Search results for: Allen Claire Arances
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 117

Search results for: Allen Claire Arances

27 Corporate Life Cycle and Corporate Social Responsibility Performance: Empirical Evidence from Pharmaceutical Industry in China

Authors: Jing (Claire) LI

Abstract:

The topic of corporate social responsibility (CSR) is significant for pharmaceutical companies in China at this current stage. This is because, as a rapid growth industry in China in recent years, the pharmaceutical industry in China has been undergone continuous and terrible incidents relating to CSR. However, there is limited research and practice of CSR in Chinese pharmaceutical companies. Also, there is an urgent call for more research in an international context to understand the implications of corporate life cycle on CSR performance. To respond to the research need and research call, this study examines the relationship between corporate life cycle and CSR performance of Chinese listed companies in pharmaceutical industry. This research studies Chinese listed companies in pharmaceutical industry for the period of 2010-2017, where the data is available in database. Following the literature, this study divides CSR performance with regards to CSR dimensions, including shareholders, creditors, employees, customers, suppliers, the government, and the society. This study uses CSR scores of HEXUN database and financial measures of these CSR dimensions to measure the CSR performance. This study performed regression analysis to examine the relationship between corporate life cycle stages and CSR performance with regards to CSR dimensions for pharmaceutical listed companies in China. Using cash flow pattern as proxy of corporate life cycle to classify corporate life cycle stages, this study found that most (least) pharmaceutical companies in China are in maturity (decline) stage. This study found that CSR performance for most dimensions are highest (lowest) in maturity (decline) stage as well. Among these CSR dimensions, performing responsibilities for shareholder is the most important among all CSR responsibilities for pharmaceutical companies. This study is the first to provide important empirical evidence from Chinese pharmaceutical industry on the association between life cycle and CSR performance, supporting that corporate life cycle is a key factor in CSR performance. The study expands corporate life cycle and CSR literatures and has both empirical and theoretical contributions to the literature. From perspective of empirical contributions, the findings contribute to the argument that whether there is a relationship between CSR performance and various corporate life cycle stages in the literature. This study also provides empirical evidence that companies in different corporate life cycles have difference in CSR performance. From perspective of theoretical contributions, this study relates CSR and stakeholders to corporate life cycle stages and complements the corporate life cycle and CSR literature. This study has important implications for managers and policy makers. First, the results will be helpful for managers to have an understanding in the essence of CSR, and their company’s current and future CSR focus over corporate life cycle. This study provides a reference for their actions and may help them make more wise resources allocation decisions of CSR investment. Second, policy makers (in the government, stock exchanges, and securities commission) may consider corporate life cycle as an important factor in formulating future regulations for companies. Future research can explore the "process-based" differences in CSR performance and more industries.

Keywords: China, corporate life cycle, corporate social responsibility, pharmaceutical industry

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26 On-Ice Force-Velocity Modeling Technical Considerations

Authors: Dan Geneau, Mary Claire Geneau, Seth Lenetsky, Ming -Chang Tsai, Marc Klimstra

Abstract:

Introduction— Horizontal force-velocity profiling (HFVP) involves modeling an athletes linear sprint kinematics to estimate valuable maximum force and velocity metrics. This approach to performance modeling has been used in field-based team sports and has recently been introduced to ice-hockey as a forward skating performance assessment. While preliminary data has been collected on ice, distance constraints of the on-ice test restrict the ability of the athletes to reach their maximal velocity which result in limits of the model to effectively estimate athlete performance. This is especially true of more elite athletes. This report explores whether athletes on-ice are able to reach a velocity plateau similar to what has been seen in overground trials. Fourteen male Major Junior ice-hockey players (BW= 83.87 +/- 7.30 kg, height = 188 ± 3.4cm cm, age = 18 ± 1.2 years n = 14) were recruited. For on-ice sprints, participants completed a standardized warm-up consisting of skating and dynamic stretching and a progression of three skating efforts from 50% to 95%. Following the warm-up, participants completed three on ice 45m sprints, with three minutes of rest in between each trial. For overground sprints, participants completed a similar dynamic warm-up to that of on-ice trials. Following the warm-up participants completed three 40m overground sprint trials. For each trial (on-ice and overground), radar was used to collect instantaneous velocity (Stalker ATS II, Texas, USA) aimed at the participant’s waist. Sprint velocities were modelled using custom Python (version 3.2) script using a mono-exponential function, similar to previous work. To determine if on-ice tirals were achieving a maximum velocity (plateau), minimum acceleration values of the modeled data at the end of the sprint were compared (using paired t-test) between on-ice and overground trials. Significant differences (P<0.001) between overground and on-ice minimum accelerations were observed. It was found that on-ice trials consistently reported higher final acceleration values, indicating a maximum maintained velocity (plateau) had not been reached. Based on these preliminary findings, it is suggested that reliable HFVP metrics cannot yet be collected from all ice-hockey populations using current methods. Elite male populations were not able to achieve a velocity plateau similar to what has been seen in overground trials, indicating the absence of a maximum velocity measure. With current velocity and acceleration modeling techniques, including a dependency of a velocity plateau, these results indicate the potential for error in on-ice HFVP measures. Therefore, these findings suggest that a greater on-ice sprint distance may be required or the need for other velocity modeling techniques, where maximal velocity is not required for a complete profile.   

Keywords: ice-hockey, sprint, skating, power

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25 A Review of How COVID-19 Has Created an Insider Fraud Pandemic and How to Stop It

Authors: Claire Norman-Maillet

Abstract:

Insider fraud, including its various synonyms such as occupational, employee or internal fraud, is a major financial crime threat whereby an employee defrauds (or attempts to defraud) their current, prospective, or past employer. ‘Employee’ covers anyone employed by the company, including contractors, directors, and part time staff; they may be a solo bad actor or working in collusion with others, whether internal or external. Insider fraud is even more of a concern given the impacts of the Coronavirus pandemic, which has generated multiple opportunities to commit insider fraud. Insider fraud is something that is not necessarily thought of as a significant financial crime threat; the focus of most academics and practitioners has historically been on that of ‘external fraud’ against businesses or entities where an individual or group has no professional ties. Without the face-to-face, ‘over the shoulder’ capabilities of staff being able to keep an eye on their employees, there is a heightened reliance on trust and transparency. With this, naturally, comes an increased risk of insider fraud perpetration. The objective of the research is to better understand how companies are impacted by insider fraud, and therefore how to stop it. This research will make both an original contribution and stimulate debate within the financial crime field. The financial crime landscape is never static – criminals are always creating new ways to perpetrate financial crime, and new legislation and regulations are implemented as attempts to strengthen controls, in addition to businesses doing what they can internally to detect and prevent it. By focusing on insider fraud specifically, the research will be more specific and will be of greater use to those in the field. To achieve the aims of the research, semi-structured interviews were conducted with 22 individuals who either work in financial services and deal with insider fraud or work within insider fraud perpetration in a recruitment or advisory capacity. This was to enable the sourcing of information from a wide range of individuals in a setting where they were able to elaborate on their answers. The principal recruitment strategy was engaging with the researcher’s network on LinkedIn. The interviews were then transcribed and analysed thematically. Main findings in the research suggest that insider fraud has been ignored owing to the denial of accepting the possibility that colleagues would defraud their employer. Whilst Coronavirus has led to a significant rise in insider fraud, this type of crime has been a major risk to businesses since their inception, however have never been given the financial or strategic backing required to be mitigated, until it's too late. Furthermore, Coronavirus should have led to companies tightening their access rights, controls and policies to mitigate the insider fraud risk. However, in most cases this has not happened. The research concludes that insider fraud needs to be given a platform upon which to be recognised as a threat to any company and given the same level of weighting and attention by Executive Committees and Boards as other types of economic crime.

Keywords: fraud, insider fraud, economic crime, coronavirus, Covid-19

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24 Translation and Validation of the Pain Resilience Scale in a French Population Suffering from Chronic Pain

Authors: Angeliki Gkiouzeli, Christine Rotonda, Elise Eby, Claire Touchet, Marie-Jo Brennstuhl, Cyril Tarquinio

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Resilience is a psychological concept of possible relevance to the development and maintenance of chronic pain (CP). It refers to the ability of individuals to maintain reasonably healthy levels of physical and psychological functioning when exposed to an isolated and potentially highly disruptive event. Extensive research in recent years has supported the importance of this concept in the CP literature. Increased levels of resilience were associated with lower levels of perceived pain intensity and better mental health outcomes in adults with persistent pain. The ongoing project seeks to include the concept of pain-specific resilience in the French literature in order to provide more appropriate measures for assessing and understanding the complexities of CP in the near future. To the best of our knowledge, there is currently no validated version of the pain-specific resilience measure, the Pain Resilience scale (PRS), for French-speaking populations. Therefore, the present work aims to address this gap, firstly by performing a linguistic and cultural translation of the scale into French and secondly by studying the internal validity and reliability of the PRS for French CP populations. The forward-translation-back translation methodology was used to achieve as perfect a cultural and linguistic translation as possible according to the recommendations of the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group, and an online survey is currently conducted among a representative sample of the French population suffering from CP. To date, the survey has involved one hundred respondents, with a total target of around three hundred participants at its completion. We further seek to study the metric properties of the French version of the PRS, ''L’Echelle de Résilience à la Douleur spécifique pour les Douleurs Chroniques'' (ERD-DC), in French patients suffering from CP, assessing the level of pain resilience in the context of CP. Finally, we will explore the relationship between the level of pain resilience in the context of CP and other variables of interest commonly assessed in pain research and treatment (i.e., general resilience, self-efficacy, pain catastrophising, and quality of life). This study will provide an overview of the methodology used to address our research objectives. We will also present for the first time the main findings and further discuss the validity of the scale in the field of CP research and pain management. We hope that this tool will provide a better understanding of how CP-specific resilience processes can influence the development and maintenance of this disease. This could ultimately result in better treatment strategies specifically tailored to individual needs, thus leading to reduced healthcare costs and improved patient well-being.

