SPECIAL EDITORIAL
Ethical Considerations for Surgeons Shrikant Mali, MDS ETHICAL CONSIDERATIONS FOR SURGEONS
The surgeon is a unique medical professional in that “any operation performed harms before healing. Consequently, by striving to minimise this necessary temporary injury to the patient while maximising the therapy's curative potential, surgeons have forever engaged in ethical deliberations.” Surgeons are responsible for all activities related to patients' treatment and care in surgical units, and it is therefore important for them to act in the best and correct way toward patients, relatives, and colleagues. The primary surgeon in whose hands the patient has placed his care remains legally and ethically responsible for the patient's outcome. It is neither unethical nor illegal for a trainee to be performing a procedure under the close supervision and assistance of the expert. It is the responsibility of the senior to ensure that the quality of care delivered and procedure done are of a high standard. An operation is an exercise in trust. The surgeon must assure himself/herself that all members of the team are up to the demanding performance expected of them at that specific time and under those specific circumstances. This means that he/she is putting his/her trust in the hospital where he/she works and all the people bearing even peripheral responsibility for the success of the undertaking, whether they work under his/her direct supervision. “Postoperative care starts in the operating room.” Hemodynamic instability thrashes the biochemical foundations of life, particularly in those who can least afford the insult. Surgeons work hard to get the patient off the roller coaster as quickly as possible. Fortunately, most of the time, surgeons avoid the painful slow deterioration experienced by this man and his family. When surgical therapy goes dreadfully wrong, there is a different connotation about responsibility, whether what went wrong occurred in the operating room or afterward. With postoperative problems, it seems the patient's body failed, whereas problems developing in the operating room imply that the surgeon's skills were not up to the task. After long difficult procedures, especially emergency procedures, fatigue takes 2 different forms. If the patient is doing well, the surgeon is tired and happy. If the patient is dead or not doing well, the surgeon is depleted. Surgical organizations and surgeons have traditionally had less interest in ethics discussion than their medical colleagues. Most What Is This Box? A QR Code is a matrix barcode readable by QR scanners, mobile phones with cameras, and smartphones. The QR Code links to the online version of the article.
From the Mahatma Gandhi Vidya Mandir Karamveer Bhaurao Hiray Dental College, Nashik, Maharashtra, India. Address correspondence and reprint requests to Shrikant Mali, MDS, Flat no 2, Jyoti Savitri Apt, above Bank of Maharashtra, Ashoka Marg Nashik, Maharashtra, India; E-mail: [email protected] The author reports no conflicts of interest. Copyright © 2014 by Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000001292
6
surgeons are viewed by colleagues and society as like a cavalier and “cowboy” in attitude. A daring surgeon is rated better than one who shows ethical concerns about the treatment he/she is about to deliver. However, given a choice, most patients would like to place themselves in the hands of the latter. Surgeons also share a unique relationship with their patient. The invasive and potentially lifethreatening nature of surgical therapy demands a high level of faith from the patient. As compared with a medical patient who, to some degree, always has control over his treatment, a surgical patient places his/her life entirely in the hands of his/her surgeon. Therefore, there exists an increased need to know more about ethics pertaining to surgeons in particular, and this has led to renewed interest by them in the discussion of bioethics issues. The field of ethics, also called moral philosophy, involves systematizing, defending, and recommending concepts of right and wrong behaviors. Ethical considerations, such as diagnosis and treatment, are essential features of the surgical care for each patient. In ethical terms, it is not only what a surgeon does that is important but also how he/she does it. As surgeons, we study to achieve specialized knowledge and supplement this with training and experience. Our patients and our governments grant us certain privileges but expect us to be guided by ethical principles. We set the standards for entry, assessment, training, and certification into our specialty and seek to ensure these standards are maintained throughout a professional lifetime. Our patients allow us the right, after careful explanation, to perform operations upon them, which cannot be free of potential complications. Everyone is vulnerable, and it is reasonable to suggest that surgeons are especially vulnerable in their professional role as it often concerns questions about life and death and issues that affect the patients' quality of life. Surgeons today are confronted with more ethical dilemmas than before because of the growth in scientific knowledge, an increase in the availability and efficiency of medical technology, a more equal relationship between patients and surgeons, and changes in the organizational arrangement and financing of the healthcare system. The growth in scientific knowledge and technology has given surgeons new and better diagnostic equipment and treatment opportunities. The development of better anesthetic methods and less invasive surgical techniques has made it possible to increase the frequency of surgery and perform rather extensive operations in outpatient facilities. The frequency of surgical treatment is expanding, and surgeons are able to successfully operate older patients and patients with multiple and more serious diseases than before. New treatment opportunities have increased the number of possible ethical dilemmas in surgical practice and put heavy pressure on the individual surgeon who has a personal responsibility for all decisions concerning the patients' treatment and care. Economic factors are said to increasingly determine the patterns of clinical work, either directly or indirectly, and surgeons experience the ethical dilemma of allocating limited resources. The fear of being sued can lead to defensive medicine and reduced trust between physicians and their patients. Healthcare is increasingly perceived as a commodity; consumerism may lead surgeons to spend more time attending to patients' wants than before, and this has made the surgeons' work more complicated. Ethical considerations cannot be avoided when surgeons have to
