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1.
Rheumatology (United Kingdom) ; 62(Supplement 2):ii90-ii91, 2023.
Article in English | EMBASE | ID: covidwho-2324859

ABSTRACT

Background/Aims When the COVID-19 pandemic began, steps were taken to minimise risk to those vulnerable to severe outcomes. For immunosuppressed patients with rheumatoid arthritis (RA), consideration was given to reducing risk whilst mindful of compromising control of their underlying condition. At Leeds Teaching Hospitals NHS Trust, patients receiving rituximab (RTX) were considered for a reduced dose regimen. A retrospective study, using real-world data, was undertaken to assess the impact of lower doses of RTX on response to treatment. Methods The clinical records of all patients with RA who had received RTX between March 2020 and March 2021 were reviewed. Demographics and previous RTX exposure were recorded. The dose of RTX given during the specified period was noted. Response to treatment was recorded pragmatically by physicians as good, partial or none, based on patient reported VAS for disease activity and swollen and tender joint counts, given the limitations placed on face-to-face patient review due to the pandemic. The time to subsequent RTX treatment and the need for steroid treatment for flares was also studied. Results The number of patients treated with RTX was 282, of whom 89 patients received full dose (1g x 2 infusions), 192 patients received half dose (500mg x 2 infusions). The mean age was 61 years. 77% were female. 9% were RTX-naive, 80% had previously had full dose. Follow-up data were available for 185/192 of the group receiving 1g and 88/89 of the group receiving 2g. Clinical outcomes were as follows for the two groups (1g RTX vs 2g RTX): no response 10.3% vs 9.1%;partial response:34.9% vs 20% %;good response: 54.8% vs 70.9%. The mean length of response was 7.5 months in the patients receiving 1g of RTX compared to 8.6 months in the group receiving 2g of RTX. Similar number of patients required steroid for a flare after receiving Ig of RTX (23.9%) compare to those receiving 2g of RTX (25.8%). Conclusion A majority of patients receiving RTX for RA at either standard or reduced dose reported clinical response. Those receiving lower dose RTX were more likely to report a partial response whilst those receiving full dose were more likely to report a good response. Duration of response and need for steroid therapy for flare of RA between treatments did not significantly differ between groups. Further analysis of factors that may influence clinical response to lower dose RTX is ongoing, which could guide tailored therapy regimens should the need arise again.

2.
COVID-19 and a World of Ad Hoc Geographies: Volume 1 ; 1:515-537, 2022.
Article in English | Scopus | ID: covidwho-2321829

ABSTRACT

For this chapter, I raise social psychologist Margaret Wetherell's metaphorical sledgehammer, breaking down the affective-discursive practices which come freighted with emotions, politics, as well as the promise of dignity and a renascent sense of community as we transition into, through and eventually out of, coronacrisis. I examine how we make meaning during COVID, across thresholds of physical distance, observing the ad hoc signage which mark interventions into public space through queueing stickers, yard signs, and window decals which help us navigate through the everyday spaces of the pandemic. Here, I conduct multimodal discourse analysis of the semiotic landscapes of Lincoln, Nebraska and Sioux Falls, South Dakota during the height of the first wave of the pandemic (Spring into Summer 2020) in the Great Plains region of the United States. I argue that these semiotic landscapes form a diverse, polysemic affective regime spatialized across a patchwork of bodies. By analyzing the affective regimes and practices instantiated by ad hoc signage in public spaces, I aim to understand the discursive and embodied (and discursively embodied) forces which quicken common things and common landscapes with theoretical importance in these exceptional times. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

3.
International Encyclopedia of Education: Fourth Edition ; : 574-585, 2022.
Article in English | Scopus | ID: covidwho-2250959

ABSTRACT

Against the backdrop of the Covid-19 pandemic, this paper reviews the global contribution and significance of the work of Education International, an international professional trade union organization. It provides a short history of the organization, of its key values and core objectives are, and an indication of the ways it works multilaterally with international organizations, such as the International Labor Organization, UNESCO and the OECD and various systems of education around the world. The second half of this paper describes some of the ways in which Education International approaches some of key issues of policy and practice, both long-standing, such as social equality and human rights, and those that are emerging, such as uses of new technologies, privatization, decolonization of education and climate change. The paper demonstrates the importance of professional voice of teachers and their attempts to organize collectively in the defense and promotion of major educational and social principles. © 2023 Elsevier Ltd. All rights reserved.