Keywords: chronic pain, pain measure, pain resilience, questionnaire adaptation

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23 Cognition in Context: Investigating the Impact of Persuasive Outcomes across Face-to-Face, Social Media and Virtual Reality Environments

Authors: Claire Tranter, Coral Dando

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Gathering information from others is a fundamental goal for those concerned with investigating crime, and protecting national and international security. Persuading an individual to move from an opposing to converging viewpoint, and an understanding on the cognitive style behind this change can serve to increase understanding of traditional face-to-face interactions, as well as synthetic environments (SEs) often used for communication across varying geographical locations. SEs are growing in usage, and with this increase comes an increase in crime being undertaken online. Communication technologies can allow people to mask their real identities, supporting anonymous communication which can raise significant challenges for investigators when monitoring and managing these conversations inside SEs. To date, the psychological literature concerning how to maximise information-gain in SEs for real-world interviewing purposes is sparse, and as such this aspect of social cognition is not well understood. Here, we introduce an overview of a novel programme of PhD research which seeks to enhance understanding of cross-cultural and cross-gender communication in SEs for maximising information gain. Utilising a dyadic jury paradigm, participants interacted with a confederate who attempted to persuade them to the opposing verdict across three distinct environments: face-to-face, instant messaging, and a novel virtual reality environment utilising avatars. Participants discussed a criminal scenario, acting as a two-person (male; female) jury. Persuasion was manipulated by the confederate claiming an opposing viewpoint (guilty v. not guilty) to the naïve participants from the outset. Pre and post discussion data, and observational digital recordings (voice and video) of participant’ discussion performance was collected. Information regarding cognitive style was also collected to ascertain participants need for cognitive closure and biases towards jumping to conclusions. Findings revealed that individuals communicating via an avatar in a virtual reality environment reacted in a similar way, and thus equally persuasive, when compared to individuals communicating face-to-face. Anonymous instant messaging however created a resistance to persuasion in participants, with males showing a significant decline in persuasive outcomes compared to face to face. The findings reveal new insights particularly regarding the interplay of persuasion on gender and modality, with anonymous instant messaging enhancing resistance to persuasion attempts. This study illuminates how varying SE can support new theoretical and applied understandings of how judgments are formed and modified in response to advocacy.

Keywords: applied cognition, persuasion, social media, virtual reality

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22 Effects of Soil Neutron Irradiation in Soil Carbon Neutron Gamma Analysis

Authors: Aleksandr Kavetskiy, Galina Yakubova, Nikolay Sargsyan, Stephen A. Prior, H. Allen Torbert

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The carbon sequestration question of modern times requires the development of an in-situ method of measuring soil carbon over large landmasses. Traditional chemical analytical methods used to evaluate large land areas require extensive soil sampling prior to processing for laboratory analysis; collectively, this is labor-intensive and time-consuming. An alternative method is to apply nuclear physics analysis, primarily in the form of pulsed fast-thermal neutron-gamma soil carbon analysis. This method is based on measuring the gamma-ray response that appears upon neutron irradiation of soil. Specific gamma lines with energies of 4.438 MeV appearing from neutron irradiation can be attributed to soil carbon nuclei. Based on measuring gamma line intensity, assessments of soil carbon concentration can be made. This method can be done directly in the field using a specially developed pulsed fast-thermal neutron-gamma system (PFTNA system). This system conducts in-situ analysis in a scanning mode coupled with GPS, which provides soil carbon concentration and distribution over large fields. The system has radiation shielding to minimize the dose rate (within radiation safety guidelines) for safe operator usage. Questions concerning the effect of neutron irradiation on soil health will be addressed. Information regarding absorbed neutron and gamma dose received by soil and its distribution with depth will be discussed in this study. This information was generated based on Monte-Carlo simulations (MCNP6.2 code) of neutron and gamma propagation in soil. Received data were used for the analysis of possible induced irradiation effects. The physical, chemical and biological effects of neutron soil irradiation were considered. From a physical aspect, we considered neutron (produced by the PFTNA system) induction of new isotopes and estimated the possibility of increasing the post-irradiation gamma background by comparisons to the natural background. An insignificant increase in gamma background appeared immediately after irradiation but returned to original values after several minutes due to the decay of short-lived new isotopes. From a chemical aspect, possible radiolysis of water (presented in soil) was considered. Based on stimulations of radiolysis of water, we concluded that the gamma dose rate used cannot produce gamma rays of notable rates. Possible effects of neutron irradiation (by the PFTNA system) on soil biota were also assessed experimentally. No notable changes were noted at the taxonomic level, nor was functional soil diversity affected. Our assessment suggested that the use of a PFTNA system with a neutron flux of 1e7 n/s for soil carbon analysis does not notably affect soil properties or soil health.

Keywords: carbon sequestration, neutron gamma analysis, radiation effect on soil, Monte-Carlo simulation

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21 In Response to Worldwide Disaster: Academic Libraries’ Functioning During COVID-19 Pandemic Without a Policy

Authors: Dalal Albudaiwi, Mike Allen, Talal Alhaji, Shahnaz Khadimehzadah

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As a pandemic, COVID-19 has impacted the whole world since November 2019. In other words, every organization, industry, and institution has been negatively affected by the Coronavirus. The uncertainty of how long the pandemic will last caused chaos at all levels. As with any other institution, public libraries were affected and transmitted into online services and resources. As internationally, have been witnessed that some public libraries were well-prepared for such disasters as the pandemic, and therefore, collections, users, services, technologies, staff, and budgets were all influenced. Public libraries’ policies did not mention any plan regarding such a pandemic. Instead, there are several rules in the guidelines about disasters in general, such as natural disasters. In this pandemic situation, libraries have been involved in different uneasy circumstances. However, it has always been apparent to public libraries the role they play in serving their communities in excellent and critical times. It dwells into the traditional role public libraries play in providing information services and sources to satisfy their information-based community needs. Remarkably increasing people’s awareness of the importance of informational enrichment and enhancing society’s skills in dealing with information and information sources. Under critical circumstances, libraries play a different role. It goes beyond the traditional part of information providers to the untraditional role of being a social institution that serves the community with whatever capabilities they have. This study takes two significant directions. The first focuses on investigating how libraries have responded to COVID-19 and how they manage disasters within their organization. The second direction focuses on how libraries help their communities to act during disasters and how to recover from the consequences. The current study examines how libraries prepare for disasters and the role of public libraries during disasters. We will also propose “measures” to be a model that libraries can use to evaluate the effectiveness of their response to disasters. We intend to focus on how libraries responded to this new disaster. Therefore, this study aims to develop a comprehensive policy that includes responding to a crisis such as Covid-19. An analytical lens inside the libraries as an organization and outside the organization walls will be documented based on analyzing disaster-related literature published in the LIS publication. The study employs content analysis (CA) methodology. CA is widely used in the library and information science. The critical contribution of this work is to propose solutions it provides to libraries and planers to prepare crisis management plans/ policies, specifically to face a new global disaster such as the COVID-19 pandemic. Moreover, the study will help library directors to evaluate their strategies and to improve them properly. The significance of this study lies in guiding libraries’ directors to enhance the goals of the libraries to guarantee crucial issues such as: saving time, avoiding loss, saving budget, acting quickly during a crisis, maintaining libraries’ role during pandemics, finding out the best response to disasters, and creating plan/policy as a sample for all libraries.

