Mortality Rates and a Clinical Predictive Model for the Elderly on Maintenance Hemodialysis: A Large Observational Cohort Study of 17,354 Asian Patients.

INTRODUCTION: Mortality following hemodialysis initiation may influence the decision to initiate hemodialysis in elderly patients. Our objective is to demonstrate mortality following hemodialysis initiation in elderly patients (≥70 years) and to derive a prediction risk score based on clinical and laboratory indicators to determine risk of all-cause mortality in patients aged ≥80 years. METHODS: We identified elderly patients (≥70 years) who initiated maintenance hemodialysis between January 2005 and December 2016 using data from the Thai Renal Replacement Therapy (TRT) registry. The mortality rate was determined based on age categories. A predictive risk score for all-cause mortality was created for 4,451 patients aged ≥80 years by using demographics, laboratory values, and interview-based parameters. Using a flexible parametric survival analysis, we predicted mortality 3 months, 6 months, 1 year, 5 years, and 10 years after hemodialysis initiation. RESULTS: 17,354 patients (≥70 years) were included, mean age 76.9 ± 5.1 years, 46.5% male, and 6,309 (36.4%) died. Patients aged <80 years had a median survival time of 110.6 months. A 9-point risk score was developed to predict mortality in patients aged ≥80 years: age >85 years, male, body mass index <18.5 kg/m2, hemoglobin <10.0 g/dL, albumin <3.5 g/dL, substantial assistance required in daily living (1 point each), and Karnofsky Performance Status (KPS) score <50 (3 points). C-statistic of 0.797 indicated high model discrimination. Internal validation demonstrated good agreement between observed and anticipated mortalities. CONCLUSIONS: Hemodialysis is appropriate for patients aged 70-80 years. A risk score for mortality in patients aged ≥80 years has been developed. The score is based on seven readily obtainable and evaluable clinical characteristics.

Enhancing healthcare quality and outcomes for peritoneal dialysis patients in Thailand: An evaluation of key performance indicators and PDOPPS cohort representativeness.

AIM: To assess whether the peritoneal dialysis (PD) centres included in the Peritoneal Dialysis Outcomes and Practise Patterns Study (PDOPPS) in Thailand are representative of other PD centres in the country, based on 8 key performance indicators (KPIs 1-8). METHODS: A retrospective analysis was conducted comparing PD-related clinical outcomes between PD centres included in the PDOPPS (the PDOPPS group) and those not included (the non-PDOPPS group) from January 2018 to December 2019. Logistic regression analysis was used to identify predictors associated with achieving the target KPIs. RESULTS: Of 181 PD centres, 22 (12%) were included in the PDOPPS. PD centres in the PDOPPS group were larger and tended to serve more PD patients than those in the non-PDOPPS group. However, the process and outcome KPIs (KPIs 1-8) were comparable between the 2 groups. Large hospitals (≥120 beds), providing care to ≥100 PD cases and having experience for >10 years were independent predictors of achieving the peritonitis rate target of <0.5 episodes/year. Most PD centres in Thailand showed weaknesses in off-target haemoglobin levels and culture-negative peritonitis rate. CONCLUSIONS: The PD centres included in Thai PDOPPS were found to be representative of other PD centres in Thailand in terms of clinical outcomes. Thus, Thai PDOPPS findings may apply to the broader PD population in Thailand.

Constipation and clinical outcomes in peritoneal dialysis: Results from Thailand PDOPPS.

BACKGROUND: Patient-reported outcome measures (PROMs) are widely recognized as valuable predictors of clinical outcomes in peritoneal dialysis (PD). Our study aimed to explore the connections between patient-reported constipation and clinical outcomes. METHODS: We assessed constipation in patients across 22 facilities participating in the Thailand Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014 to 2017. Constipation diagnosis utilized objective assessment tools such as the Bristol stool form scale (BSFS) and a self-reported questionnaire known as the constipation severity score (CSS). The BSFS is a 7-level scale that visually inspects feces based on texture and morphology, while the CSS measures constipation duration and severity using a 5-point Likert scale for various factors. We employed Cox proportional hazards model regression to determine the associations between constipation and clinical outcomes, including mortality, hemodialysis (HD) transfer and peritonitis. RESULTS: Among 975 randomly selected PD patients from 22 facilities, 845 provided written informed consent, and 729 completed CSS questionnaire. Constipation was prevalent in the PD population (13%), particularly among older patients, those who were caregiver dependent, had diabetes and poorer nutritional status (indicated by lower time-averaged serum albumin, potassium, creatinine and phosphate concentrations). Twenty-seven percent of which experiencing symptoms of constipation for over a year. Notably, self-reported constipation at baseline was significantly associated with a shorter time to first peritonitis and higher rates of peritonitis and death. However, no significant association was found between constipation and HD transfer after adjusting for various factors, including age, gender, PD vintage, comorbidities, shared frailty by study sites and serum albumin. CONCLUSION: Patient-reported constipation independently correlated with increased risks of peritonitis and all-cause mortality, though no such correlation was observed with HD transfer. These findings underscore the need for further investigation to identify effective interventions for constipation in PD patients.

