Homelessness: partnerships and approaches to tackling complex needs

Purpose: This paper – the first of three – aims to explore some of the complex physical and mental health needs of those experiencing homelessness. It will act as a leader to the other articles by establishing the nature of the problem and offer a rationale for carrying out a service user needs assessment as part of a review of local service provision in the North West of England against the backdrop of the current COVID-19 epidemic. Design/methodology/approach: There are a number of complex social and health inequalities often experienced by those who are homeless. Effectively tackling these requires a co-ordinated multi-agency response to both prevent and tackle the harms associated with being and becoming homeless. Findings: Partnership working offers the best opportunity to meet the complex needs of those experiencing homelessness. The current delivery model being actioned in the North West of England highlights the importance of the links between statutory and non-statutory services. An ongoing service user needs assessment will further help to highlight contemporary issues faced by those experiencing homelessness and those providing services in the context of the COVID-19 epidemic. Social implications: Future papers as part of this series of three will consider the implications of social exclusion and barriers to accessing services faced on a day-to-day basis by those experiencing homelessness. Originality/value: The opportunity to reflect on established views in relation to the nature and scope of homelessness. It will consider the implications exclusion from society and service provision that this group face on a day-to-day basis. The paper will describe a contemporary approach to tackling current issues faced by those experiencing homelessness in the current context of the COVID-19 epidemic. © 2022, Emerald Publishing Limited.

Homelessness: partnerships and approaches to tackling complex needs

PurposeThis paper - the first of three - aims to explore some of the complex physical and mental health needs of those experiencing homelessness. It will act as a leader to the other articles by establishing the nature of the problem and offer a rationale for carrying out a service user needs assessment as part of a review of local service provision in the North West of England against the backdrop of the current COVID-19 epidemic. Design/methodology/approachThere are a number of complex social and health inequalities often experienced by those who are homeless. Effectively tackling these requires a co-ordinated multi-agency response to both prevent and tackle the harms associated with being and becoming homeless. FindingsPartnership working offers the best opportunity to meet the complex needs of those experiencing homelessness. The current delivery model being actioned in the North West of England highlights the importance of the links between statutory and non-statutory services. An ongoing service user needs assessment will further help to highlight contemporary issues faced by those experiencing homelessness and those providing services in the context of the COVID-19 epidemic. Social implicationsFuture papers as part of this series of three will consider the implications of social exclusion and barriers to accessing services faced on a day-to-day basis by those experiencing homelessness. Originality/valueThe opportunity to reflect on established views in relation to the nature and scope of homelessness. It will consider the implications exclusion from society and service provision that this group face on a day-to-day basis. The paper will describe a contemporary approach to tackling current issues faced by those experiencing homelessness in the current context of the COVID-19 epidemic.

Delta variant neutralizing antibody response following maternal COVID19 vaccination

Objective: To evaluate whether COVID19 vaccination during pregnancy confers immunological response to SARS-CoV-2 Delta variant. Study Design: Prospective cohort study of pregnant patients who had received any available COVID19 vaccine. Maternal and umbilical cord serum was collected at delivery. SARS-CoV-2 neutralization was measured with spike-pseudotyped viruses in HEK-293T-ACE2 cells as a function of reduction in Luc reporter activity using an env-deficient lentiviral system to produce viral particles pseudotyped with the B1.617.2 (Delta variant) spike. Neutralization titers represented the serum dilution at which relative luminescence units (RLU) were reduced by either 50%(ID50) or 80%(ID80) compared with virus control wells. RLU threshold for detection was 20. Result(s): Maternal and neonatal umbilical cord samples were collected from 20 individuals who received COVID19 vaccination during pregnancy. Most (n=16, 80%) received Pfizer, 2 Moderna, 2 Johnson&Johnson. One individual (5%) was vaccinated in first trimester, 11(55%) in second trimester, and 8(40%) in third trimester). Most individuals had detectable levels of neutralizing antibodies to SARS-CoV-2 Delta variant in maternal (n=15, 75%) and neonatal (n=17, 85%) serum. (Figure) No significant difference between maternal and neonatal serum titers. Conclusion(s): COVID19 vaccination during pregnancy yields an immunologic response in maternal serum that results in circulating neutralizing antibodies against SARS-CoV-2 Delta variant in maternal and neonatal serum at delivery. Disclosure: No [Formula presented] Copyright © 2022

