The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline on the monitoring, management, and treatment of kidney transplant recipients is intended to assist the practitioner caring for adults and children after kidney transplantation. The guideline development process followed an evidence-based approach, and management recommendations are based on systematic reviews of relevant treatment trials. Critical appraisal of the quality of the evidence and the strength of recommendations followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The guideline makes recommendations for immunosuppression and graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy, and other complications that are common in kidney transplant recipients, including hematological and bone disorders. Limitations of the evidence, especially the lack of definitive clinical outcome trials, are discussed and suggestions are provided for future research. This summary includes a brief description of methodology and the complete guideline recommendations but does not include the rationale and references for each recommendation, which are published elsewhere.
Secondary Authors Vincent T. Armenti, MD, PhD, Professor of Surgery, Temple University School of Medicine, Abdominal Transplant Program, Philadelphia, Pennsylvania Phyllis August, MD, MPH, Professor of Medicine, Division of Hypertension, Weill Medical College of Cornell University, New York, New York Lisa A. Coscia, RN, BSN, CCTC, Research Coordinator, National Transplantation Pregnancy Registry, Temple University School of Medicine, Philadelphia, Pennsylvania Connie L. Davis, MD, Professor of Medicine, Div. of Nephrology, Univ. of Washington, Box 356174, 1959 NE Pacific St., Seattle, WA 98195 John M Davison MD, Professor of Obstetric Medicine, Consultant Obstetrician, University of Newcastle upon Tyne, School of Surgical and Reproductive Sciences, Faculty of Medical Sciences, William Leech Building, Newcastle upon Tyne NE2 4HH, UK Thomas Easterling, MD, Professor, Maternal Fetal Medicine, University of Washington, Box 356460, 1959 ND Pacific Street, Seattle, WA 98195 Jan M. Friedman, MD, PhD, Professor of Medical Genetics, Department of Medical Genetics, University of British Columbia, Vancouver, British Columbia, Canada V6T 1Z3 Susan Hou, MD, Professor of Medicine, Department of Medicine, Loyola University Medical Center, Maywood, IL Janet Karlix, Pharm, D, FCCP, Associate Professor, College of Pharmacy, University of Florida, Gainesville, FL Kathleen D, Lake, Pharm.D., BCPS, FCCP, Adjunct Professor, University of Michigan Medical School and College of Pharmacy, Ann Arbor, MI, Medical Transplant Liaison, Roche Laboratories, Nutley, NJ Marshall Lindheimer, MD, Professor Emeritus, Departments of Obstetrics & Gynecology, and Medicine,, University of Chicago, Chicago, Ill Arthur J. Matas, MD, Professor of Surgery, University of Minnesota, Department of Surgery, University of Minnesota Hospital, Minneapolis, MN Michael J. Moritz, MD, Professor of Surgery, Drexel University College of Medicine, Director, Abdominal Transplantation, Hahnemann University Hospital, Philadelphia, Pennsylvania Caroline A. Riely, MD, Professor, Medicine and Pediatrics, Chief of Hepatology Section, Gastroenterology Division, University of Tennessee Science Center Lainie Friedman Ross, MD, PhD, Associate Director, MacLean Center for Clinical Medical Ethics, Associate Professor, University of Chicago, Department of Pediatrics, Chicago, Illinois James R. Scott, MD, Professor and Chair Emeritus, Department of Obstetrics and Gynecology, University of Utah Medical Center, Salt Lake City, Utah Lynne E. Wagoner, MD, Director, Heart Failure and Transplantation, Associate Professor, Division of Cardiology, University of Cincinnati, Cincinnati, Ohio Lucile Wrenshall, MD, PhD, Associate Professor, Department of Surgery, Division of Transplantation, University of Nebraska Medical Center, Omaha, NE And the consensus committee organizers of the Women's Health Committee of the American Society of Transplantation: Patricia L. Adams, MD, Professor of Medicine, Associate Dean for Student Services, Wake Forest University School of Medicine, Med Center Blvd, Win...
Leflunomide inhibits Polyoma virus replication in vitro and closely monitored leflunomide therapy with specifically targeted blood levels appears to be a safe and effective treatment for Polyoma BK nephropathy.
Evidence-informed decision-making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient-centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis. Key stakeholders including eight patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations; flexibility to consider evolving priorities over time; deconstruction of language and meaning for conceptual consistency and clarity; understanding of potential overlap and associations between outcomes; and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive and validated outcome measures that could be used in clinical care (quality ndicators) and trials (including pragmatic trials), and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment, and improved patient outcomes.
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