Florida Health Research Articles

Assessing user perspectives on clinical pharmacogenomics consultation documentation: a user-centered evaluation.

The University of Florida Health Precision Medicine Program plays a crucial role in delivering pharmacogenomics (PGx) result notes to providers who request PGx testing. Despite this, there is currently a lack of a formal assessment of provider needs and established best practice design principles to guide the ongoing development of PGx result notes. This study aims to enhance the content and format of the PGx consult note at UF Health by incorporating valuable feedback from healthcare providers. Through in-depth user sessions involving 11 participants, we evaluated the usability of our consult note template. While overall satisfaction with the content was noted, specific sections, including those addressing phenoconversion and the medication list, were identified for revision to enhance clarity based on insightful provider feedback.

Rapid recognition and optimal management of hemophilia in the emergency department: A quality improvement project.

This study aimed to assess the effectiveness of a continuous quality improvement initiative at the University of Florida Health Physicians practice in reducing the time to administer factor replacement therapy (FRT) for hemophilia patients presenting with bleeding in the emergency department (ED). The study, a quasi-experimental, interventional design, was conducted between January 2020 and January 2023. The intervention, implemented in September 2021, involved training ED physicians, creating a specialized medication order set within the electronic health record (EHR), and a rapid triage system. The effectiveness was measured by comparing the time from ED arrival to factor administration before and after the intervention and benchmarking it against the National Bleeding Disorders Foundation's Medical and Scientific Advisory Council (MASAC)-recommended 1-hour timeline for factor administration. An interrupted time series (ITS) analysis with a generalized least squares model assessed the intervention's impact. A total of 43 ED visits (22 pre-intervention and 21 post-intervention) were recorded. Post-intervention, the average time from ED arrival to factor administration decreased from 5.63 to 3.15hours. There was no significant increase (27%vs. 29%) in the patients receiving factor within 1-hour of ED arrival. The ITS analysis predicted a 20-hour reduction in the average quarterly time to administer factor by the end of the study, an 84% decrease. The quality improvement program decreased the time to administer FRT for patients with hemophilia in the ED. However, the majority of patients did not achieve the 1-hour MASAC-recommended timeline for factor administration after ED arrival.

Development and validation of a race-agnostic computable phenotype for kidney health in adult hospitalized patients.

Standard race adjustments for estimating glomerular filtration rate (GFR) and reference creatinine can yield a lower acute kidney injury (AKI) and chronic kidney disease (CKD) prevalence among African American patients than non-race adjusted estimates. We developed two race-agnostic computable phenotypes that assess kidney health among 139,152 subjects admitted to the University of Florida Health between 1/2012-8/2019 by removing the race modifier from the estimated GFR and estimated creatinine formula used by the race-adjusted algorithm (race-agnostic algorithm 1) and by utilizing 2021 CKD-EPI refit without race formula (race-agnostic algorithm 2) for calculations of the estimated GFR and estimated creatinine. We compared results using these algorithms to the race-adjusted algorithm in African American patients. Using clinical adjudication, we validated race-agnostic computable phenotypes developed for preadmission CKD and AKI presence on 300 cases. Race adjustment reclassified 2,113 (8%) to no CKD and 7,901 (29%) to a less severe CKD stage compared to race-agnostic algorithm 1 and reclassified 1,208 (5%) to no CKD and 4,606 (18%) to a less severe CKD stage compared to race-agnostic algorithm 2. Of 12,451 AKI encounters based on race-agnostic algorithm 1, race adjustment reclassified 591 to No AKI and 305 to a less severe AKI stage. Of 12,251 AKI encounters based on race-agnostic algorithm 2, race adjustment reclassified 382 to No AKI and 196 (1.6%) to a less severe AKI stage. The phenotyping algorithm based on refit without race formula performed well in identifying patients with CKD and AKI with a sensitivity of 100% (95% confidence interval [CI] 97%-100%) and 99% (95% CI 97%-100%) and a specificity of 88% (95% CI 82%-93%) and 98% (95% CI 93%-100%), respectively. Race-agnostic algorithms identified substantial proportions of additional patients with CKD and AKI compared to race-adjusted algorithm in African American patients. The phenotyping algorithm is promising in identifying patients with kidney disease and improving clinical decision-making.

