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Leaving the Emergency Room in a Fog (Sep-09)

Consider this scenario:

Alfred made a visit to his local Emergency Room. What was his diagnosis? What did the medical team do for his problem? What was he supposed to do to continue care at home? And what symptoms was he supposed to watch for to alert him to return to the ER?

Alfred woke up at 4 am on Sunday morning with pain in his left foot. That place where his new running shoes had rubbed a raw spot earlier in the week was getting worse. By 9 am, the foot was red and swollen, with a large oozing sore, and Alfred decided to go to the Emergency Room at his local hospital.

Late on Sunday afternoon, Alfred returned home from the ER. He crutched his way into the house and collapsed on the sofa. His teenage son quizzed him.

"What did they say was wrong?"
"Oh, an infection," replied Alfred.
"Well, what did they do for it?"
"I think they cut a chunk out of my foot," said Alfred.
"Whoa! Did they give you any medicine?"
"Yeah, a shot," said Alfred.
"And what’s with the crutches?"
"I’m supposed to use them for a while," said Alfred, looking annoyed.
"How long a while?"
"It’s written down," said Alfred, digging a crumpled sheet of paper out of his pocket.
"Says here you should take some prescription and elevate your left leg for two days."
"Two days? I have to go to work tomorrow," groaned Alfred.
"And you’re supposed to go back to the ER if you have a fever or pain in your leg. Where’s the prescription?"
"Here, look through my wallet. Maybe I stuck it in there," said Alfred.
The good news is that Alfred recovered completely, with some assistance and cajoling from his son. But how common is it for people who go to the Emergency Room to be foggy about what happened and what they should do once they leave the ER?
What do you think is the percentage of ER patients who do not understand at least one of the following: their diagnosis, the emergency care they received, their discharge care, or their return instructions?
 
  • 38%
  • 48%
  • 78%
  • 88%

How do your answers compare?

A recent study in the Annals of Emergency Medicine found that 78% of emergency room patients showed deficient comprehension in at least one of these areas:
 
  • Diagnosis
  • Emergency care that was given
  • Post-ER care needs
  • Symptoms that would require a return to the ER
51% of patients showed deficient comprehension in two or more areas. Only 22% of reports from patients were in complete harmony with what their care teams reported in all four areas. The biggest area of misunderstanding was in patients' post-ER care needs, such as medications, self-care steps, follow-up from their regular doctors, or follow-up with specialists.
 
Even more alarming is that, according to the study, "most patients appear to be unaware of their lack of understanding and report inappropriate confidence in their comprehension and recall." The patients were quite sure of what they knew 80% of the time—even when what they knew was not right.
 
These results suggest that Emergency Room teams need to do a better job of making sure that patients go home with clear information and instructions—and that patients and their loved ones shouldn't leave until they fully comprehend their situation.
 
Lead author Kirsten G. Engel, MD, conducted this study, "Patient Comprehension of Emergency Department Care and Instructions," with Michele Heisler, MD, Dylan M. Smith, PhD , Claire H. Robinson, MPH, Jane H.Forman, ScD, MHS, and Peter A. Ubel, MD, most of whom are affiliated with CBDSM.
 
The researchers carried out detailed interviews with 140 English-speaking patients who visited one of two Emergency Departments in southeast Michigan and were released to go home. These interviews were compared with the patients' medical records, and the comparisons revealed serious mismatches between what the medical teams found or advised and what the patients comprehended.
 
"It is critical that emergency patients understand their diagnosis, their care, and, perhaps most important, their discharge instructions," says Kirsten Engel, a former UM Robert Wood Johnson Clinical Scholar who is now at Northwestern University. "It is disturbing that so many patients do not understand their post-Emergency-Department care, and that they do not even recognize where the gaps in understanding are. Patients who fail to follow discharge instructions may have a greater likelihood of complications after leaving the Emergency Department."
 
Peter A. Ubel, the study's senior author, agrees: "Doctors need to not only ask patients if they have questions, but ask them to explain, in their own words, what they think is wrong with their health and what they can do about it. And patients need to ask their doctors more questions, and even need to explain to their doctors what they think is going on."
 
Read the article:

 

Lesly Dossett, MD, MPH

Faculty

Dr. Lesly Dossett MD, MPH is Assistant Professor of Surgery in the Division of Surgical Oncology at the University of Michigan. Dr. Dossett is an Honors Program and Summa Cum Laude graduate of Western Kentucky University. She earned her medical degree at Vanderbilt University School of Medicine in 2003, attending on a United States Navy Health Professions Scholarship. She completed general surgery residency at Vanderbilt University Medical Center in 2010, where she served as Administrative Chief Resident.

Last Name: 
Dossett

Drilling for Answers (Sep-08)

Find out about some experimental treatments for Parkinson's Disease. And then decide how you'd respond if you had a chance to participate in this research. In this interactive decision, we’re going to ask you about some experimental treatments for Parkinson’s Disease.

What is Parkinson’s Disease?

Up to 1 million Americans are currently diagnosed with Parkinson’s Disease, a brain disease that gradually worsens over many years and causes tremors, stiffness, slowness of movement, and balance problems. Some people with Parkinson’s Disease also experience changes in memory, concentration, and mood.

The average age at onset of symptoms is 65, but 5% to 10% have onset before the age of 45. The symptoms are caused by the death of cells in the brain that make a chemical called dopamine. Medications that are available to treat Parkinson’s Disease provide more dopamine to the brain or mimic the action of dopamine in the brain. In early stages of Parkinson’s Disease, symptoms generally respond well to medications. Over time, the medications become less effective and may cause more side effects.

What treatments are researchers developing?

One experimental procedure to treat moderate to advanced Parkinson’s Disease is gene transfer, which involves neurosurgery to insert a gene into the brain, to lower the side effects of medications and to increase the effectiveness of medications. Note that no stem cells or fetal cells are used. The patient is sedated but remains awake. The scalp is numbed by injections of local anesthetics (like Novocaine), so the patient should not feel discomfort. The surgeon drills two small holes into the skull and injects a liquid containing the gene on each side of the brain into areas known to be affected in Parkinson’s Disease.

