RESUMEN
3 An important component for the provision of patient-centric healthcare is the ability to collect blood samples remotely in a manner that delivers samples of a quality comparable to that of current standard phlebotomy collection, enabling routine clinical testing, monitoring disease progression and testing drug concentrations.2-4-г, This blood sampling could be performed at the patient's home, at a nearby pharmacy, or at a local clinic, rather than a centralized facility. Examples of commercially available devices include the Neoteryx Mitra,13 Tasso-M20, SST and Tasso+,14 SeventhSense TAP and TAP II,15 Trajan hemaPEN,16 Labcorp Pixel,17 Capitainer qDBS,1" HemaXis DB10 and DX,19 and Drawbridge OneDraw.20 These devices are capable of collecting from as little as 20 microliters (approximately half a drop) to several hundred microliters of blood and have been widely used to determine clinical parameters,21 drug concentrations,5'22 therapeutic drug monitoring,23 and, more recently, COVID antibody levels.24,25 Some of these devices enable the collection of a fixed volume of blood, collected as dried blood, which can then be shipped and handled at room temperatures-avoiding the need for freezers and dry ice for storing and shipping samples-enabling its adoption even in remote areas with limited infrastructure. Patient-centric blood sampling techniques have been gaining popularity for use in pharmaceutical drug development;however, to date they have not been broadly accessible to the general public.26 This can be partially attributed to the "cliniccentric" healthcare model, where reimbursement is dependent on in-person visits and sample collection. [...]the status quo remains and anyone who needs a blood test is required to go to the doctor's office or clinic. [...]studies have demonstrated that the overall cost to society will be lower, by improving health outcomes and allowing broader access and patient convenience.27 The availability and adoption of patient-centric approaches can provide access and treatment options to clinical trial participants not geographically co-located with the investigative sites and improving access in rural or lesser developed communities, globally, potentially improving the health of the general population.
RESUMEN
[...]of the significant cost of development, companies seek to recoup finances through data exclusivity and patent protection of intellectual property, such as the drug product's formulation. Bio/pharma companies reformulate existing therapies for a whole host of reasons, such as treating underserved or neglected disease areas, improving patient adherence (particularly for target patient groups, such as paediatrics), reducing the potential of drug abuse, and providing alternative options in crisis situations-as has been apparent during the COVID-19 pandemic. Pentamidine is an anti-infective agent that can be used to treat an earlier stage of the disease;however, it is unable to penetrate the blood-brain barrier sufficiently to treat the secondary stage of HAT. [...]it was hypothesized that a combined pentamidine-Pluronic formulation may be a suitable approach to provide patients with a single therapeutic option for treatment of all stages of HAT. [...]it was concluded that the pharmacokinetic data attained supports the use of safety and tolerability data from the conventional risperidone formulation for further testing of VAL401 (4).
