Search results for: binary logistic regression

Authors: Genevaive Melendres

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School administrators face the reality of teachers losing their engagement, or schools losing the teachers. This study is then conducted to identify a structural model that best predict work engagement of private secondary teachers in Davao City. Ninety-three teachers from four sectarian schools and 56 teachers from four non-sectarian schools were involved in the completion of four survey instruments namely Organizational Climate Questionnaire, Leader Behavior Descriptive Questionnaire, Organizational Commitment Scales, and Utrecht Work Engagement Scales. Data were analyzed using frequency distribution, mean, standardized deviation, t-test for independent sample, Pearson r, stepwise multiple regression analysis, and structural equation modeling. Results show that schools have high level of organizational climate dimensions; leaders oftentimes show work-oriented and people-oriented behavior; teachers have high normative commitment and they are very often engaged at their work. Teachers from non-sectarian schools have higher organizational commitment than those from sectarian schools. Organizational climate and leadership behavior are positively related to and predict work engagement whereas commitment did not show any relationship. This study underscores the relative effects of three variables on the work engagement of teachers. After testing network of relationships and evaluating several models, a best-fitting model was found between leadership behavior and work engagement. The noteworthy findings suggest that principals pay attention and consistently evaluate their behavior for this best predicts the work engagement of the teachers. The study provides value to administrators who take decisions and create conditions in which teachers derive fulfillment.

Keywords: leadership behavior, organizational climate, organizational commitment, private secondary school teachers, structural model on work engagement

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Authors: Endang Lukitaningsih, Fathul Jannah, Arief R. Hakim, Ratna D. Puspita, Zullies Ikawati

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Rifampicin is a semisynthetic antibiotic derivative of rifamycin B produced by Streptomyces mediterranei. RIF has been used worldwide as first line drug-prescribed throughout tuberculosis therapy. This study aims to develop and to validate an HPLC method couple with a UV detection for determination of rifampicin in spiked human plasma and its application for bioequivalence study. The chromatographic separation was achieved on an RP-C18 column (LachromHitachi, 250 x 4.6 mm., 5μm), utilizing a mobile phase of phosphate buffer/acetonitrile (55:45, v/v, pH 6.8 ± 0.1) at a flow of 1.5 mL/min. Detection was carried out at 337 nm by using spectrophotometer. The developed method was statistically validated for the linearity, accuracy, limit of detection, limit of quantitation, precise and specifity. The specifity of the method was ascertained by comparing chromatograms of blank plasma and plasma containing rifampicin; the matrix and rifampicin were well separated. The limit of detection and limit of quantification were 0.7 µg/mL and 2.3 µg/mL, respectively. The regression curve of standard was linear (r > 0.999) over a range concentration of 20.0 – 100.0 µg/mL. The mean recovery of the method was 96.68 ± 8.06 %. Both intraday and interday precision data showed reproducibility (R.S.D. 2.98% and 1.13 %, respectively). Therefore, the method can be used for routine analysis of rifampicin in human plasma and in bioequivalence study. The validated method was successfully applied in pharmacokinetic and bioequivalence study of rifampicin tablet in a limited number of subjects (under an Ethical Clearance No. KE/FK/6201/EC/2015). The mean values of Cmax, Tmax, AUC(0-24) and AUC(o-∞) for the test formulation of rifampicin were 5.81 ± 0.88 µg/mL, 1.25 hour, 29.16 ± 4.05 µg/mL. h. and 29.41 ± 4.07 µg/mL. h., respectively. Meanwhile for the reference formulation, the values were 5.04 ± 0.54 µg/mL, 1.31 hour, 27.20 ± 3.98 µg/mL.h. and 27.49 ± 4.01 µg/mL.h. From bioequivalence study, the 90% CIs for the test formulation/reference formulation ratio for the logarithmic transformations of Cmax and AUC(0-24) were 97.96-129.48% and 99.13-120.02%, respectively. According to the bioequivamence test guidelines of the European Commission-European Medicines Agency, it can be concluded that the test formulation of rifampicin is bioequivalence with the reference formulation.

Keywords: validation, HPLC, plasma, bioequivalence

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Authors: Lian Tong, Yan Ye, Qiong Yan

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Background: Children with attention-deficit/hyperactivity disorder (ADHD) often experience sleep problems, but the comorbidity mechanism has not been sufficiently studied. This study aimed to determine the comorbidity of ADHD and sleep problems as well as the moderating effects of bedtime activities and depression/anxiety symptoms on the relationship between ADHD and sleep problems. Methods: We recruited 934 primary students from third to fifth grade and their parents by stratified random sampling from three primary schools in Shanghai, China. This study used parent-reported versions of the ADHD Rating Scale-IV, Children’s Sleep Habits Questionnaire, and Achenbach Child Behavior Checklist. We used hierarchical linear regression analysis to clarify the moderating effects of bedtime activities and depression/anxiety symptoms. Results: We found that children with more ADHD symptoms had shorter sleep durations and more sleep problems on weekdays. Screen time before bedtime strengthened the relationship between ADHD and sleep-disordered breathing. Children with more screen time were more likely to have sleep onset delay, while those with less screen time had more sleep onset problems with increasing ADHD symptoms. The high bedtime eating group experienced more night waking with increasing ADHD symptoms compared with the low bedtime eating group. Anxiety/depression exacerbated total sleep problems and further interacted with ADHD symptoms to predict sleep length and sleep duration problems. Conclusions: Bedtime activities and emotional problems had important moderating effects on the relationship between ADHD and sleep problems. These findings indicate that appropriate bedtime management and emotional management may reduce sleep problems and improve sleep duration for children with ADHD symptoms.

Keywords: ADHD, sleep problems, anxiety/depression, bedtime activities, children

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Authors: Yeşim Özer Özkan, Fatma Büşra Fincan

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Biased sample is a regression of an observation, design process and all of the specifications lead to tendency of a side or the situation of leaving from the objectivity. It is expected that, test items are answered by the students who come from different social groups and the same ability not to be different from each other. The importance of the expectation increases especially during student selection and placement examinations. For example, all of the test items should not be beneficial for just a male or female group. The aim of the research is an investigation of item bias whether or not the exam included in 2014 free boarding and scholarship examination in terms of gender variable. Data which belong to 5th, 6th, and 7th grade the secondary education students were obtained by the General Directorate of Measurement, Evaluation and Examination Services in Turkey. 20% students were selected randomly within 192090 students. Based on 38418 students’ exam paper were examined for determination item bias. Winsteps 3.8.1 package program was used to determine bias in analysis of data, according to Rasch Model in respect to gender variable. Mathematics items tests were examined in terms of gender bias. Firstly, confirmatory factor analysis was applied twenty-five math questions. After that, NFI, TLI, CFI, IFI, RFI, GFI, RMSEA, and SRMR were examined in order to be validity and values of goodness of fit. Modification index values of confirmatory factor analysis were examined and then some of the items were omitted because these items gave an error in terms of model conformity and conceptual. The analysis shows that in 2014 free boarding and scholarship examination exam does not include bias. This is an indication of the gender of the examination to be made in favor of or against different groups of students.

