Faculty Bibliography

INTRODUCTION/UNASSIGNED:Physicians in the United States play an essential role guiding patients through single patient pre-approval access (PAA) to investigational medical products via either the Food and Drug Administration (FDA)'s Expanded Access (EA) or the federal Right To Try (RTT) pathways. In this study, we sought to better understand pediatric hematologist/oncologists' attitudes about seeking PAA, on behalf of single patients, to investigational drugs outside of clinical trials. METHODS/UNASSIGNED:A cross-sectional survey was developed and sent to pediatric hematologist/oncologists via St. Baldrick's Foundation's email distribution list. RESULTS/UNASSIGNED: = 46) had prior experience with single patient PAA. Respondents were most concerned about the unknown risks and benefits of investigational drugs and financial implications of PAA for patients. One hundred percent and 91.1% of respondents indicated a willingness to support patients through EA and RTT pathways, respectively. When asked about their most recent experience with PAA, 40 out of 46 indicated that they used the FDA's EA pathway to seek PAA and 4 out of 46 indicated that they used the RTT pathway. Of 44 respondents who had used the EA or RTT pathway, 43 indicated that the biotechnology or pharmaceutical company they solicited granted access to the requested product. CONCLUSION/UNASSIGNED:Survey results support other findings suggesting a need for additional physician support and education about PAA and that physicians may have unequal access to information about investigational drugs and concerns about financial implications of PAA for their patients.

Although racial/ethnic disparities in police contact are well documented, less is known about other dimensions of inequity in policing. Sexual minority groups may face disproportionate police contact. We used data from the P18 Cohort Study (Version 2), a study conducted to measure determinants of inequity in STI/HIV risk among young sexual minority men (YSMM) in New York City, to measure across-time trends, racial/ethnic disparities, and correlates of self-reported stop-and-frisk experience over the cohort follow-up (2014-2019). Over the study period, 43% reported stop-and-frisk with higher levels reported among Black (47%) and Hispanic/Latinx (45%) than White (38%) participants. Stop-and-frisk levels declined over follow-up for each racial/ethnic group. The per capita rates among P18 participants calculated based on self-reported stop-and-frisk were much higher than rates calculated based on New York City Police Department official counts. We stratified respondents' ZIP codes of residence into tertiles of per capita stop rates and observed pronounced disparities in Black versus White stop-and-frisk rates, particularly in neighborhoods with low or moderate levels of stop-and-frisk activity. YSMM facing the greatest economic vulnerability and mental disorder symptoms were most likely to report stop-and-frisk. Among White respondents levels of past year stop-and-frisk were markedly higher among those who reported past 30 day marijuana use (41%) versus those reporting no use (17%) while among Black and Hispanic/Latinx respondents stop-and-frisk levels were comparable among those reporting marijuana use (38%) versus those reporting no use (31%). These findings suggest inequity in policing is observed not only among racial/ethnic but also sexual minority groups and that racial/ethnic YSMM, who are at the intersection of multiple minority statuses, face disproportionate risk. Because the most socially vulnerable experience disproportionate stop-and-frisk risk, we need to reach YSMM with community resources to promote health and wellbeing as an alternative to targeting this group with stressful and stigmatizing police exposure.