How would gene transfer surgery be tested?

To see if the gene transfer surgery is truly effective, investigators need to compare a group that receives the gene transfer surgery with a group that does not. People would be randomly assigned (e.g., by flipping a coin) to one of the two groups. This kind of study could be done in two ways.

  • An open study could be done, where everyone knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications only. The other half would receive their usual medications plus the gene transfer surgery.

  • A blinded study could be done, where neither the patient nor the evaluating researcher knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications plus gene transfer surgery. The other half of the patients would receive their usual medications plus “sham surgery.” Patients receiving sham surgery have the two small holes drilled into the skull. But the protective coverings in the brain are not disturbed, and there is no insertion of any material into the brain.

    In a blinded study, only the surgeon would know who has received the gene transfer surgery and who has received sham surgery. If the gene transfer surgery is found to be both safe and effective, those in the sham surgery group would have the option of receiving the gene transfer at a later date without cost, using the holes drilled during the sham surgery.

What are the risks of these studies?

For surgery patients in both an open study and a blinded study, the surgery poses potential risks. There is a 1% to 4% risk of bleeding into the brain (usually minor, but there is a less than 1% chance that it could result in death or substantial disability). There is also a 1% to 5% risk of infection developing in the skin or brain, which would be treated with antibiotics. Overall, the risk of bleeding and infection is smaller for sham surgery than for actual gene transfer surgery.

Those subjects receiving the gene transfer surgery would face additional risks, including the possibility of brain tumors, inflammation of the brain, and a worsening of the Parkinson’s Disease. Patients in pilot studies have been followed for only one year, so longer-term effects are not known.

What are the pros and cons of the two kinds of studies?

When deciding whether or not to adopt a new procedure, it’s important to get accurate, unbiased evidence. If we adopt a new procedure that is unsafe or ineffective, people will end up receiving unnecessary surgeries. If we fail to adopt an effective procedure, we miss the opportunity to offer people a treatment that could benefit them.

Most, but not all, researchers in the field believe that the blinded study, using sham surgery, would provide better quality data than the open study. These researchers worry that if people know which procedure they receive, the results of the study may be difficult to interpret because expectations of both the patient and the evaluating researcher can unintentionally bias the results.

However, some people, including some researchers, worry that a study using sham surgery may not be worth the risks and burdens. The patients with Parkinson’s Disease who get the sham surgery undergo a neurosurgical procedure that provides no benefit to them, while being exposed to the risks and burdens of the procedure. There is also the worry that people with moderate to advanced Parkinson’s Disease are vulnerable to exploitation because having a serious, incurable illness may put them in a desperate situation.

Now, you decide!

Imagine that you have moderate to advanced Parkinson’s Disease. You can do most things independently, but involuntary movements interfere with your routine activities. Daily chores take twice as long compared to people without Parkinson’s Disease. For some parts of the day, your movement is extremely slow and you need help with daily activities.

You are asked to participate in either an open study or a blinded (sham surgery) study. Which study would you choose to participate in?
  • Blinded study (sham surgery)
  • Open study
  • Would not participate

Researchers have found that only about 35% of the general population would choose, as you did, to participate in the blinded study. As reported in a 2008 article in the journal Movement Disorders, about 55% of the general population would choose the open study, and the remaining 10% said they would not participate.

When these same questions were posed to people who actually have Parkinson’s Disease, the response was quite different: 24.5% picked the blinded study, 41.5% picked the open study, and 34% said they would not participate. The researchers observe that patients with chronic illness adapt to their disabilities; the people with Parkinson’s Disease might have felt that they had less to gain or more to lose from the benefits and risks associated with a trial involving surgery. Alternatively, people without Parkinson’s Disease may have over-estimated the impact that disability might have on them or underestimated their ability to function.

In this study, people were also asked to imagine that they were members of an ethics review committee deciding whether to allow certain studies. About 81% of respondents said that they would definitely or probably allow the open study for gene transfer. 55% said that they would definitely or probably allow the blinded (sham surgery) study. These results were the same for both the general population and people with Parkinson’s Disease. In other words, a very large majority of both Parkinson’s patients and non-Parkinson’s patients endorsed the open study as ethically acceptable. A majority endorsed sham surgery as an ethically acceptable control condition.

In analyzing these results and reading the written remarks added by the respondents, the researchers comment, “Education seems to play a strong role in people’s willingness to take a more societal perspective and balance the burdens to participants with the overall scientific and societal benefit. . . Those opposed to sham surgery appeared to have an intrinsic objection to blinding, and to focus on the invasive nature of the sham surgery per se . . .Given the complexity of the topic, it may be that laypersons, especially those with less education, may need more opportunity to learn and deliberate on the issues.”

Interestingly, scientists researching Parkinson’s Disease were presented with these same questions in a related study (Kim SY, Frank S, Holloway R, Zimmerman C, Wilson R, Kieburtz K. Science and ethics of sham surgery: A survey of Parkinson disease clinical researchers. Arch Neurol 2005;62:1357-1360.) Only 50% of these clinical researchers would allow open studies, and 94% would support controlled studies using sham surgery.

In conclusion, “Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery.”

For a complete discussion of this research, see Frank S, Wilson R, Holloway R, Zimmerman C, Peterson A, Kieburtz K, Kim SY. Ethics of sham surgery: Perspective of patients. Movement Disorders 2008;23(1):63-68. The senior author, Scott Y. Kim, MD, PhD, is a faculty member at the Center for Behavioral and Decision Sciences at the University of Michigan.

Read the article:

Ethics of sham surgery: Perspective of patients.
Frank S, Wilson R, Holloway RG, Zimmerman C, Peterson DR, Kieburtz K, Kim SY. Movement Disorders 2008;23:63-8.

