New York Times
April 28, 2008
By GARDINER HARRIS
Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff and students in all 129 of the nation’s medical colleges, an influential college association has concluded.
The proposed ban is the result of a two-year effort by the Association of American Medical Colleges to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations.
Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the association’s report would transform medical education.
“Most medical schools do not have strong conflict-of-interest policies, and this report will change that,” he said.
The new rules would apply only to medical schools, but they will have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University.
“We’re hoping the example set by academic medical colleges will be contagious,” Dr. Rothman said.
Drug companies spend billions of dollars wooing doctors — more than they spend on research or consumer advertising. Medical schools, packed with prominent professors and impressionable trainees, are particularly attractive marketing targets.
So companies have for decades provided faculty and students free food and gifts, offered lucrative consulting arrangements to top-notch teachers and even ghost-wrote research papers for busy professors.
“Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception among colleagues, students, trainees and the public that practitioners are being ‘bought’ or ‘bribed’ by industry,” the association’s report states.
A group of influential doctors decried these practices in a 2006 article in JAMA, the Journal of the American Medical Association, and said medical schools should ban them. In the article’s wake, the medical college association created a task force.
With Dr. Roy Vagelos, a former Merck chief executive, serving as the task force’s chairman and the chief executives of Pfizer, Eli Lilly, Amgen and Medtronic on the roster, some who advocate for greater restrictions on industry influence in medicine predicted that the report would be weak.
They were wrong.
In addition to the gift, food and travel bans, the report recommended that medical schools should “strongly discourage participation by their faculty in industry-sponsored speakers’ bureaus,” in which doctors are paid to promote the benefits of drugs and devices.
It recommended that schools set up centralized systems for accepting free drug samples or “alternative ways to manage pharmaceutical sample distribution that do not carry the risks to professionalism with which current practices are associated.” It suggested that schools audit independently accredited medical education seminars given by faculty “for the presence of inappropriate influence.” And it said the rules should apply to faculty members even when they are off-duty or away from school.
Speakers’ bureaus and drug samples are central pillars of the industry’s marketing operations, and many medical school professors have resisted efforts to restrict them. Only a handful of medical schools currently bar faculty members from serving on speakers’ bureaus, so if this recommendation is widely adopted, it could transform the relationship between medical school faculty and industry, and it could change substantially the way medical education is routinely delivered.
Indeed, the chief executives of Pfizer and Eli Lilly dissented from the report’s recommendation regarding speakers’ bureaus.
“We continue to believe that these types of programs, which are subject to clear regulations regarding their content, can be worthwhile educational activities,” wrote Jeffrey B. Kindler of Pfizer and Sidney Taurel of Lilly.
David Beier, an Amgen senior vice president, wrote a letter that endorsed the report’s recommendations but disagreed with some of its text “because we have a different view about the accuracy concerning representations about the motives of the participants in industry-academic interactions.”
Ken Johnson of the Pharmaceutical Research and Manufacturers of America, said his group would review the report.
“Providing physicians — and medical students — with timely, accurate information about the medicines they prescribe clearly benefits patients and advances healthcare throughout the United States,” Mr. Johnson said.
Dr. Robert J. Alpern, dean of the Yale School of Medicine, said the university currently had no limits on participation in company speakers’ bureaus. But because of the medical college association’s report, he said, “I’m thinking of taking on the speakers’ bureaus.”
“I don’t have a problem with doctors making $3,000 or $5,000 a year on the side, but it’s a totally different thing when it’s $80,000,” he said. Even more distasteful, Dr. Alpern said, is that the slides used in many of these presentations are created by drug makers, not the speakers.
“That’s like ghost-talking,” Dr. Alpern said
Dr. Arthur S. Levine, dean of the University of Pittsburgh School of Medicine said that when he graduated from medical school in 1964, Eli Lilly gave him his first doctor’s bag, and Roche gave him an Omega watch for being valedictorian. He still has the watch.
But this year’s graduating class of doctors at Pittsburgh will not be allowed to accept any of these gifts, and the daily pizza lunches brought by drug companies are gone, he said.
“Nobody has become anorexic” since the school adopted a strict gift and food ban in February, Dr. Levine said.
Julie Gottlieb, assistant dean of policy coordination for Johns Hopkins University School of Medicine, said Hopkins had adopted some of the association’s recommendations and was considering others.
“This report is bound to influence our deliberations,” she said.
Dr. Vagelos, formerly of Merck, said that the report’s recommendations are certain to face resistance among faculty who like the present system.
“The outcome of this for the industry is that those companies that are strong in science will always be welcome at medical colleges and others won’t,” Dr. Vagelos said.
Monday, August 25, 2008
Jump in US measles cases linked to vaccine fears
By MIKE STOBBE – 4 days ago
ATLANTA (AP) — Measles cases in the U.S. are at the highest level in more than a decade, with nearly half of those involving children whose parents rejected vaccination, health officials reported Thursday.
Worried doctors are troubled by the trend fueled by unfounded fears that vaccines may cause autism. The number of cases is still small, just 131, but that's only for the first seven months of the year. There were only 42 cases for all of last year.
"We're seeing a lot more spread. That is concerning to us," said Dr. Jane Seward, of the Centers for Disease Control and Prevention.
Pediatricians are frustrated, saying they are having to spend more time convincing parents the shot is safe.
"This year, we certainly have had parents asking more questions," said Dr. Ari Brown, an Austin, Texas, physician who is a spokeswoman for the American Academy of Pediatrics.
The CDC's review found that a number of cases involved home-schooled children not required to get the vaccines. Others can avoid vaccination by seeking exemptions, such as for religious reasons.
Measles, best known for a red skin rash, is a potentially deadly, highly infectious virus that spreads through contact with a sneezing, coughing, infected person.
It is no longer endemic to the United States, but every year cases enter the country through foreign visitors or Americans returning from abroad. Measles epidemics have exploded in Israel, Switzerland and some other countries. But high U.S. childhood vaccination rates have prevented major outbreaks here.
In a typical year, only one outbreak occurs in the United States, infecting perhaps 10 to 20 people. So far this year through July 30 the country has seen seven outbreaks, including one in Illinois with 30 cases, said Seward, of the CDC's Division of Viral Diseases.
None of the 131 patients died, but 15 were hospitalized.
Childhood measles vaccination rates have stayed above 92 percent, according to 2006 data. However, the recent outbreaks suggest potential pockets of unvaccinated children are forming. Health officials worry that vaccination rates have begun to fall — something that won't show up in the data for a couple of years.
The vaccine is considered highly effective but not perfect; 11 of this year's cases had at least one dose of the vaccine.
Of this year's total, 122 were unvaccinated or had unknown vaccination status. Some were unvaccinated because the children were under age 1 — too young to get their first measles shot.
In 63 of those cases — almost all of them 19 or under — the patient or their parents refused the shots for philosophical or religious reasons, the CDC reported.
In Washington state, an outbreak was traced to a church conference, including 16 school-aged children who were not vaccinated. Eleven of those kids were home schooled and not subject to vaccination rules in public schools. It's unclear why the parents rejected the vaccine.
The Illinois outbreak — triggered by a teenager who had traveled to Italy — included 25 home-schooled children, according to the CDC report.
The nation once routinely saw hundreds of thousands of measles cases each year, and hundreds of deaths. But immunization campaigns were credited with dramatically reducing the numbers. The last time health officials saw this many cases was 1997, when 138 were reported.
The Academy of Pediatrics has made educating parents about the safety of vaccines one of its top priorities this year. That's partly because busy doctors have grown frustrated by the amount of time they're spending answering parents' questions about things they read on the Internet or heard from TV talk shows.
In June, the CDC interviewed 33 physicians in Austin, suburban Seattle and Hollywood, Fla., about childhood vaccinations. Several complained about patient backlogs caused by parents stirred up by information of dubious scientific merit, according to the CDC report.
Questions commonly center on autism and the fear that it can be caused by the measles shots or by a mercury-based preservative that used to be in most vaccines. Health officials say there is no good scientific proof either is a cause. Also, since 2001, the preservative has been removed from shots recommended for young children, and it was never in the measles-mumps-rubella combination vaccine. It can still be found in some flu shots.
Brown said she wrote a 16-page, single-spaced document for parents that explains childhood vaccinations and why doctors do not believe they cause autism. She began handing it out this spring, and thinks it's been a help to parents and a time-saver for her.
"People want that level of information," she said.
At least one outbreak this year of another preventable disease was blamed on lack of immunizations. At least 17 children were sick with whooping cough at a private school in the San Francisco Bay area, and 13 were not vaccinated against the disease, which can be fatal to children.
Associated Press writer Marcus Wohlsen in San Francisco contributed to this story.
On the Net:
The CDC report: http://www.cdc.gov/mmwr
ATLANTA (AP) — Measles cases in the U.S. are at the highest level in more than a decade, with nearly half of those involving children whose parents rejected vaccination, health officials reported Thursday.
Worried doctors are troubled by the trend fueled by unfounded fears that vaccines may cause autism. The number of cases is still small, just 131, but that's only for the first seven months of the year. There were only 42 cases for all of last year.
"We're seeing a lot more spread. That is concerning to us," said Dr. Jane Seward, of the Centers for Disease Control and Prevention.
Pediatricians are frustrated, saying they are having to spend more time convincing parents the shot is safe.
"This year, we certainly have had parents asking more questions," said Dr. Ari Brown, an Austin, Texas, physician who is a spokeswoman for the American Academy of Pediatrics.
