturated fatty acids were associated with greater body mass index (BMI, r = 0.230), waist circumference (r = 0.203), triceps skinfold (r = 0.197), fat tissue index (r = 0.150), serum insulin (r = 0.280), and homeostatic model assessment of insulin resistance (r = 0.276), but lower malnutrition inflammation score (MIS, r = - 0.160). Greater TG monounsaturated fatty acid levels were associated with lower lean tissue index (r = - 0.197) and serum albumin (r = - 0.188), but higher MIS (r = 0.176). Higher levels of TG n-3 polyunsaturated fatty acids (PUFAs) were associated with lower MIS (r = - 0.168) and interleukin-6 concentrations (r = - 0.115). Higher levels of TG n-6 PUFAs were associated with lower BMI (r = - 0.149) but greater serum albumin (r = 0.112). In conclusion, TG monounsaturated fatty acids were associated with poor nutritional status, while TG n-3 PUFAs were associated with good nutritional status. On the other hand, TG saturated fatty acids and TG n-6 PUFAs had both favorable and unfavorable associations with nutritional parameters.

Muscle Status Response to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting: A Multi-Center Randomized, Open Label-Controlled Trial.

Background: Muscle wasting, observed in patients with end-stage kidney disease and protein energy wasting (PEW), is associated with increased mortality for those on hemodialysis (HD). Oral nutritional supplementation (ONS) and nutrition counseling (NC) are treatment options for PEW but research targeting muscle status, as an outcome metric, is limited. Aim: We compared the effects of combined treatment (ONS + NC) vs. NC alone on muscle status and nutritional parameters in HD patients with PEW. Methods: This multi-center randomized, open label-controlled trial, registered under ClinicalTrials.gov (Identifier no. NCT04789031), recruited 56 HD patients identified with PEW using the International Society of Renal Nutrition and Metabolism criteria. Patients were randomly allocated to intervention (ONS + NC, n = 29) and control (NC, n = 27) groups. The ONS + NC received commercial renal-specific ONS providing 475 kcal and 21.7 g of protein daily for 6 months. Both groups also received standard NC during the study period. Differences in quadriceps muscle status assessed using ultrasound (US) imaging, arm muscle area and circumference, bio-impedance spectroscopy (BIS), and handgrip strength (HGS) methods were analyzed using the generalized linear model for repeated measures. Results: Muscle indices as per US metrics indicated significance (p < 0.001) for group × time interaction only in the ONS + NC group, with increases by 8.3 and 7.7% for quadriceps muscle thickness and 4.5% for cross-sectional area (all p < 0.05). This effect was not observed for arm muscle area and circumference, BIS metrics and HGS in both the groups. ONS + NC compared to NC demonstrated increased dry weight (p = 0.039), mid-thigh girth (p = 0.004), serum prealbumin (p = 0.005), normalized protein catabolic rate (p = 0.025), and dietary intakes (p < 0.001), along with lower malnutrition-inflammation score (MIS) (p = 0.041). At the end of the study, lesser patients in the ONS + NC group were diagnosed with PEW (24.1%, p = 0.008) as they had achieved dietary adequacy with ONS provision. Conclusion: Combination of ONS with NC was effective in treating PEW and contributed to a gain in the muscle status as assessed by the US, suggesting that the treatment for PEW requires nutritional optimization via ONS.

A challenge to chronic kidney disease in Asia: The report of the second Asian Forum of Chronic Kidney Disease Initiative.

