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1.
State and Local Government Review ; 2022.
Article in English | PubMed Central | ID: covidwho-2194508

ABSTRACT

Juneau, Alaska, kept COVID-19 deaths lower than in other similar jurisdictions. We argue that adaptive leadership—the early decisions and actions of Juneau's leaders, effective communications, and emergent new collaborative structures—in the context of municipal ownership of key assets enabled Juneau's success. The result of 61 interviews and follow-up research, this case study contributes a better understanding of which institutional design, communication, and collaborative factors mattered in responding to the pandemic. Adaptive leadership provides a better explanation for Juneau's success than alternatives that focus on its isolation, home-rule status, and socio-economic structure.

2.
Open Forum Infectious Diseases ; 9(Supplement 2):S765-S766, 2022.
Article in English | EMBASE | ID: covidwho-2189949

ABSTRACT

Background. Patients receiving CAR-T therapy may have impaired humoral responses to SARS-CoV-2 vaccinations due to their high net state of immunosuppression associated with the underlying disease, prior lines of therapy and CAR-T treatment associated hypogammaglobinemia. Comprehensive data on vaccine immunogenicity in this patient population are currently lacking. Methods. A single-center retrospective study of adults receiving CD19 CAR-T therapy for non-Hodgkin's lymphoma was conducted between 3/27/2018 - 8/31/ 2021. Patients received at least two doses of COVID-19 vaccinations with BNT162b2 (Pfizer, BioNTech), mRNA-1273 (Moderna), or 1 dose of Ad26.COV2.S (Janssen) and had SARS-CoV-2 anti-spike (S) levels measured at least one month after the last vaccine dose. We excluded patients who received COVID-19 monoclonal antibody therapy or immunoglobulin within 3 months of the index anti-S titer. Patients were followed from the time of the first COVID-19 vaccines through their index anti-S antibody result. Patients were censored on the first day of any additional antineoplastic therapy after disease relapse. Our primary endpoint was the percentage of patients who develop a positive anti-S response (assessed by anti-S assay cutoff of >0.8 U/mL, Roche assay). Results. Twenty-five patients met eligibility. Median age was 65 years (range 41 - 78), and majority of patients were male (72%). The number of patients with a positive antibody response was 12 (48%). Median number of vaccines received was 3. 18 patients (72%) received Pfizer vaccines, 4 patients (16%) received Moderna, 2 patients (8%) received Moderna and Pfizer, and 1 patient (4%) received Janssen and Pfizer. Median anti-S titers among patients with a positive response was 111 U/mL (range 2.44 - 12500). Two patients (8%) had COVID-19, both with negative anti-S responses. Conclusion. Our analysis shows that only 48% of patients who received CAR-T therapy developed a positive antibody response after at least two COVID-19 vaccine doses, with a low median titer among responders. This patient population is at higher risk for developing severe COVID-19 disease and likely remains vulnerable even after vaccination. Alternative approaches are needed to prevent COVID-19 and mitigate disease severity in patients undergoing CAR-T.

