Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol.

BACKGROUND: Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. METHODS: The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. DISCUSSION: TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. TRIAL REGISTRATION: ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.

PD effluent specimen collection: Your questions answered.

When a patient on peritoneal dialysis (PD) presents with suspected PD-related peritonitis (e.g. cloudy PD fluid and abdominal pain), one of the most important initial aspects of management is for the nephrology nurse/home dialysis nurse to collect PD effluent specimens for white blood cells count, Gram stain, culture and sensitivity for inspection and to send for laboratory testing before antibiotics are started. A review by seven members of the International Society for Peritoneal Dialysis (ISPD) Nursing Committee of all 133 questions posted to the ISPD website 'Questions about PD' over the last 4 years (January 2018-December 2021), revealed 97 posted by nephrology nurses from around the world. Of these 97 questions, 10 were noted to be related to best practices for PD effluent specimen collection. For our review, we focused on these 10 questions along with their responses by the members of the ISPD 'Ask The Experts Team', whereby existing best practice recommendations were considered, if available, relevant literature was cited and differences in international practice discussed. We revised the original responses for clarity and updated the references. We found that these 10 questions were quite varied but could be organised into four categories: how to collect PD effluent safely; how to proceed with PD effluent collection; how to collect PD effluent for assessment; and how to proceed with follow-up PD effluent collection after intraperitoneal antibiotics have been started. In general, we found that there was limited evidence in the PD literature to answer several of these 10 questions posted to the ISPD website 'Questions about PD' by nephrology nurses from around the world on this important clinical topic of best practices for PD effluent specimen collection. Some of these questions were also not addressed in the latest ISPD Peritonitis Guidelines. Moreover, when polling members of our ISPD Nursing Committee we found when answering a few of these questions, nursing practice varied within and among countries. We encourage PD nurses to conduct their own research on this important topic, focusing on areas where research evidence is lacking.

Early Identification of CKD-A Scoping Review of the Global Populations.

Introduction: Decisions on whether to screen for chronic kidney disease (CKD) or not remain contentious in nephrology. This study provides a global overview of early CKD identification efforts. Methods: Guidelines for scoping reviews were followed and studies were identified by searching MEDLINE, EMBASE, Cochrane Library, CINAHL, ISI Web of Science, and PsycINFO. Data extracted from included studies focused on the following 4 themes: study population, measurement methods, interventions used, and available policies. Results: We identified 290 CKD screening and detection programs from 83 countries. Overall sample size was 3.72 million (North East Asia: 1.19 million), detection of CKD was the aim in 97.6%, 63.1% used population-based screening methods, and only 12.4% were in rural populations. Reported CKD prevalence (stages 3-5) was higher in targeted- (14.8%) than population-based studies (8.0%). Number of persons needed to screen (NNS) to identify 1 case was also lower in targeted studies (7 vs. 13). Single measurements (80%) and the combination of estimation of glomerular filtration rate with a urine test (albuminuria/proteinuria) (71.4%) were frequently used to detect CKD. Only 2.8% of studies included an intervention such as pharmacotherapy in identified cases. Policies on early identification were available in 30.1% of countries included. Conclusion: Methods for early CKD identification vary worldwide, often leading to wide variations in the reported prevalence. Efforts to standardize measurement methods for early detection focusing on high-risk populations and ensuring appropriate interventions are available to those identified with CKD will improve the value of programs and improve patient outcomes.

ISPD peritonitis guideline recommendations: 2022 update on prevention and treatment.

