Medical University Of South Carolina Research Articles

Abstract PO5-08-08: Tumor Registry Guided Genetic Testing: Opportunities Unlocked

Abstract Introduction With the expansion of guidelines for germline genetic testing, more patients are eligible for testing. Unfortunately, many remain untested. Testing is critical, as patients with pathogenic variants (and their families) can benefit from more aggressive screening and preventative strategies, as well as targeted therapies (e.g., poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors) if cancer does occur. Objectives To study the prevalence of Hereditary Breast Ovarian Cancer (HBOC) genetic testing eligibility and uptake among cancer patients from the tumor registry at the Medical University of South Carolina (MUSC) in order to identify a group of living patients who require testing now. Methods This Quality Improvement study included patients 18 years of age or older diagnosed with breast, ovarian/fallopian/primary peritoneal, pancreas and prostate cancers between 1991 and 2021 as reported to the MUSC Tumor Registry. Each patient was evaluated using the latest National Comprehensive Cancer Network (NCCN) criteria for breast-ovarian genetic testing (Excluding family history criteria, which were not available in the tumor registry). Using our genetic testing database, we also determined which had had testing. We describe the prevalence of genetic testing performed vs the number of patients that would benefit from testing under the newest guidelines. Results Patients identified as eligible for testing included 399 breast cancer patients, all 544 ovarian/fallopian/primary peritoneal cancer patients, all 1534 pancreas cancer patients and 872 prostate cancer patients. Reported testing of eligible patients was low (breast: 35%, Ovarian: 33%, pancreas: 4%, and prostate cancer: 6%). Of eligible patients not tested, 310 patients with breast cancer, 343 patients with ovarian/fallopian/primary peritoneal cancer, 717 patients with pancreas cancer and 763 patients with prostate cancer, are alive and eligible for testing (2133 patients) Discussion Using Tumor Registry data plus genetic testing data allowed us to detect a large number of living patients with cancer that would be eligible for HBOC genetic testing. This is despite the fact that this approach underestimates the number of patients that would benefit from further testing as it does not include family history and other factors. A similar approach for colorectal or other cancers will yield additional patients. Conclusion Most cancer patients eligible for breast ovarian genetic testing have not been tested. There is an opportunity to use Tumor Registry and genetic testing data to identify a large number of living patients who can be approached for testing. As we showed in our study, by adopting updated cancer genetic testing guidelines, there is increased opportunity to detect more patients that would benefit from such testing. In our study this benefit is shown especially in the prostate and pancreas cancer groups. Next steps will be to determine how best to notify and make testing available to these patients. Table 1. Testing Status Comparison Assessing Genetic Testing Rates Using Tumor Registry Among Eligible Patients with Breast, Ovarian/Fallopian/Primary Peritoneum, Pancreas and Prostate cancer as per the New Testing Guidelines Citation Format: Kevin Hughes, Antoine Finianos, Kiersten Meeder. Tumor Registry Guided Genetic Testing: Opportunities Unlocked [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-08-08.

Converting IMPROVE bleeding and VTE risk assessment models into a fast-and-frugal decision tree for optimal VTE prophylaxis

AbstractCurrent hospital venous thromboembolism (VTE) prophylaxis for medical patients is characterized by both underuse and overuse. The American Society of Hematology (ASH) has endorsed the use of risk assessment models (RAM) as an approach to individualize VTE prophylaxis by balancing overuse (excessive risk of bleeding) and underuse (risk of avoidable VTE). ASH has endorsed IMPROVE (International Medical Prevention Registry on Venous Thromboembolism) risk assessment models; the only RAM to assess short-term bleeding and VTE risk in acutely ill medical inpatients. ASH, however, notes that no RAMs have been thoroughly analyzed for their effect on patient outcomes. We aimed to validate the IMPROVE models and adapt them into a simple, fast-and-frugal (FFT) decision tree to evaluate the impact of VTE prevention on health outcomes and costs. We used 3 methods: the “best evidence” from ASH guidelines, a “learning health system paradigm” combining guideline and real-world data from the Medical University of South Carolina (MUSC), and a “real-world data” approach based solely on MUSC data retrospectively extracted from electronic records. We found that the most effective VTE prevention strategy used the FFT decision tree, guided by an IMPROVE VTE score of ≥2 or ≥4 and a bleeding score of <7. This method could prevent 45% of unnecessary treatments, saving ∼$5 million annually for patients such as the MUSC cohort. We recommend integrating IMPROVE models into hospital electronic medical records as a point-of-care tool, thereby enhancing VTE prevention in hospitalized medical patients.

Higher education response to institutional upheaval: Outcomes of industry collaborations during the COVID-19 pandemic

Institutional upheaval spurred by the COVID-19 crisis suddenly and dramatically transformed the rules of the game for higher education organizations. The global pandemic thrust colleges and universities into ambiguous institutional environments. Disruption of established routines and supply networks resulted in the near collapse of global supply chains providing personal protective equipment (PPE), particularly N95 masks, needed by healthcare workers on the medical frontlines. This study describes and analyzes higher education and industry (HEI) partnership collaborations that adapted rapidly and responded effectively to meet the critical PPE need. The Citadel, Military College of South Carolina (The Citadel), along with the Tommy and Victoria Baker School of Business (BSB) and its Innovation Lab., engaged in a partnership with medical professionals at the Medical University of South Carolina (MUSC). This partnership successfully manufactured, assembled, and distributed one thousand 3D-printed N95 masks in a crucial 16-week period. The study also shows how organizations in both institutional fields were able to expand dynamic capabilities enabling them to sense opportunities and to seize them by engaging and supporting each other in rapid and effective resource reconfigurations. This HEI collaboration culminated in a memorandum of understanding for ongoing collaboration to develop innovations for future responses to healthcare challenges.

