Covid-19 Vaccination Impact on Atrial Arrhythmias - Real-World Evidence from the Certitude Registry

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

Relationship between Covid 19 Vaccination and Psa Level

INTRODUCTION AND OBJECTIVE: Some reports have indicated that the COVID vaccine could affect parameters used for some cancer screenings. The effect of COVID vaccination on breast cancer screening mammograms has been hotly debated and anecdotal reports of a rise in prostate-specific antigen (PSA) after COVID vaccination have appeared in the media. We explored the relationship between PSA levels and COVID vaccination. METHOD(S): With IRB approval, we queried the electronic medical record for men who received at least two mRNA COVID vaccine injections (Pfizer or Moderna), at least one PSA test within two years prior to the first vaccine injection and at least one PSA within one year of their second injection and before any third injection. PSA results were grouped according to the timing of the post vaccination PSA. The pre-vaccine PSA closest to the first injection was used. Both within and between subject analyses were conducted. Wilcoxon signed rank tests were performed to compare PSAs pre- and post- vaccine for each time defined group. McNemar tests were used to assess the percentage of patients crossing a 4.0 ng/dl threshold when compared with their prevaccine PSA. Difference in relative PSA change across the groups was compared using a Kruskal Wallis test. RESULT(S): 5713 men met inclusion criteria. Median prevaccine PSA was 1.2 ng/dl (IQR 0.6-2.7 ng/dl). The median time difference between vaccine injection 1 and 2 was 22 days (IQR 21- 28 days). Within each time group, a significant increase in PSA was observed pre to post and a higher proportion of men went above 4.0 relative to those going below. However, no significant differences were observed across groups (Table 1). CONCLUSION(S): Due to the lack of intergroup differences, PSA increases most likely reflect natural progression rather than any temporal effect of vaccination.

Covid‐19 outbreak and stocks return on the West African Economic and Monetary Union's stock market: An empirical analysis of the relationship through the event study approach

This study uses the Wilcoxon's signed ranks test to identify the effect of the Covid‐19 outbreak on the stocks returns of companies listed on the West African Economic and Monetary Union's (WAEMU) stock market by considering two event dates (January 23, 2020 and March 2, 2020). To account for the temporal volatility in the event approach, the study resort to a GARCH model. Empirical findings suggest that January 23, 2020 event (first case of death due to Covid‐19 in China) have had a minor impact on the WAEMU stock market while the event on March 2, 2020 (first case of Covid‐19 in the WAEMU) strongly affected the financial market. This negative impact is much more pronounced for the distribution sectors (−34.16%). Robustness analysis reveals that the main information leading to disruption on the market is the weekly death cases and not the confirmed cases. In addition, government anti‐Covid‐19 measures such as social distancing and governance positively affect the stock return whereas lockdown, public health measures and movement restrictions contribute to a decline in the stock's price.

An Evaluative Study on Strategic Directives for Brand Delight and Its Impact on Customer Retention in Indian Food Industry Amidst Covid-19

This study is an evaluative study on strategic perspectives on brand delight and its impact on Indian fast-food Industry amidst Covid19. The global crisis and turmoil have crippled and transformed the entire operations of the globe. The Indian fast-food industry has been closed for almost six months. There is a need for revamping and restarting this industry for economic and social contributions.As social distancing, wearing masks and following the government norms has become the order of the day, this has also led to change in consumer's perceptions and attitudes. The study by nature evaluates strategic perspectives which could lead to brand delight in Indian fast food industry. This would also ensure brand retention in these challenging times. As there has been very little empirical investigations which have been attempted in this industry during these tough times in India, this study addresses the research gaps and also provides practical inputs for Indian fast-food industry on consumer perception towards brand delight and retention, which is the need of the hour. This is an empirical and quantitative study which attempts to provide strategic perspectives for Indian fast-food industry by collecting primary data through Questionnaire. The primary data for the study has been collected with 64 fast food consumers from Delhi, Mumbai, Ahmedabad, Amritsar and Calcutta. Stratified random sampling has been used in this study. The collected data has been analysed using SPSS tools as correlation, Wilcoxon signed rank test and Friedman two-way non-parametric Anova test has been conducted in this study. In this study it is found that brand communication can be made very effective using Digital display & advertisements &SEO Tools getting next Social media like FB getting least ranking which is very surprising. In this study it is also found that image of the product and awareness, popularity of fast-food leads to more purchase of fast-food products. It is found from this study that there is a positive correlation between the factors of satisfaction with fast food products and engagement and expectation of more products in fast food industry. It was also found that majority of the respondents love Indian dishes and Indian restaurants, Dominos, Pizza hut, McDonald are their favourite choices and also, they expecting to have more spicy and vegetarian varieties in fast food industry. The factors for customer retention have been provided in this study which includes Pleasing environment and good food are my preferences for happiness and satisfaction, Variety of dishes and menu has attracted customers to this food and customers are happy with the experience and would come again, & Communication of staff is very essential which makes consumers happy and satisfied. From these findings it is concluded that Indian fast-food industry must have these strategic perspectives for brand delight and customer retention.Copyright © 2020 Ubiquity Press. All rights reserved.

