Cultivating the Human Dimension in Research.

According to "Research Exemplars," research requires attending to matters of heart as much as mind. The human dimension in research-relationships, passion, resilience, and leadership-was the common thread in their advice for a successful career. We discuss strategies to cultivate intra- and inter-personal skills fostering these aspects of research.

Providing Adolescents with Access to Online Patient Portals: Interviews with Parent-Adolescent Dyads.

OBJECTIVE: To identify perceived benefits, problems, facilitators, and barriers to adolescent online patient portal use. STUDY DESIGN: Qualitative, semi-structured interviews with dyads of parents and adolescents with or without chronic illness. The study team purposively sampled for racial and ethnic minorities and fathers. Three team members then performed thematic analysis of the transcripts, with subsequent dyadic analysis of themes represented by related parents and adolescents. RESULTS: We performed 102 interviews with 51 dyads of parents and adolescents (26 with chronic illness, 25 without chronic illness). Nearly all participants believed that adolescents should be permitted portal access. We identified 4 themes related to portal benefits: improves adolescent's knowledge of health; supports medical self-management and autonomy; strengthens communication and relationships; and supports parental influence. We identified 4 themes related to portal problems: misunderstanding or confusion; emotional distress; strain on relationships; and irresponsible use of portal. Facilitators of portal use included severity of illness, adolescent's curiosity, and ease of technology use. Barriers included lack of awareness or interest, complexity of information, and access difficulties. Twenty adolescents (39%) did not know they could access the portal, and 23 (45%) lacked interest in portals. Parents and adolescents seldom used the portal as a collaborative tool, and instead were engaging with the portal independently. CONCLUSION: Parents and adolescents perceive several benefits and problems with portal use, but many adolescents lack interest in using portals. Adolescent portals represent an underutilized resource to engage adolescents in their care.

Principal Investigators' Priorities and Perceived Barriers and Facilitators When Making Decisions About Conducting Essential Research in the COVID-19 Pandemic.

At the onset of the COVID-19 pandemic in the United States, stay-at-home orders disrupted normal research operations. Principal investigators (PIs) had to make decisions about conducting and staffing essential research under unprecedented, rapidly changing conditions. These decisions also had to be made amid other substantial work and life stressors, like pressures to be productive and staying healthy. Using survey methods, we asked PIs funded by the National Institutes of Health and the National Science Foundation (N = 930) to rate how they prioritized different considerations, such as personal risks, risks to research personnel, and career consequences, when making decisions. They also reported how difficult they found these choices and associated symptoms of stress. Using a checklist, PIs indicated those factors in their research environments that made their decisions easier (i.e., facilitators) or more difficult (i.e., barriers) to make. Finally, PIs also indicated how satisfied they were with their decisions and management of research during the disruption. Descriptive statistics summarize PIs' responses and inferential tests explore whether responses varied by academic rank or gender. PIs overall reported prioritizing the well-being and perspectives of research personnel, and they perceived more facilitators than barriers. Early-career faculty, however, rated concerns about their careers and productivity as higher priorities compared to their senior counterparts. Early-career faculty also perceived greater difficulty and stress, more barriers, fewer facilitators, and had less satisfaction with their decisions. Women rated several interpersonal concerns about their research personnel more highly than men and reported greater stress. The experience and perceptions of researchers during the COVID-19 pandemic can inform policies and practices when planning for future crises and recovering from the pandemic.

Multilevel barriers and facilitators of communication in pediatric oncology: A systematic review.

Multiple factors can facilitate or impede the fulfillment of communication functions in pediatric cancer. In this systematic review, we evaluated 109 studies from the preceding 20 years that presented qualitative or quantitative evidence of barriers or facilitators to communication in pediatric cancer. Using a multilevel framework developed in our prior study, we then analyzed and categorized the levels of barriers and facilitators identified in included studies. The vast majority of studies focused on individual-level barriers, rather than team, organization/system, collaborating hospital, community, or policy-level barriers. Future studies should explore the full range of factors that affect communication.

Enabling Hotspot Detection and Public Health Response to the COVID-19 Pandemic.

