Energy and Macronutrient Intakes in Young Athletes: A Systematic Review and Meta-analysis.

The aim of this study was to conduct a systematic review and meta-analysis of differences in energy and macronutrient intakes between young athletes and non-athletes, considering age, gender and sport characteristics. The study included original research articles that compared energy and macronutrient intakes of 8 to 18-year-old athletes to non-athletes. Mean difference (MD) meta-analyses were performed to quantify energy and macronutrient intake differences between athletes and non-athletes. Eighteen observational studies were included. Results revealed that the energy and carbohydrate consumption of athletes was higher than that of non-athletes (MD=4.65kcal/kg/d, p<0.01 and MD=1.65% of total energy intake, p<0.01, respectively). Subgroup analyses revealed a significant effect of total training time on the observed mean differences between athletes and non-athletes. As practice time increased, the differences between athletes and non-athletes increased for carbohydrate and decreased for protein. Sport type analysis revealed a higher protein intake by mixed sport athletes compared to endurance and power sports. Analyses also indicated an age effect: the older the athletes, the smaller the differences between athletes and non-athletes for energy intake. However, the methods used to match groups and estimate dietary intakes forced us to moderate the results. More rigorous research methods are needed to define the dietary intakes of athletes and non-athletes.

Implementing a Social Needs Screening and Referral Program Among Veterans: Assessing Circumstances & Offering Resources for Needs (ACORN).

BACKGROUND: The Department of Veterans Affairs (VA) healthcare system routinely screens Veterans for food insecurity, housing instability, and intimate partner violence, but does not systematically screen for other health-related social needs (HRSNs). OBJECTIVES: To (1) develop a process for systematically identifying and addressing Veterans' HRSNs, (2) determine reported prevalence of HRSNs, and (3) assess the acceptability of HRSN screening among Veterans. DESIGN: "Assessing Circumstances and Offering Resources for Needs" (ACORN) is a Veteran-tailored HRSN screening and referral quality improvement initiative. Veterans were screened via electronic tablet for nine HRSNs (food, housing, utilities, transportation, legal needs, social isolation, interpersonal violence, employment, and education) and provided geographically tailored resource guides for identified needs. Two-week follow-up interviews with a purposive sample of Veterans explored screening experiences. PARTICIPANTS: Convenience sample of Veterans presenting for primary care at a VA urban women's health clinic and suburban community-based outpatient clinic (October 2019-May 2020). MAIN MEASURES: Primary outcomes included prevalence of HRSNs, Veteran-reported acceptability of screening, and use of resources guides. Data were analyzed using descriptive statistics, chi-square tests, and rapid qualitative analysis. KEY RESULTS: Of 268 Veterans screened, 50% reported one or more HRSNs. Social isolation was endorsed most frequently (29%), followed by educational needs (19%), interpersonal violence (12%), housing instability (9%), and utility concerns (7%). One in five Veterans reported at least one form of material hardship. In follow-up interviews (n = 15), Veterans found screening acceptable and felt VA should continue screening. No Veterans interviewed had contacted recommended resources at two-week follow-up, although several planned to use resource guides in the future. CONCLUSION: In a VA HRSN screening and referral program, Veterans frequently reported HRSNs, felt screening was important, and thought VA should continue to screen for these needs. Screening for HRSNs is a critical step towards connecting patients with services, identifying gaps in service delivery, and informing future resource allocation.

Ethical Considerations in Precision Medicine and Genetic Testing in Internal Medicine Practice: A Position Paper From the American College of Physicians.

This American College of Physicians position paper aims to inform ethical decision making for the integration of precision medicine and genetic testing into clinical care. Although the positions are primarily intended for practicing physicians, they may apply to other health care professionals and can also inform how health care systems, professional schools, and residency programs integrate genomics into educational and clinical settings. Addressing the challenges of precision medicine and genetic testing will guide ethical and responsible implementation to improve health outcomes.