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
choose between what ought to be done among the many courses of action that are available for patients in particular situations. If surgeons adhered too closely to the aphorism “first, do no harm” (primum non nocere), they would never operate. More so than their colleagues in other specialties, surgeons often deliberately inflict harm to benefit the patient. Opening the belly or sawing open the skull invariably causes harm. Unpleasant side effects are common. Beneficence, nonmaleficence, and confidentiality, originally described by the earliest records of the oath, continue to be the guiding principles for surgical care into the 21st century. The foundation of medical ethics is supported by 4 pillars: • Autonomy: patient has the right to choose or refuse the treatment. Respect the capacity of individuals to make their own choices and act accordingly. • Beneficence: a doctor should act in the best interest of the patient. Relieve pain and suffering; foster the interests and well-being of other persons and society. • Nonmaleficence: first, do no harm. • Justice: it concerns the distribution of health resources equitably. Added to the abovementioned 4 pillars are 2 more aspects, which form the cornerstones of medical practice: • Dignity: the patient and the persons treating the patient have the right to dignity. • Truthfulness and honesty: the concept of informed consent and truth telling. For a patient to make a fully informed decision, he must understand all risks and benefits of the procedure and the likelihood of success. This requires that the patient be well informed during the consent process. Patients may choose among treatment options or refuse care, even if the recommended treatment is lifesaving. Disclosure refers to the provision of relevant information by the surgeon and its comprehension by the patient. Opposite to a common surgeon's belief, most patients want to know about the nature of their illness, the reason for surgery, and so forth. Withholding information during the consent process in the belief that disclosure would lead to the harm or suffering of the patient is called “therapeutic privilege.” Voluntariness refers to the patient's right to come to a decision freely, without force, coercion, or manipulation. Internal and external factors can affect the patient's decision about treatment. The concept of autonomy is rooted in the right of the individual to make decisions regarding personal matters. Autonomy requires that the patient have autonomy of thought, intention, and action when making decisions regarding healthcare procedures. It also justifies the patient's right to refuse any treatment and to be informed of the consequences of the treatment. The surgeon-patient relationship has been described as an often-conflicting power dichotomy. An extreme on the side of patient autonomy denies any room for surgeon decision making. The “physician's role is to disclose factual information about diagnosis, prognosis, treatment options, etc. A patient's role, on the other hand, is to inform his or her physician about values and preferences concerning treatment.” The assumption here seems to be that all value judgments should be the patient's responsibility. Paternalism, as the opposite of the informative model, often involves some form of interference with or refusal to conform to patients' preferences. Surgeons should take steps to minimize the potential for manipulation. Patients can be manipulated when the information they receive is incomplete or biased. For this reason, a useful strategy is to ask patients to review information in their own words. Another source of manipulation is disclosing information just before a major procedure has to be performed. The setting (ie, operating room) and the immediacy of the medical procedure militate against a patient
Special Editorial
being able to make a free or voluntary decision. A “do not resuscitate” order is withholding of cardiopulmonary resuscitation—this includes management of airway, intubation, and pharmacologic interventions to stimulate the heart, chest compressions, and defibrillation. Beyond the intent to help the patient, beneficence further demands that surgeon develop and maintain skills and knowledge specific to the patient population that they care for such that they may provide the best possible care. One is ethically required to continually update training, maintain appropriate knowledge and skill, consider individual circumstances of all patients and evidencebased medicine as it applies to the individual patient, and strive for net benefit. The ethical issues discussed under the principle of beneficence—technical ability; recognition of the limits of one's competence; the ability to exercise good judgment; adequate selfcare; strict infection control measures; mechanical checks of systems and equipment; and the need for research, quality improvement, and continuous professional development—all contribute to reducing the occurrence of surgical complications and also fall under the principle of nonmaleficence. If the intent of therapy constitutes beneficence, even if it results in harm, it is ethically justified based on double effect. The principle of double effect allows the surgeon to perform surgery and aggressively treat pain and suffering if the intent is to do good with the understanding that the side effect of the treatment may harm the patient. The fourth ethical principle, justice, concerns the distribution of resources that may be scarce and also seeks to protect vulnerable populations. Justice mandates that the burdens and benefits of treatment, even new or experimental treatments, must be distributed equally among all groups in society including the old people. Medical futility has been defined as “a clinical action serving no useful purpose in attaining a specified goal for a given patient.” It occurs when (1) there is a defined goal, (2) an action is directed at achieving this goal, and (3) there is virtual certainty that the action will fail in achieving this goal. The American Medical Association states that physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. In communicating with families, surgeon must distinguish between aggressive treatments that may be futile to prolong life and those that are beneficial as they provide comfort. Pain control, respect for patient dignity, and reassurance of the patient and/or surrogate that the medical team will not abandon care even when specific treatments are deemed futile are of utmost importance.
