Bioethics Topics Becoming Inherently More Political Medicine, June 15... · Bioethics Topics...

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Bioethics Topics Becoming Inherently More Political The Politicizing of Bioethics: A Brief Historical Overview. R. Alta Charo, JD R. Alta Charo, JD -Special Presentation Originally, bioethics occupied a small niche in which a small group of scholars/clinicians discussed ethical issues. It has changed its focus throughout the years and has moved toward topics that are inherently more political. Originally, bioethics occupied a small niche in the corner of medicine in which a small group of scholars and clinicians discussed ethical issues. However, in recent years, bioethical issues have become part of public policy debates, local elections, and national elections. Although some people say that ethics has become over- politicized and is a relatively arcane field, others can see that the field of bioethics has become central to political discourse in recent years. The 1960s and 1970s: In its earlier incarnation in the 1960s and 1970s, bioethics focused on the doctor-patient relationship, which was inherently a private relationship. Although this relationship is not embedded in the public policy debates we see today, there was a set of implicit political assumptions about the doctor-patient relationship that were not drawn out to any great extent. For example, the discussion around autonomy, patient autonomy in particular, was linked to discussions about personal liberties (a classic topic for political philosophy) and to a growing mid-century movement of consumerism. The 1980s: In the 1980s, the doctor-patient relationship began to focus on certain situations, such as use of reproductive technologies, surrogacy, artificial insemination, and in vitro fertilization (IVF). In the 1980s, the role of the government as it related to these topics became much more obvious. Should the government enforce the contracts that people were writing for their exchange of gametes in a surrogacy context? Should the government regulate either the safety or the morality of IVF? In the 1980s, because of changes in the administration in Washington, DC, abortion began to be discussed, which previously had been only a doctor- patient discussion. The abortion discussion began to move into the U.S. Supreme Court and out into areas such as research ethics. It had a profound influence on the regulatory response to infertility treatments and IVF. Recent Changes in Bioethics: As time passed, bioethicists began working on topics that were inherently more openly political. They consistently began to ask about when and how the government should be involved. Since then, we have only added to that collection of topics. We now discuss the role of the government in deciding whether life-sustaining technologies can be withheld or withdrawn, and if so, with what levels of proof and documentation. We discuss the role of government in making decisions about which therapy should be available (or not available) to people based on a moral judgment about the effect on society. Therefore, we now need to be thinking about both what is right and wrong for an individual patient (or for the doctor-patient relationship) and what is right and wrong for the government to do by law. (Reviewer-). © 2010, Oakstone Medical Publishing Keywords: Bioethics, Politics, History Print Tag: Refer to original journal article

Transcript of Bioethics Topics Becoming Inherently More Political Medicine, June 15... · Bioethics Topics...

Bioethics Topics Becoming Inherently More Political

The Politicizing of Bioethics: A Brief Historical Overview.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Originally, bioethics occupied a small niche in which a small group of scholars/clinicians discussed ethical issues. It has changed its focus throughout the years and has moved toward topics that are inherently more political.

Originally, bioethics occupied a small niche in the corner of medicine in which a small group of scholars and clinicians discussed ethical issues. However, in recent years, bioethical issues have become part of public policy debates, local elections, and national elections. Although some people say that ethics has become over-politicized and is a relatively arcane field, others can see that the field of bioethics has become central to political discourse in recent years. The 1960s and 1970s: In its earlier incarnation in the 1960s and 1970s, bioethics focused on the doctor-patient relationship, which was inherently a private relationship. Although this relationship is not embedded in the public policy debates we see today, there was a set of implicit political assumptions about the doctor-patient relationship that were not drawn out to any great extent. For example, the discussion around autonomy, patient autonomy in particular, was linked to discussions about personal liberties (a classic topic for political philosophy) and to a growing mid-century movement of consumerism. The 1980s: In the 1980s, the doctor-patient relationship began to focus on certain situations, such as use of reproductive technologies, surrogacy, artificial insemination, and in vitro fertilization (IVF). In the 1980s, the role of the government as it related to these topics became much more obvious. Should the government enforce the contracts that people were writing for their exchange of gametes in a surrogacy context? Should the government regulate either the safety or the morality of IVF? In the 1980s, because of changes in the administration in Washington, DC, abortion began to be discussed, which previously had been only a doctor-patient discussion. The abortion discussion began to move into the U.S. Supreme Court and out into areas such as research ethics. It had a profound influence on the regulatory response to infertility treatments and IVF. Recent Changes in Bioethics: As time passed, bioethicists began working on topics that were inherently more openly political. They consistently began to ask about when and how the government should be involved. Since then, we have only added to that collection of topics. We now discuss the role of the government in deciding whether life-sustaining technologies can be withheld or withdrawn, and if so, with what levels of proof and documentation. We discuss the role of government in making decisions about which therapy should be available (or not available) to people based on a moral judgment about the effect on society. Therefore, we now need to be thinking about both what is right and wrong for an individual patient (or for the doctor-patient relationship) and what is right and wrong for the government to do by law. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, History

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Clinicians Not in a Vacuum -- Politics Influence Medicine

Politically Neutral Position May Not Be Possible in Bioethics Discussions.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Much of what physicians do is influenced by government laws and regulations, though clinicians may not notice this fact. Therefore, many “medical debates” cannot take place free of political influences.

Some clinicians say that issues of life and death and the withholding or withdrawing life support are primarily issues for the doctor-patient relationship and not political issues. However, I find it difficult to talk about these topics outside of a political context because much of what physicians do is embedded in law and government, though clinicians may not notice this fact. The government is involved in setting standards for the education of physicians, for their licensure, for the quality of products that they use, for the level of information that their patients are entitled to receive, for management of patient records, and for the oversight of research using living patients, their records, or their stored tissue. Clearly, the role of clinicians is influenced by government regulations and laws. Are Bioethicists Objective? One of the impressions/expectations that people have is that bioethicists carry out their role in an objective, dispassionate, and morally neutral manner. Can bioethicists be objective and morally neutral? This discussion may remind you of the many hearings for Supreme Court appointments that tend to revolve around the question of whether a nominee can be dispassionate and free of external influences. I find myself persuaded that it is not possible to divorce one’s self completely from either external influences or one’s own instinctive political philosophy. For example, in the context of decisions around whether to withhold or withdraw an intrusive medical treatment, one common approach among bioethicists is to say that the patient is the person most primarily affected by this decision, and one of the most important things a patient can have may be the only thing left to a patient, which is the dignity that comes with being in control of his or her future. Because of this, a patient should to be entitled to refuse treatment or to have it withdrawn. However, others find that arguments of autonomy and personal liberty are far less compelling than their vision of a world in which social justice is primary. Therefore, if patients can order something withheld or withdrawn, then we will have power imbalances, which could lead to certain classes of people (the elderly, the disabled, etc) feeling pressured to agree to withholding or withdrawing expensive, difficult care. As a result, this group of bioethicists would conclude there should be some limits on autonomy. This is not a debate that can take place outside and free of a political philosophy about how society is best organized. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Objectivity

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From Bedside to Courtroom -- Policies Debated at Many Levels

Various Levels of Debate for Public Policy Discussions.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Conversations between a physician and patient cannot take place at the bedside without knowing that these discussions are reflected at many other levels: from municipal and state levels on up to judicial levels.

In medicine, conversations about public policy take place at the bedside and at every level above that. For example, imagine a bedside conversation with a patient who wants to advance the process of dying, whether with assisted dying or with the withholding or withdrawing of treatment. To the doctor and patient, this decision may appear to be very private. Hospital Policies: The decision to live or die steps outside of the private realm when the hospital, where this decision is taking place, has a policy on assisted dying. In addition, that hospital’s policy may be tied to the nature of the hospital’s mission. This could be a secular hospital, or it could be affiliated with a particular religious tradition that has rules and philosophies about what can and cannot be done. Municipal Policies: Whether something is considered a crime is inherently a legal and political decision. Therefore, actions being discussed by a physician and patient may be considered a crime at the level of the municipality in the state where the hospital is located. As a result, we have very active state debates about whether certain actions/decisions can be prohibited completely or whether they should be heavily regulated by law. Judicial Policies: At the judicial level, both state and federal constitutions, as well as state and federal statutes, may have some effect on our understanding of the range of rights of a patient or the range of duties of a physician. Conclusions: Therefore, these conversations cannot take place at the bedside without knowing that they are going to be reflected at many other levels. Each successive level tends to answer to different priorities. The physician’s priority may be to best serve the patient and his or her own conscience, while priorities for a state or municipal prosecutor may be about sending a clear signal to the public regarding what is and is not permitted. Remember, one of the rules of criminal law is to deter future crime. For the judicial system, one of the priorities is to answer to our understanding about the meaning of the Constitution of the United States. Is it a living transformative document that reacts to changing times and understanding, or is it something that we need to keep rather static and tied to the most obvious plain meaning of its words? These kinds of considerations -- constitutional for the courts and public order for prosecutors -- will influence how they evaluate what to do in a given situation. Physicians must be aware that the same situation may feel like it has only one priority -- the patient -- yet all priorities will influence how a situation must be handled. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Public Policies, Levels of Debate

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Who Am I -- Keep Identities Straight in Political Debates

Physician’s Role in Political Debates -- Political Activist vs Medical Expert: Part 1.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

When engaged in any kind of moral or political argumentation, physicians must remember which type of judgment they are offering. Is it a professional opinion or is it the opinion of a private citizen?

(Card 1 of 2) Although some physicians like to believe that their decisions are apolitical, they work in a broader social, political, and cultural context than just in the clinic or hospital. Does it make sense to aspire to remain politically neutral at the bedside when discussing issues that have broader consequences and overtones? One of the hardest things for all physicians to do is to learn how to participate in this world as both a professional and as a citizen without getting the 2 identities confused. Professional Role: As a physician who is using your professional medical judgment, it is appropriate at the bedside to focus on those things for which you have technical expertise. For example, you understand the nature of infections and infection control, and you look at a patient and try to understand how best to manage that infection. There will still be some irreducible level of political philosophy present in this discussion because the whole question of who is in control -- you or your patient -- is part of a political philosophy, but it is subtle. Political Role: When the state legislature engages in a debate about whether some aspect of medicine should be regulated, you wear 2 hats -- the professional physician and the private citizen. In these debates, you should be participating to offer your professional judgment about the effect it would have on medical practice, and as a citizen, you should offer your judgment about whether this matches your notion of where the state should or should not involve itself. Professional vs Personal Judgments: The trick is to not use the white coat of authority when it comes to talking about political values. It is one thing to don the white coat to say, for example, that a particular technique for human reproduction is dangerous and it poses a dramatically increased risk of birth defects -- this is a technical judgment. But to don the white coat and say, for example, that this technique is unnatural and wrong and that it should be prohibited is not using your professional judgment -- it is using your personal judgment. When you are engaged in any kind of moral or political argumentation, remember to step back and say, “I am telling you this as a citizen, I am not telling you this as a doctor.” (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Physicians’ Roles in Debates

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Gray Zone -- Medical Expert vs Political Activist in Debates

Physician’s Role in Political Debates -- Political Activist vs Medical Expert: Part 2.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

An extremely fuzzy boundary distinguishes between those debated topics for which a physician’s medical expertise is relevant and those for which a physician’s political activism is relevant.

(Card 2 of 2) Many people go into medicine and bioethics with a strong sense of right and wrong. They may have strong opinions about what is appropriate or inappropriate in given medical situations. If physicians become involved in cases for which they have a strong sense that something is not going right or that there is an injustice, then is it appropriate for them to act as political activists as opposed to medical experts? Political Activist vs Medical Expert: In my opinion, there is an extremely fuzzy boundary that distinguishes between those topics for which your professional expertise is relevant and those for which it is not. For example, imagine a debate on assistance in dying. As a physician who wants to make a statement about this, it seems entirely natural that you might testify to your experience watching people die, testify to your best observations as to whether they would have preferred one option over another, testify to the capacity of the pharmaceutical industry to provide the kinds of drugs needed to make this easy and painless, and testify to the psychiatric community’s capacity to distinguish between authentic and inauthentic desire. These are all topics for which medical judgment is both pertinent and essential. However, if you want to organize around the notion that assisting people in dying is somehow against God’s law (not a professional judgment), then you are voicing your religious or spiritual convictions and you need to identify yourself as such. Debates on the Medical Profession: I think one of the trickier in-between grounds is when the debate begins to address the nature of the medical profession. For example, one of the arguments in that debate about assistance in dying has been that it is not the role of physicians to help people die; it is the role of physicians to help keep people alive or keep them comfortable while alive. Some believe that assistance in dying, if it is to be a practice in this society, should be a practice of some other profession. That, to me, seems like a legitimate discussion for professionals about how to define their profession. It is not about whether the practice should be legal or illegal, but it is about the nature of the medical profession as opposed to some other profession being responsible for assistance in dying. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Physicians’ Roles in Debates

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Truth, Not Distortion, Critical in Political Debates

Stem Cell Research Debate: Example of Professional Expertise vs Political Activism.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

During a political debate about medical issues, if you are uncomfortable with where the truth lies, then the answer is not to distort the truth but to simply decide that you are not going to engage in that debate.

