After a case conference on informed consent, a skeptical colleague approached me and said, “Medicine is far too complicated. Patients will never really understand enough to make fully informed health care decisions. That expectation puts an unreasonable burden on physicians.” I’m glad he shared that comment with me. It belies the continuing challenges in providing informed consent (IC) and its role in improving care. There was no simple response to his claim, so in the end I responded in the simplest way I knew how. I asked him if he wanted his spouse or his brother to fully understand their care when they saw their physician.
My colleague was right: Medicine is complicated. But I continued to worry that resistance to promoting IC persisted because it was primarily believed to be a legal formality that does not meaningfully benefit patients or physicians. If clinicians believe that IC is simply a bureaucratized exercise designed to meet specific legal requirements and not advance patient care, then they’re right to be frustrated at the time and energy required to complete it. My clunky question for my colleague was intended to get at this. After stripping away everything else, what is IC good for, and why should physicians actively promote it?
IC is so critical to the practice of medicine and protecting patients’ right to participate in decisions about their care, that it was codified in law. IC is often believed to be a discrete event such as obtaining a required signature on a form for a specific procedure, but it is more generally seen as a process.1 For valid IC to occur, the physician is obligated to disclose all the relevant information about a proposed treatment or procedure to the patient, and the patient has to understand that information and be able to make a voluntary choice. Patients provide their IC not just for discrete procedures, but for the range of medical care including a physical examination, changes in treatment plans, radiology and laboratory studies, and plans for follow-up. The risks, benefits, and amount of information documented or exchanged varies, but the process remains the same.
How can physicians help patients in a practical way become truly informed in decisions about care? Bioethicist Harold Brody, MD, has written extensively about improving disclosure in IC and believes that the current legal standards fall short in guiding clinicians to fulfill the ethical ideals of informed consent.2 Dr Brody suggests a different approach. The physician should make his/her thinking sufficiently transparent enough that patients understand how a recommendation was made (i.e., by identifying the problem and the advantages and disadvantages of the medically reasonable options). He suggests that this standard “…requires the physician to engage in the typical patient-management thought process, only to do it out loud in language understandable to the patient.”
Here’s an example from a nephrologist’s outpatient practice. Most physicians probably have had this sort of conversation already in one form or another, but for those who have not, or at least not consistently, the intent is to demonstrate the discrete steps of disclosure and understanding in enabling an ethically strong IC process.
“I’m concerned that your blood pressure has been consistently elevated. I recommend that we go up on medication A because it will lower your blood pressure which can reduce your risk of stroke, heart attack, and progression of your kidney disease. Most patients do fine with this higher dose, but for patients who have side effects, they usually report X and Y. Serious side effects, which are extremely rare and for which I will monitor you, include Z. There are at least 2 alternatives that I can see to this approach. The first is to do nothing, which I don’t advise because it won’t reduce your risk of the health problems I mentioned. The second alternative is to start a new medication, but I think my recommendation is preferable because it will mean fewer pills for you, and because you are already tolerating medication A. What do you think about what I’ve said?”
If the patient nods in agreement, the disclosure obligation has likely been met. To ensure patient understanding, the physician goes on, “What questions did you have? To make sure I haven’t made this too complicated, can you tell me in your own words why I made this recommendation? I don’t want this to feel like a test. Gauging your understanding helps me know if I need to clarify anything I’ve told you.”
If you timed yourself saying that, you saw that it took about 60 seconds. In established patients or for patients with routine medication changes, these conversations are likely to be even shorter. In conversations about more complicated decisions, it might be longer, but the basic structure remains.3
When physicians make patients’ care understandable to them, they honor their basic obligation to respect patients’ autonomy, promote their participation in decisions about their care, and ultimately help them make the right decisions for themselves. If IC is important to the ethical practice of medicine, it is for this reason. Ideally, by making a physician’s thought process transparent to the patient, it helps the physician to make their language understandable and ideally better inform patients about their care. That’s a burden that we can probably all bear.
David J. Alfandre MD, MSPH, is a health care ethicist for the National Center for Ethics in Health Care (NCEHC) at the Department of Veterans Affairs (VA) and an Associate Professor in the Department of Medicine and the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the NCEHC or the VA.
1. Braddock CH 3rd, Edwards KA, Hasenberg NM, et al. Informed decision making in outpatient practice: time to get back to basics. JAMA. 1999;282:2313-2320.
2. Brody H. Transparency: informed consent in primary care. Hastings Cent Rep. 1989;19:5-9.
3. Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372:855-862.