RWD111 Influenza Vaccine Sales During the COVID-19 Era

Objectives: The circulation of the SARS-Cov2 responsible of the COVID-19 pandemic was still active during the 2021/22 influenza season. As such, immunization against influenza was still highly recommended to protect populations and relief healthcare systems. The objective of this study was to observe the evolution of influenza vaccines sales during the pooled 2020/22 seasons compared to pre-COVID-19 influenza seasons. Method(s): Leveraging previous research, we focused on influenza vaccine sales or prescription/reimbursement for the influenza seasons 2015/16 to 2021/22 in three countries: France, UK and US. Data were collected for each season from September/October to January/February. Data for France were extracted from the Assurance Maladie (reimbursement data) while data for the UK were selected from the Vantage IQ database (prescription data), and data from the CDC were considered for the US (distributed doses). We used non-parametric Wilcoxon signed-rank tests to highlight significant vaccine sales variations for the combined 2020/22 seasons compared to previous seasons. Result(s): A +26.28% increase in reimbursed influenza vaccines was observed in France for the combined 2020/22 seasons compared to the pre-COVID-19 period (p=0.0313), with significant augmentations observed for each month from October to February. Similar observations were noted for the UK and the US, with overall increases of +28.83% (prescribed vaccines) and +16.21% (distributed vaccines) respectively (p= 0.0313). However, reductions in vaccine volumes were noted between the 2020/21 and 2021/22 seasons in France and the US, with -12.26% and -11.00% respectively. Conclusion(s): We observed a significant increase in influenza vaccine sales for the seasons 2020/22 compared to pre-COVID-19 seasons, most likely attributable to the Covid-19 pandemic. However, drops in influenza vaccine volumes were observed in 2021/22 for France and the US compared to 2020/21, highlighting potential early signs of vaccine fatigue and drop in awareness, with the risk of returning to pre-COVID-19 vaccine volume levels. Copyright © 2022

Trend of Obesity and Body Mass Index (Bmi) before and after the Covid-19 Lockdown in Children 2-19 Years of Age Presented to Ambulatory Clinics at a Community Hospital

Background: In March 2020, World Health Organization declared COVID-19 outbreak a pandemic, with children forced to be away from structured school settings making them experience circumstances that could accelerate weight gain, including increased stress, irregular mealtimes, increased screen time, and lesss physical activity. Recent studies showed increased body mass index (BMI) trends in children during COVID-19 pandemic and recommended replicating this result with other population. Our study aims to measure the BMI trends before and after the COVID-19 pandemic lockdown in children 2-19 years of age presented to ambulatory clinics at a local community with the majority of black race. Method(s): A retrospective study on children aged 2-19 years who presented to ambulatory clinics affiliated with Brookdale Hospital, New York from 10/1/2018 to 10/31/2021. We included subjects with at least two BMI readings before COVID-19 lock down in March 2020, and at least one reading afterwards. Children who were underweight at baseline (BMI percentile < 5) or with medical conditions that may cause impact on weight such as endocrinological conditions (e.g. diabetes mellitus or hypothyroidism), genetic (e.g. Prader Willi syndrome), gastrointestinal diseases (e.g. inflammatory bowel disease or celiac disease), psychiatric diagnoses (e.g. eating disorders), as well as children who received systemic steroids > 2 weeks, were excluded from the study. Two baseline BMI readings were taken for all subjects during the pre-COVID period from October 2018 until March 2020 (one during the first 9 months, baseline-1;and second during the following 9 months, baseline-2). In the post-COVID period, the latest BMI measurement for the same cohort, at least 9 months from COVID-19 lockdown, was retrieved for comparison. Data was analyzed using SPSS software. The percentage of overweight and obese children was compared between different timelines using Chi-squared test. Change of BMI percentiles over time was tested for significance using the Wilcoxon Signed Ranks test. Result(s): After implementing the exclusion criteria, final number of studied patients was 3713. Children < 5 years old were 905 (24.4%), 5-12 years old were 1707 (46%), and > 12 years old were 1101 (29.7%). The median age (IQR) was 9 (5-12) years, with 1844 (49.6%) males. Black race accounted for 1777 (47.9%) while Hispanics or Latinos were 470 (12.7%), with other ethnicities being 1466 (39.4%). There was no difference in the percentage of obese children from baseline-1 (806/3713=21.7%) to baseline-2 (829/3713=22.3%), p-value=0.795, but this increased significantly in the post-COVID period (1136/3713= 30.6%), p-value <0.001 (figure 1). There was no significant change in the percentage of overweight children between the three timelines. The BMI percentile median (IQR) did not change between baseline-1 = 70 (36-93) and baseline-2 = 71 (35- 93), however, this increased significantly to 81 (36-93) in the post-COVID period, p-value<0.001 compared to both baseline-1 and baseline-2. Comparing the change in BMI percentiles from baseline 2 to post-COVID in the different age groups, it was more evident in the <5 years age group (median increment of 4.3 percentile) and 5-12 years age group (median increment of 3.9 percentile) compared to the >12 years age group (median increment of 0.7 percentile), p-value<0.001 (table 1). Conclusion(s): In our local community, COVID-19 lockdown resulted in a higher prevalence of obesity and an overall increase in BMI percentiles among children aged 2-19 years. The increase in BMI percentiles was more evident in children less than 12 years of age.

Telehealth utilization in gynecologic oncology clinical trials (295)