An induced pluripotent stem cell line (MUSIi019-A) generated from a patient with distal renal tubular acidosis carrying a compound heterozygous mutation in solute carrier family 4 member 1 (SLC4A1) gene.

Distal renal tubular acidosis (dRTA), a disease characterized by the failure of the distal nephron to secrete acid into the urine, can be caused by mutations in SLC4A1 gene encoding erythroid and kidney anion exchanger 1 (AE1). Here, an induced pluripotent stem cell (iPSC) line was generated from a patient with dRTA and hemolytic anemia carrying compound heterozygous SLC4A1 mutations containing c.1199_1225del (p.Ala400_Ala408del), resulting in Southeast Asian ovalocytosis (SAO), and c.1331C>A (p.Thr444Asn). Peripheral blood mononuclear cells (PBMCs) were reprogrammed using Sendai viral reprogramming. The established iPSC line, MUSIi019-A, exhibited pluripotent property and retained the same mutations observed in the patients.

Fatality rate, risk factors, and functional decline in peritoneal dialysis patients with coronavirus disease 2019: A nationwide cohort study.

Background: The fatality rates and factors associated with death from coronavirus disease 2019 (COVID-19) in hemodialysis patients have been extensively investigated. However, data on peritoneal dialysis (PD) patients remain scarce. Materials and methods: In this nationwide cohort study, we assessed the 28-day COVID-19-related fatality rate in PD patients between August 2021 and July 2022 using data from the InCov19-PD registry. Predictors associated with death were evaluated using a multivariable Cox regression model. Changes in functional status before and during COVID-19 were also examined. Results: A total of 1,487 eligible participants were evaluated. During the study period, 196 participants died within 28 days after COVID-19 diagnosis (case fatality rate: 13%). In a multivariable Cox regression model, an increased risk of death within 28 days after COVID-19 diagnosis among PD patients was independently associated with functional impairment during COVID-19 [adjusted hazard ratio (HR) 2.46, 95% confidence interval (CI) 1.59-3.81], SARS-CoV-2 infection with the Delta variant (HR 2.23, 95% CI 1.55-3.21), and the need for respiratory support (HR 7.13, 95% CI 3.74-13.57) (p < 0.01 for all). Conversely, the number of COVID-19 vaccines administered (HR 0.69, 95% CI 0.55-0.87; p = 0.001) and receiving corticosteroid therapy during COVID-19 (HR 0.72, 95% CI 0.54-0.97; p = 0.03) were associated with a decreased risk of death within 28 days after COVID-19 diagnosis. The number of functionally independent PD patients dropped from 94% at baseline to 63% during COVID-19 (p < 0.01). Conclusions: The COVID-19-related 28-day fatality rate was high among PD patients. The predictors of COVID-19-related death in PD patients were similar to those in hemodialysis patients. During COVID-19, PD patients commonly experienced functional deterioration.

Impaired trafficking and instability of mutant kidney anion exchanger 1 proteins associated with autosomal recessive distal renal tubular acidosis.

