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Calls have been made for researchers prospectively and continuously to engage study communities. If done, this typically occurs through a specific research study or collaboration. Rarely are community mores examined in-depth to understand implications for research ethics policy processes. We describe a qualitative study designed to understand local community values, beliefs, and practices that relate to research ethics in Botswana and explore how communities would want their interests represented. Through focus group discussions across two different selected ethnic communities and in-depth interviews with paramount chiefs, we highlight a range of community values and expectations that represent concrete behavioral representations of respect and trustworthiness. Communities are willing to engage in the process of enhancing research and research ethics policies and procedures. We invite future research and training that seek to connect local conceptualizations of substantive and procedural aspects of research ethics.

Objective : We characterize public values regarding vaccinomics, which aims to improve vaccine safety and effectiveness using genomics. Methods: Panel survey (2020) of ≥18-year-olds with embedded animation introduced vaccinomics. Sociodemographic, health, and vaccination-related items were adapted from validated scales. Novel items measured trust in public health authorities, vaccinomics-related values, and preferences for federal funding: vaccinomics compared with vaccine issues and chronic diseases. Beginning and end of survey confidence in vaccine safety was measured to assess potential changes. Data were weighted to the U.S. Census. Vaccinomics-related concerns were stratified by sociodemographic characteristics, vaccine hesitancy status (composite outcome), reported serious vaccine reactions, and trust in public health authorities (PHA). Log binomial regression models estimated associations between these variables and agency to make vaccine-related decisions. Results: Most (70.7%, N = 1,925) respondents expected vaccinomics would increase their vaccine confidence compared to now. Agreement was highest among those without serious vaccine reaction experience (unexperienced: 74.2% versus experienced: 62.3%), with high trust in PHA (high: 83.3% versus low: 57.4%), and low vaccine hesitancy among parents of teenagers (low: 78.8% versus high: 62.5%) and adults without minor children (low: 79.8% versus high: 60.6%; all p < .01). Belief that vaccination was an individual's choice was associated with reported serious reactions (adjusted Prevalence Ratio (aPR): 1.16; 95% CI: 1.07, 1.25) and low trust (aPR: 0.91; 0.84, 0.98). Beginning versus end of survey vaccine safety perceptions were similar. Conclusion: Federal funding, communications, and policies should assure the public that vaccinomics will not remove their decision-making power and engender trust in PHA.

Purpose: Research in genetics and infectious diseases (ID) presents novel configurations of ethical, legal, and social issues (ELSIs) related to the intersection of genetics with public health regulations and the control of transmissible diseases. Such research includes work both in pathogen genetics and on the ways that human genetics affect responses to ID. This paper identifies and systematizes the unique issues at this intersection, based on an interdisciplinary expert review., Basic Procedures: This paper presents results of a formal issue-spotting exercise among twenty experts in public health, law and genomics, biobanking, genetic epidemiology, ID medicine and public health, philosophy, ethics and ID, ethics and genomics, and law and ID. The focus of the exercise was on the collection, storage, and sharing of genetic information relating to ID., Main Findings: The issue-spotting exercise highlighted the following ELSIs: risks in reporting to government authorities, return of individual research results, and resource allocation - each taking on specific configurations based on the balance between public health and individual privacy/protection., Principal Conclusions: The public health implications of interactions between genomics and ID frame considerations for equity and justice. In the context of the COVID-19 pandemic, these issues are especially pressing., Competing Interests: Conflict of Interest The authors have no conflicts of interest to declare.

Scholars from a range of disciplines including medicine, sociology, psychology, and philosophy have addressed the concepts of ambiguity and uncertainty in medical practice and training. Most of this scholarship has been descriptive, focusing on defining and measuring ambiguity and uncertainty tolerance or tracking clinicians' responses to ambiguous and uncertain situations. Meanwhile, scholars have neglected some fundamental normative questions: Is tolerance of uncertainty good; if so, to what extent? Using a philosophical approach to these questions, we show that neither tolerance nor intolerance of uncertainty is necessarily a good or bad trait. Rather, both tolerance and intolerance of uncertainty can give physicians advantages while at the same time exposing them to pitfalls in clinical practice. After making this case, we argue that cultivating certain virtues-like courage, diligence, and curiosity-could help clinicians avoid the dangers of excessive tolerance and intolerance of uncertainty. Finally, we suggest that medical educators develop curricula and career counseling beginning with matriculation and proceeding through specialty choice and residency training that explicitly address trainees' responses to clinical uncertainty. These programs should encourage trainees, students and residents, to be mindful of their reactions to uncertainty and help them develop virtues that will allow them to avoid the hazards of extreme tolerance or intolerance of uncertainty., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

Objectives : We aimed to elucidate public values regarding the use of genomics to improve vaccine development and use (vaccinomics). Methods : Adults ≥18 years-old were recruited through social media and community organizations, and randomly assigned to one of four nested discussion groups in Boulder, CO and Baltimore, MD. Participants rated their confidence in vaccine safety and effectiveness prior to and after discussing vaccinomics. Before departing, they prioritized funding for vaccinomics versus federal priorities (vaccine safety and efficacy, new vaccines, and free vaccines) and chronic diseases (cancer, heart disease, and diabetes). Grounded Theory-influenced methods were used to identify themes. Results : Participants broadly supported vaccinomics. Emergent themes: concerns about reduced privacy/confidentiality, increased genetically based stigma/discrimination, and reduced agency to make vaccine-related decisions through genetically based prioritization. Participants supported vaccinomics' potential for increased personalization. Some participants favored prioritizing others over themselves during a vaccine shortage, while others did not. Some participants worried health insurance companies would discriminate against them based on information discovered through vaccinomics. Participants feared inequitable implementation of vaccinomics would contribute to discrimination and marginalization of vulnerable populations. Discussing vaccinomics did not impact perceptions of vaccine safety and effectiveness. Federal funding for vaccinomics was broadly supported. Conclusion : Participants supported vaccinomics' potential for increased personalization, noting policy safeguards to facilitate equitable implementation and protect privacy were needed. Despite some concerns, participants hoped vaccinomics would improve vaccine safety and effectiveness. Policies regarding vaccinomics' implementation must address public concerns about the privacy and confidentiality of genetic information and potential inequities in access to vaccinomics' benefits.