The CDC's review found that a number of cases involved home-schooled children not required to get the vaccines. Others can avoid vaccination by seeking exemptions, such as for religious reasons.
Measles, best known for a red skin rash, is a potentially deadly, highly infectious virus that spreads through contact with a sneezing, coughing, infected person.
It is no longer endemic to the United States, but every year cases enter the country through foreign visitors or Americans returning from abroad. Measles epidemics have exploded in Israel, Switzerland and some other countries. But high U.S. childhood vaccination rates have prevented major outbreaks here.
In a typical year, only one outbreak occurs in the United States, infecting perhaps 10 to 20 people. So far this year through July 30 the country has seen seven outbreaks, including one in Illinois with 30 cases, said Seward, of the CDC's Division of Viral Diseases.
None of the 131 patients died, but 15 were hospitalized.
Childhood measles vaccination rates have stayed above 92 percent, according to 2006 data. However, the recent outbreaks suggest potential pockets of unvaccinated children are forming. Health officials worry that vaccination rates have begun to fall — something that won't show up in the data for a couple of years.
The vaccine is considered highly effective but not perfect; 11 of this year's cases had at least one dose of the vaccine.
Of this year's total, 122 were unvaccinated or had unknown vaccination status. Some were unvaccinated because the children were under age 1 — too young to get their first measles shot.
In 63 of those cases — almost all of them 19 or under — the patient or their parents refused the shots for philosophical or religious reasons, the CDC reported.
In Washington state, an outbreak was traced to a church conference, including 16 school-aged children who were not vaccinated. Eleven of those kids were home schooled and not subject to vaccination rules in public schools. It's unclear why the parents rejected the vaccine.
The Illinois outbreak — triggered by a teenager who had traveled to Italy — included 25 home-schooled children, according to the CDC report.
The nation once routinely saw hundreds of thousands of measles cases each year, and hundreds of deaths. But immunization campaigns were credited with dramatically reducing the numbers. The last time health officials saw this many cases was 1997, when 138 were reported.
The Academy of Pediatrics has made educating parents about the safety of vaccines one of its top priorities this year. That's partly because busy doctors have grown frustrated by the amount of time they're spending answering parents' questions about things they read on the Internet or heard from TV talk shows.
In June, the CDC interviewed 33 physicians in Austin, suburban Seattle and Hollywood, Fla., about childhood vaccinations. Several complained about patient backlogs caused by parents stirred up by information of dubious scientific merit, according to the CDC report.
Questions commonly center on autism and the fear that it can be caused by the measles shots or by a mercury-based preservative that used to be in most vaccines. Health officials say there is no good scientific proof either is a cause. Also, since 2001, the preservative has been removed from shots recommended for young children, and it was never in the measles-mumps-rubella combination vaccine. It can still be found in some flu shots.
Brown said she wrote a 16-page, single-spaced document for parents that explains childhood vaccinations and why doctors do not believe they cause autism. She began handing it out this spring, and thinks it's been a help to parents and a time-saver for her.
"People want that level of information," she said.
At least one outbreak this year of another preventable disease was blamed on lack of immunizations. At least 17 children were sick with whooping cough at a private school in the San Francisco Bay area, and 13 were not vaccinated against the disease, which can be fatal to children.
Associated Press writer Marcus Wohlsen in San Francisco contributed to this story.
On the Net:
The CDC report: http://www.cdc.gov/mmwr
AMA Virtual Mentor August - Informed Consent 4
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 527-530.
MEDICINE AND SOCIETY
The Patient’s Piece of the Informed Consent Pie
Abraham P. Schwab, PhD
I’ve tried to quit smoking more times than I can count. Several years ago, I asked my family physician for a well-known drug to help me quit. He responded by providing me with a list of support groups, suggesting I try one. I responded that I was not a “support group” person. He suggested I try one anyway. The interaction struck me as odd, given that the physician and I clearly had the same goal—I was to quit smoking—but the physician was dictating the means of achieving that goal.
Part of my surprise in this case arose from my confusion about the role of informed consent in medical practice. In what follows I provide a more accurate, though less appealing, view of informed consent. The concept of informed consent has been defined in many ways: shared decision-making [1], an attempt to balance patient self-determination and patient well-being [2], a necessary supplement to physician altruism [3], and a ritual of trust [4]. Despite all these definitions, this practice, this legal requirement, this form we must sign before receiving care, is not particularly well understood by medical practitioners and patients.
Take for example a recent piece in the Journal of General Internal Medicine by Peter Schwartz and Eric Meslin [5]. In the abstract they note a relationship between, “the ethical principle of respect for autonomy and its application in informed consent or [emphasis added] shared decision-making.” Early in the article they state: “This principle [of respecting patient autonomy] requires, among other things, that patients guide their health care by providing informed consent to proposed interventions or [emphasis added] by participating in shared decision making” [5]. They conclude with, “while respect for autonomy is central to health care ethics, it can be difficult to clarify what level of disclosure or understanding is necessary for a specific patient in a specific situation. . . to adequately consent to medical interventions” [6]. While accurately indicating that there exists some relationship between respect for autonomy, informed consent, and shared decision making, these quotes fail to recognize the very limited scope of informed consent and the substantial differences between its requirements and those of shared decision making. Specifically, as every physician knows, informed consent is legally required. As an aspect of patients’ autonomous decision making, however, informed consent is a negative—not a positive—expression of autonomy. Shared decision making, on the other hand, is more likely to include positive expressions of patient autonomy, but it is not legally required and may or may not be part of the patient-physician encounter.
Schwartz and Meslin follow a view common to the discussion of informed consent in bioethics. Buchanan and Brock’s [2] well-known discussion of competence is representative of this “patient-centric” view. On their view, two values ground the practice of informed consent: promoting the patient’s well-being while preserving the patient’s self-determination. Yet the legal, clinical, and etymological background of informed consent suggest otherwise. The legal history emphasizes the right of refusal—patients must be informed so that they can agree (or not) to what the physician recommends [7]. The clinical history of informed consent emphasizes an ever-increasing encroachment on physician authority—interventions previously performed without patient consent now require it (e.g., childhood immunizations), though this is not true in all cases (e.g., episiotomy). The language itself, “informed” and “consent,” implies that physicians make a judgment to which patients agree (or not). In short, informed consent is less about patient decisions than it is about restraining physicians. Informed consent operates like a pie crust that keeps the filling of physician judgment and activity from spilling onto the table and the floor—it constrains physician activity; it does not enhance patient autonomy.
In the best cases, then, to push the pie analogy a little further, patients are allowed in the kitchen but they are not allowed to touch the ingredients or use any utensils to help with the pie filling. When asked, the patient may choose among fillings the physician offers, but they are not entitled to produce their own filling or direct what fillings the physician offers. The patient may also refuse every filling the physician offers, and so refuse to make a pie.
Competence, power relations, and bias further attenuate the meaningfulness of a right of refusal. First, patients may lack even the basic components of decision-making competence; they cannot meaningfully say “no.” Second, information can be challenged by the patient (e.g., “Why do you recommend that?”), but the physician is the locus of control for the structure of the process and the type and amount of information provided. Third, the biases of human judgment often undermine patient decision making so that the decision to say “no” reveals more about the conditions under which the decision was made than about the preferences of the patient.
Setting aside the important, though well-covered, questions about competence, the effects of power and the implications of bias warrant a few more words. Patients and physicians inhabit different positions of power—physicians with esoteric knowledge of potential benefit and patients with the right of refusal. These differences in power structure the informed consent process in unappealing ways. Specifically, physicians are the means through which patients’ refusals become possible. That is, physicians make patients aware of those interventions that they (the patients) are empowered to refuse—patients’ ability to restrain physician activity is the responsibility of the physicians themselves. Ready-made consent forms ease the discharge of this responsibility. Much like a ready-made pie crust, consent forms have been standardized to limit the need of physicians to be actively involved in reining in their work, the refusal of their recommendations. Far from ideal, the ready-made pie crust still controls the filling better than no crust at all. 528
The problems of a ready-made pie crust and other means of limiting physician involvement in informed consent (e.g., having the nurse do it) are even less appealing when the biases of patient judgment are considered. Large numbers of studies illustrate the predictable biases in human judgment, many using hypothetical or actual medical judgments [8-12]. What this research means for informed consent is not entirely clear, but a few preliminary conclusions can be drawn. First, certain conditions give rise to biased decisions to consent (or refuse) by patients. Second, these conditions can be controlled by medical practitioners. Take for example the effect of presenting information as proportions rather than as percentages. Robust evidence indicates that information presented as proportions leads to more accurate interpretations of the information by both lay individuals and experts [13]. Naive and expert decision makers alike have been shown to identify more accurately the implications of this statement: “The test accurately identifies 8 out of 10 true positives and 9 out of 10 true negatives for a disease with 1 out of 100 prevalence”; than of this statement: “The test identifies 80 percent of true positives and 90 percent of true negatives for a test with 1 percent prevalence.” The decision to present in one manner rather than the other, however, rests solely with the clinician. The physician who views the principle of informed consent as a means for allowing naive patients to determine the adequacy of his or her clinical recommendations lacks motivation to incorporate these conclusions from cognitive psychology.
In sum, informed consent is the patient’s only piece of the pie that is medical care. This piece is best represented as the crust—the limit on the filling that is physician activity. This crust, however, is often provided to the patient by less-than-ideally motivated physicians or other medical practitioners in the manner that they, and not the patient or other experts (i.e., cognitive psychologists), deem appropriate.
