Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial.

BACKGROUND: The Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise. METHODS: To evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting. RESULTS: The analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient. CONCLUSIONS: A multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987.

Physician leadership development: Evidence-informed design tempered with real-life experience.

This article describes key considerations for creation of evidence-informed in-house physician leadership development. Ten elements extracted from a scan of the peer-reviewed and grey literature are presented, and key learnings at the Queen Elizabeth II Health Sciences Centre, a quaternary academic health sciences centre in Halifax, Nova Scotia, are highlighted. Each element is briefly described with practical considerations and challenges to implementation outlined in the context of the former Capital District Health Authority, where the authors collaborated to create in-house physician leadership development prior to the consolidation of health districts in that province. The purpose of this article is to share how the authors used evidence to plan physician leadership development and to explore the additional situational and contextual factors and considerations needed for implementation.

Collaborative implementation science: a Can-SOLVE CKD case example.

ABSTRACT: Research is critical for uncovering new and effective therapies for better health outcomes, yet there remains a significant lag between identifying evidence-based interventions and implementing them into practice. Research teams can often be experienced in evidence generation, but less so in evidence implementation, underscoring the need for more customized tools to support them in this latter step. The implementation stage can be especially challenging given how strategies must be tailored to the unique end users and contexts of a given intervention. Therefore, our patient-oriented kidney research network sought to create an "Implementation Toolkit" and "Pathway to Implementation" guide to help research teams and their operational and clinical partners in implementing their interventions. Importantly, the tools were created using input and feedback from diverse groups, including patient partners, implementation science experts, researchers, operational leaders, and policymakers, all of whom play role in supporting the implementation of health interventions. Our tools are widely applicable to diverse teams, regardless of the intervention or innovation being implemented. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A214.

Canadian Society of Nephrology commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD.

The KDIGO (Kidney Disease: Improving Global Outcomes) 2012 clinical practice guideline for anemia management in patients with chronic kidney disease provides the structural and evidence base for the Canadian Society of Nephrology commentary on this guideline's relevancy and application to the Canadian health care system. While in general agreement, we provide commentary on 11 of the 61 KDIGO guideline statements. Specifically, we agreed that a therapeutic trial of iron is appropriate in cases in which a reduction in erythropoiesis-stimulating agent (ESA) dosage or avoidance of ESA and transfusion is desired, transferrin saturations are >30%, and ferritin concentrations are >500 µg/L. However, we concluded that there is insufficient evidence to support an upper target or threshold for ferritin and transferrin saturation levels. We agree with the initiation of ESA treatment when hemoglobin (Hb) level is 90-100 g/L; however, we specifically state that an acceptable range for Hb level is 95-115 g/L, with a target of 100-110 g/L, and add caution to individualization above this range due to concerns regarding the safety of ESAs. We agree that ESAs should be used with considerable caution in patients with active malignancy, history of stroke, or history of malignancy, and we suggest initiating ESA therapy at Hb level of 90 g/L and to aim for a Hb level in the range of 90-105 g/L. The reader is encouraged to note the level of evidence and review the entire KDIGO anemia guideline to interpret the guideline statements and commentary appropriately.

Oral sodium thiosulfate as maintenance therapy for calcific uremic arteriolopathy: a case series.

BACKGROUND: Calcific uremic arteriolopathy (CUA) is a rare but serious disorder affecting 4% of dialysis patients. Intravenous sodium thiosulfate (IV STS) has been shown as an effective treatment. In Canada, the average cost of IV STS is about CAD 12,000 per month, while the cost of compounded oral STS is CAD 45 per month. METHODS: Prospective cohort where all patients diagnosed with CUA during the year 2011 were included. They were treated initially with IV STS. Afterwards, each patient had a baseline bone scan and was started on oral STS for a total of 6 months followed by a repeat bone scan. A single radiologist, blinded to the dates of both scans for a given patient, read all scans. RESULTS: Four patients were studied. The intravenous dose used was 25 g three times a week for an average duration of 131 days. After the maintenance therapy, 2 patients developed further regression of the lesions, 1 had stable lesions, and 1 got worse; however, nonadherence to the drug was confirmed. The oral medication was well tolerated with no reported side effects. CONCLUSION: Oral STS, after IV STS, seems to stabilize, or even improve CUA lesions, and therefore could be useful as maintenance therapy, especially since its cost is much more reasonable than IV STS and due to the ongoing shortage of the IV formulation.