Surgical Research/Development of New Techniques Surgeons are generally conservative guardians, given to using traditional techniques that have been validated by years of experience. This trait is expressed daily in the operating room in the ritualized routines used for skin preparation, draping, and conduct of orderly procedures. As a general rule, new procedures introduced in the past have been carefully worked out in the animal laboratory and in the dissecting room of the anatomy or pathology department. They have been presented for approval to colleagues. New procedures may be disapproved by credentials committees, operating room committees, research ethics boards, or the surgeon-in-chief. There is a perception, however, that surgical procedures, both well established and innovative, are held to a less-rigorous standard than are medical treatments, both ethically and methodologically, resulting in procedures being “smuggled” into practice without proper review. Surgeons prefer to rely on case series, a type of study that tracks individual patients and records their outcomes but does not compare the procedure with an alternative. Because most case series tend to favor any given intervention, multiple similar reports reinforce a possibly mistaken view that the surgery provides benefits.
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
7
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
Special Editorial
It is probably true that most proposed surgical innovations would not pass the internal review board of the hospital and would be dropped at the drawing board stage. Great surgical procedures have evolved out of an exploratory mode. Improvement came simultaneously from many areas, including anesthesia, life-saving equipments, and surgical techniques. It is unlikely and probably unreasonable that surgery shall ever fit the traditional “regulatory ethics paradigm.” Surgical innovation is acceptable because it focuses on patients and is clinically driven. As the need for more rigorous evaluation of surgical research is recognized, so too is the need for proper application of ethical principles and oversight to that research. New surgical techniques are often not innovations so much because of evolution and improvements. Successive adaptations of existing techniques lead to the emergence of new procedures that are not radical innovations produced by a specific research program but part of a continuum formed by the evolution of day-to-day practices. Occasionally, new procedures arise in dramatic circumstances when surgeons, often in an emergency, decide to try a new approach although there is no adequate statistical support for its efficacy. If they are successful, their techniques may subsequently form the basis of new protocols and be routinely applied. In other words, surgical innovation is mainly the result either (rarely) of bold experimentation or (more frequently) of historic observations. Innovation through deviation from standard practice is an important means of improving surgical care and needs to be encouraged even if results may not always turn out as expected. Fraud in surgical research is as unethical as in any other area. Modification of research proposals, toning them down for easy ethical committee clearance, and the desire to better one's results by paying less attention to ethics are unacceptable. Publication of fabricated data, plagiarism, and “gift” authorship are among the well-known unethical practices. Surgical audit should be an essential part of surgical practice to assess the quality of care being provided and to improve the outcome. The evidence collected would guide and influence surgical practices and possibly change them for the better. A particular method of treatment or an operative procedure can no longer be left to personal whims and fancies, because alternatives abound and the choice would depend upon the given setup, infrastructure, and the level of professional competence available. The best and safest surgical procedure in a given clinical situation is the one that provides the best clinical outcome. Such procedures have to be identified, and only those that provide optimum benefit ought to be practiced on a regular basis.