Purpose: Tolerance for ambiguity (TFA) is important for physicians, with implications for ethical behavior and patient care. This study explores how medical students' TFA changes from matriculation to graduation and how change in empathy and openness to diversity are associated with this change., Method: Data for students who took the Matriculating Student Questionnaire (MSQ) in 2013 or 2014 and the Medical School Graduation Questionnaire (GQ) in 2017 or 2018 were drawn from the Association of American Medical Colleges (n = 17,221). Both the MSQ and GQ included a validated TFA scale and a shortened version of the Interpersonal Reactivity Index; the MSQ also included an openness to diversity scale. Tercile groups were used to assess how TFA changed from the MSQ to GQ, and regression analyses were used to assess associations between change in TFA and openness to diversity and between change in TFA and change in empathy., Results: Mean TFA scores decreased (d = -.67) among students with the highest TFA at matriculation but increased (d = .60) among students with the lowest TFA at matriculation. Regression results showed that change in TFA was significantly and positively associated with change in empathy (beta = .05, P < .001) and that openness to diversity (as reported at matriculation) was significantly and positively associated with TFA at graduation (beta = .05, P < .001)., Conclusions: This is the first nationally representative study to suggest that medical students' TFA changes over time, but in different directions depending on TFA at matriculation. TFA over time was also associated with change in empathy and openness to diversity. Medical schools should consider strategies to assess TFA in their admissions processes and for cultivating TFA throughout the learning process., (Copyright © 2020 by the Association of American Medical Colleges.)

The impact of host genomics on an individual's susceptibility, immune response, and risk of severe outcomes for a given infectious pathogen is increasingly recognized. As we uncover the links between host genomics and infectious disease, a number of ethical, legal, and social issues need to be considered when using that information in clinical practice or workforce decisions. We conducted a survey of the clinical staff at 10 federally funded Regional Ebola and Other Special Pathogen Treatment Centers to understand their views regarding the ethical, legal, and social issues related to host genomics and the administrative and clinical functions of high-level isolation units. Respondents overwhelmingly agreed that genomics could provide valuable information to identify patients and employees at higher risk for poor outcomes from highly infectious diseases. However, there was considerable disagreement about whether such data should inform the allocation of scarce resources or determine treatment decisions. While most respondents supported a confidential employer-based genomic testing system to inform individual employees about risk, respondents disagreed about whether such information should be used in staffing models. Respondents who thought genomic information would be valuable for patient treatment were more willing to undergo genetic testing for staffing purposes. Most respondents felt they would benefit from additional training to better interpret results from genetic testing. Although this study was completed before the COVID-19 pandemic, the responses provide a baseline assessment of provider attitudes that can inform policy during the current pandemic and in future infectious disease outbreaks.

Infectious disease outbreaks highlight the importance of trust in public health authorities to avoid fear and improve adherence to recommendations. There is currently no established and validated measure for trust in public health authorities. We aimed to develop and validate an instrument that measures trust in public health authorities and to assess the association between trust in public health authorities and vaccine attitudes. We developed 20 items to measure trust in public health authorities. After implementing a survey in January 2020, we investigated relationships between the items, reduced the number of items, and identified latent constructs of the scale. We assessed variability in trust and how trust was associated with vaccine attitudes, beliefs, and self-reported vaccine acceptance. The pool was reduced to a 14-item trust in public health authorities scale and we found that this trust model was strongly associated with acceptance of vaccines. Our scale can be used to examine the relationship between trust in public health authorities and adherence to public health recommendations. The measure needs to be validated in other settings to determine whether they are associated with other areas where the public question public health authority recommendations.

We have never been so aware of masks. They were in short supply in the early days of COVID-19, resulting in significant risk to health care workers. Now they are highly politicized with battles about mask-wearing protocols breaking out in public. Although masks have obtained a new urgency and ubiquity in the context of COVID-19, people have thought about both the literal and metaphorical role of masks in medicine for generations. In this paper, we discuss three such metaphors-the masks of objectivity, of infallibility, and of benevolence-and their powerful role in medicine. These masks can be viewed as inflexible barriers to communication, contributing to the traditional authoritarian relationship between doctor and patient and concealing the authenticity and vulnerability of physicians. COVID masks, by contrast, offer a more nuanced and morally complex metaphor for thinking about protecting people from harm, authentic and trustworthy communication, and attention to potential inequities both in and beyond medical settings. We highlight the morally relevant challenges and opportunities that masks evoke and suggest that there is much to be gained from rethinking the mask metaphor in medicine.

Purpose: As many as 20% of oncology patients receive chemotherapy in the last 14 days of their lives. This study characterized conversations between patients and cancer clinicians on chemotherapy cessation in the setting of advanced cancer., Methods: This 3-site study captured real-time, audio-recorded interviews between oncology clinicians and patients with cancer during actual clinic visits. Audio-recordings were reviewed for discussion of chemotherapy cessation and were analyzed qualitatively., Results: Among 525 recordings, 14 focused on stopping chemotherapy; 14 patients participated with 11 different clinicians. Two types of nonmutually exclusive conversation elements emerged: direct and specific elements that described an absence of effective therapeutic options and indirect elements. An example of a direct element is as follows: "…You know this is…always really tough…But I-I think that you may need more help…I think we're close to stopping chemotherapy…And hospice is really helpful to have in place…" In contrast, the second conversation element was more convoluted: "…transplant is not an option and surgery is not an option…The options…are taking a pill…It doesn't shrink the tumor…It may help you live a little longer. But I'm worried if [you] had the pill, it's still a therapy and it still has side effects. I [am] worried if I give it to you now, that you're so weak, it will make you worse." No relationship seemed apparent between conversation elements and chemotherapy cessation., Conclusions: Conversations on chemotherapy cessation are complex; multiple factors appear to drive the decision to stop.

The pandemic of SARS-CoV-2 has led to unprecedented changes to society, causing unique problems that call for extraordinary solutions. We consider one such extraordinary proposal: 'safer infection sites' that would offer individuals the opportunity to be intentionally infected with SARS-CoV-2, isolate, and receive medical care until they are no longer infectious. Safer infection could have value for various groups of workers and students. Health professionals place themselves at risk of infection daily and extend this risk to their family members and community. Similarly, other essential workers who face workplace exposure must continue their work, even if have high-risk household members and live in fear of infecting. When schools are kept closed because of the fear that they will be sites of significant transmission, children and their families are harmed in multiple ways and college students who are living on campus, whether or not they are attending classes in person, are contributing to high rates of transmission and experiencing high rates of exposure. We consider whether offering safer infection sites to these groups could be ethically defensible and identify the empirical unknowns that would need to resolve before reaching definitive conclusions. This article is not an endorsement of intentional infection with the coronavirus, but rather is meant to spark conversation on the ethics of out-of-the-box proposals. Perhaps most meaningfully, our paper explores the value of control and peace of mind for those among us most impacted by the pandemic: those essential workers risking the most to keep us safe., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Racial disparities in both obstetrics and COVID-19 are well documented. Troublingly, implicit biases and related testimonial injustice potentiate adverse outcomes for women of color whose voices and concerns have been historically discredited by the medical establishment. In the context of COVID-19, the restriction of hospital visitors for infection prevention and control in a labor and delivery setting may disproportionately burden black women by eliminating or severely limiting access to essential in-person advocacy, which threatens to exacerbate existing disparities in maternal and neonatal outcomes. The potential disproportionate impact of visitor restrictions on women of color should inform the ongoing pandemic response., Competing Interests: No competing financial interests exist., (© Alexandra Norton et al., 2020; Published by Mary Ann Liebert, Inc.)

