|
1
|
Serre J, Mulier G, Boud'hors C, Lemerle M, Abdel-Nabey M, Orvain C, Chaba A, Biard L, Demiselle J, Zafrani L. Impact of early versus conventional kidney replacement therapy initiation in tumor lysis syndrome: a target trial emulation. Ann Intensive Care 2025; 15:49. [PMID: 40180676 PMCID: PMC11968619 DOI: 10.1186/s13613-025-01439-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2024] [Accepted: 01/16/2025] [Indexed: 04/05/2025] Open
Abstract
BACKGROUND In the context of tumor lysis syndrome (TLS), the optimal timing and criteria for initiating kidney replacement therapy (KRT) remain unclear. This study aims to assess the effect of initiating KRT at various phosphatemia thresholds on Major Adverse Kidney Events at day 30 (MAKE30). METHODS AND RESULTS We retrospectively emulated a pragmatic clinical trial comparing the effect of KRT initiation at various phosphatemia thresholds versus a conventional approach during TLS on MAKE30. All consecutive patients admitted to the ICU at Saint-Louis University hospital in Paris and Angers University hospital between January 2007 and June 2020, presenting with laboratory TLS were included. The design criteria of a clinical trial were mimicked by using the cloning, censoring and weighting method. The primary outcome was the MAKE30 composite outcome, considering only KRT requirement between day 7 and day 30 for the dialysis criteria. We evaluated multiple phosphatemia thresholds to guide KRT initiation, ranging from 6.20 mg.dL-1 to 9.30 mg.dL-1. Among the initial population of 220 patients, 192 were included in the emulated trial (median age 60 years old, with non-Hodgkin Lymphoma and Acute Leukemia being the most frequent hematological malignancies). TLS-related AKI occurred in 140 patients, and 75 patients met the criteria for MAKE30. Regardless of the phosphate threshold considered, KRT initiation based on phosphate level was not associated with a significant difference in the MAKE30 rate. KRT requirement during the first 7 days (Odd Ratio [OR] 4.01 [1.65-4.86], p = 0.003) and non-renal SOFA (OR 1.39 per 1 point increment [1.25-1.57], p < 0.001) were identified as factors associated with MAKE30 (multivariable analysis). CONCLUSION Our results do not support the strategy of KRT initiation based on a sole critical phosphatemia level in TLS patients.
Collapse
Affiliation(s)
- Justine Serre
- Department of Medical Intensive Care, Hôpital Saint-Louis, AP-HP, Paris, France
| | - Guillaume Mulier
- Department of Biostatistics and Medical Information, AP-HP, Hôpital Saint-Louis, Université Paris Cité, Paris, France
| | - Charlotte Boud'hors
- Department of Nephrology, Dialysis, Transplantation, CHU Angers, Angers, France
| | - Marie Lemerle
- Department of Medical Intensive Care, CHU Angers, Angers, France
| | | | - Corentin Orvain
- Department of Hematology, CHU Angers, Angers, France
- Federation hospitalo-universitaire « Grand Ouest against Leukemia », Nantes, France
- Inserm UMR 1307, CNRS UMR 6075, Nantes Université, Université d'Angers, Angers, CRCI2NA, France
| | - Anis Chaba
- Department of Medical Intensive Care, Hôpital Saint-Louis, AP-HP, Paris, France
| | - Lucie Biard
- Department of Biostatistics and Medical Information, AP-HP, Hôpital Saint-Louis, Université Paris Cité, Paris, France
| | - Julien Demiselle
- Department of Medical Intensive Care, Nouvel Hôpital Civil, Strasbourg University Hospital, Strasbourg, France
- CRBS (Centre de Recherche en Biomédecine de Strasbourg), FMTS (Fédération de Médecine Translationnelle de Strasbourg), INSERM UMR 1260, Regenerative Nanomedicin, University of Strasbourg, Strasbourg, France
| | - Lara Zafrani
- Department of Medical Intensive Care, Hôpital Saint-Louis, AP-HP, Paris, France.
- INSERM UMR 944, Université Paris Cité, Paris, France.
| |
Collapse
|
|
2
|
Van Biesen W, Ponikvar JB, Fontana M, Heering P, Sever MS, Sawhney S, Luyckx V. Ethical considerations on the use of big data and artificial intelligence in kidney research from the ERA ethics committee. Nephrol Dial Transplant 2025; 40:455-464. [PMID: 39572076 PMCID: PMC11879022 DOI: 10.1093/ndt/gfae267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Indexed: 03/06/2025] Open
Abstract
In the current paper, we will focus on requirements to ensure big data can advance the outcomes of our patients suffering from kidney disease. The associated ethical question is whether and how we as a nephrology community can and should encourage the collection of big data of our patients. We identify some ethical reflections on the use of big data, and their importance and relevance. Furthermore, we balance advantages and pitfalls and discuss requirements to make legitimate and ethical use of big data possible. The collection, organization, and curation of data come upfront in the pipeline before any analyses. Great care must therefore be taken to ensure quality of the data at this stage, to avoid the 'garbage in garbage out' problem and suboptimal patient care as a consequence of such analyses. Access to the data should be organized so that correct and efficient use of data is possible. This means that data must be stored safely, so that only those entitled to do so can access them. At the same time, those who are entitled to access the data should be able to do so in an efficient way, so as not to hinder relevant research. Analysis of observational data is itself prone to many errors and biases. Each of these biases can finally result in provision of low-quality medical care. Secure platforms should therefore also ensure correct methodology is used to interpret the available data. This requires close collaboration of a skilled workforce of experts in medical research and data scientists. Only then will our patients be able to benefit fully from the potential of AI and big data.
Collapse
Affiliation(s)
- Wim Van Biesen
- Department of Nephrology, University Hospital Gent, Gent, Belgium
| | - Jadranka Buturovic Ponikvar
- University Medical Centre Ljubljana, Division of Internal Medicine, Department of Nephrology, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Slovenia
| | - Monica Fontana
- European Renal Association, Headquarters, Parma, Emilia-Romagna, Italy
| | - Peter Heering
- KFH, Solingen General Hospital. Solingen, Germany. Dept of Nephrology and Hypertension, Univ of Cape Town, Cape Town, South Africa
| | - Mehmet S Sever
- Istanbul School of Medicine, Nephrology department, Millet Caddesi, Capa-Istanbul, Turkey
| | - Simon Sawhney
- Aberdeen Centre for Health Data Sciences, University of Aberdeen, Aberdeen, UK
| | - Valerie Luyckx
- Department of Public and Global Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
- Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| |
Collapse
|
|
3
|
Lewandowski MJ, Kurnikowski A, Vanek L, Bretschneider P, Schwaiger E, Krenn S, Hödlmoser S, Gauckler P, Pirklbauer M, Horn S, Brunner M, Zitt E, Kirsch B, Windpessl M, Aringer I, Wiesholzer M, Ritschl V, Stamm T, Jauré A, Hecking M. Patient and Caregiver Perspectives on Gender Disparity in CKD: An Interview Study. KIDNEY360 2025; 6:227-235. [PMID: 39451005 PMCID: PMC11882245 DOI: 10.34067/kid.0000000594] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Accepted: 09/23/2024] [Indexed: 10/26/2024]
Abstract
Key Points Women felt vulnerable and felt that their housework obligations may interfere with CKD treatment, especially dialysis. Women felt they were good at protecting their health, whereas men might expect help from others and live in denial when confronted with advanced CKD. Background CKD affects more women than men worldwide; however, men comprise most patients who receive KRT. We aimed to describe the perspectives of patients and their caregivers regarding gender disparities in CKD. Methods Semi-structured interviews were conducted with 45 patients with CKD (20 women) and 14 caregivers (12 women) from seven clinics in Austria. The interviews were analyzed thematically. Results Five themes were identified in this study. Participants perceived that women were disadvantaged and vulnerable (silent and intimidated, single mother predicament, impeded access to care and support because of socioeconomic disadvantage, had to fend for themselves); fulfilling gender roles and norms (primarily responsible for childcare, pressure to perform well as homemakers, put others' needs before their own, encouraging husband's treatment adherence); and protecting their own health (self-disciplined, vigilant, confronted health challenges, advocated for their needs). Men were seen to place the onus of care on others (expected help from family, relied on others for decisions). Both men and women experienced a disease-related identity crisis and distress (women: impaired body image, mental distress; men: denial and self-destruction, emasculated by sickness). Conclusions Women with CKD felt vulnerable and were inclined to fulfill gender norms and responsibilities as caregivers, but were also vigilant about protecting their own health. Men tended to be reluctant to accept CKD and appeared to depend on others for disease management. Better awareness and addressing these concerns can inform strategies to minimize gender disparities in access to care and outcomes in CKD.
Collapse
Affiliation(s)
- Michał J. Lewandowski
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Amelie Kurnikowski
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Lenka Vanek
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Philipp Bretschneider
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Elisabeth Schwaiger
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
- Department of Internal Medicine, Brothers of Saint John of God Eisenstadt, Eisenstadt, Austria
| | - Simon Krenn
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Sebastian Hödlmoser
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Philipp Gauckler
- Clinical Department of Nephrology and Hypertensiology, Medical University of Innsbruck, Innsbruck, Austria
| | - Markus Pirklbauer
- Clinical Department of Nephrology and Hypertensiology, Medical University of Innsbruck, Innsbruck, Austria
| | - Sabine Horn
- Department of Internal Medicine, Landeskrankenhaus Villach, Villach, Austria
| | - Maria Brunner
- Department of Internal Medicine, Landeskrankenhaus Villach, Villach, Austria
| | - Emanuel Zitt
- Department of Internal Medicine III, Landeskrankenhaus Feldkirch, Feldkirch, Austria
| | - Bernhard Kirsch
- Department of Internal Medicine III, Landesklinikum Mistelbach, Mistelbach, Austria
| | - Martin Windpessl
- Department of Internal Medicine IV, Klinikum Wels-Grieskirchen, Wels, Austria
| | - Ida Aringer
- Center for Medical Statistics, Informatics and Intelligent Systems (Institute of Outcomes Research), Medical University of Vienna, Vienna, Austria
| | - Martin Wiesholzer
- Center for Medical Statistics, Informatics and Intelligent Systems (Institute of Outcomes Research), Medical University of Vienna, Vienna, Austria
| | - Valentin Ritschl
- Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia
| | - Tanja Stamm
- Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia
| | - Allison Jauré
- Department of Internal Medicine I, Universitätsklinikum St. Pölten, Saint Pölten, Austria
| | - Manfred Hecking
- Clinical Division of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| |
Collapse
|
|
4
|
Doutreligne M, Struja T, Abecassis J, Morgand C, Celi LA, Varoquaux G. Step-by-step causal analysis of EHRs to ground decision-making. PLOS DIGITAL HEALTH 2025; 4:e0000721. [PMID: 39899627 PMCID: PMC11790099 DOI: 10.1371/journal.pdig.0000721] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/30/2023] [Accepted: 12/10/2024] [Indexed: 02/05/2025]
Abstract
Causal inference enables machine learning methods to estimate treatment effects of medical interventions from electronic health records (EHRs). The prevalence of such observational data and the difficulty for randomized controlled trials (RCT) to cover all population/treatment relationships make these methods increasingly attractive for studying causal effects. However, researchers should be wary of many pitfalls. We propose and illustrate a framework for causal inference estimating the effect of albumin on mortality in sepsis using an Intensive Care database (MIMIC-IV) and comparing various sensitivity analyses to results from RCTs as gold-standard. The first step is study design, using the target trial concept and the PICOT framework: Population (patients with sepsis), Intervention (combination of crystalloids and albumin for fluid resuscitation), Control (crystalloids only), Outcome (28-day mortality), Time (intervention start within 24h of admission). We show that too large treatment-initiation times induce immortal time bias. The second step is selection of the confounding variables based on expert knowledge. Increasingly adding confounders enables to recover the RCT results from observational data. As the third step, we assess the influence of multiple models with varying assumptions, showing that a doubly robust estimator (AIPW) with random forests proved to be the most reliable estimator. Results show that these steps are all important for valid causal estimates. A valid causal model can then be used to individualize decision making: subgroup analyses showed that treatment efficacy of albumin was better for patients >60 years old, males, and patients with septic shock. Without causal thinking, machine learning is not enough for optimal clinical decision on an individual patient level. Our step-by-step analytic framework helps avoiding many pitfalls of applying machine learning to EHR data, building models that avoid shortcuts and extract the best decision-making evidence.
