The Point-of-Care Peritoneal Dialysis System Early Evaluation Study (POC-PDEE): A pilot proof-of-principal study of the Ellen Medical Devices Point-of-Care affordable peritoneal dialysis system.

The global unmet need for kidney replacement therapy means that millions of people die every year as they cannot afford treatment. Peritoneal dialysis (PD) offers comparable survival to haemodialysis and is often more affordable, but one barrier to increasing access is that conventional manufacturing and distribution of PD fluid is costly. Here we report the results from a pilot proof-of-principal study demonstrating for the first time that the Ellen Medical Devices Point-of-Care system can be used by patients to produce sterile PD fluid at the point-of-care. With further development, this low-cost system could offer a solution to the many millions of people around the world who currently cannot afford treatment for kidney failure.

A Quality Analysis of Donor Nephrectomy-Related Information on YouTube; Education or Misinformation?

INTRODUCTION: There currently remains an urgent need to increase living kidney donation to help mitigate the high demand for waitlisted kidney failure patients. Potential kidney donors can readily access social media, particularly YouTube, to gain basic knowledge about live donor nephrectomy surgical procedures. YouTube is an open-source platform where anyone can upload videos about any topic without peer review or quality control and is frequently used for disseminating health education. This study aims to assess the quality and accuracy of information regarding live donor nephrectomy on YouTube. METHODS: A YouTube search was performed using the keywords "donor nephrectomy" and "kidney transplant." A total of 57 videos were assessed for eligibility criteria. Two validated tools for evaluating health information, the DISCERN and The Patient Education Materials Assessment Tool for Audiovisual Materials tools, were used to assess YouTube video information quality, understandability, and actionability. RESULTS: A total of 53 of 57 screened videos were included in this study, with 4 videos being excluded for not being primarily in the English language. The mean (SD) DISCERN score was 23.3 (±8.3), and the mean (SD) The Patient Education Materials Assessment Tool for Audiovisual Materials Understandability and Actionability scores of 41.7% (±17.5) and 8.2% (±22.9%), respectively. Although videos were generally relevant in content to donor nephrectomy, videos lacked quality information and actionable items. CONCLUSIONS: Information on living donor nephrectomies is prevalent on YouTube. Our assessment using quality measures of selected videos illustrates substantial misinformation on living donor nephrectomies. YouTube has the potential to be a source of reliable and accurate information on living donor nephrectomies and donations.

Vitamin D Therapy in Adults With CKD: A Systematic Review and Meta-analysis.

RATIONALE & OBJECTIVE: Vitamin D is widely used to manage chronic kidney disease-mineral and bone disorder (CKD-MBD). We evaluated the effects of vitamin D therapy on mortality, cardiovascular, bone, and kidney outcomes in adults with CKD. STUDY DESIGN: Systematic review of randomized controlled trials (RCT) with highly sensitive searching of MEDLINE, Embase, and CENTRAL, through February 25, 2023. SETTING & STUDY POPULATIONS: Adults with stage 3, 4, or 5 CKD, including kidney failure treated with dialysis. Recipients of a kidney transplant were excluded. SELECTION CRITERIA FOR STUDIES: RCTs with≥3 months of follow-up evaluating a vitamin D compound. DATA EXTRACTION: Data were extracted independently by three investigators. ANALYTICAL APPROACH: Treatment estimates were summarized using random effects meta-analysis. Primary review endpoints were all-cause death, cardiovascular death, and fracture. Secondary outcomes were major adverse cardiovascular events, hospitalization, bone mineral density, parathyroidectomy, progression to kidney failure, proteinuria, estimated glomerular filtration rate, hypercalcemia, hyperphosphatemia, biochemical markers of CKD-MBD, and various intermediate outcome measures of cardiovascular disease. Risk of bias was assessed using the Cochrane Risk of Bias (RoB) 2 tool. Evidence certainty was adjudicated using GRADE. RESULTS: Overall, 128 studies involving 11,270 participants were included. Compared with placebo, vitamin D therapy probably had no effect on all-cause death (relative risk [RR], 1.04; 95% CI, 0.84-1.24); and uncertain effects on fracture (RR, 0.68; 95% CI, 0.37-1.23) and cardiovascular death (RR, 0.73; 95% CI, 0.31-1.71). Compared with placebo, vitamin D therapy lowered serum parathyroid hormone and alkaline phosphatase, but increased serum calcium. LIMITATIONS: Data were limited by trials with short-term follow-up periods, small sample size, and the suboptimal quality. CONCLUSIONS: Vitamin D therapy did not reduce the risk of all-cause death in people with CKD. Effects on fracture and cardiovascular and kidney outcomes were uncertain. TRIAL REGISTRATION: Registered at PROSPERO with study number CRD42017057691. PLAIN-LANGUAGE SUMMARY: Chronic kidney disease (CKD) is associated with increased risk of death, cardiovascular disease, and fractures. This excess risk is thought to be related to changes in bone and mineral metabolism, leading to the development of CKD-mineral and bone disorder (CKD-MBD) which is characterized by vascular calcification and reduced bone quality. Vitamin D is commonly used in the treatment of this condition. We reviewed randomized controlled trials examining the effect of vitamin D therapy in CKD. We found that vitamin D therapy affects serum biomarkers, including an increase in serum calcium. However, it probably has no effect on risk of all-cause death in CKD, and the effects on other clinical bone, cardiovascular, and kidney outcomes are uncertain.