Background: The Scholarly Concentrations program was established at Johns Hopkins University School of Medicine in 2009 with the aim of instilling passion for scholarship., Objective: Our study aimed to determine whether the Scholarly Concentrations program achieves positive changes in medical student self-efficacy in conducting research and, if so, whether this results in future career aspirations toward scholarship., Design: We used the Clinical Research Appraisal Inventory-Short Form (CRAI-SF) to assess changes in self-efficacy among students completing the Scholarly Concentrations program between 2014 and 2017. We calculated composite mean scores of six domains. We included outcomes on whether students published a manuscript, overall program perceptions, and likelihood of future research careers. We analyzed relationships between CRAI-SF scores and outcomes using paired t-tests and multivariable-adjusted logistic regression., Results: A total of 419 students completed the Scholarly Concentrations program. All 6 CRAI domain scores showed significant improvements in self-efficacy between the pre-Scholarly Concentrations and post-Scholarly Concentrations ratings (range of changes 0.76-1.39, p < 0.05 for all). We found significant associations between post-Scholarly Concentrations self-efficacy ratings and course satisfaction (adjusted OR 1.57 [95% CI 1.20, 2.07]) and mentor satisfaction (OR 1.46 [1.15, 1.86]), as well as students' intent to conduct future research (OR 1.46 [1.15, 1.86]). These results were robust to sensitivity analyses, and pronounced in the group of students without prior research experience., Conclusions: Our findings suggest that a Scholarly Concentrations program is associated with an increased self-efficacy for research, and these changes in self-efficacy are associated with higher satisfaction in the scholarly experience and increased likelihood of pursuing scholarly work. Other medical schools could use such a tool of self-efficacy to both investigate the overall Scholarly Concentrations experience and understand factors that may increase interest in future physician-scientist pathways.

Background: Pragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems., Objective: We sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided., Design: Prospective, qualitative focus group study., Participants: Focus groups were conducted in Baltimore, MD; Houston, TX; and Seattle, WA (overall N = 66), during July and August 2019., Approach: All groups discussed a hypothetical scenario involving the detection of a PCT-CF of contraindicated medications. Participants were asked about their reactions to the PCT-CF and issues related to its disclosure., Key Results: Reactions to learning about the PCT-CF were mixed, ranging from fear of a significant health problem, anger that the contraindicated medications had gone unnoticed and/or for being included in research without their permission, to gratitude for the information. Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. Many wanted their treating clinician to be informed of the PCT-CF so that they would be prepared to answer patients' questions and to discuss treatment options., Conclusions: The detection of PCT-CFs is likely to increase with further expansion of PCTs. As such, clinicians will undoubtedly become involved in the management of PCT-CFs. Our data illustrate some of the challenges clinicians may face when their patients are informed of a PCT-CF and the need to develop guidance for disclosing PCT-CFs in ways that align with patients' preferences and values.

Genomic studies of patients with COVID-19, or exposed to it, are underway to delineate host factors associated with variability in susceptibility, infectivity, and disease severity. Here, we highlight the ethical implications-both potential benefits and harms-of genomics for clinical practice and public health in the era of COVID-19.

Background: The protection that an influenza vaccine offers can vary significantly from person to person due to differences in immune systems, body types, and other factors. The question, then, is what is the value of efforts to reduce this variability such as making vaccines more personalized and tailored to individuals., Methods: We developed a compartment model of the United States to simulate different influenza seasons and the impact of reducing the variability in responses to the influenza vaccine across the population., Results: Going from a vaccine that varied in efficacy (0-30%) to one that had a uniform 30% efficacy for everyone averted 16.0-31.2 million cases, $1.9-$3.6 billion in direct medical costs, and $16.1-$42.7 billion in productivity losses. Going from 0-50% in efficacy to just 50% for everyone averted 27.7-38.6 million cases, $3.3-$4.6 billion in direct medical costs, and $28.8-$57.4 billion in productivity losses. Going from 0-70% to 70% averted 33.6-54.1 million cases, $4.0-$6.5 billion in direct medical costs, and $44.8-$64.7 billion in productivity losses., Conclusions: This study quantifies for policy makers, funders, and vaccine developers and manufacturers the potential impact of efforts to reduce variability in the protection that influenza vaccines offer (eg, developing vaccines that are more personalized to different individual factors)., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Context: Pragmatic clinical trials (PCTs), which are becoming widespread since they are relatively inexpensive and offer important benefits for healthcare decision-making, can also present practical, ethical, and legal challenges. One such challenge involves managing "pragmatic clinical trial collateral findings" (PCT-CFs), or information emerging in a PCT that is unrelated to the primary research question(s), yet may have implications for individual patients, clinicians, or health care systems from whom or within which data were collected. The expansion of PCTs makes it likely healthcare systems will increasingly encounter PCT-CFs, yet little guidance exists regarding their appropriate management., Methods: We conducted semi-structured interviews with key stakeholders experienced in the conduct or oversight of PCTs and those in health system leadership. Interviews explored respondents' experience with PCTs and PCT-CFs, and actual or hypothetical reactions to PCT-CF management. We used standard methods of qualitative analysis to identify key themes., Findings: Forty-one stakeholders participated. Four key themes emerged. First, discussions of PCT-CFs are complicated by layers of ambiguity related to both the nature of PCTs themselves, and unanticipated results that emanate from them. Second, management of PCT-CFs is context-specific, and not amenable to a "one-size-fits-all" approach. Third, there was a wide diversity of attitudes regarding the scope of researcher responsibilities in PCTs. Fourth, PCT-CFs had generally not been previously considered by respondents, but there was widespread belief in the importance of prospective planning to anticipate such issues in future PCTs., Conclusions: PCT-CFs are likely to increase, yet those charged with PCT-CF decision-making and their disclosure are unlikely to have experience with these issues. Further deliberation about the ethical obligations and implementation processes regarding PCT-CFs is needed. To enhance the likelihood of developing sound policies and practices, such deliberations should include the input and perspectives of key stakeholders in PCTs, including professionals, policy makers, and patients., Competing Interests: Dr. Sugarman serves on Merck KGaA's Bioethics Advisory Panel and Stem Cell Research Oversight Committee; IQVIA's Ethics Advisory Panel; Apsen Neurosciences Scientific Advisory Board; and consulted with Biogen and Portola Pharmaceuticals. None of these are related to the material described in this manuscript. None of the other authors have relationships to disclose., (© 2020 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

