fvWillingness to Vaccinate Children against COVID-19 Declined During the Pandemic

Objectives To document the level of vaccine hesitancy in caregivers' of children younger than 12 years of age over the course of the pandemic in Pediatric Emergency Departments (ED). Study design Ongoing multicenter, cross-sectional survey of caregivers presenting to 19 pediatric EDs in the USA, Canada, Israel, and Switzerland during first months of the pandemic (phase1), when vaccines were approved for adults (phase2) and most recently when vaccines were approved for children (phase3). Results Willingness to vaccinate rate declined over the study period (59.7%, 56.1% and 52.1% in the three phases). Caregivers who are fully vaccinated, who have higher education, and those worried their child had COVID-19 upon arrival to the ED, were more likely to plan to vaccinate in all three phases. Mothers were less likely to vaccinate early in the pandemic, but this hesitancy attenuated in later phases. Older caregivers were more willing to vaccinate, and caregivers of older children were less likely to vaccinate their children in phase 3. During the last phase, willingness to vaccinate was lowest in those who had a primary care provider but did not rely on their advice for medical decisions (34%). Those with no primary care provider and those who do and rely on their medical advice, had similar rates of willingness to vaccinate (55.1% and 52.1%, respectively). Conclusions COVID-19 vaccine hesitancy is widespread and growing over time, and public health measures should further try to leverage identified factors associated with hesitancy in order to enhance vaccination rates among children.

Willingness to vaccinate children against COVID-19 declined during the pandemic.

OBJECTIVES: To document the level of vaccine hesitancy in caregivers' of children younger than 12 years of age over the course of the pandemic in Pediatric Emergency Departments (ED). Study design Ongoing multicenter, cross-sectional survey of caregivers presenting to 19 pediatric EDs in the USA, Canada, Israel, and Switzerland during first months of the pandemic (phase1), when vaccines were approved for adults (phase2) and most recently when vaccines were approved for children (phase3). RESULTS: Willingness to vaccinate rate declined over the study period (59.7%, 56.1% and 52.1% in the three phases). Caregivers who are fully vaccinated, who have higher education, and those worried their child had COVID-19 upon arrival to the ED, were more likely to plan to vaccinate in all three phases. Mothers were less likely to vaccinate early in the pandemic, but this hesitancy attenuated in later phases. Older caregivers were more willing to vaccinate, and caregivers of older children were less likely to vaccinate their children in phase 3. During the last phase, willingness to vaccinate was lowest in those who had a primary care provider but did not rely on their advice for medical decisions (34%). Those with no primary care provider and those who do and rely on their medical advice, had similar rates of willingness to vaccinate (55.1% and 52.1%, respectively). CONCLUSIONS: COVID-19 vaccine hesitancy is widespread and growing over time, and public health measures should further try to leverage identified factors associated with hesitancy in order to enhance vaccination rates among children.