How can physicians distinguish when they are involved in a rational argument for a particular medical position or strategy as a medical expert versus when they are involved in a political kind of discourse as a political activist? How different is it to be functioning as a political strategist as opposed to making a rational dispassionate clinical argument? The answer is that these 2 areas are very different. To illustrate the differences, let us look at the debate over stem cell research. Stem Cell Research: The area of stem cell research has been hotly debated for a decade because it involved, for many years, use of stem cells that came from early embryos. We are now working on many other options in stem cell therapies. Nonetheless, embryonic stem cell therapy was clearly controversial because of its origins with human embryos, whether the concern was about destruction of the human embryo or about building on the field of in vitro fertilization. Many physicians and scientists entered the debate, which was a political debate about whether there should be criminal penalties for performing stem cell research and, if the practice was not going to be criminalized, should it be funded by the government or by private sources? There were many different versions of political argument at that time. As a result, it was very hard for people who were deep into that debate to remember that one of the primary obligations of professional is to be true to his or her discipline. This means that, as a clinician, you must be true to your best evidence-based judgment about how many people might actually be able to benefit from a particular kind of therapy. Is it a small number or a large number? As a scientist, it can be very hard to remain true to your discipline in which you acknowledge the uncertainty about whether something will work, how long it will take to work, or how likely it is that some other kind of technique will turn out to be easier or better for the same purpose. In the stem cell debate, we saw distortion on all of these topics. We saw distortion on the sheer number of patients who might benefit from embryonic stem cell therapy. We saw distortion about prospects for alternatives, such as altered adult stem cells or induced pluripotent stem cells to substitute for embryonic stem cells. In the end, this was not a debate of which we should be proud. Remember, if you are uncomfortable with where the truth lies, then the answer is to simply decide that you are not going to engage in that debate rather than to distort the truth. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Stem Cell Research

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Life Science Debates Grow in Complexity as Technology Advances

The Growing Political Debates Over Scientific Issues.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Many political debates regarding issues in the life sciences have sharpened because we are more buffeted by the wave of options coming at us -- options for which we were not necessarily prepared.

Medicine and science are inseparable from the larger social and political context in which we exist. The question is often asked if over-politicalization of scientific issues has become worse over time or if it is just more visible? Because I am not a historian, I cannot speak with authority on whether it has gotten worse over time on the scale of hundreds of years. Like many other people, I have casually stated that I believe the partisan nature of politics has worsened dramatically. Nonetheless, I have been reminded by my friends who are historians about how incredibly partisan, vicious, and defamatory politics was in the 19th century, meaning that politics is hardly worse now than it was then. Therefore, speaking only to the decades that I can remember, I would say that we, in the life sciences, have developed more capacity to take control of things that used to be out of our control, and with that comes a recurring debate about whether we should exercise that control. Are we mature enough to exercise that control? If some of us are mature enough, but not others, then who decides who is mature enough? Is it the government’s role to tell us what we ought to decide, or is it each of us who decides on our own? In previous centuries, we did not have the capacity to make as many decisions. For example, we did not have to make a decision about the direction of human development before about 1979 because we did not have the ability to maintain an embryo outside the body before that time. We never before had to ask questions like whether an embryo had some entitlement to call on those of us who are living, conscious, and capable to do things to nurture it? Could an embryo be sold? Could it be donated? Could it be used for research? If so, who decides these things -- the people who made the embryo, the people who donated the gametes, the government, the doctor, or the laboratory? We would not have asked these questions before because we did not have the capacity to make decisions at that time. This has been true for a number of scientific issues. We now have a capacity to extend life way beyond the stages we could have 50 to 60 years ago, which brings fresh questions about when to extend life versus when to simply surrender to the inevitable. I think this has sharpened the debate, not because we are meaner but because we are more buffeted by the kind of wave of options coming at us -- options for which we were not necessarily prepared. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Political vs Scientific Issues

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Roles of Bioethics Commissions Vary Widely

Various Roles and Mandates of Bioethics Commissions.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Some bioethics commissions are formed as think tanks to explore various perspectives on general biomedical topics, while other commissions are formed to help determine public policy on specific issues.

Various bioethics commissions have been in place since the 1980s, and those involved with early commissions were mostly scholars. However, these commissions are playing a much more public role now. Because many different kinds of bioethics commissions have been formed throughout the years, it is difficult to generalize about their roles. Specific Mandates: Some commissions have been formed with very specific mandates. For example, in 1994, the National Institutes of Health (NIH) formed the Human Embryo Research Panel to answer a single question with a goal of influencing federal policy: what are the ethically distensible options for NIH funding in the area of embryo research? This question was presented to the NIH after a 12-year moratorium on federal funding. Therefore, after a decade in which they did not have to think about these issues, the NIH needed some fresh eyes with which to assess the question. General Mandates: Other commissions have been formed with a much less specific mandate. President Clinton formed the National Bioethics Advisory Commission (NBAC) with a mission to work on topics relevant to the federal agency. The NBAC’s charter gave commission members some suggestions, but there were no demands. In many ways, the NBAC served these purposes: to anticipate the areas into which life sciences and medicine would be expanding and for which federal agencies might have to make decisions but for which no sustained examination of merits, implications, or options for federal action had been performed. For example, the NBAC discussed the topic of research with biological materials because the amount of stored human tissue had increased greatly, along with possible uses for it in genetics research. This was relevant to a number of federal agencies that funded, supervised, or benefited from research. The mandate for the President's Council on Bioethics under President Bush was to become a national seminar in which to explore points of view and then publish documents that would lay out those arguments without any necessary goal of influencing federal policy. National Positions: From 1978 to 1983, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research actively published very pointed policy-oriented documents that tried to give a single answer to various questions such as how we define death. This particular question was important in everything from who has to continue paying for the hospital stay and the equipment, to whether hospital workers could absent themselves from this patient’s care, to whether organs could be removed to transplant. Thus, this commission was attempting to come up with a single national position on something that had been the subject of chaos at the state level. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Bioethics Commissions

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Public, Expert Opinions Sought by Bioethics Commissions

How Bioethics Commissions Work: Part 1.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Although bioethics commissions vary considerably, members may consist of people from various academic disciplines as well as representatives of public and patient groups.

(Card 1 of 3) President Clinton’s National Bioethics Advisory Commission (NBAC) was formed to answer certain questions. I served on this commission, which had approximately 18 members from across various academic disciplines as well as representatives of public and patient groups. This commission certainly was a place to throw hot potatoes, which was especially true when Dolly (the first cloned sheep) appeared. The commission was also given the privilege of picking its own topics. Public Meetings: Very early after formation of the commission, we began a series of public meetings in which we explored where medicine was going and where new dilemmas were likely to present themselves. During the course of those meetings, some of which took place at the National Institutes of Health (NIH), we concluded that research with human biological materials was going to become an increasingly important part of the research scene in the United States. Yet, a number of people who testified before us or sent in comments stated that the oversight for research with human biological materials was incredibly confusing: it varied from state to state, and there was a genuine lack of understanding as to what rules actually applied, let alone what rules ought to apply. If I work with human tissues, should I think of myself as somehow not working on human beings? What if the tissue has a name and an address attached, and when I work on the tissue I am learning that Joe Smith has Alzheimer disease or prostate cancer. I have learned something about Joe Smith even though I am not working on Joe himself. Should Joe have some protection from my intrusion? These kinds of questions were coming up more frequently as the tissue banks grew, and the range of experiments or research studies that people wanted to propose was also growing. Information Gathering: By following this kind of spiraling conversation about what was important and what was confused, we settled on the topic and then systematically began to invite experts to testify before us, write contract papers, and to have staff research the factual elements of this topic. How many tissue banks were there? What kinds of tissues were being stored? Where were they coming from? What do people know about the tissues that were being taken from them? If the tissues are surgical waste, do patients know that these are being taken, and does the surgical waste have any link back to them? How much information about the individual is being stored? Who has access to the information? What kinds of research are being done? What is being published? (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Bioethics Commissions

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Recommendations Submitted for Federal Consideration

How Bioethics Commissions Work: Part 2.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

At the end of all fact-finding and discussion, a bioethics commission may write a set of final recommendations on a given topic. However, the group receiving these recommendations are not required to adopt them.

(Card 2 of 3) Public Input for Principles to Be Applied: After gathering facts on a specific topic, President Clinton’s National Bioethics Advisory Commission (NBAC) stepped back and had a series of public discussions during everyday proceedings about very basic things in terms of principles that needed to be applied. To what degree of personal privacy are U.S. citizens entitled? If it is a matter of debate, what is the range? What are the current regulations that protect personal privacy? What are the regulations about confidentiality where information has been revealed but the universe of people who have access to it is limited? What are the possibilities for breach, and how does breach hurt somebody? Is it dignitary harm only, or does it actually threaten their well-being in terms of employment or insurability for life or health insurance? Formulating Options: With these questions answered, we could then begin to formulate options. We could have a very robust system of oversight for research on these tissues, which made it much harder to use them without getting individualized permission from all the people from whom the tissues were taken, and the cost to the research enterprise would be substantial. That is one set of options and we would explore that, and we would try to set out what the world would look like if we made that balance. Then we would ask what the world would look like if we allowed much more access to these tissues. There was a much higher risk that people would feel insulted and betrayed if not actually harmed in their employability, but this would allow more research to go on for breast cancer, prostate cancer, schizophrenia, or any number of disorders with genetic components. Final Recommendations: At the end of all of that, we then wrote up a set of recommendations, and we explicitly decided that the recommendation would be based on the assumption that we were not going to have a wholesale reform of our current system of oversight of human subjects. This was done because we wanted to be useful to federal agencies. We chose a very pragmatic approach and we explicitly said, “Within existing rules, how can these rules be interpreted, applied, and understood so that we can achieve a reasonable balance between the patient’s interests and the vital interests in the research enterprise?” Recommendations made by our commission were sent to the Department of Health and Human Services, which accepted some and rejected others and eventually came up with its own policy, which is the one we have today. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Bioethics Commissions

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Federal Government Can Reject Recommendations

How Bioethics Commissions Work: Part 3.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

Bioethics commissions may give recommendations for appropriate actions or policies. However, the federal agency receiving these recommendations must decide what is best based on the goals of the government.

(Card 3 of 3) Recommendations: In the final phase of a bioethics commission’s work, members will write recommendations for a given topic. In the case of President Clinton’s National Bioethics Advisory Commission (NBAC), final recommendations regarding use of human tissue in research were submitted to the Department of Health and Human Services (HHS), which rejected some of these recommendations. The question is sometimes asked about what happens to the published work when recommendations are rejected? The answer is that the work is still available. It is published, so people can read it. Because of the terms of the NBAC’s charter, when some of the recommendations were rejected by Donna Shalala, then Secretary of HHS, she was required to write a statement explaining her reasons for the rejection. In this case, she found some of the recommendations too protective of patients and, as such, would interfere too much with research. In her written statement, she said that the reasons for rejecting the recommendation was that she did not balance the interest of patients and the interest of the research enterprise the same way that our commission did. It was not that she disputed that these were the issues; instead it was that the judgment of the federal government embodied in that department believed that a different balance should be effectuated. Our role had been to clarify what was at issue and then to give our best advice, as 18 individuals, as to what the appropriate balance would be. Her job at the federal agency was also to decide what the right balance would be based on the goals of the government of which she was a part. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics, Bioethics Commissions

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Physicians Report Real Effects of Political Decisions

The Physician’s Witness Helps Keep Political Decisions Grounded in Reality.

R. Alta Charo, JD

R. Alta Charo, JD -Special Presentation

A physician’s participation in political debates can perhaps best be manifested by his or her testifying to the effects of those group decisions on the many individuals that are served in the clinic or hospital.

Because clinicians are on the “working front” where the effects of many political decisions are felt, physicians should know that they have an important role to serve as witnesses to the various effects of those decisions. For example, the big debate in 2009-2010 is that of the reform of health insurance and access to health care. This is a debate in which the voice of the physician is crucial. I believe that every physician knows that the choices made in practice are influenced to some degree by the availability of financing to support those choices. This is true, even though physicians are certainly not disinterested parties in this debate because their own livelihood and their own sense of self are on the line. Physicians’ Role: Physicians must recognize that much of the reason they went into medicine was because they were interested in helping people one-by-one. They were drawn to a truly service-oriented profession that was highly personal. Nonetheless, physicians exist in a world that is about more than just one-on-one decisions. Instead, the world is about group-by-group decisions, and a physician’s participation can perhaps best be manifested by testifying to the effects of those group decisions about what the government will or will not do or about what the government will or will not fund. The physician can serve as a witness to the effects of those group decisions on the many individuals that they serve. Physicians can help keep everyone grounded in the reality of the effect of political decisions. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics

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Diverse Views Prevent Science From Driving Policies

Politics, Bioethics, and Science Policy.

Turner L:

HEC Forum 2008; 20 (March): 29-47

Because of the highly diverse world in which we live and function, we must understand that “science” or “scientific facts” do not drive science and technology policies in and of themselves.

Although many people believe that science policy should be based only on “science” or “scientific facts,” the formation of science policy is also affected by ethical and political considerations. Reaching a consensus during the development of policies within institutions, professional societies, or legislative assemblies is challenging, at best. Hospital Policies: The process of developing hospital policies is often challenged by conflicts or power struggles between administrators, doctors, nurses, and allied health professionals; moral disagreements; and patient versus hospital interests. Policymakers must be responsive to complaints about marginalization, authoritarianism, and underrepresentation. In some situations, patient representatives, family representatives, and/or local community leaders may need to be included in the policymaking process. The more diverse the membership on a policymaking commission, the more difficult it may be to arrive at a consensus. A variety of religious and cultural traditions as well as competing political philosophies may promote conflict over basic moral premises and make finding the “common ground” very difficult. Scientific Fact vs Moral Issues: Although many believe that scientific issues remain politically and morally neutral as public policy is being developed, scientific facts will not end policy disputes and ethical conflicts between political parties, various citizen and religious groups, and scientific communities. At some point in the process, some may accuse the committee of corrupting the science with politics. The politicization of policymaking can be seen in the neglect of scientific evidence, the ignoring of research findings, and the removal of qualified individuals from the advisory board. Because of diverse interests and worldviews in the United States, science policy cannot be developed in an apolitical setting. Even reaching a resolution to highly contested topics is a political process. The bottom line is that in our pluralistic society, science, nature, and the laws of physics cannot in and of themselves dictate social policies. Value judgments cannot be squeezed out of science policies. We should expect that social policymaking, as it relates to bioethics issues, will include both substantive convictions that are not reducible to scientific evidence along with scientific facts. For any given policy under development, the process will involve only a small subset of available, qualified participants who are selected by an inherently political process of its own. In addition, committee members may disagree about what can be called reliable, accurate, and credible knowledge. Conclusions: Because of the highly diverse world in which we live and function, we must understand that “science” or “scientific facts” do not drive science and technology policies in and of themselves. Reviewer's Comments: Science never has, and never will be, completely divorced from politics. Politics (among other factors) inevitably impacts which scientific questions are asked, what funding is available, and which findings get published. Understanding the relationship between science and politics can help physicians, as consumers of science, to be more critical, and thus more discerning, readers of the scientific literature. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Political vs Scientific Policies

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Few Political Policies Based on Individual’s Best Interest

“Culture of Life” Politics at the Bedside -- The Case of Terri Schiavo.