There is growing evidence that human genetics plays a significant role in shaping human responses to infectious diseases. For instance, individuals' genetic susceptibility or resistance to infectious disease is likely to affect disease transmission. Yet little attention has been paid to the ethical, legal, and social implications of research in genomics and infectious disease, despite the unique ethical issues that arise in this arena. This article presents results from a pilot study exploring ethics in research on human genetics and response to HIV and other infectious diseases and is focused on perspectives from expert stakeholders. Whereas chairs of institutional review boards, biobank directors, and researchers in genomics and infectious disease expressed similar views about research privacy in the context of a public health emergency, they expressed different perspectives about the role that public health considerations ought to play in the return of individual results to research participants. These perspectives highlight the need to emphasize the importance of broad dialogue for helping various parties navigate the ethically complex current and future challenges of genomics and infectious disease research., (© 2020 by The Hastings Center. All rights reserved.)

Purpose: Shared decision-making (SDM) has a significant role in surgical encounters, where decisions are influenced by both clinician and patient preferences. Herein, we sought to explore surgeons' practices and beliefs about SDM., Methods: We performed a qualitative study consisting of semi-structured individual interviews with 18 surgeons from private practice and academic surgery practices in Baltimore, Maryland. We purposively sampled participants to maximize diversity of practice type (academic vs private), surgical specialty, gender, and experience level. Interview topics included benefits and challenges to patient involvement in decision-making, communicating uncertainty to patients, and use of decision aids. Interviews were audio-recorded and transcribed. Transcripts were analyzed using content analysis to identify themes., Results: Surgeons were supportive of patients being involved in decision-making, particularly in cases with uncertainty about treatment options. However, surgeons identified SDM as being more appropriate for patients whom surgeons perceived as interested in decision-making involvement and for decisions in which surgeons did not have strong preferences. Additionally, surgeons reported typically presenting only a subset of available options, remaining confident in their ability to filter less suitable options based on intuitive risk assessments. Surgeons differed in their approach to making recommendations, with some guiding patients towards what they saw as the correct or optimal decision while others sought to maintain neutrality and support of the patients' chosen decision., Conclusions: Many surgeons do not believe SDM is universally optimal for every surgical decision. They instead use assessments of patient disposition or potential clinical uncertainty to guide their perceived appropriateness of using SDM., Competing Interests: Conflicts of Interest Apart from funding sources noted below, the authors have no conflicts to disclose., (© 2020 Aurora Health Care, Inc.)

Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as ?pragmatic clinical trial collateral findings,? or ?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice.

Background: Little is known about how complementary and alternative medicine (CAM) is discussed in cancer care across varied settings in the U.S., Methods: In two practices affiliated with one academic medical center in southern California (SoCal), and one in the upper Midwest (UM), we audio-recorded patient-clinician interactions in medical oncology outpatient practices. We counted the frequency and duration of CAM-related conversations. We coded recordings using the Roter Interaction Analysis System. We used chi-square tests for bivariate analysis of categorical variables and generalized linear models for continuous variables to examine associations between dialogue characteristics, practice setting, and population characteristics with the occurrence of CAM discussion in each setting followed by multivariate models adjusting for clinician clustering., Results: Sixty-one clinicians and 529 patients participated. Sixty-two of 529 (12%) interactions included CAM discussions, with significantly more observed in the SoCal university practice than in the other settings. Visits that included CAM were on average 6 minutes longer, with CAM content lasting an average of 78 seconds. In bivariate tests of association, conversations containing CAM included more psychosocial statements from both clinicians and patients, higher patient-centeredness, more positive patient and clinician affect, and greater patient engagement. In a multivariable model including significant bivariate terms, conversations containing CAM were independently associated with higher patient-centeredness, slightly longer visits, and being at the SoCal university site., Conclusion: The frequency of CAM-related discussion in oncology varied substantially across sites. Visits that included CAM discussion were longer and more patient centered., Implications for Practice: The Institute of Medicine and the American Society of Clinical Oncology have called for more open discussions of complementary and alternative medicine (CAM). But little is known about the role population characteristics and care contexts may play in the frequency and nature of those discussions. The present data characterizing actual conversations in practice complements a much larger literature based on patient and clinician self-report about CAM disclosure and use. It was found that CAM discussions in academic oncology visits varied significantly by practice context, that the majority were initiated by the patient, and that they may occur more when visit time exists for lifestyle, self-care, and psychosocial concerns., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article., (© AlphaMed Press 2019.)

