Natural Language Processing to Identify Home Health Care Patients at Risk for Becoming Incapacitated With No Evident Advance Directives or Surrogates.

OBJECTIVES: Home health care patients who are at risk for becoming Incapacitated with No Evident Advance Directives or Surrogates (INEADS) may benefit from timely intervention to assist them with advance care planning. This study aimed to develop natural language processing algorithms for identifying home care patients who do not have advance directives, family members, or close social contacts who can serve as surrogate decision-makers in the event that they lose decisional capacity. DESIGN: Cross-sectional study of electronic health records. SETTING AND PARTICIPANTS: Patients receiving post-acute care discharge services from a large home health agency in New York City in 2019 (n = 45,390 enrollment episodes). METHODS: We developed a natural language processing algorithm for identifying information documented in free-text clinical notes (n = 1,429,030 notes) related to 4 categories: evidence of close relationships, evidence of advance directives, evidence suggesting lack of close relationships, and evidence suggesting lack of advance directives. We validated the algorithm against Gold Standard clinician review for 50 patients (n = 314 notes) to calculate precision, recall, and F-score. RESULTS: Algorithm performance for identifying text related to the 4 categories was excellent (average F-score = 0.91), with the best results for "evidence of close relationships" (F-score = 0.99) and the worst results for "evidence of advance directives" (F-score = 0.86). The algorithm identified 22% of all clinical notes (313,290 of 1,429,030) as having text related to 1 or more categories. More than 98% of enrollment episodes (48,164 of 49,141) included at least 1 clinical note containing text related to 1 or more categories. CONCLUSIONS AND IMPLICATIONS: This study establishes the feasibility of creating an automated screening algorithm to aid home health care agencies with identifying patients at risk of becoming INEADS. This screening algorithm can be applied as part of a multipronged approach to facilitate clinician support for advance care planning with patients at risk of becoming INEADS.

Impact of a Genetic Diagnosis for a Child's Autism on Parental Perceptions.

Genetic testing is recommended as part of an autism assessment, and most parents support genetic testing for their minor children. However, the impact on parents of receiving a monogenetic/ copy number variant diagnosis for autism in their child is not well understood. To explore this, we surveyed and interviewed parents of children in the SPARK study, a study of autism that includes genetic testing. Surveys were administered one month before and one and 12 months after parents received their child's genetic result. Interviews were conducted approximately one month after results disclosure. A genetic diagnosis (GD) for their child appeared to reduce parents' sense of self-blame and feelings of guilt, and this impact was relatively stable. The data also indicate a modest impact on parents' actions related to the condition, perceptions of themselves, and some aspects of life planning for their child, as measured by quantitative instruments at one month and 12 months after receipt of results. Other measures of parental identity and expectations for their child, in contrast, showed little change following receipt of genetic findings. Overall, parents who were told that no GD was identified showed minimal changes in their responses over time. These results suggest a discernable but relatively limited impact of genetic test results on parents of children with autism. These results should be reassuring to clinicians caring for children with autism and are consistent with studies in other areas of medicine that have suggested that genetic results tend to have fewer effects-negative or positive-than were anticipated.

Understanding Ethical Challenges in Medical Education Research.

Rapidly advancing biomedical and electronic technologies, ongoing health disparities, and new online educational modalities are all changing medicine and medical education. As medical training continues to evolve, research is increasingly critical to help improve it, but medical education research can pose unique ethical challenges. As research participants, medical trainees may face several risks and in many ways constitute a vulnerable group. In this commentary, the author examines several of the ethical challenges involved in medical education research, including confidentiality and the risk of stigma; the need for equity, diversity, and inclusion; genetic testing of students; clustered randomized trials of training programs; and questions about quality improvement activities. The author offers guidance for navigating these ethical challenges, including the importance of engaging with institutional review boards. Academic medical institutions should educate and work closely with faculty to ensure that all research adheres to appropriate ethical guidelines and regulations and should provide instruction about the ethics of medical education research to establish a strong foundation for the future of the field. Research on medical education will become increasingly important. Given the potential sensitivity of the data collected in such research, investigators must understand and address potential ethical challenges as carefully as possible.