Keywords: gender, item bias, placement test, Rasch model

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Authors: Mari Jaakkola, Jasmiina Haverinen, Tiina Tolonen, Vesa Virtanen

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These process monitoring of biogas plant gives valuable information of the function of the process and help to maintain a stable process. The costs of basic monitoring are often much lower than the costs associated with re-establishing a biologically destabilised plant. Reactor acidification through reactor overload is one of the most common reasons for process deterioration in anaerobic digesters. This occurs because of a build-up of volatile fatty acids (VFAs) produced by acidogenic and acetogenic bacteria. VFAs cause pH values to decrease, and result in toxic conditions in the reactor. Ammonia ensures an adequate supply of nitrogen as a nutrient substance for anaerobic biomass and increases system's buffer capacity, counteracting acidification lead by VFA production. However, elevated ammonia concentration is detrimental to the process due to its toxic effect. VFAs are considered the most reliable analytes for process monitoring. To obtain accurate results, sample storage and transportation need to be carefully controlled. This may be a challenge for off-line laboratory analyses especially when the plant is located far away from the laboratory. The aim of this study was to investigate the correlation between fatty acids, ammonium, and bacteria in the anaerobic digestion samples obtained from an industrial biogas factory. The stability of the analytes was studied comparing the results of the on-site analyses performed in the factory site to the results of the samples stored at room temperature and -18°C (up to 30 days) after sampling. Samples were collected in the biogas plant consisting of three separate mesofilic AD reactors (4000 m³ each) where the main feedstock was swine slurry together with a complex mixture of agricultural plant and animal wastes. Individual VFAs, ammonium, and nutrients (K, Ca, Mg) were studied by capillary electrophoresis (CE). Longer chain fatty acids (oleic, hexadecanoic, and stearic acids) and bacterial profiles were studied by GC-MSD (Gas Chromatography-Mass Selective Detector) and 16S rDNA, respectively. On-site monitoring of the analytes was performed by CE. The main VFA in all samples was acetic acid. However, in one reactor sample elevated levels of several individual VFAs and long chain fatty acids were detected. Also bacterial profile of this sample differed from the profiles of other samples. Acetic acid decomposed fast when the sample was stored in a room temperature. All analytes were stable when stored in a freezer. Ammonium was stable even at a room temperature for the whole testing period. One reactor sample had higher concentration of VFAs and long chain fatty acids than other samples. CE was utilized successfully in the on-site analysis of separate VFAs and NH₄ in the biogas production site. Samples should be analysed in the sampling day if stored in RT or freezed for longer storage time. Fermentation reject can be stored (and transported) at ambient temperature at least for one month without loss of NH₄. This gives flexibility to the logistic solutions when reject is used as a fertilizer.

Keywords: anaerobic digestion, capillary electrophoresis, ammonium, bacteria

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Authors: F. A. Adesoji, A. A. Ayandele

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There has been a concern over non-responsiveness of educational programme in Nigeria’s higher institutions to adequately meet social needs. The study, therefore, investigated the effectiveness of basic elements of the Social Studies Curriculum, the contributions of the Teacher–Related Variables (TRV) such as qualification, area of specialization, teaching experience, teaching methods, gender and teaching facilities to the implementation of the curriculum (IOC) in the Colleges of Education (COEs). The study adopted the descriptive survey design. Four COEs in Oyo, Osun, Ondo and Lagos States were purposively selected. Stratified sampling technique was used to select 455 Social Studies students and 47 Social Studies lecturers. Stakeholders’ Perception of Social Studies Curriculum (r = 0.86), Social Studies Curriculum Resources scale (r = 0.78) and Social Studies Basic Concepts Test (r = 0.78) were used for data collection. Data were analysed using descriptive statistics, multiple regression, and t-test at 0.05 level of significance. COEs teachers and students rated the elements of the curriculum to be effective with mean scores x̄ =3.02 and x̄ =2.80 respectively; x̄ =5.00 and x̄ = 2.50 being the maximum and minimum mean scores. The finding showed average level of availability (x̄ =1.60), adequacy (x̄ =1.55) and utilization (x̄ =1.64) of teaching materials, x̄ =3.00 and x̄ =1.50 being maximum and minimum mean scores respectively. Academic performance of the students is on average with the mean score of x̄ =51.4775 out of maximum mean score of x̄ =100. The TRV and teaching facilities had significant composite contribution to IOC (F (6,45) = 3.92:R² = 0.26) with 39% contributions to the variance of IOC. Area of specialization (β= 29, t = 2.05) and teaching facilities (β = -25, t = 1.181) contributed significantly. The implementation of bachelor degree in Social Studies curriculum was effective in the colleges of education. There is the need to beef-up the provision of facilities to improve the implementation of the curriculum.

Keywords: bachelor degree in social studies, colleges of education in southwestern Nigeria, curriculum implementation, social studies curriculum

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Authors: Amare Nigatu, Mågne Bratveit, Bente E. Moen

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Background: Pesticide exposure is an important public health concern in Ethiopia, but there is limited information on pesticide intoxications. Residents may have an increased risk of pesticide exposure through proximity of their homes to farms using pesticides. Also the pesticide exposure might be related to employment at these farms. This study investigated the prevalence of acute pesticide intoxications (API) by residence proximity to a nearby flower farm and assessed if intoxications are related to working there or not. Methods: A cross-sectional survey involving 516 persons was conducted. Participants were grouped according to their residence proximity from a large flower farm; living within 5 kilometers and 5-12 kilometers away, respectively. In a structured interview, participants were asked if they had health symptoms within 48 hours of pesticide exposure in the past year. Those, who had experienced this and reported two or more typical pesticide intoxication symptoms, were considered as having had API. Chi-square and independent t-tests were used to compare categorical and continuous variables, respectively. Confounding variables were adjusted by using binomial regression model. Results: The prevalence of API in the past year among the residents in the study area was 26%, and it was higher in the population living close to the flower farm (42%) compared to those living far away (11%), prevalence ratio (PR) = 3.2, 95% CI: 2.2-4.8, adjusted for age, gender & education. A subgroup living close to the farm & working there had significantly more API (56%) than those living close & did not work there (16%), adjusted PR = 3.0, 95% CI: 1.8-4.9. Flower farm workers reported more API (56%) than those not working there (13%,), adjusted PR = 4.0, 95% CI: 2.9-5.6. Conclusion: The residents living closer than 5 kilometers to the flower farm reported significantly higher prevalence of API than those living 5-12 kilometers away. This increased risk of API was associated with work at the flower farm.

