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Health state utilities (HSU) data collected in real-world evidence studies are at risk of bias. Although numerous guidance documents are available, practical advice to avoid bias in HSU studies is limited. Thus, the objective of this article was to develop a concise toolbox intended for investigators seeking to collect HSU in a real-world setting. The proposed toolbox builds on existing guidance and provides practical steps to help investigators perform good quality research. The toolbox aims at increasing the credibility of HSU data for future reimbursement decision making.

Introduction To prevent bleeding after native kidney biopsy (NKB), nephrologists often prescribe desmopressin, especially for patients with reduced estimated glomerular filtration rate (eGFR) at risk of uremia-related platelet dysfunction. However, only 1 randomized study has suggested a beneficial effect for desmopressin in patients with eGFR ≥60 ml/min per 1.73 m2. This retrospective cohort study aimed to evaluate desmopressin effect on postbiopsy bleeding in all patients, regardless of eGFR and other comorbidities. Methods In this retrospective cohort study, all adult patients who underwent an NKB from April 1, 2013, to April 30, 2018, in a tertiary hospital were identified. The association between desmopressin use and bleeding complications, including hemoglobin fall, transfusion, hematoma, symptomatic hematoma, urgent radiologic study, and hypotension, was analyzed using multivariable logistic regression models. Results A total of 413 native kidney biopsies were studied, 79% of which were performed after receiving desmopressin. Patients receiving desmopressin had worse chronic kidney disease (eGFR 28 vs. 45 ml/min per 1.73 m2; P < 0.001) and were more often hospitalized (48% vs. 32%; P = 0.009). Despite higher bleeding risk, patients using desmopressin had a similar likelihood of symptomatic hematomas (odds ratio [OR], 0.39; 95% confidence interval [CI], 0.13–1.14) and a lower need for urgent radiologic studies (OR, 0.33; 95% CI, 0.11–0.98). Conclusion Patients at higher risk of bleeding using desmopressin before kidney biopsy had bleeding complications similar to those not using desmopressin. These results highlight potential important clinical and financial benefits of desmopressin use before kidney biopsy., Graphical abstract

Laparoscopic sleeve gastrectomy induces weight loss via the creation of a restrictive gastric tube for early satiety and is associated with an accelerated gastric transit time. A prospective, single-dose pharmacokinetic study was performed, prior to and after laparoscopic sleeve gastrectomy, for tacrolimus, extended-release tacrolimus, mycophenolate mofetil, and enteric-coated mycophenolate sodium. The study included 12 morbidly obese patients in chronic renal failure. The median decrease in body mass index was 8.8 kg/m2 with an excess body weight loss of 54.9%. The AUC24 of all drugs were increased after laparoscopic sleeve gastrectomy by 46%, 55%, 77%, and 74%, respectively. The maximum concentrations were increased for tacrolimus, extended-release tacrolimus, and mycophenolate mofetil by 43%, 46%, and 65%. The apparent total clearances were decreased for tacrolimus, mycophenolate mofetil, and enteric-coated mycophenolate sodium by 36%, 57%, and 38%. Laparoscopic sleeve gastrectomy can be associated with significant changes in pharmacokinetics of the drugs evaluated. The mechanism is likely decreased apparent drug clearance due to an increased drug exposure (from a more distal site of intestinal absorption with decreased intestinal metabolism), or decreased clearance (liver metabolism). Adapting the monitoring of immunosuppression will be important to avoid overdosing and potential side effects.

Residual renal function and diuresis preservation are associated with improved volume control and lower mortality in peritoneal dialysis (PD). Loop diuretics are used to maintain diuresis, although their optimal dosage remains unclear. This study aimed to compare the pharmacodynamics of a 250-mg and a 500-mg dose of oral furosemide in PD patients. 12 patients with a diuresis > 100 mL per day were randomized in a crossover pattern to successively receive an oral dose of 250 mg and 500 mg of furosemide. Twelve-hour natriuresis and diuresis were measured before and after each furosemide dose. Fractional excretion of sodium (FENa) and absolute sodium excretion increased after each dose, although these rises were not statistically significantly different (5.8% (250 mg) vs. 6.9% (500 mg), p = 0.57 for FENa and 42.6 mmol/12h (250 mg) vs. 70.8 mmol/12h (500 mg), p = 0.07 for absolute sodium excretion). Urinary volume was significantly increased after the 500-mg dose, whilst the difference did not reach statistical significance after the 250-mg dose. Furthermore, the higher dose was associated with a greater increase in diuresis than the lower dose (226 mL (250 mg) vs. 522 mL (500 mg), p = 0.04). Furosemide could be used at oral single doses reaching 500 mg in PD patients requiring greater volume control.

