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Funded by the Department of Veterans Affairs.

Funding Years: 2012-2013.

Diabetes is a complex, chronic disease encompassing many domains of treatment. VHA and others have created diabetes guidelines to help support providers and patients in making choices about optimal treatment approaches. However, most guidelines are broad in nature, and offer relatively little guidance on how to personalize care in order to maximize treatment benefits, minimize the intensity and negative effects of treatment, and best align with individual treatment preferences. 

We will test the effectiveness of a personalized decision support program. Our long term goals are:

  • To test and implement a decision support program, including decision coaching supported by an interactive, personalized decision support tool, in clinical practice via our Patient-Aligned Care Team (PACT) laboratory.
  • To assess the impact of personalized decision support on patient-centeredness, patient satisfaction, and the effectiveness of risk communication and treatment decision making.

We propose an interventional study to examine the effectiveness of personalized decision support. The intervention will consist of two key components: a decision coach  and a personalized diabetes decision support tool. The decision support tool has mostly been developed via AHRQ and local pilot funding mechanisms, and is informed by personalized estimation of treatment benefits for blood glucose, blood pressure, and lipid treatment based on extensive modeling work done by our investigative team. The personalized benefit information is communicated through graphical risk communication methods (pictographs).  

PI(s): Angela Fagerlin 

Parents' decision-making about medicating infants (Jul-13)

Imagine that you are the parent of a 1-month-old infant. Your infant spits up a lot. Often there is so much spit-up that you are amazed that there is anything left in your infant’s stomach.  After spitting-up, your infant cries a lot. The crying and spitting seems especially bad after eating. But sometimes it seems like she is uncomfortable most of the time. It seems like there is nothing that you can do to stop the crying or to soothe your infant. You are worried that an infant who is this uncomfortable, and that spits up this much, might not be healthy. So, you decided to take your infant to the doctor to be checked.

After listening to your story and examining your infant, your doctor says, “You infant has something called GERD, or Gastroesophageal Reflux Disease. GERD happens when infants have a weak valve at the entrance to their stomach and, as a result, food and acid from the stomach can travel back up toward the infant’s mouth. When this happens, the infant may spit-up, and the acid in the spit-up may make her uncomfortable, and cause her to cry. Some doctors prescribe a medication that is often used to treat infants with GERD. Most infants grow out of GERD on their own, but medication is an option if you want it. However, studies have shown that this medicine probably doesn’t do anything to help improve symptoms in babies with GERD. This is the same medication that is taken by adults who have bothersome heartburn. This medication is generally considered safe for infants, and rarely causes serious side effects. I’ll give you this prescription and leave it up to you to decide whether or not you want to give it to your infant.”

Should this patient get a liver transplant? (Nov-08)

There aren't enough donor organs to go around for patients who need aliver transplant. This sometimes forces doctors to make tough choices.If you were the doctor, how would you decide in the following scenario?  There aren't enough donor organs to go around for patients who need a liver transplant. This sometimes forces doctors to make tough choices. If you were the doctor, how would you decide in the following scenario?Suppose there is a person who develops acute liver failure (ALF). While waiting for a liver transplant, this person gets sicker and sicker. When an organ is finally available, the chance that this person will survive WITH a transplant is only 42% at five years after the transplant. Since the average survival for most patients who receive a liver transplant is 75% at five years, the doctor wonders if it would be better to save the liver for someone else. Two possible ethical principles may guide the doctor in making this decision. 

Using the principle of URGENCY, the doctor would give the first available organ to the sickest patient on the transplant waiting list, the ALF patient, because she/he is otherwise likely to die within a few days.

Using the principle of UTILITARIANISM, the doctor would try to maximize the quality and quantity of life of all the people on the transplant list. Let's say there are 25 other patients currently on the waiting list, and transplanting the ALF patient increases their risk of death by 2% each, for a cumulative harm of 50%. Since this harm of 50% is more than the benefit to the ALF patient (42%), the liver should be saved for someone else on the list.

A third possibility is for the doctor to weigh both URGENCY and UTILITARIANISM in making a decision about a transplant.

If you were the ALF patient's doctor, what would you base your decision about a transplant on?
 
  • URGENCY (sickest patient on the list gets preference)
  • UTILITARIANISM (maximize benefit for the entire waiting list)
  • A combination of URGENCY and UTILITARIANISM

How do your answers compare?

There's no absolutely right or wrong answer in this case—the choice depends on which of several competing ethical principles or which combination of principles you follow. In choosing a combination of URGENCY and UTILITARIANISM, you've decided to try to balance the needs of the sickest patient with the needs of all the people on the transplant waiting list.

