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Objectives: The decision-making process for taking vaccination is influenced by a multitude of factors such as individual beliefs concerning vaccinations, trust in contextual forces, and sociodemographic. This study established a model to understand the relationship between people's beliefs in the safety, importance and effectiveness of vaccines, their trust in the medical advice from the government and doctors and their behaviors of having their children vaccinated from infectious diseases in low-and-middle-income countries (LMIC). Method(s): We structured a structural equation model with two latent variables, Motivation and Trust, and their relationships with the vaccination taking behavior. Motivation is constructed by people's beliefs in the safety, importance and effectiveness of vaccines and trust is constructed by people's trust in government, medical providers and scientists. This study used the 2018 Wellcome Global Monitor dataset and focused on people in 80 LMIC. The countries were divided into eight geographic regions: Eastern Africa, Central & Southern Africa, Norther Africa & Middle East, Western Africa, Central Asia, Southeast Asia, South Asia and Southern& Eastern Europe. Result(s): The latent variable Motivation is significantly positively associated with parental vaccination behaviors in all geographic areas except for South Asia and Western Africa. South Asia is the only area where the trust in government and medical system, providers had a significant association with vaccination behavior and such association is positive. Conclusion(s): In most LMIC, positive attitudes about vaccines are associated with an improved vaccine rate. Increasing people's belief in vaccines' importance, safety and effectiveness will be essential both for boosting vaccination rates and scaling up a vaccine for COVID-19. In South Asia, trust in the government and the public health system are important in deciding taking vaccines. In these countries, policymakers need to think of ways to improve people's trust in the public health system and further effectively communicate important health messages.Copyright © 2023
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Background: Cardiac screening of youth for prevention of sudden cardiac death in the young (SCDY) has been debated due to the absence of large population-specific screening data with outcomes. Despite years of screening by US public screening groups (PSG), there is minimal coordination of effort and no standardized methods for real-world data collection. Objective(s): To understand the methods, quality, outcomes, and best practices of youth screening, the Cardiac Safety Research Consortium Pediatric Cardiology Working Group, in collaboration with FDA and PSGs, developed and enabled a scalable system to collect a uniform pediatric cardiac screening dataset including digital ECGs and post-screening electronic follow-up data. Method(s): Front end data collection (figure) was developed to include use of a universal unique ID system to align paper/digital collection of health and ECG data. PSGs use secure data transfer portals for digital ECG data upload for conversion to device-agnostic standardized FDA format to store in the national pediatric cardiac screening data warehouse. Follow-up data are obtained at designated post-screening intervals (one week, one and 3 months for pilot study) using initial text message contact followed by electronic consent (REDCap) and answering online health surveys. Result(s): Fourteen PSGs in ten states participated in the pilot study. PSG warehouse data include 33840 retrospective ECG datasets collected from 2010 to 2021 containing limited screened history/symptoms but demographics similar to US census as follows: Age 13-30y, Male/Female 57/43%, Asian 6%, Black 19%, Native American <1%, Pacific Islander <1%, White 68%, Other 4%;Hispanic/Non-Hispanic 27%/79%. Individual PSG site demographics reflected local populations. Prospective data collection since 2021 include >4000 uniform screening datasets (age, sex, race, ethnicity, ht, wt, screening H&P, COVID history, medications, digital ECG with results, screening outcome, and, if applicable, ECHO results). Follow up participation allowing initial cellular contact was high (avg 73%, range 51-91%/screening). Conclusion(s): Establishment of a national pediatric cardiac data warehouse enables large-scale aggregation of pediatric cardiac screening information to address deficits in the understanding and prevention of SCDY. This large real-world dataset will help establish normative data for pediatric ECGs which can facilitate development of new diagnostic tools such as machine learning and support pediatric drug and device development. [Formula presented]Copyright © 2023
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Background: The COVID-19 vaccines were developed unprecedentedly and have proven safe and efficacious in reducing transmissibility and severe infection. The impact of mRNA-based COVID-19 vaccines on atrial arrhythmias (AA) incidence is unknown. Objective(s): To analyze the incidence of AA after COVID-19 vaccination in patients with a cardiac implantable electronic device (CIED). Method(s): BIOTRONIK Home Monitoring data and Medicare claims data from CERTITUDE patients implanted with a CIED between 2010-20 were utilized to identify recipients of one or more doses of the COVID-19 vaccine in 2021. Those who had influenza vaccination in 2020 were also identified in the same cohort as a control. From remote monitoring data, the number of atrial high rate events (AHR) and % burden of AA in the three months post-vaccination was compared to the preceding three months using Wilcoxon signed rank test. Kruskal-Wallis test was used for group difference comparisons. New AF diagnosis was determined from ICD-10 diagnosis codes in Medicare claims. Result(s): First and 2nd doses of COVID vaccine (50% Pfizer, 47% Moderna, and 3% J&J) were administered to 7757 and 6579 individuals with a CIED (age 76.2 (+/-9.0) y, 49% males), respectively. In the same cohort, 4723 (61%) individuals received the influenza vaccine. A statistically significant increase in the number of AHR episodes and % burden of AA was noted in the three months post-vaccination compared to the preceding three months after the 1st and 2nd doses of the COVID-19 vaccine (Figure). No such association was noted following influenza vaccination. In subgroup analysis, AHR episodes increased significantly in age groups >70 and men. Post-vaccination increase in AHR episodes was more significant in those without a pre-vaccination history of AHR episodes (mean increase of AHR 6.9+/-88.4, p<0.001) and was non-significant in those with a preceding history of AHR (p=0.8). Among the 764 patients with no AF diagnosis in claims preceding the first COVID-19 vaccine, 87 (11.4%) developed a new AF diagnosis or AHR event in the first three months post-vaccination. Conclusion(s): We report a small but significant increase in the number of CIED-detected atrial arrhythmias following vaccination for COVID-19 but not influenza, specifically in men and age >70 years. Acknowledging the immense public health benefit of COVID-19 vaccines, our results should prompt increased awareness of evaluating for AF in this high-risk group following vaccination. [Formula presented]Copyright © 2023
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Introduction: Pediatric eye care access, particularly in rural areas, has been an ongoing concern. The COVID-19 pandemic has led to a growing appreciation and acceptance of a role for telemedicine in pediatric eye care. However, many at-home visual acuity (VA) charts and apps have poor test design or inaccurate optotype sizes, and may passively provide misinformation for clinical decision making.1-3 We evaluated the new M&S EyeSimplify At-Home Visual Acuity Tests, which include web-based versions of the ATS-HOTV and E-ETDRS tests commonly used in clinical trials. Method(s): Children with and without VA deficits were enrolled. In-office VA was tested with the M&S Smart System ATS-HOTV (ages 3-6;N = 34;68 eyes) or E-ETDRS (ages 7-12;N = 31;62 eyes) protocol. The child was registered on the EyeSimplify web-based portal and the parent was emailed a link to the at-home VA test. The portal notified us when at-home testing was completed and provided us on-line access to VA results. Equivalence of the two test settings was evaluated by mean difference and 95% limits of agreement (LOA) using Bland-Altmann analysis. Result(s): The mean difference between in-office and at-home was small for both ATS-HOTV (0.01 + 0.08 logMAR) and E-ETDRS 0.04 + 0.08 logMAR;95% LOA = -0.15 to 0.17 and -0.11 to 0.19, respectively, comparable to test-retest agreement in an office setting. Conclusion/Relevance: The M&S EyeSimplify At-Home Visual Acuity Tests provided VA equivalent to in-office testing. If the burden of travel is significant, at-home testing may provide the information needed to continue care via telemedicine consultation when it might otherwise be discontinued or delayed.Copyright © 2022