Annas GJ:

N Engl J Med 2005; 352 (April 21): 1710-1715

Most political policies are based on the best interest of entire groups, not individuals. However, some rulings have been made regarding the health care of individuals in persistent vegetative states.

Background: Most political policies are based on the best interest of entire groups, not individuals. However, for patients in a persistent vegetative state (PVS), rulings have sometimes been made based on the specific health care of individuals. Karen Quinlan: In 1976, Karen Quinlan was in a PVS. When her parents asked that the ventilator be removed, physicians refused because they feared the legal liability, although they had no problem with the ethics of such actions. The New Jersey Supreme Court granted the physicians legal immunity in this case. As a result of this case, states passed “living will” legislation to provide legal immunity to physicians who honored patients’ health care wishes when they became incompetent. Nancy Cruzan: In 1990, the U.S. Supreme Court made a constitutional law based on the case of Nancy Cruzan, a young woman in a PVS who required a feeding tube to stay alive. The Missouri Supreme Court had said that those who spoke for Nancy must produce “clear and convincing” evidence that she wanted the tube feeding discontinued. After this Supreme Court ruling, people were encouraged to legally designate someone to make health care decisions for them should they become incompetent. Terri Schiavo: After a cardiac arrest in 1990, Terri Schiavo lived in a PVS and required tube feeding to keep her alive. Her husband petitioned the court to discontinue tube feeding, on the grounds that Terri would not have wanted to continue to receive this intervention under such circumstances. The judge agreed, deciding in the husband’s favor, and an appeals court came to the same conclusion. However, the woman’s parents challenged the findings, claiming that Terri would want to continue treatment and based on their conviction that life should be preserved regardless of its quality. Based on the findings of 5 physicians who were directed by the court to examine Schiavo, an appeals court affirmed the original decision. The parents went to the state legislature in an effort to have the feeding tube reinserted. The legislature passed “Terri’s Law” giving Governor Jeb Bush the authority to have the tube reinserted, which he did. In 2004, the Florida Supreme Court ruled that Terri’s Law was unconstitutional. In January 2005, Governor Bush petitioned the U.S. Supreme Court to hear an appeal, but they refused. The feeding tube was removed on March 18, 2005. Two days later, the U.S. Congress met to consider emergency legislation for Schiavo. On March 21, 2005, the Senate and House passed a bill to allow the parents’ appeal to be heard by the U.S. District Court for the Middle District of Florida. In the end, the judge denied the parents’ request for the tube’s reinsertion. Reviewer's Comments: For >30 years, there has been a legal, medical, and ethical consensus regarding the withholding and withdrawing of life-sustaining medical treatments. The Schiavo case, while tragic, offered nothing new to these established precedents; it did, however, show how political considerations are sometimes inserted into private bedside interactions between doctors, patients, and families. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics

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Clearly Distinguish Political Advocacy From Scholarly Efforts

What Happens When Politics Discovers Bioethics?

Kahn JP:

Hastings Center Report 2006; 36 (May-June): 10

As bioethics is pulled into heated political debates, bioethicists need to help ensure that policy and politics remain 2 separate entities.

In this editorial on policy and politics, Jeffery Kahn states that the policy debates in which bioethicists traditionally have participated are now evolving into heated political debates. The input of bioethicists has changed now that so many of the debates have placed bioethics into the Culture Wars. As the field of bioethics matured, it developed a reputation for “clearheaded analysis,” and those who became bioethicists wanted to make a difference in the policy issues at hand. Kahn wonders if this reputation will be maintained as bioethicists find themselves participating in heated political debates. The academic practice of bioethics may not translate clearly into the field of politics. For example, the “shades of gray” reasoning taught to bioethicists may become corrupted into black and white opinions by the media, thus soiling the scholarly reputation of bioethicists. Kahn states that probably the biggest danger of entering political debates is that bioethicists may be labeled with certain political commitments and leanings rather than with scholarly credibility. Although Kahn does not believe that bioethicists should hide from political issues of the day, bioethicists need to clearly distinguish their academic work from their political activism to the best of their abilities. Bioethics as politics should be clearly distinguished from bioethics as scholarship: political advocacy should not be confused with scholarly efforts. If successful, bioethicists should continue to be appointed to government commissions based on their scholarly expertise rather than on their political bias. In these positions, bioethicists can help ensure that policy and politics remain 2 separate entities. Reviewer's Comments: Kahn advocates for bioethicists to separate their political from scholarly roles. To do so requires a level of self-awareness regarding the political aspects of one’s scholarly endeavors. Without such clarity, it is difficult, if not impossible, to make such a separation. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Politics

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Conflict Common but Impasse Signals Escalating Problem

Conflict in Doctor-Patient Interactions: When Does It Become a Problem?

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

In doctor-patient interactions, conflict is not necessarily a problem because most people work it out. The problem is when a conflict reaches an impasse and one of the parties withdraws from the relationship.

Most clinicians have interactions with patients that do not go well. Sometimes patients frustrate us. Sometimes patients drive us crazy. And sometimes, we have conflicts with our patients. Often, these patients get labeled as being “difficult patients.” Doctor-Patient Conflict: Conflict in the doctor-patient relationship is quite common. A recent study looked at primary care physicians and their interactions with patients, and it demonstrated that about 40% of these interactions resulted in conflict. So, almost 1 of every 2 interactions is associated with some level of conflict. However, just because doctor-patient conflict is common does not mean that it is a problem. Most people who practice medicine have a reasonable set of skills to work through the conflict. These solvable types of conflict are not the interactions we think about when someone refers to a “difficult patient” or “difficult family.” The Impasse: A problem occurs when conflict develops into an impasse, which is when both parties (doctor and patient) have taken an intractable position on something about which they disagree. For example, it could be something as simple as a patient with the common cold believing they should get a prescription for antibiotics, while the physician believes strongly that antibiotics are not in the patient’s best interest. The Escalation: When 2 people get into an impasse, the conflict starts to escalate because people become more committed to their position and become less flexible about either hearing the other party or being able to modify their position. The problem is not the conflict per se, given that conflict is so common and most of it is worked out between people. The problem is when the conflict reaches an impasse and the doctor and/or the patient starts to withdraw from the relationship. When people start to withdraw from the relationship, they become more rigid. This results in less of a hope of moving the conflict forward toward a resolution. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Ethics Committees Deal With More Than Ethical Dilemmas

Conflict Resolution Important Part of Ethics Committee’s Work: Part 1.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

Some problems brought before an ethics committee are related to true ethical dilemmas, but more often than not, actual problems are about fundamental conflicts or bad communications between people.

(Card 1 of 2) As most ethics committee members can tell you, many issues are framed as ethical dilemmas when in reality they are more like a fundamental conflict or communication problem between medical staff, patients, and/or family members. Sometimes there truly is an ethical dilemma, but more often than not, it is a problem between people, and the conflict is not over ethics per se. Typically, the conflict is more about the fact that the individuals involved are not able to talk to each other in a way that allows them to move forward. It seems that people call the ethics committee when there are elements of an ethical dilemma attached to the conflict. For example, it may be a question of whether to withdraw life support from a patient, where one side thinks it is time, the other side disagrees, and the 2 sides reach an impasse. Then they call the ethics committee because they need help. I believe one of the valuable things that ethics committees contribute is the ability to listen to each party and determine just what kind of help is needed. Is there truly an ethical impasse here, where value systems are clashing and no acceptable solution is apparent? Are people just having a difficult time communicating their feelings, fears, and concerns? Are they having a difficult time listening to the other party, making it impossible for them to understand what is driving the other person’s behavior? A common role for an ethics committee is to help sort out answers to these questions and then come together to help people find a solution to their conflicts. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Ethics Committee Can Serve as Safe Sounding Boards

Conflict Resolution Important Part of Ethics Committee’s Work: Part 2.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

Some issues brought to an ethics committee may have only a small ethical component. In such cases, what is needed most is a safe forum in which 2 parties can safely exchange views and resolve a conflict.

(Card 2 of 2) Ethics committees commonly are asked to help resolve problems that are not true ethical dilemmas. Instead, their intervention may help 2 parties sort through feelings and conflicts to come to an understanding of each other’s views and, hopefully, to resolve the problem. An example of a common case is as follows. Case Scenario: An elderly gentleman (aged 83 years) who had a history of hypertension and diabetes presented to the emergency department with a massive stroke and was in the ICU on a ventilator. The stroke was catastrophic. The patient’s wife was deceased, and there was no living will or declared health care power of attorney, so the patient’s exact wishes were not known at the time. He had 3 adult children. Conflicts: Because the likelihood of recovery was very, very low, 2 of the adult children believed that their father had lived a good life and that it was okay to withdraw life support and let him die. However, the third child, who had moved away from the family and came back to visit his father in the hospital, began to raise a brouhaha, saying, “We can’t give up on Dad. We need to do everything possible, and all the aggressive medical therapy that is available should be given to him.” This created a conflict within the family, and it also created a conflict among the medical staff. In addition, this generated a conflict between the staff and the family because staff members believed the outcome was most likely going to be poor and that aggressive medical care was akin to torturing this fellow and delaying the inevitable. Involving the Ethics Committee: Was this truly an ethical dilemma? There may have been a small ethical component, but what was most needed was a safe forum in which family members could exchange views and reach a decision. During discussions with the ethics committee, many feelings were revealed regarding the question of the father’s treatment. The children were first concerned about their responsibility to their father. They also shared their feelings about the lives they had had with their father. For example, the son who was being disruptive felt like he had let his father down in his life and felt like he really needed to step up and “fight” for his father at the end of his father’s life. This particular piece of information helped the family to look at this son as someone who was trying his best to help his father rather than as an out-of-control disruptive individual who was demanding inappropriate medical care. Here was a case where the ethics committee’s involvement helped solve a family conflict rather than addressing a true ethical dilemma. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Relationships Key to Solving Ethical Conflicts

The Ethics Consultation: A Brief Overview of the Process.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

Because the solution to most conflicts will come through relationships, ethics consultants must set the stage for respectful, collegial, and compassionate relationships in the face of very intense conflicts.

The actual process of an ethics consultation may be foreign to many people. When someone requests an ethics consult, the consultant first comes and evaluates the situation. The Relationship: When I am involved in an ethics conflict as a member of an ethics committee, an important part of my job is to build a relationship of some sort with every person involved (the patient, the family, the nurse, the physician, etc). This is an important part of my job because, even when there are clearly contrasting ethical views and opinions in a true ethical dilemma, we somehow must find the solution. That solution will come through relationships. One of the things that we can do as ethics consultants is to set the stage for respectful, collegial, and compassionate relationships in the face of very intense conflicts. The Facts: Drawing from the old axiom that good facts make good ethics, the second task for an ethics consultant is to get the story from everyone involved and to do his or her best to discover actual facts for the given situation. Getting Help: If an ethics consultant finds that he/she needs help, then colleagues may need to be contacted and brought up to speed. Do you have a group model of doing ethics consults? Do you do it by yourself or with 1 or 2 other people? Because these situations are intense and complicated, doing consults alone may be risky. Having the help of your colleagues may be beneficial, even if they are just available for bouncing ideas back and forth. Bringing People Together: If the conflict persists, then the next step is to bring people together in a format to move the conflict forward as opposed to setting up a situation that may actually exacerbate the conflict. Some of these conflicts are intense, and the stakes are very high. Conflicts often revolve around life and death decisions, and people have strong feelings about the topic. Therefore, creating an environment that is respectful and that allows people to speak their mind and feel heard and understood is a very important part of setting the stage for the medical staff, the patient, and the family to work out their differences and move toward a resolution. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Accept People Where They Are, as They Are

The Ethics Consultation -- The ARCH Principle: Part 1.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

In the ARCH principle, acceptance means that you accept every person “where they are, as they are.” You accept that they have good reasons for what they want to do, which allows you to listen to them.

(Card 1 of 3) During an intense ethical conflict, an ethics consultant must help create a respectful environment in which people may voice their perspectives and feel understood. The goal is to help people communicate with one another so that they may work out their differences and move toward a resolution. The ARCH Principle: When all involved parties are brought together to discuss a conflict, first ask everyone to introduce themselves and say why they are there and their role in the impasse. The second thing is to follow the ARCH principle, which is a mnemonic for “Acceptance,” “Respect,” “Curiosity,” and “Honesty.” Because the emotion of these conflicts can be very distracting, use this principle to guide your interactions as a consultant. Acceptance: In the ARCH principle, acceptance means that you accept every person “where they are, as they are.” You are not trying to change them. Acceptance does not mean agreement. For example, you do not have to agree with either position of withdrawing life support or pursuing aggressive care. However, when you accept people “where they are, as they are,” you accept that they have good reasons for what they want to do, which allows you to listen to them. If someone becomes unreasonable, it can be difficult to calm yourself and listen. Nonetheless, you must try to stay connected to these people. Respect: The second part of the ARCH principle is respect. The way you speak to someone is very important as part of the process of building a relationship, even if they are unreasonable. Respect can move a relationship toward being more reasonable and consolatory. Respect is seen in simple things like referring to someone as Mr or Mrs, allowing people to finish their sentences, and the tone of your voice. Curiosity: The third part of the ARCH principle is curiosity. What do curious people do? They ask questions. When there is an intense ethical dilemma, people often behave in a way that is controlling because they want you to hear their position and to “side with them.” As a result, they speak and behave in a way that is controlling. When you are curious as opposed to controlling, you ask questions. For example, even if you think a person is unreasonable, you do not say, “You know, I do not like the tone of your voice right now. I do not think your opinion is valid.” Instead, you say things like, “I am having a hard time understanding this. Can you help me understand your position? Can you help me understand why your dad might want that done now?” (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Controlling Behavior, Sense of Control Two Different Things

The Ethics Consultation -- The ARCH Principle: Part 2.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

During a meeting to help resolve an ethical conflict, most people who display controlling behaviors are not actually trying to be controlling. Instead, they are trying to gain a sense of control.