Keywords: acute pesticide intoxications, self-reported symptoms, flower farm workers, living proximity

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Authors: John Akinwumi Makinde

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Nigerian manufacturing industry, particularly the fast moving consumer producing firms play vital roles in Nigerian economy. This sector’s product acceptability is given very little attention along with social media advertising that communicate product information to audience across the globe need to be documented. Procter and Gamble Plc operate in Nigeria with appreciable number of fast moving consumer goods that service Nigerian economy. Social media advertising disposition of the company and product acceptability of the company deserve some elucidations. This study therefore examined the impact of social media advertising on product acceptability of FMCG in Nigerian manufacturing industry, using Procter and Gamble Plc as case study. The study employed the case study type of descriptive survey research design. The population consisted of 235 customers of G&P Plc, which were selected through random sampling method. A total of 235 copies of questionnaires titled 'Social Media Advertising and Product Acceptability (SMA-PA) Questionnaire' was administered and retrieved. Data generated were analysed using frequency distribution and regression analysis at 0.05 level. It was found that social media advertising positively and significantly motivated customers to buy product of P&G Plc (r =.147**, N= 235, p(.000) < .01). Findings also showed that social media advertising has significant impact on product acceptability of FCMG in P&G Plc (F(2,61)=22.250; R2=.629; P(.000) < .05). The study concluded that social media advertising is a determinant factor of consumer decision to accept fast moving consumer goods in Nigerian manufacturing industry. It is recommended that with the growing market of FMCG, there is need to educate the market with the product unique features, standard and quality on social media. Finally, Fast Moving Consumer Goods firms should deploy excellent marketing mix on social media.

Keywords: advertising, fast moving consumer goods, manufacturing industry, product acceptability, social media

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Authors: Sara Ataei, Maryam Taghizadeh-Ghehi, Amir Sarayani, Asieh Ashouri, Amirhossein Moslehi, Molouk Hadjibabaie, Kheirollah Gholami

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Background: Acute kidney injury (AKI) is common in hematopoietic stem cell transplantation (HSCT) patients with an incidence of 21–73%. Prevention and early diagnosis reduces the frequency and severity of this complication. Predictive biomarkers are of major importance to timely diagnosis. Neutrophil gelatinase associated lipocalin (NGAL) is a widely investigated novel biomarker for early diagnosis of AKI. However, no study assessed NGAL for AKI diagnosis in HSCT patients. Methods: We performed further analyses on gathered data from our recent trial to evaluate the performance of urine NGAL (uNGAL) as an indicator of AKI in 72 allogeneic HSCT patients. AKI diagnosis and severity were assessed using Risk–Injury–Failure–Loss–End-stage renal disease and AKI Network criteria. We assessed uNGAL on days -6, -3, +3, +9 and +15. Results: Time-dependent Cox regression analysis revealed a statistically significant relationship between uNGAL and AKI occurrence. (HR=1.04 (1.008-1.07), P=0.01). There was a relation between uNGAL day +9 to baseline ratio and incidence of AKI (unadjusted HR=.1.047(1.012-1.083), P<0.01). The area under the receiver-operating characteristic curve for day +9 to baseline ratio was 0.86 (0.74-0.99, P<0.01) and a cut-off value of 2.62 was 85% sensitive and 83% specific in predicting AKI. Conclusions: Our results indicated that increase in uNGAL augmented the risk of AKI and the changes of day +9 uNGAL concentrations from baseline could be of value for predicting AKI in HSCT patients. Additionally uNGAL changes preceded serum creatinine rises by nearly 2 days.

Keywords: acute kidney injury, hemtopoietic stem cell transplantation, neutrophil gelatinase-associated lipocalin, Receiver-operating characteristic curve

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Authors: Md. Wasiul Islam, Md. Jamius Shams Sowrov

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The Sundarbans is the largest single tract of mangrove forest in the world. This is located in the southwest corner of Bangladesh. This is a unique ecosystem which is a great breeding and nursing ground for a great biodiversity. It supports the livelihood of about 3.5 million coastal dwellers and also protects the coastal belt and inland areas from various natural calamities. Historically, the management of the Sundarbans was controlled by the Bangladesh Forest Department following top-down approach without the involvement of local communities. Such fence and fining-based blue-print approach was not effective to protect the forest which caused Sundarbans to degrade severely in the recent past. Fifty percent of the total tree cover has been lost in the last 30 years. Therefore, local multi-stakeholder based bottom-up co-management approach was introduced at some of the parts of the Sundarbans in 2006 to improve the biodiversity status by enhancing the protection level of the forest. Various co-management organizations were introduced under co-management approach where the local community people could actively involve in various activities related to the management and welfare of the Sundarbans including the decision-making process to achieve the goal. From this backdrop, the objective of the study was to assess the performance of co-management organizations to facilitate sustainable management of the Sundarbans mangrove forests. The qualitative study followed face-to-face interview to collect data using two sets of semi-structured questionnaires. A total of 40 respondents participated in the research that was from eight villagers under two forest ranges. 32 representatives from the local communities as well as 8 official representatives involved in co-management approach were interviewed using snowball sampling technique. The study shows that the co-management approach improved governance system of the Sundarbans through active participation of the local community people and their interactions with the officials via the platform of co-management organizations. It facilitated accountability and transparency system to some extent through following some formal and informal rules and regulations. It also improved the power structure of the management process by fostering local empowerment process particularly the women. Moreover, people were able to learn from their interactions with and within the co-management organizations as well as interventions improved environmental awareness and promoted social learning. The respondents considered good governance as the most important factor for achieving the goal of sustainable management and biodiversity conservation of the Sundarbans. The success of co-management planning process also depends on the active and functional participation of different stakeholders including the local communities where co-management organizations were considered as the most functional platform. However, the governance system was also facing various challenges which resulted in barriers to the sustainable management of the Sundarbans mangrove forest. But still there were some members involved in illegal forest operations and created obstacles against sustainable management of the Sundarbans. Respondents recommended greater patronization from the government, financial and logistic incentives for alternative income generation opportunities with effective participatory monitoring and evaluation system to improve sustainable management of the Sundarbans.