Neoadjuvant cemiplimab in patients (pts) with stage II–IV (M0) cutaneous squamous cell carcinoma (CSCC): Primary analysis of a phase II study

Background: CSCC is highly immune-responsive;a prior pilot study demonstrated a high rate of pathologic complete response (pCR) or major pathologic response (MPR, ≤10% viable tumor), using cemiplimab anti-programmed death 1 (PD-1) therapy in the neoadjuvant setting. Here, we present the primary analysis of a confirmatory, open-label, multicenter, Phase 2, single-arm trial of neoadjuvant cemiplimab in pts with resectable Stage II–IV (M0) CSCC. Methods: Pts received cemiplimab 350 mg IV q3W for up to 4 doses before surgery. The primary endpoint was pCR rate per independent central pathologic review (ICPR). Key secondary endpoints included MPR rate per ICPR, objective response rate (ORR;complete response [CR] + partial response [PR]) per RECIST v1.1, investigator-assessed pCR and MPR, safety and tolerability. Results: At data cutoff date of 01 Dec 2021, 79 pts were enrolled (67 male;median age 73.0 yrs [range, 66.0–81.0];ECOG performance status 0 (n=60) and 1 (n=19) with stage II (n=5), III (n=38), or IV(M0) (n =36) disease;62 pts received all 4 doses (median number of doses given (Q1:Q3), 4 (4:4);70 pts underwent surgery. The study met its primary endpoint: pCR was observed in 40 (50.6%) pts (95% confidence interval [CI], 39.1–62.1%). MPR was observed in an additional 10 (12.7%) pts (95% CI, 6.2–22.0%). ORR was 68.4% (95% CI, 56.9–78.4) (5 CR, 49 PR, 16 stable disease, 8 progressive disease (PD), 1 non evaluable. Reasons 9 pts did not have surgery: 3 responders declined surgery, 2 lost to follow-up or noncompliance, 2 had inoperable PD, 2 due to AE. Fourteen (17.7%) pts experienced Grade ≥3 AE. Four pts died due to AEs: 1 exacerbation of cardiac failure, 2 myocardial infarctions, and 1 COVID-19 pneumonia. The most common AEs regardless of attribution (all grades) were fatigue (30.4%), rash maculo-papular (13.9%), diarrhea (13.9%) and nausea (13.9%). Conclusions: The pCR + MPR of 63.3% by ICPR in pts with Stage II–IV (M0) CSCC is the highest observed in a multicenter anti-PD-1 neoadjuvant monotherapy study for any solid tumor type. The safety profile of neoadjuvant cemiplimab is consistent with previous anti-PD-1 monotherapy experience. Ongoing follow-up will describe disease-free survival. Clinical trial identification: NCT04154943. Editorial acknowledgement: Medical writing support was provided by John G Facciponte, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Legal entity responsible for the study: Regeneron Pharmaceuticals, Inc., and Sanofi. Funding: Regeneron Pharmaceuticals, Inc., and Sanofi. Disclosure: N. Gross: Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Advisory Board: PDS Biotechnology, Shattuck Labs and Genzyme;Financial Interests, Personal, Advisory Role: PDS Biotechnology, Shattuck Labs and Genzyme. D.M. Miller: Financial Interests, Personal, Advisory Role: Castle Biosciences, EMD Serono, Merck KGaA, Merck Sharpe & Dome, Pfizer, Regeneron, Sanofi Genzyme;Financial Interests, Personal, Ownership Interest: Checkpoint Therapeutics;Financial Interests, Personal, Research Grant: Kartos Therapeutics, NeoImmune Tech, Inc., Regeneron Pharmaceuticals, Inc. N. Khushanlani: Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc., Bristol Myers Squibb, HUYA Bioscience International, Merck, Novartis, GlaxoSmithKline, Celgene, Amgen;Financial