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Michael Poulin,PhD, has joined the faculty at the University at Buffalo, State University of New York (SUNY) as an AssistantProfessor of Psychology. Dr. Poulin was a post-doctoral fellow at CBSSM for twoyears, under the mentorship of StephanieBrown, PhD. During this time he was anactive member of the CBSSM research community and a delightful colleague. Dr. Poulin's research focuses on the effects of stress on health and well-being, especiallythe ways people cope with stressful events. He examines how people's beliefsabout the world, including religious beliefs and beliefs about thetrustworthiness of others, influence adjustment to stress.
Imagine that you are concerned about your risk for heart disease. You look on the Web and find a risk calculator for heart disease.
The calculator asks you some questions about your health and uses your answers to estimate how likely you are to develop certain diseases. The health questions include things like age, gender, weight, height, whether you are a smoker, and whether you have diabetes or high blood pressure.
Imagine that you have answered all the health questions.
The Center for Bioethics and Social Sciences in Medicine (CBSSM) is supported by the University of Michigan Medical School Dean's Office, the Office of Clinical Affairs, and the Department of Internal Medicine. CBSSM is directed by Dr. Reshma Jagsi, MD, DPhil. CBSSM was established in July 2010 at the University of Michigan Medical School through the merger of the Bioethics Program with the Center for Behavioral and Decision Sciences in Medicine (CBDSM).
The mission of CBSSM is to be the premier intellectual gathering place of clinicians, social scientists, bioethicists, and all others interested in improving individual and societal health through scholarship and service.
CBSSM is a multidisciplinary unit integrating bioethics with key social science disciplines. CBSSM acts as a "home" for anyone interested in applying empirical social science methods to improve health. The primary research interests of CBSSM faculty focus on five overarching themes:
- Clinical and research ethics
- Health communication and decision-making
- Medicine and society
- Health, justice and community
- Genomics, health and society
CBSSM attracts scholars from across departmental and disciplinary boundaries and in so doing, provides fertile ground for new synergies. Our team includes:
- Social and cognitive psychologists
- Behavioral economists
- Clinicians from many specialties
- Decision scientists
- Survey methodologists
- Public health researchers
Currently, CBSSM is housed in the North Campus Research Complex in Ann Arbor. Faculty investigators, project managers, and research associates are supported by a core administrative and financial staff. CBSSM gives considerable attention to training the next generation of interdisciplinary scholars, offering support to junior investigators who can collaborate with seasoned researchers in an umbrella organization.
Find out about some experimental treatments for Parkinson's Disease. And then decide how you'd respond if you had a chance to participate in this research. In this interactive decision, we’re going to ask you about some experimental treatments for Parkinson’s Disease.
What is Parkinson’s Disease?
Up to 1 million Americans are currently diagnosed with Parkinson’s Disease, a brain disease that gradually worsens over many years and causes tremors, stiffness, slowness of movement, and balance problems. Some people with Parkinson’s Disease also experience changes in memory, concentration, and mood.
The average age at onset of symptoms is 65, but 5% to 10% have onset before the age of 45. The symptoms are caused by the death of cells in the brain that make a chemical called dopamine. Medications that are available to treat Parkinson’s Disease provide more dopamine to the brain or mimic the action of dopamine in the brain. In early stages of Parkinson’s Disease, symptoms generally respond well to medications. Over time, the medications become less effective and may cause more side effects.
What treatments are researchers developing?
One experimental procedure to treat moderate to advanced Parkinson’s Disease is gene transfer, which involves neurosurgery to insert a gene into the brain, to lower the side effects of medications and to increase the effectiveness of medications. Note that no stem cells or fetal cells are used. The patient is sedated but remains awake. The scalp is numbed by injections of local anesthetics (like Novocaine), so the patient should not feel discomfort. The surgeon drills two small holes into the skull and injects a liquid containing the gene on each side of the brain into areas known to be affected in Parkinson’s Disease.
How would gene transfer surgery be tested?
To see if the gene transfer surgery is truly effective, investigators need to compare a group that receives the gene transfer surgery with a group that does not. People would be randomly assigned (e.g., by flipping a coin) to one of the two groups. This kind of study could be done in two ways.
An open study could be done, where everyone knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications only. The other half would receive their usual medications plus the gene transfer surgery.
A blinded study could be done, where neither the patient nor the evaluating researcher knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications plus gene transfer surgery. The other half of the patients would receive their usual medications plus “sham surgery.” Patients receiving sham surgery have the two small holes drilled into the skull. But the protective coverings in the brain are not disturbed, and there is no insertion of any material into the brain.
In a blinded study, only the surgeon would know who has received the gene transfer surgery and who has received sham surgery. If the gene transfer surgery is found to be both safe and effective, those in the sham surgery group would have the option of receiving the gene transfer at a later date without cost, using the holes drilled during the sham surgery.
What are the risks of these studies?
For surgery patients in both an open study and a blinded study, the surgery poses potential risks. There is a 1% to 4% risk of bleeding into the brain (usually minor, but there is a less than 1% chance that it could result in death or substantial disability). There is also a 1% to 5% risk of infection developing in the skin or brain, which would be treated with antibiotics. Overall, the risk of bleeding and infection is smaller for sham surgery than for actual gene transfer surgery.
Those subjects receiving the gene transfer surgery would face additional risks, including the possibility of brain tumors, inflammation of the brain, and a worsening of the Parkinson’s Disease. Patients in pilot studies have been followed for only one year, so longer-term effects are not known.
What are the pros and cons of the two kinds of studies?