Identifying social determinants of health from clinical narratives: A study of performance, documentation ratio, and potential bias

ObjectiveTo develop a natural language processing (NLP) package to extract social determinants of health (SDoH) from clinical narratives, examine the bias among race and gender groups, test the generalizability of extracting SDoH for different disease groups, and examine population-level extraction ratio. MethodsWe developed SDoH corpora using clinical notes identified at the University of Florida (UF) Health. We systematically compared 7 transformer-based large language models (LLMs) and developed an open-source package – SODA (i.e., SOcial DeterminAnts) to facilitate SDoH extraction from clinical narratives. We examined the performance and potential bias of SODA for different race and gender groups, tested the generalizability of SODA using two disease domains including cancer and opioid use, and explored strategies for improvement. We applied SODA to extract 19 categories of SDoH from the breast (n = 7,971), lung (n = 11,804), and colorectal cancer (n = 6,240) cohorts to assess patient-level extraction ratio and examine the differences among race and gender groups. ResultsWe developed an SDoH corpus using 629 clinical notes of cancer patients with annotations of 13,193 SDoH concepts/attributes from 19 categories of SDoH, and another cross-disease validation corpus using 200 notes from opioid use patients with 4,342 SDoH concepts/attributes. We compared 7 transformer models and the GatorTron model achieved the best mean average strict/lenient F1 scores of 0.9122 and 0.9367 for SDoH concept extraction and 0.9584 and 0.9593 for linking attributes to SDoH concepts. There is a small performance gap (∼4%) between Males and Females, but a large performance gap (>16 %) among race groups. The performance dropped when we applied the cancer SDoH model to the opioid cohort; fine-tuning using a smaller opioid SDoH corpus improved the performance. The extraction ratio varied in the three cancer cohorts, in which 10 SDoH could be extracted from over 70 % of cancer patients, but 9 SDoH could be extracted from less than 70 % of cancer patients. Individuals from the White and Black groups have a higher extraction ratio than other minority race groups. ConclusionsOur SODA package achieved good performance in extracting 19 categories of SDoH from clinical narratives. The SODA package with pre-trained transformer models is available at https://github.com/uf-hobi-informatics-lab/SODA_Docker.

Tele-Oncology Use During the COVID-19 Pandemic: Patient Experiences and Communication Behaviors with Clinicians.

Background: Tele-oncology became a widely used tool during the COVID-19 pandemic, but there was limited understanding of how patient-clinician communication occurred using the technology. Our goal was to identify how communication transpired during tele-oncology consultations compared with in-person appointments. Methods: A convergent parallel mixed-method design was utilized for the web-based survey, and follow-up interviews were conducted with cancer patients from March to December 2020. Participants were recruited from the University of Florida Health Cancer Center and two national cancer organizations. During the survey, participants rated their clinician's patient-centered communication behaviors. Open-ended survey responses and interview data were combined and analyzed thematically using the constant comparative method. Results: A total of 158 participants completed the survey, and 33 completed an interview. Ages ranged from 19 to 88 years (mean = 64.2; standard deviation = 13.0); 53.2% identified as female and 44.9% as male. The majority of respondents (76%) considered communication in tele-oncology equal to in-person visits. Preferences for tele-oncology included the ability to get information from the clinician, with 13.5% rating tele-oncology as better than in-person appointments. Tele-oncology was considered worse than in-person appointments for eye contact (n = 21, 12.4%) and virtual waiting room times (n = 50, 29.4%). The following qualitative themes corresponded with several quantitative variables: (1) commensurate to in-person appointments, (2) uncertainty with the digital platform, (3) lack of a personal connection, and (4) enhanced patient experience. Conclusion: Patient-centered communication behaviors were mostly viewed as equally prevalent during tele-oncology and in-person appointments. Addressing the challenges of tele-oncology is necessary to improve the patient experience.

Examination of Pediatric Burn Incidence and the Impact of Social Determinants of Health in Florida.

