Impact of Prior Abdominal Procedures on Peritoneal Dialysis Catheter Outcomes: Findings From the North American Peritoneal Dialysis Catheter Registry.

RATIONALE & OBJECTIVE: A history of prior abdominal procedures may influence the likelihood of referral for peritoneal dialysis (PD) catheter insertion. To guide clinical decision making in this population, this study examined the association between prior abdominal procedures and outcomes in patients undergoing PD catheter insertion. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Adults undergoing their first PD catheter insertion between November 1, 2011 and November 1, 2020, at 11 institutions in Canada and the US participating in the International Society for Peritoneal Dialysis (ISPD) North American Catheter Registry. EXPOSURE: Prior abdominal procedure(s), defined as any procedure that enters the peritoneal cavity. OUTCOMES: Primary outcome: time to the first of abandonment of the PD catheter, or interruption/termination of PD. SECONDARY OUTCOMES: rates of emergency room visits, hospitalizations, and procedures. ANALYTICAL APPROACH: Cumulative incidence curves were used to describe the risk over time and an adjusted Cox proportional hazards model was used to estimate the association between the exposure and primary outcome. Models for count data were used to estimate the associations between the exposure and secondary outcomes. RESULTS: A total of 855 patients met the inclusion criteria. Thirty-one percent had a history of a prior abdominal procedure and 20% experienced at least one PD catheter-related complication that led to the primary outcome. Prior abdominal procedures were not associated with an increased risk of the primary outcome [Adjusted HR 1.12 (95% CI 0.68-1.84)]. Upper abdominal procedures were associated with a higher adjusted hazard of the primary outcome, but there was no dose-response relationship concerning the number of procedures. There was no association between prior abdominal procedures and other secondary outcomes. LIMITATIONS: Observational study and cohort limited to sample of patients felt to be potential candidates for PD catheter insertion. CONCLUSION: A history of prior abdominal procedure(s) does not appear to influence catheter outcomes following PD catheter insertion. Such a history should not be a contraindication to peritoneal dialysis.

The Association of Intra-Abdominal Adhesions with Peritoneal Dialysis Catheter-Related Complications.

BACKGROUND: This study investigated the association of intra-abdominal adhesions with the risk of peritoneal dialysis (PD) catheter complications. METHODS: Individuals undergoing laparoscopic PD catheter insertion were prospectively enrolled from eight centers in Canada and the United States. Patients were grouped based on the presence of adhesions observed during catheter insertion. The primary outcome was the composite of PD never starting, termination of PD, or the need for an invasive procedure caused by flow restriction or abdominal pain. RESULTS: Seven hundred and fifty-eight individuals were enrolled, of whom 201 (27%) had adhesions during laparoscopic PD catheter insertion. The risk of the primary outcome occurred in 35 (17%) in the adhesion group compared with 58 (10%) in the no adhesion group (adjusted HR, 1.64; 95% confidence interval [CI], 1.05 to 2.55) within 6 months of insertion. Lower abdominal or pelvic adhesions had an adjusted HR of 1.80 (95% CI, 1.09 to 2.98) compared with the no adhesion group. Invasive procedures were required in 26 (13%) and 47 (8%) of the adhesion and no adhesion groups, respectively (unadjusted HR, 1.60: 95% CI, 1.04 to 2.47) within 6 months of insertion. The adjusted odds ratio for adhesions for women was 1.65 (95% CI, 1.12 to 2.41), for body mass index per 5 kg/m 2 was 1.16 (95% CI, 1.003 to 1.34), and for prior abdominal surgery was 8.34 (95% CI, 5.5 to 12.34). Common abnormalities found during invasive procedures included PD catheter tip migration, occlusion of the lumen with fibrin, omental wrapping, adherence to the bowel, and the development of new adhesions. CONCLUSIONS: People with intra-abdominal adhesions undergoing PD catheter insertion were at higher risk for abdominal pain or flow restriction preventing PD from starting, PD termination, or requiring an invasive procedure. However, most patients, with or without adhesions, did not experience complications, and most complications did not lead to the termination of PD therapy.

Multicentre registry analysis of incremental peritoneal dialysis incidence and associations with patient outcomes.

BACKGROUND: Incremental peritoneal dialysis (PD) is increasingly advocated to reduce treatment burden and costs, with potential to better preserve residual kidney function. Global prevalence of incremental PD use is unknown and use in Australia and New Zealand has not been reported. METHODS: Binational registry analysis including incident adult PD patients in Australia and New Zealand (2007-2017), examining incidence of and outcomes associated with incremental PD (first recorded PD exchange volume <42 L/week (incremental) vs. ≥42 L/week (standard)). RESULTS: Incremental PD use significantly increased from 2.7% of all incident PD in 2007 to 11.1% in 2017 (mean increase 0.84%/year). Duration of incremental PD use was 1 year or less in 67% of cases. Male sex, Aboriginal and Torres Strait Islander (ATSI) or Maori ethnicities, age 45-59 years, medical comorbidities or treatment at a centre with low use of automated PD or icodextrin was associated with lower incidence of incremental PD use. Low body mass index and higher estimated glomerular filtration rate was associated with higher incidence. After accounting for patient and centre variables, commencing PD with an incremental prescription was associated with reduced peritonitis risk (adjusted hazard ratio 0.73, 95% confidence interval (CI) 0.61-0.86).When kidney transplantation and death were considered as competing risks, the association between incremental PD and peritonitis was not significant (sub-hazard ratio [SHR] 0.91, 95%CI 0.71-1.17, p = 0.5), however cumulative incidence of 30-day transfer to haemodialysis was lower in those receiving incremental PD (SHR 0.73, 95%CI 0.56-0.94, p = 0.01). There was no association between incremental PD and death. CONCLUSIONS: Incremental PD use is increasing in Australia and New Zealand and is not associated with patient harm.

Early Experience with Modified Dose Nirmatrelvir/Ritonavir in Dialysis Patients with Coronavirus Disease 2019.

BACKGROUND: Nirmatrelvir/ritonavir was approved for use in high-risk outpatients with coronavirus disease 2019 (COVID-19). However, patients with severe CKD were excluded from the phase 3 trial, and the drug is not recommended for those with GFR <30 ml/min per 1.73 m 2 . On the basis of available pharmacological data, we developed a modified low-dose regimen of nirmatrelvir/ritonavir 300/100 mg on day 1, followed by 150/100 mg daily from day 2 to 5. In this study, we report our experience with this modified dose regimen in dialysis patients in the Canadian province of Ontario. METHODS: We included dialysis patients who developed COVID-19 and were treated with the modified dose nirmatrelvir/ritonavir regimen during a 60-day period between April 1 and May 31, 2022. Details of nirmatrelvir/ritonavir use and outcomes were captured manually, and demographic data were obtained from a provincial database. Data are presented with descriptive statistics. The principal outcomes we describe are 30-day hospitalization, 30-day mortality, and required medication changes with the modified dose regimen. RESULTS: A total of 134 dialysis patients with COVID-19 received nirmatrelvir/ritonavir during the period of study. Fifty-six percent were men, and the mean age was 64 years. Most common symptoms were cough and/or sore throat (60%). Medication interactions were common with calcium channel blockers, statins being the most frequent. Most patients (128, 96%) were able to complete the course of nirmatrelvir/ritonavir, and none of the patients who received nirmatrelvir/ritonavir died of COVID-19 in the 30 days of follow-up. CONCLUSIONS: A modified dose of nirmatrelvir/ritonavir use was found to be safe and well tolerated, with no serious adverse events being observed in a small sample of maintenance dialysis patients.