RESUMEN
Background The COVID-19 pandemic has had marked effects on mental health, including in pediatric populations. Pediatric patients have faced mental health concerns at increased rates including anxiety and depression. Furthermore, patients with eating disorders represent a vulnerable group who have been negatively impacted as well, as a result of lack of support, loss of in-person follow-up and increased relapse. In our centre, and nationally, clinicians have noted a trend towards increased eating disorder referrals and increased hospitalizations during the pandemic. Objectives The objective of this study was to determine the incidence, severity and triggers for eating disorders in the adolescent population during the COVID-19 pandemic and how it compares to the year prior. As well, the subset of patients who were hospitalized for medical stabilization were further analyzed to determine severity of illness. Design/Methods A retrospective chart review compared the first year of the COVID-19 pandemic (March 2020-March 2021), to the previous 12 months. Inclusion criteria included referrals to an eating disorder clinic and inpatient admissions to pediatrics or mental health services during the specified time frame. Data collected included age of onset, triggers, comorbid mental health conditions, and weight measures. Among hospitalized patients, orthostatic vital changes, need for NG feeds, length of medical stabilization and length of mental health hospitalization were included. Results Overall, 76 patients were included in the study. 44 (57.9%) were referred after COVID, which was significantly increased from the prior year (p=0.05). On average, patients presented at a younger age (14.2 ± 2.3 vs. 14.9 ± 1.9;p=0.08). Pre-COVID, approximately 44% of referrals were from family physicians and 19% from pediatrics. During COVID, approximately 39% were from family doctors and 25% from pediatricians. There was an increase in the number of patients requiring hospitalization for treatment (16 vs. 3), with 50% of the post-COVID admissions being direct from the ED Clinic on initial assessment. The reason for hospitalization was unstable vitals/ bradycardia in 68.7% of admissions;self-harm comprised the majority of the other admissions. Conclusion Our results support national and international reports that eating disorder incidence has increased during COVID-19. Patients described loss of routine, anxiety, and isolation as triggers related to the pandemic. Disruptions to daily life including school, sports, recreation, and relationships had profound effects on the mental health of children. The effect of social media on body image has also contributed. It is important for clinicians to screen for mental health conditions, including eating disorders at all available opportunities. Furthermore, this study demonstrates the need for increased services at our centre. Limitations for this study include that it is a single-centre study with a relatively small patient population. As well, it does not capture patients who may have been referred only to psychiatry.
RESUMEN
Without the structure and schedule of traditional activities such as in-person school and socialization, evidence is emerging of pediatric sleep changes during the COVID-19 pandemic. A narrative review was conducted of the sleep literature during the pandemic for preschoolers, school-aged children, and adolescents. Changes in sleep and risk and protective factors for sleep heath during the COVID-19 pandemic are reviewed along with real-life clinical case examples for each developmental period. Given the high rates of pediatric sleep disturbance, clinicians, researchers, and policymakers should refine screening strategies and facilitate referrals for behavioral interventions to support sleep health during pandemics and other natural disasters. (PsycInfo Database Record (c) 2023 APA, all rights reserved)
RESUMEN
The aim of the study was to study the clinical and epidemiological features of the new COVID-19 coronavirus infection in children hospitalized in the infectious department. Material and methods. 249 case histories of patients from 0 to 18 years of age who are on inpatient treatment at <<Clinical Hospital N1>> in Smolensk for the period from April 2020 to July 2022 were studied by the continuous sampling method. Verification of a new coronavirus infection was carried out by examining smears from the nasopharynx and oropharynx for the presence of SARS-CoV-2 by real-time PCR. Results. The prevalence of patients from 1 to 3 (19.3%, 49.1%) and from 6-15 (15.8%, 50.5%) years was revealed both in 2020 and in 2021 and the first half of 2022. No significant differences in gender were found. The largest number of cases in 2020 was registered in April (16%) and November (14%), in 2021 - in December (18%) and November (16%). The prevailing severity in both 2020 and 2021, 2022 was the average severity (63%, 72%, 93%, respectively). The main syndromes of COVID-19 have been identified: intoxication syndrome, respiratory catarrhal syndrome, bronchopulmonary, intestinal. Bilateral pneumonia was most often detected (47% in 2020, 44% in 2021, 62% in 2022), right-sided pneumonia (33% in 2020, 30% in 2021, 31% in 2022), and left-sided pneumonia (20%, 26% and 7%, respectively). The main co-morbid pathologies are noted, and cases of somatic diseases first registered against the background of COVID-19 are described.Copyright © Children Infections.All rights reserved
RESUMEN
Aim: The aim of this research is to analyze the pediatric COVID-19 literature published in Turkey and to guide future research. Material(s) and Method(s): Between 11.03.2010 and 11.12.2022, the Web of Science (WoS) All Databases collection was searched for publications related to COVID-19 and pediatric patients. The keywords used during this search were coronavirus-19, COVID-19, SARS-CoV-2, novel coronavirus, 2019-nCoV, pandemic, and/or pediatric, pediatric, children, child. After this search, the selected publications were scanned one by one to determine whether they were suitable for the present study. Authors, organizations, journals, document types, distribution of publications by years (months), most used keywords were obtained from the Web of Science (WoS) All Databases collection. Descriptive analyzes were made from all these obtained data. Result(s): The number of COVID-19 publications originating from Turkey in the field of pediatrics was determined as 375. 48.2% of all publications were published in 2022. These 375 publications were published in 167 different journals. In these publications, the most active author, journal and organization were Yasemin Ozsurekci, Turkish Archives of Pediatrics and University of Health Sciences, Turkey, respectively. The most commonly used keywords were ''child, patient, pandemic, SARS-CoV and vaccine. The most active document types were research articles (295 (78.6%)), editorial materials (15 (4.0%)), letters (43 (11.5%)) and review articles (22 (5.9%)). Discussion(s): We analyzed all articles about COVID-19 from Turkey in the field of pediatrics published so far in the WoS Databases collection. It is obvious that a large literature has emerged in our country on pediatric patients, although not as much as in adults. The long-term adverse effects of the pandemic on pediatric practice and especially on children will need to be evaluated in more detail in future research.Copyright © 2023, Derman Medical Publishing. All rights reserved.
