Disclaimer: The opinions expressed in this article are those of the expert author and do not reflect the opinions of Expert Institute or its affiliates.
Informed consent is a relatively new concept in medicine. It involves communication between patient and physician about a specific treatment. It’s also when a patient gives their authorization to undergo the treatment.
From an ethical perspective, informed consent combines a minimum of three elements: disclosure, competency, and choice. In many ways, the legal concerns of informed consent focus on disclosure. Meanwhile, the ethical concerns of informed consent focus on competency. Both disciplines seek to improve the likelihood that a patient’s choice is consistent with the facts of the medical case, as well as their own values. But defining adequate disclosure or competency remains somewhat foggy. In this article, I’ll be digging into the contributing factors of sufficient patient consent from the legal perspective.
To fully understand the concept of informed consent, let’s look at two patient scenarios:
A patient has arrived from out of town to see a prominent surgeon. She has a medical problem for which there are both medical and surgical treatment options. After consultation with the surgeon, the patient is interested in surgery. The surgeon offers to perform the case the next day and consents the patient in his office. The next day the surgery is performed and after a brief hospital recovery, the patient returns to her hometown. The patient later learns more about the non-surgical treatment options for her condition. As a result, she feels the surgeon did not adequately inform her prior to the surgery.
Another patient visits a different surgeon for the same medical problem. After consultation with this surgeon, a surgical approach is again pursued. The surgeon’s office arranges all the necessary pre-operative clearances and schedules the procedure to occur about one month later. The surgical consent is, however, not completed in the office due to an oversight. The surgeon meets the patient in the preoperative area. Her intravenous lines are inserted and she is gowned for surgery. The surgeon performs the consent for the procedure. As before the patient later learns more about the non-surgical treatment options for her condition and feels the surgeon did not adequately inform her prior to her surgery.
In both of these cases, it could be argued disclosure was satisfied insofar as a consent document was signed. But from a legal standpoint, do these women have a basis for their complaint with regard to their surgical informed consent?
Complete competency in any given area is a tricky business. Competency on paper doesn’t always translate to real-life instances. In the above cases, competency is tainted by a compelling situation. Could the women in these cases have walked away and reflected on their treatment options? As an observer, does your opinion change if you knew that the first physician was paid on productivity? He was having a slow month and there was available operating room time the following day. How does that affect your sense of whether the surgeon competently disclosed all available details about the patient’s treatment options?
Categories of Care
Proper informed consent also relies on care type. Researchers at my institution have classified care into three categories:
- Evidence-based care
- Preference-based care
- Supply-sensitive care
Evidence-based care is care that has known benefits for a given clinical condition. Taking an ACE inhibitor if you’re a diabetic has plentiful evidence as an effective course of treatment. The research also shows that failing to take an ACE inhibitor risks injury.
Preference-based care is care that may have evidence to recommend it but shows no preference for one approach over another. Mastectomy or lumpectomy for treating breast cancer is an example of preference-based care. There is no known difference in outcomes with either treatment approach.
The last category of care, supply-sensitive care, refers to care dictated by the supply available. In other words, the more cardiologists you have in a community, the more stress tests or angiograms will be performed. Supply-sensitive care is the antithesis of value. It maximizes neither outcomes nor cost. Supply-sensitive care is also arguably ethically problematic. The driver of the care is not dependent on patient needs.
Take, for example, the elevated volume of hysterectomies performed in the Midwest and South, as compared to New England. These regions don’t have higher rates of gynecologic disease. Rather, this is an instance of supply-sensitive care. To be fair, this sort of discrepancy may not be all about the physicians. Patients may prefer care that physicians facilitate or endorse. Nevertheless, irrespective of who is driving who, when the facts of the medical case do not align with the evidence, competency is questionable. Thus, questioning the validity of informed consent.
When Margin is the Mission
As is true in many areas of life, both margin and mission compel medicine. Striving to better the world has to at least break even. Margin can, however, become the mission. Without any malintent, the surgeons in our two cases may merely seek to facilitate patient convenience and margin for their hospitals.
What if the mission focuses on ensuring patients have the best chance to make a fact- and value-congruent care decision? This could override a convenience or margin focus. But the reality is, the fiduciary relationship between patient and clinician typically guides the mission. As a result, beneficence and nonmaleficence duties constrain the clinician’s power. As for our two example cases, those duties could be questioned.
Expert Witness Bio E-008283
This highly qualified and board certified expert currently serves as Professor and Co-Director of Female Pelvic Medicine and Reconstructive Surgery at a major medical university. He received a B.S. from the College of William and Mary, a M.S. in Botany from the University of Georgia, a M.D. from the Medical College of Georgia, and a M.A. in Bioethics and Health Policy from Loyola University Chicago. He also finished a fellowship in Female Pelvic Medicine and Reconstructive Surgery at the Cleveland Clinic Foundation. In addition, he has been published nationally for his work and research in urogynecology, pelvic floor surgery, and bioethics. A member of both the American College of Obstetricians and Gynecologists, he was previously Associate Professor of Obstetrics and Gynecology at the Geisel School of Medicine.
B.S., The College of William and Mary
M.S., Botany, University of Georgia
M.D., Medical College of Georgia
M.A., Bioethics and Health Policy, Loyola University Chicago
Residency, Obstetrics and Gynecology, Brown University Affiliated Hospitals
Fellowship, Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Foundation
Board Certified: Obstetrics and Gynecology, Female Pelvic Medicine and Reconstructive Surgery
Member, Committee on Ethics, American College of Obstetricians and Gynecologists
Member, Health Policy Committee, American Urogynecologic Society
Former, Associate Professor of Obstetrics and Gynecology, Geisel School of Medicine
Current, Adjunct Faculty, major medical university
Current, Professor, major medical university
Current, Co-Director of Female Pelvic Medicine and Reconstructive Surgery, university-affiliated hospital