Clinical Ethics PDF

Contents {#contents.TOCHeading} ======== [Introduction 3](#introduction) [THE FOUR TOPICS 4](#the-four-topics) [RESOURCES IN CLINICAL ETHICS 6](#resources-in-clinical-ethics) [ACKNOWLEDGEMENTS 7](#acknowledgements) [BIBLIOGRAPHY 7](#bibliography) [The four topics chart 8](#the-four-topics-chart) [Medical Indications 9](#medical-indications) [1.1 INDICATED AND NONINDICATED INTERVENTIONS 17](#indicated-and-nonindicated-interventions) [1.2 CLINICAL JUDGMENT AND CLINICAL UNCERTAINTY 23](#clinical-judgment-and-clinical-uncertainty) [1.3 CARDIOPULMONARY RESUSCITATION (CPR) AND ORDERS NOT TO RESUSCITATE (DNR) 28](#cardiopulmonary-resuscitation-cpr-and-orders-not-to-resuscitate-dnr) [1.4 MEDICAL ERROR 37](#medical-error) [1.5 DETERMINATION OF DEATH 38](#determination-of-death) [1.6 SUMMARY 41](#summary) [1P PEDIATRIC NOTES 42](#p-pediatric-notes) [**Patient Preferences** 44](#patient-preferences) [**2.1 INFORMED CONSENT** 48](#informed-consent) [**2.2 DECISIONAL CAPACITY** 61](#decisional-capacity) [**2.3 DECISION MAKING FOR THE MENTALLY INCAPACITATED PATIENT** 75](#decision-making-for-the-mentally-incapacitated-patient) [**2.4 SURROGATE DECISION-MAKERS** 81](#surrogate-decision-makers) [**2.5 FAILURE TO COOPERATE IN THE THERAPEUTIC RELATIONSHIP** 86](#failure-to-cooperate-in-the-therapeutic-relationship) [**2P PEDIATRIC NOTES** 96](#p-pediatric-notes-1) TOPIC THREE Quality of Life 3.1 Divergent Evaluations of Quality of Life 116 3.2 Enhancement Medicine 125 3.3 Compromised Quality of Life and Life-Sustaining Interventions 126 3.4 Pain Relief for Terminally Ill Patients 144 3.5 Medically Assisted Dying 148 3.6 Care of the Dying Patient 155 3.7 Treatment of Attempted or Suspected Suicides 156 3P Pediatric Notes 158 TOPIC FOUR Contextual Features\..... 4.1 Health Professions 165 4.2 Other Interested Parties 170 4.3 Confidentiality of Medical Information 174 4.4 Economics of Clinical Care 181 4.5 Allocation of Scarce Health Resources 187 4.6 Influence of Religion on Clinical Decisions 199 4.7 Role of Law in Clinical Ethics 201 4.8 Clinical Research 203 4.9 Clinical Teaching 211 4.10 Public Health 214 4.11 Organizational Ethics 219 4P Pediatric Notes 222 Locator\... Pullout Card-The Four Topics Chart \...109..161 225 Introduction ============ This book is about the ethical issues that clinicians encounter in caring for patients. In order to practice excellent clinical care, clinicians and those studying to become clinicians must understand ethical issues such as informed consent, truth telling, confidentiality, privacy, the distinction between research and clinical care, and end-of-life care. Clinicians must apply this knowledge in their daily practices. By clinicians we mean not only physicians and surgeons but also nurses, social workers, psychologists, clinical ethicists, medical technicians, chaplains, and others responsible for the welfare of patients. Some of these clinicians will also be members of ethics committees who deliberate about the ethics policies of their hospitals and about ethical problems in particular cases. Our audience also includes families and other persons close to patients, who may participate in decisions about their care. Our goal in writing this book is to help clinicians understand and manage the cases they encounter in their practices, and on those occasions when ethical disagreements emerge, to guide patients, families, clinicians, and ethics committees toward the resolution of clinical ethical conflicts. Ethical issues are imbedded in every clinical encounter between patients and caregivers because the care of patients always involves both technical and moral considerations. The central feature of this clinical encounter is the therapeutic relationship between a physician and a patient, a relationship that is permeated with ethical responsibilities. Physicians must aim, in the words of Hippocrates, \"to help and do no harm.\" Modern physicians approach the doctor-patient relationship with a professional identity that includes the obligations to provide competent care to the patient, to pre- serve confidentiality, and to communicate honestly and compassionately. In the usual course of a therapeutic relationship, clinical care and ethical duties run smoothly together. The reason is that generally the patient and physician share the same goal: to respond to the medical problems and needs of the patient. For example, a patient presents with a distressing cough and wants relief; a physician responds to the patient by utilizing the correct means to diagnose and treat this condition. In this situation, the treatment for, say, a mild asthma attack is effective and the patient is satisfied. At the same time an ethical action has taken place: the patient is helped and not harmed. In other cases, this simple scene becomes complicated. The patient\'s asthma may be caused by a cancer obstructing the airway. This disease may be life-threatening and the treatment may be complex, difficult and may prove unsuccessful. On other occasions, the smooth course of the doctor-patient relationship may be interrupted by what we call an ethical question: a doubt about the right action when ethical responsibilities conflict or when their meaning is uncertain or confused. For example, the physician\'s duty to cure is countered by a patient\'s refusal of indicated treatment, or the patient cannot afford treatment because of lack of insurance. The principles that usually bring the clinician and the patient into a therapeutic relationship seem to collide. This collision blocks the process of deciding and acting that is intrinsic to clinical care. This confusion and conflict can become distressing for all parties. This book, then, aims to elucidate both the ethical dimensions of care in ordinary clinical activities that are not controversial, as well as when doubt about right action blocks decision. Clinical ethics, then, is a structured approach to ethical questions in clinical medicine. Clinical ethics depends on the larger discipline of bioethics, which in turn draws upon disciplines such as moral philosophy, health law, communication skills, and clinical medicine. The scholars called \"bioethicists\" must master this field. However, clinicians in the daily practice of medicine can manage with a basic understanding of certain key ethical issues such as informed consent and end-of-life care. Central to the practical application of clinical ethics is the ability to identify and analyze an ethical question and to reach a reasonable conclusion and recommendation for action. In this book, we provide a method to identify the ethical dimensions of patient care and to analyze and resolve ethical problems. This method is useful for structuring the questions faced by any clinician who cares for patients. THE FOUR TOPICS --------------- Bioethics identifies four ethical principles that are particularly relevant to clinical medicine: the principles of beneficence, non-maleficence, respect for autonomy, and justice. To these, some bioethicists add empathy, compassion, fidelity, integrity, and other virtues. The bioethical literature discusses these principles and virtues at length. In this book, we only explain them briefly. We rather direct our reader\'s attention to how these general principles interact within the concrete circumstances of a clinical case, and how they serve as guides to action in specific circumstances. Thus we propose four topics that we believe constitute the essential structure of a case in clinical medicine, namely, medical indications, patient preferences, quality of life, and contextual features. Some users of this book call these four topics \"the Four Boxes.\" Every clinical case is a mass of detail that the clinician must interpret in order to carry out the reasoning process necessary for diagnosis and treatment. Every clinician learns early in training a common pattern for organizing that mass of detail: chief complaint, history of the chief complaint, general medical history of the patient, results of physical examination, and results of laboratory studies. The data that are sorted into these patterns lead the clinician to decisions about diagnosis and treatment. Our four topics or boxes provide a similar pattern for collecting, sorting, and ordering the facts of a clinical ethical problem. Each topic or \"box\" is filled with the actual facts of the clinical case that are relevant to the identification of the ethical problem, and the contents of all four are viewed together for a comprehensive picture of the ethical dimensions of the case. Medical indications refer to the diagnostic and therapeutic interventions that are being used to evaluate and treat the medical problem in the case. Patient preferences state the express choices of the patient about their treatment, or the decisions of those who are authorized to speak for the patient when the patient is incapable of doing so. Quality of life describes features of the patient\'s life prior to and following treatment, insofar as these features are pertinent to medical decisions. Contextual features identify the familial, social, institutional, financial, and legal settings within which the particular case takes place, insofar as they influence medical decisions. Under each of these headings, a series of questions are posed to assure that needed information has been gathered. We believe that these four topics are the essential and constant constituents of any clinical case, which is, of course, unique and varying in its own circumstances. The chart at the end of this introduction depicts these four topics and the relevant questions. The subtitle of our book states that clinical ethics is a practical approach. This implies that the approach must go beyond simply identifying the problem, by collecting and sorting the facts of the case. It must guide practice, that is, it must lead from identification of the ethical problem to decisions about how to manage the problem. It must show the clinician how to manage those obstacles to decision making that the ethical problem had posed. Clinical ethics is seldom a matter of deciding between ethical versus unethical, between good and right versus bad and wrong; rather it involves finding the better, most reasonable solutions among the relevant options. While clinical ethics can sometimes help to rule out options that are unethical, more frequently, clinical ethics can clarify a range of permissible options that patients and clinicians may choose. Our approach seeks to guide the clinician, and others involved in the case, toward such resolutions. After all relevant information is gathered into the Four Boxes, the relationship between that information and the principles must be assessed. It sometimes happens that when the data is collected and properly sorted, an obvious pattern appears that will identify the ethical problem. The circumstances of a case often point to one of the fundamental principles as most important in the specific case analysis. For example, a patient has a critical disease in its terminal stage, has never expressed preferences about treatment, has no relatives to speak for him, and faces great suffering during the time remaining. This appears at first sight as a case in which the principles of beneficence and non-maleficence are central. Further, aggressive treatment is no longer likely to be beneficial; this patient needs palliative care. At second sight, however, the question becomes a matter of the principle of respect for autonomy: who is authorized to make the decision to transition from intensive to palliative care? Ethical reflection moves from this dilemma between two fundamental principles to an evaluation of how the circumstances of the case give greater weight to one or the other of these principles. For example, after all reasonable attempts to effectively treat a patient have failed, the continued application of aggressive measures causes more harm than good to this patient. In this light, the principle of non-maleficence becomes the most dominant one, and provides an ethical reason for a decision to provide only palliative care. The clinician can then formulate a recommendation to the patient or other decision makers. This resolution of the case is based on an assessment of the facts of the case in relation to the ethical principles relevant to the case. However, this assessment calls for a further move: the present case must be compared to similar cases. It is certainly true that in medicine every case is unique, and every patient \"a statistic of one.