INTRODUCTION: Public-facing maps of COVID-19 cases, hospital admissions, and deaths are commonly displayed at the state, county, and zip code levels, and low case counts are suppressed to protect confidentiality. Public health authorities are tasked with case identification, contact tracing, and canvasing for educational purposes during a pandemic. Given limited resources, authorities would benefit from the ability to tailor their efforts to a particular neighborhood or congregate living facility. METHODS: We describe the methods of building a real-time visualization of patients with COVID-19-positive tests, which facilitates timely public health response to the pandemic. We developed an interactive street-level visualization that shows new cases developing over time and resolving after 14 days of infection. Our source data included patient demographics (ie, age, race and ethnicity, and sex), street address of residence, respiratory test results, and date of test. RESULTS: We used colored dots to represent infections. The resulting animation shows where new cases developed in the region and how patterns changed over the course of the pandemic. Users can enlarge specific areas of the map and see street-level detail on residential location of each case and can select from demographic overlays and contour mapping options to see high-level patterns and associations with demographics and chronic disease prevalence as they emerge. CONCLUSIONS: Before the development of this tool, local public health departments in our region did not have a means to map cases of disease to the street level and gain real-time insights into the underlying population where hotspots had developed. For privacy reasons, this tool is password-protected and not available to the public. We expect this tool to prove useful to public health departments as they navigate not only COVID-19 pandemic outcomes but also other public health threats, including chronic diseases and communicable disease outbreaks.

Exploring perceptions of healthcare technologies enabled by artificial intelligence: an online, scenario-based survey.

BACKGROUND: Healthcare is expected to increasingly integrate technologies enabled by artificial intelligence (AI) into patient care. Understanding perceptions of these tools is essential to successful development and adoption. This exploratory study gauged participants' level of openness, concern, and perceived benefit associated with AI-driven healthcare technologies. We also explored socio-demographic, health-related, and psychosocial correlates of these perceptions. METHODS: We developed a measure depicting six AI-driven technologies that either diagnose, predict, or suggest treatment. We administered the measure via an online survey to adults (N = 936) in the United States using MTurk, a crowdsourcing platform. Participants indicated their level of openness to using the AI technology in the healthcare scenario. Items reflecting potential concerns and benefits associated with each technology accompanied the scenarios. Participants rated the extent that the statements of concerns and benefits influenced their perception of favorability toward the technology. Participants completed measures of socio-demographics, health variables, and psychosocial variables such as trust in the healthcare system and trust in technology. Exploratory and confirmatory factor analyses of the concern and benefit items identified two factors representing overall level of concern and perceived benefit. Descriptive analyses examined levels of openness, concern, and perceived benefit. Correlational analyses explored associations of socio-demographic, health, and psychosocial variables with openness, concern, and benefit scores while multivariable regression models examined these relationships concurrently. RESULTS: Participants were moderately open to AI-driven healthcare technologies (M = 3.1/5.0 ± 0.9), but there was variation depending on the type of application, and the statements of concerns and benefits swayed views. Trust in the healthcare system and trust in technology were the strongest, most consistent correlates of openness, concern, and perceived benefit. Most other socio-demographic, health-related, and psychosocial variables were less strongly, or not, associated, but multivariable models indicated some personality characteristics (e.g., conscientiousness and agreeableness) and socio-demographics (e.g., full-time employment, age, sex, and race) were modestly related to perceptions. CONCLUSIONS: Participants' openness appears tenuous, suggesting early promotion strategies and experiences with novel AI technologies may strongly influence views, especially if implementation of AI technologies increases or undermines trust. The exploratory nature of these findings warrants additional research.

Applying the Delphi Method to Define a Focus for the National Outcomes Registry for Tracking the Hand (NORTH).

Surgical registries have provided reliable, generalizable, and applicable clinical data that have shaped many fields. Broad collection of defined data can answer clinical questions with greater numbers of patients and more ability to generalize to routine clinical care than randomized trials. National hand surgical registries exist outside the United States. Before the pursuit of a registry, the focus of such an effort must be defined to ensure that registry goals are feasible. This article presents the consensus process conducted by the American Society for Surgery of the Hand's Registry Task Force exploring potential diagnoses for a hand registry.

Navigating Complex, Ethical Problems in Professional Life: a Guide to Teaching SMART Strategies for Decision-Making.

This article demonstrates how instructors of professionalism and ethics training programs can integrate a professional decision-making tool in training curricula. This tool can help trainees understand how to apply professional decision-making strategies to address the threats posed by a variety of psychological and environmental factors when they are faced with complex professional and ethical situations. We begin by highlighting key decision-making frameworks and discussing factors that may undermine the use of professional decision-making strategies. Then, drawing upon findings from past research, we present the "SMART" professional decision-making framework: seeking help, managing emotions, anticipating consequences, recognizing rules and context, and testing assumptions and motives. Next, we present a vignette that poses a complex ethical and professional challenge and illustrate how each professional decision-making strategy could or should be used by characters in the case. To conclude, we review a series of educational practices and pedagogical tools intended to help trainers facilitate trainee learning, retention, and application of "SMART" decision-making strategies.

How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge.