Collapse
Affiliation(s)
- Matthieu Doutreligne
- Soda Team, Inria Saclay, Palaiseau, France
- Mission Data, Haute Autorité de Santé, Saint-Denis, France
| | - Tristan Struja
- Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America
- Medical University Clinic, Division of Endocrinology, Diabetes & Metabolism, Kantonsspital Aarau, Aarau, Switzerland
| | | | - Claire Morgand
- Agence Régionale de Santé Ile-de-France, Saint-Denis, France
| | - Leo Anthony Celi
- Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America
- Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America
- Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America
| | | |
Collapse
|
|
5
|
Kubo T, Takeuchi T, Inoue N, Cama-Olivares A, Chandramohan D, Tolwani AJ, Wille KM, Fushimi K, Neyra JA, Wakabayashi K. Impact of early initiation of renal replacement therapy in patients on venoarterial ECMO using target trial emulation with Japanese nationwide data. Sci Rep 2025; 15:1074. [PMID: 39774191 PMCID: PMC11707199 DOI: 10.1038/s41598-025-85109-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2024] [Accepted: 01/01/2025] [Indexed: 01/11/2025] Open
Abstract
While renal replacement therapy (RRT) allows for precise fluid management as well as addressing electrolyte imbalances and the removal of other necessary compounds, its early initiation has not shown benefit in the general critically ill population. Moreover, the effects of early RRT initiation specifically in patients on venoarterial extracorporeal membrane oxygenation (VA-ECMO) also remain unclear. This retrospective study investigated adult patients who underwent VA-ECMO between April 2018 and March 2022 and used the clone-censor-weight method to emulate a hypothetical target trial and compare two groups: patients who initiated RRT within 2 days of VA-ECMO initiation (Early) and those who did not (Late). The primary outcomes were 28-day and 90-day hospital mortality analyzed by Cox proportional hazards models and the secondary outcome was 90-day RRT dependence by pooled logistic regression models. Inverse probability censoring weights were applied to adjust the models. A total of 2,513 VA-ECMO patients were cloned into both groups. The 28-day and 90-day mortalities were lower in the Early group (HR 0.59 [95% CI 0.53-0.68] and 0.67 [0.61-0.75]). However, the early group experienced greater RRT dependence at 90 days than the late group (OR 2.58 [1.94-3.46]). In conclusion, early initiation of RRT (within 2 days of VA-ECMO) was associated with lower hospital mortality but with a higher likelihood of 90-day RRT dependence in adult patients on VA-ECMO.
Collapse
Affiliation(s)
- Toshihiro Kubo
- Department of Intensive Care Medicine, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan
| | - Tomonori Takeuchi
- Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, THT 647, 1720 2nd Avenue S, Birmingham, AL, 35233, USA
- Department of Health Policy and Informatics, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan
| | - Norihiko Inoue
- Department of Health Policy and Informatics, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan
| | - Augusto Cama-Olivares
- Department of Internal Medicine, Brookwood Baptist Health, 833 Princeton Avenue SW, Birmingham, AL, 35211, USA
| | - Deepak Chandramohan
- Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, THT 647, 1720 2nd Avenue S, Birmingham, AL, 35233, USA
| | - Ashita J Tolwani
- Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, THT 647, 1720 2nd Avenue S, Birmingham, AL, 35233, USA
| | - Keith M Wille
- Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, University of Alabama at Birmingham, 1900 University Blvd, Birmingham, AL, 35294, USA
| | - Kiyohide Fushimi
- Department of Health Policy and Informatics, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan
| | - Javier A Neyra
- Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, THT 647, 1720 2nd Avenue S, Birmingham, AL, 35233, USA
| | - Kenji Wakabayashi
- Department of Intensive Care Medicine, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
| |
Collapse
|
|
6
|
Abdel-Rahman EM, Hasan I, Abdelrazeq AS, Rawabdeh A, Liu M, Ghahramani N, Sheikh-Hamad D, Murea M, Kadambi P, Ikizler TA, Awad AS. Early Versus Late Initiation of Dialysis in CKD Stage 5: Time for a Consensus. Kidney Int Rep 2025; 10:54-74. [PMID: 39810788 PMCID: PMC11725814 DOI: 10.1016/j.ekir.2024.10.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2024] [Revised: 09/18/2024] [Accepted: 10/01/2024] [Indexed: 01/16/2025] Open
Abstract
Chronic kidney disease (CKD), a major global public health problem, emerged as one of the leading causes of death, affecting over 800 million individuals worldwide, with significant burden to patients and their caregivers, and may lead to end-stage kidney disease (ESKD). The decision on optimal initiation of chronic dialysis is a common problem faced by nephrologists, patients, and caregivers due to lack of adequate data. Determining the ideal time to initiate maintenance dialysis for individuals struggling with ESKD has remained a puzzle. Currently, there is no consensus among guidelines as to the best time to initiate dialysis. Discrepancies in guidelines stem from lack of adequate data, necessitating larger randomized controlled trials to fill this major gap and come to a universal acceptance by the nephrology community about the optimal time to initiate dialysis for patients with advanced CKD. The fact that there has been only 1 randomized controlled trial that addressed early versus late dialysis initiation is inadequate to convincingly answer such as critical clinical decision making. In this review, we analyze the available literature and try to come up with recommendations for further studies to guide nephrologists about the best time to initiate dialysis for patients approaching ESKD.
Collapse
Affiliation(s)
| | - Irtiza Hasan
- Department of Medicine, University of Florida College of Medicine, Jacksonville, Florida, USA
| | | | - Ali Rawabdeh
- Department of Medicine, University of Florida College of Medicine, Jacksonville, Florida, USA
| | - Mei Liu
- Department of Health Outcomes & Biomedical Informatics, University of Florida College of Medicine, Gainesville, Florida, USA
| | - Nasrollah Ghahramani
- Department of Medicine, Penn State College of Medicine, Hershey, Pennsylvania, USA
| | | | - Mariana Murea
- Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
| | - Pradeep Kadambi
- Department of Medicine, University of Florida College of Medicine, Jacksonville, Florida, USA
| | - T. Alp Ikizler
- Department of Medicine, Vanderbilt School of Medicine, Nashville, Tennessee, USA
| | - Alaa S. Awad
- Department of Medicine, University of Florida College of Medicine, Jacksonville, Florida, USA
| |
Collapse
|
|
7
|
Zoccali C, Tripepi G. Clinical trial emulation in nephrology. J Nephrol 2025; 38:11-23. [PMID: 39602027 DOI: 10.1007/s40620-024-02158-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Accepted: 11/05/2024] [Indexed: 11/29/2024]
Abstract
Trial emulation, also known as target trial emulation, has significantly advanced epidemiology and causal inference by providing a robust framework for deriving causal relationships from observational data. This approach aims to reduce biases and confounding factors inherent in observational studies, thereby improving the validity of causal inferences. By designing observational studies to mimic randomized controlled trials (RCTs) as closely as possible, researchers can better control for confounding and bias. Key components of trial emulation include defining a clear time-zero, simulating random assignment using techniques like propensity score matching and inverse probability treatment weighting, assessing group comparability by standardized mean differences and establishing a clear comparison strategy. The increasing availability of large-scale real-world databases, such as research cohorts, patient registries, and hospital records, has driven the popularity of target trial emulation. These data sources offer information on patient outcomes, treatment patterns, and disease progression in real-world settings. By applying the principles of target trial emulation to these rich data sources, researchers can design studies that provide robust causal inferences about the effects of interventions, informing clinical guidelines and regulatory decisions. Despite its advantages, trial emulation faces challenges like data quality, unmeasured confounding, and implementation complexity. Future directions include integrating trial emulation with machine learning techniques and developing methods to address unmeasured confounding. Overall, trial emulation represents a significant advancement in epidemiology, offering a valuable tool for deriving accurate and reliable causal inferences from observational data, ultimately improving public health outcomes.
Collapse
Affiliation(s)
- Carmine Zoccali
- Renal Research Institute, New York, NY, USA.
- Institute of Molecular Biology and Genetics (Biogem), Ariano Irpino, Italy.
- Associazione Ipertensione Nefrologia Trapianto Renale (IPNET), c/o Nefrologia, Grande Ospedale Metropolitano, 89125, Reggio Calabria, Italy.
| | - Giovanni Tripepi
- CNR-IFC, Institute of Clinical Physiology, Research Unit of Clinical Epidemiology, IPNET c/o Nefrologia, Grande Ospedale Metropolitano, 89125, Reggio Calabria, Italy
| |
Collapse
|
|
8
|
Cseprekal O, Jacquelinet C, Massy Z. Push toward pre-emptive kidney transplantation - for sure? Clin Kidney J 2024; 17:sfae335. [PMID: 39698373 PMCID: PMC11653007 DOI: 10.1093/ckj/sfae335] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2024] [Indexed: 12/20/2024] Open
Abstract
Pre-emptive kidney transplantation (PKT) has long been considered the optimal treatment for patients with end-stage chronic kidney disease (CKD) seeking the most favourable long-term outcomes. However, the significant growth in transplant procedures over recent decades has led to a notable increase in wait-listed patients and a disproportionate demand for donor organs. This situation necessitates a re-evaluation of transplantation timing and the establishment of rational indications from both societal and clinical perspectives. An increasing number of retrospective analyses have challenged the universal benefit of PKT, suggesting that premature indications for living or deceased donor PKT may not always yield superior hard outcomes compared with non-PKT approaches. Conventional predictive models have shown limitations in accurately assessing risks for certain subpopulations, potentially leading to significant disparities among wait-listed patients. To address these challenges, we propose the following considerations. Prediction models should not only optimize the distribution of our limited donor resources, but should also illuminate foreseeable risks associated with a potentially 'unsuccessful' PKT. Therefore, this article seeks to underscore the necessity for further discourse on the smouldering concept of when and for whom living or deceased donor PKT should be considered. Is it universally beneficial, or should the clinical paradigm be re-evaluated? In the endeavour to attain superior post-PKT survival outcomes compared with non-PKT or conservative treatment, it seems critical to acknowledge that other treatments may provide more favourable results for certain individuals. This introduces the intricate task of effectively navigating the complexities associated with 'too early' or 'unsuccessful' PKT.