Objectives: While pembrolizumab improves overall survival (OS) in a subset of advanced nonsmall cell lung cancer (aNSCLC) patients (pts) in clinical trials, individuals with poor Eastern Cooperative Oncology Group performance status (ECOG PS) were excluded. Furthermore, some studies have identified a potential link between improved pt outcomes and development of immune related adverse events (irAE.) In a large provincial cohort, we studied the efficacy and safety of pembrolizumab for poor ECOG PS pts and whether irAE correlate with improved OS., Materials and Methods: aNSCLC pts treated with pembrolizumab between 06/2015 and 08/2018 at BC Cancer were retrospectively identified. Kaplan-Meier curves of OS from initiation of pembrolizumab were plotted. 3-, 6-, and 9- month landmark Kaplan-Meier analysis was performed and log-rank tests used to determine an association of irAE subtypes with OS. Multivariable logistic regression identified variables associated with grade ≥3 irAE within 3 months of pembrolizumab initiation., Results: Of 190 pts, 74.2% were treatment naïve and 92.6% had PD-L1 expression ≥ 50%. Median OS in the 1st line and ≥2nd line settings were 24.3 months (95% CI, 9.7-not reached, NR) and 13.4 months (95% CI, 8.1-NR), respectively. Pts with ECOG PS 2/3 had lower median OS than if ECOG PS 0/1 (5.8 months vs. 16.7 months, p < 0.0001). In multivariable analysis, the odds of grade ≥ 3 irAE within 3 months was 6.3 fold higher if ECOG PS 2/3 versus 0/1 (p = 0.05). Development of pneumonitis at the 9 month landmark weakly correlated with decreased OS (p = 0.09)., Conclusion: In the studied cohort, ECOG PS 2/3 pts had a significantly lower OS and greater odds of experiencing high-grade irAE than if ECOG PS 0/1. Development of irAE did not result in improved OS. Randomized trials to determine benefit of pembrolizumab for poor ECOG PS pts are needed., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Biomedical science is usually framed for the public in terms of its "promise." When a breakthrough results from scientific inquiry, that promise is translated into a hope for a cure. The "promise" of such advances in biomedical research can have a paradoxical effect. In the case of pediatric neuromuscular disease, rather than reducing suffering, the expectation of cure can be a burden-both physically and emotionally-for affected children and their families. If a family expects a cure, it is likely to do everything possible to help the child live as long as possible, in the hope that the child will eventually receive it. I am not arguing that the appropriate response to the paradox of promise is to impede scientific progress. What is needed, however, is a broader conception of hope-one that values hope for a good day, a good quality of life, good relationships, or even a good death-alongside the hope for a cure., (© 2019 The Hastings Center.)

Introduction: The programmed death 1 antibodies (PD-1 Ab) nivolumab and pembrolizumab improve overall survival (OS) in advanced non-small-cell lung cancer (NSCLC). We evaluated the correlation between immune-related adverse events (irAE) and treatment interruption due to irAE on clinical efficacy of PD-1 Ab in advanced NSCLC., Patients and Methods: Advanced NSCLC patients treated with PD-1 Ab between June 2015 to November 2017 at BC Cancer were identified. Demographic, tumor, treatment details, and frequency and grade (Common Terminology Criteria for Adverse Events, version 4.0) of irAE were abstracted from chart review. Kaplan-Meier curves of OS from initiation of PD-1 Ab were generated. Multivariable analysis with 6- and 12-week landmark analysis was performed by Cox proportional hazard regression models., Results: In a cohort of 271 patients, irAEs were observed in 116 patients (42.8%). Nivolumab recipients developing colitis had lower OS compared to those who did not at the 6-week landmark (P = .010) and 12-week landmark (P = .072). For the entire cohort, 56 patients (20.7%) needed treatment interruption because of an irAE. Treatment interruption correlated with lower OS at the 6-week landmark (P = .005) and 12-week landmark (P = .008). Six-week landmark multivariable analysis identified Charlson Comorbidity Index score of 3 or higher, Eastern Cooperative Oncology Group Performance Status of 2 or higher, presence of liver metastases, and irAE greater than grade 2 versus no irAE to be associated with decreased OS (each P < .05)., Conclusion: Treatment interruption due to irAE was associated with a lower median OS compared to continuous PD-1 Ab therapy. Shorter OS seen with severe irAE might reflect the need for improved physician education in irAE treatment algorithms., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Personal genetic information (PGI) about HIV is produced in research and entering the clinic and direct-to-consumer market, but little consideration has been given to ethical and social issues, public perspectives, and potential behavioral implications., Objectives: This research queried the views of research participants at risk for or infected with HIV, exploring their perspectives on HIV-related PGI and its ethical, social, and behavioral implications., Methods: We used focus groups to collect rich information about participants' perspectives on the ethical, social, and behavioral implications of PGI about HIV and host genetic research. We evaluated their reactions to three different types of genetic variants: those that made them more susceptible to HIV, more protected from or resistant to HIV, or more likely to transmit HIV to others., Results: Overall, participants wanted PGI about HIV. Their reasons included a mix of personal or family health benefit and benefit to others, which varied in emphasis depending on variant type. While susceptibility variant information was seen primarily in terms of personal or family health benefit, for transmissibility and protective variant information, benefit to others emerged as a major reason for wanting PGI about HIV. Participants thought transmissibility variant information would help them prevent others from becoming infected, and protective variant information would allow them to volunteer for targeted research to help treat, cure, or prevent HIV. Possible harms were raised regarding the tendencies among some individuals to increase risky behavior with modulations in perceived risk. Potential behavioral implications were seen as significant, though complex, reflecting multifaceted risk perceptions., Conclusions: Our study adds to the evidence that participants in genetic research, across disease type, have a strong desire for PGI. For participants in research on the genetics of HIV, and potentially other infectious diseases, their desire for PGI is grounded in a perceived duty not to infect others, where they feel a moral responsibility regarding research participation and behavior change. Wider dissemination of HIV-related PGI may well increase research participation, but could have mixed effects on risk behavior. More research is needed on the implications of different variant types of PGI beyond susceptibility factors, especially protective variants or resistance factors., (© 2019 S. Karger AG, Basel.)

Phylogenetic analysis of pathogens is an increasingly powerful way to reduce the spread of epidemics, including HIV. As a result, phylogenetic approaches are becoming embedded in public health and research programmes, as well as outbreak responses, presenting unique ethical, legal, and social issues that are not adequately addressed by existing bioethics literature. We formed a multidisciplinary working group to explore the ethical issues arising from the design of, conduct in, and use of results from HIV phylogenetic studies, and to propose recommendations to minimise the associated risks to both individuals and groups. We identified eight key ethical domains, within which we highlighted factors that make HIV phylogenetic research unique. In this Review, we endeavoured to provide a framework to assist researchers, public health practitioners, and funding institutions to ensure that HIV phylogenetic studies are designed, done, and disseminated in an ethical manner. Our conclusions also have broader relevance for pathogen phylogenetics., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Context: Negative bias toward patients with obesity is an ethical challenge in patient care. Several interventions to mitigate medical students' negative weight bias have been tried but none with an explicit focus on ethics. Here we describe first-year medical students' attitudes toward obesity and our effort to improve their attitudes through an innovative ethics session embedded within the required course, "Obesity, Nutrition, and Behavior Change," at Johns Hopkins University School of Medicine., Methods: Precourse survey data were collected from 6 first-year cohorts (2012-2017). Before the ethics session, students take the Implicit Association Test (IAT) to measure implicit weight bias. During the session, students discuss their classmates' personal struggles with weight, beliefs about causes of obesity, and the IAT results. They also watch and discuss video clips from the TV show House depicting negative weight bias. In addition, the 2017 cohort was surveyed 4 months later to evaluate the impact of different components of the session on students' self-reported attitudes., Results: All students responded to the precourse survey. Across cohorts, IAT results revealed that 70% of students held a thin preference, 18% were neutral and 12% held a fat preference. Forty-seven percent had personally struggled with weight loss. While most students thought obesity is a disease (89%) or behavioral (88%), 74% thought it results from ignorance, and 28% thought people with obesity are lazy. Among the 59 respondents to the follow-up survey, 30% reported improvement in their attitudes after the session. Over 40% thought it was useful to discuss students' personal struggles with weight and the IAT and survey results, and over 70% thought the House video clips were useful., Conclusions: Medical students have negative attitudes about obesity that are consistent over time. Providing opportunities for students to discuss their personal experiences and beliefs about obesity within an ethics framework and using popular media as a basis for discussion might improve their attitudes toward obesity., (© 2018 American Medical Association. All Rights Reserved.)

