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Thu, September 11, 2014

Brian Zikmund-Fisher, Nicole Exe, and Holly Witteman’s study “Numeracy and Literacy Independently Predict Patients’ Ability to Identify Out-of-Range Test Results” in the Journal of Medical Internet Research was featured in Modern Healthcare and other media outlets. The articles discuss patients' understanding and informed decision making when they have direct access to lab reports and test results. In the Wall Street Journal, Dr. Zikmund-Fisher was quoted, "If we don't make it clear to patients what these numbers mean, we can't expect them to know what to do."

Funded by National Institutes of Health

Funding Years: 2015-2018

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

PI(s): Robert Silbergleit

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

Michael Fetters, MD, MPH, MA

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

J. Scott Roberts, PhD

Faculty

Scott Roberts, PhD, is Professor of Health Behavior & Health Education at the University of Michigan’s School of Public Health (U-M SPH), where he directs the School’s Public Health Genetics program and teaches a course on public health ethics. A clinical psychologist by training, Dr. Roberts conducts research on the psychosocial implications of genetic testing for adult-onset diseases.

Last Name: 
Roberts

Aisha Langford PhD, MPH

Alumni

Dr. Aisha Langford was a VA and CBSSM Postdoctoral Research Fellow, 2013-2015. She received her PhD from the department of Health Behavior and Health Education at the University of Michigan School of Public Health in Ann Arbor. From 2007 -2013, she directed the University of Michigan Comprehensive Cancer Center’s Community Outreach Program. Her research interests include chronic disease prevention and control, health communications, medical decision making, and clinical trial participation. Aisha is from the San Francisco Bay Area and earned her BA from the University of Virginia.

Last Name: 
Langford

Supporting information for: 2018 CBSSM Research Colloquium and Bishop Lecture (Barbara Koenig, PhD)

Parent Perceptions of Antenatal Consultation for Extreme Prematurity
Presenter: Stephanie Kukora, MD
 

Co-authors: Naomi Laventhal, MD, MA; Haresh Kirpilani, MD; Ursula Guillen, MD
 

Antenatal consultation (AC) for extreme prematurity is routine in neonatology practice, but questions remain about how best to meet the needs of expectant parents. Decision-aids have demonstrated improvement in communication of statistical outcomes, but whether they are uniformly helpful in AC, and whether provision of outcome data is essential to shared decision-making in the AC encounter remains uncertain.

To characterize the experience of parents threatened with extreme prematurity between 22 and 25 weeks gestation who received AC, identify aspects that parents perceived as favorable or unfavorable, and identify areas for improvement.

We analyzed free text responses of expectant parents enrolled in a multi-center randomized trial evaluating the use of a validated decision-aid (DA) compared to standard counseling. Qualitative thematic analysis of responses identified items valued for decision-making about delivery room resuscitation.

 201 parents were enrolled; 126 provided substantive free-text comments. 45 (36%) parents described their counseling experience positively.  31 (25%) reported a negative experience, and 23 (18%) offered suggestions for improvement.  Desire for a tailored approach was a major theme reported by many parents, with subthemes of too much or too little information, facts vs values-based counseling, and diverse learning styles.  Another major theme was shared decision-making. Subthemes included:  good or poor understanding of the decision/options; trust; parent engagement, feeling supported in decision-making.  Need for clinician sensitivity also emerged as a major theme, with subthemes of hope, thoughtful timing of AC, and identification and support of parents’ stress and emotions. 31 parents receiving AC with the DA (n=102) commented that visual depiction of the statistical information helpful.

Many parents expressed that factual information about outcomes was influential to their decisions, but some parents dislike this approach.  In addition to tailoring how and what information is communicated during AC, clinicians should be sensitive to parents’ individual needs in this context.