Comparing survival in patients with chronic kidney disease across three countries - Results from the study of heart and renal protection-extended review.

AIM: This study examined whether survival and causes of death differed between participants enrolled from Australia (AUS), Malaysia (MYL), and New Zealand (NZ) in extended follow-up of the Study of Heart and Renal Protection (SHARP), a randomized controlled trial (RCT) of participants with moderate to severe chronic kidney disease comparing placebo to combination therapy with Simvastatin and Ezetimibe. METHODS: All participants alive at final SHARP study visit in participating centres were eligible for inclusion. Consenting participants were re-enrolled following final SHARP Study visit and followed for 5 years. Data collection included: significant medical events, hospital admissions and requirement for kidney replacement therapy. Data linkage was performed to national kidney and mortality registries. The primary outcome was all-cause mortality compared across the three countries. RESULTS: The SHARP trial randomized 2029 participants from AUS (1043/2029, 51%), MYL (701/2029, 35%), and NZ (285/2029, 14%), with 1136 participants alive and eligible for extended follow-up at the end of SHARP. In multivariable analysis, risk of death was increased for participants in MYL (HR 1.37, 95% CI 1.17-1.61, p < .001) and NZ (HR 1.28, 95% CI 1.04-1.57, p = .02) when compared to AUS participants. Adjustment for kidney transplantation as a competing risk did not explain the variation seen between countries. CONCLUSION: This study allows a better understanding of the differences in long-term mortality risk across participants from AUS, MYL, and NZ in extended follow-up of the SHARP study and demonstrates the feasibility and value of extended follow-up of participants enrolled in RCTs.

A Survey of Environmental Sustainability Practices in Dialysis Facilities in Australia and New Zealand.

BACKGROUND AND OBJECTIVES: Climate change is the biggest global health threat of the twenty-first century. Health care itself is a significant contributor to greenhouse gas emissions, and dialysis programs contribute disproportionately. Nephrology societies have called for increased recognition and action to minimize the environmental effect of dialysis care, but little data exist regarding environmental sustainability practices within dialysis facilities worldwide. This survey reports a baseline of environmental sustainability practices of dialysis facilities in Australia and New Zealand. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: An online survey was used to collect data regarding key areas of environmental sustainability practices within dialysis facilities between November 2019 and December 2020. An invitation to complete the survey was sent to the heads of all dialysis facilities in Australia and New Zealand. RESULTS: Responses were received from 132 dialysis facilities, representing 33% (122 of 365) of dialysis services within Australia and New Zealand. Most responses were from public satellite facilities (53 of 132; 40%), in-center dialysis facilities (33 of 132; 25%), and co-located dialysis and home therapies facilities (28 of 132; 21%). Opportunities for improvement in environmental sustainability practices were identified in three domains. (1) Culture. A minority of facilities reported having an environmental sustainability strategy in place (44 of 132; 33%) or undertaking sustainability audits (27 of 132; 20%). Only 7% (nine of 132) reported the inclusion of environmental training in staff induction programs. (2) Building design, infrastructure, and energy use. Few facilities reported the use of renewable energy (18 of 132; 14%), reclaiming reverse osmosis reject water (16 of 126; 13%), or the use of motion-sensor light switches (58 of 131; 44%). (3) Operations. A minority of facilities reported waste management education (47 of 131; 36%), auditing waste generation (23 of 132; 17%), or that environmental sustainability was considered in procurement decisions (33 of 132; 25%). CONCLUSIONS: Environmental sustainability is not currently prioritized in clinical practice, building design and infrastructure, or management systems in Australian and New Zealand dialysis facilities responding to this survey.

Impact of educational instruction on medical student performance in simulation patient.