RESUMEN
Serum ferritin is one of the most widely used laboratory tests and is associated with both iron deficiency and iron overload. Currently, more and more attention is paid to the involvement of ferritin in processes other than iron metabolism. Low serum ferritin is unanimously associated with iron deficiency, while elevated serum ferritin may be a consequence of various medical conditions such as iron overload, an inflammatory process, SARS-CoV-2, organ failure, cancer, and endocrine disorders, including metabolic syndrome. We present a review of the literature on the role of ferritin in a variety of less obvious disease states in children.Copyright © 2023 Termedia Publishing House Ltd.. All rights reserved.
RESUMEN
From the perspective of the IRB, the requirements for data safety monitoring as appropriate for assent by minors, for permission from parents, is already there to apply to COVID-19 research. If you had a research protocol seeking to enroll minors, and it required them to give up standard of care therapy in order to participate and they had asthma, that would be cause for concern by the IRB. Russell-Einhorn: We've drawn lines to review this research for adults vs. pediatrics for numerous years. Since we do make a distinction between a minor and an adult, and a 17-yearold is considered a minor.
RESUMEN
[...]on 25 Nov. 2020, the European Commission (EC) announced the new Pharmaceutical Strategy for Europe, which is likely to result in significant changes to the European Union (EU) regulatory framework and will have a substantial impact on both the marketing of medicinal products and the strategic business planning of pharmaceutical companies (2). (2021), the priority areas are as follows: * The performance and adequacy of the current legislation * Unmet medical needs-with a definition or set of principles for "unmet medical needs" under discussion * Incentives for innovation, including the area of unmet needs and a reflexion on regulatory data and market exclusivity * Antimicrobial resistance that includes measures to support innovation of antibiotic development * Future-proofing the regulatory framework for novel products * Improved patient access to, and affordability of, medicines in the EU * Competitiveness of the European markets to ensure affordable medicines, including considering measures to support patients' access to affordable medicines * Encouraging the repurposing of off patent medicines * Ensuring security of supply of medicinal products in the EU * Ensuring high-quality manufacture and distribution in the EU including consideration of the need to strengthen or adapt good manufacturing practice (GMP) to reflect new manufacturing methodologies * Environmental challenges (4). Availability, accessibility, and affordability of medicinal products The section on 'Prioritising unmet medical needs' in the strategy reflects the belief within EU Bianca Piachaud-Moustakis is lead writer at PharmaVision, Pharmavision.co.uk. institutions that "current incentive models neither provide an adequate solution for unmet medical needs nor appropriately incentivise investments in innovation" (2).
