• A qualitative study exploring midlife women’s stages of change from domestic violence towards freedom

      Keeling, June J.; Smith, Debra; Fisher, Colleen; University of Chester; University of Central Lancashire; The University of Western Australia (BioMed Central, 2016-03-08)
      Background Domestic Violence (DV) remains a significant global health problem for women in contemporary society. Existing literature on midlife women’s experiences of domestic violence is limited and focuses on health implications. Leaving a violent relationship is a dynamic process that often requires multiple attempts and separations prior to final termination. The aim of this study was to explore the process of leaving a violent relationship for midlife women. Methods This qualitative study involved fifteen women aged between 40–55 who had accessed residential and non-residential community support services for domestic violence within the UK. Community-based support agencies provided these women with access to letters of invitation and participant information sheet explaining the study. The women notified agency staff who contacted the research team to arrange a mutually convenient time to meet within a safe place for both the women and researchers. It was stressed to all potential participants that no identifiable information would be shared with the agency staff. Women were considered survivors of DV if they defined themselves as such. Data were gathered through semi structured interviews, transcribed verbatim and thematically analysed. Results Midlife women appear to differ from younger women by transitioning quickly though the stages of change, moving rapidly through the breaking free onto the maintenance stage. This rapid transition is the resultant effect of living with long-term violence causing a shift in the women’s perception towards the violent partner, with an associated reclamation of power from within the violent relationship. A realisation that rapid departure from the violence may be critical in terms of personal safety, and the realisation that there was something ‘wrong’ within the relationship, a ‘day of dawning’ that had not been apparent previously appears to positively affect the trajectory of leaving. Conclusions Midlife women appeared to navigate through the stages of change in a rapid linear process, forging ahead and exiting the relationship with certainty and without considering options. Whilst these findings appear to differ from younger women’s process of leaving, further research is needed to explore and understand the optimum time for intervention and support to maximise midlife women’s opportunities to escape an abusive partner, before being reflected appropriately in policy and practice.
    • Quality of life improved for patients after starting dialysis but is impaired, initially, for their partners: a multi-centre, longitudinal study

      Moore, Currie; orcid: 0000-0003-4629-6858; email: currie.moore@postgrad.manchester.ac.uk; Carter, Lesley-Anne; Mitra, Sandip; Skevington, Suzanne; Wearden, Alison (BioMed Central, 2020-05-18)
      Abstract: Background: Quality of life (QOL) is important to patients with end stage renal disease and their partners. Despite the first 12 weeks being a critical time in the treatment pathway, limited research exists which examines how the transition onto dialysis impacts QOL. In this study we measured QOL in patients and their partners at pre-dialysis and over the first 12 weeks on dialysis to investigate QOL during this crucial period. Methods: Patients and their partners, recruited from 10 renal units in England, completed questionnaires at pre-dialysis (n = 166 participants, 83 couples), 6 weeks (n = 90 participants, 45 couples) and 12 weeks (n = 78, 39 couples) after starting dialysis. On each occasion participants completed a QOL questionnaire (WHOQOL-BREF). Multilevel modelling accommodated the nested structure of couples with repeated measures within participants. Three-level random intercept models estimated changes in WHOQOL general QOL and its four domains (Physical, Psychological, Social and Environment). Two-level random intercept models assessed the relationship between baseline clinical and socio-demographic variables with changes in general QOL. Results: Patients reported positive changes in general QOL from pre-dialysis to 6 weeks (β = 0.42, p < 0.001, 95% CI 0.19, 0.65) and from pre-dialysis to 12 weeks (β = 0.47, p < 0.001, 95% CI 0.24, 0.71). Partners’ general QOL decreased significantly from pre-dialysis to 6 weeks (β = − 0.24, p = 0.04, 95% CI -0.47, − 0.01) but returned to its original level at 12 weeks. Patients reported improvements in the physical domain between pre-dialysis and 12 weeks (β = 6.56, p < 0.004, 95% CI 2.10, 11.03). No other domains changed significantly in patients or partners. Only in patients were there significant associations between moderator variables and general QOL. High comorbidity risk level and diabetes were associated with poorer QOL at pre-dialysis whereas being female and having an arteriovenous fistula were linked with improvements in general QOL. Conclusions: Patients reported significant improvements in their general and physical QOL after starting dialysis. Partners’ general QOL worsened after patients started dialysis but improved by 12 weeks. Both patients and partners may benefit from additional educational and counselling services in the lead up to, and immediately after starting dialysis, which could facilitate the transition onto dialysis and improve QOL in both. Study registration: This study was adopted on the NIHR Clinical Research Network (UK). The details of this study are registered on the Research Registry website (www.researchregistry.com). The identifier for this study is researchregistry2574.
    • Quantifying Cooperation Benefits for New Dams in Transboundary Water Systems Without Formal Operating Rules

