[Show abstract][Hide abstract] ABSTRACT: Purpose: Human biospecimens are central to biobanking efforts, yet how members of the public think about biobank procurement strategies is not well understood. This study aimed to explore public perspectives toward the procurement of residual clinical material versus "direct" procurement strategies such as the drawing of blood.Methods: Members of the public residing in and beyond the biobank catchment area of the University of Iowa Hospitals and Clinics were randomly selected to participate in focus groups and a telephone survey.Results: The majority of survey participants (75%, n=559) found both residual and direct procurement strategies equally workable. Small proportions preferred either residual (15%; n=117) or direct (5%; n=40) procurement. Focus group participants (n=48) could identify benefits to both procurement strategies, but raised concerns about possible donor inconvenience/discomfort and reduced biospecimen accrual in the case of direct procurement. Residual procurement raised concerns about lower-quality samples being procured without full donor awareness. Conclusion: Biobanks should consider that members of the public in their research programs may be willing to make specimen donations regardless of whether a residual or direct procurement strategy is employed. Limiting patient discomfort and inconvenience may make direct procurement strategies more acceptable to some members of the public. Ensuring donor awareness through effective informed consent may allay public concerns about the indirectness of donating clinical biospecimens.
Biopreservation and Biobanking 06/2013; 11(3):137-43. · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Next generation sequencing offers benefit of improved health through knowledge, but comes with challenges, such as inevitable incidental findings (IFs). The applicability of recommended criteria for disclosure of individual results when applied to disclosure of IFs is not well known. The purpose of this study was to examine how medical genetic specialists, genomic researchers, and Institutional Review Board (IRB) chairs perceive the importance of recommended criteria when applied to genetic/genomic IFs. We conducted telephone interviews with medical genetic specialists (genetic counselors, genetic nurses, medical geneticists, laboratory professionals), genomic researchers, and IRB chairs (N = 103). Respondents rated and discussed the importance of nine recommended criteria regarding disclosure of genetic/genomic IFs. Stakeholders agreed the most important criteria for disclosure were: (1) the IF points to a life-threatening condition; (2) there is a treatment; (3) individuals indicate in writing they wanted to be informed of IFs. Criteria rated less important were: analytic validity, high penetrance, association with a young age of onset and relative risk more than 2.0. Respondents indicated that some technical criteria were confusing, and in need of context. Our findings suggest that development of guidelines regarding management of IF include multiple stakeholders' perspectives and be based on a common language.
Journal of Genetic Counseling 04/2013; · 1.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: Ethics education is an established part of the medical school curriculum and typically involves preclinical instruction that includes formal ethical terminology. However, it is not clear whether the language of ethics taught in preclinical settings is applied by students during the clinical years of training. Methods: We used a survey and a content analysis of written reflections to determine whether third-year (clinical) medical students were able to recall and apply ethical principles and other sources of ethical value they were taught as second-year (preclinical) students. Results: The majority of clinical students were able to recall the four ethical principles, appreciated the relevance of preclinical ethics education, and had positive self-assessments of their clinical-ethical reasoning abilities. However, they were less able to recall other (nonprinciple) sources of ethical value and infrequently used ethical terms spontaneously in written reflections about ethically or professionally challenging issues. Conclusions: Ethics educators should consider the extent to which preclinical ethics education depends on a formal language of ethics and should develop ways to reinforce that language meaningfully through experience-based learning opportunities during the clinical years of training, with special emphasis on the way clear ethical reasoning and communication demonstrate respect for other persons.
[Show abstract][Hide abstract] ABSTRACT: Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond.
To explore publicly accessible IRB websites for guidance in this area, using summative content analysis.
Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of 'significant new findings' (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level.
IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined.
Journal of medical ethics 03/2012; 38(7):417-22. · 1.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Genomic research can produce findings unrelated to a study's aims. The purpose of this study was to examine researcher and Institutional Review Board (IRB) chair perspectives on genomic incidental findings (GIFs).
Nineteen genomic researchers and 34 IRB chairs from 42 institutions participated in semi-structured telephone interviews. Researchers and chairs described GIFs within their respective roles. Few had direct experience with disclosure of GIFs. Researchers favored policies where a case by case determination regarding whether GIF disclosure would be offered after discovery, whereas IRB chairs preferred policies where procedures for disclosure would be determined prior to approval of the research.
