Ophthalmology ethics





Introduction


Issues that challenge our ethical and moral value systems have been part of medicine throughout recorded history. As early as the 5th century bc , Hippocrates recognized the role of ethics, virtue, and moral compass in the practice of medicine in what has become known as the Hippocratic oath , which physicians in many countries pledge upon receiving their medical degrees. The Hippocratic oath captures many of the fundamental ethical principles of modern medicine:



  • 1.

    Treat the sick to the best of your ability


  • 2.

    Do no harm


  • 3.

    Work within your scope of practice and training and not beyond your expertise


  • 4.

    Always place the patient interest above your own


  • 5.

    Maintain absolute patient privacy


  • 6.

    Be respectful of colleagues


  • 7.

    Be committed to teaching future generations of medical trainees



These foundational ethical values are still relevant thousands of years later, yet the influence of ethics on the practice of medicine continues to evolve as society changes and technologic advances in medicine present us with new challenges and considerations. The 1960s brought an accelerated evolution of medical technology. Medicine was now able to prolong the end of life, engage in heroic surgical interventions, and save the lives of infants born at increasingly earlier ages of prematurity. With this progress also came increased attention to the ethical issues that attended such advances. The field of bioethics began to take shape and has undergone remarkable growth to the point where it has become a fundamental part of undergraduate, graduate, and continuing medical education, as well as everyday practice. Medical and professional societies around the World, including the American Academy of Ophthalmology (AAO) and the American Academy of Optometry, have since created Codes of Ethics and manuals to help guide our behavior and medical decisions. Many training programs in ophthalmic assisting and other ophthalmic fields now include ethics in their curricula.


Every individual who plays a role in the ophthalmic care of patients will face ethical dilemmas and it is important to develop an approach to these scenarios so that they are always resolved in the best interest of the patient. In trying to resolve these moral quandaries, each of us brings our own set of moral values and knowledge to the process. Given the almost infinite variety in our religious, family, cultural, and experiential backgrounds, it seems impossible to have a set of “right answers” that could dictate our response to ethical dilemmas when they arise. This is further complicated by the intricate details of each situation and the rich context of the lives of our patients, each with their own unique background and circumstances. The writings of philosophers and bioethicists represent many schools of thought (which are well beyond the scope of this chapter) that attempt to give us formulas or orientation of our thought processes to address our ethical challenges. Policymakers have laid out for us guidelines that prescribe acceptable and unacceptable actions and decisions as judged by peers and colleagues in the same institution or field. The law, reacting to events that question our actions within the context of our society’s regulations on behavior, places further boundaries on our actions and decisions. Figs. 49.1 and 49.2 offer diagrammatic approaches—one more simple and workable (see Fig. 49.1 ) and the other perhaps more complex and attuned to the deliberations of the person with a deeper interest in bioethics (see Fig. 49.2 )—to how these circles of considerations in our lives might intersect to help us address ethical issues in our minds and in our practice.




Fig. 49.1


A simplified model for ethical consideration recognizing the intersection of ethics, policy, and law.



Fig. 49.2


A more complex model for ethical consideration that is perhaps more applicable to a person with a deeper interest in bioethics.


Medical ethics provides us with a set of values, virtues, and principles that help us when we are faced with a difficult patient decision, but it is important to understand that these tenets are not meant to be used as hard and fast rules. The word ethics is indeed a plural word. There is more than one ethic depending on the specifics of the situation at hand and the background of the professional. Each situation may be resolved differently depending on unique patient factors. Empathetically understanding the rich context of each patient’s situation—wishes, culture, family, religion, disease, prognosis, education level, support systems, and alternative healthcare practices—is perhaps the first step in laying the foundation for understanding and resolving potential conflicts. Practitioners must also understand and reflect on their own orientation, potential conflicts and biases when dealing with these issues.


Each of us may make different decisions, but we must ensure that we practice within our policy guidelines and governing laws, as well as the ethics boundaries beyond which most reasonable people would recognize transgression. Within those boundaries is a wide zone of possible pathways to resolution of an ethical dilemma. Choosing the resolution that best suits the needs and desires of the patient is paramount, and finding a solution that is agreeable to the ophthalmic team and the individual practitioner responsible for the patient’s care is most desirable.


This chapter is not intended to be a prescription of correct answers to every ethical issue that might confront eye care professionals; each concept addressed could itself become an entire chapter or book. Subsequently, we highlight frequently encountered ethical situations and provide a context in which they might be considered. We raise questions one might ask in trying to bring to consciousness those variables that should be addressed in resolving an ethical dilemma. We highlight in italics the essential ethical terms that the reader should endeavor to fully understand. The readers of this textbook will likely come from many jurisdictions, professions, and societies, so the following discussion must be interpreted within each specific context.


Informed consent


Gone are the days when physicians simply told their patients what must be done to their bodies to treat their disease. Rather, we have developed a healthy recognition of the importance of autonomy : the right of people to make their own decisions about what they will and will not allow. Informed consent represents a partnership between medical professionals and their patients. Doctors have a fiduciary duty to ensure that each patient understands the treatment recommendations. Admittedly, this is not always entirely possible because patients rarely can achieve the same level of understanding as the doctor. In some cases, patients may have such strong feelings of trust toward their physician that they make little effort to attain the knowledge level of truly informed consent and instead wish for the doctor to “do what’s best for me.” Yet the obligation, both ethically and legally, of the physician remains to at least attempt to demonstrate that the patient does indeed have some comprehension of the medical plan.