The impact of an "acute dialysis start" on the mortality attributed to the use of central venous catheters: a retrospective cohort study.

BACKGROUND: Central venous catheters (CVCs) are associated with early mortality in dialysis patients. However, some patients progress to end stage renal disease after an acute illness, prior to reaching an estimated glomerular filtration rate (eGFR) at which one would expect to establish alternative access (fistula/peritoneal dialysis catheter). The purpose of this study was to determine if exclusion of this "acute start" patient group alters the association between CVCs and mortality. METHODS: We conducted a retrospective cohort study of 406 incident dialysis patients from 1 Jan 2006 to 31 Dec 2009. Patients were classified as acute starts if 1) the eGFR was >25 ml/min/1.73 m2, ≤ 3 months prior to dialysis initiation and declined after an acute event (n = 45), or 2) in those without prior eGFR measurements, there was no supporting evidence of chronic kidney disease on history or imaging (n = 12). Remaining patients were classified as chronic start (n = 349). RESULTS: 98 % and 52 % of acute and chronic starts initiated dialysis with a CVC. There were 148 deaths. The adjusted mortality hazard ratio (HR) for acute vs. chronic start patients was 1.84, (95 % CI [1.19-2.85]). The adjusted mortality HR for patients dialyzing with a CVC compared to alternative access was 1.19 (95 % CI [0.80-1.77]). After excluding acute start patients, the adjusted HR fell to 1.03 (95 % CI [0.67-1.57]). CONCLUSIONS: A significant proportion of early dialysis mortality occurs after an acute start. Exclusion of this population attenuates the mortality risk associated with CVCs.

Multifaceted Intervention to Increase the Use of Home Dialysis: A Cluster Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Home dialysis therapies (peritoneal and home hemodialysis) are less expensive and provide similar outcomes to in-center hemodialysis, but they are underutilized in most health systems. Given this, we designed a multifaceted intervention to increase the use of home dialysis. In this study, our objective was to evaluate the effect of this intervention on home dialysis use in CKD clinics across Canada. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a cluster randomized controlled trial in 55 CKD clinic clusters in nine provinces in Canada between October 2014 and November 2015. Participants included all adult patients who initiated dialysis in the year following the intervention. We evaluated the implementation of a four-component intervention, which included phone surveys from a knowledge translation broker, a 1-year center-specific audit/feedback on home dialysis use, delivery of an educational package (including tools aimed at both providers and patients), and an academic detailing visit. The primary outcome was the proportion of patients using home dialysis at 180 days after dialysis initiation. RESULTS: A total of 55 clinics were randomized (27 in the intervention and 28 in the control), with 5312 patients initiating dialysis in the 1-year follow-up period. In the primary analysis, there was no difference in the use of home dialysis at 180 days in the intervention and control clusters (absolute risk difference, 4%; 95% confidence interval, -2% to 10%). Using a difference-in-difference comparison, the use of home dialysis at 180 days was similar before and after implementation of the intervention (difference of 0% in intervention clinics; 95% confidence interval, -2% to 3%; difference of 0.8% in control clinics; 95% confidence interval, -1% to 3%; P=0.84). CONCLUSIONS: A multifaceted intervention did not increase the use of home dialysis in adults initiating dialysis. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis, NCT02202018.

Interprovincial differences in the achievement of K/DOQI targets of mineral metabolism in Canada.