Internet Survey Lab

Overview

The Internet Survey Lab at the Center for Bioethics and Social Sciences in Medicine (CBSSM), led by Dr. Brian Zikmund-Fisher, facilitates the programming of complex experimental designs, using the graphical and interactive capabilities of the Internet. CBSSM has extensive experience in developing, programming and conducting survey research using Internet-based methodologies. 

Why We Use the Internet

A key advantage of Internet surveys is that they can shape and direct a user's experience in response to computer generated randomization and/or respondents' own answers to questions earlier in the survey. Additionally, page and answer order can be truly randomized as appropriate to limit cognitive biases. The unique advantage of Internet surveys, however, is that many different types of stimuli can be randomized or varied; static visual images, movies, or sounds can all be used in addition to text. Furthermore, the nature of the browser interface enables user-directed interactivity, such as user-adjustable risk communication graphics, that provide unique opportunities for both knowledge communication and response assessment.

Using the Internet to conduct survey research is also very efficient: we can develop and test surveys in only a few months' time, and once a survey is ready, large scale data collection (e.g., 1500-3000 completed surveys) can be completed in only 2-3 weeks.  Such surveys can also be cost effective, since while significant effort goes into development, creation, and testing of the survey, almost no personnel effort is required for data collection, entering, coding, or cleaning.  In addition, oftentimes several small surveys can be combined into a single instrument, creating further efficiencies.

Sometimes, our studies use large, demographically diverse samples obtained through commercial survey research firms. This methodology allows us to tailor the population being surveyed on multiple demographic variables (e.g., sampling only women age 40-75 for a study about breast cancer treatments) and provides us with ample statistical power to conduct multi-factorial experimental tests. Other times, we use more inexpensive samples from Amazon Mechanical Turk (MTurk) for quick pilot testing or to enable rapid, iterative testing of designs. Regardless, the use of randomized designs ensures high internal validity for the research despite the use of an Internet-only sample.

CBSSM Surveys

CBSSM has had considerable success using this methodology, publishing multiple manuscripts in highly regarded peer-reviewed journals. Studies that have used this methodology have addressed a variety of topics, including:

  • The use of pictographs to display risk (20082008, 2014) including in comparison to other graphical formats (2008, 2010, 2010). 
    Note: to create your own pictographs, see www.iconarray.com.
  • Misprediction of happiness between younger and older adults (2005)
  • Elicitation of utility and willingness to pay (200720072008)
  • Research ethics, e.g., participation of mentally vs. medically ill in research (2005)
  • Risk communications that emphasize incremental risks instead of absolute risks (2008)
  • Simplifying risk communications about adjuvant therapy options (2008).
  • Effect of risk labels on prenatal screening decisions (2007).
  • Time-insensitivity in people's understanding of survival curves (20052007)
  • Self-other discrepancies in medical decisions (20062008)
  • Sequential vs. all at once presentations of risk information (2011)
  • Testing of animated or interactive risk graphics (2011, 2012, 2014)
  • Optimal levels of precision in risk communications (2011, 2012)
  • Framing of health promotion messages (2012)
  • Exploration of role of narratives in decision making (2010)
  • Values Clarification (2015)
  • Intuition and Deliberation in Decision Making (2015)

Contact Us

For questions about our methods or inquiries about potential Internet survey research collaborations, please contact Brian Zikmund-Fisher at bzikmund@umich.edu.

Announcement of Position: Clinician Ethicist

Announcement of Position: Clinician Ethicist


Background
The Program in Clinical Ethics within the Center for Bioethics and Social Sciences in Medicine (CBSSM) represents an expansion of existing services designed to promote a culture of patient-centered excellence by developing a comprehensive set of ethics-related activities. The aims of this program are to: liaise with and provide support to the adult and pediatrics ethics committees; streamline clinical ethics consultation; assist with ethics-related policy development on a regular and proactive basis; organize and administer structured educational programs in clinical ethics; and coordinate empiric research with relevance to clinical ethics within CBSSM.


Program Organization
The Program in Clinical Ethics is co-directed by the chairs of the adult and pediatric ethics committees and consultation services, Christian J. Vercler, MD MA and Andrew G. Shuman, MD. A dedicated clinician ethicist will manage the program on a daily basis. A cadre of eight faculty ethicists will rotate on service throughout the year and work closely with the clinician ethicist. Trainees and students will rotate as well. Dedicated administrative support will be organized through CBSSM.


Position
One individual will serve as the program’s clinical ethicist. This individual will serve as the “first responder” and contact person for all ethics consults during business hours, ensure continuity with consults, and work in conjunction with faculty ethicists. The role will include arranging team/family meetings, ensuring follow-ups on all consults, and arranging additional consultations as needed for selected cases. He/she will also regularly review relevant institutional policies and attend all ethics committee meetings. Another major component of this role will be to organize and participate in educational efforts and preventative ethics rounds. This position will provide $50,000 of direct salary support annually, to be distributed and allocated in conjunction with their home department. The initial appointment will last two years and is renewable.


Qualifications
Candidates are expected to be employees or faculty at UMHS with a master’s or equivalent terminal degree in their field; any professional background is acceptable. Direct experience with clinical ethics consultation is required. Familiarity with ethics education and related clinical research would be helpful. Excellent organizational and communication skills across multidisciplinary medical fields are required. Candidates are expected to have qualifications that meet the standards outlined by The American Society for Bioethics and Humanities (ASBH) for accreditation for clinical ethics consultants.