BACKGROUND Type 2 diabetes mellitus (T2DM) imposes a substantial burden owing to its increasing prevalence and life-threatening complications. In patients who do not achieve glycemic targets with oral antidiabetic drugs, the initiation of insulin is recommended. However, a serious concern regarding insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and the use of health care resources. However, health economics and outcomes research (HEOR) data for economic modelling are limited, particularly regarding utility values and productivity losses. OBJECTIVE This real-world prospective study aims to assess the impact of hypoglycemia on productivity and utility in insulin-treated adults with T2DM from Ontario and Quebec, Canada. METHODS This noninterventional, multicenter, 3-month prospective study will recruit patients from 4 medical clinics and 2 endocrinology or diabetes clinics. Patients will be identified using appointment lists and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be aged ≥18 years, diagnosed with T2DM, and treated with insulin. Utility and productivity will be measured using the EQ-5D-5L questionnaire and Institute for Medical Technology Assessment Productivity Cost Questionnaire, respectively. Questionnaires will be completed 4, 8, and 12 weeks after recruitment. Generalized estimating equation models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure the precision of HEOR estimates. RESULTS This study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for the economic modeling of T2DM. CONCLUSIONS Insulin therapy is expensive, and hypoglycemia is a significant component of economic evaluation. Robust HEOR data may help health technology assessment agencies in future reimbursement decision-making. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/35461

Background Type 2 diabetes mellitus (T2DM) imposes a substantial burden owing to its increasing prevalence and life-threatening complications. In patients who do not achieve glycemic targets with oral antidiabetic drugs, the initiation of insulin is recommended. However, a serious concern regarding insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and the use of health care resources. However, health economics and outcomes research (HEOR) data for economic modelling are limited, particularly regarding utility values and productivity losses. Objective This real-world prospective study aims to assess the impact of hypoglycemia on productivity and utility in insulin-treated adults with T2DM from Ontario and Quebec, Canada. Methods This noninterventional, multicenter, 3-month prospective study will recruit patients from 4 medical clinics and 2 endocrinology or diabetes clinics. Patients will be identified using appointment lists and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be aged ≥18 years, diagnosed with T2DM, and treated with insulin. Utility and productivity will be measured using the EQ-5D-5L questionnaire and Institute for Medical Technology Assessment Productivity Cost Questionnaire, respectively. Questionnaires will be completed 4, 8, and 12 weeks after recruitment. Generalized estimating equation models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure the precision of HEOR estimates. Results This study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for the economic modeling of T2DM. Conclusions Insulin therapy is expensive, and hypoglycemia is a significant component of economic evaluation. Robust HEOR data may help health technology assessment agencies in future reimbursement decision-making. International Registered Report Identifier (IRRID) PRR1-10.2196/35461

Quantification of the M-type phospholipase A2 receptor antibodies (anti-PLA2R) is now an essential tool for diagnosis and management of primary membranous nephropathy (MN). Since October 2018, Hôpital Maisonneuve-Rosemont (HMR) has been designated as Quebec's reference center for serum anti-PLA2R antibody testing by theTo describe the 2-step method of serum qualitative and quantitative anti-PLA2R antibody testing during its first year of use in Quebec and analyze its diagnostic value in the province's population.Retrospective cohort study.Single-center academic teaching hospital in Quebec, Canada.All patients who had a serum anti-PLA2R antibody test analyzed at HMR from October 1, 2018, to October 1, 2019, were included in the study.Serum anti-PLA2R antibodies were screened by indirect immunofluorescence tests. If results were positive or undetermined, it was followed by a quantitative enzyme-linked immunosorbent assay (ELISA) test. Both tests were based on a commercial kit developed by the same company.We calculated sensitivity, specificity, predictive value, and likelihood ratio for both tests, using kidney biopsy findings performed at HMR as the gold standard.In Quebec, a total of 1690 tests were performed among 1025 patients during the study year. A small proportion of these patients (8%) were followed at HMR. Patients tested at HMR and in the rest of Quebec had similar characteristics. Test validity was only characterized for patients tested at HMR. Sensitivity and specificity were, respectively, 58% and 100% for the qualitative test, and 71% and 100% for the quantitative test. The combined net sensitivity was 42% and the net specificity 100%. The net positive and negative predictive value were 100% and 84% respectively, whereas the net negative likelihood ratio was 0.58.As the detailed analysis was only possible in the small proportion of patients clinically followed at HMR, there is a possible selection bias. Another potential selection bias was the focus on patients who were selected to have a kidney biopsy, probably because of more severe disease, higher probability of glomerulonephritis, or lesser number of comorbidities. Given the retrospective nature of this study, there was no systematic kidney biopsy or serum PLA2R antibody testing performed. Finally, we were unable to provide detailed information on the timing between immunosuppressive therapy and anti-PLA2R results.Serum anti-PLA2R antibody testing was widely used in Quebec during its first year of availability. A 2-step approach, using a qualitative test first, followed by a quantitative test if the results are positive or undetermined, appears efficient to avoid useless quantitative testing in negative patients and to better characterize undetermined results on immunofluorescence.Due to the retrospective nature of this study, no trial registration was performed.La quantification des anticorps des récepteurs de la phospholipase A2 de type M (anti-PLA2R) est désormais un outil essentiel pour le diagnostic et la prise en charge de la glomérulonéphrite extra-membraneuse primaire (GEMp). Depuis octobre 2018, l’Hôpital Maisonneuve-Rosemont (HMR) a été désigné par l’Institut National d’Excellence en Santé et Services Sociaux (INESSS)—l’organisme règlementant l’usage des médicaments et des tests au Québec—comme le centre hospitalier de référence dans la province pour le dépistage des anticorps sériques anti-PLA2R.Décrire la méthode en deux étapes du test qualitatif et quantitatif des anticorps anti-PLA2R sériques au cours de sa première année d’utilisation au Québec et évaluer sa valeur diagnostique dans la population de la province.Étude de cohorte rétrospective.Un centre hospitalier universitaire du Québec (Canada).Ont été inclus tous les patients dont le test des anticorps sériques anti-PLA2R a été analysé à HMR entre le 1er octobre 2018 et le 1er octobre 2019.Les anticorps sériques anti-PLA2R ont été détectés par immunofluorescence indirecte. Les résultats positifs ou indéterminés ont été suivis d’un test ELISA quantitatif. Les deux tests ont été réalisés à l’aide de trousses commerciales développées par la même entreprise.Nous avons analysé la sensibilité, la spécificité, la valeur prédictive et le rapport de vraisemblance des deux tests avec comme référence des résultats de biopsie rénale obtenus à HMR.Au Québec, au cours de l’année de l’étude, 1 690 tests ont été effectués sur 1 025 patients; une faible proportion de ces patients (8 %) étaient suivis à HMR. Les patients, qu’ils aient été testés à HMR et ailleurs au Québec, présentaient des caractéristiques semblables. La validité du test n’a été caractérisée que pour les patients testés à HMR. La sensibilité et la spécificité s’établissaient respectivement à 58 % et à 100 % pour le test qualitatif, et à 71 % et 100 % pour le test quantitatif. La sensibilité nette combinée était de 42 % et la spécificité nette, de 100 %. Les valeurs prédictives nettes, positive et négative, étaient respectivement de 100 % et de 84 %, alors que le ratio net de probabilité négative était de 0,58.L’étude présente un possible biais de sélection puisque l’analyse détaillée n’était possible que pour la faible proportion de patients suivis à HMR. L’accent mis sur les patients sélectionnés pour une biopsie rénale, probablement en raison d’une maladie plus grave, d’une probabilité plus élevée de glomérulonéphrite ou d’un moins grand nombre de comorbidités, constitue un autre possible biais de sélection. Aucune biopsie rénale ou test d’anticorps de PLA2R sérique systématique n’a été effectué puisque l’étude est rétrospective. Enfin, il n’a pas été possible de fournir des informations détaillées sur le temps écoulé entre le traitement immunosuppresseur et les résultats du test d’anticorps anti-PLA2R.Le test d’anticorps sériques anti-PLA2R a été largement utilisé au Québec au cours de sa première année de disponibilité. Une approche en deux étapes, constituée d’un test qualitatif suivi d’un test quantitatif si le résultat est positif ou indéterminé, semble efficace pour éviter de procéder inutilement à des tests quantitatifs chez les patients négatifs et pour caractériser plus précisément les résultats indéterminés par immunofluorescence.L’essai n’a pas été enregistré puisqu’il s’agit d’une étude rétrospective.