\" Nevertheless, the case at hand will have similarities with other cases. Other cases may have been thoughtfully considered-perhaps even adjudicated in the law-and may provide guidance whereby to assess the present case. Such cases are called paradigm cases. Reference to paradigm cases do not prove that a case is correctly assessed; rather they are examples of serious assessments in prior, similar cases, to which the current case can be compared, in order to guide the clinician in this case. It is important to note that even similar cases have variable nuances. The present case may have circumstances that make it more complex than previous cases; or it may represent a novel problem due to innovative technology. Clinicians and ethicists should be familiar with these paradigm cases, and be able to discern how they differ and how the circumstances bond with principles in the current case. We describe some of the important paradigm cases. This book is arranged to follow the four-box model. Each chapter is devoted to one of the four topics. Each chapter begins with some general considerations and ethical principles most relevant to that topic. A series of questions that exemplify major issues under each topic are posed. Clinical situations that commonly generate ethical problems associated with that topic are stated and illustrated by cases. A COMMENT that provides a distillation of prevailing opinion from the bioethical literature follows. We conclude with RECOMMENDATIONS that the three authors formulate from their own extensive experience as clinicians and clinical ethics consultants. Although this book does not discuss pediatric ethics, at the end of each chapter we have placed \"Pediatric Notes\" to alert readers about certain ethical problems in pediatric medicine that require special consideration. When these arise, the sources for pediatric ethics should be consulted. One such source is Frankel LR, Goldworth A, Rorty MV, Silverman WD. Ethical Dilemmas in Pediatrics. Cambridge, MA: Cambridge University Press; 2005. RESOURCES IN CLINICAL ETHICS ---------------------------- In addition to our method for identifying and assessing a case in ethical terms, we also provide capsules of essential information about common problems, such as Orders Not to Resuscitate or Withholding Life Support. The issues that we treat in capsule form have been discussed and debated in the ever-increasing literature of bioethics. We refer readers to certain sources where they can find more extended discussions and references, and complete references are provided at the end of this section. The standard text of scholarly bioethics, in which basic concepts are amply explained, is Principles of Biomedical Ethics. The major reference work in medical ethics is Encyclopedia of Bioethics. We regularly refer to three books that contain fuller treatments of the matters that we treat only in capsule form. They are Resolving Ethical Dilemmas: A Guide for Clinicians; The Oxford Handbook of Bioethics; and The Cambridge Textbook of Bioethics. Our pages regularly refer to their relevant chapters. Another book collects cases that represent difficult problems confronting clinical ethicists: Complex Ethics Consultations: Cases that Haunt Us. A number of journals are now dedicated to bioethics: The Hastings Center Report, The American Journal of Bioethics, Journal of Medical Ethics, Cambridge Quarterly of Healthcare Ethics, Journal of Theoretical Medicine, and Journal of Clinical Ethics. Also, articles on bioethics ap- pear regularly in the medical and nursing journals. We do not reference this extensive journal literature, unless we use data drawn from an article or an article is \"classic\" in defining and describing an issue. This literature is indexed at PubMed and Medline at the National Library of Medicine\'s Bioethics Portal (www.nlm.nih.gov/bsd/bioethics.html). Extensive bibliographic resources can be found at the National Reference Center for Bioethics Literature at Georgetown University\'s ETHXWeb (http://bioethics.georgetown.edu/databases/index.htm); Clinical Ethics Center of the National Institutes of Health (www.nih.gov/sigs/bioethics); and, for cases and discussions, the American Medical Association\'s online journal Virtual Mentor is an excellent resource (http://virtualmentor.ama- assn.org). The Web site UpToDate (www.uptodate.com) contains a number of useful reviews of major topics, as does the Web site of the University of Washington Department of Bioethics and Humanities (http://depts.washington.edu/bhdept). Of less relevance to ethics at the bed- side, but still helpful, is United Nations Educational, Scientific and Cultural Organization\'s Global Ethics Observatory (http://www.unesco.org/shs/ ethics/geobs). Also see McGraw-Hill\'s AccessMedicine Web site (www.accessmedicine.com) for thousands of images and illustrations, interactive assessment, case files, diagnostic tools, and up-to-date information for research, education, self-assessment, and board review. ACKNOWLEDGEMENTS ---------------- The authors gratefully acknowledge the advice and assistance of the following people: Drs. Katrina Bramstedt, David Brush, Michael Cantwell. Farr Curlin, Lainie Ross, William Stewart, and Daniel Sulmasy, as well as Ms. Helene Starks, Ms. Donna Vickers, and Mr. Wesley McGaughey. BIBLIOGRAPHY ------------ American Journal of Bioethics. Taylor and Francis Group Inc. http://www. bioethics.net. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 6th ed. New York, NY: Oxford University Press; 2009. Cambridge Quarterly of Healthcare Ethics. 40 West 20th Street, New York, NY 10011-4211. http://www.journals.cup.org. Ford PJ, Dudzinski DM. Complex Ethics Consultations: Cases that Haunt Us. New York, NY: Cambridge University Press; 2008 Frankel LR, Goldworth A, Rorty MV, Silverman WA, eds. Ethical Dilemmas in Pediatrics. New York, NY: Cambridge University Press; 2005. Journal of Clinical Ethics. 17100 Cole Road, Hagerstown, MD 21740. http://www.clinicalethics.com. Journal of Medical Ethics. BMJ Publishing Group, British Medical Association, Tavistock Square London WCIH 9JR, UK. http://www.jme.bmj.com. Lo B. Resolving Ethical Dilemmas: A Guide for Clinicians. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2009. Post SG, ed. Encyclopedia of Bioethics. 3rd ed. Farmington Hills, MI: Gale; 2003. Singer PA, Viens AM. The Cambridge Textbook of Bioethics. New York, NY: Cambridge University Press; 2008. Steinbock B, ed. The Oxford Handbook of Bioethics. New York, NY: Oxford University Press; 2009. The Hastings Center Report. The Hastings Center, Garrison, NY, 10524-5555. E-mail: mail\@thehastingscenter.org; [[http://www.thehastingscenter.org]](http://www.thehastingscenter.org). Walters L, Kahn TJ, eds. Bibliography of Bioethics. Washington, DC: Georgetown University Press. \[Published annually\]. The four topics chart --------------------- \[image\] TOPIC ONE Medical Indications =================== This chapter treats the first topic relevant to any ethical problem in clinical medicine, namely, the indications for or against medical intervention. In most cases, treatment decisions that are based on medical indications are straightforward and present no obvious ethical problems. EXAMPLE. A patient complains of frequent urination accompanied by a burning sensation. The physician suspects a urinary tract infection, obtains a confirmatory culture, and prescribes an antibiotic. The physician explains to the patient the nature of the condition and the reason for prescribing the medication. The patient obtains the prescription, takes the medication, and is cured of the infection. This is a case of clinical ethics, not because it shows an ethical problem, but because it demonstrates how the principles commonly considered necessary for ethical medical care, namely, respect for autonomy, beneficence, non-maleficence, and justice, are satisfied in the clinical circumstances of this case. Medical indications are sufficiently clear so that the physician can make a diagnosis and prescribe an effective therapy to benefit the patient. The patient\'s preferences coincide with the physician\'s recommendations. The patient\'s quality of life, presently made unpleasant by the infection, is improved. This case occurs in a context in which medications are avail- able, insurance pays the bill, and no problems with family or institution are present. This case, which raises no ethical concerns, would present an ethical problem if the patient stated that he did not believe in antibiotics, or if the urinary tract infection developed in the last days of a terminal illness, or if the infection was associated with a sexually transmitted disease in which sexual partners might be endangered, or if the patient could not pay for the care. Sometimes, these problems can be readily resolved; at other times, they can become major obstacles in the management of the case. In this chapter, we first define medical indications and explain the ethical principles most relevant to medical indications, namely, beneficence and non-maleficence. We discuss the relationship of these principles to medical professionalism. We then pose a series of questions that link medical indications to these principles. In discussing these questions, we treat important features of clinical medicine related to medical indications, including the goals and benefits of medicine, clinical judgment and uncertainty, evidence-based medicine, and medical error. We offer typical cases to il- lustrate these discussions. We then consider three ethical issues in which medical indications are particularly prominent: (1) non-beneficial (or futile) treatment, (2) cardiopulmonary resuscitation (CPR) and do-not-resuscitate (DNR) orders, and (3) the determination of death. **1.0.1 Definition of Medical Indications** Medical Indications are the facts, opinions, and interpretations about the patient\'s physical and/or psychological condition that provide a reasonable basis for diagnostic and therapeutic activities aiming to realize the overall goals of medicine: prevention, cure, and care of illness and injury. Every discussion of an ethical problem in clinical medicine should begin with a statement of medical indications. In the usual clinical presentation, this review of indications for medical intervention leads to the determination of goals and the formulation of recommendations to the patient. Therefore, medical indications are those facts about the patient\'s physiological or psychological condition that indicate which forms of diagnostic, therapeutic or educational interventions are appropriate. **1.0.2 The Ethical Principles of Beneficence and Non-maleficence** Medical Indications describe the day-to-day work of clinical care for patients diagnosing their condition and providing helpful treatments. The ethical principles that should govern these activities are the principles of beneficence and non-maleficence, that is, acting so as to benefit the patients and not harm them. The most ancient moral maxim of medicine, stated in the Hippocratic oath, is \"I will use treatment to benefit the sick according to my ability and judgment but never with a view to injury and wrongdoing." Another Hippocratic imperative to physicians states, "be of benefit and do no harm" (Epidemics I). There are many ways to benefits\\ persons, for example, by educating, hiring, and promoting an employee; giving a recommendation; and making a gift. There are also many ways to harm, for example, by slandering, stealing, and beating. In medicine, benefit and harm have a specific meaning: helping by trying to heal and doing so as safely and painlessly as possible. Therefore, in medical ethics, beneficence primarily means the duty to try to bring about those improvements in physical or psychological health that medicine can achieve. These objective effects of diagnostic and therapeutic actions are, for example, diagnosing and curing an infection, treating cancer that leads to remission, and facilitating the healing of a fracture. Non-maleficence means going about these activities in ways that prevent further injury or reduce its risk. So, this topic will treat medical benefits as objective contributions to the health of a patient. The subjective aspects of patients\' choices, that is, their estimate of the value and utility that medical contributions bring to them personally and their acceptance and rejection of them, are discussed under Topic Two, \"Patient Preferences,\" and Topic Three, \"Quality of Life.