A Delayed Evening Meal Enhances Sleep Quality in Young Rugby Players.

The aim of this study was to examine the effect of delayed evening mealtime on sleep quality in young athletes. Twelve rugby players (age 15.8 ± 0.7 years) participated in a crossover within-participant design. Adolescents spent five consecutive days in each of two conditions, separated by a 2-week washout period: routine dinner (3.5 hr before bedtime) and late dinner (LD, 1.5 hr before bedtime). Other mealtimes as well as bedtime and wake-up time were usual and remained the same in both conditions. Their schedules, dietary intakes, and physical activity were controlled and kept constant throughout the study. Sleep was assessed using polysomnography on the first and the last nights in the individual rooms of the boarding school. An increase in total sleep time by 24 min (p = .001, d = 1.24) and sleep efficiency by 4.8% was obtained during LD (p = .001, d = 1.24). Improvement in sleep efficiency was mainly due to a lower wake after sleep onset (-25 min, p = .014, d = -3.20), a decrease of microarousals (-25%, p = .049, d = -0.64), and awakenings ≥90 s (-30%, p < .01, d = -0.97) in LD compared to routine dinner. There were no significant differences in sleep architecture except for a shorter slow-wave sleep (N3) latency (-6.9 min, p = .03, d = -0.778) obtained during LD. In this study, evening dinner 1.5 hr before bedtime leads to better quality and less fragmented sleep compared to evening dinner 3.5 hr before bedtime in young athletes.

Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder: The PRIME Care Randomized Clinical Trial.

Importance: Selecting effective antidepressants for the treatment of major depressive disorder (MDD) is an imprecise practice, with remission rates of about 30% at the initial treatment. Objective: To determine whether pharmacogenomic testing affects antidepressant medication selection and whether such testing leads to better clinical outcomes. Design, Setting, and Participants: A pragmatic, randomized clinical trial that compared treatment guided by pharmacogenomic testing vs usual care. Participants included 676 clinicians and 1944 patients. Participants were enrolled from 22 Department of Veterans Affairs medical centers from July 2017 through February 2021, with follow-up ending November 2021. Eligible patients were those with MDD who were initiating or switching treatment with a single antidepressant. Exclusion criteria included an active substance use disorder, mania, psychosis, or concurrent treatment with a specified list of medications. Interventions: Results from a commercial pharmacogenomic test were given to clinicians in the pharmacogenomic-guided group (n = 966). The comparison group received usual care and access to pharmacogenomic results after 24 weeks (n = 978). Main Outcomes and Measures: The co-primary outcomes were the proportion of prescriptions with a predicted drug-gene interaction written in the 30 days after randomization and remission of depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) (remission was defined as PHQ-9 ≤ 5). Remission was analyzed as a repeated measure across 24 weeks by blinded raters. Results: Among 1944 patients who were randomized (mean age, 48 years; 491 women [25%]), 1541 (79%) completed the 24-week assessment. The estimated risks for receiving an antidepressant with none, moderate, and substantial drug-gene interactions for the pharmacogenomic-guided group were 59.3%, 30.0%, and 10.7% compared with 25.7%, 54.6%, and 19.7% in the usual care group. The pharmacogenomic-guided group was more likely to receive a medication with a lower potential drug-gene interaction for no drug-gene vs moderate/substantial interaction (odds ratio [OR], 4.32 [95% CI, 3.47 to 5.39]; P < .001) and no/moderate vs substantial interaction (OR, 2.08 [95% CI, 1.52 to 2.84]; P = .005) (P < .001 for overall comparison). Remission rates over 24 weeks were higher among patients whose care was guided by pharmacogenomic testing than those in usual care (OR, 1.28 [95% CI, 1.05 to 1.57]; P = .02; risk difference, 2.8% [95% CI, 0.6% to 5.1%]) but were not significantly higher at week 24 when 130 patients in the pharmacogenomic-guided group and 126 patients in the usual care group were in remission (estimated risk difference, 1.5% [95% CI, -2.4% to 5.3%]; P = .45). Conclusions and Relevance: Among patients with MDD, provision of pharmacogenomic testing for drug-gene interactions reduced prescription of medications with predicted drug-gene interactions compared with usual care. Provision of test results had small nonpersistent effects on symptom remission. Trial Registration: ClinicalTrials.gov Identifier: NCT03170362.