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

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


Timeline

  • Application is due December 11, 2015 with interviews shortly thereafter
  • Appointment will take effect January 1, 2016


Contacts

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

Supporting information for: 2016 CBSSM Research Colloquium and Bishop Lecture (William Dale, MD, PhD)

Katrina Hauschildt, MA, PhD Candidate, Department of Sociology: “Language and Communication as Professionalization Projects in Clinical Ethics Consultation”


Although sociologists have examined the field of bioethics broadly, less empiric research has explored the process of clinical ethics consultation (CEC) in practice. This paper seeks to describe how UMHS’ CEC service focuses on communication, language, and terminology in professionalizing their membership and broadening the scope of their services. The CEC service established a specific communication standard for its written recommendations that emphasizes specificity and clarity for patients and their families, other providers, and members of the ethics committee. By identifying and reinforcing the importance of language and word choice in their own recommendations, newer members of the CEC are “trained” in how to craft recommendations, develop a specific jargon, and establish communication standards that differ from those used in other aspects of medical practice and documentation. The CEC service is often involved in addressing a variety of communication issues that arise in patient care, and these problems are thusly considered within the professional scope of the CEC service. By establishing the CEC service as an appropriate resource for dealing with communication issues between patients and their care team, the CEC service expands the professional boundaries of their work beyond strictly ethical expertise. The implications of these processes for professionalization and communication may be applicable to CEC services more broadly.


Devan Stahl, PhD, Assistant Professor of Clinical Ethics, Center for Ethics and Humanities in the Life Sciences, MSU: "Is there a right not to know?"


There is a widespread presumption within medicine that terminally ill patients have a “right not to know” their prognosis. Guidelines for giving bad news (SPIKES; ABCDE) all require that the patient be asked first. There may be a dark side to this practice, however: terminally ill patients’ ignorance or denial of their prognosis too often lasts to the very end, one important factor discouraging timely referral and use of palliative and hospice care. Because of a possible link between a right not to know one’s prognosis and the aggressive treatment that patients with advanced illness too often receive at the end of life, the claim that there is a right not to know needs much more serious examination than it has received.

The authors argue that patients with advanced illness do not have a right not to know their prognosis. Withholding prognostic information in deference to a right not to know impedes patients’ capacity to make informed autonomous decisions about their treatment, encourages denial, and increases the likelihood of poor end of life care.

Chithra Perumalswami, MD MSc, Robert Wood Johnson Foundation/Veterans Affairs Clinical Scholar: "Insurance Status of Elderly Americans and Location of Death"


Context:  The decision to forego curative treatments (which includes the Medicare Skilled Nursing Facility Medicare benefit) is not financially neutral for terminally ill patients who do not have concurrent insurance (Medicaid or private insurance) in that they are subsequently asked to pay for room and board of the nursing home if they choose the Medicare hospice benefit.  The association between insurance status and location of death is currently unknown.  
Purpose: To determine whether the concurrent insurance status with Medicare (Medicaid vs. private insurance) of decedents is associated with location of death in a nationally representative survey of elderly Americans.
Methods: Longitudinal analysis of 7,979 decedents aged 50 years or older in the Health and Retirement Study from 2000-2010 (6 biennial waves). We examined associations between insurance status and location of death (home, hospital, nursing home, hospice) using multinomial logistic regression models and adjusting for demographic, socioeconomic, and clinical variables.
Results:  Decedents with dual eligible insurance before or at the time of death were significantly more likely to die in a nursing home than to die in a hospital (relative risk ratio (RRR) 2.6; 95% CI, 1.9-3.6, p<0.001). 
Those dying in a nursing home tended to be unpartnered (widowed, separated or divorced, never married), cognitively impaired or with dementia. Elderly Americans less likely to die in a nursing home were blacks and Hispanics, individuals with cancer, and those with the highest wealth.
Conclusions:  Dual eligible patients are substantially more likely to die in a nursing home than a hospital, and therefore may miss out on valuable services at the end of life, including hospice care. This study may have several implications for current proposed Medicare policy changes to allow patients access to both curative care and hospice care at the same time. 

Lauren B. Smith, MD, Associate Professor, Department of Pathology/Ginny Sheffield, UM Medical Student (M3): "Special treatment for the VIP patient:  Is it ethical?  Is it dangerous?"


The care of VIP patients is often prioritized at medical centers and this prioritization may lead to disparate access to care and patient safety issues. VIP patients may be donors, celebrities, or other physicians. Allowing VIP patients access to earlier care or “special treatment” not only raises social justice issues, but also has been shown to lead to medical error and suboptimal treatment. Ethical considerations will be discussed and recommendations will be presented.

Naomi Laventhal, MD, MA, Assistant Professor, Department of Pediatrics and Communicable Diseases: "Roman Charity Redux: The Moral Obligations of the Breastfeeding Physician"


Female physicians must often reconcile the seemingly contradictory goals of valuing the health and well-being of their patients above all else, and actively mothering young children. One of the fundamental ethical precepts in medicine is for the physician to put the best interests of her patient ahead of her own.  For example the Fellowship Pledge of the American College of Surgeons states, “I pledge . . . to place the welfare and the rights of my patient above all else.” The challenge of weighing the needs of one’s own children against those of a patient is painfully acute for the breastfeeding physician. Is it ethically permissible to leave a busy clinic - or a patient in the under anesthesia in the operating room - in order to express breastmilk? Pragmatic strategies, such as mandates for appropriate space and time to pump, offer modest gains. However, we will suggest the need to re-envision the concept of “patient-first”, which is a vestige of the patriarchal hegemony that gave rise to our modern medical ethos, whereby nursing mothers are highly disadvantaged and virtually unable to reach the highest moral ideals of the profession.  Is the “right” to breastfeed absolute, or if should it be superseded by the needs of the patient? We will explore whether this issue is deeply personal, to be reconciled by affected individuals, or warrants an “outside-in” approach in which  physicians and bioethicists collectively and more philosophically consider whether and how to support women who choose to work and breastfeed.