Collapse
Affiliation(s)
- Orsolya Cseprekal
- Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary
- Agence de la Biomedicine, La Plaine Saint-Denis, Île-de-France, Paris, France
- INSERM Unit 1018, Team 5, CESP, Hôpital Paul Brousse, Paris-Sud University and Versailles Saint-Quentin-en-Yvelines University, Villejuif, France
| | - Christian Jacquelinet
- Agence de la Biomedicine, La Plaine Saint-Denis, Île-de-France, Paris, France
- INSERM Unit 1018, Team 5, CESP, Hôpital Paul Brousse, Paris-Sud University and Versailles Saint-Quentin-en-Yvelines University, Villejuif, France
| | - Ziad Massy
- INSERM Unit 1018, Team 5, CESP, Hôpital Paul Brousse, Paris-Sud University and Versailles Saint-Quentin-en-Yvelines University, Villejuif, France
- Association pour l'Utilisation du Rein Artificiel dans la région Parisienne, Paris, France
- Ambroise Paré University Hospital, APHP, Department of Nephrology, Boulogne-Billancourt, Paris, France
| |
Collapse
|
|
9
|
Lambourg E. Improving the quality of pharmacoepidemiological studies using the target trial emulation framework. Nat Rev Nephrol 2024; 20:769. [PMID: 39138342 DOI: 10.1038/s41581-024-00884-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/15/2024]
Affiliation(s)
- Emilie Lambourg
- Horiana, Bordeaux, France.
- Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, UK.
| |
Collapse
|
|
10
|
Okada A, Aso S, Kurakawa KI, Inoue R, Watanabe H, Sasabuchi Y, Yamauchi T, Yasunaga H, Kadowaki T, Yamaguchi S, Nangaku M. Adding biomarker change information to the kidney failure risk equation improves predictive ability for dialysis dependency in eGFR <30 ml/min/1.73 m 2. Clin Kidney J 2024; 17:sfae321. [PMID: 39564392 PMCID: PMC11574387 DOI: 10.1093/ckj/sfae321] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2024] [Indexed: 11/21/2024] Open
Abstract
Background Although the kidney failure risk equation (KFRE), a well-known predictive model for predicting dialysis dependency, is useful, it remains unclear whether the addition of biomarker changes to the KFRE model in patients with an estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 will improve its predictive value. Methods We retrospectively identified adults with eGFR <30 ml/min/1.73 m2 without dialysis dependency, and available health checkup data for two successive years using a large Japanese claims database (DeSC, Tokyo, Japan). We dichotomized the entire population into a training set (50%) and a validation set (the other half). To assess the incremental value in the predictive ability for dialysis dependency by the addition of changes in eGFR and proteinuria, we calculated the difference in the C-statistics and net reclassification index (NRI). Results We identified 4499 individuals and observed 422 individuals (incidence of 45.2 per 1000 person-years) who developed dialysis dependency during the observation period (9343 person-years). Adding biomarker changes to the KFRE model improved C-statistics from 0.862 to 0.921, with an improvement of 0.060 (95% confidence intervals (CI) of 0.043-0.076, P < .001). The corresponding NRI was 0.773 (95% CI: 0.637-0.908), with an NRI for events of 0.544 (95% CI of 0.415-0.672) and NRI for non-events of 0.229 (95% CI of 0.186-0.272). Conclusions The KFRE model was improved by incorporating yearly changes in its components. The added information may help clinicians identify high-risk individuals and improve their care.
Collapse
Affiliation(s)
- Akira Okada
- Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Shotaro Aso
- Department of Real-world Evidence, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kayo Ikeda Kurakawa
- Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Reiko Inoue
- Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hideaki Watanabe
- Department of Clinical Epidemiology and Health Economics, The University of Tokyo, Tokyo, Japan
| | - Yusuke Sasabuchi
- Department of Real-world Evidence, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Toshimasa Yamauchi
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hideo Yasunaga
- Department of Clinical Epidemiology and Health Economics, The University of Tokyo, Tokyo, Japan
| | - Takashi Kadowaki
- Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
- Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
- Toranomon Hospital, Tokyo, Japan
| | - Satoko Yamaguchi
- Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Masaomi Nangaku
- Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| |
Collapse
|
|
11
|
Zoccali C, Tripepi G, Carioni P, Fu EL, Dekker F, Stel V, Jager KJ, Mallamaci F, Hymes JL, Maddux FW, Stuard S. Antihypertensive Drug Treatment and the Risk for Intrahemodialysis Hypotension. Clin J Am Soc Nephrol 2024; 19:1310-1318. [PMID: 39012707 PMCID: PMC11469783 DOI: 10.2215/cjn.0000000000000521] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2024] [Accepted: 07/11/2024] [Indexed: 07/18/2024]
Abstract
Key Points Antihypertensive medications are often used by hemodialysis patients, and intradialytic hypotension is a common complication in these patients. The study emulates a randomized clinical trial comparing antihypertensive drug treatment for the risk of hemodialysis hypotension in 4072 incident patients. Compared with calcium antagonists, β and α –β blockers, angiotensin converting enzyme inhibitors or angiotensin II antagonists, and diuretics may increase the risk of hemodialysis hypotension. Background Antihypertensive medications are often prescribed to manage hypertension in hemodialysis patients, and intradialytic hypotension (IDH) is a common complication in these patients. We investigated the risk of IDH in incident hemodialysis patients who initiated treatment with antihypertensive drugs in monotherapy. Methods The study was conducted as an emulation of a randomized clinical trial in 4072 incident hemodialysis patients who started antihypertensive drug treatment between January 2016 and December 2019. The primary outcome was the occurrence of IDH during hemodialysis sessions. The generalized estimating equation analysis was adjusted by inverse probability treatment weighting. Results Calcium channel blocker (CCB) use was associated with an IDH incidence rate of 7.4 events per person-year (95% confidence interval [CI], 6.2 to 8.6). Compared with CCB use, use of β and α –β blockers was strongly associated with a higher likelihood of IDH (odds ratio [OR] [95% CI, 2.27; 1.50 to 3.43]). The use of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (OR [95% CI, 1.71; 1.14 to 2.57]) and diuretics (OR [95% CI, 1.52; 1.07 to 2.16]) were also associated with a higher likelihood of IDH compared with CCB use. Conclusions The study suggests that using β and α –β blockers, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, and diuretics may increase the risk of IDH in hemodialysis patients compared with CCB use.
Collapse
Affiliation(s)
- Carmine Zoccali
- Renal Research Institute, New York, New York
- Institute of Molecular Biology and Genetics (Biogem), Ariano Irpino, Italy
- Associazione Ipertensione Nefrologia Trapianto Renale (IPNET), c/o Nefrologia, Grande Ospedale Metropolitano, Reggio Calabria, Italy
| | - Giovanni Tripepi
- CNR-IFC, Institute of Clinical Physiology, Research Unit of Clinical Epidemiology, Reggio Calabria, Italy
| | - Paola Carioni
- Fresenius Medical Care, Global Medical Office, Crema, Italy
| | - Edouard L. Fu
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Friedo Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Vianda Stel
- Department of Medical Informatics, ERA Registry, Amsterdam UMC location and the University of Amsterdam, Amsterdam, The Netherlands
- Quality of Care, Amsterdam Public Health, Amsterdam, The Netherlands
| | - Kitty J. Jager
- Department of Medical Informatics, ERA Registry, Amsterdam UMC location and the University of Amsterdam, Amsterdam, The Netherlands
- Quality of Care, Amsterdam Public Health, Amsterdam, The Netherlands
| | - Francesca Mallamaci
- CNR-IFC, Institute of Clinical Physiology, Research Unit of Clinical Epidemiology, Reggio Calabria, Italy
- Nephrology, Dialysis and Transplantation Unit, Azienda Ospedaliera “Bianchi-Melacrino-Morelli” Grande Ospedale Metropolitano of Reggio Calabria, Reggio Calabria, Italy
| | - Jeffrey L. Hymes
- Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts
| | | | - Stefano Stuard
- Fresenius Medical Care, Global Medical Office, Bad Homburg, Germany
| |
Collapse
|
|
12
|
Montez-Rath ME, Thomas IC, Charu V, Odden MC, Seib CD, Arya S, Fung E, O'Hare AM, Wong SPY, Kurella Tamura M. Effect of Starting Dialysis Versus Continuing Medical Management on Survival and Home Time in Older Adults With Kidney Failure : A Target Trial Emulation Study. Ann Intern Med 2024; 177:1233-1243. [PMID: 39159459 PMCID: PMC11995948 DOI: 10.7326/m23-3028] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/21/2024] Open
Abstract
BACKGROUND For older adults with kidney failure who are not referred for transplant, medical management is an alternative to dialysis. OBJECTIVE To compare survival and home time between older adults who started dialysis at an estimated glomerular filtration rate (eGFR) less than 12 mL/min/1.73 m2 and those who continued medical management. DESIGN Observational cohort study using target trial emulation. SETTING U.S. Department of Veterans Affairs, 2010 to 2018. PARTICIPANTS Adults aged 65 years or older with chronic kidney failure and eGFR below 12 mL/min/1.73 m2 who were not referred for transplant. INTERVENTION Starting dialysis within 30 days versus continuing medical management. MEASUREMENTS Mean survival and number of days at home. RESULTS Among 20 440 adults (mean age, 77.9 years [SD, 8.8]), the median time to dialysis start was 8.0 days in the group starting dialysis and 3.0 years in the group continuing medical management. Over a 3-year horizon, the group starting dialysis survived 770 days and the group continuing medical management survived 761 days (difference, 9.3 days [95% CI, -17.4 to 30.1 days]). Compared with the group continuing medical management, the group starting dialysis had 13.6 fewer days at home (CI, 7.7 to 20.5 fewer days at home). Compared with the group continuing medical management and forgoing dialysis completely, the group starting dialysis had longer survival by 77.6 days (CI, 62.8 to 91.1 days) and 14.7 fewer days at home (CI, 11.2 to 16.5 fewer days at home). LIMITATION Potential for unmeasured confounding due to lack of symptom assessments at eligibility; limited generalizability to women and nonveterans. CONCLUSION Older adults starting dialysis when their eGFR fell below 12 mL/min/1.73 m2 who were not referred for transplant had modest gains in life expectancy and less time at home. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs and National Institutes of Health.
