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James Burke, MD

Faculty

Jim Burke, M.D. is a neurologist who completed residency and a stroke fellowship at the University of Michigan. His undergraduate degree is from the University of Notre Dame and his medical degree from the Loyola University Stritch School of Medicine. He is interested in understanding how physicians use the complex information acquired from modern diagnostic tests and improving decisions to order such tests.

Research Interests: 
Last Name: 
Burke

Chris Krenz, BA

Research Associate

Chris Krenz joined CBSSM in the fall of 2014. He received his BA in Sociology from the University of Michigan, minoring in Philosophy. Before coming to CBSSM, Chris was located at the Institute for Social Research, working on projects concerning the health of Pacific Islanders and other minority populations.

Chris primarily works with Dr. Raymond De Vries on a study exploring factors that influence whether biobank donors provide consent for their biological material to be used in research.

Research Interests: 
Last Name: 
Krenz
Tue, January 16, 2018

CBSSM Director, Reshma Jagsi was recently interviewed for the LA Times article, "Will medicine be the next field to face a sexual harassment reckoning?" This article discusses her 2014 survey on sexual harassment and gender bias in academic medicine, as well as her recent article on the #MeToo movement as it relates to medicine in the New England Journal of Medicine.

What is the price of life? (Aug-03)

Do you think that your life is worth more than the amount that the government usually uses as the maximum to spend to provide one year of life?

Imagine that you are a member of a government panel that is trying to decide how cost-effective a medical treatment must be in order for the government to cover the costs of the treatment. Suppose that a certain treatment could provide one additional year of life to an otherwise healthy person. What is the highest amount the government should be willing to pay per person for this treatment?

How do your answers compare?

For the past twenty years, the figure most often used as the maximum amount to spend to provide one year of life has been $50,000. This figure was originally proposed since it was the cost of a year of kidney dialysis, a lifesaving treatment that the U.S. government funds in Medicare.

Should the number be higher or lower than the current standard?

Conventional wisdom would suggest that the number be higher to take into account the inflation that has occurred in the years since the standard was developed. Current practices such as annual Pap smear screening for women with low risk for cervical cancer, which has a cost of $700,000 per year of life gained, also suggest that society is willing to pay more than the current standard for a year of life. The authors of the cited article recommend, based on current treatment practices and surveys of the general public, that the cost-effectiveness threshold should be revised to be around $200,000.

Should the number increase, decrease, or stay the same over time?

Again, it seems that the threshold amount should increase over time due to inflation. However, other factors come in to play that affect the value.

Since new technologies are emerging all the time, some of which will be deemed cost-effective, there will be more and more treatments to be offered in the future. Also, the rate of use of treatments is an important consideration, because even if a new treatment is more cost-effective than an old one, if it is used more often it will end up costing more to society overall. With more treatments becoming available and more people being given treatments, the threshold cost will probably have to decrease so that insurance companies and the government can keep up with the increasing availability and demand.

Why is this important?

Insurance companies and government health care entities face a continuing struggle when trying to determine which medical treatments to cover. Health care costs are increasing rapidly, so these groups will be facing even tougher decisions in the future. Establishing cost-effectiveness guidelines would be extremely helpful as an aid to making the decisions about treatment coverage. Evidence shows that the current threshold is probably not an accurate reflection of the desires of society or actual prescribing practices. It needs to be adjusted to become useful once again, and must be reevaluated periodically to make sure the value keeps up with trends in the health care market, rather than being left alone without question for two decades as is the current situation.

For more information see:

Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn't it increase at the rate of inflation? Archives of Internal Medicine. 163:1637-1641, 2003.

Drilling for Answers (Sep-08)

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.

You are asked to participate in either an open study or a blinded (sham surgery) study. Which study would you choose to participate in?
  • 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.