Archana Bharadwaj, Graduate Student, UM School of Public Health: "Patient understanding and satisfaction regarding the clinical use of whole genome sequencing: Findings from the MedSeq Project"


Background: The expanded use of Whole Genome Sequencing (WGS) has generated excitement due its potential to tailor medical treatment. However, clinical use of WGS poses challenges for informed consent and disclosure of results. Few empirical studies have examined patients’ understanding of and satisfaction with the clinical communication of WGS results.
Methods: The MedSeq Project is a randomized clinical trial examining the impacts of WGS in primary care and cardiology. We analyzed survey data from patients’ initial enrollment and at multiple time points following physician disclosure of results. Domains of interest included understanding of informed consent, subjective understanding, satisfaction with communication of results, and decisional regret.
Results: Survey responses were provided by 202 participants (mean age = 55 years; 51% male; 80% college graduates). At enrollment, participants understood the majority of key facts about the study (mean = 19.6 / 22 items answered correctly), although some incorrectly answered items addressing results to be returned (e.g., 18% believed they would receive their entire DNA sequence. Higher informed consent knowledge scores were associated with female gender and higher genomic knowledge, subjective numeracy, and education levels (all p < .05). After results disclosure, participants had low scores of decisional regret regarding study participation; they also reported high levels of satisfaction with their physicians’ disclosure of results (mean = 5.9 on a 6-point scale), although ~20% of participants reported receiving “too much” information. Satisfaction with communication did not vary by participants’ demographics or other characteristics (e.g. genomic knowledge).
Conclusions: This study suggests that the intervention was well understood by patients, with low levels of decisional regret and high satisfaction with communication. Future research will need to examine these issues in more diverse samples, where misconceptions about the clinical WGS and concerns about information overload may be magnified.

Kayte Spector-Bagdady, JD, MBioethics, CBSSM Postdoctoral Research Fellow: "Direct‐to‐Consumer Biobanking"


23andMe is back on the market as the first direct‐to‐consumer genetic testing company that “includes reports that meet Food and Drug Administration standards for being clinically and scientifically valid.” Its current product includes 36 health‐related carrier‐status reports and consumers’ raw genetic data. But while its front‐end product is selling individual genetic tests online, its back‐end business model is amassing one of the largest privately owned genetic databases in the world.
This article argues that as the Department of Health and Human Services revises its regulation of research with human subjects as well as its proposal to exempt autosomal recessive carrier screens from premarket authorization it should contemplate the intersection of these areas of rulemaking—and consider how enhancing the security of federally funded research but loosening private access to biospecimens will drive more research into the private sector and result in less, not more, protection for human subjects.

Panel Presentation (Susan Goold, MD, MHSA, MA & colleagues): "Community engagement in setting research priorities: Representation, Participation and Evaluation"


We describe a 5-year project that engaged minority and underserved communities throughout the state of Michigan in deliberations about health research priorities to increase community voice in how limited health research resources are allocated. DECIDERS (Deliberative Engagement of Communities in DEcisions about Research Spending) formed a state-wide Steering Committee (SC) to develop a version of the deliberative exercise CHAT for health research priorities, then convened 47 groups to evaluate the tool and describe community research priorities.
Facilitators: Susan Goold and Zachary Rowe, Co-Directors
Panelists: Karen Calhoun, Charo Ledon, Esther Onaga, Lisa Szymecko

Supporting information for: 2013 CBSSM Research Colloquium and Bishop Lecture (Ruth Macklin, PhD)

PhotoVoice:  Promoting individual wellbeing and improving disaster response policies in Japan and beyond

Mieko Yoshihama, PhD, ACSW, LMSW, Professor, School of Social Work, University of Michigan

Co-authors: Yukiko Nakamura, Ochanomizu University Department of Interdisciplinary Gender Studies, Tokyo, Japan; Tomoko Yunomae, Women's Network for East Japan Disaster

Conducted in collaboration with local women’s organizations, PhotoVoice Project is aimed at strengthening gender-informed disaster policies and response in Japan by engaging the very women affected by the disasters in the analyses of their own conditions and advocacy efforts.  PhotoVoice, a method of participatory action research, involves participants taking photographs of their lives and communities, followed by a series of small-group discussions about their experiences while sharing their photographs (Wang & Burris, 1997). 

After the Great East Japan Disasters of March 11, 2011, a diverse group of women (N=35) in five localities in the most disaster-affected areas of northern Japan participated in PhotoVoice group discussions (4-7 sessions in each location).  A significant minority of the participants have been assisting other disaster victims as part of their regular employment or through volunteer effort. 

The participants’ photographs and narratives identified various ways in which Japanese sociocultural and structural factors affected women’s vulnerabilities in and after disasters.  Traumatic stress and compassion fatigue were prevalent, yet denial and suppression were common response.  Facilitated group discussions served as a collective space for grieving the loss and rebuilding their lives.  Through repeated group discussions, participants also questioned and identified limitations and failures of the current disaster policies as well as those concerning nuclear energy.  Also evident were participants’ increased interest and desire to speak out, similar to the processes of politicalization and conscientization/conscientização (Freire, 1970). 

Findings of the project elucidate how individuals respond to trauma, dislocation, and devastation; how individual experiences are influenced by sociocultural and structural forces; and how individuals make sense of disaster and structural inequity, and to formulate action to address them.  Findings of the project also suggest that participatory action research such as PhotoVoice could promote participants’ growth and wellbeing by providing space for collective reflections, rebuilding, and action.

Mieko Yoshihama is a Professor of Social Work at the University of Michigan. Dr. Yoshihama's research interests are violence against women, immigrants, mental health, and community organizing. Combining research and social action at local, state, national, and international levels over the last 25 years, Dr. Yoshihama focuses on the prevention of gender-based violence and promotion of the safety and wellbeing of marginalized populations and communities.

 

Representing torture of women in custody in the U.S.

Carol Jacobsen, MFA, Professor, The University of Michigan Penny Stamps School of Art & Design, Women’s Studies; Human Rights Director, Michigan Women’s Justice & Clemency Project

More than a decade ago, Amnesty International launched its first ever campaign on torture in the U.S.  Working with human rights activists, including prisoners, attorneys, artists, and others, the ongoing campaign has focused on the four point chaining, rape, retaliation, medical neglect and other forms of abuse of women occurring in U.S. prisons.  As a grassroots, feminist filmmaker working with Amnesty on this issue, in my role as Director of the Michigan Women’s Justice & Clemency Project, and as an educator of visual art, women’s studies and human rights, many questions arise about issues of state and individual power, gender, race, representation, exploitation, censorship and voice as we struggle to make torture a visible and public issue in order to ultimately end it.  This presentation will include an excerpt from my film, Segregation Unit.