BACKGROUND: Abnormalities in mineral metabolism in chronic kidney disease are associated with increased morbidity and mortality. The Kidney Disease Outcomes Quality Initiative (K/DOQI) clinical practice guidelines were established in 2003 to address issues in the management of mineral and bone metabolism. The goal of this study was to compare (i) mineral metabolism control among Canadian haemodialysis (HD) patients with K/DOQI-defined targets and Dialysis Outcomes and Practice Patterns Study II (DOPPS II) data and (ii) the effect of different treatment strategies. METHODS: A cross-sectional study of 2215 HD patients was conducted. Phosphorus (P), calcium (Ca), intact parathyroid hormone (iPTH) and calcium-phosphate product (CaXP) were analysed. In addition, management was compared between provinces with more or less restricted access to the phosphate binder sevelamer. RESULTS: K/DOQI targets for P, Ca, iPTH and CaXP K/DOQI targets were met by 59.7%, 58.6%, 29.7% and 83.3%, respectively. A greater proportion of patients were within target compared with those in DOPPS II (2002-2004). Targets were more likely to be reached by patients residing in provinces with formularies allowing less restricted access to sevelamer: P: 61.8% vs 55.7% (P = 0.01); CaXP: 85.5% vs 79.1% (P = 0.0006). As expected, patients in provinces with more restrictive formularies were more often receiving doses of elemental calcium > 1.5 g/day than those with more open listings (62.1% vs 14.0%, P < 0.0001) and were less likely to receive sevelamer (14.1% vs 42.4%, P = 0.0001). CONCLUSION: Mineral metabolism parameters were more frequently within the target range amongst (i) patients in the current study compared with those in the DOPPS II era and (ii) patients in provinces with less restricted access to sevelamer.

Macrocytosis may be associated with mortality in chronic hemodialysis patients: a prospective study.

BACKGROUND: Macrocytosis occurs in chronic hemodialysis (CHD) patients; however, its significance is unknown. The purpose of this study was to establish the prevalence and distribution of macrocytosis, to identify its clinical associations and to determine if macrocytosis is associated with mortality in stable, chronic hemodialysis patients. METHODS: We conducted a single-centre prospective cohort study of 150 stable, adult CHD patients followed for nine months. Macrocytosis was defined as a mean corpuscular volume (MCV) > 97 fl. We analyzed MCV as a continuous variable, in tertiles and using a cutoff point of 102 fl. RESULTS: The mean MCV was 99.1 ± 6.4 fl, (range 66-120 fl). MCV was normally distributed. 92 (61%) of patients had an MCV > 97 fl and 45 (30%) > 102 fl. Patients were not B12 or folate deficient in those with available data and three patients with an MCV > 102 fl had hypothyroidism. In a logistic regression analysis, an MCV > 102 fl was associated with a higher Charlson-Age Comorbidity Index (CACI) and higher ratios of darbepoetin alfa to hemoglobin (Hb), [(weekly darbepoetin alfa dose in micrograms per kg body weight / Hb in g/L)*1000]. There were 23 deaths at nine months in this study. Unadjusted MCV > 102 fl was associated with mortality (HR 3.24, 95% CI 1.42-7.39, P = 0.005). Adjusting for the CACI, an MCV > 102 fl was still associated with mortality (HR 2.47, 95% CI 1.07-5.71, P = 0.035). CONCLUSIONS: Macrocytosis may be associated with mortality in stable, chronic hemodialysis patients. Future studies will need to be conducted to confirm this finding.

Canadian Association of Paediatric Nephrologists COVID-19 Rapid Response: Guidelines for Management of Acute Kidney Injury in Children.