Funded by VA Health Services Research and Development Career Development Award

Funding Years: 2015-2019

Heart attack and stroke, which together are called cardiovascular disease, cause over 1/3 of all deaths in VA patients. The current guidelines for the prevention of these conditions focus on lowering patients'blood pressure and cholesterol levels. A new treatment strategy, which I call benefit-based tailored treatment, that instead guides treatment decisions based on the likelihood that a medication would prevent a heart attack or stroke could prevent more cardiovascular disease, with lower medication use, and be more patient centered. The purpose of this Career Development Award is to develop and assess tools and approaches that could enable the implementation of benefit-based tailored treatment of cardiovascular disease, in particular a decision support tool and educational program for clinicians and a performance profiling system. The decision support tool will enable better care by showing clinicians patient-specific estimates of the likelihood that their medication decisions will prevent a cardiovascular disease event. The performance profiling system will encourage better care by assessing the quality of care provided at VA sites and in PACT teams based on how well the medical care provided follows this treatment strategy. The project will have three aims:
Aim 1 : In the first aim, I will seek to understand clinicians'and patients'perceptions of and receptivity to the use of benefit-based tailored treatment for cardiovascular disease. Information gained from qualitative research with clinicians will help assess and improve the usability and effectiveness of the decision support tool and educational program for clinicians, along with the acceptability of the treatment strategies in general. Information gained from focus groups with patients will help learn their priorities in cardiovascular disease prevention, to help identify ways to make the interventions and their assessments more patient-centered.
Aim 2 : In the second aim, the decision support tool and educational program will be assessed in a real-world randomized pilot study involving thirty clinicians. Half of the clinicians will be provided the decision support tool and education intervention for ten patients each, the other half will receive a traditional quality improvement program and treatment reminders. The study will have formative goals of ensuring that clinicians and patients believe the tool is valuable and does not disrupt care processes or workflow for anyone in the PACT team. This will be studied with qualitative and survey assessments. The primary summative outcome will be the influence of the intervention on clinicians'treatment decisions. Secondary outcomes will assess patients'satisfaction with their visits and their clinicians.
Aim 3 :
The third aim will develop and evaluate a novel performance measurement system based on benefit- based tailored treatment. First, the performance profiling system will be developed. Then the profiling system's ability to reliably differentiate high quality from low-quality care will be evaluated.

PI: Jeremy Sussman

Funded by: NIH

Funding Years: 2016-2021

 

There is a fundamental gap in understanding how Mild Cognitive Impairment (MCI) influences treatment and Decision Making for serious illnesses, like Cardiovascular disease (CVD), in older patients. Poor understanding of Clinical Decision Making is a critical barrier to the design of interventions to improve the quality and outcomes of CVD care of in older patients with MCI. The long-term goal of this research is to develop, test, and disseminate interventions aimed to improve the quality and outcomes of CVD care and to reduce CVD-related disability in older Americans with MCI. The objective of this application is to determine the extent to which people with MCI are receiving sub-standard care for the two most common CVD events, Acute myocardial infarction (AMI) and acute ischemic stroke, increasing the chance of mortality and morbidity in a population with otherwise good quality of life, and to determine how MCI influences patient preferences and physician recommendations for treatment. AMI and acute ischemic stroke are excellent models of serious, acute illnesses with a wide range of effective therapies for acute management, Rehabilitation, and secondary prevention. Our central hypothesis is that older Adults with MCI are undertreated for CVD because patients and physicians overestimate their risk of dementia and underestimate their risk of CVD. This hypothesis has been formulated on the basis of preliminary data from the applicants' pilot research. The rationale for the proposed research is that understanding how patient preferences and physician recommendations contribute to underuse of CVD treatments in patients with MCI has the potential to translate into targeted interventions aimed to improve the quality and outcomes of care, resulting in new and innovative approaches to the treatment of CVD and other serious, acute illnesses in Adults with MCI. Guided by strong preliminary data, this hypothesis will be tested by pursuing two specific aims: 1) Compare AMI and stroke treatments between MCI patients and cognitively normal patients and explore differences in Clinical outcomes associated with treatment differences; and 2) Determine the influence of MCI on patient and surrogate preferences and physician recommendations for AMI and stroke treatment. Under the first aim, a health services research approach- shown to be feasible in the applicants' hands-will be used to quantify the extent and outcomes of treatment differences for AMI and acute ischemic stroke in older patients with MCI. Under the second aim, a multi-center, mixed-methods approach and a national physician survey, which also has been proven as feasible in the applicants' hands, will be used to determine the influence of MCI on patient preferences and physician recommendations for AMI and stroke treatment. This research proposal is innovative because it represents a new and substantially different way of addressing the important public health problem of enhancing the health of older Adults by determining the extent and causes of underuse of effective CVD treatments in those with MCI. The proposed research is significant because it is expected to vertically advance and expand understanding of how MCI influences treatment and Decision Making for AMI and ischemic stroke in older patients. Ultimately, such knowledge has the potential to inform the development of targeted interventions that will help to improve the quality and outcomes of CVD care and to reduce CVD-related disability in older Americans.