Objective: In this article, the authors characterize the different ways patients and clinicians discuss complementary and alternative medicine (CAM) during routine cancer care., Methods: Over a period of two years, the authors audio-recorded clinical interactions between 37 medical oncology clinicians and a sample of 327 oncology patients at an academic cancer center in the Midwest United States. Recordings of conversations that included any discussion of CAM were transcribed and analyzed using a qualitative content analysis approach., Results: Out of 327 conversations, CAM was mentioned and/or discussed in only 31 encounters. Communication dynamics between clinician and patient involve several factors: the condition of the patient and his or her knowledge about and experience with CAM, the clinician's knowledge and values about CAM, perceived assumptions and stereotypes about CAM, and institutional response to the integration of CAM in cancer care., Conclusion: Addressing the difficult and sensitive topic of CAM in cancer care requires hearing patients in a manner meaningful to them. In that sense, CAM can serve as an important marker and test case in the march toward shared decision-making and patient-centered communication generally.

Purpose: To validate a brief index of patient and family experiences of respect in the intensive care unit., Material and Methods: A survey including the 10-item ICU-RESPECT scale was administered to patients and family members in one ICU at a large west coast academic medical center. Confirmatory psychometric analyses were conducted., Results: Based on 142 completed surveys, factor analysis confirmed a unidimensional scale with an alpha of 0.90, an Eigen value of 4.9, and factor loadings from 0.50 to 0.86. The mean total score was 7.59 (SD = 3.06) out of a maximum of 10. Among the 106 surveys that included demographics, overall scores did not differ by type of respondent (patient or family) or by gender. There were modest differences in overall scores by patient race. Two individual items differed by type of respondent., Conclusions: The ICU-RESPECT index demonstrates reliability and concurrent validity in a different ICU setting from the one where the index was developed. Future research should assess the scale's predictive validity, and factors associated with variation in scores. As hospitals address patient experience more broadly in response to national metrics, the index could identify particular behaviors or ICUs that would benefit from interventions to enhance respectful treatment., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Although "respect" and "dignity" are intuitive concepts, little formal work has addressed their systematic application in the ICU setting. After convening a multidisciplinary group of relevant experts, we undertook a review of relevant literature and collaborative discussions focused on the practice of respect in the ICU. We report the output of this process, including a summary of current knowledge, a conceptual framework, and a research program for understanding and improving the practice of respect and dignity in the ICU. We separate our report into findings and proposals. Findings include the following: 1) dignity and respect are interrelated; 2) ICU patients and families are vulnerable to disrespect; 3) violations of respect and dignity appear to be common in the ICU and overlap substantially with dehumanization; 4) disrespect may be associated with both primary and secondary harms; and 5) systemic barriers complicate understanding and the reliable practice of respect in the ICU. Proposals include: 1) initiating and/or expanding a field of research on the practice of respect in the ICU; 2) treating "failures of respect" as analogous to patient safety events and using existing quality and safety mechanisms for improvement; and 3) identifying both benefits and potential unintended consequences of efforts to improve the practice of respect. Respect and dignity are important considerations in the ICU, even as substantial additional research remains to be done.

Objectives: To develop a valid, reliable measure that reflected the environment of respectfulness within the ICU setting., Design: We developed a preliminary survey instrument based on conceptual domains of respect identified through prior qualitative analyses of ICU patient, family member, and clinician perspectives. The initial instrument consisted of 21 items. After five cognitive interviews and 16 pilot surveys, we revised the instrument to include 23 items. We used standard psychometric methods to analyze the instrument., Settings: Eight ICUs serving adult patients affiliated with a large university health system., Subjects: ICU clinicians., Interventions: None., Measurements and Main Results: Based on 249 responses, we identified three factors and created subscales: General Respect, Respectful Behaviors, and Disrespectful Behaviors. The General Respect subscale had seven items (α = 0.932) and reflected how often patients in the ICU are treated with respect, in a dignified manner, as an individual, equally to all other patients, on the "same level" as the ICU team, as a person, and as you yourself would want to be treated. The Respectful Behaviors subscale had 10 items (α = 0.926) and reflected how often the ICU team responds to patient and/or family anxiety, makes an effort to get to know the patient and family as people, listens carefully, explains things thoroughly, gives the opportunity to provide input into care, protects patient modesty, greets when entering room, and talks to sedated patients. The subscale measuring disrespect has four items (α = 0.702) and reflects how often the ICU team dismisses family concerns, talks down to patients and families, speaks disrespectfully behind their backs, and gets frustrated with patients and families., Conclusions: We created a reliable set of scales to measure the climate of respectfulness in intensive care settings. These measures can be used for ongoing quality improvement that aim to enhance the experience of ICU patients and their families.

History has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a prime example, we focus on vitamin D research. We aim to provide an overview of the ethical issues in placebo-controlled studies and guide future discussion about the ethical use of placebo groups. Research in the field of vitamin D shows variation in how placebo groups are used. We outline four types of control groups in use: active-control, placebo-control with restrictions on supplementation, placebo-control without supplementation restrictions, and placebo-control with rescue repletion therapy. The first two types highlight discrete ethical issues: active-control trials limit the ability to detect a difference; placebo-control trials that restrict supplementation potentially place subjects at risk of undue harm. The final two, placebo-control without supplementation restrictions or with rescue repletion therapy, offer potential solutions to these ethical challenges. Building on this, guidelines should be established and enforced on the use of placebo in supplementation studies. Furthermore, the field of vitamin D research has the potential to set an example worthy of emulation., Competing Interests: The authors declare no conflict of interest.