The role of stroke care infrastructure on the effectiveness of a hub-and-spoke telestroke model in South Carolina

ObjectiveTo examine the relationship between stroke care infrastructure and stroke quality-of-care outcomes at 29 spoke hospitals participating in the Medical University of South Carolina (MUSC) hub-and-spoke telestroke network. Materials and methodsEncounter-level data from MUSC's telestroke patient registry were filtered to include encounters during 2015-2022 for patients aged 18 and above with a clinical diagnosis of acute ischemic stroke, and who received intravenous tissue plasminogen activator. Unadjusted and adjusted generalized estimating equations assessed associations between time-related stroke quality-of-care metrics captured during the encounter and the existence of the two components of stroke care infrastructure—stroke coordinators and stroke center certifications—across all hospitals and within hospital subgroups defined by size and rurality. ResultsTelestroke encounters at spoke hospitals with stroke coordinators and stroke center certifications were associated with shorter door-to-needle (DTN) times (60.9 min for hospitals with both components and 57.3 min for hospitals with one, vs. 81.2 min for hospitals with neither component, p <.001). Similar patterns were observed for the percentage of encounters with DTN time of ≤60 min (63.8% and 68.9% vs. 32.0%, p <.001) and ≤45 min (34.0% and 38.4% vs. 8.42%, p <.001). Associations were similar for other metrics (e.g., door-to-registration time), and were stronger for smaller (vs. larger) hospitals and rural (vs. urban) hospitals. ConclusionsStroke coordinators or stroke center certifications may be important for stroke quality of care, especially at spoke hospitals with limited resources or in rural areas.

Supporting clinical research professionals through educational innovations.

Clinical Research Professionals (CRPs) are essential members of the Clinical and Translational Research Workforce. Many academic medical institutions struggle to recruit and retain these vital team members. One strategy to increase job satisfaction and promote the retention of CRPs is through educational initiatives that provide training and professional development. The South Carolina Clinical and Translational Research (SCTR) Institute Workforce Development (WD) team at the Medical University of South Carolina (MUSC) developed several trainings as part of our larger educational portfolio for CRPs. In 2022 WD implemented a digital badge micro-credential for SCTR's Core Clinical Research Training (CCRT) course in collaboration with institution-wide education and technology offices. Beginning in January 2023, individuals were able to earn the CCRT Certified Digital Badge upon successful completion of the CCRT course.

Abstract C067: Evaluation of data from a new mobile HPV vaccination program in South Carolina, U.S.

Abstract Purpose: Human papillomavirus (HPV) infections are linked to at least six different types of cancer. The Medical University of South Carolina (MUSC) Hollings Cancer Center (HCC) and Department of Pediatrics leaders identified less-than-optimal HPV vaccination rates in rural and medically underserved communities in South Carolina (SC) (80% in urban cities vs. 62% in rural areas). Forty-three percent of SC’s 46 counties include areas classified as rural by the U.S. Census, and 14% of the state’s population lives in rural areas. SC’s population demographics are typical of the Deep South region of the U.S. and primarily comprise non-Hispanic White (69%) and non-Hispanic Black (27%) residents, with a small but growing Hispanic/Latinx population (6.0%).  SC compares unfavorably with the U.S. averages in educational levels and per capita and median household incomes. These social determinants of health-related factors contribute to lower levels of knowledge about, and access to, the HPV vaccine.  Methods: To address the major public health issue of low HPV vaccination rates in rural SC, the MUSC HCC and Department of Pediatrics created a statewide community engagement-focused HPV Vaccination Van Program with funding from the HealthyMe/HealthySC (HMHSC) program and MUSC HCC. The Program launched in October of 2021. It  provides HPV and other childhood vaccinations in school districts, HMHSC health clinics, and other community settings throughout SC, focusing on children aged 9–18 years who are eligible for the U.S. Centers for Disease Control and Prevention’s Vaccines for Children Program. The prioritization of the selection of counties for inclusion in the Program is based on geospatial analyses highlighting the current HPV vaccination rates in each county. Results: As of 5 June 2023, the Program has administered childhood vaccinations to 734 participants in 28/46 counties (60%) of SC. Three-hundred and forty-six of the participants received HPV vaccinations. They were predominantly female (56.4%), aged 4–18 years (97.1%), and self-identified as non-Hispanic White (46.0%), non-Hispanic Black (31.9%), Hispanic/Latino (14.9%), Asian American (1.2%), Multiracial (3.3%), or Other (2.4%), with 0.3% of the participants not reporting their racial/ethnic identification. Slightly more than half of the participants (52.9%) had Medicaid insurance  and 25.1% reported having no insurance coverage. Conclusions: The number of children receiving the HPV vaccine through the Program, and the number of counties served, is expected to expand as the Program’s relationship with SC’s school districts and other community-based organizations grows. The Program provides a model for delivering mobile HPV vaccinations to rural children, thus reducing their cancer risk. Citation Format: Marvella E. Ford, Kathleen B. Cartmell, Angela M. Malek, Nhi Phuong Le, Chloe Keeve, I'Ayana Sanders, Jerlinda Ross, Melanie Slan, Joan McLauren, Mina Platt, Ellen Gomez, Jessica Zserai, Beth Poore, Christina Cody, Victoria Ladd, Mary S. Beattie, J. David Suddoth, Kapri Kreps, James R. Roberts. Evaluation of data from a new mobile HPV vaccination program in South Carolina, U.S. [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 C067.