3.
BMJ Open ; 12(9), 2022.
Article in English | EMBASE | ID: covidwho-2064156

ABSTRACT

Purpose To investigate the robustness and longevity of SARS-CoV-2 immune responses conferred by natural infection and vaccination among priority populations such as immunocompromised individuals and people with post-acute sequelae of COVID-19 in a prospective cohort study (Stop the Spread Ottawa - SSO) in adults living in the Ottawa region. In this paper, we describe the study design, ongoing data collection and baseline characteristics of participants. Participants Since October 2020, participants who tested positive for COVID-19 (convalescents) or at high risk of exposure to the virus (under surveillance) have provided monthly blood and saliva samples over a 10-month period. As of 2 November 2021, 1026 adults had completed the baseline survey and 976 had attended baseline bloodwork. 300 participants will continue to provide bimonthly blood samples for 24 additional months (ie, total follow-up of 34 months). Findings to date The median age of the baseline sample was 44 (IQR 23, range: 18-79) and just over two-thirds (n=688;67.1%) were female. 255 participants (24.9%) had a history of COVID-19 infection confirmed by PCR and/or serology. Over 600 participants (60.0%) work in high-risk occupations (eg, healthcare, teaching and transportation). 108 participants (10.5%) reported immunocompromising conditions or treatments at baseline (eg, cancer, HIV, other immune deficiency, and/or use of immunosuppressants). Future plans SSO continues to yield rich research potential, given the collection of pre-vaccine baseline data and samples from the majority of participants, recruitment of diverse subgroups of interest, and a high level of participant retention and compliance with monthly sampling. The 24-month study extension will maximise opportunities to track SARS-CoV-2 immunity and vaccine efficacy, detect and characterise emerging variants, and compare subgroup humoral and cellular response robustness and persistence.

4.
EJVES Vascular Forum ; 54:e38, 2022.
Article in English | EMBASE | ID: covidwho-2004042

ABSTRACT

Aims: Delays in turnaround time (TAT) have significant financial implications for the National Health Service, estimated to be as much as £347 327 per year. Considering this, we aimed to reduce the TAT by 25% in a vascular surgical theatre, via a Quality Improvement Project (QIP), as part of an MBBS component. We hypothesised that improvements in TAT would also lead to beneficial secondary effects, such as improved theatre utilisation, reduced on the day cancellations, and fewer minutes overrun. Methods: TAT was defined as the time between the last patient going to recovery (“wheels out”) to the next one entering the theatre (“wheels in”). Using the electronic theatre record system “Galaxy”, we established a baseline average TAT using data from October 2019 to January 2020. To identify the common issues underlying TAT delays, a group of three medical students undertook a four week research period, involving ad hoc staff interviews and review of postoperative debrief forms. From this, we constructed our interventions and implemented them over a six week period. Results: Our research period suggested ward-based preparation was a common reason for delay. To address this, we created interventions that focused on giving the ward staff more time, to promote “patient readiness”. An advanced warning system when sending for the patient (30 minutes prior to the end of surgery;previously, the ward was only notified when the patient was being closed) and a newly designed ward based checklist (shown in Fig. 1;the checklist allowing systematic review of tasks needed to be completed) were utilised. Baseline average TAT was 51.7 minutes and the pre-intervention theatre utilisation percentage was 86%. After a PDSA cycle using the interventions described above, we reduced the average TAT to 42.1 minutes, an 18.4% decrease. Figure 2 shows a run chart visualising these results. While the reduction did not meet our 25% target, it remains a significant one. Unfortunately, reduced TAT did not translate into significant improvement in theatre utilisation, on the day cancellations, or minutes overrun, all of which remained at the median of the pre-intervention period. However, improvements in these metrics were impeded by factors out of our control (e.g., surgical complications causing delays). These “unpreventable” delays had particularly significant impacts on our results when they occurred due to the intervention period being conducted over only one PDSA cycle (owing to the COVID-19 pandemic halting elective procedures). Conclusion: Our ward based interventions have shown they can reduce turnaround times in vascular surgery. Less idle theatre time and improved theatre utilisation will be imperative in reducing the backlog of surgeries the COVID pandemic has created. While this QIP was unable to translate reduced TAT to beneficial secondary effects, such as improved theatre utilisation, we hypothesise that with a larger sample size, reduced turnaround times will improve these long term, as there will be more opportunity for the interventions to have their effect without being obstructed by unpreventable delays. Therefore, we believe these interventions should be considered for further exploration on a larger scale to ascertain their true value. This will begin with the resumption of our second PDSA cycle, once surgeries resume [Formula presented] [Formula presented]