Going back to my attempt to quit smoking, I had no legal right to demand pharmaceutical assistance. My only choice was consenting to go to the support group or refusing it. I did not go.
Notes and References
1. Paterick TJ, Carson GV, Allen MC, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313-319.
2. Buchanan A, Brock DW. Deciding for others. Milbank Q 1986;64(Suppl 2):67-80.
3. Katz J. Informed consent—must it remain a fairy tale? J Contemp Health Law Policy. 1994;10:69-91.
4. Wolpe P. The triumph of autonomy in American bioethics: a sociological view. In: Bioethics and Society: Constructing the Ethical Enterprise. DeVries R, Subedi J, eds. Upper Saddle River, NJ: Prentice Hall; 1998:38-59.
5. Schwartz PH, Meslin EM. The ethics of information: absolute risk reduction and patient understanding of screening. J Gen Intern Med. 2008;23(6):867.
6. Schwartz, 869.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 529
7. For an excellent review of the legal precedents on informed consent see Poland SC. Landmark legal cases in bioethics. Kennedy Inst Ethics J. 1997;7(2):191-209 (specifically 192-196).
8. Baumann AO, Deber RB, Thompson GG. Overconfidence among physicians and nurses: the ‘micro-certainty, macro-uncertainty’ phenomenon. Soc Sci Med. 1991;32(2):167-174.
9. Hall KH. Reviewing intuitive decision-making and uncertainty: the implications for medical education. Med Educ. 2002;36(3):216-224.
10. McNeil BJ, Pauker SG, Sox HC Jr, Tversky A. On the elicitation of preferences for alternative therapies. N Engl J Med. 1982;306(21):1259-1262.
11. Salovey P, Williams-Piehota P. Field experiments in social psychology: message framing and the promotion of health protective behaviors. Am Behav Sci. 2004;47(5):488-505.
12. Williams-Piehota P, Pizarro J, Schneider TR, Mowad L, Salovey P. Matching health messages to monitor-blunter coping styles to motivate screening mammography. Health Psychol. 2005;24(1):58-67.
13. Gigerenzer G, Hoffrage U. How to improve Bayesian reasoning without instruction: frequency formats. Psychol Rev. 1995;102(4):684-704.
Abraham P. Schwab, PhD, is an assistant professor in the Philosophy Department of Brooklyn College of the City University of New York. He works in the “no man’s land where epistemology, moral philosophy, and the study of medical practice meet.” His areas of interest include research ethics, clinical decision making (patient and physician), and naturalized moral epistemology.
Acknowledgement
The author thanks Bob Baker and Rosamond Rhodes for their valuable input. Finally, the author thanks, yet again, Dr. Joseph C. Muhler for his insight into the practice of medicine.
The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.
Copyright 2008 American Medical Association. All rights reserved.
530 Virtual Mentor, August 2008—Vol 10 www.virtualmentor.org
August 2008, Volume 10, Number 8: 527-530.
MEDICINE AND SOCIETY
The Patient’s Piece of the Informed Consent Pie
Abraham P. Schwab, PhD
I’ve tried to quit smoking more times than I can count. Several years ago, I asked my family physician for a well-known drug to help me quit. He responded by providing me with a list of support groups, suggesting I try one. I responded that I was not a “support group” person. He suggested I try one anyway. The interaction struck me as odd, given that the physician and I clearly had the same goal—I was to quit smoking—but the physician was dictating the means of achieving that goal.
Part of my surprise in this case arose from my confusion about the role of informed consent in medical practice. In what follows I provide a more accurate, though less appealing, view of informed consent. The concept of informed consent has been defined in many ways: shared decision-making [1], an attempt to balance patient self-determination and patient well-being [2], a necessary supplement to physician altruism [3], and a ritual of trust [4]. Despite all these definitions, this practice, this legal requirement, this form we must sign before receiving care, is not particularly well understood by medical practitioners and patients.
Take for example a recent piece in the Journal of General Internal Medicine by Peter Schwartz and Eric Meslin [5]. In the abstract they note a relationship between, “the ethical principle of respect for autonomy and its application in informed consent or [emphasis added] shared decision-making.” Early in the article they state: “This principle [of respecting patient autonomy] requires, among other things, that patients guide their health care by providing informed consent to proposed interventions or [emphasis added] by participating in shared decision making” [5]. They conclude with, “while respect for autonomy is central to health care ethics, it can be difficult to clarify what level of disclosure or understanding is necessary for a specific patient in a specific situation. . . to adequately consent to medical interventions” [6]. While accurately indicating that there exists some relationship between respect for autonomy, informed consent, and shared decision making, these quotes fail to recognize the very limited scope of informed consent and the substantial differences between its requirements and those of shared decision making. Specifically, as every physician knows, informed consent is legally required. As an aspect of patients’ autonomous decision making, however, informed consent is a negative—not a positive—expression of autonomy. Shared decision making, on the other hand, is more likely to include positive expressions of patient autonomy, but it is not legally required and may or may not be part of the patient-physician encounter.
Schwartz and Meslin follow a view common to the discussion of informed consent in bioethics. Buchanan and Brock’s [2] well-known discussion of competence is representative of this “patient-centric” view. On their view, two values ground the practice of informed consent: promoting the patient’s well-being while preserving the patient’s self-determination. Yet the legal, clinical, and etymological background of informed consent suggest otherwise. The legal history emphasizes the right of refusal—patients must be informed so that they can agree (or not) to what the physician recommends [7]. The clinical history of informed consent emphasizes an ever-increasing encroachment on physician authority—interventions previously performed without patient consent now require it (e.g., childhood immunizations), though this is not true in all cases (e.g., episiotomy). The language itself, “informed” and “consent,” implies that physicians make a judgment to which patients agree (or not). In short, informed consent is less about patient decisions than it is about restraining physicians. Informed consent operates like a pie crust that keeps the filling of physician judgment and activity from spilling onto the table and the floor—it constrains physician activity; it does not enhance patient autonomy.
In the best cases, then, to push the pie analogy a little further, patients are allowed in the kitchen but they are not allowed to touch the ingredients or use any utensils to help with the pie filling. When asked, the patient may choose among fillings the physician offers, but they are not entitled to produce their own filling or direct what fillings the physician offers. The patient may also refuse every filling the physician offers, and so refuse to make a pie.
Competence, power relations, and bias further attenuate the meaningfulness of a right of refusal. First, patients may lack even the basic components of decision-making competence; they cannot meaningfully say “no.” Second, information can be challenged by the patient (e.g., “Why do you recommend that?”), but the physician is the locus of control for the structure of the process and the type and amount of information provided. Third, the biases of human judgment often undermine patient decision making so that the decision to say “no” reveals more about the conditions under which the decision was made than about the preferences of the patient.
Setting aside the important, though well-covered, questions about competence, the effects of power and the implications of bias warrant a few more words. Patients and physicians inhabit different positions of power—physicians with esoteric knowledge of potential benefit and patients with the right of refusal. These differences in power structure the informed consent process in unappealing ways. Specifically, physicians are the means through which patients’ refusals become possible. That is, physicians make patients aware of those interventions that they (the patients) are empowered to refuse—patients’ ability to restrain physician activity is the responsibility of the physicians themselves. Ready-made consent forms ease the discharge of this responsibility. Much like a ready-made pie crust, consent forms have been standardized to limit the need of physicians to be actively involved in reining in their work, the refusal of their recommendations. Far from ideal, the ready-made pie crust still controls the filling better than no crust at all. 528
The problems of a ready-made pie crust and other means of limiting physician involvement in informed consent (e.g., having the nurse do it) are even less appealing when the biases of patient judgment are considered. Large numbers of studies illustrate the predictable biases in human judgment, many using hypothetical or actual medical judgments [8-12]. What this research means for informed consent is not entirely clear, but a few preliminary conclusions can be drawn. First, certain conditions give rise to biased decisions to consent (or refuse) by patients. Second, these conditions can be controlled by medical practitioners. Take for example the effect of presenting information as proportions rather than as percentages. Robust evidence indicates that information presented as proportions leads to more accurate interpretations of the information by both lay individuals and experts [13]. Naive and expert decision makers alike have been shown to identify more accurately the implications of this statement: “The test accurately identifies 8 out of 10 true positives and 9 out of 10 true negatives for a disease with 1 out of 100 prevalence”; than of this statement: “The test identifies 80 percent of true positives and 90 percent of true negatives for a test with 1 percent prevalence.” The decision to present in one manner rather than the other, however, rests solely with the clinician. The physician who views the principle of informed consent as a means for allowing naive patients to determine the adequacy of his or her clinical recommendations lacks motivation to incorporate these conclusions from cognitive psychology.
In sum, informed consent is the patient’s only piece of the pie that is medical care. This piece is best represented as the crust—the limit on the filling that is physician activity. This crust, however, is often provided to the patient by less-than-ideally motivated physicians or other medical practitioners in the manner that they, and not the patient or other experts (i.e., cognitive psychologists), deem appropriate.
Going back to my attempt to quit smoking, I had no legal right to demand pharmaceutical assistance. My only choice was consenting to go to the support group or refusing it. I did not go.