PURPOSE: This article provides guidance on managing acute kidney injury (AKI) and kidney replacement therapy (KRT) in pediatrics during the COVID-19 pandemic in the Canadian context. It is adapted from recently published rapid guidelines on the management of AKI and KRT in adults, from the Canadian Society of Nephrology (CSN). The goal is to provide the best possible care for pediatric patients with kidney disease during the pandemic and ensure the health care team's safety. INFORMATION SOURCES: The Canadian Association of Paediatric Nephrologists (CAPN) COVID-19 Rapid Response team derived these rapid guidelines from the CSN consensus recommendations for adult patients with AKI. We have also consulted specific documents from other national and international agencies focused on pediatric kidney health. We identified additional information by reviewing the published academic literature relevant to pediatric AKI and KRT, including recent journal articles and preprints related to COVID-19 in children. Finally, our group also sought expert opinions from pediatric nephrologists across Canada. METHODS: The leadership of the CAPN, which is affiliated with the CSN, solicited a team of clinicians and researchers with expertise in pediatric AKI and acute KRT. The goal was to adapt the guidelines recently adopted for Canadian adult patients for pediatric-specific settings. These included specific COVID-19-related themes relevant to AKI and KRT in a Canadian setting, as determined by a group of kidney disease experts and leaders. An expert group of clinicians in pediatric AKI and acute KRT reviewed the revised pediatric guidelines. KEY FINDINGS: (1) Current Canadian data do not suggest an imminent threat of an increase in acute KRT needs in children because of COVID-19; however, close coordination between nephrology programs and critical care programs is crucial as the pandemic continues to evolve. (2) Pediatric centers should prepare to reallocate resources to adult centers as needed based on broader health care needs during the COVID-19 pandemic. (3) Specific suggestions pertinent to the optimal management of AKI and KRT in COVID-19 patients are provided. These suggestions include but are not limited to aspects of fluid management, KRT vascular access, and KRT modality choice. (4) Considerations to ensure adequate provision of KRT if resources become scarce during the COVID-19 pandemic. LIMITATIONS: We did not conduct a formal systematic review or meta-analysis. We did not evaluate our specific suggestions in the clinical environment. The local context, including how the provision of care for AKI and acute KRT is organized, may impede the implementation of many suggestions. As knowledge is advancing rapidly in the area of COVID-19, suggestions may become outdated quickly. Finally, most of the literature for AKI and KRT in COVID-19 comes from adult data, and there are few pediatric-specific studies. IMPLICATIONS: Given that most acute KRT related to COVID-19 is likely to be required in the pediatric intensive care unit initial setting, close collaboration and planning between critical care and pediatric nephrology programs are needed. Our group will update these suggestions with a supplement if necessary as newer evidence becomes available that may change or add to the recommendations provided.

CSN COVID-19 Rapid Review Program: Management of Acute Kidney Injury.

PURPOSE: Severe acute kidney injury (AKI) is a potential complication of COVID-19-associated critical illness. This has implications for the management of COVID-19-associated AKI and the resulting increased need for kidney replacement therapy (KRT) in the intensive care unit (ICU) and elsewhere in the hospital. The Canadian Society of Nephrology COVID-19 Rapid Review Team has sought to collate and synthesize currently available resources to inform ethically justifiable decisions. The goal is the provision of the best possible care for the largest number of patients with kidney disease while considering how best to ensure the safety of the health care team. INFORMATION SOURCES: Local, provincial, national, and international guidance and planning documents related to the COVID-19 pandemic; guidance documents available from nephrology and critical care-related professional organizations; recent journal articles and preprints related to the COVID-19 pandemic; expert opinion from nephrologists from across Canada. METHODS: A working group of kidney specialist physicians was established with representation from across Canada. Kidney physician specialists met via teleconference and exchanged e-mails to refine and agree on the proposed suggestions in this document. KEY FINDINGS: (1) Nephrology programs should work with ICU programs to plan for the possibility that up to 30% or more of critically ill patients with COVID-19 admitted to ICU will require kidney replacement therapy (KRT). (2) Specific suggestions pertinent to the optimal management of AKI and KRT in patients with COVID-19. These suggestions include, but are not limited to, aspects of fluid management, KRT vascular access, and KRT modality choice. (3) We describe considerations related to ensuring adequate provision of KRT, should resources become scarce during the COVID-19 pandemic. LIMITATIONS: A systematic review or meta-analysis was not conducted. Our suggestions have not been specifically evaluated in the clinical environment. The local context, including how the provision of acute KRT is organized, may impede the implementation of many suggestions. Knowledge is advancing rapidly in the area of COVID-19 and suggestions may become outdated quickly. IMPLICATIONS: Given that most acute KRT related to COVID-19 is likely to be required initially in the ICU setting, close collaboration and planning between critical care and nephrology programs is required. Suggestions may be updated as newer evidence becomes available.

