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"Ethical disasters" or egregious violations of professional ethics in medicine often receive substantial amounts of publicity, leading to mistrust of the medical system. Efforts to understand wrongdoing in medical practice and research are hampered by the absence of a clear taxonomy. This article describes the authors' process of developing a taxonomy based on (1) reviews of academic literature, ethics codes, government regulations, and cases of wrongdoing; (2) consultation with experts in health law and healthcare ethics; and (3) application of the taxonomy to published cases of wrongdoing in medical research and practice. The resulting taxonomy includes 14 categories of wrongdoing in medical practice and 15 categories of wrongdoing in medical research. This taxonomy may be useful to oversight bodies, researchers who seek to understand and reduce the prevalence of wrongdoing in medicine, and librarians who index literature on wrongdoing. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Monshi and Zieglmayer's case study presents Sri Lankan participants as having views on the privacy of health information that differ radically from those commonly found in Western nations. This article explores 2 questions that their case study raises for the ethical review of research in international settings: First, are allegedly universal ethical principlesof the sort promulgated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978)useful in international settings', and second, how should research oversight bodies address the challenges that arise in international behavioral and social science research? [ABSTRACT FROM AUTHOR]

Serious and continuing research noncompliance and integrity violations undermine the quality of research and trust in science. When researchers engage in these behaviors, institutional officials (IOs) often develop corrective action plans. Ideally, such plans address the root causes so noncompliance or research integrity violations discontinue. The aim of this study was to identify what IOs perceive as causes and action plan activities typically prescribed. We conducted semi-structured in-depth interviews with 47 IOs at research institutions across the U.S. including: institutional review board and institutional animal care and use committee chairs and directors, chief research officers, research compliance and integrity officers, and institutional conflicts of interest chairs and directors. The most common root causes identified were: 1) lack of knowledge or training, 2) failure to provide research team supervision, and 3) researcher attitudes toward compliance. The most common action plan activities include: 1) retraining in compliance or research integrity, 2) follow-up and hands-on involvement with the researcher, and 3) mandated oversight or mentoring. Because the most commonly identified action plan activities fail to adequately address the majority of root causes, our findings suggest a need for IOs to rethink existing approaches to action plan development to more effectively target root causes.

Background: Effective leadership and management practices contribute to responsible, high-quality research and the well-being of team members. We describe the development and initial validation of a measure assessing principal investigators' leadership and management practices and a measure of research team practices., Methods: Using a cross-sectional survey design, 570 postdoctoral researchers funded by the National Institutes of Health reported on the perceived behaviors of their principal investigator (PI) and the research team. The PI leadership and management items factored into two dimensions: fostering relationships and directing research., Results: Correlations of these new scales with existing, validated measures of ethical leadership and general leader behavior provided evidence of convergent validity. Providing evidence for criterion-related validity, scores on the new measures predicted lab climate for research ethics, self-reported productivity, and job satisfaction. Research team practices provided additional predictive value beyond leadership and management behaviors., Conclusions: This study provides construct validity evidence for the new Leadership and Management in Science (LAMPS) Measure and the Research Team Practices (RTP) Measure. Qualitative responses to an open-ended item reinforced the importance of relationships and directive supervision for a positive environment. These measures can be useful tools for future research or may be useful for PIs seeking feedback about their practices.