Background: Medullary thyroid carcinoma (MTC) accounts for 1-2% of all thyroid cancers. The clinical course of metastatic disease can be indolent. Our aim was to characterize the natural history of disease to evaluate the true proportion of patients who would be eligible for the currently available systemic therapies., Methods: The British Columbia Cancer Agency (BCCA) provides cancer care to a population of 4.6 million. A retrospective chart review was conducted of all patients with MTC referred to the BCCA from 1991 to 2013. Clinical characteristics, pathology, treatment and outcome data were collected. Relapse free survival and overall survival was determined for patients based on staging at the time of diagnosis., Results: Of the 98 patients referred to the BCCA during the study period, inherited mutations were found in 6% though 60% did not undergo genetic testing. Based on clinical SEER staging at diagnosis 50% had localized disease, 38% regional, and 12% had distant metastasis. 77% had complete surgical resection of which 25% received adjuvant radiation therapy. Five year relapse free survival (RFS) for localized and regional disease was 75% and 66%, respectively ( p  = 0.006). Initial treatment of 23 patients with locally unresectable and metastatic disease predominantly involved multiple modalities. Of the 37 patients with relapsed or metastatic MTC only 7 (19%) patients received one or more course of chemotherapy for metastatic disease: 1 temsirolimus, 2 adriamycin, 3 sunitinib, 3 sorafenib, and 3 vandetanib. Five year OS based on clinical SEER stage: localized 93%, regional 72% and distant 33% ( p  < 0.001)., Conclusion: Localized and regional MTC treatment patterns reflect multidisciplinary management based on disease characteristics. Patients with distant disease had poor outcomes with 28% of patients dying from disease. In our cohort the minority of patients ultimately received systemic therapy due to timing and lack of TKI availability.

When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.

Background: Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering., Methods: hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated., Results: On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold., Conclusions: Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration., (Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Objective: Treating patients and family members with respect and dignity is a core objective of health care, yet it is unclear how best to measure this in the ICU setting. Accordingly, we sought to create a direct observation checklist to assess the "respect and dignity status" of an ICU., Design: A draft checklist based on previous work was iteratively revised to enhance accuracy and feasibility., Setting: Seven ICUs within the Johns Hopkins Health System., Subjects: A total of 351 patient-clinician encounters with 184 different patients., Interventions: Four study team members pilot tested the checklist between January and August 2015., Measurements and Main Results: Standard psychometric analyses were performed. The direct observation checklist exhibits strong content and face validity as well as high reliability and internal consistency. All items load on one factor that supports the unidimensionality of the total index. Furthermore, concurrent validity of the direct observation checklist is demonstrated by statistically significant differences in mean scores between ICUs, between types of clinicians, and between patients' clinical status and mood., Conclusions: We rigorously developed, pilot tested, and analyzed a direct observation checklist designed to assess the extent to which patients and families in the ICU setting are treated with respect and dignity. Future research should validate this checklist in other settings and compare its results with other measures. Data gathered about individual items on the direct observation checklist could be used to target areas for training and education; doing so should help facilitate more respectful treatment of patients and their families.

Information about wetland dynamics remains a major missing gap in characterizing, understanding, and projecting changes in atmospheric methane and terrestrial water storage. A review of current satellite methods to delineate and monitor wetland change shows some recent advances, but much improved sensing technologies are still needed for wetland mapping, not only to provide more accurate global inventories but also to examine changes spanning multiple decades. Global Navigation Satellite Systems Reflectometry (GNSS-R) signatures from aircraft over the Ebro River Delta in Spain and satellite measurements over the Mississippi River and adjacent watersheds demonstrate that inundated wetlands can be identified under different vegetation conditions including a dense rice canopy and a thick forest with tall trees, where optical sensors and monostatic radars provide limited capabilities. Advantages as well as constraints of GNSS-R are presented, and the synergy with various satellite observations are considered to achieve a breakthrough capability for multidecadal wetland dynamics monitoring with frequent global coverage at multiple spatial and temporal scales.

Purpose: The purpose of the study is to develop a brief index of patient and family experiences of respect in the intensive care unit (ICU)., Materials and Methods: We designed a questionnaire with 44 items representing 12 themes that emerged from prior in-depth interviews with ICU patients and families. After pilot testing, items with minimal variability were eliminated. The resulting 21-item questionnaire was administered to patients and families in 5 adult ICUs. Psychometric analyses were conducted., Results: Fifty-seven questionnaires were completed. Factor analysis resulted in a unidimensional scale consisting of 10 items with an α of .85 and an Eigen value of 11.3. Factor loadings ranged from 0.54 to 0.84, and item-test correlations ranged from 0.47 to 0.71. The mean total score was 7.25 out of a maximum of 10. Scores were lower for surgical than medical or disease-specific ICUs., Conclusions: The "ICU-RESPECT" index demonstrates high reliability and concurrent validity in ICU patients and families. Future research should validate this index in other ICU settings, assess its predictive validity, and evaluate different methods for maximizing response rate. As hospitals address patient experience more broadly in response to national metrics, the index could identify particular behaviors or ICUs that would benefit from interventions to enhance respectful treatment., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Inhibitors of the programmed cell death 1 (PD-1) signaling axis have recently demonstrated efficacy and are rapidly being incorporated into the treatment of non-small cell lung cancers (NSCLCs). Despite clear benefits to certain patients, the association of these responses with a predictive biomarker remains uncertain. Several different biomarkers have been proposed, with differing results and conclusions. This study compares multiple methods of biomarker testing for treatment of NSCLCs with PD1-axis inhibitors. Tissue microarrays of matched primary and metastatic NSCLCs were used to compare four different PD-1 ligand (PD-L1) IHC techniques, as well as RNA ISH. Additional cases with whole genome and transcriptome data were assessed for molecular correlates of PD-L1 overexpression. Eighty cases were included in the IHC study. Multiple IHC methodologies showed a high rate of agreement (Kappa = 0.67). When calibrated to RNA expression, agreement improved significantly (Kappa = 0.90, p=0.0049). PD-L1 status of primary and metastatic tumors was discordant in 17 (22%) cases. This study suggests that different IHC methodologies for PD-L1 assessment provide slightly different results. There is significant discordance between the PD-L1 status of primary tumors and lymph node metastases. RNA ISH may be a useful adjunct to complement PD-L1 IHC testing., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2016 The Histochemical Society.)

