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Funded by National Institutes of Health

Funding Years: 2015-2018

Institutional Review Boards (IRBs) provide oversight to clinical research involving human subjects to protect participants and ensure ethical research conduct. Local IRBs review research performed just at their own site, while Central Institutional Review Boards (CIRBs) review research being conducted at many sites. Regardless of whether reviews are performed locally or centrally, they must take into account any local context specific to the site where the research will be performed. CIRBs may provide more effective, equitable, and efficient review of large multicenter clinical trials, but whether CIRBs can effectively consider local context is unknown. Local context review is especially important in a kind of research called exception from informed consent for emergency research. In this kind of research, patients who are comatose or otherwise critically ill and unable to consent for themselves may still participate in trials if thir condition is life-threatening and the experimental therapy is only effective if given right away. To perform this kind of trial, researchers must also consult with the community and publically disclose information about the study. Information about those consultations must then be considered by an IRB as part of local context review. The purpose of this project is to explore, revise, and test measures of local context review of community consultation for this type of research, by local and central IRBs. We will work with key stakeholders to identify goals and processes, use these data to develop measures in domains such as trustworthiness and acceptability, and then use these measures to compare local IRB reviews to those of a simulated CIRB for a real trial. This project will be conducted within the Neurological Emergencies Treatment Trials (NETT) network and the Pediatric Emergency Care Applied Research Network (PECARN). These networks will serve as an "empirical ethics lab" in which best practices are developed.

PI(s): Robert Silbergleit

Co-I(s): Michael Fetters, Michael Geisser, Adrianne Haggins, Alan Sugar, Sacha Montas

Conference on Bioethics: First Do No Harm: Avoiding Overdiagnosis and Overtreatment in Medicine

Sat, November 11, 2017, 8:45am
Location: 
Sheraton Ann Arbor Hotel | 3200 Boardwalk Street | Ann Arbor, MI

Registration available here.
 
8:45 am
Welcome, Opening Remarks, and Presentation of Certification of Appreciation Award to Blue Cross Blue Shield of Michigan Foundation
Lauren B. Smith, MD, Chair, MSMS Committee on Bioethics; Department of Pathology, University of Michigan
Audrey J. Harvey, CEO, Blue Cross Blue Shield of Michigan Foundation; and,
Shauna Ryder-Diggs, MD, Blue Cross Blue Shield of Michigan Foundation
 
9:00 - 10:00 am
7 Assumptions that Drive Too Much Medical Care
H. Gilbert Welch, MD, MPH, Professor of Medicine, Community & Family Medicine, The Dartmouth Institute, The Geisel School of Medicine at Dartmouth, Adjunct Professor, Business Administration, Tuck School
of Business and Adjunct Professor, Public Policy, Dartmouth College
 
10:00 - 11:00 am
Responding to those who Hope for a Miracle
Devan Stahl, PhD, Assistant Professor, Center for Ethics & Humanities in the Life Sciences, Department of Pediatrics & Human Development, Michigan State University
 
11:15 am - 12:15 pm
Whose Decision is it Anyway? Code Status and the Unilateral DNAR
Adam Marks, MD, Associate Director of the Adult Palliative and Supportive Care Clinic, East Ann Arbor Health and Geriatrics Center, Adult Palliative Care Medical Director, Arbor Hospice
 
1:15 - 2:15 pm
Capacity for Preferences: An Overlooked Factor in Ethical Dilemmas with Incapacitated Patients
Jason A. Wasserman, PhD, Associate Professor, Biomedical Science, Faculty Advisor on Professionalism, Oakland University William Beaumont School of Medicine; and,
Mark C. Navin, PhD, Associate Professor of Philosophy, Oakland University William Beaumont School of Medicine
 
2:15 - 3:15 pm
Over-treatment/Over-diagnosis of Genetic Testing
Michele Gornick, PhD, MA, Department of Internal Medicine, University of Michigan Medical School
 