Objectives: This study aimed to evaluate the effects, and timing of, a video educational intervention on medical student performance in manikin-based simulation patient encounters. Methods: This prospective mixed-methods study was conducted as part of the University of Toledo College of Medicine and Life Sciences undergraduate medical curriculum. One hundred sixty-six students second-year students participated in two simulations on a single day in September 2021. A 7-minute video intervention outlining the clinical diagnostic approach to pulmonary complaints was implemented. Students were randomized into 32 groups which were divided into two cohorts. One received the video prior to simulation-1 (n=83) and the other between simulation-1 and simulation-2 (n=83). Each simulation was recorded and assessed using a 44-point standardized checklist. Comparative analysis to determine differences in performance scores was performed using independent t-tests and paired t-tests. Results: Independent t-tests revealed the video-prior cohort performed better in simulation-1 (t(30)= 2.27, p= .03), however in simulation-2 no significant difference was observed between the cohorts. Paired t-test analysis revealed the video-between cohort had significant improvement from simulation-1 to simulation-2 (t(15)= 3.06, p = .01); no significant difference was found for the video-prior cohort. Less prompting was seen in simulation-2 among both the video-prior (t(15)= -2.83, p= .01) and video-between cohorts (t(15)= -2.18, p= .04). Conclusions: Simulation training, and targeted educational interventions, facilitate medical students to become clinically competent practitioners. Our findings indicate that guided video instruction advances students' clinical performance greater than learning through simulation alone. To confirm these findings, similar investigations in other clinical training exercises should be considered.

Patient and Clinician Perspectives on the use of Remote Patient Monitoring in Peritoneal Dialysis.

Background: Numerous factors influence patient recruitment to, and retention on, peritoneal dialysis (PD), but a major challenge is a perceived "inaccessibility" to treating clinicians. It has been suggested that remote patient monitoring (RPM) could be a means of improving such oversight and, thereby, uptake of PD. Objective: To describe patient and clinician perspectives toward RPM and the use of applications (Apps) suitable for mobiles, tablets, or computers to support the provision of PD care. Design: Qualitative design using semi-structured interviews. Setting: All patient participants perform PD treatment at home under the oversight of an urban PD unit in Sydney, Australia. Patient and clinician interviews were conducted within the PD unit. Participants: 14 participants (5 clinicians [2 nephrologists, 3 PD nurses] and 9 patients treated with PD). Methods: Semi-structured interviews were conducted using interview guides tailored for clinician and patient participants. Transcripts were coded and analyzed by a single researcher using thematic analysis. Results: Six themes were identified: perceived benefits of RPM implementation (offering convenience and efficiency, patient assurance through increased surveillance, more complete data and monitoring adherence), uncertainty regarding data governance (protection of personal data, data reliability), reduced patient engagement (transfer of responsibility leading to complacency), changing patient-clinician relationships (reduced patient-initiated communication, the need to maintain patient independence), increased patient and clinician burden (inadequate technological literacy, overmanagement leading to frequent treatment changes), and clinician preference influencing patient behavior. Limitations: The interviews were conducted in English only and with participants from a single urban dialysis unit, which may limit generalizability. Conclusions: For patients and clinicians, advantages from the use of RPM in PD may include increased patient confidence and assurance, improved treatment oversight, more complete data capture, and overcoming barriers to data documentation. Careful patient selection and patient and clinician education may help to optimize the benefits of RPM, maintain patient independence, and reduce the risks of patient disengagement. The use of an App may support RPM; however, participants expressed concerns about increasing the burden on some patients through the use of unfamiliar technology. Human Research Ethics Committee Approval Number: CH62/6/2019-028.