4.
Rupkatha Journal on Interdisciplinary Studies in Humanities ; 14(4), 2022.
Article in English | Scopus | ID: covidwho-2285185

ABSTRACT

As Covid-19 restrictions promise to loosen and international borders begin to open, transnational students are again preparing for language education abroad. However, due to students' low reading rates (RRs), target institutions' courses' large reading demands pose potential challenges to students' success. To address this, this study explored the potential of employing an unassisted repeated reading procedure (rate build-up, RBU) to increase prospective transnational students' RRs. The study investigated the RBU procedure's potential with this population by comparing the procedure's effects on traditional degree-seeking learners' RRs in a Taiwanese university setting and those of potential transnationals targeted for studies in a similar setting. Assessing each group's pre and post-reading gains using inferential statistics, significant reading gains and large Cohen d effect sizes were found for both groups, indicating the generalizability of this procedure. It was further found that students with higher starting RRs demonstrated greater gains. Limitations and suggestions for further research are also addressed. © 2022 Aesthetics Media Services. All rights reserved.

5.
Physical Activity and Health ; 6(1):208-218, 2022.
Article in English | Scopus | ID: covidwho-2262965

ABSTRACT

Background: The purpose of this paper is to describe the effects on preparation for sprinting performance in Hong Kong university-level athletes during the COVID-19 pandemic. Changes in training methods, and well-being of athletes due to COVID-19 pandemic were also investigated. Methods: Using Google Form, the study recall period was established during the closure of sports facilities in Hong Kong (2/2020-2/2021) during the COVID-19 pandemic. Physical state preparation (PSP), Mental state preparation (MSP), Nutritional preparation (NP), and Major changes in training methods (MTM) were analyzed. Results: The results demonstrated no significant mean difference between male and female athletes on the effects of COVID-19 regarding the PSP, MSP, NP, and MTM. However, both males and females were highly disrupted in relation to performance preparation. Conclusions: The pandemic affected physical performance, stress, and mental state, impacted on nutritional regimes, changed training locations and recovery strategies, and lowered training quantity and quality. In addition, athletes received less coaching, and had less accessibility to training equipment. Athletes and coaches should reflect on the effects of the COVID-19 pandemic to address personal training needs, while sports professionals need to carefully prepare themselves for sprinting performance, in relation to the current COVID-19 situation. © 2022 The Author(s).

6.
Open Forum Infectious Diseases ; 9(Supplement 2):S484, 2022.
Article in English | EMBASE | ID: covidwho-2189787

ABSTRACT

Background. Coronavirus disease 2019 (COVID-19) results from SARS-CoV-2-induced hyperinflammatory immune response, orchestrated by granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF increases interleukin-6 (IL-6) levels, ultimately leading to increased C-reactive protein (CRP). The LIVE-AIR trial demonstrated that lenzilumab, the GM-CSF neutralizing antibody, improved the likelihood of survival without invasive mechanical ventilation (IMV) in hospitalized COVID-19 patients requiring supplemental oxygen but not IMV. This sub-analysis correlated levels of cytokines before and after lenzilumab treatment. Methods. LIVE-AIR was a phase 3, randomized, double-blind, placebocontrolled trial (NCT04351152). Patients hospitalized with COVID-19 pneumonia, requiring only supplemental oxygen, were randomized to receive lenzilumab (1800 mg in three equally divided doses of 600 mg, q8h) or placebo IV infusion, in addition to standard of care which included remdesivir and corticosteroids. Blood taken at baseline (BL) and subsequent to treatment through day 10 (D10) were obtained and analyzed by high sensitivity enzyme immunoassay for GM-CSF, IL-6, and CRP. Results. Baseline IL-6 levels (Loge-transformed for all cytokines and biomarkers) were linearly correlated with higher baseline GM-CSF levels (slope=0.60, p< 0.001). Baseline CRP levels were linearly correlated with higher baseline IL-6 levels (slope=0.29, p < 0.001). GM-CSF levels decreased with lenzilumab treatment on day 1 (D1) which persisted through D10 (Table). In contrast, GM-CSF increased with placebo treatment. IL-6 levels decreased only with lenzilumab treatment. CRP following lenzilumab or placebo treatment decreased on D1 to similar levels and further decreased on D10 only with lenzilumab treatment. Cytokine Levels Associated with Lenzilumab Treatment Conclusion. Lenzilumab decreased GM-CSF as well as downstream cytokines and systemic biomarkers of inflammation during the hyperinflammatory immune response of COVD-19.