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Significant progress in understanding cancer pathogenesis, it remains one of the leading causes of death after cardiovascular diseases. Similarly viral infections have emerged from wildlife or re-emerged, generating serious threats to the global health. As a result, there is an urgent need for the development of novel, more effective anticancer and antiviral therapeutics. Scientists, medicinal chemists and researchers are continuously finding novel targets, mechanisms and molecules against theses severe and dangerous infections. Therefore, ongoing extensively study and research emphasizes 1,3,4 thiadiazole pharmacophore have versatile pharmacological actions. Due to mesoionic behaviour of 1,3,4 thiadiazole pharmacophore allows to enter and easily cross biological membrane which allow to interact various biological proteins. In this review study an attempt has been made of various mechanisms involved in cancer and viral prevalence with updated studies done so far. This review study also findings the role of 1,3,4 thiadiazole motif in the management of various cancers and viral infection. This study also highlighting research statics on clinical trials and various patents containing 1,3,4 thiadiazole derivatives. © 2022 The Author(s)
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Introduction: Insomnia disorder (ID) and major depressive disorder (MDD) are highly comorbid, above 80% of MDD patients have insomnia disorder. Acupuncture as a major complementary and alternative medicine (CAM) therapy, is utilized extensively in Asia to treat mental health disorders.Transcutaneous electrical cranial-auricular stimulation (TECAS) is a potential new type of acupuncture treatment for MDD and ID which combines the scalp points and auricular points most commonly used by acupuncturists. It has the advantages of portability, quantifiable stimulation parameters and comfort, especially for home treatment under the normal situation of COVID-19, which can avoid the risk of infection due to frequent hospital trips. Materials / Methods: 10 ID-MDD patients were treated by TECAS which was administered at the bilateral auricular acupoints, Bai Hui (GV-20) and Yin Tang (GV-29) (waveform:4/20 Hz, wave width: 0.2ms+/-30%) for twice a day last 8 weeks. Pittsburgh Sleep Quality Index (PSQI) and Hamilton Depression Rating Scale(HAMD) of ID-MDD patients were evaluated before and after treatment. Result(s): HAMD-17 scores of 10 patients were lower at 4 and 8 weeks than before TECAS treatment, and the reduction was greater at 4 weeks than at 8 weeks. PSQI scores of 8 patients decreased at 4 and 8 weeks compared with before treatment, and the decrease was greater in the fourth week than in the 8th week. Insomnia of 2 patients improved at 4 weeks of treatment, but became worse in the 8th week as before treatment.7 out of 10 patients showed full insomnia response (50% reduction in PSQI) and 8 patients showed full depression response (50% reduction in HAMD-17 scores). Discussion(s): We suggest TECAS is a good therapeutic strategy to modulate the vagus nerve and trigeminal nerve propagate through electrical stimulation projected by neurons from peripheral sites to the central nervous system. Furthermore, we speculate that TECAS can make the trigeminal nerve afferent fibers and vagus nerve auricular branch carry messages from head facial stimulation to NTS, locus coeruleus, raphe nucleus, medullary reticular activating system and structure of the thalamus, and then to feel, edge, cortical and subcortical structures, so the electrical stimulation subcortical can cause direct regulation, namely the change of cortical excitability. Conclusion(s): These preliminary results in this group of CID-MDD patients are encouraging and need to be replicated in prospective sham-controlled studies with larger sample sizes. In addition, for patients with insomnia and depression, it is important to consider combining TECAS with psychotherapy to avoid the interference of acute negative emergency events. Acknowledgements: The support of National Key R&D Program of China (No.2018YFC1705800) and Key Laboratory of Acupuncture and Chronobiology of Sichuan Province(No.2021004) for this project is gratefully acknowledged. Learning Objectives: 1. To provide a new non-drug method for acupuncture treatment of insomnia and depression;2. Provide preliminary experimental results for the large-sample experimental design of TECAS for the treatment of insomnia and depression;3. Compared with previous studies on insomnia and depression, the regularity and characteristics of TECAS in treating insomnia and depression were found. Keywords: Transcutaneous Electrical Cranial-Auricular Stimulation (TECAS), insomnia disorder, a case series, acupuncture, Major Depressive Disorder Copyright © 2022
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SESSION TITLE: Late Breaking Procedures Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/18/2022 01:30 pm - 02:30 pm PURPOSE: The Galaxy SystemTM (Noah Medical, San Carlos, CA) is a novel robotic endoluminal platform using electromagnetic navigation combined with integrated tomosynthesis technology and augmented fluoroscopy. It provides intraprocedural imaging to correct CT-to-body divergence and novel confirmation of tool-in-lesion. The primary aim of this study was to assess the tool-in-lesion accuracy of the robotic bronchoscope with integrated digital tomosynthesis and augmented fluoroscopy. METHOD(S): Over four separate days, four operators (the authors) conducted the experiment using four pigs. Each physician performed between 4 and 6 nodule biopsies for 20 lung nodule biopsies. A porcine model (S. s. domesticus) was utilized. Each pig was anesthetized with volatile gas and underwent tracheostomy with an 8.5 endotracheal tube and bilateral chest tube thoracostomy. Anesthesia was monitored by a veterinarian with invasive hemodynamic monitoring. Under CT fluoroscopic guidance, simulated lung nodules were created by percutaneous injection of a gelatinous agar solution containing purple dye and radiopaque material into the lung periphery. A CT was then performed for pre-procedure planning. Using Galaxy's "Tool in Lesion TOMO+" with augmented fluoroscopy, the physician navigated to the lung nodules and a tool (needle) was placed into the lesion. Tool in lesion was defined by the needle in or tangential to the lesion determined by CBCT. Center strike was defined as the needle in the middle third in three orthogonal angles (axial, sagittal, and coronal) on CBCT. RESULT(S): Lung nodules' average size was 16.3+/-0.97 mm and were predominantly in the lower lobes (65%). Only 15% (3/20) had a bronchus sign and the average distance to the pleura was 6.88+/-5.5 mm. All four operators successfully navigated to all (100%) of the lesions in an average of 3 minutes and 39 seconds. The median number of tomosynthesis sweeps was 3 and augmented fluoroscopy was utilized in most cases (17/20 or 85%). Tool in lesion after final tomography sweep was 100% (20/20). Biopsy yielding purple pigmentation on microscopic or gross examination was also 100% (20/20). Center strike rate was 60%. CONCLUSION(S): The Galaxy SystemTM demonstrated successful digital tomography confirmed tool in lesion success in 100% (20/20) of lesions as confirmed by CBCT. Successful biopsy was achieved in 100% of lesions as confirmed by intralesional pigment acquisition. CLINICAL IMPLICATIONS: The combination of robotic navigation, catheter maneuverability and real-time correction for CT body divergence capitalizes on the strengths of all three technologies to improve diagnosis. Additional clinical trials are warranted to see if high success rates can be reproduced in patients. DISCLOSURES: Consultant relationship with Medtronic ILS Please note: $20001 - $100000 by Krish Bhadra, value=Consulting fee Consultant relationship with Veractye Please note: $1-$1000 by Krish Bhadra, value=Consulting fee Consultant relationship with Bodyvision Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Consultant relationship with Merit Endotek Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Human Factor Testing relationship with Auris Surgical Robotics Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Consultant relationship with Intuitive Surgical Robotics Please note: $5001 - $20000 by Krish Bhadra, value=Consulting fee Consultant relationship with Biodesix Please note: $5001 - $20000 by Krish Bhadra, value=Consulting fee Consultant relationship with Noah Medical Please note: 5/2020 Added 06/01/2022 by Krish Bhadra, value=Consulting fee Speaker relationship with Body Vision Please note: 2015 - present Added 05/29/2022 by Douglas Hogarth, value=Ownership interest Consultant relationship with Magnisity Please note: 2021 - present Added 05/29/2022 by Douglas Hogarth, value=Ownership interest Consultant relationship with Auris (J&J Ethicon) Please note: 2014-present Added 05/29/2022 by Douglas Hogarth, value=Honoraria Consultant relationship with Boston Scientific Please note: 2008 - present Added 05/29/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with Medtronic Please note: 2010-2019 Added 05/29/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with Broncus Please note: 2017-2021 Added 05/29/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with PulmonX Please note: $5001 - $20000 by Douglas Hogarth, value=Consulting fee Removed 06/08/2022 by Douglas Hogarth Consultant relationship with Spiration Please note: $5001 - $20000 by Douglas Hogarth, value=Consulting fee Removed 06/08/2022 by Douglas Hogarth Consultant relationship with Eolo Please note: $20001 - $100000 by Douglas Hogarth, value=Ownership interest Removed 06/08/2022 by Douglas Hogarth Consultant relationship with Noah Please note: 2019 - present Added 06/08/2022 by Douglas Hogarth, value=Ownership interest Consultant relationship with Noah Please note: 2019 - present Added 06/08/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with Medtronic Corporation Please note: $5001 - $20000 by Amit Mahajan, value=Consulting fee Consultant relationship with Boston Scientific Corporation Please note: $1001 - $5000 by Amit Mahajan, value=Consulting fee Consultant relationship with Pulmonx Corporation Please note: $5001 - $20000 by Amit Mahajan, value=Consulting fee Consultant relationship with Ambu USA Please note: $1-$1000 by Amit Mahajan, value=Consulting fee Consultant relationship with Circulogene Please note: $1001 - $5000 by Amit Mahajan, value=Consulting fee Consultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee Copyright © 2022 American College of Chest Physicians
