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Michael Weekes

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Nick K. Jones1,2*, Lucy Rivett1,2*, Chris Workman3, Mark Ferris3, Ashley Shaw1, Cambridge COVID-19 Collaboration1,4, Paul J. Lehner1,4, Rob Howes5, Giles Wright3, Nicholas J. Matheson1,4,6¶, Michael P. Weekes1,7¶1 Cambridge University NHS Hospitals Foundation Trust, Cambridge, UK2 Clinical Microbiology & Public Health Laboratory, Public Health England, Cambridge, UK3 Occupational Health and Wellbeing, Cambridge Biomedical Campus, Cambridge, UK4 Cambridge Institute of Therapeutic Immunology & Infectious Disease, University of Cambridge, Cambridge, UK5 Cambridge COVID-19 Testing Centre and AstraZeneca, Anne Mclaren Building, Cambridge, UK6 NHS Blood and Transplant, Cambridge, UK7 Cambridge Institute for Medical Research, University of Cambridge, Cambridge, UK*Joint first authorship¶Joint last authorshipCorrespondence: [email protected] UK has initiated mass COVID-19 immunisation, with healthcare workers (HCWs) given early priority because of the potential for workplace exposure and risk of onward transmission to patients. The UK’s Joint Committee on Vaccination and Immunisation has recommended maximising the number of people vaccinated with first doses at the expense of early booster vaccinations, based on single dose efficacy against symptomatic COVID-19 disease.1-3At the time of writing, three COVID-19 vaccines have been granted emergency use authorisation in the UK, including the BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech). A vital outstanding question is whether this vaccine prevents or promotes asymptomatic SARS-CoV-2 infection, rather than symptomatic COVID-19 disease, because sub-clinical infection following vaccination could continue to drive transmission. This is especially important because many UK HCWs have received this vaccine, and nosocomial COVID-19 infection has been a persistent problem.Through the implementation of a 24 h-turnaround PCR-based comprehensive HCW screening programme at Cambridge University Hospitals NHS Foundation Trust (CUHNFT), we previously demonstrated the frequent presence of pauci- and asymptomatic infection amongst HCWs during the UK’s first wave of the COVID-19 pandemic.4 Here, we evaluate the effect of first-dose BNT162b2 vaccination on test positivity rates and cycle threshold (Ct) values in the asymptomatic arm of our programme, which now offers weekly screening to all staff.Vaccination of HCWs at CUHNFT began on 8th December 2020, with mass vaccination from 8th January 2021. Here, we analyse data from the two weeks spanning 18thto 31st January 2021, during which: (a) the prevalence of COVID-19 amongst HCWs remained approximately constant; and (b) we screened comparable numbers of vaccinated and unvaccinated HCWs. Over this period, 4,408 (week 1) and 4,411 (week 2) PCR tests were performed from individuals reporting well to work. We stratified HCWs <12 days or > 12 days post-vaccination because this was the point at which protection against symptomatic infection began to appear in phase III clinical trial.226/3,252 (0·80%) tests from unvaccinated HCWs were positive (Ct<36), compared to 13/3,535 (0·37%) from HCWs <12 days post-vaccination and 4/1,989 (0·20%) tests from HCWs ≥12 days post-vaccination (p=0·023 and p=0·004, respectively; Fisher’s exact test, Figure). This suggests a four-fold decrease in the risk of asymptomatic SARS-CoV-2 infection amongst HCWs ≥12 days post-vaccination, compared to unvaccinated HCWs, with an intermediate effect amongst HCWs <12 days post-vaccination.A marked reduction in infections was also seen when analyses were repeated with: (a) inclusion of HCWs testing positive through both the symptomatic and asymptomatic arms of the programme (56/3,282 (1·71%) unvaccinated vs 8/1,997 (0·40%) ≥12 days post-vaccination, 4·3-fold reduction, p=0·00001); (b) inclusion of PCR tests which were positive at the limit of detection (Ct>36, 42/3,268 (1·29%) vs 15/2,000 (0·75%), 1·7-fold reduction, p=0·075); and (c) extension of the period of analysis to include six weeks from December 28th to February 7th 2021 (113/14,083 (0·80%) vs 5/4,872 (0·10%), 7·8-fold reduction, p=1x10-9). In addition, the median Ct value of positive tests showed a non-significant trend towards increase between unvaccinated HCWs and HCWs > 12 days post-vaccination (23·3 to 30·3, Figure), suggesting that samples from vaccinated individuals had lower viral loads.We therefore provide real-world evidence for a high level of protection against asymptomatic SARS-CoV-2 infection after a single dose of BNT162b2 vaccine, at a time of predominant transmission of the UK COVID-19 variant of concern 202012/01 (lineage B.1.1.7), and amongst a population with a relatively low frequency of prior infection (7.2% antibody positive).5This work was funded by a Wellcome Senior Clinical Research Fellowship to MPW (108070/Z/15/Z), a Wellcome Principal Research Fellowship to PJL (210688/Z/18/Z), and an MRC Clinician Scientist Fellowship (MR/P008801/1) and NHSBT workpackage (WPA15-02) to NJM. Funding was also received from Addenbrooke’s Charitable Trust and the Cambridge Biomedical Research Centre. We also acknowledge contributions from all staff at CUHNFT Occupational Health and Wellbeing and the Cambridge COVID-19 Testing Centre.

