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Funded by NIH - Department of Health and Human Services

Funding Years: 2014-2016

This proposal's main objective is the development of a novel Perfusion Monitoring Device (PMD) based upon diffuse correlation spectroscopy (DCS), which will enable microsurgeons to assess the level of vascularization of buried (prelaminated) flaps and the successful perfusion of transplanted microvascular grafts. The PMD will shift current assessment of buried flap vascularization from subjective to direct quantitative determination. Currently there is no widely accepted clinical method of measuring buried flap vascularization or successful transplanted microvascular graft perfusion. The PMD would fill this need. The PMD leverages the recent availability of compact low-cost light sources, solid state detectors, and CPUs to simplify and miniaturize the measurement of buried flap vascularization and successful transplanted microvascular graft perfusion. The development of this technology is critical both for accident victims and for wounded soldiers, who have returned home with complex maxillofacial injuries. These injuries result in devastating soft tissue defects, i.e. avulsion of the lips that require innovative surgical approaches that include the use of tissue engineering in combination with microvascular surgery to develop unique prevascularized prelaminated flaps that are critical in the reconstruction of complex human anatomy such as the lips. Since these unique prelaminated flaps are buried under the skin we need novel PMDs to monitor their vascularization so that they can be harvested for transplantation at the most optimal moment. We will use both phantoms and an animal model in this Phase I proposal for the development of the PMD using DCS.

PI(s): Stephen Feinberg, Sean Edwards

Co-I(s): Brent Ward, H. Myra Kim, Joseph Helman, Mary-Ann Mycek

ELSI-LHS Symposium

Wed, November 15, 2017, 8:00am to 4:00pm
Location: 
Palmer Commons, 100 Washtenaw Ave

Join us for our 2nd annual symposium and workshop on the ethical, legal and social implications of learning health systems (ELSI-LHS).


This year's focus will be on data and knowledge sharing.


NOV 15 - 8:00 am - 4:00 pm: The symposium will lay out the ELSI of data sharing and translation in learning health systems that strive to be both FAIR (findable, accessible, interoperable, and reusable) and fair. The day will interactively address critical issues on data and knowledge sharing.


Speakers include John Wilbanks, Elizabeth Pike, Kenneth Goodman, Debra Mathews, Peter Embi, Peter Singleton, Warren Kibbe, Joon-Ho Yu and more to come!


Proceeds will be synthesized into draft recommendations for data and translation to practice & streamline future ELSI-LHS research.


We have issued a Call for Poster Abstracts to be included in the 2nd annual symposium. Poster displays should relate to the conference theme, "Data and Knowledge Sharing," and may relate to either ELSI or technical aspects of learning health systems. Abstracts and posters should be developed for an interdisciplinary audience including social scientists, informaticians, health care providers, and community members.


To submit an abstract, please go to: 2017 ELSI Abstract Submission
#elsilhs

CBSSM is a co-sponsor of this event.

David Sandberg, PhD

Faculty

Dr. Sandberg is a pediatric psychologist and clinical researcher.  As a pediatric psychologist, he delivers psychoeducational and behavioral health services to persons with endocrine disorders and their families, in particular, conditions affecting linear growth or disorders of sex development (DSD), i.e., congenital conditions in which development of sex chromosomes, gonads or sex anatomy is atypical.

Last Name: 
Sandberg

Funded by Patient-Centered Outcomes Research Institute (PCORI)

Funding Years: 2014 - 2016.

