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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.

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.

This qualitative study examined the views of clinical governance leads in South West England on the development of clinical governance, and its relationship to education in primary care. Information was obtained from semi‐structured interviews with clinical governance leads, and supplementary methods were used to confirm key findings. Four principal themes emerged: education, support, barriers, and evolution. Education is central to achieving the clinical governance agenda. There is a range of educational needs within primary care and these must be integrated into practice professional development plans, which will be shaped by national and local priorities. A need for PCG clinical governance tutors to support this process emerged. A range of supporting mechanisms was identified, as were barriers: principally inadequate resources and a rigid agenda imposed from above. Existing educationalists will need to change their role within the new structures, and this should be an evolutionary rather than a revolutionary process.

While there is debate about the extent to which patients are harmed when they are cared for in hospital, it is clear that admission as an inpatient is not without risk. This paper presents works on the progress to date with identifying what these risks are and quantifying the likelihood and severity of the risk. The clinical risk profiling tool that has been developed as part of this exercise has assisted with the identification and prioritisation of clinical risks and is the first step in risk reduction and elimination.

Clinical governance was introduced in 1997 as a comprehensive framework to improve the healthcare quality in the National Health Service. Since then, the proliferation of various definitions and models of clinical governance illustrates that different perceptions are emerging on clinical governance. However, none of these definitions captures the essence of clinical governance in terms of its organisation‐wide implications for continuous quality improvement. Although there is discrete mention of structure, process and outcomes in the literature on clinical governance, it is hard to find any clear explanation on how clinical governance influences organisational elements. This paper therefore analyses clinical governance in terms of the inputs, processes, structure and the outcomes of healthcare organisations. The fact that the introduction of any new governance framework will have much wider implications for the management of healthcare organisations is illustrated through a refined definition of clinical governance presented in this paper.

Recent criticism of some aspects of current practice within the NHS has placed the role of clinical audit increasingly under the spotlight. In a recent publication, the National Institute for Clinical Excellence states that “the time has come for everyone in the NHS to take clinical audit very seriously”. This article considers the intimate link between clinical audit and clinical governance, a philosophy that has not yet been universally adopted. It describes the key principles of risk management within the context of clinical audit, and examines the audit burden imposed on primary and secondary care by assessors, National Service Frameworks and regulatory bodies. It discusses the challenges risk managers face in adopting a systematic review of care that seeks to avoid harm to patients, while improving outcomes and care standards.

The article examines and comments on the development of clinical management at an NHS hospital Trust. It utilises a qualitative case study methodology to collect data from key stakeholders at this Trust. The data suggest some of the reasons why doctors may be receptive or non‐receptive to the notion of clinical management. It recommends that attention is focused on the specialty context as a key factor in influencing the development of clinical management. It also suggests there may be other important factors, for example: training; the role of change agents; structure of clinical directorates; and individual factors such as cognition, attitudes and motivation.

To provide an overview of a model for clinical governance in the National Health Service that incorporates continuous improvement and innovation as a core theme.

The paper considers the core functions of clinical governance and how these are related to established structures and roles within the modern NHS. A case study approach is used to describe the implementation of a theoretical model in a large teaching NHS Trust.

A clinical governance cycle is described that comprises three functional domains: accountability, assurance, and innovation. For each domain there is a definable outcome and a key role. Critical success factors for implementation of the model are described.

This paper introduces a new model for clinical governance that focuses on continuous improvement. The paper will be of particular interest to managers and lead clinicians responsible for the development of robust systems for clinical governance and modernisation in the NHS.

Clinical governance is at the heart of the drive to improve the quality of patient care in the National Health Service. National targets, the National Service Frameworks and NICE Guidance are providing a top‐down mechanism to deliver this improved care. Improved patient care will not happen, however, without the active and enthusiastic participation of clinicians and clinical teams. This article sets out the mechanism that Dorset Healthcare NHS Trust, a specialist mental health and learning disability trust, has established to foster and develop the involvement of clinical teams in clinical governance. The article describes the development of team‐based clinical governance portfolios and sets out how they have been used to focus clinical teams on clinical governance activities.

This study seeks to establish whether the published test characteristics of the CORE (Clinical Outcomes in Routine Evaluation Measure) outcome measure can be reproduced in a therapeutic forensic setting. The measure has been designed to address the needs of psychological therapy services for clinical, audit and management feedback regardless of the clinical setting, mode of therapy, or specific problems (clinical population) of the patients (CORE System Group, 1998). Data was collected on 53 men and compared with the normative data for clinical and non‐clinical samples published in the CORE manual.The findings show that:• the inmate sample means fall between those of the clinical and non‐clinical samples• the internal consistency of the measure was found to be generally as good as that claimed by the authors of the test• the test/retest stability figures were lower in the inmate sample• age effects were generally the same as those quoted in the manual• the refusal rate and incidence of missing items indicate that the test had good acceptability by the forensic group.It is concluded that CORE is a useful tool in a therapeutic forensic setting.