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In 1972, Canterbury v. Spence changed American health law, and with it, the patient-physician relationship. Some ethicists cite this as the beginning of modern medical ethics. Before a patient agreed to a surgical procedure, he was to be informed about its risks and benefits. Failure to do so was negligence. Part III of that appellate court decision gives a concise history explaining why the judges did not consider their decision revolutionary. That, however, wasn’t the way doctors experienced it. A decade earlier, arguments had been advanced justifying why it was better not to tell a patient he had cancer. Not all physicians agreed with that practice, labeled therapeutic privilege. But after Canterbury, such paternalism was no longer acceptable (with extremely rare exceptions).
Per Canterbury:
"The root premise is the concept, fundamental in American jurisprudence, that ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body.’ ... True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make such a decision possible."
As outlined by that court, informed consent is not a form that needs to be signed. It is the professional duty to communicate information to the patient. That includes overcoming cultural and language barriers, poor health literacy, and denial.
The standard for what is contained in informed consent has evolved. Not every minute risk need be discussed. In many states, the requirements went from a professional standard (What information did other physicians customarily disclose?) to a reasonable person standard (What information would a reasonable patient want to know?) Then, as with many ideas that start out with good intentions, the whole thing spun out of control. The amount of material to be disclosed expanded without bound. There can be too much of a good thing. All too often, modern medical consent forms have become like the End User License Agreement (EULA) I ignore whenever I install computer software. Don’t most people just click the box that says, "I have read and accepted the terms of the EULA," without actually reading it? As if you really had a choice?
On taking my mother to the emergency department recently, I was given a binder filled with 32 pages of orientation materials, privacy notifications, descriptions of patient rights and responsibilities, and other paraphernalia, in addition to a five-page consent form for general medical care. I read it only out of sheer boredom while waiting 6 hours for test results to come back. The 47 pages of information in the discharge packet 2 days later were never read. But what I really wanted was a CD copy of her MRI to take to her follow-up appointment with a different doctor. That, I was told, could be obtained only from Health Information Services, which wasn’t open on a Sunday.
This experience has strongly reinforced my prior belief that idolizing autonomy can become counterproductive. Some people have the notion that maximizing autonomy is achieved by increased information sharing, or more practically, adding another form. The word camouflage comes to mind. You can’t see the forest for the trees. A hospital a few years ago wondered whether it should notify patients that a surgical resident might perform part of the procedure. The best advice seemed to be yes, include a sentence about that on the consent form. Almost no one will ever see it.
Medicine desperately needs its own version of the Paperwork Reduction Act of 1995 (PRA). I say this not to reduce the burden on the physician, but as a patient advocate hoping to improve the focus on important facts, thereby actually enhancing decision making rather than obfuscating it.
"The PRA mandates that all federal government agencies must obtain a Control Number from OMB [Office of Management and Budget] before promulgating a form that will impose an information collection burden on the general public. Once obtained, approval must be renewed every 3 years. In order to obtain or renew such approval, an agency must fill out OMB Form 83-I, attach the proposed form, and file it with OIRA [Office of Information and Regulatory Affairs]. On Form 83-I, the agency must explain the reason why the form is needed and estimate the burden in terms of time and money that the form will impose upon the persons required to fill it out."
Having government paperwork to reduce paperwork seems a little, no, a lot oxymoronic. However, the administrator of the OIRA appointed by President Barack Obama is Cass R. Sunstein, one of the coauthors of a book called, "Nudge: Improving Decisions about Health, Wealth, and Happiness." Advertisers have accumulated a vast science on how to influence people to buy things they don’t need. "Nudge" suggests it is time to use that research in behavioral economics to nudge people to default toward making good decisions. This approach, called libertarian paternalism, may also seem like an oxymoron. But then, lately, so has the term informed consent.
Dr. Kevin T. Powell is an associate professor of pediatrics at St. Louis University and a pediatric hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He said he had no relevant financial disclosures. E-mail Dr. Powell.