Informed Consent The concept of patient consent for medical procedures evolved during the 20th century as a reaction to the cruelties committed by Nazi concentration camp “doctors.” The core principles of the 10-point Nuremberg Code include voluntary informed consent, lack of coercion, properly formulated experiments, and beneficence toward participants. The Nuremberg Code has been largely superseded by the World Medical Association's Declaration of Helsinki, last revised in 2008. The Nuremburg code established the concept of informed consent for research participants to include a requirement that research benefit societal good and patients be informed and volunteer to participate of their own free will without coercion. The process requires a competent physician, adequate transfer of information, and consent of the patient. In the event that a patient is unable to give consent, a surrogate may consent on the patient's behalf. Poor communication, both in the preoperative conversation about risks and benefits and postoperatively when complications have arisen, can lead to considerable and avoidable emotional
8
distress. Surgeons should communicate appropriately not only to patients but also to the other members of the team, from the anesthetist to the operating theater assistant. The surgeon's obligations regarding informed consent should be understood to be primarily moral as well as legal. Without a doubt, the surgeon doing the procedure is the best person to obtain consent. The basic elements of informed consent include preconditions, information, and consent. Preconditions for informed consent include patient competence to make decisions and the patient's willingness to participate in the consent process. Information is the body of facts provided by the surgeon to the patient such that the patient has sufficient knowledge to make a decision. The purpose of informed consent is not to give the patient a mini-medical education. It is to give the patient sufficient information to understand that the patient is being asked to authorize surgery, what the surgery involves, and its expected outcomes. True surgical informed consent consists of name of the procedure, detailed explanation of the procedure in layman's terms and in a language that is easily understood by the patient, risks of the procedure and their effects on lifestyle, reasonable alternatives, and competency of the patient. The patient acknowledges that they understand the procedure or treatment offered and authorizes proceeding with the intended treatment. It is not necessary for the consent to be written. In a life-threatening situation or a situation where written consent cannot be obtained, a verbal consent is adequate. In the interests of the physician, a written consent is preferable. Likewise, consent can be retracted verbally by the patient. All invasive procedures and, sometimes, noninvasive procedures (such as HIV testing) require consent. Under ideal circumstances, the taking of informed consent should occur a few days before surgery to facilitate unhurried, uncoerced decision making; to obtain more information; to discuss the matter with family members; and to review the decisions made. As an alternative to quoting actual figures of complication risks, a verbal scale from very high, to moderate, to very low, up to negligible could be used. The use of “up-to-date written material, visual and other aids to explain complex aspects of treatment where appropriate and/or practicable.” It is the duty of the surgeon to inform the patient about the costs to be incurred and how they are expected to pay. A competent patient is one who (1) understands his/her situation, (2) understands the risks associated with the decision at hand, and (3) can communicate a decision based on that understanding. A competent patient may become temporarily incompetent once premedicated preoperatively. Therefore, it is imperative that all strong premedication be withheld until the consent process is completed. It is not justifiable to withhold pain relievers from a suffering patient under the pretext of obtaining consent, for that might amount to some form of coercion. However, numerous studies on this issue have demonstrated that these patients take the same decision in the preoperative room as otherwise. It therefore seems justified to continue taking consents in the preoperative room. Minors by definition are incompetent and must be decided for by the parents/caregivers. General rules to follow in consent for surgery and anesthesia are to inform the patient of common risks even if they are not serious and very serious risks, such as death, even if they are not common. It is unreasonable to expect that a physician would explain all the risks associated with a procedure, including anecdotal ones, as the list may run into several pages. The informed consent process requires that a separate discussion of anesthesia risks be carried out by the anesthesia provider. There is no “legally foolproof ” consent form. A signed consent form of any nature neither guarantees a physician protection against legal action nor ensures patient satisfaction. It merely demonstrates that some process to exchange information was followed. © 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
Moral action requires both the possession of virtues and knowledge of moral principles because, to discharge the duties required by the principles, a surgeon must exercise discernment, integrity, benevolence, trustworthiness, humility, conscientiousness, and other virtues. A conscientious surgeon approaching retirement age may acknowledge that his/her eyesight is failing and that minute vascular work is proving far tougher than previously. Surgeons have a duty to stop operating when their health leads to substandard care. The incidence of surgical complications due to human error is likely to increase with lack of sleep, poor concentration, stress, and other physical and psychologic deficiencies. Faulty equipment compromises patient care and increases the likelihood of surgical complications. Thoroughness and meticulousness can be viewed as aspects of the virtue of conscientiousness that are especially pertinent to the ethical surgeon. A high measure of thoroughness in the operating theater and in the surgeon's professional and educational development is necessary for ensuring the highest standards of patient care and the lowest rates of complications. The duty of honesty requires the surgeon, in all but the most exceptional
Special Editorial
circumstances where serious harm may realistically result, to specify whether the complication was caused by an error. This requirement also falls within the principle of justice as the patient has a right to this information. The patient may be entitled to compensation. As surgeons, our dealings with those industries that provide our medicines and devices must be clear cut, open, and defined. Benefits should be a simple recompense for out-of-pocket expense, for the design and delivery of new products, to support the education of our trainees and less-advantaged surgical fraternity and to encourage research, wherever possible through a nonpersonal institutional structure. Any benefits should be documented and recorded, not just in our own notes but in our institutions. Our patients should be told whether we benefit from the implants we use, whether by royalty, consultancy fee, or contract. We should be absolutely transparent in declaring any conflict of interest in articles, research projects, and lectures. We cannot simply look back to a perfect world where all surgeons were supposedly above reproach and revered. As associations, however, we should set standards that reassure our patients.