Collapse
Affiliation(s)
- Maria E Montez-Rath
- Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California (M.E.M., E.F.)
| | - I-Chun Thomas
- Geriatric Research, Education, and Clinical Center, Veterans Affairs Palo Alto, Palo Alto, California (I.-C.T.)
| | - Vivek Charu
- Quantitative Sciences Unit, Department of Medicine, and Department of Pathology, Stanford University School of Medicine, Stanford, California (V.C.)
| | - Michelle C Odden
- Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, and Geriatric, Research, Education, and Clinical Center, Veterans Affairs Palo Alto, Palo Alto, California (M.C.O.)
| | - Carolyn D Seib
- Department of Surgery, Stanford University School of Medicine, and Division of General Surgery, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (C.D.S.)
| | - Shipra Arya
- Department of Surgery, Stanford University School of Medicine, and Division of Vascular Surgery, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (S.A.)
| | - Enrica Fung
- Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California (M.E.M., E.F.)
| | - Ann M O'Hare
- Division of Nephrology, Department of Medicine, University of Washington, and Hospital and Specialty Medicine Service and Center of Innovation for Veteran-Centered and Value-Driven Care, Veterans Affairs Puget Sound Health Care System, Seattle, Washington (A.M.O., S.P.Y.W.)
| | - Susan P Y Wong
- Division of Nephrology, Department of Medicine, University of Washington, and Hospital and Specialty Medicine Service and Center of Innovation for Veteran-Centered and Value-Driven Care, Veterans Affairs Puget Sound Health Care System, Seattle, Washington (A.M.O., S.P.Y.W.)
| | - Manjula Kurella Tamura
- Division of Nephrology, Department of Medicine, Stanford University School of Medicine, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Palo Alto, Palo Alto, California (M.K.T.)
| |
Collapse
|
|
13
|
Vanek L, Gülmez D, Kurnikowski A, Krenn S, Mussnig S, Lewandowski M, Gauckler P, Pirklbauer M, Horn S, Brunner M, Zitt E, Kirsch B, Windpessl M, Eller K, Odler B, Aringer I, Wiesholzer M, Stamm T, Jauré A, Hecking M. Patient and Caregiver Perspectives on Gender Disparity in Chronic Kidney Disease: Questionnaire Survey, Based on an Interview Study. Am J Nephrol 2024; 55:561-582. [PMID: 39191222 PMCID: PMC11446334 DOI: 10.1159/000540850] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2024] [Accepted: 08/06/2024] [Indexed: 08/29/2024]
Abstract
INTRODUCTION Chronic kidney disease (CKD) in stages 3-5 without albuminuria occurs more often in women than in men; however, most patients initiating and receiving kidney replacement therapy are men. Sex-determined biological factors and gender-related aspects both likely account for this discrepancy. Patient opinions on gender-related discrepancies in kidney care have not been investigated. METHODS Building upon the findings of semi-structured interviews previously conducted with CKD patients and their caregivers, two questionnaires were developed to investigate patient behavior and opinions relating to gender and CKD. These questionnaires containing 39 items were distributed to eight outpatient clinics in Austria. Responses were descriptively analyzed and compared between genders, as well as between age-groups and CKD stages. RESULTS Questionnaires from 783 patients and 98 caregivers were included in the analysis and covered health awareness and self-management of disease, the impact of gender roles and gender equality, and patient autonomy and trust in the health-care system. A total of 56.1% of men patients and 63.1% of women patients found that women were better at looking after their health compared to men (41.1%/34.3% no difference, 2.8%/2.6% men better). A total of 95.4% of men patients, 95.0% of women patients, 100% of men caregivers, and 95.5% of women caregivers stated that all patients with kidney disease were treated completely equally, irrespective of gender. CONCLUSION Neither the patients nor the caregivers stated gender-determined treatment decisions in CKD care. Both men and women however agreed that women are better at maintaining their own health and excel in disease self-management.
Collapse
Affiliation(s)
- Lenka Vanek
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria,
- Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria,
| | - Dilara Gülmez
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria
- Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria
| | - Amelie Kurnikowski
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria
- Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria
| | - Simon Krenn
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria
- Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria
| | - Sebastian Mussnig
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria
- Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria
| | - Michał Lewandowski
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria
| | - Philipp Gauckler
- Medical University of Innsbruck, Clinical Department of Nephrology and Hypertensiology, Medical University of Innsbruck, Innsbruck, Austria
| | - Markus Pirklbauer
- Medical University of Innsbruck, Clinical Department of Nephrology and Hypertensiology, Medical University of Innsbruck, Innsbruck, Austria
| | - Sabine Horn
- Department of Internal Medicine, Landeskrankhaus Villach, Villach, Austria
| | - Maria Brunner
- Department of Internal Medicine, Landeskrankhaus Villach, Villach, Austria
| | - Emanuel Zitt
- Department of Internal Medicine III, Landeskrankenhaus Feldkirch, Feldkirch, Austria
| | - Bernhard Kirsch
- Department of Internal Medicine III, Landesklinikum Mistelbach, Mistelbach, Austria
| | - Martin Windpessl
- Department of Internal Medicine IV, Klinikum Wels-Grieskirchen, Wels, Austria
| | - Kathrin Eller
- Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | - Balasz Odler
- Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | - Ida Aringer
- Department of Internal Medicine I, Universitätsklinikum St. Pölten, St. Pölten, Austria
| | - Martin Wiesholzer
- Department of Internal Medicine I, Universitätsklinikum St. Pölten, St. Pölten, Austria
| | - Tanja Stamm
- Center for Medical Statistics, Informatics and Intelligent Systems (Institute of Outcomes Research), Medical University of Vienna, Vienna, Austria
| | - Allison Jauré
- Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia
| | - Manfred Hecking
- Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria
- Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria
| |
Collapse
|
|
14
|
Frévent C, Ahmed MS, Dabo-Niang S, Genin M. A Shared-Frailty Spatial Scan Statistic Model for Time-to-Event Data. Biom J 2024; 66:e202300200. [PMID: 38988210 DOI: 10.1002/bimj.202300200] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2023] [Revised: 01/24/2024] [Accepted: 05/04/2024] [Indexed: 07/12/2024]
Abstract
Spatial scan statistics are well-known methods widely used to detect spatial clusters of events. Furthermore, several spatial scan statistics models have been applied to the spatial analysis of time-to-event data. However, these models do not take account of potential correlations between the observations of individuals within the same spatial unit or potential spatial dependence between spatial units. To overcome this problem, we have developed a scan statistic based on a Cox model with shared frailty and that takes account of the spatial dependence between spatial units. In simulation studies, we found that (i) conventional models of spatial scan statistics for time-to-event data fail to maintain the type I error in the presence of a correlation between the observations of individuals within the same spatial unit and (ii) our model performed well in the presence of such correlation and spatial dependence. We have applied our method to epidemiological data and the detection of spatial clusters of mortality in patients with end-stage renal disease in northern France.
Collapse
Affiliation(s)
- Camille Frévent
- Université de Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, Université de Lille, Lille, France
| | - Mohamed-Salem Ahmed
- Université de Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, Université de Lille, Lille, France
- Alicante SARL, Lesquin, France
| | - Sophie Dabo-Niang
- CNRS, UMR 8524 - Laboratoire Paul Painlevé, Université de Lille, Lille, France
- MODAL team, INRIA Lille-Nord Europe, Villeneuve-d'Ascq, France
| | - Michaël Genin
- Université de Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, Université de Lille, Lille, France
| |
Collapse
|
|
15
|
Bakari AI, Yahaya JJ, Matobogolo BM, Abraham ZS, Mpondo B. Adequacy of haemodialysis and associated factors among patients with end-stage kidney disease in Tanzania. J Taibah Univ Med Sci 2024; 19:287-295. [PMID: 38283378 PMCID: PMC10821596 DOI: 10.1016/j.jtumed.2023.12.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2023] [Revised: 12/07/2023] [Accepted: 12/25/2023] [Indexed: 01/30/2024] Open
Abstract
Objectives Adequate haemodialysis helps maintain normal renal function by removing toxins and other waste products in patients with end-stage kidney disease. This study was aimed at determining the prevalence and predictors of adequacy of haemodialysis and outcomes in patients with end-stage kidney disease. Methods This longitudinal analytical hospital-based study was conducted at two dialysis centres in Dodoma city, Tanzania, between February and July of 2020. Adequacy of haemodialysis was measured with single-pool (sp) Kt/V and urea reduction rate (URR) formulae. Binary logistic regression and multivariable analysis were used to assess the independent predictors of adequacy of haemodialysis. Results The analysis included 100 patients with a mean age of 50.6 ± 15.0 years. The prevalence of adequacy of haemodialysis according to URR and sp-Kt/V was 72 % and 75 %, respectively. Having <12 months since dialysis initiation (AOR = 7.3, 95 % CI = 0.11-0.90, p = 0.032), fewer than three dialysis sessions per week (AOR = 6.9, 95 % CI = 1.52-31.49, p = 0.013) and severe anaemia (AOR = 2.2, 95 % CI = 0.26-0.93, p = 0.033) were predictors of inadequate haemodialysis, according to the URR formula. Having fewer than three dialysis sessions per week was significantly associated with inadequate haemodialysis (AOR = 5.6, 95 % CI = 1.47-19.66, p = 0.011), according to the sp-Kt/V formula. The mortality rate was 11.2 %, and cardiovascular disease and uremic syndrome were responsible for most deaths. Conclusion This study indicated a high percentage of adequacy of haemodialysis among patients with end-stage kidney disease. Having fewer than three dialysis sessions per week, late initiation of dialysis after diagnosis of end-stage kidney disease and severe anaemia were predictors of inadequate haemodialysis among patients.
Collapse
Affiliation(s)
- Abilah I. Bakari
- Department of Internal Medicine, School of Medicine and Dentistry, University of Dodoma, Dodoma, Tanzania
| | - James J. Yahaya
- Department of Pathology, School of Health Sciences, Soroti University, Soroti, Uganda
| | - Boaz M. Matobogolo
- Department of Internal Medicine, School of Medicine and Dentistry, University of Dodoma, Dodoma, Tanzania
| | - Zephania S. Abraham
- Department of Surgery, School of Medicine and Dentistry, University of Dodoma, Dodoma, Tanzania
| | - Bonaventura Mpondo
- Department of Internal Medicine, School of Medicine and Dentistry, University of Dodoma, Dodoma, Tanzania
| |
Collapse
|
|
16
|
Fu EL, Levey AS, Coresh J, Grams ME, Faucon AL, Elinder CG, Dekker FW, Delanaye P, Inker LA, Carrero JJ. Accuracy of GFR estimating equations based on creatinine, cystatin C or both in routine care. Nephrol Dial Transplant 2024; 39:694-706. [PMID: 37813817 DOI: 10.1093/ndt/gfad219] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2023] [Indexed: 10/11/2023] Open
Abstract
BACKGROUND New equations to estimate glomerular filtration rate based on creatinine (eGFRcr), cystatin C (eGFRcys) or both (eGFRcr-cys) have been developed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and the European Kidney Function Consortium (EKFC). There is a need to evaluate the performance of these equations in diverse European settings to inform implementation decisions, especially among people with key comorbid conditions. METHODS We performed a cross-sectional study including 6174 adults referred for single-point plasma clearance of iohexol in Stockholm, Sweden, with 9579 concurrent measurements of creatinine and cystatin C. We assessed the performance of the CKD-EPI 2009/2012/2021, EKFC 2021/2023, revised Lund-Malmö (RLM) 2011 and Caucasian, Asian, Pediatric and Adult (CAPA) 2014 equations against measured GFR (mGFR). RESULTS Mean age was 56 years, median mGFR was 62 mL/min/1.73 m2 and 40% were female. Comorbid conditions were common: cardiovascular disease (30%), liver disease (28%), diabetes (26%) and cancer (26%). All eGFRcr-cys equations had small bias and P30 (the percentage of estimated values within 30% of mGFR) close to 90%, and performed better than eGFRcr or eGFRcys equations. Among eGFRcr equations, CKD-EPI 2009 and CKD-EPI 2021 showed larger bias and lower P30 than EKFC 2021 and RLM. There were no meaningful differences in performance across eGFRcys equations. Findings were consistent across comorbid conditions, and eGFRcr-cys equations showed good performance in patients with liver disease, cancer and heart failure. CONCLUSIONS In conclusion, eGFRcr-cys equations performed best, with minimal variation among equations in this Swedish cohort. The lower performance of CKD-EPI eGFRcr equations compared with EKFC and RLM may reflect differences in population characteristics and mGFR methods. Implementing eGFRcr equations will require a trade-off between accuracy and uniformity across regions.