Update on Progress of the Mesenchymal Stromal Cell Trial in Refractory Lupus

BodyThere is a growing interest and use of cellular therapies in almost all fields of medicine. Mesenchymal stromal cells (MSCs) are pluripotent in their ability to differentiate in chondrocytes, adipocytes and osteoblasts. They more recently were reported to have significant immune activity, primarily by producing anti-inflammatory molecules. They can be derived from umbilical cords, adipose tissue and bone marrow primarily. Recent studies have tested their safety and efficacy in immune mediated diseases including graft versus host disease, inflammatory bowel disease and Type I diabetes among others. Reports of uncontrolled trials of MSCs in China suggest safety and efficacy of MSCs as treatment for refractory lupus. Based on encouraging results of a Phase I trial of 6 patients with lupus treated with MSCs, we initiated the first placebo- controlled trial of MSCs to treat lupus patients refractory to standard of care medications. There are nine participating centers across the US. The trial has two cohorts, one receiving low dose MSCs (one million cells/kg) and a high dose cohort of five million cells per kg, given as a one- time infusion. Patients then attend 10 follow-up visits over a year. Primary outcome is a decrease in the SRI of 4 at week 24. Inclusion criteria are patients with confirmed lupus refractory to 6 months of standard of care therapy defined by a SLEDAI of 6 or greater at screening. Exclusions were ongoing use of biologics, pregnancy, active infections, cancer, active CNS lupus or advanced renal disease. The first patient was screened in November of 2018. Patients are randomized with a 2/1 ratio of MSCs/placebo. Cohort 1 consisting of 41 patients was completed in May of 2021. We have infused 10 out of 40 patients in Cohort 2 to this point. Extensive studies of B cell, T cell, monocyte, dendritic cell and PMN number, function and phenotype are being performed. To this point there are no safety signals or concerns with DSMB reviews quarterly. There have been no SAEs attributed to the investigational product. Given the blind of the study, we cannot report on efficacy, though there are a number of participants who met the primary outcome of an SRI of 4 at 24 weeks. COVID had a profound impact on the study due to halting of enrollment for 5 months and a need for video visits due to institutional policies. A significant issue was protocol changes regarding disease activity measures in video visits. Other delays included a designed 12-week safety assessment upon completion of Cohort 1 prior to enrollment in Cohort 2 as well as a staggered start for the first six patients in Cohort 2 requiring a safety assessment by the DSMB chair at week 1 post infusion prior to the screening of the next patient. ConclusionsThere is no safety signal between the active treatment and placebo group in either Cohort to this date. Efficacy assessments await completion of the study as the two cohorts are combined for determination of efficacy. COVID has a profound impact on enrollment and management of the study. Results of the validity of assessment of different disease measures via video appointments is being assessed to inform future trials. We believe we will reach our enrollment goal and the study will answer the primary aim of whether MSCs are a potential therapeutic for patients with refractory lupus.

Seasonal Variation Impact on Oocyte Retrieval Outcomes

Objective: To evaluate whether seasonal variability influences the number of oocytes retrieved in patients undergoing IVF and oocyte cryopreservation. Previous studies have been conducted evaluating the impact of seasonal variability on unassisted conception and birth rates. Seasonal patterns associated with assisted reproductive technology outcomes, including fertilization rates and embryo quality, have been studied in small cohorts of patients and with mixed results. Some studies have suggested higher odds of clinical pregnancy from IVF in warmer months, while others did not demonstrate a difference by season. The impact of seasonality on oocyte retrieval (OR) outcomes has not been specifically addressed to date. Material(s) and Method(s): This was a retrospective cohort study of all patients who underwent an OR from November 2019 to January 2022 at a single academic institution located in the Northeast in the United States. Patients were stratified by the season their procedure occurred: Winter (December 21 - March 20), Spring (March 21 - June 20), Summer (June 21 - September 20), and Fall (September 21 - December 20). No cases were conducted in the Spring of 2020 secondary to the COVID19 pandemic. The primary outcome was the average number of oocytes retrieved. ANOVA was used to compare the four seasons with p<0.05 defining significance. Result(s): During the study period, 1469 patients underwent an egg retrieval, of which 378 occurred in the Winter, 257 in the Spring, 364 in the Summer and 470 in the Fall. According to the National Weather Service, the average temperature in the Winter is 36.1degree Fahrenheit, Spring is 58.1degree Fahrenheit, Summer is 75.8degree Fahrenheit, and Fall is 53.5degree Fahrenheit in New York City. There was no significant difference in the number of oocytes retrieved across all seasons (p=0.53). Additionally, patient characteristics were similar across seasons with no significant differences in age, AMH and BMI. Conclusion(s): The average number of oocytes retrieved did not vary by season. Differences temperature, day length, precipitation, and humidity may not be associated with OR success. Impact Statement: Seasonal variation does not impact oocyte retrieval outcomes. [Formula presented] Support: None REFERENCES:: Farland, L. V., Correia, K. F., Missmer, S. A., & Racowsky, C. (2020). Seasonal variation, temperature, day length, and IVF outcomes from fresh cycles. Journal of Assisted Reproduction and Genetics, 37(10), 2427-2433. Copyright © 2022

Factors associated with unvaccinated caregivers who plan to vaccinate their children.