\" Beauchamp TL, Childress JF. Chapter 4: Non-maleficence; Chapter 5: Beneficence. In: Beauchamp TL, Childress JF, eds. Principles of Biomedical Ethics. 6th ed. New York, NY: Oxford University Press; 2009:140-186; 197-239. **1.0.3 Benefit-Risk Ratio** In medicine, beneficence and non-maleficence are assessed in what is called \"Benefit-Risk Ratio\" reasoning. It would be clearly wrong for a physician to set out to harm a patient, but it is almost inevitable that when a physician attempts to benefit a patient, by medication or surgery, for example, some harm or risk of harm is possible or may ensue. Every surgical procedure causes a wound; most drugs have adverse effects. Therefore, the principles of beneficence and non-maleficence do not merely instruct the clinician to help and do no harm; they coalesce to guide the clinician\'s assessment of how much risk is justified by the intended benefit. A physician must calculate this \"ratio\" and fashion it into a recommendation to the patient who will, in the last analysis, evaluate it in light of his or her own values. Examples. (1) A patient with asthma and diabetes needs a course of steroids for worsening asthma, but the doctor knows that steroids will make diabetes control more difficult. (2) A surgeon takes a beta-blocking drug to decrease tremor before operating, but the use of the beta-blocker exacerbates his asthma. **1.0.4 The Therapeutic Relationship and Professionalism** The competence of a physician to benefit the patient by his or her medical knowledge and skill, as well as the expectation and desire of the patient to be benefited by these skills, is a key moral aspect of a therapeutic relationship. The principles of beneficence and non-maleficence are the central ethical aspects of this relationship. This therapeutic relationship has further implications for physicians as professionals. As the Charter on Medical Professionalism states, professionalism \"demands placing the interest of patients above those of the physician, set- ting and maintaining standards of competence and integrity, and providing à encourages expert advice to society on matters of health.\" Professionalism placing care for the patient ahead of the business of medicine. This im- plies that physicians should primarily pursue the goals of medicine in their dealings with patients, rather than favoring personal, private goals. More directly, physicians must avoid exploitation of patients for their own profit or reputation. The benefits of medicine are optimal when physicians and other health professionals demonstrate a professionalism that includes honesty and integrity, respect for patients, a commitment to patients\' welfare, a compassionate regard for patients, and a dedication to maintain competency in knowledge and technical skills. In manifesting these virtues, professionalism and ethics are linked. The ethical and professional responsibilities of physicians are closely tied to their ability to fulfill the goals of medicine in conjunction with their respect for patients\' preferences about the goals of their lives. Charter on Medical Professionalism. Ann Intern Med. 2002;136:243-246; Lancet. 2002;359:520-522. Dugdale LS, Siegler M, Rubin DT. Medical professionalism: crossing a genera- tional divide. Perspect Biol Med. 2008;51(4):554-564. **1.0.5 A Clinical Approach to Beneficence and Non-maleficence** The general principles of beneficience and non-maleficence must be situated in the clinical circumstances of the patient. In order to do this, we propose that clinicians first consider the topic of Medical Indications. We ask five questions that define the scope of the topic of Medical Indications. These questions form the structure of this chapter. In answering them, we will explain how the clinical circumstances are linked to the principles of beneficence and non-maleficence. These five questions are as follows: 1\. What is the patient\'s medical problem? Is the problem acute? chronic? critical? reversible? emergent? terminal? 2\. What are the goals of treatment? 3\. In what circumstances are medical treatments not indicated? 4\. What are the probabilities of success of various treatment options? 5\. In sum, how can this patient be benefited by medical and nursing care, and how can harm be avoided? **1.0.6 Question One-What Is the Patient\'s Medical Problem? Is the Problem Acute? Chronic? Critical? Reversible? Emergent? Terminal?** Clinical medicine is not abstract; it deals with particular patients who present with particular health problems. Therefore, clinical ethics must begin with as clear and detailed a picture as possible of those problems. This picture is usually obtained through the standard methods of clinical medicine history, physical diagnosis, data from laboratory studies- interpreted against a background of clinical experience. This leads to a differential diagnosis, as well as a management plan for further diagnostic tests and for treatment. As clinicians synthesize and organize the patient\'s case, they consider the issues discussed below in Question 2. **1.0.7 Important Distinctions: Is the Problem Acute? Chronic? Critical? Reversible? Emergent? Terminal?** Any differential diagnosis or treatment option will implicitly answer these questions. However, it is important to raise them explicitly at the time of an ethics discussion or consultation. The ethical implications of particular choices are often significantly influenced by the answer to these questions. Persons involved in an ethics discussion, such as the family of a patient or an ethics committee member, may not be fully aware of these important features. It is necessary to be clear about whether the ethical problem pertains to an acute reversible condition of a patient who has a terminal disease (such as pneumonia in a patient with widely metastatic cancer) or to an acute episode of a chronic condition (such as ketoacidosis in a diabetic patient). Therefore, the following points must be clear to all participants in an ethics discussion: \(a) The disease: A disease may be acute (rapid onset and short course) or chronic (persistent and progressive). It can be an emergency (causing immediate disability unless treated) or a nonemergency (slowly progressive). Finally, a disease can be curable (the primary cause is known and treatable by definitive therapy) or incurable. \(b) The treatment: Proposed treatments depend on the particular disease being treated. Patients\' decisions about treatment will vary on the basis of their goals, desires, and values. A medical intervention may be burdensome (known to cause serious adverse effects) or non-burdensome (unlikely to have serious side effects). The potential burdens of an intervention are considered by patients and physicians when deciding on a treatment plan. In addition, interventions may be curative (offering definitive correction of a condition) or supportive (offering relief of symptoms and slowing the progression of diseases that are currently incurable). For certain progressive diseases such as diabetes, supportive intervention, such as tight glycemic control, can be very efficacious, stopping or reversing disease progression and allowing the patient to maintain a high quality of life for many years. For other conditions, such as amyotrophic lateral sclerosis (Lou Gehrig disease) or Alzheimer disease, interventions and treatments rarely delay the progression of disease but may palliate symptoms and successfully treat acute episodes. **1.0.8 Four Typical Cases** We offer four typical patients who will reappear throughout this book as our major examples. The patients in these cases are given the names Mr. Cure, Ms. Cope, Mr. Care, and Ms. Comfort. These pseudonyms are chosen to suggest prominent features of their medical condition. Mr. Cure suffers from bacterial meningitis, a serious but curable acute condition. Ms. Cope has a chronic condition, insulin-dependent diabetes that requires not only continual medical treatment but also the patient\'s active involvement in her own care. Mr. Care has multiple sclerosis (MS), a disease that cannot currently be cured but whose inexorable deterioration can sometimes be delayed by treatments and always can be alleviated by good medical care. Ms. Comfort has breast cancer that has metastasized, for which there is a low probability of cure even under a regimen of intensive intervention. CASE I. Mr. Cure, a 24-year-old graduate student, has been brought to the emergency room (ER) by a friend. Previously in good health, he is complaining of a severe headache and stiff neck. Physical examination shows a somnolent patient without focal neurologic signs but with a temperature of 39.5°C and nuchal rigidity. An examination of spinal fluid reveals cloudy fluid with a white blood cell count of 2000; a Gram stain of the fluid shows many gram-positive diplococci. A diagnosis of bacterial meningitis is made; administration of antibiotics is recommended. COMMENT. In this case, the medical indications are the clinical data that suggest a diagnosis of bacterial meningitis for which a specific therapy, namely, administration of antibiotics, is appropriate. Nothing yet suggests that this case poses any ethical problem. However, in Topic Two, we shall see how ethical problems emerge from what appears to be a noncontroversial clinical situation: Mr. Cure will refuse therapy. That refusal will cause consternation among the physicians and the nurses caring for him; it will also raise an ethical conflict between the duty of physicians to benefit the patient versus the autonomy of the patient. When that problem appears, clinicians may be tempted to leap directly to the ethical problems of the patient\'s refusal. We suggest that the first step in ethical analysis not be such a leap but rather a clear exposition of the medical indications. Analysis should begin with answers to the questions, \"What is the diagnosis?\" \"What are the medical indications for treatment?\" \"What are the probabilities of success?\" \"What are the consequences of failure to treat?\" and \"Are there any reasonable alternatives for treating this clinical problem?\" CASE II. Ms. Cope is a 42-year-old woman whose insulin-dependent diabetes was diagnosed at age 18. Despite good compliance with an insulin and dietary regimen, she experienced frequent episodes of ketoacidosis and hypoglycemia, which necessitated repeated hospitalizations and ER care. For the last few years, her diabetes has been controlled with an implanted insulin pump. Twenty-four years after the onset of diabetes, she has no functional impairment from her disease. However, fundoscopic examination reveals a moderate number of microaneurysms, and urinalysis shows increased microalbuminuria. CASE III. Mr. Care, a 44-year-old man, was diagnosed with MS 15 years ago. For the past 12 years, he has experienced progressive deterioration and has not responded to the medications currently approved to delay MS progression. He is now confined to a wheelchair and for 2 years has required an indwelling Foley catheter because of an atonic bladder. In the last year, he has become profoundly depressed, is uncommunicative even with close family, and rarely rises from bed. CASE IV. Ms. Comfort is a 58-year-old woman with metastatic breast cancer. Three years ago, she underwent a mastectomy with reconstruction. Dissected nodes revealed infiltrative disease. She received several courses of chemotherapy and radiation. COMMENT. In these four cases, we present a very simplified picture of patients seen in terms of medical indications, that is, diagnosis and treatment. No particular ethical problems are described. As the book advances, various problems will arise that merit the name clinical ethical problems. Some of these are related to changes in medical indications themselves, whereas some are due to the patients\' preferences, their quality of life, and the con- text of care. Topics Two, Three, and Four treat these questions. Mr. Cure, Ms. Cope, Mr. Care, and Ms. Comfort will appear frequently in the coming pages. Details of these cases will occasionally be changed to illustrate various points as the text proceeds. In addition to these four model cases, many other case examples will appear in which the patients will be designated by initials. The first question of Topic One, which examines the patient\'s immediate presenting problems, as well as the patient\'s overall clinical condition, is centrally important in developing both a clinical and an ethical analysis of the situation. This information is the sort usually found in the patient\'s chart. We emphasize that any clinical assessment or any ethics consultation must begin with a complete review of this information. We also emphasize that in some cases, an ethics consultation by a clinically knowledgeable ethicist might reveal that some important information is missing and that clinicians should be encouraged to obtain it to make the ethical analysis more relevant and helpful. **1.0.9 Question Two-What Are the Goals of Treatment?