Guangming Wang

and 4 more

Tam Hunt

and 1 more

Tam Hunt [1], Jonathan SchoolerUniversity of California Santa Barbara Synchronization, harmonization, vibrations, or simply resonance in its most general sense seems to have an integral relationship with consciousness itself. One of the possible “neural correlates of consciousness” in mammalian brains is a combination of gamma, beta and theta synchrony. More broadly, we see similar kinds of resonance patterns in living and non-living structures of many types. What clues can resonance provide about the nature of consciousness more generally? This paper provides an overview of resonating structures in the fields of neuroscience, biology and physics and attempts to coalesce these data into a solution to what we see as the “easy part” of the Hard Problem, which is generally known as the “combination problem” or the “binding problem.” The combination problem asks: how do micro-conscious entities combine into a higher-level macro-consciousness? The proposed solution in the context of mammalian consciousness suggests that a shared resonance is what allows different parts of the brain to achieve a phase transition in the speed and bandwidth of information flows between the constituent parts. This phase transition allows for richer varieties of consciousness to arise, with the character and content of that consciousness in each moment determined by the particular set of constituent neurons. We also offer more general insights into the ontology of consciousness and suggest that consciousness manifests as a relatively smooth continuum of increasing richness in all physical processes, distinguishing our view from emergentist materialism. We refer to this approach as a (general) resonance theory of consciousness and offer some responses to Chalmers’ questions about the different kinds of “combination problem.”  At the heart of the universe is a steady, insistent beat: the sound of cycles in sync…. [T]hese feats of synchrony occur spontaneously, almost as if nature has an eerie yearning for order. Steven Strogatz, Sync: How Order Emerges From Chaos in the Universe, Nature and Daily Life (2003) If you want to find the secrets of the universe, think in terms of energy, frequency and vibration.Nikola Tesla (1942) I.               Introduction Is there an “easy part” and a “hard part” to the Hard Problem of consciousness? In this paper, we suggest that there is. The harder part is arriving at a philosophical position with respect to the relationship of matter and mind. This paper is about the “easy part” of the Hard Problem but we address the “hard part” briefly in this introduction.  We have both arrived, after much deliberation, at the position of panpsychism or panexperientialism (all matter has at least some associated mind/experience and vice versa). This is the view that all things and processes have both mental and physical aspects. Matter and mind are two sides of the same coin.  Panpsychism is one of many possible approaches that addresses the “hard part” of the Hard Problem. We adopt this position for all the reasons various authors have listed (Chalmers 1996, Griffin 1997, Hunt 2011, Goff 2017). This first step is particularly powerful if we adopt the Whiteheadian version of panpsychism (Whitehead 1929).  Reaching a position on this fundamental question of how mind relates to matter must be based on a “weight of plausibility” approach, rather than on definitive evidence, because establishing definitive evidence with respect to the presence of mind/experience is difficult. We must generally rely on examining various “behavioral correlates of consciousness” in judging whether entities other than ourselves are conscious – even with respect to other humans—since the only consciousness we can know with certainty is our own. Positing that matter and mind are two sides of the same coin explains the problem of consciousness insofar as it avoids the problems of emergence because under this approach consciousness doesn’t emerge. Consciousness is, rather, always present, at some level, even in the simplest of processes, but it “complexifies” as matter complexifies, and vice versa. Consciousness starts very simple and becomes more complex and rich under the right conditions, which in our proposed framework rely on resonance mechanisms. Matter and mind are two sides of the coin. Neither is primary; they are coequal.  We acknowledge the challenges of adopting this perspective, but encourage readers to consider the many compelling reasons to consider it that are reviewed elsewhere (Chalmers 1996, Griffin 1998, Hunt 2011, Goff 2017, Schooler, Schooler, & Hunt, 2011; Schooler, 2015).  Taking a position on the overarching ontology is the first step in addressing the Hard Problem. But this leads to the related questions: at what level of organization does consciousness reside in any particular process? Is a rock conscious? A chair? An ant? A bacterium? Or are only the smaller constituents, such as atoms or molecules, of these entities conscious? And if there is some degree of consciousness even in atoms and molecules, as panpsychism suggests (albeit of a very rudimentary nature, an important point to remember), how do these micro-conscious entities combine into the higher-level and obvious consciousness we witness in entities like humans and other mammals?  This set of questions is known as the “combination problem,” another now-classic problem in the philosophy of mind, and is what we describe here as the “easy part” of the Hard Problem. Our characterization of this part of the problem as “easy”[2] is, of course, more than a little tongue in cheek. The authors have discussed frequently with each other what part of the Hard Problem should be labeled the easier part and which the harder part. Regardless of the labels we choose, however, this paper focuses on our suggested solution to the combination problem.  Various solutions to the combination problem have been proposed but none have gained widespread acceptance. This paper further elaborates a proposed solution to the combination problem that we first described in Hunt 2011 and Schooler, Hunt, and Schooler 2011. The proposed solution rests on the idea of resonance, a shared vibratory frequency, which can also be called synchrony or field coherence. We will generally use resonance and “sync,” short for synchrony, interchangeably in this paper. We describe the approach as a general resonance theory of consciousness or just “general resonance theory” (GRT). GRT is a field theory of consciousness wherein the various specific fields associated with matter and energy are the seat of conscious awareness.  A summary of our approach appears in Appendix 1.  All things in our universe are constantly in motion, in process. Even objects that appear to be stationary are in fact vibrating, oscillating, resonating, at specific frequencies. So all things are actually processes. Resonance is a specific type of motion, characterized by synchronized oscillation between two states.  An interesting phenomenon occurs when different vibrating processes come into proximity: they will often start vibrating together at the same frequency. They “sync up,” sometimes in ways that can seem mysterious, and allow for richer and faster information and energy flows (Figure 1 offers a schematic). Examining this phenomenon leads to potentially deep insights about the nature of consciousness in both the human/mammalian context but also at a deeper ontological level.