Introduction: Research has provided novel insights into how light stimulates circadian rhythms through specialised retinal ganglion cells to the suprachiasmatic nucleus. In addition, there has been a revolution in light-emitting diode (LED) technology, leading to tunable LED light sources and lighting systems, enabling 24-hour dynamic light scenarios with bright blue-enriched short wavelength light during the day and dim evening light, stimulating the circadian system. These dynamic LED lighting systems are now being implemented at hospitals without adequate understanding of how it may affect the health and well-being of patients and staff., Methods and Analysis: An optimised dynamic LED lighting scenario is investigated at a newly built psychiatric hospital in Copenhagen. In the 12 months baseline period, a standard lighting scenario with dynamic colour temperature and fixed light intensity is investigated. In the following 12-month intervention period, a new DEL scenario is investigated, having dynamic colour temperature as well as dynamic light intensity with a higher daytime and lower evening-time melanopic daylight equivalent illuminance. This setting is furthermore adjusted for geographical orientation to compensate for differences in sunlight access in wintertime. The study uses a quasiexperimental design comparing patients admitted in the two study periods. Prior to each of the study periods, daylight and the contribution from the LED-lighting scenarios was measured. Patient sociodemographic and mental health data will be retrieved retrospectively from electronic medical records and by questionnaires administered in the two periods, evaluating lighting, noise, sleep quality and quality of life. Primary outcome is the proportion of patients receiving pro re nata medications. Secondary outcomes are the length of stay, sleep onset latency, sleep quality and quality of life., Ethics and Dissemination: No ethical issues are expected. The results will be disseminated through peer-reviewed international journal, lectures, posters and interviews., Trial Registration Number: NCT05868291., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Clinical trials for upcoming disease-modifying therapies of spinocerebellar ataxias (SCA), a group of rare movement disorders, lack endpoints sensitive to early disease progression, when therapeutics will be most effective. In addition, regulatory agencies emphasize the importance of biological outcomes., Objectives: READISCA, a transatlantic clinical trial readiness consortium, investigated whether advanced multimodal magnetic resonance imaging (MRI) detects pathology progression over 6 months in preataxic and early ataxic carriers of SCA mutations., Methods: A total of 44 participants (10 SCA1, 25 SCA3, and 9 controls) prospectively underwent 3-T MR scanning at baseline and a median [interquartile range] follow-up of 6.2 [5.9-6.7] months; 44% of SCA participants were preataxic. Blinded analyses of annual changes in structural, diffusion MRI, MR spectroscopy, and the Scale for Assessment and Rating of Ataxia (SARA) were compared between groups using nonparametric testing. Sample sizes were estimated for 6-month interventional trials with 50% to 100% treatment effect size, leveraging existing large cohort data (186 SCA1, 272 SCA3) for the SARA estimate., Results: Rate of change in microstructural integrity (decrease in fractional anisotropy, increase in diffusivities) in the middle cerebellar peduncle, corona radiata, and superior longitudinal fasciculus significantly differed in SCAs from controls (P < 0.005), with high effect sizes (Cohen's d = 1-2) and moderate-to-high responsiveness (|standardized response mean| = 0.6-0.9) in SCAs. SARA scores did not change, and their rate of change did not differ between groups., Conclusions: Diffusion MRI is sensitive to disease progression at very early-stage SCA1 and SCA3 and may provide a >5-fold reduction in sample sizes relative to SARA as endpoint for 6-month-long trials. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)

Cognitive and Behavioural Therapy for Insomnia (CBT-I) is the gold standard treatment for chronic insomnia, with one crucial step being the restriction of time spent in bed. This restriction often intensifies early afternoon sleepiness, leading to a natural gateway for a short recuperative nap, which might foster adherence to CBT-I over time. In practice, mental health professionals providing CBT-I lack consensus on whether or not to tolerate short naps during the CBT-I period for requesting patients. In this pilot study, we examined the effects of authorised napping on CBT-I efficiency in patients with insomnia (a napping group was compared with a matched non-napping group, n = 108). We report that napping enhanced early afternoon alertness and importantly did not affect CBT-I-mediated improvements in the Insomnia Severity Index and Beck Depression Inventory-2 and in self-reported sleep efficiency, latency, and wake after sleep onset (assessed by the sleep diaries). Further investigations using objective methods of sleep assessments are now needed to confirm that napping behaviour does not compromise the improvements enabled by CBT-I and may even strengthen adherence to the treatment., (© 2024 The Author(s). Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Combativeness is a social illness. We are surrounded by culture wars over abortion, vaccine mandates, transgender care, how we die, and even how we define death. The problem is not that we disagree, but how we disagree: too often, with anger, aggression, and a sense of urgency to win against the other. Bioethicists have the knowledge and skills needed to model constructive disagreement and respectful calls for change. Bioethicists may have increased awareness that everyone suffers from unconscious self-serving biases-we are all imperfect. They are trained to recognize competing values and to engage in processes of balancing values in social contexts. Clinical ethicists are additionally trained in mediation, which involves acknowledging goodwill, listening deeply, apologizing when needed, and seeking common ground. In short, bioethicists have many of the tools needed to be healers of a culture afflicted with combativeness., (© 2024 The Hastings Center.)

Youth prefer to be involved in treatment decisions, yet youth participation is minimally present in decisions like stem cell transplant (SCT) that require frequent medications and social isolation to be successful in curing cancer and chronic illness. The purpose of our study is to identify the barriers and facilitators to youth decision-making involvement in the youth-parent interaction when referred for treatment with SCT. We report qualitative findings from our theory-driven mixed-methods study. We thematically analyzed our field notes of youth and parent observations and audio-recordings during SCT consultations and semi-structured interviews. Data were collected from 10 youth, 8 to 16 (median 12) years of age, and their parents ( n = 20). Three themes emerged: (a) Reluctant unless motivated, (b) Uncertain but capable, and (c) Limited unless supported. Our findings emphasize the critical role parents may take in facilitating youth involvement in decisions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication or this article.

Objective: We attempted to conduct a randomized controlled trial of three different informed consent training formats to evaluate their effectiveness. We recruited 503 clinical research professionals, who received $50 for participation. Incidental findings showed unexpectedly low rates of compliance with completing the study training protocols, resulting in insufficient statistical power to test our original hypotheses. In this report, we conducted a secondary analysis of the data in which we characterize and evaluate the observed low compliance. This involved using literature on average reading times, speed-reading times, and video play speeds to calculate the timeframes required to complete the three training formats., Results: Only 13% of participants completed the training in a reasonable timeframe. Furthermore, only 46% of participants completed the training in the minimum possible timeframe. These findings lead us to ask whether online research training is effective, since no training can be effective if participants do not actually complete the training. Given extensive requirements for educational training among clinical research professionals, we feel the burden of proof is on training programs to demonstrate that they have positive effects., (© 2024. The Author(s).)