 

Hospice Care Quality in U.S. Nursing Homes Reported by Patients and Caregivers in Yelp Reviews

Presenter: Chithra Perumalswami, MD, MSc
 

Co-authors: Jayme Laurencelle, MD; Shawna O’Reilly, MD; Jennifer Griggs, MD, MPH; Raina Merchant, MD, MSHP
 

Background: The need to assess the quality of hospice care provided in nursing homes is a national priority. Patients and caregivers often utilize online forums such as Yelp to informally report on the experience of their healthcare episodes. These narratives are a unique data source and may provide valuable insights into the quality of care provided in U.S. nursing homes at the end of life.

Objective: To explore the content of Yelp reviews of nursing homes providing care at the end of life, specifically utilizing quality measures for palliative and hospice care determined by the National Quality Forum (NQF).

Methods: We performed a qualitative content analysis of 3421 Yelp reviews.  The reviews were double coded and the final coding scheme incorporated concepts from all of the NQF domains. Larger themes were determined by consensus.

Results: Four themes were identified: 1) staff interpersonal expertise (empathic characteristics and effective communication), 2) staff technical competence (expertise in skills, staff attention, and efficiency of response), 3) systems issues (physical facility characteristics and cleanliness), and 4) patient wellbeing (physical and emotional wellbeing, family trust and confidence in care).

Conclusion: Yelp reviews of nursing homes providing hospice identify concepts that are mostly congruent with the current NQF domains. Medicare uses the NQF domains and preferred practices in the Hospice Quality Reporting Program (HQRP) to measure and report on quality. Utilizing Yelp reviews may help to identify additional quality measures, including a more nuanced view of aspects of quality of care in nursing homes at the end of life. Future research should focus on how to make such unprompted narratives more accessible and on how to incorporate additionally identified concepts regarding quality into the HQRP.


Impact of MCI on Patient and Care Partner Preferences and Physician Decision Making for Cardiovascular Treatment

Presenters: Bailey Reale, MPH; Emilie Blair
 

Co-authors: Darin Zahuranec, MD, MS; Kenneth Langa, PhD;  Jane Forman, ScD, MHS; Bruno Giordani, PhD; Brenda Plassman, PhD; Kathleen Welsh-Bohmer, PhD; Colleen Kollman, MBA; Deborah Levine, MD, MPH
 

Background: The leading cause of death for the 5.4 million older adults with mild cognitive impairment (MCI) in the US is cardiovascular disease (CVD). Despite this, patients with pre-existing MCI may receive fewer treatments for CVD events such compared to cognitively normal patients. We conducted interviews of patients, care partners, and physicians to understand how MCI influences decision making for CVD treatments.

Methods: Qualitative study based on in-depth, semi-structured, in-person interviews with patient-care partner dyads (n=23) and physicians (n=18) using a standard guide. We used qualitative content analysis to identify unifying and recurrent themes. We gathered reflections on data suggesting neurologists recommend fewer treatments for stroke to older adults with MCI and elicited how MCI influences patient-care partner preferences for 5 common CVD treatments. We also sought to understand how a patient’s having MCI influenced physicians’ decisions to recommend these 5 CVD treatments.

Results: Most MCI patients, cognitively normal patients, and their care partners wanted all 5 stroke treatments (Table 1). Participants reported several factors affecting their decision-making for treatment (Table 1). Some participants thought that physicians might recommend fewer stroke treatments to patients with pre-existing MCI because physicians have biases about MCI patients (Table 1).

Most physicians described MCI as influencing their recommendations for CVD treatments in at least one of five ways (Table 2). Physicians reported recommending CVD treatments less to MCI patients due to their assumptions about the MCI patients and MCI itself (Table 2).

Conclusions: MCI patients have similar preferences for treatments for CVD events as do cognitively normal patients, yet physicians often recommend these treatments less often to MCI patients. We need to better understand how physician recommendations contribute to potential underuse of effective CVD treatments in MCI patients in order to improve the quality of CVD care for this large and growing population.