Vaccine hesitancy is complex and a threat to global public health during the ongoing COVID-19 pandemic. Our objective was to determine factors associated with caregivers' willingness to vaccinate children despite not being immunized themselves against COVID-19. The International COVID-19 Parental Attitude Study (COVIPAS), a multinational cohort study, recruited caregivers of children 0-18 years old in 21 Emergency Departments (EDs) in USA, Canada, Israel, and Switzerland during November-December 2021. Of a total of 4536 caregivers who completed the survey, 882 (19.4%) were unvaccinated, and 62 (7.0%) of the unvaccinated planned to vaccinate their children. Unvaccinated caregivers with children that had their childhood vaccines up-to-date (OR 3.03 (1.36, 8.09), p = 0.01), and those very worried their child has COVID-19 in the ED (OR 3.11 (1.44, 6.34), p < 0.01) were much more likely to plan to immunize their children. Primary care providers and public health agencies should not assume that unvaccinated parents will not vaccinate their children. Determining child's vaccination status and parental level of concern about COVID-19 may help identify caregivers who are open to give their children the vaccine.

Parents' intent to vaccinate against influenza during the COVID-19 pandemic im two regions in Switzerland

AIMS OF THE STUDY: The COVID-19 pandemic is likely to overlap with the seasonal influenza epidemic, increasing the risk of overextending the health system capacity in Switzerland. Influenza vaccine uptake has remained low in most countries, including Switzerland. The aim of the study was to determine parents' intentions towards influenza vaccination of their children as well as themselves, and to assess regional differences. METHODS: Parents presenting to four pediatric emergency departments (PEDs;Zurich, Bern, Bellinzona, Geneva) were asked to complete an online survey during and after the first lockdown of the COVID-19 pandemic (April - June 2020). The anonymized survey included demographic information, vaccination history and intentions to vaccinate against influenza, as well as attitudes towards future vaccination against COVID-19. RESULTS: The majority of children (92%;602/654) were up-to-date on their vaccination schedule. In 2019/2020, 7.2% (47/654) were vaccinated against influenza. Children with chronic illnesses were more frequently vaccinated compared to healthy children (19.2% vs 5.6%;p = 0.002). For the coming winter season, 111 (17%) parents stated they plan to vaccinate their children against influenza, more than double the rate from last year, and 383 (59.2%) parents suggest they will vaccinate against COVID-19 once a vaccine is available. Regional differences between "German" and "Latin" Switzerland were found for parents' intent to have their children vaccinated against influenza next season (Zurich and Bern 14.3%, Bellinzona and Geneva 27.2%, p < 0.001) but not for a hypothetical vaccination against COVID-19 (Zurich and Bern 59.1%, Bellinzona and Geneva 59.7%, p = 0.894). CONCLUSIONS: The COVID-19 pandemic resulted in a substantial increase of parents' intention to vaccinating their children against influenza, especially in hard-hit "Latin" Switzerland. The Swiss government and public health organizations can leverage these regional results to promote influenza vaccination among children for the coming seasons.

Caregiver-reported delay in presentation to pediatric emergency departments for fear of contracting COVID-19: A multinational cross-sectional study

BACKGROUND: Visits to pediatric emergency departments have decreased up to 75% during the pandemic, with corresponding increases in high acuity visits, inpatient admissions, and intensive care unit admissions compared to historical cohorts. OBJECTIVES: To determine if caregivers of children presenting to pediatric emergency departments (EDs) during the COVID-19 pandemic are delaying presenting to care for fear of contracting COVID-19. Secondary objectives were to: a) evaluate potential predictors of delay;b) describe the proportion of children whose symptoms worsened during time to presentation. DESIGN/METHODS: A multicentre cross-sectional survey study of caregivers accompanying their children aged 0-19 years old to 16 pediatric EDs in 6 countries, from May-June 2020. An anonymous online survey, completed by caregivers via RedCAP, included caregiver and child demographics, presenting complaints, if they delayed presentation and whether symptoms worsened during this interval, as well as caregiver concerns about the child or caregiver having COVID-19 at the time of ED visit. RESULTS: Of 1543 caregivers completing the survey, 287 (18.6%) reported a delay in seeking ED care due to concerns of contracting COVID-19 in the hospital. Of those, 124 (43.2%) stated their child's symptoms worsened during the waiting interval. Caregiver relationship to child [mother] (OR 1.85, 95% CI 1.27-2.76), presence of chronic illness in child (OR 1.78. 95% CI 1.14-2.79), younger age of caregiver (OR 0.965, 95% CI 0.943-0.986), and caregiver concerns about lost work during the pandemic (OR 1.08, 95% CI 1.04-1.12), were independently associated with a COVID-19-related delayed presentation in multivariate regression analysis. CONCLUSION: Almost one in five caregivers reported delaying ED presentation for their ill or injured child, specifically due to fear of contracting COVID-19 while in hospital. Mothers, younger caregivers, caregivers of children with chronic illness, and those concerned about lost work were at highest risk for delay.