Collapse
Affiliation(s)
- Edouard L Fu
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Andrew S Levey
- Division of Nephrology, Department of Internal Medicine, Tufts Medical Center, Boston, MA, USA
| | - Josef Coresh
- Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA
| | - Morgan E Grams
- Division of Precision Medicine, Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA
| | - Anne-Laure Faucon
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
- INSERM UMR 1018, Department of Clinical Epidemiology, Paris-Saclay University, Paris, France
| | - Carl-Gustaf Elinder
- Division of Renal Medicine, Department of Clinical Intervention, and Technology, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden
| | - Friedo W Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Pierre Delanaye
- Department of Nephrology-Dialysis-Transplantation, University of Liège, CHU Sart Tilman, Liège, Belgium
- Department of Nephrology-Dialysis-Apheresis, Hôpital Universitaire Carémeau, Nîmes, France
| | - Lesley A Inker
- Division of Nephrology, Department of Internal Medicine, Tufts Medical Center, Boston, MA, USA
| | - Juan-Jesus Carrero
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
- Division of Nephrology, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden
| |
Collapse
|
|
17
|
Ou SH, Chang WC, Wu LY, Wang SI, Wei JCC, Lee PT. Diabetic Macular Edema Is Predictive of Renal Failure in Patients With Diabetes Mellitus and Chronic Kidney Disease. J Clin Endocrinol Metab 2024; 109:761-770. [PMID: 37804118 DOI: 10.1210/clinem/dgad581] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2023] [Revised: 09/16/2023] [Accepted: 09/27/2023] [Indexed: 10/08/2023]
Abstract
CONTEXT Chronic hyperglycemia in patients with diabetes mellitus (DM) causes retinal damage and leakage, resulting in vision loss. Although diabetic retinopathy (DR) and diabetic kidney disease (DKD) are usually correlated, the relationship between diabetic macular edema (DME) and DKD remains unknown. OBJECTIVE To assess whether DME presence can predict renal failure in patients with DM and chronic kidney disease (CKD). METHODS This retrospective cohort study used data from 120 healthcare organizations in the TriNetX network. Electronic medical records of approximately 90 million patients were reviewed. The study population was classified into DME and non-DME cohorts. Primary and secondary outcomes were new-onset end-stage renal disease (ESRD) and all-cause mortality, respectively. Covariate factors were incorporated to reduce confounding effects. RESULTS Before matching, the DME cohort used more medication and had poorer renal function and blood sugar control than the non-DME cohort. Subsequently, the 2 groups were well-matched in demographics, socioeconomic status, lifestyle, comorbidities, and medication usage. The DME cohort had a significantly higher risk of ESRD, dialysis, and renal transplantation than the non-DME cohort. Subgroup analyses showed consistent results irrespective of follow-up duration, initial estimated glomerular filtration rate, or glycated hemoglobin levels. Additionally, the DME cohort had a lower risk of all-cause mortality than the non-DME cohort. CONCLUSION Statistically significant 5-year increased risks of ESRD, dialysis, and renal transplantation were observed in patients with concurrent DME. Therefore, close monitoring and follow-up of the renal function in DM patients with DME are necessary and strongly recommended.
Collapse
Affiliation(s)
- Shih-Hsiang Ou
- Division of Nephrology, Department of Internal Medicine, Pingtung Veterans General Hospital, Pingtung 900, Taiwan
- Division of Nephrology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung 813414, Taiwan
- Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei 112304, Taiwan
| | - Wei-Che Chang
- Division of Nephrology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung 813414, Taiwan
| | - Ling-Ying Wu
- Department of Obstetrics and Gynecology, Kaohsiung Municipal Feng Shan Hospital-Under the management of Chang Gung Medical Foundation, Kaohsiung 830, Taiwan
| | - Shiow-Ing Wang
- Center for Health Data Science, Department of Medical Research, Chung Shan Medical University Hospital, Taichung 40201, Taiwan
- Institute of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan
- Department of Nursing, Jen-Teh Junior College of Medicine, Nursing and Management, Miaoli 356006, Taiwan
| | - James Cheng-Chung Wei
- Institute of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan
- Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung 40201, Taiwan
- Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan
- Graduate Institute of Integrated Medicine, China Medical University, Taichung 413, Taiwan
| | - Po-Tsang Lee
- Division of Nephrology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung 813414, Taiwan
- Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei 112304, Taiwan
| |
Collapse
|
|
18
|
Ertuglu L, Ikizler TA. Nutrition Management in Geriatric Patients with CKD. KIDNEY360 2024; 5:310-319. [PMID: 38297445 PMCID: PMC10914191 DOI: 10.34067/kid.0000000000000364] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/05/2023] [Accepted: 01/11/2024] [Indexed: 02/02/2024]
Abstract
Sarcopenia, defined as age-related decline in skeletal muscle mass and functional capacity, is a hallmark nutritional abnormality observed in patients with moderate-to-advanced CKD. Uremic state and associated medical conditions also predispose older patients with CKD to protein-energy wasting, a nutritional abnormality that could include sarcopenia. Prevention of protein and energy depletion and replenishing the already low nutritional reserves elderly patients with CKD should focus on conventional and innovative strategies. This review aims to provide an overview of the mainstay of nutritional therapy in this patient population, such as intake of adequate amounts of protein and energy along with preserving fluid, electrolyte, and mineral balance, and to discuss more innovative interventions to aid these approaches.
Collapse
Affiliation(s)
- Lale Ertuglu
- Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
| | | |
Collapse
|
|
19
|
Sun Z, Cheng K, Jin G, Jia J. Increasing serum miR-409-3p predicts the major adverse cardiac adverse events in elderly patients after hip fracture surgery. BMC Musculoskelet Disord 2023; 24:920. [PMID: 38017411 PMCID: PMC10683352 DOI: 10.1186/s12891-023-07049-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2023] [Accepted: 11/20/2023] [Indexed: 11/30/2023] Open
Abstract
BACKGROUND Major adverse cardiovascular events (MACE) are critical complications responsible for the morbidity and mortality of elderly hip fracture patients. There was an urgent need to explore an effect biomarker for predicting MACE in elderly patients receiving hip fracture surgery. OBJECTIVE This study focused on an age-related miRNA, miR-409-3p, and assessed its significance in elderly hip fracture patients. METHODS A total of 267 hip fracture patients were enrolled in this study including 104 elderly patients (age ≥ 60 years). All patients were followed up for 1 year to monitor the occurrence of MACE. The risk factors for the occurrence of MACE were evaluated by the logistic regression analysis. RESULTS Elderly age and reduced cardiac and renal function were identified as risk factors for MACE in hip fracture patients. Elderly patients also showed a high incidence of MACE. In elderly hip fracture patients, significant upregulation of miR-409-3p was observed, which was associated with patients' elderly age, higher level of revised cardiac risk index (RCRI), lower left ventricular ejection fraction (LVEF), and higher levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase-MB (CK-MB), and high sensitivity troponin I (hsTnI). Additionally, miR-409-3p was identified as an independent factor for the MACE in elderly patients received hip fracture surgery. CONCLUSION Upregulated miR-409-3p was an age-related miRNA and could predict the occurrence of MACE in elderly hip fracture patients.
Collapse
Affiliation(s)
- Zhengtao Sun
- Department of Osteoarticular Surgery, Linfen People's Hospital, No.319 Gulou West Street, Yao Du District, Linfen, 041000, China
| | - Kai Cheng
- Department of Osteoarticular Surgery, Linfen People's Hospital, No.319 Gulou West Street, Yao Du District, Linfen, 041000, China
| | - Guochao Jin
- Department of Osteoarticular Surgery, Linfen People's Hospital, No.319 Gulou West Street, Yao Du District, Linfen, 041000, China
| | - Jian Jia
- Department of Osteoarticular Surgery, Linfen People's Hospital, No.319 Gulou West Street, Yao Du District, Linfen, 041000, China.
| |
Collapse
|
|
20
|
Sheng YP, Ma XY, Liu Y, Yang XM, Sun FY. Independent risk factors for depression in older adult patients receiving peritoneal dialysis for chronic kidney disease. World J Psychiatry 2023; 13:884-892. [DOI: 10.5498/wjp.v13.i11.884] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2023] [Revised: 09/22/2023] [Accepted: 10/11/2023] [Indexed: 11/17/2023] Open
Abstract
BACKGROUND According to the trend of global population aging, the proportion of elderly patients with chronic kidney disease (CKD) is expected to increase. However, there are more than 20 million people in China with decompensated kidney function, of which 19.25% are elderly people. Therefore, special attention should be paid to the education years, sleep quality, anxiety status, comorbidities with diabetes, cardiovascular disease (CVD), and anemia as independent risk factors for depression in elderly CKD patients. This study explores the clinical mana-gement of elderly CKD patients that should address these risk factors to prevent depression and improve their prognosis.
AIM To investigate depression risk factors in older patients receiving peritoneal dialysis, aiding future prevention of depression in these patients.
METHODS This retrospective study included a primary study population of 170 patients with CKD who received peritoneal dialysis from January 2020 to December 2022. We assessed the patients’ mental status using the Beck Depression Inventory Score-II (BDI-II), Self-Rating Anxiety Scale (SAS), Anxiety Inventory Score, and the Pittsburgh Sleep Quality Index (PSQI). Logistic regression was employed to identify depression independent risk factors among these patients.
RESULTS The non-depressed group had a significantly longer education period than the depressed group (P < 0.05). The depressed group exhibited significantly higher mental status scores than the non-depressed group (P < 0.001). Patients with diabetes mellitus (DM) or CVD had a higher probability of developing dep-ression. Patients with depression had significantly lower hemoglobin and albumin levels than patients without depression (P < 0.05). Spearman correlation analysis of BDI-II scale scores, measuring depression, indicated positive correlations with BDI-II and SAS scores as risk factors for depression in patients with CKD. In contrast, years of education, hemoglobin levels, and peritoneal Kt/V were negatively correlated, serving as protective factors against depression. An analysis of variance for influences with significant differences in the univariate analysis revealed that years of schooling, BDI-II, SAS, PSQI, DM, CVD, and hemoglobin levels independently influenced depression in older patients with CKD.