Canadian Society of Nephrology Commentary on the Kidney Disease Improving Global Outcomes 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder.

PURPOSE OF REVIEW: (1) To provide commentary on the 2017 update to the Kidney Disease Improving Global Outcomes (KDIGO) 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD); (2) to apply the evidence-based guideline update for implementation within the Canadian health care system; (3) to provide comment on the care of children with chronic kidney disease (CKD); and (4) to identify research priorities for Canadian patients. SOURCES OF INFORMATION: The KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of CKD-MBD. METHODS: The commentary committee co-chairs selected potential members based on their knowledge of the Canadian kidney community, aiming for wide representation from relevant disciplines, academic and community centers, and different geographical regions. KEY FINDINGS: We agreed with many of the recommendations in the clinical practice guideline on the diagnosis, evaluation, prevention, and treatment of CKD-MBD. However, based on the uncommon occurrence of abnormalities in calcium and phosphate and the low likelihood of severe abnormalities in parathyroid hormone (PTH), we recommend against screening and monitoring levels of calcium, phosphate, PTH, and alkaline phosphatase in adults with CKD G3. We suggest and recommend monitoring these parameters in adults with CKD G4 and G5, respectively. In children, we agree that monitoring for CKD-MBD should begin in CKD G2, but we suggest measuring ionized calcium, rather than total calcium or calcium adjusted for albumin. With regard to vitamin D, we suggest against routine screening for vitamin D deficiency in adults with CKD G3-G5 and G1T-G5T and suggest following population health recommendations for adequate vitamin D intake. We recommend that the measurement and management of bone mineral density (BMD) be according to general population guidelines in CKD G3 and G3T, but we suggest against routine BMD testing in CKD G4-G5, CKD G4T-5T, and in children with CKD. Based on insufficient data, we also recommend against routine bone biopsy in clinical practice for adults with CKD or CKD-T, or in children with CKD, although we consider it an important research tool. LIMITATIONS: The committee relied on the evidence summaries produced by KDIGO. The CSN committee did not replicate or update the systematic reviews.

JUSTIFICATION: (1) Commenter les recommandations du KDIGO 2017 (Kidney Disease Improving Global Outcomes) sur les bonnes pratiques cliniques pour le diagnostic, l'évaluation et le traitement des troubles du métabolisme minéral osseux associés aux maladies rénales chroniques (TMO-MRC); (2) appliquer les lignes directrices actualisées et fondées sur les données probantes en vue de leur mise en œuvre dans le système de soins de santé canadien; (3) commenter les soins prodigués aux enfants atteints d'insuffisance rénale chronique (IRC) et (4) définir les priorités de recherche des patients Canadiens. SOURCES: Les recommandations du KDIGO 2017 (Kidney Disease Improving Global Outcomes) sur les bonnes pratiques cliniques pour le diagnostic, l'évaluation et le traitement des troubles du métabolisme minéral osseux associés aux maladies rénales chroniques (TMO-MRC). MÉTHODOLOGIE: Les coprésidents du comité ont sélectionné les membres potentiels sur la base de leur connaissance du secteur de la santé rénale au Canada, tout en visant une bonne représentation de toutes les disciplines concernées, des centres universitaires et communautaires et des différentes régions géographiques. PRINCIPAUX COMMENTAIRES: Nous approuvons un grand nombre des recommandations du KDIGO. Cependant, compte tenu de la rareté des anomalies du calcium et du phosphate et de la faible probabilité d'anomalies graves de la PTH (hormone parathyroïde), nous déconseillons le dépistage et la surveillance des taux de calcium, de phosphate, de PTH et de phosphatase alcaline chez les adultes atteints d'IRC de stade G3. Nous suggérons de mesurer ces paramètres chez les adultes de stade G4 et nous le recommandons pour les patients de stade G5. Chez les enfants, nous appuyons la recommandation de commencer la surveillance des TMO-MRC dès le stade G2, mais nous suggérons de mesurer le calcium ionisé plutôt que les taux de calcium total ou de calcium corrigé en fonction de l'albumine. En ce qui concerne la vitamine D, nous déconseillons le dépistage de routine des carences chez les adultes atteints d'IRC de stade G3 à G5 et G1T à G5T; nous suggérons plutôt de suivre les recommandations visant la population générale pour un apport adéquat en vitamine D. Nous recommandons que la mesure et la prise en charge de la densité minérale osseuse (DMO) se fassent en suivant les recommandations pour la population générale chez les adultes atteints d'IRC de stade G3 et G3T, mais nous déconseillons les tests de DMO de routine chez les adultes de stades G4-G5 et G4T-G5T, de même que chez les enfants atteints d'IRC. En raison de données insuffisantes, nous déconseillons également la pratique systématique d'une biopsie osseuse chez les adultes atteints d'IRC ou d'IRC-TMO, ainsi que chez les enfants atteints d'IRC, bien que nous la considérions comme un important outil de recherche. LIMITES: Le comité s'est appuyé sur le résumé des preuves rédigé par le KDIGO. Le comité de la SCN n'a pas reproduit ou mis à jour les revues systématiques.