Notes and References
1. Paterick TJ, Carson GV, Allen MC, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313-319.
2. Buchanan A, Brock DW. Deciding for others. Milbank Q 1986;64(Suppl 2):67-80.
3. Katz J. Informed consent—must it remain a fairy tale? J Contemp Health Law Policy. 1994;10:69-91.
4. Wolpe P. The triumph of autonomy in American bioethics: a sociological view. In: Bioethics and Society: Constructing the Ethical Enterprise. DeVries R, Subedi J, eds. Upper Saddle River, NJ: Prentice Hall; 1998:38-59.
5. Schwartz PH, Meslin EM. The ethics of information: absolute risk reduction and patient understanding of screening. J Gen Intern Med. 2008;23(6):867.
6. Schwartz, 869.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 529
7. For an excellent review of the legal precedents on informed consent see Poland SC. Landmark legal cases in bioethics. Kennedy Inst Ethics J. 1997;7(2):191-209 (specifically 192-196).
8. Baumann AO, Deber RB, Thompson GG. Overconfidence among physicians and nurses: the ‘micro-certainty, macro-uncertainty’ phenomenon. Soc Sci Med. 1991;32(2):167-174.
9. Hall KH. Reviewing intuitive decision-making and uncertainty: the implications for medical education. Med Educ. 2002;36(3):216-224.
10. McNeil BJ, Pauker SG, Sox HC Jr, Tversky A. On the elicitation of preferences for alternative therapies. N Engl J Med. 1982;306(21):1259-1262.
11. Salovey P, Williams-Piehota P. Field experiments in social psychology: message framing and the promotion of health protective behaviors. Am Behav Sci. 2004;47(5):488-505.
12. Williams-Piehota P, Pizarro J, Schneider TR, Mowad L, Salovey P. Matching health messages to monitor-blunter coping styles to motivate screening mammography. Health Psychol. 2005;24(1):58-67.
13. Gigerenzer G, Hoffrage U. How to improve Bayesian reasoning without instruction: frequency formats. Psychol Rev. 1995;102(4):684-704.
Abraham P. Schwab, PhD, is an assistant professor in the Philosophy Department of Brooklyn College of the City University of New York. He works in the “no man’s land where epistemology, moral philosophy, and the study of medical practice meet.” His areas of interest include research ethics, clinical decision making (patient and physician), and naturalized moral epistemology.
Acknowledgement
The author thanks Bob Baker and Rosamond Rhodes for their valuable input. Finally, the author thanks, yet again, Dr. Joseph C. Muhler for his insight into the practice of medicine.
The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.
Copyright 2008 American Medical Association. All rights reserved.
530 Virtual Mentor, August 2008—Vol 10 www.virtualmentor.org
Wednesday, August 20, 2008
AMA Virtual Mentor August - Informed Consent 3
Virtual Mentor
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 487-491.
CLINICAL CASE
Informed Refusal in the Emergency Department…Is It Really Informed?
Commentary by Matthew R. Lewin, MD, PhD
Dr. Padgett was the attending physician during the night shift in an urban hospital emergency department. He had one resident and one intern working with him. Over the span of 4 hours, he had seen 17 patients. There were 21 patients still in the waiting room when an ambulance arrived carrying Ms. Burton, a 38-year-old professional woman, who had been drinking alone. As she exited the bar, bystanders witnessed her fall from standing height, hitting her forehead. The EMS run sheet said it was uncertain whether she’d had any loss of consciousness. Witnesses could only attest to the fact that, if she had lost consciousness, it was a brief loss because they heard her muttering expletives on the sidewalk seconds later. Her prehospital fingerstick glucose was normal. She arrived in the emergency department on a spine board, wearing a cervical collar, and very angry about being taken to the hospital against her will.
Ms. Burton was perfectly oriented, alert, intoxicated on alcohol, and combative with staff, refusing care. She had signs of a fall—a contusion and abrasion to her left orbit and forehead. She growled her displeasure as Dr. Padgett checked her vital signs, which were unremarkable except for a modest elevated blood pressure and tachycardia. To the extent that a neurological exam could be performed, it was nonfocal.
After the exam, when Dr. Padgett told Ms. Burton that he was ordering a CT scan of her head to check for intracranial bleeding, she refused. Dr. Padgett began explaining the reasons for his decision and the consequences of bleeding in her skull, but Ms. Burton was having none of it, claiming that she couldn’t afford those tests. She removed the IV from her arm, flung it in the direction of Dr. Padgett, and attempted to clamber over the railings of the gurney only to be restrained by nurses and staff concerned about her fall risk.
Ms. Burton admitted, by now, to having a headache at the site of the forehead contusion, but said she’d go home and come back immediately if she "got worse." She steadfastly denied depression, suicidal ideation, or even alcohol abuse, simply stating that she only drank on weekends, that she was a professional, and that this had happened "many times before." She refused to allow phone calls to family, friends, or co-workers claiming that this was "none of their business."
Commentary
Let’s see. I have a combative patient who may or may not have a significant brain injury and a busy, understaffed emergency department. The patient appears to have decision-making capacity, but has trauma above the clavicle, a headache despite intoxication, and is irritable and impatient—all classic signs of acute brain injury. We haven’t even considered other elements of the differential diagnosis for these signs, which include electrolyte abnormalities, arrhythmias, cerebellar dysfunction, normal pressure hydrocephalus, Wernicke’s encephalopathy, toxic alcohols, and infection. Ms. Burton may have a second diagnosis that is equally important and potentially discoverable simply because she fell.
I have several options. Option 1: Try to reason with her and then let her go at her own peril (assuming she can walk). I might ask her if she would accept the CT scan if she weren’t charged for it. If the answer is "No, let me go," that would call her judgment into question because she is contradicting her stated reason for refusing care. In that case, I could put her on a legal, medical hold for being a danger to herself—a weak argument to an informed consent "absolutist," for whom the patient’s reasons for refusing don’t really matter as long as she has demonstrated the ability to reason and is oriented. I could also call a psychiatrist to assess her decision-making capacity, but the psychiatrist will confront the same problem I have of sorting out the irritability from acute brain injury, something I am far more likely to have seen and with greater frequency than the average psychiatrist. Nevertheless, the patient might sober up even before the psychiatrist’s assessment and benefit from the consultation that would at least touch on substance abuse.
I am completely opposed to this two-part option—letting the patient check out against medical advice or seeking a psychiatric consult. We don’t have the time or resources to wait for a consultant when the patient isn’t even medically cleared for psychiatric assessment. The patient will receive referrals for psychiatric and substance abuse counseling, whether she sees a psychiatrist tonight or not. If she leaves the department against medical advice, she will still be responsible for the ambulance bill, facility and nursing charges, and the medical screening exam by Dr. Padgett. Although the hospital will be willing to accept some type of payment schedule, it will be hard for Ms. Burton to argue that she is being charged for care that was unreasonable, considering her risk factors for significant brain injury.
Option 2: Do nothing except observe her. Considering her determination to leave, this would require commitment from the staff to keep her in her gurney whether or not she was on a medical hold. Restrained patients have to be monitored at all times, and intoxicated patients can’t be walking around the emergency department since they are fall risks, something this patient has already proven. I could call the nursing supervisor to see if there are staff members able and willing to float down to the ED to help out. Alternatively, there might be security staff credentialed as sitters. If she sobers up, can walk, and still has decision-making capacity, then it should be safe for her to go home, even if she lives alone. This approach is commonly referred to as "metabolizing to freedom." Given that most brain injuries are not, in fact,
neurosurgical emergencies, even when there is blood, a respectable minority would argue that it is not even important to identify all bleeds—especially if the patient’s mentation clears.
My failure to mention obtaining a blood alcohol level (BAL) until now is deliberate. This patient is a binge drinker, and there is no way to predict the rate at which she clears alcohol from her system. Furthermore, BAL does not predict decision-making capacity. Although a lay jury might acquit me for acting without the patient’s consent if I found a high BAL, the science does not. Many people have very high intellectual function with very high concentrations of alcohol in their blood, making any decision about her capacity based on the BAL a falsely reassuring prejudice.
This option is more appealing in the sense that the patient is potentially spared the expense of the test she says she doesn’t want, but we still get to observe her. If her behavior improves at a rate within some reasonable range for alcohol intoxication, she can be reexamined and released. The problem is that she is actively trying to "escape," and it is not clear whether her attempts are prompted by a quite rational fear of the bill she will receive or whether she is suffering from an injured brain. Bills from the radiology department will be much more difficult to negotiate than mine and the emergency department’s facility and nursing fees. I can certainly cancel my pro-fee and reduce the ED charges by advocating for the patient, but I cannot ask the radiology department to cut their charges for the test I order. The patient could pay the negotiated fees over an extended period of time, if she needs further financial assistance. I routinely write letters on behalf of self-insured patients. Why should they pay the "billed" rates that are discounted to third-party payers and government programs such as Medicaid? In my experience, the hospitals are happy to collect less in exchange for less trouble.
Option 3: Restrain, sedate and get a CT scan of Ms. Burton’s brain. This option places the interests of the emergency department and its patients as a whole over the immediate interests of the individual patient. This patient is a distraction to my staff and to me that comes at the expense of others’ care and safety. Acting on this option resolves the medical questions quickly, spares resources (e.g., staff and bed) for the benefit of others, and most safely returns the patient to her home or the street—but it completely ignores the patient’s stated wishes. If her brain CT is normal, she can refuse imaging of her cervical spine (heretofore neglected in the discussion, but definitely indicated). She can remain in a cervical collar until the dust settles. If she has a clinically significant fracture, that isn’t likely to be the reason she is agitated. If her CT scan is positive, then we would proceed with cervical spine imaging and not ask her permission.
