A global pilot comparative, cross-sectional study of clinical research nurses/research midwives: Definition, knowledge base, and communication skills related to the conduct of decentralized clinical trials.

Background: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research: the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries: The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes: (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.

Working From Within: The Rural Community Participatory Design Framework.

OBJECTIVE: This article describes the development of the rural community-based participatory design framework to guide healthcare design teams in their integration of rural community and clinical voice during the planning, design, and construction of a healthcare facility. BACKGROUND: Rural communities are facing an alarming rate of healthcare facility closures, provider shortages, and dwindling resources, which are negatively impacting population health outcomes. A prioritized focus on rural care access and delivery requires design teams to have a deeper understanding of the contextual considerations necessary for a successful healthcare facility project, made possible through engagement and partnership with rural dwelling community members and healthcare teams. METHOD: The rural community participatory design framework is adapted from the rural participatory research model, selected due to its capture of key concepts and characteristics of rural communities. Underpinning theories included rural nursing theory and theory of the built environment. RESULTS: The framework encompasses healthcare facility project phases, key translational concepts, and common traits across rural communities and cultures. As a middle-range theoretical framework, it is being tested in a current healthcare project with a Critical Access Hospital in Montana to facilitate design team and stakeholder collaboration. CONCLUSION: The rural community participatory design framework may be utilized by design teams as a means of familiarization with rural cultures, norms, values, and critical needs, which relate to meaningful design. The framework further enables design teams to critically appraise best practices of stakeholder engagement throughout the project lifecycle.

When to err is inhuman: An examination of the influence of artificial intelligence-driven nursing care on patient safety.

Artificial intelligence, as a nonhuman entity, is increasingly used to inform, direct, or supplant nursing care and clinical decision-making. The boundaries between human- and nonhuman-driven nursing care are blurred with the advent of sensors, wearables, camera devices, and humanoid robots at such an accelerated pace that the critical evaluation of its influence on patient safety has not been fully assessed. Since the pivotal release of To Err is Human, patient safety is being challenged by the dynamic healthcare environment like never before, with nursing at a critical juncture to steer the course of artificial intelligence integration in clinical decision-making. This paper presents an overview of artificial intelligence and its application in healthcare and highlights the implications which affect nursing as a profession, including perspectives on nursing education and training recommendations. The legal and policy challenges which emerge when artificial intelligence influences the risk of clinical errors and safety issues are discussed.

A mixed-methods pilot examination of Montana, North Dakota nurse practitioner telepresence behaviors through web-camera eye-tracking and qualitative descriptive interviews.

BACKGROUND: The use of telehealth for mental health-related encounters has increased exponentially since the COVID-19 pandemic. However, little is known how nurse practitioners (NPs) in rural areas establish connection and presence with patients through telehealth. PURPOSE: To leverage web-camera eye-tracking technology coupled with qualitative interviews to better understand rural NPs' perceptions, beliefs, experiences, and visual cues of connection and presence during mental health-related telehealth encounters. METHODS: This mixed-methods study employed web-camera eye-tracking technology to measure eye contact, facial/body movements with microexpressions, and auditory expressions during a simulated mental health-related telehealth visit. A qualitative descriptive methodology was used to conduct semistructured interviews with participants regarding utilization of telehealth in rural mental health care delivery. Sticky software, R, and STATA were used for the quantitative eye-tracking and demographic data analyses. Qualitative findings were analyzed using inductive thematic analysis. RESULTS: Ten NPs participated in the eye-tracking aspect of the study; among them, three completed semistructured interviews. Eye-tracking areas of interest were significant for the number of fixations (p = .005); number of visits (p < .001); time until notice (p < .001); and time viewed (p < .001). The category Workflow had the greatest number of thematic units (n = 21) derived from semistructured interviews. CONCLUSIONS: Although an accessible means of obtaining data, web-camera eye tracking poses challenges with data usability. This prompts further attention to research, optimizing the telehealth milieu to lessen patient and provider frustrations with technological or environmental issues. IMPLICATIONS: Nurse practitioners provide a key voice in the design and deployment of telehealth platforms congruent with the comprehensive assessment and presence of remote care delivery.