[Teaching digital competences in nursing education-a comparative analysis of the federal and state framework curricula]. / Vermittlung digitaler Kompetenzen in der Pflegeausbildung ­ eine Vergleichsanalyse der Rahmenpläne von Bund und Ländern.

BACKGROUND AND OBJECTIVE: The digital transformation of healthcare requires changed competences in the nursing professions. The reform of nursing education opens up the opportunity to anchor the requisite content in vocational education. The framework curricula of the expert commission ("Rahmenpläne der Fachkommission nach § 53 Pflegeberufegesetz") form the basis for the federal states to create their own framework curricula. This paper examines to what extent and in what form the framework curricula take up digitalisation. MATERIAL AND METHODS: The framework curricula were investigated in an explicative-qualitative content analysis between August and October 2021. First, the frequency of previously defined keywords was determined. This was followed by a systematic context analysis. RESULTS: Merely six federal states had created their own framework curriculum; the others used the federal framework curriculum, which only addresses the acquisition of competences in the field of digitalisation to a small extent. Digitalisation was addressed to varying degrees in the federal state's own framework plans but only selectively overall. Recommendations for practical exercise formats were hardly given. DISCUSSION: The acquisition of competences in the area of digitalisation forms the foundation for later professional life and is an important component of the digital transformation. In the context of the possibility of modifying nursing education until 2024, the topic should be taken into focus more strongly. Improvements can also be made directly at technical and vocational schools as well as universities since the framework curricula are sometimes only of a recommendatory nature.

Provider Perceptions of Virtual Care During the Coronavirus Disease 2019 Pandemic: A Multispecialty Survey Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to a dramatic increase in virtual care (VC) across outpatient specialties, but little is known regarding provider acceptance of VC. OBJECTIVE: The objective of this study was to assess provider perceptions of the quality, efficiency, and challenges of VC versus in-person care with masks. DESIGN: This was a voluntary survey. PARTICIPANTS: Mental health (MH), primary care, medical specialty, and surgical specialty providers across the 8 VA New England Healthcare System medical centers. MEASURES: Provider ratings of: (1) quality and efficiency of VC (phone and video telehealth) compared with in-person care with masks; (2) challenges of VC; and (3) percentage of patients that providers are comfortable seeing via VC in the future. RESULTS: The sample included 998 respondents (49.8% MH, 20.6% primary care, 20.4% medical specialty, 9.1% surgical specialty; 61% response rate). Most providers rated VC as equivalent to or higher in quality and efficiency compared with in-person care with masks. Quality ratings were significantly higher for video versus phone (χ2=61.4, P<0.0001), but efficiency ratings did not differ significantly. Ratings varied across specialties (highest in MH, lowest in SS; all χ2s>24.1, Ps<0.001). Inability to conduct a physical examination and patient technical difficulties were significant challenges. MH providers were comfortable seeing a larger proportion of patients virtually compared with the other specialties (all χ2s>12.2, Ps<0.01). CONCLUSIONS: Broad provider support for VC was stratified across specialties, with the highest ratings in MH and lowest ratings in SS. Findings will inform the improvement of VC processes and the planning of health care delivery during the COVID-19 pandemic and beyond.

On All Accounts: Cost-Effectiveness Analysis of Limited Preoperative Optimization Efforts Before Colon Cancer Surgery.