BACKGROUND: Mutations in solute carrier family 4 member 1 (SLC4A1) encoding anion exchanger 1 (AE1) are the most common cause of autosomal recessive distal renal tubular acidosis (AR dRTA) in Southeast Asians. To explain the molecular mechanism of this disease with hematological abnormalities in an affected family, we conducted a genetic analysis of SLC4A1 and studied wild-type and mutant AE1 proteins expressed in human embryonic kidney 293T (HEK293T) cells. METHODS: SLC4A1 mutations in the patient and family members were analyzed by molecular genetic techniques. Protein structure modeling was initially conducted to evaluate the effects of mutations on the three-dimensional structure of the AE1 protein. The mutant kidney anion exchanger 1 (kAE1) plasmid construct was created to study protein expression, localization, and stability in HEK293T cells. RESULTS: We discovered that the patient who had AR dRTA coexisting with mild hemolytic anemia carried a novel compound heterozygous SLC4A1 mutations containing c.1199_1225del (p.Ala400_Ala408del), resulting in Southeast Asian ovalocytosis (SAO), and c.1331C > A (p.Thr444Asn). Homologous modeling and in silico mutagenesis indicated that these two mutations affected the protein structure in the transmembrane regions of kAE1. We found the wild-type and mutant kAE1 T444N to be localized at the cell surface, whereas the mutants kAE1 SAO and SAO/T444N were intracellularly retained. The half-life of the kAE1 SAO, T444N, and SAO/T444N mutants was shorter than that of the wild-type protein. CONCLUSION: These results suggest impaired trafficking and instability of kAE1 SAO/T444N as the likely underlying molecular mechanism explaining the pathogenesis of the novel SLC4A1 compound heterozygous mutation identified in this patient.

Predictors and outcomes of peritoneal dialysis-related infections due to filamentous molds (MycoPDICS).

INTRODUCTION: We sought to evaluate the predictors and outcomes of mold peritonitis in patients with peritoneal dialysis (PD). METHODS: This cohort study included PD patients from the MycoPDICS database who had fungal peritonitis between July 2015-June 2020. Patient outcomes were analyzed by Kaplan Meier curves and the Log-rank test. Multivariable Cox proportional hazards model regression was used to estimating associations between fungal types and patients' outcomes. RESULTS: The study included 304 fungal peritonitis episodes (yeasts n = 129, hyaline molds n = 122, non-hyaline molds n = 44, and mixed fungi n = 9) in 303 patients. Fungal infections were common during the wet season (p <0.001). Mold peritonitis was significantly more frequent in patients with higher hemoglobin levels, presentations with catheter problems, and positive galactomannan (a fungal cell wall component) tests. Patient survival rates were lowest for non-hyaline mold peritonitis. A higher hazard of death was significantly associated with leaving the catheter in-situ (adjusted hazard ratio [HR] = 6.15, 95%confidence interval [CI]: 2.86-13.23) or delaying catheter removal after the diagnosis of fungal peritonitis (HR = 1.56, 95%CI: 1.00-2.44), as well as not receiving antifungal treatment (HR = 2.23, 95%CI: 1.25-4.01) or receiving it for less than 2 weeks (HR = 2.13, 95%CI: 1.33-3.43). Each additional day of antifungal therapy beyond the minimum 14-day duration was associated with a 2% lower risk of death (HR = 0.98, 95%CI: 0.95-0.999). CONCLUSION: Non-hyaline-mold peritonitis had worse survival. Longer duration and higher daily dosage of antifungal treatment were associated with better survival. Deviations from the 2016 ISPD Peritonitis Guideline recommendations concerning treatment duration and catheter removal timing were independently associated with higher mortality.

Spiritual well-being and its relationship with patient characteristics and other patient-reported outcomes in peritoneal dialysis patients: Findings from the PDOPPS.

BACKGROUND: Spiritual well-being (SWB), an individual's understanding of the meaning and purpose of life, may help patients with chronic or terminal illnesses cope with their diseases. This study aimed to assess SWB in patients on peritoneal dialysis (PD), as well as its relationship with patient characteristics and patient-reported outcomes (PRO). METHODS: The data were obtained from questionnaires that formed part of the PD Outcomes and Practice Patterns Study (PDOPPS). Measures used in this study were SWB scores derived from the WHO quality of life, spirituality, religiousness and personal beliefs (WHOQOL-SRPB) tool including 32 items from eight facets; physical (PCS) and mental component summary (MCS) scores of the 12-Item Short-Form Health Survey (SF-12), Center of Epidemiologic Studies Depression Scale-10 (CES-D-10) scores, burden of kidney disease scores and functional status scores. RESULTS: Overall, 529 out of 848 participants (62%) completely responded to the questionnaires and were included in the analysis. Over two-thirds of PD patients (70%) had moderate or higher SWB scores. The SWB scores were significantly lower in patients with age >65 years and unemployed status. SWB scores positively correlated with higher PCS, MCS, burden of kidney disease scores and functional status scores, while negatively correlated with depression scores by CES-D-10 scale. Patients who reported significant depressive symptoms (CES-D-10 score ≥ 10) had significantly lower SWB scores. CONCLUSION: Better SWB was significantly associated with better health-related QOL (HRQOL) and the absence of depressive symptoms. SWB may be an essential consideration in the delivery of high-quality PD.

