Clinical Practice Guideline on Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis

Abstract

Executive Summary The Renal Physicians Association (RPA) and the American Society of Nephrology (ASN) in conjunction with representatives from multiple disciplines and organizations in the dialysis community, kidney patients and family members, and internal medicine physicians as well as a bioethicist and a public policy expert comprised a working group that completed the Clinical Practice Guideline on Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis late last year. The guideline presents recommendations concerning withholding or withdrawing dialysis in adult patients with either acute renal failure (ARF) or end-stage renal disease (ESRD). These recommendations are based on the expert consensus opinion of the RPA/ASN Working Group. The members of the working group included: Alvin H. Moss, M.D., chair William F. Owen, Jr., M.D., vice chair Richard Albert, M.D. Eileen Brewer, M.D. Helen Danko, M.S., R.N. John H. Galla, M.D. Roman M. Hendrickson, M.D. Albert R. Jonsen, Ph.D. Judith Kari, M.S.W. Bertram Kasiske, M.D. Karren King, M.S.W. Jenny Kitsen John M. Newmann, Ph.D., M.P.H. Christy A. Price, R.N., M.S.N. Richard Rettig, Ph.D. Dale Singer, M.H.A. Group members developed a priori analytic frameworks for decisions to withhold or withdraw dialysis in patients with ARF and ESRD. Systematic literature reviews were conducted to address pre-specified questions derived from the frameworks. In most instances, the relevant evidence that was identified was contextual in nature and only provided indirect support to the recommendations. The research evidence, case and statutory law, and ethical principles were used by the Working Group in the formulation of their recommendations. The recommendations are not mandatory, but rather flexible guidelines that may be tailored to a particular patient, provider, and geographic circumstance. They allow the renal care team to use discretion as they are applied to individual patients. They are intended for use by providers and patients (and their families or advisors) in the United States and its trust territories to aid in dialysis decision-making. They are not intended for use by regulatory agencies for reimbursement or other decisions. The working group proposed and prioritized key questions related to the models using a combined nominal and modified Delphi process. Questions specified information that was either desirable or necessary to make informed and ethical decisions about withholding or withdrawing dialysis. Such questions were categorized as directly informative to the evidence model or as background and contextual in nature. These key questions guided analysis of the evidence. Standard forms were used to abstract data from each study. Such data included information about study purposes and designs, participant descriptors, methodologic characteristics, outcome measures, and results. Peer review of the guideline was obtained after development of the evidence model and selection of relevant literature to identify any major oversights in formulation of the evidence model and any seminal research evidence that was missed in the literature search. A second level of peer review was conducted when the draft guideline document and recommendations were completed. Peer reviewers were nominated by stakeholder organizations and other volunteers from the nephrology community. The final guideline was submitted to multiple organizations to request their endorsement. At press time the following organizations had endorsed the guideline recommendations: Renal Physicians Association, American Society of Nephrology, American Society of Pediatric Nephrology, American Nephrology Nurses Association, National Kidney Foundation, American Association of Kidney Patients, National Renal Administrators Association, and Forum of End-Stage Renal Disease Networks. The guideline includes nine recommendations that are listed below. The recommendations are supported by 15 prognostic tables and 302 references. Recommendations 1. Shared Decision-Making. A patient-physician relationship that promotes shared decision-making is recommended for all patients with either ARF or ESRD. Shared decision-making should involve at a minimum the patient and the physician. If a patient lacks decision-making capacity, decisions should involve the patient's legal agent. With the patient's consent, shared decision-making may include family members or friends and other members of the renal care team. 2. Informed Consent or Refusal. Physicians should fully explain diagnosis, prognosis, and all treatment options to each patient. The explanation of treatment options should include: (1) available dialysis modalities; (2) not starting dialysis and continuing conservative management which should include end-of-life care; (3) a time-limited trial of dialysis; and (4) stopping dialysis and receiving end-of-life care. Choices among options should be made by patients or, if patients lack decision-