Peritoneal dialysis (PD)-associated peritonitis is a serious complication of PD and prevention and treatment of such is important in reducing patient morbidity and mortality. The ISPD 2022 updated recommendations have revised and clarified definitions for refractory peritonitis, relapsing peritonitis, peritonitis-associated catheter removal, PD-associated haemodialysis transfer, peritonitis-associated death and peritonitis-associated hospitalisation. New peritonitis categories and outcomes including pre-PD peritonitis, enteric peritonitis, catheter-related peritonitis and medical cure are defined. The new targets recommended for overall peritonitis rate should be no more than 0.40 episodes per year at risk and the percentage of patients free of peritonitis per unit time should be targeted at >80% per year. Revised recommendations regarding management of contamination of PD systems, antibiotic prophylaxis for invasive procedures and PD training and reassessment are included. New recommendations regarding management of modifiable peritonitis risk factors like domestic pets, hypokalaemia and histamine-2 receptor antagonists are highlighted. Updated recommendations regarding empirical antibiotic selection and dosage of antibiotics and also treatment of peritonitis due to specific microorganisms are made with new recommendation regarding adjunctive oral N-acetylcysteine therapy for mitigating aminoglycoside ototoxicity. Areas for future research in prevention and treatment of PD-related peritonitis are suggested.

International peritoneal dialysis training practices and the risk of peritonitis.

BACKGROUND: The effects of training practices on outcomes of patients receiving peritoneal dialysis (PD) are poorly understood and there is a lack of evidence informing best training practices. This prospective cohort study aims to describe and compare international PD training practices and their association with peritonitis. METHODS: Adult patients on PD <3 months participating in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) were included. Training characteristics (including duration, location, nurse affiliation, modality, training of family members, use of individual/group training and use of written/oral competency assessments) were reported at patient and facility levels. The hazard ratio (HR) for time to first peritonitis was estimated using Cox models, adjusted for selected patient and facility case-mix variables. RESULTS: A total of 1376 PD patients from 120 facilities across seven countries were included. Training was most commonly performed at the facility (81%) by facility-affiliated nurses (87%) in a 1:1 setting (79%). In the UK, being trained by both facility and third-party nurses was associated with a reduced peritonitis risk [adjusted HR 0.31 (95% confidence interval 0.15-0.62) versus facility nurses only]. However, this training practice was utilized in only 5 of 14 UK facilities. No other training characteristics were convincingly associated with peritonitis risk. CONCLUSIONS: There was no evidence to support that peritonitis risk was associated with when, where, how or how long PD patients are trained.

Burden of Kidney Disease, Health-Related Quality of Life, and Employment Among Patients Receiving Peritoneal Dialysis and In-Center Hemodialysis: Findings From the DOPPS Program.

RATIONALE & OBJECTIVE: Individuals faced with decisions regarding kidney replacement therapy options need information on how dialysis treatments might affect daily activities and quality of life, and what factors might influence the evolution over time of the impact of dialysis on daily activities and quality of life. STUDY DESIGN: Observational cohort study. SETTING & PARTICIPANTS: 7,771 hemodialysis (HD) and peritoneal dialysis (PD) participants from 6 countries participating in the Peritoneal and Dialysis Outcomes and Practice Patterns Studies (PDOPPS/DOPPS). PREDICTORS: Patient-reported functional status (based on daily living activities), country, demographic and clinical characteristics, and comorbidities. OUTCOME: Employment status and patient-reported outcomes (PROs) including Kidney Disease Quality of Life (KDQOL) instrument physical and mental component summary scores (PCS, MCS), kidney disease burden score, and depression symptoms (Center for Epidemiologic Studies Depression Scale [CES-D] score > 10). ANALYTICAL APPROACH: Linear regression (PCS, MCS, kidney disease burden score), logistic regression (depression symptoms), adjusted for predictors plus 12 additional comorbidities. RESULTS: In both dialysis modalities, patients in Japan had the highest PCS and employment (55% for HD and 68% for PD), whereas those in the United States had the highest MCS score, lowest kidney disease burden, and lowest employment (20% in HD and 42% in PD). After covariate adjustment, the association of age, sex, dialysis vintage, diabetes, and functional status with PROs was similar in both modalities, with women having lower PCS and kidney disease burden scores. Lower functional status (score <11) was strongly associated with lower PCS and MCS scores, a much greater burden of kidney disease, and greater likelihood of depression symptoms (CES-D, >10). The median change in KDQOL-based PROs was negligible over 1 year in participants who completed at least 2 annual questionnaires. LIMITATIONS: Selection bias due to incomplete survey responses. Generalizability was limited to the dialysis populations of the included countries. CONCLUSIONS: Variation exists in quality of life, burden of kidney disease, and depression across countries but did not appreciably change over time. Functional status remained one of the strongest predictors of all PROs. Routine assessment of functional status may provide valuable insights for patients and providers in anticipating outcomes and support needs for patients receiving either PD or HD.

