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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.

All colleges of medicine in the Gulf Cooperation Council (GCC) adopt English as a language of instructions. This study aimed to examine medical students' views on introducing medical terminology in Arabic within an English-based curriculum.

This descriptive study targeted preclinical second- and fourth-year students in the College of Medicine and Medical Sciences at the Arabian Gulf University, during the academic year 2022–2023 (n = 407). Within the pharmacology teaching material in unit I (second year) and unit VIII (fourth year), which are taught in English, students were provided with medical terms in Arabic. At the end of these two units, students' views were sought by using a self-administered questionnaire.

The number of respondents was 263 (response rate 64.1%: 22.2% males, 77.8% females). Most participants received their school education mainly in Arabic (78.8%). A significant percentage of students believed that providing Arabic terms helped their learning (79.8%). If pharmacology is taught exclusively in English, majority of the students anticipated to face difficulties when explaining drug treatment to their patients in the future (71.3%). Most respondents expected this intervention to help them communicate with patients (86.7%), and preferred to include it in the clinical skills training (82.2%). The second-year students and those whose school education was mainly in Arabic were more likely to agree to the intervention (p < 0.05 for both).

The introduction of medical terms in Arabic is an acceptable alternative to complete Arabization, and is believed to help students in their learning and communication with their patients.

The purpose of this study is to evaluate the determinants of health outcomes of dialysis patients, while specifically focusing on the role of dialysis process measures and dialysis practice characteristics. The dialysis industry is facing a major transition from a volume-based health care system to a value-based cost-efficient care model, in the USA. Under the bundled Prospective Payment System, the treatment-based payment model is subject to meeting quality thresholds as defined by clinical process measures including dialysis adequacy and anemia management. Few studies have focused on studying these two processes and their association with the quality of patient health outcomes.

In this study, the authors focus on identifying the determinants of patient health outcomes among freestanding dialysis clinics, using a large cross-sectional data set of 4,571 dialysis clinics in the USA. The authors use econometric analyses to estimate the association between dialysis facility characteristics and practice patterns and their association with dialysis process measures and hospitalization risk.

The authors find that reusing dialyzers and increasing the number of dialysis stations is associated with higher levels of clinical quality. This research indicates that deploying more nurses on-site allows patients to avail adequate dialysis, while increasing the supply of physicians can hurt anemia control process. In addition, the authors report that offering peritoneal dialysis and late night shifts are not beneficial practices in terms of their impact on the hospitalization risk.

While early studies of dialysis care mainly focused on the associations between practice patterns and patient outcomes, this research reveals the underlying mechanisms of these relationships by exploring the mediation effects of clinical dialysis processes on patient outcomes. The results indicate that dialysis process measures mediate the impact of the operational characteristics of dialysis centers on patient hospitalization rates.

This study offers several managerial insights for owners and operators of dialysis clinics with respect to the association between managerial and clinical practices that they deploy within dialysis clinics and their impact on clinical quality measures as well as hospitalization risk of patients. Managers can draw on this study to optimize staffing levels in their dialysis clinics, and implement innovative clinical practices.

Considering the growth in healthcare expenditures in developing and developed countries, and specifically for costly diagnoses such as dialyses, this study offers several insights related to the inter-relationships between dialysis practice patterns and their clinical quality measures.

This study makes several major contributions. First, the authors address the extant gap in the literature on the relationships between dialysis facility and practice characteristics and clinical outcomes, while specifically highlighting the role of clinical process measures as antecedents of patient hospitalization ratio, a key metric used to measure performance of dialysis clinics. Second, this study sheds light on the underlying mechanisms that serve as enablers of the dialysis adequacy and anemia management. To the best of the authors’ knowledge, this is the first study to explore these relationships in the dialysis industry. The authors’ approach provides a new direction for future studies to explore the pathways that may impact clinical quality measures in the delivery of dialysis services.

A large number of studies indicate that coercive forms of organizational control and performance management in health care services often backfire and initiate dysfunctional consequences. The purpose of this article is to discuss new approaches to performance management in health care services when the purpose is to support innovative changes in the delivery of services.

The article represents cross-boundary work as the theoretical and empirical material used to discuss and reconsider performance management comes from several relevant research disciplines, including systematic reviews of audit and feedback interventions in health care and extant theories of human motivation and organizational control.