Interests, Personal, Advisory Board: EMD Serono, Regeneron Pharmaceuticals, Inc., Genentech, AstraZeneca (data safety monitoring committee), Merck, Array Biopharma, Jounce Therapeutics, Immunocore, Bristol Myers Squibb, HUYA Bioscience International;Financial Interests, Personal, Other, honoraria: Sanofi;Financial Interests, Personal, Stocks/Shares: Bellicum Pharmaceuticals, Mazor Robotics, Amarin, Transenetrix. V. Divi: Financial Interests, Institutional, Research Grant: Genentech. E.S. Ruiz: Financial Interests, Personal, Advisory Board: Genentech, Leo Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Sanofi;Financial Int rests, Personal, Advisory Role, consulting fees: Genentech, Leo Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Sanofi;Financial Interests, Personal, Member of the Board of Directors: Checkpoint Therapeutics. E.J. Lipson: Financial Interests, Personal, Other, Advisory board and consulting fees: Bristol Myers-Squibb, Eisai, Genentech, Immunocore, Instil Bio, MacroGenics, Merck, Natera, Nektar Therapeutics, Odonate Therapeutics, OncoSec, Pfizer, Rain Therapeutics, Regeneron, Sanofi;Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Merck, Regeneron. F. Meier: Financial Interests, Personal, Other, Travel support, speaker’s fees or advisor’s honoraria: Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche and Sanofi;Financial Interests, Personal, Research Grant: Novartis and Roche. P.L. Swiecicki: Financial Interests, Institutional, Research Grant: Ascentage Pharma, Pfizer;Financial Interests, Personal, Advisory Board: Prelude Therapeutics, Elevar Therapeutics, Regeneron Pharmaceuticals. J.L. Atlas: Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals, Inc., Sanofi, and Bristol Myers Squibb. J.L. Geiger: Financial Interests, Institutional, Research Grant: Alkermes, Debio, Merck, Regeneron Pharmaceuticals, Inc., and Roche/Genentech;Financial Interests, Personal, Advisory Role: Exelixis, Merck and Regeneron Pharmaceuticals, Inc. A. Hauschild: Financial Interests, Personal and Institutional, Other, Institutional grants, speaker’s honoraria and consultancy fees: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Provectus and Roche;Financial Interests, Institutional, Other, Institutional grants and consultancy fees: EMD Serono, Philogen and Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Advisory Role: OncoSec Medical. J.H. Choe: Financial Interests, Personal, Advisory Role: Exelixis, Coherus Biosciences, Regeneron Pharmaceuticals, Inc. B.G.M. Hughes: Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, Eisai, Merck Sharp & Dohme, Pfizer and Roche;Financial Interests, Institutional, Research Grant: Amgen. S. Yoo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. K. Fenech: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. M.D. Mathias: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. H. Han: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. M.G. Fury: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.;Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. D. Rischin: Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals, Inc., Genentech, Sanofi, Kura Oncology, Roche, Merck Sharp & Dohme, Merck KGaA, Bristol Myers Squibb, GlaxoSmithKline, ALX Oncology;Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline, Bristol Myers Squibb;Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline, Bristol Myers Squibb. All other authors have declared no conflicts of interest.

