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Tue, January 10, 2017

Geoffrey Barnes was featured in a recent MHealth Lab article, "Medication Adherence a Problem in Atrial Fibrillation Patients." Dr. Barnes is the lead author of JAMA Cardiology article, which reports that while anticoagulant therapy is important for stroke prevention in people with atrial fibrillation, many people don’t stick with it for various reasons (side effects, physician advice, etc.).

Registration is now open for the April 25, 2017 CBSSM Research Colloquium & Bishop Lecture in Bioethics. This event is free and open to the public. Registration is encouraged, as it will help us to estimate numbers for catering and lunch. Please RSVP by April 18th.

The keynote address is the Bishop Lecture in Bioethics, an endowed lectureship made possible by a gift from the estate of Ronald C. and Nancy V. Bishop.  Norman Daniels, PhD will present 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.

Location: Great Lakes Room, Palmer Commons, 100 Washtenaw Ave, Ann Arbor, MI 48109
Click here to register for the Colloquium!

Click here for the Colloquium Schedule and Presentation Abstracts.

Andrew Barnosky received the Kaiser Permanente Award for Excellence in Clinical Teaching. The Kaiser Award is the most prestigious teaching award given by the Medical School. Made possible by a grant from the Kaiser Foundation Hospitals, it consists of an honorarium of $1,000 and a certificate which is presented to each awardee at the Graduation Luncheon. Two awards are given each year – one for preclinical and one for clinical teaching. Congratulations!

You can read the press release here.

Supporting information for: 2012 CBSSM Research Colloquium

Making a baby in the 21st century: An updated user manual

Presenting author: Melissa Constantine, PhD, Postdoctoral Research Fellow, CBSSM

Genetic testing has had a major role in prenatal care for decades.  Aneuploidy screening tests use non-invasive measurements of maternal serum markers to indicate whether a fetus is at increased risk for Down syndrome (trisomy 21) and Edward syndrome (trisomy 18), chromosomal abnormalities for which there are no curative or interventional treatments.  Prenatal screening is often a starting point on a pathway of decision making regarding invasive testing – with associated non-negligible miscarriage risks – and the termination of pregnancy.  As such, decisions to accept or refuse prenatal screening are preference sensitive and patient informed consent or informed refusal is warranted.

In the last year, new methods of genetic analysis for fetal diagnosis for multiple conditions have been introduced for clinical use, and the array of detectable fetal conditions is expanding.  Clinically, the new methods substantially improve on current diagnostic protocols; they are non-invasive, safe, easy to use, have sensitivity and specificity approaching 100% and can be administered as early as 7-10 weeks gestation.  Yet the uptake of a prenatal diagnostic testing for genetic conditions will continue to be a value-laden, preference sensitive choice and the need for informed consent will remain.

Ostensibly, the purpose of offering testing and the subsequent decision is to increase a woman’s control in her reproductive choices.  Some characteristics of the new testing technologies, such as earlier, confirmatory diagnosis, may enhance this control, although research on the process and experience of decision making for prenatal testing has consistently identified several aspects of current testing protocols that actually diminish control and obfuscate the perception of choice.  This presentation will explore how the clinical integration of the new genetic tests may mitigate, or exacerbate, women’s control in decision making and choice for prenatal diagnosis.

Dr. Melissa Constantine earned her Ph.D. in Health Service Research from the University of Minnesota and is currently a Postdoctoral Research Fellow at the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.  Dr. Constantine’s work in measurement and psychometrics includes development and validation of health-related scales such as the Pelvic Organ Prolapse and Incontinence Sexual Questionnaire (PISQ-IR).  Her research interests focus on the ethical and social implications of the clinical integration of prenatal genetic tests.


Using community-based participatory research and user-centered design approaches in developing an interactive diabetes decision aid

Presenting authors: Vida A. Henderson, PharmD, MPH, MFA, Center for Health Communications Research; and Deliana Ilarraza

Co-authors: Kathryn LC Barr, MPH; Lawrence An, MD; William Newhouse; Michele Heisler, MD, MPH

Background: Together, community-based participatory research (CBPR), user-centered design (UCD) and health information technology (HIT) offer promising approaches to improve health disparities.

Objectives: This presentation will describe the application of CBPR and UCD principles to the development of iDecide/Decido, an interactive, tailored, web-based decision aid delivered by community health workers (CHWs) to African-American and Latino participants with diabetes in Southwest and Eastside Detroit. The decision aid is offered in English or Spanish and is delivered on an iPad in participants’ homes.