Researcher and IRB chair perspectives on management of GIFs overlap, but each group provides a unique perspective on decisions regarding disclosure of GIFs in research. Engagement of both groups is essential in efforts to provide guidance for researchers and IRBs regarding disclosure of GIFs in research.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Treatment decisions should be based on patients' goals of care to provide an ethical, patient-centered framework for decision-making. OBJECTIVES: The purpose of this study is to improve our understanding about how patients' and surrogates' goals of care are communicated and interpreted in an MICU. METHODS: One hundred patients admitted to an MICU, or their surrogates, responded to an open-ended question about goals of care for their hospitalization followed by a closed-ended question regarding their most important goal of care. Investigators interpreted participants' open-ended responses and compared these interpretations with participants' closed-ended, most-important-goal selections. RESULTS: Investigators' interpretations of participants' open-ended goals of care responses matched participants' closed-ended most important goal of care in only 28 of 100 cases. However, there was good inter-rater reliability between investigators in their interpretation of participants' open-ended responses, with agreement in 78 of 100 cases. CONCLUSIONS: Clinicians should be cautious in interpreting patients' or surrogates' responses to open-ended questions about goals of care. A shared understanding of goals of care may be facilitated by alternating open-ended and closed-ended questions to clarify patients' or surrogates' responses.
Journal of Hospice and Palliative Nursing 01/2012; 14(2):126-132. · 0.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects.
Journal of Empirical Research on Human Research Ethics 12/2011; 6(4):53-67. · 1.49 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To assess healthcare personnel (HCP) perceptions regarding implementation of sensor-based electronic systems for automated hand hygiene adherence monitoring.
Using a mixed-methods approach, structured focus groups were designed to elicit quantitative and qualitative responses on familiarity, comfort level, and perceived impact of sensor-based hand hygiene adherence monitoring.
A university hospital, a Veterans Affairs hospital, and a community hospital in the Midwest.
Focus groups were homogenous by HCP type, with separate groups held for leadership, midlevel management, and frontline personnel at each hospital.
Overall, 89 HCP participated in 10 focus groups. Levels of familiarity and comfort with electronic oversight technology varied by HCP type; when compared with frontline HCP, those in leadership positions were significantly more familiar with ([Formula: see text]) and more comfortable with ([Formula: see text]) the technology. The most common concerns cited by participants across groups included lack of accuracy in the data produced, such as the inability of the technology to assess the situational context of hand hygiene opportunities, and the potential punitive use of data produced. Across groups, HCP had decreased tolerance for electronic collection of spatial-temporal data, describing such oversight as Big Brother.
While substantial concerns were expressed by all types of HCP, participants' recommendations for effective implementation of electronic oversight technologies for hand hygiene monitoring included addressing accuracy issues before implementation and transparent communication with frontline HCP about the intended use of the data.
Infection Control and Hospital Epidemiology 11/2011; 32(11):1091-6. · 4.02 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Education in ethics and professionalism should reflect the realities medical students encounter in the hospital and clinic.
We performed content analyses on Case Observation and Assessments (COAs) written by third-year medical students about ethical and professional issues encountered during their internal medicine and paediatrics clinical clerkships.
A cohort of 141 third-year medical students wrote 272 COAs. Content analyses identified 35 subcategories of ethical and professional issues within 7 major domains: decisions regarding treatment (31.4%), communication (21.4%), professional duties (18.4%), justice (9.8%), student-specific issues (5.4%), quality of care (3.8%), and miscellaneous (9.8%).
Students encountered a wide variety of ethical and professional issues that can be used to guide pre-clinical and clinical education. Comparison of our findings with results from similar studies suggests that the wording of an assignment (specifying "ethical" issues, "professional" issues, or both) may influence the kinds of issues students identify in their experience-based clinical narratives.
Journal of medical ethics 09/2011; 38(2):130-2. · 1.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks.
The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa.
Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use.
Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result.
Genetics in medicine: official journal of the American College of Medical Genetics 05/2011; 13(9):821-31. · 3.92 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Decisions about CPR in the medical ICU (MICU) are important. However, discussions about CPR (code status discussions) can be challenging and may be incomplete if they do not address goals of care.
We interviewed 100 patients, or their surrogates, and their physicians in an MICU. We queried the patients/surrogates on their knowledge of CPR, code status preferences, and goals of care; we queried MICU physicians about goals of care and treatment plans. Medical records were reviewed for clinical information and code status orders.