(Card 2 of 3) While working with people who have an ethical conflict, the consultant may use the ARCH principle as a guide for interacting with the involved parties to help them communicate clearly and move toward a resolution. The “C” in ARCH stands for curiosity -- asking questions of people in a way that helps them further clarify their feelings or beliefs. However, in some meetings, you may forget and behave in a controlling manner rather than in a curious manner. Controlling vs Curious: For example, presenting a unilateral position is controlling -- saying, “I will only do this. I will never do that. I will not change until you change.” Typically, these people are not actually trying to be controlling. Instead, they are trying to gain a sense of control, which is a very different thing. However, the expression of their behavior is experienced by others as being controlling. Sometimes, someone becomes highly emotional in a meeting and starts standing up and shouting. If he or she becomes scary and intimidating, maybe even threatening in some ways, then you know the situation is rapidly escalating. A controlling response by you as the consultant would be something like, “Mr Jones sit down. We do not talk like that in this hospital.” However, using the ARCH principle, a curious response by you would be, “Mr Jones, I can tell by the way you are speaking now how deeply you care about your father. Can we talk for a few minutes more about your worries for your father?” Threatening Behavior: Remember, there is a difference between escalating behavior and a true threat. Safety is paramount. If we do not feel safe, then we cannot function. If you are in a room with someone whose threatening behavior is escalating and who may potentially attack you, then you need to get to a safe place. In those extreme situations, do not worry about being curious or controlling. Instead, worry about the safety of everyone in the room. The thing to do is say, “I think for right now we need to put a hold on our meeting. We are going to go out of this room and talk in the hall for a while and try to collect our thoughts. Then we will reconvene in 30 minutes.” The key is to get out of the room. However, sometimes people are clearly becoming agitated or upset in a meeting, but they are not behaving in a threatening manner. If you are controlling, you might say, “Sit down or I’m going to call security.” In this case, you are issuing an ultimatum, which will make the person feel out of control and potentially provide a trigger for the escalation of that person’s behavior. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Honesty Still the Best Policy

The Ethics Consultation -- The ARCH Principle: Part 3.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

During an ethical conflict, the consultant must make honest statements geared toward keeping the conversation going between involved parties. As long as the conversation keeps going, there is hope of finding a resolution.

(Card 3 of 3) During ethical conflicts, an ethics consultant must help create a respectful environment in which people may come together to voice their perspectives and feel understood. The ARCH Principle: It is important for you, as the ethics consultant, to follow the ARCH principle when dealing with people in these emotionally intense situations. ARCH is a pneumonic for “Acceptance,” “Respect,” “Curiosity,” and “Honesty.” Acceptance means to accept people “where they are, as they are” -- choosing to believe that their motives are good. Respect is reflected in the way you speak to the involved parties, including your tone of voice and choice of words. Respect is very important for building a good working relationship. Curiosity is about asking questions to help the involved parties more clearly communicate their perspectives and clarify their beliefs. Honesty: The fourth part of the ARCH principle is honesty. Honesty is using yourself in an honest way in the interaction to move the process forward. The key here is using honesty to move the process forward. For example, a most unhelpful thing would be to say, “You know Mr Jones, I think you are behaving like a jerk right now.” While this may be an honest statement, it is not going to move the process forward. However, restating this by saying something like, “You know, Mr Jones, I can tell that you are frustrated by this. I too am frustrated and I am worried about whether we are going to be able to find a solution.” This is an honest statement, but it is said in a way that is geared toward keeping the conversation going. As long as you are keeping the conversation going, you have hope of finding a resolution. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Trusting Relationships Lead to Collaboration

The Importance of Relationships in Shaping Collaborative Problem-Solving Processes.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

If you go into a meeting trying to convince others that your point of view is the only correct position, then the other people in the room will likely respond by being more fixed in their opposing positions.

A good ethics consultant uses the ARCH principle (acceptance, respect, curiosity, and honesty) to set the environment for people being open to listening to each other and to other points of view. Once this is achieved, then the question becomes, “How do you talk to someone when you have very different points of view?” What if the situation is such that there is complete disagreement between what the doctor and the health care team members believe versus what the family members believe? You may have established a relationship through ARCH, but you still have to move toward a resolution. Is it a reasonable or appropriate goal for the health care team to try to convince the family to change their minds? Collaboration, Not Coercion: Without first developing a trusting relationship, problem solving is going to be very difficult. It takes time and energy to build these relationships in the face of conflicts. The relationship is the foundation of the problem-solving process because you are trying to develop trust and a style of working with people with whom you outright disagree. With trusting relationships, the problem-solving process becomes collaborative rather than conflicted or controlling. So then, what should the next goal be? If your goal is to get the others to see the world your way, then you will be trying to control them. It is okay for you to have your views, but as part of this process, you must be open to why the others have their views and what is driving their views. For example, if you go into a meeting with your goal being the immediate withdrawal of life support because you believe the patient is suffering, then it is going to be a difficult meeting because the other people in the room who disagree with you may believe that you are being coercive. This makes the others feel frightened and out of control. When this happens, people respond by being more fixed in their position -- they dig their heels in deeper. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Unfamiliar Roles Make Patients Feel Incompetent

Competency Is Key Principle in Building Collaborative Relationships.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

During ethical dilemmas, patients and families are thrust into a role for which they do not feel a sense of competence, so they forget some of their preexisting competencies, such as the ability to work with people.

Unfortunately, in medicine, the doctor-patient relationship can become conflicted. However, with some work, this relationship can be turned back into a collaborative relationship. To help guide this process of change, we have the Five Universal Principles for Collaborative Doctor-Patient Relationships. One of the key principles is that of “Competence.” Competence can be seen as a person having a sense of (or actual) mastery over his or her life. For example, an eighth grader may have a sense of competence over the ability to throw a baseball or to add simple numbers. When people feel competent, they feel in control. During ethical dilemmas, patients and families are thrust into a role they did not choose and for which they do not feel a sense of competence. They do not feel competent as a patient, they do not understand medicine, and they are frightened. As a result, they can forget some of their preexisting competencies, like intelligence, humor, and the ability to work with people. When we start with highlighting people’s competencies, it gives us a better chance of helping them be open to our methods. For example, an 85-year-old man is in the ICU after having a catastrophic stroke. After being told of his very poor prognosis, 2 of his adult children want to consider withdrawing life support because the end is inevitable, the father may be suffering, and the father has had a good life. However, a third son believes aggressive life support measures should be provided to his father. He believes that he is the only advocate for his father’s life at this time, considering how his siblings completely disagree. As the impasse is discussed, the third son’s behavior begins to escalate. The question is, how do you highlight the competencies in someone whose behaviors are becoming difficult? One possibility may be to remind him of his competencies by saying, “Mr Jones, it is clear to me that you want to be a good son to your father right now. It is also clear to me that, in the course of your life, you have been very successful in solving difficult problems. This is a difficult problem. I wonder how we can use those skills that you already have in this current situation.” By reminding them of skills they have, you highlight people’s competencies in an effort to get them thinking about how to creatively apply those competencies to the current dilemma. Remember that a statement of competency is not a compliment. Compliments are transient. When you highlight someone’s competencies, you are speaking to their core about something that is important to them. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Building Relationships Secret to Conflict Resolution

Tips and Resources for Learning to Manage Doctor-Patient Conflicts.

George F. Blackall, PsyD

George F. Blackall, PsyD -Special Presentation

Doctor-patient conflicts can be resolved when we get creative, remain open to people, and stay connected. Resolution is possible whenever we continue to build relationships in the face of these intense conflicts.

Most physicians must deal with doctor-patient conflicts in their practices. Some also must deal with finding resolutions to ethical dilemmas. General Tips: Because these dilemmas can be very difficult, the stakes are often very high. One of the key things that can be very helpful is to start with the assumption that, generally speaking, people’s motives are good. Everyone really is trying to do the right thing. As physicians, our task is to find a way to keep the conversation going until there is a shift in the process. That shift might be that the patient’s medical state declares itself. That shift might be that people have genuine conversations about their fears and their feelings about what is happening -- these conversations can help people find creative approaches and solutions to their problems. When we get creative, remain open to people, and stay connected, then these issues can be resolved. I am often asked to describe the magic formula for resolving these issues and dilemmas. However, there is no magic formula. Nonetheless, when good people come together with a genuine interest and the skills to build relationships in the face of these intense conflicts, there is always a way out. To help us learn about developing these resolution skills, resources are readily available. Resources: The following book provides details about learning to deal with conflict and presents a number of cases to help illustrate important concepts: Blackall GF, Simms S, Green MJ. Breaking The Cycle: How to Turn Conflict Into Collaboration When You And Your Patients Disagree. 1st ed. Philadelphia, PA: American College of Physicians; 2009. In addition, the following Web site has links and other resources on it: www.doctorpatientcommunication.org. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Ethics Committees, Conflict Management

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Younger Docs Most Likely to Encounter Difficult Patients

Burden of Difficult Encounters in Primary Care: Data From the Minimizing Error, Maximizing Outcomes Study.

An PG, Rabatin JS, et al:

Arch Intern Med 2009; 169 (February 23): 410-414

Physicians with the most frequent number of encounters with difficult patients tend to be significantly younger and to be women. They also are 12 times more likely to report burnout than are those with low levels of difficult encounters.

Background: The problem of “difficult patient” encounters is common, with almost 1 in 6 patients being identified as “difficult” by their doctors. Attributes of patients that lead to this label include having mental disorders, presenting with >5 somatic symptoms, exhibiting high use of health services, having a list of complaints, and/or having threatening or abrasive personalities. However, common attributes of physicians who have encounters with difficult patients are less well known. Objective: To compare selected characteristics of primary care physicians who have high numbers of encounters with difficult patients with attributes of those who do not. Design: Nested analysis. Methods: Using survey methodology, levels of stress, burnout, job satisfaction, time pressure, intent to leave the practice, and medical errors were compared among 422 general internists and family physicians located in 5 regions of the United States. Results: The most frequently identified type of encounter that doctors identified as “difficult” was when patients insisting on being prescribed an unnecessary drug (36.7%). Frequent difficult encounters also resulted from patient dissatisfaction with care (16.1%) and unrealistic patient expectations of care (13.7%). Physicians classified as having the least problems with difficult encounters were almost unanimous in their reports of having no perceived difficulty with patients. Conversely, physicians classified as having the worst problems with difficult encounters were almost unanimous in their reports of working with many difficult patients. These physicians were significantly younger (aged 41 years), were more likely to be women, were 12.0 times more likely to report burnout, and were 3.8 times less likely to be highly satisfied with their jobs than were physicians with low levels of difficult encounters. Conclusions: Because encounters with difficult patients may be common for some physicians, additional training for handling these situations is recommended. These difficult encounters are associated with job dissatisfaction and physician burnout. Reviewer's Comments: While physicians often identify challenging patients as “difficult,” such labels are seldom constructive. By definition, challenging encounters involve a relationship between at least 2 people, only 1 of whom is the patient. Doctors can help prevent and manage difficult encounters by shifting their focus away from challenging behaviors and instead attending to the patient’s strengths, skills, and competencies. Doing so involves changing the physicians’ responses to these encounters rather than trying to change the patient. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Patient Relations, Difficult Encounters, Common Physician Attributes

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Good Verbal, Nonverbal Cues Improve Patient Outcomes

Physician-Patient Communication in the Primary Care Office: A Systematic Review.

Beck RS, Daghtridge R, Sloane PD:

J Am Board Fam Pract 2002; 15 (January-February): 25-38

During the patient interview, physicians can improve patient satisfaction and compliance by expressing empathy for the patient’s situation, by being courteous, friendly, and reassuring, and by encouraging questions.

Background: During the patient interview, physicians give a number of verbal and nonverbal cues to their patients that may be linked with patient satisfaction and health-related outcomes. Objective: To determine which verbal and nonverbal cues are given by the physician to the patient that can be linked with favorable patient satisfaction and health-related outcomes. Design: Literature review of 14 studies regarding office interactions that were published between 1975 and 2000. Methods: These studies evaluated the physician’s vocal intonations, proximity/touch of the doctor to the patient, and the positioning of movements of the head, face, trunk, and extremities. In addition, physicians’ verbal behaviors for gathering information from the patient, developing relationships, and decision making were evaluated. The effect that these verbal and nonverbal behaviors had on patient outcomes (patient recall, satisfaction with the office visit, compliance, symptom resolution, health status, and mortality rate) were also evaluated. Results/Conclusions: Verbal behaviors linked to improved patient satisfaction, compliance, and comprehension included expressing empathy for patients’ situations, courtesy, friendliness, reassurance, support, encouraging patients’ questions, giving good explanations, and offering positive reinforcement/good feelings toward patients’ actions, possessions, or self. Another beneficial verbal behavior was that of laughing or joking for tension release. The following behaviors enhanced information exchange: listening, health education, summarizing patient statements, talking on the patient’s level, addressing patient problems of daily living/social function, and psychosocial counseling. Shared decision making between the doctor and patient was associated with improved health outcomes. Helpful nonverbal behaviors for physicians included leaning forward and directly facing the patient during the interview. Leaning backward and frequent touching of patient during the interview were behaviors associated with decreased levels of patient satisfaction. Further studies are needed to address the effects of physicians’ facial expressions, voice intonations, touch, and gestures on patient satisfaction and outcomes. Reviewer's Comments: Since doctors are almost always alone with patients during their interactions, physicians are often unaware of their verbal and nonverbal communication skills and shortcomings. This study provides useful guidance regarding specific learnable skills that can improve important patient outcomes. The challenge is for doctors to know which skills are needed, something that requires one to obtain critical feedback about communication skills in a timely fashion. One solution is to periodically video or audiotape one’s interactions with patients and then to review them with a trusted colleague. Though potentially awkward, doing so can be an eye-opening experience that can lead to important quality improvement in communication with patients. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Patient Relations, Verbal Cues, Nonverbal Cues

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Watch Your Words -- Conflict Common With Patients

An Anatomy of Conflicts in Primary Care Encounters: A Multi-Method Study.