A prospective evaluation of renal replacement therapy modality eligibility.

BACKGROUND: Patient eligibility for renal replacement therapy (RRT) modalities is frequently debated, but little prospective data are available from large patient cohorts. METHODS: We prospectively evaluated medical and psychosocial eligibility for the three RRT modalities in patients with chronic kidney disease (CKD) stages III-V who were enrolled in an ongoing prospective cohort study conducted at seven North American nephrology practices. RESULTS: Ninety-eight percent of patients were considered medically eligible for haemodialysis (HD), 87% of patients were assessed as medically eligible for peritoneal dialysis (PD) and 54% of patients were judged medically eligible for transplant. Age was the leading cause of non-eligibility for both PD and transplant. Anatomical concerns (adhesions, hernias) were the second most frequent concern for PD eligibility followed by weight. Weight was also a concern for transplant eligibility. The proportion of patients medically eligible for RRT did not vary by CKD stage. There was, however, significant inter-centre variation in the proportion of patients medically eligible for PD and transplant. Ninety-five percent of patients were considered psychosocially eligible for HD, 83% of patients were assessed as psychosocially eligible for PD and 71% of patients were judged psychosocially eligible for transplant. The percentage of patients who were assessed as having neither medical nor psychosocial contraindications for RRT was 95% for HD, 78% for PD and 53% for transplant. CONCLUSIONS: Most CKD patients are considered by their medical care providers to be suitable for PD. Enhanced patient education, promotion of home dialysis for suitable patients and empowerment of patient choice are expected to augment growth of home dialysis modalities.

Association Between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada.

Importance: Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. Objective: To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. Design, Setting, and Participants: This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28 468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. Main Outcomes and Measures: The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. Results: The final cohort comprised 28 468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P = .004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P < .001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P < .001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. Conclusions and Relevance: The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.

Topic maps for exploring nosological, lexical, semantic and HL7 structures for clinical data.

A topic map is implemented for learning about clinical data associated with a hospital stay for patients diagnosed with chronic kidney disease, diabetes and hypertension. The question posed is: how might a topic map help bridge perspectival differences among communities of practice and help make commensurable the different classifications they use? The knowledge layer of the topic map was generated from existing ontological relationships in nosological, lexical, semantic and HL7 boundary objects. Discharge summaries, patient charts and clinical data warehouse entries rectified the clinical knowledge used in practice. These clinical data were normalized to HL7 Clinical Document Architecture (CDA) markup standard and stored in the Clinical Document Repository. Each CDA entry was given a subject identifier and linked with the topic map. The ability of topic maps to function as the infostructure ;glue' is assessed using dimensions of semantic interoperability and commensurability.