Keywords: Bangladesh, co-management approach, co-management organizations, governance, Sundarbans, sustainable management

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Authors: Joel S. Akintayo, Ramat T. Salman

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The stakeholders’ pressure on corporate managers to maintain firm’s profitability has created economic incentives for management to engage in earnings management practices. Therefore, this study examines the effects of audit quality and corporate governance on earnings management of quoted deposit money banks (DMBs) in Nigeria. This study specifically investigates the influence of audit tenure, audit fee, board independence, and board size on earnings management of DMBs. Explanatory research design was employed in carrying out the study while secondary data were sourced from the annual reports and accounts of all the 15 quoted DMBs in Nigerian Stock Exchange as at December 31, 2015 for a period of 10 years covering from 2006 to 2015. The data obtained for the study were analyzed using panel regression analysis approach. The findings reveal that board independence has a negative significant effect on earnings management at a 5% level of significance (p=0.002), while audit fee has a positive significant effect on earnings management at a 5% level of significance (p=0.013) and audit tenure has a negative significant effect on earnings management of DMBs at a 5% level of significance (p=0.003). Surprisingly, board size was statistically not significant at a 5% level of significance (p=0.086). The study concludes that high audit quality and sound corporate governance could improve the earnings quality of DMBs. Hence, the study recommends that the authorities saddled with the responsibility of banking supervision in Nigeria such the Securities and Exchange Commission (SEC) and CBN to advise the National Assembly in Nigeria to pass into law the three years professional requirement for audit tenure.

Keywords: audit quality, audit tenure, audit fee, board independence, corporate governance, earnings management

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Authors: Alyaa Farouk AbdelFattah Ibrahim, Agnes Monica, Dolores I. Cabansag

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The prevalence of diabetes mellitus is reaching epidemic proportions in many parts of the world causing an increasing public health concern. Cases of Type 2 diabetes are rapidly increasing in the Middle East region. Deprived of lifestyle deviations, a section of the Middle East’s inhabitants will be pretentious by 2035. As all sociocultural factors have created unhealthy lifestyles, which have become part of the social norms within Saudi society, thereby increased the prevalence of sedentary lifestyle and obesity in women living in Saudi Arabia. So, this study aimed to assess the impact of diabetes mellitus on quality of life of female nursing students in King Saud bin Abdulaziz University for Health Sciences, Riyadh. In a crossectional study design, 151 nursing students at King Saud bin Abdulaziz University for health sciences in Riyadh were included in the study. Biosociodemographic questionnaire and Short-Form 36 (SF-36) Health Related Quality of life Survey Arabic version were used for data collection, and all included students were screened for random blood glucose level. Results depicted that among 151 subjects included in the study 17 (11.3%) had diagnosed medical problems, and 29.4% of those participants with medical problems were diabetics. Univariate regression model for the relation between diabetes mellitus and overall percent score of SF-36 health survey domains showed no statistically significant difference between diabetic and non-diabetic subjects 0.990(0.931-1.053). In conclusion, although the diabetes prevalence was high among the study subjects it did not affect their quality of life may be due to age of the study population.

Keywords: diabetes mellitus, diabetes prevalence, quality of life, university students' health

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Authors: Sarpong Boateng, Rohit Balasundaram, Akua Afrah Amoah

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Introduction: Racial and Gender disparities have been found to be independently associated with Salivary Gland Cancers (SGCs) survival; however, to our best knowledge, there are no previous studies on the interplay of these social determinants on the prognosis of SGCs. The objective of this study was to examine the joint effect of race and gender on the survival of SGCs. Methods: We analyzed survival outcomes of 13,547 histologically confirmed cases of SGCs using the Surveillance Epidemiology and End Results (SEER) database (2004 to 2015). Multivariable Cox regression analysis and Kaplan-Meier curves were used to estimate hazard ratios (HR) after controlling for age, tumor characteristics, treatment type and year of diagnosis. Results: 73.5% of the participants were whites, 8.5% were blacks, 10.1% were Hispanics and 58.5% were males. Overall, males had poorer survival than females (HR = 1.16, p=0.003). In the adjusted multivariable model, there were no significant differences in survival by race. However, the interaction of gender and race was statistically significant (p=0.01) in Hispanic males. Thus, compared to White females (reference), Hispanic females had significantly better survival (HR=0.53), whiles Hispanic males had worse survival outcomes (HR=1.82) for SGCs. Conclusions: Our results show significant interactions between race and gender, with racial disparities varying across the different genders for SGCs survival. This study indicates that racial and gender differences are crucial factors to be considered in the prognostic counseling and management of patients with SGCs. Biologic factors, tumor genetic characteristics, chemotherapy, lifestyle, environmental exposures, and socioeconomic and dietary factors are potential yet proven reasons that could account for racial and gender differences in the survival of SGCs.

Keywords: salivary, cancer, survival, disparity, race, gender, SEER

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Authors: Syed Asif Ali Naqvi, Muhammad Azeem Tufail

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Inadequate sanitation causes direct costs of treating illnesses and loss of income through reduced productivity. This study estimated the economic cost of health (ECH) due to poor sanitation and factors determining the lack of access to latrine for the rural, backward hamlets and slums of district Faisalabad, Pakistan. Cross sectional data were collected and analyzed for the study. As the population under study was homogenous in nature, it is why a simple random sampling technique was used for the collection of data. Data of 440 households from 4 tehsils were gathered. The ordinary least square (OLS) model was used for health cost analysis, and the Probit regression model was employed for determining the factors responsible for inaccess to toilets. The results of the study showed that condition of toilets, situation of sewerage system, access to adequate sanitation, Cholera, diarrhea and dysentery, Water and Sanitation Agency (WASA) maintenance, source of medical treatment can plausibly have a significant connection with the dependent variable. Outcomes of the second model showed that the variables of education, family system, age, and type of dwelling have positive and significant sway with the dependent variable. Variable of age depicted an insignificant association with access to toilets. Variable of monetary expenses would negatively influence the dependent variable. Findings revealed the fact, health risks are often exacerbated by inadequate sanitation, and ultimately, the cost on health also surges. Public and community toilets for youths and social campaigning are suggested for public policy.