Targeted Education ApproaCH to improve Peritoneal Dialysis Outcomes (TEACH-PD): A feasibility study.

BACKGROUND: There is substantial variation in peritonitis rates across peritoneal dialysis (PD) units globally. This may, in part, be related to the wide variability in the content and delivery of training for PD nurse trainers and patients. AIM: The aim of this study was to test the feasibility of implementing the Targeted Education ApproaCH to improve Peritoneal Dialysis Outcomes (TEACH-PD) curriculum in real clinical practice settings. METHODS: This study used mixed methods including questionnaires and semi-structured interviews (pretraining and post-training) with nurse trainers and patients to test the acceptability and usability of the PD training modules implemented in two PD units over 6 months. Quantitative data from the questionnaires were analysed descriptively. Interviews were analysed using thematic analysis. RESULTS: Ten PD trainers and 14 incident PD patients were included. Mean training duration to complete the modules were 10.9 h (range 6-17) and 24.9 h (range 15-35), for PD trainers and patients, respectively. None of the PD patients experienced PD-related complications at 30 days follow-up. Three (21%) patients were transferred to haemodialysis due to non-PD-related complications. Ten trainers and 14 PD patients participated in the interviews. Four themes were identified including use of adult learning principles (trainers), comprehension of online modules (trainers), time to complete the modules (trainers) and patient usability of the manuals (patient). CONCLUSION: This TEACH-PD study has demonstrated feasibility of implementation in a real clinical setting. The outcomes of this study have informed refinement of the TEACH-PD modules prior to rigorous evaluation of its efficacy and cost-effectiveness in a large-scale study.

Public health investments and mortality risk in Brazilian peritoneal dialysis patients.

BACKGROUND: End-stage kidney disease (ESKD) treatment is very costly and accounts for a significant percentage of public healthcare expenditures. Beyond direct costs, dialysis patients use other healthcare levels, but the impact of public investment on each of these levels is unclear. This study aimed to investigate the association between direct financing at different healthcare levels and overall mortality in peritoneal dialysis (PD) patients. METHODS: We included all adult incident PD patients from a Brazilian prospective, nationwide PD cohort. Overall mortality was the primary outcome of interest. We used a three-level multilevel survival analysis to investigate whether mortality was associated with the investments destined to different levels of healthcare complexity: (i) primary, (ii) medium and high and (iii) professional healthcare training and community awareness. RESULTS: We evaluated 5707 incident PD patients from 78 Brazilian cities, which were divided into four quartiles for each healthcare level (Groups I-IV). After taking the highest quartile (Group IV) as a reference, investment in the primary health level was not associated with patient survival. Otherwise, medium and high complexity levels were associated with higher mortality risk. Also, investment in healthcare manager training and community awareness had an impact on patient survival. CONCLUSIONS: Investments in different levels of the healthcare system have distinct impacts on PD patient survival. Investment in healthcare manager training and community awareness seems to be a promising strategy on which to focus, given the relatively low cost and positive impact on outcome.

Temporal Trends and Factors Associated with Medication Prescription Patterns in Peritoneal Dialysis Patients.