Weingarten MA, Guttman N, et al:

Fam Pract 2010; 27 (February): 93-100

Approximately 40% of doctor-patient encounters result in conflict. In Israel, physicians found it most difficult to show empathy to patients during resource-related conflicts.

Background: Doctor-patient conflicts are common and can disrupt effective communication and care. In Israel, where this study takes place, conflicts often arise between doctors and patients around the issue of health care rationing. Objective: To determine various causes and associated outcomes of doctor-patient conflicts so that educational interventions may be developed for physicians. Design: Multi-method, multistage study of general practitioners in Israel. Methods: Physician focus groups (56 physicians in 7 focus groups) were organized to gather data on physicians’ perspectives regarding doctor-patient conflicts. These data were used to build a model for analyzing responses to conflict. In addition, videotaped sessions of 251 doctor-patient interactions were used to gather data on actual doctor-patient communications. These sessions allowed development of 40 different categories of conflict. Results: Of 291 videotaped doctor-patient interactions, 113 (40%) contained elements of conflict. The 3 main causes of these conflicts included (1) concerns about medical management of the presenting problem, (2) concerns regarding management of background health issues, and (3) concerns regarding bureaucratic issues, such as authorizations. Physicians tended to show less empathy toward the patient when the conflict was caused by disagreements about health care rationing and resources. Physicians tended to dominate conversations in all doctor-patient encounters, regardless of the nature of the conflict. Female doctors were less likely to be involved in a conflicted interaction with a male patient. Previous studies have established that the doctor-patient medical encounter involves 5 stages: opening and agenda setting, history taking, physical examination, counseling, and closing. Generally, history taking and counseling make up the largest segment of these encounters. However, in conflicted encounters, counseling was the largest part of the visit. In addition, during conflicted medical encounters, discussion around the conflict-related topic took a disproportionate amount of time. Conclusions: Approximately 40% of doctor-patient encounters result in conflict. During conflicted medical encounters, a disproportionate amount of time is devoted to the conflict-related topic, thereby limiting therapeutic elements of the interaction. Physicians appear to find it most difficult to show empathy to patients during resource-related conflicts. Reviewer's Comments: Conflicts between doctors and patients are both common and distracting. An effective way to address conflicts is to attend to the relationship. While potentially more time-consuming in the short term, it establishes trust and results in a more therapeutic (and less conflicted) interaction in the long term. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Patient Relations, Conflicts, Causes, Outcomes

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Many Sources for Conflict of Interest in Medicine

Definitions and Various Sources of Conflict of Interest.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

Not every financial conflict of interest in medicine is industry-related. For example, fee-for-service for medical practitioners is an example of a financial conflict of interest that is not related to the pharmaceutical industry.

“Conflict of interest” has many definitions. One helpful definition formulated by Dennis Thompson was recently used by the Institute of Medicine in a 2009 report on conflicts of interest. He defined a conflict of interest as a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. To simplify this, think in the context of a patient’s care in which a primary interest would be the interest of the patient, the patient’s health, or even public health, but the secondary interest would be related to the pharmaceutical industry. For example, if a physician has interactions with the pharmaceutical industry, he or she may feel some obligations of reciprocity that might be at odds with the primary interest (to care for patient’s health). Sources of Conflict of Interest: There are several sources of conflict of interest. Some conflicts of interest are financial, while some are not. An example of a conflict that is not financial is that of an academic or biomedical researcher who has invested a significant part of his or her career pursuing a research agenda. His or her reputation may turn on the success of studies that build on an earlier body of work and support that research agenda. Clearly, such a researcher may have a conflict of interest because, on the one hand, the primary interest of a researcher should be the integrity of science and the pursuit of truth, yet the reputational investment in the research project may be at odds with that primary interest. In other words, some data may be unfavorable to the research agenda and the reputation of the researcher who is dependent on that agenda, so there is tension. Financial Conflicts of Interest: Not every financial conflict of interest is necessarily industry-related. For example, fee-for-service for medical practitioners is an example of a financial conflict of interest that is not related to the pharmaceutical industry. One of the reasons why we become very concerned about industry-related conflicts of interest is because of their increasingly pervasive nature and their systemic effects. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest, Definition, Sources

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Is Industry Funding of CME Events Truly Unavoidable?

Avoidable and Unavoidable Conflicts of Interest in Medicine.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

For academic medical centers in the United States, >50% of all continuing medical education (CME) events are underwritten by the pharmaceutical industry. However, in Canada, industry funds only 14% of CME events at academic medical centers.

In medicine, conflicts of interest are everywhere. Sometimes they are unavoidable. Even when they are avoidable, these conflicts of interest continue to be ubiquitous. As physicians, we have a conflict of interest between our desires to spend more time with our families and our patients’ needs and desires to have more time with us. The physician who is in the room with her patient but wants to rush home because it is her 5-year-old’s birthday party is facing a conflict. This is an inevitable type of conflict of interest. The question becomes, when is a conflict of interest morally problematic -- when do we and when don’t we need to be concerned about a particular conflict of interest? Avoidable Conflicts of Interest: Some conflicts are avoidable, but we have come to accept them because they are so pervasive. We are challenged to identify these avoidable conflicts of interest and get rid of them. Unavoidable Conflicts of Interest: Some conflicts of interest are unavoidable. Nonetheless, we need to identify them and do a better job of managing them. A good example of what seemed to be an unavoidable conflict of interest, until very recently, has been industry funding of continuing medical education (CME). For academic medical centers in the United States, >50% of all CME events are underwritten by the pharmaceutical industry. Therefore, it is tempting to say that this conflict of interest is simply unavoidable -- we need industry funding for CME events for health professionals. However, in Canada, only 14% of CME events at academic medical centers are funded by industry. If you look outside the profession of medicine to other professions, you will find many other examples of continuing professional education that do not rely on funding from a source that creates conflict of interest. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflict of Interest

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Sense of Reciprocity Activated by Free Gifts

Industry Influences May Be Subtle -- The Psychology of Reciprocity: Part 1.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

An increasing body of social science data shows that subtle forms of industry interaction play against our sense of reciprocity. Receipt of small gifts with company logos subtly influences the clinical judgment of health professionals.

(Card 1 of 3) We have learned a lot in the last several decades about the nature of conflict-of-interest problems in which industry interacts with physicians. This problem is actually about how good people can be led astray, despite their best intentions. Cognitive and behavioral psychologists have told us that all sorts of subtle influences arise from our interactions with industry of which we may not necessarily be aware. These kinds of influences operate at a very subtle level and unwittingly exploit characteristics that we normally value in people. For example, I sent you a draft paper of mine and asked for your comments. You commented in great detail, and sent it back to me within 24 hours. The following month, you asked me to look at one of your papers. Instead of sending this back to you quickly, I hold it for 3 months, and despite your repeated requests to provide comment, I never respond. In this case, there has been a failure of reciprocity. I have not reciprocated your excellent behavior as a scholarly colleague. Psychology of Reciprocity: Reciprocity is a positive trait that we, as physicians, look for in our colleagues in medical practice, in our partners, and in our friends. Reciprocity is something we value in terms of building relationships. However, reciprocity can be a serious problem if it impairs the judgment of a health professional in the conduct of medical practice or medical research. An increasing body of social science data shows that there are subtle forms of influence that play against our sense of reciprocity. Therefore, receipt of small gifts with company logos, such as mugs, pens, and pencils, start to subtly exercise their influence on the clinical judgment of health professionals. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest

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Little Gifts Have Big Impacts on Physicians

Industry Influences May Be Subtle -- The Psychology of Reciprocity: Part 2.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

Even small gifts of very limited value can have a major impact on people’s cognitive assessment. The emerging body of social science data says that small gifts have a major impact on physician’s professional judgments.

(Card 2 of 3) Although professional conferences underwritten by a pharmaceutical company are not equivalent to the small gift of a pen with the company’s logo or a pizza lunch, the hazards of subtle influence and reciprocity arise from each. As physicians, we may be most acutely aware of these obligations in relation to an all-expenses-paid junket to some exotic location, but we may not be aware of subtle forms of influence that arise from small gifts. Even little things like a pen with the company’s logo or a pizza lunch actually affect people’s clinical judgments. Empirical data from social science studies demonstrate that even these interactions have an effect on practitioners’ decision making and professional judgment. Subtle Influence of Free Lunches: For example, 1 study looked at free lunches sponsored by drug companies. In many cases, these lunches affected physicians’ prescribing habits, even though they could not remember attending the lunch. All these interactions create different varieties of the same problem -- the often subtle and undetected obligations of reciprocity and influence. When you ask physicians whether they are impacted by these small interactions, most say they are not. Then, they will go on to say that they worry that their colleagues are indeed influenced. Self-Serving Bias: Cognitive and behavioral psychologists tell us that these responses are an example of self-serving bias. Self-serving bias is something that all human beings have -- we all identify and process information in a way that serves our own interests. This is why these interactions are particularly problematic. Subtle Influence of “Having”: There are some wonderful experiments in which the people on 1 side of a room receive free mugs, and those on the other side receive free pens. Next, the people are asked who would be willing to swap their mugs or their pens. Remember, neither group had either of these items for longer than 10 minutes. However, the process of possessing these items for 5 or 10 minutes causes people to endow them with special values that they would not have anticipated otherwise. Therefore, even tiny items of very limited value can have a major impact on people’s cognitive assessment. We should take into account this emerging body of social science data that says small gifts really have a major impact. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest

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Industry Interactions Alter Prescribing Habits of Docs

Industry Influences May Be Subtle -- The Psychology of Reciprocity: Part 3.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

The data from a number of empirical studies clearly demonstrate that interactions with industry representatives (including receiving free samples, etc) drastically alter prescribing habits of physicians, even when they do not recall the interaction.

(Card 3 of 3) Subtle Influence of Industry Logos: A group of experimental subjects were told that a fictitious company was sponsoring a study in which they would be participating. Subjects were then asked to rate works of art from –5 (dislike) to +5 (like very much). They rated a number of images of famous paintings that were flashed before them. Randomly, the logo of the fictitious corporation said to be sponsoring this experiment was flashed alongside these pictures as experimental subjects evaluated them. What happened? The valuations accorded to pictures with randomly assigned logos were higher than those without the logo. In other words, just being told that the experiment was being funded by a company caused people to alter their esthetic judgment. Now, obviously, that was not intentional on the part of any experimental subjects, but nonetheless, the effect was real. Effects of Industry Interactions on Physicians: Looking at medical practice and medical care directly, the data from a number of empirical studies clearly demonstrate that interactions with industry representatives (including receiving free samples, etc) drastically alter prescribing habits of physicians, even when they do not recall the interaction. As a result of industry interactions, physicians tend to prescribe newer and more expensive patented drugs. The reality with many of these drugs is that the side effect profile is not as well known, so the drugs are not only expensive but they also impose increased hazards on the patient. Recently, the Food and Drug Administration reviewed all of its new drug approvals over a course of 7 to 10 years. They determined that about 83% of these drugs offered no significant improvement over existing therapies. As a result, the trend revealed by several studies is that physicians are often being led to prescribe more expensive patented drugs with less known side effect profiles and not necessarily an enhanced benefit over existing cheaper therapies provided by generic drugs. If this is true, then physicians have reasons to worry about those interactions with industry. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest

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Study Design Can Be Tweaked to Improve Outcomes

Outcomes More Favorable for Industry-Sponsored Research.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

So that funding will continue, researchers may desire to provide outcomes that are favorable to their sponsors. They do not falsify or fabricate results, but they may look carefully at the study’s design and presentation of results.

Empirical studies show that industry-funded research tends to produce outcomes that are many, many times more favorable than those produced by non–industry-funded research. The mechanism behind this finding is very fascinating, and further empirical studies are needed to fully define it. However, there are a number of potential explanations for why industry-funded studies may provide more favorable outcomes for industry sponsors. Methodology: One explanation is that the methodology leads to these kinds of favorable results. For example, if you are looking to demonstrate the comparative efficacy of a new drug, then you might overdose the new drug just a touch, and underdose the competitor drug. On the other hand, if you are looking at side effects, you might underdose the new drug so that the side effects are not so drastic. Therefore, some studies need to explore methodological reasons for favorable outcomes in industry-sponsored research. Funding Needs: Another possible explanation for these favorable outcomes is that the researcher has had a long-term relationship with a pharmaceutical company. Therefore, the researcher may desire to provide an end result that is favorable to the sponsor so that funding will continue. This does not mean that researchers necessarily take the treacherous route of falsification or fabrication, but there are gray areas and complicated decisions to be taken in relation to both the design of the study and the presentation of the results. For cases in which the results are “close calls,” it may be that, as a result of these subtle obligations, researchers are making choices that are favorable to industry sponsors. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest, Research

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Evidence Makes the Case -- Time to Limit Industry Interactions

Evidence Overwhelming for Need to Regulate Physician-Industry Interactions.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

There is a huge body of empirical data regarding the negative impact of industry interactions with physicians in medical care. Although not everyone agrees, we now need to limit the physician’s interactions with industry.

Conflict of interest is a very important topic in medicine. Studies have shown that even small gifts from industry influence professional decisions made by physicians. When do we decide that we have enough information regarding these negative effects that we should proceed with regulating the physician’s interaction with industry? In my opinion, there is a huge body of empirical data at a number of levels regarding the impact of industry interactions with physicians in medical care. These data come from studies looking directly at the behavior of physicians in medical practice coupled with other laboratory studies abstracted from medical practice. I think these studies overwhelmingly make the case for the need to regulate the physician’s interactions with industry. Not everyone endorses this position; some dispute the extent of this evidence. In my view, we are at the stage where we need to start addressing the problem. Indeed, bodies like the American Association of Medical Colleges and the Institute of Medicine have reached the same conclusion. Possible Regulatory Measures: In many cases, institutions and a number of academic medical centers have adopted conflict-of-interest policies. For example, they recognize problems that a gift from industry may cause and have eliminated or prohibited these gifts. There are other areas where there is still much debate, such as in the area of continuing medical education. When an Institute of Medicine committee met last year to discuss its report on conflicts of interest, they recognized that the funding of continuing medical education in the United States was a problem. They recognized that it should not continue being so vastly underwritten by industry, because, when industry funds medical education, the primary purpose for them is marketing. So the Institute of Medicine has rightly said that something needs to be done to change the practice, but they could not agree on precisely what should be done. Therefore, they suggested that a deliberative process be initiated and that another committee take up this issue and reach a conclusion within 24 months of the publication of their report last year. Changes in Ethical Standards: I see that ethical standards are evolving. I believe it is pretty clear that some behaviors, which would have been considered ethical 10 or 20 years ago, are now no longer considered ethical, such as the receipt of out-and-out gifts. Other behaviors are in a state of flux, but I think we are going to see new ethical norms evolving over time. An example of this is the problem of industry funding of continuing medical education. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest, Regulations

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Positive Incentives May Reduce Industry Sponsorships

The Carrot and the Stick -- Limiting Physician-Industry Interactions: Part 1.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

Industry funding of continuing medical education (CME) might decrease if active participation in providing CME is an additional factor assessed during promotion and tenure considerations at academic medical centers.