Keywords: sanitation, toilet, economic cost of health, water, Punjab

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Authors: Gemma Postil, Claire Zanin, Michael Halpin, Caroline Ritter

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Illness experience research typically focuses on people that are living with a medical condition; however, the broad consequences of the COVID-19 pandemic are impacting those without the virus itself, as many experienced extensive lockdowns, social isolation, and distress. Drawing on conceptual work in the illness experience literature, we argue that policy and social changes tied to COVID-19 produce biographical disruptions. In this sense, we argue that the COVID-19 pandemic produces illness experience without illness, as the pandemic comprehensively impacts health and biography. This paper draws on 30 in-depth interviews with young adults living in Prince Edward Island (PEI), which were conducted as part of a larger project to understand how young adults navigate compliance with the COVID-19 pandemic. We then inductively analyzed the interviews with a constructivist grounded theory approach. Specifically, we demonstrate that young adults living in PEI during the COVID-19 pandemic experienced biographical disruptions throughout the pandemic despite not contracting the virus. First, we detail how some participants experience biographical acceleration, with the pandemic accelerating relationships, home buying, and career planning. Second, we demonstrate biographical stagnation, wherein participants report being unable to pursue major life milestones. Lastly, we describe biographical regression, wherein participants feel they are losing ground during the pandemic and are actively falling behind their peers. These findings provide the novel application of illness experience concepts to the context of the COVID-19 pandemic, contribute to work on illness experience and ambiguity, and extend Bury’s conceptualization of biographical disruption. In conclusion, we demonstrate that young adults experienced the biographical disruption expected from having COVID-19 without having an illness, highlighting the depth to which the pandemic affected young adults.

Keywords: illness experience, lived experience, biographical disruption, COVID-19, young adults

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Authors: P. R. Prabhu, S. M. Kulkarni, S. S. Sharma, K. Jagannath, Achutha Kini U.

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In the present study, response surface methodology has been used to optimize turn-assisted deep cold rolling process of AISI 4140 steel. A regression model is developed to predict surface hardness and surface roughness using response surface methodology and central composite design. In the development of predictive model, deep cold rolling force, ball diameter, initial roughness of the workpiece, and number of tool passes are considered as model variables. The rolling force and the ball diameter are the significant factors on the surface hardness and ball diameter and numbers of tool passes are found to be significant for surface roughness. The predicted surface hardness and surface roughness values and the subsequent verification experiments under the optimal operating conditions confirmed the validity of the predicted model. The absolute average error between the experimental and predicted values at the optimal combination of parameter settings for surface hardness and surface roughness is calculated as 0.16% and 1.58% respectively. Using the optimal processing parameters, the hardness is improved from 225 to 306 HV, which resulted in an increase in the near surface hardness by about 36% and the surface roughness is improved from 4.84µm to 0.252 µm, which resulted in decrease in the surface roughness by about 95%. The depth of compression is found to be more than 300µm from the microstructure analysis and this is in correlation with the results obtained from the microhardness measurements. Taylor Hobson Talysurf tester, micro Vickers hardness tester, optical microscopy and X-ray diffractometer are used to characterize the modified surface layer.

Keywords: hardness, response surface methodology, microstructure, central composite design, deep cold rolling, surface roughness

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Authors: Lakmali Anthony, Madeline Gillies

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Background: Incisional and ventral hernias are highly prevalent, with primary ventral hernias occurring in approximately 20% of adults and incisional hernias developing in up to 30% of midline abdominal incisions. Recent data from the United States have shown an increasing incidence of elective incisional and ventral hernia repair (IVHR) and emergency repair of complicated hernias. This study examines Australian population trends in IVHR over a two-decade study period. Methods: This retrospective study was performed using procedure data from the Australian Institute of Health and Welfare, and population data from the Australian Bureau of Statistics captured between 2000 and 2021 to calculate incidence rates per 100,000 population by age and sex for selected subcategories of IVHR operations. Trends over time were evaluated using simple linear regression. Results: There were 809,308 IVHR operations performed in Australia during the study period. The cumulative incidence adjusted for the population was 182 per 100,000; this increased by 9.578 per year during the study period (95% CI = 8.431- 10.726, p<.001). IVHR for primary umbilical hernias experienced the most significant increase in population-adjusted incidence, 1.177 per year. (95% CI = 0.654- 1.701, p<.001). Emergency IVHR for incarcerated, obstructed, and strangulated hernias increased by 0.576 per year (95% CI = 0.510 -0.642, p<.001). Only 20.2% of IVHR procedures were performed as day surgery. Conclusions: Australia has seen a significant increase in IVHR operations performed in the last 20 years, particularly those for primary ventral hernias. IVHR for hernias complicated by incarceration, obstruction, and strangulation also increased significantly. The proportion of IVHR operations performed as day surgery is well below the target set by the Royal Australasian College of Surgeons. With the increasing incidence of IVHR operations and an increasing proportion of these being emergent, elective IVHR should be performed as day surgery when it is safe.

Keywords: ventral, incisional, hernia, trends

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Authors: Mohd Najib Mansor, Nur Syamilah Md. Noor, Abdul Rahim Anuar, Shazida Jan Mohd Khan, Ahmad Zubir Ibrahim, Badariah Hj Din, Abu Sufian Abu Bakar, Kalsom Kayat, Wan Nurmahfuzah Jannah Wan Mansor

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This study aimed and focused on the behavior of youth entrepreneurs’ especially entrepreneurial self-efficacy and the performance in micro SMEs in Malaysia. Entrepreneurship development calls for support from various quarters, and mostly the need exists to initiate a youth entrepreneurship culture and drive amongst the youth in the society. Although backed up by the government and non-government organizations, micro-entrepreneurs are still facing challenges which greatly delay their progress, growth and consequently their input towards economic advancement. Micro-entrepreneurs are confronted with unique difficulties such as uncertainty, innovation, and evolution. Reviews on the development of entrepreneurial characteristics such as need for achievement, internal locus of control, risk-taking and innovation and have been recognized as highly associated with entrepreneurial behavior. The data in this study was obtained from the Department of Statistics, Malaysia. A random sampling of 830 respondents was distributed to 14 states that involve of micro-entrepreneurs. The study adopted a quantitative approach whereby a set of questionnaire was used to gather data. Multiple regression analysis was chosen as a method of analysis testing. The result of this study is expected to provide insight into the factor affecting entrepreneurial behavior and performance of youth entrepreneurs in micro SMEs. The finding showed that the Malaysian youth entrepreneurs do not have the entrepreneurial self-efficacy within themselves in order to accomplish greater success in their business venture. The establishment of entrepreneurial schools to allow our youth to be exposed to entrepreneurship from an early age and the development of special training focuses on the creation of business network so that the continuous entrepreneurial culture is crafted.