Informed consent is more than the signed piece of paper titled “consent form.” Informed consent is a process, documented in the patient’s health record, wherein the physician or a trained delegate (e.g., the ophthalmic assistant) educates the patient and asks for his or her participation in the decision-making process.


When the physician delegates part of the informed consent discussion, there must be an opportunity for the patient to ask questions of and speak directly to the physician, if desired. Some situations require little more than the patient’s action. When a patient sits at the slit lamp and puts the head forward, it is an implied consent to be examined. But when the medical encounter is to involve aspects of risk, in particular risks of bodily harm as in surgery or laser treatment, then a more formal informed consent process, preferably documented by the patient’s signature, is required. Performing a procedure without consent may be considered as battery by the legal system. Clearly there will be situations—usually those surrounding medical emergencies—when the informed consent process must be either abbreviated or abandoned because of the time-sensitive nature of the problem and the inability of the patient to consent or a substitute decision maker to be contacted. However, this scenario is almost never seen in the management of eye diseases outside of the hospital setting.


The disclosure of risk is considered in the context of what a reasonable patient would want to know. The eye doctor must inform the patient of all common risks, no matter how small, including those that may result not only in changes in function but also appearance. Patients also have a right to be informed of all serious risks, no matter how uncommon. Although the risk is rare, a reasonable patient would still likely want to know about the risk of death from general anesthesia or the risk of vision loss or blindness from cataract surgery.


Comprehension is another foundation of informed consent. Patients are allowed to refuse treatment, even if their decision will result in death or blindness, if they are deemed to have the capacity to decide. If the decision-making capacity of the patient is in question, for example, in patients with dementia or cognitive impairment, then a substitute decision maker must be found. The substitute decision maker may be a legal designation by power of attorney or it may be a family designation by virtue of marriage, age, or sibship. Informed consent for children is discussed in the following text.


Even when the patient is deemed capable of making a decision, the ophthalmologist must ensure that the necessary information is presented in an understandable way. Risks may be better described in relative terms rather than with incidence data. For example, one might say that the risk of an entirely well young adult dying from general anesthesia is less than the risk of dying in a road traffic accident. Another useful way of communicating risk is to translate risk percentages into Numbers Needed to Harm (NNH). For example, if the risk of surgical complication in procedure X is 1%, you could tell the patient, “if 100 patients were to have surgery X, one would have a more complicated course.” Written information is also helpful, especially if it can be taken home and reviewed, but it must be readable, comprehendible, and ideally at a grade 6 to 8 level.


Consent forms with many pages have become common, yet one can question whether they are likely to be read and understood by an average patient. No document can replace the conversation between physician and patient. The patient must also be given the opportunity to ask questions and receive answers before making a voluntary decision without influence or coercion.


Confidentiality


The ophthalmic healthcare team, like all medical professionals, has a duty to protect the confidentiality of the patient. The fulfillment of this duty enhances the trust relationship and respects the autonomy of the patient.


Sharing of health records with other medical professionals is just one aspect of the confidentiality issue. One should remember that although the chart itself belongs to the physician or the healthcare institution, the information in the chart belongs to the patient. Information should not be shared with others, especially those outside the patient care team, without the patient’s documented consent.


Ophthalmic professionals must also guard against accidental violations of confidentiality that can occur through the discussion of cases in public places, such as elevators and registration desks or in easily overheard phone conversations. Patient charts should not be left in accessible view and computer screens with patient information should be protected by a password or screen saver. The use of email is governed by a variety of jurisdiction-specific law and policy because society is still addressing the challenge such communication imposes in our world of increasing electronic interaction. Encryption of messages may be a helpful safeguard. Portable electronic devices and hard-copy documents taken out of the patient care setting may be easily lost or stolen. Identifiable patient information should not leave the patient care setting in either form unless appropriate safeguards are in place (e.g., remote access to a secure server via a handheld device). Attention must be paid to photographs and other communications, such as texts that exist on cell phones, tablets, or other portable devices. Such content should be immediately transferred to the patient’s chart or electronic medical record and deleted from the device. Password protection of such devices may be an insufficient safeguard. Electronic medical records, although secure, may also increase opportunities for access to patient information by curious individuals who are not directly involved in the patient’s care. Without specific patient consent, such access is not allowed and many hospital systems now have tracking systems in place to monitor and ensure that only appropriate providers are accessing patient information.


