Comprehensive Critical Care: Adult Second Edition Pamela R Roberts, MD, FCCM, FCCP Editor S Rob Todd, MD, FACS, FCCM, Editor Copyright 2017 Society of Critical Care Medicine, exclusive of any U.S Government material All rights reserved No part of this book may be reproduced in any manner or media, including but not limited to print or electronic format, without prior written permission of the copyright holder The views expressed herein are those of the authors and do not necessarily reflect the views of the Society of Critical Care Medicine Use of trade names or names of commercial sources is for information only and does not imply endorsement by the Society of Critical Care Medicine This publication is intended to provide accurate information regarding the subject matter addressed herein However, it is published with the understanding that the Society of Critical Care Medicine is not engaged in the rendering of medical, legal, financial, accounting, or other professional service and THE SOCIETY OF CRITICAL CARE MEDICINE HEREBY DISCLAIMS ANY AND ALL LIABILITY TO ALL THIRD PARTIES ARISING OUT OF OR RELATED TO THE CONTENT OF THIS PUBLICATION The information in this publication is subject to change at any time without notice and should not be relied upon as a substitute for professional advice from an experienced, competent practitioner in the relevant field NEITHER THE SOCIETY OF CRITICAL CARE MEDICINE, NOR THE AUTHORS OF THE PUBLICATION, MAKE ANY GUARANTEES OR WARRANTIES CONCERNING THE INFORMATION CONTAINED HEREIN AND NO PERSON OR ENTITY IS ENTITLED TO RELY ON ANY STATEMENTS OR INFORMATION CONTAINED HEREIN If expert assistance is required, please seek the services of an experienced, competent professional in the relevant field Accurate indications, adverse reactions, and dosage schedules for drugs may be provided in this text, but it is possible that they may change Readers must review current package indications and usage guidelines provided by the manufacturers of the agents mentioned Managing Editor: Kathy Ward Editorial Assistant: Danielle Stone Printed in the United States of America First Printing, May 2017 Society of Critical Care Medicine Headquarters 500 Midway Drive Mount Prospect, IL 60056 USA Phone 1+ 847 827-6869 Fax 1+ 847 827-6886 International Standard Book Number: 978-1-620750-62-9 Contributors Pamela R Roberts, MD, FCCM, FCCP, Editor Professor and Vice Chair Section Chief of Critical Care Medicine Director of Research John A Moffitt Endowed Chair Department of Anesthesiology The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma American Society of Anesthesiologists, committee member; ASPEN, committee member S Rob Todd, MD, FACS, FCCM, Editor Professor of Surgery Chief, Acute Care Surgery Baylor College of Medicine Chief, General Surgery and Trauma Ben Taub Hospital Houston, Texas No disclosures Christine Cocanour, MD, FACS, FCCM, Section Editor Professor of Surgery Division of Trauma and Critical Care University of California Davis Medical Center Sacramento, California No disclosures Stephen O Heard, MD, Section Editor Professor University of Massachusetts Medical School University of Massachusetts Memorial Medical Center Worcester, Massachusetts No disclosures Judith Jacobi, BCPS, PharmD, MCCM, Section Editor Critical Care Pharmacist Indiana University Health Methodist Hospital Indianapolis, Indiana American College of Clinical Pharmacy past president Rosemary Kozar, MD, PhD, Section Editor Professor R Adams Cowley Shock Trauma Center University of Maryland Baltimore, Maryland American Association for the Surgery of Trauma, American College of Surgeons, National Trauma Institute Drew A MacGregor, MD, Section Editor Professor of Internal Medicine and Anesthesiology Program Director, Critical Care Medicine Fellowship Wake Forest University Health Science Winston-Salem, North Carolina No disclosures Frederick A Moore, MD, MCCM, Section Editor Head, Acute Care Surgery University of Florida Gainesville, Florida No disclosures Laura Moore, MD, Section Editor Chief of Surgical Critical Care University of Texas Health Science Center at Houston Houston, Texas No disclosures Mehmet Ozcan, MD, Section Editor The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma American Society of Anesthesiologists, Neuroanestheisa Committee Member; Society of Neurosciences in Anesthesiology and Critical Care, Scientific Committee Member Greta Piper, MD, Section Editor New York University Langone Medical Center New York, New York Eastern Association for Surgery of Trauma committee Janice L Zimmerman, MD, MCCM, FCCP, Section Editor Head, Division of Critical Care Houston Methodist Hospital Houston, Texas ACCP, ACP, WFSICCM, PAIF Adil M Abuzeid, MBBS Assistant Professor of Surgery Medical College of Georgia Section of Trauma/Surgical Critical Care Augusta University Medical Center Augusta, Georgia No disclosures Ravi Agarwala, MD, FRCPC Assistant Professor Department of Anesthesiology Section on Critical Care Wake Forest University School of Medicine Winston-Salem, North Carolina No disclosures Nestor Arita, MD Baylor College of Medicine Houston, Texas No disclosures Vinod P Balachandran, MD Resident, Department of Surgery New York Presbyterian Hospital Weill Cornell Medical College New York, New York Bristol Meyers Squibb, grant Robert A Balk, MD J Bailey Carter, MD Professor of Medicine Director, Division of Pulmonary and Critical Care Medicine Rush Medical College and Rush University Medical Center Chicago, Illinois No disclosures Debasree Banerjee, MD, MS Brown University Rhode Island Hospital Providence, Rhode Island CHEST, women’s health network member; CHEST