Publications by authors named "Friedo W Dekker"

374 Publications

Assisted peritoneal dialysis across Europe: Practice variation and factors associated with availability.

Perit Dial Int 2021 Oct 21:8968608211049882. Epub 2021 Oct 21.

Department of Nephrology and Hypertension, University Medical Centre Utrecht, the Netherlands.

Background: In Europe, the number of elderly end-stage kidney disease patients is increasing. Few of those patients receive peritoneal dialysis (PD), as many cannot perform PD autonomously. Assisted PD programmes are available in most European countries, but the percentage of patients receiving assisted PD varies considerably. Hence, we assessed which factors are associated with the availability of an assisted PD programme at a centre level and whether the availability of this programme is associated with proportion of home dialysis patients.

Methods: An online survey was sent to healthcare professionals of European nephrology units. After selecting one respondent per centre, the associations were explored by tests and (ordinal) logistic regression.

Results: In total, 609 respondents completed the survey. Subsequently, 288 respondents from individual centres were identified; 58% worked in a centre with an assisted PD programme. Factors associated with availability of an assisted PD programme were Western European and Scandinavian countries (OR: 5.73; 95% CI: 3.07-10.68), non-academic centres (OR: 2.01; 95% CI: 1.09-3.72) and centres with a dedicated team for education (OR: 2.87; 95% CI: 1.35-6.11). Most Eastern & Central European respondents reported that the proportion of and home dialysis patients was <10% (72% and 63%), while 27% of Scandinavian respondents reported a proportion of >30% for both and home dialysis patients. Availability of an assisted PD programme was associated with a higher incidence (cumulative OR: 1.91; 95% CI: 1.21-3.01) and prevalence (cumulative OR: 2.81; 95% CI: 1.76-4.47) of patients on home dialysis.

Conclusions: Assisted PD was more commonly offered among non-academic centres with a dedicated team for education across Europe, especially among Western European and Scandinavian countries where higher incidence and prevalence of home dialysis patients was reported.[Formula: see text].
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http://dx.doi.org/10.1177/08968608211049882DOI Listing
October 2021

First steps in the physician-scientist pipeline: a longitudinal study to examine the effects of an undergraduate extracurricular research programme.

BMJ Open 2021 Sep 13;11(9):e048550. Epub 2021 Sep 13.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Objectives: Medicine is facing a physician-scientist shortage. By offering extracurricular research programmes (ERPs), the physician-scientist training pipeline could already start in undergraduate phases of medical training. However, previous studies into the effects of ERPs are mainly retrospective and lack baseline measurements and control groups. Therefore, the current study mimics a randomised controlled trial to examine the effects of an ERP.

Design: Prospective cohort study with baseline measurement and comparable control group.

Setting: One cohort of 315 medical undergraduates in one Dutch University Medical Center are surveyed yearly. To examine the effects of the ERP on academic achievement and motivational factors, regression analyses were used to compare ERP students to students showing ERP-interest only, adjusted for relevant baseline scores.

Participants: Out of the 315 students of the whole cohort, 56 participated within the ERP and are thus included. These ERP students are compared with 38 students showing ERP-interest only (ie, control group).

Primary Outcome Measure: Academic achievement after 2 years (ie, in-time bachelor completion, bachelor grade point average (GPA)) and motivational factors after 18 months (ie, intrinsic motivation for research, research self-efficacy, perceptions of research, curiosity).

Results: ERP participation is related to a higher odds of obtaining a bachelor degree in the appointed amount of time (adjusted OR=2.95, 95% CI 0.83 to 10.52). Furthermore, starting the ERP resulted in higher levels of intrinsic motivation for research, also after adjusting for gender, age, first-year GPA and motivational baseline scores (β=0.33, 95% CI 0.04 to 0.63). No effect was found on research self-efficacy beliefs, perceptions of research and curiosity.

Conclusions: Previous research suggested that intrinsic motivation is related to short-term and long-term research engagement. As our findings indicate that starting the ERP is related to increased levels of intrinsic motivation for research, ERPs for undergraduates could be seen as an important first step in the physician-scientist pipeline.
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http://dx.doi.org/10.1136/bmjopen-2020-048550DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438822PMC
September 2021

The best solution down the line: an observational study on taurolidine- versus citrate-based lock solutions for central venous catheters in hemodialysis patients.

BMC Nephrol 2021 Sep 13;22(1):308. Epub 2021 Sep 13.

Department of Nephrology and Hypertension, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.

Introduction: To prevent infection and thrombosis of central venous catheters (CVCs) in hemodialysis patients, different CVC lock solutions are available. Taurolidine-based solutions and citrate in different concentrations are frequently used, but no definite conclusions with regard to superiority have been drawn.

Methods: In this retrospective, observational, multicenter study, we aimed to assess the risk for removal of CVC due to infection or catheter malfunction in hemodialysis patients with CVC access for different lock solutions: taurolidine, high-concentrated citrate (46.7%) and low-concentrated citrate (4 or 30%). A multivariable Cox-regression model was used to calculate hazard ratio's (HR).

Results: We identified 1514 patients (median age 65 years, 59% male). In 96 (6%) taurolidine-based lock solutions were used. In 1418 (94%) citrate-based lock solutions were used (high-concentrated 73%, low-concentrated 20%). Taurolidine-based lock solutions were associated with a significantly lower hazard for removal of CVC due to infection or malfunction combined (HR 0.34, 95% CI 0.19-0.64), and for removal of CVC due to infection or malfunction separately (HR 0.36, 95% CI 0.15-0.88 and HR0.33, 95% CI 0.14-0.79). High-concentrated citrate lock solutions were not associated with a decreased hazard for our outcomes, compared to low-concentrated citrate lock solutions.

Conclusion: Removal of CVC due to infection or catheter malfunction occurred less often with taurolidine-based lock solutions. We present the largest cohort comparing taurolidine- and citrate-based lock solutions yet. However, due to the retrospective observational nature of this study, conclusions with regard to superiority should be drawn with caution.
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http://dx.doi.org/10.1186/s12882-021-02519-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8439004PMC
September 2021

Person centred care provision and care planning in chronic kidney disease: which outcomes matter? A systematic review and thematic synthesis of qualitative studies : Care planning in CKD: which outcomes matter?

BMC Nephrol 2021 Sep 13;22(1):309. Epub 2021 Sep 13.

Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.

Rationale & Objective: Explore priorities related to outcomes and barriers of adults with chronic kidney disease (CKD) regarding person centred care and care planning.

Study Design: Systematic review of qualitative studies.

Search Strategy & Sources: In July 2018 six bibliographic databases, and reference lists of included articles were searched for qualitative studies that included adults with CKD stages 1-5, not on dialysis or conservative management, without a previous kidney transplantation.

Analytical Approach: Three independent reviewers extracted and inductively coded data using thematic synthesis. Reporting quality was assessed using the COREQ and the review reported according to PRISMA and ENTREQ statements.

Results: Forty-six studies involving 1493 participants were eligible. The period after diagnosis of CKD is characterized by feelings of uncertainty, social isolation, financial burden, resentment and fear of the unknown. Patients show interest in ways to return to normality and remain in control of their health in order to avoid further deterioration of kidney function. However, necessary information is often unavailable or incomprehensible. Although patients and healthcare professionals share the predominant interest of whether or not dialysis or transplantation is necessary, patients value many more outcomes that are often unrecognized by their healthcare professionals. We identified 4 themes with 6 subthemes that summarize these findings: 'pursuing normality and control' ('pursuing normality'; 'a search for knowledge'); 'prioritizing outcomes' ('reaching kidney failure'; 'experienced health'; 'social life'; 'work and economic productivity'); 'predicting the future'; and 'realising what matters'. Reporting quality was moderate for most included studies.

Limitations: Exclusion of non-English articles.

Conclusions: The realisation that patients' priorities do not match those of the healthcare professionals, in combination with the prognostic ambiguity, confirms fatalistic perceptions of not being in control when living with CKD. These insights may contribute to greater understanding of patients' perspectives and a more person-centred approach in healthcare prioritization and care planning within CKD care.
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http://dx.doi.org/10.1186/s12882-021-02489-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438879PMC
September 2021

A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk.

Kidney Int 2021 Aug 19. Epub 2021 Aug 19.

Department of Medicine and Surgery and Nephrology Unit, University Hospital Parma, Parma, Italy.

Lung congestion is a risk factor for all-cause and cardiovascular mortality in patients on chronic hemodialysis, and its estimation by ultrasound may be useful to guide ultrafiltration and drug therapy in this population. In an international, multi-center randomized controlled trial (NCT02310061) we investigated whether a lung ultrasound-guided treatment strategy improved a composite end point (all-cause death, non-fatal myocardial infarction, decompensated heart failure) vs usual care in patients receiving chronic hemodialysis with high cardiovascular risk. Patient-Reported Outcomes (Depression and the Standard Form 36 Quality of Life Questionnaire, SF36) were assessed as secondary outcomes. A total of 367 patients were enrolled: 183 in the active arm and 180 in the control arm. In the active arm, the pre-dialysis lung scan was used to titrate ultrafiltration during dialysis and drug treatment. Three hundred and seven patients completed the study: 152 in the active arm and 155 in the control arm. During a mean follow-up of 1.49 years, lung congestion was significantly more frequently relieved in the active (78%) than in the control (56%) arm and the intervention was safe. The primary composite end point did not significantly differ between the two study arms (Hazard Ratio 0.88; 95% Confidence Interval: 0.63-1.24). The risk for all-cause and cardiovascular hospitalization and the changes of left ventricular mass and function did not differ among the two groups. A post hoc analysis for recurrent episodes of decompensated heart failure (0.37; 0.15-0.93) and cardiovascular events (0.63; 0.41-0.97) showed a risk reduction for these outcomes in the active arm. There were no differences in patient-reported outcomes between groups. Thus, in patients on chronic hemodialysis with high cardiovascular risk, a treatment strategy guided by lung ultrasound effectively relieved lung congestion but was not more effective than usual care in improving the primary or secondary end points of the trial.
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http://dx.doi.org/10.1016/j.kint.2021.07.024DOI Listing
August 2021

Prediction or causality? A scoping review of their conflation within current observational research.

Eur J Epidemiol 2021 Sep 15;36(9):889-898. Epub 2021 Aug 15.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Etiological research aims to uncover causal effects, whilst prediction research aims to forecast an outcome with the best accuracy. Causal and prediction research usually require different methods, and yet their findings may get conflated when reported and interpreted. The aim of the current study is to quantify the frequency of conflation between etiological and prediction research, to discuss common underlying mistakes and provide recommendations on how to avoid these. Observational cohort studies published in January 2018 in the top-ranked journals of six distinct medical fields (Cardiology, Clinical Epidemiology, Clinical Neurology, General and Internal Medicine, Nephrology and Surgery) were included for the current scoping review. Data on conflation was extracted through signaling questions. In total, 180 studies were included. Overall, 26% (n = 46) contained conflation between etiology and prediction. The frequency of conflation varied across medical field and journal impact factor. From the causal studies 22% was conflated, mainly due to the selection of covariates based on their ability to predict without taking the causal structure into account. Within prediction studies 38% was conflated, the most frequent reason was a causal interpretation of covariates included in a prediction model. Conflation of etiology and prediction is a common methodological error in observational medical research and more frequent in prediction studies. As this may lead to biased estimations and erroneous conclusions, researchers must be careful when designing, interpreting and disseminating their research to ensure this conflation is avoided.
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http://dx.doi.org/10.1007/s10654-021-00794-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8502741PMC
September 2021

Mapping Health-Related Quality Of Life After Kidney Transplantation By Group Comparisons: A Systematic Review.

Nephrol Dial Transplant 2021 Aug 2. Epub 2021 Aug 2.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Background: Health-related quality of life (HRQOL) is becoming an increasingly important outcome in kidney transplantation. To describe HRQOL in kidney transplant recipients (KTRs), this systematic review summarizes literature that compared HRQOL between KTRs to other relevant populations (i.e. patients receiving dialysis, patients on the waiting list for kidney transplantation, patients with chronic kidney disease [CKD] not receiving renal replacement therapy (RRT), the general population, and healthy controls) and themselves before kidney transplantation.

Methods: The literature search was conducted in PubMed, EMBASE, Web of Science, and COCHRANE Library. Eligible studies published between January 2000 and October 2020 were included.

