Welcome to the Ethics Forum! The optometric profession has long recognized its ethical responsibilities to patients, colleagues, other health care professionals and the public. This forum provides an opportunity to review a hypothetical case study containing potential ethical challenges and includes suggestions on how one might handle the situation based upon the American Optometric Association Standards of Professional Conduct and Code of Ethics.

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If you have any questions on ethics, please submit them to EthicsQuestion@aoa.org. The AOA Ethics and Values Committee will respond to your questions as soon as possible. If you have an ethical challenge you wish to share, please feel free to submit a case description to ethics@aoa.org. The case description will be reviewed by the AOA Ethics and Values Committee and may be featured in a future Ethics Forum.

Ethical Dilemmas in Maximizing Optometric Practice Profitability: Understanding Informed Consent & Conflict of Interest

By Thomas A. Wong, O.D.

Case Study #8

Dr. Patel is a doctor of optometry and faculty member at a teaching institution in a large, urban metropolitan area. She routinely sees many diabetic and glaucoma patients in the institution's primary eye care clinic. Some of these patients are severely disabled with limited autonomy. The university's eye clinic has retinal specialists who see patients in the clinic twice a week. The retinologists perform fluorescein angiographies (FAs), YAG laser capsulotomies and other procedures. A few times a month, Dr. Patel orders FAs to help her decide which patients she can follow, and which to refer to the retinal specialist for possible surgical intervention. The primary eye care clinic has recently purchased a new optical coherence tomography (OCT) with angiography (OCT-A) features, and a new wide-angle fundus camera also with angiography features. These new technologies allow for a much safer analysis of blood flow in the retina without the risks involved in performing FA. Furthermore, FA does a poor job imaging the radial peripapillary and the deep capillary networks. OCT-A does a superior job imaging those layers without the risks. Although rare, FA can cause nausea, allergic reactions and even anaphylaxis and cardiac arrest. FA is the standard of care in the evaluation and treatment of diabetic retinopathy with clinically significant macular edema (CSME). However, new technologies such as OCT-A can sometimes provide superior diagnostic imaging without the risks to patients. These technologies are expensive, and not the standard of care, as many retinal specialists have not yet invested in this technology. Moreover, traditional FA does a better job showing the exact location of capillary leakage to better direct surgical intervention. OCT-A shows blood flow within the blood vessels. Dr. Patel regularly struggles with what tests to order. Is the standard of care worth it, and does she run the risk of ordering too many imaging tests that really do not benefit the patient and are possibly unnecessary?

Is the Standard of Care Worth It?

Should Dr. Patel be ordering FAs, which are invasive procedures with significant risks and costs? The retinal specialist may order the test again prior to surgery. Should Dr. Patel just refer to the retinal specialist and let him/her order testing rather than risk duplication? Should new technologies that also involve significant cost to the patient and practice such as OCT-A be used instead? Do we have evidence-based studies supporting these new technologies? In the end, are these tests benefitting the patient?

Diabetic Retinopathy & Health Care Measures:

To provide better patient outcomes for our patients, let's consider the following facts about managing diabetic retinopathy:

  • According to the Centers for Disease Control and Prevention (CDC), approximately 11 percent of Americans age 20 and older with diabetes had some form of visual impairment (3.8 percent uncorrectable and 7.2 percent correctable). (source: CDC) From 2000 to 2010, the number of cases of diabetic retinopathy increased 89 percent from 4.06 million to 7.69 million.


    From 2010 to 2050, the number of Americans with diabetic retinopathy is expected to nearly double, from 7.7 million to 14.6 million. Hispanic Americans are expected to see the greatest increase in cases, rising more than three-fold from 1.2 million to 5.3 million. (source: National Eye Institute, NIH)

  • Total costs related to retinal disorders are $8.7 billion; the cost of retinal disorders for persons with diabetes could be as high at $4.1billion. (source: Prevent Blindness America)
  • Gaps/variations in care: Age, race and socioeconomic status can impact screening levels, disease course and mortality rates

The American Medical Association's Physician Consortium on Performance Improvement (PCPI) develops and maintains measures that support federal programs such as the Physician Quality Reporting System or the Electronic Health Record Incentive Program also known as Meaningful Use. The PCPI stewards select measure(s) including the following:

PCPI Measure #7: Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy

PCPI Measure #8: Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care

PCPI-physicianconsortium.org

Balancing Patient Economics with Patient Need

The Physician's Oath of the World Medical Association states that the health of the patient shall be the physician's first consideration. While there is no doubt that the profitability of any practice is important (as practices do not exist and remain viable unless they are profitable), FAs and newer medical imaging technologies introduce additional costs to patients. When practices purchase these technologies, there is always the concern that additional tests will be ordered to pay for these new devices. Large HMOs run the risk of pressuring their doctors not to order tests, because they are increasing their costs by covering the procedures and paying for their technicians to perform the tests. Doctors of optometry, like medical doctors, are routinely faced with these ethical dilemmas balancing the economics of running their practices and doing what is in the best interest of the patient. The modern doctor of optometry should understand the ethical, legal and economic issues to help solve these dilemmas. So, what are the ethical issues? What is the Standard of Care? How does one balance patient economics with good clinical care? The Standard of Care is often defined by the legal system, and the question, "What would a reasonable practitioner do under similar circumstances?" Our focus today will be on the ethical issues, and what constitutes informed consent.

