Biomedical Ethics Research Unit

United States

Biomedical Ethics Research Unit

United States

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James K.M.,Biomedical Ethics Research Unit | Cowl C.T.,Mayo Medical School | Tilburt J.C.,Biomedical Ethics Research Unit | Tilburt J.C.,Mayo Medical School | And 5 more authors.
Mayo Clinic Proceedings | Year: 2011

OBJECTIVE: To assess the impact of direct-to-consumer (DTC) predictive genomic risk information on perceived risk and worry in the context of routine clinical care. PATIENTS AND METHODS: Patients attending a preventive medicine clinic between June 1 and December 18, 2009, were randomly assigned to receive either genomic risk information from a DTC product plus usual care (n=74) or usual care alone (n=76). At intervals of 1 week and 1 year after their clinic visit, participants completed surveys containing validated measures of risk perception and levels of worry associated with the 12 conditions assessed by the DTC product. RESULTS: Of 345 patients approached, 150 (43%) agreed to participate, 64 (19%) refused, and 131 (38%) did not respond. Compared with those receiving usual care, participants who received genomic risk information initially rated their risk as higher for 4 conditions (abdominal aneurysm [P=.001], Graves disease [P=.04], obesity [P=.01], and osteoarthritis [P=.04]) and lower for one (prostate cancer [P=.02]). Although differences were not significant, they also reported higher levels of worry for 7 conditions and lower levels for 5 others. At 1 year, there were no significant differences between groups. CONCLUSION: Predictive genomic risk information modestly influences risk perception and worry. The extent and direction of this influence may depend on the condition being tested and its baseline prominence in preventive health care and may attenuate with time. © 2011 Mayo Foundation for Medical Education and Research.


Antiel R.M.,Mayo Medical School | James K.M.,Biomedical Ethics Research Unit | Sheeler R.D.,Mayo Medical School | Liebow M.,Mayo Medical School | And 4 more authors.
Journal of General Internal Medicine | Year: 2014

BACKGROUND: Little is known about how U.S. physicians' political affiliations, specialties, or sense of social responsibility relate to their reactions to health care reform legislation. OBJECTIVE: To assess U.S. physicians' impressions about the direction of U.S. health care under the Affordable Care Act (ACA), whether that legislation will make reimbursement more or less fair, and examine how those judgments relate to political affiliation and perceived social responsibility. DESIGN: A cross-sectional, mailed, self-reported survey. PARTICIPANTS: Simple random sample of 3,897 U.S. physicians. MAIN MEASURES: Views on the ACA in general, reimbursement under the ACA in particular, and perceived social responsibility. KEY RESULTS: Among 2,556 physicians who responded (RR2: 65 %), approximately two out of five (41 %) believed that the ACA will turn U.S. health care in the right direction and make physician reimbursement less fair (44 %). Seventy-two percent of physicians endorsed a general professional obligation to address societal health policy issues, 65 % agreed that every physician is professionally obligated to care for the uninsured or underinsured, and half (55 %) were willing to accept limits on coverage for expensive drugs and procedures for the sake of expanding access to basic health care. In multivariable analyses, liberals and independents were both substantially more likely to endorse the ACA (OR 33.0 [95 % CI, 23.6-46.2]; OR 5.0 [95 % CI, 3.7-6.8], respectively), as were physicians reporting a salary (OR 1.7 [95 % CI, 1.2-2.5]) or salary plus bonus (OR 1.4 [95 % CI, 1.1-1.9) compensation type. In the same multivariate models, those who agreed that addressing societal health policy issues are within the scope of their professional obligations (OR 1.5 [95 % CI, 1.0-2.0]), who believe physicians are professionally obligated to care for the uninsured / under-insured (OR 1.7 [95 % CI, 1.3-2.4]), and who agreed with limiting coverage for expensive drugs and procedures to expand insurance coverage (OR 2.3 [95 % CI, 1.8-3.0]), were all significantly more likely to endorse the ACA. Surgeons and procedural specialists were less likely to endorse it (OR 0.5 [95 % CI, 0.4-0.7], OR 0.6 [95 % CI, 0.5-0.9], respectively). CONCLUSIONS: Significant subsets of U.S. physicians express concerns about the direction of U.S. health care under recent health care reform legislation. Those opinions appear intertwined with political affiliation, type of medical specialty, as well as perceived social responsibility. © 2013 Society of General Internal Medicine.