5.
Critical Care Medicine ; 50(1 SUPPL):43, 2022.
Article in English | EMBASE | ID: covidwho-1692106

ABSTRACT

INTRODUCTION: The U.S. healthcare system remains vulnerable to crisis and troubled by resource inequities. Uneven distribution and scarcity of critical care (CC) clinicians is one example: COVID19 overwhelmed many hospitals with critically ill patients forcing some clinicians to provide care beyond their normal scope of practice and level of comfort. METHODS: The National Emergency Tele-Critical Care Network (NETCCN) was developed to address this problem by providing on-demand access to CC experts. NETCCN was funded by the Coronavirus, Aid, Relief, and Economic Security (CARES) Act;as a collaboration between the U.S. Army's Telemedicine and Advanced Technology Research Center (TATRC), the Department of Health and Human Services Assistant Secretary for Preparedness and Response (HHS ASPR), and the Society of Critical Care Medicine (SCCM). NETCCN focused on rapid development and deployment of technology platforms that were simple and user-friendly, cyber-secure, and HIPAA compliant, and only required a cellular connected mobile device. This federally funded resource allowed local non-CC caregivers to consult with CC experts. RESULTS: NETCCN has deployed to six states/territories, eight hospitals and cared for hundreds of patients in locations unfamiliar with managing critically-ill patients. While limited in scope, the NETCCN experience highlights key challenges and successes to address or sustain moving forward. Fear commonly prevented wider acceptance and use of NETCCN support. Clinicians fear judgment when asking questions;hospital administrators fear violating laws or disrupting “normal” practice patterns;and provider groups fear loss of market share. Despite laws that permit expedience during disaster conditions, major policy barriers, particularly local credentialing and privileging processes, hinder the use of tele-CC consultation solutions. Finally, lack of consistent federal, state, and local telehealth policies, especially for in-patient and e-consult services, caused confusion and prevented wider deployment of NETCCN. CONCLUSIONS: A federal capability that provides telemedicine support to hospitals or communities in crisis as part of a disaster response system is feasible, but policy barriers and cultural expectations impede rapid adoption.

6.
British Journal of Surgery ; 108(SUPPL 7):vii57, 2021.
Article in English | EMBASE | ID: covidwho-1585065

ABSTRACT

Aim: One of the factors influencing theatre efficiency is turn-around time (TAT). The aim of this QIP was to reduce turnaround times by 25% thereby reducing financial implications of theatre idle time. Methods: Baseline data was obtained from electronic theatre record system 'Galaxy' for the period October 2019 to February 2020. TAT (Time from the last patient going to recovery and the next one coming into the theatre) was measured and a period average was established. This QIP mapped processes and conducted interviews, to identify issues contributing to longer turnaround times. Interventions were then constructed and implemented over 6 weeks. Results: One of preventable causes of delay identified from staff interviews and personal observations was inadequate patient preparation by the ward. Preintervention percentage theatre utilisation was 86% and turnaround times was 51.7 minutes. A PDSA cycle was initiated focusing on advanced warning (30 minutes prior to the end of the previous surgery) from theatres to wards and advanced preparation from wards, using a newly designed ward-based checklist. After the first PDSA cycle there has been an improvement in TAT to 42.8 minutes, a decrease of 18.2%. Whilst this did not meet our goal of a 25% reduction, this remains significant. Unfortunately due to COVID -19 the second cycle has been delayed. Conclusions: Affordable and sustainable improvements will be needed in post COVID-19 recovery phase to tackle the backlog of surgeries. This project has demonstrated that advanced warning system can decrease turnaround times.