Methods: The overlapping principles of CBPR and UCD used to develop iDecide/Decido include: a community or user-focused approach; equitable academic and community partnership in all study phases; an iterative development process that relies on input from all stakeholders; and a program experience that is specified, adapted, and implemented with the target community.

Results: Collaboration between community members, researchers, and developers are especially evident in the program’s: design concept, animations, pictographs, issue cards, goal setting, tailoring, and additional CHW tools.

Conclusions:  Applying the principles of CBPR and UCD can be successfully employed in developing health information tools that are easy to use and understand, interactive, and target health disparities.

Vida Henderson, PharmD, MPH, MFA, currently works with the behavioral science team at the Center for Health Communications Research where she writes and tests tailored content for multi-media health behavior interventions. She has worked as a clinical pharmacist providing health education and medication counseling to low-income communities; and she has served as a faculty member at Xavier University of Louisiana College of Pharmacy in New Orleans.  Vida has recently received a Master of Public Health degree in Health Behavior and Health Education from the University of Michigan. Her research interests include health communications, spirituality and health, and health disparities.

Deliana Ilarraza is a Community Health Worker for the Community Health and Social Services Center (CHASS)/REACH Detroit Partnership.  Deliana works with community organizations, schools and churches, establishing sites for physical activity classes and conducting diabetes awareness and prevention programs and studies.  She has worked with the National Kidney Foundation of Michigan, the Adolescent Diabetes Health Literacy Study, and the Journey to Health diabetes management and empowerment program, facilitating workshops, teaching curricula, and evaluation.


Resident attitudes toward ethical and medical decision-making for neonates born at the limit of viability

Presenting author: Naomi Laventhal, MD, MA, Clinical Lecturer, Department of Pediatrics and Communicable Diseases, CBSSM faculty

Co-author: Stephanie Kukora, MD

Background: Existing guidelines call for consistent resuscitation practices for extremely preterm infants based on epidemiologic data, but appropriate frameworks for value-driven decision-making in this context are still debated. Neonatologists’ attitudes are well-studied, but those of resident physicians are poorly understood.

Objectives: To describe residents’ knowledge of our practices, attitudes toward gestational age (GA) based resuscitation thresholds, and ethically relevant considerations for decision-making at the margin of gestational viability.

Methods: We surveyed our pediatric residents anonymously, asking them to identify current practices and ideal GA thresholds for offering and insisting on resuscitation, and the importance of contributing factors in decision-making for extremely preterm infants. Results: Response rate 61% (n =36).  Many (62%) residents correctly identified 23 weeks as the lower threshold for resuscitation in our NICU (range 21 - 24), despite finding our practices inconsistent (84%) and unclear (89%). Fewer (21%) correctly identified 24 weeks as the latest GA that parents may refuse resuscitation (range 23 - 42, 32% 25 weeks, 21% 26 weeks, 16% >26 weeks). Most disagreed with our current practices, identifying a preferred older GA for the lower threshold: 48% at 24 weeks, and 18% at 25 weeks (range 23-27). Most thought the upper threshold for elective resuscitation was too low, with 24% and 28% indicating 25 and 26 weeks, respectively, and 33% ≥28 weeks (range 24-40).  Compared to current considerations, they reported scientific evidence to be undervalued (p<.0001), and attendings’ personal beliefs to be overvalued (p<.0001). Responses trended toward family social and financial situations being undervalued. 

Conclusions: Our residents recognize decision-making for extremely preterm infants that is supported by known epidemiology, but attribute it to physicians’ personal beliefs, rather than scientific evidence. This suggests educational deficits, and a need for further study in a larger sample.  Preferences for a higher GA threshold for initiating resuscitation and a wider GA range in which parents may refuse it may reflect disproportionate pessimism about preterm infants.

Dr. Naomi Laventhal joined U-M in 2009, after completing her residency in pediatrics, fellowships in neonatology and clinical medical ethics, and a master’s degree in public policy at the University of Chicago.  In the Brandon Neonatal Intensive Care Unit at C.S. Mott Children’s Hospital she cares for critically ill newborns, provides prenatal consultation for parents expecting to deliver premature infants, and teaches neonatal-perinatal medicine and bioethics to residents and medical students.  Her research is in neonatal clinical ethics, and is currently focused on decision making for infants born at the margin of gestational viability.   Dr. Kukora is a resident in Pediatrics, having completed her MD at the University of Texas Southwestern Medical School.