Pulmonary Arterial Hypertension 2015 (Actelion), grant Michael L Bentley, PharmD, FCCM, FCCP, FNAP Virginia Tech Carilion School of Medicine Roanoke, Virginia Director, Global Health Science The Medical Affairs Company, Kennesaw, Georgia, representing The Global Health Science Center, The Medicines Company Parsippany, New Jersey American College of Clinical Pharmacy, committees; National Academies of Practice, committee M Camilla Bermudez, MD Associate Program Director Geisinger Medical Center Danville, Pennsylvania No disclosures Alisha Bhatia, MD Department of Anesthesiology Rush University Medical Center Chicago, Illinois No disclosures Natalie Bradford, MD Clinical Fellow in Electrophysiology Department of Medicine Section on Cardiology Wake Forest University School of Medicine Winston-Salem, North Carolina No disclosures Timothy G Buchman, MD, PhD, MCCM Founding Director, Emory Center for Critical Care Emory University Hospital Atlanta, Georgia No disclosures Ramon F Cestero, MD, FACS Associate Professor of Surgery Medical Director, Surgical Trauma ICU Program Director, Surgical Critical Care Fellowship Department of Surgery/Division of Trauma and Emergency Surgery The University of Texas Health Science Center San Antonio San Antonio, Texas No disclosures Anna Chen, MD Geisinger Medical Center Danville, Pennsylvania No disclosures Sherry H-Y Chou, MD, MMSc, FNCS Department of Critical Care Medicine University of Pittsburgh Medical Center Pittsburgh, Pennsylvania No disclosures Craig M Coopersmith, MD Associate Director, Emory Center for Critical Care Emory University School of Medicine Atlanta, Georgia No disclosures John Crommett, MD Associate Professor MD Anderson Cancer Care Center Houston, Texas No disclosures James M Cross, MD, FACS Professor of Surgery University of Texas Medical School at Houston Houston, Texas No disclosures Quinn A Czosnowski, PharmD Clinical Pharmacy Specialist, Critical Care Indiana University Health – Methodist Hospital Indianapolis, Indiana No disclosures Kimberly A Davis, MD, MBA Professor of Surgery Vice Chairman of Clinical Affairs Chief of the Section of General Surgery, Trauma, and Surgical Critical Care Yale School of Medicine Trauma Medical Director Surgical Director Quality and Performance Improvement Yale-New Haven Hospital New Haven, Connecticut AAST, EAST, ACS, ACS COT, CT Trauma Conference Inc, SCCPDS R Phillip Dellinger, MD, MCCM Chairman/Chief, Department of Medicine Senior Critical Care Attending Cooper University Hospital Camden, New Jersey No disclosures Gozde Demiralp, MD Assistant Professor Director, Critical Care Anesthesiology Fellowship Medical Director, Preoperative Anesthesia Unit Division of Critical Care Medicine Department of Anesthesiology University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma No disclosures Sylvia Y Dolinski, MD, FCCP Professor of Anesthesiology and Critical Care Department of Anesthesiology Medical College of Wisconsin Department of Anesthesiology Clement J Zablocki VA Medical Center Milwaukee, Wisconsin American Board of Anesthesiology, ASA, IARS, SOCCA Soumitra R Eachempati, MD, FACS, FCCM Professor, Department of Surgery Weill Medical Center of Cornell University New York, New York No disclosures Brian Erstad, PharmD, MCCM Professor and Head University of Arizona College of Pharmacy Tucson, Arizona American College of Clinical Pharmacy, Treasurer Etienne Gayat, MD, PhD Lariboisiere University Hospital Paris, France No disclosures Fredric Ginsberg, MD, FACC, FCCP Medical Director, Cooper Heart Institute Cooper University Hospital Associate Professor of Medicine Cooper Medical School of Rowan University Camden, New Jersey No disclosures Amanda M Gomes, MD University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma ASA, Blood Management Committee Marcos Emanuel Gomes, MD Assistant Professor of Anesthesiology and Critical Care Medicine Medical Director of the PACU Department of Anesthesiology The University of Oklahoma Sciences Center Oklahoma City, Oklahoma No disclosures Sara R Gregg, MHA Senior Center Administrator Emory Critical Care Center Atlanta, Georgia ACHE, member; HFMA, member Rebeca L Halfon, BS, PharmD Houston Methodist Hospital Houston, Texas No disclosures Jennifer E Hofer, MD University of Chicago Chicago, Illinois No disclosures David T Huang, MD, MPH University of Pittsburgh Pittsburgh, Pennsylvania La Jolla, consultant; ACEP, sepsis committee Christopher G Hughes, MD Associate Professor of Anesthesiology Vanderbilt University School of Medicine Nashville, Tennessee No disclosures Todd Huzar, MD Assistant Professor of Surgery University of Texas Health Science Center at Houston Houston, Texas No disclosures Nabil M Issa, MD Associate Professor of Surgery Northwestern University Feinberg School of Medicine Division of Trauma and Critical Care Northwestern Memorial Hospital Chicago, Illinois ACS, ASE, COT Heather J Johnson, PharmD University of Pittsburgh School of Pharmacy Pittsburgh, Pennsylvania American College of Clinical Pharmacy, member and speaker; American Society of Health System Pharmacy, speaker, own stock in Pfizer Christina C Kao, MD Baylor College of Medicine Houston, Texas No disclosures Lillian S Kao, MD, MS University of Texas Medical School at Houston University of Texas Health Center at Houston Houston, Texas No disclosures Shravan Kethireddy, MD Geisinger Health System Danville, Pennsylvania No disclosures Mark A Kleman, DO Nephrology Fellow Geisinger Health System Danville, Pennsylvania No disclosures Scott E Kopec, MD, FCCP Associate Professor of Medicine Division of Pulmonary, Allergy, and Critical Care Medicine University of Massachusetts