BACKGROUND: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health-funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. METHODS: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal-numerical reasoning and learning orientation. RESULTS: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). CONCLUSION: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.

The "Ought-Is" Problem: An Implementation Science Framework for Translating Ethical Norms Into Practice.

We argue that once a normative claim is developed, there is an imperative to effect changes based on this norm. As such, ethicists should adopt an "implementation mindset" when formulating norms, and collaborate with others who have the expertise needed to implement policies and practices. To guide this translation of norms into practice, we propose a framework that incorporates implementation science into ethics. Implementation science is a discipline dedicated to supporting the sustained enactment of interventions. We further argue that implementation principles should be integrated into the development of specific normative claims as well as the enactment of these norms. Ethicists formulating a specific norm should consider whether that norm can feasibly be enacted because the resultant specific norm will directly affect the types of interventions subsequently developed. To inform this argument, we will describe the fundamental principles of implementation science, using informed consent to research participation as an illustration.

What Explains Associations of Researchers' Nation of Origin and Scores on a Measure of Professional Decision-Making? Exploring Key Variables and Interpretation of Scores.

Researchers encounter challenges that require making complex professional decisions. Strategies such as seeking help and anticipating consequences support decision-making in these situations. Existing evidence on a measure of professional decision-making in research (the PDR) that assesses the use of decision-making strategies revealed that NIH-funded researchers born outside of the U.S. tended to score below their U.S. counterparts. To examine potential explanations for this association, this study recruited 101 researchers born in the United States and 102 born internationally to complete the PDR and measures of basic personal values, values in scientific work, discrimination between the seriousness of rules in research, exposure to unprofessional research practices, and acculturation to American culture. Several variables were associated with PDR scores-discrimination between types of rules in research, exposure to unprofessional research practices, acculturation, and the basic personal values of power, security, and benevolence. However, only security, benevolence, acculturation, and rule discrimination were also associated with nation of origin. In multivariate models, the variance explained by these variables in accounting for the association of nation of origin and PDR scores was somewhat overlapping, thus, only security and benevolence remained as unique, statistically significant predictors. Thus, this study identified some important variables in the association of nation of origin and PDR, but more research is needed. In a secondary analysis to examine the "clinical significance" (the practical importance) of scores on the PDR, this study examined aggregated PDR score data from the present sample and past samples of investigators. This analysis identified scores that may suggest a concern versus those scores that may be interpreted as excellent, proficient, or marginal. Implications for training and mentoring, along with considerations for future research are discussed.

Development and Preliminary Validation of a New Measure of Values in Scientific Work.

In this paper we describe the development and initial psychometric evaluation of a new measure, the values in scientific work (VSW). This scale assesses the level of importance that investigators attach to different VSW. It taps a broad range of intrinsic, extrinsic, and social values that motivate the work of scientists, including values specific to scientific work (e.g., truth and integrity) and more classic work values (e.g., security and prestige) in the context of science. Notably, the values represented in this scale are relevant to scientists regardless of their career stage and research focus. We administered the VSW and a measure of global values to 203 NIH-funded investigators. Exploratory factor analyses suggest the delineation of eight VSW, including autonomy, research ethics, social impact, income, collaboration, innovation and growth, conserving relationships, and job security. These VSW showed predictable and distinct associations with global values. Implications of these findings for work on research integrity and scientific misconduct are discussed.

The Role of Culture and Acculturation in Researchers' Perceptions of Rules in Science.

Successfully navigating the norms of a society is a complex task that involves recognizing diverse kinds of rules as well as the relative weight attached to them. In the United States (U.S.), different kinds of rules-federal statutes and regulations, scientific norms, and professional ideals-guide the work of researchers. Penalties for violating these different kinds of rules and norms can range from the displeasure of peers to criminal sanctions. We proposed that it would be more difficult for researchers working in the U.S. who were born in other nations to distinguish the seriousness of violating rules across diverse domains. We administered a new measure, the evaluating rules in science task (ERST), to National Institutes of Health-funded investigators (101 born in the U.S. and 102 born outside of the U.S.). The ERST assessed perceptions of the seriousness of violating research regulations, norms, and ideals, and allowed us to calculate the degree to which researchers distinguished between the seriousness of each rule category. The ERST also assessed researchers' predictions of the seriousness that research integrity officers (RIOs) would assign to the rules. We compared researchers' predictions to the seriousness ratings of 112 RIOs working at U.S. research-intensive universities. U.S.-born researchers were significantly better at distinguishing between the seriousness of violating federal research regulations and violating ideals of science, and they were more accurate in their predictions of the views of RIOs. Acculturation to the U.S. moderated the effects of nationality on accuracy. We discuss the implications of these findings in terms of future research and education.