Susanne Schilling*^

and 9 more

Jessica mead

and 6 more

The construct of wellbeing has been criticised as a neoliberal construction of western individualism that ignores wider systemic issues including increasing burden of chronic disease, widening inequality, concerns over environmental degradation and anthropogenic climate change. While these criticisms overlook recent developments, there remains a need for biopsychosocial models that extend theoretical grounding beyond individual wellbeing, incorporating overlapping contextual issues relating to community and environment. Our first GENIAL model \cite{Kemp_2017} provided a more expansive view of pathways to longevity in the context of individual health and wellbeing, emphasising bidirectional links to positive social ties and the impact of sociocultural factors. In this paper, we build on these ideas and propose GENIAL 2.0, focusing on intersecting individual-community-environmental contributions to health and wellbeing, and laying an evidence-based, theoretical framework on which future research and innovative therapeutic innovations could be based. We suggest that our transdisciplinary model of wellbeing - focusing on individual, community and environmental contributions to personal wellbeing - will help to move the research field forward. In reconceptualising wellbeing, GENIAL 2.0 bridges the gap between psychological science and population health health systems, and presents opportunities for enhancing the health and wellbeing of people living with chronic conditions. Implications for future generations including the very survival of our species are discussed.  

Mark Ferris

and 14 more

IntroductionConsistent with World Health Organization (WHO) advice [1], UK Infection Protection Control guidance recommends that healthcare workers (HCWs) caring for patients with coronavirus disease 2019 (COVID-19) should use fluid resistant surgical masks type IIR (FRSMs) as respiratory protective equipment (RPE), unless aerosol generating procedures (AGPs) are being undertaken or are likely, when a filtering face piece 3 (FFP3) respirator should be used [2]. In a recent update, an FFP3 respirator is recommended if “an unacceptable risk of transmission remains following rigorous application of the hierarchy of control” [3]. Conversely, guidance from the Centers for Disease Control and Prevention (CDC) recommends that HCWs caring for patients with COVID-19 should use an N95 or higher level respirator [4]. WHO guidance suggests that a respirator, such as FFP3, may be used for HCWs in the absence of AGPs if availability or cost is not an issue [1].A recent systematic review undertaken for PHE concluded that: “patients with SARS-CoV-2 infection who are breathing, talking or coughing generate both respiratory droplets and aerosols, but FRSM (and where required, eye protection) are considered to provide adequate staff protection” [5]. Nevertheless, FFP3 respirators are more effective in preventing aerosol transmission than FRSMs, and observational data suggests that they may improve protection for HCWs [6]. It has therefore been suggested that respirators should be considered as a means of affording the best available protection [7], and some organisations have decided to provide FFP3 (or equivalent) respirators to HCWs caring for COVID-19 patients, despite a lack of mandate from local or national guidelines [8].Data from the HCW testing programme at Cambridge University Hospitals NHS Foundation Trust (CUHNFT) during the first wave of the UK severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic indicated a higher incidence of infection amongst HCWs caring for patients with COVID-19, compared with those who did not [9]. Subsequent studies have confirmed this observation [10, 11]. This disparity persisted at CUHNFT in December 2020, despite control measures consistent with PHE guidance and audits indicating good compliance. The CUHNFT infection control committee therefore implemented a change of RPE for staff on “red” (COVID-19) wards from FRSMs to FFP3 respirators. In this study, we analyse the incidence of SARS-CoV-2 infection in HCWs before and after this transition.