RESUMEN
EU officials acknowledge that the trial landscape in response to the pandemic has been fragmented, with a multitude of small, national trials, struggling to generate robust and actionable clinical data, with great duplication of efforts and direct competition for shared resources and participant populations. The European drug industry worked on complex clinical trials in 2020 with researchers in the European Organization for Research into Treatments for Cancer and specialists in the Association of Clinical Research Organizations, as well as with the European Union's Clinical Trial Expert Group, composed of national health ministry officials. [...]the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is developing guidelines on Adaptive Clinical Trials with a timeline of 2023, and on Good Clinical Practice Renovation to address the increasing diversity of clinical trial designs and data sources.
RESUMEN
Variant Omicron was discovered as a newest severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first emergence of the omicron variant was detected in November 2021. In this study, we investigated the clinical manifestation, laboratory and radiological findings and responding to treatment of 70 pediatric patients with positive RT- PCR COVID-19 in Omicron peak. We described 20 criteria associated with efficacy, such as demographic data, clinical manifestation, laboratory and radiological findings. All of the patients received Remdesivir that 5.7% of patients responded to the treatment. No patients were given Intravenous Immunoglobulin (IVIG). This is the first study aimed at assessing symptoms clinical manifestation among hospitalization pediatrics patients in pediatric Hospital of Amir kola, Babol. The findings of this study can be effective in preventing and controlling disease transmission among children.
RESUMEN
BackgroundThe advent of biologic treatment (bDMARD) in childhood rheumatic diseases (RD) has changed their evolution and prognosis. Evidence is robust for diseases such as juvenile idiopathic arthritis (JIA) and systemic lupus erythematosus (SLE), but in other diseases we still have to learn which is the ideal therapy, time to discontinuation and the potential adverse events (AE) in short and long term.ObjectivesIdentify the clinical and treatment characteristics of pediatric patients with rheumatic diseases with bDMARD treatment and describe the development of AE.MethodsBIOBADAMEX is a prospective ongoing cohort of Mexican patients with RD using bDMARDs since 2016. We included all patients younger than 18 years of age registered in BIOBADAMEX. Descriptive statistics were used for the baseline characteristics and the Chi-square test to analyze the differences between the characteristics of the groups in relation to the development of AE.ResultsA total of 45 patients were included, 31 (69%) of them female, mean age of 13.3 (±3.6) years. (Table 1).The most frequent diagnosis was JIA 25 (56%), followed by SLE 9 (20%), uveitis 5 (11%), polymyositis/dermatomyositis and hidradenitis 2 (4%) respectively;systemic sclerosis and CINCA 1 patient (2%) respectively. The mean duration disease in years was 4.67 (±2.1). Nine patients (20%) used a biologic prior to the current;23 (51%) patients had comorbidities.The most frequent bDMARDs used was Adalimumab (ADA) in 17 (38%) patients followed by Rituximab in 15 (33%) and Tocilizumab in 10 (22%), Infliximab, Abatacept and Canakinumab were used in one patient respectively.When compared by groups, ADA and Tocilizumab were the most used bDMARDs in JIA, Rituximab the only one used in SLE and PM/DM, and ADA the only one for uveitis.15 patients discontinued biological treatment, 4 (27%) due to AE. 82% used an additional synthetic DMARD, being methotrexate the most used in 48% of patients. Steroids were used by 21 (47%) of the patients with a median dose of 10mg (IQR 5 - 25).Fifteen AEs were recorded: 7 (47%) were infections, 5 of these (71%) were COVID;allergies and neutropenia in 2 (13%) patients respectively. By disease infections were more frequent in patients with JIA and Uveitis;neutropenia only occurred in patients with JIA (p 0.95). 