** In order to understand the ethical issues in a case, it is necessary to consider the clinical situation of the patient, that is, the nature of the disease, the treatment proposed, and the goals of intervention. The analysis and resolution of an ethical issue often depend on a clear perception of these factors. The general goals of medicine are as follows: 1\. Cure of disease 2\. Maintenance or improvement of quality of life through relief of symptoms, pain, and suffering 3\. Promotion of health and prevention of disease 4\. Prevention of untimely death 5\. Improvement of functional status or maintenance of compromised status 6. Education and counseling of patients regarding their condition and prognosis 7\. Avoidance of harm to the patient in the course of care 8\. Providing relief and support near time of death In every particular case, these general goals are made specific by understanding the nature of the disease(s) involved in the case and the range of available, appropriate treatment. Therefore, attention must be paid to the distinctions stated above (see Section 1.0.7), as specific to the patient\'s disease and to the particular circumstances of the patient. In many cases, most of the general goals of medicine can be achieved simultaneously. For example, in the case of Mr. Cure and his bacterial meningitis, a course of antibiotics should cure the disease; relieve the symptoms, such as headache and fever; protect his nervous system from damage; and restore his health (therefore, avoiding the need for support in time of death). However, at times, goals will conflict. For example, when considering the use of antihypertensive drugs, the goal of reducing the risk of heart attack and stroke may conflict with the goal of avoiding harmful side effects, such as impotence and fatigue, that will impair a patient\'s quality of life. In other cases, goals such as curing disease may be impossible to achieve because of a patient\'s advanced condition and/or limitations in scientific and medical knowledge. In every medical case, the goals must be clear and conflicts between goals must be understood and managed, as much as possible. An old medical maxim sums up the goals of medicine concisely: \"cure sometimes, relieve often, comfort always.\" While the old maxim remains true, modern medicine has changed its application. Cure is much more often achieved now than in the past: developments in anesthesia and asepsis have expanded surgical possibilities, and the development of modern pharmacology has expanded effective medical treatments. Many chronic diseases that were once lethal can now be effectively managed. In recent years, the medical profession has taken more seriously the mandate to \"comfort al- ways\" and has improved its ability to provide palliation to chronically and terminally ill patients. An ethical problem may appear in a case if the goals of intervention are poorly defined, are unclear or confused, or are overtaken by the rapid course of disease-goals that are perfectly reasonable when a patient is admitted for surgery may no longer be reasonable when, postoperatively, the patient becomes septic. Sometimes the ethical problem merely reflects a failure to clarify for all participants the feasible goals that the physician has identified; at other times, there may be a genuine conflict between goals. Clinical ethics consultation may assist clinicians to clarify when cure is possible, how long intensive medical interventions should be continued, and when comfort should become the primary mode of care. In every case, patients and physicians should clarify the goals of intervention when deciding on a course of treatment. This clarification entails, first of all, the physician\'s knowledge and skill in diagnosis and treatment: he or she must, to the extent possible in a given clinical setting, set and reset goals realistically. In addition, he or she must take account of the patient\'s own goals (Topic Two, \"Patient Preferences,\" and Topic Three, \"Quality of Life\"). 1.1 INDICATED AND NONINDICATED INTERVENTIONS -------------------------------------------- **1.1.1 Question Three: In What Circumstances Are Medical Treatments Not Indicated?** One of the major sources of ethical problems is the determination whether a particular intervention is, or is not, indicated. Innumerable interventions are available to modern medicine, from counseling to drugs to surgery. any particular clinical case, only some of these available interventions are indicated, that is, only some interventions are clearly related to the needs and data of the clinical situation and to the goals of medicine. The competent clinician always judges what intervention is indicated for the case at hand. Therefore, the term \"medically indicated\" describes what a sound clinical judgment determines to be physiologically and medically appropriate in the circumstances of a particular case. Interventions are indicated, then, when the patient\'s physical or mental condition may be improved by their application. Interventions may nonindicated for a variety of reasons. First, the intervention may have no scientifically demonstrated effect on the disease to be treated and yet be erroneously selected by the clinician or desired by the patient. An example of such an intervention would be high-dose chemotherapy followed by bone marrow transplantation for widely metastatic breast cancer or the use of estrogens for a postmenopausal woman in the mistaken belief that it will decrease the risk of coronary artery disease. These treatments are nonindicated. Second, an intervention known to be efficacious in general may not have the usual effect in some patients because of individual differences in constitution or in the disease. An example of this type of intervention would be a patient who takes a cholesterol-lowering statin drug and subsequently experiences an acute myopathy, a rare but known serious complication. Statins are not indicated for this patient. Third, an intervention appropriate at one time in the patient\'s course may cease to be appropriate at a later time. An example of this would be ventilatory support, indicated when a patient is admitted to the hospital after cardiac arrest but no longer indicated when the patient is determined to have profound anoxic brain damage and suffers multisystem organ failure. This last situation occurs when a patient is so seriously ill or injured that sound clinical judgment would suggest that the goals of restoration of health and function are unattainable and, thus, certain medical interventions that usually perform these functions are not indicated or should be limited. These cases present themselves in several ways: the dying patient, the terminal patient, and the patient with progressive, lethal disease. We illustrate these three conditions by following the case of Mr. Care. CASE. Mr. Care, a 44-year-old married man with two adult children, was diagnosed as having MS 15 years ago. During the past 12 years, the patient has experienced progressive deterioration and has not responded to the drugs currently approved to delay progression of MS. He is now confined to a wheelchair and for the last 2 years has required an indwelling Foley catheter because of an atonic bladder. He is now blind in one eye, with markedly decreased vision in the other. He has been hospitalized several times because of pyelonephritis and urosepsis. In the course of the last year, he has become profoundly depressed, is uncommunicative even with close family, and refuses to leave his bed. During the entire course of his illness, he has refused to discuss the issue of terminal care, saying he found such discussion depressing and discouraging. Decisions about what treatment is indicated for Mr. Care are influenced by whether he is viewed as a \"dying\" patient, a terminally ill patient, or as an incurable patient. These three terms are explained below (and also in Topic Three, Section 3.3, where considerations of quality of life are added to medical indications). **1.1.2 The Dying Patient** Many interventions become nonindicated when the patient is about to die. In this section, we use the word dying to describe a situation when clinical conditions indicate definitively that the patient\'s organ systems are dis- integrating rapidly and irreversibly. Death can be expected within hours. This condition is sometimes described as \"actively dying\" or \"imminently dying.\" In this situation, indications for medical intervention change significantly. We return to the case of Mr. Care. CASE. Mr. Care, in the advanced stages of MS, suffers from deep decubitus ulcers and osteomyelitis, neither of which has responded to treatment efforts, including skin grafts. During the past month, the patient has been admitted three times to the intensive care unit (ICU) with aspiration pneumonia and has required mechanical ventilation. He is admitted again, requiring ventilation and, after 4 days, becomes septic. On the next day, he is noted to have increasingly stiff lungs and poor oxygenation. In several hours, his blood pressure is 60/40 mm Hg and decreasing. He is unresponsive to pressors and volume expanders. His arterial oxygen saturation is 45%. He is anuric, his creatinine is 5.5 mg/dL and rising, and his arterial pH is 6.92. A house officer asks whether ventilation and pressors are futile and should be discontinued. COMMENT. Mr. Care has multisystem organ failure and is dying. Medical intervention at this point is sometimes called futile, that is, offering no therapeutic benefit to the patient. Judgments about futility are often very controversial and its meaning will be fully discussed below in Section 1.2.2. At this point in Mr. Care\'s case, the house officer uses the word futile in a quite obvious, noncontroversial way: as a shorthand description of a condition in which physiological systems have deteriorated so drastically that no known medical intervention can reverse the decline. The judgment of futility in this case approaches certainty. Some commentators use the phrase physiological futility for this situation, and some believe that it is the only situation in which the word futility should be applied. RECOMMENDATION. Mr. Care is dying. His death will take place within hours. Ventilation and vasopressors are no longer indicated, because they are now having no positive physiological effect. Physiologic futility is an ethical justification for the physician to recommend withdrawing all interventions, with the exception of those that may provide comfort. If the patient\'s family requests continued interventions, see the discussion in Section 1.2.2. **1.1.3 The Terminally Ill Patient** Judgments about whether certain interventions are indicated must be re-evaluated when a patient is in a terminal condition. There is no standard clinical definition of terminal. The word is often loosely used to refer to the prognosis of any patient with a lethal disease. In the Medicare and Medicaid eligibility rules for reimbursement of hospice care, terminal is defined as a prediction having 6 months or less to live. This is an administrative rather than a clinical definition. In clinical medicine, terminal should be applied only to those patients whom experienced clinicians expect will die from a lethal, progressive disease, despite appropriate treatment, in a relatively short period, measured in days, weeks, or several months at