Keywords: Covid-19, policy, preparedness, public libraries

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20 Applying a SWOT Analysis to Inform the Educational Provision of Learners with Autism Spectrum Disorders

Authors: Claire Sciberras

Abstract:

Introduction: Autism Spectrum Disorder (ASD) has become recognized as being the most common childhood neurological condition. Indeed, numerous studies demonstrate an increase in the prevalence rate of children diagnosed with ASD. Concurrent with these findings, the European Agency for Special Needs and Inclusive Education reported a similar escalating tendency in prevalence also in Malta. Such an increase within the educational context in Malta has led the European Agency to call for increased support within educational settings in Malta. However, although research has addressed the positive impact of mainstream education on learners with ASD, empirical studies vis-à-vis the internal and external strengths and weaknesses present within the support provided in mainstream settings in Malta is distinctly limited. In light of the aforementioned argument, Malta would benefit from research which focuses on analysing the strengths, weaknesses, opportunities, and threats (SWOTs) which are present within the support provision of learners with ASD in mainstream primary schools. Such SWOT analysis is crucial as lack of appropriate opportunities might jeopardize the educational and social experiences of persons with ASD throughout their schooling. Methodology: A mixed methodological approach would be well suited to examine the provision of support of learners with ASD as the combination of qualitative and quantitative approaches allows researchers to collect a comprehensive range of data and validate their results. Hence, it is intended that questionnaires will be distributed to all the stakeholders involved so as to acquire a broader perspective to be collected from a wider group who provide support to students with ASD across schools in Malta. Moreover, the use of a qualitative approach in the form of interviews with a sample group will be implemented. Such an approach will be considered as it would potentially allow the researcher to gather an in-depth perspective vis-à-vis to the nature of the services which are currently provided to learners with ASD. The intentions of the study: Through the analysis of the data collected vis-à-vis to the SWOTs within the provision of support of learners with ASD it is intended that; i) a description in regards to the educational provision for learners with ASD within mainstream primary schools in Malta in light of the experiences and perceptions of the stakeholders involved will be acquired; ii) an analysis of the SWOTs which exist within the services for learners with ASD in primary state schools in Malta is carried out and iii) based on the SWOT analysis, recommendations that can lead to improvements in practice in the field of ASD in Malta and beyond will be provided. Conclusion: Due to the heterogeneity of individuals with ASD which spans across several deficits related to the social communication and interaction domain and also across areas linked to restricted, repetitive behavioural patterns, educational settings need to alter their standards according to the needs of their students. Thus, the standards established by schools throughout prior phases do not remain applicable forever, and therefore these need to be reviewed periodically in accordance with the diversities and the necessities of their learners.

Keywords: autism spectrum disorders, mainstream educational settings, provision of support, SWOT analysis

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19 Multicenter Evaluation of the ACCESS HBsAg and ACCESS HBsAg Confirmatory Assays on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis B Surface Antigen

Authors: Vanessa Roulet, Marc Turini, Juliane Hey, Stéphanie Bord-Romeu, Emilie Bonzom, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Vanessa Viotti, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. has recently developed fully automated assays for the detection of HBsAg on a new immunoassay platform. The objective of this European multicenter study was to evaluate the performance of the ACCESS HBsAg and ACCESS HBsAg Confirmatory assays† on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer. Methods: The clinical specificity of the ACCESS HBsAg and HBsAg Confirmatory assays was determined using HBsAg-negative samples from blood donors and hospitalized patients. The clinical sensitivity was determined using presumed HBsAg-positive samples. Sample HBsAg status was determined using a CE-marked HBsAg assay (Abbott ARCHITECT HBsAg Qualitative II, Roche Elecsys HBsAg II, or Abbott PRISM HBsAg assay) and a CE-marked HBsAg confirmatory assay (Abbott ARCHITECT HBsAg Qualitative II Confirmatory or Abbott PRISM HBsAg Confirmatory assay) according to manufacturer package inserts and pre-determined testing algorithms. False initial reactive rate was determined on fresh hospitalized patient samples. The sensitivity for the early detection of HBV infection was assessed internally on thirty (30) seroconversion panels. Results: Clinical specificity was 99.95% (95% CI, 99.86 – 99.99%) on 6047 blood donors and 99.71% (95%CI, 99.15 – 99.94%) on 1023 hospitalized patient samples. A total of six (6) samples were found false positive with the ACCESS HBsAg assay. None were confirmed for the presence of HBsAg with the ACCESS HBsAg Confirmatory assay. Clinical sensitivity on 455 HBsAg-positive samples was 100.00% (95% CI, 99.19 – 100.00%) for the ACCESS HBsAg assay alone and for the ACCESS HBsAg Confirmatory assay. The false initial reactive rate on 821 fresh hospitalized patient samples was 0.24% (95% CI, 0.03 – 0.87%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS HBsAg assay had equivalent sensitivity performances compared to the Abbott ARCHITECT HBsAg Qualitative II assay with an average bleed difference since first reactive bleed of 0.13. All bleeds found reactive in ACCESS HBsAg assay were confirmed in ACCESS HBsAg Confirmatory assay. Conclusion: The newly developed ACCESS HBsAg and ACCESS HBsAg Confirmatory assays from Beckman Coulter have demonstrated high clinical sensitivity and specificity, equivalent to currently marketed HBsAg assays, as well as a low false initial reactive rate. †Pending achievement of CE compliance; not yet available for in vitro diagnostic use. 2023-11317 Beckman Coulter and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

Keywords: dxi 9000 access immunoassay analyzer, hbsag, hbv, hepatitis b surface antigen, hepatitis b virus, immunoassay

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18 Dyadic Video Evidence on How Emotions in Parent Verbal Bids Affect Child Compliance in a British Sample

Authors: Iris Sirirada Pattara-Angkoon, Rory Devine, Anja Lindberg, Wendy Browne, Sarah Foley, Gabrielle McHarg, Claire Hughes

Abstract:

Introduction: The “Terrible Twos” is a phrase used to describe toddlers 18-30 months old. It characterizes a transition from high dependency to their caregivers in infancy to more autonomy and mastery of the body and environment. Toddlers at this age may also show more willfulness and stubbornness that could predict a future trajectory leading to conduct disorders. Thus, an important goal for this age group is to promote responsiveness to their caregivers (i.e., compliance). Existing literature tends to focus on praise to increase desirable child behavior. However, this relationship is not always straightforward as some studies have found no or negative association between praise and child compliance. Research suggests positive emotions and affection showed through body language (e.g., smiles) and actions (e.g., hugs, kisses) along with positive parent-child relationship can strengthen the praise and child compliance association. Nonetheless, few studies have examined the influences of positive emotionality within the speech. This is important as implementing verbal positive emotionality is easier than physical adjustments. The literature also tends not to include fathers in the study sample as mothers were traditionally the primary caregiver. However, as child-caring duties are increasing shared equally between mothers and fathers, it is important to include fathers within the study as studies have frequently found differences between female and male caregiver characteristics. Thus, the study will address the literary gap in two ways: 1. explore the influences of positive emotionality in parental speech and 2. include an equal sample of mothers and fathers. Positive emotionality is expected to positively correlate with and predict child compliance. Methodology: This study analyzed toddlers (18-24 months) in their dyadic interactions with mothers and fathers. A Duplo (block) task was used where parents had to work with their children to build the Duplo according to the given photo for four minutes. Then, they would be told to clean up the blocks. Parental positive emotionality in different speech types (e.g., bids, praises, affirmations) and child compliance were measured. Results: The study found that mothers (M = 28.92, SD = 12.01) were significantly more likely than fathers (M = 23.01, SD = 12.28) to use positive verbal emotionality in their speech, t(105) = 4.35, p< .001. High positive emotionality in bids during Duplo task and Clean Up was positively correlated with more child compliance in each task, r(273) = .35, p< .001 and r(264) = .58, p< .001, respectively. Overall, parental positive emotionality in speech significantly predicted child compliance, F(6, 218) = 13.33, p< .001, R² = .27) with emotionality in verbal bids (t = 6.20, p< .001) and affirmations (t = 3.12, p = .002) being significant predictors. Conclusion: Positive verbal emotions may be useful for increasing compliance in toddlers. This can be beneficial for compliance interventions as well as to the parent-child relationship quality through reduction of conflict and child defiance. As this study is correlational in nature, it will be important for future research to test the directional influence of positive emotionality within speech.

Keywords: child temperament, compliance, positive emotion, toddler, verbal bids

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17 Determinants of Life Satisfaction in Canada: A Causal Modelling Approach

Authors: Rose Branch-Allen, John Jayachandran

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Background and purpose: Canada is a pluralistic, multicultural society with an ethno-cultural composition that has been shaped over time by immigrants and their descendants. Although Canada welcomes these immigrants, many will endure hardship and assimilation difficulties. Despite these life hurdles, surveys consistently disclose high life satisfaction for all Canadians. Most research studies on Life Satisfaction/ Subjective Wellbeing (SWB) have focused on one main determinant and a variety of social demographic variables to delineate the determinants of life satisfaction. However, very few research studies examine life satisfaction from a holistic approach. In addition, we need to understand the causal pathways leading to life satisfaction, and develop theories that explain why certain variables differentially influence the different components of SWB. The aim this study was to utilize a holistic approach to construct a causal model and identify major determinants of life satisfaction. Data and measures: This study utilized data from the General Social Survey, with a sample size of 19, 597. The exogenous concepts included age, gender, marital status, household size, socioeconomic status, ethnicity, location, immigration status, religiosity, and neighborhood. The intervening concepts included health, social contact, leisure, enjoyment, work-family balance, quality time, domestic labor, and sense of belonging. The endogenous concept life satisfaction was measured by multiple indicators (Cronbach’s alpha = .83). Analysis: Several multiple regression models were run sequentially to estimate path coefficients for the causal model. Results: Overall, above average satisfaction with life was reported for respondents with specific socio-economic, demographic and lifestyle characteristics. With regard to exogenous factors, respondents who were female, younger, married, from high socioeconomic status background, born in Canada, very religious, and demonstrated high level of neighborhood interaction had greater satisfaction with life. Similarly, intervening concepts suggested respondents had greater life satisfaction if they had better health, more social contact, less time on passive leisure activities and more time on active leisure activities, more time with family and friends, more enjoyment with volunteer activities, less time on domestic labor and a greater sense of belonging to the community. Conclusions and Implications: Our results suggest that a holistic approach is necessary for establishing determinants of life satisfaction, and that life satisfaction is not merely comprised of positive or negative affect rather understanding the causal process of life satisfaction. Even though, most of our findings are consistent with previous studies, a significant number of causal connections contradict some of the findings in literature today. We have provided possible explanation for these anomalies researchers encounter in studying life satisfaction and policy implications.