Experiment on identical siblings separated at birth: ethical implications for researchers, universities, and archives today.

Several films, including Three Identical Strangers, examined ethical problems in an experiment that involved identical siblings who were adopted as infants and separated into different families to examine the effects of nature versus nurture. The study was primarily designed and directed by Dr Peter Neubauer. The experiment, conducted in the 1960's through 1980's, serves as an important cautionary case study, raising several critical and ongoing ethical issues faced by researchers, universities and archives today. The organisation coordinating the study donated the research records to Yale University under the condition that they remain sealed until 2065, and has impeded study participants' full access to research material. This case raises questions of what investigators, their descendants, research ethics committees or institutional review boards (IRBs), universities and archives should do with study records when researchers retire or die-whether universities should accept researchers' donations of archival records that may contain patient or participant data, and if so, under what conditions. This study also poses crucial issues for IRBs-for example, whether researchers themselves or their designates should control all access to study records, particularly if controversy or lawsuits ensue. These questions will become increasingly crucial since the amount of research has burgeoned over recent decades, and investigators, on retirement or death, may want to donate their archives to universities. This experiment thus highlights ethical questions to which researchers, IRBs, universities, healthcare institutions, archivists and libraries should attend.

What Does It Mean for a Case to be 'Local'?: the Importance of Local Relevance and Resonance for Bioethics Education in the Asia-Pacific Region.

Contemporary bioethics education has been developed predominately within Euro-American contexts, and now, other global regions are increasingly joining the field, leading to a richer global understanding. Nevertheless, many standard bioethics curriculum materials retain a narrow geographic focus. The purpose of this article is to use local cases from the Asia-Pacific region as examples for exploring questions such as 'what makes a case or example truly local, and why?', 'what topics have we found to be best explained through local cases or examples?', and 'how does one identify a relevant local case?' Furthermore, we consider the global application of local cases to help extend the possible scope of the discussion, opening new avenues for the development of practical bioethics educational materials. We begin with a background description and discussion of why local cases enhance bioethics education, move to an overview of what is currently available and what is not for the region, and then outline a discussion of what it means to be local using example cases drawn from Hong Kong, Australia, Pakistan, and Malaysia. We are not creating a casebook but rather constructing by example a toolbox for designing active and dynamic learning cases using regional diversity as contextualised cases with generalised principles.

Correction: Evaluation of the cost and effectiveness of diverse recruitment methods for a genetic screening study.

The original version of this Article contained an error in the undergraduate degree awarded to the author Ian Halim, which was incorrectly given as BS. This has now been corrected to BA in both the PDF and HTML versions of the Article.

How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study.

PURPOSE: Conflicts of interest (COIs) are important ethical concerns because they may affect scientific decision making, research integrity, and the safety and fairness of studies. No research to date has examined COIs of single institutional review boards (sIRBs), which are now mandated by the National Institutes of Health, and will be by the revised Common Rule in 2020, for all multisite research. This study investigated how different types of sIRBs manage their own COIs by documenting existing processes for and comparing commercial, government, and academic sIRBs. METHOD: One hundred three personnel from 20 commercial, government, or academic sIRBs participated in semistructured interviews about their processes for and experiences with managing COIs when conducting multisite research review. RESULTS: Variability in COI management policies exist across types of sIRBs. Commercial sIRBs were aware of their own COIs given their for-profit model, and managed them by using firewalls, relying on external reviewers, and turning down potential clients. Government sIRBs described unique COIs stemming from the same agency funding the sIRB and the research being reviewed. They addressed these by discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies. In contrast to commercial and government sIRBs, academic sIRBs did not report any specific policies to manage their COIs, which are similar to those of local IRBs. CONCLUSIONS: As sIRBs become increasingly common, researchers will need to weigh the different COIs inherent to each type of sIRB. Additionally, academic sIRBs may consider implementing specific policies for managing their COIs.