The medical professional may also be faced with situations in which there is a conflict between the patient’s desire for confidentiality and the medical professional’s desire or obligation to transmit information about the patient to other individuals. A patient may disclose to an ophthalmic assistant that the cause of his or her periocular ecchymosis was an assault by their spouse, but then ask that the ophthalmologist not be told. The ophthalmologist may become aware through evaluation of ophthalmic findings that a patient is infected with human immunodeficiency virus (HIV), but the patient does not wish to tell his or her sexual partner. If these situations can be anticipated, then the patient should be forewarned that disclosure will obligate the physician to make the necessary transmittal of information either to public authorities (e.g., HIV is a reportable communicable disease) or private individuals who may be at risk. Yet this obligation may hold even if the patient disclosed without being forewarned. In a landmark United States case, Tarasoff vs. Regents of the University of California , where a psychiatrist came to know that a patient was likely to murder, the court ruled that the physician had a duty to warn and protect by either notifying the intended victim or informing the police. The most desirable outcome in such difficult cases would be the resolution of conflict through a trusting partnership between patient and physician, perhaps with the assistance of nursing, counseling, and social work support, but if the ophthalmic professional feels that such partnership is not reasonably achievable in a satisfactory time frame, then the duty to breach confidentiality may apply.


Truth telling


Truth telling is another fundamental tenet that underlies the ethical practice of medicine. It is a foundation to the resolution of many issues discussed in this chapter (e.g., informed consent, duty to warn). Truth telling enhances trust and partnership and aids patients in understanding their disease. Sometimes, however, the ophthalmic team will receive requests to withhold the truth. The daughter of a 75-year-old man with ocular melanoma might say, “Please don’t tell my father he has cancer.” Although the physician may empathize with the daughter’s sentiment and truly feel that such information might do more harm than good if disclosed to the patient, it should be recognized that the courts in the Western world have found this principle of “therapeutic privilege” to be tenuous at best. Research studies have shown repeatedly that in general, patients do want to be told the truth about their condition, and the healthcare team should endeavor to do so. Much has been written about patient communication and the breaking of bad news. It would benefit the members of the healthcare team to become skilled in these techniques. It is important to take time with patients and explore the reasons for the request of nondisclosure as this will likely lead to a strengthening of the doctor–family–patient relationship and easier resolution of the ethical dilemma.


Boundary issues


Respect for persons also entails that their bodies not be violated in nonconsensual ways, such as sexual advances or touching. This principle applies not only between coworkers in an ophthalmology office or clinic but also between healthcare professionals and their patients. Violation of boundaries may also come in the form of personal affronts without actual physical touching. Examples might include comments with inappropriate sexual content or aggressive and condescending behavior. The field of organizational ethics addresses many of these scenarios and the relationships between coworkers in various roles. In general, it is advisable for healthcare professionals to similarly avoid such behaviors, gestures, and advances toward their patients, including activities, such as dating or sexual liaison. Many professional medical colleges prohibit consensual sexual relationships between patients and providers.


Multiculturalism


Many societies represent a rich blend of ethnicity, religion, and culture. With this variety in the patient population, ophthalmic professionals will likely encounter behaviors that seem foreign, and at times objectionable. One must respect that there are a wide variety of behaviors to which the terms right and wrong do not apply. Rather, tolerance and understanding, often reached simply through dialog, become the basis of therapeutic success and patient compliance. A simple example, a patient’s appointment could be altered to a day that does not conflict with a religious holiday rather than demanding compliance with the original date.


There may be times when a cultural belief is not consistent with the laws or policies that govern the society in which the patient lives. If a mother has used her urine to treat her child’s red eye and in doing so caused the child to contract gonorrhea conjunctivitis, then education to avoid this practice—in addition to bacterial culture, treatment for gonorrhea in the family, and communicable disease reporting to authorities—is certainly indicated. To do so in a culturally sensitive way may be challenging. All medical professionals working in culturally diverse communities are encouraged to read Anne Fadiman’s book, The Spirit Catches You and You Fall Down (Farrar, Straus and Giroux, New York, 1997).


Vulnerable populations


One must be particularly careful in addressing ethical dilemmas where the patient is part of a vulnerable population , such as children (see following text), prisoners, minorities, and other groups who may, by virtue of their position in society, prejudice, mental incapacity, and prior unjust treatment, have impaired decision-making capacity or a lack of proper empowerment. Illness and infirmity may in themselves make the patient more vulnerable and less able to engage in capable decision making. The ophthalmic team must guard against bias and parentalism in these cases and maintain a healthy respect for the autonomy of these individuals. It is easy to become “blinded” by our beneficent parentalistic desires to benefit the patient, make decision for them, and in so doing ignore the importance of autonomy for all patients. One might argue that extra care is required to uphold the rights, boundaries, privileges, and autonomy of such patients.


Pediatric ethics


The ethical issues surrounding the care of children have enormous scope that extends well beyond the reaches of this chapter. Children are indeed a vulnerable population yet they do have a right to respect for their autonomy, which, even if they are not currently able to express it, will eventually blossom. It is recommended that children be involved in their health care as much as possible, including discussions about their disease and proposed treatment.


Infants and young children may not have the ability to participate meaningfully in the informed consent process so their parents or guardians become substitute decision makers. The physician must ensure that substitute decision makers make decisions that are in the best interest of the child. Although adults have the right to refuse treatment for themselves, even though such refusal could lead to death or blindness, they do not have the right to make such decisions for their children in most jurisdictions in North America. In such cases, if the healthcare team is unable to form a partnership with the family that would lead to a satisfactory resolution of the conflict, then the physician may be obligated to approach the child protection or legal system for intervention on behalf of the child. Before resorting to these means, attempts to resolve conflicts with the use of social workers, clergy, mental health professionals, and other mediators can be helpful.