Results: 44 studies comprising 6929 KTRs were included in this systematic review. Despite the study heterogeneity, KTRs reported a higher HRQOL after kidney transplantation compared with pre-transplantation and compared with patients receiving dialysis with or without being on the waiting list, especially in disease-specific domains (i.e. burden and effects of kidney disease). Additionally, KTRs had similar to marginally higher HRQOL compared with patients with CKD stage 3-5 not receiving RRT. When compared with healthy controls or the general population, KTRs reported similar HRQOL in the first one or two years after kidney transplantation, and lower physical HRQOL and lower to comparable mental HRQOL in studies with longer post-transplant time.

Conclusions: The available evidence suggests that HRQOL improves after kidney transplantation and can be restored to but not always maintained at pre-CKD HRQOL levels. Future studies investigating intervention targets to improve or maintain post-transplant HRQOL are needed.
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http://dx.doi.org/10.1093/ndt/gfab232DOI Listing
August 2021

Pharmacoepidemiology for nephrologists (part 1): concept, applications and considerations for study design.

Clin Kidney J 2021 May 14;14(5):1307-1316. Epub 2020 Dec 14.

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna, Sweden.

Randomized controlled trials on drug safety and effectiveness are the foundation of medical evidence, but they may have limited generalizability and be unpowered to detect rare and long-term kidney outcomes. Observational studies in routine care data can complement and expand trial evidence on the use, safety and effectiveness of medications and aid with clinical decisions in areas where evidence is lacking. Access to routinely collected large healthcare data has resulted in the proliferation of studies addressing the effect of medications in patients with kidney diseases and this review provides an introduction to the science of pharmacoepidemiology to critically appraise them. In this first review we discuss the concept and applications of pharmacoepidemiology, describing methods for drug-utilization research and discussing the strengths and caveats of the most commonly used study designs to evaluate comparative drug safety and effectiveness.
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http://dx.doi.org/10.1093/ckj/sfaa244DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247736PMC
May 2021

Stopping mineralocorticoid receptor antagonists after hyperkalaemia: trial emulation in data from routine care.

Eur J Heart Fail 2021 Jul 1. Epub 2021 Jul 1.

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.

Aims: Whether to continue or stop mineralocorticoid receptor antagonists (MRA) after an episode of hyperkalaemia is a challenge in clinical practice. While stopping MRA may prevent recurrent hyperkalaemias, it deprives patients of their cardioprotection. We here assessed the association between stopping vs. continuing MRA therapy after hyperkalaemia and the subsequent risks of adverse health events.

Methods And Results: Observational study from the Stockholm CREAtinine Measurements (SCREAM) project 2006-2018. We identified patients initiating MRA and surviving a first-detected episode of hyperkalaemia (plasma potassium >5.0 mmol/L). Using target trial emulation methods, we assessed the association between stopping vs. continuing MRA within 6 months after hyperkalaemia and subsequent outcomes. The primary outcome was the composite of hospital admission with heart failure, stroke, myocardial infarction, or death. The secondary outcome was occurrence of another hyperkalaemia event. Among 39 518 patients initiating MRA, we identified 7366 who developed hyperkalaemia. Median age was 76 years, 45% were women and 69% had a history of heart failure. Following hyperkalaemia, 2222 (30%) discontinued treatment. Compared with continuing MRA, stopping therapy was associated with a lower 2-year risk of recurrent hyperkalaemia [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.72-0.79], but a higher risk of the primary outcome (HR 1.10, 95% CI 1.06-1.14). Similar results were observed in patients with heart failure, after censoring when treatment decision was changed, and across pre-specified subgroups.

Conclusions: Stopping MRA after an episode of hyperkalaemia was associated with reduced risk for recurrent hyperkalaemia, but higher risk of death or cardiovascular events. Recurrent hyperkalaemia was common in either strategy.
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http://dx.doi.org/10.1002/ejhf.2287DOI Listing
July 2021

Appraising prediction research: a guide and meta-review on bias and applicability assessment using the Prediction model Risk Of Bias ASsessment Tool (PROBAST).

Nephrology (Carlton) 2021 Jun 17. Epub 2021 Jun 17.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Over the past few years, a large number of prediction models have been published, often of poor methodological quality. Seemingly objective and straightforward, prediction models provide a risk estimate for the outcome of interest, usually based on readily available clinical information. Yet, using models of substandard methodological rigour, especially without external validation, may result in incorrect risk estimates and consequently misclassification. To assess and combat bias in prediction research the prediction model risk of bias assessment tool (PROBAST) was published in 2019. This risk of bias (ROB) tool includes four domains and 20 signalling questions highlighting methodological flaws, and provides guidance in assessing the applicability of the model. In this paper, the PROBAST will be discussed, along with an in-depth review of two commonly encountered pitfalls in prediction modelling that may induce bias: overfitting and composite endpoints. We illustrate the prevalence of potential bias in prediction models with a meta-review of 50 systematic reviews that used the PROBAST to appraise their included studies, thus including 1510 different studies on 2104 prediction models. All domains showed an unclear or high ROB; these results were markedly stable over time, highlighting the urgent need for attention on bias in prediction research. This article aims to do just that by providing (1) the clinician with tools to evaluate the (methodological) quality of a clinical prediction model, (2) the researcher working on a review with methods to appraise the included models, and (3) the researcher developing a model with suggestions to improve model quality.
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http://dx.doi.org/10.1111/nep.13913DOI Listing
June 2021

Von Willebrand factor, ADAMTS13 and mortality in dialysis patients.

BMC Nephrol 2021 Jun 16;22(1):222. Epub 2021 Jun 16.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.

Background: Von Willebrand Factor (VWF) multimers are cleaved into smaller and less coagulant forms by the metalloprotease ADAMTS13. The aim of this study was to investigate the association between VWF and ADAMTS13 and mortality in dialysis patients.

Methods: We prospectively followed 956 dialysis patients. VWF levels and ADAMTS13 activity were measured. Cox proportional hazard analyses were used to calculate hazard ratios (HRs) with 95 % confidence intervals (CIs) to investigate the association between quartiles of VWF levels and ADAMTS13 activity and all-cause mortality. HRs were adjusted for age, sex, body mass index, cardiovascular disease, dialysis modality, primary kidney disease, use of antithrombotic medication, systolic blood pressure, albumin, C-reactive protein and residual GFR.