Evaluation of the cost and effectiveness of diverse recruitment methods for a genetic screening study.

PURPOSE: Recruitment of participants from diverse backgrounds is crucial to the generalizability of genetic research, but has proven challenging. We retrospectively evaluated recruitment methods used for a study on return of genetic results. METHODS: The costs of study design, development, and participant enrollment were calculated, and the characteristics of the participants enrolled through the seven recruitment methods were examined. RESULTS: A total of 1118 participants provided consent, a blood sample, and questionnaire data. The estimated cost across recruitment methods ranged from $579 to $1666 per participant and required a large recruitment team. Recruitment methods using flyers and staff networks were the most cost-efficient and resulted in the highest completion rate. Targeted sampling that emphasized the importance of Latino/a participation, utilization of translated materials, and in-person recruitments contributed to enrolling a demographically diverse sample. CONCLUSIONS: Although all methods were deployed in the same hospital or neighborhood and shared the same staff, each recruitment method was different in terms of cost and characteristics of the enrolled participants, suggesting the importance of carefully choosing the recruitment methods based on the desired composition of the final study sample. This analysis provides information about the effectiveness and cost of different methods to recruit adults for genetic research.

Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.

Impact of Receiving Secondary Results from Genomic Research: A 12-Month Longitudinal Study.

The impact of returning secondary results from exome sequencing (ES) on patients/participants is important to understand as ES is increasingly utilized in clinical care and research. Participants were recruited from studies using ES and were separated into two arms: 107 who had ES and were offered the choice to learn secondary results (ES group) and 85 who had not yet had ES (No ES group). Questionnaires were administered at baseline and 1 and 12 months, following results disclosure (ES group) or enrollment (No ES group). While the majority (65%) elected to learn all results following pre-test counseling, it was reduced from the 76% who indicated a desire for all results at baseline. Thirty-seven percent received results associated with an increased personal disease risk. There were no differences in changes in any of the psychological and social measures from baseline to post-results disclosure between the ES and No ES groups. Receiving a wide range of secondary findings appeared to have little measurable impact on most participants. The experience of learning secondary results may be related to participants' previous experiences with genetics, as well as the genetic counseling provided. Future research with a more diverse, genetically naïve group, as well as scalable methods of delivery, is needed.

Research Participants' Preferences for Hypothetical Secondary Results from Genomic Research.

Secondary or incidental results can be identified in genomic research that increasingly uses whole exome/genome sequencing. Understanding research participants' preferences for secondary results and what influences these decisions is important for patient education, counseling, and consent, and for the development of policies regarding return of secondary results. Two hundred nineteen research participants enrolled in genomic studies were surveyed regarding hypothetical preferences for specific types of secondary results, and these preferences were correlated with demographic information and psychosocial data. The majority of research participants (73%) indicated a preference to learn about all results offered, with no clear pattern regarding which results were not desired by the remaining participants. Participants who reported greater interest in genetic privacy were less likely to indicate a preference to learn all results, as were individuals who self-identified as Jewish. Although most research participants preferred to receive all secondary results offered, a significant subset preferred to exclude some results, suggesting that an all-or-none policy would not be ideal for all participants. The correlations between preferences to receive secondary results, religious identification, and privacy concerns demonstrate the need for culturally sensitive counseling and educational materials accessible to all education levels to allow participants to make the best choices for themselves.

How old is too old? Challenges faced by clinicians concerning age cutoffs for patients undergoing in vitro fertilization.