Introduction Burn injuries are a major mechanism of trauma worldwide, caused by friction, cold, heat, radiation, chemical, or electric sources. Most often, burn injuries occur due to heat contact from hot liquids, solids, or fire, termed scald burns and flame burns, respectively. These types of injuries are complex and carry major injury and mortality risks, especially in pediatric populations. Burn trauma prevention has been a major focus in the US, with initiatives to increase public health outreach and safety measures. Unfortunately, children in socioeconomically disadvantaged situations may face these types of injuries at disproportionately higher rates, and we aim to highlight these disparities, if any, within our Florida community. Materials and methods This study was designed as a retrospective observational analysis using publicly available data from the Florida Health Community Health Assessment Resource Tool Set (CHARTS). Data was extracted for nonfatal burn injuries resulting in ED visits in the years 2018-2020. This data was limited to those ranging from 0 to 19 years old and converted to rates of burn injuries per 100,000. Sociodemographic details for each county were recorded from County Health Rankings & Roadmaps and compared with burn data in each respective county. Frequencies were generated for categorical data, and statistical analyses for burn rates and sociodemographic details were performed with a generalized linear model using a Poisson distribution and bivariate correlation for a p < 0.05. Results In Florida, the median annual burn rate per 100,000 was 136 (IQR: 96-179), with Jackson county holding the highest rate of 323 and Glades, Hardee, and Lafayette each holding a rate of 0. Of the 18 socioeconomic factors examined, a total of five were found to have no statistically significant effect on nonfatal burn injury ED visits: severe housing problems, percentage of Asians, teen births, percentage of children (<18 years) in poverty, and severe housing cost burden. The two most important factors to be found in nonfatal burn ED visits of pediatric patients were the percentage of those younger than 19 years old without health insurance and the average grade level performance of third-grader reading scores. When adjusting for the small sample size using Firth's bias-adjusted estimates and overdispersion, both reading scores and those without insurance play a significant role in pediatric burn injuries. For each increase in a single point in reading scores, the incidence rate ratio decreases by 97.1% (95% CI). For every percentage increase in children insured, there is a 28.8% decrease in pediatric burn injuries (95% CI). Conclusions This analysis highlights increased pediatric burn rates across multiple social determinants of health (SDOH) in all 67 Florida counties. The findings here demonstrate that there may continue to be a disproportionate distribution of burn rates among lower and higher sociodemographic areas. This study further highlights this trend within the Florida community, and continued research will be necessary to meet the needs of lower sociodemographic areas to improve burn rates in vulnerable populations, such as children, who are at increased risk of injury.

Abstract 1010: Feasibility of serial microbiome collection in a multi-site neoadjuvant pancreatic cancer clinical trial allowing for a diverse patient population

Abstract Background: Pancreatic cancer portends a very poor prognosis. It is the third leading cause of cancer deaths in the United States. African Americans have a 50- 90% increased incidence of pancreatic cancer in comparison to other racial groups. 20% of patients present with operable disease and will have a median overall survival of 2.5 years if able to undergo surgical resection. There is a desperate need to discover novel ways of treating pancreatic cancer. Understanding of the microbiome may be informative to overcoming chemotherapy resistance, toxicity and improving outcomes and disparities. The aim of this study is to (1) identify changes in the microbiota during neoadjuvant treatment of pancreatic ductal adenocarcinoma that correlate with treatment response and (2) identify changes in the microbiota during neoadjuvant treatment of pancreatic ductal adenocarcinoma that correlate with treatment toxicity in a diverse patient population. Methods: Patients with resectable or borderline resectable pancreatic cancer who are enrolled in a multi-site clinical trial (NCT03483038) receiving neoadjuvant NEO-Nali-IRI (oxaliplatin, liposomal irinotecan and 5- FU) followed by surgical resection were asked to provide serial microbiome collections of saliva, urine (collected in clinic), and stool with a dietary log during the following four (or five) time points: at baseline, mid-therapy (after C4), at completion of chemotherapy (after C8), after radiation if applicable, and at 4-6 weeks post-operative. Participants were given stool collection kits during clinic visits for home sample acquisition. All stool samples were mailed to the University of Florida Health Cancer Center Microbiome Biorepository. Demographics, stage, medical history and concurrent medications including antimicrobics and probiotics, chemotherapy dose-reductions, delays, discontinuations, adverse events, safety adverse events, attribution of causality, and hospitalizations were obtained. Outcomes include imaging response using RECIST criteria, CA 19-9 trend, development of metastatic disease, and the ability to proceed to definitive surgical resection. DNA will be extracted from stool and analyzed using 16S rRNA sequencing methods to determine signatures and alpha/beta biodiversity. Descriptive statistics and correlative analysis will be reported. Continuous and categorical variables will be compared with Student’s t-test and Chi-squared test. Multiple groups will be compared by ANOVA. Kaplan-Meier logistic regression will be performed to compare outcomes between the different microbiota groupings. Conclusion: Serial microbiome collection from a multi-site clinical trial is feasible during neoadjuvant chemotherapy for pancreatic cancer and can increase the diversity of the sample population. Citation Format: Sherise Rogers, Ryan Thomas, Ibrahim Nassour, Ilyas Sahin, Brian Ramnaraign, Karen Russell, Steven Hughes, Kathryn Hitchcock, Omar Kayaleh, Anita Turk, Maisey Ratcliff, Thomas George. Feasibility of serial microbiome collection in a multi-site neoadjuvant pancreatic cancer clinical trial allowing for a diverse patient population [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1010.