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
9
Ethical Considerations for Surgeons Shrikant Mali, MDS ETHICAL CONSIDERATIONS FOR SURGEONS
The surgeon is a unique medical professional in that “any operation performed harms before healing. Consequently, by striving to minimise this necessary temporary injury to the patient while maximising the therapy's curative potential, surgeons have forever engaged in ethical deliberations.” Surgeons are responsible for all activities related to patients' treatment and care in surgical units, and it is therefore important for them to act in the best and correct way toward patients, relatives, and colleagues. The primary surgeon in whose hands the patient has placed his care remains legally and ethically responsible for the patient's outcome. It is neither unethical nor illegal for a trainee to be performing a procedure under the close supervision and assistance of the expert. It is the responsibility of the senior to ensure that the quality of care delivered and procedure done are of a high standard. An operation is an exercise in trust. The surgeon must assure himself/herself that all members of the team are up to the demanding performance expected of them at that specific time and under those specific circumstances. This means that he/she is putting his/her trust in the hospital where he/she works and all the people bearing even peripheral responsibility for the success of the undertaking, whether they work under his/her direct supervision. “Postoperative care starts in the operating room.” Hemodynamic instability thrashes the biochemical foundations of life, particularly in those who can least afford the insult. Surgeons work hard to get the patient off the roller coaster as quickly as possible. Fortunately, most of the time, surgeons avoid the painful slow deterioration experienced by this man and his family. When surgical therapy goes dreadfully wrong, there is a different connotation about responsibility, whether what went wrong occurred in the operating room or afterward. With postoperative problems, it seems the patient's body failed, whereas problems developing in the operating room imply that the surgeon's skills were not up to the task. After long difficult procedures, especially emergency procedures, fatigue takes 2 different forms. If the patient is doing well, the surgeon is tired and happy. If the patient is dead or not doing well, the surgeon is depleted. Surgical organizations and surgeons have traditionally had less interest in ethics discussion than their medical colleagues. Most What Is This Box? A QR Code is a matrix barcode readable by QR scanners, mobile phones with cameras, and smartphones. The QR Code links to the online version of the article.
From the Mahatma Gandhi Vidya Mandir Karamveer Bhaurao Hiray Dental College, Nashik, Maharashtra, India. Address correspondence and reprint requests to Shrikant Mali, MDS, Flat no 2, Jyoti Savitri Apt, above Bank of Maharashtra, Ashoka Marg Nashik, Maharashtra, India; E-mail: [email protected] The author reports no conflicts of interest. Copyright © 2014 by Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000001292
6
surgeons are viewed by colleagues and society as like a cavalier and “cowboy” in attitude. A daring surgeon is rated better than one who shows ethical concerns about the treatment he/she is about to deliver. However, given a choice, most patients would like to place themselves in the hands of the latter. Surgeons also share a unique relationship with their patient. The invasive and potentially lifethreatening nature of surgical therapy demands a high level of faith from the patient. As compared with a medical patient who, to some degree, always has control over his treatment, a surgical patient places his/her life entirely in the hands of his/her surgeon. Therefore, there exists an increased need to know more about ethics pertaining to surgeons in particular, and this has led to renewed interest by them in the discussion of bioethics issues. The field of ethics, also called moral philosophy, involves systematizing, defending, and recommending concepts of right and wrong behaviors. Ethical considerations, such as diagnosis and treatment, are essential features of the surgical care for each patient. In ethical terms, it is not only what a surgeon does that is important but also how he/she does it. As surgeons, we study to achieve specialized knowledge and supplement this with training and experience. Our patients and our governments grant us certain privileges but expect us to be guided by ethical principles. We set the standards for entry, assessment, training, and certification into our specialty and seek to ensure these standards are maintained throughout a professional lifetime. Our patients allow us the right, after careful explanation, to perform operations upon them, which cannot be free of potential complications. Everyone is vulnerable, and it is reasonable to suggest that surgeons are especially vulnerable in their professional role as it often concerns questions about life and death and issues that affect the patients' quality of life. Surgeons today are confronted with more ethical dilemmas than before because of the growth in scientific knowledge, an increase in the availability and efficiency of medical technology, a more equal relationship between patients and surgeons, and changes in the organizational arrangement and financing of the healthcare system. The growth in scientific knowledge and technology has given surgeons new and better diagnostic equipment and treatment opportunities. The development of better anesthetic methods and less invasive surgical techniques has made it possible to increase the frequency of surgery and perform rather extensive operations in outpatient facilities. The frequency of surgical treatment is expanding, and surgeons are able to successfully operate older patients and patients with multiple and more serious diseases than before. New treatment opportunities have increased the number of possible ethical dilemmas in surgical practice and put heavy pressure on the individual surgeon who has a personal responsibility for all decisions concerning the patients' treatment and care. Economic factors are said to increasingly determine the patterns of clinical work, either directly or indirectly, and surgeons experience the ethical dilemma of allocating limited resources. The fear of being sued can lead to defensive medicine and reduced trust between physicians and their patients. Healthcare is increasingly perceived as a commodity; consumerism may lead surgeons to spend more time attending to patients' wants than before, and this has made the surgeons' work more complicated. Ethical considerations cannot be avoided when surgeons have to