An enabling approach to performance management in health care services can potentially contribute to innovative changes. Key design elements to operationalize such an approach are a formative and learning-oriented use of performance measures, an appeal to self- and social-approval mechanisms when providing feedback and support for local goals and action plans that fit specific conditions and challenges.

The article suggests how to operationalize an enabling approach to performance management in health care services. The framework is consistent with new governance and managerial approaches emerging in public sector organizations more generally, supporting a higher degree of professional autonomy and the use of nonfinancial incentives.

Assessment of complex clinical skills and abilities is a challenge in mental health education. In the present study, an objective structured clinical examination (OSCE) was adapted to psychology and implemented in a Master in Psychology program. The purpose of the present study was to examine aspects of validity of this OSCE.

A total of 55 students enrolled in the Master in the Psychology program at Umeå University, Sweden, participated in two OSCE occasions. In addition to OSCE data, questionnaires were administered immediately after the OSCE to students (n = 18) and examiners (n = 13) to examine their perceptions of the OSCE.

The results provided support for different aspects of validity. The level of internal consistency was close to acceptable, and there was a good correspondence between global ratings and checklist scores for many stations. However, adding an additional category to the global rating scale and reviewing some of the station checklists might improve the assessment further. The present cut-score of the OSCE was comparable to a cut-score set by the borderline regression model. In general, students and examiners perceived the OSCE as a high-quality examination, although examiners raised some issues that could improve the OSCE further.

In conclusion, OSCE is a promising assessment in psychology, both from a psychometric perspective and from a test-taker and examiner perspective. The present study is an important contribution to the field as there are only a few examples where OSCE has been used in clinical psychology, and to the best of the authors’ knowledge, this paper is the first to evaluate the validity of such an assessment.

Quantifying the performance level of surgeons with digital virtual reality (VR) simulators can help ensure that quality requirements in healthcare are met. In order to better understand integration amongst quality principles, practices and technologies in the adoption and diffusion of VR simulators, the authors applied a technological innovation system (TIS) framework. The purpose of this study is to understand how the adoption and diffusion of VR surgical simulators in a Swedish healthcare context is influenced by various system factors.

In this study, single-case holistic design based on innovation system theory was used to analyse the adoption of digital quality technologies related to surgical performance in Swedish hospitals. The case employs a mixed methods approach triangulating data longitudinally from published documents and expert interviews.

Adoption of digital technologies regarding surgical performance is restricted by system factors relating to inconsistent normative and regulatory requirements for quantified performance criteria to judge surgical expertise. Addressing these systems' weaknesses with evidence-based training programmes can have a significant impact on the further development of the innovation system and can ultimately affect healthcare reliability and quality.

This paper explores quality management (QM) challenges in the context of digital transformation in healthcare. The paper attempts to fill the gap for TIS studies in a healthcare context and highlight the role of innovation function strength along the value chain and in relation to technology cycles to increase the understanding of adoption of digital technologies relating to surgical performance.

During the 1990s, Italian healthcare organisations (HOs) underwent a process of corporatisation, and the most innovative HOs introduced the balanced scorecard (BSC) to address the need for broader accountability. Currently, there is a limited understanding of the dynamics and outcomes of such a process. Therefore, this study aims to explore whether the BSC is still considered an effective performance management tool and analyse the factors driving and hindering its evolution and endurance in public and non-profit HOs.

We conducted a retrospective longitudinal analysis of two pioneering cases in the adoption of the BSC: one in a public hospital and the other in a non-profit hospital. Data collection relied on accessing institutional documents and reports from the early 2000s to the present, as well as conducting semi-structured interviews with the internal sponsors of the BSC.

We found evidence of three main categories of factors that trigger or hinder the adoption and development of the BSC: (1) the role of the internal sponsor and professionals’ commitment; (2) information technology and the controller’s technological skills; and (3) the relationship between the management and professionalism logics during the implementation process. At the same time, there is no evidence to suggest that specific technical features of the BSC influence its endurance.

