Given this potential for blurred lines about novel approaches to medical conditions, how do we communicate this to patients? This is where the role of informed consent becomes essential. Informed consent is key to respecting patients’ autonomy – a central tenet of medical ethics. For patients to make autonomous choices they need basic facts to make informed decisions.6 These facts must be unbiased and free from conflicts, and they must not only be truthful but also be comprehensive and free from omission. It is in this informed consent process that we must explain that a technique or procedure is new, outline the risks and benefits, and share our actual experiences with said procedure especially if it is limited.7 We must also be aware of how certain biases and conflicts can affect our decisions to adapt and recommend innovative therapies. We may have incentives to offer innovative therapies to be on the “cutting edge” and attract patients. We may have explicit financial gain if working directly with device manufacturers or reimbursed by our institutions per procedure. Conflicts of interest are not only financial, but they can also be the prospects of promotion or career advancement.3 Institutions as well are incentivized to advertise the “latest” to bolster their prestige and reputations. Ultimately, we should act to the highest levels of professionalism, and ethics, by ignoring benefit to ourselves as physicians and always focusing on the benefits for our patients.7
What about when patients ask for specific innovative procedures as Mrs. Jones did above? What is our responsibility then? In situations where patients specifically push for a new procedure, it remains our duty to inform patients about the novelty of the procedure and the limited study of its safety and efficacy. When speaking about the “experience” with a novel procedure, it is tempting to speak globally and broadly. For example, Dr. Indo spoke about the procedure being done hundreds of times across the country and being safe in this context. It is our duty to be transparent, disclose our own experiences, and consider our own skills when recommending a novel procedure.7 It should be noted that patients are a vulnerable population and many times at the mercy of our recommendations. We’ve often heard patients say “Whatever you say doc; You’re the doctor;” or “I’ll do what you think is best” when presented with treatment options. This is an incredible amount of power, and we must protect this trust patients place in us by clearly acknowledging the uncertainties of new procedures and placing their benefit over our own potential gain.
Dr. Williams is a general surgery resident at the University of Chicago and a fellow at the MacLean Center for clinical medical ethics. Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, vice chairman for ethics, professional development, and wellness, and chief of endocrine surgery, department of surgery, and the associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. The authors have no conflicts to disclose.
References
1. Goyal H et al. Ther Adv Gastrointest Endosc. 2021;14. doi: 10.1177/2631774520984627.
2. Machytka E et al. Gastrointestinal Endosc. 2017;86(5):904-12. doi: 10.1016/j.gie.2017.07.009.
3. Eastwood GL. J Gastroenterol Hepatol (Australia). 2015;30(S1):8-11. doi: 10.1111/jgh.12755.
4. Neugebauer EAM et al. Surg Endosc. 2010;24(7):1594-1615. doi: 10.1007/s00464-009-0818-3.
5. Eaton, ML and Kennedy, DL. Innovation in Medical Technology: Ethical Issues and Challenges. Baltimore: Johns Hopkins University Press, 2007.
6. Angelos P. Ann Thorac Surg. 2019;108(6):1611-2. doi: 10.1016/j.athoracsur.2019.08.010.
7. Angelos P. Virtual Mentor. 2011;13(1):6-9. doi: 10.1001/virtualmentor.2011.13.1.ccas1-1101.