Objectives: In light of the COVID-19 pandemic, the Society of Gynecologic Oncology (SGO), National Cancer Institute, and Food and Drug Administration published clinical practice statements encouraging the use of telemedicine in clinical trials, which had previously been prohibited. Our study aimed to assess the feasibility and safety of telehealth utilization in clinical trials for gynecologic malignancies. Methods: A retrospective cohort study was performed. Patients who were enrolled in a gynecologic oncology clinical trial at the University of Pennsylvania Health System from March 16, 2020, to August 30, 2020, were included. Receipt of care during the telehealth period (March 16, 2020, to August 30, 2020) was compared to the pre-telehealth period (September 30, 2019, to March 15, 2020). Pairwise comparisons of clinical trial outcomes were performed between the two time periods, using paired t-test, Wilcoxon signed-rank test, simple linear regression, Chi-square, and ANOVA. Results: Thirty-one patients met the inclusion criteria. The mean age was 63.7 years (SD 10.3);84% were non-Hispanic White. The median distance from home zip code to study center was 25.2 miles (IQR: 16-46, range: 1.9-170). Most patients had high-grade serous ovarian carcinoma (84%) and had the disease at an advanced stage (Stage III 48%, Stage IV 38.7%). Trial drugs included 22.6% (n=7) intravenous only, 29% (n=9) oral only, and 48.4% (n=15) combination oral/intravenous therapies. The median duration of enrollment was similar between pre-telehealth (5.2 months, IQR: 3.2-5.6) and telehealth periods (5.6 months, IQR: 3.8-5.6), (p=0.682). During the TELEHEALTH period, significantly more virtual provider visits (p <0.001) and remote laboratory testing (p=0.015) occurred, with similar rates of remote imaging (p=0.551). Delayed provider visits (p = 0.965), laboratory testing (p = 0.989) and imaging (p = 0.999) occurred infrequently in both timeframes. The number of patient touchpoints (portal messages and phone calls) per month did not increase (p = 0.147). Patients who lived farther from the study center were more likely to use remote imaging (p = 0.013);however, the distance was not associated with the use of virtual provider visits (p = 0.309) or remote laboratory testing (p = 0.821). Number of dose reductions (p = 0.112) and toxicity-related treatment delays (p = 0.888) were similar. Increased need for extra imaging was noted in the telehealth period (p=0.007) and was not associated with disease progression (p=0.614). Extra provider visits, emergency department visits, and hospital admissions were infrequent and similar in both timeframes (Table 1). The total number of deviations was increased (p=0.010);however, when adjusted for minor deviations documenting telehealth use or deferment of research-related laboratory testing given the pandemic precautions, there was no difference between timeframes (p = 0.468). The total number of adverse events and severe adverse events did not increase in the telehealth period (p=0.494 and p=0.601, respectively). Conclusions: Utilizing telehealth in clinical trials for gynecologic oncology patients did not increase clinical workload or adverse patient outcomes. Documentation of telehealth use and pause of research-related laboratory collections resulted in a higher number of protocol deviations during the telehealth period. Telehealth should be incorporated into future clinical trials as it appears safe and feasible and may facilitate access for remote, rural, and under-served populations.

Feasibility of virtual stress management and resiliency training (SMART) for oncology fellows during the COVID-19 pandemic

Background: Stress Management and Resiliency Training (SMART) is a validated resilience training program designed to reduce stress, improve emotional resilience, and decrease burnout. The prevalence of burnout among practicing oncologists is as high as 40%, but unknown among oncology trainees. We implemented a virtual format of the SMART program to the Hematology/Oncology fellowship at Mayo Clinic to assess the feasibility of such a delivery, measure baseline rates of burnout in this group, and to investigate if a virtual method of delivery is as effective as in-person delivery as described in the literature. Methods: The SMART project was a mixed-methods, prospective, single arm clinical trial. Hematology/Oncology Fellows at Mayo Clinic were invited to participate. Four one-hour training sessions were conducted virtually. Fellows were given access to SMART online video modules and a book which supported the content covered during virtual training, a companion resilience mobile app, and a paperback mindfulness journal. Stress, burnout, and emotional resilience were measured at baseline and three months post-intervention using the Perceived Stress Scale (PSS), Maslach Burnout Inventory (MBI), and Connor-Davidson Resilience Scale (CD-RISC2). Changes in mean scores on the PSS, MBI, and CD-RISC2 were assessed using the Wilcoxon signed-rank test. Program feedback and feasibility data were obtained during a virtual focus group. Audio transcripts from the focus group were codified for thematic analysis and verified by intercoder triangulation. A 6-month assessment will be due in March 2022. Results: 26 of 50 fellows invited participated in our study. At baseline, 24% of participants had measurable burnout and 92% had moderate to high stress. At 3-months, the number of participants with moderate to high stress decreased to 71%, while rates of burnout remained unchanged. The PSS demonstrated a decrease in mean stress (-10.9%, p = 0.005), while the MBI demonstrated decreased emotional exhaustion (MBI-EE -6.01%, p = 0.04), an improved sense of personal achievement (MBI-PA 28.1%, p < 0.001), but slightly worse feelings of depersonalization (MBI-DP 16.46%, p = 0.05). The CD-RISC2 suggested no change in global emotional resilience (-0.71%, p = 0.82). Thematic analysis of the focus group data revealed that participants overwhelmingly found the program beneficial (83% of all responses), 20% indicated improved stress, and 15% indicated improved work performance. Conclusions: Oncology fellows in this study had lower rates of burnout compared to practicing oncologists. Virtual implementation of the SMART program is feasible and resulted in improvements in stress and prevented worsened burnout. Outcomes were comparable to previously published studies conducted in-person. Focus group participants found the training beneficial, reported lower stress, and improved work performance.

CAN DOSAGE of INFLIXIMAB BE ADJUSTED to 8 WEEK INTERVALS WITHOUT LOSING EFFICACY in ARTHRITIS PATIENTS on MAINTENANCE THERAPY with MORE FREQUENT INFUSIONS?