There is also a firm legal and moral obligation to report an adult or parents suspected of harming a child to protection authorities. Some healthcare professionals fail to report because of a lack of confidence in the system, a fear that parent and child will be separated unjustly, uncertainty over the diagnosis, a feeling that a well-known “good family” could never abuse or neglect their child, a fear of lost patient referrals, or a disinclination to have to take time to go to court to testify. In reality, the facts suggest that these fears and concerns are largely unjustified and inaccurate. In all cases, the health professional’s legal obligation to report is the primary responsibility.


Older children often have an ability to participate in their own care decisions even if they are not mature enough to give full consent. In these situations, one should try to obtain the child’s assent , or agreement, to proceed with the medical plan. This can be done by involving the child in the decision-making process with the parents or guardians, asking the child directly about questions or concerns and even documenting in the chart that this process occurred, with or without the child’s signature. Ascertaining when a child is able to give full consent, separate from that of the parents, is defined by law in some jurisdictions or in others is determined by an assessment from the ophthalmic team. In most Canadian provinces, there is no stipulated legal age of consent. Older children and adolescents may have wishes that differ from those of their parents. Taking a family-centered approach to care, which attempts to find therapeutic alliance, requires time, patience, and perhaps the support of other professionals in the field. The healthcare team is advised to maintain a manifest respect for the child’s autonomy, confidentiality, and right to know the truth about his or her care.


Futility


Just as the adult patient may decide against treatments proposed by the physician, the physician may refuse to give a treatment requested by the patient if, in the best judgment of the physician, the treatment is unlikely to result in any benefit. For example, if an eye is hopelessly blinded by glaucoma and the entirely asymptomatic patient (i.e., with no pain) desires another surgery to bring the pressure down from 30, the doctor may refuse. There should be ample evidence to support the physician’s position. If this difference in viewpoint leads to an irresolvable conflict between the doctor and patient, then the doctor can attempt to find an alternative care provider or a second opinion for the patient. Indeed, physicians may do this under any circumstance in which they feel they can no longer provide a therapeutic alliance with the patient, provided that the decision is not made on the basis of class or cultural distinction, prejudice, or malicious intent.


Medical error


Much attention has been paid to error in medicine with large studies confirming its high incidence and prevalence. Every ophthalmic team member will at some time make an error that may or may not lead to patient harm. Of course, we must always strive to reduce error and many strategies have evolved to encourage this, including the systems approach, which attempts to prevent error by adapting the environment in which we work. For example, if two eyedrop bottles are so similar that they could easily be mistaken for each other, it may be desirable to place colored tape around one bottle or move the two different medications to different locations in the office. Providers should have established systems of double-checking patient demographics before inputting information into charts, completing testing, and uploading patient information. Marking the eye to be operated before surgery and preoperative “time outs” are system interventions to avoid performing surgery on the wrong eye or patient.


A less desirable approach to error, which has been unfortunately all too prevalent in medicine, is that of individual blame, punishment, and secrecy. The aviation industry has been a leader in the recognition that a nonpunitive approach and the encouragement of error reporting with team problem solving is the most productive path toward error reduction. Members of the team should be encouraged to identify areas of weakness in office systems where potential errors can occur in an attempt to minimize future errors.


Disclosure of error to patients is a fundamental part of an ethical response. Research studies continue to show that patients do want to know when errors are made. Disclosure of error leads to a reduction in malpractice claims and judgments, as well as an increase in the trusting partnership between doctor and patient. Disclosure may present difficult challenges and may take time. There is also a gray zone between complications , (i.e., a known adverse event with a known frequency that accompanies a procedure) and medical errors (i.e., a preventable mistake or judgement) that can complicate the discussion. An example of a complication would be posterior capsular rupture in cataract surgery and an example of a medical error would be implanting the incorrect lens power.


If the outcome is not influenced (i.e., no objective harm is done) does the patient need to know about complications and/or errors? This question often arises in cases of surgical complications that do not necessarily impact the patient’s visual outcome. Some would argue that disclosure of such technical events would be too complicated for the patient to understand even though this same patient was presumed to understand enough to give consent for surgery. Others would wish not to worry the patient unnecessarily, although the principle of such therapeutic privilege, as discussed earlier, is tenuous and runs contrary to what patient-based research would recommend. The surgeon may take special actions (e.g., dilated postoperative examination, more frequent postoperative visits) to guard against potential increased risks, such as retinal detachment, associated with surgical complications. Without being informed, the patient may wonder why his or her care is different from other patients who were befriended in the pre- or postoperative waiting areas before surgery and are seen again at follow-up visits.


Disclosure of complications and medical error is often difficult for physicians and all members of the healthcare team but it is essential to maintain trust in the patient-provider relationship. The healthcare team should address error in a positive alliance with the patient and identify the factors that led to its occurrence, as well as the measures that can be taken to prevent its recurrence. In cases of complications, patients will want to know how it may impact their recovery and outcome. In cases of medical error, patients are often reassured to know when new measures are put in place to reduce risk of similar events in future patients.