Background Estimating glomerular filtration rate (GFR) in acute kidney injury (AKI) is challenging, with limited data comparing estimated and gold standard methods to assess GFR. The objective of our study was to assess the performance of the kinetic estimated GFR (KeGFR) and Jelliffe equations to estimate GFR in AKI, using a radioisotopic method (technetium-diethylenetriaminepentaacetic acid) as a reference measure. Methods We conducted a prospective multicenter observational study in hospitalized patients with AKI. We computed the Jelliffe and KeGFR equations to estimate GFR and compared these estimations to measured GFR (mGFR) by a radioisotopic method. The performances were assessed by correlation, Bland–Altman plots and smoothed and linear regressions. We conducted stratified analyses by age and chronic kidney disease (CKD). Results The study included 119 patients with AKI, mostly from the intensive care unit (63%) and with Stage 1 AKI (71%). The eGFR obtained from the Jelliffe and KeGFR equations showed a good correlation with mGFR (r = 0.73 and 0.68, respectively). The median eGFR by the Jelliffe and KeGFR equations was less than the median mGFR, indicating that these equations underestimated the mGFR. On Bland–Altman plots, the Jelliffe and KeGFR equations displayed a considerable lack of agreement with mGFR, with limits of agreement >40 mL/min/1.73 m2. Both equations performed better in CKD and the KeGFR performed better in older patients. Results were similar across AKI stages. Conclusions In our study, the Jelliffe and KeGFR equations had good correlations with mGFR; however, they had wide limits of agreement. Further studies are needed to optimize the prediction of mGFR with estimatation equations.

To evaluate the impact of concomitant use of conventional synthetic DMARDs (csCMARD) on adherence, switching and dose of biologic disease modifying antirheumatic drugs (bDMARD) in rheumatoid arthritis (RA) patients treated with bDMARDs.This was a population-based cohort study conducted in five provinces of Canada (Alberta, Manitoba, Ontario, Quebec, and Saskatchewan), and one American database (IBM® MarketScan® Databases). Adult RA patients entered the study after a 3-month initiation period of bDMARDs between 1 January 2007, and 30 March 2014. Concomitant csDMARD exposure was compared to non-csDMARD exposure on the following outcomes: discontinuation of bDMARD therapy, switching of bDMARDs, and percent change in dose of bDMARD compared to initial dose. The effect of the time-varying changes in csDMARD exposure was analyzed using marginal structural models. Dose change was analyzed using linear regression. Results from each participating site were combined using likelihood ratio meta-analysis.The study population comprised 20,221 new users of bDMARDs: adalimumab (7609), etanercept (9809), abatacept (1024), infliximab (1779). Concomitant use of csDMARD therapy was not significantly associated with reduced discontinuation of bDMARD treatment (hazard ratio 0.90, 95% intrinsic confidence interval 0.79 to 1.02) or reduced switching of bDMARDs (hazard ratio 0.95, 95% intrinsic confidence interval 0.80 to 1.11), but was associated with a small increase in bDMARD dose compared to the mean dose over the first three months of treatment (mean percentage change in dose +0.56% mg/day, 95% intrinsic confidence interval +0.14% to +0.97%).In this large study of RA patients using bDMARDs in Canada and the United States, we found no clear evidence that patients who received concomitant csDMARD therapy were less likely to discontinue, switch or increase their dose of bDMARD.