Objective: To identify perceived benefits, problems, facilitators, and barriers to adolescent online patient portal use., Study Design: Qualitative, semi-structured interviews with dyads of parents and adolescents with or without chronic illness. The study team purposively sampled for racial and ethnic minorities and fathers. Three team members then performed thematic analysis of the transcripts, with subsequent dyadic analysis of themes represented by related parents and adolescents., Results: We performed 102 interviews with 51 dyads of parents and adolescents (26 with chronic illness, 25 without chronic illness). Nearly all participants believed that adolescents should be permitted portal access. We identified 4 themes related to portal benefits: improves adolescent's knowledge of health; supports medical self-management and autonomy; strengthens communication and relationships; and supports parental influence. We identified 4 themes related to portal problems: misunderstanding or confusion; emotional distress; strain on relationships; and irresponsible use of portal. Facilitators of portal use included severity of illness, adolescent's curiosity, and ease of technology use. Barriers included lack of awareness or interest, complexity of information, and access difficulties. Twenty adolescents (39%) did not know they could access the portal, and 23 (45%) lacked interest in portals. Parents and adolescents seldom used the portal as a collaborative tool, and instead were engaging with the portal independently., Conclusion: Parents and adolescents perceive several benefits and problems with portal use, but many adolescents lack interest in using portals. Adolescent portals represent an underutilized resource to engage adolescents in their care., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The association between the administration of sodium-glucose cotransporter 2 inhibitors (SGLT2is) during acute kidney injury (AKI) and the incidence of major adverse kidney events (MAKEs) is not known., Methods: This retrospective cohort study included patients with AKI and compared the outcomes for those who were treated with SGLT2is during hospitalization and those without SGLT2i treatment. The associations of SGLT2i use with MAKEs at 10 and 30-90 days, each individual MAKE component, and the pre-specified patient subgroups were analyzed., Results: From 2021 to 2023, 374 patients were included in the study-316 without SGLT2i use and 58 with SGLT2i use. Patients who were treated with SGLT2is were older; had a greater prevalence of diabetes, hypertension, chronic heart failure, and chronic kidney disease; required hemodialysis less often; and presented stage 3 AKI less frequently than those who were not treated with SGLT2is. Logistic regression analysis with nearest-neighbor matching revealed that SGLT2i use was not associated with the risk of MAKE10 (OR 1.08 [0.45-2.56]) or with MAKE30-90 (OR 0.76 [0.42-1.36]). For death, the stepwise approach demonstrated that SGLT2i use was associated with a reduced risk (OR 0.08; 0.01-0.64), and no effect was found for kidney replacement therapy (KRT). The subgroups of patients who experienced a reduction in the risk of MAKEs in patients with AKI treated with SGLT2is were those older than 61 years, those with an eGFR >81, and those without a history of hypertension or DM ( p ≤ 0.05 for all)., Conclusion: The use of SGLT2is during AKI had no effect on short- or medium-term MAKEs, but some subgroups of patients may have experienced benefits from SGLT2i treatment., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Alcantar-Vallin, Zaragoza, Díaz-Villavicencio, Hernandez-Morales, Camacho-Guerrero, Perez-Venegas, Carmona-Morales, Oseguera-Gonzalez, Murguia-Soto, Chávez-Alonso, Arredondo-Dubois, Orozco-Chan, Gómez-Fregoso, Rodríguez-García, Navarro-Blackaller, Medina-González, Martínez Gallardo-González, Abundis-Mora, Vega-Vega, García-García and Chávez-Iñiguez.)

Background : A person's cultural background shapes how they interpret and navigate problems. Given that large numbers of international researchers work and train in the U.S. we sought to better understand how researchers use the decision-making strategy of seeking help to navigate ethical and professional challenges. Methods : Participants ( N  = 300) were researchers working or training in the U.S. who were born in East Asia (EA) or born in the U.S. They completed a screening survey; then a subset completed think-aloud interviews ( n  = 66) focused on how they would respond to three hypothetical research scenarios. Results : Thematic analysis of the transcripts showed that seeking help was a commonly endorsed strategy, with some nuances between groups. Themes included seeking help in the form of getting advice, seeking someone to help solve the problem, and gathering information. Endorsement of the seeking help strategy frequently depended on participants' relationships; desiring to seek help from people they trusted. Notably, EA participants tended to prefer seeking help in ways that avoided reputational harm to others. Conclusion : A better understanding of how researchers from different cultural backgrounds use decision-making strategies can inform how to make educational programs more inclusive and comprehensive to more effectively develop researchers' ethical and professional decision-making skills.