STATEMENT OF PROBLEM OR QUESTION (ONE SENTENCE): In the transition away from traditional doctors' offices, how can we optimize shared multi-use clinical spaces to serve clinicians' needs LEARNING OBJECTIVES 1: Identify ways in which a practice that relies upon shared clinical spaces can remain familiar and effective for clinical work. LEARNING OBJECTIVES 2: Determine how might technology help clinicians develop a sense of belonging, professional pride, and patient rapport in multi-use spaces by allowing them to display personal information and patient education materials related to their practice. DESCRIPTION OF PROGRAM/INTERVENTION, INCLUDING ORGANIZATIONAL CONTEXT (E.G. INPATIENT VS. OUTPATIENT, PRACTICE OR COMMUNITY CHARACTERISTICS): The traditional doctor's office is being rapidly replaced by multi-use clinical environments that combine exam rooms with shared touchdown spaces, promoting efficient use of space & team-based care approach while utilizing network technologies. While potentially efficient & lower-cost, there's a need to assess the impact of these configurations on clinician workflows, professional identity & explore opportunities to improve their build and aesthetics. We conducted need assessment interviews with 9 clinicians, health technologists, 2 operational leaders, shadowed 3 clinicians & conducted 4 site visits across various clinical practices. We then issued a 10-question survey and conducted 2 HCD workshops with 12 clinicians to understand the new conditions of clinical work, their impact on clinicians' professional & personal identity, practice habits, to identify areas for potential optimization to improve clinical workflow & experience. Workshops were divided in three phases: explore, ideate and create. MEASURES OF SUCCESS (DISCUSS QUALITATIVE AND/OR QUANTITATIVEMETRICSWHICHWILL BE USEDTOEVALUATE PROGRAM/INTERVENTION): We report qualitative success metrics used to evaluate the results of the HCD workshops: 1. Understanding of what shared multi-use work spaces mean to participating clinicians. 2. Identified needs, potential concerns and pain points of clinicians and stakeholders. 3. Group generation of potential solutions without bias towards feasibility. 4. Described solutions using quick prototyping tools. FINDINGS TO DATE (IT IS NOT SUFFICIENT TO STATE FINDINGS WILL BE DISCUSSED): Clinicians identified the lack of customization and capability for sharing information about their areas of expertise and tailored patient education materials as the most significant problem, and had privacy concerns about sharing personal information on a digital display. Potential solutions include customizable content display controlled by patients that fosters engagement, exploring education materials, patient testimonials, information about the care team and wait time as well as patient-specific information, such as labs and imaging. KEY LESSONS FOR DISSEMINATION (WHAT CAN OTHERS TAKE AWAY FOR IMPLEMENTATION TO THEIR PRACTICE OR COMMUNITY): The use of the HCD principles helped us better understand the challenges of multi-use spaces for clinicians, and identify potential technology solutions for data sharing, patient education, personalization, and efficiencies. It is crucial to design these spaces and choose appropriate technology solutions that will help reduce patients' anxiety by ensuring privacy, comfort, thorough understanding of care plans and boost collaborative care decision making between clinicians and patients

LEARNINGOBJECTIVES 1: Interpersonal /Communication Skill: 1) Identify communication skills needed to recruit older adults LEARNING OBJECTIVES 2: 2) Assess feasibility of GOSCEs to enhance recruitment skills in RAs. SETTING AND PARTICIPANTS: Convenience sample of 18 (5 male, 13 female) Research Assistants (RAs) at an urban hospital who recruit older adults for clinical trials. DESCRIPTION: Increasing older adults' participation in clinical trials is urgently needed. We developed a remote, three station simulation (Group Objective Structured Clinical Exam - GOSCE) to teach RAs communication skills. This 2-hour course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs); and a debrief to review experiences, highlight best practices. After discussion, RAs rotated (3 per group) through the stations, each with SP and faculty observer who provided immediate feedback. Thus, learners had opportunities for active and observational learning.Scenarios were: 1) an older white woman with hearing impairment; 2) an older white woman and family member together; and 3) an older Black man mistrustful due to history of racism in medical research. SPs completed behaviorally anchored checklists (11 communication skills across all cases, and 5-7 case-specific questions). Learners completed a 36- item survey of self-assessed change in skill after the workshop; insights on recruitment practice; and educational value. EVALUATION: The communication checklist across all cases included: relationship development (5 items, mean of 58% well done (range: 50-75%), patient education (3 items, 44% (42-58%)), patient satisfaction (2 items, 54% (50-58%)), and information gathering (1 item, 92%). Seventeen RAs completed the survey, 100% felt the workshop provided valuable feedback and taught relevant material, 88% would participate again and 52%reported that the workshop improved their recruitment skills. All RAs reported encountering situations similar to hearing impairment and family member cases, and the majority rated the cases as high in educational value. Just 45% reported experiencing a case similar to the Black male case, and 100% rate it as high in educational value. Key points identified by RAs included the value of building a trusting relationship with potential subjects, recognizing possible barriers to communication early on and addressing these directly in a supportive and respectful style. DISCUSSION / REFLECTION / LESSONS LEARNED: Remote GOSCEs are a feasible mechanism for training RAs in subject recruitment focused on the unique needs of older adults. Responses to the RA survey suggest that GOSCEs are feasible for training RAs in simulated clinical scenarios with which participants are familiar and unfamiliar. SP assessment of RAs identified areas for further reinforcement to improve recruitment skills. This innovation is a feasible, high yield strategy for training research staff. It is highly adaptable to the specific recruitment needs and skills of a clinical trials and will add to the literature on educating RAs

Growing concerns about the safety of long-term opioid therapy and its uncertain efficacy for non-cancer pain have led to relatively rapid opioid deprescribing in chronic pain patients who have been taking opioid for years. To date, empirically supported processes for safe and effective opioid tapering are lacking. Opioid tapering programs have shown high rates of dropouts and increases in patient distress and suicidal ideation. Therefore, safe strategies for opioid deprescribing that are more likely to succeed are urgently needed. In response to this demand, the EMPOWER study has been launched to examine the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings (https://empower.stanford.edu/). The EMPOWER protocol requires an efficient process for ensuring that collaborative opioid tapering would be offered to the most appropriate patients while identifying patients who should be offered alternate treatment pathways. As a first step, clinicians need a screening tool to identify patients with Opioid Use Disorder (OUD) and to assess for OUD severity. Because such a tool is not available, the study team composed of eight chronic pain and/or addiction experts has extended a validated screening instrument to develop a brief and novel consensus screening tool to identify OUD and assess for OUD severity for treatment stratification. Our screening tool has the potential to assist busy outpatient clinicians to assess OUD among patients receiving long-term opioid therapy for chronic pain.