Kim S.P.,Mayo Medical School | Boorjian S.A.,Mayo Medical School | Shah N.D.,Knowledge and Evaluation Research Unit | Weight C.J.,University of Minnesota | And 8 more authors.
Journal of Urology | Year: 2013

Purpose: We described population level trends in radical prostatectomy for patients with prostate cancer by hospitals with robotic surgery, and assessed whether socioeconomic disparities exist in access to such hospitals. Materials and Methods: After merging the NIS (Nationwide Inpatient Sample) and the AHA (American Hospital Association) survey from 2006 to 2008, we identified 29,837 patients with prostate cancer who underwent radical prostatectomy. The primary outcome was treatment with radical prostatectomy at hospitals that have adopted robotic surgery. Multivariate logistic regression was used to identify patient and hospital characteristics associated with radical prostatectomy performed at hospitals with robotic surgery. Results: Overall 20,424 (68.5%) patients were surgically treated with radical prostatectomy at hospitals with robotic surgery, while 9,413 (31.5%) underwent radical prostatectomy at hospitals without robotic surgery. There was a marked increase in radical prostatectomy at hospital adopters from 55.8% in 2006 and 70.7% in 2007 to 76.1% in 2008 (p <0.001 for trend). After adjusting for patient and hospital features, lower odds of undergoing radical prostatectomy at hospitals with robotic surgery were seen in black patients (OR 0.81, p <0.001) and Hispanic patients (OR 0.77, p <0.001) vs white patients. Compared to having private health insurance, being primarily insured with Medicaid (OR 0.70, p <0.001) was also associated with lower odds of being treated at hospitals with robotic surgery. Conclusions: Although there was a rapid shift of patients who underwent radical prostatectomy to hospitals with robotic surgery from 2006 to 2008, black and Hispanic patients or those primarily insured by Medicaid were less likely to undergo radical prostatectomy at such hospitals. © 2013 American Urological Association Education and Research, Inc.


Kim S.P.,Mayo Medical School | Karnes R.J.,Mayo Medical School | Nguyen P.L.,Dana-Farber Cancer Institute | Ziegenfuss J.Y.,HealthPartners Institute for Education and Research | And 8 more authors.
Journal of Urology | Year: 2013

Purpose: Although clinical guidelines recommend assessing quality of life, cancer aggressiveness and life expectancy for making localized prostate cancer treatment decisions, it is unknown whether instruments that objectively measure such outcomes have disseminated into clinical practice. In this context we determined whether quality of life and prediction instruments for prostate cancer have been adopted by radiation oncologists and urologists in the United States. Materials and Methods: Using a nationally representative mail survey of 1,422 prostate cancer specialists in the United States, we queried about self-reported clinical implementation of quality of life instruments, prostate cancer nomograms and life expectancy prediction tools in late 2011. The Pearson chi-square test and multivariate logistic regression were used to determine differences in the use of each instrument by physician characteristics. Results: A total of 313 radiation oncologists and 328 urologists completed the survey for a 45% response rate. Although 55% of respondents reported using prostate cancer nomograms, only 27% and 23% reported using quality of life and life expectancy prediction instruments, respectively. On multivariate analysis urologists were less likely to use quality of life instruments than radiation oncologists (OR 0.40, p <0.001). Physicians who spent 30 minutes or more counseling patients were consistently more likely to use quality of life instruments (OR 2.57, p <0.001), prostate cancer nomograms (OR 1.83, p = 0.009) and life expectancy prediction tools (OR 1.85, p = 0.02) than those who spent less than 15 minutes. Conclusions: Although prostate cancer nomograms have been implemented into clinical practice to some degree, the use of quality of life and life expectancy tools has been more limited. Increased attention to implementing validated instruments into clinical practice may facilitate shared decision making for patients with prostate cancer. © 2013 American Urological Association Education and Research, Inc.