      Gonzalez, Jose M.; Matrosov, Evgenii S.; Obuobie, Emmanuel; Mul, Marloes; Pettinotti, Laetitia; Gebrechorkos, Solomon H.; Sheffield, Justin; Bottacin-Busolin, Andrea; Dalton, James; Smith, D. Mark; et al. (Frontiers Media S.A., 2021-05-07)
      New dams impact downstream ecosystems and water infrastructure; without cooperative and adaptive management, negative impacts can manifest. In large complex transboundary river basins without well codified operating rules and extensive historical data, it can be difficult to assess the benefits of cooperating, in particular in relation to new dams. This constitutes a barrier to harmonious development of river basins and could contribute to water conflict. This study proposes a generalised framework to assess the benefits of cooperation on the management of new dams in water resource systems that do not have formal sharing arrangements. Benefits are estimated via multi-criteria comparison of historical reservoir operations (usually relatively uncooperative) vs. adopting new cooperative rules which would achieve the best results for riparian countries as evaluated by a water resources simulator and its performance metrics. The approach is applied to the Pwalugu Multipurpose Dam (PMD), which is being built in Ghana in the Volta river basin. The PMD could impact downstream ecosystems and infrastructure in Ghana and could itself be impacted by how the existing upstream Bagre Dam is managed in Burkina Faso. Results show that with cooperation Ghana and Burkina Faso could both increase energy production although some ecosystem services loss would need to be mitigated. The study confirms that cooperative rules achieve higher overall benefits compared to seeking benefits only for individual dams or countries.
    • Quantitative Magnetic Resonance Imaging in Perianal Crohn’s Disease at 1.5 and 3.0 T: A Feasibility Study

      Alyami, Ali; email: aalmansour@jazanu.edu.sa; Hoad, Caroline L.; orcid: 0000-0001-5483-1027; email: Caroline.L.Hoad@nottingham.ac.uk; Tench, Christopher; email: Christopher.Tench@nottingham.ac.uk; Bannur, Uday; email: uday.bannur@nuh.nhs.uk; Clarke, Christopher; orcid: 0000-0002-8092-9877; email: christopher.clarke@nuh.nhs.uk; Latief, Khalid; email: khalid.latief@nuh.nhs.uk; Argyriou, Konstantinos; orcid: 0000-0002-2026-9678; email: kosnar2@yahoo.gr; Lobo, Alan; email: alan.lobo@nhs.net; Lung, Philip; email: philliplung@nhs.net; Baldwin-Cleland, Rachel; email: r.baldwin@nhs.net; et al. (MDPI, 2021-11-17)
      Perianal Crohn’s Disease (pCD) is a common manifestation of Crohn’s Disease. Absence of reliable disease measures makes disease monitoring unreliable. Qualitative MRI has been increasingly used for diagnosing and monitoring pCD and has shown potential for assessing response to treatment. Quantitative MRI sequences, such as diffusion-weighted imaging (DWI), dynamic contrast enhancement (DCE) and magnetisation transfer (MT), along with T2 relaxometry, offer opportunities to improve diagnostic capability. Quantitative MRI sequences (DWI, DCE, MT and T2) were used in a cohort of 25 pCD patients before and 12 weeks after biological therapy at two different field strengths (1.5 and 3 T). Disease activity was measured with the Perianal Crohn’s Disease Activity index (PDAI) and serum C-reactive protein (CRP). Diseased tissue areas on MRI were defined by a radiologist. A baseline model to predict outcome at 12 weeks was developed. No differences were seen in the quantitative MR measured in the diseased tissue regions from baseline to 12 weeks; however, PDAI and CRP decreased. Baseline PDAI, CRP, T2 relaxometry and surgical history were found to have a moderate ability to predict response after 12 weeks of biological treatment. Validation in larger cohorts with MRI and clinical measures are needed in order to further develop the model.
    • Quantized Vortex Rings and Loop Solitons