7.
Pediatric Blood and Cancer ; 69(Supplement 5):S44, 2022.
Article in English | EMBASE | ID: covidwho-2085158

ABSTRACT

Background and Aims: Background and Aims Pediatric advance care planning (pACP) is a process of preparation and skill development to facilitate discussions about future medical care choices. We evaluated the efficacy of FACE-TC on adolescents' decisional support, preparedness, and quality of life (QoL) and other patient-reported outcome (PRO) measures. Method(s): Single blinded, intent-to-treat randomized clinical trial. Adolescent/family dyads were randomized at a 2:1 ratio to either FACE- TC or Treatment as Usual (TAU) at four pediatric hospitals. FACE-TC dyads received 3 weekly 60-minute sessions: pACP Survey;Next Steps: Respecting Choices interview;and Five Wishes. All received pACP information. Outcome measures were: Decisional Support and Preparedness;FACIT-Spirituality;and PROMIS measures. Result(s): 126 dyads underwent randomization (83 FACE-TC and 43 TAU). Compared to TAU, FACE-TC adolescents were significantly more likely to agree or strongly agree to I feel prepared for the future (76%vs.94%, p=0.025) and to I feel we are now on the same page (76%vs.94%, p=0.044) at 3 months post-intervention (N=107). There was no intervention effect at 12-months (N=104). Compared to TAU, FACE-TC had no significant effect on meaning/purpose or peace at 3-months, and significantly decreased meaning/peace at 12-months [Mean, SD=28(4) vs.26(5), p=0.029]. Compared to TAU, FACE-TC had no effect on the PROMIS [BJ1] measures at 3 months, and significantly increased Pain Interference [Mean, SD=40(80 vs.4 (10), p=0.030];Anxiety [42(12) vs.52(10), p=0.001];and Depressive symptoms [43(8) vs.49(11), p=0.007] at 12-months. Conclusion(s): FACE-TC increased adolescents' feelings of being prepared and supported. By 12-months FACE-TC adolescents had more pain interference and anxiety and depressive symptoms. The outbreak of COVID during the 12-month follow-up visits may have impacted these outcomes given these effects were not observed at 3-months post-intervention. Justin N. Baker, Sarah Friebert, Jennifer S. Needle, Jessica D. Thompkins, Daniel Grossoehme, Jiji Jiang, Jichuan Wang, Maureen E. Lyon.

8.
Journal of the American Academy of Child and Adolescent Psychiatry ; 61(10 Supplement):S98-S99, 2022.
Article in English | EMBASE | ID: covidwho-2076257