Han L.C.,Biomedical Ethics Research Unit | Olson J.E.,Mayo Medical School | Koenig B.A.,University of California at San Francisco | Ziegenfuss J.Y.,HealthPartners Institute for Education and Research
Public Health Genomics | Year: 2013

Background: Biobanks are an important resource for genetic and epidemiologic research, but bias may be introduced if those who accept the recruitment invitation differ systematically from those who do not in terms of attributes important to health-related investigations. To understand potential bias in a clinic-based biobank of biological samples, including genetic data linked to electronic health record information, we compared patient characteristics and self-reported information among participants, nonresponders and refusers. We also compared reasons for nonparticipation between refusers and nonresponders to elucidate potential pathways to reduce nonparticipation and any uncovered bias. Methods: We mailed recruitment packets to 1,600 adult patients with upcoming appointments at Mayo Clinic (Rochester, Minn., USA) and recorded their participation status. Administrative data were used to compare characteristics across groups. We used phone interviews with 26 nonresponders and 26 refusers to collect self-reported information, including reasons for nonparticipation. Participants were asked to complete a mailed questionnaire. Results: We achieved 26.2% participation (n = 419) with 12.1% refusing (n = 193) and 61.8% nonresponse (n = 988). In multivariate analyses, sex, age, region of residence, and race/ethnicity were significantly associated with participation. The groups differed in information-seeking behaviors and research experience. Refusers more often cited privacy concerns, while nonresponders more often identified time constraints as the reason for nonparticipation. Conclusion: For genomic medicine to advance, large, representative biobanks are required. Significant associations between patient characteristics and nonresponse, as well as systematic differences between refusers and nonresponders, could introduce bias. Oversampling or recruitment changes, including heightened attention to privacy protection and participation burden, may be necessary to increase participation among less-represented groups. Copyright © 2013 S. Karger AG, Basel.


Ridgeway J.L.,Mayo Medical School | Han L.C.,Biomedical Ethics Research Unit | Olson J.E.,Mayo Medical School | Lackore K.A.,Mayo Medical School | And 3 more authors.
Public Health Genomics | Year: 2013

Background: Biobanks are an important resource for genetic and epidemiologic research, but bias may be introduced if those who accept the recruitment invitation differ systematically from those who do not in terms of attributes important to health-related investigations. To understand potential bias in a clinic-based biobank of biological samples, including genetic data linked to electronic health record information, we compared patient characteristics and self-reported information among participants, nonresponders and refusers. We also compared reasons for nonparticipation between refusers and nonresponders to elucidate potential pathways to reduce nonparticipation and any uncovered bias. Methods: We mailed recruitment packets to 1,600 adult patients with upcoming appointments at Mayo Clinic (Rochester, Minn., USA) and recorded their participation status. Administrative data were used to compare characteristics across groups. We used phone interviews with 26 nonresponders and 26 refusers to collect self-reported information, including reasons for nonparticipation. Participants were asked to complete a mailed questionnaire. Results: We achieved 26.2% participation (n = 419) with 12.1% refusing (n = 193) and 61.8% nonresponse (n = 988). In multivariate analyses, sex, age, region of residence, and race/ethnicity were significantly associated with participation. The groups differed in information-seeking behaviors and research experience. Refusers more often cited privacy concerns, while nonresponders more often identified time constraints as the reason for nonparticipation. Conclusion: For genomic medicine to advance, large, representative biobanks are required. Significant associations between patient characteristics and nonresponse, as well as systematic differences between refusers and nonresponders, could introduce bias. Oversampling or recruitment changes, including heightened attention to privacy protection and participation burden, may be necessary to increase participation among less-represented groups. Copyright © 2013 S. Karger AG, Basel.