87% of the AEs were non-serious, 1 patient with JIA presented a severe AE and one patient with SLE a fatal AE associated with COVID (p 0.93), with no statistically significant difference between groups.ConclusionJIA is the most frequent indication to use bDMARD as worldwide reported. The AE in this analysis are similar to previous registries in terms of the prevalence of infections, in our group the most frequent infectious complication was COVID, being fatal in one patient related with rituximab in SLE. Our study did not find statistically significant differences in the development of AE between diseases;however, they will continue to be reported and the number of patients in the registry will increase.References[1] Sterba,Y.et al. Curr Rheumatol Rep 2016;18,45[2] Fuhlbrigge RC, et al. 2021;47(4):531-543.Table 1.Baseline CharacteristicsBaseline characteristics (n = 45)n%Female, n(%)3168.9Age, media (SD)13.3 (±3.6)Index Body Mass, media (SD)19.6 (±4.9)Dx n(%)n %- JIA25 55.6- SLE9 20- PM/DM2 4.4- Uveitis5 11.1- Hidradenitis2 4.4- Systemic sclerosis1 2.2- CINCA1 2.2Disease duration(years) media (IQR)4.67±2.1Current treatment n(%)n %- Infliximab1 2.2- Adalimumab17 37.8- Rituximab15 33.3- Abatacept1 2.2- Tocilizumab10 22.2- Canakinumab1 2.2Treatment duration (months) median (IQR)4.5 (0.56 – 36.9)Treatment suspension, n(%)15 (33.2)Months to suspension, median (IQR)0.66 (0.46 – 1)Discontinue cause, n(%)n %- Inefficacy1 6.6- Remission1 6.6- Side effects4 26.6- Others5 33.3- Unknown4 26.6Steroids use, n(%):21 46.7Steroids dose (mg), median (IQR)10 5 – 25DMARDs use n(%):37 82.2AE, n(%):15 33.3By disease:AE TypeInfectionAllergyNeutropeniaOtherChi2JIA31230.95SLE1101Uveitis3000Acknowledgements:NIL.Disclosure of InterestsSamara Mendieta: None declare , Alfonso Torres: None declared, Fedra Irazoque-Palazuelos: None declared, Sandra Sicsik: None declared, Iris Jazmin Colunga-Pedraza: None declared, Daniel Xavier Xibille Friedmann: None declared, Deshire Alpizar-Rodriguez Employee of: Scientific advisor in GSK-Mexico, VIJAYA RIVERA TERAN: None declared.
RESUMEN
Introduction: The people worldwide have been affected by severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) infection since its appearance in December, 2019. Kawasaki disease-like hyperinflammatory shock associated with SARS-CoV-2 infection in previously healthy children has been reported in the literature, which is now referred to as a multisystem inflammatory syndrome in children (MIS-C). Some aspects of MIS-C are similar to those of Kawasaki disease, toxic shock syndrome, secondary hemophagocytic syndrome, and macrophage activation syndrome. Case Presentation: This study reported an 11-year-old boy with MIS-C presented with periorbital and peripheral edema, abdominal pain, elevated liver enzymes, severe right pleural effusion, moderate ascites, and severe failure of right and left ventricles. Conclusion(s): Due to the increasing number of reported cases of critically ill patients afflicted with MIS-C and its life-threatening complications, it was recommended that further studies should be carried out in order to provide screening tests for myocardial dysfunction. Adopting a multidisciplinary approach was found inevitable.Copyright © 2023, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.
RESUMEN
[...]patients have been restricted from accessing services, resulting in delayed diagnoses and potential disruptions to therapy. [...]there has been a new emphasis on accelerating the movement of treatment into the community setting. The overall economic forecast, and the forecast for drug budgets, have also been subdued due to the pandemic. 1.Benefit s of early advice in oncology strategy development Sponsors ca n be highly strategic: i n tlie cu rrent landscape by seeking regulatory and p ayep advice early in the drug developmeAt process. A number of recent Oncologic Drug Advisory Committee (ODAC) meetings have resulted in withdrawals of accelerated approval where confirmation of clinical benefit was not forthcoming or where confirmatory studies were not successful.