Background: Infiximab is usually given every 8 weeks. To increase dosage, the dose can be increased or the interval between infusions shortened. To minimize patient visits and workload for the medical staff during the Corona pandemic, we intended to change all infiximab infusions to 8 week intervals. For patients with infammatory bowel disease, a trough level of serum (s-) concentration of infixi-mab of 3-7 μ g/ml is recommended. In Rheumatology the usefulness of assessing s-concentration is controversial. (1, 2) Objectives: To evaluate if 8 week interval infiximab dosage, with retained weekly dose, can be used in arthritis patients, without worsening of disease activity or general health and study if s-concentration of infiximab is related to disease activity and general health. Methods: All arthritis patients on stable infiximab treatment were evaluated at the time for infiximab infusion. Disease activity, DAS28-CRP, VAS pain, global, fatigue, doctors' global, HAQ, and ASDAS-CRP, BASFI for spondyloarthritis (SpA) patients were registered in the Swedish Rheumatology Quality registry (SRQ). Blood tests for CRP, ESR and s-concentration of infiximab were taken before infusion start. S-concentration was analysed at Karolinska Hospital, Solna, Sweden with an in-house ELISA. Antibodies were assessed if s-concentration was <0.5 μ g/ml. Patients with infusion intervals less than 8 weeks were recommended a switch to 8 week intervals with maintained weekly dose of infiximab. The new dose was given the same day and patients with changed doses were re-evaluated after 24 weeks. Paired samples T-test and Wilcoxon signed rank test for paired data were used for comparison of disease activity and general health after dosage change. Linear regression analyses were used to explore associations between s-concentration, disease activity and general health. Results: Of 91 assessed patients, 66 with shorter intervals were recommended dosage change. The remaining 25 patients had infiximab every 8 weeks and served as controls. For baseline characteristics see Table 1. Dosage was changed in 58 patients and 90% (n=52) remained on 8 week intervals after 24 weeks, with a mean (SD) dose of infiximab of 5.3 (1.9) mg/kg. All assessed disease variables (DAS28-CRP, VAS pain, global, fatigue, Dr global, HAQ, ASDAS-CRP, BASFI, CRP and ESR) remained unchanged (p=0.051 (pain)-0.83) (Figure 1 A, B) while S-concentration was lower (p<0.001) at follow up. S-concentration of infiximab did not relate to disease activity neither at baseline nor at follow up (p=0.15-0.24). (Figure 1 C, D) Conclusion: Adjustment of infiximab dosage to every 8 weeks worked for a majority of the arthritis patients in this clinical setting without worsening of disease activity or general health. S-concentration of infiximab did not relate to disease activity or general health.

LAPAROSCOPIC CERCLAGE SACROHYSTEROPEXY: ANATOMICAL AND SUBJECTIVE POST-OPERATIVE OUTCOMES AT 6 WEEKS

Introduction: Our group first described a novel approach for hysteropexy in 2017. This procedure utilized a combined laparoscopic and vaginal approach to place a polypropylene mesh sling around the cervicouterine junction as a cerclage and attach this mesh to the sacrum. Previous outcomes comparing this technique to laparoscopic hysterectomy and sacrocervicopexy showed equivalent anatomical and subjective outcomes with decreased suturing and intraoperative time compared to traditional sacrocervicopexy at 6 weeks, 6 months and 12 months. The procedure was refined in 2019 when vaginal attachment of the mesh was replaced with a novel laparoscopic mesh attachment technique, now referred to as total laparoscopic cerclage sacrohysteropexy (TLCSH). Objective: To assess postoperative outcomes of the novel, modified TLCSH. Methods: This was a retrospective study of patients who underwent TLCSH from February 2019 to October 2021. Chart review was performed to obtain patient demographics, baseline pelvic organ prolapse quantification (POP-Q) scores and 6- week outcome data. Anatomical success was a composite of anterior, posterior and apical success. We defined anterior and posterior compartment success as Ba and Bp ≤0, respectively. Apical success was defined as C ≤ half the total vaginal length (TVL). As a more conservative measure, we also defined success as C < -4 and C ≤ -2/3 TVL. Subjective outcomes, including patient-reported pelvic organ prolapse distress inventory (POPDI-6), patient global impression of improvement (PGI-I) and satisfaction, were also assessed at 6 weeks. Data are reported as median (interquartile range) and were compared with the Wilcoxon signed rank test. Results: A total of 117 patients underwent TLCSH and 107 (91%) had a 6- week post-operative visit at a median time of 2 months (1-2). Of patients who had a 6-week visit, 9 had a telehealth visit due to COVID-19 and did not have a POP-Q assessment, and 1 patient only had point C documented and therefore was only included in the point C analysis. Pre-operative characteristics are in Table 1. Post-operative changes for points C, Ba, Bp, and GH were significantly improved (P < 0.001 for all;Table 2). Most patients (93%) had surgical success as defined by C ≤ half TVL. Using the more restrictive definitions of apical success there was 94% success with C < -4 and 35% with C ≤ -2/3 TVL. At 6 weeks, 31% of patients were stage 0, 54% stage I, and 15% stage II. There were no mesh exposures. Subjective outcomes were available for 50 (47%) patients. While only available for a portion of patients, median POPDI-6 scores improved significantly from 30 (21-50) to 4 (0-21), P < 0.001. Most patients (85%) reported that they were “very satisfied,” 12% reported “satisfied,” 2% reported “neutral;” none reported “unsatisfied” or “very unsatisfied.” The median PGI-I score was 1 (1-2), with 1 and 2 corresponding to “very much better” and “much better,” respectively. Conclusions: TLCSH results in anatomical success, in addition to decreased POPDI-6 scores and high PGI-I scores at 6 weeks. Given this novel technique, additional follow-up time with further analysis is necessary to assess whether this procedure is a durable repair for long-term prolapse reduction and patient satisfaction. (Table Presented).

COVID-19 management in a UK Tertiary Centre with High Consequence Infectious Diseases Centre: Nutritional status, intervention and outcome