CONCLUSION Education, BDI-II, SAS, PSQI, DM, and CVD are independent risk factors for depression in older patients with CKD; therefore, post-treatment psychological monitoring of high-risk patients is crucial to prevent depression.
Collapse
Affiliation(s)
- Yu-Ping Sheng
- Department of Nephrology, Cangzhou Central Hospital, Cangzhou 061000, Hebei Province, China
| | - Xiao-Ying Ma
- Department of Nephrology, Cangzhou Central Hospital, Cangzhou 061000, Hebei Province, China
| | - Ye Liu
- Department of Nephrology, Cangzhou Central Hospital, Cangzhou 061000, Hebei Province, China
| | - Xing-Meng Yang
- Department of Nephrology, Cangzhou Central Hospital, Cangzhou 061000, Hebei Province, China
| | - Fu-Yun Sun
- Department of Nephrology, Cangzhou Central Hospital, Cangzhou 061000, Hebei Province, China
| |
Collapse
|
|
21
|
Dąbek B, Dybiec J, Frąk W, Fularski P, Lisińska W, Radzioch E, Młynarska E, Rysz J, Franczyk B. Novel Therapeutic Approaches in the Management of Chronic Kidney Disease. Biomedicines 2023; 11:2746. [PMID: 37893119 PMCID: PMC10604464 DOI: 10.3390/biomedicines11102746] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2023] [Revised: 10/02/2023] [Accepted: 10/06/2023] [Indexed: 10/29/2023] Open
Abstract
Chronic kidney disease (CKD) is a progressive and incurable disease that impairs kidney function. Its prevalence is estimated to affect up to 800 million individuals within the general population, and patients with diabetes and hypertension are particularly at risk. This disorder disrupts the physiological mechanisms of the body, including water and electrolyte balance, blood pressure regulation, the excretion of toxins, and vitamin D metabolism. Consequently, patients are exposed to risks such as hyperkalemia, hyperphosphatemia, metabolic acidosis, and blood pressure abnormalities. These risks can be reduced by implementing appropriate diagnostic methods, followed by non-pharmacological (such as physical activity, dietary, and lifestyle adjustment) and pharmacological strategies after diagnosis. Selecting the appropriate diet and suitable pharmacological treatment is imperative in maintaining kidney function as long as possible. Drugs such as finerenone, canakinumab, and pentoxifylline hold promise for improved outcomes among CKD patients. When these interventions prove insufficient, renal replacement therapy becomes essential. This is particularly critical in preserving residual renal function while awaiting renal transplantation or for patients deemed ineligible for such a procedure. The aim of this study is to present the current state of knowledge and recent advances, providing novel insights into the treatment of chronic kidney disease.
Collapse
Affiliation(s)
- Bartłomiej Dąbek
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Jill Dybiec
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Weronika Frąk
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Piotr Fularski
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Wiktoria Lisińska
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Ewa Radzioch
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Ewelina Młynarska
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Jacek Rysz
- Department of Nephrology, Hypertension and Family Medicine, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| | - Beata Franczyk
- Department of Nephrocardiology, Medical University of Lodz, ul. Zeromskiego 113, 90-549 Lodz, Poland
| |
Collapse
|
|
22
|
Okazaki M, Obi Y, Shafi T, Rhee CM, Kovesdy CP, Kalantar-Zadeh K. Residual Kidney Function and Cause-Specific Mortality Among Incident Hemodialysis Patients. Kidney Int Rep 2023; 8:1989-2000. [PMID: 37849997 PMCID: PMC10577493 DOI: 10.1016/j.ekir.2023.07.020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2023] [Revised: 07/16/2023] [Accepted: 07/24/2023] [Indexed: 10/19/2023] Open
Abstract
Introduction The survival benefit of residual kidney function (RKF) in patients on hemodialysis is presumably due to enhanced fluid management and solute clearance. However, data are lacking on the association of renal urea clearance (CLurea) with specific causes of death. Methods We conducted a longitudinal cohort study of 39,623 adults initiating thrice-weekly in-center hemodialysis from 2007 to 2011 and had data on renal CLurea and urine volume. Multivariable cause-specific proportional hazards model was used to examine the associations between baseline RKF and cause-specific mortality, including sudden cardiac death (SCD), non-SCD cardiovascular death (CVD), and non-CVD. Restricted cubic splines were fitted for change in RKF over 6 months after initiating hemodialysis. Results Among 39,623 patients with data on baseline renal CLurea and urine volume, there was a significant trend toward a higher mortality risk across lower RKF levels, irrespective of cause of death in a case-mix adjustment model (Ptrend < 0.05). Adjustment for ultrafiltration rate (UFR) slightly attenuated the association between low renal CLurea and high cause-specific mortality, whereas adjustment for highest potassium did not have substantial effect. Among 12,169 patients with data on change in RKF, a 6-month decline in renal CLurea showed graded associations with SCD, non-SCD CVD, and non-CVD risk, whereas the graded associations between faster 6-month decline in urine output and higher death risk were clear only for SCD and non-CVD. Conclusion Lower RKF and loss of RKF were associated with higher cause-specific mortality among patients initiating thrice-weekly in-center hemodialysis.
Collapse
Affiliation(s)
- Masaki Okazaki
- Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology, Hypertension and Kidney Transplantation, University of California Irvine School of Medicine, Orange, California, USA
- Department of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Yoshitsugu Obi
- Division of Nephrology, University of Mississippi Medical Center, Jackson, Mississippi, USA
| | - Tariq Shafi
- Division of Nephrology, Houston Methodist Hospital, Houston, Texas, USA
| | - Connie M. Rhee
- Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology, Hypertension and Kidney Transplantation, University of California Irvine School of Medicine, Orange, California, USA
- Division of Nephrology, Hypertension, and Kidney Transplantation, University of California Irvine Medical Center, Orange, California, USA
| | - Csaba P. Kovesdy
- Division of Nephrology, University of Tennessee Health Science Center, Memphis, Tennessee, USA
- Nephrology Section, Memphis Veterans Affairs Medical Center, Memphis, Tennessee, USA
| | - Kamyar Kalantar-Zadeh
- Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology, Hypertension and Kidney Transplantation, University of California Irvine School of Medicine, Orange, California, USA
- Los Angeles County Harbor-UCLA Medical Center, and The Lundquist Institute, Torrance, California, USA
- Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, California, USA
- Nephrology Section, Tibor Rubin Veterans Affairs Medical Center, Long Beach, California, USA
| |
Collapse
|
|
23
|
Chiu M, Silver SA, Berall L, Ethier I, Harris C, More K, Nadeau-Fredette AC, Tennankore K, Hingwala J. Variability in Reporting eGFR at Dialysis Initiation in Canada: A Research Letter. Can J Kidney Health Dis 2023; 10:20543581231203065. [PMID: 37786814 PMCID: PMC10541730 DOI: 10.1177/20543581231203065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2023] [Accepted: 07/16/2023] [Indexed: 10/04/2023] Open
Abstract
Background Estimated glomerular filtration rate (eGFR) at dialysis initiation is increasingly recognized as a key quality indicator (QI) for patients with end-stage kidney disease (ESKD). Specifically, guidelines recommend assessing deferral of dialysis initiation until symptoms arise or if the eGFR is ≤6 mL/min/1.73 m2. Despite the recognition of the importance of this QI, how eGFR at the time of dialysis initiation is defined, collected, and tracked at dialysis centers across Canada remains unknown. Objectives To identify how provincial renal programs define eGFR at dialysis initiation, to compare practice across Canadian provinces, and to determine if there is a consistent benchmark for deferred dialysis start. Design Cross-sectional survey distributed to the medical leads of each provincial renal program, administered from July 2021 to November 2021. Quebec was not included given it did not yet participate in Canadian Organ Replacement Register (CORR) data submission. Setting The survey was designed and distributed by the Canadian Society of Nephrology Quality Improvement & Implementation Science Committee (CSN-QUIS) Indicator Working Group. Methods The survey asked respondents on how eGFR is defined, collected, reported, and perceived barriers to QI data collection. The National Senior Renal Leaders Forum helped identify the key provincial medical leads to disseminate the survey for completion. Results Surveys were distributed to the medical leads of the 9 provincial renal programs that participate in CORR. In total, there were 8 responses. Five provinces submit eGFR for all new dialysis starts and 3 provinces only submit this information for chronic patients. There is variation in determining when a patient with acute kidney injury requiring dialysis is classified as a chronic patient. Four provinces use a 30-day trigger, 3 provinces use a 90-day trigger, and the patient's nephrologist makes this determination in 1 province. The creatinine used for the eGFR at dialysis initiation was the value measured on the first dialysis session (ie, day 0) for 5 provinces; the last outpatient clinic creatinine value in 2 provinces, and 1 province did not have a standard definition. Three provinces did not have a benchmark target for eGFR at dialysis initiation, 1 province had a target of <9.5 mL/min/1.73 m2, 3 provinces had a target of <10 mL/min/1.73 m2, 1 province had a target of <15 mL/min/1.73 m2. All 8 responding provincial medical leads support the establishment of a national benchmark for this measure. Limitations This survey was restricted to provincial medical leads and therefore is unable to determine practice at individual dialysis sites. The survey was not anonymous, so it may be subject to conformity bias. Conclusions There is wide variability in how eGFR at dialysis initiation is measured and reported across Canada. Additionally, there is no consensus on a benchmark target for an intent-to-defer dialysis strategy. Standardization of target eGFR at dialysis initiation may facilitate national reporting and quality improvement initiatives.
Collapse
Affiliation(s)
- Michael Chiu
- Division of Nephrology, Department of Medicine, London Health Sciences Centre, Western University, London, ON, Canada
| | - Samuel A. Silver
- Division of Nephrology, Kingston Health Sciences Center, Queen’s University, Kingston, ON, Canada
| | - Laura Berall
- Division of Nephrology, Department of Medicine, Humber River Hospital, Queen’s University, Toronto, ON, Canada
| | - Isabelle Ethier
- Division of Nephrology, Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada
- Health Innovation and Evaluation Hub, Centre de recherche du Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada
| | - Claire Harris
- Division of Nephrology, Department of Medicine, Vancouver General Hospital, The University of British Columbia, Vancouver, BC, Canada
| | - Keigan More
- Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS, Canada
| | - Annie-Claire Nadeau-Fredette
- Division of Nephrology, Department of Medicine, Hôpital Maisonneuve-Rosemont, Université de Montréal, Montreal, QC, Canada
| | - Karthik Tennankore
- Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS, Canada
| | - Jay Hingwala
- Division of Nephrology, Winnipeg Health Sciences Centre, University of Manitoba, Winnipeg, MB, Canada
| |
Collapse
|
|
24
|
Hansford HJ, Cashin AG, Jones MD, Swanson SA, Islam N, Douglas SRG, Rizzo RRN, Devonshire JJ, Williams SA, Dahabreh IJ, Dickerman BA, Egger M, Garcia-Albeniz X, Golub RM, Lodi S, Moreno-Betancur M, Pearson SA, Schneeweiss S, Sterne JAC, Sharp MK, Stuart EA, Hernán MA, Lee H, McAuley JH. Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review. JAMA Netw Open 2023; 6:e2336023. [PMID: 37755828 PMCID: PMC10534275 DOI: 10.1001/jamanetworkopen.2023.36023] [Citation(s) in RCA: 20] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2023] [Accepted: 08/22/2023] [Indexed: 09/28/2023] Open
Abstract
Importance Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice. Objective To assess the reporting of observational studies that explicitly aimed to emulate a target trial. Evidence Review We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation. Findings A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation. Conclusion and Relevance In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.