Dr. Padgett has been "on" for at least 4 hours and probably has no more than 4 to 8 hours to resolve the case of Ms. Burton before he will have to sign her out to the next attending. Sign-out is notoriously dangerous under the best of circumstances, and Dr. Padgett will be signing out a patient with altered mental status to the next attending, Dr. M’Fleur, who did not see the patient at presentation or during any of the repeat
neurological examinations. As far as Dr. M’Fleur is concerned, this is a new patient with a new baseline. If Dr. Padgett elected to use chemical or physical restraints or both, Ms. Burton’s neurological examination could be compromised by sedation or she may simply be hung-over and sleepy. How is Dr. M’Fleur supposed to assess the patient or have any idea about the rate at which Ms. Burton should be improving? Dr. M’Fleur is inheriting a high-risk situation, even if the patient hadn’t refused care, and Dr. Padgett was merely following the "metabolize to freedom" strategy.
As a general rule, I have a lower threshold for CT scanning if I am signing out an intoxicated patient. It is not appropriate to risk patient safety and foist diagnostic dilemmas or my clinical style onto the new team.
Dr. Padgett’s medical decision making has to account for his presence or absence at the time he anticipates Ms. Burton’s disposition home or admission for observation by the neurosurgical or medicine services. Supposing the ED is so busy or Dr. Padgett is so tied up with other patients that he cannot return to the bedside for reassessment of Ms. Burton, resulting in a potentially dangerous delay in her care? Post hoc critiques of his care will call his judgment into question: Wasn’t it obvious that she had a bleed?
Scarce Resources
Allocation of scarce resources must also be considered. Every decision the physician makes about one patient has a consequence for every other patient in the emergency department. Every action, procedure, phone call or order consumes nursing time, clerical time, adds to the physician’s "to do" list, and, ultimately, affects patient flow through the department. Thus, practical considerations inevitably come into play with any patient—especially challenging ones like Ms. Burton.
Much has been written about the differences between emergency medicine and primary care practice. Among many factors, emergency department personnel do not usually know the patient or their families; the patient has experienced an acute change in health; decisions are made quickly and independent of outside information or consultation with others who do know the patient; the physician is working in an open and uncontrolled environment; and anxiety, pain, alcohol, and altered mental status are frequent occurrences, typically with a high frequency of serious, underlying pathology. If there is no way for the emergency physician to buy enough time to make a safe decision for the patient or avoid compromising the safety of others, the physician must make a decision which is, ideally: (1) based on impartiality, (2) universalizable to other situations, and (3) what others would likely find justifiable given the same set of circumstances. This is a sort of formalized "golden rule."
I don’t know what Dr. Padgett should do, but I know what I would do, absent the luxury of time, personnel, and a family member of Ms. Burton whom I could contact. I would sedate or restrain Ms. Burton, or both, image her brain, and hope it is normal. She would be discharged with written instructions, referrals, and a personal note from me that if she cannot pay the full bill, I will advocate for significant reduction. After that, it is her choice and responsibility to take me up on my offer to write a letter on her behalf. She is free to file a complaint against me, which might help reduce her bill even further or erase it if she is sufficiently resourceful.
Given more resources or time I would observe her. Given a responsible family member or close friend who says she is "always this way," when intoxicated, and if she has not indicated that she has any intention to harm herself, I would honor her wishes without much hesitation.
Did I mention that I saw this patient last night…?
Matthew R. Lewin, MD, PhD, is an assistant professor of emergency medicine in the Department of Emergency Medicine at the University of California, San Francisco. His research interests include basic respiratory physiology, pharmacology, and the practice of general emergency medicine.
The people and events in this case are fictional. Resemblance to real events or to names of people, living or dead, is entirely coincidental.
The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.
Copyright 2008 American Medical Association. All rights reserved.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 491
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 487-491.
CLINICAL CASE
Informed Refusal in the Emergency Department…Is It Really Informed?
Commentary by Matthew R. Lewin, MD, PhD
Dr. Padgett was the attending physician during the night shift in an urban hospital emergency department. He had one resident and one intern working with him. Over the span of 4 hours, he had seen 17 patients. There were 21 patients still in the waiting room when an ambulance arrived carrying Ms. Burton, a 38-year-old professional woman, who had been drinking alone. As she exited the bar, bystanders witnessed her fall from standing height, hitting her forehead. The EMS run sheet said it was uncertain whether she’d had any loss of consciousness. Witnesses could only attest to the fact that, if she had lost consciousness, it was a brief loss because they heard her muttering expletives on the sidewalk seconds later. Her prehospital fingerstick glucose was normal. She arrived in the emergency department on a spine board, wearing a cervical collar, and very angry about being taken to the hospital against her will.
Ms. Burton was perfectly oriented, alert, intoxicated on alcohol, and combative with staff, refusing care. She had signs of a fall—a contusion and abrasion to her left orbit and forehead. She growled her displeasure as Dr. Padgett checked her vital signs, which were unremarkable except for a modest elevated blood pressure and tachycardia. To the extent that a neurological exam could be performed, it was nonfocal.
After the exam, when Dr. Padgett told Ms. Burton that he was ordering a CT scan of her head to check for intracranial bleeding, she refused. Dr. Padgett began explaining the reasons for his decision and the consequences of bleeding in her skull, but Ms. Burton was having none of it, claiming that she couldn’t afford those tests. She removed the IV from her arm, flung it in the direction of Dr. Padgett, and attempted to clamber over the railings of the gurney only to be restrained by nurses and staff concerned about her fall risk.
Ms. Burton admitted, by now, to having a headache at the site of the forehead contusion, but said she’d go home and come back immediately if she "got worse." She steadfastly denied depression, suicidal ideation, or even alcohol abuse, simply stating that she only drank on weekends, that she was a professional, and that this had happened "many times before." She refused to allow phone calls to family, friends, or co-workers claiming that this was "none of their business."
Commentary
Let’s see. I have a combative patient who may or may not have a significant brain injury and a busy, understaffed emergency department. The patient appears to have decision-making capacity, but has trauma above the clavicle, a headache despite intoxication, and is irritable and impatient—all classic signs of acute brain injury. We haven’t even considered other elements of the differential diagnosis for these signs, which include electrolyte abnormalities, arrhythmias, cerebellar dysfunction, normal pressure hydrocephalus, Wernicke’s encephalopathy, toxic alcohols, and infection. Ms. Burton may have a second diagnosis that is equally important and potentially discoverable simply because she fell.
I have several options. Option 1: Try to reason with her and then let her go at her own peril (assuming she can walk). I might ask her if she would accept the CT scan if she weren’t charged for it. If the answer is "No, let me go," that would call her judgment into question because she is contradicting her stated reason for refusing care. In that case, I could put her on a legal, medical hold for being a danger to herself—a weak argument to an informed consent "absolutist," for whom the patient’s reasons for refusing don’t really matter as long as she has demonstrated the ability to reason and is oriented. I could also call a psychiatrist to assess her decision-making capacity, but the psychiatrist will confront the same problem I have of sorting out the irritability from acute brain injury, something I am far more likely to have seen and with greater frequency than the average psychiatrist. Nevertheless, the patient might sober up even before the psychiatrist’s assessment and benefit from the consultation that would at least touch on substance abuse.
I am completely opposed to this two-part option—letting the patient check out against medical advice or seeking a psychiatric consult. We don’t have the time or resources to wait for a consultant when the patient isn’t even medically cleared for psychiatric assessment. The patient will receive referrals for psychiatric and substance abuse counseling, whether she sees a psychiatrist tonight or not. If she leaves the department against medical advice, she will still be responsible for the ambulance bill, facility and nursing charges, and the medical screening exam by Dr. Padgett. Although the hospital will be willing to accept some type of payment schedule, it will be hard for Ms. Burton to argue that she is being charged for care that was unreasonable, considering her risk factors for significant brain injury.
Option 2: Do nothing except observe her. Considering her determination to leave, this would require commitment from the staff to keep her in her gurney whether or not she was on a medical hold. Restrained patients have to be monitored at all times, and intoxicated patients can’t be walking around the emergency department since they are fall risks, something this patient has already proven. I could call the nursing supervisor to see if there are staff members able and willing to float down to the ED to help out. Alternatively, there might be security staff credentialed as sitters. If she sobers up, can walk, and still has decision-making capacity, then it should be safe for her to go home, even if she lives alone. This approach is commonly referred to as "metabolizing to freedom." Given that most brain injuries are not, in fact,
neurosurgical emergencies, even when there is blood, a respectable minority would argue that it is not even important to identify all bleeds—especially if the patient’s mentation clears.
My failure to mention obtaining a blood alcohol level (BAL) until now is deliberate. This patient is a binge drinker, and there is no way to predict the rate at which she clears alcohol from her system. Furthermore, BAL does not predict decision-making capacity. Although a lay jury might acquit me for acting without the patient’s consent if I found a high BAL, the science does not. Many people have very high intellectual function with very high concentrations of alcohol in their blood, making any decision about her capacity based on the BAL a falsely reassuring prejudice.
This option is more appealing in the sense that the patient is potentially spared the expense of the test she says she doesn’t want, but we still get to observe her. If her behavior improves at a rate within some reasonable range for alcohol intoxication, she can be reexamined and released. The problem is that she is actively trying to "escape," and it is not clear whether her attempts are prompted by a quite rational fear of the bill she will receive or whether she is suffering from an injured brain. Bills from the radiology department will be much more difficult to negotiate than mine and the emergency department’s facility and nursing fees. I can certainly cancel my pro-fee and reduce the ED charges by advocating for the patient, but I cannot ask the radiology department to cut their charges for the test I order. The patient could pay the negotiated fees over an extended period of time, if she needs further financial assistance. I routinely write letters on behalf of self-insured patients. Why should they pay the "billed" rates that are discounted to third-party payers and government programs such as Medicaid? In my experience, the hospitals are happy to collect less in exchange for less trouble.