Coronavirus disease 2019 (COVID-19) has rapidly spread across the globe. Elderly individuals and patients with comorbidities such as obesity, diabetes, and hypertension have been shown to have a higher risk of hospitalization, severe disease, and mortality.1 To date, little data has been published on the timely identification and correction of undernutrition in patients hospitalised with COVID-19. We previously reported a retrospective analysis of the management and 28-day outcomes of 316 consecutive adult patients with SARS-CoV-2 PCR-confirmed COVID-19 admitted to our centre, within the first wave of the pandemic between 8th January 2020 and 16th April 2020.2 The study was registered as a clinical service evaluation and was exempt from ethical approval. A total of 316 patients (55% male) were identified with a median (IQR) [range] age of 75 (60 – 83) [23 – 101] years. Twenty-seven of 316 (9%) patients were healthcare workers, and 60 (19%) were admitted from a care home. The median (IQR) duration of admission was 8 (4 – 14) days, and 59 (19%) patients were admitted to critical care. In total, 84 (27%) patients died within 28 days of admission (or before discharge where admission duration >28 days). We here present further hitherto unpublished analyses of the nutritional status, intervention and outcomes of this cohort. Gastrointestinal symptoms present at admission were: anorexia (97 [31%]), diarrhoea (64 [20%]), vomiting (43 [14%]) and abdominal pain (33 [10%]). Admission weight was recorded in 151 (48%) patients, with a median [range] 74.5kg [32.4-168.0]. Where measured (62 [20%] patients), there was significant weight loss observed during admission;median (IQR) weight 77.4kg (65.5-96) at admission and 73.7kg (61.4-94.5) last recorded weight on admission (P=0.0001, paired Wilcoxon signed-rank test). Forty-eight (15%) patients were assessed by a dietitian during their admission. Fifty-three (17%) patients received oral nutritional supplements whilst an inpatient and 38 (12%) received enteral feeding. Of those patients receiving enteral feeding, 30 (79%) had tube placement confirmed by chest x-ray. In conclusion, gastrointestinal symptoms that are commonly associated with reduced nutritional intake were common in these patients hospitalised with COVID-19. There was evidence of reduced nutritional screening on admission compared with pre-COVID practice. This may have been associated with barriers associated with initial infection prevention and control requirements as well as focus on respiratory issues, and should be addressed in future waves of infection. Updated safety advice on enteral tube feeding including confirmation of tube placement was followed in the majority of cases.3 Future studies should aim to better establish the particular circumstances in COVID-19 where nutritional support impacts outcome. 1. Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention 2020 Apr 7;323(13):1239-1242. 2. Baker KF, Hanrath AT, Schim van der Loeff I, Tee SA, Capstick R, Marchitelli G, Li A, Barr A, Eid A, Ahmed S, Bajwa D, Mohammed O, Alderson N, Lendrem C, Lendrem DW, COVID-19 Control Group, COVID-19 Clinical Group, Pareja-Cebrian L, Welch A, Field J, Payne BAI, Taha Y, Price DA, Gibbins C, Schmid ML, Hunter E, Duncan CJA. COVID-19 Management in a UK NHS Foundation Trust with a High Consequence Infectious Diseases Centre: A Retrospective Analysis. Med Sci (2021);9(1):6. 3. Nasogastric tube safety Special Interest Group. May 2020. Enteral tube feeding safety in COVID-19 patients. BAPEN. )

Implementation of an Institutional Simulation Curriculum to Teach Team Leadership Skills, Management of Critically Ill Patients, and Emergent Procedures to Pediatric Residents

Background: Simulation in medical training is effective at increasing clinical knowledge, improving comfort with procedures, and teaching crisis resource management skills. Uniquely, simulation can also expose trainees to standardized cases independent of available clinical experience. This is especially important at a time when the COVID-19 pandemic has paradoxically led to decreased emergency department visits and hospitalizations, and, consequentially, decreased clinical opportunities for trainees. We developed and piloted a formal, longitudinal, high-fidelity simulation curriculum for pediatric residents, led by pediatric emergency medicine fellows in a unique, near-peer training program. The project goal was to assess the efficacy of this curriculum at increasing resident selfreported comfort in leading a team, managing critically ill patients, and performing essential emergent procedures. Methods: Six cases were designed by pediatric residents and emergency medicine fellows for the curriculum. Cases were reviewed by faculty members, focused on a critically ill pediatric patient, and included an associated emergent procedure. Three of the cases were used for the study, which was conducted over a four-month period in the 2021 academic year. Study participation was voluntary, and 27 pediatric residents participated, completing up to three cases each. Data was collected as self-reported Likert scales for questions regarding leadership, individual medical knowledge, and comfort with procedures. Surveys were completed prior to the curriculum implementation, following each case, and at study conclusion. To account for expected improvements during traditional residency training, data was also collected for two control cases not used in the study. Wilcoxon Signed-Rank test was used to compare pre- and post-intervention assessments. For significant results, the Dwass-Steel-Chritchlow-Fligner method was used to examine pair-wise comparisons by trainee post-graduate year. Results: Results are summarized in Table 1 and Table 2. There was a significant improvement in self-reported ability to function as team leader, identify and designate roles, effectively organize and minimize noise in the room, effectively use closed loop communication, and access additional resources. There was also an increase in self-reported comfort level with both medical knowledge and performing emergent procedures. There was no significant difference between responses based on trainee year. As expected, residents also reported an improvement in medical knowledge about control cases, although the improvement was less than with the implemented cases. When the size of this effect was compared between implemented and control cases, there was a trend towards significance favoring the simulated cases, suggesting that statistical significance may be achieved with a larger sample size. Conclusion: The implementation of a simulation curriculum can lead to improvements in pediatric resident's self-reported comfort with crisis resource management, team leadership, clinical knowledge, and emergent procedures. The effect on medical knowledge and comfort with procedures may be significantly different than the gains expected naturally over time in pediatric residency training.

Increasing Underrepresented Minority Undergraduate Student Exposure to Pediatrics via a Longitudinal Mentorship Program

