Awareness and treatment of chronic hepatitis B in Malaysia-findings from a community-based screening campaign.

INTRODUCTION: In 2016 the World Health Organization (WHO) had adopted a global strategy to eliminate Hepatitis B (HBV) by 2030 through five core interventions. One of which is the "cascade of care", the continuum of services that persons with chronic Hepatitis B Virus (HBV) should receive as they progress from screening to diagnosis to treatment to chronic care. We determined the prevalence of the awareness and treatment of chronic HBV in Malaysia based on a large sample data from a screening campaign. METHODS: A total of 10,436 subjects participated in the HBV screening campaign organized by the Hepatitis Free Pahang Malaysia (HFP). Between in 2018 and 2019, HFP organized a total of 109 health fairs in partnership with local non-governmental organizations (NGO) to conduct HBV screening mostly in small towns and villages largely in the state of Pahang. All screen-positive subjects were recalled to undergo laboratory-based HBsAg and HBV DNA tests. Patients with confirmed chronic HBV were referred to local health services, while continued being monitored by HFP. RESULTS: We estimated 13.1% of Malaysian adults aged 20 or older with chronic HBV were aware of their HBV status, and of those only 0.7% had received prior anti-viral treatment, but among those with baseline HBV DNA level > 20,000 IU/ml, 15.6% were subsequently treated. Tenofovir disoproxil fumarate was the only medicine used on all treated patients. CONCLUSION: Few Malaysian adults with HBV were aware of their infection and even less received anti-viral therapy. Concerted public health efforts are urgently needed to improve HBV screening and care cascade in order to meet WHO's targets for HBV elimination.

A variant e13a3 BCR-ABL1 fusion transcript in refractory adult B-cell acute lymphoblastic leukemia achieving complete remission with CAR-Tcell therapy.

Acute lymphoblastic leukemia (ALL) cases with e13a3 fusion transcripts are extremely rare. We report a 24-year-old male with Ph-positive (Ph+) ALL with an aberrant e13a3 fusion transcript treated with CD19-specific chimeric antigen receptor T-cell (CAR-T) therapy. He developed refractory disease post-chemotherapy induction, andreceived allogeneic hematopoietic stem cell transplantation (allo-HSCT) after salvage with imatinib in combination with chemotherapy regimen. Unfortunately, the patient relapsed after +90 days post-transplant. He was consented to CAR-T therapy trial and achieved complete remission, highlighting the efficacy of CAR-T treatment in relapsed-refractory B-ALL irrespective of the underlying genetic drivers in leukemia cells .

Retrospective Analysis of Cancer Care Performance and Survival Outcome for Nasopharyngeal Carcinoma at a leading Cancer Treatment Centre in Malaysia 2008-2012.

Objective: This report focuses on a private medical centre cancer care performance as measured by patient survival outcome for up to 5 years. Methods: All patients with nasopharyngeal cancer treated at SJMC between 2008 and 2012 were enrolled for this observational cohort study. Mortality outcome was ascertained through record linkage with national death register, linkage with hospital registration system and finally through direct contact by phone. Result: 266 patients treated between 2008 and 2012 were included for survival analysis. 31% of patients were diagnosed with Early NPC Cancer (Stage I or II), another 44% with Locally Advanced Cancer (Stage III) and 25% with late stage IV metastatic cancer. 2%, 27% and 67% had WHO Class I, II and III NPC respectively. The overall survival at 5 years was 100% for patients with Stage I disease, 91% for Stage II disease, 72% for Stage III disease, and decreasing to 44% for Stage IV disease. Overall survival at 5 years for all stages was 73%. Conclusion: SJMC is among the first hospitals in Malaysia to embark on routine measurement of the performance of its cancer care services and its results are comparable to any leading centers in developed countries.

Estimating dengue incidence and hospitalization in Malaysia, 2001 to 2013.