It’s all about Context: A Mixed-Methods Study of Institutional Review Board’s Local Context Assessment
Presenter: Adrianne Haggins, MD


Co-authors: Deneil Harney; Sacha Montas, MD, JD; Joy Black, BSN, MS; Neil Dickert, MD, PhD; Timothy Guetterman, PhD; Michael Fetters, MD; Robert Silbergleit, MD


Background: Local context assessment ostensibly allows review boards to closely consider the potential impact to study populations, the institution, and local laws and regulations.  Given the trend toward utilization of central review boards for multicenter trials, a better understanding of single institution review board assessment processes are needed.

 Objective: To explore how local context assessments in multicenter trials are made by single institution review boards.

Methods: We used a mixed methods approach to explore attitudes and perceptions of key stakeholders.  We elicited stakeholder perspectives by observing, and audiotaping IRB deliberations of trials conducted under exception from informed consent (EFIC). In-depth semi-structured interviews (n=26) and an online survey (n=80, response rate=13%) were conducted of IRB stakeholders (IRB members, central review board members, regulatory officials, etc.). Two authors independently reviewed the observations and interview transcripts to identify meaningful statements, which were grouped into codes and broader themes.  Descriptive statistics were performed on the survey results.

Results: Deliberations related to local context highlighted the importance of taking into consideration: scientific rigor, community consultation and public disclosure process, as well as local laws/regulations, weighing relative benefit vs. risk, medical standards/practices, concerns of local groups, prior experiences with investigators and within the institution.  Themes from interviews underscored the important role investigators, and IRB community members are expected to play in knowing the local population and community. Top reasons for considering local context included: knowing about community concerns, showing respect for local public, and the influence of local laws/ordinances on clinical care.

Conclusion: Local context assessment provides a mechanism to ensure research and investigators are perceptive to the concerns and impact on the broader community. A wide variety of factors are considered. To further inform central review processes, future research is needed to differentiate which factors are essential for a high-quality local context assessment.   


Does Enhancing Individual Choice and Control Promote Freedom? Challenges in Contemporary Bioethics

Bishop Lecture Keynote Presenter: Barbara Koenig, PhD
 

Over the past three decades, the discipline of bioethics has advocated for enhanced patient choice and control over a range of medical decisions, from care near the end of life to participation in clinical research. Using two current policy challenges in California—1) the advent of legally sanctioned medical aid in dying and, 2) efforts to share UC Health “big data” from the electronic health record in research with private sector partners—Professor Koenig will explore how current bioethics practices may unintentionally and ironically impede our shared goals of promoting human freedom.

 

CBSSM Seminar: Dina Hafez Griauzde, MD

Wed, January 18, 2017, 3:00pm
Location: 
NCRC, Building 16, Room 266C

Dina Hafez Griauzde, MD
Robert Wood Johnson Foundation Clinical Scholar
VA Special Fellow, Ann Arbor Veterans’ Affairs Medical Center
Clinical Lecturer, Internal Medicine

Abstract: Greater purpose in life (measured using a validated scale)  is associated with lower rates of certain chronic conditions such as cardiovascular disease and stroke.  In this seminar, we will discuss the role of purpose in life in the development of prediabetes and type 2 diabetes as well as the potential to augment ongoing type 2 diabetes prevention efforts with strategies that promote greater purpose in life.

Bioethics Grand Rounds -Reshma Jagsi, MD, DPhil

Wed, October 25, 2017, 12:00pm
Location: 
UH Ford Auditorium

Reshma Jagsi, MD, DPhil

Title – "Ethical Issues Related to Fundraising from Grateful Patients"

Abstract: Health care institutions are becoming increasingly deliberate about philanthropic fundraising given the need to sustain their missions in the face of decreases in governmental research funds and lowering reimbursement for clinical care.  Donations from grateful patients constitute 20% of all philanthropic contributions to academic medical centers, totaling nearly $1 billion a year in recent years.  Institutions frequently employ development professionals to facilitate philanthropy. The development literature describes various approaches for identifying patients capable of contributing, cultivating potential donors, and engaging physicians in the solicitation of grateful patients, emphasizing that patients themselves may also benefit from exercising altruism in this way.  However, little evidence exists to guide the ethical practice of grateful patient fundraising, and concerns exist regarding privacy and confidentiality, patient vulnerability, and physicians' conflicts of obligations in this context.  Therefore, we will discuss how the process of philanthropic development should be structured in order to demonstrate respect for all persons involved, including patients who donate, those who might consider donation, those who do not wish to donate, and those who cannot afford to do so.