Background: Major depressive disorder (MDD) is a debilitating condition that affects more than 300 million people worldwide. Current treatments are based on a trial-and-error approach, and reliable biomarkers are needed for more informed and personalized treatment solutions. One of the potential biomarkers, gamma-frequency (30-80 Hz) brainwaves, are hypothesized to originate from the excitatory-inhibitory interaction between the pyramidal cells and interneurons. The imbalance between this interaction is described as a crucial pathological mechanism in neuropsychiatric conditions, including MDD, and the modulation of this pathological interaction has been investigated as a potential target. Previous studies attempted to induce gamma activity in the brain using rhythmic light and sound stimuli (GENUS - Gamma Entrainment Using Sensory stimuli) that resulted in neuroprotective effects in Alzheimer's disease (AD) patients and animal models. Here, we investigate the antidepressant, cognitive, and electrophysiological effects of the novel light therapy approach using 40 Hz masked flickering light for patients diagnosed with MDD., Methods and Design: Sixty patients with a current diagnosis of a major depressive episode will be enrolled in a randomized, double-blinded, placebo-controlled trial. The active treatment group will receive 40 Hz masked flickering light stimulation while the control group will receive continuous light matched in color temperature and brightness. Patients in both groups will get daily light treatment in their own homes and will attend four follow-up visits to assess the symptoms of depression, including depression severity measured by Hamilton Depression Rating Scale (HAM-D 17 ), cognitive function, quality of life and sleep, and electroencephalographic changes. The primary endpoint is the mean change from baseline to week 6 in depression severity (HAM-D 6 subscale) between the groups.

Background: Apolipoprotein L1 (ApoL1) variants G1 and G2 are associated with a higher risk of kidney disease. ApoL1 risk variants are predominantly seen in individuals with sub-Saharan African ancestry. In most transplant centers, potential organ donors are being selectively genetically tested for ApoL1 risk variants. Transplant programs have highly variable ApoL1 testing practices and need guidance on essential ApoL1 clinical policy questions., Methods: We conducted a Delphi consensus panel focused on ApoL1 clinical policy questions, including who gets tested, who decides whether testing occurs, how test results are shared, who receives test results, and how test results are used. A total of 27 panelists across seven stakeholder groups participated: living kidney donors ( n =4), deceased donor family members ( n =3), recipients of a deceased donor kidney ( n =4), recipients of a living donor kidney ( n =4), nephrologists ( n =4), transplant surgeons ( n =4), and genetic counselors ( n =4). Nineteen panelists (70%) identified as Black. The Delphi panel process involved two rounds of educational webinars and three rounds of surveys administered to panelists, who were asked to indicate whether they support, could live with, or oppose each policy option., Results: The panel reached consensus on one or more acceptable policy options for each clinical policy question; panelists supported 18 policy options and opposed 15. Key elements of consensus include the following: ask potential donors about African ancestry rather than race; make testing decisions only after discussion with donors; encourage disclosure of test results to blood relatives and organ recipients but do not require it; use test results to inform decision making, but never for unilateral decisions by transplant programs., Conclusions: The panel generally supported policy options involving discussion and shared decision making among patients, donors, and family stakeholders. There was general opposition to unilateral decision making and prohibiting donation altogether., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Nephrology.)

Insomnia: DEFINITIONS, EPIDEMIOLOGY AND CHANGES WITH AGE. Chronic insomnia is a disorder defined as a subjective complaint relating to the quality and/or quantity of sleep associated with daytime impact, and which must be present 3 nights per week for a period of at least 3 months. This is a common sleep problem in the general population and represents a significant proportion of reasons for consultation in the general practice. It requires early identification at all ages of life to allow the establishment of adequate care, which will have the benefit of both improving the quality of life of these patients in the short term and preventing the consequences of chronic insomnia., Competing Interests: J. M. Dubois déclare n’avoir aucun lien d’intérêts. A. Rouen déclare avoir été pris en charge, à l’occasion de déplacements pour congrès, par Asten. D. Léger déclare avoir participé à des interventions ponctuelles pour Idorsia, BioSerenity, Vanda Pharma, iSommeil, Sanofi et avoir été pris en charge, à l’occasion de déplacements pour congrès, par Linde, SOS Oxygène et VitalAire.

Background: A growing number of reproductive-age women in the U.S. have chronic medical conditions, increasing their risk of perinatal morbidity and mortality. Still, they experience unintended pregnancies at similar rates to low-risk mothers. We have limited understanding of how these individuals consider decisions about pregnancy and contraceptive use. The purpose of this study was to understand factors that influence reproductive decision-making among pregnant women with chronic medical conditions., Methods: We conducted 28 semi-structured interviews with pregnant women with pre-existing medical conditions admitted to a tertiary maternal hospital to examine factors influencing reproductive decision making. Maternal demographic characteristics, medical history, and pregnancy outcome data were obtained through participant surveys and abstraction from electronic health records. Interview transcripts were coded and analyzed using Dedoose® with both deductive and inductive content analysis., Results: Out of 33 eligible participants, 30 consented to participate and 28 completed interviews. The majority of participants identified as black, Christian, made less than $23,000 yearly, and had a variety of preexisting medical conditions. Overarching themes included: 1) Perceived risks-benefits of pregnancy, 2) Perceived risks-benefits of birth control, 3) Determinants of contraceptive utilization, and 4) Perceived reproductive self-agency. Contraception was viewed as acceptable, but with concerning physical and psychological side effects. Although some considered pregnancy as a health threat, more experienced pregnancy as positive and empowering. Few planned their pregnancies., Conclusions: Preexisting health conditions did not significantly influence reproductive decision-making. Barriers to birth control use were generally based in patient value-systems instead of external factors. Interventions to improve uptake and use of birth control in this cohort should focus on improving care for chronic health conditions and influencing patient knowledge and attitudes toward contraception., (© 2023. The Author(s).)