Medical School Worcester, Massachusetts No disclosures Anand Kumar, MD Professor University of Manitoba South Winnipeg, Canada No disclosures Jennifer A LaRosa, MD, FCCM, FCCP Patient Safety and Quality Officer Rutgers University School of Medicine Berkeley Heights, New Jersey ACCP, writer and speaker Geoffrey S F Ling, MD, PhD, FAAN Wakefield AJ, Harvey P, Linnell J MMR—responding to retraction Lancet 2004;363:1327-1328 The International Early Lung Cancer Action Program Investigators Survival of patients with stage I lung cancer detected on CT screening N Engl J Med 2006;355:1763-1771 Henschke C Clarification of funding of early lung cancer study N Engl J Med 2008;358:1862 CHAPTER 51 Ethical Concerns in the Management of Critically Ill Patients Fred Rincon, MD, MSc, MBE, FACP, FCCP, FCCM Key words: autonomy, beneficence, nonmaleficence, justice Medical ethics entails the study of moral issues related to the practice of medicine Questions about the behaviors of healthcare providers, the decisionmaking process, and stakeholders’ values, rights, and responsibilities generate ethical reflection that requires a thorough understanding of philosophical concepts, religion, and the jurisdictional laws Most texts in medical ethics are written from Western perspectives, which are primarily based on Judeo-Christian philosophical traditions Japanese and Chinese medical ethics may have different emphases and priorities, so becoming acquainted with the jurisdictional cultural trends and laws is an important step toward becoming proficient at dealing with ethical issues in the ICU When the possibility of significant disability or even death arises, it is difficult to predict how fears of future outcome will ultimately alter the predefined preferences of an individual patient or his or her surrogate decision maker When issues relating to advance directives and the withholding and withdrawal of life-supportive therapy arise, clinical prognostic questions require specific answers, so clinicians should attempt to achieve the highest level of certainty regarding the diagnosis and prognosis with the patient’s wishes in mind PRINCIPLES OF ETHICS Autonomy Autonomy is defined as the ability to self-rule, self-determine, or self-govern Personal autonomy requires, at a minimum, self-rule that is free from coercion from others or from limitations such as inadequate understanding that prevent meaningful choice This principle supports the notion that rational individuals with decisional capacity (or competency in legal terms) are uniquely qualified to decide what is best for themselves This also means that people should be allowed to do whatever they want, even if doing so involves considerable risk or would be deemed foolish by others, provided that their decision does not infringe on the autonomy of another Courts have routinely upheld the right of competent persons to refuse lifesaving interventions such as blood transfusions because either medical therapies in general or specific therapies are prohibited by the patient’s religious or moral beliefs The universal right of respect for a patient’s autonomy is rooted in the rulings from the Nuremberg trials, known as the Nuremberg Code, which is the basis of modern statements of human rights such as the Declaration of Helsinki and the Belmont Report These landmark statements support and guide the basic requirements of voluntary informed consent and the individual’s right to refuse treatment or participation in research Additionally, a patient’s right to confidentiality is based on the principle of autonomy In general, people have no legal obligation to keep other people’s secrets, but in the practice of medicine, we have both a moral and a legal obligation to protect our patients’ confidential information Beneficence The principle of beneficence is inherent in the role of physicians and healthcare providers and determines our duty to prevent evil or harm by promoting good and enhancing the welfare of others In conjunction with autonomy, promoting the welfare of others is the foundation of the physician-patient relationship, as morality requires not only that we treat persons autonomously and refrain from doing harm but also that we contribute to their well-being Similarly, physicians and healthcare providers are required to balance benefits, risks, and costs to improve the welfare of people overall As such, the role of physicians and healthcare providers as promoters of well-being involves not only their patients but the community as a whole In certain circumstances, physicians may be morally and legally obliged to supersede the physician-patient relationship Some jurisdictions, for example, require that physicians report clinical situations that may be associated with risks to other citizens, such as reporting a newly diagnosed epilepsy case to a governmental office of motor vehicles Similarly, when physicians believe or fear that a patient may be dangerous to another person, a duty to prevent evil or harm may be invoked In the case of Tarasoff (Tarasoff v Regents of the University of California, 551 P2d 334 [1976]), the court recognized the duty of a physician to warn another person of a dangerous patient’s intent to harm that person even if this meant violating the patient-physician confidentiality agreement One’s perceptions and intentions—even if in the best interest— should not supersede the wishes or well-being of another competent human being Nonmaleficence The principle of nonmaleficence was introduced by Beauchamp and Childress This principle establishes the duty to refrain from inflicting harm on others and is sometimes defined by