Contexte: De nombreux facteurs influent sur le recrutement et la rétention des patients en dialyse péritonéale (DP); un des principaux défis étant une impression d'« inaccessibilité ¼ aux cliniciens traitants. La télésurveillance des patients (TSP) a été suggérée comme possible moyen d'améliorer le suivi et, par conséquent, l'adhésion des patients à la DP. Objectif: Décrire les points de vue des patients et des cliniciens à l'égard de la TSP et de l'utilisation d'applications adaptées aux téléphones intelligents, aux tablettes ou aux ordinateurs pour aider à la prise en charge de la DP. Type d'étude: Étude qualitative menée par le biais d'entretiens semi-structurés. Cadre: Tous les patients suivant des traitements de DP à domicile sous la supervision de l'unité de DP d'un centre urbain de Sydney (Australie). Les entretiens avec les patients et les cliniciens ont été menés au sein de l'unité de DP. Participants à l'étude: 14 participants, soit 5 cliniciens (2 néphrologues, 3 infirmières et infirmiers en DP) et 9 patients sous DP. Méthodologie: Des entretiens semi-structurés ont été menés à l'aide de guides d'entrevue adaptés aux cliniciens et aux patients participants. Les transcriptions ont été codées, puis une analyse thématique par un seul chercheur a été réalisée. Résultats: Six thèmes ont été dégagés : 1) avantages perçus de la TSP (intervention pratique et efficace, patients rassurés par une surveillance accrue, données plus complètes et meilleur suivi de l'observance); 2) incertitude quant à la gouvernance des données (protection des données personnelles, fiabilité des données); 3) réduction de la participation des patients (transfert de responsabilité menant à la complaisance); 4) évolution de la relation patient-clinicien (réduction des échanges initiés par le patient, nécessité de maintenir l'indépendance du patient); 5) fardeau accru pour le patient et le clinicien (connaissances technologiques inadéquates, gestion excessive conduisant à de fréquents changements du traitement) et; 6) comportement du patient influencé par la préférence du clinicien. Limites: Les entretiens ont été menés uniquement en anglais, auprès de participants provenant d'une seule unité de dialyse en centre urbain, ce qui pourrait limiter la généralisabilité des résultats. Conclusion: Selon les patients et les cliniciens interrogés, la TSP en contexte de DP pourrait offrir plusieurs avantages : confiance et assurance accrues pour les patients, meilleure surveillance du traitement, saisie plus complète des données et suppression des entraves liées à la documentation des données. Une sélection rigoureuse des patients et une formation adéquate du patient et du clinicien pourraient contribuer à optimiser les avantages de la TSP, à maintenir l'indépendance du patient et à réduire les risques de désengagement. L'utilisation d'une application pourrait appuyer la TSP; des participants ont cependant exprimé des inquiétudes quant à une augmentation du fardeau pour certains patients moins familiers avec ce type de technologie. Numéro d'approbation du Comité d'éthique pour la recherche sur l'être humain : CH62/6/2019 ­ 028.

Data Challenges in Addressing Chronic Kidney Disease in Low- and Lower-Middle-Income Countries.

The burden of chronic kidney disease (CKD) is growing globally, particularly in low- and lower-middle-income countries (LLMICs) where access to treatment is poor and the largest increases in disease burden will occur. The individual and societal costs of kidney disease are well recognized, especially in developed health care systems where treatments for the advanced stages of CKD are more readily available. The consequences of CKD are potentially more catastrophic in developing health care systems where such resources are often lacking. Central to addressing this challenge is the availability of data to understand disease burden and ensure that investments in treatments and health resources are effective at a local level. Use of routinely collected administrative data is helpful in this regard, however, the barriers to developing a more systematic focus on data collection should not be underestimated. This article reviews the current tools that have been used to measure the burden of CKD and considers limitations regarding their use in LLMICs. A review of the literature investigating the use of registries, disease specific databases and administrative data to identify populations with CKD in LLMICs, which indicate these to be underused resources, is included. Suggestions regarding the potential use of administrative data for measuring CKD burden in LLMICs are explored.

The Impact of Clinical Presentation on Survival in Patients Requiring Hemodialysis Catheters for Acute and Unplanned Dialysis: A Prospective Observational Study.