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SESSION TITLE: COVID-19 Infections: Issues During and After Hospitalization SESSION TYPE: Original Investigations PRESENTED ON: 10/17/2022 01:30 pm - 02:30 pm PURPOSE: It has been established that recipients of solid organ transplants have worse outcomes compared to the general population from COVID-19 infections. We sought to determine the course and outcomes of lung transplant recipients (LTR) with COVID-19 infections based on vaccination status and treatments. METHODS: We performed a retrospective study of all LTR from Inova Fairfax Hospital with COVID-19 infections. Infection was confirmed based on symptoms and testing from an urgent care, hospital, or home kit. Patients with presumed but unconfirmed COVID-19 infections were excluded. The study timeframe was the two-year period: 3/1/2020 - 2/28/2022. Data collected included patient demographics, transplant type, immunosuppression, immunization status, episodes of rejection, donor derived cell-free DNA (dd-cfDNA) values (where available), spirometric data, outpatient/inpatient treatments, hospitalization data, and outcomes including death, infections, and other complications. The severity of illness was based on the 8-point ordinal scale. RESULTS: There were 45 LTR who tested positive during the study period;22 male and 23 female, average age of 57 and mean time from transplant of 4 years. 11 of the patients were unvaccinated (UV), 2 partially vaccinated (PV), 11 vaccinated non-boosted (VNB), and 21 vaccinated and boosted (VB). In total, 34 (76%) LTR required hospitalization. Of those hospitalized: 7 UV, 1 PV, 11 VNB, and 15 FV. In addition, 7 of those hospitalized required intubation with only 1/7 surviving to discharge. Overall, 8/45 (17.8%) patients died from COVID-19: 3 UV, 1PV, 1 VNB, 3VB. Infectious complications included 3 cases of PCP, 1 empyema, and 1 reactivation of CMV. For individuals who had spirometry at least 2 weeks after diagnosis (n =25), FVC decreased in 17 LTR by an average of 0.17 L, the FEV1 decreased in 14 LTR by an average of 0.14 L. On repeat spirometry testing (n=14), FVC further decreased in 9 LTR by 0.25 L and the FEV1 further decreased in 7 LTR by 0.13 L. CONCLUSIONS: A large proportion of LTR with COVID-19 infections require hospitalization (76%) with a high associated mortality rate and a sustained lung function decline seen in many who survive. The high mortality was independent of vaccination status, likely reflecting the inability of LTR to mount an immune response. A high index of suspicion and monitoring for superimposed infections, especially PCP, appears prudent. The sustained decline in lung function raises the notion of COVID-19 as a precipitating factor for chronic lung allograft dysfunction (CLAD). CLINICAL IMPLICATIONS: LTR who contract COVID-19 infection represent a high-risk population, even in those fully vaccinated, with potential for hospitalization, death, loss of lung function, and infectious complications. In this population, new algorithms for immunosuppression, monitoring and treatments may help to improve outcomes. DISCLOSURES: No relevant relationships by Shambhu Aryal No relevant relationships by A. Whitney Brown, value=Honoraria Removed 04/03/2022 by A. Whitney Brown No relevant relationships by A. Whitney Brown, value=Honoraria Removed 04/03/2022 by A. Whitney Brown No relevant relationships by A. Whitney Brown, value=Consulting fee Removed 04/03/2022 by A. Whitney Brown No relevant relationships by Jessica Chun No relevant relationships by Meg Fregoso No relevant relationships by Vikramjit Khangoora Advisory Committee Member relationship with Boehringer Ingelheim Please note: 2019-2021 Added 04/03/2022 by Christopher King, value=Consulting fee Advisory Committee Member relationship with Actelion Please note: 2019-2022 Added 04/03/2022 by Christopher King, value=Consulting fee Advisory Committee Member relationship with United Therapeutics Please note: 2019-2022 Added 04/03/2022 by Christopher King, value=Consulting fee Speaker/Speaker's Bureau relationship with Actelion Please note: 2019-2022 Added 04/0 /2022 by Christopher King, value=Consulting fee Speaker/Speaker's Bureau relationship with United Therapeutics Please note: 2020-22 Added 04/03/2022 by Christopher King, value=Consulting fee Consultant relationship with Veracyte Please note: $1001 - $5000 by Steven Nathan, value=Honoraria Removed 03/29/2022 by Steven Nathan Consultant relationship with United Therapeutics Please note: $5001 - $20000 by Steven Nathan, value=Consulting fee Consultant relationship with Bellerophon Please note: $5001 - $20000 by Steven Nathan, value=Consulting fee Speaker/Speaker's Bureau relationship with Roche-Genentech Please note: $5001 - $20000 by Steven Nathan, value=Honoraria Speaker/Speaker's Bureau relationship with Boerhinger-Ingelheim Please note: $20001 - $100000 by Steven Nathan, value=Honoraria No relevant relationships by Alan Nyquist No relevant relationships by Michelle Schreffler Speaker/Speaker's Bureau relationship with United Therapeutics Please note: 2020-2022 Added 04/01/2022 by Oksana Shlobin, value=Consulting fee Speaker/Speaker's Bureau relationship with Bayer Please note: 2020-2022 Added 04/01/2022 by Oksana Shlobin, value=Honoraria Speaker/Speaker's Bureau relationship with Janssen&Janssen Please note: 2020-2022 Added 04/01/2022 by Oksana Shlobin, value=Honoraria Consultant relationship with Altavant Please note: 2020-2022 Added 04/01/2022 by Oksana Shlobin, value=Consulting fee Consultant relationship with Acceleron Please note: 2020-2022 Added 04/01/2022 by Oksana Shlobin, value=Honoraria Consultant relationship with United Therapeutics Please note: 2020-2022 Added 04/01/2022 by Oksana Shlobin, value=Honoraria No relevant relationships by Anju Singhal No relevant relationships by Christopher Thomas
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SESSION TITLE: Autoimmune Diseases Gone Wild: Rare Cases of Pulmonary Manifestations SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 01:35 pm - 02:35 pm INTRODUCTION: Post-Covid-19 Multisystem Inflammatory Syndrome (MIS) is a severe hyperinflammatory syndrome associated with either the acute or recovery phase of covid-19 infection affecting multiple organ systems requiring hospitalization. This syndrome has been described in both children (MIS-C) and adults (MIS-A). Several case reports and systematic reviews have reported an association between post-covid-19 MIS-A and several autoimmune diseases. CASE PRESENTATION: We herein report a case of a 27-year-old female with no known chronic medical condition and a non-contributory family history who was diagnosed with post-covid-19 multisystem inflammatory syndrome in adults (MIS-A). She presented with generalized partial thickness erythematous skin ulcerations with tender blistering and painful erosion of her mucus membranes (oral and vaginal mucosa). This was diagnosed as Steven Johnsons syndrome. She was pulsed with intravenous methylprednisone. During this therapy, she progressed to severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilation (fig 1). Bronchoscopy revealed mild pulmonary hemorrhage fig 2a&b). Serological testing heralded a new onset systemic lupus erythematosus in light of positive antinuclear antibodies, anti Ds DNA and anti Smith antibodies. Her course was complicated by significant proteinuria and an active renal cast suggestive of lupus nephritis. This necessitated further treatment for active lupus. She was successfully extubated and discharged home. DISCUSSION: We arrived at the diagnosis of post-covid-19 multisystem inflammatory syndrome in adults (MIS-A) in light of her presenting with fever, hypotension, persistent sinus tachycardia and new onset atrial fibrillation), acute pancreatitis, acute kidney injury, elevation in transaminases, new onset skin rash, elevated inflammatory markers and a recent history of positive SARS-CoV-2 infection. Covid-19 has been reported to induce wide spread vasculitis resulting in MIS-A or MIS-C by triggering type 3 hypersensitivity (1). Also, multiple case reports and systemic reviews have reported a direct association between MIS-A and several autoimmune diseases including SLE, SJS (2). The patient recovered with high dose corticosteroid and supportive therapy indicating her severe ARDS was most likely due associated to SJS, SLE and MIS-A. Clinicians should also keep in mind that SARS-CoV-2 PCR swab may be negative at the time patient presents with symptoms of MIS-A as the infection might have occurred about 4-5weeks prior just as in our patient(3) CONCLUSIONS: We cannot underscore enough the importance of clinicians having a high index of suspicion for this syndrome in patients with acute or recent covid-19 infection, with or without a positive PCR covid-19 test. Early involvement of a multidisciplinary approach and appropriate management is essential to mitigate morbidity and mortality in these patients. Reference #1: Roncati L, Ligabue G, Fabbiani L, Malagoli C, Gallo G, Lusenti B, et al. Type 3 hypersensitivity in COVID-19 vasculitis. Clin Immunol Orlando Fla. 2020 Aug;217:108487. Reference #2: Gracia-Ramos AE, Martin-Nares E, Hernández-Molina G. New Onset of Autoimmune Diseases Following COVID-19 Diagnosis. Cells [Internet]. 2021 Dec 20 [cited 2022 Mar 22];10(12):3592. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700122/ Reference #3: Morris SB. Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection — United Kingdom and United States, March–August 2020. MMWR Morb Mortal Wkly Rep [Internet]. 2020 [cited 2022 Mar 22];69. Available from: https://www.cdc.gov/mmwr/volumes/69/wr/mm6940e1.htm DISCLOSURES: No relevant relationships by Isaac Ikwu No relevant relationships by Anthony Lyonga Ngonge No relevant relationships by Alem Mehari No relevant relationships by Noordeep Panesar no disclosure on file for Vis al Poddar;No relevant relationships by Emnet Yibeltal
