Informed Consent: Communication is the Key
by Larry Czaplyski
Informed consent, although an established part of the medical landscape is still a controversial subject. A reason for this is the belief that patient autonomy, the basis for informed consent, makes it difficult for physicians to use their hard-won skills and expertise for their patients’ well being.
Increasingly, however, physicians are realizing that there is a middle ground between the paternalistic model of medical decision making, where the physician makes all decisions without providing any information, and its mirror image, the independent choice model, where the physician provides information without making any decisions.
For thousands of years, physicians have made decisions for their patients based on traditional medical principles, including beneficence, which directs the physician to provide the optimum treatment for the patient.
But about thirty years ago, issues began to appear that were difficult to solve using traditional ethics. New medical and reproductive technologies, research controversies, and a societal ethos that questioned all authority posed difficult questions. The new discipline of bioethics emerged to provide answers. One result of its inquiries was the principle of patient autonomy, which promotes the primacy of the individual in medical decision making.
Courts began to look at the risks of medical treatment through the prism of individual autonomy. They increasingly found that autonomy demanded the patient’s consent. In Canterbury v. Spence, a landmark ruling, the court said that meaningful consent provides the patient with the “opportunity to evaluate knowledgeably the options available and the risks attendant upon each.”
Legal rulings in favor of consent have continued. Today, the prevailing opinion is that while physicians have the expertise to determine the medical risks of a treatment, it is the patient who has the right to choose or reject the treatment. The physician must respect the patient’s choice.
Why is it important?
A certain percentage of cases have bad outcomes even with textbook perfect performance by all medical staff. While some patients would risk a bad outcome for the possibility of relief, others wouldn’t take the chance.
That’s why informed consent is important: it gives an individual who is of legal age, free from coercion, and with the mental capacity, the chance to decide whether or not to proceed with a medical procedure.
According to Dr. Howard Brody, Director of the Center for Ethics at Michigan State University, informed consent gives “…each patient the opportunity to become involved in making health care decisions to the extent that that individual wants to be involved.”
Dr. James Davos, a practitioner of Family Medicine in Madison, Wisconsin, adds, “Patients don’t know if they should purchase an MRI, a repirator, intubation, or an series of tests because they don’t understand what they are buying and why. Our job is to try to help them make informed decisions…”
What you need to disclose
“In almost all circumstances, patients should be offered all information relative to their condition and treatment options that are genuinely available regardless of the physician’s opinion about them,” says Dr. Ira Byock, a specialist in Palliative Medicine in Missoula, Montana. Typically this includes:
1. What you believe your patient’s medical condition or problem is.
2. The nature of the treatment you recommend.
3. The risks and benefits of the recommended treatment.
4. The probability or likelihood of success of the recommended treatment.
5. Alternatives to the recommended treatment.
6. The risks and benefits of doing nothing.
You need to disclose to the patient only enough information to make an informed choice. According to Dr. Brody, there is “… a fallacy about informed consent, that the main purpose is either to give the patient a “dose” of information; or else to cover the physician’s butt legally by saying that he or she followed the rules…the better approach is to get into an open, honest conversation with the patient to try to determine how involved the patient wishes to be and how much information he wants.”
Dr. Brody continues, “Physicians, I fear, tend to avoid this manner of thinking because “open conversation” suggests physician loss of control, whereas if you say that you have to tell the patient six things about each alternative treatment, it sounds like you are still in control.”
Typically disclosure is measured against two standards: the reasonable doctor standard or the reasonable patient standard. Most states follow the reasonable doctor standard. It requires you to disclose all facts that a reasonable medical practitioner would give to a patient regarding the proposed treatment. The reasonable patient standard requires you to disclose all risks that a reasonable person would require before deciding to accept or reject a proposed treatment.
Making Sure the patient understands
When talking with patients, as with anyone, remember that communication can be a difficult process. According to Dr. Josh Korman, a plastic surgeon in Mountainview, CA, only “… a small percentage of what the physician tells the patient is actually heard by the patient…it is important to tell the patient several times what they need to hear.”
Dr. Edward S. Bessman, Chairman of the Department of Emergency Medicine at Johns Hopkins Bayview Medical Center, agrees, “Tell them what you’re going to tell them, tell them, tell them what you told them, then have them repeat it back.”
When disclosing information, don’t worry about whether the patient understands the complexities of your diagnosis and its attendant treatment protocols. “You are not running a medical training program,’ says Dr. Brody, ‘you are trying to work with the patient to see what he needs to know to operate at the best level he’s capable of and wants to operate at… it still demands some respect and some effort to try to work with the patient to identify his real needs…”
Find out what the patient expects the treatment to accomplish. Dr. Kathryn M. Andolsek, a clinical professor at Duke University Medical Center actively helps patients to do this. “I use lots of prefaces: ‘sometimes patients in your situations have concerns about…’ ‘many patients in the past have asked me about…’ when they don’t come up with many questions on their own.”
Be especially thorough when the patient asks about risks: these questions often point directly to the areas that the patient considers most important. Dr. Steven Kemp, a pediatric endocrinologist at Arkansas Children’s Hospital, says “I try to have a dialog with the patient explaining my view of the risks in language that is as non-technical as possible, giving data, and asking for the patient’s questions. I encourage patients to tell me their understanding of the risks.”
Give your patient the opportunity to ask questions and clear up any confusion. “I think,’ says Dr. Byock, ‘the doctor has to make all reasonable efforts to convey the information and get a sense that the patient understands…if there’s a question in the doctor’s mind…ask the patient to explain if they understand the procedure or treatment option being discussed…when we’re talking about very serious conditions…a single visit may well not be enough.”