Pediatric influenza in the emergency department: diagnosis and management

Influenza in children is a significant cause of morbidity and mortality. Presenting symptoms of influenza vary greatly among children;clinical presentation should be assessed for severity of illness and potential complications. Available clinical and laboratory findings should be used to guide treatment for young children with fever. Clinicians should be aware of up-to-date recommendations to diagnose and treat children with influenza and to ensure public health engagement to prevent and manage influenza epidemics. This issue reviews common complications of influenza infection, offers guidance for infection control measures, and provides evidence-based recommendations for the management of pediatric patients with influenza in the emergency department.

COVID-19 and consent for research: Navigating during a global pandemic

The modern ethical framework demands informed consent for research participation that includes disclosure of material information, as well as alternatives. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic (COVID-19) results in illness that often involves rapid deterioration. Despite the urgent need to find therapy, obtaining informed consent for COVID-19 research is needed. The current pandemic presents three types of challenges for investigators faced with obtaining informed consent for research participation: (1) uncertainty over key information to informed consent, (2) time and pressure constraints, and (3) obligations regarding disclosure of new alternative therapies and re-consent. To mitigate consenting challenges, primary investigators need to work together to jointly promote urgent care and research into COVID-19. Actions they can take include (1) prior plan addressing ways to incorporate clinical research into clinical practice in emergency, (2) consider patients vulnerable with early deliberation on the consent process, (3) seek Legally Authorized Representatives (LARs), (4) create a collaborative research teams, (5) aim to consent once, despite evolving information during the pandemic, and (6) aim to match patients to a trial that will most benefit them. The COVID-19 pandemic both exacerbates existing challenges and raises unique obstacles for consent that require forethought and mindfulness to overcome. While research teams and clinician-investigators will need to be sensitive to their own contexts and adapt solutions accordingly, they can meet the challenge of obtaining genuinely informed consent during the current pandemic. © The Author(s) 2020.

FROM PEN TO KEYBOARD: TRANSITION TO A SPECIALTY ELECTRONIC MEDICAL RECORD

Objective: The importance of converting paper medical records to electronic versions has been nationally recognized. There are certain specialties, including Reproductive Endocrinology and Infertility (REI), which have lagged behind the initiative in transitioning to an electronic medical record (EMR). Our objective is to describe the essential steps required for a successful transition to EMR in a large university academic REI clinic, and to report results from an internal survey regarding the perception of transition among multidisciplinary staff members. Design: Descriptive and Survey study. Materials and Methods: We reviewed the processes executed during our transition from paper to electronic health records. To ensure that the system was designed to match the workflow of the practice, a plan was determined for all fields of the division (andrology, embryology, third party reproduction, clinical services outside of IVF, billing, radiology and laboratory services). The process began with clear goals of implementing an EMR system at 6 ambulatory locations, which was accomplished in a series of 5 rollout periods. Six months following the go live date of EMR implementation, an anonymous survey was administered to staff members regarding the EMR transition and effect of EMR on remote-work during the COVID-19 pandemic. Results: Patients’ safety is of paramount importance, and correct identification of patient, partner, and gametes is a vital objective while transitioning to a paperless system. Challenges recognized during this process were communication, services sharing a single location with differing needs (andrology, embryology, third party reproduction, billing, laboratory, clinical), requirements from multiple regulatory bodies (eg. FDA, CDC, SART), integration of fertility software into existing University health system EMR, complexity of a workflow with multiple providers interacting with patients, and the unique safety procedures involved with fertility care, including witnessing of specimens. Thirty-eight staff members, including physicians, nurses, embryologists, and office staff responded to the survey. Most respondents were between age 31-40y (32%), 21-30y (21%), or 51-60 y (21%). Sixteen percent of respondents did not feel comfortable with EMR use prior to implementation. Almost one third of respondents (29%) had been working in the fertility field for 1-5 y, 27% for 6-10 years, and another 21% for more than 20 years. Seventy percent of staff members felt the education received prior to EMR transition was well organized with attainable goal. Most (90%) were satisfied with the EMR transition process, 79% identified a positive impact on work patterns since EMR transition, and 87% reported improved communication. Over 90% of staff members believed that the EMR transition prepared them to utilize TeleHealth remotely during the COVID-19 pandemic. Conclusions: With proper planning and commitment of administration and staff, a successful transition from paper charts to EMR can be accomplished in a busy REI practice.