Results: Of the 956 dialysis patients, 288 dialysis patients died within three years (mortality rate 151 per 1000 person-years). The highest quartile of VWF as compared with lower levels of VWF was associated with a 1.4-fold (95 %CI 1.1-1.8) increased mortality risk after adjustment. The lowest quartile of ADAMTS13 activity as compared with other quartiles was associated with a 1.3-fold (95 %CI 1.0-1.7) increased mortality risk after adjustment. The combination of the highest VWF quartile and lowest ADAMTS13 quartile was associated with a 2.0-fold (95 %CI 1.3-3.0) increased mortality risk as compared with the combination of the lowest VWF quartile and highest ADAMTS13 quartile.

Conclusions: High VWF levels and low ADAMTS13 activity were associated with increased mortality risks in dialysis patients.
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http://dx.doi.org/10.1186/s12882-021-02420-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207579PMC
June 2021

Outcomes after kidney transplantation, let's focus on the patients' perspectives.

Clin Kidney J 2021 Jun 20;14(6):1504-1513. Epub 2021 Jan 20.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Graft function and patient survival are traditionally the most used parameters to assess the objective benefits of kidney transplantation. Monitoring graft function, along with therapeutic drug concentrations and transplant complications, comprises the essence of outpatient management in kidney transplant recipients (KTRs). However, the patient's perspective is not always included in this process. Patients' perspectives on their health after kidney transplantation, albeit subjective, are increasingly acknowledged as valuable healthcare outcomes and should be considered in order to provide patient-centred healthcare. Such outcomes are known as patient-reported outcomes (PROs; e.g. health-related quality of life and symptom burden) and are captured using PRO measures (PROMs). So far, PROMs have not been routinely used in clinical care for KTRs. In this review we will introduce PROMs and their potential application and value in the field of kidney transplantation, describe commonly used PROMs in KTRs and discuss structural PROMs implementation into kidney transplantation care.
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http://dx.doi.org/10.1093/ckj/sfab008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162867PMC
June 2021

Pharmacoepidemiology for nephrologists (part 2): potential biases and how to overcome them.

Clin Kidney J 2021 May 14;14(5):1317-1326. Epub 2020 Dec 14.

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna, Sweden.

Observational pharmacoepidemiological studies using routinely collected healthcare data are increasingly being used in the field of nephrology to answer questions on the effectiveness and safety of medications. This review discusses a number of biases that may arise in such studies and proposes solutions to minimize them during the design or statistical analysis phase. We first describe designs to handle confounding by indication (e.g. active comparator design) and methods to investigate the influence of unmeasured confounding, such as the E-value, the use of negative control outcomes and control cohorts. We next discuss prevalent user and immortal time biases in pharmacoepidemiology research and how these can be prevented by focussing on incident users and applying either landmarking, using a time-varying exposure, or the cloning, censoring and weighting method. Lastly, we briefly discuss the common issues with missing data and misclassification bias. When these biases are properly accounted for, pharmacoepidemiological observational studies can provide valuable information for clinical practice.
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http://dx.doi.org/10.1093/ckj/sfaa242DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087121PMC
May 2021

Patient-Reported Measures and Lifestyle Are Associated With Deterioration in Nutritional Status in CKD Stage 4-5: The EQUAL Cohort Study.

J Ren Nutr 2021 Apr 27. Epub 2021 Apr 27.

Renal unit, Department of clinical intervention and technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.

Objective: The aim of this study was to explore the changes in nutritional status before dialysis initiation and to identify modifiable risk factors of nutritional status decline in older adults with advanced renal disease.

Design And Methods: The European Quality Study on treatment in advanced chronic kidney disease (EQUAL) is a prospective, observational cohort study involving six European countries. We included 1,103 adults >65 years with incident estimated glomerular filtration rate <20 mL/min/1.73 m not on dialysis, attending nephrology care. Nutritional status was assessed with the 7-point Subjective Global Assessment tool (7-p SGA), patient-reported outcomes with RAND-36 and the Dialysis Symptom Index. Logistic regression was used to estimate the associations between potential risk factors and SGA decline.

Results: The majority of the patients had a normal nutritional status at baseline, 28% were moderately malnourished (SGA ≤5). Overall, mean SGA decreased by -0.18 points/year, (95% confidence interval -0.21; -0.14). More than one-third of the study participants (34.9%) deteriorated in nutritional status (1 point decline in SGA) and 10.9% had a severe decline in SGA (≥2 points). The proportion of patients with low SGA (≤5) increased every 6 months. Those who dropped in SGA also declined in estimated glomerular filtration rate and mental health score. Every 10 points decrease in physical function score increased the odds of decline in SGA by 23%. Lower physical function score at baseline, gastrointestinal symptoms, and smoking were risk factors for impaired nutritional status. There was an interaction between diabetes and physical function on SGA decline.

Conclusions: Nutritional status deteriorated in more than one-third of the study participants during the first year of follow-up. Lower patient-reported physical function, more gastrointestinal symptoms, and current smoking were associated with decline in nutritional status.
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http://dx.doi.org/10.1053/j.jrn.2021.03.006DOI Listing
April 2021

Donor type and 3-month hospital readmission following kidney transplantation: results from the Netherlands organ transplant registry.

BMC Nephrol 2021 Apr 27;22(1):155. Epub 2021 Apr 27.

Department of Clinical Epidemiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.

Background: Hospital readmission after transplantation is common in kidney transplant recipients (KTRs). In this study, we aim to compare the risk of 3-month hospital readmission after kidney transplantation with different donor types in the overall population and in both young (< 65 years) and elderly (≥65 years) KTRs.

Methods: We included all first-time adult KTRs from 2016 to 2018 in the Netherlands Organ Transplant Registry. Multivariable logistic regression models were used to estimate the effect while adjusting for baseline confounders.

Results: Among 1917 KTRs, 615 (32.1%) had at least one hospital readmission. Living donor kidney transplantation (LDKT) recipients had an adjusted OR of 0.76 (95%CI, 0.61 to 0.96; p = 0.02) for hospital readmission compared to deceased donor kidney transplantation (DDKT) recipients. In the young and elderly, the adjusted ORs were 0.69 (95%CI, 0.52 to 0.90, p = 0.01) and 0.93 (95%CI, 0.62 to 1.39, p = 0.73) and did not differ significantly from each other (p-value for interaction = 0.38). In DDKT, the risk of hospital readmission is similar between recipients with donation after cardiac death (DCD) or brain death (DBD) and the risk was similar between the young and elderly.