Impaired physicians and ophthalmic professionals


Patients have the expectation that their ophthalmic care-takers are competent . To violate this entrustment by allowing the practice of professionals who are under the influence of drugs or alcohol, or otherwise impaired by medical illness or knowledge deficiency, would be an unethical breach of our duty to do no harm (nonmaleficence) . Most professional regulatory bodies have mechanisms by which such professionals can find supportive help designed to achieve reentry, when possible, into the medical care system once the individual is deemed competent to practice again.


Difficulties arise when a member of the team is unsure about the status of a colleague’s competence, in particular with regards to deficiencies of knowledge, suboptimal skillsets (e.g., the surgeon with “bad hands”), or unsatisfactory decision making. Older professionals may be felt to be “outdated.” One must be careful that such determinations are made without prejudice and not by individual observations. Some practitioners, such as the retinal surgeons who are asked to retrieve dropped pieces of lens matter from the vitreous, may occasionally or even regularly see what at first appears to be the error or incompetence of another ophthalmologist. They must be careful to remind themselves that the true story of the events that led to the occurrence is not known and may have a satisfactory explanation. Assuming the incompetence of another surgeon, and in particular reporting this to the patient, is fraught with danger on many levels. Consultation with coworkers and even frank discussions with the individual about whom there is concern are advisable. If there is sufficient evidence that incompetency to practice exists, then delay in intervention will inevitably lead to patient harm. It is highly recommended that these issues be addressed before such events occur.


Resource allocation


The allocation of scarce resources has become an increasingly frequent ethical challenge as the cost of ophthalmic care continues to rise with recent scientific advances in eye care. A formal ethical approach to resource allocation is often necessary when there is limited material (i.e., corneal transplants), a large number of patients requiring limited resources (i.e., cataract surgery in public hospitals), or in the adoption of innovative expensive technologies (i.e., toric/multifocal implants) and pharmaceuticals (i.e., antivascular endothelial growth factor [VEGF] agents). Should those with the financial means be allowed to pay for faster access to medically-necessary surgery in private centers? Should only those with financial means have access to innovative technologies? Should patients without insurance be able to access expensive medications if required to save their vision? Should surgical resources be allocated to surgeons equally or should it be based on patient outcomes or on surgical efficiency/proficiency? Should surgeons be allowed to choose a more expensive suture, surgical blade, or intraoperative laser, even if there is no demonstrable benefit to the patient? Should the donor cornea go to the 1-month-old infant with unilateral Peters anomaly or to the 80-year-old person with bilateral pseudophakic bullous keratopathy?


Resolution of these issues is often difficult, complex, and far removed from the patient, yet still affecting their care. A full discussion of these issues is beyond the scope of this chapter, but perhaps the starting point is recognition of the best interest of the patient (beneficence) , if not most patients, in the resource allocation decision-making process. There is also an ethical duty to best represent the interests of society, which can at times compete with the interests of an individual patient. Clearly we cannot provide every possible aspect of medical care to every patient. Societies often use a utilitarian approach to resource allocation to achieve the greatest good for the greatest number of patients.


Research ethics


Research is designed to answer questions and improve patient care. Research studies are constructed to follow the scientific method, which allows these questions to be ans-wered in a fashion that minimizes bias and the influence of chance. Research is also distinguished by the informed consent, which allows patients to understand the level of evidence base for the proposed intervention in the context of their care, and the research ethics board (REB)-mandated monitoring (also known as an institutional review board [IRB]), which protects participants from unintended harm as early as possible. Research can take place in academic health sciences centers or in the community ophthalmic practice.


The researcher has certain ethical responsibilities toward the research subject, which include informed consent, confidentiality, disclosure, and respect for the subject’s autonomy. There is also a duty to ensure that the patient is not enrolled in a frivolous project unlikely to yield meaningful results, a project in which the potential benefits are outweighed by potential harm, or a project that enhances discrimination toward the patient or the group they represent. Refusal to participate in research must not influence the care or the access to care that a patient receives.


Recognizing the difficulties in honoring these obligations, all research should be evaluated in advance and approved by an REB, the membership of which should be multidisciplinary, with representation of the lay public as well. REBs are available both inside and outside academic institutions. Research done in the community is not an excuse for avoidance of REB review. Most jurisdictions are now requiring even retrospective chart reviews to obtain such approval. REBs may try to streamline these processes. Although the process of REB approval may seem arduous, its objective is to facilitate good research rather than impede progress, while protecting both the researcher and the patient.


Surgical innovation


Ophthalmology is a highly technologic field and it is not uncommon for eye surgeons to find themselves “trying something new.” Such presumed advances may come as the result of publications in the peer-reviewed literature, a “throw-away” publication, a presentation at a meeting, conversations with colleagues, or de novo from the creative mind of a thoughtful practitioner. The innovation may be as simple as a new way of tying a knot during surgery or as complex as a piggyback intraocular lens implanted into a neonate to deal with aphakic high hyperopia with a predicted removal of the second lens at a later date. Other examples include new intraocular lens technologies, new glaucoma surgeries and devices, new techniques and lasers for refractive surgery, and smaller instrumentation for retinal surgery. Some innovations are clearly novel treatments (e.g., the development of new glaucoma surgical devices) whereas others are applications of existing technology and experience from one patient population to another (e.g., specialty intraocular lenses in children or anti-VEGF injection for retinopathy of prematurity). Some innovations may be new only to that physician (e.g., switching to smaller-gauge phacoemulsification). Should all surgical innovation be allowed to proceed outside that purview of the research paradigm with involvement of an REB?


