Yoxas/statistical_literacy huggingface dataset:
Intermediate acceptance criteria are the foundation for developing control strategies in process validation stage 1 in the pharmaceutical industry. At drug substance or product level such intermediate acceptance criteria for quality are available and referred to as specification limits. However, it often remains a challenge to define acceptance criteria for intermediate process steps. Available guidelines underpin the importance of intermediate acceptance criteria, because they are an integral part for setting up a control strategy for the manufacturing process. The guidelines recommend to base the definition of acceptance criteria on the entirety of process knowledge. Nevertheless, the guidelines remain unclear on how to derive such limits. Within this contribution we aim to present a sound data science methodology for the definition of intermediate acceptance criteria by putting the guidelines recommendations into practice (ICH Q6B, 1999). By using an integrated process model approach, we leverage manufacturing data and experimental data from small scale to derive intermediate acceptance criteria. The novelty of this approach is that the acceptance criteria are based on pre-defined out-of-specification probabilities, while also considering manufacturing variability in process parameters. In a case study we compare this methodology to a conventional +/- 3 standard deviations (3SD) approach and demonstrate that the presented methodology is superior to conventional approaches and provides a solid line of reasoning for justifying them in audits and regulatory submission.
Intermediate clinical endpoints (ICEs) are frequently used as primary endpoint in randomised trials (RCTs). We aim to assess whether changes in different ICEs can be used to predict changes in overall survival (OS) in adjuvant breast cancer trials. Individual patient level data from adjuvant phase III RCTs conducted by the Gruppo Italiano Mammella (GIM) and Mammella Intergruppo (MIG) study groups were used. ICEs were computed according to STEEP criteria. Using a two-stage meta-analytic model, we assessed the surrogacy of each ICE at both the outcome (i.e., OS and ICE are correlated irrespective of treatment) and trial (i.e., treatment effects on ICE and treatment effect on OS are correlated) levels. The following ICEs were considered as potential surrogate endpoints of OS: disease-free survival (DFS), distant disease-free survival (DDFS), distant relapse-free survival (DRFS), recurrence-free survival (RFS), recurrence-free interval (RFI), distant recurrence-free interval (DRFI), breast cancer-free interval (BCFI), and invasive breast cancer-free survival (IBCFS). The estimates of the degree of correlation were obtained by copula models and weighted linear regression. Kendall's τ and R2 ≥ 0.70 were considered as indicators of a clinically relevant surrogacy. Among the 12,397 patients enrolled from November 1992 to July 2012 in six RCTs, median age at enrolment was 57 years (interquartile range (IQR) 49-65). After a median follow-up of 10.3 years (IQR 6.4-14.5), 2131 (17.2%) OS events were observed, with 1390 (65.2%) attributed to breast cancer. At the outcome-level, Kendall's τ ranged from 0.69 for BCFI to 0.84 for DRFS. For DFS, DDFS, DRFS, RFS, RFI, DRFI, BCFI, and IBCFS endpoints, over 95% of the 8-year OS variability was attributable to the variation of the 5-year ICE. At the trial-level, treatment effects for the different ICEs and OS were strongly correlated, with the highest correlation for RFS and DRFS and the lowest for BCFI. Our results provide evidence supporting the use of DFS, DDFS, DRFS, RFS, RFI, DRFI, and IBCFS as primary endpoint in breast cancer adjuvant trials. This analysis was supported by the Italian Association for Cancer Research ("Associazione Italiana per la Ricerca sul Cancro", AIRC; IG 2017/20760) and by Italian Ministry of Health-5 × 1000 funds (years 2021-2022).
Internal Medicine (IM) residents frequently encounter, but feel unprepared to diagnose and treat, patients with substance use disorders (SUD). This is compounded by negative regard for patients with SUD. Optimal education strategies are needed to empower IM residents to care for patients with SUD. The objective of this study was to evaluate a brief SUD curriculum for IM residents, using resident-empaneled patients as an engaging educational strategy. Following a needs assessment, a 2-part SUD curriculum was developed for IM residents at the University of Chicago during the 2018-2019 academic year as part of the ambulatory curriculum. During sessions on Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD), a facilitator covered concepts about screening, diagnosis, and treatment. In session, residents completed structured worksheets applying concepts to one of their primary care patients. A post-session assessment included questions on knowledge, preparedness & attitudes. Resident needs assessment (n = 44/105, 42% response rate) showed 86% characterized instruction received during residency in SUD as none or too little, and residents did not feel prepared to treat SUD. Following the AUD session, all residents (n = 22) felt prepared to diagnose and treat AUD. After the OUD session, all residents (n = 19) felt prepared to diagnose, and 79% (n = 15) felt prepared to treat OUD. Residents planned to screen for SUD more or differently, initiate harm reduction strategies and increase consideration of pharmacotherapy. A brief curricular intervention for AUD and OUD using resident-empaneled patients can empower residents to integrate SUD diagnosis and management into practice.