      Green, P. J.; Grant, M. J.; Nevin, J. W.; Walmsley, P. M.; email: paul.walmsley@manchester.ac.uk; Golov, A. I.; orcid: 0000-0002-7244-5899 (Springer US, 2020-08-29)
      Abstract: The vortex filament model is used to investigate the interaction of a quantized vortex ring with a straight vortex line and also the interaction of two solitons traveling in opposite directions along a vortex. When a ring reconnects with a line, we find that a likely outcome is the formation of a loop soliton. When they collide, loop solitons reconnect as they overlap each other producing either one or two vortex rings. These simulations are relevant for experiments on quantum turbulence in the zero temperature limit where small vortex rings are expected to be numerous. It seems that loop solitons might also commonly occur on vortex lines as they act as transient states between the absorption of a vortex ring before another ring is emitted when the soliton is involved in a reconnection.
    • Quotidian Science Fiction: Posthuman Dreams of Emancipation

      Hay, Jonathan (The University of Iowa, 2019-06-13)
    • ‘Radial force’ of colonic stents: A parameter without consistency, definition or standard

      Laasch, Hans-Ulrich; orcid: 0000-0003-3109-6933; Milward, Graham D.; orcid: 0000-0002-0980-6567; Edwards, Derek W.; orcid: 0000-0001-6192-5056 (Society of Gastrointestinal Intervention, 2020-07-31)
    • Radical hydroxymethylation of alkyl iodides using formaldehyde as a C1 synthon.

      Caiger, Lewis; orcid: 0000-0001-5156-9684; Sinton, Conar; orcid: 0000-0002-5588-7548; Constantin, Timothée; orcid: 0000-0001-5376-1557; Douglas, James J; Sheikh, Nadeem S; Juliá, Fabio; orcid: 0000-0001-8903-4482; Leonori, Daniele; orcid: 0000-0002-7692-4504 (2021-07-06)
      Radical hydroxymethylation using formaldehyde as a C1 synthon is challenging due to the reversible and endothermic nature of the addition process. Here we report a strategy that couples alkyl iodide building blocks with formaldehyde through the use of photocatalysis and a phosphine additive. Halogen-atom transfer (XAT) from α-aminoalkyl radicals is leveraged to convert the iodide into the corresponding open-shell species, while its following addition to formaldehyde is rendered irreversible by trapping the transient O-radical with PPh . This event delivers a phosphoranyl radical that re-generates the alkyl radical and provides the hydroxymethylated product. [Abstract copyright: This journal is © The Royal Society of Chemistry.]
    • Radical hydroxymethylation of alkyl iodides using formaldehyde as a C1 synthon.