Implementation of PDOPPS in a middle-income country: Early lessons from Thailand.

BACKGROUND: Despite the implementation of a 'Peritoneal Dialysis (PD) First' policy in Thailand since 2008, nationwide PD practices and patients' outcomes have rarely been reported. METHODS: As part of the multinational PD Outcomes and Practice Patterns Study (PDOPPS), PD patients from 22 PD centres from different geographic regions, sizes and affiliations, representing Thailand PD facilities, have been enrolled starting in May 2016. Demographic, clinical and laboratory data and patients' outcomes were prospectively collected and analysed. RESULTS: The pilot and implementation phases demonstrated excellent concordance between study data and validation data collected at enrolment. In the implementation phase, 848 PD patients (including 262 (31%) incident PD patients) were randomly sampled from 5090 patients in participating centres. Almost all participants (95%) performed continuous ambulatory PD (CAPD), and a high proportion had hypoalbuminemia (67%, serum albumin < 3.5 g/dL), anaemia (42%, haemoglobin <10 g/dL) and hypokalaemia (37%, serum potassium < 3.5 mmol/L). The peritonitis rate was 0.40 episodes/year, but the culture-negative rate was high (0.13 episodes/year, 28% of total episodes). The patients from PD clinics located in Bangkok metropolitan region had higher socio-economic status, more optimal nutritional markers, blood chemistries, haemoglobin level and lower peritonitis rates compared to the provincial regions, emphasizing the centre effect on key success factors in PD. CONCLUSIONS: Participation in the PDOPPS helps unveil the critical barriers to improving outcomes of PD patients in Thailand, including a high prevalence of hypokalaemia, anaemia, poor nutritional status and culture-negative peritonitis. These factors should be acted upon to formulate solutions and implement quality improvement on a national level.

Barriers to and constraints of acute peritoneal dialysis in acute kidney injury: A nationwide survey.

This national survey of barriers to and constraints of acute peritoneal dialysis (aPD) in acute kidney injury (AKI) was performed by distributing an online questionnaire to all medical directors of public dialysis units registered with the Nephrology Society of Thailand during September-November 2019. One hundred and thirteen adult facilities responded to the survey covering 75 from 76 provinces (99%) of Thailand. aPD was performed in 66 centres (58%). In facilities where aPD practice was available, the utilization rate was relatively low (<10 cases/year) and limited to specific conditions, including HIV seropositive patients, previous receiving dialysis education and plan and difficult vascular access creation. Only 9% of facilities performed aPD routinely, but interestingly all such units permitted bedside catheter insertion by the nephrologists or internists. The major constraints placed on aPD practice were PD catheter insertion competency, timely catheter insertion support and the medical supporting team's knowledge/competency deficits. aPD for AKI is underutilized in Thailand and limited by the inability to undertake timely PD catheter insertion and knowledge and competency deficits.

Efficacy and safety of recombinant human erythropoietin (Hema-Plus®) for management of anemia in Thai patients on peritoneal dialysis.

BACKGROUND: Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach. AIM: To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD). METHODS: This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36. RESULTS: All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators' assessment. At week 12, the QoL scores in all domains were significantly increased from baseline. CONCLUSION: Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile.

Association between intelectin-1 variation and human kidney stone disease in northeastern Thai population.

An interplay of multiple genetic and environmental factors implicates an incidence of human kidney stone disease (KSD). However, the genetic factors associated with KSD are not completely known or understood. To identify KSD-associated genetic variations among the northeastern Thai patients, a genome-wide association study (GWAS) was conducted. We initially employed genotyping of single nucleotide polymorphism (SNP) using Genome-Wide Human SNP Array 6.0 in 105 patients and in 105 normal control subjects. To overcome the limitation of small sample size, we set forth to analyze SNPs as clusters based on the concept of linkage disequilibrium (LD) and haplotype. Using this analysis, 29 genes were identified. Three candidate SNPs, including rs2039415, rs2274907, and rs3747515, were selected on the basis of haplotype analysis, potentially functional SNPs, and the functions of associated genes. Further genotyping of these SNPs in a larger sample size (altogether 216 patients and 216 control subjects) showed that the candidate SNP rs2274907 remained significantly different between case and control subjects in both genotype frequencies (OR 2.44, 95% CI 1.38-4.30; p = 0.0015) and allele frequencies (OR 1.54, 95% CI 1.17-2.03; p = 0.0021). The non-synonymous SNP rs2274907 (c.326T > A) located in exon 4 of the ITLN1 gene results in a substitution of valine (V) by aspartate (D) at position 109 (p.V109D). This substitution could affect the predicted hydrogen (H)-bonds between lysine (K) 107 and glutamine (Q) 104, which supports its association with KSD in this population.