BACKGROUND: Reports suggest that preoperative optimization of a patient's serious comorbidities is associated with a reduction in postoperative complications. OBJECTIVE: The purpose of this study was to assess the cost and benefits of preoperative optimization, accounting for total costs associated with postoperative morbidity. DESIGN: This study is a decision tree cost-effectiveness analysis with probabilistic sensitivity analysis (10,000 iterations). SETTING: This is a hypothetical scenario of stage II colon cancer surgery. PATIENT: The simulated 65-year-old patient has left-sided, stage II colon cancer. INTERVENTION: Focused preoperative optimization targets high-risk comorbidities. OUTCOMES: Total discounted (3%) economic costs (US $2018), effectiveness (quality-adjusted life-years), incremental cost-effectiveness ratio (incremental cost-effectiveness ratio, cost/quality-adjusted life-years gained), and net monetary benefit. RESULTS: We calculated the per individual expected health care sector total cost of preoperative optimization and sequelae to be $12,395 versus $15,638 in those not optimized (net monetary benefit: $1.04 million versus $1.05 million). A nonoptimized patient attained an average 0.02 quality-adjusted life-years less than one optimized. Thus, preoperative optimization was the dominant strategy (lower total costs; higher quality-adjusted life-years). Probabilistic sensitivity analysis demonstrated 100% of simulations favoring preoperative optimization. The breakeven cost of optimization to remain cost-effective was $6421 per patient. LIMITATIONS: Generalizability must account for the lack of standardization among existing preoperative optimization efforts, and decision analysis methodology provides guidance for the average patient or general population, and is not patient-specific. CONCLUSIONS: Although currently not comprehensively reimbursed, focused preoperative optimization may reduce total costs of care while also reducing complications from colon cancer surgery. See Video Abstract at http://links.lww.com/DCR/B494. EN TODO CASO ANLISIS DE RENTABILIDAD DE LOS ESFUERZOS LIMITADOS DE OPTIMIZACIN PREOPERATORIA ANTES DE LA CIRUGA DE CNCER DE COLON: ANTECEDENTES:Los informes sugieren que la optimización preoperatoria de las comorbilidades graves de un paciente se asocia con una reducción de las complicaciones postoperatorias.OBJETIVO:El propósito de este estudio fue evaluar el costo y los beneficios de la optimización preoperatoria, teniendo en cuenta los costos totales asociados con la morbilidad postoperatoria.DISEÑO:Análisis de costo-efectividad de árbol de decisión con análisis de sensibilidad probabilístico (10,000 iteraciones).AJUSTE ENTORNO CLINICO:Escenario hipotético Cirugía de cáncer de colon en estadio II.PACIENTE:Paciente simulado de 65 años con cáncer de colon en estadio II del lado izquierdo.INTERVENCIÓN:Optimización preoperatoria enfocada dirigida a comorbilidades de alto riesgo.RESULTADOS:Costos económicos totales descontados (3%) (US $ 2018), efectividad (años de vida ajustados por calidad [AVAC]), relación costo-efectividad incremental (ICER, costo / AVAC ganado) y beneficio monetario neto (NMB).RESULTADOS:Calculamos que el costo total esperado por sector de atención médica individual de la optimización preoperatoria y las secuelas es de $ 12,395 versus $ 15,638 en aquellos no optimizados (NMB: $ 1.04 millones versus $ 1.05 millones, respectivamente). Un paciente no optimizado alcanzó un promedio de 0.02 AVAC menos que uno optimizado. Por lo tanto, la optimización preoperatoria fue la estrategia dominante (menores costos totales; mayores AVAC). El análisis de sensibilidad probabilístico demostró que el 100% de las simulaciones favorecían la optimización preoperatoria. El costo de equilibrio de la optimización para seguir siendo rentable fue de $ 6,421 por paciente.LIMITACIONES:La generalización debe tener en cuenta la falta de estandarización entre los esfuerzos de optimización preoperatorios existentes y esa metodología de análisis de decisiones proporciona una guía para el paciente promedio o la población general, no específica del paciente.CONCLUSIONES:Si bien actualmente no se reembolsa de manera integral, la optimización preoperatoria enfocada puede reducir los costos totales de la atención y al mismo tiempo reducir las complicaciones de la cirugía de cáncer de colon. Consulte Video Resumen en http://links.lww.com/DCR/B494.

Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors.

BACKGROUND: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. OBJECTIVE: To characterize the development of ventilator triage policies and compare policy content. DESIGN: Survey and mixed-methods content analysis. SETTING: North American hospitals associated with members of the Association of Bioethics Program Directors. PARTICIPANTS: Program directors. MEASUREMENTS: Characteristics of institutions and policies, including triage criteria and triage committee membership. RESULTS: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. LIMITATION: The results may not be generalizable to institutions without academic bioethics programs. CONCLUSION: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation. PRIMARY FUNDING SOURCE: None.

Neuronal-specific microexon splicing of TAF1 mRNA is directly regulated by SRRM4/nSR100.

Neuronal microexons represent the most highly conserved class of alternative splicing events and their timed expression shapes neuronal biology, including neuronal commitment and differentiation. The six-nt microexon 34' is included in the neuronal form of TAF1 mRNA, which encodes the largest subunit of the basal transcription factor TFIID. In this study, we investigate the tissue distribution of TAF1-34' mRNA and protein and the mechanism responsible for its neuronal-specific splicing. Using isoform-specific RNA probes and antibodies, we observe that canonical TAF1 and TAF1-34' have different distributions in the brain, which distinguish proliferating from post-mitotic neurons. Knockdown and ectopic expression experiments demonstrate that the neuronal-specific splicing factor SRRM4/nSR100 promotes the inclusion of microexon 34' into TAF1 mRNA, through the recognition of UGC sequences in the poly-pyrimidine tract upstream of the regulated microexon. These results show that SRRM4 regulates temporal and spatial expression of alternative TAF1 mRNAs to generate a neuronal-specific TFIID complex.

Gender Wage Disparities in Medicine: Time to Close the Gap.

Women physicians are paid less than their male peers across medical specialties and geographies. While the medical literature to date has focused on documenting the existence of a wage gap, less attention has been paid to fixing this gap. We focus on interventions around auditing, salary transparency, family leave, and childcare that can be implemented to advance gender wage parity.

Spread and clinical severity of respiratory syncytial virus A genotype ON1 in Germany, 2011-2017.

BACKGROUND: The Respiratory Syncytial Virus (RSV) A genotype ON1, which was first detected in Ontario (Canada) in 2010/11, appeared in Germany in 2011/12. Preliminary observations suggested a higher clinical severity in children infected with this new genotype. We investigated spread and disease severity of RSV-A ON1 in pediatric in- and outpatient settings. METHODS: During 2010/11 to 2016/17, clinical characteristics and respiratory samples from children with acute respiratory tract infections (RTI) were obtained from ongoing surveillance studies in 33 pediatric practices (PP), one pediatric hospital ward (PW) and 23 pediatric intensive care units (PICU) in Germany. RSV was detected in the respiratory samples by PCR; genotypes were identified by sequencing. Within each setting, clinical severity markers were compared between RSV-A ON1 and RSV-A non-ON1 genotypes. RESULTS: A total of 603 children with RSV-RTI were included (132 children in PP, 288 in PW, and 183 in PICU). Of these children, 341 (56.6%) were infected with RSV-A, 235 (39.0%) with RSV-B, and one child (0.2%) with both RSV-A and RSV-B; in 26 (4.3%) children, the subtype could not be identified. In the 341 RSV-A positive samples, genotype ON1 was detected in 247 (72.4%), NA1 in 92 (26.9%), and GA5 in 2 children (0.6%). RSV-A ON1, rarely observed in 2011/12, was the predominant RSV-A genotype in all settings by 2012/13 and remained predominant until 2016/17. Children in PP or PW infected with RSV-A ON1 did not show a more severe clinical course of disease compared with RSV-A non-ON1 infections. In the PICU group, hospital stay was one day longer (median 8 days, inter-quartile range (IQR) 7-12 vs. 7 days, IQR 5-9; p = 0.02) and duration of oxygen treatment two days longer (median 6 days, IQR 4-9 vs. 4 days, IQR 2-6; p = 0.03) for children infected with RSV-A ON1. CONCLUSIONS: In children, RSV-A ON1 largely replaced RSV-A non-ON1 genotypes within two seasons and remained the predominant RSV-A genotype in Germany during subsequent seasons. A higher clinical severity of RSV-A ON1 was observed within the group of children receiving PICU treatment, whereas in other settings clinical severity of RSV-A ON1 and non-ON1 genotypes was largely similar.