Conclusion: A lower risk of post-transplant 3-month hospital readmission was found in recipients after LDKT compared to DDKT, and this benefit of LDKT might be less dominant in elderly patients. In DDKT, having either DCD or DBD donors is not associated with post-transplant 3-month hospital readmission, regardless of age. Tailored patient management is needed for recipients with DDKT and elderly KTRs.
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http://dx.doi.org/10.1186/s12882-021-02363-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8077946PMC
April 2021

Twelve tips for fostering the next generation of medical teachers.

Med Teach 2021 Apr 22:1-5. Epub 2021 Apr 22.

Center for Innovation in Medical Education, Leiden University Medical Center, Leiden, The Netherlands.

Medical professionals with a special interest in and focus on education are essential to provide good quality education. Despite high numbers of students expressing an interest in teaching, concerns are rising regarding the supply of medical teachers, with few junior educators on the career ladder. To date, only some medical schools offer in-depth courses to students wanting to explore or aspire a career as a specialised medical teacher. We propose twelve tips for an elective course to foster the next generation of medical teachers. This course aims to enhance theoretical foundations and educational practices to cultivate the next generation of medical teachers.
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http://dx.doi.org/10.1080/0142159X.2021.1912311DOI Listing
April 2021

Assessing physical activity and function in patients with chronic kidney disease: a narrative review.

Clin Kidney J 2021 Mar 8;14(3):768-779. Epub 2020 Sep 8.

ERA-EDTA Registry, Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Physical activity potentially improves health outcomes in patients with chronic kidney disease (CKD) and recipients of kidney transplants. Although studies have demonstrated the beneficial effects of physical activity and exercise for primary and secondary prevention of non-communicable diseases, evidence for kidney patients is limited. To enlarge this evidence, valid assessment of physical activity and exercise is essential. Furthermore, CKD is associated with a decline in physical function, which may result in severe disabilities and dependencies. Assessment of physical function may help clinicians to monitor disease progression and frailty in patients receiving dialysis. The attention on physical function and physical activity has grown and new devices have been developed and (commercially) launched on the market. Therefore the aims of this review were to summarize different measures of physical function and physical activity, provide an update on measurement instruments and discuss options for easy-to-use measurement instruments for day-to-day use by CKD patients. This review demonstrates that large variation exists in the different strategies to assess physical function and activity in clinical practice and research settings. To choose the best available method, accuracy, content, preferable outcome, necessary expertise, resources and time are important issues to consider.
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http://dx.doi.org/10.1093/ckj/sfaa156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986327PMC
March 2021

Validation of risk scores for ischaemic stroke in atrial fibrillation across the spectrum of kidney function.

Eur Heart J 2021 04;42(15):1476-1485

Department of Clinical Epidemiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands.

Aims: The increasing prevalence of ischaemic stroke (IS) can partly be explained by the likewise growing number of patients with chronic kidney disease (CKD). Risk scores have been developed to identify high-risk patients, allowing for personalized anticoagulation therapy. However, predictive performance in CKD is unclear. The aim of this study is to validate six commonly used risk scores for IS in atrial fibrillation (AF) patients across the spectrum of kidney function.

Methods And Results: Overall, 36 004 subjects with newly diagnosed AF from SCREAM (Stockholm CREAtinine Measurements), a healthcare utilization cohort of Stockholm residents, were included. Predictive performance of the AFI, CHADS2, Modified CHADS2, CHA2DS2-VASc, ATRIA, and GARFIELD-AF risk scores was evaluated across three strata of kidney function: normal kidney function [estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2], mild CKD (eGFR 30-60 mL/min/1.73 m2), and advanced CKD (eGFR <30 mL/min/1.73 m2). Predictive performance was assessed by discrimination and calibration. During 1.9 years, 3069 (8.5%) patients suffered an IS. Discrimination was dependent on eGFR: the median c-statistic in normal eGFR was 0.75 (range 0.68-0.78), but decreased to 0.68 (0.58-0.73) and 0.68 (0.55-0.74) for mild and advanced CKD, respectively. Calibration was reasonable and largely independent of eGFR. The Modified CHADS2 score showed good performance across kidney function strata, both for discrimination [c-statistic: 0.78 (95% confidence interval 0.77-0.79), 0.73 (0.71-0.74) and 0.74 (0.69-0.79), respectively] and calibration.

Conclusion: In the most clinically relevant stages of CKD, predictive performance of the majority of risk scores was poor, increasing the risk of misclassification and thus of over- or undertreatment. The Modified CHADS2 score performed good and consistently across all kidney function strata, and should therefore be preferred for risk estimation in AF patients.
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http://dx.doi.org/10.1093/eurheartj/ehab059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046502PMC
April 2021

Points of attention when conducting etiological research.

Nephrology (Carlton) 2021 Sep 25;26(9):701-707. Epub 2021 Mar 25.

ERA-EDTA Registry, Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Epidemiological studies often aim to investigate the causal contribution of a risk factor to a disease or other outcome. In etiological research, one is usually interested in the (biological) mechanism(s) underlying the studied relationship. Inappropriate conduct of an etiological study may have major implications for the correctness of the results and interpretation of the findings. Therefore, in this paper, we aim to describe step by step how etiological research should be carried out, together with its  common pitfalls. These steps involve finding and formulating a well-defined etiological research question, choosing an appropriate study design including a suitable comparison group, adequate modelling, and adequate reporting and interpretation of the results.
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http://dx.doi.org/10.1111/nep.13875DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451743PMC
September 2021

Kidney Failure Prediction Models: A Comprehensive External Validation Study in Patients with Advanced CKD.

J Am Soc Nephrol 2021 05 8;32(5):1174-1186. Epub 2021 Mar 8.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Background: Various prediction models have been developed to predict the risk of kidney failure in patients with CKD. However, guideline-recommended models have yet to be compared head to head, their validation in patients with advanced CKD is lacking, and most do not account for competing risks.

Methods: To externally validate 11 existing models of kidney failure, taking the competing risk of death into account, we included patients with advanced CKD from two large cohorts: the European Quality Study (EQUAL), an ongoing European prospective, multicenter cohort study of older patients with advanced CKD, and the Swedish Renal Registry (SRR), an ongoing registry of nephrology-referred patients with CKD in Sweden. The outcome of the models was kidney failure (defined as RRT-treated ESKD). We assessed model performance with discrimination and calibration.