Abstract 471: Attenuation of circulating miR-17-5p, miR-20b-5p, and miR-106a-5p in low-risk prostate cancer patients following proton therapy

Abstract Introduction: Liquid biopsies offer a novel approach to diagnose, predict cancer outcomes, and monitor treatment response by analyzing tumor-derived substances. Circulating cell-free microRNAs (miRNAs) show clinical promise as biomarkers within prostate cancer (PCa) and have been implicated with PCa prognosis and outcomes. However, their potential for monitoring and assessing radiotherapy (RT) treatment response remains understudied. Understanding miRNA expression changes during RT is crucial, as they impact RT efficacy by directly affecting genes and proteins within RT-response pathways. Aim: This study aimed to profile the expression of three oncogenes, miR-17-5p, miR-20b-5p, and miR-106a-5p and to determine their association with PCa risk groups in patients receiving proton therapy (PT). Patients and Methods: Plasma was obtained from the University of Florida Health Proton Therapy Institute Outcomes Tracking Protocol biobank. Plasma was collected from men diagnosed with localized PCa without metastatic disease at three time points: prior to PT (PRE-PT), at 4 weeks following the start of PT (4WKSPD1), and at 8 weeks following the start of PT (8WKSPD1). The pilot study consisted of 38 patients, with 23 categorized as low-risk and 15 categorized as high-risk for PCa. MiRNA expression levels were evaluated using reverse transcription-polymerase chain reaction and quantified using the Livak method. Results: The study revealed a downregulation of miR-17-5p in response to PT, with median gene expression levels decreasing from 0.73 at PRE-PT to 0.587 at 8WKSPD1. Low-risk PCa patients also showed distinct miRNA expression changes with all three miRNAs (miR-17-5p, miR-20b-5p, and miR-106a-5p) downregulated from 0.953, 1.037, and 1.010 at PRE-PT to 0.398, 0.216, and 0.298 at 8WKSPD1, respectively. Statistical analysis using a Kruskal-Wallis test followed by a Dunn's post-hoc test identified significant differences (p=0.035) specifically between PRE-PT and 8WKSPD1 for miR-17-5p. Conclusion: The study revealed that PT led to a time-dependent reduction in miRNA levels, indicating a higher responsiveness in low-risk compared to high-risk PCa patients. This differential response highlights miR-17-5p, miR-20b-5p, and miR-106a-5p as potential PT response biomarkers, with clinical implications for personalizing PCa treatment. These results underscore the necessity for further validation of these miRNAs to maximize their clinical utility. Citation Format: Johnny Velasquez, Curtis Bryant, Nancy Mendenhall, Luisel Ricks-Santi. Attenuation of circulating miR-17-5p, miR-20b-5p, and miR-106a-5p in low-risk prostate cancer patients following proton therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 471.

MicroRNAs as biomarkers of brain injury in neonatal encephalopathy: an observational cohort study

Neonatal Encephalopathy (NE) is a major cause of lifelong disability and neurological complications in affected infants. Identifying novel diagnostic biomarkers in this population may assist in predicting MRI injury and differentiate neonates with NE from those with low-cord pH or healthy neonates and may help clinicians make real-time decisions. To compare the microRNA (miRNA) profiles between neonates with NE, healthy controls, and neonates with low cord pH. Moreover, miRNA concentrations were compared to brain injury severity in neonates with NE. This is a retrospective analysis of miRNA profiles from select samples in the biorepository and data registry at the University of Florida Health Gainesville. The Firefly miRNA assay was used to screen a total of 65 neurological miRNA targets in neonates with NE (n = 36), low cord pH (n = 18) and healthy controls (n = 37). Multivariate statistical techniques, including principal component analysis and orthogonal partial least squares discriminant analysis, and miRNA Enrichment Analysis and Annotation were used to identify miRNA markers and their pathobiological relevance. A set of 10 highly influential miRNAs were identified, which were significantly upregulated in the NE group compared to healthy controls. Of these, miR-323a-3p and mir-30e-5p displayed the highest fold change in expression levels. Moreover, miR-34c-5p, miR-491-5p, and miR-346 were significantly higher in the NE group compared to the low cord pH group. Furthermore, several miRNAs were identified that can differentiate between no/mild and moderate/severe injury in the NE group as measured by MRI. MiRNAs represent promising diagnostic and prognostic tools for improving the management of NE.

The frequency and timing of sepsis-associated coagulopathy in the neonatal intensive care unit.

