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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.

The aim of this study was to explore empirical literature on the experiences of pre-registration student nurses during mental health clinical placements and identify factors that enhance practice learning.

An integrative mixed-methods approach and constant comparative synthesis were chosen. Eligible studies were from 2009 onwards sampling student experiences of mental health placements within undergraduate and postgraduate degree entry to practice nursing programmes, excluding academic-only experiences. The search was last conducted on 14th August 2021 and included MEDLINE, CINAHL and APA PsycINFO databases.

The search strategy identified 579 studies, of which 10 met the eligibility criteria. Seven of the articles reported qualitative research; two were based on quantitative studies, and one had a mixed-methods design. There was international representation across six countries. All studies examined the experiences of pre-registration student nurses during mental health clinical placements. The total number of participants was 447, comprised of students, nongovernmental organisations and community members.

The review identified four influential themes that enhance practice learning: immersion in the nursing role; relationships that empower autonomous learning; opportunity for defined and subtle skill development; and student experiences of people with mental health needs. Further research is required on culture, subtle skill development and the socialisation process of students with the mental health nurse professional identity.

The primary objective of this paper is to show a systematic and methodological approach for the digitalization of critical clinical pathways (CPs) within the healthcare domain.

The methodology entails the integration of service design (SD) and action research (AR) methodologies, characterized by iterative phases that systematically alternate between action and reflective processes, fostering cycles of change and learning. Within this framework, stakeholders are engaged through semi-structured interviews, while the existing and envisioned processes are delineated and represented using BPMN 2.0. These methodological steps emphasize the development of an autonomous, patient-centric web application alongside the implementation of an adaptable and patient-oriented scheduling system. Also, business processes simulation is employed to measure key performance indicators of processes and test for potential improvements. This method is implemented in the context of the CP addressing transient loss of consciousness (TLOC), within a publicly funded hospital setting.

The methodology integrating SD and AR enables the detection of pivotal bottlenecks within diagnostic CPs and proposes optimal corrective measures to ensure uninterrupted patient care, all the while advancing the digitalization of diagnostic CP management. This study contributes to theoretical discussions by emphasizing the criticality of process optimization, the transformative potential of digitalization in healthcare and the paramount importance of user-centric design principles, and offers valuable insights into healthcare management implications.

The study’s relevance lies in its ability to enhance healthcare practices without necessitating disruptive and resource-intensive process overhauls. This pragmatic approach aligns with the imperative for healthcare organizations to improve their operations efficiently and cost-effectively, making the study’s findings relevant.

Value-based healthcare suggested using patient-reported information to complement the information available in the medical records and administrative healthcare data to provide insights into patients' perceptions of satisfaction, experience and self-reported outcomes. However, little attention has been devoted to questions about factors fostering the use of patient-reported information to create value at the system level.

Action research design is carried out to elicit possible triggers using the case of patient-reported experience and outcome data for breast cancer women along their clinical pathway in the clinical breast network of Tuscany (Italy).

The case shows that communication and engagement of multi-stakeholder representation are needed for making information actionable in a multi-level, multispecialty care pathway organized in a clinical network; moreover, political and managerial support from higher level governance is a stimulus for legitimizing the use for quality improvement. At the organizational level, an external facilitator disclosing and discussing real-world uses of collected data is a trigger to link measures to action. Also, clinical champion(s) and clear goals are key success factors. Nonetheless, resource munificent and dedicated information support tools together with education and learning routines are enabling factors.

Current literature focuses on key factors that impact performance information use often considering unidimensional performance and internal sources of information. The use of patient/user-reported information is not yet well-studied especially in supporting quality improvement in multi-stakeholder governance. The work appears relevant for the implications it carries, especially for policymakers and public sector managers when confronting the gap in patient-reported measures for quality improvement.

The future increase of chronic diseases in the world requires new challenges in the health domain to improve patients' care from the point of view of the organizational processes, clinical pathways and technological solutions of digital health. For this reason, the present paper aims to focus on the study and application of well-known clinical practices and efficient organizational approaches through an innovative model (TALIsMAn) to support new care process redesign and digitalization for chronic patients.

In addition to specific clinical models employed to manage chronic conditions such as the Population Health Management and Chronic Care Model, we introduce a Business Process Management methodology implementation supported by a set of e-health technologies, in order to manage Care Pathways (CPs) digitalization and procedures improvement.