Examining Utilization of an Outpatient Telenutrition Service Across Primary Care Clinics in South Carolina.

Introduction: Limited research exists on outpatient telenutrition, and more evidence is needed on service utilization and program evaluation. This study explored service utilization trends and patterns of the Medical University of South Carolina (MUSC) Outpatient Telehealth Nutrition (OT Nutrition) service. Methods: De-identified patient service utilization data were obtained from MUSC's OT Nutrition administrative files (2012-2020). Service utilization (referrals, visits scheduled, consultations, no-shows, no-show rate) was measured at the clinic level and stratified by patient type (adult/pediatric) and clinic rurality (rural/urban). Data were analyzed using descriptive statistics and a K-means cluster analysis. Results: Service utilization (2012-2020) reflected 6,212 referrals, 3,993 visits scheduled, and 2,880 consultations across 56 clinics. Yearly utilization trends showed high variability with no statistically significant differences observed on univariate comparisons of patient type or clinic rurality. The introduction of the Direct-To-Consumer modality mitigated a 36.7% decrease in consultations during the COVID-19 pandemic in 2020. Results of a K-means cluster analysis (p < 0.001) indicated 7% (n = 4) of clinics were very high and high utilizers, 36% (n = 21) were moderate and low utilizers, and 53% (n = 31) were very low utilizers. Discussion: Telenutrition can be delivered effectively to patients without requiring travel outside patients' medical homes or residences. Although continued advocacy is necessary for South Carolina to expand telenutrition coverage, more research is needed to evaluate the OT Nutrition service. Cluster analysis is an effective tool for identifying statistically significant groupings of clinics based on service utilization and could be used with implementation science in future program evaluation.

Implementation Mapping for Managing Patients at High Risk for Hereditary Cancer

IntroductionCurrently, no standard workflow exists for managing patients with pathogenic variants (PVs) that put them at higher risk for hereditary cancers. As a result, follow-up care for individuals with PVs is logistically challenging and results in poor guideline adherence. This research addressed this challenge by creating clinical management strategies for individuals identified as high risk for hereditary cancers. MethodsAn implementation mapping approach was used to develop and evaluate the establishment of a Hereditary Cancer Clinic (HCC) at the Medical University of South Carolina (MUSC) throughout 2022 and 2023. This approach consisted of five steps: conduct a needs assessment, identify objectives, select implementation strategies, produce implementation protocols, and develop an evaluation plan. The needs assessment consisted of qualitative interviews with patients (n=11), specialists (n=9), and members of the implementation team (n=4). Interviews were coded using the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to establishment of the HCC. Objectives were identified, then the team selected implementation strategies, and produced implementation protocols to address concerns identified during the needs assessment. A second round of patient interviews was conducted to assess patient education materials. ResultsThe research team developed a long-term evaluation plan to guide future assessment of implementation, service, and clinical/patient outcomes. ConclusionsThis approach provides the opportunity for real-time enhancements and impact, with strategies for care specialists, patients, and implementation teams. Findings support ongoing efforts to improve patient management and outcomes, while providing an opportunity for long-term evaluation of implementation strategies and guidelines for patients at high risk for hereditary cancers.

Anticipating adaptation: tracking the impact of planned and unplanned adaptations during the implementation of a complex population-based genomic screening program.

In 2021, the Medical University of South Carolina (MUSC) launched In Our DNA SC. This large-scale initiative will screen 100,000 individuals in South Carolina for three preventable hereditary conditions that impact approximately two million people in the USA but often go undetected. In anticipation of inevitable changes to the delivery of this complex initiative, we developed an approach to track and assess the impact of evaluate adaptations made during the pilot phase of program implementation. We used a modified version of the Framework for Reporting Adaptations and Modification-Enhanced (FRAME) and Adaptations to code adaptations made during the 3-month pilot phase of In Our DNA SC. Adaptations were documented in real-time using a REDCap database. We used segmented linear regression models to independently test three hypotheses about the impact of adaptations on program reach (rate of enrollment in the program, rate of messages viewed) and implementation (rate of samples collected) 7 days pre- and post-adaptation. Effectiveness was assessed using qualitative observations. Ten adaptations occurred during the pilot phase of program implementation. Most adaptations (60%) were designed to increase the number and type of patient contacted (reach). Adaptations were primarily made based on knowledge and experience (40%) or from quality improvement data (30%). Of the three adaptations designed to increase reach, shortening the recruitment message potential patients received significantly increased the average rate of invitations viewed by 7.3% (p = 0.0106). There was no effect of adaptations on implementation (number of DNA samples collected). Qualitative findings support improvement in effectiveness of the intervention after shortening the consent form and short-term positive impact on uptake of the intervention as measured by team member's participation. Our approach to tracking adaptations of In Our DNA SC allowed our team to quantify the utility of modifications, make decisions about pursuing the adaptation, and understand consequences of the change. Streamlining tools for tracking and responding to adaptations can help monitor the incremental impact of interventions to support continued learning and problem solving for complex interventions being delivered in health systems based on real-time data.

Shannon D. Jones, MLS, MEd, AHIP, FMLA, Medical Library Association President, 2022-2023.