the maxim primum non nocere Obligations of nonmaleficence include not only duties not to inflict harm but also duties not to impose risk or harm In cases of risk imposition, both the law and morality recognize a standard of due care that determines whether the agent who is causally responsible for the risk is legally or morally responsible as well This standard is specific to the principle of nonmaleficence Understanding of what lack of due care implies is what defines negligence The line between due care and inadequate care is often difficult to draw Specific situations in the ICU that relate to the principle of nonmaleficence and lack of due care include withholding and withdrawal of life support, extraordinary (or heroic) treatments, sustenance of technologies and medical treatments, intended effects and merely foreseen effects (theory of double effect), and situations in which definitions of killing versus letting die may become nebulous Justice The principle of justice demands that one act to promote the greatest benefit to the greatest number of individuals while inflicting the least amount of harm This principle stipulates that similar cases be treated in a similar manner, that the benefits and burdens be shared equally within society, that goods be distributed according to need, that individuals be rewarded for contributions made, and that the degree of effort determine an individual’s reward WHAT IS ETHICAL? This is a difficult question, and every individual is ultimately responsible for making his or her own morally correct decisions and implementing them To this end, ethical dilemmas emerge because of a conflict between moral values, and their interpretation, among the agents involved in the decision-making process There are several “rational” ways of approaching ethical dilemmas that are characterized by a systematic and reflective use of reason in the decision-making process: principlism, deontology, consequentialism and utilitarianism, and virtue ethics TREATING PATIENTS IN THE ICU Consent for Treatment The concept of informed consent stems from a principle of personal autonomy This principle, well guarded by the US Constitution, allows for moral selfdetermination and is based on two important elements: voluntary choice and decisional capacity It represents the ultimate overt expression of individual human rights Technically, medical professionals can determine decision-making capacity but lack the legal authority to determine competence; however, their assessment of decision-making capacity serves not only as a guide for many legal determinations but also as the functional equivalent of such determinations in the absence of legal proceedings In the United States, the legal doctrine of informed consent incorporates a third element: the disclosure of information, without which voluntary choice and competence cannot be properly exercised However, excessive emphasis on the disclosure requirement may undermine the implementation of informed consent It is the physician’s finding of incapacity that causes alternative forms for obtaining consent to be sought and a patient’s legal rights to be temporarily suspended without the involvement of the court Frequently in the ICU, critical care specialists encounter situations where patients seem to lack decisionmaking capacity This is why, according to Bateman-White et al, “it is critical that physicians learn to apply the standards of assessment of decisional capacity that are used to arrive at a legal determination of competence” and facilitate the institution of medical therapies But how can we assess decision-making capacity in emergency situations, and particularly in critically ill patients? According to Akinsanya et al and Beauchamp and Childress, to determine whether a patient lacks capacity, a physician must establish that the subject is able to (a) understand the information relevant to the decision; (b) retain that information; (c) use or weigh that information in making the decision, including information about the reasonable and foreseeable consequences of deciding one way or another or failing to make the decision; and (d) communicate the decision (whether by talking, using sign language, or any other means) However, determining all of these points may be difficult in critically ill patients, because evidence shows that even in the absence of cognitive impairment, acute illness can impair the understanding of disease and especially the concepts of proportionality and risk Given this, it has been suggested that a procedure for capacity assessment be developed and standardized Such a procedure should include determining whether the patient understands concise points, such as the diagnosis; assessing the proposed treatment, including the risks and potential benefits of the treatment and its alternatives; and outcome statistics Decision Making in the ICU When a critically ill patient is deemed not to have capacity, the physician must seek an alternate pathway to determine how to obtain consent and proceed with medical interventions The options in these cases are to determine whether the patient has drafted an advance directive such as a living will or durable power of attorney (for healthcare) or, in the absence of an advance directive, to seek the substituted judgment of a proxy, family member, friend, or surrogate authorized by the state law Should the physician be unable to identify an alternative form of consent, the physician must choose to invoke a best interest standard In the case of an emergency, a justification for treatment using the doctrine of implied consent may be applied In nonemergency cases, an