Beneficence in Ophthalmology

From EyeWiki


Beneficence demands that healthcare providers "do good" for the patient by prioritizing the patient's interests. As an ophthalmologist, upholding beneficence may require maintaining quality of care, avoiding conflicts of interest, and ethically conducting research.

Introduction

Beneficence is a basic principle of medical ethics which may be defined as seeking to benefit the patient by prioritizing the patient's well-being and interests. Beneficence is sometimes encapsulated in the simple command to physicians to "do good" and may be compared to the principle of non-maleficence, the imperative to "do no harm." Along with non-maleficence, autonomy, and justice, beneficence is considered one of the four core principles in medical ethics.[1] It is closely related to the physician's role as a fiduciary, a role which emphasizes the physician's ethical and legal obligation to prioritize the interests of the patient.

Beneficence is a foundational principle for many professional codes of ethics, including the Code of Ethics of the American Academy of Ophthalmology (AAO). In its opening statements, this code states that ethical issues in ophthalmology should be resolved when "the best interests of patients are served" and that "it is the responsibility of an ophthalmologist to act in the best interest of the patient," illustrating the overriding importance of beneficence.[2] Although the doctor's duty to "do good" to patients may seem obvious, beneficence not infrequently comes into conflict with other concerns in ophthalmology and other medical fields. In ophthalmology, upholding beneficence requires maintaining high quality patient care, avoiding conflicts of interest, and ethically conducting human subject research.

Maintaining Quality of Care

Beneficence demands that the ophthalmologist continually seek to provide the best possible care for patients. In routine clinical decision making, this often means balancing benefits and risks of treatment options. For example, the ophthalmologist who recommends cataract surgery after considering risks of complications and concluding there is a net benefit to the patient has exercised beneficence. To provide effective care, the ophthalmologist is also obligated to maintain competence in their craft. Per the AAO Code of Ethics, competence for an ophthalmologist means holding sufficient technical ability, knowledge, and morals to provide quality ophthalmic care.[2]

Adapting to Developments in the Field

Ophthalmologists carry an obligation to stay abreast of developments in the field. By updating his or her knowledge base and treatment repertoire, the ophthalmologist can continually increase the benefit which she or he provides patients. In recent years, the field of ophthalmology has seen widespread adoption of important new treatment options, such as vascular endothelial growth factor (VEGF) inhibitors for neovascular disease processes and minimally invasive surgical procedures for glaucoma. Likewise, ethical issues in medical genetics have continued to expand as more is learned about the hereditary nature and genetic implications of ophthalmic diseases. Beneficence demands that the ophthalmologist incorporate such developments into his or her practice whenever possible and appropriate.

In some cases, interpreting the literature on new ophthalmic treatments may be made more difficult by the presence of commercial bias. Industry-funded studies of new pharmaceuticals, though an important source of data, may contain bias in abstracts and discussion sections which may affect conclusions and utilization.[3] Not surprisingly, one study of publications on topical prostaglandin analogues used for treating glaucoma found that while only 24% of industry-funded studies had a statistically significant primary outcome measure, 90% of the industry-funded studies had pro-drug conclusions in their abstracts.[4] Staying up-to-date with new therapeutics, and providing the best possible care for patients, therefore requires thorough and critical review of relevant literature but also recognition of sources of bias.

Avoiding Conflicts of Interest

Because beneficence demands that the patient's interests be prioritized, the principle may be compromised when conflicts of interest occur. These COI may affect patient care. In ophthalmology as in other surgical specialties, these areas of COI may be financial, industry related, or commercial. The AAO Code of Ethics has an enforceable rule requiring that ophthalmologists disclose to patients, colleagues, and the public all such COI, defined as situations in which "professional judgment concerning the well-being of the patient has a reasonable chance of being influenced by other interests of the provider."[2]

Relationships with Industry

It is common for ophthalmologists to have ties to industry, ranging from friendly relationships with drug representatives to paid consulting work or research for corporations.[5] While such relationships are not necessarily unethical, they may compromise beneficence if they affect patient care. The AAO Ethics statement states that "clinical judgment and practice must not be affected by economic interest in, commitment to, or benefit from professionally-related commercial enterprises."[2]

In practice, it may be difficult to completely mitigate COI and the ways that COI might affect clinical judgement are sometimes subtle or nuanced. For example, one common practice is for the drug representative who visits the clinic to provide lunch for a clinic's staff. Even these “minor” inexpensive industry “gifts” could affect recipient behavior and physicians likely underestimate their impact.[5] Many institutions and organizations actively prohibit such contact or limit providers to modest meals associated with the educational content. Some individual physicians also self-prohibit or self-limit such gifts in order to avoid COI.