In this profile, Shannon D. Jones, MLS, MEd, AHIP, FMLA, Medical Library Association President, 2022-2023, MJ Tooey describes her as someone who "takes chances on people, valuing those others might not see as valuable". Jones embraces lifelong learning, and it shows up in her collegiate journey; she has been a student of leadership, a leader of institutions, especially within the Medical Library Association (MLA); and a leader in librarianship. She is a trailblazer, the second African American MLA president, and a champion of diversity, equity, inclusion, and belonging. Jones has been Director of Libraries & Professor at the Medical University of South Carolina (MUSC) for the past seven years and is also Director of Region 2 of the National Network of Libraries of Medicine, National Library of Medicine.

Evaluation of the First-Year Data from an HPV Vaccination Van Program in South Carolina, U.S.

Human papillomavirus (HPV) infections are linked to at least six different types of cancer. The Medical University of South Carolina (MUSC) Hollings Cancer Center (HCC) and Department of Pediatrics leaders identified suboptimal rates of HPV vaccinations in rural and medically underserved communities in South Carolina (SC). To address this major public health problem in SC, they received funding from the HealthyMe/HealthySC (HMHSC) program and HCC to create a statewide community engagement-focused HPV Vaccination Van Program in October 2021. The Program provides HPV vaccinations and other childhood immunizations in school districts and HMHSC health clinics throughout SC, focusing on children aged 9-18 who are eligible for the U.S. Centers for Disease Control and Prevention's Vaccines for Children Program. As of 14 December 2022, the Program administered vaccinations in 16 counties of SC to 552 participants, 243 of whom received HPV vaccinations and were predominantly female (57.2%), aged 4-18 (95.9%), and self-identified as White (44.0%), Black (33.2%), or Hispanic/Latino (15.1%). Most had Medicaid (53.1%)/no insurance coverage (25.1%). The Program is expected to expand as the Program's relationship with SC's school districts grows. The Program provides a model for delivering mobile HPV vaccinations to rural children, thus reducing their cancer risk.

637. Transplant Candidacy for Persons Living with HIV and End-Stage Renal Disease at MUSC

Abstract Background Persons Living with HIV (PLWH) with chronic kidney disease progress to end-stage renal disease (ESRD) at a faster rate than HIV-negative individuals. Unfortunately, there is increasing data to suggest that PLWH are less likely to be waitlisted. We reviewed the transplant care continuum among PLWH at the Medical University of South Carolina (MUSC). Methods This was a retrospective review of PLWH and ESRD who either received care at MUSC Health Care System or were referred for Kidney transplant at MUSC between May 1st, 2012 and December 31st, 2021. Cases were included if a PLWH and ESRD had not died before being referred for kidney transplant, had evidence of pursuit of kidney transplant, and sufficient data of their transplant process were available in the medical record system. Descriptive statistics were used to analyze demographic and clinical characteristics as well as the transplant care continuum of PLWH and ESRD at MUSC. Results 57 PLWH and ESRD were included in the analysis. Of these, 45 (79%) were referred for kidney transplant (Table 1). The median age at the time of referral was 52 (range 26 - 78), 33 (73%) were males and 42 (93%) were of the Black race. The most common causes of ESRD were Multifactorial (36%), HIV-Associated Nephropathy (24%) and unknown (16%). Almost all patients had hypertension (96%) and 29% of patients had diabetes. Additionally, prevalent comorbidities include psychiatric conditions (53%), history of substance use (43%) and history of tobacco use (36%). Of those referred for kidney transplantation, 32 (71%) started a transplant evaluation, 24 (53%) completed the transplant evaluation, 22 (49%) were waitlisted, and 13 (29%) were transplanted. Common reasons why patients did not complete transplant evaluation included not meeting HIV criteria for transplant (9%), having too many comorbidities (9%), and not completing testing (9%). Clinical Characteristics of the 45 HIV Patients with ESRD Who Were Referred to Kidney Transplant at MUSC Clinical Data on Transplant Care Continuum, n = 45 Conclusion The majority of PLWH with ESRD seen at MUSC were referred for kidney transplant and started the evaluation process. More is needed, though, to assist patients in completing the transplant evaluation process and making it to the transplant waitlist, with the ultimate goal of transplantation. Disclosures All Authors: No reported disclosures.

The Emergence of Virtual Tumor Boards in Neuro-Oncology: Opportunities and Challenges.