When deciding whether or not to adopt a new procedure, it’s important to get accurate, unbiased evidence. If we adopt a new procedure that is unsafe or ineffective, people will end up receiving unnecessary surgeries. If we fail to adopt an effective procedure, we miss the opportunity to offer people a treatment that could benefit them.
Most, but not all, researchers in the field believe that the blinded study, using sham surgery, would provide better quality data than the open study. These researchers worry that if people know which procedure they receive, the results of the study may be difficult to interpret because expectations of both the patient and the evaluating researcher can unintentionally bias the results.
However, some people, including some researchers, worry that a study using sham surgery may not be worth the risks and burdens. The patients with Parkinson’s Disease who get the sham surgery undergo a neurosurgical procedure that provides no benefit to them, while being exposed to the risks and burdens of the procedure. There is also the worry that people with moderate to advanced Parkinson’s Disease are vulnerable to exploitation because having a serious, incurable illness may put them in a desperate situation.
Now, you decide!
Imagine that you have moderate to advanced Parkinson’s Disease. You can do most things independently, but involuntary movements interfere with your routine activities. Daily chores take twice as long compared to people without Parkinson’s Disease. For some parts of the day, your movement is extremely slow and you need help with daily activities.
- Blinded study (sham surgery)
- Open study
- Would not participate
Researchers have found that only about 35% of the general population would choose, as you did, to participate in the blinded study. As reported in a 2008 article in the journal Movement Disorders, about 55% of the general population would choose the open study, and the remaining 10% said they would not participate.
When these same questions were posed to people who actually have Parkinson’s Disease, the response was quite different: 24.5% picked the blinded study, 41.5% picked the open study, and 34% said they would not participate. The researchers observe that patients with chronic illness adapt to their disabilities; the people with Parkinson’s Disease might have felt that they had less to gain or more to lose from the benefits and risks associated with a trial involving surgery. Alternatively, people without Parkinson’s Disease may have over-estimated the impact that disability might have on them or underestimated their ability to function.
In this study, people were also asked to imagine that they were members of an ethics review committee deciding whether to allow certain studies. About 81% of respondents said that they would definitely or probably allow the open study for gene transfer. 55% said that they would definitely or probably allow the blinded (sham surgery) study. These results were the same for both the general population and people with Parkinson’s Disease. In other words, a very large majority of both Parkinson’s patients and non-Parkinson’s patients endorsed the open study as ethically acceptable. A majority endorsed sham surgery as an ethically acceptable control condition.
In analyzing these results and reading the written remarks added by the respondents, the researchers comment, “Education seems to play a strong role in people’s willingness to take a more societal perspective and balance the burdens to participants with the overall scientific and societal benefit. . . Those opposed to sham surgery appeared to have an intrinsic objection to blinding, and to focus on the invasive nature of the sham surgery per se . . .Given the complexity of the topic, it may be that laypersons, especially those with less education, may need more opportunity to learn and deliberate on the issues.”
Interestingly, scientists researching Parkinson’s Disease were presented with these same questions in a related study (Kim SY, Frank S, Holloway R, Zimmerman C, Wilson R, Kieburtz K. Science and ethics of sham surgery: A survey of Parkinson disease clinical researchers. Arch Neurol 2005;62:1357-1360.) Only 50% of these clinical researchers would allow open studies, and 94% would support controlled studies using sham surgery.
In conclusion, “Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery.”
For a complete discussion of this research, see Frank S, Wilson R, Holloway R, Zimmerman C, Peterson A, Kieburtz K, Kim SY. Ethics of sham surgery: Perspective of patients. Movement Disorders 2008;23(1):63-68. The senior author, Scott Y. Kim, MD, PhD, is a faculty member at the Center for Behavioral and Decision Sciences at the University of Michigan.
Read the article:
Ethics of sham surgery: Perspective of patients.
Frank S, Wilson R, Holloway RG, Zimmerman C, Peterson DR, Kieburtz K, Kim SY. Movement Disorders 2008;23:63-8.
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
On Thursday, May 19, at 4:30 pm in the Alumni Center, the Inaugural Bishop Lecture in Bioethics was held. Established by a generous gift from the estate of Ronald C. and Nancy V. Bishop, both graduates of the University of Michigan Medical School (Class of '44), the inaugural address was given by John D. Lantos, MD, in a talk entitled, "The Complex Ethical Mess Surrounding Genetic Testing in Children."
Dr. Lantos is the Director of the Children's Mercy Bioethics Center in Kansas City and is a leading voice in bioethics. He has authored or edited five books and numerous publications, including Do We Still Need Doctors?, The Lazarus Case, Neonatal Bioethics, and The Last Physician: Walter Percy and the Moral Life of Medicine. Lantos has discussed designer babies on Larry King Live, medical errors on Oprah, and ethics consultations on Nightline. The Center for Bioethics and Social Sciences in Medicine co-sponsored the event. Over 75 people attended the lecture, which was followed by a reception.
|John D. Lantos, MD|
Check out Brian Zikmund-Fisher's article in Risk Sense: “Do You Know What Messages Your Patient Stories Are Really Sending?" in which he discusses a purpose, content, and valence-based taxonomy of patient narratives in decision aids.
More information can also be found in: Victoria A. Shaffer and Brian J. Zikmund-Fisher (2013). All Stories Are Not Alike: A Purpose-, Content-, and Valence-Based Taxonomy of Patient Narratives in Decision Aids. Med Decis Making, 33: 4-13. doi:10.1177/0272989X12463266
Funded by: Oregon Health & Science University, and Agency for Health Care Quality & Research
Funding Years: 2015-2017
The purpose of this study is to evaluate approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. The investigators will observe grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather data from the grantees to assess how effective the interventions are.