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How 'Innovation' Informs Consent

The common scenario for the consent process is that when a patient has a medical condition requiring surgery, the surgeon explains the surgical risks. The patient might not want to have the operation, but once it is clear that the benefits outweigh the risks, the patient consents to the operation. This dynamic of the surgeon explaining what the patient needs and the patient considering that advice before agreeing to the operation is well accepted and firmly grounded on the principle of respect for patient autonomy. Unfortunately, in the current era of Internet marketing and the public’s fascination with the latest innovative technology, the traditional consent process is often dramatically altered.

Recently, a patient of mine requested a surgical procedure not commonly performed in the United States. The patient stated that she had read all about it on the Internet. When I asked what she had learned, my patient described the new surgical approach as an "innovative technique" that made use of the "latest technology" to allow the surgery to be performed in a "minimally invasive" fashion. When I pointed out that this approach was new and therefore less was known about it, she assured me that she likes to take on new challenges and she would be happy to be a pioneering patient for this innovative procedure.

In some ways, this scenario may sound ideal. A patient has actively explored the options to treat her disease and has found something appealing. Certainly education is good, and what could be better than a motivated patient taking an active role in her own health care decision making? Nevertheless, something made me uncomfortable. Perhaps it was the fact that the patient had misinterpreted the information that she had read and was requesting a procedure for which there was very little published safety data. Perhaps her enthusiasm for the operation took me by surprise. As I presented the risks, she seemed to disregard each and every one, having decided that this operation was "the best one" for her. Our traditional roles in the consent process had changed: The patient was pushing for an operation while the surgeon was wary of the unknown risks.

If a patient is already sold on a new procedure even before seeing a surgeon, then the surgeon has the ethical responsibility to ensure that risks are adequately considered. In this setting, the traditional emphasis on respecting the autonomous choices of patients may need to be tempered by the principle of nonmaleficence – that is, the physician’s responsibility to avoid bringing harm to the patient. I would never endorse a shift back to the old days of paternalism, when doctors made decisions for patients. However, we may be seeing the emergence of an era in which surgeons must exercise their professionalism by not offering patients everything that they might want.

The best surgeons are not always those who offer the latest high-tech, innovative procedures, but rather those who carefully explain why such an operation may not be appropriate. Surgeons have always had the ethical responsibility to apply their surgical skills to benefit their patients, and now they have the added challenge of trying to convince their patients that, despite marketing claims, a new operation may not be improved.

In trying to talk patients out of operations that they want, surgeons must ignore self-interest and, as objectively as possible, make thoughtful recommendations. As the public’s fascination with the "new," "high tech," and "innovative" procedures grows, the challenge will be to ignore the hype and make recommendations based on what is truly known about safety and efficacy.

Dr. Peter Angelos is an ACS Fellow, the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

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The common scenario for the consent process is that when a patient has a medical condition requiring surgery, the surgeon explains the surgical risks. The patient might not want to have the operation, but once it is clear that the benefits outweigh the risks, the patient consents to the operation. This dynamic of the surgeon explaining what the patient needs and the patient considering that advice before agreeing to the operation is well accepted and firmly grounded on the principle of respect for patient autonomy. Unfortunately, in the current era of Internet marketing and the public’s fascination with the latest innovative technology, the traditional consent process is often dramatically altered.

Recently, a patient of mine requested a surgical procedure not commonly performed in the United States. The patient stated that she had read all about it on the Internet. When I asked what she had learned, my patient described the new surgical approach as an "innovative technique" that made use of the "latest technology" to allow the surgery to be performed in a "minimally invasive" fashion. When I pointed out that this approach was new and therefore less was known about it, she assured me that she likes to take on new challenges and she would be happy to be a pioneering patient for this innovative procedure.

In some ways, this scenario may sound ideal. A patient has actively explored the options to treat her disease and has found something appealing. Certainly education is good, and what could be better than a motivated patient taking an active role in her own health care decision making? Nevertheless, something made me uncomfortable. Perhaps it was the fact that the patient had misinterpreted the information that she had read and was requesting a procedure for which there was very little published safety data. Perhaps her enthusiasm for the operation took me by surprise. As I presented the risks, she seemed to disregard each and every one, having decided that this operation was "the best one" for her. Our traditional roles in the consent process had changed: The patient was pushing for an operation while the surgeon was wary of the unknown risks.