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SESSION TITLE: Unique Inflammatory and Autoimmune Complications of COVID-19 Infections SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: Viral infections can induce an immune cascade which may incite varied autoimmune disease to take action. One such disease is dermatomyositis, a rare inflammatory disease with multisystemic involvement. As we enter the post pandemic era, several unique complications related to COVID-19 are now surfacing. Here we present a case of a 57-year-old female who developed dermatomyositis after recent Covid-19 infection. CASE PRESENTATION: Patient is a 57-year-old female who presented to our pulmonary clinic with complaints of cough and shortness of breath (SOB). Patient reported feeling ill since contracting COVID-19 in November 2020. Two months after being diagnosed with COVID-19 she started to experience generalized muscle and joint pain;she underwent extensive rheumatological workup which was consistent with Sjogren disease for which she was started on hydroxychloroquine. A month after initiation of medication she started to experience worsening cough and SOB and underwent pulmonary function testing (PFT) in our clinic which showed evidence of restrictive lung disease. Chest CT was consistent with interstitial changes, therefore a diagnosis of ILD (interstitial lung disease) due to connective tissue disorder was made. Further assessment revealed positive CPK and anti-Jo1 antibodies indicative of dermatomyositis as a cause of her ILD. She was started on oral steroids which helped improve her symptoms. DISCUSSION: Several viruses including EBV, Hepatitis C, Rubella, HTLV-1 and Parvovirus have been associated with development of autoimmune diseases. Viral infections, like COVID-19 have shown to trigger an intense immune response which in turn may lead to autoimmune activity against host antigen. SARS-CoV2 has been found to enter muscle cells through ACE-2 receptors, allowing for transfer of genetic material and skeletal muscle damage. Another proposed mechanism of COVID induced myopathy has been T-cell clonal expansion by the virus up regulating TLR4 receptors increasing expression of ACE2, therefore facilitating entry of viruses leading to further inflammation. Identification of very specific T cell receptor epitopes for SARS-COv2 in patients with dermatomyositis has suggested COVID-19 as a trigger for CD8-T cells which leads to dermatomyositis in these patients. Autoimmune reactions occur from varying mechanisms like epitope spreading and bystander activation to molecular mimicry triggered by viral infections. CONCLUSIONS: SARS-COv2 presented with several challenges in the field of medicine. As we enter the post COVID period in medicine, we will continue to face several challenges proposed by the inflammatory surge caused by this disease. It is therefore important clinicians recognize and report these rare cases to increase awareness regarding several post covid diseases. Reference #1: HUSSEIN, H. M.;RAHAL, E. A. The role of viral infections in the development of autoimmune diseases. Critical Reviews in Microbiology, [s. l.], v. 45, n. 4, p. 394–412, 2019. DOI 10.1080/1040841X.2019.1614904. Disponível em: https://search-ebscohost-com.proxy.lib.wayne.edu/login.aspx?direct=true&db=a9h&AN=138199390&site=ehost-live&scope=site. Acesso em: 4 abr. 2022. DISCLOSURES: No relevant relationships by Kevser Akyuz No relevant relationships by Ranim Chamseddin No relevant relationships by Padmini Giri No relevant relationships by verisha khanam No relevant relationships by Emad Shehada No relevant relationships by Abdullah Yesilyaprak
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SESSION TITLE: Global Pulmonary Cases SESSION TYPE: Global Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Progressive fibrosing interstitial lung diseases (PF-ILD) consist of a group of interstitial lung diseases (ILD) showing similar clinical phenotype of accelerated respiratory failure, frequent disease exacerbation with earlier mortality. CASE PRESENTATION: 48 year old male patient, smoker for 20 years (smoking index 20),presented with severe COVID pneumonia 9 months back where he has been admitted to ICU for 7 days. CTPA excluded PE but revealed severe covid pneumonia. inflammatory markers were consistent with cytokine storm. he has been commenced ono2 therapy with HNNC, steroid therapy(dexamethasone 6 mg for 15 days ), tocilizumab & remdisivir. he discharged from hospital after 15 days with o2 sat around 90 % on RA but still he has dyspnea on mild exertion. discharged on 40 mg steroid and tapered according to his repsonce.3 months later during his FU FVC was 55% of predicted with o2 sat on RA 84, 90 % on 2 L/M.HRCT chest showed diffuse reticulation with starting traction bronchiectasis more in both upper lobes occupying more than 10 % of lung parenchyma. he continued on CS 30 MG and with consideration of antifibrotic medications.after 2 months he developed pneumothorax on the right side where ICT was inserted for 7 days.4 months later he presented with gradual progressive SOB and gradual increase o2 requirement up to 6 L/M to maintain o2 sat around 90%.he became wheelchair bound during all his daily activities. FVC BECAME 40 %.ABG showed PO2 around 54 mmHg. evidence of irreversible lung disease, such as severe bullous destruction or evidence of established fibrosis.HRCT chest showed extensive reticulation with fibrotic changes, interstitial thickening associated with lung architecture distortion, with multiple bilateral bullous destruction on left and right upper lobe.(figure 1-2).MDT decide to start nintadanibe with discussion with lung transplantation team for possible listing. DISCUSSION: we reported a case of post covid lung fibrosis who is fulfilling criteria for being progressive and being fibrotic, as he showed decrease in FCV over 6 months more than 10%, progressive of respiratory symptoms and progression of lung fibrosis with development of bullous changes in both upper lobes. initially we know that it is too Early to address the POST COVID ILD in full details but there are many cases have been progressed and developed end sage fibrotic lung diseases.(1-2). then, the 2nd question that should be there, is "there any role of smoking for this rapid progression with development of this pattern".as there some reports about this risk but no clear evidence on large patient population CONCLUSIONS: is post covid lung fibrosis will be one of causes for progressive fibrosing lung pathology& what are the risk factors?the answer of these questions should be addressed as it may affect morbidity and mortality especially with increasing number of COVID cases. Reference #1: 1-Udwadia ZF, Pokhariyal PK, Tripathi AK, Kohli A. Fibrotic interstitial lung disease occurring as sequelae of COVID-19 pneumonia despite concomitant steroids. Lung India 2021;38:S61-3. Reference #2: 2-Kayhan S, Kocakoç E. Pulmonary fibrosis due to COVID-19 pneumonia. Korean J Radiol 2020;21:1273. Reference #3: 3-Vardavas CI, Nikitara K (2020) COVID-19 and smoking: a systematic review of the evidence. Tob Induc Dis. 18:20, DISCLOSURES: No relevant relationships by Usama Abu Elhassan No relevant relationships by Safwat Ali Mohammed Eldaaboo
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SESSION TITLE: Drug-Induced Lung Injury and Disease SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 01:35 pm - 02:35 pm INTRODUCTION: COVID-19 has been notorious to cause "happy hypoxia” or presentation with profound hypoxia yet without proportional signs of respiratory distress. Methemoglobinemia is a rare and potentially life threatening condition characterized by an inability of hemoglobin to bind oxygen leading to diffuse tissue hypoxia. Diagnosis of methemoglobinemia in a patient with COVID-19 may be masked if the index of suspicion is low. We present such case of dapsone-induced methemoglobinemia in the setting of COVID-19. CASE PRESENTATION: A 64-year-old male presented to the hospital with fatigue. His past medical history included Type 1 Diabetes Mellitus (DM), hypertension and dermatitis herpetiformis. He also reported a 6 day history of testing positive for COVID-19 as an outpatient. His initial vital signs were stable and his peripheral oximeter showed a 96% saturation on 2L O2. Physical exam was unremarkable without any signs of respiratory distress. His labs were notable for blood glucose of 500, high anion gap metabolic acidosis concerning for diabetic ketoacidosis (DKA). A chest X-ray (CXR) revealed bilateral infiltrates. He was initiated on insulin drip and per hospital protocol initiated on Remdesevir and Decadron for COVID-19 treatment. Patient's DKA subsequently resolved. However on Day 4, patient's oxygen saturation decreased suddenly to the 80s without any signs of respiratory distress. Infectious workup including CBC, sputum culture, antigen for streptococcus, legionella returned negative. His CXR remained unchanged. Arterial blood gas (ABG) demonstrated pH of 7.45, pCo2 46mm Hg, pO2 157 mm Hg. Methemoglobin level was found to be 14.1%. He was given methylene blue 1 mg/kg and dapsone was discontinued. His methemoglobin level improved to 3.4% the next day. He was subsequently discharged home without need for supplemental oxygen. DISCUSSION: Methemoglobinemia can be acquired through drugs that oxidize the ferrous hemoglobin to ferric form. Dapsone is one such agent commonly used for dermatological conditions and opportunistic infection prophylaxis. The oxidative stress caused due to COVID-19 coupled with Dapsone use may have precipitated methemoglobinemia in our patient. Since the presentation can easily mimic "happy hypoxia", index of suspicion for methemoglobinemia can be low and thus can have profound consequences if undetected and not treated. CONCLUSIONS: In the setting of COVID-19 pneumonia with refractory hypoxemia, clinicians should have a high index of suspicion for methemoglobinemia especially in patients on highly oxidative medications. Reference #1: Burke P, et al. Dapsone-induced methemoglobinemia: case of the blue lady. Can Fam Physician. 