ethics or risk management consultation (with the hospital’s legal office) is advisable Physicians are always encouraged to request ethical and legal counseling when treating incapacitated patients who require medical care and are specifically unbefriended, meaning that they have no legally authorized surrogate, family member, or friend willing or able to speak on their behalf Decision Making and Competency These are terms that may be used interchangeably Technically, medical professionals can determine decision-making capacity but lack the legal authority to determine competence However, their assessment of decisionmaking capacity serves not only as a guide for many legal determinations but also as the functional equivalent of such determinations in the absence of legal proceedings Competency is defined as the ability to perform certain tasks and the ability to make a decision A competent individual must be able to perform well in the following capacities: (a) understand the information, (b) understand the current situation and its consequences, (c) rationally consider information in light of one individual’s values, and (d) make an informed decision It is the physician’s finding of incapacity that causes alternative forms of consent to be sought and a patient’s legal rights to be temporarily suspended without the involvement of the court Disclosure In the United States and its jurisdictions, the legal doctrine of informed consent incorporates a third element, the disclosure of information Without disclosure, voluntary choice and competence cannot be properly exercised In clinical practice and research, excessive emphasis on the disclosure requirement may undermine the implementation of informed consent A frequently expressed issue regarding the consenting process is that too much disclosure may produce anxiety in the patient and impose an undue influence to agree to a particular therapy or to participate in research This may be particularly true in critically ill patients whose decisions made under duress may be clouded with misinformation Nevertheless, the Declaration of Helsinki, the most widely recognized code of ethics related to human research, explains that subjects must receive information concerning the objectives, methods, benefits, and potential harms of the study at hand The main problem with the enforcement of disclosure in research is that although institutional review boards (IRBs) monitor the inclusion of relevant information pertaining to the study, there is no oversight of what investigators tell prospective research subjects Other potential conflicts of interest such as financial relationships between industry and investigators, or if financial incentives to enroll subjects and maintain them in the study have been provided may need to be scrutinized by the IRB Understanding Understanding refers to the patient’s ability to comprehend propositions related to the intervention or treatment being sought or to understand the implications of participation in research in the setting of his or her condition (objectives, risks, benefits, alternatives, and potential outcomes) Appropriate understanding depends on several factors, including level of intelligence, language skills, attention, orientation, recall, and memory When approaching patients to obtain consent for procedures or participation in research, healthcare professionals must determine each patient’s level of education to appropriately convey the necessary information Similarly, disclosure of information related to the proposed intervention in the form of statistics may be helpful Patients with appropriate understanding can discuss the differences between proposed interventions and alternatives Voluntariness The universal right of respect for a patient’s autonomy is rooted in the rulings from the proceedings of the Nuremberg trials of 1947 These are the basis of modern statements of human rights and serve as guidance to the basic requirements of voluntary informed consent and the individual’s right to refuse treatment or participate in research The informed consent process should be guided by the freedom to act voluntarily, without coercive forces or undue influence Several issues that arise regarding the delivery of care or consent for research may impede voluntariness in critically ill patients First, the natural setting of critical illness can lead to confusion, inability to evaluate concepts (eg, risk-benefit ratio), and delirium, which may impede the appropriate consent process for clinical care and research Second, the frightening setting of the ICU may impose coercive forces in subjects who need emergency treatments or who have terminal illnesses if patients believe they have little choice but to be treated or participate in the proposed research Third, the enthusiasm of the practitioner or investigator could lead to undue influences by manipulation of the information or incomplete disclosure Implied Consent When available sources for consent are lacking, a legal exception to the requirement of direct consent may be invoked in emergency situations in which consent of a reasonable person to an appropriate treatment can be assumed In a few life-threatening conditions, such as sepsis or myocardial infarction, patients can be involved in the consent process, and risks, benefits, and alternatives to the proposed intervention can be discussed However, physicians often use the principle of implied consent to perform lifesaving interventions in patients who lack decision-making capacity or surrogates The emergency doctrine of implied consent allows providers to deliver lifesaving interventions if