PI: Deborah Levine

CO(s): Darin Zahuranec, MD & Ken Lenga, MD. PhD.

Announcement of Position: Faculty Ethicist

Announcement of Position: Faculty Ethicist


Background
The Clinical Ethics Service within the Center for Bioethics and Social Sciences in Medicine (CBSSM) promotes a culture of patient-centered excellence by performing a comprehensive set of ethics-related activities. The aims of this service are to: liaise with and provide support to the adult and pediatric ethics committees; provide clinical ethics consultation and engage in preventative ethics endeavors; assist with ethics-related policy development on a regular and proactive basis; organize and administer structured educational programs in clinical ethics; and coordinate empiric research with relevance to clinical ethics within CBSSM.

Program Organization
The Clinical Ethics Service is led by Christian J. Vercler, MD MA and Andrew G. Shuman, MD. A dedicated clinical ethicist will manage the program on a daily basis. A cadre of faculty ethicists will rotate on service throughout the year and work closely with the clinical ethicist. Trainees and students will rotate as well. Dedicated administrative support is organized through CBSSM.


Position
The Clinical Ethics Service employs a roster of faculty ethicists who are responsible for staffing ethics consultations arising from any of the clinical venues (inpatient and outpatient; adult and pediatric) within Michigan Medicine during their time on service. They will supervise and participate in the institutional educational endeavors and preventative ethics rounds in a regular and on-going manner. Faculty ethicists will also develop and provide clinical rotations for medical students and house officers on a cohesive ethics service. Each faculty member will be expected to rotate on service for four to six weeks per year, and attend/participate in committee meetings and other events throughout the academic year (this will not necessarily require suspension of other activities when on-service). Depending on the total number appointed, each faculty ethicist will receive $15,000-$20,000 of direct salary support annually, to be distributed and allocated in conjunction with their home department. The initial appointment will last two and a half years and is renewable. Additional appointments will last two years.


Qualifications
Candidates are expected to have faculty appointments at University of Michigan and be in good academic standing; any professional background is acceptable. Candidates are expected to have qualifications that meet the standards outlined by The American Society for Bioethics and Humanities (ASBH) for accreditation for clinical ethics consultants. Direct experience with clinical ethics consultation is required. Familiarity with ethics education and related clinical research would be helpful. Excellent organizational and communication skills across multidisciplinary medical fields are required.


Application Process
Candidates will be vetted and chosen by a selection committee. Candidates are asked to submit:

  • Curriculum vitae or resume
  • One page maximum summary of (1) education/training related to ethics consultation; (2) clinical ethics consultation experience; and (3) motivation/interest in the position
  • Letter of support from Department Chair/Division Head/Center Director or equivalent
  • Submit formal application via email to: lynnam@med.umich.edu


Timeline

  • Application is due September 25, 2017
  • Appointment will take effect January 1, 2018

Contacts

  • Leaders of the Clinical Ethics Service: Christian J. Vercler, MD MA & Andrew G. Shuman, MD
  • Administrative contact: Valerie Kahn – valkahn@med.umich.edu 734 615 5371

Adult Ethics Committee

The Michigan Medicine Committee advisory groups are appointed by the Hospital's Office of Clinical Affairs. They review ethical or moral questions that may come up during an adult patient's care. The consultants facilitate communication among adult patients, their families and the treatment team to assist everyone in making appropriate choices when difficult decisions need to be made. The Committee's goal is to help everyone decide the right thing to do. The Michigan Medicine Adult Ethics Committee is a sub-committee of the Executive Committee on Clinical Affairs as determined by the Medical Staff Bylaws.