Unfortunately, there are many examples of surgical innovation that proceeded without a research protocol and led to disaster: anterior chamber closed loop intraocular lenses are but one example. Some would argue that a better understanding of innovation would arise if we instead referred to it as “nonvalidated” intervention. One might doubt that patients would have much interest in being subjected to nonvalidated care. Yet patients are attracted to “sexy” innovations that they read about in the media (e.g., “bladeless” refractive surgery). Surgeons may face conflicts-of-interest in their desire to adopt innovations. We know that patients are attracted to the term innovation, with a presumption in society and the media that newer is better. For surgeons, being labelled an innovator may attract patient referrals or they may have a desire to remain on “the cutting edge” and adopt new technologies that may lack evidence. Others would argue that innovation is an inherent part of surgery and an intrinsic part of medicine and therefore not a form of research. Some innovations, for example, occur in emergency settings where REB review is not possible. When faced with an expulsive hemorrhage, the surgeon will use any reasonable means at that moment to close the eye and may invent a new method. The majority of major practice changes, however, are done with sufficient forethought that REB approval could indeed be sought, with the aim of ensuring the optimal outcome while protecting the best interests of patient and researcher. To reduce the “red tape” presented by REBs, some centers have tried a parallel system specifically for surgical innovation, one designed to be more expeditious and attuned to the unique nature of surgical practice. Institutions may adopt procedures where peer review is a minimum standard, perhaps in the form of approval by the departmental chief, before proceeding.


All of these considerations have in common a desire to enforce some regulation of the current freedom of ophthalmologists “to do whatever they want” and thus respect the rights of the patient to informed consent, truth telling, and protection from harm while facilitating the progress of ophthalmic care.


Genetics ethics


Genetics has become an increasingly prominent part of virtually every aspect of medicine. Ophthalmic professionals, in almost every aspect of the field, must have a working knowledge of genetics, from age-related macular degeneration and cataract to steroid-induced glaucoma and congenital malformations. Advances in genetics are already bringing to ophthalmology the possibility of gene-based therapy for a variety of diseases, especially hereditary retinal dystrophies.


Recognition of the role of genetics in eye disease brings with it some special ethical challenges. There may be confidentiality issues with the sharing of information within families and the need to obtain such information to give appropriate genetic counseling. Insurance companies may have a desire to obtain information about patient risk for diseases they have not yet developed and then classify the asymptomatic disorder as preexisting, and therefore uninsurable in the United States. The Genetic Information Nondiscrimination Act of 2008 prohibits insurance companies for some insurance products from using genetic information in this fashion.


Parents may ask about prenatal testing for ocular disease and consider terminating pregnancies of otherwise healthy infants. They may ask for presymptomatic predictive testing of their children for genetic disease that is unlikely to develop until the child is an adult. There is some evidence that there may be harmful psychosocial effects to both positive and negative predictive test results. Perhaps children identified as having the gene mutation for retinitis pigmentosa in the family will be steered away from certain career options only to find that when they become of age to pursue a career, there is a cure for their disease and they have missed the opportunity to prepare for the field they desire. Depression and even suicide may follow a positive predictive test. A negative test in a highly affected family with a disease-based identity may result in the child being ostracized as not one of the group.


Ultimately, ophthalmologists might even have to contend with the issue of eugenics as we become capable of eliminating gene defects from society through sperm and egg selection or gene repair. Should parents be allowed to choose the iris color of their children? There is a primate model for correction of X-linked recessive red–green color deficiency, a very common mutation that results in color blindness. Is this a disease? With the recent promising treatment of Leber congenital amaurosis using intraocular gene therapy we are beginning to see the power and potential of ocular gene therapy. With that must come a careful appraisal of the potential ethical implications should these technologies be used without caution and deliberation.


It would be unreasonable to expect all ophthalmologists to be up to date with every genetics advancement, but the ophthalmic team must be cognizant of these ethical issues in genetics. When faced with such dilemmas, it is useful to call on the support and intervention of genetics professionals, such as ocular geneticists, genetic counselors, or medical geneticists. They can act as consultants and partners to help address the concerns brought forward by the patient or anticipated by the team.


Conflicts of interest


Healthcare providers encounter many potential conflicts of interest in practice and we need to develop ways to identify and resolve these conflicts in the best interest of our patients. Conflicts arise when we benefit as providers from a medical decision made by a patient and the conflict may, if not properly addressed, influence our informed consent discussion or our recommendations.


The most common and easily identified conflicts are financial. For example, we are often paid when a patient is seen or has a procedure; we may be paid if a patient agrees to have a test or diagnostic service; we may have established professional relationships and directly or indirectly benefit when patients use certain industry products or receive care from other healthcare providers.


Many conflicts, however, are not financial and may be harder for us to recognize or identify. We may have nonfinancial relationships with industry representatives who are friends of the office. Gift giving from industry representatives often in the form of office supplies, meals, or education is known to powerfully influence the way we prescribe, the way we provide patient education, and the way we make medical decisions. Another nonfinancial conflict may relate to our desire to adopt new technology into the office and to stay at the cutting edge of innovation. In our eagerness to adopt these technologies, we may inadvertently encourage patients to accept innovative treatments without adequately emphasizing the lack of evidence supporting many up-and-coming technologies.