CBDSM researcher Michael Volk, MD, is the lead author on a recent article that tackles difficult decisions like this one. Volk and his colleagues examined a method to incorporate competing ethical principles in a decision analysis of liver transplantation for a patient with ALF. Currently, liver transplantation in the United States is determined by the principle of “sickest first," with patients at highest risk for death on the waiting list receiving first priority. In other words, the principle of URGENCY is paramount. However, most experts agree that, given the limited supply of organs, there should be a cutoff for posttransplant survival below which transplantation is no longer justified.

Where does society draw this line? And what framework can we use for ethical guidance?

Decision analysis of resource allocation would utilize the principle of UTILITARIANISM, to maximize the broad social benefit. But surveys of the general public have shown that most people prefer to temper utilitarianism with other considerations, such as equal opportunity, racial equity, and personal responsibility. Another factor that might be considered is the principle of fair chances. This is the idea that patients who have not had a chance at a liver transplant should receive priority over those who have already had once chance at a transplant.

Volk constructed a mathematical model (Markov model) to test the use of competing ethical principles. First he compared the benefit of transplantation for a patient with ALF to the harm caused to other patients on the waiting list, to determine the lowest acceptable five-year survival rate for the transplanted ALF patient. He found that giving a liver to the ALF patient resulted in harms to the others on the waiting list that cumulatively outweighed the benefit of transplantation for the ALF patient. That is, using UTILITARIANISM as the sole guiding ethical principle gave a clear threshold for the transplant decision: if the ALF patient did not have a five-year survival rate of at least 48%, she/he should not receive a transplant under this principle.

But UTILITARIANISM is not always the sole guiding ethical principle. When Volk adjusted the model to incorporate UTILITARIANISM, URGENCY, and other ethical principles such as fair chances, he got different thresholds. Depending on the combination of ethical principles used, Volk and his colleagues have shown that the threshold for an acceptable posttransplant survival at five years for the ALF patient would range from 25% to 56%.

The authors of this study conclude:

"Our model is an improvement over clinical judgment for several reasons. First, the complexity of the various competing risks makes clinical decision making challenging without some form of quantitative synthesis such as decision analysis. Second, a systematic approach helps ensure that all patients are treated equally. Most important, this study provides moral guidance for physicians who must simultaneously act as patient advocates and as stewards of scarce societal resources."

Volk ML, Lok ASF, Ubel PA, Vijan S, Beyond utilitarianism: A method for analyzing competing ethical principles in a decision analysis of liver transplantation, Med Decis Making 2008;28, 763-772.

Online: http://mdm.sagepub.com/cgi/content/abstract/28/5/763

More information:

Beyond utilitarianism: A method for analyzing competing ethical principles in a decision analysis of liver transplantation.
Volk M, Lok AS, Ubel PA, Vijan S. Medical Decision Making 2008;28(5):763-772.

 

Funded by NIH - Department of Health and Human Services

Funding Years: 2012-2017

Treatments for cancer impose substantial burden and morbidity but net survival benefit of different strategies is often small and virtually always uncertain. Thus, clinicians may do more harm than good if treatment is too aggressive. There are a number of management strategies for breast cancer aimed at reducing unnecessary morbidity and burden on patients with favorable disease. A key barrier to advancing these initiatives is the need for a better understanding of the challenges of individualizing cancer care. The goal of this program is to improve population health by helping clinicians and their patients address the challenges of individualizing treatment of breast cancer for patients with favorable prognosis. Objective 1: To examine the challenges of individualizing treatment for women with breast cancer. Two projects will each undertake an observational study of patients newly diagnosed with breast cancer (including their attending clinicians) who were reported to the SEER registries of Georgia and New Jersey during an 18 month period to examine patient and clinician factors associated with key evaluative tests, treatments, and patient appraisal of decision quality. Project 1 will focus on challenges for surgeons and their patients with regard to locoregional therapy. Project 2 will focus on challenges for medical oncologists and their patients with regard to systemic therapy. Objective 2: To improve treatment decision quality. Project 3 will perform a randomized controlled trial of a practice based online decision tool for patients newly diagnosed with breast cancer in the Detroit and Atlanta SEER regions intended to improve decision quality. Objective 3: To accelerate the dissemination of SEER-based research findings by implementing and evaluating a tailored online portal aimed at all surgeons and medical oncologists who treated the patient samples in P1 and P2 to evaluate whether our research findings can more directly and promptly inform clinicians knowledge and attitudes about individualizing treatment. Objective 4: To advance methods in SEER population translational research focused on quality of cancer care. We propose four shared resource cores that will support program project activities, advance innovative methods in oncology population sciences, and advance team mission and long-term strategic planning.