ABSTRACT

Objectives: The onset of the COVID-19 pandemic over 2 years ago has given rise to a new outlook on the need and utilization of distance learning to support child mental health. Such initiatives as the national establishment of Child Psychiatry Access Programs (CPAPs) are poised to address this need by integrating distance-learning models into their telehealth operations to support primary care providers (PCPs) in the identification and management of child mental health concerns. The aim of this presentation is to review how the Child Access to Mental Health and Psychiatry program (CHAMP) in Mississippi, established in Mississippi in 2018 by funding from the Health Resources and Services Administration (HRSA), is answering one of the charges from HRSA to provide educational training opportunities. Method(s): CHAMP initiated the use of the Extension for Community Healthcare Outcomes (ECHO) model to impart knowledge about various topics and issues related to child mental health to PCPs across Mississippi. Outcomes data of ECHO offerings will be reviewed. Result(s): ECHO allows PCPs to learn about a specific topic through a brief didactic presentation followed by a case presentation that promotes collaboration in establishing treatment recommendations from those in the behavioral health field. This presentation will discuss how CHAMP has used the ECHO model with 254 PCPs and learners and will present information on learners' initial satisfaction and program effectiveness in increasing PCP efficacy to treat different aspects of child mental health as well as lessons learned from ECHO implementation and future steps in education. Conclusion(s): In addition to training PCPs, CHAMP seeks to enhance the medical training of psychiatry students and residents by enlisting their involvement in consultation calls during their regular rotation hours performed in the same specialty clinic where CHAMP programmatic operations are based. CON, EBP, RP Copyright © 2022

9.
Aims Allergy and Immunology ; 6(3):170-187, 2022.
Article in English | Web of Science | ID: covidwho-2044069

ABSTRACT

The components of the immune system develop in utero and like a computer, some components are immediately functional (the innate components) but other components must learn the programs and details necessary to function (antigen adaptive components). Like other systems, including military and municipal, the innate and antigen specific components develop into an immune system that helps maintain and surveil the other body processes and systems for aberrations, provide surveillance and protection of the mucoepithelial borders and protection from microbial invasion. Inability, excesses, or errors in these processes cause disease. Aging of the immune system brings immunosenescence, inflammaging, more errors, and decreased surveillance which increases risk for new infections (e.g. COVID-19, influenza), recurrence of latent infections, cancer and autoimmune and inflammatory diseases. With greater understanding of the surveillance, effector and regulatory deficits upon aging, better therapies can be developed.

10.
J R Soc Interface ; 19(194): 20220477, 2022 09.
Article in English | MEDLINE | ID: covidwho-2018414

ABSTRACT

Periodic resurgences of COVID-19 in the coming years can be expected, while public health interventions may be able to reduce their intensity. We used a transmission model to assess how the use of booster doses and non-pharmaceutical interventions (NPIs) amid ongoing pathogen evolution might influence future transmission waves. We find that incidence is likely to increase as NPIs relax, with a second seasonally driven surge expected in autumn 2022. However, booster doses can greatly reduce the intensity of both waves and reduce cumulative deaths by 20% between 7 January 2022 and 7 January 2023. Reintroducing NPIs during the autumn as incidence begins to increase again could also be impactful. Combining boosters and NPIs results in a 30% decrease in cumulative deaths, with potential for greater impacts if variant-adapted boosters are used. Reintroducing these NPIs in autumn 2022 as transmission rates increase provides similar benefits to sustaining NPIs indefinitely (307 000 deaths with indefinite NPIs and boosters compared with 304 000 deaths with transient NPIs and boosters). If novel variants with increased transmissibility or immune escape emerge, deaths will be higher, but vaccination and NPIs are expected to remain effective tools to decrease both cumulative and peak health system burden, providing proportionally similar relative impacts.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , COVID-19/prevention & control , Humans , Public Health , Seasons , Vaccination
11.
Cytotherapy ; 24(5):S106, 2022.
Article in English | EMBASE | ID: covidwho-1996724