If a patient is already sold on a new procedure even before seeing a surgeon, then the surgeon has the ethical responsibility to ensure that risks are adequately considered. In this setting, the traditional emphasis on respecting the autonomous choices of patients may need to be tempered by the principle of nonmaleficence – that is, the physician’s responsibility to avoid bringing harm to the patient. I would never endorse a shift back to the old days of paternalism, when doctors made decisions for patients. However, we may be seeing the emergence of an era in which surgeons must exercise their professionalism by not offering patients everything that they might want.

The best surgeons are not always those who offer the latest high-tech, innovative procedures, but rather those who carefully explain why such an operation may not be appropriate. Surgeons have always had the ethical responsibility to apply their surgical skills to benefit their patients, and now they have the added challenge of trying to convince their patients that, despite marketing claims, a new operation may not be improved.

In trying to talk patients out of operations that they want, surgeons must ignore self-interest and, as objectively as possible, make thoughtful recommendations. As the public’s fascination with the "new," "high tech," and "innovative" procedures grows, the challenge will be to ignore the hype and make recommendations based on what is truly known about safety and efficacy.

Dr. Peter Angelos is an ACS Fellow, the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

The common scenario for the consent process is that when a patient has a medical condition requiring surgery, the surgeon explains the surgical risks. The patient might not want to have the operation, but once it is clear that the benefits outweigh the risks, the patient consents to the operation. This dynamic of the surgeon explaining what the patient needs and the patient considering that advice before agreeing to the operation is well accepted and firmly grounded on the principle of respect for patient autonomy. Unfortunately, in the current era of Internet marketing and the public’s fascination with the latest innovative technology, the traditional consent process is often dramatically altered.

Recently, a patient of mine requested a surgical procedure not commonly performed in the United States. The patient stated that she had read all about it on the Internet. When I asked what she had learned, my patient described the new surgical approach as an "innovative technique" that made use of the "latest technology" to allow the surgery to be performed in a "minimally invasive" fashion. When I pointed out that this approach was new and therefore less was known about it, she assured me that she likes to take on new challenges and she would be happy to be a pioneering patient for this innovative procedure.

In some ways, this scenario may sound ideal. A patient has actively explored the options to treat her disease and has found something appealing. Certainly education is good, and what could be better than a motivated patient taking an active role in her own health care decision making? Nevertheless, something made me uncomfortable. Perhaps it was the fact that the patient had misinterpreted the information that she had read and was requesting a procedure for which there was very little published safety data. Perhaps her enthusiasm for the operation took me by surprise. As I presented the risks, she seemed to disregard each and every one, having decided that this operation was "the best one" for her. Our traditional roles in the consent process had changed: The patient was pushing for an operation while the surgeon was wary of the unknown risks.

If a patient is already sold on a new procedure even before seeing a surgeon, then the surgeon has the ethical responsibility to ensure that risks are adequately considered. In this setting, the traditional emphasis on respecting the autonomous choices of patients may need to be tempered by the principle of nonmaleficence – that is, the physician’s responsibility to avoid bringing harm to the patient. I would never endorse a shift back to the old days of paternalism, when doctors made decisions for patients. However, we may be seeing the emergence of an era in which surgeons must exercise their professionalism by not offering patients everything that they might want.

The best surgeons are not always those who offer the latest high-tech, innovative procedures, but rather those who carefully explain why such an operation may not be appropriate. Surgeons have always had the ethical responsibility to apply their surgical skills to benefit their patients, and now they have the added challenge of trying to convince their patients that, despite marketing claims, a new operation may not be improved.

In trying to talk patients out of operations that they want, surgeons must ignore self-interest and, as objectively as possible, make thoughtful recommendations. As the public’s fascination with the "new," "high tech," and "innovative" procedures grows, the challenge will be to ignore the hype and make recommendations based on what is truly known about safety and efficacy.

Dr. Peter Angelos is an ACS Fellow, the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

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