Keywords: youth entrepreneurs, micro entrepreneurs, entrepreneurial self-efficacy, entrepreneurial performance

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Authors: Gülçin Akbas Uslu

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Honor cultures put importance on the sexual purity of women. Women are expected to avoid acts that may spoil their honor. The emphasis on honor leads to the subordination of women and the dominance of men. In order to protect and clean honor, women are exposed to physical and psychological violence. Therefore, understanding the motivations driving people to endorse honor bears importance. For this purpose, this study aims to explore honor endorsement from the joint perspective of System Justification Theory (SJT) and Regulatory Focus Theory (RFT). SJT asserts that people have a tendency to support and rationalize the system. The motivation to maintain the system may be a factor in the endorsement of honor. RFT proposes two distinct regulatory processes, namely promotion and prevention focus. Having a dominant prevention focus, such as a deep concern for responsibilities, risk avoidance, and minimizing negative outcomes, may have a role in honor. Data were collected conveniently from 366 participants (216 women; 150 men). Participants filled out Honor Endorsement Index, Honor Based System Justification Scale and Regulatory Focus Orientation Scale Results revealed that both regulatory focus and system justification play a role in understanding honor. One-way ANOVA findings showed that individuals with a dominant prevention focus endorse honor beliefs more than individuals with a dominant promotion focus. Besides, regression analysis revealed that prevention focus and system justification significantly and positively predict honor. Results provide clarifications for why honor has an important meaning in individuals’ life and why honor-based violence is approved. These findings bear great importance in Turkey, where emphasis on honor is high and can be used in reducing people’s adherence to honor, which is based on women’s sexuality and men’s power over women.

Keywords: honor, system justification theory, regulatory focus theory, prevention focus

Procedia PDF Downloads 154

Authors: Kelly Grani Yuen

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Accounting scandals and auditing frauds are perceived to be driven by aggressive companies and misrepresentation of audit reports. However, local legal systems and law enforcements may affect the services auditors provide to their ‘important’ clients. Under the civil law and common law jurisdictions, the standard setters, the government, and the regulatory bodies treat cases differently. As such, whether or not different forms of legal systems and extent of law enforcement plays an important role in auditor’s Audit Quality is a question this paper attempts to explore. The paper focuses on the investigation in Asia, where Hong Kong represents the common-law jurisdiction, while Taiwan and China represent the civil law jurisdiction. Only the ten reputable accounting firms are used in this study due to the differences in rankings and establishments of some of the small local audit firms. This will also contribute to the data collected between the years 2007-2013. By focusing on the use of multiple regression based on the dependent (Audit Quality) and independent variables (Client Importance, Law Enforcement, and Press Freedom), six different models are established. Results demonstrate that since different jurisdictions have different legal systems and market regulations, auditor’s treatment on ‘important’ clients will vary. However, with the moderators in place (law enforcement and press freedom), the relationship between client importance and audit quality may be smoothed out. With that in mind, this study contributes to local governments and standard setters’ consideration on legal reform and proper law enforcement in the market. Perhaps, with such modifications on the economic systems, collusion between companies and auditors can finally be put to a halt.

Keywords: audit quality, client importance, jurisdiction, modified audit opinions

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Authors: Said Rashid Aal Abdulsallam

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The purpose of this paper is to measure ISO 9001:2008 effectiveness and determines its impact on the performance dimensions in terms of service quality, operational performance and customer satisfaction from the perspectives of both service providers and receivers. The paper is based on an empirical study carried out on all the ISO 9001:2008 certified departments in the Ministry of Education in the Sultanate of Oman. Data were obtained from the certified departments and their equivalent clients through two structured online questionnaires. Exploratory factor analyses are applied to extract the underlying factors of the indicators of ISO 9001 objectives and performance dimensions. Multiple linear regression analyses are also applied in order to determine the impact of ISO 9001 effectiveness on the performance dimensions of the certified departments. The study sample includes all the ISO 9001 certified departments in the Ministry of Education. The study instruments used target both the service providers as well as the service receivers with the purpose of alleviating the subjective nature of the data collected from the service providers who may be biased in favour of ISO 9001 quality management system or their performance. The findings of the study verify the effectiveness of the application of ISO 9001:2008 quality management system. Additionally, the study reveals that the ISO 9001 certified departments have achieved the ISO 9001 the standard's objectives including prevention of nonconformities, continuous improvement and customer satisfaction focus at different rates. The study also proves that there is a significant relation between the achievement of the ISO 9001 standard objectives and the operational performance of the departments. Even though the operational performance service quality of the ISO 9001 certified departments has substantially improved from the perspective of the departments, the customer satisfaction has not notably increased from the perspective of the service receivers.

Keywords: iso 9001, customer satisfaction, operational performance, public organization, quality management

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Authors: Karina Reiter, Stefan Dullinger, Christoph Plutzar, Dietmar Moser

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Due to population growth and changing patterns of production and consumption, the demand for natural resources and, as a result, the pressure on Earth’s ecosystems are growing. Biodiversity mapping can be a useful tool for assessing species endangerment or detecting hotspots of extinction risks. This paper explores the benefits of using the change in trophic energy flows as a consequence of the human alteration of the biosphere in biodiversity mapping. To this end, multiple linear regression models were developed to explain species richness in areas where there is no human influence (i.e. wilderness) for three taxonomic groups (birds, mammals, amphibians). The models were then applied to predict (I) potential global species richness using potential natural vegetation (NPPpot) and (II) global ‘actual’ species richness after biomass appropriation using NPP remaining in ecosystems after harvest (NPPeco). By calculating the difference between predicted potential and predicted actual species numbers, maps of estimated species richness loss were generated. Results show that biomass appropriation for human use can indeed be linked to biodiversity loss. Areas for which the models predicted high species loss coincide with areas where species endangerment and extinctions are recorded to be particularly high by the International Union for Conservation of Nature and Natural Resources (IUCN). Furthermore, the analysis revealed that while the species distribution maps of the IUCN Red List of Threatened Species used for this research can determine hotspots of biodiversity loss in large parts of the world, the classification system for threatened and extinct species needs to be revised to better reflect local risks of extinction.