This study aimed to develop a template-based attenuation correction (AC) for the nonhuman primate (NHP) brain. We evaluated the effects of AC on positron emission tomography (PET) data quantification with two experimental paradigms by comparing the quantitative outcomes obtained using a segmentation-based AC versus template-based AC. Population-based atlas was generated from ten adult rhesus macaques. Bolus experiments using [ 18 F]PF-06455943 and a bolus-infusion experiment using [ 11 C]OMAR were performed on a 3T Siemens PET/magnetic resonance-imaging (MRI). PET data were reconstructed with either μ map obtained from the segmentation-based AC or template-based AC. The standard uptake value (SUV), volume of distribution ( V T ), or percentage occupancy of rimonabant were calculated for [ 18 F]PF-06455943 and [ 11 C]OMAR PET, respectively. The leave-one-out cross-validation showed that the absolute percentage differences were 2.54 ± 2.86% for all region of interests. The segmentation-based AC had a lower SUV and V T (∼10%) of [ 18 F]PF-06455943 than the template-based method. The estimated occupancy was higher in the template-based method compared to the segmentation-based AC in the bolus-infusion study. However, future studies may be needed if a different reference tissue is selected for data quantification. Our template-based AC approach was successfully developed and applied to the NHP brain. One limitation of this study was that validation was performed by comparing two different MR-based AC approaches without validating against AC methods based on computed tomography (CT)., Competing Interests: The authors declare no competing financial interest., (© 2023 The Authors. Published by American Chemical Society.)

Competing Interests: The authors have no conflict of interest to declare.

In January 2023, a new NIH policy on data sharing went into effect. The policy applies to both quantitative and qualitative research (QR) data such as data from interviews or focus groups. QR data are often sensitive and difficult to deidentify, and thus have rarely been shared in the United States. Over the past 5 y, our research team has engaged stakeholders on QR data sharing, developed software to support data deidentification, produced guidance, and collaborated with the ICPSR data repository to pilot the deposit of 30 QR datasets. In this perspective article, we share important lessons learned by addressing eight clusters of questions on issues such as where, when, and what to share; how to deidentify data and support high-quality secondary use; budgeting for data sharing; and the permissions needed to share data. We also offer a brief assessment of the state of preparedness of data repositories, QR journals, and QR textbooks to support data sharing. While QR data sharing could yield important benefits to the research community, we quickly need to develop enforceable standards, expertise, and resources to support responsible QR data sharing. Absent these resources, we risk violating participant confidentiality and wasting a significant amount of time and funding on data that are not useful for either secondary use or data transparency and verification.

Importance: Many health care systems offer adolescents access to health information through online patient portals, but few studies have explored how to engage adolescents in using and benefiting from online portals., Objective: To determine how US children's hospitals have attempted to encourage adolescent portal use, barriers to engaging adolescents, and ideal future goals for engagement., Design, Setting, and Participants: This qualitative study performed structured qualitative interviews with informatics administrators from children's hospitals across the US between February and July 2022. Informatics administrators were employed by US health care systems that managed a children's hospital with at least 50 dedicated pediatrics beds. Data analysis was performed from November 2022 to January 2023., Main Outcomes and Measures: This study used thematic analysis of (1) current steps that health care systems had taken to engage adolescents in using their online patient portals and (2) barriers to engaging adolescents and ideal future goals and outcomes of engagement., Results: Among 58 total interviews with 65 informatics administrators who represented 63 hospitals across 58 health care systems, 6 themes of approaches to engaging adolescents in portal use were identified: (1) promoting and educating adolescents about portal enrollment, (2) establishing workflows to support enrollment, (3) seeking and incorporating feedback, (4) creating a culture or environment supporting engagement, (5) increasing portal utility, and (6) limited efforts. Barriers to engaging adolescents in portal use related to either (1) stakeholder investment, interest, and capabilities or (2) intersecting technical, ethical, and legal factors. Participants identified 4 ideal future efforts to engage adolescents: (1) develop adaptable private means of communication with adolescents, (2) use adolescent-centric user design, (3) enhance promotion and education about portal use, and (4) simplify and adapt workflows to encourage enrollment. Participants described 3 ideal outcomes of this future engagement: (1) provide education about current health, (2) prepare for transition to adulthood, and (3) improve digital health education of adolescents., Conclusions and Relevance: In this qualitative study of informatics administrators, children's hospitals across the US were found to have varying degrees of efforts to engage adolescents in using their portals. Most of these efforts focused on supporting adolescent enrollment, but fewer efforts focused on making the portal useful and interesting to adolescents.