BACKGROUND: Epidemiologic measures of the dengue burden such as prevalence and incidence are important for policy-making and monitoring the progress of disease control. It is a common practice where epidemiologic and economic research estimate dengue burden based on notification data. However, a basic challenge in estimating the incidence of dengue is that a significant proportion of infected population are asymptomatic. It can be overcome by using mathematical models that relate observed prevalence and mortality to incidence. In this study, we estimate the trend of dengue incidence and hospitalization in Malaysia. METHODS: This study is based entirely on the available secondary data sources on dengue in Malaysia. The age-specific incidence of dengue between 2001 and 2013 was estimated using the prevalence and mortality estimates in an incidence-prevalence-mortality (IPM) model. Data on dengue prevalence were extracted from six sero-surveys conducted in Malaysia between 2001 and 2013; while statistics on dengue notification and Case Fatality Rate were derived from National Dengue Surveillance System. Dengue hospitalization data for the years 2009 to 2013 were extracted from the Health Informatics Centre and the volumes of dengue hospitalization for hospitals with missing data were estimated with Poisson models. RESULTS: The dengue incidence in Malaysia varied from 69.9 to 93.4 per 1000 population (pkp) between 2001 and 2013.The temporal trend in incidence rate was decreasing since 2001. It has been reducing at an average rate of 2.57 pkp per year from 2001 to 2013 (p = 0.011). The age-specific incidence of dengue decreased steadily with dengue incidence reaching zero by age > 70 years. Dengue notification rate has remained stable since 2001 and the number of notified cases each year was only a small fraction of the incident cases (0.7 to 2.3%). Similarly, the dengue hospitalization was larger but still a small fraction of the incident cases (3.0 to 5.6%). CONCLUSION: Dengue incidence can be estimated with the use of sero-prevalence surveys and mortality data. This study highlights a reducing trend of dengue incidence in Malaysia and demonstrates the discrepancy between true dengue disease burden and cases reported by national surveillance system. Sero-prevalence studies with representative samples should be conducted regularly to allow better estimation of dengue burden in Malaysia.

Validity of International Classification of Diseases (ICD) coding for dengue infections in hospital discharge records in Malaysia.

BACKGROUND: Hospitalization due to dengue illness is an important measure of dengue morbidity. However, limited studies are based on administrative database because the validity of the diagnosis codes is unknown. We validated the International Classification of Diseases, 10th revision (ICD) diagnosis coding for dengue infections in the Malaysian Ministry of Health's (MOH) hospital discharge database. METHODS: This validation study involves retrospective review of available hospital discharge records and hand-search medical records for years 2010 and 2013. We randomly selected 3219 hospital discharge records coded with dengue and non-dengue infections as their discharge diagnoses from the national hospital discharge database. We then randomly sampled 216 and 144 records for patients with and without codes for dengue respectively, in keeping with their relative frequency in the MOH database, for chart review. The ICD codes for dengue were validated against lab-based diagnostic standard (NS1 or IgM). RESULTS: The ICD-10-CM codes for dengue had a sensitivity of 94%, modest specificity of 83%, positive predictive value of 87% and negative predictive value 92%. These results were stable between 2010 and 2013. However, its specificity decreased substantially when patients manifested with bleeding or low platelet count. CONCLUSION: The diagnostic performance of the ICD codes for dengue in the MOH's hospital discharge database is adequate for use in health services research on dengue.

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 randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis.

OBJECTIVE: We evaluate the efficacy of human umbilical cord-derived mesenchymal stem cell (hUC-MSC) for the treatment of lupus nephritis (LN). Previous reports showed hUC-MSC could have dramatic treatment effect. METHODS: Eighteen patients with WHO class III or IV LN were randomly assigned to hUC-MSC (dose 2×108 cells) or placebo. All patients received standard immunosuppressive treatment, which consisted of intravenous methylprednisolone and cyclophosphamide, followed by maintenance oral prednisolone and mycophenolate mofetil. RESULTS: Remission occurred in 9 of 12 patients (75%) in the hUC-MSC group and 5 of 6 patients (83%) in the placebo group. Remission was defined as stabilisation or improvement in renal function, reduction in urinary red cells and protein. A similar proportion of patients on hUC-MSC and placebo achieved complete remission. Improvements in serum albumin, complement, renal function, Systemic Lupus Erythematosus Disease Activity Index and British Isles Lupus Assessment Group scores were similar in both groups. One patient on placebo had a stroke and another had ascites. One patient on hUC-MSC had leucopenia, pneumonia and subcutaneous abscess and another died of severe pneumonia. The trial was abandoned after 18 patients were enrolled when it had become obvious it would not demonstrate a positive treatment effect. CONCLUSION: hUC-MSC has no apparent additional effect over and above standard immunosuppression. TRIAL REGISTRATION NUMBER: NCT01539902; Results.