Keywords: biodiversity loss, biomass harvest, human appropriation of net primary production, species richness

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Authors: Panos Xenos, Milton Nektarios, John Yfantopoulos

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Background: Policy makers, professional organizations and payers have introduced a variety of initiatives and reforms for the health systems worldwide, aimed at improving hospital efficiency. Their efforts are concentrated in two main categories: to constrain increasing healthcare costs and to enhance quality of services provided. Research Objectives: This study examines the efficiency of 112 Greek public hospitals for the year 2009, evaluates the importance of bootstrapping techniques and investigates the effect of contextual factors on hospital efficiency. Furthermore, the effect of qualitative evidence, on hospital efficiency is explored using data from 28 large hospitals. Methods: We applied Data Envelopment Analysis, augmented by bootstrapping techniques, to estimate efficiency scores. In order to measure the effect of environmental factors on hospital efficiency we used Tobit regression analysis. The significance of our models is evaluated using statistical tests to compare distributions. Results: The Kolmogorov-Smirnov test between the original and the bootstrap-corrected efficiency indicates that their distributions are significantly different (p-value<0.01). The environmental factors, that seem to influence efficiency, are Occupancy Rating and the ratio between Outpatient Visits and Inpatient Days. Results indicate that the inclusion of the quality variable in DEA modelling generates statistically significant variations in efficiency scores (p-value<0.05). Conclusions: The inclusion of quality variables and the use of bootstrap resampling in efficiency analysis impose a statistically significant effect on the distribution of efficiency scores. As a policy conclusion we highlight the importance of these methods on hospital efficiency analysis and, by implication, on healthcare resource allocation.

Keywords: hospitals, efficiency, quality, data envelopment analysis, Greek public hospital sector

Procedia PDF Downloads 309

Authors: Sheeba Farhan

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This study is conducted to explore the predictive relationship of perceived stress and self-esteem with social support of students and to explore the factors, which contribute to develop or enhance the level of stress in students of private universities in Karachi-Pakistan. After literature review following hypotheses were formulated; 1)social support would predict perceived stress of students of business administration of private organizations of Higher education, 2) social support would predict the self-esteem of students of private organizations of Higher education, 3) there will be a relationship of perceived stress and self-esteem of students of private organizations of Higher education, 4) there will be a relationship of self esteem and social support of students of private organizations of Higher education. Sample of the study is comprise of 100 students of private organizations of Higher education in Karachi- Pakistan (i.e. males= 50 & females= 50). The age range of participants is 18-26 years. The measures, used in the study are: Demographic information form, a semi structured interview form, Rosenberg self esteem scale (Rosenberg, 1965) and perceived stress scale (Cohen, Kamarck, and Mermelstein, 1983) and multidimensional scale of perceived social support (Zimet, 1988) Descriptive statistics is used for getting a better statistical view of characteristics of sample. Regression analysis is used to explore the predictive relationship of study related stress and self esteem with academic achievement of students of private organizations of Higher education. Percentages and ratios were calculated to explore the level of perceived stress with respect to Socio-demographic characteristics in students of private organizations of Higher education. Finding shows that social support is significantly associated with the higher level of self-esteem among students of graduation but insignificantly associated with stress that has been experienced by them. These results are correlated with a wide variety of studies in which social support has proposed to be a predictor of well being for the students.

Keywords: private universities of Karachi-Pakistan, Self-esteem, social support, stress

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Authors: Masoud Ghahvechi Pour

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Risk management is a systematic and regular process of identifying, analyzing and responding to risks throughout the project's life cycle in order to achieve the optimal level of elimination, reduction or control of risk. The purpose of project risk management is to increase the probability and effect of positive events and reduce the probability and effect of unpleasant events on the project. Risk management is one of the most fundamental parts of project management, so that unmanaged or untransmitted risks can be one of the primary factors of failure in a project. Effective risk management does not apply to risk regression, which is apparently the cheapest option of the activity. However, the main problem with this option is the economic sensitivity, because what is potentially profitable is by definition risky, and what does not pose a risk is economically interesting and does not bring tangible benefits. Therefore, in relation to the implemented project, effective risk management is finding a "middle ground" in its management, which includes, on the one hand, protection against risk from a negative direction by means of accurate identification and classification of risk, which leads to analysis And it becomes a comprehensive analysis. On the other hand, management using all mathematical and analytical tools should be based on checking the maximum benefits of these decisions. Detailed analysis, taking into account all aspects of the company, including stakeholder analysis, will allow us to add what will become tangible benefits for our project in the future to effective risk management. Identifying the risk of the project is based on the theory that which type of risk may affect the project, and also refers to specific parameters and estimating the probability of their occurrence in the project. These conditions can be divided into three groups: certainty, uncertainty, and risk, which in turn support three types of investment: risk preference, risk neutrality, specific risk deviation, and its measurement. The result of risk identification and project analysis is a list of events that indicate the cause and probability of an event, and a final assessment of its impact on the environment.

Keywords: risk, management, knowledge, risk management

Procedia PDF Downloads 66

Authors: Salihah Alghamdi, Surajit Ray

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Space-time data can be observed over irregularly shaped manifolds, which might have complex boundaries or interior gaps. Most of the existing methods do not consider the shape of the data, and as a result, it is difficult to model irregularly shaped data accommodating the complex domain. We used a method that can deal with space-time data that are distributed over non-planner shaped regions. The method is based on partial differential equations and finite element analysis. The model can be estimated using a penalized least squares approach with a regularization term that controls the over-fitting. The model is regularized using two roughness penalties, which consider the spatial and temporal regularities separately. The integrated square of the second derivative of the basis function is used as temporal penalty. While the spatial penalty consists of the integrated square of Laplace operator, which is integrated exclusively over the domain of interest that is determined using finite element technique. In this paper, we applied a spatio-temporal regression model with partial differential equations regularization (ST-PDE) approach to analyze a remote sensing data measuring the greenness of vegetation, measure by an index called enhanced vegetation index (EVI). The EVI data consist of measurements that take values between -1 and 1 reflecting the level of greenness of some region over a period of time. We applied (ST-PDE) approach to irregular shaped region of the EVI data. The approach efficiently accommodates the irregular shaped regions taking into account the complex boundaries rather than smoothing across the boundaries. Furthermore, the approach succeeds in capturing the temporal variation in the data.