Predicting risk factors for pediatric mortality in clinical trial research: A retrospective, cross-sectional study using a Healthcare Cost and Utilization Project database.

Introduction: Incorporating real-world data using "big data" analysis in healthcare are useful to extract specific information for healthcare delivery system improvement. All-cause mortality is an essential measure to enhance patient safety in clinical trial research, especially for underrepresented pediatric participants. Objective: This study aimed to determine the associations between pediatric mortality and patient-specific factors using the Healthcare Cost and Utilization Project (HCUP) database. Methods: Data from the 2019 the HCUP Kids' Inpatient Database (KID) were used to conduct a logistic regression analysis to determine associations between pediatric patients' the chance of survival and their demographic and socioeconomic background, discharge records, and hospital information. Results: Total number of diagnoses (OR = 0.84), total number of procedures (OR = 0.86), length of stay (OR = 1.04), age intervals greater than 1 year (OR > 1.0), transfer into the hospital from a different acute care (OR = 0.34), major diagnoses of multiple significant trauma (OR = 0.03) or hepatobiliary system and pancreas (OR = 0.10), region of hospital - west and midwest (OR > 1.0), and medium or larger hospital bed size (OR > 1.0) were all significantly associated with the chance of survival for patients participating in pediatric clinical trials (p < 0.05). Conclusion: Real-world clinical trial data analysis showed the potential improvement area including reallocating trial resources to promote trial quality and safe participation for pediatric patients. Pediatric trials need tools that are developed using user-centered design approaches to satisfy the unique needs and requirements of pediatric patients and their caregivers. Safe intrahospital transfer procedures and active dissemination of successful trial best practices are crucial to trial management, adherence, quality, and safety.

Examining the Impact of Virtual Animal Stimuli on College Students' Affect and Perception of their Academic Advising Experience.

The benefits of animal-assisted interventions (AAI) involving animals in therapy are widely accepted. The presence of animals in therapy can decrease a patient's reservation about therapy and promote a sense of comfort and rapport during the therapy process. Using survey data from college students (n = 152) attending a large public four-year institution, this study is the first to investigate the benefits of virtual animal stimuli during academic advising appointments. It posits that exposure to virtual animal stimuli can influence positive mental health and well-being in academic advising settings. Specifically, the research questions explored how different types of video content influence students' affect and how virtual animal stimuli impact students' perception of their advisor and university. College students were randomly assigned to watch one of four types of virtual stimuli (wild animals, companion animals, nature, and a control) prior to their advising session. Subjective measures were collected at baseline and after the advising session. Results indicated animal stimuli increase positive affect, and companion animal stimuli influence the student's perception of the advisor. This study supports the notion that companion animal videos positively impact students' well-being and interactions with their advisors and may have broader implications beyond the academic setting.

Developing a Preclinical Nurse-Nurse Communication Framework for Clinical Trial Patient-Related Safety Information.

Clinical trial trials have become increasingly complex in their design and implementation. Investigational safety profiles are not easily accessed by clinical nurses and providers when trial participants present for clinical care, such as in emergency or urgent care. Wearable devices are now commonly used as bridging technologies to obtain participant data and house investigational product safety information. Clinical nurse identification and communication of safety information are critical to dissuade adverse events, patient injury, and trial withdrawal, which may occur when clinical care is misaligned to a research protocol. Based on a feasibility study and follow-up wearable device prototype study, this preclinical nurse-nurse communication framework guides clinical nurse verbal and nonverbal communication of safety-related trial information to direct patient care activities in the clinical setting. Communication and information theories are incorporated with Carrington's Nurse-to-Nurse Communication Framework to encompass key components of a clinical nurse's management of a trial participant safety event when a clinical trial wearable device is encountered during initial assessment. Use of the preclinical nurse-nurse communication framework may support clinical nurse awareness of trial-related wearable devices. The framework may further emphasize the importance of engaging with research nurses, patients, and caregivers to acquire trial safety details impacting clinical care decision-making.