Option 3: Restrain, sedate and get a CT scan of Ms. Burton’s brain. This option places the interests of the emergency department and its patients as a whole over the immediate interests of the individual patient. This patient is a distraction to my staff and to me that comes at the expense of others’ care and safety. Acting on this option resolves the medical questions quickly, spares resources (e.g., staff and bed) for the benefit of others, and most safely returns the patient to her home or the street—but it completely ignores the patient’s stated wishes. If her brain CT is normal, she can refuse imaging of her cervical spine (heretofore neglected in the discussion, but definitely indicated). She can remain in a cervical collar until the dust settles. If she has a clinically significant fracture, that isn’t likely to be the reason she is agitated. If her CT scan is positive, then we would proceed with cervical spine imaging and not ask her permission.
Dr. Padgett has been "on" for at least 4 hours and probably has no more than 4 to 8 hours to resolve the case of Ms. Burton before he will have to sign her out to the next attending. Sign-out is notoriously dangerous under the best of circumstances, and Dr. Padgett will be signing out a patient with altered mental status to the next attending, Dr. M’Fleur, who did not see the patient at presentation or during any of the repeat
neurological examinations. As far as Dr. M’Fleur is concerned, this is a new patient with a new baseline. If Dr. Padgett elected to use chemical or physical restraints or both, Ms. Burton’s neurological examination could be compromised by sedation or she may simply be hung-over and sleepy. How is Dr. M’Fleur supposed to assess the patient or have any idea about the rate at which Ms. Burton should be improving? Dr. M’Fleur is inheriting a high-risk situation, even if the patient hadn’t refused care, and Dr. Padgett was merely following the "metabolize to freedom" strategy.
As a general rule, I have a lower threshold for CT scanning if I am signing out an intoxicated patient. It is not appropriate to risk patient safety and foist diagnostic dilemmas or my clinical style onto the new team.
Dr. Padgett’s medical decision making has to account for his presence or absence at the time he anticipates Ms. Burton’s disposition home or admission for observation by the neurosurgical or medicine services. Supposing the ED is so busy or Dr. Padgett is so tied up with other patients that he cannot return to the bedside for reassessment of Ms. Burton, resulting in a potentially dangerous delay in her care? Post hoc critiques of his care will call his judgment into question: Wasn’t it obvious that she had a bleed?
Scarce Resources
Allocation of scarce resources must also be considered. Every decision the physician makes about one patient has a consequence for every other patient in the emergency department. Every action, procedure, phone call or order consumes nursing time, clerical time, adds to the physician’s "to do" list, and, ultimately, affects patient flow through the department. Thus, practical considerations inevitably come into play with any patient—especially challenging ones like Ms. Burton.
Much has been written about the differences between emergency medicine and primary care practice. Among many factors, emergency department personnel do not usually know the patient or their families; the patient has experienced an acute change in health; decisions are made quickly and independent of outside information or consultation with others who do know the patient; the physician is working in an open and uncontrolled environment; and anxiety, pain, alcohol, and altered mental status are frequent occurrences, typically with a high frequency of serious, underlying pathology. If there is no way for the emergency physician to buy enough time to make a safe decision for the patient or avoid compromising the safety of others, the physician must make a decision which is, ideally: (1) based on impartiality, (2) universalizable to other situations, and (3) what others would likely find justifiable given the same set of circumstances. This is a sort of formalized "golden rule."
I don’t know what Dr. Padgett should do, but I know what I would do, absent the luxury of time, personnel, and a family member of Ms. Burton whom I could contact. I would sedate or restrain Ms. Burton, or both, image her brain, and hope it is normal. She would be discharged with written instructions, referrals, and a personal note from me that if she cannot pay the full bill, I will advocate for significant reduction. After that, it is her choice and responsibility to take me up on my offer to write a letter on her behalf. She is free to file a complaint against me, which might help reduce her bill even further or erase it if she is sufficiently resourceful.
Given more resources or time I would observe her. Given a responsible family member or close friend who says she is "always this way," when intoxicated, and if she has not indicated that she has any intention to harm herself, I would honor her wishes without much hesitation.
Did I mention that I saw this patient last night…?
Matthew R. Lewin, MD, PhD, is an assistant professor of emergency medicine in the Department of Emergency Medicine at the University of California, San Francisco. His research interests include basic respiratory physiology, pharmacology, and the practice of general emergency medicine.
The people and events in this case are fictional. Resemblance to real events or to names of people, living or dead, is entirely coincidental.
The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.
Copyright 2008 American Medical Association. All rights reserved.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 491
AMA Virtual Mentor August - Informed Consent 2
Virtual Mentor
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 492-495.
CLINICAL CASE
Informed Consent: When and Why
Commentary by Erin A. Egan, MD, JD
Dr. Wood opened the door to the exam room and smiled at Mrs. Robertson who was waiting in her patient gown. "Hi, Mrs. R, I’d like to ask a favor. Del, here, is on a family medicine rotation and, if it’s OK with you, he’ll assist with your exam today. Is that alright with you?"
"Sure," replied Mrs. Robertson, "I’m all for medical education."
"Thank you," said Del.
"Why don’t you begin by checking Mrs. Robertson’s vitals," instructed Dr. Wood. After noting these results, Dr. Wood took over the physical, asking questions and sharing a few observations with Del. Dr. Wood then asked Mrs. Robertson to undo her gown and he proceeded to conduct a breast exam by raising her arm, pressing on her breast to check for lumps, and looking carefully at the nipples for signs of discharge. After examining both breasts and palpating Mrs. Robertson’s liver and ovaries, Dr. Wood asked Del to step outside and send the nurse in, so he could collect a Pap smear.
After Mrs. Robertson left, Del said, "This is my first rotation, and one thing I’ve been wondering, Dr. Wood, is do we just do all of the standard aspects of the physical on our patients without asking? Like the breast exam, for instance. Because I’m so young and everything, I feel as though I should ask permission, but you just went right ahead. She didn’t object so I guess it’s OK, but is that routine? Where is the line where I have to ask or get consent? Did you ask consent to do the Pap, or is it all assumed consent?
Dr. Wood considered Del’s question. "That’s a really good point. Mrs. Roberston has been my patient for a while, for one thing. But still, I don’t recall ever having my professors tell me specifically what are or are not the trigger events for a consent—verbal or otherwise—in a routine check-up. I can’t remember a lot of articles on that, and I’ve been in practice for quite a while."
Commentary
What level of consent is required for a patient-physician encounter? There is no fixed answer. The threshold varies with each patient, each physician, the type of interaction, and the risks and benefits that intervention presents. That being said, there are some general rules about when to obtain consent. Our case deals with
Virtual Mentor, August 2008—Vol 10 www.virtualmentor.org 492
consent in the context of an interview and examination, not the invasive procedure setting that usually sparks informed consent concerns. Nevertheless patients deserve to be told about and agree to all aspects of proposed care, regardless of whether they are undergoing a procedure or having a conversation. Often consent is tacit—a patient’s presence and cooperation with the interview and the exam are taken to mean that he or she consents to the proceedings. If the patient is likely to have made assumptions about the interaction that are untrue, the physician should correct those misconceptions. A clear example of this is described in the case—a patient should be made aware that a medical student is involved in her care and should be allowed to consent to or refuse the student’s participation with special attention given to sensitive aspects of the history and examination [1, 2].
The basis for the informed consent requirement is the principle of respect for personal autonomy [3]. The ethical responsibility to respect the autonomy of a person is fulfilled by telling a patient what he or she needs to know to make informed decisions about treatment options. Clinical judgment is involved here; what is the balance between too little information and too much? Legal guidance for adequacy of disclosure for informed consent can be thought of as providing either what a reasonable patient would want to know or what a reasonable physician would disclose [4]. The exact standards vary by state, but these guidelines can help physicians determine when they need to get a patient’s consent and what they should disclose.
Small variations in details can change the informed consent requirement. It is probably safe to assume that a patient who comes to a cardiologist expects to have a heart exam, so the physician need not solicit "consent," but he or she should engage in the good clinical practice of telling the patient what he or she is doing throughout the examination. Imagine that our cardiologist believes that a breast exam could be relevant to making an accurate diagnosis. It is reasonable to anticipate that the patient would want to be informed of that exam and allowed to ask questions before it is performed since this may exceed the scope of what the patient expects and involves a particularly sensitive area of the body. An informal (not written) discussion explaining why the breast exam is necessary, providing information to the patient based on her concerns, and obtaining verbal assent from the patient after this explanation may be "consent" enough. Described in this way, consent sounds like a laborious practice that requires so much time that it will limit the number of patients a physician can see. Actually discussing a procedure or exam takes as much time as it took to read this. Often the need for a formal discussion doesn’t come up, but is more a part of the exchange that occurs while care is provided and received.