7.
Blood ; 138:3113, 2021.
Article in English | EMBASE | ID: covidwho-1582197

ABSTRACT

Background: Vaso-occlusive crises (VOC) are the most common acute complication of sickle cell disease (SCD). Crizanlizumab, an anti-P-selectin monoclonal antibody, is an FDA-approved disease-modifying therapy (DMT) for SCD patients (pts) aged ≥16 yrs to reduce the frequency of VOC. To better understand its use and impact, the National Alliance for Sickle Cell Centers (NASCC) conducted a retrospective study of pts prescribed crizanlizumab from 11/2019-6/30/2021. NASCC is a non-profit organization formed to support SCD centers in delivering quality comprehensive care by setting and adopting specific standards and advocating for improved health outcomes in SCD. This study describes the largest real-world cohort of pts treated with crizanlizumab. Methods: This is a two-part study. Part 1 was to evaluate NASCC center crizanlizumab practice and to summarize data on insurance approval and the frequency of drug discontinuation. Part 2 includes pt level data to evaluate reasons for discontinuation and acute care utilization pre and post therapy. Acute care use includes day hospital/infusion, emergency department visits, and hospitalizations for VOC (excluding COVID-19). The index date for each pt is defined as the 1st crizanlizumab infusion date. Chart review (electronic health records) was used to identify all acute care visits 12 months pre-index and ≤12 months post index. Acute care data will be analyzed in aggregate. Evaluation of center-specific use of crizanlizumab, time to initial site level formulary approval and drug discontinuation were analyzed. Pt level data collection is ongoing to include sufficient time post index date. VOC characteristics will be summarized using medians, median differences (pre/post treatment), and 95% confidence intervals. Additional evaluation of effectiveness of crizanlizumab will include analysis based on number of doses received, pre-treatment VOC burden, concomitant hydroxyurea (HU) use and genotype. Results: Data includes pts prescribed crizanlizumab at 11 NASCC centers. Site- formulary approvals to use crizanlizumab varied from 12/2019-12/2020. As a result, the 1st pt to receive treatment at each site varied from 1/15/2020-1/20/2021. Mean time from site-level approval to first infusion was 77 days (range: 0-394). Over 50% of sites received insurance denials mainly due to “insufficient medical necessity” or “medication not covered by the prescription plan.” Sites were able to successfully appeal denials for 71% of pts (Table 1). Treatment Delivery: Each site gives infusions over 30 minutes and the majority (64%) do not use pre-medication unless pts had reactions. Some sites use diphenhydramine/acetaminophen (3) or normal saline and ketorolac (1). All sites prescribe crizanlizumab to pts of all SCD genotypes. Pts Treated: 297 pts were prescribed crizanlizumab of whom 238 received ≥ 1 infusion. There was variation in number of pts/site (range 6-73, mean 21) due to time to site-level approval, insurance and pt population. Of these 238, 75 pts (32%) discontinued treatment (0-17 pts/site). Sites reported pts perceived lack of improvement or feeling their overall pain was increased, transportation issues and infusion related reactions (IRRs) characterized by pain as some of the reasons for discontinuation. Evaluation of real-world efficacy measured by changes in acute care utilization, including sub-analysis by genotype, pre-treatment VOC burden and concomitant HU use, are pending sample size dependent feasibility. Discussion: This is the first multi-center real-world analysis of crizanlizumab. Findings demonstrate some insurance barriers to therapy. The majority of pts who initiated crizanlizumab have remained on therapy;however, 1/3 of pts had lack of effect or barriers to care. Pt level data will include characteristics related to treatment failure or IRR. Improving the understanding of phenotype-specific response to novel therapies is essential in SCD. Conclusion: Post-approval therapies for rare diseases must undergo real-world evaluation to ensure study results transla e to the community. NASCC uses defined criteria for multidisciplinary care for Alliance inclusion and findings reflect the use of DMT in such centers. This is the first NASCC study of DMT in SCD. Part 2 of the study will give early insights into the effectiveness of crizanlizumab;long term follow-up is needed for a full understanding of its utility in SCD. [Formula presented] Disclosures: Kanter: Fulcrum Therapeutics, Inc.: Consultancy;Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Forma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees;Beam: Honoraria, Membership on an entity's Board of Directors or advisory committees;Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees;Graphite Bio: Consultancy;GuidePoint Global: Honoraria;Fulcrum Tx: Consultancy. Manwani: Novartis: Consultancy. Idowu: Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding;Pfizer: Research Funding;Global Blood Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau;Forma Therapeutics, Inc.: Research Funding;Ironwood: Research Funding. Treadwell: National Alliance of Sickle Cell Centers: Other: Early Evaluation of the Use of Crizanlizumab in Sickle Cell Disease. Clay: GBT: Membership on an entity's Board of Directors or advisory committees;Novartis: Honoraria. Little: Hemex Health, Inc.: Patents & Royalties;Biochip Labs: Patents & Royalties. Desai: Global Blood Therapeutics: Honoraria, Research Funding;Novartis: Research Funding, Speakers Bureau;Pfizer: Other: Publication Fee, Research Funding;Forma: Consultancy;Foundation for Sickle Cell Research: Honoraria. Lanzkron: Shire: Research Funding;Pfizer: Current holder of individual stocks in a privately-held company;Bluebird Bio: Consultancy;Teva: Current holder of individual stocks in a privately-held company;Novo Nordisk: Consultancy;GBT: Research Funding;Imara: Research Funding;CSL Behring: Research Funding;Novartis: Research Funding.