BackgroundVirtual tumor board (VTB) platforms are an important aspect of cancer management. They enable easier access to a multidisciplinary team of experts. To deliver high-quality cancer care, it is necessary to coordinate numerous therapies and providers, share technical knowledge, and maintain open lines of communication among all professionals involved. The VTB is an essential tool in the diagnosis and treatment of brain cancer. For patients with glioma and brain metastases, multidisciplinary tumor board guidelines should guide diagnosis and therapy throughout the course of the illness. VTBs are an emerging resource across various cancer care networks in the United States.MethodologyWe performed a systematic search of all VTBs incorporating a platform designed for this specific role. We reviewed the records of the Genomet VTB, the Medical University of South Carolina (MUSC) VTB, and Xcures VTB. Summary data examined included the year of launch, demographics, characteristics of cases, average response time, advantages, and how they handle protected health information.ResultsOverall, 30% of VTBs examined were launched in 2017. All had a Health Insurance Portability and Accountability Act-compliant online environment. On a review of Xcures records, the median age of the female patients was 57 years and the median age of the male patients was 55 years. The data showed that 44% (4.4 out of every 10 patients) with a confirmed treatment chose the VTB integrated option. Overall, 76% of patients in the Xcures registry had primary central nervous system tumors, with at least 556 patients in the tumor registry which included 46% glioblastoma cases (96% primary, 4% secondary). In the MUSC VTB project, 112 thoracic tumor cases and nine neuro-oncology cases were reviewed. The tumor board met weekly, and the average response time was within 24 hours of case review and presentation. The Genomet VTB de-identifies all patient information; this is a virtual platform primarily focused on neuro-oncology cases. Cases involved a median of five specialists most commonly neuro-oncologists, neurosurgeons, radiation oncologists, molecular pathologists, and neuroradiologists. The case review revealed an age range of six months to 84 years (mean age = 44.5 years), with 69.6% males and 30.4% females, 43.5% glioblastomas, 8.7% adenocarcinomas, and 8.7% infratentorial tumors. The average response time observed in all cases was ≤24 hours.ConclusionsVTBs allow for quicker expert analysis of cases. This has resulted in an accelerated number of cases reviewed with a shortened communication time. More studies are needed to gain additional insights into user engagement metrics.

A pragmatic implementation research study for In Our DNA SC: a protocol to identify multi-level factors that support the implementation of a population-wide genomic screening initiative in diverse populations

BackgroundIn 2021, the Medical University of South Carolina (MUSC) partnered with Helix, a population genetic testing company, to offer population-wide genomic screening for Centers for Disease Control and Preventions’ Tier 1 conditions of hereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemia to 100,000 individuals in South Carolina. We developed an implementation science protocol to study the multi-level factors that influence the successful implementation of the In Our DNA SC initiative.MethodsWe will use a convergent parallel mixed-methods study design to evaluate the implementation of planned strategies and associated outcomes for In Our DNA SC. Aims focus on monitoring participation to ensure engagement of diverse populations, assessing contextual factors that influence implementation in community and clinical settings, describing the implementation team’s facilitators and barriers, and tracking program adaptations. We report details about each data collection tool and analyses planned, including surveys, interview guides, and tracking logs to capture and code work group meetings, adaptations, and technical assistance needs.DiscussionThe goal of In Our DNA SC is to provide population-level screening for actionable genetic conditions and to foster ongoing translational research. The use of implementation science can help better understand how to support the success of In Our DNA SC, identify barriers and facilitators to program implementation, and can ensure the sustainability of population-level genetic testing. The model-based components of our implementation science protocol can support the identification of best practices to streamline the expansion of similar population genomics programs at other institutions

The consortium of Researchers for ECT (CORE) - past, present and future

Abstract The Consortium of Researchers for ECT (CORE) was established in 1996 with the goal to conduct multicenter clinical trials in Electroconvulsive Therapy (ECT). The group comprised of four clinical sites: Medical University of South Carolina (MUSC) in Charleston, SC, Mayo Clinic, Rochester MN, University of Texas SW, Dallas TX, and Hillside Hospital, Glen Oaks NY, NY. The database coordinating center was based at MUSC. The CORE group conducted 3 multicenter clinical trials, all funded by the National Institute of Mental health (NIMH). The first study by the group compared the clinical outcomes of 201 patients who were randomly assigned to receive continuation ECT or continuation pharmacotherapy for 6 months after a successful course of bitemporal ECT for major depression. This is the first randomized controlled trial to establish the clinical effectiveness of continuation ECT. The second study by the CORE group, with the addition of the New Jersey Medical School in Newark, NJ and the subtraction of the clinical site of MUSC, compared the effectiveness and tolerability of the 3 most used electrode placements, i.e. bitemporal, bifrontal and right unilateral (RUL) for the treatment of unipolar depression. The study found only numerical but no statistically significant differences in the efficacy and tolerability of the 3 placements with bitemporal slightly more effective than bifrontal and frontal slightly more effective than RUL. The third study by the group, Preventing Relapse in Depressed Elderly (PRIDE) compared the efficacy and tolerability of continuation ECT plus venlafaxine to venlafaxine alone in preventing relapse after acute ECT in geriatric patients. The combination of venlafaxine and continuation ECT was superior to venlafaxine alone. We’ll discuss in detail the primary results of the above studies, as well as additional analyses that have contributed to the shaping of the current clinical practice of ECT. Keywords: Electroconvulsive, Multicenter, Depression, Research Collaboration

472. Clinical Outcomes of Solid Organ Transplant Recipients with Severe Acute Respiratory Syndrome Coronavirus 2: 2021 Update