Sabbatini A.K.,University of Michigan | Tilburt J.C.,Mayo Medical School | Tilburt J.C.,Biomedical Ethics Research Unit | Tilburt J.C.,Center for the Science of Health Care Delivery | And 6 more authors.
Journal of General Internal Medicine | Year: 2014

BACKGROUND: Physicians have dual responsibilities to make medical decisions that serve their patients' best interests but also utilize health care resources wisely. Their ability to practice cost-consciously is particularly challenged when faced with patient expectations or requests for medical services that may be unnecessary. OBJECTIVE: To understand how physicians consider health care resources and the strategies they use to exercise cost-consciousness in response to patient expectations and requests for medical care. DESIGN: Exploratory, qualitative focus groups of practicing physicians were conducted. Participants were encouraged to discuss their perceptions of resource constraints, and experiences with redundant, unnecessary and marginally beneficial services, and were asked about patient requests or expectations for particular services. PARTICIPANTS: Sixty-two physicians representing a variety of specialties and practice types participated in nine focus groups in Michigan, Ohio, and Minnesota in 2012 MEASUREMENTS: Iterative thematic content analysis of focus group transcripts PRINCIPAL FINDINGS: Physicians reported making trade-offs between a variety of financial and nonfinancial resources, considering not only the relative cost of medical decisions and alternative services, but the time and convenience of patients, their own time constraints, as well as the logistics of maintaining a successful practice. They described strategies and techniques to educate patients, build trust, or substitute less costly alternatives when appropriate, often adapting their management to the individual patient and clinical environment. CONCLUSIONS: Physicians often make nuanced trade-offs in clinical practice aimed at efficient resource use within a complex flow of clinical work and patient expectations. Understanding the challenges faced by physicians and the strategies they use to exercise cost-consciousness provides insight into policy measures that will address physician's roles in health care resource use. © Society of General Internal Medicine 2014.


Thorsteinsdottir B.,Mayo Medical School | Swetz K.M.,Mayo Medical School | Tilburt J.C.,Mayo Medical School | Tilburt J.C.,Biomedical Ethics Research Unit | Tilburt J.C.,Knowledge Evaluation Research Unit
Journal of General Internal Medicine | Year: 2013

The current practice of hemodialysis for the frail elderly frequently ignores core bioethical principles. Lack of transparency and shared decision making coupled with financial incentives to treat have resulted in problems of overtreatment near the end of life. Imminent changes in reimbursement for hemodialysis will reverse the financial incentives to favor not treating high-risk patients. In this article, we describe what is empirically known about the approach to hemodialysis today, and how it violates four core ethical principles. We then discuss how the new financial system turns physician and organizational incentives upside down in ways that may exacerbate the ethical dilemmas, but in the opposite direction. © 2013 Society of General Internal Medicine.


Comfere N.I.,Mayo Medical School | Peters M.S.,Mayo Medical School | Jenkins S.,Mayo Medical School | Lackore K.,Mayo Medical School | And 2 more authors.
Journal of Cutaneous Pathology | Year: 2015

Background Communication failures between clinicians and dermatopathologists are prevalent. Our primary objective was to characterize the concerns and challenges of dermatopathologists posed by incomplete or inaccurate clinical information in the skin biopsy requisition form. Methods An explanatory sequential, mixed-methods study design comprised of a survey sent to 1103 members of the American Society of Dermatopathology (ASDP), followed by two focus group sessions. Results A total of 54% (598/1103) of dermatopathologists completed the questionnaire. Most dermatopathologists (80%; 436/548) viewed their roles to be providers of histopathological diagnosis and a report that is clinically meaningful. Paper or electronic requisition forms were the most common communication method (85%; 458/541) and were associated with the highest rates of dissatisfaction in 36% (193/537) of respondents. Inadequacy of specimens emerged as an important factor influencing judgment of the quality of provided clinical information. 44.7% (261/584) of dermatopathologists spent 30 minutes or more on average every day searching for relevant clinical information to assist with their histopathologic interpretation. Conclusion ASDP dermatopathologists expressed significant dissatisfaction with the quality of clinical information in the requisition form and the time spent gathering information necessary for accurate, timely and clinically meaningful diagnosis. These findings have implications for the quality, safety and efficiency of dermatologic care. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.


Nishimura A.,University of Washington | Carey J.,Mayo Medical School | Carey J.,Knowledge and Evaluation Research Unit | Erwin P.J.,Mayo Medical School | And 6 more authors.
BMC Medical Ethics | Year: 2013

Background: Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose. To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods. The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results: Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions: Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons. © 2013 Nishimura et al.; licensee BioMed Central Ltd.

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