RESUMEN
BackgroundIgA vasculitis (IgAV) is a rare autoimmune disease affecting small vessels. It is well established that the incidence is higher in children (3 to 26 per 100,000 children/year,) [1] than in adults (0.1 to 1.8 per 100,000 individuals/year) [1]. However others epidemiological data and impact of the COVID-19 on IgAV remain overlooked [2].ObjectivesTo collect and analyze epidemiological data on IgAV in both adults and children in France.MethodsWe conducted an observational study using a national database called "BNDMR” [3] (Banque Nationale de Données Maladies Rares) on IgA vasculitis (code ORPHA761), which gathered patients managed in the French rare disease expert network. The incidence was estimated from the date of diagnosis, and we calculated the median annual incidence over the period 2010-2022. We specifically assessed the north/south gradient (latitude of the residence higher/lower than the median of the latitudes), the seasonality, and the impact of the COVID-19 pandemic compared to other patients reported within the same period and addressed in the same expert centers used as controls.ResultsDuring this 12-year period, 1988 patients with IgAV were reported (1498 children;490 adults). The male to female ratio was 1.57 for adults and 1.05 for children. The median IgAV annual incidence was 15 cases/year [IQR 9-30] and 82 cases/year [IQR 72-86] for adult and children cases respectively. Time to diagnosis was less than 1 month for both. Compared with other patients reported in the same expert centers, IgAV was more frequently reported in the southern part of France than in the north (OR 4.88 [95% confidence intervals: 4.17 - 5.74] in adults and OR 1.51 [1.35 - 1.68] in children). IgAV was also more frequently observed in winter than during the rest of the year in both adults (OR 1.60 [1.39 - 1.82]) and children (OR 1.22 [1.01 - 1.48]). The incidence of IgAV decreased during the COVID-19 pandemic period (from March 2020 to September 2022) in children (OR 0.62 [0.47 - 0.81]) but not in the adult population (OR 0.90 [0.76 - 1.06]).ConclusionOur study confirms the winter seasonality and sex ratio in IgAV [4,5], but suggests that the incidence or the reporting of IgAV decreased in children during the COVID19 pandemia, possibly due to barrier measures [6]. The observed north/south gradient need confirmation. The main limitation of this study is a possible IgAV under-reporting as this study rely only on cases addressed in expert centers.References[1]Audemard-Verger A, Pillebout E, Guillevin L, Thervet E, Terrier B. IgA vasculitis (Henoch-Shönlein purpura) in adults: Diagnostic and therapeutic aspects. Autoimmun Rev. 2015;14(7):579-585. doi:10.1016/j.autrev.2015.02.003[2]Deshayes S, Moulis G, Pillebout E, Aouba A, Audemard-Verger A. Positive predictive value of hospital discharge diagnosis code to identify immunoglobulin A vasculitis in France: A validation study. Eur J Intern Med. 2017;43:e18-e19. doi:10.1016/j.ejim.2017.05.025[3]Jannot AS, Messiaen C, Khatim A, Pichon T, Sandrin A, BNDMR infrastructure team. The ongoing French BaMaRa-BNDMR cohort: implementation and deployment of a nationwide information system on rare disease. J Am Med Inform Assoc. 2022;29(3):553-558. doi:10.1093/jamia/ocab237[4]Piram M, Maldini C, Biscardi S, et al. Incidence of IgA vasculitis in children estimated by four-source capture-recapture analysis: a population-based study. Rheumatology (Oxford). 2017;56(8):1358-1366. doi:10.1093/rheumatology/kex158[5]Gardner-Medwin JMM, Dolezalova P, Cummins C, Southwood TR. Incidence of Henoch-Schönlein purpura, Kawasaki disease, and rare vasculitides in children of different ethnic origins. Lancet. 2002;360(9341):1197-1202. doi:10.1016/S0140-6736(02)11279-7[6]Kaya Akca U, Atalay E, Cuceoglu MK, et al. Impact of the COVID-19 pandemic on the frequency of the pediatric rheumatic diseases. Rheumatol Int. 2022;42(1):51-57. doi:10.1007/s00296-021-05027-7Figure.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
RESUMEN
We will review the intersection of COVID-19 and children, including acute COVID-19, long COVID, and multisystem inflammatory syndrome in children (MIS-C) based on our local experiences. We will review available local epidemiologic COVID-19 data in pediatrics that has led our MIS-C team's prevention and treatment strategy. We will review the recommended treatments for pediatric acute COVID-19 and MIS-C in children, and evidence-based prevention strategies and walk through our experiences in implementing these prevention and treatment strategies.
