Tom Valley is a fellow in the Division of Pulmonary and Critical Care Medicine in the Department of Internal Medicine at the University of Michigan. He received his undergraduate degrees in history and chemistry from Emory University, and his medical degree from the University of Miami. He completed his internal medicine residency at the University of Texas-Southwestern/Parkland Memorial Hospital, after which he served as Chief Medical Resident at UTSW/PMH. He joined the University of Michigan as a pulmonary and critical care fellow in 2013. He is currently a research mentee of Drs.
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In the January-February issue of IRB: Ethics & Human Research, Scott Y.H. Kim, Raymond de Vries, Renee Wilson, Sonali Parnami, Samuel Frank, Karl Kieburtz, and Robert G. Holloway present results of a study about the therapeutic orientation of research participants.
The authors examined the relationship between understanding and appreciation of randomization probabilities in 29 individuals recruited for a sham surgery controlled intervention study in Parkinson's disease. 83% provided the correct, quantitative answer to the understanding question; of those, one group (55%) answered the appreciation question correctly using quantitative terms, whereas the remaining group (45%) provided only qualitative comments.
The therapeutic orientation of research participants raises concerns about the adequacy of consent because such an orientation could cloud understanding of key elements of research. Further, even if participants understand (i.e., intellectually comprehend) elements of research, they may not appreciate them because they fail to apply such facts to themselves.
Study participants frequently made "unrealistic" probability statements, even while providing correct quantitative responses. Analysis showed that this apparent "irrationality" may in fact hide a deeper rationality -- namely, conversational rationality, which is part of the contextual nature of meaning conveyed in everyday language. Ignoring conversational rationality may lead to wrongly labeling research subjects as irrational. Click here for more information.
Michele Heisler, MD, MPA, is Professor of Internal Medicine at the University of Michigan Medical School, Professor, School of Public Health, and Research Scientist at the Ann Arbor VA's Center for Clinical Research Management. Dr. Heisler's clinical interest is chronic disease, with a focus on diabetes. Her research centers on patient self-management of chronic illnesses, patient-doctor relations and disparities in processes and outcomes in chronic illnesses.
What's the difference between opting in and opting out of an activity? Who decides if people will be put automatically into one category or another? Click this interactive decision to learn how default options work.
Imagine that you're a US Senator and that you serve on the Senate's Committee on Health, Education, Labor, and Pensions. The Infectious Diseases Society of America has come before your committee because they believe that too many health care workers are getting sick with influenza ("flu") each year and infecting others. As a result, your Senate committee is now considering a new bill that would require that all health care workers get annual influenza vaccinations ("flu shots") unless the worker specifically refuses this vaccination in writing.
Do you think you would support this bill for mandatory flu shots for health care workers?
Imagine that you're the human resources director at a mid-sized company that's initiating an employee retirement plan. Management is concerned that many employees are not saving enough for retirement. They're considering a policy that would automatically deduct retirement contributions from all employees' wages unless the employee fills out and submits a form requesting exemption from the automatic deductions.
Do you think a policy of automatic retirement deductions is reasonable for your company to follow?
Organ transplants save many lives each year, but there are always too many deserving patients and too few organs available. To try to improve the number of organs available for donation, the state legislature in your state is considering a new policy that all people who die under certain well-defined circumstances will have their organs donated to others. The system would start in three years, after an information campaign. People who do not want to have their organs donated would be given the opportunity to sign a refusal of organ donation when they renewed their drivers' licenses or state ID cards, which expire every three years. Citizens without either of these cards could also sign the refusal at any drivers' license office in the state. This is a policy similar to ones already in place in some European countries.
Does this seem like an appropriate policy to you?
How do your answers compare?
For many decisions in life, people encounter default options-that is, events or conditions that will be set in place if they don't actively choose an alternative. Some default options have clear benefits and are relatively straightforward to implement, such as having drug prescriptions default to "generic" unless the physician checks the "brand necessary" box. Others are more controversial, such as the automatic organ donation issue that you made a decision about.
Default options can strongly influence human behavior. For example, employees are much more likely to participate in a retirement plan if they're automatically enrolled (and must ask to be removed, or opt out) than if they must actively opt in to the plan. Researchers have found a number of reasons for this influence of default options, including people's aversion to change.
But default options can seem coercive also. So, an Institute of Medicine committee recently recommended against making organ donation automatic in the US. One reason was the committee's concern that Americans might not fully understand that they could opt out of donation or exactly how they could do so.
The policy scenarios presented to you here have been excerpted from a 2007 article in the New England Journal of Medicine titled "Harnessing the Power of Default Options to Improve Health Care," by Scott D. Halpern, MD, PhD, Peter A. Ubel, MD, and David A. Asch, MD, MBA. Dr. Ubel is the Director of the Center for Behavioral and Decision Sciences in Medicine.
This article provides guidance for policy-makers in setting default options, specifically in health care. Generally, default options in health care are intended to promote the use of interventions that improve care, reduce the use of interventions that put patients at risk, or serve broader societal agendas, such as cost containment.