the failure to perform such interventions in a timely way could potentially lead to increased morbidity and mortality If the following conditions are met, the physician can use the doctrine of implied consent: (a) the treatment in question represents the usual and customary standard of care for the condition being treated, (b) it would be clearly harmful to the patient to delay treatment awaiting explicit consent, and (c) patients ordinarily would be expected to consent to the treatment in question if they had the capacity to do so Advance Directive or Living Will The advance directive or living will is probably the best tool to direct care in the event of incapacity, but it is most helpful in end-of-life situations related to terminal conditions, futile care, and multiple-organ dysfunction These documents can have shortcomings related to care in the ICU: (a) the physician may not find instructions that clearly guide a treatment decision about particular therapies pertinent to ICU care (central lines, chest tubes, renal replacement therapy, thrombolysis, etc) and (b) the ethical argument can be made that a patient can’t predict his or her own reaction when faced with disability Studies have demonstrated a tendency among nondisabled people to view a disabling condition as equivalent to death, and historically, quality outcomes research has frequently combined death with the severe disability group For example, quality of life after acute ischemic stroke may be seen as high even in the setting of respiratory failure with ventilator dependency This may be explained by the transforming potential of a phenomenon called response shift, where patients redefine their personal values and their sense of reaction when facing disability In this sense, advance directives or living wills, even if legally valid, may be suboptimal for finding treatment directions in critically ill patients, particularly given that goals of self-determination and perceptions that guide one’s chosen moral course may change Substituted Judgment Standard Obtaining informed consent by an authorized surrogate decision maker is an alternative to gaining direct informed consent Appointees by advance directive, living will, or durable power of attorney (for healthcare decisions) or family members identified by state law are expected to make the same decisions as the patient would if the patient’s capacity were intact This idea of substituted judgment is widely accepted as a valid means of respecting patient preferences Shortcomings of the substituted judgment standard are related to the poor accuracy of the proxy’s ability to predict the patient’s will, which some studies have found to be no better than random chance, and the inherent difficulty of making therapeutic decisions for other persons, which may make proxies reluctant to participate in the consent process and may lead them to defer to the physician’s expertise without even considering the full disclosure of risks and benefits associated with the intervention Particular to cases of withdrawal of life support (discussed subsequently), this standard is based on landmark court decisions in cases such as Karen Quinlan, an alleged incompetent (70 NJ 10 1976) In this case, the Supreme Court of New Jersey established the concept of substituted judgment standard The court determined that a guardian ad litem (appointed by court order) was not necessary to represent a patient independently in a particular case and allowed family members to make decisions on the patient’s behalf The ruling is rooted in an individual’s legal right to privacy and the notion that a family member can make the assertion based on the family’s best judgment (substituted judgment standard) The decision included legal immunity for the physicians and the suggestion to involve ethics committees in such cases Best Interest Standard When one is making decisions for patients who lack decision-making capacity and have no discernable preferences, widespread support exists for using the best interest standard, which was introduced to give some standing to the interests of incapacitated patients independent of their family or guardians views According to Loretta Kopelman, “The best interest standard should be understood as an umbrella covering different usages First, it could be used to express moral, legal, medical, or other social goals or ideas that should guide choices Second, it can be used in making practical and reasonable decisions about what should be done in a particular situation, given the available and usually less than ideal options.” Pertinent to incompetent or incapacitated patients, the basis of this standard is framed by landmark court decisions such as that of Conroy (In re Conroy, 486 A2d 1209 [NJ 1985]) In this case, the Supreme Court of New Jersey permitted the use of the best interest standard to allow the guidance of therapy for an incapacitated patient whose guardian did not know the patient’s explicit wishes for a particular situation This principle is also applicable in cases where the burden of a therapy outweighs the benefits and the pain of interventions, which would make them inhumane Some of the shortcomings of using the best interest standard are the possibility that the physician will be judged as paternalistic and the possibility that some will find the principle to be vague and open to abuse, based on the inherent interpretation that it can guide decision makers to do whatever they happen to think is best Principle of Clear and Convincing Evidence In some jurisdictions, the principle of clear and convincing evidence may be used in lieu of the substituted judgment