Clinical Nurses' Identification of a Wearable Universal Serial Bus Used for Pediatric Oncology Clinical Trial Participant Safety Management.

The expanded access to clinical trials has provided more patients the opportunity to participate in novel therapeutics research. There is an increased likelihood of a patient, as a pediatric oncology clinical trial participant, to present for clinical care outside the research site, such as at an emergency room or urgent care center. A novel wearable universal serial bus device is a proposed technology to bridge potential communication gaps, pertaining to critical information such as side effects and permitted therapies, between research teams and clinical teams where investigational agents may be contraindicated to standard treatments. Fifty-five emergency and urgent care nurses across the United States were presented, via online survey without priming to the context of clinical trials or the device, a picture of a pediatric patient wearing the novel wearable device prompted to identify significant, environmental cues important for patient care. Of the 40 nurses observing the patient photo, three identified the wearable device within Situational Awareness Global Assessment Tool formatted narrative response fields. Analysis of the narrative nurse-participant responses of significant clinical findings upon initial assessment of the pediatric patient photo is described, as well as the implications for subsequent prototyping of the novel universal serial bus prototype.

Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials.

Introduction: Clinical research professionals (i.e., clinical research assistants, clinical research nurses, clinical research coordinators, etc.), as outlined by the Joint Task Force (JTF) Core Competency Framework, are highly trained to support the breadth of clinical trial operations and manage participant care. Clinical research professionals are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials grow in complexity and their management expands beyond traditional, site-based operations models to decentralized and/or hybrid models, the need becomes great to ensure adequate staffing. However, rural hospitals frequently lack the research staff or patient recruiters that would allow them to support decentralized clinical trials across a sizeable rural geographic demographic. Methods: This paper examines the contributory factors of the clinical research professional workforce contraction and response efforts at professional and organizational levels within a large, Magnet-designated healthcare system in the rural northwestern United States. Perspectives are shared on adapting the Core Competency Framework to reflect the unique strengths and opportunities towards decentralized trials in rural regions of the United States and areas of priority for workforce cultivation and retention. A descriptive survey was used to gather initial data identifying the current research perspectives of healthcare workers working across a rural community. Participants were asked to complete questions about the JTF Competency domains and behavior-based questions. Analysis: Both competency and behavior-based questions were asked and related to roles. These were then cross-referenced using a Rasmussen Ladder system. Descriptive statistics were conducted for sample characteristics, self-reported competency domain questions, and behavior questions. Results and discussion: Survey findings suggest that although healthcare workers and clinical research teams interact, they are unlikely to ask their patients to participate in research. Based on the limited response rate, results suggest that better education throughout the rural community could benefit from decentralized research efforts. Increased use of technology was also highlighted as an area of interest.

Exploring women's oxytocin responses to interactions with their pet cats.

BACKGROUND: Extensive research has evaluated the involvement of the neuropeptide oxytocin (OT) in human social behaviors, including parent-infant relationships. Studies have investigated OT's connection to human attachment to nonhuman animals, with the majority of the literature focusing on domestic dogs (Canis lupis familiaris). Utilizing what is known about OT and its role in maternal-infant and human-dog bonding, we apply these frameworks to the study of human-domestic cat (Felis catus) interactions. METHODS: We investigated changes in salivary OT levels in 30 U.S. women of reproductive age before and after two conditions: reading a book (control) and interacting with their pet cat. Participant and cat behavioral patterns during the cat interaction condition were also quantified to determine if differences in women's OT concentrations were associated with specific human and cat behaviors. RESULTS: Our results revealed no changes in women's OT levels during the cat interaction, relative to the control condition, and pre-cat interaction OT levels. However, differences in women's OT concentrations were correlated with some human-cat interactions (e.g., positively with petting cat and cat approach initiation, negatively with cat agonistic behavior) but not all observed behaviors (e.g., use of gentle or baby voice) coded during human-cat interactions. DISCUSSION: This study is the first to explore women's OT in response to interactions with their pet cat and has identified distinct human and cat behaviors that influence OT release in humans.