Keywords: irregularly shaped domain, partial differential equations, finite element analysis, complex boundray

Procedia PDF Downloads 140

Authors: Célia Barreto Carvalho, Carolina da Motta, José Pinto-Gouveia, Ermelindo Bernardo Peixoto

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Auditory hallucinations among the most invalidating and distressing experiences reported by patients diagnosed with schizophrenia, leading to feelings of powerlessness and helplessness towards their illness. In more severe cases, these auditory hallucinations can take the form of commanding voices, which are often related to high suicidality rates in these patients. Several authors propose that the meanings attributed to the hallucinatory experience, rather than characteristics like form and content, can be determinant in patients’ reactions to hallucinatory activity, particularly in the case of voice-hearing experiences. In this study, 48 patients diagnosed with paranoid schizophrenia presenting auditory hallucinations were studied. Multiple regression analyses were computed to study the influence of several developmental aspects, such as family and social dynamics, bullying, depression, and socio-cognitive variables on the auditory hallucinations, on patients’ attributions and relationships with their voices, and on the resulting invalidation of hallucinatory experience. Overall, results showed how relationships with voices can mirror several aspects of interpersonal relationship with others, and how self-schemas, depression and actual social relationships help shaping the voice-hearing experience. Early experiences of victimization and submission help predict the attributions of omnipotence of the voices, and increased hostility from parents seems to increase the malevolence of the voices, suggesting that socio-cognitive factors can significantly contribute to the etiology and maintenance of auditory hallucinations. The understanding of the characteristics of auditory hallucinations and the relationships patients established with their voices can allow the development of more promising therapeutic interventions that can be more effective in decreasing invalidation caused by this devastating mental illness.

Keywords: auditory hallucination, beliefs, life events, schizophrenia

Procedia PDF Downloads 452

Authors: Antonia Hoffmann, Andrea Stübner

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Resource scarcity and rising material prices are forcing companies to rethink their business models. The conventional linear system of economic growth and rising social needs further exacerbates the problem of resource scarcity. Therefore, it is necessary to separate economic growth from resource consumption. This can be achieved through the circular economy (CE), which focuses on sustainable product life cycles. However, companies face challenges in implementing CE into their businesses. Small and medium-sized enterprises are particularly affected by these problems, as they have a limited resource base. Collaboration and social interaction between different actors can help to overcome these obstacles. Based on a self-generated sample of 1,023 German small and medium-sized enterprises, we use a questionnaire to investigate the influence of social capital and its three dimensions - structural, relational, and cognitive capital - on the implementation of CE and the mediating effect of dynamic capabilities in explaining these relationships. Using regression analyses and structural equation modeling, we find that social capital is positively associated with CE implementation and dynamic capabilities partially mediate this relationship. Interestingly, our findings suggest that not all social capital dimensions are equally important for CE implementation. We theoretically and empirically explore the network forms of social capital and extend the CE literature by suggesting that dynamic capabilities help organizations leverage social capital to drive the implementation of CE practices. The findings of this study allow us to suggest several implications for managers and institutions. From a practical perspective, our study contributes to building circular production and service capabilities in small and medium-sized enterprises. Various CE activities can transform products and services to contribute to a better and more responsible world.

Keywords: circular economy, dynamic capabilities, SMEs, social capital

Procedia PDF Downloads 82

Authors: Ade Oyedijo

Abstract:

This paper reports the findings of a study on the strategic and organizational antecedents and effects of two opposing pay patterns used by some manufacturing companies in Lagos Nigeria with particular reference to the behavioural correlates of the pay strategies considered. The assumed relationship between pay strategies and some organizational correlates such as business and corporate strategies and firm size was considered problematic in view of their likely implications for employee motivation and citizenship behaviour and firm performance. The survey research method was used for the study. Structured, close ended questions were used to collect primary data from the respondents. A multipart Likert scale was used to measure the pay orientations of the respondent firms and the job and organizational involvement of the respondent employees. Utilizing hierarchical linear regression method and "t-test" to analyze the data obtained from 48 manufacturing companies of various sizes and strategies, it was found that the dominant pattern of employee compensation in the sampled manufacturing companies. The study also revealed that the choice of a pay strategy was strongly influenced by organizational size as well as the type of business and corporate level strategies adopted by afirm. Firms pursuing a strategy of related and unrelated diversification are more likely to adopt the algorithmic compensation system than single product firms because of their relatively larger size and scope. However; firms that pursue a competitive advantage through a business level strategy of cost efficiency are more likely to use the experiential, variable pay strategy. The study found that an algorithmic compensation strategy is as effective as experiential compensation strategy in the promotion of organizational citizenship behaviour and motivation of employees.

Keywords: compensation, corporate strategy, business strategy, motivation, citizenship behaviour, algorithmic, experiential, organizational commitment, work environment

Procedia PDF Downloads 391

Authors: Salwa M. Almomen, Mona A. Almaghrabi, Saja M. Alhabardi, Adel A. Alrwisan

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Background: Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders. Methods: We examined the clinical review documents for drugs approved in the US from 2011 to 2016 to evaluate their hepatic safety profile. Predictors: we assessed whether these medications meet Hy’s Law with hepatotoxicity grade ≥ 3, labeled hepatic adverse effects at approval, or accelerated approval status. Outcome: post-marketing regulatory action related to hepatotoxicity, including product withdrawal or updates to warning, precaution, or adverse effects sections. Statistical analysis: drugs were included in the analysis from the time of approval until the end of 2019 or the first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. Results: We included 192 medications in the study. We classified 48 drugs as having grade ≥ 3 hepatotoxicities, 43 had accelerated approval status, and 74 had labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥ 3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17-2.23), 0.92 (95%CI, 0.29-2.93) for a drug approved via accelerated approval program, and was 0.91 (95%CI, 0.33-2.56) for drugs with labeled hepatotoxicity information at approval time. Conclusion: This study does not provide conclusive evidence on the association between post-marketing regulatory action and grade ≥ 3 hepatotoxicity, accelerated approval status, or availability of labeled information at approval due to sampling size and channeling bias.

Keywords: accelerated approvals, hepatic adverse effects, drug-induced liver injury, hepatotoxicity predictors, post-marketing withdrawal

Procedia PDF Downloads 152