Distrust of pediatricians’ sleep advice: Focus group results from the Project for African American Infant Safety

Presenting author:  Kathryn L. Moseley, MD, MPH, Assistant Professor, Department of Pediatrics and Communicable Diseases, CBSSM faculty

Co-author: Jennifer C. Sanchez, MPH

Background: Sudden Infant Death Syndrome (SIDS) is the number one cause of death for infants from birth to one year of age and can be reduced by placing the infant in the supine sleeping position. Although the number of SIDS-related deaths is decreasing, it still remains a significant issue, especially in the African American population where the supine sleep position is used less.  PrAAIS (Project for African American Infant Safety) is a randomized controlled trial promoting infant supine sleep among African American parents of newborns in Detroit, Michigan through the creation and distribution of tailored health educational materials.

Methods: We conducted six exploratory focus groups with a total of 29 African American parents of young infants to identify barriers and facilitators to infant supine sleep. 

Results: A prominent barrier that emerged during data analysis was distrust of physicians’ advice about supine sleep. This distrust stemmed from: a) skepticism of the validity of information provided by childless pediatricians, b) the paternalistic instructional style of pediatricians’ sleep advice (“you must do this”), and c), the frequent changes in sleep position recommendations that are not consistent with mothers’ lived experience, where the only rationale provided is that “studies show…”

Discussion: Parental distrust is not surprising, given these assessments.  Our results suggest that physicians may become more trustworthy sources of information about supine sleep if they: a) openly acknowledge parental confusion about the guidelines, b) provide concrete advice on methods to successfully achieve infant supine sleep in a more participatory manner, and c) place the danger of ignoring the guidelines in context through a discussion of both the relative and absolute risk to their infant of dying from SIDS or suffocation.

Dr. Kathryn Moseley is a clinical bioethicist as well as board-certified pediatrician and neonatologist.  For eleven years, Dr. Moseley was the Director of Bioethics for the Henry Ford Health System in Detroit, Michigan, overseeing a busy ethics consultation service.  She joined U-M in 2002 with a joint appointment in the Program in Bioethics and the Child Health Evaluation and Research Unit to conduct research on the racial differences in health care decision-making she discovered doing clinical ethics consultations and how those decisions are affected by culture and trust.  She recently received a grant from the NIH to conduct a 5-year trial of a culturally-tailored intervention to decrease the incidence of Sudden Infant Death Syndrome in the African American community.  She co-chairs the Pediatric Ethics Committee and directs the ethics consultation service at C.S. Mott Children’s Hospital.


What’s in a name? The effect of a disease label on parents’ decision to medicate a colicky infant

Presenting author: Laura D. Scherer, PhD, Postdoctoral Research Fellow, CBSSM and VA

Co-authors: Brian K. Zikmund-Fisher, PhD; Angela Fagerlin, PhD; Beth A. Tarini, MD

It is common for physicians to diagnose infants who have excessive regurgitation and associated crying with Gastroesophageal Reflux Disease (GERD).  From 1999-2004 there was a 7-fold increase in the use of prescription medications to treat GERD in infants <1 year old (Hassal, 2012).  However, clinical trials have shown that existing medications are no better than placebo in treating these symptoms (Orenstein et al., 2009) and the majority of infants grow out of this behavior without medical intervention.  Given this, it is unclear why medical treatment of GERD persists.  One possibility is that the way that physicians frame their assessment of the symptoms influences parents’ perceived need to medicate their child.  In the present study, we examined how a doctor’s explanation—in particular, the doctor’s use of the diagnostic label “GERD”—influences parents’ desire for medical interventions. To explore this question, we asked parents in the waiting room of a general pediatrics clinic to read a scenario (2x2 randomized design) in which they were asked to imagine they had an infant who cried and spit up excessively.  The scenario then described a pediatric appointment in which the infant either received a formal diagnosis of GERD, or not.  In addition, half of parents were explicitly told that existing medications are ineffective at treating the symptoms, or not.  Results showed that the presence of a GERD diagnosis made parents more interested in medicating their infant, even when they were explicitly told that the medications do not work.  Moreover, the GERD diagnosis made parents less likely to think that their infant would get better without medication, relative to parents who received no diagnosis.  In conclusion, physician labeling of normal infants as “diseased” may increase parents’ willingness to medicate their child.