Collapse
Affiliation(s)
- Harrison J. Hansford
- School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - Aidan G. Cashin
- School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - Matthew D. Jones
- School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - Sonja A. Swanson
- Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania
- CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
| | - Nazrul Islam
- Oxford Population Health, Big Data Institute, University of Oxford, Oxford, United Kingdom
- Faculty of Medicine, University of Southampton, Southampton, United Kingdom
| | - Susan R. G. Douglas
- School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia
| | - Rodrigo R. N. Rizzo
- School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - Jack J. Devonshire
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - Sam A. Williams
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - Issa J. Dahabreh
- CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
| | - Barbra A. Dickerman
- CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
| | - Matthias Egger
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
- Centre for Infectious Disease Epidemiology and Research, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom
| | - Xabier Garcia-Albeniz
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- RTI Health Solutions, Barcelona, Spain
| | - Robert M. Golub
- Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois
| | - Sara Lodi
- CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts
| | - Margarita Moreno-Betancur
- Clinical Epidemiology & Biostatistics Unit, Murdoch Children’s Research Institute, Royal Children’s Hospital, Parkville, Victoria, Australia
- Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia
| | - Sallie-Anne Pearson
- School of Population Health, Faculty of Medicine and Health, UNSW Sydney, New South Wales, Australia
| | - Sebastian Schneeweiss
- Division of Pharmacoepidemiology, Department of Medicine, Brigham & Women’s Hospital, Harvard Medical School, Boston, Massachusetts
| | - Jonathan A. C. Sterne
- Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom
- NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom
- Health Data Research UK South-West, Bristol, United Kingdom
| | - Melissa K. Sharp
- Department of Public Health and Epidemiology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Elizabeth A. Stuart
- Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
| | - Miguel A. Hernán
- CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
| | - Hopin Lee
- University of Exeter Medical School, Exeter, United Kingdom
| | - James H. McAuley
- School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| |
Collapse
|
|
25
|
Fu EL. Target Trial Emulation to Improve Causal Inference from Observational Data: What, Why, and How? J Am Soc Nephrol 2023; 34:1305-1314. [PMID: 37131279 PMCID: PMC10400102 DOI: 10.1681/asn.0000000000000152] [Citation(s) in RCA: 43] [Impact Index Per Article: 21.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2022] [Accepted: 04/17/2023] [Indexed: 05/04/2023] Open
Abstract
ABSTRACT Target trial emulation has drastically improved the quality of observational studies investigating the effects of interventions. Its ability to prevent avoidable biases that have plagued many observational analyses has contributed to its recent popularity. This review explains what target trial emulation is, why it should be the standard approach for causal observational studies that investigate interventions, and how to do a target trial emulation analysis. We discuss the merits of target trial emulation compared with often used, but biased analyses, as well as potential caveats, and provide clinicians and researchers with the tools to better interpret results from observational studies investigating the effects of interventions.
Collapse
Affiliation(s)
- Edouard L Fu
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| |
Collapse
|
|
26
|
Fu EL, Levey AS, Coresh J, Elinder CG, Rotmans JI, Dekker FW, Paik JM, Barany P, Grams ME, Inker LA, Carrero JJ. Accuracy of GFR Estimating Equations in Patients with Discordances between Creatinine and Cystatin C-Based Estimations. J Am Soc Nephrol 2023; 34:1241-1251. [PMID: 36995139 PMCID: PMC10356168 DOI: 10.1681/asn.0000000000000128] [Citation(s) in RCA: 47] [Impact Index Per Article: 23.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2022] [Accepted: 03/13/2023] [Indexed: 03/31/2023] Open
Abstract
SIGNIFICANCE STATEMENT Large discordances between eGFR on the basis of creatinine (eGFR cr ) or cystatin C (eGFR cys ) are common in clinical practice. However, which GFR estimating equation (eGFR cr , eGFR cys , or eGFR cr-cys ) is most accurate in these settings is not known. In this real-world study of 9404 concurrent measurements of creatinine, cystatin C, and iohexol clearance, all three equations performed similarly when eGFR cr and eGFR cys were similar (45% of cases). However, with large discordances (55% of cases), eGFR cr-cys was much more accurate than either alone. These findings were consistent among individuals with cardiovascular disease, heart failure, diabetes mellitus, liver disease, and cancer who have been underrepresented in research cohorts. Thus, when eGFR cr and eGFR cys are largely discordant in clinical practice, eGFR cr-cys is more accurate than eGFR cr or eGFR cys . BACKGROUND Cystatin C is recommended as a confirmatory test to eGFR when more precise estimates are needed for clinical decision making. Although eGFR on the basis of both creatinine and cystatin (eGFR cr-cys ) is the most accurate estimate in research studies, it is uncertain whether this is true in real-world settings, particularly when there are large discordances between eGFR based on creatinine (eGFR cr ) and that based on cystatin C (eGFR cys ). METHODS We included 6185 adults referred for measured GFR (mGFR) using plasma clearance of iohexol in Stockholm, Sweden, who had 9404 concurrent measurements of creatinine, cystatin C, and iohexol clearance. The performance of eGFR cr , eGFR cys , and eGFR cr-cys was assessed against mGFR with median bias, P30 , and correct classification of GFR categories. We stratified analyses within three categories: eGFR cys at least 20% lower than eGFR cr (eGFR cys eGFR cr ). RESULTS eGFR cr and eGFR cys were similar in 4226 (45%) samples, and among these samples all three estimating equations performed similarly. By contrast, eGFR cr-cys was much more accurate in cases of discordance. For example, when eGFR cys eGFR cr (8% of samples), the median biases were -4.5, 8.4, and 1.4 ml/min per 1.73m 2 . The findings were consistent among individuals with cardiovascular disease, heart failure, diabetes mellitus, liver disease, and cancer. CONCLUSIONS When eGFR cr and eGFR cys are highly discordant in clinical practice, eGFR cr-cys is more accurate than either eGFR cr or eGFR cys .
Collapse
Affiliation(s)
- Edouard L. Fu
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Andrew S. Levey
- Division of Nephrology, Department of Internal Medicine, Tufts Medical Center, Boston, Massachusetts
| | - Josef Coresh
- Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland
| | - Carl-Gustaf Elinder
- Division of Renal Medicine, Department of Clinical Intervention and Technology, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden
| | - Joris I. Rotmans
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
| | - Friedo W. Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Julie M. Paik
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts
| | - Peter Barany
- Division of Renal Medicine, Department of Clinical Intervention and Technology, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden
| | - Morgan E. Grams
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
| | - Lesley A. Inker
- Division of Nephrology, Department of Internal Medicine, Tufts Medical Center, Boston, Massachusetts
| | - Juan-Jesus Carrero
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
| |
Collapse
|
|
27
|
Pizzarelli F, Basile C, Aucella F, Dattolo PC. Chronic kidney disease in the elderly and frail patient: perspectives with opinions and comments. J Nephrol 2023:10.1007/s40620-023-01676-y. [PMID: 37303023 DOI: 10.1007/s40620-023-01676-y] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2023] [Accepted: 05/08/2023] [Indexed: 06/13/2023]
Abstract
Chronic kidney disease is common in elderly and frail people. The importance of age in staging chronic kidney disease is discussed as well as the possible constraints of staging what is actually a 'continuum' of disease progression. Frailty is a biological state characterized by the decline of several physiological systems and strongly correlated with adverse health outcomes, including mortality. Frailty is measured by the Comprehensive Geriatric Assessment, which focuses on quantitative rating scales that determine not only the clinical profile and pathological risk of frail individuals, but also their residual capacities, functional status, and quality of life. There is circumstantial evidence that Comprehensive Geriatric Assessment can improve both survival and quality of life in elderly chronic kidney disease patients. Despite the long list of emerging risk factors and markers of chronic kidney disease progression, it is the authors' opinion that a single biochemical parameter can hardly cover the complexity of chronic kidney disease in elderly and frail patients. Among the numerous clinical scores proposed, the European Renal Best Practice guidelines recommend the Renal Epidemiology and Information Network score and the Kidney Failure Risk Equations. The former provides a reasonable estimate of short-term mortality risk, the latter provides the risk of chronic kidney disease progression. In conclusion, the elderly individual with advanced chronic kidney disease is often comorbid and frail with peculiarities in terms of disease grading, clinical assessment and monitoring. The time has come to reshape the care of this growing number of patients by focusing on multidisciplinary teams both in the hospital and in the community.
Collapse
Affiliation(s)
| | - Carlo Basile
- Associazione Nefrologica Gabriella Sebastio, Martina Franca, Italy.
| | - Filippo Aucella
- Nephrology and Dialysis Unit, "Casa Sollievo Della Sofferenza" Foundation, Scientific Institut for Reserch and Health Care, San Giovanni Rotondo, FG, Italy
| | | |
Collapse
|
|
28
|
Moranne O, Hamroun A, Couchoud C. What does the French REIN registry tell us about Stage 4-5 CKD care in older adults? FRONTIERS IN NEPHROLOGY 2023; 2:1026874. [PMID: 37675001 PMCID: PMC10479600 DOI: 10.3389/fneph.2022.1026874] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/24/2022] [Accepted: 12/02/2022] [Indexed: 09/08/2023]
Abstract
The aim of this paper is to illustrate all the clinical epidemiology searches made within the French network REIN to improve CKD stage 4-5 care in older adults. We summarize various studies describing clinical practice, care organization, prognosis and health economics evaluation in order to develop personalized care plans and decision-making tools. In France, for 20 years now, various databases have been mobilized including the national REIN registry which includes all patients receiving dialysis or transplantation. REIN data are indirectly linked to the French administrative healthcare database. They are also pooled with data from the PSPA cohort, a multicenter prospective cohort study of patients aged 75 or over with advanced CKD, monitored for 5 years, and the CKD-REIN clinical-based prospective cohort which included 3033 patients with CKD stage 3-4 from 2013 to 2016. During our various research work, we identified heterogeneous trajectories specific to this growing older population, raising ethical, organizational and economic issues. Renal registries will help clinicians, health providers and policy-makers if suitable decision- making tools are developed and validated.