2013 Sep;59(9):958-61. Reference #2: Naymagon L., Berwick S., Kessler A., et al. The emergence of methemoglobinemia amidst the COVID-19 pandemic. Am. J. Hematol. 2020;95: E196-E197 https://doi.org/10.1002/ajh.25868 Reference #3: Faisal H, Bloom A, Gaber AO. Unexplained Methemoglobinemia in Coronavirus Disease 2019: A Case Report. A&A Pract. 2020;14(9):e01287. doi:10.1213/XAA.0000000000001287 DISCLOSURES: No relevant relationships by Syed Azharuddin Speaker/Speaker's Bureau relationship with gsk Please note: 2020-present by Tariq Cheema, value=Honoraria Speaker/Speaker's Bureau relationship with GSK Please note: 2020 Added 04/14/2022 by Tariq Cheema, value=Honoraria Removed 04/14/2022 by Tariq Cheema Speaker/Speaker's Bureau relationship with BI Please note: 2020-PRESENT Added 04/14/2022 by Tariq Cheema, value=Honoraria Speaker/Speaker's Bureau relationship with astra zeneca Please note: 2020-Present Added 04/14/2022 by Tariq Cheema, value=Honoraria Speaker/Speaker's Bureau relationship with regeneron Please note: 2021-Present Added 04/14/2022 by Tariq Cheema, value=Honoraria No relevant relationships by Deeksha Ramanujam No relevant relationships by Alisha Sharma
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SESSION TITLE: Issues After COVID-19 Vaccination Case Posters SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Since the onset of the COVID-19 pandemic, vaccines were introduced to mitigate the spread of the virus. Depending on the COVID-19 vaccine, regimens consist of one dose (ie, J&J) or two doses (ie, Pfizer and Moderna) and is followed by a third dose/booster (for immunocompromised/immunocompetent individuals). Here, we present a case of COVID-19 infection in a triple vaccinated patient with concurrent rheumatoid arthritis (RA) receiving disease modifying antirheumatic drugs (DMARDs) who was unable to mount an adequate immune response to the vaccine. CASE PRESENTATION: Patient is a 67 year old male with PMH of RA (on DMARDs) presented to the ED with complaints of shortness of breath. He was on treatment for RA with leflunomide, rituximab and prednisone. He was COVID-19 triple vaccinated. In ED, the patient was found to be hypoxic, saturating at 87% on room air with a respiratory rate of 18. Physical examination was significant for coarse breath sounds bilaterally and remaining vitals were unremarkable. Patient was initially placed on 3 L oxygen via NC but due to persistent hypoxia, was transitioned to high-flow nasal cannula. Further investigations revealed that the patient was COVID-19 positive. He was treated with remdesivir and dexamethasone. His oxygen requirements continued to escalate and he was ultimately intubated. While in the ICU, the patient's hypoxia continued to worsen despite optimal medical and ventilatory management and he subsequently died. DISCUSSION: DMARDs are a group of medications used to slow the progression of rheumatoid arthritis. They work by reducing the immune response of B cells, T cells and cytokines. Our patient was on two commonly prescribed medications for rheumatoid arthritis, leflunomide and rituximab. The former acts by inhibiting the pyrimidine synthesis pathway, thereby decreasing T lymphocyte production and the latter depletes CD-20 positive B cells. While there is limited data on COVID-19 vaccine, it has been established that patients on DMARDs have reduced antibody titres after immunization against influenza and pneumonia vaccinations [1, 2]. A study assessing the effectiveness of a third vaccine dose in patients taking rituximab vs placebo found a significant difference in seroconversion (78.8% vs 18.2%, p=<0.0001) and neutralizing activity (80.0% vs 21.9%, p=<0.0001) [3]. In our case, the patient was on two immunosuppressive drugs which suppressed both the humoral and cell mediated immunity, resulting in an inadequate immune response and subsequently developing COVID. CONCLUSIONS: This case highlights patients on immunosuppressant therapy failing to mount an adequate immune response to the COVID-19 vaccine, warranting more booster doses in patients on DMARDs. Reference #1: Adler S, Krivine A, Weix J et al. Protective effect of A/ H1N1 vaccination in immune-mediated disease–a prospectively controlled vaccination study. Rheumatology 2012;51:695–700. Reference #2: Franca ILA, Ribeiro ACM, Aikawa NE et al. TNF blockers show distinct patterns of immune response to the pandemic influenza A H1N1 vaccine in inflammatory arthritis patients. Rheumatology 2012;51:2091–8. Reference #3: David S, Koray T, Filippo F et al. Efficacy and safety of SARS-CoV-2 revaccination in non-responders with immune-mediated inflammatory disease. http://dx.doi.org/10.1136/annrheumdis-2021-221554 DISCLOSURES: No relevant relationships by Gursharan Kaur No relevant relationships by Aishwarya Krishnaiah No relevant relationships by sandeep mandal
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SESSION TITLE: Post-COVID-19 Infection Complications SESSION TYPE: Case Report Posters PRESENTED ON: 10/17/2022 12:15 pm - 01:15 pm INTRODUCTION: The COVID-19 pandemic has been full of obstacles for the medical field. Considerable advancements have been made, yet we continue to discover new associations with this novel virus. In this case, we discuss a patient who was hospitalized for COVID-19 on 7/18/2020 in the intensive care unit. He developed a persistent cough with hemoptysis several months after discharge and was found to have active tuberculosis. The COVID-19 pandemic has continued to raise concerns regarding the repercussions of this infection, and as this case shows, includes reactivation of latent tuberculosis infections (LTBI) in affected patients. CASE PRESENTATION: A 59-year-old Latino male never-smoker with a history of diabetes (A1c 8.4%) presented 07/18/2020 for complaints of shortness of breath and cough. At that time, he tested positive for COVID-19. He was escalated to the ICU and required intubation. During his hospitalization, he received remdesivir for 5 days and dexamethasone 6 mg daily for 10 days with taper prior to his discharge. He was able to be extubated and oxygen requirement decreased to 2 liters nasal cannula. Patient was subsequently discharged on 09/14/2020. He began developing a persistent cough with noted hemoptysis in 02/2021 and was referred to pulmonology at that time. High resolution CT scan of the chest was ordered and revealed thick-walled cavitary lesions of various sizes throughout both lungs although with an upper lobe predominance and tree-in-bud nodularity as well as tracheomegaly. AFB and QuantiFERON Gold assay were positive. Patient reported he had done multiple mission trips to endemic areas before COVID pandemic but had not been during the pandemic. Patient underwent quarantine and treatment for active tuberculosis. DISCUSSION: Tuberculosis reactivation results from previous latent bacteria that becomes active either from inducible factors or spontaneously. Risk factors for reactivation include HIV/AIDS, steroid use, diabetes, kidney disease, and smoking. [1] The primary basis of these risk factors is the immunosuppression conferred to the patient. COVID-19 has the potential to cause a disruption of the immune system which could predispose a patient to reactivation of LTBI. Studies have shown that defects or interference of the IFN-γ pathway can cause susceptibility to intracellular infections, including tuberculosis.[2] There may be an acquired disruption in this pathway caused by COVID-19, although more research is required. CONCLUSIONS: The COVID-19 pandemic has raised concerns for increased risk of reactivation of latent infection as well. In this case, the patient had multiple risk factors, but certainly a diagnosis of COVID-19 could weaken the immune system allowing for the reactivation of LTBI. This association will require more research to solidify. It is important, as seen in the case discussed above, to continue to be vigilant in diagnosis and treatment of our patients. Reference #1: Riley L. UpToDate. UpToDate – Evidence-based Clinical Decision Support ;Wolters Kluwer. Published September 15, 2021. Accessed February 2, 2022. https://www.uptodate.com/contents/tuberculosis-natural-history-microbiology-and-pathogenesis?search=tuberculosis&source=search_result&selectedTitle=4~150&usage_type=default&display_rank=4 Reference #2: Kampmann B, Hemingway C, Stephens A, et al. Acquired predisposition to mycobacterial disease due to autoantibodies to IFN-gamma. J Clin Invest 115: 2480-2488, 2005. DISCLOSURES: No relevant relationships by Steven Colby No relevant relationships by Radhika Shah