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Objective There is a strong consensus that mood enhancement is a primary benefit of physical activity (PA). However, the evidence about the positive effect of PA on the mood states of persons with schizophrenia is scarce, probably due to the limited psychometric properties of the most widely used instrument to assess mood. Therefore, this study aimed to assess the construct validity of the Portuguese short version of the Profile of Mood States (POMS-SV) for persons with schizophrenia. Additionally, a comparative analyse was conducted to explore the mood states according to different demographic variables. The sample consisted of 106 in and outpatients (n=47 women) with schizophrenia. Methods Cronbach’s alpha coefficient was used to assess internal consistency. Exploratory and confirmatory analyses were carried out to examine the factor structure and structural validity of the questionnaire, respectively. Pearson’s correlations were calculated in order to examine the associations between the POMS subscales. Mann-Whitney and Kruskal-Wallis tests were used to compare means differences of POMS subscales and total scales between sociodemographic groups. Results The Portuguese version of the POMS-SV revealed a model of 31 items and 6 factors with good internal consistency and good fit indexes for the application in persons with schizophrenia. Significant differences were found in gender, marital status, and engaged PA in the negative mood sub-scales. Conclusion The POMS-SF exhibited good psychometric properties and appears to be a valid and reliable instrument to assess mood states in a population of both in and outpatients with schizophrenia. The results of the present study support its application in clinical practice and research with expanded usefulness in PA settings.

Baochuang Qi

and 9 more

SDRC is implicated in the pathogenesis of Staphylococcus aureus osteomyelitis. However, the precise mechanism by which SDRC contributes to the progression of this infection remains unclear. To explore SDRC’s role in osteomyelitis, experiments were conducted on mouse models infected with Staphylococcus aureus strains containing either the wild type SDRC sequence or a knockout (KO-SDRC) sequence. Levels of inflammatory factors like IL-6 and TNF-α were measured using Elisa. Furthermore, changes in osteogenic indicators such as ALP, OST, and Runx2 were detected using qPCR and Western blot analysis. Additionally, transcriptome sequencing was employed to gain deeper insights into the potential molecular mechanisms underlying SDRC’s promotion of Staphylococcus aureus-induced osteomyelitis. The study revealed that the ability of Staphylococcus aureus to form biofilms was significantly weakened in strains where the SDRC protein was knocked out. Moreover, mice infected with the KO-SDRC strain exhibited enhanced ossification processes. Transcriptome sequencing demonstrated significant overexpression of the Myh7 gene in the SDRC knockout osteomyelitis mouse. Subsequent knockout of the Myh7 gene led to notable reductions in mRNA and protein expressions of osteogenic indicators including Runx2, ALP, OSX, and Osteocalcin. Overall, these findings suggest that SDRC plays a crucial role in promoting the malignant progression of osteomyelitis caused by Staphylococcus aureus. Its main mechanism involves enhancing the formation of Staphylococcus aureus biofilms. Conversely, Myh7 may exert an inhibitory effect on the SDRC protein, reducing biofilm formation and mitigating the severity of osteomyelitis. These findings offer novel insights into potential therapeutic targets for the treatment of osteomyelitis.

