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The European Union (EU) Medical Device Regulations (MDR) 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study aims to investigate the impact of these strengthened requirements on medical device manufacturers by investigating the challenges they encounter while generating an MDR-compliant clinical evaluation report.

A systematic literature review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method of peer-reviewed literature and various government jurisdictional reports and legislation.

The findings from the study understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant clinical evaluation report. Resulting from the challenges they are facing, manufacturers of certain CE-marked medical devices are planning to remove (and have removed) devices from the EU market upon expiration of their certificate, and in the case of new and innovative devices, some manufacturers are planning to launch in other markets ahead of the EU. These challenges will lead to a potential shortage of certain medical devices in the EU and a delay in access to new devices, thereby negatively impacting patients’ quality of life.

This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the EU. A limitation is the lack of literature analysing the regulations and their effects.

This study has both theoretical contributions in that, to the best of the authors’ knowledge, it is the first detailed and systematic review of the new MDR Regulations and has implications for practice as manufacturers and policymakers can leverage it alike to understand the challenges of the new MDR.

Imprisonment impacts women’s childbearing and mothering experiences. Using sociological concepts of total institutions, pains of imprisonment and gendered pains of imprisonment, this study aims to explore the childbearing experiences of 18 Filipino incarcerated women.

A qualitative, inductive approach was undertaken to explore imprisoned women’s pregnancy experiences. This research project used reflexive thematic analysis to examine the data from semi-structured interviews with 18 Filipino pregnant prisoners.

The participants’ experiences of childbearing in prison were reflected in three overarching themes: lack of autonomy over pregnancy; reduced capacity to manage discomforts and needs; and coping with prison deprivations. These themes embody women’s experiences of how imprisonment disrupts Filipino women’s childbearing and mothering experiences. Furthermore, the results illustrated how the women navigated the prison regime to address their needs and cope with the pains of imprisonment.

Although there is a small but growing body of research specifically focusing on mothering and imprisonment, little consideration has been given to analyzing Filipino women’s pregnancy experiences in custody. This paper highlights an urgent need to reform correctional policies and practices to address incarcerated women’s distinct needs.

This study aims to examine whether inmate’s social support network is related to changes in anthropometric data among individuals in Canadian correctional facilities.

Methods: A total of 754 participants in federal correctional facilities who had been incarcerated for at least six months responded to the questionnaire by interview regarding their social support network. Chi-square tests and non-parametric tests for median comparison were used to measure changes in anthropometric data [weight and body mass index (BMI)] between the date of admission into custody and the date of the interview. Subsequently, a multivariate regression analysis for BMI change was conducted to adjust for covariates such as sex, age and ethnicity.

Results: Participants who received more than two visits per month had significantly lower weight gain (2.6 kg) than those who received less than one visit per month (7.1 kg, p = 0.02). Similar results were observed for the average change in BMI (p = 0.01). The influence of an external social support network on BMI change remained significant after adjusting for covariates. Conclusions: An individual's external social support network (outside the prison environment) may protect against weight gain in correctional facilities. Given how social support will vary based on the prison context by country and jurisdiction, individual and organizational strategies should be considered to maintain a healthy social support network and increase the number of visits (at every stage of incarceration) to counteract this weight gain and its adverse health consequences.

The social support network outside the prison environment may protect against weight gain in correctional facilities. Strategies should be considered to maintain a healthy social support network and increase the number of visits to counteract this weight gain and its adverse health consequences.

Research shows that there are mechanisms of information simplification that lead to the danger that first, laypeople rely on their own epistemological skills when assessing scientific claims. Second, laypeople underestimate their dependence on experts when they receive simplified information. This underestimation can be problematic because scientific knowledge, due to its complexity, usually cannot be fully understood without further advice from experts. Compared to laypersons, adult education practitioners can be expected to have a higher level of scientific literacy in relation to knowledge in their professional field because they are familiar with the structure of knowledge through their formal education. The present study examines whether the “easiness effect” also occurs in adult education practitioners when they read simplified and highly simplified texts about research findings.

The sample consisted of 1.267 continuing education institutions. For the survey experiment, particioants were randomly assigned to tree text types at the end of the survey: easy, less scientific and scientific text. We used the difference-in-difference method to analyze the data.

The study examined whether easily presented research findings influenced self-assessment and reliance on experts. The results of our study support the hypothesis that the easiness effect is also present among professional practitioners.

The use of clear and nontechnical language is essential for ensuring that scientific knowledge is accessible and utilizable outside of academic circles. This aspect gains particular significance in educational research, as it enables professional practitioners to comprehend and ideally implement, research findings in their daily routines to address and resolve real-world challenges in their educational environments. Previous studies have demonstrated that the way text is presented influences laypeople's perceived reliance on experts. Building upon the conceptual framework of the easiness effect, this survey experiment took an additional step by focusing specifically on a targeted audience: professional practitioners in adult education.

This study investigates whether the underrepresentation of women in executive-level roles within the supply chain management (SCM) field is justified or the result of gender injustices. The analysis examines if there is a gender compensation gap within executive-level SCM roles and whether performance differences or other observable factors explain disparities.

Publicly reported executive compensation and financial data are merged to empirically test if gender differences exist and investigate whether the underrepresentation of women in executive-level SCM roles is unjust.

Women occupy only 6.29% of the positions in the sample of 447 SCM executives. Unlike prior studies, we find that women executives receive higher compensation. The analysis does not identify observable factors explaining the limited inclusion of women in top-level roles, suggesting that gender injustices are prevalent in SCM.