Fifty patients/surrogates recalled discussing CPR preferences with a physician, and 51 recalled discussing goals of care. Eighty-three patients/surrogates preferred full code status, but only four could identify the three main components of in-hospital CPR (defibrillation, chest compressions, intubation). There were 16 discrepancies between code status preferences expressed during the interview and code status orders in the medical record. Respondents' average prediction of survival following in-hospital cardiac arrest with CPR was 71.8%, and the higher the prediction of survival, the greater the frequency of preference for full code status (P = .012). Of six possible goals of care, approximately five were affirmed by each patient/surrogate and physician, but 67.7% of patients/surrogates differed with their physicians about the most important goal of care.
Patients in the MICU and their surrogates have inadequate knowledge about in-hospital CPR and its likelihood of success, patients' code status preferences may not always be reflected in code status orders, and assessments may differ between patients/surrogates and physicians about what goal of care is most important.
[Show abstract][Hide abstract] ABSTRACT: Our objective was to validate 6 literature-derived goals of care by analyzing open-ended and closed-ended responses about goals of care from a previous study of hospitalized patients. Eight clinicians categorized patients' open-ended articulations of their goals of care using a literature-derived framework and then compared those categorizations to patients' own closed-ended selections of their most important goal of care. Clinicians successfully categorized patients' open-ended responses using the literature-derived framework 83.5% of the time, and their categorizations matched patients' closed-ended most important goal of care 87.8% of the time. Goals that did not fit within the literature-derived framework all pertained to the goal of understanding a patient's diagnosis or prognosis; this seventh potential goal can be added to the literature-derived framework of 6 goals of care.
The American journal of hospice & palliative care 11/2010; 28(5):335-41.
[Show abstract][Hide abstract] ABSTRACT: Surrogate decision makers for persons with advanced dementia play a key role in making decisions about medical treatments for their loved ones. We conducted in-depth interviews of 20 surrogates to examine their goals of care preferences and beliefs about personhood. All surrogates believed the goal of comfort was important, and 30.0% believed that curing physical problems was important. Significant proportions of surrogates acknowledged dementia-related changes in patients' ability to reason, communicate, and relate to others. Qualitative findings demonstrated diverse beliefs regarding the impact of dementia on factors related to personhood, for example, dignity, respect from others, and having a life worth living. In conclusion, the surrogates we interviewed expressed diverse preferences regarding goals of care and diverse assessments about the impact of dementia on personhood.
The American journal of hospice & palliative care 02/2010; 27(6):387-97.
[Show abstract][Hide abstract] ABSTRACT: Goals of care are often mentioned as an important component of end-of-life discussions, but there are diverse assessments regarding the type and number of goals that should be considered. To address this lack of consensus, we searched MEDLINE (1967-2007) for relevant articles and identified the number, phrasing, and type of goals they addressed. An iterative process of categorization resulted in a list of 6 practical, comprehensive goals: (1) be cured, (2) live longer, (3) improve or maintain function/quality of life/ independence, (4) be comfortable, (5) achieve life goals, and (6) provide support for family/caregiver. These goals can be used to articulate goal-oriented frameworks to guide decision making toward the end of life and thereby harmonize patients' treatment choices with their values and medical conditions.
The American journal of hospice & palliative care 01/2010; 25(6):501-11.
[Show abstract][Hide abstract] ABSTRACT: Code status discussions may fail to address patients' treatment-related goals and their knowledge of cardiopulmonary resuscitation (CPR). This study aimed to investigate patients' resuscitation preferences, knowledge of CPR and goals of care. Design, setting, patients and measurements: 135 adults were interviewed within 48 h of admission to a general medical service in an academic medical centre, querying code status preferences, knowledge about CPR and its outcome probabilities and goals of care. Medical records were reviewed for clinical information and code status documentation.
41 (30.4%) patients had discussed CPR with their doctor, 116 (85.9%) patients preferred full code status and 11 (8.1%) patients expressed code status preferences different from the code status documented in their medical record. When queried about seven possible goals of care, patients affirmed an average of 4.9 goals; their single most important goals were broadly distributed, ranging from being cured (n = 36; 26.7%) to being comfortable (n = 8; 5.9%). Patients' mean estimate of survival to discharge after CPR was 60.4%. Most patients believed it was helpful to discuss goals of care (n = 95; 70.4%) and the chances of surviving in hospital CPR (n = 112; 83.0%). Some patients expressed a desire to change their code status after receiving information about survival following in hospital CPR (n = 11; 8.1%) or after discussing goals of care (n = 2; 1.5%).
Doctors need to address patients' knowledge about CPR and take steps to avoid discrepancies between treatment orders and patients' preferences. Addressing CPR outcome probabilities and goals of care during code status discussions may improve patients' knowledge and influence their preferences.
Journal of medical ethics 07/2009; 35(6):338-42. · 1.42 Impact Factor