BackgroundThe Centers for Disease Control and Prevention identified solid organ transplant (SOT) recipients as persons at high risk to develop severe illness secondary to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). We reviewed the clinical characteristics and outcomes of SOT recipients who had SARS-CoV-2 at our center. MethodsThis was a retrospective review of SOT recipients diagnosed with SARS-CoV-2 between March 1st 2020 and February 28th 2021 in the Medical University of South Carolina (MUSC) Health Care system. Subjects were included if they had undergone SOT at any time prior to a positive SARS-CoV-2 PCR. Descriptive statistics were used to analyze demographic and clinical characteristics. Primary outcomes included need for hospitalization, complications, and estimated all-cause mortality. Results96 SOT recipients were diagnosed with SARS-CoV-2. Seven patients were excluded as they initially tested positive and were admitted to another facility or had a simultaneously positive IgG. 89 SOT recipients were analyzed, of which, 39 (44%) were managed as an outpatient and 50 (56%) required admission. 13 (33%) of outpatient recipients were treated with a monoclonal antibody. Of those hospitalized, 24 (48%) were male, 34 (68%) were Black, and 34 (68%) were kidney transplant recipients. Median age at positive test was 53 years of age and median time from transplant to positive test was 3.1 years. Median length of stay was three days (range 0.1–108.6). 17 (34%) patients required supplemental oxygen and 11 (22%) received care in the intensive care unit. Complications, including bacterial infections (16%), fungal infections (2%), CMV reactivation (6%), and rejection (2%) were rare. Three patients (3%) died during the study time period. ConclusionThe majority of SOT recipients with SARS-CoV-2 in our cohort required admission, however they experienced few complications and a low mortality, despite their high-risk status. Disclosures All Authors: No reported disclosures

Support Methodologies for African American Women With Lupus - Comparing Three Methods' Effects on Patient Activation and Coping.

Introduction: Systemic lupus erythematosus (SLE) is a chronic inflammatory disease in which the immune system attacks healthy tissues. While pharmaceutical therapies are an important part of disease management, behavioral interventions have been implemented to increase patients’ disease self-management skills, provide social support, and encourage patients to take a more active role in their care.Methods: Three interventions are considered in this study; peer-to-peer methodology, patient support group, and a patient navigator program that were implemented among largely African American women with SLE at the Medical University of South Carolina (MUSC). Outcomes of interest were patient activation and lupus self-efficacy. We used a Least Squares Means model to analyze change in total patient activation and lupus self-efficacy independently in each cohort. We adjusted for demographic variables of age, education, income, employment, and insurance.Results: In both unadjusted and adjusted models for patient activation, there were no statistically significant differences among the three intervention methodologies when comparing changes from baseline to post intervention. Differences in total coping score from baseline to post intervention in the patient navigator group (−101.23, p-value 0.04) and differences in scores comparing the patient navigator with the support group were statistically significant (116.96, p-value 0.038). However, only the difference in total coping from baseline to post intervention for the patient navigator program remained statistically significant (−98.78, p-value 0.04) in the adjusted model.Conclusion: Tailored interventions are a critical pathway toward improving disease self-management among SLE patients. Interventions should consider including patient navigation because this method was shown to be superior in improving self-efficacy (coping scores).

Editorial introductions.