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
choose between what ought to be done among the many courses of action that are available for patients in particular situations. If surgeons adhered too closely to the aphorism “first, do no harm” (primum non nocere), they would never operate. More so than their colleagues in other specialties, surgeons often deliberately inflict harm to benefit the patient. Opening the belly or sawing open the skull invariably causes harm. Unpleasant side effects are common. Beneficence, nonmaleficence, and confidentiality, originally described by the earliest records of the oath, continue to be the guiding principles for surgical care into the 21st century. The foundation of medical ethics is supported by 4 pillars: • Autonomy: patient has the right to choose or refuse the treatment. Respect the capacity of individuals to make their own choices and act accordingly. • Beneficence: a doctor should act in the best interest of the patient. Relieve pain and suffering; foster the interests and well-being of other persons and society. • Nonmaleficence: first, do no harm. • Justice: it concerns the distribution of health resources equitably. Added to the abovementioned 4 pillars are 2 more aspects, which form the cornerstones of medical practice: • Dignity: the patient and the persons treating the patient have the right to dignity. • Truthfulness and honesty: the concept of informed consent and truth telling. For a patient to make a fully informed decision, he must understand all risks and benefits of the procedure and the likelihood of success. This requires that the patient be well informed during the consent process. Patients may choose among treatment options or refuse care, even if the recommended treatment is lifesaving. Disclosure refers to the provision of relevant information by the surgeon and its comprehension by the patient. Opposite to a common surgeon's belief, most patients want to know about the nature of their illness, the reason for surgery, and so forth. Withholding information during the consent process in the belief that disclosure would lead to the harm or suffering of the patient is called “therapeutic privilege.” Voluntariness refers to the patient's right to come to a decision freely, without force, coercion, or manipulation. Internal and external factors can affect the patient's decision about treatment. The concept of autonomy is rooted in the right of the individual to make decisions regarding personal matters. Autonomy requires that the patient have autonomy of thought, intention, and action when making decisions regarding healthcare procedures. It also justifies the patient's right to refuse any treatment and to be informed of the consequences of the treatment. The surgeon-patient relationship has been described as an often-conflicting power dichotomy. An extreme on the side of patient autonomy denies any room for surgeon decision making. The “physician's role is to disclose factual information about diagnosis, prognosis, treatment options, etc. A patient's role, on the other hand, is to inform his or her physician about values and preferences concerning treatment.” The assumption here seems to be that all value judgments should be the patient's responsibility. Paternalism, as the opposite of the informative model, often involves some form of interference with or refusal to conform to patients' preferences. Surgeons should take steps to minimize the potential for manipulation. Patients can be manipulated when the information they receive is incomplete or biased. For this reason, a useful strategy is to ask patients to review information in their own words. Another source of manipulation is disclosing information just before a major procedure has to be performed. The setting (ie, operating room) and the immediacy of the medical procedure militate against a patient
Special Editorial
being able to make a free or voluntary decision. A “do not resuscitate” order is withholding of cardiopulmonary resuscitation—this includes management of airway, intubation, and pharmacologic interventions to stimulate the heart, chest compressions, and defibrillation. Beyond the intent to help the patient, beneficence further demands that surgeon develop and maintain skills and knowledge specific to the patient population that they care for such that they may provide the best possible care. One is ethically required to continually update training, maintain appropriate knowledge and skill, consider individual circumstances of all patients and evidencebased medicine as it applies to the individual patient, and strive for net benefit. The ethical issues discussed under the principle of beneficence—technical ability; recognition of the limits of one's competence; the ability to exercise good judgment; adequate selfcare; strict infection control measures; mechanical checks of systems and equipment; and the need for research, quality improvement, and continuous professional development—all contribute to reducing the occurrence of surgical complications and also fall under the principle of nonmaleficence. If the intent of therapy constitutes beneficence, even if it results in harm, it is ethically justified based on double effect. The principle of double effect allows the surgeon to perform surgery and aggressively treat pain and suffering if the intent is to do good with the understanding that the side effect of the treatment may harm the patient. The fourth ethical principle, justice, concerns the distribution of resources that may be scarce and also seeks to protect vulnerable populations. Justice mandates that the burdens and benefits of treatment, even new or experimental treatments, must be distributed equally among all groups in society including the old people. Medical futility has been defined as “a clinical action serving no useful purpose in attaining a specified goal for a given patient.” It occurs when (1) there is a defined goal, (2) an action is directed at achieving this goal, and (3) there is virtual certainty that the action will fail in achieving this goal. The American Medical Association states that physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. In communicating with families, surgeon must distinguish between aggressive treatments that may be futile to prolong life and those that are beneficial as they provide comfort. Pain control, respect for patient dignity, and reassurance of the patient and/or surrogate that the medical team will not abandon care even when specific treatments are deemed futile are of utmost importance.