Milene Sobral

and 9 more

Introduction: The efficacy and safety of fibroblast growth factor 21 (FGF21) analogs in patients with nonalcoholic steatohepatitis (NASH) remains unclear. Therefore, we aimed to compare the use of FGF21 analogs with placebo in patients with NASH. Methods: We searched Medline, Embase, and Cochrane databases from inception to December 2023. The primary outcomes were: triglycerides levels, high-density lipoprotein (HDL) levels, low-density lipoprotein (LDL) levels, NASH resolution, N-terminal type III collagen propeptide (PRO-C3) levels, and adverse events. Subgroup analyses were performed according to drug dosages. We used Review Manager 5.4 to pool the data, assessing heterogeneity with I2. Results: Eight studies reporting data of 967 patients were included in this review. Follow-up ranged from 16 to 121 weeks and dosage ranged from 3 to 70mg a day. When compared to placebo, FGF21 analogs were significantly associated with a reduction in triglycerides (MD -22.07; 95% CI -36.67 to -7.47) and PRO-C3 (MD -6.12; 95% CI -8.05 to -4.20). There were no significant differences in the resolution of NASH (RR 3.57; 95% CI 0.91 to 13.94). Higher rates of adverse events (RR 1.08; 95% CI 1.01 to 1.14) were observed in patients who received the intervention. Conclusion: Despite a higher incidence of adverse events for FGF21 analogs, they showed positive effects on the lipid profile and biomarker for the formation of fibrotic tissue. However, no improvement in NASH resolution was observed. Keywords: FGF21 analog; pegozafermin; efruxifermin; pegbelfermin; fibrosis; NASH.
Modern machine learning methods, and their use alongside established paradigms such as Quality by Design, have the potential to fundamentally change the way bioprocesses are developed. In particular, horizontal knowledge transfer methods, which seek to exploit data from historical processes to facilitate process development for a new product, provide an opportunity to rethink process development workflows. In this work, we firstly assess the potential of two knowledge transfer approaches, meta learning and one-hot encoding, in combination with Gaussian process (GP) models. We compare their performance to GPs developed only on data of the new process. Using simulated mammalian cell cultivation data, we observe that both knowledge transfer approaches outperform the individual-product approach. In the second part, we address the question whether experiments for a new product could be designed more effectively by exploiting existing knowledge. In particular, we suggest to specifically design few runs for the novel product to calibrate knowledge transfer models, a task that we coin calibration design. We propose a novel, customised metric to identify a set of calibration design runs, which exploits differences in process evolutions of historical products. In two simulated case studies, we observed that training with calibration designs yields similar test set errors compared to common approaches of Design of Experiments. However, much fewer experiments are needed for the former, suggesting an interesting alternative for future bioprocess development. Overall, the results suggest that process development could be significantly streamlined when systematically carrying knowledge from one product to the next.