Characterizing Biology Education Research: Perspectives from Practitioners and Scholars in the Field.

Biology education research (BER) is a recently emerging field mainly focused on the learning and teaching of biology in postsecondary education. As BER continues to grow, exploring what goals, questions, and scholarship the field encompasses will provide an opportunity for the community to reflect on what new lines of inquiry could be pursued in the future. There have been top-down approaches at characterizing BER, such as aims and scope provided by professional societies or peer-reviewed journals, and literature analyses with evidence for current and historical research trends. However, there have not been previous attempts with a bottom-up approach at characterizing BER by directly surveying practitioners and scholars in the field. Here, we share survey results that asked participants at the Society for the Advancement of Biology Education Research (SABER) annual meeting what they perceive as current scholarship in BER as well as what areas of inquiry in the field that they would like to see pursued in the future. These survey responses provide us with information directly from BER practitioners and scholars, and we invite colleagues to reflect on how we can collectively and collaboratively continue to promote BER as a field.

Trial of a New Diabetes Education Model: Closing the Gap in Health Disparity for People with Diabetes.

BACKGROUND: Quality measures relating to diabetes care in America have not improved between 2005 and 2016, and have plateaued even in areas that outperform national statistics. New approaches to diabetes care and education are needed and are especially important in reaching populations with significant barriers to optimized care. METHODS: A pilot quality improvement study was created to optimize diabetes education in a clinic setting with a patient population with significant healthcare barriers. Certified Diabetes Care and Education Specialists (CDCES) were deployed in a team-based model with flexible scheduling and same-day education visits, outside of the traditional framework of diabetes education, specifically targeting practices with underperforming diabetes quality measures, in a clinic setting significantly impacted by social determinants of health. RESULTS: A team-based and flexible diabetes education model decreased hemoglobin A1C for individuals participating in the project (and having a second A1C measured) by an average of -2.3%, improved Minnesota Diabetes Quality Measures (D5) for clinicians participating in the project by 5.8%, optimized use of CDCES, and reduced a high visit fail rate for diabetes education. CONCLUSIONS: Diabetes education provided in a team-based and flexible model may better meet patient needs and improve diabetes care metrics, in settings with a patient population with significant barriers.

Clinical Research Integration Within the Electronic Health Record: A Literature Review.

Clinical trials have become commonplace as a treatment option. As clinical trial participants are integrated into all healthcare delivery settings, organizations are tasked with sustaining specific care regimens with appropriate documentation and maintenance of participant protections within electronic health records. Our aim was to identify the common elements necessary for electronic health record integration of clinical research for optimal trial conduct and participant management. Review of literature was conducted utilizing PubMed and CINAHL to identify relevant publications that described use of the electronic health record to directly support trial conduct, with a total of 15 publications ultimately meeting inclusion criteria. Three thematic groupings emerged that categorized common aspects of clinical research integration: functional, structural, and procedural components. These components include technological requirements (platform/system), regulatory and legal compliance, and stakeholder involvement with clinical trial procedures (recruitment of participants). Without a centralized means of providing clinicians with current treatment and adverse event management information, participant injury or likelihood of withdrawal will increase. Further research is required to develop an optimal model of research-related integration within commercial electronic health records.

Author Correction: Sampling the volatile-rich transition zone beneath Bermuda.

An Amendment to this paper has been published and can be accessed via a link at the top of the paper.

Sampling the volatile-rich transition zone beneath Bermuda.