Surgical Research/Development of New Techniques Surgeons are generally conservative guardians, given to using traditional techniques that have been validated by years of experience. This trait is expressed daily in the operating room in the ritualized routines used for skin preparation, draping, and conduct of orderly procedures. As a general rule, new procedures introduced in the past have been carefully worked out in the animal laboratory and in the dissecting room of the anatomy or pathology department. They have been presented for approval to colleagues. New procedures may be disapproved by credentials committees, operating room committees, research ethics boards, or the surgeon-in-chief. There is a perception, however, that surgical procedures, both well established and innovative, are held to a less-rigorous standard than are medical treatments, both ethically and methodologically, resulting in procedures being “smuggled” into practice without proper review. Surgeons prefer to rely on case series, a type of study that tracks individual patients and records their outcomes but does not compare the procedure with an alternative. Because most case series tend to favor any given intervention, multiple similar reports reinforce a possibly mistaken view that the surgery provides benefits.
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
7
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
Special Editorial
It is probably true that most proposed surgical innovations would not pass the internal review board of the hospital and would be dropped at the drawing board stage. Great surgical procedures have evolved out of an exploratory mode. Improvement came simultaneously from many areas, including anesthesia, life-saving equipments, and surgical techniques. It is unlikely and probably unreasonable that surgery shall ever fit the traditional “regulatory ethics paradigm.” Surgical innovation is acceptable because it focuses on patients and is clinically driven. As the need for more rigorous evaluation of surgical research is recognized, so too is the need for proper application of ethical principles and oversight to that research. New surgical techniques are often not innovations so much because of evolution and improvements. Successive adaptations of existing techniques lead to the emergence of new procedures that are not radical innovations produced by a specific research program but part of a continuum formed by the evolution of day-to-day practices. Occasionally, new procedures arise in dramatic circumstances when surgeons, often in an emergency, decide to try a new approach although there is no adequate statistical support for its efficacy. If they are successful, their techniques may subsequently form the basis of new protocols and be routinely applied. In other words, surgical innovation is mainly the result either (rarely) of bold experimentation or (more frequently) of historic observations. Innovation through deviation from standard practice is an important means of improving surgical care and needs to be encouraged even if results may not always turn out as expected. Fraud in surgical research is as unethical as in any other area. Modification of research proposals, toning them down for easy ethical committee clearance, and the desire to better one's results by paying less attention to ethics are unacceptable. Publication of fabricated data, plagiarism, and “gift” authorship are among the well-known unethical practices. Surgical audit should be an essential part of surgical practice to assess the quality of care being provided and to improve the outcome. The evidence collected would guide and influence surgical practices and possibly change them for the better. A particular method of treatment or an operative procedure can no longer be left to personal whims and fancies, because alternatives abound and the choice would depend upon the given setup, infrastructure, and the level of professional competence available. The best and safest surgical procedure in a given clinical situation is the one that provides the best clinical outcome. Such procedures have to be identified, and only those that provide optimum benefit ought to be practiced on a regular basis.