Hidden Curricula, Ethics, and Professionalism: Optimizing Clinical Learning Environments in Becoming and Being a Physician: A Position Paper of the American College of Physicians.

Much of what is formally taught in medicine is about the knowledge, skills, and behaviors required of a physician, including how to express compassion and respect for patients at the bedside. What is learned, however, includes not only admirable qualities but also behaviors and qualities that are inconsistent with ethics and professionalism. Positive role models may reinforce the character and values the profession seeks to cultivate; negative ones directly contradict classroom lessons and expectations of patients, society, and medical educators. These positive and negative lessons, which are embedded in organizational structure and culture, are the hidden curricula conveyed in medical schools, residency programs, hospitals, and clinics. This position paper from the American College of Physicians focuses on ethics, professionalism, and the hidden curriculum. It provides strategies for revealing what is hidden to foster the development of reflective and resilient lifelong learners who embody professionalism and clinicians who are, and are perceived as, positive role models. Making the hidden visible and the implicit explicit helps to create a culture reflecting medicine's core values.

Ethical Obligations Regarding Short-Term Global Health Clinical Experiences: An American College of Physicians Position Paper.

This American College of Physicians position paper aims to inform ethical decision making surrounding participation in short-term global health clinical care experiences. Although the positions are primarily intended for practicing physicians, they may apply to other health care professionals and should inform how institutions, organizations, and others structure short-term global health experiences. The primary goal of short-term global health clinical care experiences is to improve the health and well-being of the individuals and communities where they occur. In addition, potential benefits for participants in global health include increased awareness of global health issues, new medical knowledge, enhanced physical diagnosis skills when practicing in low-technology settings, improved language skills, enhanced cultural sensitivity, a greater capacity for clinical problem solving, and an improved sense of self-satisfaction or professional satisfaction. However, these activities involve several ethical challenges. Addressing these challenges is critical to protecting patient welfare in all geographic locales, promoting fair and equitable care globally, and maintaining trust in the profession. This paper describes 5 core positions that focus on ethics and the clinical care context and provides case scenarios to illustrate them.

Protecting User Privacy and Rights in Academic Data-Sharing Partnerships: Principles From a Pilot Program at Crisis Text Line.