Introduction: Many women who are solid organ transplant (SOT) recipients wish to have children after transplantation. Contraception is an important component of post-transplant planning and care, given the increased risk associated with post-transplant pregnancies. We sought to understand patient attitudes and concerns about post-transplant contraception and pregnancy., Methods: Following a comprehensive literature review, our team developed a survey that was administered to female SOT recipients of childbearing age. We used descriptive and inferential statistics to characterize participant views RESULTS: A total of 243 transplant recipients completed the survey (80.7% response rate). The mean age of respondents was 37.5 years (±8.1 years), 66.7% were kidney recipients, and 40.7% were within the first year after transplant. The most common concerns among respondents included fetal and maternal health complications. Participants generally did not agree that transplant recipients should be advised to avoid pregnancy. There was strong support for shared decision-making about pregnancy after transplantation CONCLUSION: Understanding patient perspectives can help transplant providers make better care recommendations and support patient autonomy in reproductive decisions post-transplant. Given that there are some differences in views by transplant type, individualized conversations between patients and providers are needed., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Geographical ancestry has been associated with an increased risk of various genetic conditions. Race and ethnicity often have been used as proxies for geographical ancestry. Despite numerous problems associated with the crude reliance on race and ethnicity as proxies for geographical ancestry, some genetic testing in the clinical, research, and employment settings has been and continues to be race- or ethnicity-based. Race-based or race-targeted genetic testing refers to genetic testing offered only or primarily to people of particular racial or ethnic groups because of presumed differences among groups. One current example is APOL1 testing of Black kidney donors. Race-based genetic testing raises numerous ethical and policy questions. Given the ongoing reliance on the Black race in genetic testing, it is important to understand the views of people who identify as Black or are identified as Black (including African American, Afro-Caribbean, and Hispanic Black) regarding race-based genetic testing that targets Black people because of their race. We conducted a systematic review of studies and reports of stakeholder-engaged projects that examined how people who identify as or are identified as Black perceive genetic testing that specifically presumes genetic differences exist among racial groups or uses race as a surrogate for ancestral genetic variation and targets Black people. Our review identified 14 studies that explicitly studied this question and another 13 that implicitly or tacitly studied this matter. We found four main factors that contribute to a positive attitude toward race-targeted genetic testing (facilitators) and eight main factors that are associated with concerns regarding race-targeted genetic testing (barriers). This review fills an important gap. These findings should inform future genetic research and the policies and practices developed in clinical, research, public health, or other settings regarding genetic testing., (© 2023 The Authors. Journal of Genetic Counseling published by Wiley Periodicals LLC on behalf of National Society of Genetic Counselors.)

In vivo characterization of pathologic deposition of tau protein in the human brain by PET imaging is a promising tool in drug development trials of Alzheimer disease (AD). 6-(fluoro- 18 F)-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine ( 18 F-MK-6240) is a radiotracer with high selectivity and subnanomolar affinity for neurofibrillary tangles that shows favorable nonspecific brain penetration and excellent kinetic properties. The purpose of the present investigation was to develop a visual assessment method that provides both an overall assessment of brain tauopathy and regional characterization of abnormal tau deposition. Methods: 18 F-MK-6240 scans from 102 participants (including cognitively normal volunteers and patients with AD or other neurodegenerative disorders) were reviewed by an expert nuclear medicine physician masked to each participant's diagnosis to identify common patterns of brain uptake. This initial visual read method was field-tested in a separate, nonoverlapping cohort of 102 participants, with 2 additional naïve readers trained on the method. Visual read outcomes were compared with semiquantitative assessments using volume-of-interest SUV ratio. Results: For the visual read, the readers assessed 8 gray-matter regions per hemisphere as negative (no abnormal uptake) or positive (1%-25% of the region involved, 25%-75% involvement, or >75% involvement) and then characterized the tau binding pattern as positive or negative for evidence of tau and, if positive, whether brain uptake was in an AD pattern. The readers demonstrated agreement 94% of the time for overall positivity or negativity. Concordance on the determination of regional binary outcomes (negative or positive) showed agreement of 74.3% and a Fleiss κ of 0.912. Using clinical diagnosis as the ground truth, the readers demonstrated a sensitivity of 73%-79% and specificity of 91%-93%, with a combined reader-concordance sensitivity of 80% and specificity of 93%. The average SUV ratio in cortical regions showed a robust correlation with visually derived ratings of regional involvement ( r = 0.73, P < 0.0001). Conclusion: We developed a visual read algorithm for 18 F-MK-6240 PET offering determination of both scan positivity and the regional degree of cortical involvement. These cross-sectional results show strong interreader concordance on both binary and regional assessments of tau deposition, as well as good sensitivity and excellent specificity supporting use as a tool for clinical trials., (© 2023 by the Society of Nuclear Medicine and Molecular Imaging.)

