What PIs want when hiring a clinical research coordinator.

Introduction: Clinical research coordinators (CRCs) play a key role in supporting the translational research enterprise, with responsibilities encompassing tasks related to the design, implementation, and evaluation of clinical research trials. While the literature explores CRC competencies, job satisfaction, and retention, little attention has been given to the role of the PI working with Human Resources (HR) in the CRC hiring and onboarding processes. We investigated the priorities, decision-making processes, and satisfaction levels of principal investigators (PIs) and hiring managers in CRC hiring. Methods: An online survey consisting of open-ended and fixed-choice questions to gather information on desired CRC qualifications and competencies, factors influencing hiring decisions, and overall satisfaction with selected candidates was administered. The survey utilized a Task/Competency Checklist developed from job descriptions and the literature. Respondents were asked to rank the importance of factors such as CRC skill set, years of experience, educational background, and budget constraints. Results: Results indicated that the skill set of the applicant was the most frequently cited factor influencing the hiring decision, followed by years of experience. Education and budget constraints were of lesser importance. Most respondents reported a satisfaction rating of 50% or greater with their new hires, although some participants expressed challenges related to institutional training requirements, the performance of entry-level CRCs, and the qualifications of experienced candidates. Conclusion: The hiring cycle involves HR-PI collaboration for a clear job description, effective onboarding processes, and accessible professional development opportunities to enhance PI and employee satisfaction and CRC retention.

Conceptualization, development, and early dissemination of eMPACTTM: A competency-based career navigation system for translational research professionals.

Introduction: Purposeful training and ongoing career support are necessary to meet the evolving and expanding roles of clinical research professionals (CRP). To address the training and employment needs of clinical research coordinators (CRCs), one of the largest sectors of the CRP workforce, we designed, developed, and implemented an online career navigation system, eMPACTTM (eMpowering Purposeful Advancement of Careers and Training). Methods: A design-based research method was employed as an overarching approach that frames iterative design, development, and implementation of educational interventions. The five major phases of this project - conceptualization, task analysis for measurement development, algorithms development, algorithms validation, and system evaluation - presented specific goals and relevant methods. Results: The results reported how the eMPACTTM system was conceptualized, developed, and validated. The system allowed CRCs to navigate tailored training and job opportunities by completing their task competencies and career goals. The data sets could, in turn, support employees' and training coordinators' informed decisions about organizational training needs and recruitment. The early dissemination results showed steady growth in registered CRCs and diversity in users' ethnicity and job levels. Conclusions: The eMPACTTM service showed the possibility of supporting CRCs' individual career advancement and organizational workforce enhancement and diversity. Long-term research is needed to evaluate its impact on CRC workforce development, explore key factors influencing workforce sustainability, and expand eMPACTTM service to other CRP sectors.

Changes in gastric mucosa, submucosa, and muscularis IC pH may herald irreversible tissue injury.

Previously we noted an abrupt rise in gastric intracellular pH (IC pH) and bicarbonate buffering between 15 and 30 min of cardiac arrest which we termed agonal alkalinization, failure of pH regulation. Agonal alkalinization may represent the transition point between reversible and irreversible injury. We asked the question, what is the sequence of change in IC pH within the gastric layers, mucosa, submucosa, and muscularis, and which layer is most sensitive? This research explored changes in IC pH within the stomach layers, mucosa, submucosa, and muscularis, at 0, 5, 15, 30, and 40 min, under three conditions, normoxia (control), ischemia (cardiac arrest), and eucapnic hypoxia (12 % oxygen). The mucosa was the most alkalotic gastric layer at baseline. Ischemia and hypoxia at 40″ produced different layer responses with the mucosa and submucosa the most sensitive layers during ischemia and the muscularis during hypoxia. Further study to examine the mechanism of changes between gastric layers using spatial-temporal techniques may assist in understanding the transition to irreversible injury.

Finding the right candidate: Developing hiring guidelines for screening applicants for clinical research coordinator positions.