Effectiveness and Cost of Weekly Recombinant Tissue Plasminogen Activator Hemodialysis Catheter Locking Solution.

BACKGROUND AND OBJECTIVES: Evidence to guide hemodialysis catheter locking solutions is limited. We aimed to assess effectiveness and cost of recombinant tissue plasminogen activator (rt-PA) once per week as a locking solution, compared with thrice weekly citrate or heparin, in patients at high risk of complications. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used a prospective design and pre-post comparison in three sites across Canada. Pre-post comparisons were conducted using multilevel mixed effects regression models accounting for cluster with site and potential enrollment of patients more than once. In the pre period, catheter malfunction was managed as per site-specific standard of care. The intervention in the post period was once weekly rt-PA as a locking solution (with citrate or heparin used for other sessions). The primary outcome was rate of rt-PA use for treatment of catheter malfunction. Secondary outcomes included rates of bacteremia, management of catheter malfunction, and cost. RESULTS: There were 374 patients (mean age 68 years; 52% men) corresponding to 506 enrollments. Mean length of enrollment was 200 days (SD 119) in the pre period and 187 days (SD 101) in the post period. There was a significant decline in rate of rt-PA use for treatment of catheter malfunction in the post compared with pre period (adjusted incidence rate ratio, 0.39; 95% confidence interval, 0.30 to 0.52); however, there was no difference in the rate of bacteremia, or catheter stripping or removal/replacement. The increase in mean total health care cost in the post period was CAD$962 per enrollment, largely related to costs of rt-PA as a locking solution. CONCLUSIONS: Once weekly rt-PA as a catheter locking solution was associated with a reduction in rt-PA use for treatment of catheter malfunction. Our results showing a reduction in rescue rt-PA use are consistent with a prior randomized trial, although we did not observe a reduction in bacteremia or catheter stripping/removal and did observe an increased incremental cost of this strategy primarily accounted for by the cost of the rt-PA.

Comparison of intensive versus standard hemodialysis central venous catheter dysfunction protocol using rt-PA: a quality assurance initiative.

PURPOSE: Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA) are used to treat and prevent clotting of hemodialysis (HD) catheters during HD treatments and the interdialytic period. However, evidence to guide the use of rt-PA for catheter dysfunction is limited. METHODS: We evaluated outcomes using two catheter dysfunction protocols in a cohort of consecutive prevalent dialysis patients (Jan 2013 to Sep 2014) undergoing HD with a tunneled catheter. In the intensive protocol, rt-PA was administered to all catheters based on blood flow and/or line reversal. In the standard protocol, rt-PA administration was based only on blood flow. The primary outcome was the rate of rt-PA use for catheter malfunction (rt-PA treatment days/1000 total line days; [TLD]). Secondary outcomes included the cost of rt-PA/TLD and the rate of catheter-related bacteremia. RESULTS: There were 26 and 35 patients managed by the intensive and standard protocols, respectively. The rate of rt-PA use was 52/1000 TLD (intensive) versus 39/1000 TLD (standard) (rate ratio 1.30, 95% CI 1.12-1.52 CI, p<0.001). The rate of bacteremia was 0.43 and 0.22/1000 TLD for the intensive and standard protocols, respectively (p = 0.491). The cost of rt-PA was CDN $5.58 and CDN $6.15 per TLD for the intensive protocol and standard protocol groups (p<0.001). CONCLUSIONS: Managing catheter dysfunction based on line reversal and blood flow as opposed to only blood flow was associated with a higher rate of rt-PA use, but at a reduced overall cost.

Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

BACKGROUND: Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. OBJECTIVE: The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. DESIGN: This study is a multicenter, 2-arm parallel, cluster randomized trial. SETTING: The study involves 55 advanced chronic kidney disease clinics across Canada. PATIENTS: Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. MEASUREMENTS: Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. METHODS: We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline release without active dissemination. We hypothesize that the clinics randomized to the intervention group will have a lower proportion of early dialysis starts. LIMITATIONS: Limitations include passive dissemination of the guideline through publication, and lead-time and survivor bias, which favors delayed dialysis initiation. CONCLUSIONS: If successful, this active knowledge translation intervention will reduce early dialysis starts, lead to health and economic benefits, and provide a successful framework for evaluating and disseminating future guidelines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02183987.