Sepsis is a common cause of morbidity and mortality in the neonatal intensive care unit (NICU). The frequency and severity of sepsis-associated coagulopathy as well as its relationship to illness severity are unclear. We performed a single-center, retrospective, observational cohort study of all infants admitted to the University of Florida Health (UF Health), level IV NICU between January 1st 2012 to March 1st 2020 to measure the frequency of sepsis-associated coagulopathy as well as its temporal relationship to critical illness in the NICU population. All clinical data in the electronic health record were extracted and deposited into an integrated data repository that was used for this work. We identified 225 new sepsis episodes in 216 patients. An evaluation for sepsis-associated coagulopathy was performed in 96 (43%) episodes. Gram-negative pathogen, nSOFA score at evaluation, and mortality were greater among episodes that included a coagulopathy evaluation compared with those that did not. Abnormal coagulation results were common (271/339 evaluations; 80%) and were predominantly prothrombin times. Intervention (plasma or cryoprecipitate) followed a minority (84/271; 31%) of abnormal results, occurred in 40/96 (42%) episodes that were often associated with >1 intervention (29/40; 73%), and coincided with thrombocytopenia in 37/40 (93%) and platelet transfusion in 27/40 (68%). Shapley Additive Explanations modeling demonstrated strong predictive performance for the composite outcome of death and/or treatment for coagulopathy in neonates (f1 score 0.8, area under receiver operating characteristic curve 0.83 for those with abnormal coagulation values). The three most important features influencing the composite outcome of death or treatment for coagulopathy included administration of vasoactive medications, hematologic dysfunction assessed by the maximum nSOFA platelet score, and early sepsis (≤72 h after birth). A coagulopathy evaluation was performed in a minority of NICU patients with sepsis and was associated with greater illness severity and mortality. Abnormal results were common but infrequently associated with intervention, and intervention was contemporaneous with thrombocytopenia. The most important feature that influenced the composite outcome of death or treatment for coagulopathy was the administration of vasoactive-inotropic medications. These data help to identify NICU patients at risk of sepsis-associated coagulopathy.

Success in Heart Failure? An Investigation of Heart Failure Readmission Rates and Medication Regimen Optimization.

In May 2022, the American College of Cardiology updated their guideline-directed medical therapy for congestive heart failure (CHF) to include four pillars of therapy. These pillars aim to better control patients with heart failure (HF) and reduce the incidence of hospitalization by including an evidence-based beta-blocker, an angiotensin-converting enzyme inhibitor/ angiotensin receptor blocker/angiotensin receptor/ neprilysin inhibitor, a mineralocorticoid receptor antagonist, and newly recommended sodium glucose cotransporter 2-inhibitors. This study at University of Florida Health Central Florida Hospitals reviewed patients who were diagnosed with CHF and recorded if they were readmitted with a HF exacerbation within 30 days of an initial index admission. Patients had data obtained retrospectively using electronic medical records from patient hospital encounters within the study inclusion dates; 7/1/2022-9/30/2022. Hospital readmission rates for patients with CHF, and information on each patient's medication regimen was collected to see if they met medication optimization criteria. A total of 252 patients were evaluated, with 157 meeting the inclusion criteria. Of the patients included, 23 (14.6%) experienced a hospital readmission within 30 days because of acute HF exacerbation or worsening HF. After reviewing medication regimens, 60 patients (38.2%) were receiving treatment with one pillar of therapy, 72 (45.8%) with two pillars of therapy, 12 (7.6%) with three pillars of therapy, and one patient was treated with all four pillars of therapy. In conclusion, this study showed that the recommended pillars of therapy are not being implemented and patients with CHF may benefit from medication optimization.

Increased prevalence of erythema multiforme in patients with COVID-19 infection or vaccination

Several reports stated that erythema multiforme (EM) was associated with COVID-19 with detrimental outcomes in patients. However, since most of these are case reports, it is challenging to quantitively assess their associations. Therefore, our study aims to determine the prevalence of EM in the context of COVID-19. The study was designed as a retrospective cross-sectional hospital-based study of registered patients at the University of Florida Health Hospital. The ICD-10 codes for EM, COVID-19 infection, and COVID-19 vaccines were searched in the database. The odds ratio was calculated to assess the risk of EM after COVID-19 infection or vaccination. Our study included 43,547 patients with a history of COVID-19 infection, of whom 92 developed EM. Patients with COVID-19 infection were 6.68 times more likely to have EM than those without COVID-19 (P < 0.0001). Similarly, the risk of developing EM after COVID-19 vaccination was 2.7, significantly higher than the general population (P < 0.0001). The prevalence of EM following COVID-19 infection or vaccination significantly differs from the general population, highlighting the importance of monitoring patients for EM after COVID-19 infection and/or vaccination. It is imperative to disseminate awareness to clinicians and patients regarding the impact of COVID-19 on EM.