(Card 1 of 2) Conflict of interest is a very big topic in the medical world. For academic medical centers in the United States, >50% of all continuing medical education (CME) events are underwritten by the pharmaceutical industry. Once thought to be an unavoidable conflict of interest, this topic of managing continuing education without the intervention of industry is now being strongly discussed. This is a concern for academic medical centers and for private practitioners. This problem is especially acute for physicians who are in small private practices in rural areas where their options for CME are rather limited. Alternate Sources: I would submit that, despite appearances, it is not hard to come up with alternate sources of CME without an industry sponsor. For example, lawyers find alternate ways of meeting their continuing legal education requirements. As a lawyer, points are awarded for providing educational segments for your colleagues and for attending lectures by your colleagues, all of which have been accredited for continuing professional education. In the legal world, the notion that continuing education is a professional responsibility is widely accepted. If your employer will not cover the expenses of continuing education, then it is part of your professional obligation to meet the cost of your own continuing education. This behavioral norm is still not uniformly accepted in the medical profession for historical and cultural reasons. Incentives: One way of creating policies to address conflict-of-interest issues is with a “carrot” and another way is with a “stick.” Many of the institutional policies with which I am familiar take the stick approach, which is to basically say, “Doctors you cannot do this (do not take gifts, do not do this, do not do that).” I suspect that this approach has the intended effect of disengaging physicians from industry. This is an area where there is lots of room for more work and improvement, because there are a number of carrots that one can use. CME Alternatives: I think that academic medical centers should take a “carrot” approach and encourage their people to actively provide CME programs without the support of industry. For example, positive assessments could be given for promotion and tenure requirements when an individual has dedicated some time and effort to delivering CME-accredited educational segments. In other words, promotion and tenure requirements should explicitly state that providing CME to your colleagues is an additional factor to be taken into account for promotion and tenure. If this was the case, then I believe people would be more willing to provide CME to their colleagues, and industry funding would become less necessary. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest, Regulating, Incentives

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Bye, Bye Industry -- Welcome Public Interest Medicine

The Carrot and the Stick -- Limiting Physician-Industry Interactions: Part 2.

Jonathan H. Marks, MA, BCL (Oxon)

Jonathan H. Marks, MA, BCL (Oxon) -Special Presentation

In medicine, to avoid conflicts of interest caused by industry sponsorships, we need to find ways of signaling and rewarding the practice of medicine and the conduct of medical research in the public interest.

(Card 2 of 2) Continuing Education Alternatives: I believe that free lunches sponsored by industry are something that we tend to overvalue as part of our continuing medical education (CME) experience. I believe that physicians lack the time rather than the money to buy lunch, in most cases. Therefore, why not have an internal CME event presented by a faculty member at an academic medical center. The lunch could be provided by the department either out of its internal budget or via reimbursement of the attendees, rather than relying on industry to provide it. Public Interest Medicine/Research: A larger and slightly more financially demanding topic is that of finding ways to change our professional norms. These days, we think that truly successful researchers are the ones who bring in tons of industry money. However, what if, borrowing from a legal model, we started right at the beginning and funded some of the brightest and best young people through medical school with public interest medicine fellowships -- the idea being that people who take this money to fund their way through the university would deliver at the other end by being public interest medicine practitioners. This would mean that they would be committed to not taking money from industry sources when they did medical research and that they would be committed, as practitioners, to providing greater amounts of care to people in their community who do not have access. In other words, we need to find ways of signaling and rewarding the practice of medicine and the conduct of medical research in the public interest. Special Accreditation: There is a whole host of creative possibilities for developing “carrots” to help change our professional norms. For example, institutions and health professionals could earn accreditation for their lack of dependence on industry funding, sort of like the accreditation system used to designate foods as being organic. Although accreditation schemes raise some very complicated questions about their design and operation, the idea of some third party accreditation might be a way of creating some incentives rather than just battering people with sticks. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Bioethics, Conflicts of Interest, Regulating, Incentives

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Disclosure May Not Counteract Conflicts of Interest

The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest.

Cain DM, Loewenstein G, Moore DA:

J Legal Studies 2005; 34 (January): 1-25

Research shows that people tend to be trusting of their doctors. Therefore, if a physician discloses some conflict of interest, the patient may assign more credibility, rather than less, to the doctor’s advice.

Background: Conflicts of interest are a concern for many professions. Many different solutions have been proposed and implemented to reduce problems associated with conflicts of interest, especially that of biased information and advice. Disclosure of conflicts of interest appears to be the common element in most of these proposed solutions. Research on Bias: When a researcher or physician discloses that he or she has a conflict of interest, this information should lead us to be less confident or trusting of data or information provided. However, this assumes that we know what to do with the disclosure information. Research shows that people tend to be trusting of their doctors. Therefore, if a physician discloses some conflict of interest, the patient may assign more credibility, rather than less, to the doctor’s advice. Even if we realize that we need to adjust for the disclosed conflict of interest, most of our adjustments are insufficient. Research has also shown that disclosing a conflict of interest reduces feelings of guilt, giving doctors or researchers moral license to bias their advice even more than they would have done without the disclosure. The Study: A laboratory study was performed by the authors. In this study, a person was assigned the task of estimating an unknown quantity of money in a jar (the “estimator”) and was paid for all accurate estimates. An advisor, who had more information than did the estimator, was assigned to the case. Three scenarios were set up: (1) the advisor was paid when the estimator made an accurate estimate, (2) the advisor was paid when the estimator guessed too high of a value, but this was not disclosed, and (3) the advisor was paid when the estimator guessed too high of a value, and this conflict of interest was disclosed. When the study was over, estimators earned less money and advisors made more money when conflicts of interest were disclosed. Therefore, disclosure benefitted providers of advice/information but not its recipients. Conclusions: Although disclosure may not always benefit providers of biased information and it may not always hurt recipients, the results of this report challenge the belief that disclosure is an effective remedy for conflicts of interest. Disclosing a conflict of interest to a patient does not necessarily protect that patient from the dangers posed by biased advice. The best way to counteract a conflict of interest is to eliminate it in the first place. Reviewer's Comments: Conflicts of interest in medicine are both inevitable and ubiquitous. The challenge for doctors is to: (1) know when they have a conflict of interest; (2) recognize whether the conflict is avoidable or not; and (3) avoid the conflict if possible and manage it if not possible to avoid. Disclosure has long been considered a primary way to manage conflicts of interest, but this study shows that disclosure might not be an effective remedy. If, as the study suggests, disclosure has the paradoxical effect of benefiting the individual with the conflict, alternative methods for managing conflicts of interest need to be considered. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Conflicts of Interest, Disclosure

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Free Samples Strongly Influence Prescribing Decisions

Do Drug Samples Influence Resident Prescribing Behavior? A Randomized Trial.

Adair RF, Holmgren LR:

Am J Med 2005; 118 (August): 881-884

Free drug samples do not necessarily help patients keep drug costs down because the resident physicians with access to these samples tend to prescribe the more expensive advertised drugs.

Background: When allowed, pharmaceutical companies make free drug samples readily available in residents’ clinics. Two commonly held beliefs are that free drug samples are not a form of marketing, and they help patients manage drug costs. How these free samples influence resident education and patient care is not known. Objective: To determine if prescribing decisions made by internal medicine residents are influenced by access to free drug samples. Design: Prospective randomized trial. Participants: All residents working in a primary care clinic affiliated with a teaching hospital in Minneapolis. Residents were not told about the true nature of the study. Methods: Residents were randomly assigned to 1 of 2 groups. The first group was allowed access to free drug samples. The second group agreed not to use free drug samples available in the clinic. Five drug-class pairs were monitored throughout the study. Resident prescribing practices were evaluated from July to December of 2003. Results: During the study, new drug therapies were initiated 390 times. Residents who had access to free drug samples were more likely to initiate treatment with advertised drugs than were residents without access to free samples. Access to free samples of NSAIDs, proton-pump inhibitors, and acid blockers was especially influential to the residents’ prescribing practices as they tended to prescribe inexpensive drugs significantly less than the more expensive advertised drugs. Conclusions: Access to free drug samples strongly influences the prescribing practices of resident physicians. Residents with access to free drug samples are more likely to prescribe heavily advertised (more expensive) drugs and are less likely to recommend over-the-counter drugs. Therefore, it appears that free drug samples serve as a form of marketing by the pharmaceutical companies that influence the practices of resident physicians. In addition, free drug samples do not necessarily help patients keep drug costs down because the resident physicians with access to these samples tend to prescribe the more expensive advertised drugs. Reviewer's Comments: Free drug samples are very popular among physicians and patients alike. However, one recent study found that well-off patients with health insurance are more likely to receive free prescription samples than are low-income uninsured patients. The study reported here suggests that free samples contribute to rising health care costs, because physicians with access to the samples tended to prescribe expensive medications rather than their generic counterparts. It would appear that free samples might not be so “free” after all. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Conflicts of Interest, Free Drug Samples, Influence on Prescribing Practices

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Meeting With Drug Reps -- Big Time Outlay for Little Gain

The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives.

Brody H:

Am Fam Med 2005; 3 (January/February): 82-86

Meeting with pharmaceutical representatives is a time-consuming practice for physicians that conflicts with the ethical goals of patient care and provides them with highly biased information.

In this opinion article, the author discusses ethical issues surrounding the practice of physicians interacting with pharmaceutical representatives (reps). Physicians’ Ethical Goals: Ethically, physicians have 2 primary duties. First, they must serve the interests of their patients while avoiding conflicts that divert them from this duty. Second, they must seek to be clinically competent, meaning that their practices must be based on well-grounded unbiased medical evidence. Pharmaceutical’s Goals: Pharmaceutical companies have a primary goal of increasing profits. One way to meet this goal is to influence the prescribing practices of physicians by persuading them to prescribe the most expensive drugs. It is not that pharmaceutical reps are acting inappropriately, but it is that their profit-based goals potentially conflict with the ethical goals of physicians. Doctor-Rep Interactions: Available evidence from literature reviews confirms that the frequency with which physicians have contact with pharmaceutical reps increases the likelihood that physicians will make prescribing decisions that are more favorable to the pharmaceutical industry and less favorable to the patient. For example, controlling hypertension is more likely when physicians have free choice of the drugs they prescribe than when physicians provide the patient with free drug samples from a pharmaceutical company. Even in the face of such evidence, physicians often believe that information provided by pharmaceutical reps is educational and unbiased. This tells us that physicians are not good judges of the influence being exerted on them by pharmaceutical companies. When meeting with pharmaceutical reps, physicians receive gifts, both large and small. Studies have shown that these gifts incite a sense of reciprocity, whether the physician is aware of it or not. Therefore, to meet physicians’ ethical goals, they should not accept gifts, either large or small, from pharmaceutical companies. In addition, studies show that information provided by pharmaceutical reps is biased in favor of the drug company’s product. The physician’s time would be better spent researching and reading unbiased and evidence-based data sources. Even if physicians elect to meet with pharmaceutical reps, they should dedicate time to double-checking the information provided. Conclusions: Meeting with pharmaceutical reps is a time-consuming practice for physicians that conflicts with their ethical goals of patient care and provides them with highly biased information. From a time-management perspective alone, the physician’s time would be better spent researching and reading unbiased and evidence-based data sources. Reviewer's Comments: While many physicians bristle at the suggestion that they can be influenced by the salesmanship practices of pharmaceutical representatives, research has shown that marketing works. If doctors are influenced by drug reps, the question is what to do about it. This article suggests that doctors should police themselves. If they fail in this role, history has shown that the profession is likely to be policed by others, via legislation and regulation. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Conflicts of Interest, Pharmaceutical Companies, Influence

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Clever Ideas Overcome Industry Influence

Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers.

Brennan TA, Rothman DJ, et al:

JAMA 2006; 295 (January 25): 429-433

To reduce conflicts of interest in academic medical centers, industry should not be permitted to underwrite continuing education events. However, they can deposit funds in a central repository that will be privately dispersed.