A New Perspective to Longstanding Challenges with Outpatient Hyperkalemia: A Narrative Review.

Purpose of Review: Outpatient hyperkalemia is a common problem with potentially deadly consequences. Potassium level thresholds to treat outpatient hyperkalemia are unstandardized and variable, leaving health care providers to rely on their own clinical judgment. This narrative review highlights the challenges of outpatient hyperkalemia management and includes recommendations for future studies that may standardize treatment, improve patient outcomes, and optimize health care utilization. Sources of Information: PubMed, Google Scholar, and the reference lists of identified articles were used to include English, peer-reviewed studies and guidelines for this review. Methods: This narrative review examines outpatient hyperkalemia from both a laboratory and clinical perspective. In addition to peer-reviewed literature, guidelines and expert consensus statements were included to highlight the inconsistencies and paucity of evidence that health care providers rely on to make clinical decisions. Key Findings: There are multiple reasons why outpatient hyperkalemia management is both challenging and sub-optimal. Clinicians must discern if the potassium level result is accurate and, if so, does the result warrant referral to the emergency department. Factitious hyperkalemia, or falsely elevated potassium level results due to analytical errors, occurs frequently, but there are no ways to identify it other than for hemolyzed samples. Additionally, guidelines and expert panels are inconsistent on the thresholds for treatment and the management of hyperkalemia. Finally, there are inconsistencies between laboratories as to when and how providers are notified of results, and the suggested thresholds for urgent management. A study that integrates the expertise of clinical biochemists and clinicians is needed to inform evidence-based guidelines for the management of outpatient hyperkalemia. Limitations: This was a comprehensive review of what is known and what still needs to be understood for the management of outpatient hyperkalemia. A formal tool to assess the quality of the included studies was not used and selection bias may have occurred.

Raison de la revue: L'hyperkaliémie ambulatoire est fréquente et peut avoir des conséquences mortelles. Les seuils de potassium justifiant le traitement de l'hyperkaliémie ambulatoire varient et ne sont pas normalisés; les professionnels de la santé doivent par conséquent s'en remettre à leur propre jugement clinique. Cette revue narrative met en évidence les défis liés à la prise en charge de l'hyperkaliémie ambulatoire et comprend des recommandations pour de futures études pour standardiser le traitement, améliorer les résultats des patients et optimiser l'utilisation des soins de santé. Sources d'information: PubMed, Google Scholar et les listes de références des articles répertoriés ont été utilisés pour inclure les études évaluées par les pairs et les lignes directrices rédigées en anglais. Méthodologie: Cette revue narrative examine la prise en charge de l'hyperkaliémie ambulatoire du point de vue clinique et paraclinique. En plus des articles évalués par les pairs, on a inclus des lignes directrices et des déclarations de consensus d'experts afin de mettre en évidence les incohérences et la rareté des données probantes sur lesquelles s'appuient les prestataires de soins de santé pour prendre des décisions cliniques. Principaux resultants: Plusieurs raisons peuvent expliquer pourquoi la prise en charge de l'hyperkaliémie ambulatoire est à la fois difficile et sous-optimale. Les cliniciens doivent juger eux-mêmes si le résultat du potassium est exact et, dans l'affirmative, déterminer s'il justifie l'aiguillage du patient vers les urgences. L'hyperkaliémie factice, soit des taux de potassium faussement élevés en raison d'erreurs analytiques, est fréquente, mais il n'existe aucun moyen de l'établir à l'exception des échantillons hémolysés. Aussi, les lignes directrices et les groupes d'experts ne s'entendent pas sur les seuils de traitement et de prise en charge de l'hyperkaliémie. Enfin, on observe des incohérences entre les laboratoires quant au moment et à la façon dont les prestataires sont informés des résultats, de même qu'en ce qui concerne les seuils suggérés pour une prise en charge urgente. Une étude intégrant l'expertise des biochimistes cliniques et des cliniciens est nécessaire pour éclairer des lignes directrices fondées sur des données probantes pour la prise en charge de l'hyperkaliémie ambulatoire. Limites: Il s'agit d'un examen complet de ce que l'on connaît et de ce qui doit encore être compris au sujet de la prise en charge de l'hyperkaliémie ambulatoire. Des biais de sélection pourraient s'être introduits puisqu'aucun outil formel n'a été utilisé pour évaluer les études incluses.

Recognition of Obesity and Perceptions of Weight Loss Management in Patients With Chronic Kidney Disease: A Retrospective Cross-Sectional Study.

Background: Obesity is, directly and indirectly, linked to the progression of chronic kidney disease (CKD). However, nephrologists' recognition of obesity and willingness to address and manage obesity are unknown. Objectives: The aim of this article is to investigate if obesity is recognized and documented in the clinical encounter and to examine nephrologists' perceptions of obesity and comfort with weight loss management. Design: We conducted a 2-part study. Part I used a retrospective chart review and part II used an anonymous online survey of practicing nephrologists (n = 14) in our center. Setting: The study took place in the Multi-care Kidney Clinic (MCKC) at London Health Sciences Centre in London, Ontario, Canada. Patients: In part I, we conducted a retrospective chart review of 10 random patients with advanced CKD and obesity (body mass index [BMI] > 30 kg/m2) from each of the nephrologists between January and December 2019. Methods: In part I, charts were assessed for documentation of obesity and/or a treatment plan (lifestyle counseling, pharmacologic intervention, and specialist referral). In part II, a survey completed by the nephrologists explored their current experience and perceptions of obesity and comfort with weight loss management. Responses were ranked on a 5-point Likert scale. Results: In all, 140 patient charts were reviewed. The median age was 69 (interquartile range [IQR] = 60-77) years, estimated glomerular filtration rate (eGFR) was 17 (IQR = 12-20) ml/min/1.73 m2, weight was 99 (IQR = 90-116) kg, and BMI was 36 (IQR = 33-40) kg/m2. Obesity with a BMI was documented in 36 (26%) charts, and only 2 (1%) documented a weight loss plan, which only included non-pharmacologic strategies. There were 13 survey responses (93% response rate). All nephrologists agreed that obesity negatively affects the health of patients with CKD. Twelve (92%) reported discussing obesity with patients, but none felt that they had time to treat it. All reported discussions of obesity would evoke a negative patient response, while 5 (38%) thought patients actually want to discuss obesity. Regarding treatment, 8 (62%) nephrologists felt comfortable with non-pharmacologic treatment, but only 1 respondent was comfortable with pharmacologic treatments. Twelve (92%) nephrologists thought patients should be referred to a specialist. Limitations: There was limited generalizability as this was a single center study. The BMI may reflect hypervolemia rather than body mass. Conclusion: In our study, nephrologists rarely document and manage obesity in patients with advanced CKD, despite their perception of treatment benefits. Improved outcomes of obesity management for patients with CKD will require increased knowledge and clinical tools to efficiently address obesity with patients.