Maternal diet, prior to and during pregnancy, plays an important role in the immediate and long-term health of the mother and her offspring. Our objectives were to assess diet quality among a large, diverse, urban cohort of pregnant women, and examine associations with sociodemographic and health behavior characteristics. Data were from 1,325 pregnant women enrolled in New York University Children's Health and Environment Study (NYU CHES). Diet quality was assessed using the Healthy Eating Index (HEI)-2015. Mean total HEI-2015 score was 74.9 (SD = 8.5); 376 (28%), 612 (46%), 263 (20%), and 74 (6%) of women had scores that fell into the grade range of A/B, C, D, and F, respectively. Mean HEI-2015 component scores were high for fruit and whole grains and low for protein-related, sodium, and fat-related components. In multivariable linear regression models, Hispanic women scored 1.65 points higher on the total HEI-2015 (95% CI: 0.21, 3.10) compared to non-Hispanic White women, while younger age (<30 years), parity, single status, pre-pregnancy obesity, smoking, pre-existing hypertension, moderate/severe depressive symptoms, not meeting physical activity recommendations, and not taking a vitamin before pregnancy were associated with ~1.5-5-point lower mean total HEI-2015 scores. Diet is a modifiable behavior; our results suggest a continued need for pre-conceptional and prenatal nutritional counseling.

BACKGROUND:Firearm dealer density is correlated with firearm interpersonal violence, but no quasi-experimental studies have assessed whether changes in dealer density lead to changes in firearm self-harm injuries and deaths. We assessed whether openings of firearm dealers are associated with short-term changes in local firearm self-harm injury rates. METHODS:We identified 718 openings of firearm dealers in California using licensing data, 2014-2016. We defined exposure regions based on aggregations of zip codes defined by proximity to firearm dealer openings and matched each opening to four control regions on time and determinants of firearm injury. We applied a differences-in-differences approach to compare rates of firearm self-harm, in the month before and after each opening, in places with and without openings. RESULTS:Firearm dealer openings were not associated with acute, local changes in firearm self-harm relative to places without openings (ratio of rate ratio: 0.90 [95% CI:0.68-1.19]). Results were robust to numerous sensitivity and secondary analyses. CONCLUSION:We found no associations of firearm dealer openings with acute, localized firearm self-harm deaths and injuries. Our focus on acute, local effects; broad availability of dealers and firearms; durability of firearms; or strong confounding-control may explain these null findings.

Background and Objective/UNASSIGNED:Posttraumatic stress disorder (PTSD) is a serious and frequently debilitating psychiatric condition that can occur in people who have experienced traumatic stessors, such as war, violence, sexual assault and other life-threatening events. Treatment of PTSD and traumatic brain injury (TBI) in veterans is challenged by diagnostic complexity, partially due to PTSD and TBI symptom overlap and to the fact that subjective self-report assessments may be influenced by a patient's willingness to share their traumatic experiences and resulting symptoms. Corticotropin-releasing factor (CRF) is one of the main mediators of hypothalamic pituitary adrenal (HPA)-axis responses in stress and anxiety. Methods and Results/UNASSIGNED:We analyzed serum CRF levels in 230 participants including heathy controls (64), and individuals with PTSD (53), TBI (70) or PTSD+TBI (43) by enzyme immunoassay (EIA). Significantly lower CRF levels were found in both the PTSD and PTSD+TBI groups compared to healthy control (PTSD vs Controls: P=0.0014, PTSD + TBI vs Controls: P=0.0011) and chronic TBI participants (PTSD vs TBI: P<0.0001PTSD + TBI vs TBI: P<0.0001) , suggesting a PTSD-related mechanism independent from TBI and associated with CRF reduction. CRF levels negatively correlated with PTSD severity on the CAPS-5 scale in the whole study group. Conclusions/UNASSIGNED:Hyperactivation of the HPA axis has been classically identified in acute stress. However, the recognized enhanced feedback inhibition of the HPA axis in chronic stress supports our findings of lower CRF in PTSD patients. This study suggests that reduced serum CRF in PTSD should be further investigated. Future validation studies will establish if CRF is a possible blood biomarker for PTSD and/or for differentiating PTSD and chronic TBI symptomatology.