Data sharing between technology companies and academic health researchers has multiple health care, scientific, social, and business benefits. Many companies remain wary about such sharing because of unaddressed concerns about ethics, data security, logistics, and public relations. Without guidance on these issues, few companies are willing to take on the potential work and risks involved in noncommercial data sharing, and the scientific and societal potential of their data goes unrealized. In this paper, we describe the 18-month long pilot of a data-sharing program led by Crisis Text Line (CTL), a not-for-profit technology company that provides a free 24/7 text line for people in crisis. The primary goal of the data-sharing pilot was to design, develop, and implement a rigorous framework of principles and protocols for the safe and ethical sharing of user data. CTL used a stakeholder-based policy process to develop a feasible and ethical data-sharing program. The process comprised forming a data ethics committee; identifying policy challenges and solutions; announcing the program and generating interest; and revising the policy and launching the program. Once the pilot was complete, CTL examined how well the program ran and compared it with other potential program models before putting in place the program that was most suitable for its organizational needs. By drawing on CTL's experiences, we have created a 3-step set of guidelines for other organizations that wish to develop their own data-sharing program with academic researchers. The guidelines explain how to (1) determine the value and suitability of the data and organization for creating a data-sharing program; (2) decide on an appropriate data sharing and collaboration model; and (3) develop protocols and technical solutions for safe and ethical data sharing and the best organizational structure for implementing the program. An internal evaluation determined that the pilot satisfied CTL's goals of sharing scientific data and protecting client confidentiality. The policy development process also yielded key principles and protocols regarding the ethical challenges involved in data sharing that can be applied by other organizations. Finally, CTL's internal review of the pilot program developed a number of alternative models for sharing data that will suit a range of organizations with different priorities and capabilities. In implementing and studying this pilot program, CTL aimed both to optimize its own future data-sharing programs and to inform similar decisions made by others. Open data programs are both important and feasible to establish. With careful planning and appropriate resources, data sharing between big data companies and academic researchers can advance their shared mission to benefit society and improve lives.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

PurposeThe Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health-funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research-clinical interface.MethodsA CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research-clinical interface.ResultsSurvey responses described how studies approached the research-clinical interface, including in consent practices, recording results, and using a research versus clinical laboratory. Responses revealed four characterizations of the interface: clear separation between research and clinical care, interdigitation of the two with steps to maintain separation, a dynamic interface, and merging of the two. All survey respondents utilized at least two different characterizations. Although research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains.ConclusionThese results illustrate the difficulty in applying the traditional bifurcation of research versus clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.

Ethical Issues in the Design and Implementation of Population Health Programs.

Spurred on by recent health care reforms and the Triple Aim's goals of improving population health outcomes, reducing health care costs, and improving the patient experience of care, emphasis on population health is increasing throughout medicine. Population health has the potential to improve patient care and health outcomes for individual patients. However, specific population health activities may not be in every patient's best interest in every circumstance, which can create ethical tensions for individual physicians and other health care professionals. Because individual medical professionals remain committed primarily to the best interests of individual patients, physicians have a unique role to play in ensuring population health supports this ethical obligation. Using widely recognized principles of medical ethics-nonmaleficence/beneficence, respect for persons, and justice-this article describes the ethical issues that may arise in contemporary population health programs and how to manage them. Attending to these principles will improve the design and implementation of population health programs and help maintain trust in the medical profession.

Return of genomic results to research participants: the floor, the ceiling, and the choices in between.

As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants' health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles.

Oncofertility: Fertile Ground for Conflict Between Patient Autonomy and Medical Values.

Oncofertility is a unique, multidisciplinary field that serves to bridge the gap between available fertility resources and the special reproductive needs of cancer patients. Oncofertility is a growing field due to the increasing number of survivors, development of new oncologic therapies, extension of duration of therapies, and development and refinement of reproductive therapies. While the technologies and demand for services expand, clinicians need to be appropriately prepared for dealing with various clinical scenarios that may require ethical deliberation. Three real cases are presented in which the patient wishes to pursue reproductive assistance, but her decision is met with hesitance or uncertainty by her care team. Discussion of these clinical scenarios highlights ethical implications of oncofertility practice and serves to highlight the need for the establishment of multidisciplinary care teams and guidelines to support both clinicians and patients. IMPLICATIONS FOR PRACTICE: The growing field of oncofertility is ripe for conflict between patient autonomy and medical values due to the nature of cancer and associated threat on an individual's health and survival, as well as the personal significance of childbearing. Cases are presented and ethical implications are discussed to further explore the inherent difficulties in oncofertility practice and guide clinicians in similar situations. Developing guidelines and establishing multidisciplinary teams to facilitate oncofertility discussions and care, as well as training of clinical team members, may improve patient safety, well-being, and satisfaction within the context of fertility decision making, care, and outcomes.