most. Diagnosis of a terminal condition should be based on medical evidence and clinical judgment that the condition is progressive, irreversible, and lethal. The benefits of accurate prognostication include informing patients and families about the situation, allowing them to plan their remaining time and arrange appropriate forms of care. However, such prognostication must be made with great caution. More than a few studies have shown that even experienced clinicians often fail to make accurate prognoses. Some physicians are overly pessimistic, but one major study shows that even more clinicians are inappropriately optimistic and fail to inform patients of their imminent death. Christakis N. Death Foretold: Prophecy and Prognosis in Medical Care. Chicago, IL: University of Chicago Press; 1999. CASE. Prior to the hospitalization described above, Mr. Care is living at home. He requires assistance in all activities of daily life and is confined to bed. He has become confused and disoriented. He begins to experience breathing difficulties and is brought to the emergency department. He is now unresponsive and has a high fever and labored, shallow respirations. A chest radiograph reveals diffuse haziness suggestive of adult respiratory distress syndrome; arterial blood gases show a Po~2~ of 35, Pco~2~ of 85, and pH of 7.02. Cardiac studies demonstrate an acute anteroseptal myocardial infarction. Neurologic and pulmonary consultants agree that he has primary neuromuscular respiratory insufficiency. Mr Care\'s family calls his personal physician, who immediately consults with the emergency physicians. Should Mr. Care be intubated and admitted to the ICU? Should his acute myocardial infarction be treated with emergency angioplasty and stenting, or are these procedures not indicated in this patient\'s condition? COMMENT. This acute episode is a life-threatening event superimposed upon a chronic, lethal, and deteriorating condition. Various interventions might delay Mr. Care\'s demise. A respirator may improve gas exchange and support perfusion of organ systems; fibrinolytic therapy or angioplasty plus stenting might limit the evolving infarct. These interventions aim at two of the goals of medicine: support of compromised function and prolongation of life. Given the presence of progressive and irreversible disease in its final stages and radical damage to multiple organ systems, none of the other important goals can be achieved. The patient will certainly never be restored to health, and compromised functions will not be restored but sustained temporarily by mechanical means. The following reflections are relevant: \(a) Mr. Care, now unresponsive, has declined to express preferences about the course of his care, and nothing is known from other sources about his preferences. Therefore, personal preferences, usually so important in these decisions, are not available to clinicians or to surrogates. Objective data about survival and sound clinical discretion about the probabilities of improvement are the most important factors in formulating a recommendation to forgo further treatment. \(b) Objective information that provides prognostic criteria may be useful in determining whether a particular type of intervention will be efficacious. Such objective information may include the patient\'s diagnosis, physiologic condition, functional status, nutritional status, and comorbidities, together with the patient\'s estimated likelihood of recovery. One approach to developing these data for patients admitted to the ICU is the Acute Physiology and Chronic Health Evaluation (APACHE). This system combines an acute physiologic score, the Glasgow Coma Score, age, and a chronic disease score to estimate a patient\'s risk of dying during an ICU admission. Another new and simpler system. Modified Organ Dysfunction Score (MODS), records how many of gan systems are dysfunctional and for how many days. Analyses such as these, done for this patient with pneumonia, ARDS, and acute MI, would show that the probability of his surviving this ICU admission is extremely low. Even though probability is not equivalent to certainty. in this instance, as everywhere else in medicine, it is a sound basis for clinical judgment. \(c) In these clinical circumstances, the principle of beneficence, in its sense of helping to remedy the conditions that are leading to death, is no longer applicable. In the absence of patient preferences, quality of life and appropriate use of resources become appropriate ethical considerations; see Topics Three, \"Quality of Life,\" and Four, \"Contextual Features.\" \(d) A medical judgment that none of the goals of medicine can be achieved apart from sustaining organ function provides the first ethical ground to conclude that further life-sustaining treatment can be omitted. The physician should formulate a recommendation to this effect. In addition to this ethical grounding, consent of the patient or the patient\'s designated surrogate must be sought, as explained in Topic Two. **1.1.4 The Incurable Patients with Progressive, Lethal Disease** Certain diseases follow a course of gradual and sometimes occult destruction of the body\'s physiologic processes. Patients who suffer such diseases may experience their effects continually or intermittently, and with varying severity. Eventually, the disease itself or some associated disorder will cause death. Mr. Care illustrates the features of this condition. Multiple sclerosis cannot be cured. Progressive neurologic complications that include spasticity, loss of mobility, neurogenic bladder, respiratory insufficiency, and occasionally dementia are also irreversible. Still, some interventions, such as treatment of infection, can relieve symptoms, maintain some level of function, and prolong life. CASE. For the first decade after his diagnosis with MS, Mr. Care maintained high spirits. Although he did not like to discuss his disease or its prognosis, he seemed to understand the progressive and lethal nature of his condition. However, in the last few years, he has begun to speak frequently of \"get- ting this over\" and has become deeply depressed. He has accepted several trials of antidepressant medications, but these did not improve his mental condition. As serious urinary tract and respiratory infections became more frequent, he grudgingly submitted to treatment. COMMENT. Patients in this condition are not terminal, even though the dis- ease from which they suffer is incurable. However, they may from time to time experience acute, critical episodes, which, if not treated, will lead to their death. When successfully treated, patients will be restored to their \"baseline condition.\" In a sense, they are, at each episode, \"potentially terminal.\" It may occur to such patients and to their physicians that these critical episodes offer an opportunity to end their progressive decline. Re- call the old medical maxim, \"Pneumonia is the old person\'s friend.\" In such a situation, the issues require a careful review of medical indications, because the patient\'s prognosis, with or without treatment, must be clearly understood. However, the more important questions concern patient preferences and quality of life. Therefore, the ethical dimensions of such cases will be discussed under Topics Two and Three. Singer PA, MacDonald N, Tulsky JA. Quality end of life care. In: Singer PA, Viens AM, eds. The Cambridge Textbook of Bioethics. New York, NY: Cambridge University Press; 2008:53-57. 1.2 CLINICAL JUDGMENT AND CLINICAL UNCERTAINTY ---------------------------------------------- **1.2.1 Question Four-What Are the Probabilities of Success of Various Treatment Options?** In the above cases, judgments about diagnosis and treatment reflect a certain level of certainty or uncertainty. Given the nature of medical science and the particularities of each patient, clinical judgment is never absolutely certain. Clinical medicine was described by Dr. William Osler as \"a science of uncertainty and an art of probability.\" The central task of clinicians is to reduce uncertainty to the extent possible by using clinical data, medical science, and reasoning to reach a diagnosis and propose a plan of care. The process by which a clinician attempts to make consistently good decisions in the face of uncertainty is called clinical judgment. The inevitable uncertainty of clinical judgment can be reduced by the methods of evidence-based medicine, using data from controlled clinical trials, and by the development of practice guidelines, which assist the physician\'s reasoning through a clinical problem. Although evidence-based medicine and practice guidelines aim to reduce the \"uncertainty\" and the \"probability\" of which Osler spoke, some degree of uncertainty always remains, because these methods reach general statistical conclusions that may not fit the real patient who is before the physician. In addition to uncertainty about data and their interpretation, there will be uncertainty about what action to take in particular case. This is reflected in such questions as \"Now that we have medical evidence about what is possible, what should we do?\" \"Given all the possibilities, what goals are appropriate for this patient?\" These questions cannot be solely answered by clinical data. The ethical principles of beneficence and non-maleficence reduce the scope of this sort of uncertainty by directing intention and effort away from the wide range of possible diagnoses and treatments and toward the more narrow range most likely to help this patient in these circumstances. However, the ethical principles do not dictate particular clinical decisions. These decisions must be confronted in candid, realistic discussions among clinicians, the patient, and the family. This is the shared decision making that constitutes an appropriate professional relationship; see Topic Two, \"Patient Preferences.\" Feinstein AR. Clinical Judgment. New York, NY: Krieger; 1974. Goodman KW. Ethics and Evidence-Based Medicine. Fallibility and Responsibility in Clinical Science. Cambridge, MA: Cambridge University Press; 2003. **1.2.2 Medical Futility** An important ethical problem is closely associated with the probabilistic nature of medical judgment. The question is whether a high probability that a particular treatment will be unsuccessful justifies withholding or withdrawing that treatment. This is often called the futility problem, or \"medically ineffective or nonbeneficial treatment.\" A long, hotly contested debate over \"futility\" has been inconclusive. One definition at the center of the debate states: \"futility designates an effort to provide a benefit to a patient, which reason and experience suggest is highly likely to fail and whose rare exceptions cannot be systematically produced.\" In Section 1.1.2, we have seen the term \"physiologic futility,\" that is, an utter impossibility that the desired physiologic response can be affected by any intervention. However, futility more properly is a judgment about probabilities, and its accuracy depends on empirical data drawn from clinical studies and from clinical experience. Because clinical studies that demonstrate this sort of futility are rare, and because clinical experience is so varied, clinicians make widely different estimates of futility: physicians\' judgments that various procedures should be called futile range from 0% to 50% chance of success, clustering about 10%. Some ethicists and clinicians deny the utility of the concept of futility because of its confused meaning and frequently inappropriate application. Others, including ourselves, consider it a useful term when applied thoughtfully to treatment decisions about interventions with low likelihood of success. Beauchamp TL, Childress JF. Conditions for overriding the prima facie obligation to treat. In: Beauchamp L, Childress JF, eds. Principles of Biomedical Ethics. 6th ed. New York, NY: Oxford University Press; 2009:167-169. Lo B. Futile interventions. In: Lo B, ed. Resolving Ethical Dilemmas. A Guide for Physicians. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2009:61-66. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning, and ethical implications. Ann Intern Med. 1990;112:949-954. Three main questions about futility are debated: \(1) What level of statistical or experiential evidence is required to support a judgment of futility? \(2) Who decides whether an intervention is futile, physicians or patients? \(3) What process should be used to resolve disagreements between patients (or their surrogates) and the medical team about whether a particular treatment is futile? \(1) Statistical probability. Clinical futility requires a probabilistic judgment that an intervention is highly unlikely to produce the desired result. This judgment comes from general clinical experience and from clinical studies that demonstrate low rates of success for particular interventions, such as CPR for certain types of patients, or continued ventilatory support for patients with adult respiratory disease syndrome. Even the data that are available may prove deceptive in a particular case because studies apply to groups rather than individuals. Further, a lack of agreement exists about how low a level of probability would justify calling a treatment futile. One group has suggested that if soundly designed clinical studies reveal less than a 1% chance of success, intervention should be considered futile. EXAMPLE 1. A study of 865 patients who required mechanical ventilation after bone marrow transplantation showed no survivors among the 383 patients who had lung injury or hepatic or renal failure and who required more than 4 hours of ventilator support. This study suggests that it would be probabilistically futile to intubate patients with these conditions or to continue ventilation after 4 hours. Rubenfeld GD, Crawford SW. Withdrawing life support for medically ventilated recipients of bone marrow transplantation: a case for evidence-based quali- tative guidelines. Ann Intern Med. 1996;125:625--633. EXAMPLE II. A large clinical study examined hospital discharge records of more than 5000 patients from eight U.S. cities, who suffered cardiac arrest out of hospital, were resuscitated by emergency teams, and were transported to hospital for further care. The investigators applied rules they had developed earlier for stopping CPR in the field and then tried to predict which of the resuscitated patients would survive to be discharged from the hospital. Their study was designed to validate the rules for predicting CPR futility. None of the 1192 patients who did not meet Advanced Life Support criteria for termination of CPR survived to discharge; of 776 patients who met Basic Life Support criteria, 4 (0.5%) survived to discharge. Sasson C, Hegg AJ, Macy M, et al. Prehospital termination of resuscitation in cases of refractory out-of-hospital cardiac arrest. JAMA. 2008;12:1432-1438. COMMENT. The first study was done in 1996. It clearly illustrates probabilistic futility: not a single patient from a large cohort left the ICU alive. A decade later, these data have not been contradicted. The second study was a retrospective cohort study developed to predict when it would be futile to continue resuscitation in cases of refractory out-of-hospital cardiac arrest. Applying these rules to the data accurately predicted 99.9% of the patients who did not survive to hospital discharge. Therefore, these rules predicted probabilistic futility in out-of-hospital cardiac arrests with great accuracy. \(2) Who decides? It is relatively rare that carefully designed clinical studies such as the previous reports provide hard data for determination of futility. Inevitable debates will ensue about the level of probability that should represent futility. Who has the authority to establish the goals of the intervention and to decide the level of probability for attaining such goals? Some ethicists argue that physicians have the right to refuse care that they believe is highly unlikely to produce beneficial results; other ethicists maintain that futility must be defined in light of the subjective views, values, and goals of patients and their surrogates. CASE I. A 75-year-old woman is brought to the ER by paramedics after suffering massive head trauma, with extrusion of brain tissue, as a result of a vehicular accident. She had been intubated by the paramedics. After careful evaluation, the ER physicians judged that her injuries were so severe that no intervention could retard her imminent death. When her grieving family gather in the ER, they demand that the woman be admitted to the ICU and be prepared for operation by a neurosurgeon. The physicians state that further treatment is futile. CASE II. Helga Wanglie was an elderly Minnesota woman who suffered irreversible brain damage from strokes and slipped into a chronic vegetative state. She required mechanical ventilation. Physicians and family agreed that she had no hope of regaining the ability to interact with others. However, Mrs. Wanglie\'s husband refused to authorize discontinuing the ventilator, saying that his goal (and, he asserted, hers) was that her life should not be shortened, regardless of her prospects for neurologic recovery. Physicians requested court intervention to authorize withdrawal of ventilatory support. CASE III. A 72-year-old man with late-stage emphysema is admitted to the ICU with fever, respiratory failure, and hypoxemia. While he is being intubated, he has a cardiac arrest. He is resuscitated in the unit, but remains unconscious after resuscitation. He is found to have had a large anterior wall myocardial infarction, requiring pressors to maintain blood pressure. The laboratory calls to say that blood culture data drawn in the ER are growing gram-negative bacteria. Because of his multisystem organ failure and sepsis, the physicians decide to write a DNR order, believing that a second attempt at CPR would be futile. COMMENT. In Case I, the physicians are speaking of futility in the sense used in Section 1.1.2, that is, physiological futility. The issue here is not the likelihood but the impossibility of continued life regardless of any intervention. They are ethically justified in refusing to pursue treatment. In Case II, continued ventilatory support and other interventions can extend Mrs. Wanglie\'s life. These interventions, employed for this purpose, cannot be judged physiologically futile. However, physicians judge that there is a vanishingly low probability of restoring Mrs. Wanglie\'s health and a low probability also that her life will be extended very long, even with support. They also judge that Mrs. Wanglie\'s life, if extended, will be of very low quality. Physicians may recommend termination of the intervention on the grounds of medical futility, but they lack the ethical authority to define the benefit of continued life even without consciousness. This is a matter for the patient and her surrogate to decide (as the Minnesota court determined). Some contextual features, such as scarcity of resources, might be relevant to this case (see Topic Four, \"Contextual Features,\" Section 4.5). In Case III, the patient\'s multi-organ system failure, dependence on pressors, and sepsis make it highly unlikely that a second resuscitation will succeed. A DNR order should be recommended to appropriate surrogates. \(3) Dispute Resolution. What process should be used to resolve disputes about futility? Institutions should design a policy for conflict resolution. These policies should prohibit unilateral decision making by physicians, except in cases of physiological futility. For judgments of futility based on low probability of successful treatment, policy should stress the need for valid empirical evidence, provide for consultation with outside experts and with ethics committees, and, above all, create an atmosphere of open negotiation or mediation rather than confrontation. The policy should allow physicians to withdraw from cases in which they judge continued treatment futile and should provide for transfer of patients to other institutions willing to accept them. Futility arguments should be moved into court only after all other reasonable attempts to resolve the disagreement fail. Elements of a model hospital policy on nonbeneficial care can be found in the AMA Code of Medical Ethics 2008, 2.037 ([[www.ama-assn.org]](http://www.ama-assn.org)). COMMENT. Despite continued debates about the concept of futility, we believe it is useful in medical ethics, because it highlights the necessity to make decisions about treatments that are of questionable benefit. It introduces a note of realism into excessive medical optimism by inviting physicians and families to focus on what realistically can be done for the patient under the circumstances and which goals, if any, can be realized. It provides the opportunity to open an honest discussion with patients and their families about appropriate care. It calls for a careful investigation of the literature about the efficacy of proposed treatments in particular situations. Physicians should never invoke futility, except in the sense of physiologic futility, to justify unilateral decision making or to avoid a difficult conversation with patient or family. A physician\'s judgment that further treatment would be futile does not justify a conclusion that treatment should cease; instead, it signals that discussions of the situation with patient and family are mandatory. Futility should never be invoked when the real problem is a frustration with a difficult case or a reflection of the physician\'s negative evaluation of the patient\'s future quality of life; see Topic Three, \"Quality of Life.\" Also, a futility claim by itself does not justify rules or guidelines devised by third-party payers to avoid paying for care; see Topic Four, \"Contextual Features.\" Further, even when the facts of the case sup- port a judgment of futility, we suggest that it may be advisable to avoid the actual word \"futility\" in discussions with patients or their families. Many persons may interpret this word as an announcement that the physician is \"giving up\" on the patient or that the patient is not worth further attention. At this point, rather than explicitly using futility language, clinicians should raise the question of redirecting the efforts of clinical care to palliation and comfort, because the burdens of more aggressive care far exceed the chances for benefit. Ethicists sometimes refer to this reasoning as proportionality (see Section 3.3.5). Finally, we acknowledge that a physician has the moral right to with- draw from a case in which he or she has reached an honest judgment of futility, even though continued care is demanded by others. Such a judgment would be based on the belief that nothing is being done to benefit the patient, while continued interventions actually are harming the patient. Should a physician reach this conclusion, proper steps to inform the family should be taken. Hospital policy should support physician\'s judgments in this regard. 1.3 CARDIOPULMONARY RESUSCITATION (CPR) AND ORDERS NOT TO RESUSCITATE (DNR) --------------------------------------------------------------------------- The practice of CPR provides another example in which estimations of the probability of success are often a crucial element of the ethical decision to proceed with the intervention. Cardiopulmonary resuscitation consists of a set of techniques designed to restore circulation and respiration in the event of acute cardiac or cardiopulmonary arrest. The most common causes of cardiac arrest are (1) cardiac arrhythmia, (2) acute respiratory insufficiency, and (3) hypotension. The omission of CPR after cardiopulmonary arrest will result in the death of the patient. Basic CPR, consisting of mouth-to-mouth ventilation and chest compression, is taught to lay persons for use in emergency situations. Automatic defibrillation devices are now available for lay use as well. In hospitals, advanced CPR is usually done by a trained team who respond to an urgent call. Advanced CPR techniques include closed-chest compression, intubation with assisted ventilation, electroconversion of arrhythmias, and use of cardiotonic and vasopressive drugs. CPR is an indicated procedure to reverse the effects of cardiopulmonary arrest. However, it is not indicated when a clinical judgment is made that the procedure is unlikely to do so. Therefore, clinicians must recognize situations in which low probability of success dictates a decision to refrain from CPR. The Joint Commission requires that hospitals have an explicit policy regarding CPR. Since the 1960s, those policies have required that CPR be a standing order, that is, CPR is to be performed on any patient who suffers a cardiac or respiratory arrest without needing any written order for the procedure. The policies require that an order be written to authorize omission of CPR for a particular patient. Thus, in contrast to every other hospital procedure, clinicians may withhold CPR only when a specific order states that it should be omitted. This order is designated Do-Not-Resuscitate (DNR) and is frequently called a \"No Code Order.