In this NEJM article, the researchers argue that default options are often unavoidable-otherwise, how would an emergency-room physician decide on care for an uninsured patient? Many default options already exist but are hidden. Without either returning to an era of paternalism in medicine or adopting a laissez-faire approach, the authors present ways to use default options wisely but actively, based on clear findings in the medical literature.
Some examples of default policies that may improve health care quality:
- routine HIV testing of all patients unless they opt out.
- removal of urinary catheters in hospital patients after 72 hours unless a nurse or doctor documents why the catheter should be retained.
- routine ventilation of all newly intubated patients with lung-protective settings unless or until other settings are ordered.
Drs. Halpern, Ubel, and Asch conclude, "Enacting policy changes by manipulating default options carries no more risk than ignoring such options that were previously set passively, and it offers far greater opportunities for benefit."
Read the article:
Harnessing the power of default options to improve health care.
Halpern SD, Ubel PA, Asch DA. New England Journal of Medicine 2007;357:1340-1344.
Click to decide between death and living with a colostomy. Which would you choose? Are you sure?
Given the choice, would you choose immediate death,or living with a colostomy (where part of your bowel is removed and you have bowel movements into a plastic pouch attached to your belly)?
- Immediate Death
Think about what it would be like if you were diagnosed with colon cancer. You are given the option of choosing between two surgical treatments.The first is a surgery that could result in serious complications and the second has no chance of complications but has a higher mortality rate.
|Possible outcome||Surgery 1
|Cure without complication||80%||80%|
|Cure with colostomy||1%|
|Cure with chronic diarrhea||1%|
|Cure with intermittent bowel obstruction||1%|
|Cure with wound infection||1%|
|No cure (death)||16%||20%|
If you had the type of colon cancer described above, which surgery do you think you would choose?
- Surgery 1
- Surgery 2
How do your answers compare?
Are you saying what you really mean?
CBDSM investigators Brian Zikmund-Fisher, Angela Fagerlin, Peter Ubel, teamed up with Jennifer Amsterlaw, to see if they could reduce the number of people choosing the surgery with the higher rate of death and therefore reducing the discrepancy. A large body of past research has shown that people are notoriously averse to uncertainty. The investigators had a hunch that uncertainty could account for some of the discrepancy. Surgery 1 has a greater number of ambiguous outcomes, perhaps causing people to be averse to it. In an effort to minimize this uncertainty, the investigators laid out a series of scenarios outlining different circumstances and presentations of the two surgeries. For example the research presented some of the participants with a reframing of the surgery information, such as:
|Possible outcome||Surgery 1
|Cured without complication||80%||80%|
|Cured, but with one of the following complications: colostomy, chronic diarrhea, intermittent bowl obstruction, or wound infection||4%|
|No cure (death)||16%||20%|
The investigators believed by grouping all of the complications together that people would be more apt to chose the surgery with the lower mortality rate, because seeing a single group of undesirable outcomes, versus a list, may decrease some of the ambiguity from previous research.
Although none of the manipulations significantly reduced the percentage of participants selecting Surgery 2, the versions that yielded the lowest preference for this surgery all grouped the risk of the four possible complications into a single category, as in the example shown above.
Why these findings are important
Over the past several decades there has been a push to give patients more information so they can make decisions that are consistent with their personal preferences. On the other hand there is a growing psychological literature revealing people's tendency to make choices that are in fact inconsistent with their own preferences; this is a dilemma. Because the present research suggests that the discrepancy between value and surgery choice is extremely resilient, much research still needs to be done in order to understand what underlies the discrepancy, with the goal of eliminating it.
The research reported in this decision of the month is currently in press. Please come back to this page in the near future for a link to the article.
Read the article:
Can avoidance of complications lead to biased healthcare decisions?
Amsterlaw J, Zikmund-Fisher BJ, Fagerlin A, Ubel PA. Judgment and Decision Making 2006;1(1):64-75.
Dr. Sandberg is a pediatric psychologist and clinical researcher. As a pediatric psychologist, he delivers psychoeducational and behavioral health services to persons with endocrine disorders and their families, in particular, conditions affecting linear growth or disorders of sex development (DSD), i.e., congenital conditions in which development of sex chromosomes, gonads or sex anatomy is atypical.
Consider this scenario:
Alfred woke up at 4 am on Sunday morning with pain in his left foot. That place where his new running shoes had rubbed a raw spot earlier in the week was getting worse. By 9 am, the foot was red and swollen, with a large oozing sore, and Alfred decided to go to the Emergency Room at his local hospital.
Late on Sunday afternoon, Alfred returned home from the ER. He crutched his way into the house and collapsed on the sofa. His teenage son quizzed him.
How do your answers compare?