RESUMEN
Disparities exist in access to early oral health care, disproportionately impacting minority ethnic groups and populations with low socioeconomic status. Medical dental integration provides an opportunity to create a new dental access point for early prevention and intervention as well as care coordination. The Wisconsin Medical Dental Integration (WI-MDI) model expanded early access to preventive oral health services by integrating dental hygienists (DHs) into pediatric primary care and prenatal care teams to address oral health inequities with the goal of reducing dental disease. This case study will describe how DHs were incorporated into the medical care teams in Wisconsin and how legislation expanding scope of practice made this possible. Since 2019, five federally qualified health systems, one non-profit clinic, and two large health systems have enrolled in the WI-MDI project. Thirteen DHs have worked across nine clinics in the WI-MDI project and over 15,000 patient visits to a medical provider included oral health services provided by DHs from 2019 to 2023. Dental hygienists working in alternative practice models such as those demonstrated in the innovative WI-MDI approach are positioned to reduce oral health disparities through the provision of early and frequent dental prevention, intervention, and care coordination.
RESUMEN
BackgroundCOVID-19 has shaped the world over the last 3 years. Although the risk for severe COVID-19 progression in children is low it might be aggravated by chronic rheumatic disease or treatment with immunosuppressive drugs.ObjectivesWe analyzed clinical data of COVID-19 cases among paediatric patients with rheumatic diseases reported to BIKER between March 2020 and December 2022.MethodsThe main task of the German BIKER (Biologics in Pediatric Rheumatology) registry is safety monitoring of biologic therapies in JIA. After the onset of the COVID-19 pandemic, the survey was expanded with a standardized form to proactively interview all participating centers about occurrence, presentation and outcome of SARS-CoV-2 infections in children with rheumatic diseases.ResultsA total of 68 centres participated in the survey. Clinical data from 928 COVID infections in 885 patients with rheumatic diseases could be analyzed. JIA was the most common diagnosis with (717 infections), followed by genetic autoinflammation (103 infections), systemic autoimmune diseases (78 infections), idiopathic uveitis (n=25), vasculitis (n=5).In 374 reported COVID infections (40%), patients were receiving conventional DMARDs, in 331 (36%) biologics, mainly TNF inhibitors (TNFi, n=241 (26%)). In 567 reports (61%) patients used either a biologic or a DMARD, in 339 reports patients (37%) did not use any antirheumatic medication including steroid.Over the last 3 years, COVID-19 occurred in Germany in 5 distinguishable waves, calendar weeks (CW) 10-30 in 2020, CW 21/2020 – 8/2021(both predominantly wild-type variant), CW 9-27 in 2021 (Alpha variant in the majority of infections), CW 28-51 in 2021 (Delta variant), since CW 52/2021 (several Omikron variants;Robert-Koch Institute: VOC_VOI_Tabelle.xlsx;live.com))In our cohort, patients with SARS-CoV-2 infection were slightly older during the 1st and 2nd wave (mean age 12.7+/-3.5 and 12.8+/-4.3 years) compared to the 4th and 5th wave with 11.4+/-3.9 and 11.4+/-4.2 years;p=0.01.160 asymptomatic SARS-CoV-2 infections were reported, frequencies of symptoms associated with COVID-19 are shown in table 1.Five patients were hospitalized for 4-7 days. A 3½-year-old female patient succumbed during the first wave with encephalopathy and respiratory failure. The patient had been treated with MTX and steroids for systemic JIA. Genetic testing revealed a congenital immunodeficiency. No other patient needed ventilation or intensive care. One case of uncomplicated PIMS in an MTX treated JIA patient was reported.The duration of SARS-CoV-2 infection-associated symptoms was markably