Impact: The success of any clinical research team is dependent on hiring individuals with the experience and skill set needed for a specific research project. Strategies to improve the ability of human resource (HR) recruiters to screen and advance qualified candidates for a project will result in improved initiation and execution of the project. Objective/Goals: HR recruiters play a critical role in matching research applicants to the posted job descriptions and presenting a list of top candidates to the PI/hiring manager for interview and hiring consideration. Methods/Study Population: Creating guidelines to screen for applicant qualification based on resumes when clinical research positions have multiple levels of expertise required is a complex process of discovery, moving from subjective rationale for rating individual resumes to a more structured less biased evaluation process. To improve the hiring process of the research workforce, we successfully developed guidelines for categorizing research coordinator applications by level from beginner to advanced. Results/Anticipated Results: Through guideline development, we provide a framework to reduce bias and improve the matching of applicant resumes to job levels for improved selection of top candidates to advance for interviewing. Improved applicant to job matching offers an advantage to reduce hiring time, anticipate training needs, and shorten the timeline to active project engagement. These guidelines can form the basis for initial screening and ultimately matching individual qualities to project-specific needs.

Challenges to intestinal pO2 measurement using EPR.

Acute and chronic intestinal ischemia has been linked to the development of gastrointestinal symptoms such as abdominal pain, nausea and vomiting, bowel dysfunction and more seriously, the complications of sepsis, shock and death. Advances in electron paramagnetic resonance (EPR) oximetry have resulted in accurate and reliable in vivo measurement of the partial pressure of oxygen (pO(2)) in solid organs (e.g., muscle, heart) [1], but has yet to be tested in thin walled organs such as intestine. Our ultimate goal is to noninvasively monitor intestinal pO(2) during acute and chronic intestinal ischemia in a rat model. A series of experiments to deliver oxygen-sensitive indicator probes to the small/large intestine by intravenous, luminal and wall injection, as well as direct placement of a solid probe against the outer intestinal wall were attempted. Only the LiNc:BuO:PDMS chip sutured to the peritoneal wall and in direct contact with the intestine allowed for noninvasive pO(2) measurement by EPR. However, the validity of site-specific intestinal pO(2) measurement could not be confirmed and the obtained pO(2) value likely reflected peritoneal cavity oxygenation. Developing methods for probe placement on or inside the intestinal wall are needed for noninvasive, site-specific intestinal pO(2) measurement by EPR to track changes during acute and chronic intestinal ischemia.

Improving Incident Reporting in a Hospital-Based Radiation Oncology Department: The Impact of a Customized Crew Resource Training and Event Reporting Intervention.

Background Radiation oncology (RO) is a high-risk environment with an increased potential for error due to the complex automated and manual interactions between heterogeneous teams and advanced technologies. Errors involving procedural deviations-- can adversely impact patient morbidity and mortality. Under-reporting of errors is common in healthcare for reasons such as fear of retribution, liability, embarrassment, etc. Incident reporting is a proven tool for learning from errors and, when effectively implemented, can improve quality and safety. Crew resource management (CRM) employs just culture principles with a team-based safety system. The pillars of CRM include mandatory error reporting and structured training to proactively identify, learn from, and mitigate incidents. High-reliability organizations, such as commercial aviation, have achieved exemplary safety performance since adopting CRM strategies. Objective Our aim was to double the rate of staff error reporting from baseline rates utilizing CRM strategies during a six-month study period in a hospital-based radiation oncology (RO) department. Methods This quasi-experimental study involved a retrospective review of reported radiation oncology incidents between January 2015 and March 2016, which helped inform the development and implementation of a two-step custom CRM training and incident learning system (ILS) intervention in May 2016. A convenience sample of approximately 50 RO staff (Staff) performing over 100 external beam and daily brachytherapy treatments participated in weekly training for six months while continuing to report errors on a hospital-enterprise system. A discipline-specific incident learning system (ILS) customized for the department was added during the last three months of the study, enabling staff to identify, characterize, and report incidents and potential errors. Weekly process control charts used to trend incident reporting rates (total number of reported incidents in a given month /1000 fractions), and custom reports characterizing the potential severity as well as the location of incidents along the treatment path, were reviewed, analyzed, and addressed by an RO multidisciplinary project committee established for this study. Results A five-fold increase in the monthly reported number of incidents (n = 9.3) was observed during the six-month intervention period as compared to the 16-month pre-intervention period (n = 1.8). A significant increase (>3 sigma) was observed when the custom reporting system was added during the last three study months. Conclusion A discipline-specific electronic ILS enabling the characterization of individual RO incidents combined with routine CRM training is an effective method for increasing staff incident reporting and engagement, leading to a more systematic, team-based mitigation process. These combined strategies allowed for real-time reporting, analysis, and learning that can be used to enhance patient safety, improve teamwork, streamline communication, and advance a culture of safety.