Objective: Cancer patients use complementary and alternative medicine (CAM), but do not routinely talk about it with their clinicians. This study describes CAM discussions in oncology visits, the communication patterns that facilitate these discussions and their association with visit satisfaction., Methods: 327 patients (58% female; average age 61) and 37 clinicians were recorded during an oncology visit and completed post-visit questionnaires. All CAM discussions were tagged and the Roter Interaction Analysis System (RIAS) was used to code visit dialogue., Results: CAM was discussed in 36 of 327 visits; discussions were brief (

Background: Although strong relationships between primary care providers (PCPs) and patients with addictive disease are essential for care, these relationships are often strained. Providers frequently have negative attitudes about treating these patients, in part due to the practical and psychosocial challenges that come with addictive disease. Resulting hostility frequently causes avoidance of primary care by patients with potentially increased morbidity. However, gaining knowledge of patient perspectives on these relationships could improve physician attitudes toward patients with addictive disease and relatedly improve care., Methods: The authors conducted 18 semistructured interviews of patients with current or prior debilitating addictive disease recruited from a primary care practice in East Baltimore. Interview transcripts were analyzed using editing analysis to reveal major themes., Results: Participants elucidated several provider characteristics that were essential for successful relationships. Providers needed to be knowledgeable about addiction, feel responsible for treating these patients, emphasize overall health, and engage patients in their own care. Additionally, participants strongly desired providers who treated them as "people" that they cared about. Interestingly, interviewees also frequently cited patient characteristics that could affect the strength of patient-provider relationships. These included being concerned about their health, feeling deserving of care, and having appropriate psychiatric care for concomitant mental health conditions. Practical obstacles and a disorganized mindset impeded patient-provider relationships., Conclusions: The interpersonal dynamics of the patient-provider relationship are particularly important for patients with addictive disease, as this relationship may be one of the most stable and rewarding in their lives. Patients felt that greater understanding of the practical and psychosocial challenges of addiction enabled providers to more effectively address their health concerns and to be more caring and less judgmental. It is hoped that this work will contribute to providers' understanding of patients with addictions, thus allowing them to form stronger relationships and ultimately provide better care.

Background: Shared decision making is promoted to improve cancer care quality. Patients and clinicians may have different ideas about what constitutes a cancer care decision, which may limit the validity of self-reported measures of shared decision making. We sought to estimate the extent to which patients and clinicians agree on whether a cancer care decision was made during an outpatient encounter., Methods: We surveyed patients and clinicians immediately after an oncology encounter at a large, tertiary medical centre and calculated agreement in response to the single-item question, 'Was a specific decision about cancer care made during the appointment today?' Answer options were 'yes' and 'no'. Participants were 315 oncology patients, with any solid tumour malignancy and at any stage of management, and their clinicians (22 staff oncologists, nine senior fellows and five nurse practitioners)., Results: Patients and clinicians reported having made a cancer care decision in 184 (58%) and 174 (55%) of encounters, respectively. They agreed on whether a cancer care decision was made in 213 (68%) of encounters (chance-adjusted agreement was 0.34); in 56 of the 102 discordant encounters, the patient reported making a decision while the clinician did not. We found no significant correlates with discordance., Conclusions: Patients and clinicians do not always agree on whether a cancer care decision was made. As such, measures that ask patients and/or clinicians to evaluate a decision-making process or outcome may be methodologically insufficient when they do not explicitly orient respondents towards the thing they are being asked to assess., (© 2015 John Wiley & Sons Ltd.)

It is simple enough to claim that academic research institutions ought to be trustworthy. Building the culture and taking the steps necessary to earn and preserve institutional trust are, however, complex processes. The experience motivating this special report--a request for the Center for Talented Youth at Johns Hopkins University to collaborate on research regarding the genetics of intelligence--illustrates how ensuring institutional trustworthiness can be in tension with a commitment to fostering research. In this essay, we explore the historical context for biomedical research institutions like Johns Hopkins that have worked to build local community trust. In so doing, we consider how the example under focus in this special report can lead to greater consideration of how research institutions balance fostering trust with their other commitments., (© 2015 The Hastings Center.)

Caring for critically ill and dying patients often triggers both professional and personal growth for physician trainees. In pediatrics, the neonatal intensive care unit (NICU) is among the most distressing settings for trainees. We used longitudinal narrative writing to gain insight into how physician trainees are challenged by and make sense of repetitive, ongoing conflicts experienced as part of caring for very sick and dying babies. The study took place in a 45-bed, university-based NICU in an urban setting in the United States. From November 2009 to June 2010 we enrolled pediatric residents and neonatology fellows at the beginning of their NICU rotations. Participants were asked to engage in individual, longitudinal narrative writing about their "experience in the NICU." Thematic narrative analysis was performed. Thirty-seven physician trainees participated in the study. The mean number of narratives per trainee was 12; a total of 441 narratives were available for analysis. Conflict was the most pervasive theme in the narratives. Trainees experienced conflicts with families and conflicts with other clinicians. Trainees also described multiple conflicts of identity as members of the neonatology team, as members of the medical profession, as members of their own families, and as members of society. Physician trainees experience significant conflict and distress while learning to care for critically ill and dying infants. These conflicts often led them to question their own morals and their role in the medical profession. Physician trainees should be educated to expect various types of distress during intensive care rotations, encouraged to identify their own sources of distress, and supported in mitigating their effects.

Objective: To test the effect of 1 high-intensity, and 1 reduced-intensity, educational intervention designed to improve health care provider attitudes toward youth with sickle cell disease (SCD)., Methods: We exposed a regional sample of pediatric health care providers to a 2.5-day high-intensity educational and experiential intervention using videos about the SCD patient experience. Additionally, we traveled to a different set of regional health care institutions and offered pediatric providers a reduced-intensity intervention, consisting of a 90-minute lunchtime in-service centered on our same set of videos about the patient's experience. We assessed the impact of both interventions by taking pre/post measurements of the negative and positive attitudes expressed by participating providers toward patients with SCD., Results: Both interventions tested elicited improvements in the SCD attitudes expressed by the pediatric providers as suggested through a reduction in measured negative attitude scores (20.0 vs 12.1, P < .001), and an improvement in positive attitude scores (67.1 vs 72.2, P < .001). Further testing suggested that the high-intensity intervention elicited a stronger effect than the reduced-intensity intervention across multiple attitudinal domains., Conclusions: Video-based interventions can be used to improve the attitudes of pediatric providers toward patients with SCD. The availability of interventions of varying intensities provides greater flexibility in designing efforts to advance the quality of SCD care through the improvement of provider attitudes., (Copyright © 2015 by the American Academy of Pediatrics.)