Keywords: causal model, holistic approach, life satisfaction, socio-demographic variables, subjective well-being

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16 Multicenter Evaluation of the ACCESS Anti-HCV Assay on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis C Virus Antibody

Authors: Dan W. Rhodes, Juliane Hey, Magali Karagueuzian, Florianne Martinez, Yael Sandowski, Vanessa Roulet, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. (BEC) has recently developed a fully automated second-generation anti-HCV test on a new immunoassay platform. The objective of this multicenter study conducted in Europe was to evaluate the performance of the ACCESS anti-HCV assay on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer as an aid in the diagnosis of HCV (Hepatitis C Virus) infection and as a screening test for blood and plasma donors. Methods: The clinical specificity of the ACCESS anti-HCV assay was determined using HCV antibody-negative samples from blood donors and hospitalized patients. Sample antibody status was determined by a CE-marked anti-HCV assay (Abbott ARCHITECTTM anti-HCV assay or Abbott PRISM HCV assay) with an additional confirmation method (Immunoblot testing with INNO-LIATM HCV Score - Fujirebio), if necessary, according to pre-determined testing algorithms. The clinical sensitivity was determined using known HCV antibody-positive samples, identified positive by Immunoblot testing with INNO-LIATM HCV Score - Fujirebio. HCV RNA PCR or genotyping was available on all Immunoblot positive samples for further characterization. The false initial reactive rate was determined on fresh samples from blood donors and hospitalized patients. Thirty (30) commercially available seroconversion panels were tested to assess the sensitivity for early detection of HCV infection. The study was conducted from November 2019 to March 2022. Three (3) external sites and one (1) internal site participated. Results: Clinical specificity (95% CI) was 99.7% (99.6 – 99.8%) on 5852 blood donors and 99.0% (98.4 – 99.4%) on 1527 hospitalized patient samples. There were 15 discrepant samples (positive on ACCESS anti-HCV assay and negative on both ARCHITECT and Immunoblot) observed with hospitalized patient samples, and of note, additional HCV RNA PCR results showed five (5) samples had positive HCV RNA PCR results despite the absence of HCV antibody detection by ARCHITECT and Immunoblot, suggesting a better sensitivity of the ACCESS anti-HCV assay with these five samples compared to the ARCHITECT and Immunoblot anti-HCV assays. Clinical sensitivity (95% CI) on 510 well-characterized, known HCV antibody-positive samples was 100.0% (99.3 – 100.0%), including 353 samples with known HCV genotypes (1 to 6). The overall false initial reactive rate (95% CI) on 6630 patient samples was 0.02% (0.00 – 0.09%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS anti-HCV assay had equivalent sensitivity performances, with an average bleed difference since the first reactive bleed below one (1), compared to the ARCHITECTTM anti-HCV assay. Conclusion: The newly developed ACCESS anti-HCV assay from BEC for use on the DxI 9000 ACCESS Immunoassay Analyzer demonstrated high clinical sensitivity and specificity, equivalent to currently marketed anti-HCV assays, as well as a low false initial reactive rate.

Keywords: DxI 9000 ACCESS Immunoassay Analyzer, HCV, HCV antibody, Hepatitis C virus, immunoassay

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15 Effects of a Cluster Grouping of Gifted and Twice Exceptional Students on Academic Motivation, Socio-emotional Adjustment, and Life Satisfaction

Authors: Line Massé, Claire Baudry, Claudia Verret, Marie-France Nadeau, Anne Brault-Labbé

Abstract:

Little research has been conducted on educational services adapted for twice exceptional students. Within an action research, a cluster grouping was set up in an elementary school in Quebec, bringing together gifted or doubly exceptional (2E) students (n = 11) and students not identified as gifted (n = 8) within a multilevel class (3ᵣ𝒹 and 4ₜₕ years). 2E students had either attention deficit hyperactivity disorder (n = 8, including 3 with specific learning disability) or autism spectrum disorder (n = 2). Differentiated instructions strategies were implemented, including the possibility of progressing at their own pace of learning, independent study or research projects, flexible accommodation, tutoring with older students and the development of socio-emotional learning. A specialized educator also supported the teacher in the class for behavioural and socio-affective aspects. Objectives: The study aimed to assess the impacts of the grouping on all students, their academic motivation, and their socio-emotional adaptation. Method: A mixed method was used, combining a qualitative approach with a quantitative approach. Semi-directed interviews were conducted with students (N = 18, 4 girls and 14 boys aged 8 to 9) and one of their parents (N = 18) at the end of the school year. Parents and students completed two questionnaires at the beginning and end of the school year: the Behavior Assessment System for Children-3, children or parents versions (BASC-3, Reynolds and Kampus, 2015) and the Academic Motivation in Education (Vallerand et al., 1993). Parents also completed the Multidimensional Student Life Satisfaction Scale (Huebner, 1994, adapted by Fenouillet et al., 2014) comprising three domains (school, friendships, and motivation). Mixed thematic analyzes were carried out on the data from the interviews using the N'Vivo software. Related-samples Wilcoxon rank-sums tests were conducted for the data from the questionnaires. Results: Different themes emerge from the students' comments, including a positive impact on school motivation or attitude toward school, improved school results, reduction of their behavioural difficulties and improvement of their social relations. These remarks were more frequent among 2E students. Most 2E students also noted an improvement in their academic performance. Most parents reported improvements in attitudes toward school and reductions in disruptive behaviours in the classroom. Some parents also observed changes in behaviours at home or in the socio-emotional well-being of their children, here again, particularly parents of 2E children. Analysis of questionnaires revealed significant differences at the end of the school year, more specifically pertaining to extrinsic motivation identified, problems of conduct, attention, emotional self-control, executive functioning, negative emotions, functional deficiencies, and satisfaction regarding friendships. These results indicate that this approach could benefit not only gifted and doubly exceptional students but also students not identified as gifted.

Keywords: Cluster grouping, elementary school, giftedness, mixed methods, twice exceptional students

Procedia PDF Downloads 49
14 Colocalization Analysis to Understand Yttrium Uptake in Saxifraga paniculata Using Complementary Imaging Technics

Authors: Till Fehlauer, Blanche Collin, Bernard Angeletti, Andrea Somogyi, Claire Lallemand, Perrine Chaurand, Cédric Dentant, Clement Levard, Jerome Rose

Abstract:

Over the last decades, yttrium (Y) has gained importance in high-tech applications. It is an essential part of alloys and compounds used for lasers, displays, or cell phones, for example. Due to its chemical similarities with the lanthanides, Y is often considered a rare earth element (REE). Despite their increased usage, the environmental behavior of REEs remains poorly understood. Especially regarding their interactions with plants, many uncertainties exist. On the one hand, Y is known to have a negative effect on root development and germination, but on the other hand, it appears to promote plant growth at low concentrations. In order to understand these phenomena, a precise knowledge is necessary about how Y is absorbed by the plant and how it is handled once inside the organism. Contradictory studies exist, stating that due to a similar ionic radius, Y and the other REEs might be absorbed through Ca²⁺-channels, while others suspect that Y has a shared pathway with Al³⁺. In this study, laser ablation coupled ICP-MS, and synchrotron-based micro-X-ray fluorescence (µXRF, beamline Nanoscopium, SOLEIL, France) have been used in order to localize Y within the plant tissue and identify associated elements. The plant used in this study is Saxifraga paniculata, a rugged alpine plant that has shown an affinity for Y in previous studies (in prep.). Furthermore, Saxifraga paniculata performs guttation, which means that it possesses phloem sap secreting openings on the leaf surface that serve to regulate root pressure. These so-called hydathodes could provide special insights in elemental transport in plants. The plants have been grown on Y doped soil (500mg/kg DW) for four months. The results showed that Y was mainly concentrated in the roots of Saxifraga paniculata (260 ± 85mg/kg), and only a small amount was translocated to the leaves (10 ± 7.8mg/kg). µXRF analysis indicated that within the root transects, the majority of Y remained in the epidermis and hardly penetrated the stele. Laser ablation coupled ICP-MS confirmed this finding and showed a positive correlation in the roots between Y, Fe, Al, and to a lesser extent Ca. In the stem transect, Y was mainly detected in a hotspot of approximately 40µm in diameter situated in the endodermis area. Within the stem and especially in the hotspot, Y was highly colocalized with Al and Fe. Similar-sized Y hotspots have been detected in/on the leaves. All of them were strongly colocalized with Al and Fe, except for those situated within the hydathodes, which showed no colocalization with any of the measured elements. Accordingly, a relation between Y and Ca during root uptake remains possible, whereas a correlation to Fe and Al appears to be dominant in the aerial parts, suggesting common storage compartments, the formation of complexes, or a shared pathway during translocation.