Conceptualizing compensatory responses: implications for treatment and research.

Many scientists approach the discovery and application of knowledge of physiological processes from a reductionistic paradigm. A reductionistic approach focuses on treating one or a few key disease-related variables but overlooks the interaction of systems and their dependency on one another to produce homeostasis. The purposes of this article are to examine the current paradigm underlying treatment and its effect on patient outcome and to present an alternative perspective for understanding the body's compensatory responses and their implications for treatment and research. Chaos theory and nonlinear methods are presented as possible ways to conceptualize and explore the complex integration of physiological patterns in response to disease, aging, and treatment.

Bolus vs Continuous Nasogastric Feeds in Mechanically Ventilated Pediatric Patients: A Pilot Study.

BACKGROUND: Malnutrition increases the risk of mortality and morbidity in the pediatric intensive care unit (PICU). Barriers to adequate delivery of enteral nutrition (EN) include hemodynamic instability, feeding interruptions and intolerance, and lack of standardized feeding protocols. The most recent guidelines on nutrition support for the critically ill child describe a paucity of evidence around the best method to deliver EN. There is an untested clinical assumption that bolus gastric feeding (B-GF) in intubated patients is associated with aspiration events, lung injury, and associated morbidity compared with continuous gastric feeding (C-GF). This study compared the effectiveness and safety of C-GF vs B-GF in intubated pediatric patients. METHODS: We enrolled randomized patients aged 1 month-12 years who were intubated within 24 hours and received EN starting within 48 hours of admission to a C-GF or B-GF group. Goal-directed EN volume and caloric density were increased every 3 and 12 hours, respectively, to target. Feeding interruptions and intolerance events were recorded. RESULTS: Twenty-five subjects were enrolled (B-GF = 11; C-GF = 14). At 24 hours, B-GF was associated with higher energy and protein delivery (P < 0.007) and was associated with faster time to goal volume (median B-GF = 15 hours; C-GF = 29.5 hours). No aspiration events resulting in additional lung injury were noted for either group (P = 0.866). CONCLUSIONS: B-GF was associated with superior delivery of EN with a comparable safety profile to C-GF. Further study is needed to compare both EN methods in other PICU populations.

Hypobaric hypoxia reduces GLUT2 transporter content in rat jejunum more than in ileum.

To define some of the specific cellular effects of chronic hypoxia on the small intestine, we measured the concentration of glucose transporter 2 (GLUT2) at two sites, the jejunum and ileum. Wister rats were subjected to 21-day normoxia (n = 6) or to continuous 21-day hypobaric hypoxia approximately 0.5 ATM (n = 5). Western blot analysis was performed and the abundance of GLUT2 protein was quantified as relative densitometric units and normalized to actin. GLUT2 content was similar in the jejunum and ileum under normoxic (jejunum = 0.65 +/- 0.13 mean +/- SD; ileum = 0.56 +/- 0.22 OD; mean difference 0.09, p = 0.09) and hypoxic conditions (jejunum = 0.56 +/- 0.14 OD mean +/- SD; ileum = 0.58 +/- 0.16; mean difference -0.01, p = 0.42). GLUT2 decreased by 14% of the mean normoxic jejunal levels whereas ileal GLUT2 was slightly increased. A maximum decline in weight of 15% occurred at day 4 followed by a blunted rate of weight gain for rats in the hypoxic group. Thus, sustained exposure to hypobaric hypoxia reduced the availability of GLUT2 for glucose transport in the jejunum. Regulating small intestinal content of glucose transporters may be an important mechanism for tissue adaptation to chronic hypoxia. This finding provides initial insight into hypoxic tolerance of the gut to chronic hypobaric hypoxic exposure.

Do I take the job?: Assessing fit with the organization.