In 1972, Canterbury v. Spence changed American health law, and with it, the patient-physician relationship. Some ethicists cite this as the beginning of modern medical ethics. Before a patient agreed to a surgical procedure, he was to be informed about its risks and benefits. Failure to do so was negligence. Part III of that appellate court decision gives a concise history explaining why the judges did not consider their decision revolutionary. That, however, wasn’t the way doctors experienced it. A decade earlier, arguments had been advanced justifying why it was better not to tell a patient he had cancer. Not all physicians agreed with that practice, labeled therapeutic privilege. But after Canterbury, such paternalism was no longer acceptable (with extremely rare exceptions).
Per Canterbury:
"The root premise is the concept, fundamental in American jurisprudence, that ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body.’ ... True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make such a decision possible."
As outlined by that court, informed consent is not a form that needs to be signed. It is the professional duty to communicate information to the patient. That includes overcoming cultural and language barriers, poor health literacy, and denial.
The standard for what is contained in informed consent has evolved. Not every minute risk need be discussed. In many states, the requirements went from a professional standard (What information did other physicians customarily disclose?) to a reasonable person standard (What information would a reasonable patient want to know?) Then, as with many ideas that start out with good intentions, the whole thing spun out of control. The amount of material to be disclosed expanded without bound. There can be too much of a good thing. All too often, modern medical consent forms have become like the End User License Agreement (EULA) I ignore whenever I install computer software. Don’t most people just click the box that says, "I have read and accepted the terms of the EULA," without actually reading it? As if you really had a choice?
On taking my mother to the emergency department recently, I was given a binder filled with 32 pages of orientation materials, privacy notifications, descriptions of patient rights and responsibilities, and other paraphernalia, in addition to a five-page consent form for general medical care. I read it only out of sheer boredom while waiting 6 hours for test results to come back. The 47 pages of information in the discharge packet 2 days later were never read. But what I really wanted was a CD copy of her MRI to take to her follow-up appointment with a different doctor. That, I was told, could be obtained only from Health Information Services, which wasn’t open on a Sunday.
This experience has strongly reinforced my prior belief that idolizing autonomy can become counterproductive. Some people have the notion that maximizing autonomy is achieved by increased information sharing, or more practically, adding another form. The word camouflage comes to mind. You can’t see the forest for the trees. A hospital a few years ago wondered whether it should notify patients that a surgical resident might perform part of the procedure. The best advice seemed to be yes, include a sentence about that on the consent form. Almost no one will ever see it.
Medicine desperately needs its own version of the Paperwork Reduction Act of 1995 (PRA). I say this not to reduce the burden on the physician, but as a patient advocate hoping to improve the focus on important facts, thereby actually enhancing decision making rather than obfuscating it.
"The PRA mandates that all federal government agencies must obtain a Control Number from OMB [Office of Management and Budget] before promulgating a form that will impose an information collection burden on the general public. Once obtained, approval must be renewed every 3 years. In order to obtain or renew such approval, an agency must fill out OMB Form 83-I, attach the proposed form, and file it with OIRA [Office of Information and Regulatory Affairs]. On Form 83-I, the agency must explain the reason why the form is needed and estimate the burden in terms of time and money that the form will impose upon the persons required to fill it out."
Having government paperwork to reduce paperwork seems a little, no, a lot oxymoronic. However, the administrator of the OIRA appointed by President Barack Obama is Cass R. Sunstein, one of the coauthors of a book called, "Nudge: Improving Decisions about Health, Wealth, and Happiness." Advertisers have accumulated a vast science on how to influence people to buy things they don’t need. "Nudge" suggests it is time to use that research in behavioral economics to nudge people to default toward making good decisions. This approach, called libertarian paternalism, may also seem like an oxymoron. But then, lately, so has the term informed consent.
Dr. Kevin T. Powell is an associate professor of pediatrics at St. Louis University and a pediatric hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He said he had no relevant financial disclosures. E-mail Dr. Powell.