Keywords: laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS), Phytoaccumulation, Rare earth elements, Saxifraga paniculata, Synchrotron-based micro-X-ray fluorescence, Yttrium

Procedia PDF Downloads 124
13 Determinants of Corporate Social Responsibility Adoption: Evidence from China

Authors: Jing (Claire) LI

Abstract:

More than two decades from 2000 to 2020 of economic reforms have brought China unprecedented economic growth. There is an urgent call of research towards corporate social responsibility (CSR) in the context of China because while China continues to develop into a global trading market, it suffers from various serious problems relating to CSR. This study analyses the factors affecting the adoption of CSR practices by Chinese listed companies. The author proposes a new framework of factors of CSR adoption. Following common organisational factors and external factors in the literature (including organisational support, company size, shareholder pressures, and government support), this study introduces two additional factors, dynamic capability and regional culture. A survey questionnaire was conducted on the CSR adoption of Chinese listed companies in Shen Zhen and Shang Hai index from December 2019 to March 2020. The survey was conducted to collect data on the factors that affect the adoption of CSR. After collection of data, this study performed factor analysis to reduce the number of measurement items to several main factors. This procedure is to confirm the proposed framework and ensure the significant factors. Through analysis, this study identifies four grouped factors as determinants of the CSR adoption. The first factor loading includes dynamic capability and organisational support. The study finds that they are positively related to the first factor, so the first factor mainly reflects the capabilities of companies, which is one component in internal factors. In the second factor, measurement items of stakeholder pressures mainly are from regulatory bodies, customer and supplier, employees and community, and shareholders. In sum, they are positively related to the second factor and they reflect stakeholder pressures, which is one component of external factors. The third factor reflects organisational characteristics. Variables include company size and cultural score. Among these variables, company size is negatively related to the third factor. The resulted factor loading of the third factor implies that organisational factor is an important determinant of CSR adoption. Cultural consistency, the variable in the fourth factor, is positively related to the factor. It represents the difference between perception of managers and actual culture of the organisations in terms of cultural dimensions, which is one component in internal factors. It implies that regional culture is an important factor of CSR adoption. Overall, the results are consistent with previous literature. This study is of significance from both theoretical and empirical perspectives. First, from the significance of theoretical perspective, this research combines stakeholder theory, dynamic capability view of a firm, and neo-institutional theory in CSR research. Based on association of these three theories, this study introduces two new factors (dynamic capability and regional culture) to have a better framework for CSR adoption. Second, this study contributes to empirical literature of CSR in the context of China. Extant Chinese companies lack recognition of the importance of CSR practices adoption. This study built a framework and may help companies to design resource allocation strategies and evaluate future CSR and management practices in an early stage.

Keywords: China, corporate social responsibility, CSR adoption, dynamic capability, regional culture

Procedia PDF Downloads 92
12 The Effectiveness of Prenatal Breastfeeding Education on Breastfeeding Uptake Postpartum: A Systematic Review

Authors: Jennifer Kehinde, Claire O’Donnell, Annmarie Grealish

Abstract:

Introduction: Breastfeeding has been shown to provide numerous health benefits for both infants and mothers. The decision to breastfeed is influenced by physiological, psychological, and emotional factors. However, the importance of equipping mothers with the necessary knowledge for successful breastfeeding practice cannot be ruled out. The decline in global breastfeeding rate can be linked to a lack of adequate breastfeeding education during the prenatal stage. This systematic review examined the effectiveness of prenatal breastfeeding education on breastfeeding uptake postpartum. Method: This review was undertaken and reported in conformity with the Preferred Reporting Items for Systemic Reviews and Meta-Analysis statement (PRISMA) and was registered on the international prospective register for systematic reviews (PROSPERO: CRD42020213853). A PICO analysis (population, intervention, comparison, outcome) was undertaken to inform the choice of keywords in the search strategy to formulate the review question, which was aimed at determining the effectiveness of prenatal breastfeeding educational programs in improving breastfeeding uptake following birth. A systematic search of five databases (Cumulative Index to Nursing and Allied Health Literature, Medline, Psych INFO, and Applied Social Sciences Index and Abstracts) was searched between January 2014 until July 2021 to identify eligible studies. Quality assessment and narrative synthesis were subsequently undertaken. Results: Fourteen studies were included. All 14 studies used different types of breastfeeding programs; eight used a combination of curriculum-based breastfeeding education programs, group prenatal breastfeeding counselling, and one-to-one breastfeeding educational programs, which were all delivered in person; four studies used web-based learning platforms to deliver breastfeeding education prenatally which were both delivered online and face to face over a period of 3 weeks to 2 months with follow-up periods ranging from 3 weeks to 6 months; one study delivered breastfeeding educational intervention using mother-to-mother breastfeeding support groups in promoting exclusive breastfeeding, and one study disseminated breastfeeding education to participants based on the theory of planned behaviour. The most effective interventions were those that included both theory and hands-on demonstrations. Results showed an increase in breastfeeding uptake, breastfeeding knowledge, an increase in a positive attitude to breastfeeding, and an increase in maternal breastfeeding self-efficacy among mothers who participated in breastfeeding educational programs during prenatal care. Conclusion: Prenatal breastfeeding education increases women’s knowledge of breastfeeding. Mothers who are knowledgeable about breastfeeding and hold a positive approach towards breastfeeding have the tendency to initiate breastfeeding and continue for a lengthened period. Findings demonstrate a general correlation between prenatal breastfeeding education and increased breastfeeding uptake postpartum. The high level of positive breastfeeding outcomes inherent in all the studies can be attributed to prenatal breastfeeding education. This review provides rigorous contemporary evidence that healthcare professionals and policymakers can apply when developing effective strategies to improve breastfeeding rates and ultimately improve the health outcomes of mothers and infants.

Keywords: breastfeeding, breastfeeding programs, breastfeeding self-efficacy, prenatal breastfeeding education

Procedia PDF Downloads 51
11 The Effectiveness of Prenatal Breastfeeding Education on Breastfeeding Uptake Postpartum: A Systematic Review.

Authors: Jennifer Kehinde, Claire O'donnell, Annmarie Grealish

Abstract:

Introduction: Breastfeeding has been shown to provide numerous health benefits for both infants and mothers. The decision to breastfeed is influenced by physiological, psychological, and emotional factors. However, the importance of equipping mothers with the necessary knowledge for successful breastfeeding practice cannot be ruled out. The decline in global breastfeeding rate can be linked to lack of adequate breastfeeding education during prenatal stage.This systematic review examined the effectiveness of prenatal breastfeeding education on breastfeeding uptake postpartum. Method: This review was undertaken and reported in conformity with the Preferred Reporting Items for Systemic Reviews and Meta-Analysis statement (PRISMA) and was registered on the international prospective register for systematic reviews (PROSPERO: CRD42020213853). A PICO analysis (population, intervention, comparison, outcome) was undertaken to inform the choice of keywords in the search strategy to formulate the review question which was aimed at determining the effectiveness of prenatal breastfeeding educational programs at improving breastfeeding uptake following birth. A systematic search of five databases (Cumulative Index to Nursing and Allied Health Literature, Medline, Psych INFO, and Applied Social Sciences Index and Abstracts) were searched between January 2014 until July 2021 to identify eligible studies. Quality assessment and narrative synthesis were subsequently undertaken. Results: Fourteen studies were included. All 14 studies used different types of breastfeeding programs; eight used a combination of curriculum based breastfeeding education program, group prenatal breastfeeding counselling and one-to-one breastfeeding educational programs which were all delivered in person; four studies used web-based learning platforms to deliver breastfeeding education prenatally which were both delivered online and face to face over a period of 3 weeks to 2 months with follow-up periods ranging from 3 weeks to 6 months; one study delivered breastfeeding educational intervention using mother-to-mother breastfeeding support groups in promoting exclusive breastfeeding and one study disseminated breastfeeding education to participants based on the theory of planned behaviour. The most effective interventions were those that included both theory and hands-on demonstrations. Results showed an increase in breastfeeding uptake, breastfeeding knowledge, increase in positive attitude to breastfeeding and an increase in maternal breastfeeding self-efficacy among mothers who participated in breastfeeding educational programs during prenatal care. Conclusion: Prenatal breastfeeding education increases women’s knowledge of breastfeeding. Mothers who are knowledgeable about breastfeeding and hold a positive approach towards breastfeeding have the tendency to initiate breastfeeding and continue for a lengthened period. Findings demonstrates a general correlation between prenatal breastfeeding education and increased breastfeeding uptake postpartum. The high level of positive breastfeeding outcome inherent in all the studies can be attributed to prenatal breastfeeding education. This review provides rigorous contemporary evidence that healthcare professionals and policymakers can apply when developing effective strategies to improve breastfeeding rates and ultimately improve the health outcomes of mothers and infants.