Provider perspectives on healthcare provision via telemedicine to persons with HIV living in an urban community

ObjectivesEngaging in HIV care is key to maintaining successful health outcomes for persons with HIV (PWH). Barriers to care affect engagement and can include access to transportation. Telemedicine has been used to overcome geographical barriers in rural settings, and PWH in urban areas without public transportation can also benefit from this strategy. The aim of this research is to explore the attitudes of providers in one health system about telemedicine after receiving training. MethodsFrom 2018–2020, a convenience sample of 112 providers at University of Florida Health in Jacksonville, FL were offered telemedicine training consisting of didactic, hands-on, and in-person support. Provider attitudes were assessed in pre- and post-training surveys, focus groups, and after telemedicine visits. Descriptive statistics and paired t-tests were used to analyze pre- and post-training surveys. ResultsReadiness and willingness to conduct telemedicine with PWH after training significantly increased among providers (n = 73). Providers reported increased readiness to conduct telemedicine visits (p < 0.0001), increased ability to communicate during telemedicine visits (p < 0.001), and increased confidence in troubleshooting technology issues (p < 0.0001). Of the 29 providers completing surveys after conducting telemedicine visits with PWH, 93 % reported that it was easy to access and use. Providers did report a sense of decreased patient-provider interaction via telemedicine. ConclusionFuture research should further explore provider experiences with telemedicine training and delivery to improve telemedicine training and to identify best practices and strategies/activities that promote remote efficient patient-provider interaction. Public interest summaryThe use of telemedicine has increased in all areas of health care, especially since the COVID-19 pandemic. Training providers to successfully care for patients in remote settings is essential, especially as technology platforms and capabilities evolve or become more complex. Telemedicine trainings help providers increase capacity to conduct telemedicine visits. Trainings standardize visit protocols, control provider and patient expectations, identify how to incorporate remote visits into routine clinic flows, provide tools for increasing provider competency to interact with patients and use technology features, and increase understanding of types of ongoing support providers require, such as administrative. This paper describes the attitudes of providers from University of Florida Health in Jacksonville, FL receiving training to deliver telemedicine to persons with HIV residing in an urban setting.

Impact of an enteral nutrition protocol in critically ill patients with burn injuries.

The objective of this study is to characterize the University of Florida (UF) Health Shands Burn Centers enteral nutrition protocol as it relates to total protein intake and clinical outcomes. This retrospective chart review study included 99 adult patients admitted to the UF Health Shands Burn Center from January 2012 through August 2016 with burns of twenty percent or greater TBSA and required enteral nutrition supplementation. Patients received an average of 137.8 g or 2.03 g/kg protein daily. Fifteen percent of patients experienced graft loss. The median length of stay was 35 days. Seventy-six percent survived to hospital discharge. There was no significant association between total protein intake and incidence of severe diarrhea (P=0.132). The institutions protocol achieved high protein administration while still being consistent with recommendations from the American Society of Enteral and Parenteral Nutrition (ASPEN).

Spatial patterns and sociodemographic predictors of chronic obstructive pulmonary disease in Florida.

Chronic obstructive pulmonary disease (COPD) is a chronic, inflammatory respiratory disease that obstructs airflow and decreases lung function and is a leading cause death globally. In the United States (US), the prevalence among adults is 6.2%, but increases with age to 12.8% among those 65 years or older. Florida has one of the largest populations of older adults in the US, accounting for 4.5 million adults 65 years or older. This makes Florida an ideal geographic location for investigating COPD as disease prevalence increases with age. Understanding the geographic disparities in COPD and potential associations between its disparities and environmental factors as well as population characteristics is useful in guiding intervention strategies. Thus, the objectives of this study are to investigate county-level geographic disparities of COPD prevalence in Florida and identify county-level socio-demographic predictors of COPD prevalence. This ecological study was performed in Florida using data obtained from the US Census Bureau, Florida Health CHARTS, and County Health Rankings and Roadmaps. County-level COPD prevalence for 2019 was age-standardized using the direct method and 2020 US population as the standard population. High-prevalence spatial clusters of COPD were identified using Tango's flexible spatial scan statistics. Predictors of county-level COPD prevalence were investigated using multivariable ordinary least squares model built using backwards elimination approach. Multicollinearity of regression coefficients was assessed using variance inflation factor. Shapiro-Wilks, Breusch Pagan, and robust Lagrange Multiplier tests were used to assess for normality, homoskedasticity, and spatial autocorrelation of model residuals, respectively. County-level age-adjusted COPD prevalence ranged from 4.7% (Miami-Dade) to 16.9% (Baker and Bradford) with a median prevalence of 9.6%. A total of 6 high-prevalence clusters with prevalence ratios >1.2 were identified. The primary cluster, which was also the largest geographic cluster that included 13 counties, stretched from Nassau County in north-central Florida to Charlotte County in south-central Florida. However, cluster 2 had the highest prevalence ratio (1.68) and included 10 counties in north-central Florida. Together, the primary cluster and cluster 2 covered most of the counties in north-central Florida. Significant predictors of county-level COPD prevalence were county-level percentage of residents with asthma and the percentage of current smokers. There is evidence of spatial clusters of COPD prevalence in Florida. These patterns are explained, in part, by differences in distribution of some health behaviors (smoking) and co-morbidities (asthma). This information is important for guiding intervention efforts to address the condition, reduce health disparities, and improve population health.