Background Morbid obesity in kidney transplant (KT) candidates is associated with increased complications and graft failure. Multiple series have demonstrated rapid and significant weight loss after laparoscopic sleeve gastrectomy (LSG) in this population. Long-term and post-transplant weight evolutions are still largely unknown. Methods A retrospective review was performed in eighty patients with end-stage kidney disease (ESKD) who underwent LSG in preparation for KT. Results From a median initial BMI of 43.7kg/m2 , the median change at one-year was -10.0kg/m2 . Successful surgical weight loss (achieving a BMI 50%) was attained in 76.3%, and was associated with male gender, pre-dialysis status, lower obesity class and lack of coronary artery disease. Thirty-one patients subsequently received a KT with a median delay of 16.7 months. Weight re-gain (increase in BMI of 5kg/m2 post-nadir) and recurrent obesity (weight regain +BMI>35) remain a concern, occurring post-KT in 35.7% and 17.9% respectively. Conclusions Early LSG should be considered for morbidly obese patients with ESKD for improved weight loss outcomes. Early KT after LSG does not appear to affect short-term surgical weight loss. Candidates with a BMI of up to 45kg/m2 can have a reasonable expectation to achieve the limit within one year.

Supplemental material, sj-pdf-1-cjk-10.1177_2054358120987061 for Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session (ESRD Study) by Marjolaine Giroux, Nicolas Bouchard, Anik Henderson, Lesly Lam, Van Anh Sylvie Tran, Denis Projean, Jean-François Tessier, Laurence Lepage, Paul Gavra, Georges Ouellet, Michel Vallée and Jean-Philippe Lafrance in Canadian Journal of Kidney Health and Disease

Chronic kidney disease (CKD) is a major health issue and cardiovascular risk factor. Validity assessment of administrative data for the detection of CKD in research for drug benefit and risk using real-world data is important. Existing algorithms have limitations and we need to develop new algorithms using administrative data, giving the importance of drug benefit/risk ratio in real world.The aim of this study was to validate a predictive algorithm for CKD GFR category 4-5 (eGFR30 mL/min/1.73 mThis is a retrospective cohort study using chart collection and administrative databases.The study was conducted in a community outpatient medical clinic and pre-dialysis outpatient clinic in downtown Montreal and rural area.Patient medical files with at least 2 serum creatinine measures (up to 1 year apart) between September 1, 2013, and June 30, 2015, were reviewed consecutively (going back in time from the day we started the study). We excluded patients with end-stage renal disease on dialysis. The study was started in September 2013.Glomerular filtration rate was estimated using the CKD Epidemiological Collaboration (CKD-EPI) from each patient's file. Several algorithms were developed using 3 administrative databases with different combinations of physician claims (diagnostics and number of visits) and hospital discharge data in the 5 years prior to the cohort entry, as well as specific drug use and medical intervention in preparation for dialysis in the 2 years prior to the cohort entry.Chart data were used to assess eGFR. The validity of various algorithms for detection of CKD groups was assessed with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).A total of 434 medical files were reviewed; mean age of patients was 74.2 ± 10.6 years, and 83% were older than 65 years. Sensitivity of algorithm #3 (diagnosis within 2-5 years and/or specific drug use within 2 years and nephrologist visit ≥4 within 2-5 years) in identification of CKD G4-5ND ranged from 82.5% to 89.0%, specificity from 97.1% to 98.9% with PPV and NPV ranging from 94.5% to 97.7% and 91.1% to 94.2%, respectively. The subsequent subgroup analysis (diabetes, hypertension, and65 and ≥65 years) and also the comparisons of predicted prevalence in a cohort of older adults relative to published data emphasized the accuracy of our algorithm for patients with severe CKD (CKD G4-5ND).Our cohort comprised mostly older adults, and results may not be generalizable to all adults. Participants with CKD without 2 serum creatinine measurements up to 1 year apart were excluded.The case definition of severe CKD G4-5ND derived from an algorithm using diagnosis code, drug use, and nephrologist visits from administrative databases is a valid algorithm compared with medical chart reviews in older adults.L’insuffisance rénale chronique (IRC) est un problème de santé majeur et un facteur de risque cardiovasculaire. La validité de la détection de l’IRC à partir des bases de données administratives est importante pour les études évaluant en situation réelle les bénéfices et les risques des médicaments. Les algorithmes existants comportent des limites et, compte tenu de l’importance revêtue par ce rapport bénéfices/risques, le développement de nouveaux algorithmes utilisant les bases de données administratives s’avère essentiel.Valider le pouvoir prédictif d’un algorithme pour détecter l’insuffisance rénale chronique sévère (DFGe30 mL/min/1.73 mÉtude de cohorte rétrospective réalisée à partir des dossiers médicaux et de données administratives.Des cliniques médicales communautaires et de protection rénale de Montréal et des régions rurales périphériques.Les dossiers médicaux de patients avec au moins deux mesures de la créatinine sérique (en moins d’un an) entre le 1er septembre 2013 et le 30 juin 2015 ont été revus consécutivement, en reculant dans le temps. Les patients avec insuffisance rénale terminale et dialysés ont été exclus. L’étude a débuté en septembre 2013.Le DFG a été estimé à l’aide de la formule CKD Epidemiological Collaboration (CKD-EPI) à partir du dossier médical de chaque patient. Nous avons développé différents algorithmes en utilisant trois banques de données administratives avec différentes combinaisons de facturations médicales (diagnostics et nombre de visites en néphrologie) et de données colligées au congé de l’hôpital dans les cinq ans précédant l’entrée dans la cohorte, de même qu’avec la consommation de certains médicaments et les interventions médicales subies en préparation à la dialyse dans les deux ans précédant l’entrée dans la cohorte.Les données des dossiers médicaux ont été utilisées pour définir le DFGe. La validité des algorithmes développés a été évaluée en utilisant la sensibilité, la spécificité, la valeur prédictive positive (VPP) et la valeur prédictive négative (VPN).En tout, 434 dossiers médicaux ont été revus; l’âge moyen des patients était de 74.2 ± 10.6 ans et 83% avaient plus de 65 ans. La sensibilité de l’algorithme no.3 (diagnostic dans un délai de 2 à 5 ans et/ou l’usage de médicaments spécifiques dans un délai de 2 ans, et au moins quatre visites médicales en néphrologie dans les 2 à 5 ans précédant la date d’entrée dans la cohorte) dans l’identification d’une insuffisance rénale sévère (CKD G4-5ND) variait de 82.5% à 89.0%. La spécificité de ce même algorithme variait de 97.1% à 98.9% avec une PPV et une NPV allant respectivement de 94.5.% à 97.7% et de 91.1% à 94.2%. L’analyse de sous-groupes (patients diabétiques, hypertendus, âgés de moins de 65 ans ou âgés de 65 ans et plus) ainsi que la comparaison de la prévalence prédite dans une cohorte de patients âgés par rapport aux données de la littérature font valoir la précision de notre algorithme pour les patients avec insuffisance rénale sévère (CKD G4-5ND).Notre cohorte était composée essentiellement de sujets âgées, les résultats pourraient ne pas s’appliquer à tous les adultes. Les patients n’ayant pas eu deux mesures de la créatinine sérique à l’intérieur d’un an ont été exclus.Chez les personnes âgées, la définition de cas pour une insuffisance chronique rénale sévère (CKD G4-5ND) estimée par un algorithme utilisant les codes diagnostic, la consommation de médicaments spécifiques et les services médicaux de néphrologie tirés des données administratives s’avère un algorithme valide comparativement à l’examen du dossier médical.