Intraplate magmatic provinces found away from plate boundaries provide direct sampling of the composition and heterogeneity of the Earth's mantle. The chemical heterogeneities that have been observed in the mantle are usually attributed to recycling during subduction1-3, which allows for the addition of volatiles and incompatible elements into the mantle. Although many intraplate volcanoes sample deep-mantle reservoirs-possibly at the core-mantle boundary4-not all intraplate volcanoes are deep-rooted5, and reservoirs in other, shallower boundary layers are likely to participate in magma generation. Here we present evidence that suggests Bermuda sampled a previously unknown mantle domain, characterized by silica-undersaturated melts that are substantially enriched in incompatible elements and volatiles, and a unique, extreme isotopic signature. To our knowledge, Bermuda records the most radiogenic 206Pb/204Pb isotopes that have been documented in an ocean basin (with 206Pb/204Pb ratios of 19.9-21.7) using high-precision methods. Together with low 207Pb/204Pb ratios (15.5-15.6) and relatively invariant Sr, Nd, and Hf isotopes, the data suggest that this source must be less than 650 million years old. We therefore interpret the Bermuda source as a previously unknown, transient mantle reservoir that resulted from the recycling and storage of incompatible elements and volatiles6-8 in the transition zone (between the upper and lower mantle), aided by the fractionation of lead in a mineral that is stable only in this boundary layer, such as K-hollandite9,10. We suggest that recent recycling into the transition zone, related to subduction events during the formation of Pangea, is the reason why this reservoir has only been found in the Atlantic Ocean. Our geodynamic models suggest that this boundary layer was sampled by disturbances related to mantle flow. Seismic studies and diamond inclusions6,7 have shown that recycled materials can be stored in the transition zone11. For the first time, to our knowledge, we show geochemical evidence that this storage is key to the generation of extreme isotopic domains that were previously thought to be related only to deep recycling.

Engaging in the Publication Process Improves Perceptions of Scientific Communication, Critique, and Career Skills Among Graduate Students.

Reading and critiquing primary scientific literature is an important skill for graduate students, as reviewing literature is critical to advancing science. Prior research indicates that graduate students lack understanding of effective communication as well as basic experimental design, but also that graduate students are capable of growth in their experimental design abilities when given proper opportunities. The Journal of Emerging Investigators (JEI) provides graduate students with the opportunity to review and edit original research papers submitted by middle and high school student-authors. The purpose of this project was to determine whether participation in the primary literature process through JEI effectively aids in developing graduate students' perceived abilities in the domains of communication, scientific critique, and career preparation. A 12-question survey was distributed using SurveyMonkey to 215 JEI reviewers and editors. Editors, whose role involves the synthesis of feedback from multiple reviewers and interaction with papers in their earliest stages, perceived that they benefited more than did reviewers in every domain assessed by the survey. Perceived impact on critiquing skills was only rated more highly by reviewers than by editors once the graduate students in question had reviewed 10 or more papers. The results of this research suggest that graduate students should participate early and often in the reading and reviewing of primary literature; furthermore, the study of flawed science writing can help to improve experimental design, critique, and science communication skills.

Feasibility of pancreatectomy following high-dose proton therapy for unresectable pancreatic cancer.

AIM: To review surgical outcomes for patients undergoing pancreatectomy after proton therapy with concomitant capecitabine for initially unresectable pancreatic adenocarcinoma. METHODS: From April 2010 to September 2013, 15 patients with initially unresectable pancreatic cancer were treated with proton therapy with concomitant capecitabine at 1000 mg orally twice daily. All patients received 59.40 Gy (RBE) to the gross disease and 1 patient received 50.40 Gy (RBE) to high-risk nodal targets. There were no treatment interruptions and no chemotherapy dose reductions. Six patients achieved a radiographic response sufficient to justify surgical exploration, of whom 1 was identified as having intraperitoneal dissemination at the time of surgery and the planned pancreatectomy was aborted. Five patients underwent resection. Procedures included: Laparoscopic standard pancreaticoduodenectomy (n = 3), open pyloris-sparing pancreaticoduodenectomy (n = 1), and open distal pancreatectomy with irreversible electroporation (IRE) of a pancreatic head mass (n = 1). RESULTS: The median patient age was 60 years (range, 51-67). The median duration of surgery was 419 min (range, 290-484), with a median estimated blood loss of 850 cm3 (range, 300-2000), median ICU stay of 1 d (range, 0-2), and median hospital stay of 10 d (range, 5-14). Three patients were re-admitted to a hospital within 30 d after discharge for wound infection (n = 1), delayed gastric emptying (n = 1), and ischemic gastritis (n = 1). Two patients underwent R0 resections and demonstrated minimal residual disease in the final pathology specimen. One patient, after negative pancreatic head biopsies, underwent IRE followed by distal pancreatectomy with no tumor seen in the specimen. Two patients underwent R2 resections. Only 1 patient demonstrated ultimate local progression at the primary site. Median survival for the 5 resected patients was 24 mo (range, 10-30). CONCLUSION: Pancreatic resection for patients with initially unresectable cancers is feasible after high-dose [59.4 Gy (RBE)] proton radiotherapy with a high rate of local control, acceptable surgical morbidity, and a median survival of 24 mo.