Disclosure of potential conflicts of interest to patients is important, but one must recognize that disclosure of a conflict does not remove it. Patients may not be empowered, especially when made vulnerable by status, illness, or age, to act in response to such disclosures because they may feel that to do so would deny them access to the provider they want and to whom they were referred. This may leave the patient uncomfortable, suspicious, and more likely to be a dissatisfied participant in their care. As healthcare providers, we need to spend time contemplating our financial and nonfinancial conflicts-of-interest and ensure that we are able to resolve them so that they do not influence the discussions we have with patients. One must recognize that disclosure of a conflict of interest does not remove the conflict. Patients may not be empowered, especially when made vulnerable by status, illness, or age, to act in response to such disclosures because they may feel that to do so would deny them access to the provider they want and to whom they were referred. This may leave the patient uncomfortable, suspicious, and more likely to be a dissatisfied participant in their care.


It is important to recognize that we are allowed to have conflicts so long as we are able to resolve them adequately in our patients’ best interest. In several jurisdictions, there are certain conflicts of interest that are considered “off limits” in that they are too powerful for us to be able to resolve them adequately, such as fee-splitting, which is discussed in more detail later. Healthcare providers should of course initiate and sustain referral practices based on the best interest of the patient rather than their own financial gain.


Advertising


One potential conflict-of-interest is direct to patient advertising. Physician advertising is now legal in many American jurisdictions but in Canada is still prohibited by the Canadian Medical Associated Code of Ethics. Some ophthalmologists have rejected advertising as an affront to the medical profession that degrades our field to a business no different from auto sales. Others have embraced advertising as a means of public education at a time when informed consent has received so much attention.


Advertising is considered a conflict of interest as rarely do physicians advertise solely for the altruistic benefit of disseminating information to patients. The physician’s motive of financial gain, practice advancement, and perhaps ego enhancement could result in techniques that are either coercive or even untruthful. This would likely violate our duty to do no harm. Of course, physicians can choose not to advertise, at which point the ethical issue is moot. But if they do choose to advertise, they should do so in a way that addresses some of these concerns.


Advertisement should be truthful and not misleading. Advertising does not replace informed consent. Some jurisdictions prohibit patient testimonials or acrimonious comparisons with other colleagues. Some professional societies review and regulate advertising to ensure that the potential patient is not influenced by style rather than content. Catchy radio jingles or print slogans may unduly influence and coerce patients into uninformed choices. Consultation with professional regulatory bodies is advised to ensure that the undesired effects of the conflict are minimized and the benefits to the patient maximized.


Fee splitting


Fee splitting is a conflict-of-interest where one provider provides a financial incentive to another provider for a patient referral and it can be seen in several forms. In the most typical arrangement, the ophthalmologist “pays back” the referring professional (e.g., an optometrist) as a demonstration of gratitude for a referral and presumably to provide an incentive for further referral. This reward is referred to as a kickback or profit sharing and may take the form of cash or other benefits, such as tickets to a sporting event, free meals, gift certificates. Another arrangement might involve a shared practice wherein members of the group all benefit from the aggregate activity of the group and therefore encourage referrals to each other. An example might be the multispecialty ophthalmology group who sends cataract patients to the retina specialist within the group for preoperative examination. Lastly, fee splitting may take the form of comanagement. The ophthalmologist delegates the postoperative care of patients to another provider, often an optometrist, and provides a payment in cash or in kind for that service. Alternatively, the optometrist may bill the patient directly for services that would otherwise fall under the care of the surgeon’s postoperative care and as such may not have been billable.


Although some may perceive these fee-splitting arrangements as beneficial to the patient, providing continuity of care and improved access to care, others have identified the conflict of interest that may be inherent, particularly if the patient is unaware of the arrangement. Research has shown that patients are in general unhappy with these relationships. Canada and also some American jurisdictions have policy or law that proscribes against these arrangements. The AAO’s stance has been to encourage ophthalmologists to provide postoperative care for their own patients unless there are compelling reasons why this cannot be accomplished (e.g., surgeon leaving town for holiday) and only if the patient is informed in advance. When the conflict of interest persists, physicians are encouraged to disclose these relationships to the patient in a further attempt to avoid any illusion of impropriety.


Medical industry


The medical industry provides us with our therapeutic agents, diagnostic agents, medical technology, and surgical equipment. It is a necessary and integral part of medicine. In addition to the use of these products, physicians will have direct interaction with representatives of medical industry in the form of sales representatives wanting to give information about new products, opportunities to try new products, invitations to participate or lead industry-sponsored educational events with or without social components, invitations to become a spokesperson for industry products, invitations to write papers/conduct research/write monographs sponsored by industry, offers of grants to support research activities or program development, gifts of free samples of medications or gifts ranging from items of nominal value for medical use (e.g., notepads with the drug company name on each page), to more significant gifts, such as sporting event tickets, free meals, and even all-expenses-paid trips to lovely locations with or without a sometimes nominal educational component. At large meetings, companies present enormous and elaborate displays, and every conference participant may be given a tote bag and a neck strap for their identification badge emblazoned with drug company logos.