Background: Older adults are at increased risk of cognitive impairments including Alzheimer's disease dementia. Legally authorized representatives (LARs) can provide informed consent when a participant is no longer able to, but little is known about barriers to incorporating them in research., Objective: Explore reasons for not asking and documenting participant decisions to appoint LARs among researchers conducting clinical intervention trials studying older adults or individuals with cognitive impairments., Methods: Mixed method design consisting of a survey ( N  = 1,284) and qualitative interviews ( N  = 40) regarding barriers to incorporating LARs. Participants were principal investigators and clinical research coordinators., Results: 37% ( N  = 469) had not asked and documented participant decisions about appointing LARs in the prior year. They had significantly lower confidence in resources available to incorporate LARs and lower positive attitudes compared to their counterparts who had done so. The majority (83%) had no trials studying individuals with cognitive impairments and reported LARs were not applicable. A minority (17%) had at least one trial studying individuals with cognitive impairments and reported being unaware of LARs. Qualitative findings indicate discomfort broaching a sensitive topic especially with individuals who are not yet impaired., Conclusion: Resources and education to increase awareness and knowledge of LARs are needed. Researchers studying older adults should, at minimum, have the knowledge and resources to incorporate LARs when necessary. Stigma and discomfort discussing LARs will need to be overcome, as early proactive discussions before a participant loses decisional capacity could enhance participant autonomy and facilitate recruitment and retention of older adults to research., Competing Interests: The authors have no conflict of interest to report., (© 2023 – The authors. Published by IOS Press.)

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team's larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

Effective communication is integral to patient and family-centered care in pediatric and adolescent and young adult (AYA) oncology and improving healthcare delivery and outcomes. There is limited knowledge about whether AYAs and parents have similar communication preferences and needs. By eliciting and comparing communication advice from AYAs and parents, we can identify salient guidance for how clinicians can better communicate. We performed secondary analysis of semi-structured interviews from 2 qualitative communication studies. In one study, 80 parents of children with cancer during treatment, survivorship, or bereavement were interviewed. In the second study, AYAs with cancer during treatment or survivorship were interviewed. We asked AYAs and parents to provide communication advice for oncology clinicians. Using thematic analysis, we identified categories of advice related to three overarching themes: interpersonal relationships, informational preferences, and delivery of treatment, resources, and medical care. AYAs and parents provided similar advice about the need for compassion, strong connections, hopefulness, commitment, and transparent honesty However, AYAs placed additional emphasis on clinicians maintaining a calm demeanor.

Introduction: Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes., Methods: We conducted a 1-year trial with clinical research professionals in the USA ( n = 1284) who have trials open to older adults or focus on Alzheimer's disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after 1 year. A subset of participants was interviewed ( n = 43)., Results: Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences in the adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully., Conclusions: Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having institutional review boards recommend or require ECPs may be an effective way to increase their use., (© The Author(s) 2022.)

Neurotransmitter receptors support the propagation of signals in the human brain. How receptor systems are situated within macro-scale neuroanatomy and how they shape emergent function remain poorly understood, and there exists no comprehensive atlas of receptors. Here we collate positron emission tomography data from more than 1,200 healthy individuals to construct a whole-brain three-dimensional normative atlas of 19 receptors and transporters across nine different neurotransmitter systems. We found that receptor profiles align with structural connectivity and mediate function, including neurophysiological oscillatory dynamics and resting-state hemodynamic functional connectivity. Using the Neurosynth cognitive atlas, we uncovered a topographic gradient of overlapping receptor distributions that separates extrinsic and intrinsic psychological processes. Finally, we found both expected and novel associations between receptor distributions and cortical abnormality patterns across 13 disorders. We replicated all findings in an independently collected autoradiography dataset. This work demonstrates how chemoarchitecture shapes brain structure and function, providing a new direction for studying multi-scale brain organization., (© 2022. The Author(s).)

Background: Clinicians have an ethical and practical imperative to engage adolescents and young adults (AYAs) with cancer in communication and care. Many young AYAs have involved parents, but guidelines for co-management of care with AYAs and their parents are lacking., Methods: We performed 37 semistructured interviews with AYAs aged 12-24 years at diagnosis, recruiting them from two pediatric cancer centers. We performed thematic analysis, aiming to understand how AYAs and their parents navigate their roles in communication and care., Results: We identified six roles that AYAs co-managed with their parents: (1) managing information, (2) managing social and emotional needs, (3) managing health, (4) advocating and empowering, (5) making decisions, and (6) managing logistics. AYAs tended to take more active roles in managing information and more passive roles in managing logistics, managing health, and making decisions. AYAs described how they and their parents had mutual responsibilities to be strong and to protect other's emotions. Additionally, we identified five factors that influenced AYAs' roles in communication and care: (1) AYA agency, (2) clinician encouragement, (3) emotional and physical well-being, (4) personality, preferences, and values, and (5) insights and skills., Conclusions: AYAs have nuanced preferences for how they are involved in communication and care roles. Clinicians can help families to clarify their preferences and values around these roles in a way that meets each family's unique needs. Future studies should aim to develop tools that support the fulfillment of these engagement goals., (© 2022 Wiley Periodicals LLC.)