BACKGROUND: The Asian Forum of Chronic Kidney Disease Initiative started in 2007 in Hamamatsu, Japan when delegates from 16 countries joined together to facilitate collaboration in studying chronic kidney disease (CKD) in the Asia-Pacific region. Based on the outcome of the first meeting, the second meeting was organized as a consensus conference to frame the most relevant issues, and develop research recommendations and action plan. PROCEEDINGS: The meeting was held on 4 May 2008 as a pre-conference meeting to the 11th Asian Pacific Congress of Nephrology in Kuala Lumpur. This meeting consisted of three sessions: Session I was dedicated to the estimation of glomerular filtration rate and the standardization of serum creatinine measurements. Session II discussed specific considerations in the aetiology of and risk factors for end-stage renal disease in Asia. We concluded that there were regional specific problems that might lead to a very high prevalence of end-stage renal disease. Session III discussed the issue of facilitation of coordination and integration of the CKD initiative between developed and developing countries in the Asia-Pacific region. CONCLUSION: The following action plans were formulated: (i) validating the existing global estimated glomerular filtration rate equation or creating a new one using serum creatinine standardized by a central laboratory; (ii) establishing a pan-Asian CKD registry to facilitate risk analysis of CKD and its comorbidities; (iii) adapting existing clinical practice guidelines for CKD detection and management to address specific problems in this region; and (iv) working closely with other international professional organizations to promote manpower development and education in different aspects of CKD in developing countries.

Association of dietary patterns with serum phosphorus in maintenance haemodialysis patients: a cross-sectional study.

Sources of dietary phosphate differentially contribute to hyperphosphatemia in maintenance haemodialysis (MHD) patients. This cross-sectional study in Malaysia investigated association between dietary patterns and serum phosphorus in MHD patients. Dietary patterns were derived by principal component analysis, based on 27 food groups shortlisted from 3-day dietary recalls of 435 MHD patients. Associations of serum phosphorus were examined with identified dietary patterns. Three dietary patterns emerged: Home foods (HFdp), Sugar-sweetened beverages (SSBdp), and Eating out noodles (EO-Ndp). The highest tertile of patients in HF (T3-HFdp) pattern significantly associated with higher intakes of total protein (p = 0.002), animal protein (p = 0.001), and animal-based organic phosphate (p < 0.001), whilst T3-SSBdp patients had significantly higher intakes of total energy (p < 0.001), inorganic phosphate (p < 0.001), and phosphate:protein ratio (p = 0.001). T3-EO-Ndp patients had significantly higher intakes of total energy (p = 0.033), total protein (p = 0.003), plant protein (p < 0.001), but lower phosphate:protein ratio (p = 0.009). T3-SSBdp patients had significantly higher serum phosphorus (p = 0.006). The odds ratio of serum phosphorous > 2.00 mmol/l was significantly 2.35 times higher (p = 0.005) with the T3-SSBdp. The SSBdp was associated with greater consumption of inorganic phosphate and higher serum phosphorus levels.

Association of Ultrasound-Derived Metrics of the Quadriceps Muscle with Protein Energy Wasting in Hemodialysis Patients: A Multicenter Cross-Sectional Study.

This study aimed to assess muscle wasting and risk of protein energy wasting (PEW) in hemodialysis (HD) patients using an ultrasound (US) imaging method. PEW was identified using the ISRNM criteria in 351 HD patients. Quadriceps muscle thickness of rectus femoris (RF) and vastus intermedius (VI) muscles and cross-sectional area (CSA) of the RF muscle (RFCSA) were measured using US and compared with other physical measures. Associations of US indices with PEW were determined by logistic regression. Irrespective of gender, PEW vs. non-PEW patients had smaller RF, VI muscles, and RFCSA (all p < 0.001). US muscle sites (all p < 0.001) discriminated PEW from non-PEW patients, but the RFCSA compared to bio-impedance spectroscopy had a greater area under the curve (AUC, 0.686 vs. 0.581), sensitivity (72.8% vs. 65.8%), and specificity (55.6% vs. 53.9%). AUC of the RFCSA was greatest for PEW risk in men (0.74, 95% CI: 0.66-0.82) and women (0.80, 95% CI: 0.70-0.90) (both p < 0.001). Gender-specific RFCSA values (men < 6.00 cm2; women < 4.47 cm2) indicated HD patients with smaller RFCSA were 8 times more likely to have PEW (AOR = 8.63, 95% CI: 4.80-15.50, p < 0.001). The US approach enabled discrimination of muscle wasting in HD patients with PEW. The RFCSA was identified as the best US site with gender-specific RFCSA values to associate with PEW risk, suggesting potential diagnostic criteria for muscle wasting.