ABSTRACT

Background & Aim: During the COVID pandemic the National Marrow Donor Program® (NMDP)/Be The Match® required cryopreservation of unrelated hematopoietic stem cell (HPSC) products prior to initiation of recipient conditioning to minimize risks associated with logistical complications. Transplant centers are still evaluating cryopreservation associated risk factors due to reported concerns on poor postthaw graft quality compared to fresh products. We evaluated the effect of cryopreservation on engraftment outcomes. Methods, Results & Conclusion: Data from patients receiving either unrelated HPSC fresh or cryopreserved products obtained through the NMDP were included in this study. There were 43 fresh infusions during (Table Presented) during 2019 and 54 cryopreserved infusions between January 2020 and January 2022. Neutrophil and platelet engraftments were our primary endpoints. Absolute neutrophil count (ANC) recovery was defined as an ANC of ≥ 0.5×109/L for three consecutive laboratory values obtained on different days. While platelet engraftment was determined as the first day of three consecutive measurements, obtained on different days, where the platelet count is ≥ 20×109/L without a platelet transfusion in the previous seven days. Medians for two unpaired groups were compared by using Mann-Whitney U test. Two-sided p-values < 0.05 were considered statistically significant. Of the total of fresh transplants, 62.8% of patients underwent reduced intensity conditioning (RIC) while 37.2% underwent myeloablative conditioning (MAC). Regardless of the diagnosis category and in accordance with the American Society of Blood and Marrow Transplantation (ASBMT) Standardized Request for Information (RFI), 11.6% of recipients were classified as a high risk, 20.9% as an intermediated risk, 41.9% as a low risk and 25.6% unclassified. Whereas 52.8% of patients who received cryopreserved products underwent RIC and 47.2% underwent MAC;according to ASBMT-RFI classification, 18.9% were considered as a high risk, 24.5% as an intermediated risk, 41.5% as a low risk and 15.1% unclassified. Engraftment characteristics for both groups of patients is summarized in Table I. No statistically significant differences in engraftment were observed. Our analysis suggests that compared to outcomes of fresh product transplantation, cryopreservation does not negatively effect allograft quality in terms of neutrophil and platelet engraftment.

12.
Cytotherapy ; 24(5):S103, 2022.
Article in English | EMBASE | ID: covidwho-1996723

ABSTRACT

Background & Aim: Prior to the COVID-19 pandemic, allogeneic transplants were typically performed with fresh hematopoietic stem cell (HPSC) products. Unrelated donor (UD) cells are obtained through the National Marrow Donor Program (NMDP). The logistics for coordinating collection, transport, and delivery of fresh products with preconditioning of recipients is complicated under the best circumstances. The pandemic created uncertainty and disruptions in the UD HPSC process. In March 2020 the NMDP required cryopreservation of UD HPSC products, with rare exceptions, prior to patient conditioning. The impacts of cryopreservation on allogeneic HPSC engraftment are not well defined and conflicting outcomes based on transport time and cell concentration have been published. We aimed to determine if cryopreservation, transport time and pre-processing cell concentration negatively impacted patient engraftment. Methods, Results & Conclusion: Methods: Between July 2021 and January 2022, we analyzed UD HPSC products from 24 patients for CD34+ pre- and post-thaw cell recovery and viability based on transit time and pre-processing cell concentration. Transit time, defined as the interval from end of collection to start of processing, was divided into 3 cohorts: 1-20 h, 21-40 h, and >40 h. Pre-processing nucleated cell counts were divided into 2 cohorts: <200 x106 cells/mL and >200 x106 cells/mL. Neutrophil and platelet engraftment data were obtained from the patients’ medical record. Medians for 2 unpaired groups were compared by using Mann-Whitney U test. Three or more unpaired groups were compared using one-way ANOVA with Tukey’s multiple comparisons or Kruskal Wallis non-parametric test with Dunn’s test for post hoc analysis, as appropriate. For paired data a mixed model ANOVA with Geisser-Greenhouse correction was applied. Results: Information regarding patient diseases and product characteristics are shown in Table I. There were no statistically significant differences between the nucleated cell count in the product bag reported by the collection center and those measured at the time of processing. When these parameters were evaluated based on transit time and pre-processing cell concentration, no statistically significant differences were observed. Conclusion: Although our data set is small, the results suggest that transit time and cell concentration of the HPSC product bag does not negatively impact allograft quality and engraftment. (Table Presented)