Alzheimer's disease (AD) is characterized by the brain accumulation of amyloid-β and tau proteins. A growing body of literature suggests that epigenetic dysregulations play a role in the interplay of hallmark proteinopathies with neurodegeneration and cognitive impairment. Here, we aim to characterize an epigenetic dysregulation associated with the brain deposition of amyloid-β and tau proteins. Using positron emission tomography (PET) tracers selective for amyloid-β, tau, and class I histone deacetylase (HDAC I isoforms 1-3), we find that HDAC I levels are reduced in patients with AD. HDAC I PET reduction is associated with elevated amyloid-β PET and tau PET concentrations. Notably, HDAC I reduction mediates the deleterious effects of amyloid-β and tau on brain atrophy and cognitive impairment. HDAC I PET reduction is associated with 2-year longitudinal neurodegeneration and cognitive decline. We also find HDAC I reduction in the postmortem brain tissue of patients with AD and in a transgenic rat model expressing human amyloid-β plus tau pathology in the same brain regions identified in vivo using PET. These observations highlight HDAC I reduction as an element associated with AD pathophysiology., (© 2022. The Author(s).)

In almost every clinical interaction, clinicians must navigate interpersonal challenges with near-instantaneous responses to patients. Yet medical ethics has largely overlooked these small, interpersonal exchanges, instead focusing on "big" ethical problems, such as euthanasia, brain death, or genetic modification. In 1995, Paul Komesaroff proposed the concept of microethics as a nonprinciplist approach to ethics that focuses on "what happens in every interaction between every doctor and every patient." We aim to develop a microethics framework to guide everyday clinical encounters, with a special focus on communication with patients and family members. We will advance three core insights: First, communication is an ethical act in ways seldom considered. Second, microethics is an essential lens through which to view the ethics of communication. Third, virtue can bridge reflective and automatic processes. Our intuitionist framework for microethics is thus based on this understanding of the role of virtue, and we propose six virtues that contribute to the goal of healing communication., (© 2022 The Hastings Center.)

Objective: We aimed to evaluate the racial and ethnic diversity of study participants in recent pediatric cancer communication literature., Methods: We systematically searched for communication studies in pediatric oncology published between January 2018 and September 2020, limiting analysis to US studies. We considered race and ethnicity as separate categories in our analysis. Two authors screened studies and abstracted characteristics of race and ethnicity reporting and enrollment., Results: Of 98 articles included in this analysis, many studies failed to report participants' race (21/98) and ethnicity (40/98). Most studies ascertained race and ethnicity by self-report (51/98); 25 studies did not describe how they ascertained race and ethnicity. White participants were overrepresented in studies relative to the US population (median 80% in studies vs 72% in 2020 US census). Racial and ethnic minorities were underrepresented (Black: 7% vs 14%; Asian: 4% vs 7%; Pacific Islander: 0% vs 0.5%; Native American: 0.5% vs 3%; Hispanic 8% vs 19%)., Conclusion: Communication literature in pediatric oncology underrepresents all racial and ethnic minority populations and is inconsistent in the reporting of race and ethnicity., Practice Implications: Future work should follow best practices to ensure this literature adequately represents the experiences of all families in pediatric oncology., (Copyright © 2021 Elsevier B.V. All rights reserved.)

A binary phase with Al 4 Ir composition has been discovered in the Al-Ir binary system. Single-crystal X-ray diffraction analysis reveals that it crystallizes in the trigonal space group P 3 c 1 with the unit cell parameters a = 12.8802(2) Å and c = 9.8130(2) Å. This structure is derived from the Ni 2 Al 3 structure type. The supercell is due to the ordering of the aluminum atoms, which replace the nickel atoms in the prototype structure. The crystal structure was directly imaged by atomic-scale scanning transmission electron microscopy, and the misalignment of the Al site responsible for the supercell has been clearly evidenced. Its metastable nature has been confirmed by differential thermal analysis measurements. The atomic and electronic structures of Al 4 Ir have also been investigated by density functional theory. The structural optimization leads to lattice parameters and atomic positions in good agreement with the experimental ones. The compound is metallic, with a minimum in the density of states located more than 1 eV above the Fermi energy. This suggests a metastable system, in agreement with the electron count found much above 18 electrons per Ir atom, deviating from the Hume-Rothery rule and with the presence of occupied antibonding states revealed by the crystal orbital Hamiltonian population analysis. The relative stability of the compound is ensured by the hybridization between sp-Al and d-Ir states within Ir-centered clusters, while covalent-like interactions in-between the clusters are indicated by the analysis of the electron localizability function.