Rural-urban comparisons of dengue seroprevalence in Malaysia.

BACKGROUND: Each year an estimated 390 million dengue infections occur worldwide. In Malaysia, dengue is a growing public health concern but estimate of its disease burden remains uncertain. We compared the urban-rural difference of dengue seroprevalence and determined age-specific dengue seroprevalence in Malaysia. METHODS: We undertook analysis on 11,821 subjects from six seroprevalence surveys conducted in Malaysia between 2001 and 2013, which composed of five urban and two rural series. RESULTS: Prevalence of dengue increased with age in both urban and rural locations in Malaysia, which exceeded 90 % among those aged 70 years or beyond. The age-specific rates of the 5 urban surveys overlapped without clear separation among them, while prevalence was lower in younger subjects in rural series than in urban series, the trend reversed in older subjects. There were no differences in the seroprevalence by gender, ethnicity or region. Poisson regression model confirmed the prevalence have not changed in urban areas since 2001 but in rural areas, there was a significant positive time trend such that by year 2008, rural prevalence was as high as in urban areas. CONCLUSION: Dengue seroprevalence has stabilized but persisted at a high level in urban areas since 2001, and is fast stabilizing in rural areas at the same high urban levels by 2008. The cumulative seroprevalence of dengue exceeds 90 % by the age of 70 years, which translates into 16.5 million people or 55 % of the total population in Malaysia, being infected by dengue by 2013.

Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test.

STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: The aim of this study was to monitor the quality control of robot-assisted pedicle screw fixation accuracy by using a cumulative summation (CUSUM) test at the initial stage of its application. SUMMARY OF BACKGROUND DATA: Although robot-assisted pedicle screw fixation reduces screw misplacement rates and provides critical support for minimally invasive surgical procedures, there have been no reports relating to the monitoring of quality control of the accuracy of this robot-assisted pedicle screw fixation procedure. METHODS: Patients with lumbar spinal stenosis scheduled to undergo surgery were randomly and equally assigned through 1:1 allocation to a robot-assisted minimally invasive posterior lumbar interbody fusion (Rom-PLIF) group or a conventional open posterior PLIF using freehand technique group. The accuracy of pedicle screw placement was evaluated using postoperative computed tomography. The primary outcome was the CUSUM analysis for monitoring the quality control of the accuracy of pedicle screw insertion between the Rom-PLIF and conventional open posterior PLIF using freehand technique groups. RESULTS: Of the 80 pedicle screws inserted in each group, 4 screws in the Rom-PLIF group, and 7 in the conventional open PLIF group, breached the pedicle. Of these 11 offending screws, 4 cases were categorized as grade B in the Rom-PLIF group, whereas 6 were grade B and 1 case was grade C in the Com-PLIF group, using the Gertzbein and Robbins classification. Throughout the monitoring period, there was no CUSUM test-derived indication that the quality of performance of the pedicle screw fixation procedure was inadequate in either group. CONCLUSION: First, this study demonstrates the adequacy of quality control of robot-assisted pedicle screw fixation even early in the application period based on the CUSUM analysis. Second, the CUSUM test can be a useful tool for monitoring of the quality of procedures related with spine surgery.

Breast Cancer Survival at a Leading Cancer Centre in Malaysia.