Background: The United States is increasingly diverse, but representation of minorities (specifically Black/African-American) in medicine has not followed this trend. Lack of mentorship is identified as a barrier at multiple levels. We developed and piloted a mentorship program between pediatric emergency medicine (PEM) physicians and underrepresented minority (URM) undergraduate students in the Porter Scholars program (the largest African American student organization at the University of Louisville), known as the Porter Scholars in Medicine Program (PSMP). By providing robust mentorship and educational activities, our goal is to encourage students in this program to matriculate to medical school. Methods: The pilot program included clinical experiences (simulation and ultrasound), direct mentorship, connections with medical school admissions agents, and personal development programming including a book club. Students selected for the PSMP completed a survey upon entry into the program including demographic questions, as well as 5-point Likert scale questions regarding familiarity with the medical school application process, comfort with being a physician, and barriers to becoming a physician. Additionally, they received a survey after specific experiences and at the end of the year. A final survey will be sent following graduation. Data were analyzed using descriptive statistics, and Wilcoxon-Signed Rank tests were used to compare entry to end of year results. Results: Twenty-three PEM faculty, fellows and clinicians volunteered as mentors or led clinical programs in the PSMP program. Twenty-five undergraduate students were accepted into the program in fall of 2020;22(88%) completed the initial survey. Mean age was 18.6 (+/- 0.8) years, 19 (86.4%) were female. On initial surveys, the median Likert scores were: awareness of available resources to assist with medical school application 2, understanding of the medical school application process 2.5, confidence in acceptance to medical school 3, and mentor support 4. Eight (36.3%) students completed the end of year survey. For these 8 students, significant increases in median Likert scores were noted for the following categories: awareness of available resources to assist with medical school application median 3.5 (p = 0.03) and understanding of the medical school application process median 4 (p = 0.03). While not statistically significant, increases were also noted in confidence in acceptance to medical school median 4 (p = 0.10), and mentor support median 5 (p = 0.06). Student comments were generally positive though experiences were limited by the COVID 19 pandemic, see table 2. Conclusion: This pilot program demonstrates feasibility of a longitudinal mentorship program for URM premedical students which was generally well-received by students and physicians. The pandemic was a limitation, with few opportunities for in-person activities, but we look forward to more robust programing this year.

Adaptations of Pediatric Cardiology Practice During the COVID-19 Pandemic

Background: During the initial surge of the COVID-19 pandemic in the spring and summer of 2020, pediatric heart centers were forced to rapidly alter the way patient care was provided in order to minimize interruption to patient care as well as exposure to the virus. In this study, we used a survey-based approach to characterize the changes that occurred in pediatric cardiology practices across the country during and just following the initial peak of COVID-19. Methods: In this survey based descriptive study we characterize changes that occurred within pediatric cardiology practices across the United States and describe provider experience and attitudes towards these changes during the pandemic. decision making during this period. This survey was emailed to an existing list serve of American Academy of Pediatrics Section on Cardiology and Cardiothoracic Surgery (AAP:SOCCS) members. Recipients of the survey included pediatric cardiologists, cardiothoracic surgeons, and fellows-intraining. The questionnaire was initially distributed in June 2020 and was active through August 2020. Results: Surveys were returned by 79 participants across 28 states. Areas of practice of respondents included general cardiology, non-invasive imaging, electrophysiology, heart failure/transplant, interventional cardiology, and adults with congenital heart disease. Common changes that were implemented included decreased numbers of procedures, limiting visitors, and shifting towards telemedicine encounters. There was a high level of satisfaction among providers with telemedicine encounters and a variety of platforms were utilized. Echocardiography was less likely to be performed during the pandemic as compared to prior to the pandemic in nearly all clinical scenarios presented. More than half of respondents expressed concerns about financial stability with regards to personal or practice situation but most were not frequently concerned about their personal safety. Conclusion: Pediatric cardiology practice across the country was heavily impacted by COVID-19 and required many adaptations including minimization of non-essential procedures and increasing use of telemedicine. Providers were generally satisfied with telemedicine and utilized several platforms. Financial concerns were common;however, most participants were not frequently concerned about personal safety. Inter-institutional collaboration could be useful in creating standardized protocols based on shared experiences that could be rapidly implemented in future public health crises. Experience with Telemedicine. A) Barriers to implementing telemedicine. B) Provider rated effectiveness of telemedicine. C) Home monitoring devices used as part of telemedicine program. D) Provider satisfaction vs perceived patient satisfaction with telemedicine encounters. Likelihood of Performing Echocardiography Prior to and During COVID-19 Pandemic. Participants were asked to rate the likelihood for each scenario as always, frequently, occasionally, or never. Responses were converted to a 5-point scale. Pre- and post- responses were analyzed using Wilcoxon signed-rank test. Significant decreases in likelihood of echocardiography were found in nearly all situations.

The use of andrographolide and effects on liver biochemistry in patients with gastrointestinal problems amid the pandemic of COVID-19

Objectives: In the situation of COVID-19 pandemic in Thailand, healthcare facility supply and access are limited. There was an announcement promoting Andrographolide (ADG) use in treatment of mild COVID-19 patients, but misconception of taking for prevention might occur. Moreover, the effect of ADG on liver function test (LFT) has not been established. We aim to study the prevalence of ADG use and effect on LFTs in patients with gastrointestinal (GI) problems. Materials and Methods: We conducted a cross-sectional study including GI patients at our center who voluntarily filled the ADG questionnaire in Aug-Sep 2021. LFT data at that visit and at the prior visit (if available) were obtained. The changes in LFT within the same person were analyzed using Wilcoxon signed-rank test. Wilcoxon rank-sum and Chi-square test were used to compare between patients with and without ADG consumption. Results: A total of 886 patients completed the survey, 170 patients (19.2%) took ADG within the past month. Patients who took ADG were more likely to have history of COVID-19 infection in their closed companies (5.6% vs 1.5%) compared with who did not (control group). LFT data were available in 486 (54.8%) patients, the median ALT change compared with the prior visit was higher in ADG vs control group (2 vs 0, p = 0.026), and 45% had increased ALT ([3 U/L) vs 32.2% in ADG and control group, respectively (p = 0.023). Multivariable logistic regression analysis found that factors independently associated with an increased ALT were ADG exposure (adjusted OR [aOR] of 1.62, p = 0.042), and patients with NAFLD who gained weight (aOR of 2.37, p = 0.046). Conclusion: One-fifth of GI patients recently took ADG, in which currently not indicated as it has no effect on preventing COVID-19 infection. Those who took ADG are more likely to experience an increase in ALT than who did not. Warning should be made regarding this issue.