Milad Rahimi-Majd

and 3 more

Mesophyll conductance ( g m ) describes the efficiency with which CO 2 moves from substomatal cavities to chloroplasts. Despite the stipulated importance of leaf architecture in affecting g m , there remains a considerable ambiguity about how and whether anatomy influences g m . This is, in part, because studies exploring the relationship between leaf architecture and g m have often relied on simple linear or exponential models to identify correlations. Here, we employed non-linear machine learning models to more comprehensively assess the relationship between ten leaf architecture traits and g m . These models achieved excellent predictability of g m , which depended on the leaf architecture traits considered as predictors. Dissection of the importance of leaf architecture traits in the models indicated that cell wall thickness and chloroplast area exposed to internal airspace have a large impact on interspecific variation in g m . Additionally, other leaf architecture traits, such as: leaf thickness, leaf density, and chloroplast thickness emerged as important predictors of g m . We found significant differences in the predictability between models trained on different plant functional types (PFTs): those trained on woody species could predict g m by anatomical traits on other woody PFTs, ferns, and C 3 herbaceous plants, whereas the converse did not hold in general. By moving beyond simple linear and exponential models, our analyses demonstrated that a larger suite of leaf architecture traits drive differences in g m than has been previously acknowledged. These findings pave the way for modulating g m by strategies that modify its leaf architecture determinants.

Erwin GERARD

and 9 more

Aim: The management of type 2 diabetes patients poses challenges for non-diabetologists healthcare professionals and may result in potentially inappropriate prescriptions of antidiabetic drugs which can be limited using screening tools. The aim was to set up nominal groups of healthcare professionals from several disciplines and develop a list of explicit definition of potentially inappropriate prescriptions of antidiabetic drugs. Methods: In a qualitative, nominal-groups approach, expert diabetologists, general practitioners, and pharmacists in France developed explicit definitions of potentially inappropriate prescriptions of antidiabetic drugs in patients with type 2 diabetes. The study was overseen by a steering committee and complied with the Consolidated Criteria for Reporting Qualitative Research. Results: Three nominal groups comprised a total of 30 participants (14 pharmacists, 10 diabetologists, and 6 general practitioners) and generated 89 explicit definitions. These definitions were subsequently merged and validated by the steering committee and nominal group participants, resulting in 38 validated explicit definitions of potentially inappropriate prescriptions of antidiabetic drugs. The definitions encompassed four contexts: (i) the temporary discontinuation of a medication during acute illness (n=9; 24%), (ii) dose level adjustments (n=23; 60%), (iii) inappropriate treatment initiation (n=3; 8%), and (iv) the need for further monitoring in the management of type 2 diabetes (n=3; 8%). Conclusion: This qualitative study is the first to have produced a specific tool of explicit definitions of potentially inappropriate prescriptions of antidiabetic drugs. Although the new list provides valuable insights, it must be validated by expert consensus (e.g. in a Delphi survey) before implementation in practice

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Karma Norbu

and 3 more

Introduction: Scrub typhus is a neglected life threatening acute febrile illness caused by bacteria Orientia tsutsugamushi and it is a vector-borne zoonotic disease. In 2009, scrub typhus outbreak at Gedu has awakened Bhutan on the awareness and testing of the disease.Information and data of the study highlights the need for in depth surveillance, awareness among prescribers and initiate preventive measures in the country. Methods: We used retrospective descriptive study through review of laboratory registers across three health centres in Zhemgang district, south central Bhutan. The laboratories registers have been transcribed into CSV file using Microsoft excel. Variables of interest were collected from the registers and then analysed using open statistical software R, (R Core Team (2020). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.) And use of mStats package, (MyoMinnOo (2020). mStats: Epidemiological DataAnalysis. R package version 3.4.0.) Results: Of the total 922 tests prescribed for suspected scrub typhus in the three health centers in Zhemgang, only 8.2 % (n=76) were tested positive. Of these, Panbang Hospital had highest reported positive for scrub typhus with 56.6 %( n=43) followed by Yebilaptsa Hospital 35.5 %( n=27) and Zhemgang Hospital with 7.9 %( n=6). The female gender is comparably more affected as opposed to male with 57.9% (n=44) of the positive cases being female. The prevalence of scrub typhus seems to be affected by the seasonal variation as the months of Spring, Summer and Autumn together accounts for 98.7%(n=75) of total positive cases. The year 2019 noted significant scrub typhus cases accounting to 89.5 %(n=68) of the total positive cases over the two years. Conclusions:The overall tests tested positive of the scrub typhus infection within two years was 8.2%.