Background: Financial conflicts of interest create challenges for medical ethics, scientific integrity, and the avoidance of bias in decision making for physicians. Objective: To outline a series of guidelines to help academic medical centers deal with conflicts of interest involving gifts from pharmaceutical and device industries. Inappropriate Interactions: In medicine, a conflict of interest occurs when a situation is present that has the potential to undermine the doctor’s impartiality because of the possibility of a clash between the doctor’s self-interest and the patient’s best interest. In the context of doctor-industry relations, some interactions that have the potential to undermine neutrality include gifts, payment for attendance at lectures and conferences (includes online activities), free continuing medical education (CME), payment for participation in speakers’ bureaus, ghostwriting services, free drug samples, and grants for research projects. Myths: Two commonly held beliefs among physicians are that (1) small gifts do not significantly influence physician behavior and (2) disclosure of financial conflicts sufficiently protects patients’ interest. Compelling research by sociologists has shown that even small gifts provoke a sense of reciprocity in physicians, causing them to lose their objectivity. Other research has shown that interactions with pharmaceutical representatives or attending industry-sponsored seminars result in a significant change in prescribing practices by physicians. Disclosures of conflicts of interest are not effective because (1) the accuracy of these disclosures is uncertain, (2) people receiving the disclosure are not experienced enough to recognize the extent of bias in the information they receive, and (3) disclosures may mislead people regarding the extent of a physician-industry relationship. Recommendations: All gifts, free meals, and payments for participation in meetings or online CME seminars sponsored by drug and medical device companies should be prohibited for all physicians at academic medical centers. Free drug samples should be prohibited and replaced by a voucher system for low-income patients. All interactions with pharmaceutical representatives should be discontinued. Physicians with ties to drug or medical device companies should be excluded from hospital and medical group formulary committees and from committees overseeing purchases of medical devices. CME events that are underwritten by industry should be prohibited, and a central repository should be created for funds from manufacturers wishing to support educational opportunities. These funds will be privately dispersed to approved programs, and the amount of funding by corporations should be posted on a publicly available Web site. The authors provide many other recommendations to help academic medical centers safeguard against market-driven conflicts of interest. Reviewer's Comments: This groundbreaking article has greatly influenced academic medical centers (AMCs) across the country. Since its publication, many of the leading AMCs have developed new policies that prohibit or regulate interactions between physicians and industry. While aimed at AMCs, the principles also apply to other forms of medical practices, and physicians should be aware of implications for their own work. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Conflicts of Interest, Academic Medical Centers, Limiting Industry’s Influence

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Behavioral Economics Anticipates Irrational Decisions

Introduction to Behavioral Economics: Part 1.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

Behavioral economics is very relevant to medical practice because we must worry about whether informed consent is achieving its goal when patients do not make decisions that maximize their best interests.

(Card 1 of 2) Behavioral economics is the overlap of psychology and economics -- applying insights from psychology to questions more traditionally answered by economists. This field grew out of the awareness that traditional economic theory relies too much on the idea that people are rational decision makers. Most economic models used by economists in government or academia start by assuming that people are rational decision makers and then predict what will happen from there. Behavioral economics is an area of research that says, “People are not completely rational all the time. If you really want to know how they’re going to behave, you need to account a fuller idea of what human nature really means and how people really behave.” Relevance to Health Care: Informed consent works best when a patient is given comprehensible information about their treatment alternatives, understands this, and has freedom to choose which treatment maximizes his or her best interests. In other words, if a patient gets information and makes a rational decision, we are on our way to having good informed consent. Therefore, behavioral economics is very relevant to medical practice because we must worry about whether informed consent is achieving its goal when patients cannot or do not behave rationally -- when they do not make decisions that maximize their best interests. Decision Making: To make good decisions in life, you first need to make predictions. For example, to decide if you are going to live in California or Michigan, you first must decide where you would be happier. Will a warmer climate in California bring you happiness compared to the cold winters in Michigan? Research has shown that climate has very little effect on people’s overall well-being. Knowing this, then someone who is making the decision on where to live based on climate might not be making a good decision. The same goes for medicine. For example, I had a patient once with severe ulcerative colitis (UC) who had daily cramps and bloody diarrhea despite being on maximum medical therapy. UC can be cured by removing the colon, but the surgery requires that the patient be hooked up permanently to a colostomy bag. I talked to this gentleman and said, “Medicines aren’t really doing the job anymore. Would you consider having a colostomy? I’m a primary care doctor and don’t do these surgeries, but I wondered if you wanted to talk to a surgeon.” He answered, “No way. I’d be miserable if I had a colostomy.” However, research on people who have colostomies shows they are basically as happy as people who are healthy, and they quickly adapt emotionally to having a colostomy. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Decision Making

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Do Not Assume -- Know Research on Patient Outcomes

Introduction to Behavioral Economics: Part 2.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

Unlike a patient facing a decision for the first time, the doctor is probably already experienced with the situation. Before proceeding, physicians must be familiar with general patient satisfaction for various treatment options.

(Card 2 of 2) My patient was miserable with diarrhea and yet he could not believe that he would be happy if he had a colostomy. Unlike patients such as this who are unfamiliar with certain conditions or outcomes, many doctors have seen the same situation hundreds of times. Therefore, the doctor may have a better sense of what the treatment outcome will likely be, compared to the patient. Then, as clinicians, what is our job? I would say that job one is to find out how confident we are that we really do know more than the patient about a given topic. Sometimes we physicians make mistakes, too. We assume that people with certain health conditions are miserable or happy, but we have not looked at data -- we have not dug in to find out the truth. We might actually be making assumptions about our own patients without evidence to back it up. In the case of my patient with ulcerative colitis, I knew the literature on colostomy. I knew this man was probably wrong to expect that he would be miserable if he had a colostomy. One option I had was to give him information about most colostomy patients being quite happy and quickly adapting to the colostomy bag. This is what informed consent would have had me do. However, my patient was not persuaded by the information. So what else could I do as a clinician? I was not going to coerce the patient. In this case, I told the patient, “Next time you’re seeing the gastroenterologist, why don’t you talk to some colostomy patients and find out what their actual experiences are? See if you can learn from their experience.” As it turned out, the patient returned a couple months later, and he had learned that these other patients thought a colostomy was not nearly as bad as they had originally anticipated. Nonetheless, he still refused the surgery, believing that the information he had gathered did not apply to him. At that point, my job as a clinician was done. I could not force him to have surgery. I could continue to talk to him on follow-up visits, but to bring it up every time would threaten other parts of our relationship. I believed he had made an informed decision -- even if it was the wrong decision, it was ultimately his decision to make. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics

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Are We Blind to What Controls Our Behaviors?

Who Is in Control? Forces at Play in Making Personal Choices.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

Many people hold individuals responsible for their health woes, especially those problems brought on by personal behaviors. However, many behaviors are influenced by forces beyond people’s awareness.

Generally, people in the United States tend to think of themselves as free agents. They get to make choices, they reap the benefits when things go well, and they suffer the consequences when things go badly. We tend to apply this to both financial matters and our health. Many people would hold individuals personally responsible for their health woes, especially when the woes are brought on by personal behaviors. If someone smokes, drinks excessively, or engages in risky behaviors that lead to an illness or disability, then some folks would say, “You know, it’s your fault, so it’s your problem. You brought this on by your behavior. It’s not our problem, it’s your problem.” This reasoning is only partially correct. I just finished a month of taking care of general medicine patients in the hospital. About two thirds of patients I saw had illnesses that could be blamed at least partly on behaviors: smoking, drinking, drugs, overeating, lack of exercise, etc. With that said, we must ask what percentage of people’s behavior is their fault? I am not God, so I cannot answer that question from that perspective. However, I can say that research in behavioral economics has shown many ways in which these kinds of behaviors are not conscious decisions and are influenced by forces beyond people’s awareness, and even sometimes beyond their complete control. Of course, some would say, “If somebody lights up a cigarette and sticks it in their mouth, then that’s their choice. Nobody’s got a gun to their head and tells them they have to smoke.” In answer to this charge, it is true that the individual has the best ability to stop the behavior if anyone can. The question is how did that person get addicted to tobacco in the first place? Most people start smoking before adulthood, so they become addicted at a young age. Self-control centers of the brain are still developing, even in early adulthood. Before a person is a mature decision-making human being, we often have someone who is already addicted. If someone is already addicted at age 18 years, many people still say, “Look, they are in control. They need to quit.” Look at all the physiology that is lined up against them to make it hard to quit. Most clinicians have worked with many patients on weight loss, drinking abstinence, or smoking cessation, and we realize the difficulty of these tasks. While we embrace and rejoice when our patients are able to overcome these challenges, we recognize that the same challenges are beyond many people’s abilities. I am not sure what purpose it serves to completely blame these people for all their behaviors. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Informed Decision Making, Personal Choices, Influences

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Physician’s Role Is to Help, Not Judge Patients

Helping Patients With Behavior-Related Issues.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

As physicians, our role is to try to help patients with health issues, regardless of the cause. Rather than judging our patients, we need to understand their behaviors well enough to be able to influence them.

As physicians, people come to us for help with their health issues, and we have to help them to clean up the mess they may have made with bad lifestyle choices. We ask ourselves, “Just how much actual control do people have over their health? Is health entirely under the patient’s control, or does the patient virtually have no control?” Physician’s Role: I believe our role as physicians mainly is to promote our patients’ best interests -- not to judge them for their behaviors but to help them improve their behaviors. Only in rare circumstances does a behavior rule out treatment. For example, liver transplant surgeons know that someone who is actively drinking alcohol is not a candidate for a liver transplant. These patients need to show 6 months’ abstinence from alcohol. On the other hand, as a primary care physician, I am not going to refuse to give someone cholesterol medicine just because they keep eating too much. I would not say, “Once you exercise and stop eating, then I’ll give you a pill if your cholesterol is still high.” As physicians, our role is to try to help our patients. You want to understand their behaviors well enough to be able to influence them. Little Tricks, Big Results: Many of my patients have a hard time taking their medicines every day. Maybe they have a twice-a-day pill to treat their blood pressure. They come into my office and their blood pressure is still high. I look on the computer and notice they have not renewed their medicines for a while, so they are clearly not taking their pills every day. I could scold the patient for not taking the pills, but I do not believe this is a very effective approach. First, I usually try to make sure they understand why blood pressure pills are important. Then, I try to determine if they are having side effects from the pills that are discouraging them from being compliant. Next, I try to determine if they find the pills unaffordable. After having these discussions, I try to figure out how I can help them make taking their pills an effortless habit. Typically, I will ask them how often they brush their teeth, and they usually tell me twice a day. In these cases, I say, “Lay your toothbrush on top of the pill bottle. Twice a day when you lift that toothbrush to brush your teeth, you’ll be reminded to take your pills.” I am sure every clinician has little tricks like this to help their patients. These are just a few examples of the many things we can do to help our patients without judging their behaviors. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Lifestyle Issues, Health Care

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Outside Influences, Not Willpower Alone, Affect Obesity

Obesity Epidemic: Willpower Has Not Changed, but Outside Influences Have.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

Although more people are struggling with obesity than ever before, people are no weaker-willed than they were a couple of generations ago. Instead, many other things are influencing us to eat too much.

In the United States, given how quickly obesity rates have grown, it is clear that the cause of the obesity epidemic is not simply human nature, because human nature has not changed that much in the last few generations. If we are still evolving in Darwinian terms, we are evolving incredibly slowly. Therefore, many forces must be working together to cause the current obesity epidemic. I believe that a practicing clinician will find it useful (1) to get a better understanding of why patients are eating too much and (2) to help people to recognize that their eating behaviors are caused by more than a lack of willpower and choosing to eat too much. Lifestyle Influences: The workplace has changed: industrialized countries have much less physical labor than in the past. In addition, the food industry has changed dramatically: we now have delicious, affordable foods that are incredibly easy to prepare and clean up. The cost of calories, in terms of both time and money, has dropped significantly. Appetite Influences: Several unconscious forces influence our appetites. For example, I can influence you to increase your calorie consumption by 25% if I give you a large dinner plate rather than a small one. You will not consciously decide to eat more food, but instead, you will be influenced by the visual stimulation of this plate and what looks like the right amount of food to put on it and by your mother’s voice from your childhood memories telling you to clean your plate of all food. I can change the size of glass I offer you at dinner and change how much soda you put in it. Even unconsciously, the flavor of food changes for people based on whether they think the food is healthy or unhealthy. Signals that tell us a food is unhealthy will make that food taste better to us. The same exact food will not taste as good if it is described as being healthy. People are no weaker-willed than they were a couple of generations ago. Instead, many other things are influencing us to eat too much. Clinical Applications: In the clinic, I recommend that patients put away their large dinner plates and get out smaller plates. I also remind people that if they can see food, they are more likely to eat it without even deciding to eat it. Therefore, put food out of sight. Reorganize the kitchen so that certain foods are harder to reach, making it less likely to eat those foods without forethought. Resource: Ubel PA. Free Market Madness: Why Human Nature Is at Odds With Economics -- and Why It Matters. Boston, MA; Harvard Business School Press: 2009. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Informed Decision Making

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Listen Up -- Patient Values, Understanding Influence Decisions

Helping Direct Medical Decisions: Pay Attention to Choice of Words and Patient Values.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

To make good treatment recommendations, a physician must understand how a patient interprets the physician’s words and what the patient cares most about in life -- quality or quantity of life.

We, as physicians, can influence people in many ways. As clinicians, we have a tremendous amount of power, and we could convince most patients to do almost anything. Respecting patients’ autonomy is a good thing, and coercing people is not appropriate. The lines between coercion, manipulation, persuasion, and simply informing people are fuzzy, if not indistinguishable at points. As clinicians, we must live with some discomfort as to whether our persuasion has tipped over into coercion, etc. To help us do a better job, we must first understand patients. The more we understand what our patients care about and value, the more likely we are to help guide them toward the right decision. For example, a patient had lung cancer that had metastasized to the brain. He had undergone neurosurgery to remove 1 tumor in his brain but not another. He had lung surgery to remove 1 part of his lung tumor but not the rest. The tumor continued to grow despite radiation and chemotherapy, and then pneumonia developed. He was clearly dying. His doctors were still proposing more aggressive treatment. So I asked him, “What have the doctors told you about your chances?” He said, “They said they can’t cure me, but they can treat me.” Although that was true, it is the same thing we would say to someone with diabetes or someone with HIV infection who did not have AIDS -- people who could live for decades with their diseases. However, this man was clearly going to die within the next few months, no matter what was done. So I asked him what he thought his doctors meant, and he said, “I guess it means I have hope.” He looked at me, and that is when I had to explain to him what really was happening. When we physicians communicate with patients, we are trying to help them make decisions. We have to think what our words mean to them. When we tell someone, “We can’t cure this, but we can treat it,” we might be trying to say, “I was being honest. I told him he was going to die of cancer.” However, this man’s doctors never said he was going to die of cancer. So what he heard was, “I guess that means I have hope.” When we speak to our patients, we need to understand how they interpret our words. In addition, we must find out what they care most about in life -- quality or quantity of life. Without this information, it is difficult for us to make good treatment recommendations. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Doctor-Patient Conversations, Treatment Recommendations

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Good Converations Improve Patient Care

The Doctor-Patient Conversation as a Time-Effective Tool for Improving Patient Care.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

A good conversation can improve patient care by helping the physician understand what the patient values and by helping the physician understand just what the patient knows about their disease.

