Development of a Resource Guide to Help Patients Receive Appropriate Care.

After 10 years researching physician wrongdoing (i.e., sexual violations, improper prescribing, and unnecessary procedures), we developed a resource guide to help patients receive appropriate care and respond to inappropriate care. We gathered evaluative patient feedback, engaged physicians, and disseminated the guide. It is available at beforeyourvisit.org.

Attitudes toward genomics and precision medicine.

PURPOSE: This paper reports on a novel measure, attitudes toward genomics and precision medicine (AGPM), which evaluates attitudes toward activities such as genetic testing, collecting information on lifestyle, and genome editing - activities necessary to achieve the goals of precision medicine. DISCUSSION: The AGPM will be useful for researchers who want to explore attitudes toward genomics and precision medicine. The association of concerns about precision medicine activities with demographic variables such as religion and politics, as well as higher levels of education, suggests that further education on genomic and precision activities alone is unlikely to shift AGPM scores significantly. METHODS: We wrote items to represent psychological and health benefits of precision medicine activities, and concerns about privacy, social justice, harm to embryos, and interfering with nature. We validated the measure through factor analysis of its structure, and testing associations with trust in the health information system and demographic variables such as age, sex, education, and religion. RESULTS: The AGPM had excellent alpha reliability (.92) and demonstrated good convergent validity with existing measures. Variables most strongly associated with higher levels of concern with precision medicine activities included: regular religious practice, republican political leanings, and higher levels of education.

Parental Attitudes toward Artificial Intelligence-Driven Precision Medicine Technologies in Pediatric Healthcare.

Precision medicine relies upon artificial intelligence (AI)-driven technologies that raise ethical and practical concerns. In this study, we developed and validated a measure of parental openness and concerns with AI-driven technologies in their child's healthcare. In this cross-sectional survey, we enrolled parents of children <18 years in 2 rounds for exploratory (n = 418) and confirmatory (n = 386) factor analysis. We developed a 12-item measure of parental openness to AI-driven technologies, and a 33-item measure identifying concerns that parents found important when considering these technologies. We also evaluated associations between openness and attitudes, beliefs, personality traits, and demographics. Parents (N = 804) reported mean openness to AI-driven technologies of M = 3.4/5, SD = 0.9. We identified seven concerns that parents considered important when evaluating these technologies: quality/accuracy, privacy, shared decision making, convenience, cost, human element of care, and social justice. In multivariable linear regression, parental openness was positively associated with quality (beta = 0.23), convenience (beta = 0.16), and cost (beta = 0.11), as well as faith in technology (beta = 0.23) and trust in health information systems (beta = 0.12). Parental openness was negatively associated with the perceived importance of shared decision making (beta = -0.16) and being female (beta = -0.12). Developers might support parental openness by addressing these concerns during the development and implementation of novel AI-driven technologies.

The lab management practices of "Research Exemplars" that foster research rigor and regulatory compliance: A qualitative study of successful principal investigators.

INTRODUCTION: Conducting rigorous scientific inquiry within the bounds of research regulation and acceptable practice requires a principal investigator to lead and manage research processes and personnel. This study explores the practices used by investigators nominated as exemplars of research excellence and integrity to produce rigorous, reproducible research and comply with research regulations. METHODS: Using a qualitative research design, we interviewed 52 principal investigators working in the United States at top research universities and the National Institutes of Health Intramural Research Program. We solicited nominations of researchers meeting two criteria: (1) they are federally-funded researchers doing high-quality, high-impact research, and (2) have reputations for professionalism and integrity. Each investigator received an initial nomination addressing both criteria and at least one additional endorsement corroborating criteria 2. A panel of researchers and our research team reviewed the nominations to select finalists who were invited to participate. The cohort of "Research Exemplars" includes highly accomplished researchers in diverse scientific disciplines. The semi-structured interview questions asked them to describe the routine practices they employ to foster rigor and regulatory compliance. We used inductive thematic analysis to identify common practices. RESULTS: The exemplars identified a core set of 8 practices and provided strategies for employing them. The practices included holding regular team meetings, encouraging shared ownership, providing supervision, ensuring adequate training, fostering positive attitudes about compliance, scrutinizing data and findings, and following standard operating procedures. Above all, the use of these practices aim to create a psychologically safe work environment in which lab members openly collaborate to scrutinize their work and share in accountability for rigorous, compliant research. CONCLUSIONS: Researchers typically receive limited systematic training in how to lead and manage their research teams. Training and education for principal investigators should include essential leadership and management practices and strategies that support doing high-quality research with integrity.

Knowing Your Limits: A Qualitative Study of Physician and Nurse Practitioner Perspectives on NP Independence in Primary Care.