Association of Local Unit Sampling and Microbiology Laboratory Culture Practices With the Ability to Identify Causative Pathogens in Peritoneal Dialysis-Associated Peritonitis in Thailand.

INTRODUCTION: This describes variations in facility peritoneal dialysis (PD) effluent (PDE) culture techniques and local microbiology laboratory practices, competencies, and quality assurance associated with peritonitis, with a specific emphasis on factors associated with culture-negative peritonitis (CNP). METHODS: Peritonitis data were prospectively collected from 22 Thai PD centers between May 2016 and October 2017 as part of the Peritoneal Dialysis Outcomes and Practice Patterns Study. The first cloudy PD bags from PD participants with suspected peritonitis were sent to local and central laboratories for comparison of pathogen identification. The associations between these characteristics and CNP were evaluated. RESULTS: CNP was significantly more frequent in local laboratories (38%) compared with paired PDE samples sent to the central laboratory (12%, P < 0.05). Marked variations were observed in PD center practices, particularly with respect to specimen collection and processing, which often deviated from International Society for Peritoneal Dialysis Guideline recommendations, and laboratory capacities, capabilities, and certification. Lower rates of CNP were associated with PD nurse specimen collection, centrifugation of PDE, immediate transfer of samples to the laboratory, larger hospital size, larger PD unit size, availability of an on-site nephrologist, higher laboratory capacity, and laboratory ability to perform aerobic cultures, undertake standard operating procedures in antimicrobial susceptibilities, and obtain local accreditation. CONCLUSION: There were large variations in PD center and laboratory capacities, capabilities, and practices, which in turn were associated with the likelihood of culturing and correctly identifying organisms responsible for causing PD-associated peritonitis. Deviations in practice from International Society for Peritoneal Dialysis guideline recommendations were associated with higher CNP rates.

A novel loss-of-function mutation of PBK associated with human kidney stone disease.

Kidney stone disease (KSD) is a prevalent disorder that causes human morbidity worldwide. The etiology of KSD is heterogeneous, ranging from monogenic defect to complex interaction between genetic and environmental factors. Since mutations of genes responsible for KSD in a majority of families are still unknown, our group is identifying mutations of these genes by means of genomic and genetic analyses. In this study, we identified a novel loss-of-function mutation of PBK, encoding the PDZ binding kinase, that was found to be associated with KSD in an affected Thai family. Glycine (Gly) substituted by arginine (Arg) at position 43 (p.Gly43Arg) in PBK cosegregated with the disease in affected members of this family, but was absent in 180 normal control subjects from the same local population. Gly43 is highly evolutionarily conserved in vertebrates, and its substitution affects protein structure by alterations in H-bond forming patterns. This p.Gly43Arg substitution results in instability of the variant PBK protein as examined in HEK293T cells. The variant PBK protein (p.Gly43Arg) demonstrated decreased kinase activity to phosphorylate p38 MAPK as analyzed by immunoblotting and antibody microarray techniques. Taken together, these findings suggest a possible new mechanism of KSD associated with pathogenic PBK variation.

Kidney Disease-Specific Scores and Health Utility of Continuous Ambulatory Peritoneal Dialysis and Automated Peritoneal Dialysis Patients and Their Caregivers.