Collapse
Affiliation(s)
- Olivier Moranne
- Service Néphrologie-Dialyse-Aphérèse, Hôpital Universitaire de Nîmes, Hôpital Carémeau, Nîmes, France
- UMR Inserm-UM, Institut Desbrest d'Epidemiologie et Santé publique (IDESP), Montpellier, France
| | - Aghilès Hamroun
- Service de Santé Publique, Service de Néphrologie-Dialyse-Transplantation rénale-Aphérèse, Hôpital Universitaire de Lille, Hôpital Huriez, Lille, France
| | - Cécile Couchoud
- French REIN registry, Agence de la biomédecine, La Plaine Saint-Denis, France
| |
Collapse
|
|
29
|
Hijikata Y, Ueda S, Yasuhara T, Umebayashi D, Endo T, Takami T, Mizuno M, Hida K, Hoshimaru M. Description of the Diversity in Surgical Indication and Surgical Strategies for Primary Spinal Cord Tumors: A Nationwide Survey by the Neurospinal Society of Japan. Neurospine 2022; 19:1122-1129. [PMID: 36597646 PMCID: PMC9816577 DOI: 10.14245/ns.2244686.343] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2022] [Accepted: 11/14/2022] [Indexed: 12/27/2022] Open
Abstract
OBJECTIVE To assess the current management of primary spinal cord tumors (PSCTs) and determine whether and to what extent there are differences in surgical strategies for PSCTs. METHODS The Neurospinal Society of Japan conducted a survey between April 1 and 30, 2021. Certified spine surgeons were requested for information on the frequency of surgeries in 2020 and the surgical strategies adopted for each PSCTs. The following tumor histologies were focused: schwannoma, meningioma, and cauda equina tumor as extramedullary tumors; and ependymoma, hemangioblastoma, astrocytoma, and cavernoma as intramedullary tumors. The participants were divided according to their response as follows: experts, who had experienced ≥ 100 surgeries for PSCTs, and nonexperts. RESULTS Among 308 participants (63%), 35 (11%) were experts. The total number of PSCTs in 2020 was 802 of which 564 tumors were extramedullary and 223 were intramedullary. Schwannoma accounted for 53% of the extramedullary tumors, and ependymoma accounted for 39% of the intramedullary tumors. Surgical strategies significantly differed among both the experts and nonexperts groups. Some discrepancies in the adopted surgical strategies were observed between groups. Some of the nonexperts, and none of the experts, ruled out surgery for schwannomas (Eden type 4), astrocytomas, or cavernomas. Five nonexperts (2.2%), and none of the experts, resected the entire dura for meningiomas. CONCLUSION A nationwide survey revealed that a sufficient consensus did not exist regarding surgical strategies for PSCTs. A disease-specific registry for PSCTs is necessary in academic societies.
Collapse
Affiliation(s)
- Yasukazu Hijikata
- Spine and Low Back Pain Center, Kitasuma Hospital, Kobe, Japan,Section of Clinical Epidemiology, Department of Community Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan,Corresponding Author Yasukazu Hijikata Spine and Low Back Pain Center, Kitasuma Hospital, 1-1, 1 Cho-me, Higashishirakawadai, Sma-ku, Kobe 654-0102, Japan
| | - Shigeo Ueda
- Shin-Aikai Spine Center, Katano Hospital, Katano, Japan
| | - Takao Yasuhara
- Department of Neurological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Daisuke Umebayashi
- Department of Neurosurgery, Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Toshiki Endo
- Department of Neurosurgery, Tohoku Medical and Pharmaceutical University, Sendai, Japan
| | - Toshihiro Takami
- Department of Neurosurgery, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Masaki Mizuno
- Department of Minimum-Invasive Neurospinal Surgery, Mie University Graduate School of Medicine, Tsu, Japan
| | - Kazutoshi Hida
- Department of Neurosurgery, Sapporo Azabu Neurosurgical Hospital, Sapporo, Japan
| | | |
Collapse
|
|
30
|
Morzywołek P, Steen J, Vansteelandt S, Decruyenaere J, Sterckx S, Van Biesen W. Timing of dialysis in acute kidney injury using routinely collected data and dynamic treatment regimes. Crit Care 2022; 26:365. [DOI: 10.1186/s13054-022-04252-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2022] [Accepted: 11/22/2022] [Indexed: 11/30/2022] Open
Abstract
Abstract
Background and objectives
Defining the optimal moment to start renal replacement therapy (RRT) in acute kidney injury (AKI) remains challenging. Multiple randomized controlled trials (RCTs) addressed this question whilst using absolute criteria such as pH or serum potassium. However, there is a need for identification of the most optimal cut-offs of these criteria. We conducted a causal analysis on routinely collected data (RCD) to compare the impact of different pre-specified dynamic treatment regimes (DTRs) for RRT initiation based on time-updated levels of potassium, pH, and urinary output on 30-day ICU mortality.
Design, setting, participants, and measurements
Patients in the ICU of Ghent University Hospital were included at the time they met KDIGO-AKI-stage ≥ 2. We applied inverse-probability-of-censoring-weighted Aalen–Johansen estimators to evaluate 30-day survival under 81 DTRs prescribing RRT initiation under different thresholds of potassium, pH, or persisting oliguria.
Results
Out of 13,403 eligible patients (60.8 ± 16.8 years, SOFA 7.0 ± 4.1), 5622 (63.4 ± 15.3 years, SOFA 8.2 ± 4.2) met KDIGO-AKI-stage ≥ 2. The DTR that delayed RRT until potassium ≥ 7 mmol/l, persisting oliguria for 24–36 h, and/or pH < 7.0 (non-oliguric) or < 7.2 (oliguric) despite maximal conservative treatment resulted in a reduced 30-day ICU mortality (from 12.7% [95% CI 11.9–13.6%] under current standard of care to 10.5% [95% CI 9.5–11.7%]; risk difference 2.2% [95% CI 1.3–3.8%]) with no increase in patients starting RRT (from 471 [95% CI 430–511] to 475 [95% CI 342–572]). The fivefold cross-validation benchmark for the optimal DTR resulted in 30-day ICU mortality of 10.7%.
Conclusions
Our causal analysis of RCD to compare RRT initiation at different thresholds of refractory low pH, high potassium, and persisting oliguria identified a DTR that resulted in a decrease in 30-day ICU mortality without increase in number of RRTs. Our results suggest that the current criteria to start RRT as implemented in most RCTs may be suboptimal. However, as our analysis is hypothesis generating, this optimal DTR should ideally be validated in a multicentric RCT.
Collapse
|
|
31
|
Fu EL, Coresh J, Grams ME, Clase CM, Elinder CG, Paik J, Ramspek CL, Inker LA, Levey AS, Dekker FW, Carrero JJ. Removing race from the CKD-EPI equation and its impact on prognosis in a predominantly White European population. Nephrol Dial Transplant 2022; 38:119-128. [PMID: 35689668 PMCID: PMC9869854 DOI: 10.1093/ndt/gfac197] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2022] [Indexed: 01/26/2023] Open
Abstract
BACKGROUND While American nephrology societies recommend using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate (eGFR) equation without a Black race coefficient, it is unknown how this would impact disease distribution, prognosis and kidney failure risk prediction in predominantly White non-US populations. METHODS We studied 1.6 million Stockholm adults with serum/plasma creatinine measurements between 2007 and 2019. We calculated changes in eGFR and reclassification across KDIGO GFR categories when changing from the 2009 to 2021 CKD-EPI equation; estimated associations between eGFR and the clinical outcomes kidney failure with replacement therapy (KFRT), (cardiovascular) mortality and major adverse cardiovascular events using Cox regression; and investigated prognostic accuracy (discrimination and calibration) of both equations within the Kidney Failure Risk Equation. RESULTS Compared with the 2009 equation, the 2021 equation yielded a higher eGFR by a median [interquartile range (IQR)] of 3.9 (2.9-4.8) mL/min/1.73 m2, which was larger at older age and for men. Consequently, 9.9% of the total population and 36.2% of the population with CKD G3a-G5 was reclassified to a higher eGFR category. Reclassified individuals exhibited a lower risk of KFRT, but higher risks of all-cause/cardiovascular death and major adverse cardiovascular events, compared with non-reclassified participants of similar eGFR. eGFR by both equations strongly predicted study outcomes, with equal discrimination and calibration for the Kidney Failure Risk Equation. CONCLUSIONS Implementing the 2021 CKD-EPI equation in predominantly White European populations would raise eGFR by a modest amount (larger at older age and in men) and shift a major proportion of CKD patients to a higher eGFR category. eGFR by both equations strongly predicted outcomes.
Collapse
Affiliation(s)
| | - Josef Coresh
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
| | - Morgan E Grams
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,Division of Nephrology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
| | - Catherine M Clase
- Departments of Medicine and Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
| | - Carl-Gustaf Elinder
- Division of Renal Medicine, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
| | - Julie Paik
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
| | - Chava L Ramspek
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Lesley A Inker
- Division of Nephrology, Tufts Medical Center, Boston, MA, USA
| | - Andrew S Levey
- Division of Nephrology, Tufts Medical Center, Boston, MA, USA
| | - Friedo W Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Juan J Carrero
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
| |
Collapse
|
|
32
|
Nakano M, Ogata N. Is "Renalism" No Longer an Obstacle to Angiography and Intervention in Patients With Chronic Kidney Disease? Circ J 2022; 86:797-798. [PMID: 35354716 DOI: 10.1253/circj.cj-22-0141] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
|
|
33
|
Does delivering more dialysis improve clinical outcomes? What randomized controlled trials have shown. J Nephrol 2022; 35:1315-1327. [PMID: 35041196 DOI: 10.1007/s40620-022-01246-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2021] [Accepted: 01/01/2022] [Indexed: 10/19/2022]
Abstract
Some randomized controlled trials (RCTs) have sought to determine whether different dialysis techniques, dialysis doses and frequencies of treatment are able to improve clinical outcomes in end-stage kidney disease (ESKD). Virtually all of these RCTs were enacted on the premise that 'more' haemodialysis might improve clinical outcomes compared to 'conventional' haemodialysis. Aim of the present narrative review was to analyse these landmark RCTs by posing the following question: were their intervention strategies (i.e., earlier dialysis start, higher haemodialysis dose, intensive haemodialysis, increase in convective transport, starting haemodialysis with three sessions per week) able to improve clinical outcomes? The answer is no. There are at least two main reasons why many RCTs have failed to demonstrate the expected benefits thus far: (1) in general, RCTs included relatively small cohorts and short follow-ups, thus producing low event rates and limited statistical power; (2) the designs of these studies did not take into account that ESKD does not result from a single disease entity: it is a collection of different diseases and subtypes of kidney dysfunction. Patients with advanced kidney failure requiring dialysis treatment differ on a multitude of levels including residual kidney function, biochemical parameters (e.g., acid base balance, serum electrolytes, mineral and bone disorder), and volume overload. In conclusion, the different intervention strategies of the RCTs herein reviewed were not able to improve clinical outcomes of ESKD patients. Higher quality studies are needed to guide patients and clinicians in the decision-making process. Future RCTs should account for the heterogeneity of patients when considering inclusion/exclusion criteria and study design, and should a priori consider subgroup analyses to highlight specific subgroups that can benefit most from a particular intervention.
Collapse
|