Segregation Unit, 30 min., 2000

Carol Jacobsen, Director

Narrated by Jamie Whitcomb following her release from prison, the film documents the torture she and many others have suffered (and continue to suffer) in Michigan prisons.  The film includes footage shot by guards that was obtained through subpoenas and the Freedom of Information Act in connection with Whitcomb’s successful lawsuit against the State.  Co-sponsored by Amnesty International, Segregation Unit is a nonprofit film available free to activists.

Carol Jacobsen is a social documentary artist whose works in video and photography draw on interviews, court files and records to address issues of women's criminalization, censorship and human rights.  Her work, co-sponsored by Amnesty International, is represented by Denise Bibro Gallery in New York, and has been exhibited and screened worldwide.  She has received awards from the National Endowment for the Arts, the Paul Robeson Foundation, Women in Film Foundation, Rockefeller Foundation and others. Her critical writings have appeared in the New York Law Review, Hastings Women's Law Journal, Signs Journal, Social Text, Art in America and other publications. She teaches Art, Women's Studies and Human Rights at UM, and serves as Director of the Michigan Women's Justice & Clemency Project, a grassroots advocacy and public education effort for freedom and human rights for incarcerated women.

 

Do non-welfare interests play a role in willingness to donate to biobanks?

Michele C. Gornick, PhD, Postdoctoral Research Fellow, VA Health Science, Research & Development and CBSSM, University of Michigan

Co-authors: Tom Tomlinson, PhD, Kerry Ryan, MA and Scott Kim, MD, PhD

Ethical debate has focused on protecting donor welfare and privacy interests.  Little attention has been given to individual donor concerns about the moral, societal, or religious implications of research using their donation. The current study explores the impact of non-welfare interests (NWIs) on participants’ willingness to donate de-identified tissue samples and medical records to biobanks through an experimental online survey (N=1276; 46.3% women; 19.6% racial minority).  Participants were more likely to donate to biobanks for NWI topics commonly associated with ‘science’ and medical research (evolution and stem cell research) than unfamiliar uses of biosamples (commercialization/corporate profit and risk assessment by insurance companies).  In addition, mode (single vs. multiple scenario) and timing (before vs. after blanket consent) of NWI disclosure affect individual’s willingness to donate.  Further, key subject characteristics influence participants’ willingness to donate, even after controlling for NWI scenario assignment (Racial minorities: OR = 0.59, 98% CI 0.34, 0.99, Evangelical Christians: OR = 0.55, 98% CI 0.35, 0.89, Liberal political views: OR = 1.66, 98% CI 1.06, 2.60). These data suggest that NWI issues have complex dimensions that require careful elicitation and evaluation of people’s opinions regarding them. Further, policy recommendations for biobank donation based only on welfare and privacy may neglect other interests that are highly vales by potential donors.

Michele Gornick 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 Human Genetics and MA in Statistics from the University of Michigan.  Her research is in translational medicine, specifically dealing with ethical issues surrounding the communication of genomic information to cancer patients, physicians and other health care providers.

 

Which research? Public engagement and opinions about the research use of biobank samples

C. Daniel Myers, PhD, Robert Wood Johnson Scholar in Health Policy Research, Department of Health Management and Policy, School of Public Health, University of Michigan

Daniel B. Thiel, MA, Assistant Director,  Life Sciences and Society Program, School of Public Health, University of Michigan

Co-authors: Ann Mongoven, PhD, MPH; Jodyn Platt, MPH; Tevah Platt, MPH; Susan B. King; Sharon L. R. Kardia, PhD

Do potential biobank donors approve of using biobank samples for research, and do they care what kinds of research is done on their samples?  We explored this question in various public engagement forums related to the Michigan BioTrust for Health, a recently established state research biobank of de-identified leftover newborn screening bloodspots. Results suggest that that the type of public engagement affects participant responses about whether research using leftover bloodspots is appropriate, and what types of research are should be conducted.  In more superficial kinds of engagement participants show nearly-unanimous support for research, support that does not vary greatly across different kinds of research. However, more intensive forms of engagement find somewhat greater skepticism about research, and support that varies according to what aspect of a study is emphasized—target population, disease in question, type of analysis (e.g., genetic or not).  Furthermore, more intensive engagements facilitate deeper reflection on the inherently uncertain nature of biobank research applications.  This uncertainty brings issues of governance and oversight to the foreground. While there are some areas of broad consensus, there is also widespread disagreement on what kinds of research should and should not be pursued. On a practical level, this variation suggests that singular sources on public opinion may not be adequate to judge public support for biobanking, and that research and policy communities should consider best practices for eliciting educated public opinion on acceptable research. On a more conceptual level, the variety of conceptions of appropriate research uses suggests that informed consent and community oversight processes should account for this pluralistic conception of the public good. 

C. Daniel Myers is a Robert Wood Johnson Scholar in Health Policy at the University of Michigan School of Public Health. His research focuses on how political communication affects public attitudes, particularly in the context of public deliberation. He is currently involved in research projects on the role of stories sin political communication as well as on public deliberation about priorities for patient centered outcome research. He received his Ph.D. in Political Science from Princeton University and his B.A. in Political Science from Allegheny College. Starting in 2013 he will be an Assistant Professor of Political Science at the University of Minnesota.

Daniel Thiel is currently the Assistant Director of the Life Sciences and Society Program at the University of Michigan where he wears many hats, including directing a community engagement research project about the Michigan BioTrust for Health.  Prior to this position he taught classes in political philosophy, ethics and the philosophy of law at John Jay College in New York City. His research interests are primarily in the fields of bioethics, science and technology studies and social and political philosophy.  He completed an M.A. in Philosophy at Stony Brook University and a B.A. in Philosophy at U.C. Berkeley.