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

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

Funded by NIH Department of Health and Human Services

Funding Years: 2015-2020

Colorectal rectal cancer (CRC) is the third most common cancer in the US with over 50,000 individuals dying annually from the disease. Despite multiple effective screening tests, CRC screening remains underutilized relative to other cancer screening. A driving factor behind this underutilization among insured populations is the gap that exists between a physician recommendation for care and the patient's receipt of screening. How best to support patients in CRC screening once they have a physician recommendation for care remains unknown. The proposed project will test the effectiveness and impact of a post-visit, patient portal tool, e-Assist, for engaging and supporting primary care patients in their decision making regarding, and ultimately in their obtaining, CRC screening. The tool purposely leverages the cue to action provided by a physician recommendation for care as well as the secure patient portal platform now commonly found within primary care practices. It seamlessly combines important patient-physician decision making content with assistance in removing personal and structural barriers to screening. Our research will answer four overarching questions: (1) Can a post-visit, patient portal tool, e-Assist, increase adherence to physician-recommended CRC screening? (2) How does e-Assist engage primary care patients in the CRC screening decision making process? (3) Are there subgroups of the primary care population for whom e-Assist is more engaging and effective? and (4) What adaptations are needed to e-Assist to improve its reach, and ensure its adoption, implementation, and ultimately its impact on evidence-based CRC screening use among diverse primary care patients and clinics? These questions will be addressed using a two-arm, practical randomized trial supplemented with findings from focus groups and in-depth interviews with patients, clinicians and other clinic staff to ensure a comprehensive understanding of not only program effectiveness and implementation, but the factors driving overall program impact. Results will illustrate how e-tools can be used following an office visit to support both patient decision making, and the dissemination and implementation of evidence-based cancer screening services in primary care.

PI(s): Jennifer Lafata

Co-I(s): Sarah Hawley, Kenneth Resnicow

2015 Bishop Lecture featuring Lawrence O. Gostin, J.D., LL.D. (Hon.)

Tue, March 17, 2015, 11:00am
Location: 
Founders Room, Alumni Center, 200 Fletcher St., Ann Arbor, MI

Bishop Lecture in Bioethics: "Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak" (Keynote Address for the 2015 CBSSM Research Colloquium)

Abstract: The measles outbreak of early 2015 is symptomatic of a larger societal problem–the growing number of parents who decide against vaccinating their children. This failure is causing the resurgence of childhood diseases once eliminated from the United States.
falseThis presentation explores the legal and ethical landscape of vaccine exemptions. While all states require childhood vaccinations, they differ significantly in the types of religious and/or philosophical exemptions permitted, the rigor of the application process, and available review mechanisms. States with relaxed exemption policies disproportionately experience more outbreaks of vaccine-preventable disease.

Vaccine exemptions are an illustration of the “tragedy of the commons,” in which parents choose not to vaccinate their children, relying on the fact that other parents will vaccinate their children, thus providing community immunity. However, the net result of many individual decisions not to vaccinate is the collapse of herd immunity and thus an upsurge in preventable disease and death.
The failure to vaccinate puts others at risk, thus violating an important ethical principle. However, punishing individual parents could entrench political opposition to vaccine policy. The most ethical and effective solution is for state legislatures to tighten vaccination laws, making it more difficult to obtain non-medical exemptions.

Lawrence O. Gostin, J.D., LL.D. (Hon.) is University Professor, Georgetown University’s highest academic rank conferred by the University President. Prof. Gostin directs the O’Neill Institute for National and Global Health Law and is the Founding O’Neill Chair in Global Health Law. He is Professor of Medicine at Georgetown University, Professor of Public Health at the Johns Hopkins University, and Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities. Prof. Gostin is also the Director of the World Health Organization Collaborating Center on Public Health Law & Human Rights.

  • Click here for video-recording of the 2015 Bishop Lecture

H. Myra Kim, ScD

Faculty

H. Myra Kim is a Research Scientist at the Center for Statistical Consultation and Research and and Adjunct Professor at the Department of Biostatistics. She received her Sc.D. in Biostatistics from Harvard University in 1995 and worked at Brown University as an Assistant Professor from 1995 to 1997. She has worked at UM since 1997 and has collaborated with various researchers from around the UM community as well as from other universities.