PURPOSE: A good 'fit' with an organization is critical to a leader's success yet when searching for a new position assessment an evaluation of many aspects may be overlooked, such as culture. This paper presents key considerations around 'fit' that applicants for leadership positions should consider prior to, during, and after the interview. Suggestions are provided on how to approach an evaluation of 'fit'. CONCLUSION: The importance of assessing individual fit with an organization prior to accepting a leadership position cannot be over-emphasized.

A comparison of gastric and rectal CO2 in cardiac surgery patients.

Critical care nurses assess and treat clinical conditions associated with inadequate oxygenation. Changes in regional organ (gut) blood flow are believed to occur in response to a decrease in oxygenation. Although the stomach is a widely accepted monitoring site, there are multiple methodological and measurement issues associated with the gastric environment that limit the accuracy of P CO2 detection. The rectum may provide nurses with an alternative site for monitoring changes in P CO2 without the limitations associated with gastric monitoring. This pilot study used a repeated measures design to examine changes in gastric and rectal P CO2 during elective coronary artery bypass grafting with cardiopulmonary bypass (CPB) and in the immediate 4-hr postoperative period in 26 subjects. The systemic indicators explained little variation in the regional indicators during protocol. A comparison of rectal and gastric P CO2 revealed no statistically significant differences in the direction or magnitude of change over any phase of cardiac surgery (baseline, CPB, post-CPB). A reduction in both rectal and gastric P CO2 occurred during CPB, and both values trended upward during the post-CPB phase. However, poor correlation and agreement was found between the measures of P CO2 at the two sites. Although clinically important, the cause is unclear. Possible explanations include variation in CO2 production between the gastric and rectal site, differences in sensitivity of the two monitoring instruments, or the absence of hemodynamic complications, which limited the extent of change in P CO2. Further investigation using patients with more profound changes in oxygenation are needed to identify response patterns and possible mechanisms.

Gut dysoxia: comparison of sites to detect regional gut dysoxia.

Dysoxia, a state in which O2 supply is inadequate to meet tissue metabolic needs, is often first detected in regional organs such as the gut. An increase in PCO2 is believed to reflect the development of gut dysoxia. The stomach is a well-documented clinical site for detecting gut PCO2; however, measurement issues make this a less than ideal monitoring site. Other sites along the GI tract may be equally sensitive to detect changes in PCO2. Rectal CO2 measurement may have the advantage of being less invasive, low risk, and continuous without the limitations associated with gastric monitoring. In this study, we compared PCO2 at two sites (gastric, rectum) at baseline and during a dysoxic challenge, cardiac arrest. We obtained similar values of PCO2 at both sites. Ten male Wistar rats were anesthetized with 1%-2% Isoflurane/50% nitrous oxide/balanced O2 and the tail artery and right atrium were cannulated. Severinghaus-type active tip PCO2 electrodes (Microelectrode Inc, Bedford, NH) were calibrated and one electrode was surgically inserted into the stomach (G-PCO2) and a second electrode was placed in the rectum (R-PCO2). Animals were stabilized following surgery. Cardiac arrest was induced by administering a rapid injection of norcuron (0.1-0.2 mg/kg) and potassium chloride solution (0.5 M/L; 0.12 mL/100 gm of body weight). Animals were monitored for 15 minutes post-arrest. Data were collected at one minute intervals using the software Data Collect. All data are reported as mean +/- SD. Baseline G-PCO2 was 64 +/- 17 torr, not significantly different from R-PCO2, 58 +/- 7 torr. After 15 minutes of cardiac arrest, G-PCO2 rose to 114 +/- 42 torr, again not significantly different from R-PCO2, which reached 112 +/- 35 torr. Monitoring PCO2 in the rectum is less invasive and might provide similar information when compared with gastric monitoring at baseline and during a dysoxic challenge.

Fostering the scholarship of discovery and integration for advanced practice education.

Graduate faculty are challenged to foster the scholarship of discovery and integration in their students. Fostering this scholarship requires that faculty critically analyze their approach to teaching and learning with the ultimate goal of helping students grow exponentially in ways that will continue after completion of their course or class. This article describes a course activity designed to enhance students' abilities to read, critique, and apply literature from multiple scientific disciplines to a clinical realm while maintaining their focus on their health-related scientific discipline. Applied to a course in advanced pathophysiology, the course activity described is amenable for adoption to multiple graduate-level courses and encourages individual, collective, and practice-specific growth.