 

Whose sense of public good? Public engagement results from the Michigan BioTrust and ethical implications

Ann Mongoven, PhD, MPH, Assistant Professor, Center for Ethics and Humanities in the Life Sciences and Department of Pediatrics and Human Development, Michigan State University

Co-author: Meta Kreiner, MSc

Can policy-makers assume a consensus on what constitutes “the public good” of a public health biobank? If not, what are the implications for biobank ethical policies?  We explore these questions in relationship to public engagement on the Michigan BioTrust.  The BioTrust is a recently established state research biobank of de-identified leftover newborn screening bloodspots.  BioTrust guidelines require that any research using bloodspots be (a) health research and (b) in the public good.  The biobank operates with an opt-out “blanket” presumed consent policy for bloodspots saved before 2010, and an opt-in blanket consent policy for bloodspots saved from 2010 onward.

Community engagement on this issue suggests pluralistic conceptions of what constitutes the public good among Michigan residents.  While some types of research generate broad consensus; others generate significant disagreement.   Risk/benefit assessments also vary according to both degree and kind, including: potential for scientific/medical advances, economic considerations, and individual or group risk/benefit from biobank participation.  Because the bloodspots come from children, some focus on benefits/risks for children; others do not.  These results suggest pluralistic conceptions of what constitutes “public good” are at play when citizens assess both if and when the state should use biobank samples for research, and also whether they should allow research on their own children’s bloodspots.  

The results also have implications regarding informed consent processes and community oversight for a bloodspot biobank.  Lack of consensus on what research is “in the public good” adds empirical weight to ethical requirements that biobanks inform donors before using their bloodspots for research, make lay research descriptions available,  include community oversight in biobank governance, and ensure an opt-out mechanism.  They suggest the worthiness of considering “by-study” or “tiered” consent options while underscoring their practical challenges.  Significantly, even blanket consent and community oversight processes can be improved by acknowledging lack of consensus on what constitutes the public good as a risk of participation.

Ann Mongoven is an Assistant Professor at the Center for Ethics and Humanities in the Life Sciences, Michigan State University. She earned her Ph.D. in religious studies/ethics from the University of Virginia and a M.P.H. from the Johns Hopkins University Bloomberg School of Public Health. Mongoven is also a Michigan State University Lilly Teaching Fellow.

 

Citizen recommendations for communication about biobank participation and consent: Considering source, message, channel, receiver, and timing

Andrea C. Sexton, BA, Master of Arts Student, Health and Risk Communication, College of Communication Arts and Sciences, Michigan State University

Co-authors: Ann Mongoven, PhD, MPH; Meta Kreiner, MSc

Source, message, channel, and receiver are fundamental factors in models of the communication process.  Public and clinical health practitioners must consider these factors in order to design effective health communication.  This paper a) reports citizen recommendations for a multi-faceted educational campaign on the Michigan Biotrust; b) analyzes these recommendations by source, message, channel, and receiver characteristics; and c) argues that integrating these recommendations with communication theory suggests both practical strategies for recommendation implementation and extensions of theoretical models of the communication process. 

The Michigan BioTrust for health is a state research biobank containing bloodspots leftover after newborn bloodspot screening. In November of 2011, seven deliberative processes engaged a representative sample of Michigan citizens. Five sessions were conducted in-person, each in a different Michigan city. Two sessions were run as Facebook discussion groups.

The primary recommendation from these juries is a multi-faceted campaign to increase public awareness of the BioTrust and its consent processes. The deliberators propose specific suggestions about who should provide information, what content should be communicated, the mediums through which education should occur, and their impressions of citizen responses to current and recommended BioTrust communications.

In addition to identifying source, message, channel, and receiver characteristics, jury participants distinctly emphasize the importance of communication timing.  They consider the effect of timing on receivers’ motivation and ability to process information, investigate their options, and ask questions. They also suggest a relationship between timing of communication about the Biotrust and public attitude toward the BioTrust.

Exploring jury participants’ suggestions for education about the BioTrust has implications for clinical interactions, health education curriculums, and mass media campaigns regarding informed consent for biobanks, as well as ethical solicitation of biobank participation. Additionally, emphasis on timing as a key factor in communication may warrant further consideration in theoretical models of the communication process.

Andrea Sexton is a candidate for a Master’s of Arts in Health & Risk Communication at Michigan State University where she is a research assistant in the Center for Ethics and Humanities in the Life Sciences on a project researching community engagement on the Michigan BioTrust for Health. She has also contributed to health communication research on hand washing, health website quality, nutritional labeling, and community engagement in sustainable food system development. Andrea’s research interests include community engagement in health and environmental issues and health and risk decision making. She completed her B.A. in Linguistics & Psychology at the University of Michigan.

 

Comparing male and female BRCA mutation carriers’ communication of their BRCA test results to family members

Monica Marvin, MS, Associate Director of the Genetic Counseling Program;  Genetic Counselor in the Cancer Genetics Clinic; Clinical Assistant Professor; University of Michigan, Department of Human Genetics and Internal Medicine

Co-authors: Heidi Dreyfuss, MS; Lindsay Dohany, MS; Kara Milliron, MS;  Sofia Merajver, MD, PhD; Elena Stoffel, MD, MPH; Beverly Yashar, MS, PhD; and Dana Zakalik, MD

Current national guidelines state that patients with positive BRCA results should be urged to notify at-risk relatives.  Most research on communication of BRCA results is limited to communication by females and suggests that communication to males occurs less frequently. 

The objective of this exploratory study is to identify gender-related characteristics in communication of BRCA results to improve familial communication.

677 individuals who received genetic counseling from three clinics in Michigan were invited to participate.  Subjects completed a 34-item survey comprised of novel and previously published questions exploring whom they informed, information shared, method of communication, and factors impacting the decision to undergo testing and disclose results.  Communication patterns were examined within the entire cohort and comparisons were made between males and females.