BACKGROUND: Kidney failure is associated with a high burden of morbidity and mortality. Previous studies have raised the possibility that arteriovenous fistula (AVF) creation may attenuate eGFR decline. This study aimed to compare eGFR decline in predialysis patients with an AVF, matched to patients oriented toward peritoneal dialysis (PD). METHODS: Predialysis patients with an AVF and those oriented toward PD were retrospectively matched using a propensity score. Time zero was defined as the “AVF creation date” for the AVF group and the “date when eGFR was closest to the matched patient’s eGFR at AVF creation” for the PD group. Crude and predicted eGFR decline in AVF and PD groups were compared before and after time zero using mixed-effect linear regressions. RESULTS: In total, 61 pairs were matched. Crude annual eGFR decline before AVF creation/time zero was −4.1 ml/min per m(2) per year in the AVF group versus −5.3 ml/min per m(2) per year in the PD group (P=0.75) and after time zero, −2.5 ml/min per m(2) per year in the AVF group versus −4.5 ml/min per m(2) per year in the PD group (P=0.02). The predicted annual decline decreased from −5.1 ml/min per m(2) per year in the AVF group before AVF creation to −2.8 ml/min per m(2) per year after (P

Supplemental material, Supplemental_File for Agreement Between Administrative Database and Medical Chart Review for the Prediction of Chronic Kidney Disease G category by Louise Roy, Michael Zappitelli, Brian White-Guay, Jean-Philippe Lafrance, Marc Dorais and Sylvie Perreault in Canadian Journal of Kidney Health and Disease

OBJECTIVES: (1) To evaluate the association between acute kidney injury (AKI) in the PICU and long-term mortality and (2) to determine the extent to which adding the urine output (UO)–defined AKI alters the association. METHODS: A 2-center retrospective cohort study of children (≤18 years old) admitted to the PICU between 2003 and 2005 for noncardiac surgery, with follow-up until 2010. Patients with end stage renal disease, no provincial health insurance number, who died during hospitalization, or could not be linked to administrative data were excluded. One hospitalization per patient was included. AKI was defined by using serum creatinine criteria and/or UO criteria. Mortality was ascertained by using administrative data. Cox regression analysis was performed to evaluate the association between AKI and long-term mortality. RESULTS: The study population included 2041 patients (55.7% male, mean admission age 6.5 ± 5.8 years). Of 2041 hospital survivors, 9 (0.4%) died within 30 days, 51 (2.5%) died within 1 year, and 118 (5.8%) died within 5 to 7 years postdischarge. AKI was independently associated with 5- to 7-year mortality (adjusted hazard ratio [95% confidence interval]: 3.10 [1.46–6.57] and 3.38 [1.63–7.02], respectively). Including UO did not strengthen the association. CONCLUSIONS: AKI is associated with 5- to 7-year mortality. Because this is an observational study we cannot determine if AKI is causative of mortality or of the pathophysiology. However, patients with AKI represent a high-risk group. It is reasonable that these patients be considered for targeted follow-up until future researchers better elucidate these relationships