Legal classification and international systems for monitoring and responding to novel psychoactive substances

Novel psychoactive substances make up a broad range of drugs that are not controlled by the United Nations international drug laws. They include synthetic cannabinoids, stimulants, benzodiazepines, opioids, hallucinogens, and dissociatives. Many of these substances are intended to mimic the effects of controlled drugs and are traded as ‘legal’ replacements for them. While the emergence of novel psychoactive substances is not a new phenomenon, driven by globalisation there has been a large increase in the availability, and, subsequently, harms caused by these substances since around 2008. At least until relatively recently, as the list of substances controlled at national level were largely based on those substances controlled under the international drug control system, few novel psychoactive substances were subject to control measures in many countries. However, in response to the growth in the market, increasingly some novel substances have been controlled or otherwise regulated at national level, irrespective of whether or not they are controlled internationally. Invariably, despite this, novel substances continue to appear on the drug market, albeit at a slower pace. This chapter: examines the legal classification of novel psychoactive substances;provides an overview of some of the early warning systems for monitoring and responding to these substances;discusses the current situation in Europe;and highlights the possible future of these substances and how our responses made need to adapt to ever-changing globalized drug markets. This includes a discussion of the work of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) as part of a unique regional three-step legal framework of early warning, risk assessment, and control measures that allows the European Union to rapidly detect, assess, and respond to public health and social threats caused by these substances. © 2021 Elsevier Inc. All rights reserved.

The Red Gown: Reflections on the In/Visibility of Menstruation in Scotland

During the 1990s, 2000s and 2010s, menstruation became more present in public discourse in Scotland. Despite this, little attention has been paid to the complex interplay of visibility and invisibility that characterises menstruation's place in the nation's wider cultural landscape. In this article, we explore the context of menstruation in the town of St Andrews specifically and Scotland more broadly, during the late 20th and early 21st century, and ask what this reveals about menstrual absence and presence in public debates. The University of St Andrews lies at the centre of this case study because it has been one of the Scottish institutions that has initiated a rollout of free menstrual products as a result of the Period Products (Free Provision) (Scotland) Act of 2021. The University's Centre for Contemporary Art also hosted Bee Hughes as artist-in-residence, whose practice focuses on the visible and invisible aspects of menstruation. Although impacted by a university strike and the Covid19 pandemic, our collaboration has explored collections of menstrual culture in Scotland and broader questions of menstrual representation, reflecting on how established symbols with other connotations (notably the ceremonial red gown at the University of St Andrews) might provide a way of thinking about menstrual in/visibility. In this article, we discuss how these histories might be both present (institutionalised) and absent (when not on display). This paper presents our findings, in which the artist documents their first visit to St Andrews prior to the strike and pandemic, in relation to historical and contextual materials we located together.

Respiratory Syncytial Virus (RSV) RNA in Wastewater Settled Solids Reflects RSV Clinical Positivity Rates

Wastewater-based epidemiology (WBE) uses concentrations of infectious agent targets in wastewater to infer infection trends in the contributing community. To date, WBE has been used to gain insight into infection trends of gastrointestinal diseases, but its application to respiratory diseases has been limited. Here, we report that respiratory syncytial virus (RSV) genomic ribonucleic acid can be detected in wastewater settled solids at two publicly owned treatment works. We further show that its concentration in settled solids is strongly associated (Kendalls tau = 0.65-0.77, p < 10(-7)) with clinical positivity rates for RSV at sentinel laboratories across the state in 2021, a year with anomalous seasonal trends of RSV disease. Given that RSV infections have similar clinical presentations to COVID-19, can be life threatening for some, and immunoprophylaxis distribution for vulnerable people is based on outbreak identification, WBE represents an important tool to augment current RSV surveillance and public health response efforts.