Lichen planus after COVID-19 infection and vaccination.

Lichen planus is one of the common adverse reactions after COVID-19 infection and vaccination. Despite it being reported in several case reports, the literature including a large sample of the studied population is lacking. The current study was performed to assess the risk of LP after COVID-19 infection as well as COVID-19 vaccination. The current study was designed as a retrospective cross-sectional hospital-based study of registered patients at the University of Florida (UF) health centers. The diagnoses of LP, COVID-19 infection, and COVID-19 vaccines were detected. The logistic regression model was used to assess the risk of developing LP after COVID-19 infection and vaccination. A total hospital patient of 684,110 attended UF Health centers were included in this study. 181 patients reported LP after COVID-19 vaccination and 24 patients developed LP after COVID-19 infection. The risk of developing LP after COVID-19 vaccination was 1.573 while the risk of developing LP after COVID-19 infection was 1.143. The odds of getting LP after COVID-19 vaccination are significantly developed. The current study showed that COVID-19 infection and vaccination are associated with LP. So, healthcare practitioners should be aware of this reaction for rapid recognition and treatment.

Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials.

Recruitment of cancer clinical trial (CCT) participants, especially participants representing the diversity of the US population, is necessary to create successful medications and a continual challenge. These challenges are amplified in Phase I cancer trials that focus on evaluating the safety of new treatments and are the gateway to treatment development. In preparation for recruitment to a Phase I recurrent head and neck cancer (HNC) trial, we assessed perceived barriers to participation or referral and suggestions for recruitment among people with HNC and community physicians (oncologist, otolaryngologistor surgeon). Between December 2020 and February 2022, we conducted a qualitative needs assessment via semistructured interviews with a race and ethnicity-stratified sample of people with HNC (n = 30: 12 non-Hispanic White, 9 non-Hispanic African American, 8 Hispanicand 1 non-Hispanic Pacific Islander) and community physicians (n = 16) within the University of Florida Health Cancer Center catchment area. Interviews were analyzed using a qualitative content analysis approach to describe perspectives and identify relevant themes. People with HNC reported thematic barriers included: concerns about side effects, safetyand efficacy; lack of knowledgeand systemic and environmental obstacles. Physicians identified thematic barriers of limited physician knowledge; clinic and physician barriersand structural barriers. People with HNC and physicians recommended themes included: improved patient education, dissemination of trial informationand interpersonal communication between community physicians and CCT staff. The themes identified by people with HNC and community physicians are consistent with research efforts and recommendations on how to increase the participation of people from minoritized populations in CCTs. This community needs assessment provides direction on the selection of strategies to increase CCT participation and referral. This study focused on people with HNC and community physicians' lived experience and their interpretations of how they would consider a future Phase I clinical trial. In addition to our qualitative data reflecting community voices, a community member reviewed the draft interview guide before data collection and both people with HNC and physicians aided interpretation of the findings.

Abstract PR018: Feasibility of serial microbiome collection in a multi-site neoadjuvant pancreatic cancer clinical trial allowing for a diverse patient population