MISE EN CONTEXTE: Malgré l'absence d'avantages probants pour la santé des patients et en dépit de coûts plus élevés liés à la dialyse, la décision d'amorcer un tel traitement au moment où la fonction rénale du patient est encore relativement élevée (dialyse hâtive) est en forte hausse depuis une vingtaine d'années au Canada et partout dans le monde. Toutefois, les lignes directrices canadiennes publiées en 2014 à ce sujet recommandent plutôt de retarder le démarrage de la dialyse. OBJECTIFS DE L'ÉTUDE: Cette étude a pour but d'évaluer l'efficacité et la sécurité d'une intervention au niveau de l'application des connaissances qui favoriserait le démarrage tardif de la dialyse chronique dans la pratique. CADRE ET TYPE D'ÉTUDE: Il s'agit d'un essai clinique randomisé en deux groupes parallèles avec échantillonnage par grappes (clusters). Cinquante-cinq cliniques multidisciplinaires traitant des patients en insuffisance rénale chronique et provenant de partout au Canada participent à l'étude. PATIENTS: L'étude porte sur des patients adultes suivis par un néphrologue depuis plus de trois mois et ayant démarré la dialyse au cours de la période de suivi. MESURES: Les données recueillies seront mesurées au niveau des patients et analysées par regroupement (clusters). Les paramètres de démarrage pour chaque début de dialyse seront établis par la consultation du registre canadien des insuffisances et des transplantations d'organes (RCITO). Les issues primaires sont i) la proportion de patients qui auront démarré la dialyse avec un débit de filtration glomérulaire estimé de plus de 10,5 mL/min/1,73 m2 (dialyse hâtive); ii) la proportion de patients pour lesquels l'amorce aura été faite au cours d'une hospitalisation ou lors d'une admission aux urgences. Les issues secondaires qui seront mesurées incluent : le taux de variation dans le moment du démarrage de la dialyse, le taux d'hospitalisations, le nombre de décès et les coûts associés aux soins prédialyse (lorsque l'évaluation est possible). On voudra également établir un rapport trimestriel des nouveaux cas de démarrages de dialyses, et savoir à quel point les éléments de transmission des connaissances seront acceptés dans la pratique. MÉTHODOLOGIE: Nous avons randomisé 55 cliniques multidisciplinaires en traitement de l'insuffisance rénale (clusters) au Canada à recevoir, ou non, une intervention de transmission des connaissances portant sur les lignes directrices Canadiennes du démarrage de la dialyse. L'intervention consiste en une visite médicale individuelle où l'information pertinente et des outils pédagogiques, tant pour le patient que pour le médecin traitant, sont distribués. Le suivi est assuré par rétroaction et par des vérifications ponctuelles (audits). Les groupes contrôles sont quant à eux mis au fait des nouvelles recommandations sans toutefois recevoir d'outils pédagogiques ni être soumis à la diffusion active de l'information. Nous émettons l'hypothèse que la proportion de dialyses hâtives diminuera au sein des cliniques ayant été randomisées dans le groupe où une intervention sera effectuée. LIMITES DE L'ÉTUDE: La première limite consiste en la possible diffusion passive des nouvelles lignes directrices uniquement par voie de publication. En outre, les biais liés à la survie et au délai d'exécution favorisent les démarrages tardifs de dialyse. CONCLUSION: Une intervention réussie au niveau de la transmission des connaissances contribuera à réduire le nombre d'amorces de dialyse hâtives. Dès lors, on peut penser que cela aura une incidence sur les coûts reliés à cette procédure et des avantages pour la santé des patients. Enfin, cette étude pourrait constituer un cadre favorable pour procéder à l'évaluation et à la diffusion de futures lignes directrices.