Factors associated with cesarean section in patients with COVID

Objective: Experts have suggested that earlier delivery, even in non-severe cases, may be beneficial for patients with COVID, and that patients with COVID have higher rates of cesarean section. Factors associated with this increase are currently unclear. We sought to assess demographic and clinical factors associated with cesarean section (CS) in pregnant patients diagnosed with COVID. Study Design: Retrospective cohort of PCR-confirmed COVID positive pregnant patients in a single health system who delivered between March-December of 2020. Fetal death or planned CS excluded. Demographic data, pregnancy characteristics, and specifics of COVID infection ed and compared between patients who had vaginal delivery(SVD) and CS. Secondary analysis performed for symptomatic(sx) and asymptomatic(asx) patients separately. Bivariate statistics used to analyze the data. Multivariate Poisson regression performed to estimate adjusted relative risks. Results: Of 109 COVID positive patients, 19(17.4%) had planned CS. Of 91 with labor, 22(24%) had CS. CS was associated with overall BMI > 39.9(Table1). Non-private insurance and higher maternal age were associated with significantly higher rates of CS. Multiparity was not associated with SVD. Hypertensive disorders(PEC) of pregnancy and intraamniotic infection(IAI) were also associated with CS(Table 1). In regression analyses, symptomatic disease was associated with SVD [aRR 0.41, 95%CI 0.18, 0.93]. Relative risk of CS was 3-fold higher in patients with IAI[95% CI 1.6, 5.5], and 2.3-fold-higher in BMI > 39.9[95% CI 1.1, 5.0](Table2). Among sx patients, BMI > 39.9 was associated with 4-fold increase risk of CS;while in asx patients, IAI was associated with 4-fold increase risk of CS(Table 2). Maternal age and PEC were not associated with mode of delivery. Conclusion: Some known risk factors for severe and critical COVID, including higher BMI, were associated with CS in COVID positive pregnant patients. Symptomatic disease at time of delivery was more associated with SVD. [Formula presented] [Formula presented]

Preterm birth rates and race disparities pre and post COVID vaccination

Objective: The impact of 2021 vaccination and social restriction reversal on preterm birth (PTB) is unclear. We sought to compare the rates of PTB during the COVID pre- and post- vaccination periods with pre-pandemic rate. Study Design: Retrospective cohort comparing all deliveries over 20 weeks at a single tertiary center during ‘early’ COVID (ECOVID 3/2020-6/2020) vs. ‘late’ COVID (LCOVID 3/2021–6/2021), and LCOVID vs. pre-COVID (3-6/2014-2019). PTB < 37weeks, < 34weeks and < 28weeks were compared and stratified by race/ethnicity. Results: There were 20334 deliveries including 2647 ECOVID, 2114 LCOVID and 15574 pre-COVID. We noted 87 (0.03%) and 37 (0.02%) COVID infections in pregnancy during ECOVID and LCOVID, respectively. PTB rate during LCOVID (12.1%) was lower compared to ECOVID (14.5%), p=0.02. Rate of PTB < 34 was also lower during LCOVID (4.4% vs 5.7%, p=0.04). PTB < 28 did not differ (Table1). When controlling for prior PTB, LCOVID was associated with a decreased risk of PTB, adjusted odds ratio (aOR) 0.83[95% confidence interval (CI) 0.70, 0.99]. Among the small number of American Indian patients, PTB increased during LCOVID vs. ECOVID. There were no other significant differences based on race/ethnicity. Overall, PTB rates did not differ in LCOVID vs. pre-COVID. When stratified by race and ethnicity, White individuals had reduced PTB < 37 during LCOVID compared to pre-COVID, aOR 0.70 [95% CI 0.63, 0.99]. PTB rate was unchanged comparing LCOVID vs. pre-COVID in all other racial groups. Among small numbers of Hispanic Puerto Rican patients, PTB rate increased LCOVID vs. pre-COVID (Table 2). Conclusion: During 2021, PTB rates decreased from rates observed in 2020 at the height of COVID restrictions. Among White birthing individuals, PTB decreased in 2021 compared to pre-COVID rates. This decrease was not observed in Black and Hispanic birthing individuals. These data highlight the continued racially disparate impact of the COVID pandemic on PTB rates. [Formula presented] [Formula presented]

Plastic physicians: The surgical salamanders of the COVID-19 pandemic.

At the time of writing, coronavirus disease-2019 (COVID-19) has affected 6.42 million people globally and over 380,000 deaths, with the United Kingdom now having the highest death rate in Europe. The plastic surgery department at Leeds Teaching Hospitals put necessary steps in place to maintain an excellent urgent elective and acute service whilst also managing COVID-positive medical patients in the ward. We describe the structures and pathways implemented together with complex decision-making, which has allowed us to respond early and effectively. We hope these lessons will prove a useful tool as we look to open conversations around the recovery of normal activity.