Keywords: breastfeeding, breastfeeding programs, breastfeeding self-efficacy, prenatal breastfeedng education

Procedia PDF Downloads 21
10 Balancing Biodiversity and Agriculture: A Broad-Scale Analysis of the Land Sparing/Land Sharing Trade-Off for South African Birds

Authors: Chevonne Reynolds, Res Altwegg, Andrew Balmford, Claire N. Spottiswoode

Abstract:

Modern agriculture has revolutionised the planet’s capacity to support humans, yet has simultaneously had a greater negative impact on biodiversity than any other human activity. Balancing the demand for food with the conservation of biodiversity is one of the most pressing issues of our time. Biodiversity-friendly farming (‘land sharing’), or alternatively, separation of conservation and production activities (‘land sparing’), are proposed as two strategies for mediating the trade-off between agriculture and biodiversity. However, there is much debate regarding the efficacy of each strategy, as this trade-off has typically been addressed by short term studies at fine spatial scales. These studies ignore processes that are relevant to biodiversity at larger scales, such as meta-population dynamics and landscape connectivity. Therefore, to better understand species response to agricultural land-use and provide evidence to underpin the planning of better production landscapes, we need to determine the merits of each strategy at larger scales. In South Africa, a remarkable citizen science project - the South African Bird Atlas Project 2 (SABAP2) – collates an extensive dataset describing the occurrence of birds at a 5-min by 5-min grid cell resolution. We use these data, along with fine-resolution data on agricultural land-use, to determine which strategy optimises the agriculture-biodiversity trade-off in a southern African context, and at a spatial scale never considered before. To empirically test this trade-off, we model bird species population density, derived for each 5-min grid cell by Royle-Nicols single-species occupancy modelling, against both the amount and configuration of different types of agricultural production in the same 5-min grid cell. In using both production amount and configuration, we can show not only how species population densities react to changes in yield, but also describe the production landscape patterns most conducive to conservation. Furthermore, the extent of both the SABAP2 and land-cover datasets allows us to test this trade-off across multiple regions to determine if bird populations respond in a consistent way and whether results can be extrapolated to other landscapes. We tested the land sparing/sharing trade-off for 281 bird species across three different biomes in South Africa. Overall, a higher proportion of species are classified as losers, and would benefit from land sparing. However, this proportion of loser-sparers is not consistent and varies across biomes and the different types of agricultural production. This is most likely because of differences in the intensity of agricultural land-use and the interactions between the differing types of natural vegetation and agriculture. Interestingly, we observe a higher number of species that benefit from agriculture than anticipated, suggesting that agriculture is a legitimate resource for certain bird species. Our results support those seen at smaller scales and across vastly different agricultural systems, that land sparing benefits the most species. However, our analysis suggests that land sparing needs to be implemented at spatial scales much larger than previously considered. Species persistence in agricultural landscapes will require the conservation of large tracts of land, and is an important consideration in developing countries, which are undergoing rapid agricultural development.

Keywords: agriculture, birds, land sharing, land sparing

Procedia PDF Downloads 183
9 Implementation of Smart Card Automatic Fare Collection Technology in Small Transit Agencies for Standards Development

Authors: Walter E. Allen, Robert D. Murray

Abstract:

Many large transit agencies have adopted RFID technology and electronic automatic fare collection (AFC) or smart card systems, but small and rural agencies remain tied to obsolete manual, cash-based fare collection. Small countries or transit agencies can benefit from the implementation of smart card AFC technology with the promise of increased passenger convenience, added passenger satisfaction and improved agency efficiency. For transit agencies, it reduces revenue loss, improves passenger flow and bus stop data. For countries, further implementation into security, distribution of social services or currency transactions can provide greater benefits. However, small countries or transit agencies cannot afford expensive proprietary smart card solutions typically offered by the major system suppliers. Deployment of Contactless Fare Media System (CFMS) Standard eliminates the proprietary solution, ultimately lowering the cost of implementation. Acumen Building Enterprise, Inc. chose the Yuma County Intergovernmental Public Transportation Authority (YCIPTA) existing proprietary YCAT smart card system to implement CFMS. The revised system enables the purchase of fare product online with prepaid debit or credit cards using the Payment Gateway Processor. Open and interoperable smart card standards for transit have been developed. During the 90-day Pilot Operation conducted, the transit agency gathered the data from the bus AcuFare 200 Card Reader, loads (copies) the data to a USB Thumb Drive and uploads the data to the Acumen Host Processing Center for consolidation of the data into the transit agency master data file. The transition from the existing proprietary smart card data format to the new CFMS smart card data format was transparent to the transit agency cardholders. It was proven that open standards and interoperability design can work and reduce both implementation and operational costs for small transit agencies or countries looking to expand smart card technology. Acumen was able to avoid the implementation of the Payment Card Industry (PCI) Data Security Standards (DSS) which is expensive to develop and costly to operate on a continuing basis. Due to the substantial additional complexities of implementation and the variety of options presented to the transit agency cardholder, Acumen chose to implement only the Directed Autoload. To improve the implementation efficiency and the results for a similar undertaking, it should be considered that some passengers lack credit cards and are averse to technology. There are more than 1,300 small and rural agencies in the United States. This grows by 10 fold when considering small countries or rural locations throughout Latin American and the world. Acumen is evaluating additional countries, sites or transit agency that can benefit from the smart card systems. Frequently, payment card systems require extensive security procedures for implementation. The Project demonstrated the ability to purchase fare value, rides and passes with credit cards on the internet at a reasonable cost without highly complex security requirements.

Keywords: automatic fare collection, near field communication, small transit agencies, smart cards

Procedia PDF Downloads 252
8 Prevalence of Chronic Diseases and Predictors of Mortality in Home Health Care Service: Data From Saudi Arabia

Authors: Walid A. Alkeridy, Arwa Aljasser, Khalid Mohammed Alayed, Saad Alsaad, Amani S. Alqahtani, Claire Ann Lim, Sultan H. Alamri, Doaa Zainhom Mekkawy, Mohammed Al-Sofiani

Abstract:

Introduction: The history of publicly funded Home Health Care (HHC) service in Saudi Arabia dates back to 1991. The first HC program was launched to provide palliative home care services for patients with terminal cancer. Thereafter, more programs launched across Saudi Arabia most remarkably was launching the national program for HHC by the Ministry Of Health (MOH) in 2008. The national HHC MOH program is mainly providing long-term care home care services for over 40,000 Saudi citizens. The scope of the HHC service program provided by the Saudi MOH is quite diverse, ranging from basic nursing care to specialized care programs, e.g., home peritoneal dialysis, home ventilation, home infusion therapy, etc. Objectives: The primary aim of our study is to report the prevalence of chronic conditions among Saudi people receiving long-term HHC services. Secondary aims include identifying the predictors of mortality among individuals receiving long-term HHC services and studying the association between frailty and poor health outcomes among HHC users. Methods: We conducted a retrospective and cross-sectional data collection from participants receiving HHC services at King Saud University Medical City, Riyadh, Saudi Arabia. Data were collected from electronic health records (EHR), patient charts, and interviewing caregivers from the year 2019 to 2022. We assessed functional performance by Katz's activity of daily living and the Bristol Activity of Daily Living Scale (BADLS). A trained health care provider assessed frailty using the Clinical Frailty Scale (CFS). Mortality was assessed by reviewing the death certificates if patients were hospitalized through discharge status ascertainment from EHR. Results: The mean age for deceased individuals in HHC was 78.3 years. Over twenty percent of individuals receiving HHC services were readmitted to the hospital. The following variables were statistically significant between deceased and alive individuals receiving HHC services; clinical frailty scale, the total number of comorbid conditions, and functional performance based on the KATZ activity of daily living scale and the BADLS. We found that the strongest predictors for mortality were pressure ulcers which had an odds ratio of 3.75 and p-value of < 0.0001, and the clinical frailty scale, which had an odds ratio of 1.69 and p-value of 0.002, using multivariate regression analysis. In conclusion, our study found that pressure ulcers and frailty are the strongest predictors of mortality for individuals receiving home health care services. Moreover, we found a high rate of annual readmission for individuals enrolled in HHC, which requires further analysis to understand the possible contributing factors for the increased rate of hospital readmission and develop strategies to address them. Future studies should focus on designing quality improvement projects aimed at improving the quality of life for individuals receiving HHC services, especially those who have pressure ulcers at the end of life.