OBJECTIVES: This study aimed to compare the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), the visual analogue scale (VAS), and the Kidney Disease Quality of Life 36-Item Short-Form Survey (KDQOL-36) scores of Thai continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) patients and to compare the utility scores with the EQ-5D-5L and VAS scores of caregivers. METHODS: This was a cross-sectional study completed between April 2016 and May 2017. In total, 34 CAPD patients, 30 APD patients, and their caregivers were recruited from a large university hospital in Thailand. A trained interviewer conducted face-to-face interviews. We collected demographic data and used the KDQOL-36 and EuroQol questionnaires (EQ-5D-5L and VAS) to assess the health-related quality of life. Caregivers were asked to assess their own health status using the EQ-5D-5L and VAS. RESULTS: The EQ-5D-5L and VAS responses of the CAPD and APD patients and their caregivers were not significantly different (P > .05). More than 50% of both patient groups had mobility problems, whereas most patients had no problems with self-care, doing usual activities, pain or discomfort, and anxiety or depression. As for the KDQOL-36, the physical and mental component summaries were not significantly different, and neither were the scores for all of the kidney disease-specific dimensions, including symptoms or problems, effects of kidney disease, and burden of kidney disease (all were P > .05). CONCLUSIONS: The results indicated that the quality of life of CAPD and APD patients and their caregivers were mostly equivalent. A further longitudinal study of utility score assessments of the differences in modality would be advantageous.

Cost-Utility Analysis of Continuous Ambulatory Peritoneal Dialysis and Automated Peritoneal Dialysis for Thai Patients With End-Stage Renal Disease.

BACKGROUND: Continuous ambulatory peritoneal dialysis (CAPD) is the first option for patients with end-stage renal disease under the benefit package of Thailand. Nevertheless, automated peritoneal dialysis (APD) may benefit these patients in terms of both medical and quality-of-life aspects, but it is more expensive. The economic evidence for the comparison between CAPD and APD is not inconclusive. Thus, this study aims to evaluate the cost-effectiveness of CAPD compared with APD in PD patients. OBJECTIVES: To assess the health-related quality of life and costs between patients treated with CAPD and APD. METHODS: A Markov model was developed to evaluate the cost-effectiveness of CAPD and APD from the societal perspective. Costs and outcomes were calculated over a lifetime horizon and discounted at an annual rate of 3%. The outcomes were presented as quality-adjusted life-years (QALYs) of CAPD and APD. Utility scores were calculated from the utility values of the 5-level EuroQol questionnaire. A probabilistic sensitivity analysis using 5000 Monte Carlo simulations was performed to evaluate the stability of the results. RESULTS: The costs of APD and CAPD were 12 868 080 and 11 144 786 Thai baht, respectively, whereas the QALYs were 24.28 and 24.72 QALYs, respectively. APD was more costly but less effective than CAPD. The most sensitive parameter was direct medical cost of outpatient visits. When the willingness-to-pay threshold was 160 000 Thai baht per QALY, the probability of APD providing a cost-effective alternative to CAPD was 19%. CONCLUSION: APD was not a cost-effective strategy as compared with CAPD at the current Thai threshold. These findings should encourage clinicians and policy makers to encompass the use of CAPD as a good value for money for PD treatment.

National feasibility survey of peritoneal dialysis key performance indicators in Thailand from provider perspective.

BACKGROUND: Peritoneal dialysis (PD) has been the main method of renal replacement therapy under the "PD First" policy in Thailand since 2008. Initially, the proposed 13 key performance indicators (KPIs) raised feasibility concerns because of inequitable distribution of resources such as laboratory facilities and/or specialized health-care staff for PD care throughout the country. METHODS: Data availability and goals from the health-care providers' perspective were explored using an online questionnaire survey for all PD centers registered with the Nephrology Society of Thailand from May to June 2016. The availability of essential data required for each KPI indicator to achieve the desired target was assessed using a 5-point Likert scale. RESULTS: Of the 197 centers, 119 responded to the survey (response rate of 60.41%). PD indicators with a high percentage of strongly disagree or disagree were "PD adequacy measured in the last 12 months" (26.83%), "Total weekly Kt/V ≥ 1.7" (24.59%), "3-year PD technique survival" (21.31%), "Serum parathyroid levels within 150 to 500 pg/mL" (16.94%), and a "3-year PD patient survival" (19.01%). As many as 34.17%, 39.19%, 27.27%, 28.93%, and 22.00%, respectively, did not anticipate that the targets could be achieved. Based on the findings from this survey, the national committee concluded that these indicators be removed, and only eight PD indicators were launched. CONCLUSION: Given the importance of KPIs for quality assurance and financial reimbursement, inputs from health-care providers especially data availability and achievement of targets should be considered to ensure feasibility before the final list of indicators are launched.

Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results.