Background and objectives Little is known about the long-term burden of AKI in the pediatric intensive care unit. We aim to evaluate if pediatric AKI is associated with higher health service use post–hospital discharge. Design, setting, participants, & measurements This is a retrospective cohort study of children (≤18 years old) admitted to two tertiary centers in Montreal, Canada. Only the first admission per patient was included. AKI was defined in two ways: serum creatinine alone or serum creatinine and/or urine output. The outcomes were 30-day, 1-year, and 5-year hospitalizations, emergency room visits, and physician visits per person-time using provincial administrative data. Univariable and multivariable Poisson regression were used to evaluate AKI associations with outcomes. Results A total of 2041 children were included (56% male, mean admission age 6.5±5.8 years); 299 of 1575 (19%) developed AKI defined using serum creatinine alone, and when urine output was included in the AKI definition 355 of 1622 (22%) children developed AKI. AKI defined using serum creatinine alone and AKI defined using serum creatinine and urine output were both associated with higher 1- and 5-year hospitalization risk (AKI by serum creatinine alone adjusted relative risk, 1.42; 95% confidence interval, 1.12 to 1.82; and 1.80; 1.54 to 2.11, respectively [similar when urine output was included]) and higher 5-year physician visits (adjusted relative risk, 1.26; 95% confidence interval, 1.14 to 1.39). AKI was not associated with emergency room use after adjustments. Conclusions AKI is independently associated with higher hospitalizations and physician visits postdischarge.

Background Arteriovenous fistula (AVF) is the vascular access of choice for patients on hemodialysis. Recent evidence suggests that AVF creation may slow estimated glomerular filtration rate (eGFR) decline. The study objective was to assess the impact of the AVF creation on eGFR decline, after controlling for key confounding factors. Methods This retrospective cohort study included adult patients followed in a single-center predialysis clinic between 1999 and 2016. Patients with a patent AVF were followed up to 2 years pre- and post-AVF creation. Estimated GFR trajectory was reported using linear mixed models adjusted for demographic characteristics, comorbidities and use of renin-angiotensin-aldosterone blockade. Results A total of 146 patients were studied with a median age 68.7 (60.5–75.4) years and a median eGFR at time of AVF creation of 12.8 (11.3–13.9) mL/min/1.73m2. The crude annual eGFR decline rates were − 3.60 ± 4.00 mL/min/1.73 m2 pre- and − 2.28 ± 3.56 mL/min/1.73 m2 post-AVF, resulting in a mean difference of 1.28 mL/min/1.73 m2 (95% CI 0.49, 2.07). In a mixed effect linear regression model, monthly eGFR decline was − 0.63 (95% CI -0.81, − 0.46; p 2/month. The period after AVF creation was associated with a relatively higher eGFR (β 0.94, 95% CI 0.61–1.26, p Conclusions In this cohort, AVF creation was associated with a significant reduction of eGFR decline. Further prospective studies are needed to confirm this association.

To develop a pediatric-specific hypertension algorithm using administrative data and use it to evaluate the association between acute kidney injury (AKI) in the intensive care unit (ICU) and hypertension diagnosis 5 years post-discharge. Two-center retrospective cohort study of children (≤ 18 years old) admitted to the pediatric ICU in Montreal, Canada, between 2003 and 2005 and followed until 2010. Patients with a valid healthcare number and without end-stage renal disease were included. Patients who could not be merged with the provincial database, did not survive admission, underwent cardiac surgery, had pre-existing renal disease associated with hypertension or a prior diagnosis of hypertension were excluded. AKI defined using the Kidney Disease: Improving Global Outcomes (KDIGO) definition. Using diagnostic codes and medications from administrative data, novel pediatric-specific hypertension definitions were designed. Both the evaluation of the prevalence of hypertension diagnosis and the association between AKI and hypertension occurred. Nineteen hundred and seventy eight patients were included (median age at admission [interquartile range] 4.3 years [1.1–11.8], 44% female, 325 (16.4%) developed AKI). Of these patients, 130 (7%) had a hypertension diagnosis 5 years after discharge. Patients with AKI had a higher prevalence of hypertension diagnosis [non-AKI: 84/1653 (5.1%) vs. AKI: 46/325 (14.2%), p