Keywords: homecare, Saudi, prevalence, chronic

Procedia PDF Downloads 93
7 A Study on the Relation among Primary Care Professionals Serving Disadvantaged Community, Socioeconomic Status, and Adverse Health Outcome

Authors: Chau-Kuang Chen, Juanita Buford, Colette Davis, Raisha Allen, John Hughes, James Tyus, Dexter Samuels

Abstract:

During the post-Civil War era, the city of Nashville, Tennessee, had the highest mortality rate in the country. The elevated death and disease among ex-slaves were attributable to the unavailability of healthcare. To address the paucity of healthcare services, the College, an institution with the mission of educating minority professionals and serving the under served population, was established in 1876. This study was designed to assess if the College has accomplished its mission of serving under served communities and contributed to the elimination of health disparities in the United States. The study objective was to quantify the impact of socioeconomic status and adverse health outcomes on primary care professionals serving disadvantaged communities, which, in turn, was significantly associated with a health professional shortage score partly designated by the U.S. Department of Health and Human Services. Various statistical methods were used to analyze the alumni data in years 1975 – 2013. K-means cluster analysis was utilized to identify individual medical and dental graduates into the cluster groups of the practice communities (Disadvantaged or Non-disadvantaged Communities). Discriminant analysis was implemented to verify the classification accuracy of cluster analysis. The independent t test was performed to detect the significant mean differences for clustering and criterion variables between Disadvantaged and Non-disadvantaged Communities, which confirms the “content” validity of cluster analysis model. Chi-square test was used to assess if the proportion of cluster groups (Disadvantaged vs Non-disadvantaged Communities) were consistent with that of practicing specialties (primary care vs. non-primary care). Finally, the partial least squares (PLS) path model was constructed to explore the “construct” validity of analytics model by providing the magnitude effects of socioeconomic status and adverse health outcome on primary care professionals serving disadvantaged community. The social ecological theory along with statistical models mentioned was used to establish the relationship between medical and dental graduates (primary care professionals serving disadvantaged communities) and their social environments (socioeconomic status, adverse health outcome, health professional shortage score). Based on social ecological framework, it was hypothesized that the impact of socioeconomic status and adverse health outcomes on primary care professionals serving disadvantaged communities could be quantified. Also, primary care professionals serving disadvantaged communities related to a health professional shortage score can be measured. Adverse health outcome (adult obesity rate, age-adjusted premature mortality rate, and percent of people diagnosed with diabetes) could be affected by the latent variable, namely socioeconomic status (unemployment rate, poverty rate, percent of children who were in free lunch programs, and percent of uninsured adults). The study results indicated that approximately 83% (3,192/3,864) of the College’s medical and dental graduates from 1975 to 2013 were practicing in disadvantaged communities. In addition, the PLS path modeling demonstrated that primary care professionals serving disadvantaged community was significantly associated with socioeconomic status and adverse health outcome (p < .001). In summary, the majority of medical and dental graduates from the College provide primary care services to disadvantaged communities with low socioeconomic status and high adverse health outcomes, which demonstrate that the College has fulfilled its mission.

Keywords: disadvantaged community, K-means cluster analysis, PLS path modeling, primary care

Procedia PDF Downloads 524
6 Impact of Air Pressure and Outlet Temperature on Physicochemical and Functional Properties of Spray-dried Skim Milk Powder

Authors: Adeline Meriaux, Claire Gaiani, Jennifer Burgain, Frantz Fournier, Lionel Muniglia, Jérémy Petit

Abstract:

Spray-drying process is widely used for the production of dairy powders for food and pharmaceuticals industries. It involves the atomization of a liquid feed into fine droplets, which are subsequently dried through contact with a hot air flow. The resulting powders permit transportation cost reduction and shelf life increase but can also exhibit various interesting functionalities (flowability, solubility, protein modification or acid gelation), depending on operating conditions and milk composition. Indeed, particles porosity, surface composition, lactose crystallization, protein denaturation, protein association or crust formation may change. Links between spray-drying conditions and physicochemical and functional properties of powders were investigated by a design of experiment methodology and analyzed by principal component analysis. Quadratic models were developed, and multicriteria optimization was carried out by the use of genetic algorithm. At the time of abstract submission, verification spray-drying trials are ongoing. To perform experiments, milk from dairy farm was collected, skimmed, froze and spray-dried at different air pressure (between 1 and 3 bars) and outlet temperature (between 75 and 95 °C). Dry matter, minerals content and proteins content were determined by standard method. Solubility index, absorption index and hygroscopicity were determined by method found in literature. Particle size distribution were obtained by laser diffraction granulometry. Location of the powder color in the Cielab color space and water activity were characterized by a colorimeter and an aw-value meter, respectively. Flow properties were characterized with FT4 powder rheometer; in particular compressibility and shearing test were performed. Air pressure and outlet temperature are key factors that directly impact the drying kinetics and powder characteristics during spray-drying process. It was shown that the air pressure affects the particle size distribution by impacting the size of droplet exiting the nozzle. Moreover, small particles lead to more cohesive powder and less saturated color of powders. Higher outlet temperature results in lower moisture level particles which are less sticky and can explain a spray-drying yield increase and the higher cohesiveness; it also leads to particle with low water activity because of the intense evaporation rate. However, it induces a high hygroscopicity, thus, powders tend to get wet rapidly if they are not well stored. On the other hand, high temperature provokes a decrease of native serum proteins which is positively correlated to gelation properties (gel point and firmness). Partial denaturation of serum proteins can improve functional properties of powder. The control of air pressure and outlet temperature during the spray-drying process significantly affects the physicochemical and functional properties of powder. This study permitted to better understand the links between physicochemical and functional properties of powder, to identify correlations between air pressure and outlet temperature. Therefore, mathematical models have been developed and the use of genetic algorithm will allow the optimization of powder functionalities.

Keywords: dairy powders, spray-drying, powders functionalities, design of experiment

Procedia PDF Downloads 47
5 Study of Operating Conditions Impact on Physicochemical and Functional Properties of Dairy Powder Produced by Spray-drying

Authors: Adeline Meriaux, Claire Gaiani, Jennifer Burgain, Frantz Fournier, Lionel Muniglia, Jérémy Petit

Abstract:

Spray-drying process is widely used for the production of dairy powders for food and pharmaceuticals industries. It involves the atomization of a liquid feed into fine droplets, which are subsequently dried through contact with a hot air flow. The resulting powders permit transportation cost reduction and shelf life increase but can also exhibit various interesting functionalities (flowability, solubility, protein modification or acid gelation), depending on operating conditions and milk composition. Indeed, particles porosity, surface composition, lactose crystallization, protein denaturation, protein association or crust formation may change. Links between spray-drying conditions and physicochemical and functional properties of powders were investigated by a design of experiment methodology and analyzed by principal component analysis. Quadratic models were developed, and multicriteria optimization was carried out by the use of genetic algorithm. At the time of abstract submission, verification spray-drying trials are ongoing. To perform experiments, milk from dairy farm was collected, skimmed, froze and spray-dried at different air pressure (between 1 and 3 bars) and outlet temperature (between 75 and 95 °C). Dry matter, minerals content and proteins content were determined by standard method. Solubility index, absorption index and hygroscopicity were determined by method found in literature. Particle size distribution were obtained by laser diffraction granulometry. Location of the powder color in the Cielab color space and water activity were characterized by a colorimeter and an aw-value meter, respectively. Flow properties were characterized with FT4 powder rheometer; in particular, compressibility and shearing test were performed. Air pressure and outlet temperature are key factors that directly impact the drying kinetics and powder characteristics during spray-drying process. It was shown that the air pressure affects the particle size distribution by impacting the size of droplet exiting the nozzle. Moreover, small particles lead to more cohesive powder and less saturated color of powders. Higher outlet temperature results in lower moisture level particles which are less sticky and can explain a spray-drying yield increase and the higher cohesiveness; it also leads to particle with low water activity because of the intense evaporation rate. However, it induces a high hygroscopicity, thus, powders tend to get wet rapidly if they are not well stored. On the other hand, high temperature provokes a decrease of native serum proteins, which is positively correlated to gelation properties (gel point and firmness). Partial denaturation of serum proteins can improve functional properties of powder. The control of air pressure and outlet temperature during the spray-drying process significantly affects the physicochemical and functional properties of powder. This study permitted to better understand the links between physicochemical and functional properties of powder to identify correlations between air pressure and outlet temperature. Therefore, mathematical models have been developed, and the use of genetic algorithm will allow the optimization of powder functionalities.

Keywords: dairy powders, spray-drying, powders functionalities, design of experiment

Procedia PDF Downloads 41
4 Large Scale Method to Assess the Seismic Vulnerability of Heritage Buidings: Modal Updating of Numerical Models and Vulnerability Curves

Authors: Claire Limoge Schraen, Philippe Gueguen, Cedric Giry, Cedric Desprez, Frédéric Ragueneau

Abstract:

Mediterranean area is characterized by numerous monumental or vernacular masonry structures illustrating old ways of build and live. Those precious buildings are often poorly documented, present complex shapes and loadings, and are protected by the States, leading to legal constraints. This area also presents a moderate to high seismic activity. Even moderate earthquakes can be magnified by local site effects and cause collapse or significant damage. Moreover the structural resistance of masonry buildings, especially when less famous or located in rural zones has been generally lowered by many factors: poor maintenance, unsuitable restoration, ambient pollution, previous earthquakes. Recent earthquakes prove that any damage to these architectural witnesses to our past is irreversible, leading to the necessity of acting preventively. This means providing preventive assessments for hundreds of structures with no or few documents. In this context we want to propose a general method, based on hierarchized numerical models, to provide preliminary structural diagnoses at a regional scale, indicating whether more precise investigations and models are necessary for each building. To this aim, we adapt different tools, being developed such as photogrammetry or to be created such as a preprocessor starting from pictures to build meshes for a FEM software, in order to allow dynamic studies of the buildings of the panel. We made an inventory of 198 baroque chapels and churches situated in the French Alps. Then their structural characteristics have been determined thanks field surveys and the MicMac photogrammetric software. Using structural criteria, we determined eight types of churches and seven types for chapels. We studied their dynamical behavior thanks to CAST3M, using EC8 spectrum and accelerogramms of the studied zone. This allowed us quantifying the effect of the needed simplifications in the most sensitive zones and choosing the most effective ones. We also proposed threshold criteria based on the observed damages visible in the in situ surveys, old pictures and Italian code. They are relevant in linear models. To validate the structural types, we made a vibratory measures campaign using vibratory ambient noise and velocimeters. It also allowed us validating this method on old masonry and identifying the modal characteristics of 20 churches. Then we proceeded to a dynamic identification between numerical and experimental modes. So we updated the linear models thanks to material and geometrical parameters, often unknown because of the complexity of the structures and materials. The numerically optimized values have been verified thanks to the measures we made on the masonry components in situ and in laboratory. We are now working on non-linear models redistributing the strains. So we validate the damage threshold criteria which we use to compute the vulnerability curves of each defined structural type. Our actual results show a good correlation between experimental and numerical data, validating the final modeling simplifications and the global method. We now plan to use non-linear analysis in the critical zones in order to test reinforcement solutions.