International cleft lip and palate surgical charities recognize that speech therapy is essential for successful care of individuals after palate repair. The challenge is how to ensure that cleft speech interventionists (i.e., speech-language pathologists and other speech therapy providers) provide quality care. This exploratory study investigated effects of a two-stage cleft training in Oaxaca, Mexico, aimed at preparing speech interventionists to provide research-based services to individuals born with cleft palate. Changes in the interventionists' content knowledge and clinical skills were examined. Twenty-three cleft speech interventionists from Mexico, Guatemala, and Nicaragua participated in a hybrid two-stage training, completing an online Spanish cleft speech course and a 5-day in-person training in Oaxaca. In-person training included a didactic component and supervised clinical practice with 14 individuals with repaired cleft palates. Testing of interventionists' content knowledge and clinical skills via questionnaires occurred before the online course (Test 1), immediately before in-person training (Test 2), and immediately after in-person training (Test 3). Qualitative data on experience/practice were also collected. Significant increases in interventionists' overall content knowledge and clinical skills were found posttraining. Knowledge and clinical skills increased significantly between Tests 1 and 2. Clinical skills, but not knowledge, showed further significant increases between Tests 2 and 3. Posttraining, interventionists demonstrated greater expertise in research-based treatment, and fewer reported they would use nonspeech oral motor exercises (NSOME). Findings provide preliminary support for such two-stage international trainings in preparing local speech interventionists to deliver high-quality speech services to individuals born with cleft palate. While content knowledge appears to be acquired primarily from the online course, the two-stage training incorporating in-person supervised practice working with individuals born with cleft palate may best enhance continued clinical skill development, including replacement of NSOME with evidence-based speech treatment. Such trainings contribute to building capacity for sustainable quality services for this population in underresourced regions.
International sharing of cohort data for research is important and challenging. We explored the feasibility of multicohort federated analyses by examining associations between 3 pregnancy exposures (maternal education, exposure to green vegetation, and gestational diabetes) and offspring body mass index (BMI) from infancy to age 17 years. We used data from 18 cohorts (n = 206,180 mother-child pairs) from the EU Child Cohort Network and derived BMI at ages 0-1, 2-3, 4-7, 8-13, and 14-17 years. Associations were estimated using linear regression via 1-stage individual participant data meta-analysis using DataSHIELD. Associations between lower maternal education and higher child BMI emerged from age 4 and increased with age (difference in BMI z score comparing low with high education, at age 2-3 years = 0.03 (95% confidence interval (CI): 0.00, 0.05), at 4-7 years = 0.16 (95% CI: 0.14, 0.17), and at 8-13 years = 0.24 (95% CI: 0.22, 0.26)). Gestational diabetes was positively associated with BMI from age 8 years (BMI z score difference = 0.18, 95% CI: 0.12, 0.25) but not at younger ages; however, associations attenuated towards the null when restricted to cohorts that measured gestational diabetes via universal screening. Exposure to green vegetation was weakly associated with higher BMI up to age 1 year but not at older ages. Opportunities of cross-cohort federated analyses are discussed.
International student mobility (ISM) is increasingly utilised in higher education to allow students the opportunity to engage authentically with cultures outside their own, providing an opportunity for self-growth. These growth opportunities often extend skills such as cultural competency, academic learning and self-efficacy, all of which are important skills for diagnostic radiography graduates. This study explores the motivations, benefits and pitfalls of an ISM program and highlights key considerations for academics considering organising a program within their own university. This study utilised a combination of individual and small group interviews to collect data about diagnostic radiography students' motivations, perceived benefits and pitfalls of undertaking ISM. Data were analysed using reflexive thematic analysis and overarching themes were developed. Three themes were developed from the data, challenges and uncertainty, personal growth, and support. Participants undertaking ISM faced challenges such as cultural differences, as well as feelings of uncertainty. Additionally, they highlighted the importance of organisation in mitigating these challenges. Despite the challenges faced, participants reported significant personal growth and success as a result of the program, integral to this success was the support of their peers and academic advisors. ISM programs may lead to enhanced employability of diagnostic radiography graduates, with integral skills such as teamwork, communication cultural competence being enhanced in participants. The role of support during ISM is integral to the success of the program. It is imperative for academics organising ISM programs at their institutions to deliberately consider the way in which radiography students are supported both before and during the program to enhance the experience and ensure outcomes are maximised.