- Emergency care that was given
- Post-ER care needs
- Symptoms that would require a return to the ER
Systematizing the Teaching of Medical Ethics in the Undergraduate Medical Years
Medical students at the University of Michigan encounter ethical issues throughout their four years of training. Some are obvious – decisions at the end of life, the allocation of scarce of medical resources, challenges to patient autonomy – others are less obvious – relationships between medical residents and medical students, problems with the “hidden curriculum,” and systemic discrimination in the provision of care. Our goal is to make students aware of the variety of ethical problems in medical care and to equip them to respond to these problems in a wise and responsible manner.
To that end, our curriculum efforts focus on extending the existing curriculum and on making the medical ethics curriculum for undergraduate medical students at UM more systematic and explicit. Because we want students to become well-versed in thinking through ethical dilemmas before they encounter them in their clinical work we weave ethics into the curriculum throughout the 4 years of their undergraduate training. We use the expertise of our CBSSM faculty to create novel curricular components that incorporate our empirical work in bioethics with our particular expertise in decision science.
Increasing Opportunities for Ethics Teaching in the Clerkship Years
We facilitate regular ethics discussions for medical students at the end of their required clinical rotations in Obstetrics and Gynecology (in the third year) and Emergency Medicine (in the fourth year). To facilitate these discussions, students prepare short essays on ethical dilemmas encountered in these clerkships. Students are given a summary of all the issues that came up that rotation, which is used as a starting point for a discussion facilitated by a clinical faculty member trained in ethics. In addition, the Internal Medicine subinternship (an option for fourth year students) includes an ethics discussion at the end of the rotation.
These discussions allow medical students to bring up concerns with ethical dilemmas in a safe environment, teach the students about approaches to ethics, and embed training in ethical decision-making in clinical practice. This is often the first time students learn about the role of the hospital ethics committee and how they can contact them if desired.
“That was unexpectedly awesome!"
-- Medical student after Ob/Gyn ethics discussion
Advanced Medical Therapeutics Ethics Module
All fourth year medical students are required to take an online Advanced Medical Therapeutics course. As part of the course, we created an ethics module that includes multiple cases that present ethical dilemmas. Each case includes pre-recorded videos of faculty discussing the ethical aspects of the case and interactive components requiring students to choose possible solutions to the problem, after which they receive explanations of the pros and cons of their choice.
Medical Ethics Path of Excellence
CBSSM faculty work closely with the medical school to strengthen the medical ethics curriculum for Michigan medical students. Our goal is to make students aware of the broad range of ethical challenges facing 21st century medicine – challenges in clinical care, medical research and the design of health care delivery. Most recently, a team of CBSSM faculty developed the Medical Ethics Pathway of Excellence, an opportunity for students to receive mentored training in ethics throughout their four years of medical school.
Overview of Medical Ethics Pathway to Excellence:
- Introduced in September 2013, the first 10 students were accepted in 2014. Twelve students joined in 2015.
- Students apply to the Ethics Path of Excellence at the end of February during their M1 year, and continue their studies through their M4 year. Students in the POE learn to:
- Identify ethical issues in the organization and delivery of health care
- Implement tools and strategies to address ethical issues
- Continue their professional education and development of the skills required for leadership
- Before applying to the Ethics Path of Excellence, students have the opportunity to attend fourteen interactive lunchtime lectures that review various aspects of ethics in a healthcare setting. Applicants must attend a minimum of five of these lectures.
- Students who want to serve on ethics committees and/or include ethics as part of an academic career are provided with specialized training.
- All students participate in an individualized, independent study, culminating in a capstone project in the M4 year. Often this work includes field work at CBSSM.
Beginning in 2015, the Path of Excellence has been responsible for administering the core ethics curriculum for all of the M1 students. The Ethics Path of Excellence will continue to be a co-curricular activity until 2017 when all students will be required to choose one of the paths offered in the medical school.
“We really want to educate people to be the ethics committee consultants of the future. I think it's pretty unique to have the option of pursuing this extracurricular program because essentially it teaches you leadership skills and how to be a self-directed learner. These are skills you'll really need when you become faculty. Students can take their interest in ethics and pursue it further.”
Lauren Smith, M.D., Associate Professor of Pathology
Lauren Smith is the Director of the Path of Excellence. Andrew Barnosky, Christian Vercler, Ed Goldman, Kathryn Moseley, Janice Firn, Sacha Montas, and Raymond De Vries are core faculty members.
Start Seeing Ethics Lunch Discussions
As part of the Medical Ethics Path of Excellence, we offer lunch time discussions of cutting-edge topics in ethics. The content of these discussions includes topics such as conscientious objection, mandatory vs. optional vaccinations, patient centered care and shared decision making. We have also used these discussions to hold mock ethics committee meetings with discussion of a specific case. Facilitators provide a relaxed atmosphere in which students can feel comfortable asking questions and voicing opinions.
"It is exciting to see medical students engage with the ethical issues that arise in the clinic and the classroom. With encouragement from us they are beginning to see that there is more to medical ethics than just the well-known issues at the beginning and end of life. While these ethical issues are important, there are also moral consequences associated with the mundane aspects of being a student and working with patients." Raymond De Vries, PhD, Director, Ethics Education Initiative