Getting beyond Broad Consent for Treatment
At the initiation of a health care relationship the patient signs some type of broad consent to being evaluated and treated. Routine, very low-risk procedures are done under this blanket agreement. Small changes that increase risk, encroach on a particularly sensitive subject, or have the potential to have a significant effect on the life of the patient require further discussion between the physician and the patient.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 493
Examples of procedures that require specific discussion are blood testing for HIV (versus routine blood draws); giving blood products (versus giving IV fluids); lumbar puncture (versus venipuncture). The difference between these technically similar procedures is clear: the risks are different, the personal implications are greater, or the level of training and skill needed by the clinician is greater.
Informed consent requires a discussion of risks, benefits, and alternatives with a patient who can understand and react to the information and make choices. Once a course of therapy is initiated, it may be carried out without further consent discussion, assuming that the patient doesn’t ask to revisit or revoke assent [5]. Anything that changes the equation of risks, benefits, alternatives, understanding, or ability to make a choice requires returning to the consent process with the patient. If, for example, a patient does not respond well during the course of treatment, and it becomes unlikely that he or she will benefit from the agreed-upon treatment, consent must be discussed because the potential for benefit has changed. If a complication puts a patient at higher risk for further complications with continuing treatment, the patient must decide how to balance this increased risk within his or her own values.
The consent also needs additional clarification whenever an area of special sensitivity becomes involved. In discussions of intensely personal matters, patients deserve to set the parameters of the discussion. Genital exams involve an obvious area of sensitivity, and elements of sexual history are very personal. The patient’s desire for privacy should be discussed and respected. If a patient has a particular concern or anxiety that the doctor is aware of, it should be addressed directly during a consent discussion. Finally, a patient has a right to know the level of skill and experience of anyone performing a procedure.
In sum, a solid understanding of the goals of informed consent can guide one’s decisions about when it needs to be discussed and what level of disclosure is satisfactory. Respecting a person’s right to autonomous decision making defines the boundaries of consent. Good clinical practice and an emphasis on communication as a routine part of any interaction eliminate much of the need to overthink consent in routine situations. It is respectful to introduce everyone in the room and clarify each person’s role. It is sound clinical practice to explain what you are doing while you examine a patient and to state what you will need to touch or look at. As situations become more complex and interventions more invasive, the fundamental value that is to be protected is the patient’s autonomy. If you are unsure about whether consent is needed, talking to a patient should be the first step. Having discussions about what respect and autonomy mean to them, even briefly, will help you decide how to tailor the care the patient receives to their individual needs and expectations.
Notes and References
1. American Medical Association. Opinion 8.087 Medical student involvement in patient care. Code of Medical Ethics. Chicago, IL: American Medical Association; 2008. http://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/E-
Virtual Mentor, August 2008—Vol 10 www.virtualmentor.org 494
8.087.HTM&&s_t=&st_p=&nth=1&prev_pol=policyfiles/HnE/E-7.05.HTM&nxt_pol=policyfiles/HnE/E-8.01.HTM&. Accessed June 14, 2008.
2. See the discussion in Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994:438.
3. Beauchamp, 142-146.
4. Beauchamp, 147-150.
5. For an example of this principle see Gorab v Zook, 943 P2d 423 (Colo 1997). This is Colorado case law and not binding in all states, but it explains the legal position that consent for a treatment plan holds for the duration of that treatment plan.
Erin A. Egan, MD, JD, is an assistant professor of medicine at the University of Colorado Denver, a faculty associate with the Center for Bioethics at the University of Colorado Denver (UCD), and a visiting lecturer at the Neiswanger Institute for Bioethics and Health Policy at the Loyola University Stritch School of Medicine in Maywood, Illinois. She serves on the ethics consultation subcommittee, the ethics committee, and the organizational ethics committee at UCD, is the director of quality improvement for the Hospital Medicine Group, and the program director for the Holocaust in Contemporary Bioethics Program.
The people and events in this case are fictional. Resemblance to real events or to names of people, living or dead, is entirely coincidental.
The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.
Copyright 2008 American Medical Association. All rights reserved.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 495
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 492-495.
CLINICAL CASE
Informed Consent: When and Why
Commentary by Erin A. Egan, MD, JD
Dr. Wood opened the door to the exam room and smiled at Mrs. Robertson who was waiting in her patient gown. "Hi, Mrs. R, I’d like to ask a favor. Del, here, is on a family medicine rotation and, if it’s OK with you, he’ll assist with your exam today. Is that alright with you?"
"Sure," replied Mrs. Robertson, "I’m all for medical education."
"Thank you," said Del.
"Why don’t you begin by checking Mrs. Robertson’s vitals," instructed Dr. Wood. After noting these results, Dr. Wood took over the physical, asking questions and sharing a few observations with Del. Dr. Wood then asked Mrs. Robertson to undo her gown and he proceeded to conduct a breast exam by raising her arm, pressing on her breast to check for lumps, and looking carefully at the nipples for signs of discharge. After examining both breasts and palpating Mrs. Robertson’s liver and ovaries, Dr. Wood asked Del to step outside and send the nurse in, so he could collect a Pap smear.
After Mrs. Robertson left, Del said, "This is my first rotation, and one thing I’ve been wondering, Dr. Wood, is do we just do all of the standard aspects of the physical on our patients without asking? Like the breast exam, for instance. Because I’m so young and everything, I feel as though I should ask permission, but you just went right ahead. She didn’t object so I guess it’s OK, but is that routine? Where is the line where I have to ask or get consent? Did you ask consent to do the Pap, or is it all assumed consent?
Dr. Wood considered Del’s question. "That’s a really good point. Mrs. Roberston has been my patient for a while, for one thing. But still, I don’t recall ever having my professors tell me specifically what are or are not the trigger events for a consent—verbal or otherwise—in a routine check-up. I can’t remember a lot of articles on that, and I’ve been in practice for quite a while."
Commentary
What level of consent is required for a patient-physician encounter? There is no fixed answer. The threshold varies with each patient, each physician, the type of interaction, and the risks and benefits that intervention presents. That being said, there are some general rules about when to obtain consent. Our case deals with
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consent in the context of an interview and examination, not the invasive procedure setting that usually sparks informed consent concerns. Nevertheless patients deserve to be told about and agree to all aspects of proposed care, regardless of whether they are undergoing a procedure or having a conversation. Often consent is tacit—a patient’s presence and cooperation with the interview and the exam are taken to mean that he or she consents to the proceedings. If the patient is likely to have made assumptions about the interaction that are untrue, the physician should correct those misconceptions. A clear example of this is described in the case—a patient should be made aware that a medical student is involved in her care and should be allowed to consent to or refuse the student’s participation with special attention given to sensitive aspects of the history and examination [1, 2].
The basis for the informed consent requirement is the principle of respect for personal autonomy [3]. The ethical responsibility to respect the autonomy of a person is fulfilled by telling a patient what he or she needs to know to make informed decisions about treatment options. Clinical judgment is involved here; what is the balance between too little information and too much? Legal guidance for adequacy of disclosure for informed consent can be thought of as providing either what a reasonable patient would want to know or what a reasonable physician would disclose [4]. The exact standards vary by state, but these guidelines can help physicians determine when they need to get a patient’s consent and what they should disclose.
Small variations in details can change the informed consent requirement. It is probably safe to assume that a patient who comes to a cardiologist expects to have a heart exam, so the physician need not solicit "consent," but he or she should engage in the good clinical practice of telling the patient what he or she is doing throughout the examination. Imagine that our cardiologist believes that a breast exam could be relevant to making an accurate diagnosis. It is reasonable to anticipate that the patient would want to be informed of that exam and allowed to ask questions before it is performed since this may exceed the scope of what the patient expects and involves a particularly sensitive area of the body. An informal (not written) discussion explaining why the breast exam is necessary, providing information to the patient based on her concerns, and obtaining verbal assent from the patient after this explanation may be "consent" enough. Described in this way, consent sounds like a laborious practice that requires so much time that it will limit the number of patients a physician can see. Actually discussing a procedure or exam takes as much time as it took to read this. Often the need for a formal discussion doesn’t come up, but is more a part of the exchange that occurs while care is provided and received.
Getting beyond Broad Consent for Treatment
At the initiation of a health care relationship the patient signs some type of broad consent to being evaluated and treated. Routine, very low-risk procedures are done under this blanket agreement. Small changes that increase risk, encroach on a particularly sensitive subject, or have the potential to have a significant effect on the life of the patient require further discussion between the physician and the patient.
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Examples of procedures that require specific discussion are blood testing for HIV (versus routine blood draws); giving blood products (versus giving IV fluids); lumbar puncture (versus venipuncture). The difference between these technically similar procedures is clear: the risks are different, the personal implications are greater, or the level of training and skill needed by the clinician is greater.
Informed consent requires a discussion of risks, benefits, and alternatives with a patient who can understand and react to the information and make choices. Once a course of therapy is initiated, it may be carried out without further consent discussion, assuming that the patient doesn’t ask to revisit or revoke assent [5]. Anything that changes the equation of risks, benefits, alternatives, understanding, or ability to make a choice requires returning to the consent process with the patient. If, for example, a patient does not respond well during the course of treatment, and it becomes unlikely that he or she will benefit from the agreed-upon treatment, consent must be discussed because the potential for benefit has changed. If a complication puts a patient at higher risk for further complications with continuing treatment, the patient must decide how to balance this increased risk within his or her own values.
The consent also needs additional clarification whenever an area of special sensitivity becomes involved. In discussions of intensely personal matters, patients deserve to set the parameters of the discussion. Genital exams involve an obvious area of sensitivity, and elements of sexual history are very personal. The patient’s desire for privacy should be discussed and respected. If a patient has a particular concern or anxiety that the doctor is aware of, it should be addressed directly during a consent discussion. Finally, a patient has a right to know the level of skill and experience of anyone performing a procedure.