BACKGROUND: GLOBOCAN12 recently reported high cancer mortality in Malaysia suggesting its cancer health services are under-performing. Cancer survival is a key index of the overall effectiveness of health services in the management of patients. This report focuses on Subang Jaya Medical Centre (SJMC) care performance as measured by patient survival outcome for up to 5 years. MATERIALS AND METHODS: All women with breast cancer treated at SJMC between 2008 and 2012 were enrolled for this observational cohort study. Mortality outcome was ascertained through record linkage with national death register, linkage with hospital registration system and finally through direct contact by phone or home visits. RESULTS: A total of 675 patients treated between 2008 and 2012 were included in the present survival analysis, 65% with early breast cancer, 20% with locally advanced breast cancer (LABC) and 4% with metastatic breast cancer (MBC). The overall relative survival (RS) at 5 years was 88%. RS for stage I was 100% and for stage II, III and IV disease was 95%, 69% and 36% respectively. CONCLUSIONS: SJMC is among the first hospitals in Malaysia to embark on routine measurement of the performance of its cancer care services and its results are comparable to any leading centers in developed countries.

Use of ATC to describe duplicate medications in primary care prescriptions.

PURPOSE: We aimed to demonstrate the suitability of the Anatomical Therapeutic Chemical Classification (ATC) to describe duplicate drugs and duplicate drug classes in prescription data and describe the pattern of duplicates from public and private primary care clinics of Kuala Lumpur, Malaysia. METHODS: We analyzed prescription data year 2005 from all 14 public clinics in Kuala Lumpur with 12,157 prescriptions, and a sample of 188 private clinics with 25,612 prescriptions. As ATC Level 5 code represents the molecule and Level 4 represents the pharmacological subgroup, we used repetitions of codes in the same prescription to describe duplicate drugs or duplicate drug classes and compared them between the public and private clinics. RESULTS: At Level 4 ATC, prescriptions with duplicates drug classes were 1.46% of all prescriptions in private and 0.04% in public clinics. At Level 5 ATC, prescriptions with duplicate drugs were 1.81% for private and 0.95% for public clinics. In private clinics at Level 5, 73.3% of prescriptions with duplicates involved systemic combination drugs; at Level 4, 40.3% involved systemic combination drugs. In the public sector at Level 5, 95.7% of prescriptions with duplicates involved topical products. CONCLUSIONS: Repetitions of the same ATC codes were mostly useful to describe duplicate medications; however, we recommend avoid using ATC codes for tropical products for this purpose due to ambiguity. Combination products were often involved in duplicate prescribing; redesign of these products might improve prescribing quality. Duplicates occurred more often in private clinics than public clinics in Malaysia.

How public and private reforms dramatically improved access to dialysis therapy in Malaysia.

Between 1990 and 2005, dialysis treatment rates in Malaysia increased more than eightfold. Dialysis treatment reached a level comparable to rates in developed countries. This remarkable transformation was brought about in large part by the Malaysian government's large-scale purchase of dialysis services from the highly competitive private sector. This paper traces a series of public- and private-sector reforms that dramatically increased access to dialysis for patients with kidney failure from 13 per million people in the population in 1990 to 119 per million in 2005. Not all developing countries have had uniformly positive experiences with private-sector participation in health care. However, our data suggest that strong participation by the private sector in Malaysia has helped make for a stronger health care system as well as healthier patients. Yet the policy decisions that enabled the private sector to participate fully in providing dialysis have not been repeated with other medical services.

The National Stem Cell Therapy Patient Registry of Malaysia--measuring clinical outcomes of stem cell therapy.

Very few registries worldwide focus on clinical outcomes of stem cell therapy (SCT) as the large number of applications and rapid development of the field complicates registry design considerably. The National Stem Cell Therapy Patient Registry of Malaysia aims to accommodate this by using a main protocol which covers the overall design and administration of the registry, and condition-specific sub-protocols which deal with outcome measures. The registry will start with a few sub-protocols covering existing modes of SCT in Malaysia, with new sub-protocols released periodically as the need arises.

CUSUM: a dynamic tool for monitoring competency in cataract surgery performance.