Professional Decision-Making in Research (PDR): The Validity of a New Measure.

In this paper, we report on the development and validity of the Professional Decision-Making in Research (PDR) measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability (alpha = .84) and parallel form correlation (r = .70). As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research.

Guiding Principles for Adolescent Web-Based Portal Access Policies: Interviews With Informatics Administrators.

BACKGROUND: Web-based patient portals are tools that could support adolescents in managing their health and developing autonomy. However, informatics administrators must navigate competing interests when developing portal access policies for adolescents and their parents. OBJECTIVE: We aimed to assess the perspectives of informatics administrators on guiding principles for the development of web-based health care portal access policies in adolescent health care. METHODS: We interviewed informatics administrators from US hospitals with ≥50 dedicated pediatric beds. We performed a thematic analysis of guiding principles for developing and implementing adolescent portal access policies. RESULTS: We interviewed 65 informatics leaders who represented 63 pediatric hospitals, 58 health care systems, 29 states, and 14,379 pediatric hospital beds. Participants described 9 guiding principles related to three overarching themes: (1) balancing confidentiality and other care needs, (2) balancing simplicity and granularity, and (3) collaborating and advocating. Participants described the central importance of prioritizing the health and safety of the adolescent while also complying with state and federal laws. However, there were differing beliefs about how to prioritize health and safety and what role parents should play in supporting the adolescent's health care. Participants also identified areas where clinicians and institutions can advocate for adolescents, especially with electronic health record vendors and legislators. CONCLUSIONS: Informatics administrators provided guiding principles for adolescent portal access policies that aimed to balance the competing needs of adolescent confidentiality and the usefulness of the portal. Portal access policies must prioritize the adolescent's health and safety while complying with state and federal laws. However, institutions must determine how to best enact these principles. Institutions and clinicians should strive for consensus on principles to strengthen advocacy efforts with institutional leadership, electronic health record vendors, and lawmakers.

Seeking help as a strategy for ethical and professional decision-making in research: Perspectives of researchers from East Asia and the United States.

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

Competition and Sensemaking in Ethical Situations.

Intra-organizational competition was examined in relation to ethicality. The effect of a competitor being an in-group versus and out-group member, competitor offering uncorroborated or corroborated information, and the impact of the competitor expressing selfish, pro-group, or pro-organizational level goals were examined. Findings suggest that the way competition is presented has an important influence on how well individuals are able to make sense of an ethically ambiguous situation and render an ethical decision. A main effect for information sharing was found, such that when a competitor offers uncorroborated information participants made less ethical decisions and used pro-ethical reasoning strategies less often. An additional main effect was found suggesting that participants made more ethical decisions when working with an in-group competitor rather than an out-group competitor. Complex interactive effects were also found and discussed suggesting that pro-ethical reasoning strategies may be used less often depending on information corroboration, the competitor's relative group membership status, and the motives expressed by the competitor.

Addressing serious and continuing research noncompliance and integrity violations through action plans: Interviews with institutional officials.

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

Challenges to Developing and Implementing Policies for Adolescent Online Portal Access.

BACKGROUND: After enactment of the 21st Century Cures Act, many health care systems offer adolescents and parents access to electronic health information through online portals. Few studies have evaluated adolescent portal access policies since the implementation of the Cures Act. METHODS: We performed structured interviews with informatics administrators in US hospitals with ≥50 dedicated pediatric beds. We performed thematic analysis of challenges to developing and implementing adolescent portal policies. RESULTS: We interviewed 65 informatics leaders representing 63 pediatric hospitals, 58 health care systems, 29 states, and 14 379 pediatric hospital beds. Most hospitals provided portal access to adolescents (86%) and parents (95%). Filtering of results sent to parental portals ranged widely, with 14% providing unfiltered access, 31% performing minimal filtering for sensitive information, and 43% offering limited access. Portal access policies also varied widely within states. Challenges to developing policies included legislation and compliance issues, tension between confidentiality and usefulness, clinicians' preferences and concerns, limited understanding and investment of institutions in pediatric issues, and limited focus of vendors on pediatric issues. Challenges to implementing policies included technical challenges, educating end-users, potential for parental coercion, harms of bad news, complex enrollment processes, and informatics workforce limitations. CONCLUSIONS: Adolescent portal access policies vary widely across and within states. Informatics administrators identified multiple challenges related to developing and implementing adolescent portal policies. Future efforts should strive to develop intrastate consensus on portal policies and to engage parents and adolescent patients to better understand preferences and needs.

Engaging Adolescents in Using Online Patient Portals.

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