      Caiger, Lewis; orcid: 0000-0001-5156-9684; Sinton, Conar; orcid: 0000-0002-5588-7548; Constantin, Timothée; orcid: 0000-0001-5376-1557; Douglas, James J; Sheikh, Nadeem S; Juliá, Fabio; orcid: 0000-0001-8903-4482; Leonori, Daniele; orcid: 0000-0002-7692-4504 (2021-07-06)
      Radical hydroxymethylation using formaldehyde as a C1 synthon is challenging due to the reversible and endothermic nature of the addition process. Here we report a strategy that couples alkyl iodide building blocks with formaldehyde through the use of photocatalysis and a phosphine additive. Halogen-atom transfer (XAT) from α-aminoalkyl radicals is leveraged to convert the iodide into the corresponding open-shell species, while its following addition to formaldehyde is rendered irreversible by trapping the transient O-radical with PPh<sub>3</sub>. This event delivers a phosphoranyl radical that re-generates the alkyl radical and provides the hydroxymethylated product.
    • Raising the bar? The impact of the UNISON ethical care campaign in UK domiciliary care

      Johnson, Mathew; email: Mathew.johnson@manchester.ac.uk; Rubery, Jill; Egan, Matthew (SAGE Publications, 2021-07-15)
      This article critically analyses a major trade union initiative in the United Kingdom to raise standards in public contracts for domiciliary care, and in turn to improve wages and working conditions for outsourced care workers. The campaign successfully built alliances with national employer representatives, and around 25 per cent of commissioning bodies in England, Scotland and Wales have signed a voluntary charter that guarantees workers an hourly living wage, payment for travel time and regular working hours. The campaign overall, however, has had only limited effects on standards across the sector, in which low wages, zero-hours contracts and weak career paths predominate. Furthermore, the campaign has not yet yielded significant gains in terms of union recruitment, although there are signs of sporadic mobilisations of care workers in response to localised disputes.
    • Rapid compensatory evolution can rescue low fitness symbioses following partner switching.

      Sørensen, Megan E S; Wood, A Jamie; Cameron, Duncan D; Brockhurst, Michael A; email: michael.brockhurst@manchester.ac.uk (2021-07-01)
      Partner switching plays an important role in the evolution of symbiosis, enabling local adaptation and recovery from the breakdown of symbiosis. Because of intergenomic epistasis, partner-switched symbioses may possess novel combinations of phenotypes but may also exhibit low fitness due to their lack of recent coevolutionary history. Here, we examine the structure and mechanisms of intergenomic epistasis in the Paramecium-Chlorella symbiosis and test whether compensatory evolution can rescue initially low fitness partner-switched symbioses. Using partner-switch experiments coupled with metabolomics, we show evidence for intergenomic epistasis wherein low fitness is associated with elevated symbiont stress responses either in dark or high irradiance environments, potentially owing to mismatched light management traits between the host and symbiont genotypes. Experimental evolution under high light conditions revealed that an initially low fitness partner-switched non-native host-symbiont pairing rapidly adapted, gaining fitness equivalent to the native host-symbiont pairing in less than 50 host generations. Compensatory evolution took two alternative routes: either hosts evolved higher symbiont loads to mitigate for their new algal symbiont's poor performance, or the algal symbionts themselves evolved higher investment in photosynthesis and photoprotective traits to better mitigate light stress. These findings suggest that partner switching combined with rapid compensatory evolution can enable the recovery and local adaptation of symbioses in response to changing environments. [Abstract copyright: Copyright © 2021 Elsevier Inc. All rights reserved.]
    • Rare GATA6 variants associated with risk of congenital heart disease phenotypes in 200,000 UK Biobank exomes.

      Williams, Simon G; Byrne, Dominic J F; Keavney, Bernard D; orcid: 0000-0001-9573-0812; email: bernard.keavney@manchester.ac.uk (2021-09-07)
      Congenital heart disease (CHD) has a complex and largely uncharacterised genetic etiology. Using 200,000 UK Biobank (UKB) exomes, we assess the burden of ultra-rare, potentially pathogenic variants in the largest case/control cohort of predominantly mild CHD to date. We find an association with GATA6, a member of the GATA family of transcription factors that play an important role during heart development and has been linked with several CHD phenotypes previously. Several identified GATA6 variants are previously unreported and their roles in conferring risk to CHD warrants further study. We demonstrate that despite limitations regarding detailed familial phenotype information in large-scale biobank projects, through careful consideration of case and control cohorts it is possible to derive important associations. [Abstract copyright: © 2021. The Author(s).]
    • Rates of turnover among general practitioners: a retrospective study of all English general practices between 2007 and 2019.