Results: The study included 1580 patients from EQUAL and 13,489 patients from SRR. The average statistic over the 11 validated models was 0.74 in EQUAL and 0.80 in SRR, compared with 0.89 in previous validations. Most models with longer prediction horizons overestimated the risk of kidney failure considerably. The 5-year Kidney Failure Risk Equation (KFRE) overpredicted risk by 10%-18%. The four- and eight-variable 2-year KFRE and the 4-year Grams model showed excellent calibration and good discrimination in both cohorts.

Conclusions: Some existing models can accurately predict kidney failure in patients with advanced CKD. KFRE performed well for a shorter time frame (2 years), despite not accounting for competing events. Models predicting over a longer time frame (5 years) overestimated risk because of the competing risk of death. The Grams model, which accounts for the latter, is suitable for longer-term predictions (4 years).
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http://dx.doi.org/10.1681/ASN.2020071077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259669PMC
May 2021

Academic Success Experiences: Promoting Research Motivation andSelf-Efficacy Beliefs among Medical Students.

Teach Learn Med 2021 Aug-Sep;33(4):423-433. Epub 2021 Feb 25.

Center for Innovation in Medical Education, Leiden University Medical Center, Leiden, The Netherlands.

Theory: Medicine is facing a physician-scientist shortage. Medical training could contribute to developing physician-scientists by stimulating student research involvement, as previous studies showed this is related to research involvement in professional practice. Motivation for research and research self-efficacy beliefs are related to student research involvement. Based on social cognitive theory, success experiences in doing research may enhance research motivation and self-efficacy beliefs. However, the role and type of success experiences in promoting research self-efficacy beliefs and motivation especially early in medical training has not yet been investigated. Therefore, we examined if academic success experiences within an undergraduate course in academic and scientific skills increased research motivation and self-efficacy beliefs among medical students. Furthermore, type of success experience was taken into account by looking at the effects of academic success experiences within standard (i.e., exam) versus authentic (i.e., research report and oral presentation) assessments.

Hypotheses: It was hypothesized that academic success experiences increase intrinsic motivation for research and self-efficacy beliefs. Furthermore, we hypothesized that authentic assessments influence intrinsic motivation for research and self-efficacy beliefs to a larger degree than standard assessments, as the authentic assessments mirror real-world practices of researchers.

Method: First-year undergraduate medicine students followed a course in academic and scientific skills in which they conducted research individually. Their academic success experiences were operationalized as their grades on two authentic research assessments (written report and oral presentation) and one less authentic assessment (written exam). We surveyed students before the course when entering medical school (i.e., baseline measure) and 1 year after the course in their 2nd year (i.e., postmeasure). Both the baseline and postmeasure surveys measured intrinsic motivation for research, extrinsic motivation for research, and research self-efficacy beliefs. Linear regression analyses were used to examine the relationship between academic success experiences and intrinsic motivation for research, extrinsic motivation for research, and research self-efficacy beliefs on the postmeasure. We adjusted for prior research motivation and self-efficacy beliefs at baseline. Therefore, this adjusted effect can be interpreted as an increase or decrease in motivation. In addition, we adjusted for age, gender, and grade point average (GPA) of the first 4 months, as these variables were seen as possible confounders.

Results: In total, 243 of 275 students participated (88.4%). Academic success experiences in writing and presenting research were related to a significant increase in intrinsic motivation for research. After adjusting for prior GPA, only the effect of presenting remained. Experiencing success in presenting enhanced research self-efficacy beliefs, also after adjusting for prior GPA. Higher grades on the exam did not affect intrinsic motivation for research or research self-efficacy significantly. Also, none of the success experiences influenced extrinsic motivation for research.

Conclusions: Academic success experiences on authentic research tasks, especially presenting research, may be a good way to enhance intrinsic motivation for research and research self-efficacy beliefs. In turn, research motivation and self-efficacy beliefs promote research involvement, which is a first step in the physician-scientist pipeline. Furthermore, this study established the applicability of the social cognitive theory in a research context within the medical domain.
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http://dx.doi.org/10.1080/10401334.2021.1877713DOI Listing
February 2021

Be careful with ecological associations.

Nephrology (Carlton) 2021 Jun 17;26(6):501-505. Epub 2021 Feb 17.

Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Reggio Calabria, Italy.

Ecological studies are observational studies commonly used in public health research. The main characteristic of this study design is that the statistical analysis is based on pooled (i.e., aggregated) rather than on individual data. Thus, patient-level information such as age, gender, income and disease condition are not considered as individual characteristics but as mean values or frequencies, calculated at country or community level. Ecological studies can be used to compare the aggregated prevalence and incidence data of a given condition across different geographical areas, to assess time-related trends of the frequency of a pre-defined disease/condition, to identify factors explaining changes in health indicators over time in specific populations, to discriminate genetic from environmental causes of geographical variation in disease, or to investigate the relationship between a population-level exposure and a specific disease or condition. The major pitfall in ecological studies is the ecological fallacy, a bias which occurs when conclusions about individuals are erroneously deduced from results about the group to which those individuals belong. In this paper, by using a series of examples, we provide a general explanation of the ecological studies and provide some useful elements to recognize or suspect ecological fallacy in this type of studies.
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http://dx.doi.org/10.1111/nep.13861DOI Listing
June 2021

Predicting mortality risk on dialysis and conservative care: development and internal validation of a prediction tool for older patients with advanced chronic kidney disease.

Clin Kidney J 2021 Jan 17;14(1):189-196. Epub 2020 Mar 17.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Background: Conservative care (CC) may be a valid alternative to dialysis for certain older patients with advanced chronic kidney disease (CKD). A model that predicts patient prognosis on both treatment pathways could be of value in shared decision-making. Therefore, the aim is to develop a prediction tool that predicts the mortality risk for the same patient for both dialysis and CC from the time of treatment decision.

Methods: CKD Stage 4/5 patients aged ≥70 years, treated at a single centre in the Netherlands, were included between 2004 and 2016. Predictors were collected at treatment decision and selected based on literature and an expert panel. Outcome was 2-year mortality. Basic and extended logistic regression models were developed for both the dialysis and CC groups. These models were internally validated with bootstrapping. Model performance was assessed with discrimination and calibration.