Contexte: L'obésité est directement et indirectement liée à la progression de l'insuffisance rénale chronique (IRC). La reconnaissance de l'obésité par les néphrologues et leur volonté de la prendre en charge demeurent toutefois mal connues. Objectifs: Vérifier si l'obésité est reconnue et documentée lors de la rencontre clinique. Examiner les perceptions des néphrologues quant à l'obésité et leur confort face à la gestion du poids. Conception: Notre étude était constituée de deux parties. La première consistait en un examen rétrospectif des dossiers et la deuxième en un sondage anonyme mené en ligne auprès des néphrologues praticiens (n = 14) de notre centre. Cadre: La clinique multidisciplinaire en santé rénale (CMSR) du London Health Sciences Centre de London, en Ontario (Canada). Sujets: Dans la première partie, nous avons examiné rétrospectivement les dossiers de dix patients aléatoires atteints d'IRC de stade avancé et jugés obèses (IMC > 30 kg/m2) pour chacun des néphrologues participants entre janvier et décembre 2019. Méthodologie: Dans la première partie, les dossiers ont été examinés à la recherche d'une mention de l'obésité et/ou d'un plan de traitement (conseils sur le mode de vie, intervention pharmacologique, aiguillage vers un spécialiste). Dans la deuxième partie, un sondage réalisé auprès des néphrologues a exploré leur expérience et leurs perceptions actuelles sur l'obésité et leur confort quant à la gestion de la perte de poids. Les réponses ont été classées sur une échelle Likert de 5 points. Résultats: En tout, 140 dossiers patients ont été examinés. L'âge médian s'établissait à 69 ans (ÉIQ: 60-77), le DFGe médian à 17 ml/min/1,73 m2 (ÉIQ: 12-20), le poids médian à 99 kg (ÉIQ: 90-116) et l'IMC médian à 36 kg/m2 (ÉIQ: 33-40). L'obésité avec IMC était documentée dans 36 dossiers (26%) et seulement deux dossiers (1%) comportaient un plan de perte de poids, lequel ne comprenait que des stratégies non pharmacologiques. Treize néphrologues ont répondu au sondage (taux de réponse: 93%). Tous ont convenu que l'obésité affecte négativement la santé des patients atteints d'IRC; douze (92%) ont mentionné discuter d'obésité avec leurs patients, mais aucun ne pensait avoir le temps de la traiter. Tous les répondants ont indiqué que les discussions abordant l'obésité recevaient un accueil négatif de la part du patient; seuls 5 néphrologues (38%) étaient d'avis que les patients sont réellement ouverts à discuter d'obésité. Quant à son traitement, huit néphrologues (62%) se sont dits à l'aise avec un traitement non pharmacologique; un seul répondant était à l'aise avec les traitements pharmacologiques. Selon douze répondants (92%), les patients devraient être dirigés vers un spécialiste. Limites: Étude dans un seul centre, ce qui limite la généralisabilité. L'IMC pourrait refléter une hypervolémie plutôt que la masse corporelle. Conclusion: Dans notre étude, les néphrologues ont rarement documenté et pris en charge l'obésité de leurs patients atteints d'IRC de stade avancé, et ce, bien qu'ils croient aux avantages de son traitement. Pour améliorer la prise en charge de l'obésité chez les patients atteints d'IRC, il faudra améliorer les connaissances et les outils cliniques permettant de la traiter efficacement chez ces patients.

Incremental Versus Standard (Full-Dose) Peritoneal Dialysis.

Incremental peritoneal dialysis (PD), defined as less than "standard dose" PD prescription, has a number of possible benefits, including better preservation of residual kidney function (RKF), reduced risk of peritonitis, lower peritoneal glucose exposure, lesser environmental impact, and reduced costs. Patients commencing PD are often new to kidney replacement therapy and possess substantial RKF, which may allow safe delivery of an incremental prescription, often in the form of lower frequency or duration of PD. This has the potential to help improve quality of life (QOL) and life participation through reducing time requirements and burden of treatment. Alternatively, incremental PD could potentially contribute to reduced small solute clearance, fluid overload, or patient reluctance to increase dialysis prescription when later needed. This review discusses the definition, rationale, uptake, potential advantages and disadvantages, and clinical trial evidence pertaining to the use of incremental PD.

Impact of Bioelectrical Impedance-Guided Fluid Management and Vitamin D Supplementation on Left Ventricular Mass in Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Hypervolemia and vitamin D deficiency occur frequently in patients receiving peritoneal dialysis and may contribute to left ventricular (LV) hypertrophy. The effect of bioelectrical impedance analysis (BIA)-guided volume management or vitamin D supplementation on LV mass among those receiving peritoneal dialysis is uncertain. STUDY DESIGN: Two-by-two factorial randomized controlled trial. SETTING & PARTICIPANTS: Sixty-five patients receiving maintenance peritoneal dialysis. INTERVENTION: BIA-guided volume management versus usual care and oral cholecalciferol 50,000 U weekly for 8 weeks followed by 10,000 U weekly for 44 weeks or matching placebo. OUTCOME: Change in LV mass at 1 year measured by cardiac magnetic resonance imaging. RESULTS: Total body water decreased by 0.9 + 2.4 (SD) L in the BIA group compared with a 1.5 ± 3.4 L increase in the usual care group (adjusted between-group difference: -2.4 [95% CI, -4.1 to -0.68] L, P = 0.01). LV mass increased by 1.3 ± 14.3 g in the BIA group and decreased by 2.4 ± 37.7 g in the usual care group (between-group difference: +2.2 [95% CI, -13.9 to 18.3] g, P = 0.8). Serum 25-hydroxyvitamin D concentration increased by a mean of 17.2 ± 30.8 nmol/L in the cholecalciferol group and declined by 8.2 ± 24.3 nmol/L in the placebo group (between-group difference: 28.3 [95% CI, 17.2-39.4] nmol/L, P < 0.001). LV mass decreased by 3.0 ± 28.1 g in the cholecalciferol group and increased by 2.0 ± 31.2 g in the placebo group (between-group difference: -4.5 [95% CI, -20.4 to 11.5] g, P = 0.6). LIMITATIONS: Relatively small sample size with larger than expected variation in change in LV mass. CONCLUSIONS: BIA-guided volume management had a modest impact on volume status with no effect on the change in LV mass. Vitamin D supplementation increased serum vitamin D concentration but had no effect on LV mass. FUNDING: Unrestricted Baxter International extramural grant and the Kidney Foundation of Canada. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT01045980.