OBJECTIVE: To study how IVF providers view and make decisions concerning age cutoffs and futility (e.g., whether they establish clear cutoffs, and if so, where). DESIGN: In-depth interviews of approximately 1 hour. SETTING: Not applicable. PATIENT(S): Interviewees: 27 ART providers (17 physicians, 10 other providers) and 10 patients. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Attitudes and decisions concerning age cutoffs were assessed. RESULT(S): Providers face several challenges and dilemmas concerning both the content and the process of decision-making about age cutoffs-what age cutoff to use for potential parents (women both using and not using their own eggs) and potential fathers (whether to consider the father's age, and if so, separately or only with the mother's age); what criteria to use in these decisions (how much to consider and weigh the mother's autonomy vs. the future child's well-being); how to make these decisions (e.g., "gut feelings" or perceptions of public opinion); who makes these decisions (e.g., physicians on their own vs. a formal ethics or Quality Assurance committee); and how to present/frame these issues to patients (e.g., how much to discourage older women). Patients' responses to age limitations vary (e.g., minimizing or feeling exceptions to the risks; or lying about their age). CONCLUSION(S): These data, the first to explore how providers make decisions about age cutoffs for patients, raise several critical issues. Although the American Society for Reproductive Medicine has addressed several concerns, the present data suggest additional questions and challenges, including inherent uncertainties and ethical conflicts, and have important implications for practice, policy, research, and education.

Typologies of Altruistic and Financial Motivations for Research Participation.

Questions arise concerning participants' motives in risky studies, such as HIV vaccine trials (HVTs). We interviewed in-depth 20 gay/bisexual men. Participants described both altruistic and nonaltruistic motives. Altruistic motivations emerged primarily, with nine typologies: (a) cultural, (b) community related, (c) familial, (d) religious, (e) professional, (f) political (e.g., HIV activism), (g) moral (e.g., making up for past wrongs), (h) existential (e.g., providing sense of meaning), and (i) other psychological (e.g., emotional gratification). Views of compensation varied: not a factor (55%), added incentive (25%), main motivator, but in conjunction with altruism (15%), and primary motivator (5%). HVT participants thus often have both altruistic and financial motives, and related typologies emerged. These findings have critical implications for studies on HIV, other conditions, and research ethics.

Detecting, preventing, and responding to "fraudsters" in internet research: ethics and tradeoffs.

Internet-based health research is increasing, and often offers financial incentives but fraudulent behavior by participants can result. Specifically, eligible or ineligible individuals may enter the study multiple times and receive undeserved financial compensation. We review past experiences and approaches to this problem and propose several new strategies. Researchers can detect and prevent Internet research fraud in four broad ways: (1) through the questionnaire/instrument (e.g., including certain questions in survey; and software for administering survey); (2) through participants' non-questionnaire data and seeking external validation (e.g., checking data for same email addresses, usernames, passwords, and/or fake addresses or phone numbers; (3) through computer information, (e.g., IP addresses and cookies), and 4) through study design (e.g., avoid lump sum compensation and interviewing participants). These approaches each have pros and cons, and raise ethical, legal, and logistical questions, given that ethical tensions can emerge between preserving the integrity of research vs. protecting the privacy and confidentiality of study respondents. While past discussions concerning the ethics of online research have tended to focus on the participants' ability to trust the researchers, needs now arise to examine researchers' abilities to trust the participants. This analysis has several critical implications for future practice, policy, and research.

Kamakahi vs ASRM and the future of compensation for human eggs.

A recent lawsuit that alleges that the American Society for Reproductive Medicine (ASRM) engages in price-fixing by capping the amount of compensation paid for human oocytes has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, because fewer women are then interested in donating, which then increases prices for the service that physicians, not donors, accrue, and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates, and better counseling and screening. Yet, if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other factory-produced goods and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM's current guidelines appear to address, even if imperfectly, ethical challenges that are related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM's wariness of government regulations, existing guidelines may represent a compromise by aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation, and eugenics. Although the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges, and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible (eg, raising the current caps to, say, $12,000 or $15,000, potentially increasing donation, while still avoiding certain ethical difficulties) and warrant close consideration. These complex conflicting ethical issues deserve more attention than they have received because they affect key aspects of clinical practice and the lives of countless patients.