In sum, a solid understanding of the goals of informed consent can guide one’s decisions about when it needs to be discussed and what level of disclosure is satisfactory. Respecting a person’s right to autonomous decision making defines the boundaries of consent. Good clinical practice and an emphasis on communication as a routine part of any interaction eliminate much of the need to overthink consent in routine situations. It is respectful to introduce everyone in the room and clarify each person’s role. It is sound clinical practice to explain what you are doing while you examine a patient and to state what you will need to touch or look at. As situations become more complex and interventions more invasive, the fundamental value that is to be protected is the patient’s autonomy. If you are unsure about whether consent is needed, talking to a patient should be the first step. Having discussions about what respect and autonomy mean to them, even briefly, will help you decide how to tailor the care the patient receives to their individual needs and expectations.
Notes and References
1. American Medical Association. Opinion 8.087 Medical student involvement in patient care. Code of Medical Ethics. Chicago, IL: American Medical Association; 2008. http://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/E-
Virtual Mentor, August 2008—Vol 10 www.virtualmentor.org 494
8.087.HTM&&s_t=&st_p=&nth=1&prev_pol=policyfiles/HnE/E-7.05.HTM&nxt_pol=policyfiles/HnE/E-8.01.HTM&. Accessed June 14, 2008.
2. See the discussion in Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994:438.
3. Beauchamp, 142-146.
4. Beauchamp, 147-150.
5. For an example of this principle see Gorab v Zook, 943 P2d 423 (Colo 1997). This is Colorado case law and not binding in all states, but it explains the legal position that consent for a treatment plan holds for the duration of that treatment plan.
Erin A. Egan, MD, JD, is an assistant professor of medicine at the University of Colorado Denver, a faculty associate with the Center for Bioethics at the University of Colorado Denver (UCD), and a visiting lecturer at the Neiswanger Institute for Bioethics and Health Policy at the Loyola University Stritch School of Medicine in Maywood, Illinois. She serves on the ethics consultation subcommittee, the ethics committee, and the organizational ethics committee at UCD, is the director of quality improvement for the Hospital Medicine Group, and the program director for the Holocaust in Contemporary Bioethics Program.
The people and events in this case are fictional. Resemblance to real events or to names of people, living or dead, is entirely coincidental.
The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.
Copyright 2008 American Medical Association. All rights reserved.
www.virtualmentor.org Virtual Mentor, August 2008—Vol 10 495
AMA Virtual Mentor August - Informed Consent 1
Virtual Mentor
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 485-486.
FROM THE EDITOR
The Less-Told Stories of Informed Consent
So much is written about informed consent—from how students and residents are taught to "consent" a patient (ugh) to the challenging of patients’ decision-making capability should they refuse recommended treatment. Often missing from these war(d) stories is a discussion of when in the course of ongoing patient care consent to treatment should be renegotiated. When a patient comes to the clinic or office, one assumes that he or she agrees to be asked questions about health history and to be examined. At what point in the care of that patient, though, is consent needed for a specific test or treatment intervention? And if special consent is required, for a lumbar puncture, say, must it be written, or will an oral consent, a nod of the head, or just the absence of a refusal suffice?
In this issue of Virtual Mentor, we examine the border between implicit, assumed consent and the place where explicit patient consent must be secured. We also examine two separate but equally important questions: how much information satisfies the legal and ethical stipulations that consent be "informed" and how convinced are we that the consent patients offer truly represents their understanding and acceptance of the diagnosis and treatment options the physician has presented?
Each of the four clinical cases explores a situation in which a physician confronts a serious consent question. Would a walk-in patient at a free clinic bolt if a doctor told him of the reporting requirements that go along with his HIV test? Or can the doctor withhold that information, for the patient’s good or the good of a third party—namely, the patient’s life partner? A second case places a physician in an emergency department when an intoxicated patient with head trauma refuses to cooperate with tests or scans. When is it ethical to override such a patient’s refusal of a head scan? Again, this is a serious ethical problem for the physician, with possible liability exposure as well. As a complement to this case, the clinical pearl details the classification and medical evaluation for traumatic brain injury.
The third case involves a teen whose cancer has returned. Treatment options that have toxic side effects and represent the patient’s best chance for cure are tough enough to explain to an adult, and mature minors merit special consideration. Can the teenager refuse treatment? Should the doctor downplay the effects of a therapy in an effort to convince the teen to begin treatment? Finally, recognizing that most physicians face the physical exam encounter daily, our fourth case explores the line between assumed and explicit consent during sensitive aspects of the routine physical.
Teaching about informed consent is a key to improving the quality of patient consent. This month’s medical education article looks at that subject closely. How do subtle differences in the way difficult choices are framed influence the likelihood that consent will be given—or refused? Competence to consent to treatment is not always self-evident. Paul Appelbaum’s classic article on that topic is the target of our journal discussion. Law has developed around consent controversies and has helped define the doctor’s task of explaining treatment options to patients. As the health law article explains, the classic case of Canterbury v. Spence based its guidelines for the information patients should receive on "reasonable person" and "reasonable physician" standards—what would a reasonable person want to know? What would a reasonable physician consider "material" to the patient’s decision?
Sometimes those who most need protection cannot consent for themselves to medical treatment or research. Wards of the state are a prime example of this sort of vulnerable population, and our policy forum article examines the importance of appointing effective guardians to watch out for these minors’ rights.
The medicine and society column takes on the real question at the heart of many of these boundary cases of informed consent at work: Does the informed consent process—as currently practiced in the U.S.—truly elicit patient preferences, or does it merely allow patients to select which of the physician-determined options is most acceptable (or least unacceptable) to them?
Finally, we’d like to thank Ankit Shah, MD, JD, for suggesting the month’s topic and working on the issue’s case development and article outline for us.
Sincerely,
Philip Perry, MSJ
Allison Grady
Faith Lagay, PhD
Editors, Virtual Mentor
American Medical Association Journal of Ethics
August 2008, Volume 10, Number 8: 485-486.
FROM THE EDITOR
The Less-Told Stories of Informed Consent
So much is written about informed consent—from how students and residents are taught to "consent" a patient (ugh) to the challenging of patients’ decision-making capability should they refuse recommended treatment. Often missing from these war(d) stories is a discussion of when in the course of ongoing patient care consent to treatment should be renegotiated. When a patient comes to the clinic or office, one assumes that he or she agrees to be asked questions about health history and to be examined. At what point in the care of that patient, though, is consent needed for a specific test or treatment intervention? And if special consent is required, for a lumbar puncture, say, must it be written, or will an oral consent, a nod of the head, or just the absence of a refusal suffice?
In this issue of Virtual Mentor, we examine the border between implicit, assumed consent and the place where explicit patient consent must be secured. We also examine two separate but equally important questions: how much information satisfies the legal and ethical stipulations that consent be "informed" and how convinced are we that the consent patients offer truly represents their understanding and acceptance of the diagnosis and treatment options the physician has presented?
Each of the four clinical cases explores a situation in which a physician confronts a serious consent question. Would a walk-in patient at a free clinic bolt if a doctor told him of the reporting requirements that go along with his HIV test? Or can the doctor withhold that information, for the patient’s good or the good of a third party—namely, the patient’s life partner? A second case places a physician in an emergency department when an intoxicated patient with head trauma refuses to cooperate with tests or scans. When is it ethical to override such a patient’s refusal of a head scan? Again, this is a serious ethical problem for the physician, with possible liability exposure as well. As a complement to this case, the clinical pearl details the classification and medical evaluation for traumatic brain injury.
The third case involves a teen whose cancer has returned. Treatment options that have toxic side effects and represent the patient’s best chance for cure are tough enough to explain to an adult, and mature minors merit special consideration. Can the teenager refuse treatment? Should the doctor downplay the effects of a therapy in an effort to convince the teen to begin treatment? Finally, recognizing that most physicians face the physical exam encounter daily, our fourth case explores the line between assumed and explicit consent during sensitive aspects of the routine physical.
Teaching about informed consent is a key to improving the quality of patient consent. This month’s medical education article looks at that subject closely. How do subtle differences in the way difficult choices are framed influence the likelihood that consent will be given—or refused? Competence to consent to treatment is not always self-evident. Paul Appelbaum’s classic article on that topic is the target of our journal discussion. Law has developed around consent controversies and has helped define the doctor’s task of explaining treatment options to patients. As the health law article explains, the classic case of Canterbury v. Spence based its guidelines for the information patients should receive on "reasonable person" and "reasonable physician" standards—what would a reasonable person want to know? What would a reasonable physician consider "material" to the patient’s decision?
Sometimes those who most need protection cannot consent for themselves to medical treatment or research. Wards of the state are a prime example of this sort of vulnerable population, and our policy forum article examines the importance of appointing effective guardians to watch out for these minors’ rights.
The medicine and society column takes on the real question at the heart of many of these boundary cases of informed consent at work: Does the informed consent process—as currently practiced in the U.S.—truly elicit patient preferences, or does it merely allow patients to select which of the physician-determined options is most acceptable (or least unacceptable) to them?
Finally, we’d like to thank Ankit Shah, MD, JD, for suggesting the month’s topic and working on the issue’s case development and article outline for us.
Sincerely,
Philip Perry, MSJ
Allison Grady
Faith Lagay, PhD
Editors, Virtual Mentor
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