AIMS: To apply cumulative sum (CUSUM) in monitoring performance of surgeons in cataract surgery and to evaluate the response of performance to intervention. METHOD: A CUSUM analysis was applied to 80 phacoemulsification performed by three ophthalmic trainees and one consultant, for the occurrence of posterior capsular rupture and postoperative refracted vision of worse than 6/12 among patients without pre-existing ocular comorbidity. The CUSUM score of each consecutive procedure performed by an individual surgeon was calculated and charted on CUSUM chart. When trainees' CUSUM charts showed an unacceptable level of performance, their supervisors would give feedback and impose closer monitoring of subsequent surgeries. RESULTS: CUSUM charts of the trainees demonstrated an initial upward followed by flattening trend. This reflects learning curves in their process of acquiring competency in phacoemulsification. In contrast, the consultant showed a flat curve indicating an ongoing maintenance of competence. CONCLUSION: The CUSUM analysis is able to monitor and promptly detect adverse events and trends of unacceptable outcomes in cataract surgery. This objective and dynamic monitoring makes CUSUM a useful audit tool for individual surgeons, but more so for busy consultants who need to supervise trainees.

Establishing learning curve for Tenckhoff catheter insertion by interventional nephrologist using CUSUM analysis: how many procedures and in which situation?

Peritoneal dialysis (PD) catheter insertion success rate is known to vary among different operators, and peritoneoscope PD catheter insertion demands mastery of a steep learning curve. Defining a learning curve using a continuous monitoring tool such as a Cumulative Summation (CUSUM) chart is useful for planning training programs. We aimed to analyze the learning curve of a trainee nephrologist in performing peritoneoscope PD catheter implantation with CUSUM chart. This was a descriptive single-center study using collected data from all PD patients who underwent peritoneoscope PD catheter insertion in our hospital. CUSUM model was used to evaluate the learning curve for peritoneoscope PD catheter insertion. Unacceptable primary failure rate (i.e., catheter malfunction within 1 month of insertion) was defined at >40% and acceptable performance was defined at <25%. CUSUM chart showed the learning curve of a trainee in acquiring new skill. As the trainee became more skillful with training, the CUSUM curve flattened. Technical proficiency of the trainee nephrologist in performing peritoneoscope Tenckhoff catheter insertion (<25% primary catheter malfunction) was attained after 23 procedures. We also noted earlier in our program that Tenckhoff catheters directed to the right iliac fossae had poorer survival as compared to catheters directed to the left iliac fossae. Survival of catheters directed to the left iliac fossae was 94.6% while the survival for catheters directed to the right iliac fossae was 48.6% (p < 0.01). We advocate that quality control of Tenckhoff catheter insertion is performed using CUSUM charting as described to monitor primary catheter dysfunction (i.e., failure of catheter function within 1 month of insertion), primary leak (i.e., within 1 month of catheter insertion), and primary peritonitis (i.e., within 2 weeks of catheter insertion).

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.

Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis.

AIM: Treatment of renal anaemia with epoetin is well established. However, epoetin is expensive. Biogeneric epoetin with proven efficacy would reduce cost and improve access to therapy. We conducted this first ever comparative study of a biogeneric and the original product. METHODS: Stable haemodialysis patients with haemoglobin (Hb) of at least 9 g/dL and receiving the human recombinant erythropoietin Eprex were randomized to continue Eprex or convert to GerEPO, a biogeneric epoetin, for 12 weeks. The primary efficacy variable was a change in Hb from baseline. RESULTS: Ninety-three subjects were randomized to each arm. Ninety-two and 87 subjects on the Eprex and GerEPO arms, respectively, completed the trial. Mean Hb in both groups declined over time. The mean decline in Hb was -0.47 g/dL in the Eprex group and -0.45 g/dL in the GerEPO group. The mean difference in the change in Hb from baseline to week 12 between the two groups was 0.02. The 95% confidence interval was -0.42 to 0.46, which lies within the margin of equivalence (+/-0.5 g/dL). The results of intention-to-treat analysis were similar. There were no significant differences in the epoetin dose, iron therapy or iron stores between the groups. Patients receiving GerEPO reported more adverse events. CONCLUSION: GerEPO was therapeutically equivalent to Eprex with respect to Hb response for patients with Hb in the subtherapeutic target range as is common in this study population. The trial duration was insufficient for safety evaluation, which must await further investigation. More biogeneric products should be subjected to rigorous evaluation.

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.