Internationalisation in higher education is essential, and although active learning methodologies are increasing and allow students to develop transversal skills, most still have a very local scope. In this context, the Collaborative Online International Learning (COIL) methodology is an interesting approach to benefit the students' development. It consists of an online program that involves creating multicultural teams to develop a specific learning project. Although this methodology is expanding, its use in physiology is still scarce. This paper aims to show an example of applying COIL methodology in physiology topics to enhance higher-education students' innovation and business skills. Our example project developed a sports-assessment service concept focused on physiology and biomechanics assessments. The program involved teams from Brazil, Germany, and Spain, comprising undergraduate and master students. Over seven weeks, these teams, mentored by professors and researchers, engaged in workshops covering COIL methodology, business model design, executive summary planning, economic analyses, and communication techniques. Key outcomes included learning new concepts, developing soft skills, building confidence in innovative solution proposals, and experiencing diverse cultures. Challenges faced were language barriers, scheduling, task complexity, and logistical issues. This experience confirms the effectiveness of incorporating programs using COIL methodology into educational curriculums. Doing so exposes physiology students to innovation, entrepreneurship, and business creation while strengthening their professional connections and opening up post-graduation opportunities.
Internationally, evidence exists that physicians use instant messaging services for communication tasks in everyday clinical practice However, there are only few data on physicians in Germany in this regard. Therefore, at the initiation of our project "DocTalk-Dialog meets Chatbot: Collaborative Learning and Teaching in the Process of Work", we conducted a stakeholder survey with an exploratory research approach. The aim was to gain initial insights into use of instant messaging software and attitudes towards data security and advantages and disadvantages before implementing a data-secure in-house messaging platform. N = 70 physicians at Charité-Universitätsmedizin Berlin completed an exploratory questionnaire with closed and open-ended questions. Quantitative data were analyzed using descriptive statistics and qualitative data using thematic analysis. The use of messenger software was not widespread in the sample studied. Physicians most frequently used face-to-face contact for communication. On average, up to ten instant messages were exchanged per day, mainly among colleagues, to answer mutual questions, and to send pictures. With a high awareness of privacy-related restrictions among participating physicians, advantages such as fast and uncomplicated communication were also highlighted. An instant messenger solution that complies with the German data protection guidelines is needed and should be investigated in more detail.
Internationally, the need to advance science, technology, engineering and mathematics (STEM) education is recognized as being vital for meeting social and economic challenges and developing a scientifically, mathematically, and technologically literate citizenry. In many countries, however, there are gender differences in the participation and achievement of girls and women in STEM education and STEM careers, usually to the disadvantage of females. This paper aims to identify challenges to female students' participation in STEM both at post-primary (secondary school) level and beyond in the Irish context. The research questions we aim to address in this paper are: (1) what are student attitudes towards science, technology, engineering and mathematics as measured through interest and perceived ability in STEM, students' valuing of STEM and students' commitment to STEM? and (2) what gender differences occur regarding students' attitudes to science, technology, engineering and mathematics? A survey was completed by 308 post-primary students in Ireland as part of a one-year research project titled "STEMChAT: Women as catalysts for change in STEM education." Data analysis compiled descriptive statistics, including response frequencies and percentages and median and interquartile range values, and compared gender differences in survey responses using the Kruskal-Wallis H Test. Results indicated that female students had significantly more positive attitudes to science compared to males while in comparison, males had significantly more positive responses to mathematics compared to females. Challenges regarding access to and understanding of STEM in the context of post-primary education are discussed.
Internet addiction has negative effects on psychological development, interpersonal relationships, and social adaptation in 10-year-old elementary school students. This study aimed to identify parental and child characteristics related to Internet addiction in lower-grade elementary school children. This study used a secondary data analysis. Data from the tenth Panel Study on Korean Children were used. In total, 1224 ten-year-old elementary school students were included in the analysis. The questionnaire included general, parental, and child characteristics. Of all child participants, 18.5% were in the high-risk group for Internet addiction. Lower paternal and maternal spousal satisfaction, maternal education level of high school graduate or lower, and greater permissive parenting by the mother were associated with higher odds of Internet addiction among their children. Moreover, boys and children who spent more than an hour per day without adults showed higher odds of Internet addiction. The results of this study indicate that the implementation of an intervention that improves parenting and family relationships and positively changes the environment in which children are brought up is necessary.