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Background: Dostarlimab is a programmed death 1 (PD-1) inhibitor approved in the EU as a monotherapy in patients (pts) with dMMR/MSI-H AR EC that has progressed on or after platinum-based chemotherapy;and in the US as a monotherapy in pts with dMMR AR EC that has progressed on or after platinum-based chemotherapy or dMMR solid tumors that have progressed on or after prior treatment, with no satisfactory alternative treatment options. We report on PFS and OS in 2 expansion cohorts of the GARNET trial that enrolled pts with EC. Methods: GARNET is a multicenter, open-label, single-arm phase 1 study. Pts were assigned to cohort A1 (dMMR/MSI-H EC) or A2 (MMRp/MSS EC) based on local immunohistochemistry assessment. Pts received 500 mg of dostarlimab IV every 3 weeks for 4 cycles, then 1000 mg every 6 weeks until disease progression, discontinuation, or withdrawal. PFS and OS are secondary efficacy endpoints. Results: 153 pts with dMMR/MSI-H and 161 pts with MMRp/MSS EC were enrolled and treated. The efficacy-evaluable population included 143 pts with dMMR/MSI-H EC and 156 pts with MMRp/MSS EC with measurable disease at baseline and ≥6 mo of follow-up. Median follow-up was 27.6 mo for dMMR/MSI-H and 33.0 mo for MMRp/MSS EC (Table). For pts with dMMR/MSI-H EC, median PFS (mPFS) was 6.0 mo, with 3-year estimated PFS rate of 40.1%. With 37.3% of pts experiencing an event, mOS was not reached;estimated 3-year OS was >50%. For pts with MMRp/MSS EC, mPFS was 2.7 mo. mOS was 16.9 mo with 68.9% of pts experiencing an event. Safety has been previously reported. [Formula presented] Conclusions: Dostarlimab demonstrated durable antitumor activity in dMMR/MSI-H and MMRp/MSS AR EC. dMMR/MSI-H was associated with longer PFS and OS than MMRp/MSS as expected. Clinical trial identification: NCT02715284. Editorial acknowledgement: Writing and editorial support, funded by GlaxoSmithKline (Waltham, MA, USA) and coordinated by Heather Ostendorff-Bach, PhD, of GlaxoSmithKline, was provided by Shannon Morgan-Pelosi, PhD, and Jennifer Robertson, PhD, of Ashfield MedComms, an Ashfield Health company (Middletown, CT, USA). Legal entity responsible for the study: GlaxoSmithKline. Funding: GlaxoSmithKline. Disclosure: A.V. Tinker: Financial Interests, Institutional, Sponsor/Funding: AstraZeneca;Financial Interests, Personal, Other: AstraZeneca, Eisai, GlaxoSmithKline. B. Pothuri: Financial Interests, Institutional, Funding: AstraZeneca, Celsion, Clovis Oncology, Eisai, Genentech/Roche, Karyopharm, Merck, Mersana, Takeda Pharmaceuticals, Tesaro/GSK;Financial Interests, Personal, Other: Arquer Diagnostics, AstraZeneca, Atossa, Clovis Oncology, Deciphera, Elevar Therapeutics, Imab, Mersana, Tesaro/GSK, Merck, Sutro Biopharma, Tora, GOG Partners;Financial Interests, Personal, Advisory Board: Arquer Diagnostics, AstraZeneca, Atossa, Deciphera, Clovis Oncology, Eisai, Elevar Therapeutics, Imab, Merck, Mersana, Sutro Biopharma, Tesaro/GSK, Toray;Financial Interests, Personal, Leadership Role: GOG Partners, NYOB Society Secretary, SGO Clinical Practice Committee Chair, SGO COVID-19 Taskforce Co-Chair. L. Gilbert: Financial Interests, Institutional, Funding: Alkermes, AstraZeneca, Clovis, Esperas, IMV, ImmunoGen Inc, Karyopharm, Merck Sharp & Dohme, Mersana, Novocure GmbH, OncoQuest Pharmaceuticals, Pfizer, Roche, Tesaro;Financial Interests, Personal, Other: Merck, Alkermes, AstraZeneca, Eisai, Eisai-Merck, GlaxoSmithKline. R. Sabatier: Financial Interests, Institutional, Funding: AstraZeneca, Eisai;Financial Interests, Personal, Other: AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Roche;Non-Financial Interests, Personal, Other: AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Pfizer, Roche. J. Brown: Financial Interests, Personal, Advisory Role: Caris, Clovis, Eisai, GlaxoSmithKline;Financial Interests, Personal, Funding: GlaxoSmithKline, Genentech. S. Ghamande: Financial Interests, Personal, Advisory Role: Seattle Genetics;Financial Interests, Personal, Speaker’s Bureau: GlaxoSmithKline;Financial Interests, Institutional, Funding: Abbv e, Advaxis, Bristol Myers Squibb, Clovis, Genentech, GlaxoSmithKline, Merck, Roche, Seattle Genetics, Takeda. C. Mathews: Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, Deciphera, Moderna, GSK, Regeneron, Seattle Genetics;Financial Interests, Personal, Advisory Board: IMAB biopharma. D. O'Malley: Financial Interests, Personal, Advisory Board: AstraZeneca, Tesaro/GSK, Immunogen, Ambry, Janssen/J&J, Abbvie, Regeneron, Amgen, Novocure, Genentech/Roche, GOGFoundation, Iovance, Eisai, Agenus, Merck, SeaGen, Novartis, Mersana, Clovis, Elevar, Takeda, Toray, INXMED, SDP Oncology (BBI), Arquer Diagnostics, Roche Diagnostics MSA, Sorrento, Corcept Therapeutics, Celsion Corp;Financial Interests, Personal, Funding: AstraZeneca, Tesaro/GSK, Immunogen, Janssen/J&J, Abbvie, Regeneron, Amgen, Novocure, Genentech/Roche, VentiRx, Array Biopharma, EMD Serono, Ergomed, Ajinomoto Inc, Ludwig Cancer Research, Stemcentrx, Inc, Cerulean Pharma, GOGFoundation, Bristol-Myers Squibb Co, Serono Inc, TRACON Pharmaceuticals, Yale University, New Mexico Cancer Care Alliance, INC Research, Inc, inVentiv Health Clinical, Iovance, PRA Intl, Eisai, Agenus, Merck, GenMab, SeaGen, Mersana, Clovis, SDP Oncology (BBI);Financial Interests, Personal, Other: Myriad Genetics, Tarveda. V. Boni: Financial Interests, Personal, Advisory Board: OncoArt, Guidepoint Global;Financial Interests, Personal, Speaker’s Bureau: Solti;Financial Interests, Personal, Other: START, Loxo, IDEAYA Biosciences;Financial Interests, Institutional, Research Grant: Sanofi, Seattle Genetics, Loxo, Novartis, CytomX Therapeutics, Pumo Biotechnology, Kura Oncology, GlaxoSmithKline, Roche/Genentech, Bristol-Myers Squibb, Menarini, Synthon, Janssen Oncology, Merck, Lilly, Merus, Pfizer, Bayer, Incyte, Merus, Zenith Epigenetics, Genmab, AstraZeneca, Seattle Genetics, Adaptimmune, Alkermes, Amgen, Array BioPharma, Boehringer Ingelheim, BioNTech AG, Boston Biomedical. A. Gravina: Financial Interests, Personal, Other: Gentili, Pfizer. S. Banerjee: Financial Interests, Personal, Advisory Board: Amgen, Genmab, Immunogen, Mersana, Merck Sereno, MSD, Roche, Tesaro, AstraZeneca, GSK, Oncxerna;Financial Interests, Personal, Invited Speaker: Clovis, Pfizer, Tesaro, AstraZeneca, GSK, Takeda, Amgen, Medscape, Research to Practice, Peerview;Financial Interests, Personal, Stocks/Shares: PerciHealth;Financial Interests, Institutional, Research Grant: AstraZeneca, GSK, Tesaro;Non-Financial Interests, Principal Investigator, Phase II clinical trial Global lead, ENGOTov60/GOG3052/RAMP201: Verastem;Non-Financial Interests, Principal Investigator, ENGOT-GYN1/ATARI phase II international trial (academic sponsored): Astrazeneca;Non-Financial Interests, Advisory Role: Epsilogen;Non-Financial Interests, Other, Member of membership committee: ESGO;Non-Financial Interests, Advisory Role, Medical advisor to UK ovarian cancer charity: Ovacome Charity;Non-Financial Interests, Other, Received research funding from UK based charity I have provided medical advice (non-remunerated): Lady GardenFoundation Charity. R. Miller: Financial Interests, Personal, Other: AZD, Clovis Oncology, Ellipses, GlaxoSmithKline, MSD, Shionogi, AZD, GlaxoSmithKline;Financial Interests, Personal, Speaker’s Bureau: AZD, Clovis Oncology, GSK, Roche. J. Pikiel: Financial Interests, Personal, Other: Amgen, Clovis Oncology, GlaxoSmithKline, Incyte, Novartis, Odonate Therapeutics, Pfizer, Regeneron, Roche. M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zailab;Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, Karyopharm;Financial Interests, Personal, Stocks/Shares: Karyopharm;Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, ultimovacs, Apexigen;Financial Interests, Institutional, Invited Speaker: Deciphera;Non-Financial Interests, Advisory Role: Ultimovacs, Apexigen. T. Duan: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. G. Antony: Financial Interests, Personal, Fu l or part-time Employment: GlaxoSmithKline. S. Zildjian: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. E. Zografos: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. J. Veneris: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. A. Oaknin: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, Deciphera Pharmaceuticals, Genmab, GSK, Immunogen, Mersana Therapeutics, PharmaMar, Roche, Tesaro, Merck Sharps & Dohme de España, SA, Agenus, Sutro, Corcept Therapeutics, EMD Serono, Novocure, prIME Oncology, Sattucklabs, Itheos, Eisai, F. Hoffmann-La Roche,;Financial Interests, Personal, Other, Travel and accomodation: AstraZeneca, PharmaMar, Roche;Financial Interests, Institutional, Funding: Abbvie Deutschland, Advaxis Inc., Aeterna Zentaris, Amgen, Aprea Therapeutics AB, Clovis Oncology Inc, EISAI limited LTD, F. Hoffmann –La Roche LTD, Regeneron Pharmaceuticals, Immunogen Inc, Merck, Sharp & Dohme de España SA, Millennium Pharmaceuticals Inc, PharmaMar SA, Tesaro Inc., Bristol Myers Squibb;Non-Financial Interests, Leadership Role, Executive Board member as a Co-Chair: GEICO;Non-Financial Interests, Leadership Role, Phase II Committee and Cervix Cancer Committee Representative on behalf of GEICO: GCIG;Non-Financial Interests, Officer, Chair of Gynaecological Track ESMO 2019. Scientific Track Member Gynaecological Cancers ESMO 2018, ESMO 2020, ESMO 2022. Member of Gynaecological Cancers Faculty and Subject Editor Gyn ESMO Guidelines.: ESMO;Non-Financial Interests, Member: ESMO, ASCO, GCIG, SEOM, GOG.