      Parisi, Rosa; Lau, Yiu-Shing; Bower, Peter; Checkland, Kath; Rubery, Jill; Sutton, Matt; Giles, Sally J; Esmail, Aneez; Spooner, Sharon; orcid: 0000-0001-6965-3673; Kontopantelis, Evangelos; orcid: 0000-0001-6450-5815; email: e.kontopantelis@manchester.ac.uk (2021-08-22)
      <h4>Objective</h4>To quantify general practitioners' (GPs') turnover in England between 2007 and 2019, describe trends over time, regional differences and associations with social deprivation or other practice characteristics.<h4>Design</h4>A retrospective study of annual cross-sectional data.<h4>Setting</h4>All general practices in England (8085 in 2007, 6598 in 2019).<h4>Methods</h4>We calculated turnover rates, defined as the proportion of GPs leaving a practice. Rates and their median, 25th and 75th percentiles were calculated by year and region. The proportion of practices with persistent high turnover (>10%) over consecutive years were also calculated. A negative binomial regression model assessed the association between turnover and social deprivation or other practice characteristics.<h4>Results</h4>Turnover rates increased over time. The 75th percentile in 2009 was 11%, but increased to 14% in 2019. The highest turnover rate was observed in 2013-2014, corresponding to the 75th percentile of 18.2%. Over time, regions experienced increases in turnover rates, although it varied across English regions. The proportion of practices with high (10% to 40%) turnover within a year almost doubled from 14% in 2009 to 27% in 2019. A rise in the number of practices with persistent high turnover (>10%) for at least three consecutive years was also observed, from 2.7% (2.3%-3.1%) in 2007 to 6.3% (5.7%-6.9%) in 2017. The statistical analyses revealed that practice-area deprivation was moderately associated with turnover rate, with practices in the most deprived area having higher turnover rates compared with practices in the least deprived areas (incidence rate ratios 1.09; 95% CI 1.06 to 1.13).<h4>Conclusions</h4>GP turnover has increased in the last decade nationally, with regional variability. Greater attention to GP turnover is needed, in the most deprived areas in particular, where GPs often need to deal with more complex health needs. There is a large cost associated with GP turnover and practices with very high persistent turnover need to be further researched, and the causes behind this identified, to allow support strategies and policies to be developed.
    • Rates of turnover among general practitioners: a retrospective study of all English general practices between 2007 and 2019.

      Parisi, Rosa; Lau, Yiu-Shing; Bower, Peter; Checkland, Kath; Rubery, Jill; Sutton, Matt; Giles, Sally J; Esmail, Aneez; Spooner, Sharon; orcid: 0000-0001-6965-3673; Kontopantelis, Evangelos; orcid: 0000-0001-6450-5815; email: e.kontopantelis@manchester.ac.uk (2021-08-22)
      To quantify general practitioners' (GPs') turnover in England between 2007 and 2019, describe trends over time, regional differences and associations with social deprivation or other practice characteristics. A retrospective study of annual cross-sectional data. All general practices in England (8085 in 2007, 6598 in 2019). We calculated turnover rates, defined as the proportion of GPs leaving a practice. Rates and their median, 25th and 75th percentiles were calculated by year and region. The proportion of practices with persistent high turnover (>10%) over consecutive years were also calculated. A negative binomial regression model assessed the association between turnover and social deprivation or other practice characteristics. Turnover rates increased over time. The 75th percentile in 2009 was 11%, but increased to 14% in 2019. The highest turnover rate was observed in 2013-2014, corresponding to the 75th percentile of 18.2%. Over time, regions experienced increases in turnover rates, although it varied across English regions. The proportion of practices with high (10% to 40%) turnover within a year almost doubled from 14% in 2009 to 27% in 2019. A rise in the number of practices with persistent high turnover (>10%) for at least three consecutive years was also observed, from 2.7% (2.3%-3.1%) in 2007 to 6.3% (5.7%-6.9%) in 2017. The statistical analyses revealed that practice-area deprivation was moderately associated with turnover rate, with practices in the most deprived area having higher turnover rates compared with practices in the least deprived areas (incidence rate ratios 1.09; 95% CI 1.06 to 1.13). GP turnover has increased in the last decade nationally, with regional variability. Greater attention to GP turnover is needed, in the most deprived areas in particular, where GPs often need to deal with more complex health needs. There is a large cost associated with GP turnover and practices with very high persistent turnover need to be further researched, and the causes behind this identified, to allow support strategies and policies to be developed. [Abstract copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.]
    • Ratings of perceived exertion at the ventilatory anaerobic threshold in people with coronary heart disease: A CARE CR study.