\" Questions have been raised about the standard policy requiring resuscitation except when a specific order authorizes its omission. Some commentators believe that decisions to resuscitate should be an affirmative order based on medical indications and patient preferences. We agree with this position. Under the present policies, however, the decision to write a DNR order should be based on two crucial considerations. The first is the judgment that CPR is not medically indicated in the case, that is, not likely to restore physiological function; it will be futile, in the sense explained in Section 1.2.2. The second consideration is the permission of the patient or of the designated surrogate. The medical futility of the intervention will be treated here; patient preferences, surrogate decisions, and quality of life will be discussed in Topics Two and Three. Lo B. Do not attempt resuscitation orders. In: Lo B, ed. Resolving Ethical Dilem- mas. A Guide for Physicians. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:111-116. Sanders AB. Emergency and trauma medical ethics. In: Singer PA, Viens AM, eds. The Cambridge Textbook of Bioethics. Cambridge: Cambridge University Press; 2008:469--474. **1.3.1 Medical Indications and Contraindications for CPR** All hospitalized patients who suffer unexpected cardiopulmonary arrest should be resuscitated unless the following occurs: \(a) There is conclusive evidence that the patient is dead, such as rigor mortis, exsanguination, or decapitation (physiological futility). \(b) No physiological benefit can be expected, because the patient has de- teriorated despite maximal therapy for such conditions as progressive sepsis or multisystem organ failure (probabilistic futility). \(c) The patient has a valid DNR order. International Resuscitation Guidelines 2000. Part 2: Ethical Aspects of CPR and ECC. Criteria for Not Starting CPR. Resuscitation. 2000;46(1-3):17-27. COMMENT \(a) Cardiopulmonary resuscitation is not indicated when cardiopulmonary arrest occurs as the anticipated end of a terminal illness, and when all treatment options have failed. Because cardiopulmonary arrest is the most frequent cause of death for such patients, a DNR order should be written. \(b) DNR orders are usually first considered when the patient is in a terminal condition and death appears to be imminent. A multicenter study of DNR orders in ICUS showed that fewer than 2% of patients who had DNR orders survived to be discharged from the hospital. These patients are often imminently dying, and thus highly unlikely to benefit from CPR. In such cases, the DNR order allows the patient to die without burdensome resuscitative efforts. This achieves the medical goal of a peaceful death. \(c) In the United States, the rate of DNR orders varies from 3% to 30% among hospitalized patients and between 5% and 20% among patients admitted to ICUs. Sixty-six percent to 75% of hospital deaths and 40% of deaths in ICUs are preceded by a DNR order. Even after adjusting for severity of illness, disparities exist in the use of DNR orders relative to age, race, gender, and geography. Older patients, white patients, and women are more likely to have DNR orders. Some geographic areas have a DNR rate 8 to 10 times higher than that of others. Wenger NS, Pearson ML, Desmond KA, et al. Epidemiology of do-not- resuscitate orders: disparity by age, diagnosis, gender, race, and functional impairment. Arch Intern Med. 1995;155(19):2056-2062. \(d) Studies show that the success of CPR varies with different types of patients. Survival after CPR was more likely in the following situations: (1) for patients with respiratory rather than cardiac arrest; (2) for witnessed cardiac arrests, initial ventricular tachycardia, or fibrillation; (3) for patients with no or few comorbid conditions; (4) for cardiac arrest caused by readily identifiable iatrogenic causes; and (5) for patients who experience a short duration of arrest. Survival is much less likely in patients with pre-existing hypotension, renal failure, sepsis, pneumonia, acute stroke, metastatic cancer, or a homebound lifestyle. One large study of patients older than 65 years who were resuscitated in hospital showed a survival to discharge of 18.3%, with survival rates lower for men, older patients, patients with comorbidities. Survival for black patients was 23.6% lower than for whites. Ehlenbah WJ, Barnato AE, Curtis JR. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009-361: 22-31. \(e) Among patients who experience in-hospital cardiac arrest and who are resuscitated, 10% to 17% survive to hospital discharge. For those patients who survive to discharge, several studies have shown good prognosis, with long-term survival rates of 33% to 54%. Patients who experience cardiac arrest outside the hospital have a 3% to 14% chance of survival to discharge. Among patients who survive arrest in either setting, 11% to 14% have some neurologic impairment at discharge and 26% have some restriction on activities of daily living. \(f) Studies also indicate that even for terminally ill patients, DNR orders are underused, as demonstrated by the disparity between the number of patients who had indicated a preference for such orders in relation to those for whom orders were actually written. Presumably, this happens because of a lack of communication and discussion among physicians, patients, and their families. In our view, physicians have an ethical responsibility to initiate DNR discussions in the following situations: (1) with patients who are terminally ill or patients who have an incurable disease with an estimated 50% survival of less than 3 years; (2) with all patients who suffer acute, life-threatening conditions; and (3) with all patients who request such a discussion. When patients are incapable of discussing DNR orders, physicians should have such discussions with the patients\' surrogate. \(g) Patients and families often overestimate the success of CPR. This misapprehension may be fostered by media versions of CPR. A study of cardiac resuscitation on television hospital dramas showed that 67% of televised \"patients\" survived, in contrast to the much lower numbers in \"real\" clinical situations. Also, many patients have little idea of the nature of resuscitation procedures and, when informed of them, often choose not to have resuscitation. It is essential that patients, their families, and physicians have accurate information on the benefits and risks of CPR so that they can make informed decisions about using CPR or choosing DNR status. Diem SJ, Lantos JD, Tulsky JA. Cardiopulmonary resuscitation on television. Miracles and misinformation. N Engl J Med. 1996;334(24):1578-1582. \(h) DNR orders apply only to decisions about refraining from cardiopulmonary resuscitation and should not influence decisions about interventions other than CPR. DNR orders are often written when doctors, patients, and surrogates intend to withhold or withdraw other life- prolonging treatments. When this is the case, distinct orders should be written specifying which treatments other than CPR should be withheld and under what circumstances. CASE. Mr. Care, the patient with MS, has been admitted to the hospital in coma for treatment of pneumonia and respiratory failure. In the past, he has emphasized to his family and physicians that he did not wish to be placed on permanent mechanical ventilation. Neurologic consultation concludes that his respiratory insufficiency is secondary to the advancing muscular and neurologic deterioration of MS and that respiratory failure was accelerated by his acute pneumonia. Should a DNR order be written? RECOMMENDATIONS. In the case of Mr. Care, recommendations should be made to the family that even if CPR succeeds, the patient would survive only a short time without permanent ventilatory support. Based on the patient\'s prior wishes not to be permanently intubated, a DNR order should be recommended. If the family concurs, a DNR order should be entered. If the family disagrees, an ethics review is mandatory because the fam- ily\'s decision to resuscitate is in conflict with the patient\'s own previously expressed wishes not to be on mechanical ventilation. COMMENT. Decisions to recommend DNR orders are obviously dependent on the clinical situation of each patient. For the immanently dying patient, the very low probability of success supports DNR. For other terminally ill patients, the combination of factors, such as comorbidities and age, must be taken into account in calculating the probability of success (see Sections 1.1.2, 1.1.3, and 3.3). In all cases, it is essential to recognize that CPR is not an innocuous intervention: it can cause serious bruising, broken bones, etc. Also, even if initially successful, another arrest may follow, instigating another resuscitation. Finally, intubation may initiate a life-support situation that itself may generate an ethical problem of futility. Therefore, the most careful evaluation of a patient\'s likelihood of being successfully resuscitated and of being discharged from the hospital is an essential component of an ethical decision to refrain from resuscitation. **1.3.2 Patient Choice of DNR** In addition to terminally ill and dying patients, competent, nonterminally ill patients may initiate discussion of DNR orders with their physicians. For these patients, a DNR order is an important component of advance care planning, allowing them to express preferences about treatment at the end of life, which we discuss more fully in Topic Two. Many of these patients are in the earlier phases of serious diseases, such as metastatic cancer, AIDS, or ALS. They are prepared to forgo resuscitation attempts because they are concerned that even if they are \"successfully\" resuscitated, they may experience anoxic brain damage or some other functional impairment or go on to live through a painful terminal phase of their illness. Physicians should carefully discuss these requests with the patient and honor them. While very few ICU patients with DNR orders survive to hospital discharge, outcomes for nonterminal, seriously ill patients are much better. Several published studies have shown survival to discharge to be as high as 50% to 70%. **1.3.3 DNR Orders Witbout or Contrary to Consent** Ordinarily, the consent of the patient or the patient\'s surrogate is required to write DNR orders. Three situations raise questions about this general rule. (a) A patient may be unable to give consent and no surrogate can be identified. (b) Medical indications may not support the utility of CPR, but surrogates insist that it be done. (c) In an emergency crisis, when survival is highly unlikely. Medical ethicists are divided on the question whether it is ever ethically acceptable for a physician to make a unilateral decision, that is, a decision not to resuscitate without the consent of the patient or the patient\'s surrogate, perhaps even in the face of objections from the patient or surrogate. Those in favor of unilateral decisions argue that no medical procedure that is not indicated, that is, unlikely to effect a positive change in the patient\'s condition, should be performed. Further, they argue that CPR performed in these situations can cause great distress to the patient, adding to the burdens of immanent death. Finally, they note that even a successful resuscitation in the crisis would likely lead to another crisis and another resuscitation attempt, ad infinitum. In such a situation, a physician, they say, should have the right to give a DNR order even without patient or surrogate consent. Those who oppose unilateral decisions maintain that the patient should always have the right to refuse or choose CPR, because a decision about the goals of treatment and the acceptable probability of attaining those goals is a value judgment only the patient can make. Depending on the patient\'s goals, even the remote chance