BACKGROUND: Most studies addressing hemodialysis initiation with a dialysis catheter focus on patients entering maintenance dialysis programs and exclude other patients, such as those with acute kidney injury (AKI), making interpretation and application of the results difficult for clinicians managing patients at the time of dialysis commencement. OBJECTIVE: To compare the survival of all patients requiring a catheter for hemodialysis access according to the nature of clinical presentation. DESIGN: Prospective observational. SETTING: An Australian tertiary renal unit. PATIENTS: All patients requiring a central venous catheter (CVC) for hemodialysis access between 2005 and 2015. MEASUREMENTS: Baseline comorbidities, demographics, and nature of clinical presentation. Data regarding each episode of dialysis access insufficiency and each CVC were collected. The primary outcome was all-cause mortality. METHODS: Patients were classified into 1 of 3 groups based on physician assessment at the time of presentation: patients believed to have AKI with expected renal recovery (AKI), patients considered to be entering the maintenance dialysis program without a functioning dialysis access (Maintenance Dialysis), patients unable to perform peritoneal dialysis, or use their existing hemodialysis access (Access Failure). Time-split multivariable Cox regression analyses were used to compare survival between groups. RESULTS: A total of 557 eligible patients had complete prospective data regarding CVC use and were included in the analyses. The majority of patients were in the AKI (246/557, 44%) and Maintenance Dialysis groups (182/557, 33%) compared with the Access Failure group (129/557, 23%). During a median follow-up of 3 years, 302 (54%) of the 557 patients died. Following adjustment, risk of all-cause mortality was higher in the AKI group (hazard ratio [HR]: 2.01, 95% confidence interval [CI]: 1.31-3.60, P = .001) during the first 2 years after catheter insertion and lower in years 2 to 4 (HR: 0.42, 95% CI: 0.20-0.88, P = .02) than in the reference Maintenance Dialysis group. No difference in mortality risk between the Access Failure and reference group was found. LIMITATIONS: Single-center study. Possible residual confounding owing to the observational study design. CONCLUSIONS: Patients requiring acute or unplanned hemodialysis experience high mortality, and the nature of clinical presentation does influence outcomes. Most notable is the greater early mortality experienced by patients with AKI compared to other patient groups. Prospective definition of the nature of unplanned dialysis initiation is important to accurately measure and improve outcomes in this high-risk patient population. HUMAN RESEARCH ETHICS COMMITTEE APPROVAL NUMBER: CH62/6/2017-042.

CONTEXTE: La plupart des études traitant de l'initiation d'un traitement d'hémodialyse avec cathéter portent sur des patients qui s'engagent dans un program de dialyze d'entretien et excluent les autres patients, notamment ceux atteints d'insuffisance rénale aiguë (IRA). Ceci rend difficiles l'interprétation et l'application des résultats pour les cliniciens qui traitent les patients à l'amorce de la dialyze. OBJECTIF: Comparer la survie de tous les patients nécessitant un cathéter pour l'accès à l'hémodialyse selon la nature du tableau clinique. TYPE D'ÉTUDE: Étude observationnelle prospective. CADRE: L'unité de néphrologie d'un center de soins tertiaires australien. SUJETS: Tous les patients qui, entre 2005 et 2015, ont eu besoin d'un cathéter veineux central (CVC) pour l'hémodialyse. MESURES: Les maladies concomitantes existantes et les données démographiques des patients, ainsi que la nature du tableau clinique. Les données concernant chaque CVC et épisode d'accès déficient ont été recueillies. Le principal critère de jugement était la mortalité toutes causes confondues. MÉTHODOLOGIE: Les patients ont été répartis dans trois groupes selon l'évaluation du médecin au moment de la présentation : patients soupçonnés d'IRA avec récupération rénale prévue (groupe « IRA ¼), patients sans accès fonctionnel pour la dialyze considérés comme entrant dans le program de dialyze d'entretien (groupe « dialyze d'entretien ¼), et les patients incapables de pratiquer la dialyze péritonéale ou d'utiliser leur accès vasculaire existant (groupe « échec de l'accès ¼). Des régressions de Cox multivariées à temps partagé ont été utilisées pour comparer la survie entre les groupes. RÉSULTATS: Ont été inclus dans les analyses les 557 patients admissibles pour lesquels on disposait de données prospectives complètes sur l'utilization d'un CVC. La majorité des patients se trouvaient dans les groupes « IRA ¼ (246/557; 44 %) et « dialyze d'entretien ¼ (182/557; 33 %); le groupe « échec de l'accès ¼ ne représentant que 23 % des patients inclus (129/557). Au cours d'un suivi médian de trois ans, 302 patients (54 %) sont décédés. Après correction, le risque de mortalité toutes causes confondues dans les deux premières années suivant l'insertion du cathéter était plus élevé dans le groupe IRA (RR : 2,01; IC à 95 % : 1,31-3,60; P = .001) que dans le groupe référence (dialyze d'entretien); mais moins élevé après 2 à 4 ans (RR : 0.42; IC 95 % : 0.20-0.88; P = .02). Aucune différence n'a été observée entre le groupe « échec de l'accès ¼ et le groupe de référence. LIMITES: L'étude est monocentrique et la nature observationnelle de l'étude sous-tend de possibles facteurs de confusion résiduels. CONCLUSION: Les patients nécessitant une hémodialyse aiguë ou non planifiée connaissent un taux de mortalité élevé, et la nature du tableau clinique influence les résultats. Le plus remarquable étant la mortalité précoce plus élevée des patients atteints d'IRA comparativement aux autres patients. Il est important de définir la nature prospective de l'amorce non planifiée de la dialyze afin de mesurer précisément les résultats dans cette population à haut risque, et de les améliorer.