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.

Efficacy of Potassium Supplementation in Hypokalemic Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Hypokalemia is a common electrolyte abnormality in patients on peritoneal dialysis (PD) and has been associated with increased risks of peritonitis and death. Whether correction of hypokalemia improves these outcomes is unknown. STUDY DESIGN: Multicenter, open-label, prospective, randomized controlled trial. SETTING & PARTICIPANTS: Adult (aged ≥18 years) PD patients with hypokalemia (defined as at least 3 values or an average value <3.5 mEq/L in the past 6 months). Randomization was stratified according to center and residual urine output (≤100 or >100 mL/day). INTERVENTIONS: Random assignment to either protocol-based potassium supplementation (titratable dose of oral potassium chloride to maintain serum potassium of 4-5 mEq/L) or conventional potassium supplementation (reactive supplementation when serum potassium is <3.5 mEq/L) over 52 weeks. Treatment groups were compared using intention-to-treat analyses implemented using Cox proportional hazards regression. OUTCOME: The primary outcome was time from randomization to first peritonitis episode (any organism). Secondary outcomes were all-cause mortality, cardiovascular mortality, hospitalization, and conversion to hemodialysis. RESULTS: A total of 167 patients with time-averaged serum potassium concentrations of 3.33 ± 0.28 mEq/L were enrolled from 6 PD centers: 85 were assigned to receive protocol-based treatment, and 82 were assigned to conventional treatment. The median follow-up time was 401 (IQR, 315-417) days. During the study period, serum potassium levels in the protocol-based treatment group increased to 4.36 ± 0.70 mEq/L compared with 3.57 ± 0.65 mEq/L in the group treated conventionally (mean difference, 0.66 [95% CI, 0.53-0.79] mEq/L; P < 0.001). The median time to first peritonitis episode was significantly longer in the protocol-based group (223 [IQR, 147-247] vs 133 [IQR, 41-197] days, P = 0.03). Compared with conventional treatment, the protocol-based group had a significantly lower hazard of peritonitis (HR, 0.47 [95% CI, 0.24-0.93]) but did not differ significantly with respect to any of the secondary outcomes. Asymptomatic hyperkalemia (>6 mEq/L) without characteristic electrocardiographic changes occurred in 3 patients (4%) in the protocol-based treatment group. LIMITATIONS: Not double-masked. CONCLUSIONS: Compared with reactive potassium supplementation when the serum potassium level falls below 3.5 mEq/L, protocol-based oral potassium treatment to maintain a serum potassium concentration in the range of 4-5 mEq/L may reduce the risk of peritonitis in patients receiving PD who have hypokalemia. TRIAL REGISTRATION: Registered at the Thai Clinical Trials Registry with study number TCTR20190725004.

Association between self-reported appetite and clinical outcomes of peritoneal dialysis patients: Findings from a low middle-income country.

AIM: Patient-reported outcome measures (PROM) has gained international recognition as important predictors of clinical outcomes in peritoneal dialysis (PD). We sought to understand the associations between patient-reported appetite and clinical outcomes. METHODS: In the Thailand Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS), 690 of 848 randomly selected PD patients from 22 facilities reported their appetite by using the short form (three items) of the Appetite and Diet Assessment Tool (ADAT), between 2016 and 2018. In this questionnaire, the patients rated their appetite as well as a change in appetite over time. Cox proportional hazards model regression was used to estimating associations between self-reported appetite and clinical outcomes, including mortality, haemodialysis (HD) transfer and peritonitis. RESULTS: Half of the PD patients reported a good appetite, whereas 34% and 16% reported fair and poor appetites, respectively. Poor appetite was more prevalent among female, diabetic, congestive heart failure, older age and patients who had worse nutritional indicators, including lower time-averaged serum albumin and serum creatinine concentrations, as well as a higher proportions of hypokalaemia and severe hypoalbuminemia (serum albumin <3 g/dl). After adjusting for age, sex, comorbidities, and PD vintage, poor appetite was associated with increased risks of peritonitis (adjusted hazard ratio [HR] 1.73, 95% confidence interval [CI] 1.14-2.62), HD transfer (adjusted HR 2.25, 95% CI 1.24-4.10) and all-cause mortality (adjusted HR 1.60, 95% CI 1.08-2.39) compared to patients with good appetite. CONCLUSION: Patient-reported poor appetite was independently associated with higher risks of peritonitis, HD transfer and all-cause mortality. This warrants further investigation to identify effective interventions.

Intraperitoneal Cefepime Monotherapy Versus Combination Therapy of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-Associated Peritonitis: A Multicenter, Open-Label, Noninferiority, Randomized, Controlled Trial.