Informed Consent The concept of patient consent for medical procedures evolved during the 20th century as a reaction to the cruelties committed by Nazi concentration camp “doctors.” The core principles of the 10-point Nuremberg Code include voluntary informed consent, lack of coercion, properly formulated experiments, and beneficence toward participants. The Nuremberg Code has been largely superseded by the World Medical Association's Declaration of Helsinki, last revised in 2008. The Nuremburg code established the concept of informed consent for research participants to include a requirement that research benefit societal good and patients be informed and volunteer to participate of their own free will without coercion. The process requires a competent physician, adequate transfer of information, and consent of the patient. In the event that a patient is unable to give consent, a surrogate may consent on the patient's behalf. Poor communication, both in the preoperative conversation about risks and benefits and postoperatively when complications have arisen, can lead to considerable and avoidable emotional
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distress. Surgeons should communicate appropriately not only to patients but also to the other members of the team, from the anesthetist to the operating theater assistant. The surgeon's obligations regarding informed consent should be understood to be primarily moral as well as legal. Without a doubt, the surgeon doing the procedure is the best person to obtain consent. The basic elements of informed consent include preconditions, information, and consent. Preconditions for informed consent include patient competence to make decisions and the patient's willingness to participate in the consent process. Information is the body of facts provided by the surgeon to the patient such that the patient has sufficient knowledge to make a decision. The purpose of informed consent is not to give the patient a mini-medical education. It is to give the patient sufficient information to understand that the patient is being asked to authorize surgery, what the surgery involves, and its expected outcomes. True surgical informed consent consists of name of the procedure, detailed explanation of the procedure in layman's terms and in a language that is easily understood by the patient, risks of the procedure and their effects on lifestyle, reasonable alternatives, and competency of the patient. The patient acknowledges that they understand the procedure or treatment offered and authorizes proceeding with the intended treatment. It is not necessary for the consent to be written. In a life-threatening situation or a situation where written consent cannot be obtained, a verbal consent is adequate. In the interests of the physician, a written consent is preferable. Likewise, consent can be retracted verbally by the patient. All invasive procedures and, sometimes, noninvasive procedures (such as HIV testing) require consent. Under ideal circumstances, the taking of informed consent should occur a few days before surgery to facilitate unhurried, uncoerced decision making; to obtain more information; to discuss the matter with family members; and to review the decisions made. As an alternative to quoting actual figures of complication risks, a verbal scale from very high, to moderate, to very low, up to negligible could be used. The use of “up-to-date written material, visual and other aids to explain complex aspects of treatment where appropriate and/or practicable.” It is the duty of the surgeon to inform the patient about the costs to be incurred and how they are expected to pay. A competent patient is one who (1) understands his/her situation, (2) understands the risks associated with the decision at hand, and (3) can communicate a decision based on that understanding. A competent patient may become temporarily incompetent once premedicated preoperatively. Therefore, it is imperative that all strong premedication be withheld until the consent process is completed. It is not justifiable to withhold pain relievers from a suffering patient under the pretext of obtaining consent, for that might amount to some form of coercion. However, numerous studies on this issue have demonstrated that these patients take the same decision in the preoperative room as otherwise. It therefore seems justified to continue taking consents in the preoperative room. Minors by definition are incompetent and must be decided for by the parents/caregivers. General rules to follow in consent for surgery and anesthesia are to inform the patient of common risks even if they are not serious and very serious risks, such as death, even if they are not common. It is unreasonable to expect that a physician would explain all the risks associated with a procedure, including anecdotal ones, as the list may run into several pages. The informed consent process requires that a separate discussion of anesthesia risks be carried out by the anesthesia provider. There is no “legally foolproof ” consent form. A signed consent form of any nature neither guarantees a physician protection against legal action nor ensures patient satisfaction. It merely demonstrates that some process to exchange information was followed. © 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery • Volume 26, Number 1, January 2015
Moral action requires both the possession of virtues and knowledge of moral principles because, to discharge the duties required by the principles, a surgeon must exercise discernment, integrity, benevolence, trustworthiness, humility, conscientiousness, and other virtues. A conscientious surgeon approaching retirement age may acknowledge that his/her eyesight is failing and that minute vascular work is proving far tougher than previously. Surgeons have a duty to stop operating when their health leads to substandard care. The incidence of surgical complications due to human error is likely to increase with lack of sleep, poor concentration, stress, and other physical and psychologic deficiencies. Faulty equipment compromises patient care and increases the likelihood of surgical complications. Thoroughness and meticulousness can be viewed as aspects of the virtue of conscientiousness that are especially pertinent to the ethical surgeon. A high measure of thoroughness in the operating theater and in the surgeon's professional and educational development is necessary for ensuring the highest standards of patient care and the lowest rates of complications. The duty of honesty requires the surgeon, in all but the most exceptional
Special Editorial
circumstances where serious harm may realistically result, to specify whether the complication was caused by an error. This requirement also falls within the principle of justice as the patient has a right to this information. The patient may be entitled to compensation. As surgeons, our dealings with those industries that provide our medicines and devices must be clear cut, open, and defined. Benefits should be a simple recompense for out-of-pocket expense, for the design and delivery of new products, to support the education of our trainees and less-advantaged surgical fraternity and to encourage research, wherever possible through a nonpersonal institutional structure. Any benefits should be documented and recorded, not just in our own notes but in our institutions. Our patients should be told whether we benefit from the implants we use, whether by royalty, consultancy fee, or contract. We should be absolutely transparent in declaring any conflict of interest in articles, research projects, and lectures. We cannot simply look back to a perfect world where all surgeons were supposedly above reproach and revered. As associations, however, we should set standards that reassure our patients.
© 2014 Mutaz B. Habal, MD
Copyright © 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
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