This study shows that telemedicine services with advanced devices and technologies are not enough to provide significant changes in the healthcare sector if other key aspects such as health processes, organizational systems, interactions between actors and responsibilities are not considered and improved. Therefore, new clinical models and organizational approaches are necessary together with a deep technological change, otherwise, theoretical benefits given by telemedicine services, which often employ advanced Information and Communication Technology (ICT) systems and devices, may not be translated into effective enhancements. They are obtained not only through the implementation of single telemedicine services, but integrating them in a wider digital ecosystem, where clinicians are supported in different clinical steps they have to perform.

The present work defines a novel methodological framework based on organizational, clinical and technological innovation, in order to redesign the territorial care for people with chronic diseases. This innovative ecosystem applied in the Italian research project TALIsMAn is based on the concept of a continuum of care and digitalization of CPs supported by Business Process Management System and telemedicine services. The main goal is to organize the different socio-medical activities in a unique and integrated IT system that should be sustainable, scalable and replicable.

Healthcare organizations have been facing challenges due to high costs and low efficiency in health services. The growth of costs and losses caused by avoidable mistakes lead to the search for solutions, and Health Lean Management appears as a potential solution to help in solving service quality problems, as well as reducing risks. This study aims to analyse the state of the art in the literature centred on the Lean approach in the context of risk management in healthcare organizations, and to identify new research opportunities, highlighting possible lines of future research.

Following a systematic literature review approach, 51 papers were considered relevant for this research, and reviewed to explore the development of literature in this area.

Based on the results, five main research streams were identified: (1) risk management oriented towards patient safety; (2) risk management oriented towards employee safety; (3) importance of attitudes and behaviours in risk reduction projects; (4) Lean tools used in healthcare risk management and (5) Integration of approaches. Moreover, several shortcomings were identified in literature.

Identified shortcomings represent significant opportunities for further research development.

This systematic review aimed to identify and categorize applications using Fast Healthcare Interoperability Resources (FHIR) to support activities outside of direct healthcare provision.

A systematic electronic search was performed, and 53 studies were included after the selection process.

The results show that FHIR is being used to support (1) clinical research (i.e. clinical research based on interventional trials, data interoperability to support clinical research and advanced communication services to support clinical research), (2) public health and (3) medical education. Despite the FHIR potential to support activities outside of direct healthcare provision, some barriers were identified, namely difficulties translating the proposed applications to clinical environments or FHIR technical issues that require further developments.

This study provided a broad review of how FHIR is being applied in clinical activities outside of direct clinical care and identified three major domains, that is, clinical research, public health and medical education, being the first and most representative in terms of number of publications.

The purpose of this study was to explore the clinical readiness of simulation-based education (SBE) in preparing nursing and midwifery students for clinical practice in sub-Saharan Africa. This study has synthesised the findings from existing research studies and provides an overview of the current state of SBE in nursing and midwifery programs in the region.

A qualitative meta-synthesis of previous studies was conducted using the following steps: developing a review question, developing and a search strategy, extracting and meta-synthesis of the themes from the literature and meta-synthesis of themes. Five databases were searched for from existing English literature (PubMed, Cumulative Index for Nursing and Allied Health Professional Literature [CINAHL], PsycINFO, EMBASE and ScienceDirect Medline, CINAHL and Science Direct), including grey literature on the subject. Eight qualitative studies conducted in sub-Saharan Africa between 2014 and 2022 were included. Hawker et al.'s framework was used to assess quality.

The following themes emerged from the literature. Theme 1: Improved skills and competencies through realism and repetition. Theme 2: Improved skills and competencies through realism and repetition. Theme 3: Improved learning through debriefing and reflection. Theme 4: Constraints of simulation as a pedagogical teaching strategy.

The qualitative meta-synthesis intended to cover articles from 2012 to 2022. Between 2012 and 2013, the authors could not identify purely qualitative studies from sub-Saharan Africa. The studies identified were either mixed methods or purely quantitative. This constitutes a study limitation.