Outcome measures for technique survival reported in peritoneal dialysis: A systematic review.

BACKGROUND: Peritoneal dialysis (PD) technique survival is an important outcome for patients, caregivers and health professionals, however, the definition and measures used for technique survival vary. We aimed to assess the scope and consistency of definitions and measures used for technique survival in studies of patients receiving PD. METHOD: MEDLINE, EMBASE and CENTRAL databases were searched for randomised controlled studies (RCTs) conducted in patients receiving PD reporting technique survival as an outcome between database inception and December 2019. The definition and measures used were extracted and independently assessed by two reviewers. RESULTS: We included 25 RCTs with a total of 3645 participants (41-371 per trial) and follow up ranging from 6 weeks to 4 years. Terminology used included 'technique survival' (10 studies), 'transfer to haemodialysis (HD)' (8 studies) and 'technique failure' (7 studies) with 17 different definitions. In seven studies, it was unclear whether the definition included transfer to HD, death or transplantation and eight studies reported 'transfer to HD' without further definition regarding duration or other events. Of those remaining, five studies included death in their definition of a technique event, whereas death was censored in the other five. The duration of HD necessary to qualify as an event was reported in only four (16%) studies. Of the 14 studies reporting causes of an event, all used a different list of causes. CONCLUSION: There is substantial heterogeneity in how PD technique survival is defined and measured, likely contributing to considerable variability in reported rates. Standardised measures for reporting technique survival in PD studies are required to improve comparability.

MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

BACKGROUND: Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) is a 4-year cluster-randomized clinical trial comparing the effect of using a personalized, temperature-reduced dialysate protocol versus a dialysate temperature of 36.5°C on cardiovascular-related death and hospitalization. Randomization was performed at the level of the dialysis center ("the cluster"). OBJECTIVE: The objective is to outline the statistical analysis plan for the MyTEMP trial. DESIGN: MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial. SETTING: A total of 84 dialysis centers in Ontario, Canada. PATIENTS: Approximately 13 500 patients will have received in-center hemodialysis at the 84 participating dialysis centers during the trial period (April 3, 2017, to March 1, 2021, with a maximum follow-up to March 31, 2021). METHODS: Patient identification, baseline characteristics, and study outcomes will be obtained primarily through Ontario administrative health care databases held at ICES. Covariate-constrained randomization was used to allocate the 84 dialysis centers (1:1) to the intervention group or the control group. Centers in the intervention group used a personalized, temperature-reduced dialysate protocol, and centers in the control group used a fixed dialysate temperature of 36.5°C. OUTCOMES: The primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization (defined as a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in administrative health care databases. The key secondary outcome is the mean drop in intradialytic systolic blood pressure, defined as the patients' predialysis systolic blood pressure minus their nadir systolic blood pressure during the dialysis treatment. Anonymized data on patients' predialysis and intradialytic systolic blood pressure were collected at monthly intervals from each dialysis center. ANALYSIS PLAN: The primary analysis will follow an intent-to-treat approach. The primary outcome will be analyzed at the patient level as the hazard ratio of time-to-first event, estimated from a subdistribution hazards model. Within-center correlation will be accounted for using a robust sandwich estimator. In the primary analysis, patients' observation time will end if they experience the primary outcome, emigrate from Ontario, or die of a noncardiovascular cause (which will be treated as a competing risk event). The between-group difference in the mean drop in intradialytic systolic blood pressure obtained during the dialysis sessions throughout the trial period will be analyzed at the center level using an unadjusted random-effects linear mixed model. TRIAL STATUS: The MyTEMP trial period is April 3, 2017, to March 31, 2021. We expect to analyze and report results by 2023 once the updated data are available at ICES. TRIAL REGISTRATION: MyTEMP is registered with the US National Institutes of Health at clincaltrials.gov (NCT02628366). STATISTICAL ANALYTIC PLAN: Version 1.1 June 15, 2021.

CONTEXTE: L'essai MyTEMP (Major Outcomes with Personalized Dialysate Temperature) est un essai clinique randomisé en grappes d'une durée de 4 ans comparant l'effet d'un protocole de dialysat personnalisé à température réduite par rapport au dialysat à 36,5 °C sur les hospitalisations et les décès dus à des problèmes cardiovasculaires. La répartition aléatoire des sujets a été effectuée au niveau du centre de dialyse (ci-après appelé « groupe ¼). OBJECTIFS: Exposer les grandes lignes du plan d'analyse statistique de l'essai MyTEMP. TYPE D'ÉTUDE: MyTEMP est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. CADRE: L'essai est mené dans 84 centres de dialyse en Ontario (Canada). SUJETS: On estime qu'environ 13 500 patients auront reçu des soins d'hémodialyse dans les 84 centres de dialyse participants au cours de la période de l'essai (3 avril 2017 au 1er mars 2021; suivi maximal jusqu'au 31 mars 2021). MÉTHODOLOGIE: Les résultats et les données concernant l'identification des patients et leurs caractéristiques initiales seront principalement tirés des bases de données administratives du système de santé ontarien tenues par l'ICES. Une répartition aléatoire restreinte par les covariables a été employée pour classer les 84 centres de dialyse (1:1) dans le groupe d'intervention ou le groupe témoin. Le groupe d'intervention a utilisé un protocole personnalisé de dialysat à température réduite et le groupe témoin un dialysat à température fixe (36,5 °C). RÉSULTATS: Le principal critère d'évaluation est la combinaison d'un décès d'origine cardiovasculaire ou d'une hospitalisation majeure liée à la santé cardiovasculaire (définie comme une hospitalisation pour un infarctus du myocarde, une insuffisance cardiaque congestive ou un AVC ischémique) enregistrée dans les bases de données administratives du système de santé. Le principal critère d'évaluation secondaire est la baisse moyenne de la tension artérielle systolique intradialytique, laquelle est définie comme la tension artérielle systolique du patient avant la dialyse moins la tension artérielle systolique minimale pendant la dialyse. Les données anonymisées sur la tension artérielle systolique initiale et la tension artérielle systolique intradialytique des patients ont été colligées à intervalles mensuels dans chaque centre de dialyse. PLAN D'ANALYSE: L'analyse primaire adoptera une approche fondée sur l'intention de traiter. Le principal critère d'évaluation sera analysé au niveau du patient comme le risque relatif de survenue d'un premier événement, estimé à partir d'un modèle de risques de sous-distribution. La corrélation intracentre sera prise en compte à l'aide d'un robuste estimateur sandwich. Dans l'analyse primaire, le temps d'observation des patients prendra fin s'ils présentent le principal critère d'évaluation, s'ils déménagent hors de l'Ontario ou s'ils décèdent d'une cause non cardiovasculaire (qui sera traitée comme un événement à risque concurrentiel). La différence entre les groupes quant à la baisse moyenne de la tension artérielle systolique intradialytique, obtenue pendant les séances de dialyse tout au long de l'essai, sera analysée au niveau du centre avec un modèle linéaire mixte à effets aléatoires non corrigé. STATUT DE L'ESSAI: L'essai MyTEMP couvre la période du 3 avril 2017 au 31 mars 2021. Nous comptons analyser et rendre compte des résultats d'ici 2023, dès que les données mises à jour seront disponibles à l'ICES. ENREGISTREMENT DE L'ESSAI: MyTEMP est enregistré auprès du National Institute of Health des États-Unis sur clincaltrials.gov (NCT02628366).