Behavioral abnormalities and circuit defects in the basal ganglia of a mouse model of 16p11.2 deletion syndrome.

A deletion on human chromosome 16p11.2 is associated with autism spectrum disorders. We deleted the syntenic region on mouse chromosome 7F3. MRI and high-throughput single-cell transcriptomics revealed anatomical and cellular abnormalities, particularly in cortex and striatum of juvenile mutant mice (16p11(+/-)). We found elevated numbers of striatal medium spiny neurons (MSNs) expressing the dopamine D2 receptor (Drd2(+)) and fewer dopamine-sensitive (Drd1(+)) neurons in deep layers of cortex. Electrophysiological recordings of Drd2(+) MSN revealed synaptic defects, suggesting abnormal basal ganglia circuitry function in 16p11(+/-) mice. This is further supported by behavioral experiments showing hyperactivity, circling, and deficits in movement control. Strikingly, 16p11(+/-) mice showed a complete lack of habituation reminiscent of what is observed in some autistic individuals. Our findings unveil a fundamental role of genes affected by the 16p11.2 deletion in establishing the basal ganglia circuitry and provide insights in the pathophysiology of autism.

Noninvasive monitoring of small intestinal oxygen in a rat model of chronic mesenteric ischemia.

We noninvasively monitored the partial pressure of oxygen (pO2) in rat's small intestine using a model of chronic mesenteric ischemia by electron paramagnetic resonance oximetry over a 7-day period. The particulate probe lithium octa-n-butoxynaphthalocyanine (LiNc-BuO) was embedded into the oxygen permeable material polydimethyl siloxane by cast-molding and polymerization (Oxy-Chip). A one-time surgical procedure was performed to place the Oxy-Chip on the outer wall of the small intestine (SI). The superior mesenteric artery (SMA) was banded to ~30% of blood flow for experimental rats. Noninvasive measurement of pO2 was performed at the baseline for control rats or immediate post-banding and on days 1, 3, and 7. The SI pO2 for control rats remained stable over the 7-day period. The pO2 on day-7 was 54.5 ± 0.9 mmHg (mean ± SE). SMA-banded rats were significantly different from controls with a noted reduction in pO2 post banding with a progressive decline to a final pO2 of 20.9 ± 4.5 mmHg (mean ± SE; p = 0.02). All SMA-banded rats developed adhesions around the Oxy-Chip, yet remained asymptomatic. The hypoxia marker Hypoxyprobe™ was used to validate the low tissue pO2. Brown cytoplasmic staining was consistent with hypoxia. Mild brown staining was noted predominantly on the villus tips in control animals. SMA-banded rats had an extended region of hypoxic involvement in the villus with a higher intensity of cytoplasmic staining. Deep brown stainings of the enteric nervous system neurons and connective tissue both within layers and in the mesentery were noted. SMA-banded rats with lower pO2 values had a higher intensity of staining. Thus, monitoring SI pO2 using the probe Oxy-Chip provides a valid measure of tissue oxygenation. Tracking pO2 in conditions that produce chronic mesenteric ischemia will contribute to our understanding of intestinal tissue oxygenation and how changes impact symptom evolution and the trajectory of chronic disease.

Hepatorenal syndrome: beyond liver failure.

Critical care nurses occasionally confront patient conditions that are not common. One such condition is hepatorenal syndrome (HRS). Three primary processes contribute to regional alterations in circulation in the renal and splanchnic beds. These processes include effective hypovolemia from the massive release of vasoactive mediators, thereby underfilling circulation, systemic and splanchnic vasodilation along with renal vasoconstriction, and hyperdynamic circulation. A "second-hit" hypothesis, whereby a triggering event causes intravascular volume depletion, likely initiates the development of HRS. The idea of a second hit focuses the attention of the health care team on surveillance strategies to prevent or limit HRS in patients with advanced cirrhosis and ascites. The treatment goal is to restore systemic and splanchnic vasoconstriction, while promoting renal vasodilation, balance sodium, and achieve euvolemia. The critical care nurse must maintain ongoing education to care for the patient with this complex syndrome in order to prevent complications and death.