About Us

Sometimes patients, families and staff have very difficult choices and ethical questions they need to talk about. Discussions with the Ethics Committee can be helpful and reassuring when a difficult choice must be made (for example, questions on end-of-life care, or issues of confidentiality). The goal of the Committee is to facilitate communication among adult patients, their families and the treatment team to assist everyone in making appropriate choices, as well as to assist Michigan Medicine in complying with ethical regulatory standards, when difficult decisions need to be made. The Committee provides consultation to the treatment team, patients and families on ethical, moral or philosophical problems and issues encountered in the course of managing inpatient and outpatient care.

Committee members include physicians, residents, nurses and social workers, as well as medical students, an attorney/compliance officer, a chaplain, a medical ethics professor and members from the community.

The Adult Ethics Committee meets on the third Tuesday of the month, form 12-1:30pm, at University Hospital in dining room D, if you would like to attend as a guest, please contact Amy Lynn @ lynnam@med.umich.edu

What happens when a meeting with the Ethics Committee is requested?

The consultants on call review the patient's medical situation and treatment options. In addition, concerns and feelings of the patient, family members, and the health care team are discussed. Members of the committee may visit with patients, families and medical personnel to discuss these concerns.

Ethics Committee members discuss the information which has been gathered. The Ethics Committee makes suggestions about the best course of action. Often there are a number of options available in the course of a patient's care. Final decisions are made by the patient, family and the health care team.

Request a Consult

Monday-Friday
8:00 a.m. - 5:00 p.m. Call 734-615-1379
After normal business hours, please call 936-6267 and ask for the clinical ethicist on call to be paged.

Resources

Financial Assistance

Non-Beneficial Treatment

Advance Directives

Committee Bylaws

 

For upcoming Bioethics Grand Rounds see Events

Pediatric Ethics Committee

The Michigan Medicine Committee advisory groups are appointed by the Hospital's Office of Clinical Affairs. They review ethical or moral questions that may come up during a pediatrics patient's care. The consultants facilitate communication among patients, their families and the treatment team to assist everyone in making appropriate choices when difficult decisions need to be made. The Committee's goal is to help everyone decide the right thing to do. The Michigan Medicine Ethics Committee is a sub-committee of the Executive Committee on Clinical Affairs as determined by the Medical Staff Bylaws. 

About Us


The committee is available for consultation to family members, patients, staff, and health care providers. The committee may help you and your child’s medical team clarify facts, examine ethical issues, and assist in the resolution of disagreements about your child’s care. The committee includes people with additional training in medical ethics, doctors, nurses, social workers, a lawyer, a chaplain, an administrator, and members of the community
The University of Michigan has a Pediatric Ethics Committee because the best medical care requires not only medical skill but good moral judgment. The Committee’s main purpose is to offer help and guidance on moral and ethical questions, such as:

  • Should treatment be started or stopped?
  • How much should a child be told about his or her disease?
  • Is the promise of treatment worth the suffering it may cause?
  • What is the best thing to do when we must face the end of life?
  • What happens when a meeting with the Ethics Committee is requested?

The consultants on call review the patient's medical situation and treatment options. In addition, concerns and feelings of the patient, family members, and the health care team are discussed. Members of the committee may visit with patients, families and medical personnel to discuss these concerns.

Ethics Committee members discuss the information which has been gathered. The Ethics Committee makes suggestions about the best course of action. Often there are a number of options available in the course of a patient's care. Final decisions are made by the patient, family and the health care team.

The Pediatric Ethics Committee meets on the first Tuesday of the month from 12-1:30pm at University Hospital in dining rooms C&D. If you would like to attend as a guest, please contact Amy Lynn @ lynnam@med.umich.edu

Request a Consult

Monday-Friday
8:00 a.m. - 5:00 p.m. Call 734-615-1379
After normal business hours, please call 936-6267 and ask for the clinical ethicist on call to be paged.

Resources

Financial Assistance

Non-Beneficial Treatment

Committee Bylaws

 

For upcoming Bioethics Grand Rounds see Events

 

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