13.
Perspect Public Health ; : 17579139221106399, 2022 Aug 05.
Article in English | MEDLINE | ID: covidwho-1986708

ABSTRACT

AIMS: Amid the vast digitalisation of health and other services during the pandemic, people with no digital skills are at risk of digital exclusion. This risk might not abate by the end of the pandemic. This article seeks to understand whether people with severe mental ill health (SMI) have the necessary digital skills to adapt to these changes and avoid digital exclusion. METHODS: Two hundred and forty-nine adults with SMI across England completed a survey online or offline. They provided information on their digital skills based on the Essential Digital Skills (EDS) framework, sociodemographic information, and digital access. This is the first time that the EDS is benchmarked in people with SMI. RESULTS: 42.2% had no Foundation Skills, and 46.2% lacked skills for daily life (lacking Foundation or Life Skills). 23.0% of those working lacked skills for professional life (lacking Foundation or Work Skills). The most commonly missing skills were handling passwords and using the device settings (Foundation Skills) and online problem solving (Skills for Life). People were interested in learning more about approximately half of the skills they did not have. People were more likely to lack Foundation Skills if they were older, not in employment, had a psychosis-spectrum disorder, or had no Internet access at home. CONCLUSION: A significant portion of people with SMI lacked Foundation Skills in this objective and benchmarked survey. This points to a high risk for digital exclusion and the need for focused policy and tailored health sector support to ensure people retain access to key services and develop digital skills and confidence. To our knowledge, this is the first time this has been described using the EDS framework. Services, including the National Health Service (NHS), need to be aware of and mitigate the risks.

14.
15.
Journal of Allergy and Clinical Immunology ; 149(2):AB96-AB96, 2022.
Article in English | Web of Science | ID: covidwho-1798177
16.
Journal of Allergy and Clinical Immunology ; 149(2):AB101-AB101, 2022.
Article in English | Web of Science | ID: covidwho-1798147
17.
Education and Training in Autism and Developmental Disabilities ; 57(1):104-118, 2022.
Article in English | Scopus | ID: covidwho-1787251

ABSTRACT

The ability to communicate is the most fundamental educational outcome leading to academic success (Kearns et al., 2015). This is no different for students with disabilities. Students with autism spectrum disorders (ASD), however, demonstrate difficulty with spontaneous communication and use of functional language throughout a variety of settings (Centers for Disease Control;[CDC], 2020), including academic contexts. Embedded instruction (Jimenez & Kamei, 2015) and systematic prompting (Doyle et al.,1988) have been used as strategies to improve skill acquisition for students with ASD. This study provides support to the existing literature by combining two previously evidence-based practices to increase the verbal behavior of students with autism during reading instruction. A single-subject multiple probe design across three elementary school students with ASD was used to analyze the outcomes of the use of embedded trials and systematic prompting on tacted and intraverbal responses to story questions. In addition, the content and accuracy of the responses were recorded. All students increased their ability to accurately respond and provide verbalizations about a text at the completion of the study. Limitations and future research were discussed regarding implementation of technology, distance learning, and implications due to COVID-19. © Division on Autism and Developmental Disabilities.