INTRODUCTION: Patients on peritoneal dialysis (PD) suffer from a high burden of comorbidities, which are managed with multiple medications. Determinants of prescription patterns are largely unknown in this population. This study assesses temporal changes and factors associated with medication prescription in a nationally representative population of patients on PD under the universal coverage healthcare system in Brazil. METHODS: Incident patients recruited in the Brazilian Peritoneal Dialysis Study (BRAZPD) from December 2004 to January 2011, stratified by prior hemodialysis (HD) treatment, were included in the analysis. Multivariable logistic regression was used to assess the association between medication prescription and socioeconomic factors. Yearly prevalent cross-sections were calculated to estimate prescription over time. RESULTS: Medication prescription was in general higher among patients who had previously received HD, compared with those who started renal replacement therapy (RRT) directly on PD. Prescription increased from baseline to 6 months of PD therapy, particularly in those who did not previously receive HD. After accounting for patient characteristics, significant associations were found between socioeconomic factors, geographic region, and medication prescription patterns. Finally, the prescription of all cardioprotective and anemia medications and phosphate binders increased significantly over time. CONCLUSION: In a PD population under universal coverage in a developing country, there was an increase in drug prescription during the first 6 months on PD, and a trend toward more liberal prescription of medications in later years. Independent from patient characteristics and comorbidities, socioeconomic factors influenced drug prescriptions that likely impact patient outcome, calling for public health action to decrease potential inequities in management of comorbidities in PD patients.

Peritonitis as a risk factor for long-term cardiovascular mortality in peritoneal dialysis patients: The case of a friendly fire?

AIM: Since the impact of peritonitis on long-term non-infectious mortality has not been investigated until the present, the aim of this study was to analyze the impact of peritonitis on long-term cardiovascular (CV) mortality in a large peritoneal dialysis (PD) cohort. METHODS: The analysis was based on BRAZPD II, a national prospective cohort study that recruited patients in Brazilian centres from December 2004 to January 2011. Incident adult PD patients with at least 90 days on treatment were included in the analysis. Cardiovascular death occurring after a minimum of 30 days after a peritonitis episode was considered the primary endpoint. Cox regression analysis for time-dependent variables was used for the adjustments. RESULTS: There were 2405 episodes of peritonitis in 5707 patients (48% males, 44% diabetes, 73% hypertensive). Patients with one episode of peritonitis presented a 22% increase in the hazard ratio of late CV mortality compared to those who never experienced peritonitis (HR1.22; CI95%1.01-1.47). Adjusted hazard for CV mortality showed a stepwise negative effect on survival for each additional peritonitis episode of infection: two episodes (HR1.78; CI95%1.31-2.42), three episodes (HR2.81; CI95%1.83-4.32) and four episodes (HR3.84; CI95%2.01-7.32). CONCLUSION: Peritonitis was an independent predictor of CV mortality and the frequency of peritonitis was strongly associated with an increase in this risk. This is the first study to demonstrate the impact of peritonitis on late cardiovascular mortality of PD patients, suggesting a link between acute inflammation and cardiovascular outcomes.

Disinfection of the peritoneal dialysis bag medication port: Comparison of disinfectant agent and disinfection time.

AIM: The aim of the present study was to compare different disinfection techniques for the peritoneal dialysis bag medication port (MP). METHODS: An experimental study was conducted testing different cleaning agents (70% alcohol vs 2% chlorhexidine) and time periods (5, 10 and 60 s) for disinfection of the MP. Five microorganisms (S. aureus, E. coli, A. baumannii and C. parapsilosis, CNS) were prepared for use as contaminants of the MP. MP were incubated in Tryptic soy broth at 36°C for 24 h, after which, they were seeded on a Biomérieux blood agar plate and incubated for 24 h at 36°C. RESULTS: Three hundred peritoneal dialysis bags were analyzed regarding the time expose to the disinfectant showed a statistically significant difference in the number of culture positive (7/100) P = 0.001; Gram positive (6/100) P = 0.006 for 5 s, one positive culture and turbid bag with 10 s, while friction for 60 s showed all negative results. The comparison between disinfectant, alcohol or chlorhexidine, 150 bag in each group, showed that the ones disinfected with alcohol had five turbid bags, eight positive cultures and seven germs identified, while all bags disinfected with chlorhexidine were negative for all parameters, with a difference statistically significant (P = 0.004). CONCLUSION: Our results suggest that the MP should be scrubbed with 2% chlorhexidine for at least 5 s; if alcohol 70% is used the length of friction should not be inferior to 10 s.