Internet addiction is an emerging mental health issue in this digital age. Nowadays, children start using the internet in early childhood, thus making them vulnerable to addictive use. Previous studies have reported that the risk of internet addiction tends to be higher in lower-income regions with lower quality of life, such as Indonesia. Indonesia has high risks and prevalence of internet addiction, including in children. Digital interventions have been developed as an option to combat internet addiction in children. However, little is known about what parents and therapists in Indonesia perceive about these types of interventions. This study aims to investigate the experiences, perceptions, and considerations of parents and therapists regarding digital interventions for combating internet addiction in young Indonesian children. This study used a qualitative exploratory approach through semistructured interviews. We involved 22 parents of children aged 7 to 11 years and 6 experienced internet addiction therapists for children. The interview data were transcribed and analyzed using thematic analysis. Participants in this study recognized 3 existing digital interventions to combat internet addiction: Google Family Link, YouTube Kids, and Apple parental control. They perceived that digital interventions could be beneficial in continuously promoting healthy digital behavior in children and supporting parents in supervision. However, the existing interventions were not highly used due to limitations such as the apps' functionality and usability, parental capability, parent-child relationships, cultural incompatibility, and data privacy. The findings suggest that digital interventions should focus not only on restricting and monitoring screen time but also on suggesting substitutive activities for children, developing children's competencies to combat addictive behavior, improving digital literacy in children and parents, and supporting parental decision-making to promote healthy digital behavior in their children. Suggestions for future digital interventions are provided, such as making the existing features more usable and relatable, investigating gamification features to enhance parental motivation and capability in managing their children's internet use, providing tailored or personalized content to suit users' characteristics, and considering the provision of training and information about the use of interventions and privacy agreements.
Internet Gaming Disorder (IGD), recognized as a mental disorder in both the Diagnostic and Statistical Manual (DSM-5) and International Classification of Diseases (ICD-11), poses significant threats to physical, social, and mental well-being. This study aims to delve into the experiences of individuals grappling with IGD. The study employed an interpretive phenomenology, conducting interviews with 10 graduate students at Makerere University. Participants were purposefully sampled until data saturation was achieved during interviews, which took place between May and July 2023. An interview guide facilitated data collection (Supplementary File 1), and thematic analysis was manually applied for data interpretation, utilizing intuition and imaginative approaches. The findings revealed that the majority of participants started gaming during childhood, starting with offline games. Exposure to gadgets and games, idle time, and stress emerged as key triggers for IGD. Participants reported experiencing sleep deficits, deteriorating interpersonal relationships, declining job performance, unhealthy eating habits, academic challenges, and wastage of money and time. The study also identified strategies employed by participants to mitigate their gaming behaviors, such as refraining from purchasing data, seeking support from friends, and uninstalling the game app, although relapses were common. The study highlights a global pattern of early initiation into gaming, emphasizing the need for early intervention and preventive measures. Factors such as easy accessibility and affordability of gaming platforms, idleness, and stress play significant roles in motivating internet gaming, contributing to a higher prevalence among the studied population. The research underscores the adverse effects of IGD on students, affecting academic performance, interpersonal relationships, and job performance. Notably, participants demonstrate agency in addressing IGD through practical coping strategies, including controlling data access, seeking social support, and uninstalling games. These coping mechanisms provide valuable insights into the complex nature of addressing IGD and form a basis for developing targeted interventions and support systems within the higher education setting in Uganda.
Internet has made the communication environment of ideological and political education (IPE) more complex for university students. Therefore, it is necessary to investigate the impact of university students' Internet literacy and contact on the communication effects of IPE. A total of 2283 Chinese university students were recruited to complete verified online questionnaires on Internet literacy, Internet contact duration, and the communication effects of IPE. SPSS V20 statistical software was used for the ordinal logistic regression analysis, chi-square test, and t-test. Up to 95.31 % of the university students obtained information through the Internet. There were significant differences between the ILS-high (54.93 %) and ILS-low (45.07 %) groups in both Internet literacy (P < 0.001) and Internet contact (P < 0.001). When comparing the communication effects of IPE between the ILS-high and ILS-low groups, both groups had the best emotional items and the worst cognitive dimensions. Internet literacy, Internet contact, major, and gender significantly impacted the communication effects of IPE. In the Internet era, there is an urgent need to improve university students' Internet literacy, so that they can have high Internet self-control contact skills to give full play to the positive guiding role of network media and improve the communication effects of university students' IPE.