Reasonable patients would likely expect that the medical decisions of their ophthalmologist are free from industry influence and conflict of interest. It is not difficult to see, then, why multiple studies have shown patients to object to such relationships between physicians and the medical industry. Research also indicates that despite the often-heard claims of physicians to the contrary, these practices do affect our prescribing patterns. It is then not surprising to learn that the medical industry spends billions of dollars worldwide on advertising and contacts with physicians, presumably not out of purely altruistic motives but rather in recognition of the positive effect such expenditures have on company profit.


Most ophthalmic and other medical professional societies, as well as the institutions in which physicians work, now have detailed policies regarding interaction with the medical industry. These policies grew out of the recognition of the potential for influence on the decision making of medical personnel if they stand to benefit from the largesse of industry in a personal way. Some physicians have rejected restrictions and physicians may assert that their own autonomy to conduct their lives as they see fit is no less important than that of the patient.


The pharmaceutical industry also has recognized the ethical dilemmas these relationships and activities engender. As a result, some have implemented voluntary restrictions. Companies may contribute much in the way of information and financial support for medical meetings and claim that they have not influenced the scientific content (although there may be drug company-sponsored talks on exhibit floors in addition to the official scientific program). The risk of the public perception of impropriety and the potential for adverse manifestations of conflict of interest in direct patient care remain to be resolved.


Cosmetic surgery


Patients have the autonomous right to choose what they will and will not allow to be done to their bodies (with the exception of futile interventions; see earlier text). Cosmetic surgery acts on a patient’s wish to have something normal about his or her body changed to another normal variant, often at large cost. Proponents of cosmetic surgery would argue that the patient does not perceive the condition as normal and therefore making the change, so that the patient feels more normal, is well within the helping nature of the medical profession. Analyzing the philosophic differences on this topic is beyond the scope of this chapter, but the ethical issue of conflict of interest is again worthy of consideration.


There is some discussion in ethics that informed consent discussion for cosmetic surgery should be held to a higher standard where we are not only expected to disclosure what a reasonable patient would want to know but also what is called the subjective standard , which would include information that this specific patient would want to know. Others argue that this standard is impossible to achieve because we cannot know all the individual factors that would influence a patient’s decision.


Refractive surgery


Laser and intraocular refractive surgery have proliferated worldwide. In many communities, as a procedure not covered by insurance plans, surgeons may charge sizable fees and perform the surgery exclusively in private clinics. People have flocked to have this surgery, allowing enormous numbers of patients to abandon their contact lenses and glasses. But interviews of the lay public suggest that many go for the procedure because they believe that the surgery will “fix” their bad eyes. Most of these people have normal healthy eyes, seeing 6/6 with their preoperative glasses or contact lens. Refractive surgery is considered a lifestyle surgery, not medically necessary, and is more aligned with cosmetic surgery in the expectation of a rigorous consent process that informs patients of all potential risks and benefits.


Although all illegal acts are not within the ethical and moral acceptability of the practice of medicine, some legal acts may also challenge our ethics boundaries. Creative billing also tends to raise the cost of health care to society, creating yet another conflict of interest and potential nonmaleficence.


Trainees in patient care


When trainees (e.g., medical students, ophthalmology residents, ophthalmic assistant students) are participating in the care of patients, there may be a reluctance to inform the patient for fear that the patient may reject this arrangement. In fact, research shows that patients do want to be told about the nature of such arrangements and, if properly informed and assured that appropriate supervision is in place, usually welcome this interaction and may even feel that they are making a positive contribution to the healthcare system. Some authors have argued that patients have a moral obligation to participate in the training of future professionals, particularly in a publicly funded healthcare system, such as Canada, but this does not necessarily abrogate our truth-telling duties. The ethical principles of truth telling and disclosure play a strong role in this setting. A utilitarian approach, seeking the greatest good for both the patient and society, argues that the success of these relationships, largely through the graded allocation of responsibility to trainees and the provision of appropriate supervision, is supported by the high functioning of the training system and its lack of demonstrable negative outcome effects on patient care. In fact, the highest level of care is often delivered at the academic centers where trainees are routinely part of healthcare delivery.


Resolution of ethical dilemmas


The ophthalmic team is confronted by a wide variety of ethical issues. This chapter has attempted to identify many of those issues and offer some pertinent points for reflection and consideration when attempting to resolve the dilemmas. Although there may not be a perfect right answer in each case, ophthalmic professionals should consider the relevant key ethical principles, institutional policies, and societal law. Multidisciplinary conversations with peers and colleagues can be particularly helpful. Difficult situations arise when an employee (e.g., ophthalmic assistant) has a different viewpoint on an ethical issue than his or her supervisor or employer. Open conversation can often resolve these conflicts. Consultation may be sought from bioethicists or other professionals who have had formal training in the field. Many written resources are available; ethical issues have found their way into hundreds of journal articles on virtually every topic. The University of Toronto Joint Centre for Bioethics website ( www.jointcentreforbioethics.ca ) is a useful resource that can link readers to a wide variety of information on bioethics and case management.

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Jun 26, 2022 | Posted by in OPHTHALMOLOGY | Comments Off on Ophthalmology ethics
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