      Nichols, Simon; email: s.j.nichols@shu.ac.uk; Engin, Buket; Carroll, Sean; Buckley, John; Ingle, Lee (2020-12-04)
      Exercise prescription guidelines for individuals undergoing cardiovascular rehabilitation (CR) are based on heart rate training zones and rating of perceived exertion (RPE). United Kingdom guidelines indicate that patients should exercise at an intensity of RPE 11 to 14. We aimed to determine the accuracy of this approach by comparing this RPE range with an objectively measured marker of exercise intensity, the ventilatory anaerobic threshold (VAT), and examine whether baseline directly determined cardiorespiratory fitness (CRF) affects the association between VAT and RPE. Participants underwent a maximal cardiopulmonary exercise test before an 8-week community-based CR programme. Peak oxygen uptake (V̇O2peak) and VAT were recorded, and RPE at the workload at which VAT was identified was recorded. Data were then split into tertiles, based on V̇O2peak, to determine whether RPE at the VAT differed in participants with low, moderate or higher CRF. We included 70 individuals [mean (SD) age 63.1 (10.0) years; body mass index 29.4 (4.0) kg/m2; 86% male]. At baseline, the mean RPE at the VAT (RPE@VAT) was 11.8 (95% confidence interval 11-12.6) and significantly differed between low and high CRF groups (P<0.001). The mean RPE@VAT was 10.1 (8.7-11.5), 11.8 (10.5-13.0), and 13.7 (12.5-14.9) for low, moderate and high CRF groups, respectively. When using RPE to guide exercise intensity in CR populations, one must consider the effect of baseline CRF. Mean RPEs of ∼10, 12 and 14 correspond to the VAT in low, moderate and higher-fit patients, respectively. [Abstract copyright: Copyright © 2020 Elsevier Masson SAS. All rights reserved.]
    • Re-purposing evaluation to learn about social justice: Reconfiguring epistemological politics through the regulative ideal of ‘participatory parity’

      Silver, Daniel; orcid: 0000-0001-7316-5146; email: daniel.silver@manchester.ac.uk (SAGE Publications, 2020-12-24)
      The article aims to re-purpose evaluation to learn about social justice by anchoring evaluation in normative dimensions. This article demonstrates the ways in which evaluation with an establishment orientation can limit the scope for dialogue and neglect narratives that contest the status quo. It explains how a more participatory approach that engages with the standpoints of marginalised participants can enhance the potential to learn about social justice. An ethical commitment to social justice does not mean a rejection of rigour in evidence-based evaluation. Relating Fraser’s critical theory of participatory parity to the regulative ideal of evaluation creates a foundation to systematically foreground explanations about how an intervention has delivered social justice.
    • Re-thinking public health: Towards a new scientific logic of routine animal health care in European industrial farming