IMPACT OF COVID-19 ON QUALITY OF LIFE AND PATIENT SATISFACTION AMONGST PATIENTS SEEKING FERTILITY EVALUATION AND TREATMENT

Objective: The purpose of this study was to assess the effect of the pause on fertility treatments, due to the COVID-19 pandemic, on patients’ fertility quality of life (FQoL). Design: Web-based survey. Materials and Methods: Patients seeking fertility care at a single academic fertility center from 1/2020 - 3/2020 with valid email addresses were surveyed. Patient demographics, evaluation or treatment type, history, satisfaction with newly instituted TeleHealth, viewpoint on ASRM guidance, and an adapted version of the validated Fertility Quality of Life Questionnaire (FQoL) were assessed. FQoL score was the primary outcome and was used to quantitatively assess the impact of COVID-19 on patients’ FQoL. Student’s T-tests were used to compare FQoL scores between patients who experienced a delay in evaluation or treatment vs. those who did not. Results: Four hundred fifty-six patients received a survey link and 38.8% (177/456) responded. The most common delayed treatments were intrauterine inseminations (36.0%), frozen embryo transfers (35.2%), and oocyte retrievals (26.4%). 37.3% (66/177) of patients had a TeleHealth appointment with a provider. The majority (90.9%) were dissatisfied with their encounter;however, 42.4% would consider utilizing TeleHealth in the future. Of 125 patients who experienced delays, 12.8% agreed with the decision to pause treatments and 41.6% disagreed. The remaining 45.6% patients neither agreed nor disagreed. Of the 54.2% (96/177) of patients that completed the adapted FQoL survey in its entirety, those with delayed fertility evaluation or treatment (n=77) had significantly lower mean FQoL scores than those who did not experience a delay (76.6 vs 86.5, p=0.01). 52% of patients who completed FQoL questions agreed with the pause of fertility treatments;they had significantly higher FQoL scores than those who disagreed (82.0 vs. 71.8, p<0.005). [Formula presented] Conclusions: Patients who experienced delays in fertility care due to COVID-19 reported lower FQoL compared to those who did not. Less than half of patients agreed with guidance suggesting a delay in treatments, despite continued access to care via TeleHealth. Although efforts were made to maintain open lines of communication and patient access to care during the pandemic via TeleHealth, the majority of patients were dissatisfied with their experience, regardless of delays. In spite of their experience, nearly half of participants expressed interest in using TeleHealth for future fertility care.

Coronavirus disease 2019 in children

Question: Coronavirus disease 2019 (COVID-19) is affecting millions of people worldwide. It seems that it affects mostly adults older than 40 years of age, and the death rate is highest for older individuals in the population. What should I tell parents worried about their children contracting the coronavirus (SARS-CoV-2) causing COVID-19, and what symptoms should I look for to determine if there is a need to test for the virus? Answer: The COVID-19 global pandemic affects all ages. Severe respiratory manifestations have been the mainstay of illness in adults, with what seems to be rapid deterioration necessitating mechanical ventilation. Only 5% of those tested and found to have COVID-19 have been younger than 19 years, possibly owing to limited testing, as the symptoms in children are usually mild. Symptoms in children include fever, dry cough, rhinorrhea, sore throat, and fatigue, and in 10% diarrhea or vomiting. Rarely dyspnea or hypoxemia were also described. Blood tests and imaging have been shown to be of little value in children and should only be ordered for those in whom you would normally order these investigations for viral-like illness. No specific therapy is available and supportive care with rest, fluids, and antipyretics for children is the recommended approach. Ibuprofen or acetaminophen for fever and pain can be given. Antiviral and immunomodulatory treatment is not recommended at this time for otherwise healthy children, and corticosteroids should also not be used. Children with immunocompromised states should be isolated and avoid contact with others.