The paper contributes to the debate on the key factors for implementing and sustaining multidimensional control systems in professional organisations. It emphasises the importance of knowledge-based assets and distinctive internal capabilities for the success of the business. The implications of the BSC legacy are discussed, along with future developments of multidimensional control tools aimed at supporting strategy execution.

This article aims to provide the current state of the art of the literature on the contribution of information and communication technologies (ICTs) on the measurement and management of performance in the healthcare sector. In particular, the work aims to identify current and emerging ICTs and how these relate to the performance measurement and management (PMM) cycle of healthcare organizations.

To address the research objective, we adopted a systematic literature review. In particular, we used the preferred reporting items for systematic reviews and meta-analysis (PRISMA) methodology to select articles related to the investigated topic. Based on an initial screening of 560 items retrieved from Scopus and ISI Web of Knowledge, we identified and analyzed 58 articles dealing with ICTs and PMM in the healthcare sector. The last update of the dataset refers to February 2024.

Although we attempted to address a relevant topic for both research and practice, we noticed that a relatively small sample of articles directly addressed it. Through this literature review, in addition to providing descriptive statistics of research on ICTs and PMM in healthcare, we identified six theoretical clusters of scientific streams focusing on the topic and eleven categories of ICTs effectively tackled by the literature. We then provided a holistic framework to link technologies to the different PMM phases and functions.

Nowadays, the availability of ICTs to support healthcare organizations’ processes and services is extensive. In this context, managers at various organizational levels need to understand and evaluate how each ICT can support different activities to benefit most from their adoption. The findings of this study can offer valuable insights to top and line managers of healthcare organizations for planning their investments in both existing and emerging ICTs to support the various stages of development and functions of PMM.

Most of the current literature focusing on ICTs in the healthcare sector refers to the contribution that technology provides to clinical processes and services, devoting limited attention to the impact of ICTs on administrative processes, such as PMM. To the best of the authors’ knowledge, this represents the first literature review on the contribution of ICTs to PMM in the healthcare sector. The review, differently from other research focused on specific ICTs and/or specific PMM functions, provides a holistic perspective to understand how these technologies may support healthcare organizations and systems in measuring and managing their performance.

The process of performance measurement provides support to company management to achieve the objectives established in strategic planning. Through the definition of critical success factors and related key performance indicators, performance measurement verifies the gap between planned objectives and the results achieved, informing the responsible bodies to enable them to evaluate performance and, if necessary, implement improvement actions. Although many types of companies adopt performance measurement, this process is challenging when applied to national health services. This paper aims to identify the evolution of performance measurement and the critical success factors of national health services.

The authors conducted an explorative case study of a leading national health service to delineate the evolutionary path of performance measurement and the main critical success factors.

The results indicate a significant increase in the maturity of performance measurement of a national health service that has been motivated by international reforms and national regulations. This research highlights performance measurement features such as a balanced set of metrics, targets, and incentives linked to strategic objectives and regular and frequent performance reviews. Furthermore, it identifies the performance measurement model of a leading national health service.

The evolution of performance measurement and numerous critical success factors of national health services are described; the critical success factors cover a wide range of financial to operational aspects such as patient safety, organizational appropriateness, and clinical appropriateness.

Previous research provides adequate evidence on performance management (PM) for hospitals and healthcare providers; however, less is known about their individual and PM appraisal process. Additionally, there is limited research exploring PM in the Middle Eastern context. This study investigates PM practices in the Middle Eastern healthcare industry.

This study adopts the qualitative research methodology through semi-structured interviews of healthcare professionals in Kingdom of Saudi Arabia and the United Arab Emirates. Thematic analysis was adopted for analyzing this qualitative data.

The main findings have uncovered different facets of appraisal challenges for both the appraiser (i.e. manager) and the appraisee (i.e. employee). These challenges include communication deficits, lack of goal setting standards and regular meeting updates in order to ensure employee satisfaction and motivation in the workplace.

This study has significant implications for policymakers in Middle Eastern hospitals in terms of implementing PM for their staff. Moreover, future studies can conduct in-depth analysis and provide comparison between public and private sectors in the Gulf countries.

This study is one of the first to portray challenges involved in conducting PM in the Middle East healthcare sector specifically in the UAE and Kingdom of Saudi Arabia (KSA), both from the perspectives of the appraiser and appraisee.