Frailty Severity and Hospitalization After Dialysis Initiation.

BACKGROUND: Frailty is associated with hospitalization and mortality among dialysis patients. To now, few studies have considered the degree of frailty as a predictor of hospitalization. OBJECTIVE: We evaluated whether frailty severity was associated with hospitalization after dialysis initiation. DESIGN: Retrolective cohort study. SETTING: Nova Scotia, Canada. PATIENTS: Consecutive adult, chronic dialysis patients who initiated dialysis from January 1, 2009 to June 30, 2014, (last follow-up June, 2015). METHODS: Frailty Severity, as determined by the 7-point Clinical Frailty Scale (CFS, ranging from 1 = very fit to 7 = severely frail), was measured at dialysis initiation and treated as continuous and in categories (CFS scores of 1-3, 4/5, and 6/7). Hospitalization was characterized by cumulative time admitted to hospital (proportion of days admitted/time at risk) and by the joint risk of hospitalization and death. Time at risk included time in hospital after dialysis initiation and patients were followed until transplantation or death. RESULTS: Of 647 patients (mean age: 62 ± 15), 564 (87%) had CFS scores. The mean CFS score was 4 ("corresponding to "vulnerable") ± 2 ("well" to "moderately frail"). In an adjusted negative binomial regression model, moderate-severely frail patients (CFS 6/7) had a >2-fold increased risk of cumulative time admitted to hospital compared to the lowest CFS category (IRR = 2.18, 95% confidence interval [CI] = 1.31-3.63). In the joint model, moderate-severely frail patients had a 61% increase in the relative hazard for hospitalization (hazard ratio [HR] = 1.61, 95% CI = 1.29-2.02) and a 93% increase in the relative hazard for death compared to the lowest CFS category (HR = 1.93, 95% CI = 1.16-3.22). LIMITATIONS: Potential unknown confounders may have affected the association between frailty severity and hospitalization given observational study design. The CFS is subjective and different clinicians may grade frailty severity differently or misclassify patients on the basis of limited availability. CONCLUSIONS: Among incident dialysis patients, a higher frailty severity as defined by the CFS is associated with both an increased risk of cumulative time admitted to hospital and joint risk of hospitalization and death.

CONTEXTE: La fragilité est associée à davantage d'hospitalisations et de mortalité chez les patients qui suivent des traitements de dialyze. À l'heure actuelle, peu d'études se sont penchées sur le degré de fragilité comme facteur prédictif d'hospitalization. OBJECTIFS: Nous avons évalué l'existence d'un lien entre la gravité de la fragilité et le risque d'hospitalization après l'amorce d'un traitement de dialyze. TYPE D'ÉTUDE: Étude de cohorte rétrospective. CADRE: Nouvelle-Écosse, Canada. SUJETS: L'étude porte sur des patients adultes consécutifs sous dialyze chronique et ayant entrepris leur traitement entre le 1er janvier 2009 et le 30 juin 2014 (dernier suivi en juin 2015). MÉTHODOLOGIE: L'échelle CFS (Clinical Frailty Scale) en 7 points (1 = très bonne forme physique; 7= gravement fragile) a été employée pour déterminer le niveau de gravité de la fragilité. Cette dernière a été évaluée à l'amorce de la dialyze et traitée en tant que mesure continue et selon trois niveaux d'atteinte (scores CFS de 1-3, de 4-5 et de 6-7). L'hospitalization a été caractérisée par la durée cumulative des hospitalisations (proportion de jours d'hospitalization/l'intervalle de risque) et par un risque conjoint d'hospitalization et de décès. L'intervalle de risque comprend le temps passé à l'hôpital depuis le début du traitement. Les patients ont été suivis jusqu'à la transplantation ou jusqu'au décès. RÉSULTATS: Parmi les 647 patients admissibles (âge moyen: 62 ans ± 15), 564 patients (87 %) disposaient d'un score CFS. Le score CFS moyen était de 4 (correspondant à « apparence de vulnérabilité ¼) ± 2 (« bonne forme physique ¼ à « modérément fragile ¼). Dans un modèle corrigé de régression binomiale négative, les patients jugés modérément à gravement fragiles (CFS 6/7) présentaient un risque cumulatif plus de 2 fois plus élevé d'être hospitalisés comparativement aux patients du groupe avec le score CFS le plus faible (RTI: 2,18; IC 95 %: 1,31 à 3,63). Dans le modèle conjoint, les patients jugés modérément à gravement fragiles ont présenté une augmentation de 61 % du risque relatif d'hospitalization (RR:1,61; IC 95 %: 1,29 à 2,02) et une augmentation de 93 % du risque relatif de décès comparativement aux patients avec le score CFS le plus faible (RR: 1,93; IC 95 %: 1,16 à 3,22). LIMITES: La méthodologie de l'étude (observationnelle) laisse supposer que de possibles facteurs confusionnels inconnus pourraient avoir eu une incidence sur le lien entre les hospitalisations et la gravité de la fragilité. Le score CFS est une mesure subjective. Il est possible que les cliniciens évaluent différemment la gravité de la fragilité ou classent les patients de façon erronée en raison d'une disponibilité limitée. CONCLUSION: Chez les patients dialysés, une plus grande fragilité, telle que définie par le score CFS, a été associée à la fois à un risque accru d'être hospitalisé sur une plus longue durée cumulative et à un risque conjoint d'hospitalization et de décès.

The WISHED Randomized Controlled Trial: Impact of an Interactive Health Communication Application on Home Dialysis Use in People With Chronic Kidney Disease.