Selahattin Semiz

and 2 more

Monoclonal antibodies (MAbs) are powerful therapeutic tools in modern medicine and represent a rapidly expanding multi-billion USD market. While bioprocesses are generally well understood and optimized for MAbs, online quality control remains challenging. Notably, N-glycosylation is a critical quality attribute of MAbs as it affects binding to Fcγ receptors (FcγR), impacting the efficacy and safety of MAbs. Traditional N-glycosylation characterization methods are ill-suited for online monitoring of a bioreactor; in contrast, surface plasmon resonance (SPR) represents a promising avenue, as SPR biosensors can record MAb-FcγR interactions in real-time and without labelling. In this study, we produced five lots of differentially glycosylated Trastuzumab (TZM) and finely characterized their glycosylation profile by HILIC-UPLC chromatography. We then compared the interaction kinetics of these MAb lots with four FcγRs including FcγRIIA and FcγRIIB at 5 oC and 25 oC. When interacting with FcγRIIA/B at low temperature, the differentially glycosylated MAb lots exhibited distinct kinetic behaviours, contrary to room-temperature experiments. Galactosylated TZM (1) and core fucosylated TZM (2) could be discriminated and even quantified using an analytical technique based on the area under the curve (AUC) of the signal recorded during the dissociation phase of a SPR sensorgram describing the interaction with FcγRIIA (1) or FcγRII2B (2). Because of the rapidity of the proposed method (less than 5 minutes per measurement) and the small sample concentration it requires (as low as 30 nM, exact concentration not required), it could be a valuable process analytical technology for MAb glycosylation monitoring.

Ivy Bourgeault

and 2 more

The global health workforce crisis, simmering for decades, was brought to a rolling boil by the COVID-19 Pandemic in 2020. With scarce literature, evidence, or best practices to draw from, countries around the world moved to flex their workforces to meet acute challenges of the pandemic, facing demands related to patient volume, patient acuity, and worker vulnerability and absenteeism. One early hypothesis suggested that the acute, short-term pandemic phase would be followed by several waves of resource demands extending over the longer term. However, as the acute phase of the pandemic abated, temporary workforce policies expired and others were repealed with a view of returning to “normal”. The workforce needs of subsequent phases of pandemic effects were largely ignored despite our new equilibrium resting nowhere near our pre-COVID baseline. In this paper, we describe Canada’s early pandemic workforce response. We report the results of an environmental scan of the early workforce strategies adopted in Canada during the first COVID wave of the COVID 19 pandemic. Within a three-part framework for supporting a sustainable health workforce, we describe 470 strategies and policies that aimed to increase the numbers and flexibility of health workers in Canada, and to maximise their continued availability to work. These strategies targeted all types of health workers and roles, enabling changes to the places health work is done, the way in which care is delivered, and the mechanisms by which it is regulated. Telehealth strategies and virtual care were the most prevalent, followed by role expansion, licensure flexibility, mental health supports for workers, and return to practice of retirees. We explore the degree to which these short-term, acute response strategies might be adapted or extended to support the evolving workforce’s long-term needs.

Tara Lamont

and 2 more

There is a gap between healthcare workforce research and decision-making in policy and practice. This matters more than ever given the urgent staffing crisis, with shortfalls of key workers and increasing service pressures. As a national research network, we held the first ever UK forum on health and care workforce research and evidence in March 2023 which aimed to bridge this gap. We brought together clinical and system leaders, policymakers and regulators with workforce researchers. Fifteen sessions convened by leading experts combined knowledge exchange with deliberative dialogue over two days. Topics ranged from workforce analytics, forecasting, international migration to interprofessional working. In these small groups, important knowledge gaps were identified, where existing research had not reached decision-makers. Managers were not aware of accepted high quality evidence in areas like the relationship between registered nurse staffing levels and patient outcomes. Participants also identified important gaps in research, both topic area and study design. More work is needed to engage new disciplines, from labour economics and occupational health to academic human resources. Mobilising knowledge across disciplines will strengthen the quality and range of research as well as identifying relevant and novel interventions. Discussion at the forum highlighted a number of national and local workforce initiatives which had been implemented at pace, from virtual wards to e-rostering and apprentice levies, without a good evidence base or concurrent evaluation. The pandemic had accelerated many changes, including important shifts in skill mix and new roles with little learning from other countries and systems. Existing evaluations were often small-scale or focused on individual, rather than organisational, solutions in areas such as staff wellbeing. The paper provides a summary of an emerging UK workforce research agenda developed at the forum meeting, together with actions to build workforce research capacity and increase reach of findings into policy and practice.

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