RATIONALE & OBJECTIVE: Compared to combination therapy, intraperitoneal (IP) cefepime monotherapy for continuous ambulatory peritoneal dialysis (CAPD)-associated peritonitis may provide potential benefits in lowering staff burden, shortening time-consuming antibiotic preparation, and reducing bag contamination risk. This study sought to evaluate whether cefepime monotherapy is noninferior to combination regimens. STUDY DESIGN: Multicenter, open-label, noninferiority, randomized, controlled trial. SETTING & PARTICIPANTS: Adult incident peritoneal dialysis (PD) patients with CAPD-associated peritonitis in 8 PD centers in Thailand. INTERVENTIONS: Random assignment to either IP monotherapy of cefepime, 1g/d, or IP combination of cefazolin and ceftazidime, 1g/d, both given as continuous dosing. OUTCOMES: Primary end point: resolution of peritonitis at day 10 (primary treatment response). SECONDARY OUTCOMES: initial response (day 5), complete cure (relapse/recurrence-free response 28 days after treatment completion), relapsing/recurrent peritonitis, and death from any cause. Noninferiority would be confirmed for the primary outcome if the lower margin of the 1-sided 95% CI was not less than-10% for difference in the primary response rate. A 2-sided 90% CI was used to demonstrate the upper or lower border of the 1-sided 95% CI. RESULTS: There were 144 eligible patients with CAPD-associated peritonitis, of whom 70 and 74 patients were in the monotherapy and combination-therapy groups, respectively. Baseline demographic and clinical characteristics were not different between the groups. The primary response was 82.6% in the monotherapy group and 81.1% in the combination-therapy group (treatment difference, 1.5%; 90% CI, -9.1% to 12.1%; P=0.04). There was no significant difference in the monotherapy group compared with the combination-therapy group in terms of initial response rate (65.7% vs 60.8%; treatment difference, 4.9%; 95% CI, -10.8% to 20.6%; P=0.5) and complete cure rate (80.0% vs 80.6%; treatment difference, -0.6%; 95% CI, -13.9% to 12.8%; P=0.7). Relapsing and recurrent peritonitis occurred in 4.6% and 4.6% of the monotherapy group and 4.2% and 5.6% of the combination-therapy group (P=0.9and P=0.8, respectively). There was nominally higher all-cause mortality in the monotherapy group (7.1% vs 2.7%; treatment difference, 4.4%; 95% CI, -2.6% to 11.5%), but this difference was not statistically significant (P = 0.2). LIMITATION: Not double blind. CONCLUSIONS: IP cefepime monotherapy was noninferior to conventional combination therapy for resolution of CAPD-associated peritonitis at day 10 and may be a reasonable alternative first-line treatment. FUNDING: This study is supported by The Kidney Foundation of Thailand (R5879), Thailand; Rachadaphiseksompotch Fund (RA56/006) and Rachadaphicseksompotch Endorsement Fund (CU-GRS_61_06_30_01), Chulalongkorn University, Thailand; National Research Council of Thailand (156/2560), Thailand; and Thailand Research Foundation (IRG5780017), Thailand. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02872038.

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.

Development and Validation of a Chronic Kidney Disease Prediction Model for Type 2 Diabetes Mellitus in Thailand.

OBJECTIVES: The objective of this study was to investigate predictors and develop risk equations for stage-3 chronic kidney disease (CKD) in Thai patients with type 2 diabetes mellitus (DM). METHODS: A retrospective cohort study was conducted in patients with type 2 DM. The outcome was the development of stage-3 CKD. The data set was randomly split into training and validation data sets. Cox proportional hazard regression was used for model development. Discrimination (Harrell's C statistic) and calibration (the Hosmer-Lemeshow chi-square test and survival probability curve) were applied to evaluate model performance. RESULTS: In total, 2178 type 2 DM patients without stage-3 CKD, visiting the hospital from January 1, 2008, to December 31, 2017, were recruited, with median follow-up time of 1.29 years (interquartile range, 0.5-2.5 years); 385 (17.68%) subjects had developed stage-3 CKD. The final predictors included age, male sex, urinary albumin to creatinine ratio, estimated glomerular filtration rate, and hemoglobin A1c. Two 3-year stage-3 CKD risk models, model 1 (laboratory model) and model 2 (simplified model), had the C statistic in validation data sets of 0.890 and 0.812, respectively. CONCLUSIONS: Two 3-year stage-3 CKD risk models were developed for Thai patients with type 2 DM. Both models have good discrimination and calibration. These stage-3 CKD prediction models could equip health providers with tools for clinical management and supporting patient education.

Hypokalemia in peritoneal dialysis patients in Thailand: the pivotal role of low potassium intake.

OBJECTIVE: Hypokalemia is highly prevalent in chronic peritoneal dialysis (PD) patients worldwide, particularly in Thailand. This study aims to investigate the major determinants of hypokalemia in Thai PD patients. METHODS: A cross-sectional study was performed in chronic PD patients at 4 PD centers in Bangkok, Thailand. Hypokalemia was defined if the average serum potassium level during the last 3 consecutive visits was < 3.5 mEq/L. Patients and/or their caregivers were asked to perform a 3-day dietary food record and take pre- and post-meal pictures following the instructed protocol. Daily dietary nutrients, including potassium, were estimated by a single dietician using INMUCAL-N software. Total potassium excretion was determined by 24-h PD effluents and urine collection. Intracellular and extracellular water values (ICW and ECW, respectively) were measured by electrical bioimpedance assay (BIA) to indirectly explore the role of intracellular potassium shift in hypokalemia. RESULTS: Among 60 eligible PD patients, 19 (31%) had hypokalemia. Hypokalemic patients had significantly lower dietary potassium intake (24.4 ± 11.1 vs. 30.5 ± 9.4 mEq/day, p = 0.031) and lower total potassium excretion (28.5 ± 8.4 vs. 36.7 ± 11.2 mEq/day, p = 0.006) compared to normokalemic patients. Both groups had comparable values of ICW and ECW. On logistic regression, there was no significant correlation between hypokalemia and daily PD exchange volume, total Kt/Vurea, residual renal function, concurrent medications (insulin, diuretics, renin-angiotensin-aldosterone inhibitor, and beta-blockers) or ICW. Low dietary potassium was an independent risk factor for hypokalemia. CONCLUSION: Low dietary potassium intake, rather than increased potassium excretion or intracellular shift, is the major contributing factor of hypokalemia in Thai chronic PD patients. Dietary intervention or potassium supplement protocol should be implemented.

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.