To make good treatment recommendations, we, as physicians, must understand how a patient interprets our words and what the patient cares most about in life -- quality or quantity of life. The more we understand about what our patients value, the more likely we are to help guide them toward the right medical decision. To elicit that information, I will sit down at the bedside and ask, “What do you understand about what’s going on with your health? What do you think is happening to you? For what are you hoping? What do you think is going to happen?” Just learning about their understanding of the disease is enormous. I also ask these questions in the clinic. For example, if someone comes in with high blood pressure, I will ask them, “What do you think high blood pressure is?” Many patients think high blood pressure is an emotion. Even among many of those who know that it is not an emotion, they may not realize that high blood pressure is essentially a risk factor, not a disease. Therefore, when I find out what they understand about the disease, then I can go on to better educate them. Once they understand the disease, then I can try to find out what matters to them. For example, if the patient is financially strapped and really hates taking pills, and if the risk of a heart attack or stroke in the next few years is really small whether the pills are taken or not, then the best decision might be that the patient go without the pills. However, I first have to learn about the patient’s financial situation and personal preferences before helping them make a sound decision. Time Constraints vs Patient Communications: Many clinicians wonder if this is a time-effective and reasonable way to practice medicine, given the very real time constraints in their practices. I believe it actually saves time when you practice medicine this way. No doubt, there are patients with whom the conversations last a long time, and our system does not reimburse very well for those conversations. And no doubt, there are just as many times, as you are ready to walk out of the room, the patient stops you and says, “Oh, and one more thing …” It is then that you realize you have not listened to them enough to find out what they care about, and you have to sit back down and talk about a problem you could have gotten to 10 minutes earlier. Even when we have all these conversations and do all these tests, you may find out that they are not taking their pills because they do not understand something. A good conversation can really improve care. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Doctor-Patient Conversations, Treatment Recommendations

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Docs Must Be Alert to Patient Perspectives

Patients Need Information, Time, and Understanding to Negotiate Medical Decisions.

Peter A. Ubel, MD

Peter A. Ubel, MD -Special Presentation

It is easy for physicians, who know so much more than do patients about a diagnosis, to forget what it is like to be a patient and receive what seems like bad news.

In the doctor-patient conversation, patients must be able to articulate their values and desires. However, patients facing diseases that are new to them do not know what to expect. For example, a patient who is newly diagnosed with diabetes does not know what the illness will be like. Or a patient needing a colostomy does not know what to expect regarding the colostomy bag. Because decisions people make before and after having experienced something may be very different, patients with an unfamiliar diagnosis will only be able to give their physicians partially-formed perspectives. Therefore, when we are dealing with patients who really do not know what a disease or disability is going to be like, we must ask them about what matters to them, what they care about, etc. Remember the Patient’s Perspective: We studied interactions between urologists and men with newly diagnosed prostate cancer. At the beginning, the urologist would tell the man he had cancer. Within a minute, the patient was receiving elaborate technical detail about the stage and grade of his cancer. Then, the doctor and patient would have a lengthy and often technical discussion of treatment options. A treatment decision was made within 20 minutes of the patient learning of his cancer. In this study, almost no time was allowed to acknowledge or manage the patient’s emotional response to the news that he had cancer. As we discussed this point with a group of clinicians, one urologist said, “Well, why do we have to take time to acknowledge their emotions? It’s not like we gave them bad news.” Here is the danger: when physicians know so much more than patients, we forget what it is like to be a patient. The urologist knew that diagnosis of early stage prostate cancer is not a big deal, perhaps no worse than diagnosing mild diabetes in an older man. However, when you tell a patient that he has cancer, you cannot expect him to feel like this is good news. We still need to know where our patients are coming from, how they are feeling, what questions they have, and what they are going through so that we can give good clinical advice and help them negotiate the news of their illness. Helpful Resources: To learn more about these types of issues, I have a Web site called www.peterubel.com, where I regularly write about these issues and give people kind of a different way of thinking about the world. (Reviewer-). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Informed Decision Making

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Risks, Options Determine Decision-Making Approach

A Typology of Shared Decision Making, Informed Consent, and Simple Consent.

Whitney SN, McGuire AL, McCullough LB:

Ann Intern Med 2004; 140 (January 6): 54-59

Informed consent is a useful decision-making process in situations with significant risk, while shared decision making applies when ≥2 treatment options exist, regardless of the risk.

The authors describe the importance and application of informed consent, simple consent, and shared decision making in doctor-patient interactions. These 3 measures are each designed to enhance the patient’s control over his or her medical care via a collaborative interaction with the physician. The process of shared decision making was developed from a patient ethics perspective, while informed consent was developed from a legal perspective. Informed Consent: Informed consent is a formal process in which doctors and patients must participate before certain institutions will permit the performance of a procedure. Legally, informed consent is meant to reduce a physician’s liability. However, the true intent of informed consent is for the doctor and patient to have a conversation (or a series of conversations) about the patient’s condition, proposed and alternative treatment choices, the option of non-treatment, and risks and benefits of each option. In the end, the physician and patient will have selected an intervention together. Legally, informed consent is required when an intervention (or failure to intervene) poses a significant risk of harm – a consideration of risk versus benefit. Therefore, when little or no risk exists, the decision-making process does not involve informed consent. Simple Consent: Simple consent is a decision-making process in which the patient either agrees or disagrees to a proposed plan of care. The patient’s permission to proceed with a treatment plan is explicit with informed consent and may be implicit with simple consent (agree to plan by filling prescription or altering diet according to doctor’s recommendations). Therefore, simple consent is a useful decision-making process for low-risk decisions. Shared Decision Making: This type of decision-making process occurs when real choice exists for treatment, and the physician and patient are actively involved in making the decision. This is a collaborative process. Appropriate Use of Each Process: Informed consent is needed for decisions that involve high risk and for which only 1 treatment choice exists. In these situations, informed consent may appear to be an educational process rather than a decision-making process. Simple consent is used in low-risk decisions, whether only 1 or several treatment options exist. Shared decision making should be applied when ≥2 reasonable treatment options exist, regardless of the risk (high vs low). If a high-risk decision has >1 reasonable treatment option, both informed consent and shared decision making should be applied, with a goal of making a choice that feels right to the patient. Reviewer's Comments: Informed consent and shared decision making are not simply legal processes but ethical and psychological ones as well. Mastering skills of eliciting informed consent and engaging in shared decision-making discussions are not easy. But to respect patient autonomy and help patients make decisions, we need to understand how to master these skills. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Informed Decision Making, Consent

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Cognitive Errors May Lead to Irrational Choices

Is Information Always a Good Thing? Helping Patients Make “Good” Decisions.

Ubel PA:

Med Care 2002; 40 (September): V39-V44

Patients often make cognitive errors during the medical decision-making process, and their choices appear irrational or inconsistent with their preferences. Patients can be confused by probabilities and overwhelmed by information.

When confronted with the need to make good health care decisions, patient preferences play a critical role. However, patients often make cognitive errors during the decision-making process, resulting in choices that appear irrational or inconsistent with their preferences. To help patients make sound decisions, decision aids have been developed to provide specific information (treatment options, survival rates, potential complications) relevant to different medical decisions. Nonetheless, many patients make cognitive errors during the decision-making process. Innumeracy (Poor Math Knowledge): When discussing treatment options, we typically discuss probabilities of certain outcomes, such as survival or complications. Studies have shown that people generally find probabilities and percents difficult to understand. Therefore, when outcomes are communicated in terms of probabilities and percents, many patients become confused and make what appear to be irrational choices. Too Many Options: Most people can select between 1 of 2 treatment options. However, when additional options are introduced, they may be unable to make a rational choice. Studies show that, when faced with 3 options, and selecting between the 2 best options is particularly difficult, patients will sometimes select the least preferable third option. Number of Side Effects: Sometimes patients are intimidated by the number of complications associated with a treatment option. Overwhelming patients with too much information about side effects associated with various treatment options can scare them away from the “best” option. Testimonials: Some patients want to hear from other patients who have had to make similar medical decisions. As a result, some patients become overwhelmed by the vividness of testimonials, or they may be influenced by the number of pro or con testimonials. Either way, irrational decisions may result. Recommendations: When multiple treatment options are available, we can help patients make more rational decisions by comparing various options as paired sets. Patients may be asked if they prefer option A over option B. Next, they are asked to compare options B and C and then to compare options A and C. Through the process of elimination of options in paired sets, patients can more rationally select between multiple options. Another approach is to lump treatment options into “surgical options” and “medical options.” Options in the surgical category can be discussed together, helping the patient to see which of the surgical options they would prefer. The same discussion can be had for the medical category. Then, by comparing the top choice from each category, the preferred choice can be determined. Reviewer's Comments: If doctors are to help patients make the best possible decisions about their health, it is important to understand common pitfalls in decision making that patients experience. This article provides useful information about how people actually decide, and suggests that more information isn’t necessarily better for patients. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Informed Decision Making, Cognitive Errors

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Burden of Decision Appears to Shift With Physician Recommendations

“What Should I Do, Doc?” Some Psychologic Benefits of Physician Recommendations.

Ubel PA:

Arch Intern Med 2002; 162 (May 13): 977-980

For certain high-stakes medical decisions, physician recommendations shift the psychology of the situation so that someone else appears to share in the responsibility of the decision along with the patient or family.

During the “good old days” of physician paternalism, physicians basically made all health care decisions for their patients without consideration for patient preferences. Today, patients still ask their physicians for recommendations in the medical decision-making process. The effect of patient-requested physician recommendations can influence the final decision, which makes many physicians uneasy. Commission vs Omission: Psychologists tell us that people, when looking forward (making decisions), are more fearful of the harms associated with doing something (“harms of commission”) than they are of the harms associated with not doing something (“harms of omission”). However, when looking back on their lives, people state greater regret for things not done (omissions) rather than for things done (commissions), regardless of the success or failure of the things done. People may fear harms of commission in the decision-making process because they do not want to be responsible for making a mistake with their decision. Gains vs Losses: In general, we tend to perceive losses on a larger scale than we perceive similarly sized gains. Therefore, people may have a harder time making a medical decision because they perceive harms of commission as losses. Medical decisions of omission may be easier to make because they view harms of omission as gains, not losses. Therefore, a patient’s medical decision can be subtly influenced by how a treatment option is represented to them -- as a loss versus a gain. Responsibility: An unwillingness to be responsible for high-stakes decisions also influences a patient’s or family’s ability to make medical decisions. Physician recommendations shift the psychology of the situation so that someone else appears to share in the responsibility of the decision. Therefore, certain high-stakes decisions should be framed as a recommendation rather than an open-ended question. For example, when discussing the decision for a do-not-resuscitate order for a family member, the physician can help the family by recommending that the patient not be resuscitated and then asking the family if they agree. Tips: In the case of cancer patients, physicians should consider delaying their recommendations until after having a long discussion of treatment options and patient preferences. Second opinions should be encouraged when the physician is concerned that his or her recommendation is being influenced by self interests or personal/professional biases. When making recommendations, physicians should remind patients that they may disagree and the physician will still be most willing to work with them. Reviewer's Comments: It has long been known that how we frame treatment options can greatly influence decisions that patients make. Patients need to understand their options and know that they have the right to choose among them, but this doesn’t abrogate the physician’s responsibility to use their professional expertise and judgment to advise patients and to provide considered recommendations. This article provides some interesting psychological underpinnings of why this matters in clinical practice. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Informed Decision Making, Physician Recommendations

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People Overestimate Effects of Disability on QOL

Do Nonpatients Underestimate the Quality of Life Associated With Chronic Health Conditions Because of a Focusing

Illusion?

Ubel PA, Loewenstein G, et al:

Med Decis Making 2001; 21 (May-June): 190-199

People who are unfamiliar with a particular chronic health condition tend to overestimate negative impacts that the condition will have on quality of life. The reason for this overestimation remains unknown.

Background: People who are unfamiliar with a particular chronic health condition tend to overestimate the negative impacts that the condition will have on quality of life (QOL). This is thought to occur because people focus on the parts of life that will be most affected by the illness rather than focusing on all aspects of a person’s life. As a result, when making a medical decision pertaining to a newly diagnosed chronic illness, people tend to overreact and make poor choices. Objective: To describe the results of 3 experiments investigating causes of overestimating the effects of chronic health conditions on QOL, and to determine if people can be helped to refocus their perceptions through exercises that look at the effects of the disability on all aspects of life. Methods: People were asked to give an overall estimate of QOL associated with paraplegia, below-knee amputation (BKA), or partial blindness in 1 eye (largely correctable with eyeglasses). Next, participants were given a defocusing exercise in which they were asked to look at various aspects of a person’s life and estimate how the condition would affect each of these domains. In 2 experiments, these domains included overall health, standard of living, work, love life, family life, social life, spiritual life, and leisure activities. In the third experiment, patients selected 5 life domains of their own choosing and estimated the effects on the condition on them. Finally, participants were asked to re-estimate how the disability would affect QOL after the defocusing session was completed. Results: Unexpectedly, final estimates varied widely, with some participants having unchanged QOL estimates, some having higher estimates (improved QOL), and some having decreased estimates (poorer QOL). Those who decreased their final estimates stated that the defocusing exercise made them think more seriously about consequences of the disability on all aspects of their lives. Conclusions: These authors could not prove that a focusing illusion affected people’s QOL estimates for unfamiliar chronic medical conditions. This could be interpreted as resulting from the fact that a focusing illusion does not influence the public’s QOL estimates for various chronic health conditions. An alternative interpretation is that the focusing illusion exists, but experiments in this study failed to identify the impact of the focusing illusion. Further studies are needed to help clarify this issue. Reviewer's Comments: One of the challenges that physicians face when trying to help patients make informed medical decisions is that patients often have inaccurate assumptions about what life would be like if they were ill. It is important to have effective strategies to counter such biases, but as this study shows, there is no “one size fits all” solution to this vexing problem. (Reviewer-Michael Green, MD, MS). © 2010, Oakstone Medical Publishing

Keywords: Behavioral Economics, Chronic Illness, Quality-of-Life Perceptions

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