of successful resuscitation may be of value to the patient. These critics also assert that the concept of futility is too vague to be consistently applied. Critics of unilateral DNR also warn that such decisions are open to bias against patients at risk of discrimination (see Section 3.1.1). COMMENT. If the physician has concluded that CPR has no prospect of resuscitating the patient, the physician may recommend that CPR be withheld. If the patient is unable to consent to this recommendation, and no surrogate is available, a DNR order may be written on the basis of futility. If patient or surrogates refuse the recommendation, the physician should seek a second medical opinion about the futility or utility of resuscitation. The \"two doc- tor rule\" is frequently misunderstood. The opinion of a second physician is not equivalent to permission or consent to DNR; it is simply a confirmation of the first clinical opinion that resuscitation would be unlikely to benefit the patient. Serious attempts to reconcile differences of opinion should be undertaken. An ethics consultation should be sought. If no agreement can be reached, the hospital policy on nonbeneficial care should be invoked (see Section 1.2.2). We do not believe that a physician has the right to make a unilateral decision to write a DNR order. A physician may, however, refrain from resuscitation when an arrest occurs, or is likely to occur, in a critical situation in which it is apparent that the patient\'s survival, under any circumstances, is highly unlikely. There- fore, patients arriving in the ER with extreme traumatic injuries, or after being found down for an extended period of time, need not be resuscitated. **1.3.4 Documentation of DNR Orders** Code status should be clear to all who have responsibility for the patient, particularly nurses and house officers. Attending physicians should clearly write and sign the DNR order in the patient\'s chart. The progress notes should include the medical facts and opinion underlying the order and a summary of the discussion with the patient, consultants, staff, and family. Some clear sign of the DNR status should be affixed to the chart, such as a green dot. The status of the order should be changed if the condition of the patient warrants it. Everyone involved with the care of the patient should be informed of the DNR order and its rationale. Because studies have shown that DNR means different things to different practitioners, the physician writing the order must be careful to document the specific terms of the order. The writing of a DNR order should have no direct bearing on any treatment other than CPR. If a DNR order has not been written, the patient is presumed to be \"full code.\" Code status should be re-evaluated at each hospital admission. **1.3.5 DNR Portability** Patients for whom DNR orders have been written in the hospital may be discharged with the expectation that they will die soon. Often, patients want to die in their own homes rather than in the hospital. Family members sometimes summon emergency services if these patients suffer a crisis at home. Traditionally, emergency medical service providers, because of the time constraints inherent in emergency services, were not responsible for determining whether a patient had an advance directive. They attempted to resuscitate all patients regardless of the patients\' preferences. In recent years, a method of protecting an individual\'s preference not to be resuscitated has been devised. This is called a \"portable\" DNR. These are orders issued by the patient\'s discharging physician, stated in a standard form, and indicated on bracelets, necklaces, or wallet cards. When the patient has this order, emergency technicians are authorized to refrain from CPR, although all other necessary treatments can still be provided. Almost every state now has laws or regulations mandating that EMS providers comply with out- of-hospital DNRs. Once the emergency care provider has verified that the order appears valid and that the patient is the person who has executed it, the provider cannot commence CPR except in certain circumstances, such as when the patient renounces the document. **1.3.6 POLST Orders (Physicians Orders for Life-Sustaining Treatment)** The POLST paradigm is a physician\'s order form that contains a summary of a patient\'s choices about the nature and extent of life-sustaining procedures that they wish to have done or omitted. The form contains four sections-A: Cardiopulmonary Resuscitation; B: Medical Interventions, that is, comfort measures only, limited interventions or full treatment; C: artificially administered nutrition; and D: summary of medical condition. POLST is a physician order and is signed by the physician. But unlike most physician orders, it is also signed by the patient or the surrogate. It should be a part of the patient\'s hospital record. The primary purpose of POLST is to record all the patient\'s wishes in a single document and ensure that these wishes follow the patient across different health care set- tings, for example, from the acute care hospital to a skilled nursing facility. When suitable state law and regulation allows, emergency medical personnel, as well as other providers, may honor the POLST directives. As of 2010, Washington, Oregon, California, West Virginia, North Carolina, Tennessee, and New York have recognized POLST. **1.3.7 \"Slow Codes\" and \"Partial Codes\"** The term \"slow code\" describes a subterfuge in which doctors and nurses respond slowly to a cardiac arrest and perform CPR without energy or enthusiasm to pretend that something is being done. This might be done in two circumstances: (1) when the medical team feels that resuscitation would be futile, but no discussion has taken place with the patient or the family, or (2) when the family has chosen resuscitation, although the team feels it would be useless. Some clinicians justify the \"slow code\" by suggesting that it assuages the guilt of a family who are distressed that they have not \"done everything\" for their loved one. A slow code is crass dissimulation and unethical. The expression \"partial code\" or \"chemical code\" refers to the practice of separating the various interventions that constitute resuscitation and using them selectively; for example, chest compression, assisted breathing by resuscitator bag, and cardiotonic drugs may be ordered, but electrocardioversion and intubation may be omitted. Although there may be occasional justification for such a procedure, it must be recognized that what is being done is not cardiopulmonary resuscitation in the proper sense. In our view, CPR is an integral procedure of several constituents and all these constituents should be applied unless a patient has clearly expressed preferences to the contrary. **1.3.8 DNR Orders in the Operating Room** Patients may suffer a cardiac arrest in the course of a surgical intervention. In such cases, anesthesiologists immediately initiate resuscitation. Occasionally, patients for whom a DNR order has been written, such as patients with terminal cancer, may require a palliative surgical procedure, such as emergency relief of a bowel obstruction to relieve pain or the elective insertion of a gastrostomy tube or a central venous catheter. The question is whether the DNR order should be suspended automatically during anesthesia or surgery so that resuscitation would be performed if the patient experienced a perioperative cardiac arrest. The arguments favoring automatic suspension of DNR are as follows: (1) anesthesia and surgery place patients at risk for cardiac and hemodynamic instability; (2) most arrests in the operating room are reversible, because skilled personnel and equipment are at hand; (3) in consent- ing to surgery, the patient can be assumed to give implied consent for resuscitation; and (4) surgeons and anesthesiologists should not be pre- vented from treating potentially reversible situations, especially because they do not wish deaths of terminally ill patients to be considered surgical deaths when standard resuscitative techniques have been prohibited. In one study, the majority of anesthesiologists assumed that DNR was implicitly suspended during surgery, and only half of anesthesiologists discussed this assumption with the patient or the surrogate. Those opposed to automatic suspension of DNR orders note that such a policy ignores patients\' rights and violates the standards of informed consent. Critics of automatic suspension deny that consent of the patient should be \"implied.\" They suggest that a terminally ill patient may welcome a perioperative arrest as relief from a painful death. They recommend a policy of \"required reconsideration.\" The patient who consents to elective surgery faces a different risk-benefit situation, and this merits a reevaluation of the DNR order. A specific discussion about DNR should occur between the attending physicians and surgeons and the patient or surrogates. As the result of this discussion, the DNR order should either be affirmed or suspended in anticipation of surgery. The major professional associations of surgeons, anesthesiologists, and nurses have endorsed this policy, and we recommend it as the most prudent course. A surgeon or anesthesiologist may withdraw from a case if he or she judges that failure to resuscitate intraoperatively is unethical. Another approach to this problem is to develop DNR orders that list the goals of the patient and that permit the surgeon and anesthesiologist to use their clinical judgment to try to achieve the patient\'s goals. Therefore, if the patient fears anoxic brain damage and experiences ventricular tachycardia that is promptly corrected by cardioversion, the patient\'s goal of avoiding brain damage will be met. Alternatively, if the patient experiences 15 or more minutes of cardiac arrest, secondary to an intraoperative MI, the surgeon and the anesthesiologist may stop CPR to respect the patient\'s wish not to survive with neurologic damage. Statement of the American College of Surgeons. Advance directive by patients: do not resuscitate in the operating room. Bull Am Coll Surg. 1994;79(9):29. Van Norman G. Anesthesiology ethics. In: Singer PA, Viens AM, eds. The Cam- bridge Textbook of Bioethics. New York, NY: Cambridge University Press; 2008:454-461. 1.4 MEDICAL ERROR ----------------- Physicians not only work under uncertainty, but they also make mistakes. An Institute of Medicine report (1999) on medical error estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors-more than the number who die from vehicular accidents or from breast cancer or AIDS. In that report, error was defined as the failure of a planned action to be completed as intended, or as the use of a wrong plan to achieve an aim. The report highlighted the personal and financial costs of error and noted that some errors were due to incompetence or errors of judgment by competent physicians. Other errors were caused by system failures that often went unrecognized and uncorrected. Following the IOM report, serious efforts have been launched to reduce medical error by increased reporting and analysis of error, by focusing on hospital safety through use of computerized orders and medical records, by establishing patient safety indicators, and by attempting to alleviate the effects of fatigue for house staff and nurses. Our definition of medical error is an unintentional lapse in a process usually done efficiently and effectively due to (1) inadequate information and/or (2) mistaken judgment and/or (3) defective maneuvers that may or may not be negligent, and may or may not cause harm. Every instance of presumptive error should be analyzed in terms of these elements. It is most important to determine whether or not the error was due to negligence, that is, a performance that peers in a specialty would judge as a departure from accepted standards of practice. Medical error raises ethical problems related to truth telling, which will be discussed at Section 2.1.11. Systemic error describes clinical systems or record-keeping systems that, due to unclarity or inadequacy, lead clinicians to make mistakes. For example, the abbreviation \"u\" to designate \"units of insulin\" can easily be read as \"0,\" such that 10 units is read as 100 units. Systemat

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