3:30 - 4:30 pm
Case Studies
 
4:30 pm
Closing Remarks
Lauren B. Smith, MD, University of Michigan

Funded by National Institutes of Health; National Institute of Mental Health

Funding Years: 2012-2017

This project will test a practical intervention that uses low cost technologies to activate depressed patients' existing social networks for self-management support. The intervention links patients with a "CarePartner" (CP), i.e., a non-household family member or close friend who is willing to support the patient in coordination with the clinician and any existing in-home caregiver (ICG). Through weekly automated telemonitoring, patients report their mood and self-management status, and receive tailored guidance on self-management. The CP receives a corresponding update along with guidance on how to best support the patient's self-management efforts, and the primary care team is notified about clinically urgent situations. The intervention will be tested among depressed primary care patients from clinics serving low-income and underinsured patients, whom the intervention was especially designed to benefit. Specific Aim 1 is to conduct a randomized controlled trial to compare the effectiveness of one year of telemonitoring-supported CP for depression versus usual care (control) on depression severity. Specific Aim 2 is to examine key secondary outcomes (response and remission, impairment, well-being, caregiving burden, healthcare costs) and potential moderators. Specific Aim 3 is to use a mixed-methods approach to enrich our interpretation of the statistical associations, and to discover strategies to enhance the intervention's acceptability, effectiveness, and sustainability. If the intervention proves effective without increasing clinician burden or marginal costs, then its subsequent implementation could yield major public health benefits, especially in medically underserved populations.

PI(s): James Aikens

Co-I(s): Michael Fetters, John Piette, Ananda Sen, Marcia Valenstein, Daniel Eisenberg, Daphne Watkins

Funded by Patient-Centered Outcomes Research Institute (PCORI)

Funding Years: 2014 - 2018

Obesity is increasingly considered among the most important public health problems of our times. Bariatric surgery is arguably the only treatment that has proven effective in producing long-term weight loss for patients with morbid obesity. Bariatric surgery also results in resolution of obesity related comorbid conditions, improvements in quality of life, and increased survival.

There are currently four different bariatric surgical procedures in use: adjustable gastric banding, gastric bypass, sleeve gastrectomy, and duodenal switch. Bariatric surgery is considered a highly preference sensitive medical issue. Existing decision aids in bariatric surgery are limited in that they provide information about the average comparative risks and benefits of the treatment options, but do not provide customized estimates of the risks and benefits of the different procedures for individual patients. As a result of these draw-backs, decision aids are not frequently used in making treatment decisions in bariatric surgery.

Our proposal is highly innovative in that our decision support tool integrates data from a large clinical registry with individual patient data to provide patients with real-time, customized, accurate information regarding the risks and benefits of the treatment options to better inform decision making. This tool will be continuously updated to ensure that the data on risks and benefits that it provides are accurate and current. Our tool also provides information about other attributes of the treatment options that bariatric surgery patients and other relevant stakeholders feel are important for patients to consider in deciding whether and what type of bariatric surgery to have.

The proposed research promotes shared medical decision making for patients who are considering bariatric surgery for the treatment of morbid obesity. If our intervention proves effective, it will result in improved decision quality and outcomes of care for patients. It may also result in improved efficiency of care to the extent that it serves to augment or guide communication between the patient and physician to promote shared medical decision-making.

PI(s): Nancy Birkmeyer/Amir Ghaferi

Co-I(s): Lawrence An, Mousumi Banerjee, Angela Fagerlin, Sarah Hawley, Edward Norton, Lisa Prosser

Mon, June 11, 2018

A new study shows how to personalize the lung cancer screening decision for every patient. The results could help doctors fine-tune their advice to patients, so that it’s based not just on a patient’s individual lung cancer risk and the potential benefits and harms of screening, but also a likely range of patient attitudes about looking for problems and dealing with the consequences.

Published in the Annals of Internal Medicine, the study forms the backbone for new free online decision tools aimed at physicians and their teams, and at members of the public.

The tool for clinicians, called Lung Decision Precision, was designed by a University of Michigan and Veterans Affairs team to help clinicians talk with patients and their loved ones about whether to a lung CT scan might be a good idea for them.

The same team has also launched a website for patients and their loved ones, U.S. News & World Report: Should You Get Screened for Lung Cancer?, that gives easy-to-understand information about the positives and potential negatives of lung cancer screening, and allows individuals to calculate their personal risk of lung cancer.

Tanner Caverly, M.D., M.P.H., led the team that did the new computer-based simulation analysis using data from major studies of lung cancer screening, and national data on the potential screening population under the current guidelines.

Tanner Caverly was also recently interviewed for U.S. News & World Report on the risks and benefits of lung cancer screening. According to Dr. Caverly, it important to tailor the conversation about screening because the benefit-versus-risk calculation differs for each patient.