BACKGROUND: While home dialysis therapies are more cost effective and may offer improved health-related quality of life, uptake compared to in-center hemodialysis remains low. OBJECTIVE: To test whether a web-based interactive health communication application (IHCA) compared to usual care would increase home dialysis use. DESIGN: Randomized control trial. SETTING: Patients were recruited from 3 multidisciplinary kidney clinics across Ontario, Canada (Hamilton, Kingston, London). PATIENTS: We included adults with advanced chronic kidney disease (CKD) followed in multidisciplinary kidney clinics. Patients who had not completed dialysis modality education, who did not have access to a home computer or the internet, who had significant hearing or vision impairment, who could not read/write/speak English, who had a medical contraindication for home dialysis, or who had selected conservative kidney care were excluded. MEASUREMENTS: The primary outcome was any use of home dialysis (peritoneal dialysis or home hemodialysis) within 90 days of dialysis initiation. Secondary outcomes were social support, decision conflict and dialysis knowledge measured at baseline, 6 months and 1 year. METHODS: Eligible patients were randomized to either usual care or the IHCA in addition to usual care in a 1:1 ratio. As part of usual care, all patients received education about dialysis modalities and kidney transplantation delivered by clinic nurses according to local practices. Randomization was performed using a computer-generated sequence in randomly permuted block sizes, stratified by site, and allocation occurred using sequentially numbered sealed, opaque envelopes. Participants, care providers, and outcome assessors were not blinded to the intervention. All analyses were performed blinded using an intention to treat approach. We estimated the effect of the ICHA on the odds of the primary outcome using unadjusted logistic regression models. Linear mixed models for repeated measures over time were used to analyze the impact of the IHCA on the secondary outcomes of interest. RESULTS: We randomized 140 (usual care, n = 71; IHCA, n = 69) out of a planned 264 patients (mean [SD] age 61 [14.5] years, 65% men). Among patients randomized to the IHCA group that completed 6-month and 1-year follow-up visits, 56.8% and 71.4%, respectively, had not accessed the IHCA website within the past month. There were 23 (32.4%) and 26 (37.7%) patients in the usual care and IHCA groups who received a home dialysis therapy within 90 days of dialysis initiation (odds ratio, OR = 1.3, 95% CI = [0.6-2.5], P = .5). Among the 78 patients who initiated dialysis (n = 38 usual care, n = 40 IHCA), 60.5% and 65% in the usual care and IHCA groups received a home therapy within 90 days of dialysis initiation (OR = 1.2, 95% CI = [0.5-3.0], P = .7). Secondary outcomes did not differ by intervention group over time. LIMITATIONS: The trial was underpowered due to poor recruitment and use of the IHCA was low. CONCLUSIONS: We did not find evidence of a difference in home dialysis uptake with IHCA use, but our analyses were notably underpowered. The incorporation of greater patient engagement, qualitative research and design research, and pilot implementation may help future evaluations of strategies to improve home dialysis uptake. TRIAL REGISTRATION: ClinicalTrials.gov #NCT01403454, registration date: Jul 21, 2011.

CONTEXTE: La dialyse à domicile est une modalité plus économique qui améliore la qualité de vie liée à la santé des patients. Malgré cela, son adoption demeure faible par rapport à l'hémodialyse en centre hospitalier. OBJECTIF: Vérifier si l'utilization d'une application interactive de communication en santé (AICS) accessible en ligne augmente l'adoption de la dialyse à domicile comparativement aux soins habituels. TYPE D'ÉTUDE: Essai contrôlé à répartition aléatoire. CADRE: Les patients ont été recrutés dans trois cliniques multidisciplinaires de néphrologie en Ontario, au Canada (Hamilton, Kingston, London). SUJETS: Nous avons inclus des adultes atteints d'insuffisance rénale chronique (IRC) de stade avancé suivis en clinique multidisciplinaire de néphrologie. Ont été exclus les patients n'ayant pas terminé la formation sur les modalités de dialyse, n'ayant pas accès à un ordinateur ou à Internet à domicile, ayant une déficience auditive ou visuelle importante, ne sachant pas lire, écrire ou parler en anglais, présentant une contre-indication médicale à la dialyse à domicile ou ayant choisi un traitement conservateur. MESURES: Le principal résultat était utilisation de la dialyse à domicile (dialyse péritonéale ou hémodialyse) dans les 90 jours suivant l'amorce du traitement. Les critères d'évaluation secondaires étaient le soutien social, les conflits décisionnels et les connaissances en matière de dialyse mesurés à l'inclusion, après six mois et après un an. MÉTHODOLOGIE: Les patients admissibles ont été répartis aléatoirement dans un rapport 1:1 pour recevoir les soins habituels ou l'AICS en plus des soins habituels. Dans le cadre des soins habituels, tous les patients ont reçu une formation sur les modalités de dialyse et la transplantation rénale donnée par le personnel infirmier de la clinique, conformément aux pratiques locales. La répartition aléatoire a été effectuée à l'aide d'une séquence générée par ordinateur dans des blocs de taille permutée au hasard, stratifiés par site. L'attribution s'est faite par enveloppes scellées et opaques, numérotées de façon séquentielle. L'intervention ne s'est pas faite à l'insu des participants, des fournisseurs de soins et des évaluateurs. Toutes les analyses ont été effectuées en aveugle avec une approche en intention de traiter. Nous avons estimé l'effet de l'AICS sur les probabilités du résultat principal en utilisant des modèles de régression logistique non corrigés. Des modèles mixtes linéaires pour des mesures répétées dans le temps ont été employés pour analyser l'impact de l'AICS sur les critères secondaires d'intérêt. RÉSULTATS: Des 264 patients prévus au départ (âge moyen [ÉT]: 61 [14,5] ans; 65 % d'hommes), 140 ont été répartis aléatoirement (71 en soins habituels; 69 avec l'AICS). Dans le groupe AICS, 56,8 % des patients ayant eu une visite de suivi après six mois et 71,4 % après un an n'avaient pas accédé au site Web de l'AICS au cours du mois précédent. Le nombre de patients ayant adopté la dialyse à domicile dans les 90 jours s'élevait à 23 (32,4 %) dans le groupe des soins habituels et à 26 (37,7 %) dans le groupe AICS (risque relatif [RR]: 1,3; IC 95 %: 0,6-2,5; p=0,5). Des 78 patients ayant amorcé des traitements de dialyse (38 en soins habituels; 40 avec l'AICS), la proportion de patients ayant reçu la dialyse à domicile dans les 90 suivants s'élevait à 60,5 % dans le groupe des soins habituels et à 65 % dans le groupe AICS (RR: 1,2; IC 95 %: 0,5-3,0; p=0,7). Les critères d'évaluation secondaires n'ont pas différé au fil du temps selon le groupe d'intervention. LIMITES: L'essai manque de robustesse en raison du faible recrutement et de la faible utilisation de l'AICS. CONCLUSION: Nous n'avons trouvé aucune preuve supportant une plus grande adoption de la dialyse à domicile avec l'AICS, mais nos analyses manquaient nettement de robustesse. Éventuellement, une plus grande participation des patients, une recherche qualificative et une recherche conceptuelle et une mise en œuvre pilote pourraient faciliter l'évaluation des stratégies visant à augmenter l'adoption de la dialyse à domicile.

Three Statistical Approaches for Assessment of Intervention Effects: A Primer for Practitioners.