Dietary fatty acid intake in hemodialysis patients and associations with circulating fatty acid profiles: A cross-sectional study.

OBJECTIVES: The aims of this study were threefold: first, to assess the dietary fatty acid (FA) intake and blood FA status in Malaysian patients on hemodialysis (HD); second, to examine the association between dietary FA intakes and blood FA profiles in patients on HD; and third, to determine whether blood FAs could serve as a biomarker of dietary fat intake quality in these patients. METHODS: Using 3 d of dietary records, FA intakes of 333 recruited patients were calculated using a food database built from laboratory analyses of commonly consumed Malaysian foods. Plasma triacylglycerol (TG) and erythrocyte FAs were determined by gas chromatography. RESULTS: High dietary saturated fatty acid (SFA) and monounsaturated fatty acid (MUFA) consumption trends were observed. Patients on HD also reported low dietary ω-3 and ω-6 polyunsaturated fatty acid (PUFA) consumptions and low levels of TG and erythrocyte FAs. TG and dietary FAs were significantly associated respective to total PUFA, total ω-6 PUFA, 18:2 ω-6, total ω-3 PUFA, 18:3 ω-3, 22:6 ω-3, and trans 18:2 isomers (P < 0.05). Contrarily, only dietary total ω-3 PUFA and 22:6 ω-3 were significantly associated with erythrocyte FAs (P < 0.01). The highest tertile of fish and shellfish consumption reflected a significantly higher proportion of TG 22:6 ω-3. Dietary SFAs were directly associated with TG and erythrocyte MUFA, whereas dietary PUFAs were not. CONCLUSION: TG and erythrocyte FAs serve as biomarkers of dietary PUFA intake in patients on HD. Elevation of circulating MUFA may be attributed to inadequate intake of PUFAs.

Review article: Use of renal registry data for research, health-care planning and quality improvement: what can we learn from registry data in the Asia-Pacific region?

We review renal registry data from the Asia-Pacific region with an emphasis on their uses in health care and in dialysis care in particular. The review aims to demonstrate the information value of registry data. While renal registry provides a useful data resource for epidemiological research, there are severe methodological limitations in its application for analytical or therapeutic research. However, it is the use of renal registry data for public health and health-care management purposes that registry really comes into its own, and it is primarily for these that governments have invested in national patient and disease registries. We apply data from several renal registries in the Asia-Pacific region to illustrate its wide application for planning dialysis services, for evaluating dialysis practices and health outcomes, with a view to improving the quality of dialysis care. In the course of preparing the review, we have found that the quality and accessibility of renal registry data were highly variable across the region. Given the value of renal registry, every country in the Asia-Pacific region should establish one or should ensure that their current registries are better resourced and developed. Greater data sharing and collaboration among registries in the region could help advance the nephrology to serve our patients better.

DASS21: A Useful Tool in the Psychological Profile Evaluation of Dialysis Patients.

BACKGROUND: The effect of dialysis treatment is complex, with both clinical and socio-psychological effects. In this study, we aimed to assess the psychological status of this growing population of end-stage renal disease. 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.

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.

BACKGROUND: Two major challenges in implementing budget-constrained Hepatitis screening and treatment campaign in Malaysia are the availability of low-cost point of care tests (POCT) and nucleic acid tests (NAT) for hepatitis C virus ribonucleic acid (HCV RNA) and hepatitis B virus dioxyribo nucleic acid (HBV DNA). We evaluated the performance of these tests in this study. 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.

A randomized, multicenter, open-label trial to determine peritonitis rate, product defect, and technique survival between ANDY-Disc and UltraBag in patients on CAPD.