Pharmaceutical representatives also commonly distribute free samples of new medications, which are often promoted as contributing to a safety-net for indigent patients. However, low-income and uninsured patients have been shown to be less likely than wealthy or insured patients to receive these free samples.[6] Evidence also indicates that “free samples” may alter physician prescribing patterns[7] and are another potential source of COI.

Sale of Health-Related Products

COI can also manifest in a physician’s office through the sale of eye health-related products. For example, some private practice ophthalmologists sell contact lenses or spectacles through their office optical shop.[8] This is not inherently a COI. However, policies and procedures to disclose and to limit potential COI might help.

The AMA Code of Medical Ethics has issued opinions detailing best practice for physicians who choose to sell health-related products in-office. Per the code, physicians must sell products which have scientific evidence of benefit and should generally sell only products which meet "immediate and pressing needs" of the patient.[9] In addition, physicians should not sell products which are available exclusively available at their office. In general, physicians writing prescriptions must respect patients' rights to fill these prescriptions wherever they choose.[9]

Beneficence in Research

The principle of beneficence is a cornerstone of ethics in human subject research, including all human subject ophthalmology research. Medical research should ultimately aim to benefit patients by improving medical knowledge and treatments. Such benefit may extend to research subjects themselves, if they are patients with the disease of study - in which case the research may be termed "therapeutic research" - or, when research subjects are healthy volunteers, may be intended solely for patients in the general population ("non-therapeutic research"). Regardless of the research type, research subjects are an inherently vulnerable population whose well-being and interests may be compromised by various goals of research. Landmark documents on research ethics have codified the importance of beneficence to protect research subjects.

Declaration of Helsinki

First published by the World Medical Association in 1968 and revised extensively since, the Declaration of Helsinki is a landmark statement on ethical human subject research which has profoundly influenced many national research policies. In its opening principles, the Declaration emphasizes the overriding importance of beneficence by reminding physicians that they must always be dedicated to protecting "the health, well-being and rights of patients, including those who are involved in medical research."[10] Acknowledging the vulnerability of research subjects, it notes that while “the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects." Further sections stipulate that research only occur when risks to subjects have been minimized and when the potential benefits (to the research subjects or to patients in the general population) outweigh the risks.[10]

The Declaration also states that researchers "who combine medical research with medical care" should include patients as research subjects only when it is justified by the potential medical benefit and when unlikely to negatively affect their health.[10] This implies that in deciding to enroll patients in therapeutic research, physicians use a similar risk-benefit assessment as with clinical decision making in general.

Belmont Report

Published in 1979, the Belmont Report is a foundational document in U.S. human subject research ethics which continues to guide policy and practice. It delineates three core ethical principles of human subject research: 1) respect for persons, 2) beneficence, and 3) justice. Beneficence in the Belmont Report is somewhat broad in scope and is understood to include the mandates to "do no harm" (i.e., non-maleficence) and to "maximize possible benefits and minimize possible harms."[11]

To satisfy beneficence, the report recommends that investigators systematically assess risks and benefits to subjects of proposed research protocols and organize the relevant data. This data should then be used by a review board, which will only approve the study if they find the risk-benefit ratio is sufficiently favorable. This information should also be presented to research subjects in the informed consent process.[11]

Case

Consider the following case an ophthalmologist might encounter in which beneficence must be weighed against other ethical concerns:

A 2-year-old girl is referred to you, a pediatric ophthalmologist, after her pediatrician notes a white reflex (leukocoria) in the left eye. On subsequent workup, MRI reveals a large intraocular mass, consistent with a retinoblastoma. You inform the patient's parents that the tumor currently appears limited to the eye and that with enucleation surgery, the patient's prognosis is excellent, but that if there are delays in treatment, the malignancy may spread and prognosis will quickly worsen. However, the parents refuse enucleation surgery or other treatment, stating it is necessary given that their daughter is without symptoms. As the physician, should you seek treatment over the parent's objections?