Often patients want more than information; they want guidance. Arthur Caplan, Ph.D., Director of the Center for Bioethics at the University of Pennsylvania, believes that “Recommendations are absolutely consistent with consent. Patients need to know that they can reject or argue with a recommendation… a value neutral presentation is not informed consent if the physician really does have a view about what is best.”
Dr. Bessman agrees. “The physician has an obligation to enumerate all of the treatment options, but then must also indicate what she or he thinks is the best course of action, and explain why. Too often I see clinicians abdicate this responsibility, and instead give the patient a laundry list of options and say “choose”. Presumably this is done to distance the physician from any adverse outcome by the fact that it was the patient’s choice. This is misguided. The patient deserves the benefit of the physician’s experience and judgement, which should take the form of a clear statement of what the care-giver believes ought to be done.”
But don’t forget, cautions Dr. Byock, that “ it must be crystal clear that the final decision rests with the patient…”
Dr. Kemp concurs. “Patients do not always choose the course of action that I might recommend, but I see my responsibility as one of giving as much information as is necessary in order for patients to make responsible decisions, and to honor their choice, even if it is not the choice I would have made.”
“…I have now been around long enough,’ says Dr. Brody, ‘to have seen a number of cases where the patient made a bad mistake in deciding what to do, and I agonized over it a lot, only to come to find out that it was not such a mistake at all and maybe, in the end, the patient actually knew what was best. So we have to get out of the idea that we are right all the time and that we always know what is best for each patient.”
Documentation is important, but by itself is not consent. “The gold standard is written consent signed by patient, clinician and witness,” states Dr. Bessman, “…consent is obtained when the patient agrees to the proposed plan. Signing the form simply documents the nature of the agreement.”
Dr. Byock concurs by noting that the form is “…evidence that the issue was discussed and an attorney would say that there is some value in getting it but it’s really the process of discussion and education, the responding to patient’s questions, the thorough discussion that precedes the signing of the document that really provides consent”
The law presumes consent if the procedure is simple and danger is remote or if the patient can’t consent (e.g., because the patient is unconscious) and delaying treatment would jeopardize well being or life.
If your medical opinion is that full disclosure would interfere with treatment, inflict psychological damage, or threaten your patient’s well being, you can withhold information. But you can’t withhold information to prevent your patient from refusing recommended treatment.
Dr. Ida Sim, MD, Ph.D., at the University of California at San Francisco, says, “In general, I think that it is appropriate to withhold information that will on balance cause more harm than good to the patient. For example, if a patient has psychosomatic or paranoid tendencies, it is appropriate not to mention potential side effects that are extremely rare.”
“I think that it is also appropriate to withhold information about treatments that have no chance of providing any benefit to the patient. For example, it would be acceptable not to discuss dialysis for renal failure with a cancer patient who is facing imminent death.”
Patients can also waive consent. “In some cultures,’ says Dr. Sim, ‘the elderly are not expected to participate in medical decision making, and asking them to do so could be very threatening.” If your patient doesn’t want information, you don’t have to provide it. This still respects their autonomy. But make sure you document it.
Perhaps the best way to consider informed consent is to put yourself in the patient’s place. Dr. David J. Doukas, Director of the Values in Bioethics Research Program at the University Michigan recommends that in considering informed consent, physicians should keep in mind the Golden Rule.
“American medicine has undergone a revolutionary transformation over the past century. With the legal, social, and medical changes that have occurred, we have gone from the notion of ‘Doctor Knows Best’ to ‘Patient Needs to Know.’ Forty years ago patients would almost never be told about a cancer diagnosis, now such action would be understood as unacceptable, both morally and legally. Yet, forty years ago, in those same surveys, the doctors themselves stated that they would want to know if they had cancer. So, “Do unto others…”
Arthur Caplan, Ph.D. – Director, Center for Bioethics
University of Pennsylvania
3401 Market St. Suite 320, Philadelphia, PA 19104-3308
Howard Brody, M.D., Ph.D.
Director – Center for Ethics, Dept. of Family Practice and Humanities, Michigan State University, East Lansing, MI 48824 517-353-3544 X 427, 517-355-7550
firstname.lastname@example.org OR Howard.Brody@ht.msu.edu
James R. Damos, M.D., Professor (CHS)
University of Wisconsin, Department of Family Medicine
777 South Mills Street
Madison, Wisconsin 53715
Department Voice Mail 608-263-4016
Verona Clinic 608-845-9531
Fax Number 608-845-8684
Ira Byock, MD, Associate Medical Director, Partners Hospice of Missoula
Missoula, Montana 59801
Joshua Korman, M.D., F.A.C.S.
2500 Hospital Drive, Building Nine
Mountain View, CA 94040
Edward S. Bessman, MD, FAAEM, FACEP
Interim Chairman, Department of Emergency Medicine
Johns Hopkins Bayview Medical Center
Baltimore, MD 21224 USA
Kathryn M Andolsek MD MPH
Dept of Community and Family Medicine
Duke University Medical Center
Steven Kemp, MD, Pediatric Endocrinologist
Arkansas Children’s Hospital
800 Marshall Street
Little Rock, Arkansas 72202
Ida Sim, MD, Ph.D., Assistant Professor, General Internal Medicine
Department of Medicine and Member, Graduate Group in Medical Information Sciences
University of California, San Francisco
400 Parnassus Ave., Rm. A-405
San Francisco, CA USA 94143-0320
Phone: (415) 502-1954
Fax: (415) 476-7964
David J. Doukas, MD
Director, The Values in Bioethics Research Program
Associate Professor in Family Medicine
TEL. (734) 998-7120, ext. 313