Research Interests: 
Last Name: 
Kim

Funded by: NIH

Funding Years: 2016-2020

In the past 30 years, the Incidence of thyroid cancer has tripled. The majority of the rise in thyroid cancer incidence is attributed to an increase in low-risk, well-differentiated thyroid cancer, a disease that has a 10-year mortality close to zero. Our previous work suggests that patients with low-risk thyroid cancer are at risk for overtreatment, defined as the use of Surgical and medical interventions in the absence of a clear survival benefit. The overtreatment of thyroid cancer has inherent costs, both to patient health and to society. The reason for the intensive management and potential overtreatment of low-risk thyroid cancer remains unclear. By using SEER-linked patient and physician Surveys, we plan to understand the Treatment decision making in low-risk thyroid cancer. We hypothesize that knowledge and attitudes influence decision making. Specifically, we anticipate that lack of knowledge of risks of death, recurrence and Treatment complications is associated with Treatment that is more intensive. in addition, we postulate that a general preference for active treatment will also be associated with more intensive cancer Treatment. Although both patient and physician perceptions of Treatment need (i.e., knowledge and attitudes) likely contribute to Treatment intensity, we anticipate that the primary driver will be physicians, even after controlling for their patients' perceptions. This study will serve as the foundation for future Intervention studies. By identifying the specific role of physician and patient knowledge and attitudes toward thyroid cancer Treatment, we will be able to create tailored educational interventions to personalize Surgical and medical care for thyroid cancer patients, thus minimizing overtreatment and its inherent risks and costs. As the rising Incidence, low mortality, and pattern of intensive Treatment make thyroid cancer arguably the best cancer model for overtreatment, this proposed study will also serve as a model to understand overtreatment in other malignancies.

PI: Megan Haymart

CO(s): Brian J. Zikmund-Fisher, PhD & Sarah Hawley, PhD. MPH

Funded by National Institutes of Health.

Funding Years: 2013-2017.

The clinical management of patients with cancer does not entail a "one size fits all" approach. In fact, studies of the genomic landscape of human cancers have demonstrated that cancers can have a multitude of mutations, a subset of which may be "actionable" with current drugs. Thus, the personalization of therapy for cancer will require molecular characterization of unique and shared genetic aberrations. In particular, patients who have advanced / refractory cancer and are candidates for clinical trials could potentially benefit by identifying eligibility for "targeted" drugs based on the "actionable" genesin their specific tumor. Growing technological advances in genomic sequencing has now made it possible to consider the use of sequence data in a clinical setting. Thus, the translation of high throughput sequencing would support a "personalized" strategy for cancer. However, the translation of clinical sequencing bears unique challenges including identifying patients who could benefit, developing informed consent and human subjects protections, outlining measurable outcomes, interpreting what results should be reported and validated, and how results should be reported. This proposal brings together expertise at the University of Michigan including clinical oncology, cancer genetics, genomic science/bioinformatics, clinical pathology, social and behavioral sciences, and bioethics in order to implement this clinical cancer sequencing project. We have focused our clinical sequencing effort on sarcomas and other rare cancers as this is an area of clinical strength at Michigan. Three integrated Projects have the following themes: Project 1) "Clinical Genomic Study" will identify patients with advanced or refractory sarcoma or rare cancers who are eligible for clinical trials, consent them to the study obtain biospecimens (tumor tissue, germline tissue), store clinical data, and assemble a multi-disciplinary Sequencing Tumor Board to deliberate on return of actionable or incidental genomic results; Project 2) "Sequencing & Analysis" will process biospecimens and perform comprehensive sequencing and analysis of tumors to identify point mutations, copy number changes, rearrangements/gene fusions, and aberrant gene expression under CLIA/CAP guidelines; Project 3) "Ethics & Psychosocial Analysis" will evaluate the clinician and patient response to the informed consent process, delivery of genomic sequence results, and use of genomic results.

PI(s): Arul Chinnaiyan (Main Study PI), Scott Roberts (Project 3 PI)

Co-I(s): Ajjai Alva, Rashmi Chugh, Ray De Vries, Jeffrey Innis, Lakshmi Kunju, Rohit Mehra, Nallasivam Palanisamy, Dan Robinson, Moche Talpaz, Scott Schuetze, David Smith, Elena Stoffel, Scott Tomlins, Brian Zikmund-Fisher

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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