8.
Rheumatology (United Kingdom) ; 60(SUPPL 1):i22, 2021.
Article in English | EMBASE | ID: covidwho-1266146

ABSTRACT

Background/AimsIn 2017 an audit and survey of giant-cell arteritis (GCA) services wereconducted across northwest England (reported previously). This resurvey in 2020, following publication of revised BSR guidance, soughtto identify what changes were made in the intervening period, andprovided the opportunity to assess the impact of COVID-19.MethodsRheumatologists from 16 hospitals in northwest England were invitedto complete a survey in July 2020. Questions focused on serviceprovision for GCA, including pathways, diagnostics and steroidprescription.ResultsResponses were received from 14/16 sites in 2017, and 15/16 in 2020.9/15 (60%) sites reported that the 2017 audit and survey promptedchanges to GCA services, with two (13%) stating that it clarified theneed for implementation of existing plans. Two sites had a GCApathway in 2017. Four of the seven sites who committed to introducingone have now done so, bringing the total in 2020 to six. Eight of thenine remaining sites plan to implement one, six with a specific datewithin six months. Six (40%) have completed additional local audit/QIsince 2017. Temporal artery (TA) ultrasound (US) is now available in anadditional four sites, bringing the total to 6/15 (40%) in 2020. Two sitesreported improvement in both time between first rheumatologyconsultation and TA biopsy, and time to receive results (now <7days for each task in 6/15 (40%)). Six additional sites reportedproviding leaflets on steroids routinely, bringing the total in 2020 to 12/15 (80%), versus 6/14 (43%) previously. Four sites (27%) now have adatabase of GCA patients (one in 2017). There was no major change insites having a standard protocol for steroid taper (n = 8 2017;n = 72020, 89% and 100% of whom respectively use BSR guidance), nor inthe number of patients routinely provided steroid cards (six in 2017;five in 2020). The three sites who do not report giving leaflets onsteroids routinely, all had a pathway. 8/15 (53%) reported COVID-19having an adverse effect upon services, including: reduced access todiagnostics (n = 7: TA US, biopsy, and PET-CT);delayed appointments(n = 4);delayed referrals (n = 3). The tertiary referral centre reported animprovement because access to tocilizumab was facilitated by arelaxation of rules by NHS England.ConclusionThe original audit and survey of current GCA practice in 2017highlighted areas for improvement for each site, and regionally. Sitescontributing to this re-survey report that the exercise stimulated themto improve their current care. The 2017 exercise showed a strongcorrelation between reported practice (survey) and actual practice(audit), leading us to have confidence that responses provided a truepicture of care. This work demonstrates the power of audit to driveimprovement, at a regional level.

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