BACKGROUND: The shortage of primary care providers and the provisions of the Affordable Care Act (ACA) have spurred discussion about expanding the number, scope of practice (SOP), and independence of primary care nurse practitioners (NPs). Such discussions in the media and among professional organizations may insinuate that changes to the laws governing NP practice will engender acrimony between practicing physicians and NPs. However, we lack empirical, descriptive data on how practicing professionals view NP independence in primary care. OBJECTIVE: The aim of the present study was to explore and describe the attitudes about NP independence among physicians and NPs working in primary care. DESIGN: A qualitative study based on the principles of grounded theory. PARTICIPANTS: Thirty primary care professionals in Missouri, USA, including 15 primary care physicians and 15 primary care NPs. APPROACH: Semi-structured, in-depth interviews, with data analysis guided by grounded theory. KEY RESULTS: Participants had perspectives that were not well represented by professional organizations or the media. Physicians were supportive of a wide variety of NP roles and comfortable with high levels of NP independence and autonomy. Physicians and NPs described prerequisites to NP independence that were complementary. Physicians generally believed that NPs needed some association with physicians for patient safety, and NPs preferred having a physician readily accessible as needed. The theme "knowing your limits" was important to both NPs and physicians regarding NP independence, and has not been described previously in the literature. CONCLUSIONS: NP and physician views about NP practice in primary care are not as divergent as their representative professional organizations and the news media would suggest. The significant agreement among NPs and physicians, and some of the nuances of their perspectives, supports recommendations that may reduce the perceived acrimony surrounding discussions of NP independent practice in primary care.

BETWEEN A ROCK AND A HARD PLACE: CAN PHYSICIANS PRESCRIBE OPIOIDS TO TREAT PAIN ADEQUATELY WHILE AVOIDING LEGAL SANCTION?

Prescription opioids are an important tool for physicians in treating pain but also carry significant risks of harm when prescribed inappropriately or misused by patients or others. Recent increases in opioid-related morbidity and mortality has reignited scrutiny of prescribing practices by law enforcement, regulatory agencies, and state medical boards. At the same time, the predominant 4D model of misprescribers is outdated and insufficient; it groups physician misprescribers as dated, duped, disabled, or dishonest. The weaknesses and inaccuracies of the 4D model are explored, along with the serious consequences of its application. This Article calls for development of an evidence base in this area and suggests an alternate model of misprescribers, the 3C model, which more accurately characterizes misprescribers as careless, corrupt, or compromised by impairment.

Aligning objectives and assessment in responsible conduct of research instruction.

Efforts to advance research integrity in light of concerns about misbehavior in research rely heavily on education in the responsible conduct of research (RCR). However, there is limited evidence for the effectiveness of RCR instruction as a remedy. Assessment is essential in RCR education if the research community wishes to expend the effort of instructors, students, and trainees wisely. This article presents key considerations that instructors and course directors must consider in aligning learning objectives with instructional methods and assessment measures, and it provides illustrative examples. Above all, in order for RCR educators to assess outcomes more effectively, they must align assessment to their learning objectives and attend to the validity of the measures used.

An official American Thoracic Society/International Society for Heart and Lung Transplantation/Society of Critical Care Medicine/Association of Organ and Procurement Organizations/United Network of Organ Sharing Statement: ethical and policy considerations in organ donation after circulatory determination of death.

RATIONALE: Donation after circulatory determination of death (DCDD) has the potential to increase the number of organs available for transplantation. Because consent and management of potential donors must occur before death, DCDD raises unique ethical and policy issues. OBJECTIVES: To develop an ethics and health policy statement on adult and pediatric DCDD relevant to critical care and transplantation stakeholders. METHODS: A multidisciplinary panel of stakeholders was convened to develop an ethics and health policy statement. The panel consisted of representatives from the American Thoracic Society, Society of Critical Care Medicine, International Society for Heart and Lung Transplantation, Association of Organ Procurement Organizations, and the United Network of Organ Sharing. The panel reviewed the literature, discussed important ethics and health policy considerations, and developed a guiding framework for decision making by stakeholders. RESULTS: A framework to guide ethics and health policy statement was established, which addressed the consent process, pre- and post mortem interventions, the determination of death, provisions of end-of-life care, and pediatric DCDD. CONCLUSIONS: The information presented in this Statement is based on the current evidence, experience, and clinical rationale. New clinical research and the development and dissemination of new technologies will eventually necessitate an update of this Statement.

A humble task: restoring virtue in an age of conflicted interests.

Virtues define how we behave when no one else is watching; accordingly, they serve as a bedrock for professional self-regulation, particularly at the level of the individual physician. From the time of William Osler through the end of the 20th century, physician virtue was viewed as an important safeguard for patients and research participants. However, the Institute of Medicine, Association of American Medical Colleges, and other policy groups-relying on social science data indicating that ethical decisions often result from unconscious and biased processes, particularly in the face of financial conflicts of interest-have increasingly rejected physician virtue as an important safeguard for patients.The authors argue that virtue is still needed in medicine-at least as a supplement to regulatory solutions (such as mandatory disclosures). For example, although rarely treated as a reportable conflict of interest, standard fee-for-service medicine can present motives to prioritize self-interest or institutional interests over patient interests. Because conflicts of interest broadly construed are ubiquitous, physician self-regulation (or professional virtue) is still needed. Therefore, the authors explore three strategies that physicians can adopt to minimize the influence of self-serving biases when making medical business ethics decisions. They further argue that humility must serve as a crowning virtue-not a meek humility but, rather, a courageous willingness to recognize one's own limitations and one's need to use "compensating strategies," such as time-outs and consultation with more objective others, when making decisions in the face of conflicting interests.