      Bellet, Camille; orcid: 0000-0002-2544-3436; email: camille.bellet@manchester.ac.uk; Hamilton, Lindsay; Rushton, Jonathan (Palgrave Macmillan UK, 2021-09-20)
      Abstract: This study makes the case for a new scientific logic of routine animal health care in industrial farming in Europe. We argue that the social regime underpinning scientific research and development on chronic animal disease management (CADM) in Europe stifles innovation and sustains a productivist model of animal husbandry that facilitates and maintains chronic animal diseases rather than eliminating them. Drawing on documentary analysis and qualitative interviews, the study explores the science of CADM in the broiler, cattle and pig sectors of the European food industry. Our findings show that in these major sectors, research and development on CADM is largely orientated towards a logic of growth, profitability and control rather than a recognition of the interconnection between chronic animal diseases, the food industry, and people (especially consumers) as advocated by the One Health approach. The study contributes to the literature on medical humanities and science and technology studies within One Health and public health in two ways: First, we draw new focus towards chronic animal diseases that are non-transmissible to humans and argue that while these are not zoonoses, they are equally worthy of attention for managing the emergence of new pathogens and diseases. Second, we expand the conceptualisation of One Health to include chronic animal health conditions. Our argument is that public health as an outcome of the One Health approach should be a term of reference that applies to humans and nonhumans alike whether they be farmed animals, practitioners or consumers.
    • Reading Hilary Mantel: Haunted Decades

      Pollard, Eileen (Oxford University Press (OUP), 2021-07-10)
    • Real-time monitoring of crystallization from solution by using an interdigitated array electrode sensor.

      Tong, Jincheng; orcid: 0000-0001-7762-1460; Doumbia, Amadou; orcid: 0000-0002-4136-9029; Turner, Michael L; orcid: 0000-0003-2853-5632; Casiraghi, Cinzia; orcid: 0000-0001-7185-0377 (2021-04-27)
      Monitoring crystallization events in real-time is challenging but crucial for understanding the molecular dynamics associated with nucleation and crystal growth, some of nature's most ubiquitous phenomena. Recent observations have suggested that the traditional nucleation model, which describes the nucleus having already the final crystal structure, may not be valid. It appears that the molecular assembly can range during nucleation from crystalline to partially ordered to totally amorphous phases, and can change its structure during the crystallization process. Therefore, it is of critical importance to develop methods that are able to provide real-time monitoring of the molecular interactions with high temporal resolution. Here, we demonstrate that a simple and scalable approach based on interdigitated electrode array sensors (IESs) is able to provide insights on the dynamics of the crystallization process with a temporal resolution of 15 ms.
    • Real-world evidence on Kovaltry (81-8973) in children with moderate or severe hemophilia A in Europe: a nested cohort analysis

      O’Hara, Jamie; Hirst, Ceri; orcid: 0000-0001-9094-2437; email: ceri.hirst@bayer.com; Cabre Marquez, Jose Francisco; Burke, Tom (BioMed Central, 2021-01-15)
      Abstract: Background: Untreated hemophilia A patients may experience recurrent bleeding events leading to debilitating joint damages. While RCT and pharmacokinetic data support the value of Kovaltry [an unmodified full-length recombinant factor VIII (FVIII) product], real world evidence in children is lacking. This report describes a descriptive and multivariate analysis of the effectiveness of Kovaltry in children with hemophilia A in the real-world setting, using data from medical chart abstraction and cross-sectional surveys of physicians, patients, and caregivers. Results: Male patients aged < 18 years with moderate or severe hemophilia A, residing in five European countries and treated with FVIII were studied. The co-primary endpoints were the annualized bleeding rate (ABR) and the annual FVIII utilization rate. Twenty nine patients treated with Kovaltry were included, of whom 93% had severe disease and 75% were on continuous prophylactic treatment. The mean ABR was 2.66 ± 2.06, with rates decreasing with age. The children received on average 2.45 infusions per week, consistent across age groups (median 3; range 1–3). There were no reports of inhibitor development or adverse events in the study (AEs), and all patients were satisfied or very satisfied with the treatment. An exploratory multivariate analysis suggests no significant difference in ABR or units utilized between Kovaltry and some extended half life products in children with severe hemophilia A, though characteristics of these patient cohorts were markedly different. Conclusion: This analysis demonstrates the effectiveness and safety of Kovaltry in a pan-European pediatric population with severe hemophilia A.