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Background: The poly(ADP-ribose) polymerase inhibitor niraparib showed clinical activity in advanced gBRCAm ovarian and breast cancers. LUZERN aims to assess the effectiveness of niraparib plus AI in HR+/HER2–, AI-resistant ABC with a pathogenic variant in homologous recombination-related genes. Here we report findings from the stage 1 interim analysis. Methods: This open-label, single-arm, Simon’s 2-stage, phase II trial is enrolling HR+/HER2– ABC patients (pts) with gBRCAm (cohort A;n=6 in stage 1, n=7 in stage 2) and gBRCA wild-type/HRd (cohort B;n=9 in stage 2). Pts had to have received ≤1 prior line of chemotherapy for ABC, 1–2 prior lines of endocrine therapy for early or ABC with secondary endocrine resistance to the last AI regimen. Pts receive niraparib (200/300mg daily orally) plus AI (same agent given with the prior regimen) on each 28-day cycle. Primary endpoint: clinical benefit rate (CBR) as per RECIST 1.1. Secondary endpoints: overall response rate, progression-free survival (PFS), and safety per CTCAE 5.0. If ≥1/6 pts experienced clinical benefit, the trial should proceed to stage 2. Results: Six pts were enrolled in stage 1. Median age was 46 years (range 32–76), 66.7% of pts had visceral disease, and 83.3% had received prior CDK4/6 inhibitor-containing regimen for ABC. At data cut-off, 50.0% of pts were ongoing and median duration of treatment was 4.6 months (range 2.4–5.7). One patient achieved complete response, meeting the criterion to proceed to stage 2. Median investigator-assessed PFS was 5.3 months (95%CI 3.9–NA). The most frequent adverse events (AEs) of any grade (G) were nausea (3 [50.0%]), neutropenia (2 [33.3%];16.7% G3), constipation (2 [33.3%]), and vomiting (1 [16.7%]). Serious AEs occurred in 3 pts (50.0%;G3 COVID-19 pneumonia;G3 pseudomonal bacteriemia;G2 sacral pain). No treatment-related discontinuations/deaths were reported. Conclusions: Niraparib plus AI showed preliminary activity with a tolerable safety profile in gBRCAm HR+/HER2– AI-resistant ABC pts. Based on the steering committee recommendation, enrolment in cohorts A and B is ongoing. Clinical trial identification: ClinicalTrials.gov identifier: NCT04240106. Legal entity responsible for the study: MEDSIR. Funding: GlaxoSmithKline. Disclosure: J.Á. García Saenz: Financial Interests, Personal, Advisory Board: Seagen, Gilead;Financial Interests, Personal, Invited Speaker: Novartis, Celgene, Eli Lilly, Eisai, AstraZeneca, Daiichi Sankyo, MSD, Exact Sciences;Financial Interests, Institutional, Funding: AstraZeneca. J. De la Haba Rodriguez: Financial Interests, Personal, Other, Consultant and Advisory Role, Research Funding and Speaking: Pfizer, Novartis, Roche, Lilly;Financial Interests, Personal, Other, grant support: Pfizer. J.E. Ales Martínez: Financial Interests, Personal, Other, travel grant: Pfizer;Financial Interests, Personal, Research Grant: MEDSIR. E. Alba Conejo: Financial Interests, Personal, Advisory Role: Roche, Novartis, Pfizer, Lilly, BMS, Astrazeneca, Pierre Fabre, Daiichi, Exact Sciences;Financial Interests, Personal, Research Grant: Pfizer. J. Balmaña: Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer;Financial Interests, Institutional, Other, Steering committee member: AstraZeneca;Financial Interests, Institutional, Principal Investigator: Medsir, Pfizer. J.M. Perez Garcia: Financial Interests, Personal, Advisory Role: Lilly,Roche, Eisai, Daichii Sankyo, AstraZeneca, Seattle Genetics, Medsir;Financial Interests, Personal, Other, travel expenses: Roche. M. Sampayo-Cordero: Financial Interests, Personal, Other, honoraria: Medsir, Syntax for Science, Optimapharm, and Ability pharma;Financial Interests, Personal, Research Grant: Medsir;Financial Interests, Personal, Other, travel expenses: Medsir, Syntax for Science, Optimapharm, and Roche;Financial Interests, Personal, Other, consultant: Medsir, Syntax for Science, and Optimapharm;Financial Interests, Personal, Speaker’s Bureau: Medsir;Financial Interests, Personal, Full or part-time Employment: Me sir. A. Malfettone: Non-Financial Interests, Personal, Full or part-time Employment: MEDSIR. J. Cortés: Financial Interests, Personal, Advisory Role: Roche, Celgene, Cellestia, Astrazeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp&Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks;Financial Interests, Personal, Other, honoraria: Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo;Financial Interests, Institutional, Research Grant: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London.;Financial Interests, Personal, Stocks/Shares: MEDSIR, Nektar Pharmaceuticals, Leuko (relative);Financial Interests, Personal, Other, travel, accomodation: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo, Astrazeneca. A. Llombart Cussac: Financial Interests, Personal, Leadership Role: Eisai, Celgene, Lilly, Pfizer, Roche, Novartis, and MSD;Financial Interests, Personal, Stocks/Shares: MEDSIR and Initia-Research;Financial Interests, Personal, Advisory Role: Lilly, Roche, Pfizer, Novartis, Pierre-Fabre, GenomicHealth, GSK;Financial Interests, Personal, Speaker’s Bureau: Lilly, AstraZeneca, and MSD;Financial Interests, Personal, Research Grant: Roche, Foundation Medicine, Pierre-Fabre, and Agendia;Financial Interests, Personal, Other, travel compensation: Roche, Lilly, Novartis, Pfizer, and AstraZeneca. All other authors have declared no conflicts of interest.
ABSTRACT
Background: Many patients fail to achieve a clinical benefit from ICI. Several scores have been developed to improve ICI candidates selection but it is uncertain which one better predicts patients’ outcome. Here, we performed a direct comparison of the most successful scores. Methods: This is a sub-analysis of the immunoblood prospective observational study that enrolled patients diagnosed with advanced solid tumors treated with ICI. Main clinicopathological data were retrieved from medical records and responses assessed according to RECIST 1.1 criteria. LIPI, RMH, PMH, dNLR, NLR, PIPO and GRIm scores were calculated. Receiving operator characteristics (ROC) curves and their area under curve (AUC) were used to predict PFS and durable clinical benefit (DCB;stable disease≥6 months or better). Associations with PFS, OS and DCB, where assessed with Cox and logistic regressions. Scores’ correlation was assessed with Spearman rho. Significance was set at p<0.05. Results: We recruited 155 patients (65% male, mean age 63). NSCLC (28%), colorectal (20%) breast (9%) H&N (6%) cancer and melanoma (6%) were the most frequent tumor types. Frequency of the high risk/bad outcome group of each score were: LIPI 13%, RMH 36%, PMH 54%, GRIm 14%, PIPO 6%, NLR 32% and dNRL 27%. Fair accuracy in identifying patients at higher risk of progression or mild accuracy in predicting DCB were observed for the RMH (AUC PFS: 0.7, 95%CI: 0.6-0.8;AUC DCB: 0.6, 0.5-0.8) and LIPI (AUC PFS: 0.7, 95%CI: 0.6-0.8;AUC: 0.6, 0.5-0.7) scores. All other scores provided poor/no accuracy. No significant difference was observed between RMH and LIPI AUC for PFS and DCB (both p>0.05). Additionally, only LIPI and RMH were associated with PFS (p=0.001;p<0.001), OS (p<0.001;p=0.001) and DCB (p=0.034;p=0.010) at univariate analyses. At multivariate analyses RMH and LIPI remained significantly associated with PFS (p=0.030;p=0.021) and OS (p=0.012;p<0.001). A strong correlation between both scores (rho=0.72, p<0.001) was observed. Conclusions: RMH and LIPI scores were sufficiently reliable in assessing the prognosis of patients with advanced solid tumors treated with ICI. They were superior to other analyzed scores in our population and highly correlated. Legal entity responsible for the study: Hospital Clinic y Provincial de Barcelona, Medical Oncology Department. Funding: Has not received any funding. Disclosure: J. Garcia-Corbacho: Financial Interests, Personal, Advisory Board, FGFR inhibitors implementation in clinical practice: Johnson & Johnson Pharmaceutical;Financial Interests, Institutional, Invited Speaker, Participation in clinical trials of the company as PI: Johnson and Johnson Pharmaceutical, Boehringer Ingelheim, Astellas, Cytomx, Incyte, Lilly, Menarini, Merck, Bayer, AstraZeneca, Amgen, Daiichi Sankyo. L. Mezquita: Financial Interests, Personal, Advisory Board: Takeda, AstraZeneca, Roche;Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Takeda;Financial Interests, Personal, Research Grant, SEOM Beca Retorno 2019: BI;Financial Interests, Personal, Research Grant, ESMO TR Research Fellowship 2019: BMS;Financial Interests, Institutional, Research Grant, COVID research Grant: Amgen;Financial Interests, Institutional, Invited Speaker: Inivata, Stilla. N. Baste Rotllan: Non-Financial Interests, Advisory Role: Eisai, MSD, Merck Serono, BioNTech, Roche, BMS, Exelixis. A. Prat: Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker, Lecture fees: Novartis, Daiichi Sankyo;Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Novartis, Pfizer, BMS, Puma, Oncolytics Biotech, MSD, Guardant Health, Peptomyc;Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo;Financial Interests, Institutional, Other, Contracted research: Boehringer, Medica Scientia Inno. Research;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Invited Speaker, Leadership role: Reveal Genomics, SL.;Financial I terests, Personal, Stocks/Shares: Reveal Genomics, Oncolytics Biotech;Financial Interests, Personal, Royalties: Reveal Genomics;Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Novartis;Financial Interests, Personal and Institutional, Invited Speaker: Daiichi Sankyo;Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: SOLTI Foundation, Actitud Frente al Cáncer Foundation. All other authors have declared no conflicts of interest.