Drosophila Cappuccino alleles provide insight into formin mechanism and role in oogenesis.

During Drosophila development, the formin actin nucleator Cappuccino (Capu) helps build a cytoplasmic actin mesh throughout the oocyte. Loss of Capu leads to female sterility, presumably because polarity determinants fail to localize properly in the absence of the mesh. To gain deeper insight into how Capu builds this actin mesh, we systematically characterized seven capu alleles, which have missense mutations in Capu's formin homology 2 (FH2) domain. We report that all seven alleles have deleterious effects on fly fertility and the actin mesh in vivo but have strikingly different effects on Capu's biochemical activity in vitro. Using a combination of bulk and single- filament actin-assembly assays, we find that the alleles differentially affect Capu's ability to nucleate and processively elongate actin filaments. We also identify a unique "loop" in the lasso region of Capu's FH2 domain. Removing this loop enhances Capu's nucleation, elongation, and F-actin-bundling activities in vitro. Together our results on the loop and the seven missense mutations provides mechanistic insight into formin function in general and Capu's role in the Drosophila oocyte in particular.

Comparing the Impact of Course-Based and Apprentice-Based Research Experiences in a Life Science Laboratory Curriculum.

This four-year study describes the assessment of a bifurcated laboratory curriculum designed to provide upper-division undergraduate majors in two life science departments meaningful exposure to authentic research. The timing is critical as it provides a pathway for both directly admitted and transfer students to enter research. To fulfill their degree requirements, all majors complete one of two paths in the laboratory program. One path immerses students in scientific discovery experienced through team research projects (course-based undergraduate research experiences, or CUREs) and the other path through a mentored, independent research project (apprentice-based research experiences, or AREs). The bifurcated laboratory curriculum was structured using backwards design to help all students, irrespective of path, achieve specific learning outcomes. Over 1,000 undergraduates enrolled in the curriculum. Self-report survey results indicate that there were no significant differences in affective gains by path. Students conveyed which aspects of the curriculum were critical to their learning and development of research-oriented skills. Students' interests in biology increased upon completion of the curriculum, inspiring a subset of CURE participants to subsequently pursue further research. A rubric-guided performance evaluation, employed to directly measure learning, revealed differences in learning gains for CURE versus ARE participants, with evidence suggesting a CURE can reduce the achievement gap between high-performing students and their peers.

Role modeling clinical judgment for an unfolding older adult simulation.

Nurse educators must foster development of clinical judgment in students to help them provide the best care for the increasing population of older adult patients. This article reports qualitative findings from a mixed-methods study that focused on clinical judgment in the simulated perioperative care of an older adult. The sample was composed of treatment and control groups of prelicensure students (N = 275) at five sites. The treatment group watched a video of an expert nurse role model caring for a patient similar to the simulation patient, whereas the control group did not watch the video. Four weeks after simulation, participants cared for real-life, older adult perioperative patients. After the simulated and real-life care experiences, participants completed questionnaires related to clinical judgment dimensions. These two data sets revealed rich findings about the students' simulation learning, affirming the value of expert role models. Transferability of simulation learning to practice was also explored.