shorter during the 5th wave with 6.7+/-5.1 days, compared with reports from the other 4 waves (Table1).The duration of symptoms was higher in MTX treated patients (10.2+/-8.4 days) compared to patients without treatment (7.7+/-10.8;p=0.004) or patients treated with TNFi (8.2+/-4.8, p=0.002). Although patients treated with steroids also had a longer duration of symptoms (9.7+/-7.0), this was not significant.ConclusionExcept for one patient with congenital immunodeficiency who died, no case of severe COVID-19 was reported in our cohort. At the time of infection, over 60% of patients had been treated with conventional DMARDs and/or biologics. Although MTX treated patients had a slightly longer duration of symptoms, antirheumatic treatment did not appear to have a negative impact on severity or outcome of SARS-CoV-2 infection.Table 1.Characteristics and frequency of symptoms in SARS-CoV-2 infectionsN or mean (SD)1st wave N=202nd wave N=843rd wave N=384th wave N=1245th wave N=662female14532775432age at COVID-19, years12.7 (3.5)12.8 (4.3)11.8 (3.5)11.4 (3.9)11.4 (4.2)asymptomatic126132694duration of symptoms;days,11.9 (14.7)9.2 (7.0)14.1 (11.6)10.3 (7.6)6.7 (5.1)fever1218541306cough1015652245rhinitis5261344289headache4161227171sore throat61139132musculosceletal pain2751348loss of smell/taste71162113fatigue4882680dizziness122116gastrointestinal symptoms151864dyspnea1117pneumonia11bronchitis1REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Inter stsAriane Klein Speakers bureau: Novartis, Toni Hospach Speakers bureau: Speaking fee Novartis and SOBI., Frank Dressler Speakers bureau: Abbvie, Novartis, Pfizer, Advisory Boards Novartis and Mylan, Daniel Windschall Grant/research support from: research funds by Novartis, Roche, Pfizer, Abbvie, Markus Hufnagel: None declared, Wolfgang Emminger: None declared, Sonja Mrusek: None declared, Peggy Ruehmer: None declared, Alexander Kühn: None declared, Philipp Bismarck: None declared, Maria Haller: None declared, Gerd Horneff Speakers bureau: Pfizer, Roche, MSD, Sobi, GSK, Sanofi, AbbVie, Chugai, Bayer, Novartis, Grant/research support from: Pfizer, Roche, MSD, AbbVie, Chugai, Novartis.
RESUMEN
BACKGROUND Left without being seen (LWBS) rates are an important quality metric for pediatric emergency departments (ED), with high acuity LWBS children representing a patient safety risk. Since 07/2021, our ED experienced a surge in LWBS after the most stringent COVID-19 quarantine restrictions ended. OBJECTIVES We assessed changes in LWBS rates and examined associations of system factors and patient characteristics with LWBS. METHODS We performed a retrospective study in a large, urban pediatric ED, for all arriving patients, comparing three time-periods: before COVID (PRE, 01/2018 – 02/2020), during early-COVID (COVID, 03/2020 – 06/2021), and after the emergence of COVID-19 variants and reemergence of seasonal viruses (POST, 07/2021 – 12/2021). We compared descriptive statistics of daily LWBS rates, patient demographics, and system characteristics. Negative binomial (system factors) and logistic regression (patient characteristics) models were developed to evaluate the associations between system factors and LWBS, and patient characteristics and LWBS, respectively. RESULTS Mean daily LWBS rates changed from 1.8% PRE to 1.4% COVID to 10.7% during POST. Rates increased across every patient demographic and triage level during POST, despite a decrease in daily ED volume compared to PRE. LWBS rates were significantly associated with ESI 2 patients, average ED census, and staff productivity within multiple periods. Patient characteristics associated with LWBS included lower assigned triage levels and arrival between 8PM and 4AM. CONCLUSIONS LWBS rates have shown a large and sustained increase since July 2021, even for high acuity patients. We identified system factors that may provide opportunities to reduce LWBS. Further work should develop strategies to prevent LWBS in at-risk patients.