Dr. Laura Scherer is a Postdoctoral Research Fellow at the VA Center for Clinical Management Research and the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.  She received her PhD in Social Psychology from Washington University in St. Louis, and will soon be an Assistant Professor of Psychology and Health Sciences at the University of Missouri in Columbia.  Her interests include the impact of emotions and intuition on medical decision making, and the psychological phenomena that lead to medicalization and overtreatment.


Cracking the code: Ethical issues involved in the decision to undergo genetic testing

Presenting author: Lauren B. Smith, MD, Assistant Professor, Department of Pathology, CBSSM faculty

Advances in molecular diagnostics have led to the capability of sequencing an individual’s germline DNA or exome for as little as $1000. An ethical analysis and discussion of genetic testing, both historically and as it relates to this new technology, will be presented.  The discussion will include factors related to the decision to undergo testing, possible benefits and harms, and issues surrounding research protocols and commercial testing services.  The discussion will include an overview of testing for Huntington disease, breast-ovarian cancer syndromes, and Alzheimer’s disease as illustrative examples.

Dr. Lauren Smith is an Assistant Professor in the Department of Pathology at the University of Michigan, specializing in hematopathology.  She has been a member of the University of Michigan Adult Ethics Committee since 2005 and also serves as a member of the Michigan State Medical Society Ethics Committee.  Her research interests include ethical issues in clinical medicine and pathology.


The myth of individual risk    

Presenting author: Ralph Stern, MD, PhD, Clinical Assistant Professor, Department of Internal Medicine

Co-author: Zachary Goldberger, MD

Medical decision-making often relies upon clinical prediction models to estimate individual risk.  Morbidity and mortality predictions (e.g.  Framingham for ischemic heart disease in healthy patients or APACHE for mortality in critically ill patients) are often used for treatment decisions (e.g. statins, aspirin, hypoglycemic therapy).  As such, their prognostic value carries particular importance for shared decision-making with patients and their families.  However, it remains underappreciated that clinical prediction methods were developed to analyze disease in populations, not individuals.  The notion that such models can give individual patients a unique probability of a health outcome is highly debatable.  When the goal is allocating treatments to high risk subgroups to reduce costs, these models may be useful.  But when the goal is allocating treatments to high risk individuals, none of the models should be the sole basis for clinical decisions.

 Because risk cannot be measured in an individual, there is no way to experimentally verify any of the individual predictions provided by a model.  This can only be achieved by assembling a group of patients similar to the individual in question.  That each of these groups may have a different risk means there is no such thing as individual risk, an issue identified by John Venn in 1866 and known as the reference class problem.  Different models may yield substantially different individual risk estimates.  This is an inherent limitation, which is not eliminated by inclusion of more risk factors in the model or other proposed solutions.

While these models are widely used, it remains unclear how best to apply them.  Clinicians who use these models to make patient care decisions need to be aware of their limitations. 

Dr. Ralph Stern is an Assistant Professor of Medicine in the divisions of Cardiovascular Medicine and Molecular Medicine and Genetics.  His clinical interests are hypertension and medical and cancer genetics.  His research interests include risk stratification and the clinical utility of new risk factors.

Dr. Zachary Goldberger is a 4th year cardiology fellow and Robert Wood Johnson Clinical Scholar.  His research interests center on antiarrhythmic therapy.  Specifically, he is interested in understanding the attitudes and experiences of patients receiving implantable cardioverter-defibrilators (ICDs), and creating a decision aid to enhance shared decision-making for patients receiving ICDs for primary prevention of sudden cardiac death.  He is also studying utilization of antiarrhythmic therapy and drug toxicity, as well as patterns of care in resuscitation during in-hospital cardiac arrest.  His teaching interests center on improving ECG literacy and cardiac physical examination skills in trainees.