Results: In total, 366 patients were included, of which 126 chose CC. Pre-selected predictors for the basic model were age, estimated glomerular filtration rate, malignancy and cardiovascular disease. Discrimination was moderate, with optimism-corrected C-statistics ranging from 0.675 to 0.750. Calibration plots showed good calibration.

Conclusions: A prediction tool that predicts 2-year mortality was developed to provide older advanced CKD patients with individualized prognosis estimates for both dialysis and CC. Future studies are needed to test whether our findings hold in other CKD populations. Following external validation, this prediction tool could be used to compare a patient's prognosis on both dialysis and CC, and help to inform treatment decision-making.
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http://dx.doi.org/10.1093/ckj/sfaa021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7857791PMC
January 2021

External validation of prognostic models: what, why, how, when and where?

Clin Kidney J 2021 Jan 24;14(1):49-58. Epub 2020 Nov 24.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Prognostic models that aim to improve the prediction of clinical events, individualized treatment and decision-making are increasingly being developed and published. However, relatively few models are externally validated and validation by independent researchers is rare. External validation is necessary to determine a prediction model's reproducibility and generalizability to new and different patients. Various methodological considerations are important when assessing or designing an external validation study. In this article, an overview is provided of these considerations, starting with what external validation is, what types of external validation can be distinguished and why such studies are a crucial step towards the clinical implementation of accurate prediction models. Statistical analyses and interpretation of external validation results are reviewed in an intuitive manner and considerations for selecting an appropriate existing prediction model and external validation population are discussed. This study enables clinicians and researchers to gain a deeper understanding of how to interpret model validation results and how to translate these results to their own patient population.
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http://dx.doi.org/10.1093/ckj/sfaa188DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7857818PMC
January 2021

Using datasets to ascertain the generalisability of clinical cohorts: the example of European QUALity Study on the treatment of advanced chronic kidney disease (EQUAL).

Nephrol Dial Transplant 2021 Jan 11. Epub 2021 Jan 11.

Population Health Sciences, University of Bristol, Bristol.

Background: Cohort studies are among the most robust of observational studies but have issues with external validity. This study assesses threats to external validity (generalisability) in the European QUALity (EQUAL) study, a cohort study of people over 65 years with stage 4/5 chronic kidney disease.

Methods: Patients meeting the EQUAL inclusion criteria were identified in The Health Improvement Network database and stratified into those attending renal units (secondary care cohort-SCC) and not (primary care cohort-PCC). Survival, progression to renal replacement therapy (RRT), and hospitalisation were compared.

Results: The analysis included 250, 633, and 2,464 patients in EQUAL, PCC, and SCC. EQUAL had a higher proportion of men in comparison to PCC and SCC (60.0% vs. 34.8% vs. 51.4%). Increasing age (≥85 years odds ratio (OR) 0.25 (95% confidence interval (CI) 0.15-0.40)) and comorbidity (Charlson Comorbidity Index ≥ 4 OR 0.69 (CI 0.52-0.91)) were associated with non-participation in EQUAL. EQUAL had a higher proportion of patients starting RRT at 1 year compared to SCC (8.1% vs. 2.1%%, p < 0.001). Patients in the PCC and SCC had increased risk of Hospitalisation (incidence rate ratio=1.76 (95% CI 1.27-2.47) & 2.13 (95% CI 1.59-2.86)) and mortality at one year (hazard ratio=3.48 (95% CI 2.1-5.7) & 1.7 (95% CI 1.1-2.7)) compared to EQUAL.

Conclusions: This study provides evidence of how participants in a cohort study can differ from the broader population of patients, which is essential when considering external validity and applying to local practice.
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http://dx.doi.org/10.1093/ndt/gfab002DOI Listing
January 2021

Stopping Renin-Angiotensin System Inhibitors in Patients with Advanced CKD and Risk of Adverse Outcomes: A Nationwide Study.

J Am Soc Nephrol 2021 02 28;32(2):424-435. Epub 2020 Dec 28.

Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.

Background: It is unknown whether stopping renin-angiotensin system (RAS) inhibitor therapy in patients with advanced CKD affects outcomes.

Methods: We studied patients referred to nephrologist care, listed on the Swedish Renal Registry during 2007-2017, who developed advanced CKD (eGFR<30 ml/min per 1.73 m) while on RAS inhibitor therapy. Using target trial emulation techniques on the basis of cloning, censoring, and weighting, we compared the risks of stopping within 6 months and remaining off treatment versus continuing RAS inhibitor therapy. These included risks of subsequent 5-year all-cause mortality, major adverse cardiovascular events, and initiation of kidney replacement therapy (KRT).

Results: Of 10,254 prevalent RAS inhibitor users (median age 72 years, 36% female) with new-onset eGFR <30 ml/min per 1.73 m, 1553 (15%) stopped RAS inhibitor therapy within 6 months. Median eGFR was 23 ml/min per 1.73 m. Compared with continuing RAS inhibition, stopping this therapy was associated with a higher absolute 5-year risk of death (40.9% versus 54.5%) and major adverse cardiovascular events (47.6% versus 59.5%), but with a lower risk of KRT (36.1% versus 27.9%); these corresponded to absolute risk differences of 13.6 events per 100 patients, 11.9 events per 100 patients, and -8.3 events per 100 patients, respectively. Results were consistent whether patients stopped RAS inhibition at higher or lower eGFR, across prespecified subgroups, after adjustment and stratification for albuminuria and potassium, and when modeling RAS inhibition as a time-dependent exposure using a marginal structural model.

Conclusions: In this nationwide observational study of people with advanced CKD, stopping RAS inhibition was associated with higher absolute risks of mortality and major adverse cardiovascular events, but also with a lower absolute risk of initiating KRT.
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http://dx.doi.org/10.1681/ASN.2020050682DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054897PMC
February 2021

Development and external validation study combining existing models and recent data into an up-to-date prediction model for evaluating kidneys from older deceased donors for transplantation.

Kidney Int 2021 06 16;99(6):1459-1469. Epub 2020 Dec 16.