ABSTRACT
Background: In the UK, 38% of people residing in care homes are estimated to be at high risk of malnutrition1 and it is known now that nutritional status can further be negatively affected by COVID-19 not only directly through medical complications but also social factors such as social isolation, staffing issues, increased anxiety and low mood2. Our aim is to evaluate the clinical and cost effectiveness of direct dietetic input (Rapid Access Dietetic Service) to care homes during the COVID-19 pandemic. Methods: During the first wave of the Covid-19 pandemic, a rapid access service to support care homes was set up, accepting referrals directly from the care home staff and offering a remote dietetic assessment within 1 week of referral. Patients at high risk of malnutrition / on ONS were followed up as part of a 12-week care pathway. The 12-week pathway consisted of initial and last telephone/video consultation by the dietitian and monthly telephone follow ups in between by the dietetic assistant. Care home staff were provided remote training on ‘Food First’ malnutrition management and ONS prescribing. Outcomes audited were MUST, clinical outcomes (number of falls, pressure sores, chest and UTI infections, hospital admissions, A&E attendance in the last 3 months) pre and after 12-week pathway. Cost benefit analyses were performed on both clinical outcomes and ONS changes. Service evaluation was done by requesting GP / care staff and community dietitians’ feedback. Results: 54 patients were referred by the care homes staff/GP, 24 of those because of medium/high risk of malnutrition, 30 referred for ONS review. Out of the patients who were medium/high risk (n = 24) and were onboarded onto the 12-week care pathway, the number of patients with MUST of 0 (low risk) increased 8-fold, patients with MUST of 1 (medium risk) increased 2.3 times and patients with MUST of 2 or above (high risk) declined by half after the 12-week care pathway. Cost benefit analysis on clinical outcomes showed combined estimated cost savings of £26,061 (Table 1). Out of the patients on ONS, 11 prescriptions were changed, 5 were stopped, 13 were continued resulting in a total ONS annualised savings of £12,753 / £425 per patient. The service was evaluated by the community dietitians, care staff and GPs and positive feedback was provided. [Formula presented] Discussion: Despite being an existing service, significant adaptations were made in order to continue providing care throughout the COVID-19 pandemic. All interactions and engagement with GPs and care home staff were conducted remotely in place of the usual in-person service. Despite this change, marked improvements in patient malnutrition status were seen during the 12-week care pathway. Cost benefit analysis show a combined annualised cost saving of £38,814 during the 6-month intervention from the ONS changes and clinical outcomes. This equates to an annualised cost saving of £77,628 and £718.7 per person referred. The service was highly valued by the care home staff, GPs and community dietitians as evidenced by the positive feedback received. Limitations include other possible factors may have influenced the results e.g. medications/other HCP involvement. Annualized savings for ONS changes and clinical outcomes were estimated based on savings achieved in the 6 months over the service was running. The cost of dietitian was not included as a pre-existing service was altered during the pandemic months prioritizing care homes. Conclusion: The new rapid access service for care homes resulted in residents being seen quickly and appropriately treated for malnutrition where identified. The service also resulted in significant cost savings for ONS prescriptions and avoidance of healthcare costs associated with malnutrition. Continuation of this new service model should be considered to reduce the incidence of malnutrition and effectively manage those identified as malnourished. References 1. Nutrition Screening Survey in care Homes in the UK: A report based on the amalgamated data from the four Nutrition Screening Week surveys undertaken by BAPEN in 2007, 2008, 2010 and 2011 C A Russell and M Elia on behalf of BAPEN and collaborators 2. Azzolino D, Saporiti E, Proietti M, Cesari M. Nutritional considerations in frail older patients with COVID-19. The journal of nutrition, health & aging. 2020 Jul;24:696-8. 3. National Schedule of Reference Costs 2017/2018 4. Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012 Jun;21(6):261-2, 264, 266. 5. British National Formulary – National Institute for Health and Care Excellence -
ABSTRACT
Purpose: Nearly 4 million U.S. adolescents use e-cigarettes, despite known health harms and laws prohibiting sales to people below 21 years. National surveys show that adolescents self-report buying e-cigarettes from retail stores and online. Although studies show that e-cigarette marketing is associated with adolescent e-cigarette use, these studies have not directly asked adolescents their perception of whether e-cigarette marketing in retail, online and social media influences their browsing, purchasing and use-related behavior. Methods: 90-minute, online focus groups with 14-19 year olds (May-Aug 2021). Photographs were used to help participants recall e-cigarette marketing. Participants were recruited through an Instagram post targeting 30 major U.S. cities (n=27 recruited in 3 focus groups from 10 cities thus far;recruitment ongoing). Thematic analysis was used to identify themes related to appealing marketing characteristics. Results: In addition to bright colors of e-cigarette advertising and names of flavors, participants described appealing e-cigarette marketing characteristics. Appealing characteristics in retails stores: pricing coupons, free smelling samples, individual brands displayed in separate containers, displays at the checkout counter (e.g., “there's a big difference between being at the counter, where you can pick it up yourself, and being behind the counter because I don't want to have to ask the person at the Walgreens –‘can you hand me that?’”). On social media: AYAs were attracted by youth/influencers explaining product safety (e.g., “A lot of influencers market like ‘Oh yeah, they don't have any cancer-causing chemicals”);and inability to trace messages (e.g., Snapchat). Participants also listed ways to purchase e-cigarettes using gift cards, debit cards and using fake or other people’s IDs. Conclusions: Our data show that specific appealing e-cigarette marketing characteristics in retail stores and online can and should inform FDA, state, and local regulation. Notifications on social media, similar to those created to combat misinformation about COVID-19 vaccines, may be developed and tested to prevent AYAs from accessing e-cigarette-related misinformation. Sources of Support: The research reported in this was supported by the Taube Research Faculty Scholar Endowment and the ASPiRE D&I Pilot Award.
ABSTRACT
Introduction: Residency training has faced substantial challenges during the COVID-19 pandemic. Understandably, interventional pain procedures have seen an associated reduction in case volume due to global healthcare recommendations, especially due to many interventional spine procedures being categorized as elective. For PM&R residents, the ACGME recommends observation or performance of 10 total epidural, facet, or SI joint injections and no requirement of exposure to neuromodulatory procedures during their training. This quality improvement project utilizes a 3D printed spine, medical instruments, and virtually simulated fluoroscopic images to create a hybrid training platform. The goal of the study was to enhance resident exposure to neuromodulation while improving technical proficiency, efficiency, and confidence of trainees with spinal cord stimulator placement. Methods: Current PM&R residents of all PGY levels were recruited to this study (n=10). A pre-test survey to determine baseline levels of comfort and experience with neuraxial procedures was taken by all participants. They were then taken through two standardized attempts of accessing the epidural space via interlaminar approach followed by placement of spinal cord stimulator leads. After the first attempt, a brief teaching session to correct significant deficiencies or mistakes was allotted. After the second attempt, a post-test survey to evaluate confidence levels and self-perception of procedural skill was completed. Performance during each attempt was objectively assessed via a modified Operative Performance Rating System (OPRS) evaluation. Results: During pre-test survey, participants of the study had extremely limited exposure to percutaneous lead placement (4 total cases observed, 0 performed) with correlated low confidence levels. Between first and second attempts, participants had significant improvements in their ability to safely access the epidural space (40% failure rate on first attempt, improved to 0%). Ability to effectively drive percutaneous leads was also demonstrated, with less incidence of anterior migration requiring leads to be withdrawn (53% improvement of average lead travel distance between attempts). Procedural efficiency also substantially improved (34% average decrease of total fluoroscopy time between attempts). Finally, objective OPRS evaluations and subjective participant procedural confidence levels improved proportionately with performance. Conclusion: Virtually simulated fluoroscopic training is a viable and effective method of initiating or augmenting neuromodulatory procedure education. The device provides a safe, radiation-free setting for learning procedures prior to performing them on real patients and improves the confidence, efficiency, and objective performance of participants. Ultimately, this is an even more important didactic option given ongoing events surrounding the global pandemic. Disclosure: William White, DO: None, Michael Jung, MD, MBA: None [Formula presented] [Formula presented] [Formula presented]