TRK-100STP, a sustained-release preparation of the orally active prostacyclin analogue beraprost sodium, targets renal hypoxia. This study aimed to show the superiority of TRK-100STP over placebos in patients with chronic kidney disease (with either primary glomerular disease or nephrosclerosis) to determine the recommended dose. CASSIOPEIR (Chronic Renal Failure Asian Study with Oral PGI2 Derivative for Evaluating Improvement of Renal Function) was a randomized, double-blind, placebo-controlled study conducted at 160 sites in seven Asia-Pacific countries and regions. Eligible patients (n = 892) were randomized to TRK-100STP 120, 240 µg, or placebo for a treatment period of up to 4 years. The primary efficacy endpoint was time to first occurrence of a renal composite: doubling of serum creatinine or occurrence of end-stage renal disease. No significant differences were observed in composite endpoints between TRK-100STP and placebo (P = 0.5674). Hazard ratios (95% CI) in the TRK-100STP 120 and 240 µg vs. placebo groups were 0.98 (0.78, 1.22) and 0.91 (0.72, 1.14), respectively. The overall incidence of adverse events and adverse drug reactions was comparable between treatment arms.

Comparison of EQ-5D-5L, VAS, and SF-6D in Thai Patients on Peritoneal Dialysis.

OBJECTIVES: To compare the utility scores derived from the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L), the visual analogue scale (VAS), and the 6-dimensional health state short form (SF-6D) in Thai patients on peritoneal dialysis. METHODS: Data were obtained from the 36-Item Kidney Disease Quality of Life questionnaire and the EuroQol questionnaires (EQ-5D-5L and VAS) via face-to-face interview for 64 patients on peritoneal dialysis. We compared the ceiling effect of all the utility tools by calculating the proportion at the highest scores. The mean difference in utility scores defined by patients' demographic characteristics and clinical laboratory value was evaluated using independent t tests or the Mann-Whitney U test. Moreover, the correlation was assessed using the Pearson correlation coefficient. The agreements among the instruments were illustrated with the Bland and Altman plots. RESULTS: The mean score of the EQ-5D-5L, SF-6D, and VAS were 0.801, 0.784, and 0.733, respectively. The EQ-5D-5L presented a higher percentage of the ceiling effect than did the SF-6D and VAS. The EQ-5D-5L was able to distinguish the mean difference between age groups with significant difference (P<.001). The Pearson correlation coefficients between utility scores and the 3 dimensions of the 36-Item Kidney Disease Quality of Life questionnaire had a significantly positive correlation, especially for the SF-6D. The Bland and Altman plots portrayed that the utility scores from the EQ-5D-5L were lower than those from the SF-6D and VAS among the patients in the poorer health state. CONCLUSIONS: Among the SF-6D, EQ-5D-5L, and VAS, only the EQ-5D-5L could distinguish the utility scores between different age groups. Nevertheless, the EQ-5D-5L presented the ceiling effect, whereas there was no evidence of the ceiling effect for the SF-6D. The SF-6D presented better correlation with the kidney disease-specific dimensions than did the EQ-5D-5L and VAS. Thus, the advantages and disadvantages of each utility tool should be considered.

Loss-of-function mutations of SCN10A encoding NaV1.8 α subunit of voltage-gated sodium channel in patients with human kidney stone disease.

Human kidney stone disease (KSD) causes significant morbidity and public health burden worldwide. The etiology of KSD is heterogeneous, ranging from monogenic defects to complex interaction between genetic and environmental factors. However, the genetic defects causing KSD in the majority of affected families are still unknown. Here, we report the discovery of mutations of SCN10A, encoding NaV1.8 α subunit of voltage-gated sodium channel, in families with KSD. The region on chromosome 3 where SCN10A locates was initially identified in a large family with KSD by genome-wide linkage analysis and exome sequencing. Two mutations (p.N909K and p.K1809R) in the same allele of SCN10A co-segregated with KSD in the affected family. Additional mutation (p.V1149M) of SCN10A was identified in another affected family, strongly supporting the causal role of SCN10A for KSD. The amino acids at these three positions, N909, K1809, and V1149, are highly conserved in vertebrate evolution, indicating their structural and functional significances. NaV1.8 α subunit mRNA and protein were found to express in human kidney tissues. The mutant proteins expressed in cultured cells were unstable and causing reduced current density as analyzed by whole-cell patch-clamp technique. Thus, loss-of-function mutations of SCN10A were associated with KSD in the families studied.