Department of Surgery-Organ Donation and Transplantation, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

With a rising demand for kidney transplantation, reliable pre-transplant assessment of organ quality becomes top priority. In clinical practice, physicians are regularly in doubt whether suboptimal kidney offers from older donors should be accepted. Here, we externally validate existing prediction models in a European population of older deceased donors, and subsequently developed and externally validated an adverse outcome prediction tool. Recipients of kidney grafts from deceased donors 50 years of age and older were included from the Netherlands Organ Transplant Registry (NOTR) and United States organ transplant registry from 2006-2018. The predicted adverse outcome was a composite of graft failure, death or chronic kidney disease stage 4 plus within one year after transplantation, modelled using logistic regression. Discrimination and calibration were assessed in internal, temporal and external validation. Seven existing models were validated with the same cohorts. The NOTR development cohort contained 2510 patients and 823 events. The temporal validation within NOTR had 837 patients and the external validation used 31987 patients in the United States organ transplant registry. Discrimination of our full adverse outcome model was moderate in external validation (C-statistic 0.63), though somewhat better than discrimination of the seven existing prediction models (average C-statistic 0.57). The model's calibration was highly accurate. Thus, since existing adverse outcome kidney graft survival models performed poorly in a population of older deceased donors, novel models were developed and externally validated, with maximum achievable performance in a population of older deceased kidney donors. These models could assist transplant clinicians in deciding whether to accept a kidney from an older donor.
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http://dx.doi.org/10.1016/j.kint.2020.11.016DOI Listing
June 2021

Patient-reported outcome measures ( PROMs): making sense of individual PROM scores and changes in PROM scores over time.

Nephrology (Carlton) 2021 May 25;26(5):391-399. Epub 2020 Dec 25.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Patient-reported outcome measures (PROMs) are increasingly being used in nephrology care. However, in contrast to well-known clinical measures such as blood pressure, health-care professionals are less familiar with PROMs and the interpretation of PROM scores is therefore perceived as challenging. In this paper, we provide insight into the interpretation of PROM scores by introducing the different types and characteristics of PROMs, and the most relevant concepts for the interpretation of PROM scores. Concepts such as minimal detectable change, minimal important change and response shift are explained and illustrated with examples from nephrology care.
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http://dx.doi.org/10.1111/nep.13843DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8048666PMC
May 2021

Comparative Effectiveness of Renin-Angiotensin System Inhibitors and Calcium Channel Blockers in Individuals With Advanced CKD: A Nationwide Observational Cohort Study.

Am J Kidney Dis 2021 05 24;77(5):719-729.e1. Epub 2020 Nov 24.

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Sweden.

Rationale & Objective: It is unknown whether initiating renin-angiotensin system (RAS) inhibitor therapy in patients with advanced chronic kidney disease (CKD) is superior to alternative antihypertensive agents such as calcium channel blockers (CCBs). We compared the risks for kidney replacement therapy (KRT), mortality, and major adverse cardiovascular events (MACE) in patients with advanced CKD in routine nephrology practice who were initiating either RAS inhibitor or CCB therapy.

Study Design: Observational study in the Swedish Renal Registry, 2007 to 2017.

Settings & Participants: 2,458 new users of RAS inhibitors and 2,345 CCB users with estimated glomerular filtration rates<30mL/min/1.73m (CKD G4-G5 without KRT) who were being followed up by a nephrologist. As a positive control cohort, new users of the same drugs with CKD G3 (estimated glomerular filtration rate, 30-60mL/min/1.73m) were evaluated.

Exposures: RAS inhibitor versus CCB therapy initiation.

Outcome: Initiation of KRT (maintenance dialysis or transplantation), all-cause mortality, and MACE (composite of cardiovascular death, myocardial infarction, or stroke).

Analytical Approach: HRs with 95% CIs were estimated using propensity score-weighted Cox proportional hazards regression adjusting for demographic, clinical, and laboratory covariates.

Results: Median age was 74 years, 38% were women, and median follow-up was 4.1 years. After propensity score weighting, there was significantly lower risk for KRT after new use of RAS inhibitors compared with new use of CCBs (adjusted HR, 0.79 [95% CI, 0.69-0.89]) but similar risks for mortality (adjusted HR, 0.97 [95% CI, 0.88-1.07]) and MACE (adjusted HR, 1.00 [95% CI, 0.88-1.15]). Results were consistent across subgroups and in as-treated analyses. The positive control cohort of patients with CKD G3 showed similar KRT risk reduction (adjusted HR, 0.67 [95% CI, 0.56-0.80]) with RAS inhibitor therapy compared with CCBs.

Limitations: Potential confounding by indication.

Conclusions: Our findings provide evidence from real-world clinical practice that initiation of RAS inhibitor therapy compared with CCBs may confer kidney benefits among patients with advanced CKD, with similar cardiovascular protection.
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http://dx.doi.org/10.1053/j.ajkd.2020.10.006DOI Listing
May 2021

Bleeding risk of haemodialysis and peritoneal dialysis patients.

Nephrol Dial Transplant 2021 01;36(1):170-175

Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands.

Background: Dialysis patients have an increased bleeding risk as compared with the general population. However, there is limited information whether bleeding risks are different for patients treated with haemodialysis (HD) or peritoneal dialysis (PD). From a clinical point of view, this information could influence therapy choice. Therefore the aim of this study was to investigate the association between dialysis modality and bleeding risk.

Methods: Incident dialysis patients from the Netherlands Cooperative Study on the Adequacy of Dialysis were prospectively followed for major bleeding events over 3 years. Hazard ratios with 95% confidence intervals (CIs) were calculated for HD compared with PD using a time-dependent Cox regression analysis, with updates on dialysis modality.

Results: In total, 1745 patients started dialysis, of whom 1211 (69.4%) received HD and 534 (30.6%) PD. The bleeding rate was 60.8/1000 person-years for HD patients and 34.6/1000 person-years for PD patients. The time-dependent Cox regression analysis showed that after adjustment for age, sex, primary kidney disease, prior bleeding, cardiovascular disease, antiplatelet drug use, vitamin K antagonist use, erythropoietin use, arterial hypertension, residual glomerular filtratin rate, haemoglobin and albumin levels, bleeding risk for HD patients compared with PD increased 1.5-fold (95% CI 1.0-2.2).

Conclusions: In this large prospective cohort of incident dialysis patients, HD patients had an increased bleeding risk compared with PD patients. In particular, HD patients with a history of prior bleeding had an increased bleeding risk.
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http://dx.doi.org/10.1093/ndt/gfaa216DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771974PMC
January 2021
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