Current Opinion in Otolaryngology & Head and Neck Surgery was launched in 1993. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The fields of otolaryngology and head and neck surgery are divided into 11 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Ravi N. Samy and Nael ShomanRavi N. SamyDr Ravi N. Samy, MD, FACS is Chief of the Division of Otology/Neurotology and Associate Professor in the Department of Otolaryngology – Head and Neck Surgery at the University of Cincinnati / Cincinnati Children's Hospital Medical Center, USA. Dr Ravi N. Samy has been a Neurotologist at the University of Cincinnati / Cincinnati Children's Medical Center Gardner Neuroscience Institute and the program director of the Neurotology Fellowship at the UC College of Medicine since 2005. He is also the director of the Adult Auditory Implant Program as well as a Professor of Otolaryngology. Dr Samy was born in what is now known as Chennai, India, and immigrated to the United States at the age of 4. After living for one year in Canton, Ohio and 3 years in Connecticut, he spent most of his formative years living in Texas. He went to Duke University in North Carolina for his undergraduate education. After graduating magna cum laude with a bachelor's degree in zoology, Dr Samy attended the Duke University School of Medicine until his graduation in 1995. He then completed his resident training at Stanford University School of Medicine, where he developed a love for otology, neurotology and skull base surgery. Dr Samy spent two years at the University of Iowa as a Neurotology fellow before moving back to Texas to be an assistant professor at the UT-Southwestern Medical Center in Dallas. Dr Samy decided to move to Cincinnati because he was enamored with the phenomenal academic opportunity he found in the Department of Otolaryngology at UCMC and Cincinnati Children's Hospital Medical Center (CCHMC). During his time at UCMC he has created an ACGME accredited, two-year Neurotology fellowship, which is one of approximately 20 in the country. His research interests include cochlear and auditory brainstem implantation as well as acoustic neuromas, neurofibromatosis type 2, facial nerve tumors and other diseases and disorders of the lateral skull base. Dr Samy is also interested in using novel techniques and technologies to eradicate tumors, such as the use oncolytic virotherapy. He is collaborating with researchers in India to incorporate these technologies to enhance global health and increase collaboration between UC and international institutions, thus benefiting both US citizens and those of other nations. Robert S. Hong and Zhengqing HuRobert S. HongDr Robert S. Hong, MD, PhD is a partner, Chief Financial Officer and Director of Research at Michigan Ear Institute. He is also an Associate Professor in the Department of Otolaryngology- Head & Neck Surgery at Wayne State University, and has joint appointments at Oakland University William Beaumont School of Medicine and the College of Human Medicine at Michigan State University. Dr Hong received his undergraduate degree at Harvard University and medical degree from the University of California at Irvine. He completed his otolaryngology residency at the University of Iowa and his accredited fellowship in ear and skull base surgery at Michigan Ear Institute. He is board-certified in adult and pediatric Neurotology, Otology, Otolaryngology, and Skull Base Surgery. He has a PhD in Speech and Hearing Sciences from the University of Iowa for his work toward improving the understanding of speech in noise by cochlear implant recipients. He has also completed research fellowships sponsored by the National Institutes of Health and the Doris Duke Foundation. Dr Hong is a member of the American Academy of Otolaryngology- Head & Neck Surgery the American Neurotology Society, the Otosclerosis Study Group, and the Michigan Otolaryngological Society. He is chairman of the ANS Social Media Committee and serves as President-Elect for the Michigan Otolaryngological Society. He has been the principal investigator for numerous clinical studies, including those involving Meniere's disease, tinnitus, otosclerosis, cochlear implants and other implantable hearing devices. Dr Hong is the Chief Medical Director for the Robert H. Mathog Lions Hearing Centers, Lions Foundation of Michigan— a charitable organization dedicated to providing hearing-related services to individuals and communities through screening, diagnosis, treatment, education and research, regardless of ability to pay. He is also a past Chairman of the Lions Hearing Center of Michigan and a past Director of the Lions Hearing Clinic at Michigan Ear Institute. Zhengqing HuZhengqing HuDr Zhengqing Hu, MD and PhD is Professor and Director of the Stem Cell Research Laboratory in the Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, USA. Dr Hu is also a Health Science Specialist and the Director of the Hearing Regeneration Laboratory at the John D. Dingell Veterans Affairs (VA) Medical Center, Detroit, Michigan. Dr Hu was born in Shanghai, China, where he lived for 30 years. He received his M.D. from Shanghai Medical University (currently Fudan University Shanghai Medical College), Shanghai, China. He had the residency and fellowship training, together with a PhD program focusing on neurotology and hearing research in HuaShan Hospital and EENT Hospital in Shanghai Medical University. Dr Hu became a faculty member and Attending Doctor in Renji Hospital, Shanghai Second Medical University (currently Jiaotong University School of Medicine), Shanghai, China. He went to Karolinska Institute, Stockholm, Sweden, for his second PhD program focusing on cell replacement therapy for the inner ear, which was supported by the fellowships from the Swedish Institute and Karolinska Institute-Chinese Academy of Medical Sciences. Dr Hu attended the University of Virginia for his postdoctoral training after completing his second PhD study. He joined the Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine as a faculty member and established his laboratory in 2009. He set up his hearing regeneration laboratory in John D. Dingell VA Medical Center in 2018. He has been funded by NIH, VA, and private hearing research foundations, including the American Hearing Research Foundation, Deafness Research Foundation, National Organization for Hearing Research Foundation, and the American Academy of Audiology. He is the member of the study section of national and international grant review committees, professional journal editorial committees, and professional societies. His laboratories explore stem cell-based biological and translational strategies to replace injured sensory cells and synapses to rescue hearing loss. His research focuses on inner ear developmental biology, stem cell biology, auditory synapse biology, epigenetics, and hearing regeneration research for the auditory system. Arnaud F. BewleyArnaud F. BewleyDr Arnaud F. Bewley is an Associate Professor in Otolaryngology at the University of California – Davis, USA, where he specializes in head and neck cancer surgery and microvascular free-flap reconstruction. He is the Director of the Division of Head and Neck Surgery and the Director of the Head and Neck Cancer and Microvascular Surgery Fellowship. Dr Bewley grew up in Connecticut and completed his undergraduate degree in physics at Yale University, USA. He spent a year volunteering at a health clinic in Jeremie, Haiti before studying medicine at Columbia University in New York, USA. His professional training began at University of Pennsylvania, USA, where he completed a general surgery internship followed by residency in otolaryngology. He then completed a fellowship in head and neck cancer surgery and microvascular reconstruction at the Medical University of South Carolina (MUSC), USA. His primary clinical interests include the surgical management of benign and malignant tumors of the face, mouth, throat, neck, and thyroid. He has a special interest in using advanced microvascular free-flap techniques to maximize patient post-operative function. In addition, he has an interest in using minimally invasive transoral robotic techniques to treat cancers of the tonsil and base of tongue. Dr Bewley's primary research interest is the study of oncologic outcomes following treatment of head and neck tumors. He has a particular interest in studying outcomes for advanced non-melanomatous skin cancers of the head and neck given the relative paucity of data guiding treatment of these tumors. In addition, he is involved in research to optimize post-operative care of patients after free-flap surgery and translational research on the use of fluorescence imaging to assess margin status. Dr Bewley is involved in teaching at multiple levels at UC Davis. In addition to daily proctoring of residents in the otolaryngology residency program, he is the Director of the Head and Neck / Microvascular fellowship and directs an annual otolaryngology resident bootcamp.

Assessment of Referral Patterns of Adult Patients to a Sickle Cell Disease Specialty Clinic within a Statewide Sickle Cell Network