Lunch is provided. Please note: Lunch is first come, first served.

 

Is your well-being influenced by the guy sitting next to you? (Nov-03)

Rating your satisfaction with your life may not be a completely personal decision. See how your satisfaction rating may be influenced by others.

When answering this question, imagine that there is someone in a wheelchair sitting next to you. They will also be answering this question, but you will not have to share your answers with each other.

How satisfied are you with your life in general?

Extremely satisfied 1       2       3       4       5       6       7       8       9       10 Not at all satisfied

How do you compare to the people surveyed?

You gave your life satisfaction a rating of 1, which means that you are extremely satisfied with your life. In a study done where people with a disabled person sitting next to them wrote down their life satisfaction on a questionnaire, they gave an average life satisfaction rating of 2.4, which means they were very satisfied with their lives.

What if you'd had to report your well-being to another person instead of writing it down?

In the study, half the people had to report their well-being in an interview with a confederate (a member of the research team who was posing as another participant). When the participants had to report in this way, and the confederate was not disabled, the participants rated their well-being as significantly better than those who reported by writing it on the questionnaire in the presence of a non-disabled confederate (2.0 vs. 3.4, lower score means higher well-being). The scores given when reporting to a disabled confederate elicited a well-being score that was no different than that when completing the questionnaire in the presence of a disabled confederate (2.3 vs. 2.4).

Mean life satisfaction ratings, lower score means higher satisfaction
Mode of rating well-being Disabled confederate Non-disabled Confederate
Interview (public) 2.3 2.0
Questionnaire (private) 2.4 3.4
What caused the difference in well-being scores?

When making judgments of well-being, people (at least in this study) tend to compare themselves to those around them. This effect is seen more when well-being was reported in an interview than when the score was privately written down, due to self-presentation concerns. A higher rating was given in public so as to appear to be better off than one may truly feel. Note that the effect was only seen in the case where the confederate was not disabled. While well-being ratings were better overall with a disabled confederate, there was no difference between the private and public ratings. Social comparison led to a better well-being judgment, but it appears that the participants were hesitant to rate themselves too highly in front of the disabled person for fear of making the disabled person feel worse.

Why is this important?

Subjective well-being is a commonly used measure in many areas of research. For example, it is used as one way to look at the effectiveness new surgeries or medications. The above studies show that SWB scores can vary depending on the conditions under which they are given. Someone may give a response of fairly high SWB if they are interviewed before leaving the hospital, surrounded by people more sick than they are. From this, it would appear as though their treatment worked great. But suppose that they are asked to complete a follow-up internet survey a week later. Since they do not have to respond to an actual person face-to-face, and without being surrounded by sick people, they may give a lower rating than previously. Is this because the treatment actually made their SWB worse over the longer term, or simply because a different method was used to get their response? The only way to really know would be to use the same methodology to get all their responses, which might not always be feasible. These are important considerations for researchers to keep in mind when analyzing results of their studies. Are the results they got the true SWB of their participants, or is it an artifact of how the study was done? And is there a way to know which measure is right, or are they both right which would lead to the conclusion that SWB is purely a momentary judgment based on a social context?

For more information see:

Strack F, Schwarz N, Chassein B, Kern D, Wagner D. Salience of comparison standards and the activation of social norms: Consequences for judgements of happiness and their communication. British Journal of Social Psychology. 29:303-314, 1990.

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