Findings emphasise educator training in SBE. Comprehensive multidisciplinary training, complemented by expertise and planned debriefing sessions, serves as a catalyst for fostering reflective learning. Well-equipped simulation infrastructure is essential in preparing students for their professional competencies for optimal patient outcomes. Additional research is imperative to improve the implementation of SBE in sub-Saharan Africa.

The originality and value of SBE in nursing and midwifery programs in sub-Saharan Africa lie in its contextual relevance, adaptation to resource constraints, innovative teaching methodologies, provision of a safe learning environment, promotion of interprofessional collaboration and potential for research and evidence generation. These factors contribute to advancing nursing and midwifery education and improving healthcare outcomes in the region. This study fills this gap in the literature.

The authors propose a blockchain platform for managing clinical trial data to enhance data validity, integrity, trust and transparency in the pharmaceutical research process. The authors also provide an extensive review of how blockchain technology supports the business processes of clinical trials.

A systematic literature review was conducted to identify the existing applications of blockchain in pharmaceutical process management. A conceptual design for a blockchain infrastructure to address clinical trial challenges is developed by outlining the entire clinical trial value chain and identifying the coordination and communication among its stakeholders. A stakeholder analysis is conducted to ensure that the clinical trial processes satisfy the requirements and preferences of each stakeholder.

The proposed blockchain platform offers a promising solution for enhancing integrity, trust and transparency in the clinical trial process. Additionally, blockchain can help streamline communication and collaboration between stakeholders by enabling multiple parties to access and share data in real time, lowering the possibility of delays or errors in data analysis and reporting.

The proposed blockchain platform can benefit patients by empowering them to have better-controlled access to their data and by allowing researchers to maintain adherence to reporting requirements. Additionally, the platform can benefit granting agencies, researchers and decision-makers by ensuring the integrity of clinical trial data and streamlining communication and collaboration between stakeholders.

This study builds on existing blockchain applications in pharmaceutical process management by developing a blockchain framework that can address clinical trial concerns from an integrated perspective.

This systematic review (SR) aims to evaluate and summarize the effectiveness of using eye movement desensitization and reprocessing (EMDR) intervention among individuals diagnosed with post-traumatic stress disorder (PTSD), as well as to highlight the standardized EMDR-based interventional protocol.

This SR is guided according to preferred reporting items for SRs and meta-analyses standards. Several online databases were used in searching for eligible studies in peer-reviewed journals relevant to the study keywords. The included studies were SRs and clinical trials that used EMDR interventions among patients experiencing PTSD symptoms, older than 18 years and were published in English language from 2015 to 2022. Three researchers independently contributed to study selections, data extraction and study evaluations from different aspects, including quality assessment, risk of bias and study synthesis.

A total of eight published studies met the inclusion criteria and were included in this SR; four articles were randomized controlled trials and four were SR and meta-analysis studies. In all included studies, the EMDR was used as a primary psychotherapy intervention for PTSD symptoms. The results of this extensive and comprehensive review showed that EMDR is an effective psychotherapeutic intervention to reduce and control the severity of symptoms among individuals with PTSD.

It is important to acknowledge several limitations inherent in this study. First and foremost, it is noteworthy to mention that only studies conducted in the English language were included in this review, potentially restricting the overall scope and diversity of the findings. Furthermore, the number of studies incorporated into this review was limited, which may have implications for the comprehensiveness and generalizability of the results. Finally, it is worth noting that certain studies within this review had a relatively small sample size, which could potentially limit the statistical power and precision of the conclusions drawn.

This paper, a review of the literature, gives an overview of EMDR effectiveness, provides baseline information and plays a significant role in decreasing the gap in Jordanian literature regarding using EMDR as the strongest evident psychotherapy approach for PTSD treatment to help psychiatrists, psychologists and psychiatric nurses in the health-care sectors to design comprehensive strategies to enhance and improve the quality of health care and patients’ status.

EMDR intervention offers significant alternative treatment opportunities for individuals suffering from PTSD, depression and anxiety. The implementation of EMDR for depression, anxiety and PTSD improves patient outcomes as compared to standard therapeutic modalities in PTSD.

This SR gives an overview and explains strong supportive evidence for the effectiveness of EMDR interventions among individuals with PTSD. Therefore, EMDR therapy could be assumed as one standard treatment option for PTSD, aiming at reducing treatment duration and cost of treatment and restoring the mental well-being and functionality of those suffering from PTSD.