The biomedical ethics ontology proposal: excellent aims, questionable methods.

KOEPSELL ET AL. (2009) DESCRIBE AN IDEAL biomedical ethics committee environment with efficiencies such as electronic and universal application forms and consent templates, automated decision-trees, and broad sharing of data. However, it is unclear that a biomedical ethics ontology (BMEO) is necessary or even helpful in establishing such environment. Two features of any applied ontology are particularly problematic in establishing a useful BMEO: (1) an ontology is a description of a domain of reality; and (2) the description is subject to ongoing revision as it is developed through open processes, e.g., the use of a wiki. A BMEO would need to address two main kinds of entities, regulatory definitions and ethical concepts, and is ill-suited to both. Regulatory definitions are fiats and ought to be adopted verbatim to ensure compliance, but in such cases we do not need the assistance of ontologists, and their modes of working (constant revision within open wiki-based communities) might even be counterproductive. Ethical concepts within pluralistic societies are social constructs, not a priori concepts or biological natural kinds, and the prospects of generating intuitive definitions that enjoy broad acceptance across cultures and institutional settings are slim. In making these arguments, I draw from the writings of leading applied ontologists and Koepsell et al.'s own proof of concept.

The development and assessment of an NIH-funded research ethics training program.

In an effort to increase the number of researchers with skills "in identifying and addressing the ethical, legal, and social implications of their research," the National Institutes of Health (NIH) solicited training grant proposals from 1999 to 2004 and subsequently funded approved programs. The authors describe the content, format, and outcomes of one such training program that ran from 2002 to 2006 and share key lessons learned about program formats and assessment methods. Jointly developed by the Saint Louis University Center for Health Care Ethics and the Missouri Institute of Mental Health Continuing Education department, the training program focused on mental health research and adopted a train-the-trainer model. It was offered in on-site and distance-learning formats. Key outcomes of the program included educational products (such as 70 case studies posted on the course Web site, a textbook, and an instructional DVD) and program completion by 40 trainees. Assessment involved pre- and posttesting focused on knowledge of research ethics, ethical problem-solving skills, and levels of confidence in addressing ethical issues in mental health research. The program succeeded in increasing participants' knowledge of ethical issues and their beliefs that they could identify issues, identify problem-solving resources, and solve ethical problems. However, scores on the case-based problem-solving assessment dropped in posttesting, apparently because of diminished confidence about the right course of action in the specific dilemma presented; the implications of this finding for ethics assessment are discussed. Overall satisfaction was high, and dropout rates were low but three times higher for distance-learners than for on-site participants.

Ethics education in MSN programs: a study of national trends.

The aim of this study was to determine the manner in which master's of science in nursing programs, accredited by either the National League for Nursing Accrediting Commission or the Commission on Collegiate Nursing Education, conduct ethics education. A survey method was employed to obtain requisite data. Among the main variables investigated were: the percentage of programs that require a course with formal ethics content; the average number of class hours a program or track dedicates to ethics education; required and actual credentials of instructors who teach ethics; and objectives, topics, teaching methods, and grading methods of required courses with formal ethics content. Results indicated that most programs do not require instructors to have completed formal ethics training. In terms of content, few common trends exist and there are important gaps in clinical ethics topics. Comparisons between school of medicine ethics content reported in the literature and MSN ethics content reported in this study indicate that medical schools are more exacting of their students. The study concludes with a call for the establishment of guidelines or standards relevant to ethics content in MSN curricula in the United States.

Attitudes toward death criteria and organ donation among healthcare personnel and the general public.

OBJECTIVE: To examine attitudes toward death criteria and their relation to attitudes and behaviors regarding organ donation. DATA SOURCES: This article reviews empirical studies on the attitudes of healthcare personnel and the general public regarding death criteria and organ donation. STUDY SELECTION AND DATA EXTRACTION: The review was restricted to studies that had as a primary focus attitudes toward 1 or more of the following 3 specific criteria for determining death: (1) brain death, the irreversible loss of all functions of the entire brain; (2) higher brain death, the loss of cerebral cortex function alone; and (3) the circulatory-respiratory criteria commonly used in donation after cardiac death. DATA SYNTHESIS: Studies consistently show that the general public and some medical personnel are inadequately familiar with the legal and medical status of brain death; attitudes toward the dead donor rule are strong predictors of willingness to donate organs using controversial criteria; concerns about donation after cardiac death surround the withdrawal of life support more than the actual death criteria used; and concerns about death criteria correlate with less favorable attitudes toward organ donation. CONCLUSIONS: Both general and ethical education may serve to guide policy and facilitate family member requests and informed consent dialogues. Furthermore, helping families to understand and accept not only medical and legal criteria for determining death, but also ethical criteria for withdrawing life support may help them be more comfortable with their decisions.