The Ethical Issues for Informed Consent

Disclosure vs. Autonomous Decision Making: In the history of medicine, physicians and some legal systems have attempted to equate informed consent with disclosure. Likewise, researchers and scientists have often taken the paternalistic view that disclosure of the pertinent facts, and a signature by the patient, constitutes informed consent. Researchers, doctors of optometry and many other physicians have argued in the past that the objectivity of science is the most important consideration. However, these views are untenable and universally rejected in modern bioethics. Informed consent requires autonomous decision-making, and the ability of patients and/or surrogates to understand medical procedures and to sign informed consent forms. Additionally, these consent forms can be complicated and tedious. We live in the real world, and modern bioethicists understand that the time and effort obtaining informed consent should not adversely disrupt the flow of busy practices. However, there is no excuse for not educating patients on all the risks and benefits of a procedure. Dr. Patel in her academic institution often must work with surrogates because her disabled patients have limited autonomy. This can take up a great deal of her and her staff's time. Informed consent is one of the most important concepts in all of bioethics. A doctor of optometry or any physician must accurately explain the risks and benefits of any significant procedure. A written signature on a disclosure form is not sufficient. Valid informed consent requires well-informed, autonomous decision making.

Beneficence: Some doctors of optometry and other physicians would argue that they best understand what is in the best interest of the patient. This falls under the ethical concept of beneficence. Primum non nocere theories contend that as long as no harm is done to the patient, the final decision should be made by the doctor of optometry or other physician. However, since the 1980s it has been almost universally accepted that the autonomy of the patient should not be violated.

Culturally Competent Care:

An integral part of the mission of the National Institute's Healthy People 2020 initiative is to eliminate health care disparities in the United States. Although the term 'disparities' is often interpreted to mean racial or ethnic disparities, other disparities affecting patient outcomes exist in the United States, including sex, sexual identity, age, disability, socioeconomic status and geographic region.

healthypeople.gov/2020/about/foundation-health-measures/Disparities

Do patients have a right to culturally competent care? It is not clear from a medical ethics standpoint that this is the case. Some feel that this would violate a doctor's of optometry or other physician's autonomy. However, in today's health care system it is clear that providing culturally competent care is necessary to provide good patient outcomes. In the case of informed consent, having the consent forms available in other languages (e.g., Spanish or Mandarin) is common practice in many major institution and health care facilities. Also, having medically trained personnel or services available is necessary for valid informed consent to occur.

Conflict of Interest: In a patient-centric environment a doctor's first responsibility is to the health of the patient and to order tests that improve patient outcomes. Guidelines for treatment can be found in the AOA Evidence-Based Clinical Practice Guideline, "Eye Care of the Patient with Diabetes Mellitus." There is a common misconception that the first tenet of the Hippocratic Oath is "First do no harm." The primary tenet has always been to do what is in the best interest of the patient (of course we cannot do this if we are causing significant harm). Practices and institutions should be careful not to place financial, personal, scientific and/or institutional goals over the needs and wellbeing of their patients.

Summary:

In making decisions on what tests to order, and to balance patient economics with patient care, ultimate decisions should be consistent with what is best for the patient's health by improving patient outcomes. Technology always advances, and we are obligated to understand what technologies benefit our patients. If procedures or devices present risks to patients, we must educate patients and obtain valid informed consent. Many biomedical ethicists and legal experts have concluded that mere disclosure and written signatures are invalid examples of informed consent. Valid informed consent requires autonomous decision making by patients and/or their legal surrogates. It is important for doctors of optometry to understand these important bioethical concepts when providing care to patients. Doctors of optometry are becoming increasingly familiar with the many payment options available today to cover expensive procedures (e.g., fee reductions, extended payments, promotional financing, spending accounts, etc.). Let us not forget what is in our patients' best interest!  

References:

1. Beauchamp TL, Childress JF: Principles of Biomedical Ethics. New York, Oxford University Press, 2013.  

2. Pellegrino ED, Toward a reconstruction of medical morals: The primacy of the act of   profession and the fact of illness, J Med Philosophy 4:32-56, 1979.  

3. Veatch RM: A Theory of Medical Ethics. New York, Basic Books, 1981.  

4. May WF: The Physician's Covenant. Philadelphia, Westminster, 1983.  

5. Pellegrino ED, Thomasma DT: For the Good of the Patient: The Restitution of   Beneficence in Medical Ethics. New York, Oxford University Press, 1988.  

6. Beauchamp TL, McCullough LB: Medical Ethics: The Moral Responsibilities of   Physicians. Englewood Cliffs, NJ, Prentice-Hall, 1984.  

7. Engelhardt T: The Foundations of Bioethics. New York, Oxford University Press, 1982.  

8. cdc.gov/visionhealth/data/national.htm.  

9. nei.nih.gov/eyedata/diabetic.  

10. preventblindness.org/sites/default/files/national/documents/Economic%20Burden%20of%20Vision%20Final%20Report_130611.pdf

About the author:  

Thomas A. Wong, O.D.  

Dr. Wong is the Director of New Technologies at SUNY Optometry. He is
the Former Chief of Adult & Pediatric Primary Eye Care at SUNY Optometry's
University Eye Center, and the Former Optometry Supervisor at Kaiser
Permanente Mid-Atlantic States. He is a graduate of Georgetown University,
the SUNY College of Optometry, and serves on the Board of Governors at
Georgetown University, the American Medical Association's Physician's
Consortium for Performance Improvement (PCPI), the PCPI's Technical Expert
Panel for Eye Care; he has been an active participant in Georgetown's
Kennedy Institute of Ethics' Intensive Bioethics Course
.