VEDOLIZUMAB THERAPY FOR VERY EARLY ONSET INFLAMMATORY BOWEL DISEASE

Background: Vedolizumab (VDZ) is effective in inducing and maintaining remission in patients with Inflammatory bowel disease (IBD), but limited data exists in the youngest patients diagnosed <6, known as very early onset (VEO)-IBD. We aimed to evaluate the efficacy and safety of VDZ in this cohort. Methods: This was a retrospective study of patients with VEO-IBD followed at the Children's Hospital of Philadelphia, treated with VDZ for >6 months. Data collected included demographics, disease characteristics, medications, hospitalizations, growth, surgeries, and labs. Disease activity was measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and Pediatric Crohn Disease Activity Index (PCDAI) at baseline and 6 months. Primary outcome was clinical response defined as a decrease in PUCAI>20 or PCDAI>15 at 6 months. Secondary outcomes included improvement in growth, labs, steroid use and hospitalizations. Continuous variables were analyzed using the Friedman test followed by the Wilcoxon signed-rank test. Nominal data was analyzed using McNemar's test. Results: Thirty-three children with VEO-IBD, 66% male, treated with VDZ were included. Median age of diagnosis was 3.7 years (range 1.2-6 years), with a median baseline disease duration of 3 years (range 0.1-18.5 years). IBDU was classified in 61%, and CD in 39%. Disease location was 70% colonic, 27% ileocolonic and 3% small bowel. Seven patients had prior surgeries, including diverting ileostomies (n=6) and subtotal colectomy (n=1). Nineteen (58%) patients were biologic naïve. VDZ was used as combination therapy in 6 (18%) patients (methotrexate n=4, rapamycin n=1, tacrolimus n=1). Bridge therapy was initiated in 78% of patients, with steroids (n=8) and antibiotics (n=18). Clinical response at 6 months was achieved in 19 patients (58%) with improvement in median PUCAI from 25 to 5 (p<0.01) and median PCDAI from 18.75 to 5 (p<0.05). BMI for age Z-score improved from -0.325 to 0.65 (p<0.001). Steroids and antibiotics were tapered off in 6/8 (75%) and 14/18 (78%, p<0.001) respectively. Hospital length of stay decreased significantly during the 12 months after initiating VDZ compared to 3 months prior to initiation (p<0.05). 2 patients underwent surgery including a subtotal colectomy for colonic stricture and diverting ileostomy within 2 months of starting VDZ. Adverse effects included COVID-19 infection (n=2), influenza (n=2), upper respiratory infection (n=2), pneumonia (n=1), tracheitis (n= 1), cellulitis (n=1), molluscum (n=1), and pityriasis rosea (n=1). Conclusion: VDZ is effective at inducing clinical remission in a subset of children with VEO-IBD primarily with colonic disease. It has a favorable safety profile with minimal reported adverse events observed in this study. This study is limited by small sample size and retrospective design. Larger prospective studies are warranted.

Changing of Balanced Nutrition Behavior and the Immune System during the New Normal Era of COVID-19 in South Sulawesi, Indonesia

BACKGROUND: The COVID-19 cases in Indonesia have increased during the new normal era of COVID-19. In addition to implementing health protocols, balanced nutrition to support the immune system is essential for preventing the further impact of COVID-19 contraction. AIM: This study identified the pattern of balanced nutrition behavior before and during implementing the new normal concept in South Sulawesi. METHODS: A cross-sectional survey of people aged 15 and above living in the province of South Sulawesi was conducted from November to December 2021 using online questionnaires. The survey was carried out through WhatsApp by spreading the link of the questionnaire. Data processing and analysis were performed by SPSS v.16.0 software. Differences in balanced nutrition patterns before and during the new normal era were analyzed using the Wilcoxon signed-rank test with a significant level of 0.05. RESULTS: The study shows that the community consumption patterns were significantly declined during the implementation of the new normal concept, especially the composition of dishes (p = 0.000), animal-sourced foods (p = 0.000), vegetables (p = 0.000), fruit (p = 0.000), and milk (p = 0.000). CONCLUSIONS: The implementation of the new normal behavior reduced public awareness in consuming balanced nutrition in South Sulawesi. Thereby, it might be contributing to a decrease in the immune system.

Does Tocilizumab Influence the Outcome of Patients with COVID-19 Pneumonia Compared to the Standard Therapy? Retrospective Analysis of Data Obtained during Phase I COVID Pandemic