In 1972, Canterbury v. Spence changed American health law, and with it, the patient-physician relationship. Some ethicists cite this as the beginning of modern medical ethics. Before a patient agreed to a surgical procedure, he was to be informed about its risks and benefits. Failure to do so was negligence. Part III of that appellate court decision gives a concise history explaining why the judges did not consider their decision revolutionary. That, however, wasn’t the way doctors experienced it. A decade earlier, arguments had been advanced justifying why it was better not to tell a patient he had cancer. Not all physicians agreed with that practice, labeled therapeutic privilege. But after Canterbury, such paternalism was no longer acceptable (with extremely rare exceptions).
Per Canterbury:
"The root premise is the concept, fundamental in American jurisprudence, that ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body.’ ... True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make such a decision possible."
As outlined by that court, informed consent is not a form that needs to be signed. It is the professional duty to communicate information to the patient. That includes overcoming cultural and language barriers, poor health literacy, and denial.
The standard for what is contained in informed consent has evolved. Not every minute risk need be discussed. In many states, the requirements went from a professional standard (What information did other physicians customarily disclose?) to a reasonable person standard (What information would a reasonable patient want to know?) Then, as with many ideas that start out with good intentions, the whole thing spun out of control. The amount of material to be disclosed expanded without bound. There can be too much of a good thing. All too often, modern medical consent forms have become like the End User License Agreement (EULA) I ignore whenever I install computer software. Don’t most people just click the box that says, "I have read and accepted the terms of the EULA," without actually reading it? As if you really had a choice?
On taking my mother to the emergency department recently, I was given a binder filled with 32 pages of orientation materials, privacy notifications, descriptions of patient rights and responsibilities, and other paraphernalia, in addition to a five-page consent form for general medical care. I read it only out of sheer boredom while waiting 6 hours for test results to come back. The 47 pages of information in the discharge packet 2 days later were never read. But what I really wanted was a CD copy of her MRI to take to her follow-up appointment with a different doctor. That, I was told, could be obtained only from Health Information Services, which wasn’t open on a Sunday.
This experience has strongly reinforced my prior belief that idolizing autonomy can become counterproductive. Some people have the notion that maximizing autonomy is achieved by increased information sharing, or more practically, adding another form. The word camouflage comes to mind. You can’t see the forest for the trees. A hospital a few years ago wondered whether it should notify patients that a surgical resident might perform part of the procedure. The best advice seemed to be yes, include a sentence about that on the consent form. Almost no one will ever see it.
Medicine desperately needs its own version of the Paperwork Reduction Act of 1995 (PRA). I say this not to reduce the burden on the physician, but as a patient advocate hoping to improve the focus on important facts, thereby actually enhancing decision making rather than obfuscating it.
"The PRA mandates that all federal government agencies must obtain a Control Number from OMB [Office of Management and Budget] before promulgating a form that will impose an information collection burden on the general public. Once obtained, approval must be renewed every 3 years. In order to obtain or renew such approval, an agency must fill out OMB Form 83-I, attach the proposed form, and file it with OIRA [Office of Information and Regulatory Affairs]. On Form 83-I, the agency must explain the reason why the form is needed and estimate the burden in terms of time and money that the form will impose upon the persons required to fill it out."
Having government paperwork to reduce paperwork seems a little, no, a lot oxymoronic. However, the administrator of the OIRA appointed by President Barack Obama is Cass R. Sunstein, one of the coauthors of a book called, "Nudge: Improving Decisions about Health, Wealth, and Happiness." Advertisers have accumulated a vast science on how to influence people to buy things they don’t need. "Nudge" suggests it is time to use that research in behavioral economics to nudge people to default toward making good decisions. This approach, called libertarian paternalism, may also seem like an oxymoron. But then, lately, so has the term informed consent.
Dr. Kevin T. Powell is an associate professor of pediatrics at St. Louis University and a pediatric hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He said he had no relevant financial disclosures. E-mail Dr. Powell.