standard when one is dealing with issues pertaining to withholding or withdrawing life-supportive therapies, and it may be applied to comatose patients or patients in persistent vegetative states This is one of the three main principles used in the US legal system (the other two being beyond reasonable doubt and preponderance of evidence) This principle can be used by physicians in certain states (Missouri, New York, and Florida, among others) to withdraw life support or any other intervention when there is clear and convincing evidence of a patient’s previous statements and in the absence of a declaration such as a living will, advance directive, or durable power of attorney The decision is based on Cruzan v Director, Missouri Department of Health (497 US 261), where the court endorsed the right of a competent person to refuse medical therapy even if this results in the patient’s death; more important, the court’s ruling was based on the liberty interest set forth by the Fourth Amendment of the US Constitution The case of Terri Schiavo (Schindler v Schiavo, 866 So2d 140 [Fla Dist Ct App 2004]) was ruled following the same principle and endorsing Cruzan’s historic court decision Ethics Consultations and Court-Appointed Guardianship In many jurisdictions, if no surrogate or agent is present to act on the patient’s behalf, an ethics or risk management consultation (with the hospital’s legal office) is advisable The ethics team can represent the patient’s interests by hearing the recommendations of the treating physician or healthcare providers and then deciding whether the recommended treatment plan is ethically permissible and in the patient’s interests This process is usually done with a representative of the hospital’s law office Additionally, in some jurisdictions, and in the absence of surrogate decision makers, physicians must seek representation of the patient’s interests in the decision-making process through a court-appointed guardian ad litem Emergency guardianship can be requested through consultation with the hospital’s legal team and the ethics committee One problem with this system is that court-appointed guardians are often unfamiliar with the patient and have little contact with the medical professionals treating the patients Interestingly, in a study involving homeless persons who lacked family, 80% of subjects indicated that they would prefer a physician rather than a court-appointed guardian to make such decisions Some jurisdictions allow for hospitals or ethics committees to act on behalf of the patient; likewise, treatment can be determined through concurrence with a second physician who is not directly involved in the patient’s healthcare and does not serve in a capacity of decision making The American Medical Association has recommended either the involvement of an ethics committee or, like the American College of Physicians, a judicial review for unbefriended patients Withdrawal or Withholding When one is facing withdrawal or withholding of medical interventions, ethical questions cannot be addressed successfully unless the probability of outcomes is entertained Critical care specialists should make every effort to acquire the highest level of certainty regarding the diagnosis, disease severity, and prognosis with the patient’s wishes in mind The effort will require a thorough knowledge of the literature and a multidisciplinary team approach to attain a balanced view of the impact of therapeutic decisions and the expected disability on the patient In addressing these issues, we must answer several clinical prognostic questions: What is the probability of death during the next month and next year (and what are the confidence intervals around that probability)? What are the likely causes of death during the first month and subsequently? If the patient survives, what level of disability and handicap will she or he suffer? What impact will the intervention have on survival and/or disability? Advance directives, the substituted judgment standard, the best interest standard, and the clear and convincing evidence principle may be applied in these circumstances Is There a Difference Between Withdrawing and Withholding? The approach to this question is generally guided by the ethical principles of beneficence, nonmaleficence, and distributive justice; the legal implications of due care and negligence; and strong religious views Patients, family members, and physicians and healthcare providers may have strong arguments on this issue Some may feel comfortable with both withdrawing and withholding, and some may feel comfortable when deciding not to start a therapy but may feel uncomfortable deciding when to stop that therapy, or vice versa The US court system has examined this controversy and has noted that withholding a therapy can be based on an active or inadvertent omission However, the moral and legal implications are based on the issue of intent If one has a duty to treat but actively or inadvertently omits an effective therapy, then one can be found negligent by the court system; but fundamentally, both acts are similar in that the treatment is never started In the case of Earle Spring (In the Matter of Earle Spring, 405 NE 2d 115 [Mass 1980]), a Massachusetts court commented on the issue of continuing renal replacement therapy in an elderly woman: “The question presented by modern technology, once undertaken, is at what point does it cease to perform its intended function?” In this ruling, the court upheld the concept that physicians have no duty to continue ineffective therapies and concluded that its position was consistent with a moral responsibility