Impact of Pre-Dialysis Care on Clinical Outcomes in Peritoneal Dialysis Patients.

BACKGROUND: Structured pre-dialysis care is associated with an increase in peritoneal dialysis (PD) utilization, but not with peritonitis risk, technical and patient survival. This study aimed at analyzing the impact of pre-dialysis care on these outcomes. METHODS: All incident patients starting PD between 2004 and 2011 in a Brazilian prospective cohort were included in this analysis. Patients were divided into 2 groups: early pre-dialysis care (90 days of follow-up by a nephrology team); and late pre-dialysis care (absent or less than 90 days follow-up). The socio-demographic, clinical and biochemical characteristics between the 2 groups were compared. Risk factors for the time to the first peritonitis episode, technique failure and mortality based on Cox proportional hazards models. RESULTS: Four thousand one hundred seven patients were included. Patients with early pre-dialysis care presented differences in gender (female - 47.0 vs. 51.1%, p = 0.01); race (white - 63.8 vs. 71.7%, p < 0.01); education (<4 years - 61.9 vs. 71.0%, p < 0.01), respectively, compared to late care. Patients with early pre-dialysis care presented a higher prevalence of comorbidities, lower levels of creatinine, phosphorus, and glucose with a significantly better control of hemoglobin and potassium serum levels. There was no impact of pre-dialysis care on peritonitis rates (hazard ratio (HR) 0.88; 95% CI 0.77-1.01) and technique survival (HR 1.12; 95% CI 0.92-1.36). Patient survival (HR 1.20; 95% CI 1.03-1.41) was better in the early pre-dialysis care group. CONCLUSION: Earlier pre-dialysis care was associated with improved patient survival, but did not influence time to the first peritonitis nor technique survival in this national PD cohort.

A Syllabus for Teaching Peritoneal Dialysis to Patients and Caregivers.

Being aware of controversies and lack of evidence in peritoneal dialysis (PD) training, the Nursing Liaison Committee of the International Society for Peritoneal Dialysis (ISPD) has undertaken a review of PD training programs around the world in order to develop a syllabus for PD training. This syllabus has been developed to help PD nurses train patients and caregivers based on a consensus of training program reviews, utilizing current theories and principles of adult education. It is designed as a 5-day program of about 3 hours per day, but both duration and content may be adjusted based on the learner. After completion of our proposed PD training syllabus, the PD nurse will have provided education to a patient and/or caregiver such that the patient/caregiver has the required knowledge, skills and abilities to perform PD at home safely and effectively. The course may also be modified to move some topics to additional training times in the early weeks after the initial sessions. Extra time may be needed to introduce other concepts, such as the renal diet or healthy lifestyle, or to arrange meetings with other healthcare professionals. The syllabus includes a checklist for PD patient assessment and another for PD training. Further research will be needed to evaluate the effect of training using this syllabus, based on patient and nurse satisfaction as well as on infection rates and longevity of PD as a treatment.

The Needs of Older Patients for Peritoneal Dialysis: Training and Support at Home.

Chronic kidney disease (CKD) in all its stages has become an important problem for older patients, stage 3 - 5 is expected to happen in 25 to 30% of the population, and a higher prevalence can be found in residential care and nursing homes, affecting the demand for patient education. Although older patients are able and keen to learn, there are specific needs that must be addressed. The focus of this paper is to review the demands to train and maintain older patients on peritoneal dialysis (PD) at home.