INTRODUCTION: Statistical methods to assess the impact of an intervention are increasingly used in clinical research settings. However, a comprehensive review of the methods geared toward practitioners is not yet available. METHODS AND MATERIALS: We provide a comprehensive review of three methods to assess the impact of an intervention: difference-in-differences (DID), segmented regression of interrupted time series (ITS), and interventional autoregressive integrated moving average (ARIMA). We also compare the methods, and provide illustration of their use through three important healthcare-related applications. RESULTS: In the first example, the DID estimate of the difference in health insurance coverage rates between expanded states and unexpanded states in the post-Medicaid expansion period compared to the pre-expansion period was 5.93 (95% CI, 3.99 to 7.89) percentage points. In the second example, a comparative segmented regression of ITS analysis showed that the mean imaging order appropriateness score in the emergency department at a tertiary care hospital exceeded that of the inpatient setting with a level change difference of 0.63 (95% CI, 0.53 to 0.73) and a trend change difference of 0.02 (95% CI, 0.01 to 0.03) after the introduction of a clinical decision support tool. In the third example, the results from an interventional ARIMA analysis show that numbers of creatinine clearance tests decreased significantly within months of the start of eGFR reporting, with a magnitude of drop equal to -0.93 (95% CI, -1.22 to -0.64) tests per 100,000 adults and a rate of drop equal to 0.97 (95% CI, 0.95 to 0.99) tests per 100,000 per adults per month. DISCUSSION: When choosing the appropriate method to model the intervention effect, it is necessary to consider the structure of the data, the study design, availability of an appropriate comparison group, sample size requirements, whether other interventions occur during the study window, and patterns in the data.

Longitudinal Changes in the Use of PD Assistance for Patients Maintained on Peritoneal Dialysis.

Background: Home dialysis therapies, such as peritoneal dialysis (PD), offer flexibility and improved well-being, particularly for older individuals. However, a substantial proportion require assistance with personal care and health care-related tasks. We hypothesized that patients and families would require less PD assistance as they became more familiar with PD-related tasks. The study objective was to assess whether the nature of, and need for, PD assistance decreased over time. Methods: Using a multicentered, prospective, observational study design, patients aged ≥50 years were recruited from those starting PD. Patients underwent formal evaluation using validated components of a Comprehensive Geriatric Assessment at baseline, and they were followed monthly and administered a questionnaire about the need for assistance with PD-related tasks. Results: A total of 111 patients (age 69±10 years, 68% men, and 56% diabetic) were followed for a total of 609 patient-months. Of those who needed help, 40% had help from a family member, and 33% were helped by nurses. Both the quantity and nature of help received by patients remained generally stable throughout follow-up and did not vary according to age, frailty, functional dependence, or cognitive impairment (P=0.93). The proportion of patients needing help varied widely across the 13 different tasks but appeared relatively stable across time. The paid-unpaid caregiver ratio for the different tasks did not change over time. Conclusions: Older patients initiating PD in the outpatient setting have a high need for assistance with PD-related tasks, which seems to persist over the initial 6-month period.

Quantifying the risk of insertion-related peritoneal dialysis catheter complications following laparoscopic placement: Results from the North American PD Catheter Registry.

BACKGROUND: Peritoneal dialysis (PD) is a more cost-effective therapy to treat kidney failure than in-center hemodialysis, but successful therapy requires a functioning PD catheter that causes minimal complications. In 2015, the North American Chapter of the International Society for Peritoneal Dialysis established the North American PD Catheter Registry to improve practices and patient outcomes following PD catheter insertion. AIMS: The objective of this study is to propose a methodology for defining insertion-related complications that lead to significant adverse events and report the risk of these complications among patients undergoing laparoscopic PD catheter insertion. METHODS: Patients undergoing laparoscopic PD catheter insertion were enrolled at 14 participating centers in Canada and the United States and followed using a Web-based registry. Insertion-related complications were defined as flow restriction, exit-site leak, or abdominal pain at any point during follow-up. We also included infections or bleeding within 30 days of insertion, and any immediate postoperative complications. Adverse events were categorized as PD never starting or termination of PD therapy, delay in the start of PD therapy or interruption of PD therapy, an emergency department visit or hospitalization, or need for invasive procedures. Cause-specific cumulative incidence functions were used to estimate risk. RESULTS: Five hundred patients underwent laparoscopic PD catheter insertion between 10 November 2015 and 24 July 2018. The cumulative risk of insertion-related complications 6 months from the date of insertion that led to an adverse event was 24%. The risk of flow restriction, exit-site leak, and pain at 6 months was 10.2%, 5.7%, and 5.3%, respectively. PD was never started or terminated in 6.4% of patients due to an insertion-related complication. Leaks and flow restrictions were most likely to delay or interrupt PD therapy. Flow restrictions were the primary cause of invasive procedures. Fifty percent of the complications occurred before the start of PD therapy. CONCLUSIONS: Insertion-related complications leading to significant adverse events following laparoscopic placement of PD catheters are common. Many complications occur before the start of PD. Insertion-related complications are an important area of focus for future research and quality improvement efforts.

Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.

BACKGROUND: Small randomized trials demonstrated that a lower compared with higher dialysate temperature reduced the average drop in intradialytic blood pressure. Some observational studies demonstrated that a lower compared with higher dialysate temperature was associated with a lower risk of all-cause mortality and cardiovascular mortality. There is now the need for a large randomized trial that compares the effect of a low vs high dialysate temperature on major cardiovascular outcomes. OBJECTIVE: The purpose of this study is to test the effect of outpatient hemodialysis centers randomized to (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol for 4 years on cardiovascular-related death and hospitalizations. DESIGN: The design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial. SETTING: Hemodialysis centers in Ontario, Canada, were randomized on February 1, 2017, for a trial start date of April 3, 2017, and end date of March 31, 2021. PARTICIPANTS: In total, 84 hemodialysis centers will care for approximately 15 500 patients and provide over 4 million dialysis sessions over a 4-year follow-up. INTERVENTION: Hemodialysis centers were randomized (1:1) to provide (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol of 36.5°C. For the personalized protocol, nurses set the dialysate temperature between 0.5°C and 0.9°C below the patient's predialysis body temperature for each dialysis session, to a minimum dialysate temperature of 35.5°C. PRIMARY OUTCOME: A composite of cardiovascular-related death or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) captured in Ontario health care administrative databases. PLANNED PRIMARY ANALYSIS: The primary analysis will follow an intent-to-treat approach. The hazard ratio of time-to-first event will be estimated from a Cox model. Within-center correlation will be considered using a robust sandwich estimator. Observation time will be censored on the trial end date or when patients die from a noncardiovascular event. TRIAL REGISTRATION: www.clinicaltrials.gov; identifier: NCT02628366.