18.
Genetics in Medicine ; 24(3):S174, 2022.
Article in English | EMBASE | ID: covidwho-1768093

ABSTRACT

Introduction: Phenylketonuria (PKU) is an inherited autosomal recessive disorder caused by variants in the PAH gene which encodes for phenylalanine hydroxylase (PAH). PAH deficiency leads to phenylalanine (Phe) accumulation, which untreated can cause intellectual disability, microcephaly, delayed speech, seizures, psychiatric symptoms, and behavioral abnormalities. Early detection of elevated Phe through newborn screening allows for rapid initiation of a Phe-restricted diet to prevent severe neurological outcomes;however, suboptimal Phe control throughout the lifespan is associated with increased rates of psychiatric illness and deficits in executive function even in early treated patients. Lifelong management of PKU is challenging, and it is well documented that many adult patients become lost to follow-up, despite the American College of Medical Genetics recommendation for lifelong management. Here we describe and evaluate efforts to improve follow-up care for patients with PKU of all ages at one center through formalization of clinic guidelines and creation of an overdue outreach program. Methods: The PKU clinic team is a multidisciplinary team consisting of an APN Director, physician, dieticians, diet tech, genetic counselor, registered nurse, and social worker. Regular meetings were scheduled with all clinic staff members to review PKU treatment guidelines, recommended lab monitoring, and visit frequency. After establishing formal guidelines, algorithms were created to determine thresholds for initiating patient outreach based on both age and type of PKU treatment. EMR-based data collection is used to track adherence to both clinic visits and consistent submission of Phe levels. Data was collected and analyzed for Lurie Children’s PKU program, which consists of roughly 250 patients. Baseline levels for adherence to clinic visits and filter card submission were collected at time of implementation. Data was then collected and analyzed initially after 18 months, and has been further analyzed for a second 18 months (which correlates with the start of the COVID-19 pandemic). Results: Overall baseline adherence across the PKU patient population for annual clinic visits was 72% (144/200). Clinic visit adherence increased to 88% at 18 months, and then was essentially unchanged at 86% through COVID-19 pandemic. In the pediatric patient population, annual clinic follow-up adherence was 92% (79/86) at baseline, which increased to 98% with implementation and maintained 98% during the pandemic. In the adult patient population, 54% (57/106) were adherent at baseline with clinic follow-up. With implementation compliance increased to 80% initially and was then reported to be 74% during the pandemic. Baseline for all PKU patients showed 81% (161/200) filter card submission within the last 12 months. Submission increased to 91% after 18 months of overdue outreach, and as of October 2021, 85% of all patients had submitted a filter card within the last calendar year. Adult patients specifically showed an increase, with 53% at baseline to 69% after implementation. Hyperphenylalaninemia (hyperphe) patients over the age of 2 showed an 18% (5/28) submission at baseline. With the overdue outreach program, this increased to 31% of patients initially and has further increased to 39%. Clinic visits for patients greater than 7 years old rose from 13% (3/24) initially to 57% and has further increased to 67%. Conclusion: Implementation of a coordinated overdue outreach program is successful in re-engaging patients with the PKU clinic and improving adherence to treatment recommendations. We have seen increased patient adherence across all domains, and have maintained this improved adherence despite the global COVID-19 pandemic. We believe that integrating overdue outreach guidelines into clinical practice is a replicable model for PKU clinics.

19.
Open Forum Infectious Diseases ; 8(SUPPL 1):S29, 2021.
Article in English | EMBASE | ID: covidwho-1746799

ABSTRACT

Background. Severe coronavirus disease 2019 (COVID-19) often results from the immune-mediated cytokine storm, triggered by granulocyte macrophage-colony stimulating factor (GM-CSF), potentially leading to respiratory failure and death. Lenzilumab, a novel anti-human GM-CSF monoclonal antibody, neutralizes GM-CSF and demonstrated potential to improve clinical outcomes in a matched case-cohort study of patients with severe COVID-19 pneumonia. This Phase 3 randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of lenzilumab to improve the likelihood of survival without invasive mechanical ventilation (SWOV), beyond available treatments. Methods. Hypoxic patients, hospitalized with COVID-19 (n=520), requiring supplemental oxygen, but not invasive mechanical ventilation, were randomized on Day 0 to receive lenzilumab (1800mg, n=261) or placebo (n=259), and available treatments, including remdesivir and/or corticosteroids;and were followed through Day 28. Results. Baseline demographics were comparable between groups: male, 64.7%;mean age, 60.5 years;median CRP, 79.0 mg/L. Patients across both groups received steroids (93.7%), remdesivir (72.4%), or both (69.1%). Lenzilumab improved the primary endpoint, likelihood of SWOV in the mITT population, by 1.54-fold (HR: 1.54;95%CI: 1.02-2.32, p=0.0403). Lenzilumab improved SWOV by 1.91-fold (nominal p=0.0073) and 1.92-fold (nominal p=0.0067) in patients receiving remdesivir or remdesivir and corticosteroids, respectively. A key secondary endpoint of incidence of IMV, ECMO or death was also improved in patients receiving remdesivir (p=0.020) or remdesivir and corticosteroids (p=0.0180). Treatment-emergent serious adverse events were similar across both groups. Conclusion. Lenzilumab significantly improved SWOV in hypoxic COVID-19 patients upon hospitalization, with the greatest benefit observed in patients receiving treatment with remdesivir and corticosteroids. NCT04351152.

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