Background: Sickle cell disease (SCD) is the most common inherited blood disorder in the United States (U.S.). Despite advances in the treatment for children with SCD, care for affected adults has not significantly improved and is often inaccessible. Difficulties with access to care for adults with SCD in the US is multifactorial and includes paucity of trained, specialized physicians, limited physical access to specialty centers, lack of health insurance/health care coverage, and lack of SCD-education by other medical providers. To address these issues, we have established a state-wide sickle cell disease network to improve access to care for affect adults in South Carolina. This network, (SC)2, Sickle Cell-South Carolina is working to enhance access to care and to examine ongoing barriers to care for adults with SCD. The “hub” of (SC)2 is located at the Medical University of South Carolina (MUSC); specific outside hospitals have been identified as “spokes” within the state to form the network. Clinics are either established or being established at each spoke and additional education is being given through tele-mentoring. Current knowledge of referral patterns for patients with SCD is limited. Information on the mechanism of referral and the coordination of the referral process will ultimately help to eliminate obstacles to appropriate and timely patient referrals and help develop patient engagement.Methods: This is retrospective review of patients >18 years of age referred as “new patients” to the Lifespan Comprehensive Sickle Cell Center at MUSC from October 2015-July 2017. Patients were identified through a chart review of the (SC)2 database including referral notes, telephone calls, and initial patient visits. Data collected included the age of the individual, location (within the state) in which the individual resides, presence or absence of SCD, SCD phenotype, referral source, hematologic care within the prior two years, and the consistency of follow-up after the initial visit to the Sickle Cell Center.Results: During this period, 130 new adult patients were referred to the Lifespan Sickle Cell Center at MUSC. Patients referred for care ranged in age from 18-67 (median 34.5 years) of age and 33% (34/104) were male. To be included in the results, these individuals could not have been seen be the Lifespan Sickle Cell Center within the prior three years so that patients transitioned within the center were not included. Of those patients referred during this period, 85% percent (110/130) were successfully seen at the Lifespan Sickle Cell Center for (at least) an initial visit. However, 40% of these individuals missed their first new patient visit at the Sickle Cell Center and required additional outreach in order to complete that first visit. Of those patients successfully seen for a new patient visit, 95% were confirmed to have SCD (6 individuals were diagnosed with sickle cell trait or did not have a hemoglobinopathy). Only 1/3 of the patients referred to the Sickle Cell Center had seen a hematologist in the last 2 years. The majority of the remaining affected patients had not seen a hematologist since they were children or had never seen a hematologist in their lifetime. Referral sources included primary care physicians, subspecialists, (SC)2 affiliated hospitals (spokes), non-affiliated emergency departments, community based organizations and also included family members and peers. Most of the new referrals were from outside of the Tricounty (local) area (75%) and region did not affect the likelihood of successfully establishing care.Conclusion: The development of a statewide network (SC)2 is an effective initial strategy to facilitate referrals to a SCD center for adults with SCD. Physician-mediated engagement and outreach was key for introducing the (SC)2 network to the state and enabling referrals. When patients missed their initial new visit appointments, aggressive follow-up and trouble-shooting was key to ensuring a successful visit. Additional examination of patient-specific barriers at each phase of the referral process will be key to understanding discrepancies in follow-up rates and obstacles in the referral process. The process through which patients are referred to the center and arrive for their first visit are determinants in their future medical care. Enhanced implementation of this referral process is key to the success of the (SC)2 network. DisclosuresKanter:GBT: Research Funding; American Society of Hematology (Sickle Cell Disease Guideline Panel): Membership on an entity's Board of Directors or advisory committees; MUSC: Other: The site PI for sponsored research conducted at MUSC who receives funds from: Novartis, bluebird bio, GBT, Sancillo, Apopharma, Pfizer; Pfizer: Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; NHLBI (sickle cell disease research advisory committee): Membership on an entity's Board of Directors or advisory committees, Research Funding; Apopharma: Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Bluebird Bio: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sancillo: Research Funding.

FIB-4 and Severe Liver Disease Outcomes in Primary Care: A Stratified Cox Analysis

Background: The Fibrosis-4 Index (FIB-4) non-invasively assesses fibrosis risk in chronic liver disease, but underdiagnosis limits FIB-4’s application in primary care. This study evaluates the association of FIB-4 risk with severe liver outcomes in primary care patients with and without diagnosed chronic liver disease. Methods: This retrospective cohort study of primary care data from 2007 to 2018 Included adult patients with qualifying aminotransferase and platelet count results. A single FIB-4 score was calculated for each patient using the first of these values. Patients with a chronic liver disease diagnosis or outcome prior to their FIB-4 score were excluded. FIB-4 advanced fibrosis risk categorization (low, indeterminate, and high) was the primary predictor variable. Patients were followed from FIB-4 score to a severe liver outcome, a composite of cirrhosis, liver transplantation, and hepatocellular carcinoma. We analyzed the association of FIB-4 with hazard risk of a severe liver outcome using stratified Cox regression models, stratifying patients by known chronic liver disease. Findings: 20,556 patients were followed for a mean 2,978 days (8·2 years; SD 1,201 days), and 4% of patients experienced a severe liver outcome. Of patients with low, indeterminate, and high risk FIB-4 scores, 2%, 4%, and 20% suffered a severe liver outcome, respectively. In the overall adjusted model, high risk FIB-4 scores were associated with hazard of severe liver disease (HR 6·54; 95% CI 5·49-7·77). High risk FIB-4 scores were associated with severe liver outcomes for patients with known NAFLD (HR 7·71; 95% CI 3·62-16·45), other liver disease (HR 11·12; 95% CI 8·33-14·82), and no known chronic liver disease (HR 4·04; 95% CI 3·10-5·28). Interpretation: High risk FIB-4 scores were strongly associated with risk of severe liver outcomes in patients with and without known chronic liver disease. Comprehensive FIB-4 application in primary care may signal silently advancing liver fibrosis. Funding Information: National Institute of Diabetes and Digestive and Kidney Diseases (NIH/NIDDKK23DK118200 PI: Schreiner). Declaration of Interests: All authors report no conflicts of interest with this work. Ethics Approval Statement: The Institutional Review Board at the Medical University of South Carolina (MUSC) approved this study.