The swinging gate: Genetic testing and ethical issues

Presenting author: Wendy R. Uhlmann, MS, CGC, Clinical Assistant Professor, Departments of Internal Medicine and Human Genetics

Advances in genetic testing have resulted in an exponential increase in the number of genetic tests that are available.  Given the rapid pace of genetic test introduction, few tests have practice guidelines.  As a result, healthcare professionals who order these tests and the genetic testing laboratories have gate-keeper roles with genetic testing.  Genetic tests, unlike most medical tests, present some unique considerations given the potential familial implications in addition to the fact that genetic testing is a moving target.  Communication of genetic information and genetic test results along with medical record documentation of this information raises several ethical and policy issues, including: Who needs to know?  What information should be communicated?  Who is obligated to inform whom?  What factors need to be considered in the communication of genetic information?  Cases from the University of Michigan Medical Genetics Clinic will be used to illustrate ethical issues that clinicians encounter with patients pre-testing and post-testing, including: competing obligations, testing children, carrier testing for rare autosomal recessive genetic conditions, predictive genetic testing and broader insurance issues.  Weighing risks and benefits and resolving ethical issues with genetic testing decisions and communication of test results involves consideration of the core ethical principles in addition to assessment of both professional and patient obligations.  Careful consideration is needed in weighing competing obligations.  Understanding ethical issues currently experience din genetics clinics will help guide the handling of similar and novel future challenges that will arise with advances in genetic testing and genomic medicine.

Wendy R. Uhlmann, MS, CGC, is the genetic counselor/clinic coordinator of the Medical Genetics Clinic at the University of Michigan.  She is a Clinical Assistant Professor in the Departments of Internal Medicine and Human Genetics and an executive faculty member of the genetic counseling training program.  Wendy Uhlmann is a past president of the National Society of Genetic Counselors and currently serves on the National Center for Biotechnology Information (NCBI) Board of Scientific Counselors (BOSC), Medical Genetics Working Group.

Fri, February 21, 2014

Dr. Reshma Jagsi was involved with a study that reported an increase in women who recieved breast reconstruction following a masectomy for breast cancer. The study found that, "46 percent of patients received reconstruction in 1998 but that figure rose to 63 percent by 2007." Jagsi said, "Breast reconstruction has a big impact on quality of life for breast cancer survivors. As we are seeing more women survive breast cancer, we need to focus on long term survivorship issues and ensuring that women have access to this important part of treatment."

CBSSM's Co-Director Angela Fagerlin, Ph.D., has been named one of "25 Champions of Shared Decision Making." According to the Informed Medical Decisions Foundation, "Angie has spent her career testing methods for communicating the risks and benefits of treatment options to patients, especially through decision aids. Based on the knowledge she has gained, Angie developed and tested decision aids for prostate cancer and breast cancer prevention. Her work has truly advanced the field of risk communication and patient-physician communication." 

Congratulations Angie! You can view the list here

On May 1, Jeff Kullgren, M.D., M.S., M.P.H., assistant professor of general medicine and a research scientist at VA CCMR and Mark Fendrick, M.D., director of U-M's Center for Value-Based Insurance Design (V-BID) urged the Michigan Senate Health Policy Committee to enact stronger state health care transparency laws, including requirements to make more data on price and quality publically available. "As more Americans face high levels of cost-sharing in their insurance plans, it's even more important to improve access to data that helps them anticipate their out-of-pocket expenses," Kullgren told the panel. Proposed legislation would establish an easily accessible database to help consumers compare both prices and quality of care for various medical procedures and prescriptions.      

CBSSM affiliates will be presenting at the WMU Ethics Center Conference: "Bioethics: Preparing for the Unknown" (March 17-18th).

CBSSM Postdoc Kayte Spector-Bagdady: “The Google of Personalized Healthcare: 23andMe and Enabling the Privatization of Genetic Biobanking"

Lan Le, Natalie Bartnik, Michele C. Gornick and Nicole Exe: “Examining the Psychosocial and Ethical Issues Arising from the Identification, Disclosure and Communication of Genomic Results to Patients and Clinicians,” Chair: Raymond De Vries

Other presentations with CBSSM/UM bioethics connections include:

"Patient Understanding and Satisfaction Regarding the Clinical Use of Whole
Genome Sequencing: Findings from the MedSeq Project," Archana Bharadwaj, School of Public Health

"The Voice is As Mighty as the Pen: Integrating Conversations Into Advance Care
Planning Policies," Kunal Bailoor, UM Medical School

Here is the link to the the program:

Here is the link to register:

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) invited three speakers to provide their insights on the importance of professional ethics and professionalism in neuroscience research on February 10th. The speakers included Nicholas Steneck, Ph.D., Director of the Research Ethics and Integrity Program of the Michigan Institute for Clinical and Health Research; David E. Wright, Ph.D., Director of the Office of Research Integrity at the U.S. Department of Health and Human Services; and Peggy Mason, Ph.D., Chair of the Society for Neuroscience’s Ethics Committee.

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