Reshma Jagsi, MD, DPhil

Director

Reshma Jagsi, MD, DPhil, is Professor, Deputy Chair, and Residency Program Director in the Department of Radiation Oncology and Director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.

She graduated first in her class from Harvard College and then pursued her medical training at Harvard Medical School. She also served as a fellow in the Center for Ethics at Harvard University and completed her doctorate in Social Policy at Oxford University as a Marshall Scholar.

Last Name: 
Jagsi
Research Projects: 
Press Coverage: 

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.

CBSSM Colloquium 2016-- call for abstracts

2016 CBSSM Research Colloquium – University of Michigan

 

Call for Abstracts

 

The Center for Bioethics and Social Sciences in Medicine (CBSSM) Research Colloquium will be held Wednesday, April 27, 2016 at the Founders Room, Alumni Center, 200 Fletcher Street, Ann Arbor, MI 48109.

The CBSSM Research Colloquium will feature the Bishop Lecture in Bioethics as the keynote address.  This year CBSSM is delighted to announce that William Dale, MD, PhD will present the Bishop Lecture with a talk entitled: "Why Do We So Often Overtreat, Undertreat, and Mistreat Older Adults with Cancer?"

William Dale, MD, PhD is Associate Professor of Medicine and Chief, Section of Geriatrics & Palliative Medicine & Director, SOCARE Clinic at the University of Chicago. A geriatrician with a doctorate in health policy and extensive experience in oncology, Dr. Dale has devoted his career to the care of older adults with cancer -- particularly prostate cancer. Dr. Dale has a special interest in the identification and treatment of vulnerable older patients who have complex medical conditions, including cancer. He is actively researching the interactions of cancer therapies with changes associated with aging.
 

 

Abstract submissions are welcome from all disciplines both within UM, as well as other institutions. CBSSM is an interdisciplinary center focusing on bioethics and social sciences in medicine. Our research program areas of interest include:

  • Clinical and Research Ethics - committed to empirical research in ethics (what some have called empirical ethics) by providing an evidence base for informed policy and practice.
  • Health Communication and Decision Making – using techniques from basic and applied research, determines the best practices for communicating health information to patients.
  • Medicine and Society - examines the way health care and bioethics are influenced by social structures and cultural ideas.
  • Health, Justice, and Community - aims to improve knowledge, understanding and practice in resource allocation and distributive justice, ethics of health policy (public and private) and community engagement, with the overarching goal of improving health equity.
  • Genomics, Health, and Society - examines the ethical, social and behavioral implications of advances in genomics.

For more information about our program areas: http://cbssm.med.umich.edu/


Submission Details: (Form is below)

  • Abstracts should contain a title, followed by the names and designations of all contributing authors and the contact details of the corresponding author.
  • Abstracts are to be a maximum of 300 words in length (exclusive of title and author information).
  • Presentations should last no more than 20 minutes, with an additional 5 minutes for questions.  The total time allotted is therefore 25 minutes per presentation. 
  • Abstracts should be submitted on the attached Abstract Submission form.  Submit abstracts via email to Kerry Ryan, kryanz@med.umich.edu. If you have questions about the abstract, please contact CBSSM at 734-615-8377 or email Kerry Ryan.
  • Deadline for abstract submission is Friday, March 11, 2016.
  • Notification:  Applicants will be notified by Friday, March 25, 2016.


Tentative Schedule for the Colloquium:


9:00-10:30 Presentations
10:45-12:00 Bishop Lecture:  William Dale, MD, PhD
12:00-1:15 Lunch
1:15-4:30 Presentations

Click here for Abstract Submission Form.

2017 CBSSM Research Colloquium and Bishop Lecture (Norman Daniels, PhD)

Tue, April 25, 2017, 8:30am
Location: 
Great Lakes Room, Palmer Commons, 100 Washtenaw Ave, Ann Arbor, MI 48109

The Center for Bioethics and Social Sciences in Medicine (CBSSM) Research Colloquium was held Tuesday, April 25, 2017 at the Great Lakes Room, Palmer Commons, 100 Washtenaw Ave, Ann Arbor, MI 48109.

The CBSSM Research Colloquium featured the Bishop Lecture in Bioethics as the keynote address.  Norman Daniels, PhD presented the Bishop Lecture with a talk entitled: “Universal Access vs Universal Coverage: Two models of what we should aim for."