This study only considers observable factors and cannot conclusively determine if discrimination is occurring. The low level of inclusion of women in executive roles suggests that gender injustice is intrinsic within the SCM profession. These findings will hopefully motivate firms to undertake transformative actions that result in outcomes that advance gender equity, ultimately leading to social justice for female SCM executives.

The use of social justice and feminist theories, a focus on SCM roles, and an empirical methodology utilizing objective measures represents a novel approach to investigating gender discrimination in SCM organizations, complementing prior survey-based studies.

This qualitative study interrogates the barriers that historically disadvantaged higher education students in South Africa face when it comes to access and success. It specifically explores the challenges black students encounter in gaining epistemic access within the South African higher education system.

This research draws upon empirical data collected from a mixed-methods research project conducted at six higher education institutions. It focuses on issues of epistemic access and success within humanities and sciences faculties. The dataset comprises interview transcripts involving 34 student and ten staff cases. Thematic analysis, aided by MaxQDA software, was meticulously conducted to extract and synthesise meaningful themes, crafting comprehensive narratives.

The study uncovers multifaceted challenges, including difficulties in understanding the admission process, financial barriers and language proficiency issues, faced by disadvantaged students when accessing universities and transitioning from basic to higher education. The research emphasises universities taking proactive measures, such as providing comprehensive early support, identifying at-risk students and collaborating with schools to prepare prospective students better. It advocates for the potential of resilience theory in addressing social justice issues related to access and success for these students. Furthermore, the study recommends developing inclusive curricula and underscores the need for universities to actively support disadvantaged students academically and socially.

This research departs from the conventional focus on physical access to universities, introducing a more comprehensive perspective that emphasises epistemic access as a pivotal aspect of higher education. Drawing on empirical data, it sheds light on the obstacles faced by disadvantaged students during the transition from high school to higher education while also exploring their resilience strategies.

This introduction aims to set the context for the subsequent chapters that problematize various aspects of social justice, equity, and inclusion through particular lenses, and/or methodologies. This is done by presenting the ‘problem’ of social justice and equity in education, while simultaneously making links with the Sustainable Development Goals (SDGs). The term ‘social justice’ is appearing in numerous public texts and discourses within the education field, thus becoming a key concept in current education policy and practice. Moreover, the concept of social justice is crucial to theorizing about education and schooling, consequently being considered by politicians, policymakers, and practitioners in their thinking about the nature of education and the purpose of schools. Regrettably, education practitioners, researchers, and policymakers often utilize this umbrella term (social justice) while leaving out salient details about its social, cultural, economic, and political bearing. Notwithstanding the unanimous agreement on the desirability of social justice as an educational goal, this is complemented by a parallel contestation over its actual meaning and application in relation to schooling, that is, in relation to the formulation of policy and how it is to be included in practice. This chapter seeks to unravel the conceptual confusion around the terms social justice, equity, and inclusion in relation to schooling and education, through an exploration of the existing literature in the field.

The purpose of this paper is to investigate the ending of fee-free higher education in Australia for overseas students in the 1980s, and the ways in which the government managed the diplomatic relationships that were affected by this policy shift. The introduction of fee-free higher education in Australia in 1974 was incredibly popular, and the end of the program in the late 1980s created difficulties for individuals, families and diplomatic relationships.

Using a mix of secondary sources and archival documents, this paper has a historiographical element, and an element of analysis.

This research finds that the ending of fee-free education created significant diplomatic issues with a number of Australia’s regional neighbours. It also created issues for individual students and families. The solution to these problems was, in large part, a scholarship scheme called the Equity and Merit Scholarship Scheme (EMSS). The EMSS was designed, in part, to address the issues created by the end of the fee-free program. However, the design of the scholarship scheme also created its own diplomatic issues with a different cohort of nation states.

There is limited scholarly research into the history of international education policy in Australia. This research draws on the work of some scholars of international scholarships, as well as historians of universities and education more broadly. This research adds to a growing body of work in the field of Australian international education history.

The aim of this paper is to provide insights and knowledge about the motivations and implications for social enterprises' participation in SIBs, particularly in terms of collaboration and partnership with the public sector, as well as the different positions on this issue. The overall aim, therefore, is to show how social enterprises and public organisations have interacted in the context of SIBs and what has been achieved by participating.

This multiple case study approach applies qualitative methods like observations and semi-structured and unstructured interviews.

The study shows that SIBs can be an option for financing social enterprises within a strategy of income diversification and resource dependency. Despite tensions and complexities, SIBs can renew the traditional funding relationship by adding innovation, strengthening the co-creation process and creating a stable relationship.

Research findings may lack generalisability due to the specific context in which the case study is rooted.

The paper offers practical implications in terms of insights and suggestions for social enterprises and the public sector interested in developing the scheme.

This paper adds the voice and perspective of social enterprises on the relationship with the public sector within the framework of SIBs initiatives.

This chapter discusses the findings of doctoral research into further education lecturers' and middle managers' perceptions of how Continuing Professional Development (CPD) in the sector is planned and implemented. Thematic analysis revealed that mandatory CPD is perceived to: involve conflicting purposes between those planning it and its recipients (deriving from divergent understandings of professionalism and the role of CPD among stakeholders); and be characterised as mostly generic, didactic, and ineffective, leading lecturers to compensate by engaging in additional, separate forms of CPD. This chapter demonstrates the value of practice-based doctoral study in enabling the voices of educators to be positioned at the centre of an exploration of their own professional learning.