PI(s): Steven Katz

Co-I(s): Lawrence An, Michael Elliott, Angela Fagerlin, Sarah Hawley, Timothy Hofer, Reshma Jagsi, Nancy Janz, Yun Li, Kenneth Resnicow, Jeremy Taylor, Christopher Friese

CBSSM joined 75+ exhibitors from labs and offices of the Medical School and across campus for the 2017 Researchpalooza.

Sponsored by the Office of Research, Researchpalooza is the perfect opportunity for colleagues and friends to have a great time and meet, mingle, and learn more about many of the organizations that offer their stellar services to faculty, students, and staff, all at one convenient time and location.

Funded by American Cancer Society.

Funding Years: 2014-2017.

The study will examine how informal decision supporters (e.g., partners, family, and friends) contribute decisions about surgery, radiation, and chemotherapy treatment, and how these roles may vary by race and ethnicity. The project will utilize existing resources from the Cancer Surveillance and Outcomes Research Team's (CanSORT) Program Project Grant "The Challenge of Individualizing Treatments for Patients with Breast Cancer," a $13 million award received from NCI in 2012.

PI(s): Sarah Hawley

Co-I(s): Jennifer Griggs, Nancy Janz, Steven Katz, Yun Li

 

Funded by the Informed Medical Decision Making Foundation

Funding Years: 2010-2012

The overall long-term goal of this research program is to develop values clarification exercises that improve decision quality.  The research funded by this grant aims to establish the feasibility of the development and evaluation of a dynamic interactive tool that explicitly encourages values exploration and clarification.  For this study, values exploration means that patients will be encouraged to “try on” different ideas, see immediate and dynamic visual feedback, adjust and re-adjust their values, and save settings at multiple time points in order to recall and compare thoughts and feelings.  It is hypothesized that by explicitly supporting a potentially circuitous path of values exploration, the resulting approach will be more reflective of the intuitive processes that people follow to arrive at states of greater clarity.

Angela Fagerlin (PI)

 

Michael D. Fetters, MD, MPH, MA, Associate Professor, recently gave a talk at the 38th annual North American Primary Care Research Group (NAPCRG) meeting, held November 13-17, 2010, in Seattle, WA.

The Diabetes Lobby (Dec-09)

Tell us what you think about certain public policies designed to reduce the incidence of diabetes in the US.

Please read this hypothetical news article and then answer a few questions at the end.

People with Diabetes Lobby Congress This Week

Washington, March 28 – About 1000 patients with type 2 diabetes (also commonly known as adult-onset or non-insulin-dependent diabetes) have converged here as advocates for the American Diabetes Association (ADA). They will be meeting with their members of Congress to discuss their condition and advocate for federal policies to address their disease. In addition, they will hold a rally on Thursday of this week on the National Monument grounds, to attract popular attention to their disease.
 
According to the Centers for Disease Control and Prevention, nearly 21 million Americans have diabetes, but one-third of these people do not yet know they have the disease. More than 90% of people with diabetes have type 2 diabetes, a form of diabetes which typically emerges when people are adults but which may develop during childhood. The number of people diagnosed with type 2 diabetes has been increasing every year. There were over 1 million new cases of diabetes diagnosed in 2005 among adults. Researchers believe that the conditions in the neighborhoods where people live increase their chances of getting type 2 diabetes. Rates of diabetes are highest among people living in poor neighborhoods.
 
People with type 2 diabetes develop a problem with the way their body secretes or responds to insulin, a hormone that regulates blood glucose levels. As a result, they have elevated blood sugar levels, which they must check multiple times per day and monitor their food intake. Researchers are working hard to understand more about what causes type 2 diabetes. Diabetes expert Dr. Howard Smith says, "People who live in neighborhoods where the majority of stores sell food with high calories and low nutritional value, such as fast food restaurants or convenience stores, are much more likely to develop diabetes." Several other scientific studies have supported the idea that people’s neighborhoods, including not having convenient or safe places to exercise, and being exposed to many advertisements selling high-calorie foods, are associated with the development of diabetes.
 
If left untreated, people with diabetes can become blind, have kidney damage, lose their limbs, or die. Physicians, health plans, employers, and policymakers are considering new ways to prevent diabetes, help patients manage their diabetes, and reduce this deadly epidemic. It is expected that the U.S. Senate Committee on Health, Education, and Labor will consider several bills about diabetes in the upcoming session of Congress.
 
Some people with diabetes check their blood sugar with a device called a glucometer.
 
Having read this news article, please tell us if you agree with the following policies:
 
The government should impose higher taxes on food high in calories and fat, like it does for cigarettes.
 