Norman Daniels, PhD is Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health in the Department of Global Health and Population at the Harvard School of Public Health. Formerly chair of the Philosophy Department at Tufts University, his most recent books include Just Health: Meeting Health Needs Fairly (Cambridge, 2008); Setting Limits Fairly: Learning to Share Resources for Health, 2nd edition, (Oxford, 2008); From Chance to Choice: Genetics and Justice (2000); Is Inequality Bad for Our Health? (2000); and Identified versus Statistical Lives (Oxford 2015). He has published 200 peer-reviewed articles and as many book chapters, editorials, and book reviews. His research is on justice and health policy, including priority setting in health systems, fairness and health systems reform, health inequalities, and intergenerational justice. A member of the IOM, a Fellow of the Hastings Center, and formerly on the ethics advisory boards of the CDC and the CIHR, he directs the Ethics concentration of the Health Policy PhD at Harvard and recently won the Everett Mendelsohn Award for mentoring graduate students.

2017 Colloquium Schedule:

  • 8:30     Check in, refreshments
  • 9:05     Welcome
  • 9:10     Presentation 1: “Setting priorities for Medicaid: The views of minority and underserved communities” Susan Goold, MD, MHSA, MA & Zachary Rowe, Executive Director, Friends of Parkside
  • 9:35     Presentation 2: ““How Acceptable Is Paternalism? A Survey-Based Study of Clinician and Non-clinician Opinions on Decision Making After Life Threatening Stroke” Kunal Bailoor, MD Candidate
  • 10:00   Medical Student in Ethics Award
  • 10:10   Presentation 3: “Ethical Challenges Faced by Providers in Pediatric Death: A Qualitative Thematic Analysis” Stephanie Kukora, MD
  • 10:35   Presentation 4: “Capacity for Preferences:  An overlooked criterion for resolving ethical dilemmas with incapacitated patients” Jason Wasserman, PhD & Mark Navin, PhD
  • 11:00   Break
  • 11:15  Bishop Lecture: Norman Daniels, PhD
  • 12:45  Lunch

Funded by Health and Human Services, Department of-Agency for Health Care Research and Quality

Funding Years: 2013 - 2018.

The 2011 HHS report on multiple chronic conditions highlighted the prevalence, morbidity, and cost associated with clusters of co-occurring chronic conditions, both physical and mental. Collaborative chronic care models (CCMs) are effective in treating chronic medical and mental illnesses at little to no net healthcare cost. To date CCMs have primarily been implemented at the facility level and adopted by larger, public healthcare organizations. However, the vast majority of primary care and behavioral health practices providing commercially insured care are far too small to implement such models. Health plan-level CCMs can address this unmet need. Based on a groundbreaking partnership with Aetna Inc., the goal of this study is to implement a cross-diagnosis CCM designed to improve outcomes for persons with mood disorders with an eye towards developing a business case for a generalizable plan-level CCM for solo or small practices. Mood disorders (depression and bipolar disorder) were identified by Aetna as priority conditions because of their chronic nature and high healthcare costs. While evidence-based care parameters have been well established, quality of medical and psychiatric care and health outcomes are suboptimal for persons with mood disorders. We will conduct a randomized controlled trial of the cross-diagnosis CCM vs. education control among Aetna beneficiaries across the country who were hospitalized for unipolar depression or bipolar disorder and treated in solo or small primary care or behavioral health practices. At hospitalization discharge a total of 172 solo or small practices involving a total of 344 patients will be randomized to one year of outpatient treatment augmented by the CCM or education control. CCM care management will be fully remote from practice venues and patients, implemented by the Aetna care management center in Salt Lake City. The primary health outcomes are mood disorder symptoms, health-related quality of life, hospitalizations, and guideline-based mood disorders and cardiometabolic management. Secondary outcomes include determining the provider and organizational factors associated with CCM uptake and outcomes, cost effectiveness of the CCM compared to education control, and development of a business plan based on empirical data and stakeholder input. This proposed R18 addresses AHRQ's research demonstration and dissemination priorities, particularly around prevention and care management. In addition to this groundbreaking practice-research partnership focused on solo or small practices to further implement CCMs at the health plan level, this study may also lead to the evolution of the business case for cross-diagnosis CCMs in general, and the utility of plan-level panel management and remote technologies, especially with the advent of accountable care organizations and similar initiatives.

PI(s): Amy Kilbourne

Co-I(s): Daniel Eisenberg, H. Myra Kim

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