Large studies evaluating pediatric acute kidney injury (AKI) epidemiology and outcomes are lacking, partially due to underuse of large administrative health care data.To assess the diagnostic accuracy of administrative health care data-defined AKI in children admitted to the pediatric intensive care unit (PICU).Retrospective cohort study utilizing chart and administrative data.Children admitted to the PICU at 2 centers in Montreal, QC.Patients between 0 and 18 years old with a provincial health insurance number, without end-stage renal disease and admitted to the PICU between January 1, 2003, and March 31, 2005, were included.The AKI was defined from chart data using the Kidney Disease: Improving Global Outcomes (KDIGO) definition (Chart-AKI). The AKI defined using administrative health data (Admin-AKI) was based onData available from retrospective chart review, including baseline and PICU patient characteristics, and serum creatinine (SCr) and urine output (UO) values during PICU admission, were merged with provincial administrative health care data containing diagnostic and procedure codes used for ascertaining Admin-AKI. Sensitivity, specificity, positive, and negative predictive value of Admin-AKI compared with Chart-AKI (reference standard) were calculated. Univariable associations between Admin-AKI and hospital mortality were evaluated.A total of 2051 patients (55% male, mean age at admission 6.1 ± 5.8 years, 355 cardiac surgery, 1696 noncardiac surgery) were included. The AKI defined by SCr or UO criteria occurred in 52% of cardiac surgery patients and 24% of noncardiac surgery patients. Overall, Admin-AKI detected Chart-AKI with low sensitivity, but high specificity in cardiac and noncardiac surgery patients. Sensitivity increased by 1.5 to 2 fold with each increase in AKI severity stage. Admin-AKI was associated with hospital mortality (13% in Admin-AKIThese data were generated in a PICU population; future research should study non-PICU populations.Use of administrative health care data to define AKI in children leads to AKI incidence underestimation. However, for detecting more severe AKI, sensitivity is higher, while maintaining high specificity.On dispose de peu d’études à grande échelle évaluant l’épidémiologie et l’évolution de l’insuffisance rénale aigüe (IRA) chez les enfants, notamment en raison d’une sous-utilisation des données administratives du système de santé.Évaluer la précision diagnostique de l’IRA définie à partir des données administratives en santé chez des enfants admis aux unités de soins intensifs pédiatriques (USIP).Une étude de cohorte rétrospective utilisant des données administratives et les données provenant des dossiers médicaux.Les USIP de deux centres hospitaliers de Montréal, au Canada.Ont été inclus les patients âgés de 0 à 18 ans possédant un numéro d’assurance-maladie provincial qui ont été admis aux USIP entre le 1er janvier 2003 et le 31 mars 2005 avec une insuffisance rénale non terminale.L’IRA-Dos a été définie à partir des dossiers médicaux en utilisant les critères du KDIGO (Kidney Disease: Improving Global Outcomes). L’IRA-Admin a été définie à partir des données administratives en santé avec les codes d’IRA de la neuvième révision de la Classification internationale des maladies (CIM-9).Les données tirées de l’examen rétrospectif des dossiers médicaux, soit les valeurs de créatinine sérique (SCr) et de diurèse pendant le séjour aux USIP et les caractéristiques des patients, initiales et à l’admission, ont été fusionnées aux données administratives provinciales en santé contenant les codes de diagnostic et de procédure utilisés pour établir l’IRA-Admin. La sensibilité, la spécificité et les valeurs prédictives négative et positive de l’IRA-Admin, en comparaison à l’IRA-Dos (standard de référence), ont été calculées. L’association univariée entre l’IRA-Admin et la mortalité à l’hôpital a également été évaluée.Un total de 2 051 patients ont été inclus (355 ayant subi une cardiochirurgie et 1 696 non opérés). L’âge moyen des sujets à l’admission était de 6,1 ± 5,8 ans et 55 % étaient des garçons. L’IRA définie par les critères de SCr et de diurèse a été diagnostiquée chez 52 % des patients opérés et chez 24 % des patients non opérés. Pour l’ensemble de la cohorte (patients opérés ou non), l’IRA-Admin a détecté l’IRA-Dos avec une faible sensibilité, mais avec une spécificité élevée. La sensibilité s’est accrue de 1,5 à 2 fois pour chaque passage à un stade supérieur de gravité de l’IRA. Enfin, l’IRA-Admin a été associée à un taux plus élevé de mortalité à l’hôpital (13 % des patients IRA-AdminCes résultats concernent une population de patients hospitalisés aux USIP. Des études futures devraient inclure des populations non admises aux USIP.L’utilisation des données administratives en santé pour définir l’IRA chez les enfants a mené à une sous-estimation de son incidence. Cependant, la méthode montre une plus grande sensibilité dans la détection des cas plus graves d’IRA, tout en conservant une spécificité élevée.

Additional file 1: Table S1. Baseline characteristics excluding patients with stable kidney function. Table S2. Estimated glomerular filtration rate at end of follow-up excluding patients with stable kidney function. Table S3. Determinants of the eGFR excluding patients with stable kidney disease- Adjusted mixed effect linear regression. Table S4. Determinants of the eGFR excluding patients with a change in RAAS blockade use - Adjusted mixed effect linear regression. Figure S1. Annual eGFR decline pre- and post-AVF creation over different observational periods.