Abstract Background: Pancreatic cancer portends a very poor prognosis. It is the third leading cause of cancer deaths in the United States. African Americans have a 50- 90% increased incidence of pancreatic cancer in comparison to other racial groups. 20% of patients with pancreatic cancer present with early-stage disease and will have a median overall survival of 2.5 years if able to undergo surgical resection. There is a desperate need to discover novel ways of treating pancreatic cancer. Understanding of the microbiome may be informative to overcoming chemotherapy resistance, toxicity and improving outcomes and disparities. The aim of this study is to (1) identify changes in the intestinal microbiota during neoadjuvant treatment of pancreatic ductal adenocarcinoma that correlate with treatment response and (2) identify changes in the intestinal microbiota during neoadjuvant treatment of pancreatic ductal adenocarcinoma that correlate with treatment toxicity in a diverse patient population. Methods: Patients with resectable or borderline resectable pancreatic cancer who are enrolled in a multi-site clinical trial (NCT03483038) receiving neoadjuvant NEO-Nali-IRI (oxaliplatin, liposomal irinotecan and 5- FU) followed by surgical resection were asked to provide serial microbiome collections of saliva, urine, blood, and stool with a dietary log during the following four (or five) time points: at baseline, mid-therapy (after C4), at completion of chemotherapy (after C8), after radiation if applicable, and at 4-6 weeks post-operative. Participants were given stool collection kits during clinic visits for home sample acquisition. All stool samples were mailed to the University of Florida Health Cancer Center Microbiome Biorepository. Saliva, urine and blood were collected during clinic visits. Demographics, stage, medical history and concurrent medications including antimicrobics and probiotics, chemotherapy dose-reductions, delays, discontinuations, adverse events, safety adverse events, attribution of causality, and hospitalizations were obtained. Outcomes include imaging response using RECIST criteria, CA 19-9 trend, development of metastatic disease, and the ability to proceed to definitive surgical resection. DNA will be extracted from stool and analyzed using 16S rRNA sequencing methods to determine signatures and biodiversity. Descriptive statistics and correlative analysis will be reported. Continuous and categorical variables will be compared with Student’s t-test and Chi-squared test. Multiple groups will be compared by ANOVA. Kaplan-Meier logistic regression will be performed to compare outcomes between the different microbiota groupings. Conclusion: Serial microbiome collection from a multi-site clinical trial is feasible during neoadjuvant chemotherapy for pancreatic cancer and can increase the diversity of the sample population. Citation Format: Sherise C. Rogers, Ibrahim Nassour, Ryan Thomas, Ilyas Sahin, Brian Ramnaraign, Karen Russell, Steven Hughes, Kathryn Hitchcock, Omar Kayaleh, Anita Turk, Ji-Hyun Lee, David DeRemer, Carmen Allegra, Thomas George. Feasibility of serial microbiome collection in a multi-site neoadjuvant pancreatic cancer clinical trial allowing for a diverse patient population [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr PR018.

A study of generative large language model for medical research and healthcare

There are enormous enthusiasm and concerns in applying large language models (LLMs) to healthcare. Yet current assumptions are based on general-purpose LLMs such as ChatGPT, which are not developed for medical use. This study develops a generative clinical LLM, GatorTronGPT, using 277 billion words of text including (1) 82 billion words of clinical text from 126 clinical departments and approximately 2 million patients at the University of Florida Health and (2) 195 billion words of diverse general English text. We train GatorTronGPT using a GPT-3 architecture with up to 20 billion parameters and evaluate its utility for biomedical natural language processing (NLP) and healthcare text generation. GatorTronGPT improves biomedical natural language processing. We apply GatorTronGPT to generate 20 billion words of synthetic text. Synthetic NLP models trained using synthetic text generated by GatorTronGPT outperform models trained using real-world clinical text. Physicians’ Turing test using 1 (worst) to 9 (best) scale shows that there are no significant differences in linguistic readability (p = 0.22; 6.57 of GatorTronGPT compared with 6.93 of human) and clinical relevance (p = 0.91; 7.0 of GatorTronGPT compared with 6.97 of human) and that physicians cannot differentiate them (p < 0.001). This study provides insights into the opportunities and challenges of LLMs for medical research and healthcare.

Clinician Response to Pharmacogenetic Clinical Decision Support Alerts.

The objective of this study was to characterize clinician response following standardization of pharmacogenetic (PGx) clinical decision support alerts at University of Florida (UF) Health. A retrospective analysis of all PGx alerts that fired at a tertiary academic medical center from August 2020 through May 2022 was performed. Alert acceptance rate was calculated and compared across six gene-drug pairs, patient care setting, and clinician specialty. The disposition of the triggering medication was compared with the alert response and evaluated for congruence. There were a total of 818 alerts included for analysis of alert response, 557 alerts included in acceptance rate calculations, and 392 alerts with sufficient information to assess clinical response. The overall acceptance rate was 63%. The alert response and clinical response were congruent for 47% of alerts. Alert response was influenced by the triggering gene-drug pair, clinician specialty, patient care setting, and specialty of the provider who initially ordered the PGx test. Clinical response was mostly incongruent with alert response. Alert acceptance is influenced by the triggering gene-drug pair, clinician specialty, and care setting. Alert response is not a reliable surrogate marker for clinical action. Any future research into the impact of clinical decision support (CDS) alerts should focus on clinical response rather than alert response. Given the reliance on CDS alerts to enhance uptake of PGx, it is worthwhile to further investigate their impact on prescribing and patient outcomes.