Participants included 35 males and 202 females.  Overall greater than 78% of parents shared their test results with at least one of their children with a greater percentage of fathers disclosing to their children than mothers.  The disclosure was mostly done in-person and the information shared did not vary much between genders except a greater proportion of mothers with daughter(s) discussed the impact genetics can have on their daughter’s medical management than fathers with their daughter(s).  For both males and females, the top reasons for disclosing to children included: 1) wanting to inform them about their risk, 2) feeling the results will impact management, 3) wanting to encourage testing, and 4) having a close relationship. 

In genetic counseling, gender of a BRCA mutation carrier does not appear to greatly affect the frequency or method of communication of test results.  Furthermore, we found that communication to male and female relatives occurred with a similar frequency.  This suggests that current practice effectively enables comprehensive family communication.

Monica Marvin is a Clinical Assistant Professor in the Department of Human Genetics who serves as the Associate Director of the University of Michigan Graduate Program in Genetic Counseling.  She also functions as a clinical genetic counselor in the UM Cancer Genetics Clinic.  Monica obtained her Masters Degree in genetic counseling from the University of Michigan in 1994. Prior to returning to the University of Michigan in 2005, she worked as a genetic counselor at New Jersey Medical School and Spectrum Health in Grand Rapids, MI. In addition to her work here within the University, Monica is also active in national and state-wide efforts to advance the profession of genetic counseling.  

 

A Gift for All: Everyone has something to give - Approaching dialysis patients about donating their organs

Allyce Smith, MSW, Program Coordinator, National Kidney Foundation of Michigan

Co-authors: Ann Andrews, MPH; Jerry Yee, MD; Holly Riley, MSW; Remonia Chapman; Ken Resnicow, PhD

The organ donor waiting list continues to grow.  Individuals with End Stage Renal Disease (ESRD) are not typically viewed, by themselves or their health care team, as potential donors after death. However, ESRD patients are eligible to donate and may obtain a sense of empowerment in knowing they can give, as well as receive. Others feel that asking ESRD patients to sign up on the Donor Registry is unethical. This study will evaluate the effectiveness of using peer mentor to inform dialysis patients about their ability to sign up on the Donor Registry, ultimately increasing their numbers on the Registry.

Using a cluster randomized design, this controlled intervention study is conducted in collaboration with the National Kidney Foundation of Michigan (NKFM), the University of Michigan School of Public Health (UM SPH), Greenfield Health Systems (GHS), Henry Ford Health System, and Gift of Life Michigan.  Twelve dialysis units will be  randomized to an intervention or comparison group. Participants in the comparison units receive mailings about organ donation while patients in intervention units are assigned peer mentors and meet 7 times over a 4-month period. Peer mentors are individuals with ESRD who have adjusted positively to living with kidney disease and volunteer to lend support to others coping with kidney disease. Peer mentor-patient meetings cover coping with chronic illness and leaving a legacy through deceased organ donation.  During the meetings, peer mentors utilize Motivational Interviewing, a person-centered method of guiding patient decision-making and strengthening motivation for change.

The primary outcome is mail/internet registrations on the Donor Registry.  Pre/post surveys will be used to evaluate change in organ donation knowledge and attitudes, self-reported donation status, hope for the future, and quality of life.

To date, 150 Greenfield staff, 33 peer mentors, and over 280 patients have participated in 10 dialysis units.

Allyce Haney Smith has been a program coordinator at the National Kidney Foundation of Michigan since 2010. She graduated with her Master’s degree in Social Work from the University of Michigan. She currently coordinates the project, A Gift for All: Everyone Has Something to Give. In this role, Ms. Smith works to help empower patients to become more involved in their own care and end of life decisions.

 

Putting patient-physician communication in context: An empirical analysis of sequential organization and communication transitions during visits for new diagnoses of early stage prostate cancer.

Danielle Czarnecki, PhD Candidate, Department of Sociology, University of Michigan

Co-authors: Stephen G. Henry, MD; Valerie Kahn, MPH; Wen-Ying Sylvia Chou, PhD, MPH; Angela Fagerlin, PhD; Peter A. Ubel, MD; David R. Rovner, MD, FACP; Margaret Holmes-Rovner, PhD

Background: Patients and physicians typically schedule visits to discuss new diagnoses for which patients have multiple treatment options. How communication is organized during these visits is unknown.

Objective: To investigate the organization of communication tasks and the transitions between these tasks during visits in which patients and physicians discuss diagnosis and treatment of early stage prostate cancer.

Methods: We characterized the sequential organization of 40 visits in which patients received a new diagnosis of early stage prostate cancer. We used transcripts to identify communication tasks and develop a coding system to identify transitions between these tasks. We analyzed a) the organization of communication tasks during these visits and b) how patients and physicians communicate during transitions between tasks.

Results:  We identified five major communication tasks, which typically occurred in the following sequence: diagnosis delivery, risk classification, options talk, decision talk, and next steps. Visit organization was physician-driven. Patients resisted physicians’ attempts to transition from a) options talk to decision talk and b) decision talk to next steps by requesting more information about options and clarification about the decision making process, respectively. Physicians showed resistance when patients attempted to discuss decisions before physicians finished discussing treatment options. The overall organization of communication reflected physicians’ focus on delivering a thorough discussion of treatment options. Patient speech was relatively uncommon but increased towards the end of visits. Patients showed some uncertainty about the visit purpose and their role in the decision making process.

Conclusions: In visits discussing new diagnoses of prostate cancer, the overall visit organization and communication during transitions reveal an emphasis on discussing treatment options. Physicians’ focus on discussing options fulfills an important obligation for informed consent, but may not be responsive to patients’ informational or emotional needs.

Danielle Czarnecki is a doctoral candidate in the Department of Sociology at the University of Michigan. Her dissertation research is on religion and assisted reproductive technologies. She examines how infertile Catholic and Evangelical women navigate religious and scientific discourses in their attempts to build families.

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