In practice, when physicians and healthcare providers encounter these situations, some feel morally responsible for the effects of withdrawing care; others may find that there is no difference and therefore will feel no moral responsibility for the end results According to Beauchamp and Childress, “Feelings of reluctance about withdrawing treatments are understandable, but the distinction between withdrawing and withholding is morally irrelevant and can be dangerous.” In regard to life-sustaining therapies, other courts have upheld the concept that there is no difference between withdrawing and withholding Very frequently in the ICU, physicians and healthcare providers not know whether a therapy will be effective In this case, it would be better to attempt a trial of medical therapy by setting goals of care, determining whether those goals can be achieved by ongoing reassessment, and allowing the ICU team to determine whether the therapy is effective or ineffective while maintaining good communication with patient’s family, friends, and/or surrogates This approach would allow the physician or healthcare team to withdraw an ineffective therapy rather than withhold a potentially beneficial treatment, limiting the chance for undertreatment and avoiding ethical dilemmas Finally, according to the World Health Organization, health in its broader sense is defined as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity,” a goal that is sometimes difficult to achieve in the ICU This is echoed by the words of Hippocrates: “The purpose of medicine is to do away with the sufferings of the sick, to lessen the violence of their diseases, and to refuse to treat those who are overmastered by their diseases, realizing that in such cases, medicine is powerless.” In such cases, treatment may be considered futile According to the Society of Critical Care Medicine’s Ethics Committee, treatments that offer no physiological benefit to the patient and therefore fail to achieve their intended goal may be considered futile Additionally, the committee has advised against treatments that are unlikely to confer any benefit, treatments that are possibly beneficial but extremely costly, and treatments that are controversial and of uncertain benefit SUMMARY Medical ethics deals with moral issues related to daily practice of medicine Questions about the behaviors of physicians and healthcare providers, the decision-making process, values, rights, and responsibilities generate ethical reflection that requires a thorough understanding of philosophical concepts, religion, professional societies’ position statements, and the law The principle of autonomy, professional responsibility, and the common law require physicians and other healthcare providers to obtain consent before giving any treatment A medical treatment or procedure must be adequately explained, and the patient must have the capacity to consent to it If a patient does not have decisionmaking capacity, emergency treatments must be given using alternative forms of consent In the case of life-threatening conditions when there exists the possibility of significant disability or death from complications, it is difficult to predict how fears of future disability will ultimately alter the predefined preferences of an individual patient or surrogate decision maker In issues relating to advance directives and withholding and withdrawal of life support therapy, clinical prognostic questions require specific answers, so caregivers should strive to achieve the highest level of certainty regarding the diagnosis and prognosis with the patient’s wishes in mind SUGGESTED READING White-Bateman SR, Schumacher HC, Sacco RL, et al Consent for intravenous thrombolysis in acute stroke: review and future directions Arch Neurol 2007;64:785-792 Cassell EJ, Leon AC, Kaufman SG Preliminary evidence of impaired thinking in sick patients Ann Intern Med 2001;134:1120-1123 White DB, Curtis JR, Lo B, et al Decisions to limit life-sustaining treatment for critically ill patients who lack both decision-making capacity and surrogate decision-makers Crit Care Med 2006;34:2053-2059 Silverman HJ Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients Am J Respir Crit Care Med 1996;154(3 pt 1):582-586 Shimm DS, Spece RG Jr Industry reimbursement for entering patients into clinical trials: legal and ethical issues Ann Intern Med 1991;115:148-151 Appelbaum PS, Roth LH Competency to consent to research: a psychiatric overview Arch Gen Psychiatry 1982;39:951-958 Smith HL Myocardial infarction—case studies of ethics in the consent situation Soc Sci Med 1974;8:399-404 Stein J The ethics of advance directives: a rehabilitation perspective Am J Phys Med Rehabil 2003;82:152-157 Seckler AB, Meier DE, Mulvihill M, et al Substituted judgment: how accurate are proxy predictions? Ann Intern Med 1991;115:92-98 Kopelman LM The best interests standard for incompetent or incapacitated persons of all ages J Law Med Ethics 2007;35:187-196 .. .Comprehensive Critical Care: Adult Second Edition Pamela R Roberts, MD, FCCM, FCCP Editor S Rob Todd, MD, FACS, FCCM, Editor Copyright 2017 Society of Critical Care Medicine, exclusive of any U.S... Chief of Pulmonary and Critical Care Medicine Eastern Virginia Medical School Norfolk, Virginia No disclosures Scott A Marshall, MD Vascular Neurology and Critical Care Neuroscience Critical Care Intermountain Medical Center... Division of Trauma, Critical Care, and Acute Care Surgery Department of Surgery Oregon Health and Science University Portland, Oregon No disclosures Michael Sirimaturos, PharmD, BCNSP, BCCCP, FCCM Critical Care Clinical Specialist