Laura Shinkunas

Active choice but not too active: Public perspectives on biobank consent models

Purpose: 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.Methods: 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.Results: 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.Conclusion: 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.

Code status discussions and goals of care among hospitalised adults

Background and objective: 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. Results: 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 inhospital CPR (n = 112; 83.0%). Some patients expressed a desire to change their code status after receiving information about survival following inhospital CPR (n = 11; 8.1%) or after discussing goals of care (n = 2; 1.5%). Conclusions: 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.

Informed consent and genomic incidental findings: IRB chair perspectives

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 researchers 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.

A Closer Look at the Recommended Criteria for Disclosing Genetic Results: Perspectives of Medical Genetic Specialists, Genomic Researchers, and Institutional Review Board Chairs

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.

Majority of patients with hepatitis C express physical, mental, and social difficulties with antiviral treatment

Objective The hepatitis C virus can be successfully treated in up to 60% of infected patients. However, treatment is long and is associated with significant side-effects. We investigated difficulties with this treatment as it is an important factor in patient adherence. Methods Patients receiving hepatitis C treatment in a tertiary referral center were enrolled in a cross-sectional study. Demographic data, functional and emotional status, and co-morbidities were collected from patients or abstracted from the medical records. All participants underwent a semistructured interview, which was analysed by blinded coders. Results A total of 65 patients (mean age 46.1 years; 38.5% women) were enrolled. Fifty-two (80%) described moderate to severe problems attributed to treatment, with a predominance of physical difficulties (fatigue 74% of cases; flu-like symptoms 32%). Approximately one third of patients (38%) experienced depression during treatment. In 31% of cases, physical or emotional problems forced patients to quit their jobs or reduce employment. One fifth attributed deteriorating relationships with friends and family to adverse treatment effects. Necessary lifestyle adjustments, such as alcohol abstinence, caused frictions with friends in 22% of the participants. Conclusions Our findings show a high prevalence of significant adverse effects in patients undergoing antiviral therapy. Whereas the nature and severity of these adverse reactions is consistent with earlier reports, we identified implications with worsening private and professional relationships. To encourage appropriate levels of adherence, healthcare providers should seek information about these indirect treatment effects as they monitor their patients on therapy.

Researcher and Institutional Review Board Chair Perspectives on Incidental Findings in Genomic Research

AIMS Genomic research can produce findings unrelated to a studys aims. The purpose of this study was to examine researcher and Institutional Review Board (IRB) chair perspectives on genomic incidental findings (GIFs). METHODS 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. CONCLUSIONS 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.

Goals of Care among Hospitalized Patients: A Validation Study

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.

Dementia, Goals of Care, and Personhood: A Study of Surrogate Decision Makers’ Beliefs and Values:

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.

Individual genetic and genomic research results and the tradition of informed consent: exploring US review board guidance

Background 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. Objective and methods To explore publicly accessible IRB websites for guidance in this area, using summative content analysis. Findings 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. Conclusion 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.

National survey of provider opinions on controversial characteristics of liver transplant candidates

Candidate selection for liver transplantation presents challenging ethical issues that require balancing the principles of justice and utility. The goal of this study was to assess the opinions of US transplant providers regarding the ways in which controversial medical and psychosocial characteristics influence patient eligibility for liver transplantation. An online, anonymous survey about adult patient characteristics was sent to providers (hepatologists, surgeons, psychiatrists, and social workers) at all 102 active adult liver transplant centers in the United States. A majority of the providers (251/444 or 56.5%) completed the survey. The providers were queried about 8 characteristics, and the 3 that were ranked most controversial were incarceration, marijuana use, and psychiatric diagnoses. Most providers identified a patient age ≥ 80 years (62.7%), a body mass index ≥ 45 kg/m2 (56.6%), and current incarceration with a lifetime sentence (54.7%) as absolute contraindications to liver transplantation. In a multivariate analysis, the identification of absolute contraindications varied significantly with the provider type, the center volume, and the geographical region. Less than half of the providers reported that their centers had written policies regarding most of the characteristics examined. In conclusion, providers differ significantly in their opinions on controversial patient characteristics and transplant contraindications. Along with a paucity of literature data on outcomes, these provider differences may play a role in the fact that many centers do not have formal policies for selecting patients with these characteristics. Evidence‐based data on the outcomes of such patients are needed to guide the formation of written policies to better standardize eligibility criteria. Liver Transpl 19:395–403, 2013.