  • strongly disagree
  • disagree
  • neutral
  • agree
  • strongly agree
The government should provide financial incentives to encourage grocery stores to locate in areas where there are few.
 
  • strongly disagree
  • disagree
  • neutral
  • agree
  • strongly agree
The government should regulate advertisements for junk food like it does for cigarettes and alcohol.
 
  • strongly disagree
  • disagree
  • neutral
  • agree
  • strongly agree

Generally speaking, do you usually think of yourself as a Republican, a Democrat, an Independent, or what?

  • Strong Democrat
  • Not so strong Democrat
  • Independent, close to Democrat
  • Independent
  • Independent, close to Republican
  • Not so strong Republican
  • Strong Republican
  • Don't know, haven't thought much about it

How you answered: 

Researchers affiliated with CBDSM and the School of Public Health have found that "Americans' opinions about health policy are polarized on political partisan lines. Democrats and Republicans differ in the ways that they receive and react to messages about the social determinants of health."

In the study, lead author Sarah Gollust, PhD, randomly assigned participants to read one of four hypothetical news articles about type 2 diabetes. Diabetes was used as an example of a common health issue that is widely debated and that is known to have multiple contributing factors, including genetic predisposition, behavioral choices, and social determinants (such as income or neighborhood environments).

The articles were identical except for the causal frame embedded in the text. The article that you read in this Decision of the Month presented social determinants as a cause for type 2 diabetes. Other versions of the article presented genetic predisposition or behavioral choices as a cause for type 2 diabetes, and one version had no causal language.

Dr. Gollust then asked the study participants their views of seven nonmedical governmental policies related to the environmental, neighborhood, or economic determinants of diabetes:

  • bans on fast food concessions in public schools
  • incentives for grocery stores to establish locations where there are currently few
  • bans on trans fat in restaurants
  • government investment in parks
  • regulating junk food advertisements
  • imposing taxes on junk foods
  • subsidizing the costs of healthy food

Dr. Gollust also asked participants their political party identification and a number of other self-reported characteristics.

The most dramatic finding of this study was that the news story with the social determinants as a cause for type 2 diabetes had significantly different effects on the policy views of participants, depending on whether they identified themselves as Democrats or Republicans. After reading the social determinants article, Democrats expressed a higher level of support for the proposed public health policies. Republicans expressed a lower level of support for the proposed public health policies. This effect occurred only in the group of participants who were randomly assigned to read the version of the news article with social determinants given as a cause for type 2 diabetes. Dr. Gollust summarizes: "Exposure to the social determinants message produced a divergence of opinion by political party, with Democrats and Republicans differing in their opinions by nearly 0.5 units of the 5-point scale."

The study suggests several possible explanations for these results:

"First, the social determinants media frame may have presumed a liberal worldview to which the Republican study participants disagreed or found factually erroneous (ie, not credible), but with which Democrats felt more comfortable or found more familiar. . . Second, media consumption is becoming increasingly polarized by party identification, and . . . the social determinants message may have appeared particularly biased to Republicans. . .Third, the social determinants frame may have primed, or activated, study participants' underlying attitudes about the social group highlighted in the news article. . . Fourth, participants' party identification likely serves as proxy for . . . values held regarding personal versus social responsibility for health."

Dr. Gollust and her colleagues conclude that if public health advocates want to mobilize the American public to support certain health policies, a segmented communication approach may be needed. Some subgroups of Americans will not find a message about social determinants credible. These subgroups value personal responsibility and find social determinants antagonistic to their worldview. To avoid triggering immediate resistance by these citizens to information about social determinants of health, public health advocates may consider the use of information about individual behavioral factors in educational materials, while working to build public familiarity with and acceptance of research data on social determinants.

For more details about this study:

Gollust SE, Lantz PM, Ubel PA, The polarizing effect of news media messages about the social determinants of health, Am J Public Health 2009, 99:2160-2167.
 

 

Funded by National Institutes of Health

Funding Years: 2011-2017

The CoreValve US Pivotal Trial applies clinical best practices—including CT-based sizing—and is meticulously monitored, including the use of an independent echocardiographic core lab. Within the trial, the High Risk Study randomized 795 patients between surgical aortic valve replacement (SAVR) and Transcatheter Aortic Valve Implantation (TAVI) with the CoreValve System across 45 US sites. The TAVI procedure is used as an alternative to open heart surgery and allows access to the diseased aortic valve via an artery in the leg and is designed for patients with severe aortic stenosis who are at high risk for surgery due to age or other health issues.

PI(s): David Bach, G M Deeb

Co-I(s): Devin Brown, Stanley Chetcuti, Paul Grossman, Himanshu Patel, Michael Shea, Darin Zahuranec

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