BACKGROUND: With the various twin-bag systems available on the market, we decided to conduct a therapeutic equivalence study comparing ANDY-Disc (Fresenius Medical Care, Bad Homburg, Germany) with UltraBag (Baxter, Deerfield, IL) in patients on continuous ambulatory peritoneal dialysis (CAPD) therapy. METHODS: This multicenter, open-label, parallel-group, randomized trial is designed to show the therapeutic equivalence of ANDY-Disc with UltraBag. All CAPD patients from the 6 participating centers who met inclusion/exclusion criteria were enrolled into the trial. They were randomly assigned and converted from the Y-disconnect system (Ultraset; Baxter) to the twin-bag systems. The primary outcome variable is peritonitis, and secondary outcome parameters are technique failure or product defect. RESULTS: From April 2002 to May 2003, a total of 270 patients were recruited for this study. Overall peritonitis rates were 22.9 patient-months/episode for ANDY-Disc and 35.0 patient-months/episode for UltraBag. The overall peritonitis rate for ANDY-Disc was 53% greater compared with UltraBag, but the 95% confidence interval overlaps the prespecified margin of equivalence. There were more product defects reported with ANDY-Disc; 236 product defects compared with 17 with UltraBag. The time series of the number of product defects and peritonitis count on the ANDY-Disc arm suggests a possible cause-and-effect relationship. CONCLUSION: Therapeutic equivalence of ANDY-Disc to UltraBag could not be established with respect to peritonitis. There is a trend toward greater risk for peritonitis on the Andy-Disc arm. There also is a suggestive cause-and-effect relation between the occurrence of product defect and peritonitis on the ANDY-Disc arm during the early part of the trial.

Prevention of renal failure: the Malaysian experience.

Renal replacement therapy in Malaysia has shown exponential growth since 1990. The dialysis acceptance rate for 2003 was 80 per million population, prevalence 391 per million population. There are now more than 10,000 patients on dialysis. This growth is proportional to the growth in gross domestic product (GDP). Improvement in nephrology and urology services with widespread availability of ultrasonography and renal pathology has improved care of renal patients. Proper management of renal stone disease, lupus nephritis, and acute renal failure has decreased these as causes of end-stage renal disease (ESRD) in younger age groups. Older patients are being accepted for dialysis, and 51% of new patients on dialysis were diabetic in 2003. The prevalence of diabetes is rising in the country (presently 7%); glycemic control of such patients is suboptimal. Thirty-three percent of adult Malaysians are hypertensive and blood pressure control is poor (6%). There is a national coordinating committee to oversee the control of diabetes and hypertension in the country. Primary care clinics have been provided with kits to detect microalbuminuria, and ACE inhibitors for the treatment of hypertension and diabetic nephropathy. Prevention of renal failure workshops targeted at primary care doctors have been launched, opportunistic screening at health clinics is being carried out, and public education targeting high-risk groups is ongoing. The challenge in Malaysia is to stem the rising tide of diabetic ESRD.

Bimodality in blood glucose distribution: is it universal?

OBJECTIVE: Bimodality in blood glucose (BG) distribution has been demonstrated in several populations with a high prevalence of diabetes and obesity. However, other population studies had not found bimodality, thus casting doubt on its universality. We address this question in four ethnic populations-namely Malay, Chinese, Indian, and the indigenous people of Borneo. RESEARCH DESIGN AND METHODS: A national health survey was conducted in Malaysia in 1996. A total of 18,397 subjects aged > or =30 years had post-challenge BG measurements taken. To test whether BG was consistent with a bimodal distribution, we fitted unimodal normal and skewed distribution as well a mixture of two normal distributions to the data by age and ethnic groups. RESULTS: Age-specific prevalence of diabetes varied from 1.3 to 26.3%. In all ethnic/age groups, the bimodal model fitted the log BG data better (likelihood ratio tests, all P values <0.001). CONCLUSIONS: Bimodality in BG distribution is demonstrable even in populations with a very low prevalence of diabetes and obesity. Previous studies that found unimodality had failed to detect the second mode because of inadequate sample size, bias due to treatment of subjects with known diabetes, and inclusion of subjects with type 1 diabetes in the sample. Bimodality implies that diabetes is a distinct entity rather than an arbitrarily defined extreme end of a continuously distributed measurement.