CONTEXTE: De petits essais à répartition aléatoire ont montré que l'utilisation d'un dialysat à basse température réduisait le risque d'hypotension intra-dialytique. De même, certaines études observationnelles ont démontré qu'un dialysat à basse température était associé à un plus faible risque de mortalité toute cause ou d'origine cardiovasculaire. Le temps est venu de procéder à un vaste essai à répartition aléatoire comparant les effets d'un dialysat à basse température et à température standard sur les principaux résultats cardiovasculaires. OBJECTIF: Répartir aléatoirement des centres d'hémodialyse ambulatoire pour qu'ils suivent pendant quatre ans (i) un protocole personnalisé de dialysat à basse température ou (ii) un protocole de dialysat à température standard, et tester l'effet sur les hospitalisations et la mortalité attribuables à des événements cardiovasculaires. TYPE D'ÉTUDE: Un essai clinique à répartition aléatoire en grappes. CADRE: Le 1er février 2017, des centres d'hémodialyse de l'Ontario (Canada) ont été répartis aléatoirement en vue d'un essai qui a débuté le 3 avril 2017 et qui se poursuivra jusqu'au 31 mars 2021. PARTICIPANTS: Quatre-vingt-quatre centres d'hémodialyse qui prendront en charge environ 15 500 patients pendant les quatre ans de suivi. INTERVENTION: Les centres d'hémodialyse ont été répartis aléatoirement (1:1) pour offrir (i) un protocole personnalisé de dialysat à température réduite ou (ii) un protocole de dialysat à 36,5°C. Pour le protocole personnalisé, les infirmières règlent la température du dialysat entre 0,5 et 0,9°C sous la température corporelle du patient mesurée avant la dialyse, jusqu'à une température minimale de 35,5°C. PRINCIPAUX RÉSULTATS: Un ensemble d'hospitalisations attribuables à un événement cardiovasculaire majeur (accident ischémique cérébral non fatal, infarctus du myocarde ou insuffisance cardiaque congestive) et de décès d'origine cardiovasculaire consignés dans les bases de données de santé de l'Ontario. PRINCIPALE ANALYSE ENVISAGÉE: L'analyse primaire adoptera une approche fondée sur l'intention de traiter. Un modèle de Cox servira à estimer le rapport de risque du temps écoulé jusqu'au premier événement. La corrélation intra-centre sera prise en compte à l'aide d'un estimateur sandwich robuste. Le temps d'observation sera censuré à la date de fin de l'essai ou au moment d'un décès non lié à un événement cardiovasculaire.

PD Assistance and Relationship to Co-Existing Geriatric Syndromes in Incident Peritoneal Dialysis Therapy Patients.

Background:Home dialysis therapies, including peritoneal dialysis (PD), are preferred treatment strategies, offering flexibility and improved wellbeing. However, patients with complex disease and comorbidity may require assistance with personal care and healthcare-related tasks. The study objective was to formally assess the type and frequency of PD assistance received by patients over 50, and the relationship to observed frailty, functional status, and cognitive ability at the time of PD therapy initiation.Methods:Using a multicentered, prospective observational study design, patients aged ≥ 50 years were recruited from those starting PD. Patients underwent formal evaluation using validated components of a Comprehensive Geriatric Assessment. The receipt and nature of assistance with PD tasks were assessed 1 month after dialysis start by questionnaire.Results:A total of 121 patients (age 69 ± 10 years, 67% male, 54% diabetic) were recruited. A total of 75 (62%) patients received assistance for a variety of tasks from friends or family (n = 41, 34%) or a paid caregiver (n = 34, 28%) 1 month after starting dialysis. At baseline, there was a high prevalence of functional dependency (79/120, 66%), frailty (71/110, 65%), and impaired cognition (68/115, 59%). Only 5% were fully independent, clinically robust, and scored within the normal range on cognitive testing. Factors associated with PD assistance included comorbidity (p < 0.03), cognitive impairment (p < 0.0001), and functional dependence (p < 0.02).Conclusion:Older patients initiating PD in the outpatient setting have high rates of frailty, functional dependence, and cognitive changes at the time they initiate dialysis. More research is required to better understand how those factors contribute to the use of PD assistance.

Uptake and Scalability of a Peritoneal Dialysis Virtual Care Solution: Qualitative Study.

BACKGROUND: Early research in the area of virtual care solutions with peritoneal dialysis (PD) patients has focused on evaluating the outcomes and impact of these solutions. There has been less attention focused on understanding the factors influencing the uptake, usability, and scalability of virtual care for chronic kidney disease (CKD) patients receiving PD at home. OBJECTIVE: In this context, a study was undertaken to (1) assess and understand the factors influencing the uptake of a virtual care solution and (2) provide recommendations for the scalability of a virtual care solution aimed at enhancing CKD patients' outcomes and experiences. METHODS: This study used a qualitative design with semistructured interviews and a thematic analysis approach. A total of 25 stakeholders-6 patients and 3 caregivers, 6 health care providers, 2 vendors, and 8 health system decision makers-participated in this study. RESULTS: The following three primary mechanisms emerged to influence the usability of the virtual care solution: (1) receiving hands-on training and ongoing communication from a supportive team, (2) adapting to meet user needs and embedding them into workflow, and (3) being influenced by patient and caregiver characteristics. Further, two overarching recommendations were developed for considerations around scalability: (1) co-design locally, embed into the daily workflow, and deploy over time and (2) share the benefits and build the case. CONCLUSIONS: Study findings can be used by key stakeholders in their future efforts to enhance the implementation, uptake, and scalability of virtual care solutions for CKD and managing PD at home.

Clinical Outcomes of Failing to Dose-Reduce Cephalosporin Antibiotics in Older Adults with CKD.

BACKGROUND AND OBJECTIVES: Current dosing recommendations for cephalosporin antibiotics are on the basis of pharmacokinetic studies and are frequently ignored in practice. This study was undertaken to investigate the clinical outcomes of failing to dose-reduce cephalosporin antibiotics in CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Retrospective cohort study conducted in Ontario, Canada using linked population-based health care databases. Nine thousand three hundred forty-seven outpatients (median age 83; interquartile range, 77-88 years; 57% women) with an eGFR<30 ml/min per 1.73 m2 and no prior history of dialysis were dispensed oral cephalexin, cefuroxime, or cefprozil between April of 2007 and March of 2016. Two thirds of the patients (6253 of 9347) received a higher than recommended daily dose of cephalexin (>1000 mg), cefuroxime (>500 mg), or cefprozil (>500 mg). The primary outcome was a hospital encounter (emergency room visit or hospital admission) with a condition listed as a possible side-effect of cephalosporins. Secondary outcomes were antibiotic treatment failure and all-cause mortality. All measures were assessed in the 30 days after cephalosporin initiation. RESULTS: Patients who received a higher than recommended dose of a cephalosporin antibiotic were similar in multiple indicators of baseline health to patients who received a reduced dose. Overall, 6% of patients presented to hospital with a possible cephalosporin side-effect, 13% failed antibiotic treatment, and 3% died. Compared with a reduced dose, receiving a higher dose of antibiotic was not associated with a different rate of side-effects (adjusted odds ratio, 1.00; 95% confidence interval, 0.84 to 1.20), treatment failure (1.01; 0.88 to 1.15), or death (0.99; 0.76 to 1.29). CONCLUSIONS: In this study we failed to demonstrate any association between the dose of cephalosporin antibiotic administered to elderly patients with CKD and the risk of side-effects leading to hospitalization, treatment failure, or mortality.