In this case, the principle of beneficence must be weighed against parental autonomy. Beneficence would support treating the patient because doing so will significantly improve her prognosis and is possibly life-saving. Although the parents could decide to seek treatment later, by this point, the patient's chance of survival may have decreased substantially. In contrast, an appeal to parental autonomy supports not treating. We generally recognize parents' right to make medical decisions for their children under the assumption they know their children best and have their best interests in mind.[12] Treating the patient without parental consent constrains this autonomy.

There is a consensus that providers have an obligation to challenge parents' medical decisions when those decisions place children at major risk of serious harm.[12] Such a challenge should first involve a hospital ethics committee or ethics consultant, if available, followed by child protective services or the courts if necessary.[13] Unfortunately, opinions vary widely on what level of harm justifies challenging a parent's decision, and so such cases continue to pose ethical dilemmas.[14]

References

  1. Beauchamp TL. Principles of Biomedical Ethics. 7th ed. Oxford University Press; 2013.
  2. 2.0 2.1 2.2 2.3 Code of Ethics. American Academy of Ophthalmology. Published January 1, 2020. Accessed April 4, 2021. https://www.aao.org/ethics-detail/code-of-ethics
  3. Buys YM. Evidence-Based Medicine: Can You Trust the Evidence? AMA Journal of Ethics. 2010;12(12):930-933. doi:10.1001/virtualmentor.2010.12.12.jdsc1-1012
  4. Alasbali T, Smith M, Geffen N, et al. Discrepancy between results and abstract conclusions in industry- vs nonindustry-funded studies comparing topical prostaglandins. Am J Ophthalmol. 2009;147(1):33-38.e2. doi:10.1016/j.ajo.2008.07.005
  5. 5.0 5.1 Jampol LM. A Perspective on Commercial Relationships Between Ophthalmology and Industry. Arch Ophthalmol. 2009;127(9):1194. doi:10.1001/archophthalmol.2009.180
  6. Cutrona SL, Woolhandler S, Lasser KE, Bor DH, McCormick D, Himmelstein DU. Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis. Am J Public Health. 2008;98(2):284-289. doi:10.2105/AJPH.2007.114249
  7. Chew LD, O’Young TS, Hazlet TK, Bradley KA, Maynard C, Lessler DS. A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior. J Gen Intern Med. 2000;15(7):478-483. doi:10.1046/j.1525-1497.2000.08014.x
  8. Asbell PA. Contact Lens Prescribing and Dispensing by Ophthalmologists. AMA Journal of Ethics. 2010;12(12):920-921. doi:10.1001/virtualmentor.2010.12.12.ccas3-1012
  9. 9.0 9.1 Affairs AC on E and J. AMA Code of Medical Ethics’ Opinions on the Sale and Dispensing of Health-Related Products. AMA Journal of Ethics. 2010;12(12):925-927. doi:10.1001/virtualmentor.2010.12.12.coet1-1012
  10. 10.0 10.1 10.2 WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Accessed April 8, 2021. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
  11. 11.0 11.1 Read the Belmont Report. HHS.gov. Published January 15, 2018. Accessed April 8, 2021. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
  12. 12.0 12.1 Parental Decision Making | UW Department of Bioethics & Humanities. Accessed April 8, 2021. https://depts.washington.edu/bhdept/ethics-medicine/bioethics-topics/detail/72
  13. Treatment decisions regarding infants, children and adolescents. Paediatr Child Health. 2004;9(2):99-103.
  14. Brown AEC, Slutzky AR. Refusal of Treatment of Childhood Cancer: A Systematic Review. Pediatrics. 2017;140(6). doi:10.1542/peds.2017-1951
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