BACKGROUND: No gold standard therapy was approved globally for COVID-19 pneumonia to the date of this study. The pathophysiology of SARS-CoV-2 infection displayed the predominance of hyperinflammation and immune dysregulation in inducing multiorgan damage. Therefore, the potential benefits of both immune modulation and suppression in COVID-19 have been extensively discussed as a modality to control cytokine release syndrome (CRS). Abnormally high levels of interleukin-6 (IL-6) are a common finding in COVID-19 patients with pneumonia and acute respiratory distress syndrome, so the use of IL-6 antagonist was tested as a therapeutic option in controlling the disease. Tocilizumab is a recombinant humanized anti-human IL-6 receptor monoclonal antibody that can specifically bind the membrane-bound IL-6 receptor and soluble IL-6 receptor, thereby inhibiting signal transduction. Tocilizumab is currently FDA approved for the management of rheumatoid arthritis, giant cell arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. This study is a retrospective analysis of data polled during Phase I of COVID pandemic, adopted by the isolation hospital of Kasr Al-Ainy Medical School, Cairo University, during the period from May to September 2020. AIM: The aim of this study is to evaluate tocilizumab influence in the outcome;in terms of reducing the hospital stay, risk and duration of mechanical ventilation (invasive and noninvasive), mortality, and the incidence of complications related to drugs use (secondary bacterial infection and GIT bleeding) in patients with moderate-to-severe COVID-19. METHODS: This retrospective, observational cohort study included adults (between 18 and 80 years) with moderate-to-severe COVID-19 pneumonia, who were admitted to isolation hospital of Kasr Al-Ainy Medical School, Cairo University, between May and September 2020. We segregated the patients into two groups: Group A: In addition to the standard care protocol according to the local guidelines of the Egyptian Ministry of Health and Population in that period (supplemental oxygen, steroids in a dose of 1–2 mg/kg methylprednisolone for 5–10 days, broad-spectrum antibiotics, vitamins, and prophylactic dose of anticoagulation with low-molecular-weight heparin, proton-pump inhibitor, and poly-vitamins), they received tocilizumab intravenously in a dose of 8 mg/kg bodyweight (up to a maximum of 800 mg per dose), divided in two shots 12–24 h apart. Group B: Those received the standard care protocol alone, noting that guidelines were adjusted later on according to the updated scientific publications and WHO recommendations. The primary endpoint was to evaluate the effect of different regimens in controlling the disease, the need for mechanical ventilation and its duration (either invasive or non-invasive), length of ICU stay, hospital stay, and in-hospital mortality. Comparisons between quantitative variables were done using the non-parametric Mann–Whitney U-test. For comparison of serial measurements within each patient, the non-parametric Wilcoxon signed-rank test was used. For comparing categorical data, Chi-square (2) test was performed. Exact test was used instead when the expected frequency was <5. Correlations between quantitative variables were done using Spearman correlation coefficient. RESULTS: During this period, 166 patients were admitted to ICU, suffering from severe hypoxemia with moderate to severe COVID-19 pneumonia, 10 of them were excluded (three were over 80 years old, other three had advanced stages of malignancy, two were on steroids therapy and non-invasive home ventilation due to chronic chest condition, and two were presented with MODs and deceased in <48 h from admission), thus, 156 were included in the study. Group A: Seventy-six patients (49%) received tocilizumab in addition to standard therapy, Group B: Eighty patients (51%) received standard therapy only. In Group A, the mean length of ICU stay was 8.96 days with mean length of hospital stay 13.76, compared to mean length f ICU stay 9 days in Group B (p = 0.57) and mean length of hospital stay 12.46 days (p = 0.117). In Group A, 35 patients (46%) needed non-invasive mechanical ventilation (MV),12 patients of the 35 needed invasive MV in later stage, compared to 26 patients (32%) in Group B, 14 patients of the 26 needed invasive MV in later stage (p = 0.16). In Group A, 14 patients (18.4%) needed invasive mechanical ventilation, compared to 19 patients (23.7%) in Group B (p = 0.213). In Group A, 6 (7.9%) of 76 patients died, compared to 13 (16.3%) of 80 in Group B p = 0.11. The incidence of secondary bacterial infection in Group A was 16 patients (21%) compared to 21 (26%) in Group B (p = 0.44). CONCLUSION: In this study, we did not detect statistical difference in both groups of patients coming during CRS-associated COVID-19 pneumonia, regarding (ICU stay, need for and length of MV, the incidence of secondary bacterial infection, and in-hospital mortality) for COVID-19 moderate-to-severe pneumonia.

Time Spent in the Electronic Health Record by Neurologists: Analyzing daily use inside and outside the clinic using EPIC Signal data

Objective: To quantify how long neurologists spend in the electronic health record (EHR). Background: Neurologists have extensive information needs for decision-making (e.g., neuroimaging, video-recordings) that are likely to affect time spent in the EHR. While EHRrelated burden is being increasingly studied due to the national spotlight on physician burnout, few studies have focused on neurology. Design/Methods: Data were obtained using Epic Signal, which provides detailed data on how long clinicians spent on different EHR interfaces. We focused on all neurologists from an academic health system in Florida who practiced during November 2019 to October 2020 inclusive. Our EHR outcome measures were time spent interacting with the EHR, time spent in the EHR outside scheduled clinic hours, inbox management, writing notes, and chart review. We reported the median and range of outcome measures because they had skewed distributions. We also assessed whether changes related to the coronavirus pandemic (e.g., telemedicine adoption) were associated with differences in EHR use via Wilcoxon signed-rank tests. Results: Our sample contained 2,286 physician-week observations (83 neurologists). They spent up to: 333.6 minutes/day (median:66.5, range:0.5-333.6) interacting with the EHR, 303.4 minutes/day (median:27.8, range:0.0-303.4) in the EHR outside scheduled hours, 45.6 minutes/day (median:3.4, range:0.0-45.6) in the In Basket, 240.3 minutes/day (median:31.1, range:0.0-240.3) writing notes, and 73.1 minutes/day (median:11.0, range:0.0-73.1) in clinical review. EHR measures were comparable before and during the pandemic. Conclusions: Similar to physicians in other specialties, neurologists spend a significant proportion of their clinical effort engaged with the EHR. Neurologists may benefit from interventions that reduce time spent in the EHR, such as after-hours EHR use and documentation.

Underserved Patients' Experiences Using Telemedicine for Gynecologic Care During COVID- 19

INTRODUCTION: The use of telemedicine has dramatically increased during the COVID-19 pandemic. We evaluated the experience of underserved women using telemedicine for gynecologic visits at an urban teaching hospital. METHODS: We conducted a prospective study of patient experiences using telemedicine for outpatient gynecologic visits from January 2021-September 2021. Demographic/clinical data were obtained. Participants completed a modified, previously validated Telemedicine Usability Questionnaire (TUQ), with responses on a 1-5 Likert scale. Statistical analyses used the Wilcoxon signed-rank test or t test. RESULTS: One hundred ninety two patients agreed to participate, of which 157 completed the surveys. A total of 87% had video visits, whereas 13% had telephone visits. The majority of patients were ethnic minorities (non-Hispanic White 16%, Hispanic 32%, Black 28%, and Asian 10%), median age 40 years (range 18-69 years), with 63% having income (44 vs.<39, P=.02). Race/ethnicity, income, education level, and prior experience with telemedicine had no effect on responses for this subscale. CONCLUSION: Underserved women utilizing telemedicine for outpatient gynecologic visits report largely positive experiences overall. Although telemedicine holds promise in increasing access to healthcare services, attention needs to be paid to ensure reliability among telehealth visits, particularly for older populations.