Keywords: heritage structures, masonry numerical modeling, seismic vulnerability assessment, vibratory measure

Procedia PDF Downloads 466
3 Delivering Safer Clinical Trials; Using Electronic Healthcare Records (EHR) to Monitor, Detect and Report Adverse Events in Clinical Trials

Authors: Claire Williams

Abstract:

Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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2 Non-Thermal Pulsed Plasma Discharge for Contaminants of Emerging Concern Removal in Water

Authors: Davide Palma, Dimitra Papagiannaki, Marco Minella, Manuel Lai, Rita Binetti, Claire Richard

Abstract:

Modern analytical technologies allow us to detect water contaminants at trace and ultra-trace concentrations highlighting how a large number of organic compounds is not efficiently abated by most wastewater treatment facilities relying on biological processes; we usually refer to these micropollutants as contaminants of emerging concern (CECs). The availability of reliable end effective technologies, able to guarantee the high standards of water quality demanded by legislators worldwide, has therefore become a primary need. In this context, water plasma stands out among developing technologies as it is extremely effective in the abatement of numerous classes of pollutants, cost-effective, and environmentally friendly. In this work, a custom-built non-thermal pulsed plasma discharge generator was used to abate the concentration of selected CECs in the water samples. Samples were treated in a 50 mL pyrex reactor using two different types of plasma discharge occurring at the surface of the treated solution or, underwater, working with positive polarity. The distance between the tips of the electrodes determined where the discharge was formed: underwater when the distance was < 2mm, at the water surface when the distance was > 2 mm. Peak voltage was in the 100-130kV range with typical current values of 20-40 A. The duration of the pulse was 500 ns, and the frequency of discharge could be manually set between 5 and 45 Hz. Treatment of 100 µM diclofenac solution in MilliQ water, with a pulse frequency of 17Hz, revealed that surface discharge was more efficient in the degradation of diclofenac that was no longer detectable after 6 minutes of treatment. Over 30 minutes were required to obtain the same results with underwater discharge. These results are justified by the higher rate of H₂O₂ formation (21.80 µmolL⁻¹min⁻¹ for surface discharge against 1.20 µmolL⁻¹min⁻¹ for underwater discharge), larger discharge volume and UV light emission, high rate of ozone and NOx production (up to 800 and 1400 ppb respectively) observed when working with surface discharge. Then, the surface discharge was used for the treatment of the three selected perfluoroalkyl compounds, namely, perfluorooctanoic acid (PFOA), perfluorohexanoic acid (PFHxA), and pefluorooctanesulfonic acid (PFOS) both individually and in mixture, in ultrapure and groundwater matrices with initial concentration of 1 ppb. In both matrices, PFOS exhibited the best degradation reaching complete removal after 30 min of treatment (degradation rate 0.107 min⁻¹ in ultrapure water and 0.0633 min⁻¹ in groundwater), while the degradation rate of PFOA and PFHxA was slower of around 65% and 80%, respectively. Total nitrogen (TN) measurements revealed levels up to 45 mgL⁻¹h⁻¹ in water samples treated with surface discharge, while, in analogous samples treated with underwater discharge, TN increase was 5 to 10 times lower. These results can be explained by the significant NOx concentrations (over 1400 ppb) measured above functioning reactor operating with superficial discharge; rapid NOx hydrolysis led to nitrates accumulation in the solution explaining the observed evolution of TN values. Ionic chromatography measures confirmed that the vast majority of TN was under the form of nitrates. In conclusion, non-thermal pulsed plasma discharge, obtained with a custom-built generator, was proven to effectively degrade diclofenac in water matrices confirming the potential interest of this technology for wastewater treatment. The surface discharge was proven to be more effective in CECs removal due to the high rate of formation of H₂O₂, ozone, reactive radical species, and strong UV light emission. Furthermore, nitrates enriched water obtained after treatment could be an interesting added-value product to be used as fertilizer in agriculture. Acknowledgment: This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 765860.

Keywords: CECs removal, nitrogen fixation, non-thermal plasma, water treatment

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1 MANIFEST-2, a Global, Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAK Inhibitor-Naïve Myelofibrosis Patients

Authors: Claire Harrison, Raajit K. Rampal, Vikas Gupta, Srdan Verstovsek, Moshe Talpaz, Jean-Jacques Kiladjian, Ruben Mesa, Andrew Kuykendall, Alessandro Vannucchi, Francesca Palandri, Sebastian Grosicki, Timothy Devos, Eric Jourdan, Marielle J. Wondergem, Haifa Kathrin Al-Ali, Veronika Buxhofer-Ausch, Alberto Alvarez-Larrán, Sanjay Akhani, Rafael Muñoz-Carerras, Yury Sheykin, Gozde Colak, Morgan Harris, John Mascarenhas

Abstract:

Myelofibrosis (MF) is characterized by bone marrow fibrosis, anemia, splenomegaly and constitutional symptoms. Progressive bone marrow fibrosis results from aberrant megakaryopoeisis and expression of proinflammatory cytokines, both of which are heavily influenced by bromodomain and extraterminal domain (BET)-mediated gene regulation and lead to myeloproliferation and cytopenias. Pelabresib (CPI-0610) is an oral small-molecule investigational inhibitor of BET protein bromodomains currently being developed for the treatment of patients with MF. It is designed to downregulate BET target genes and modify nuclear factor kappa B (NF-κB) signaling. MANIFEST-2 was initiated based on data from Arm 3 of the ongoing Phase 2 MANIFEST study (NCT02158858), which is evaluating the combination of pelabresib and ruxolitinib in Janus kinase inhibitor (JAKi) treatment-naïve patients with MF. Primary endpoint analyses showed splenic and symptom responses in 68% and 56% of 84 enrolled patients, respectively. MANIFEST-2 (NCT04603495) is a global, Phase 3, randomized, double-blind, active-control study of pelabresib and ruxolitinib versus placebo and ruxolitinib in JAKi treatment-naïve patients with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The aim of this study is to evaluate the efficacy and safety of pelabresib in combination with ruxolitinib. Here we report updates from a recent protocol amendment. The MANIFEST-2 study schema is shown in Figure 1. Key eligibility criteria include a Dynamic International Prognostic Scoring System (DIPSS) score of Intermediate-1 or higher, platelet count ≥100 × 10^9/L, spleen volume ≥450 cc by computerized tomography or magnetic resonance imaging, ≥2 symptoms with an average score ≥3 or a Total Symptom Score (TSS) of ≥10 using the Myelofibrosis Symptom Assessment Form v4.0, peripheral blast count <5% and Eastern Cooperative Oncology Group performance status ≤2. Patient randomization will be stratified by DIPSS risk category (Intermediate-1 vs Intermediate-2 vs High), platelet count (>200 × 10^9/L vs 100–200 × 10^9/L) and spleen volume (≥1800 cm^3 vs <1800 cm^3). Double-blind treatment (pelabresib or matching placebo) will be administered once daily for 14 consecutive days, followed by a 7 day break, which is considered one cycle of treatment. Ruxolitinib will be administered twice daily for all 21 days of the cycle. The primary endpoint is SVR35 response (≥35% reduction in spleen volume from baseline) at Week 24, and the key secondary endpoint is TSS50 response (≥50% reduction in TSS from baseline) at Week 24. Other secondary endpoints include safety, pharmacokinetics, changes in bone marrow fibrosis, duration of SVR35 response, duration of TSS50 response, progression-free survival, overall survival, conversion from transfusion dependence to independence and rate of red blood cell transfusion for the first 24 weeks. Study recruitment is ongoing; 400 patients (200 per arm) from North America, Europe, Asia and Australia will be enrolled. The study opened for enrollment in November 2020. MANIFEST-2 was initiated based on data from the ongoing Phase 2 MANIFEST study with the aim of assessing the efficacy and safety of pelabresib and ruxolitinib in JAKi treatment-naïve patients with MF. MANIFEST-2 is currently open for enrollment.

Keywords: CPI-0610, JAKi treatment-naïve, MANIFEST-2, myelofibrosis, pelabresib

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