Supplemental material, Supplementary_material_DArienzo_et_al_Revision_2_Clean for A Validation Study of Administrative Health Care Data to Detect Acute Kidney Injury in the Pediatric Intensive Care Unit by David D’Arienzo, Erin Hessey, Rami Ali, Sylvie Perreault, Susan Samuel, Louise Roy, Jacques Lacroix, Philippe Jouvet, Genevieve Morissette, Marc Dorais, Jean-Philippe Lafrance, Veronique Phan, Michael Pizzi, Rahul Chanchlani and Michael Zappitelli in Canadian Journal of Kidney Health and Disease

The optimal vitamin D3 therapy for the treatment of secondary hyperparathyroidism (SHPT) in chronic hemodialysis patients is still controversial. Recent studies suggest that uremia in end-stage renal disease is associated with enzymatic hepatic dysfunction altering 25-hydroxylation of vitamin D3. The goal of our study was to compare the efficacy of calcitriol, the fully hydroxylated active form of vitamin D3, to alfacalcidol which needs 25-hydroxylation to be effective, for the treatment of SHPT in chronic hemodialysis patients. We retrospectively reviewed 45 chronic hemodialysis patients who were switched from oral alfacalcidol to oral calcitriol for the treatment of SHPT. Parathyroid hormone (PTH), serum calcium and serum phosphorus levels were compared pre- and post-conversion using paired Student’s t tests. The mean dose of active vitamin D3 decreased from 3.50 mcg/week at baseline to 2.86 mcg (P

Supplemental material, Supplementary_table_1 for Association Between Low-Molecular-Weight Heparin and Risk of Bleeding Among Hemodialysis Patients: A Retrospective Cohort Study by Hind H. Lazrak, Emilie René, Naoual Elftouh and Jean-Philippe Lafrance in Canadian Journal of Kidney Health and Disease

Supplemental material, Appendices_(1) for Hospitalizations in Dialysis Patients in Canada: A National Cohort Study by Amber O. Molnar, Louise Moist, Scott Klarenbach, Jean-Philippe Lafrance, S. Joseph Kim, Karthik Tennankore, Jeffrey Perl, Joanne Kappel, Michael Terner, Jagbir Gill, and Manish M. Sood in Canadian Journal of Kidney Health and Disease

Hyperphosphatemia and metabolic acidosis are frequently encountered in advanced chronic kidney disease (CKD) patients. Correction of metabolic acidosis in patients with advanced CKD leads to a decrease in the progression of renal impairment and improves nutritional outcomes. Lanthanum carbonate is used for control of hyperphosphatemia. This study evaluated the effect of lanthanum carbonate on metabolic acidosis in CKD IV-V patients and in patients on dialysis.Retrospective data of patients in whom lanthanum carbonate therapy was initiated were collected from 2009 to 2013 in a single dialysis center. Of the 79 patients in whom lanthanum carbonate was introduced, 51 patients were included in the analysis. Of the 51 patients, 39 patients received chronic hemodialysis, two patients received peritoneal dialysis therapy, and 10 patients had stage IV-V CKD not on dialysis. The primary outcome was the serum bicarbonate change after the introduction of lanthanum carbonate.There was a significant increase in mean serum bicarbonate concentration of 2.79 mmol/L (p ≤ 0.001) compared to baseline. The increase remained in the CKD IV-V patients (2.50 mmol/L, p = 0.005) and in the patients on dialysis (2.81 mmol/L, p0.001). Serum bicarbonate remained higher (p0.05) than baseline up to 6 months after lanthanum carbonate introduction.In this study, lanthanum carbonate introduction increased serum bicarbonate concentration in a small sample of CKD IV-V patients and in patients on dialysis. Further studies are needed to confirm this effect and investigate whether the correction of metabolic acidosis by using lanthanum carbonate in CKD IV-V patients can improve clinical outcomes.

Background and objectives Peritoneal dialysis (PD) is associated with an increased risk of infection-related hospitalization (IRH) compared with hemodialysis. The objective of this study was to compare mortality and overall readmission after an IRH between PD and hemodialysis. Design, setting, participants, & measurements This propensity score–matched retrospective cohort study assessed patients undergoing long-term dialysis patients, derived from the Canadian Organ Replacement Register and Regie de l’assurance maladie du Quebec, who had at least one IRH between January 2001 and December 2007. Patients were followed until death, kidney transplantation, or end of the study period. To estimate the probability of receiving PD versus hemodialysis, propensity scores were obtained using multivariable logistic regression. Mortality and overall readmission risks after the initial IRH were compared using a Cox survival model. Results A total of 354 pairs of patients who had at least one IRH were matched for propensity score. During follow-up (median, 1.25 years), 138 hemodialysis patients (24.7/100 patient-years; 95% confidence interval [95% CI], 20.7 to 29.1) and 130 PD patients (21.2/100 patient-years; 95% CI, 17.7 to 25.1) died; 265 hemodialysis patients (144.6/100 patient-years; 95% CI, 127.7 to 163.1) and 299 PD patients (173.2/100 patient-years; 95% CI, 154.1 to 194.0) were readmitted for any cause; and 121 hemodialysis patients (29.7/100 patient-years; 95% CI, 24.7 to 35.5) and 168 PD patients (44.7/100 patient-years; 95% CI, 38.2 to 52.0) were readmitted for an infection. Compared with hemodialysis, PD was not associated with a different mortality risk after an IRH (hazard ratio [HR], 0.87; 95% CI, 0.69 to 1.11). PD was associated with a higher risk of infection-related overall readmission compared with hemodialysis (HR, 1.44; 95% CI, 1.14 to 1.81), but not with the risk of all-cause overall readmission (HR, 1.15; 95% CI, 0.98 to 1.36). Conclusions PD was not associated with higher mortality or all-cause overall readmission following an IRH compared with hemodialysis, but PD patients were at higher risk of infection-related overall readmission after IRH. IRHs are associated with significant mortality and overall readmissions. Evaluation of strategies to reduce infections in both hemodialysis and PD recipients are needed to improve patient care and outcomes.