Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

Nursing's Response to the Executive Order to Advance American Kidney Health.

The state of American kidney health is currently under the microscope. In the United States, approximately 20,000 persons advance to end-stage renal disease annually. Trends indicate accelerating increases in cost of care and a high mortality rate among patients with end-stage renal disease, with only 57% of patients surviving after 3 years. An executive order by the White House has placed the transformation of kidney care at the forefront of the country's health care agenda. The order focuses on key issues including improving outcomes, reducing treatment-related expenditures and increasing kidney donations. Mobilization of health care resources directed toward policymaking, workforce growth and development, and research will be critical to effectively achieve this executive order. Nursing's response, as the health care profession with the most members, will be crucial to achieving response implementation and success of the order. This article describes immediate and future actions including policy, leadership, clinical, educational, and research initiatives that the nursing profession should take to advance kidney health. It calls for specific actions by nursing and focuses on nursing organizations, nursing research, quality improvement initiatives, nursing innovation, advanced practice nursing, and the nephrology and transplant nursing workforce in order to improve kidney health nationally. The impact of the SARS-CoV-2 pandemic on kidney health and the implications for the profession of nursing are outlined. Although there are still many unknowns about the pandemic, nursing's voice is necessary to ensure the ongoing delivery of high-quality care.

Claims in orthopedic foot/ankle surgery, how can they help to improve quality of care? A retrospective claim analysis.

BACKGROUND: Orthopedic foot/ankle surgery is a high risk specialty when it comes to malpractice claims. This study aims to evaluate the incidence, characteristics and outcome of claims in this area. METHODS: This was a retrospective, 10-year claim analysis, with data from an anonymous database. Baseline claim/claimant characteristics were collected from all orthopedic foot/ankle-related cases. RESULTS: Of 460 claims in total, most were related to delay in/wrong diagnosis or to (complications of) elective surgical procedures. Whether a claim was settled was related to type of injury (fracture) and type of claim (diagnostic mistake). Median amount disbursed in settled claims was €12,549. Claim incidence did not increase over the years. CONCLUSION: Missed fracture diagnosis and "failed"/disappointing results of elective surgical procedures were the most common causes for claims. Sufficient knowledge of missed (foot) fractures and clear communication/expectation management before elective procedures could help to improve quality of healthcare and patient satisfaction.

Promoting patients' rights through hospital accreditation.

BACKGROUND: Over the past decade, hospitals in many countries, including Israel, have undergone an accreditation process aimed at improving the quality of services provided. This process also refers to the protection and promotion of patients' rights. However, reviewing the criteria and content included in this category in the Israeli context reveals definitions and implications that differ from those presented by the law - specifically the Patient's Rights Act 1995. Moreover, the rights included in it are not necessarily equally represented in other legislation. METHODS: This study seeks to examine the question of whether and to what extent the scope, contents, and definitions of patients' rights in the JCI Standards are similar to or different from patients' rights as they are addressed and protected in national legislation. The article provides a comparison and examination of the different regulatory frameworks of patients' rights, especially those in the accreditation of healthcare institution and legislation, analyzes the gaps between such frameworks, and suggests possible implications on our understanding of the concept of patients' rights. RESULTS: The patients' right chapter in the accreditation process introduces and promotes the concepts of patient and family rights, increases the awareness and compliance of such concepts, and may create greater consistency in their introduction and application. CONCLUSIONS: Discussion of the Israeli case not only demonstrates how regulatory frameworks are instrumental - for broader policy purposes, especially in the area of patients' rights and the rights of patients' families - but also calls for a more general examination of the concept of patients' rights in health policies and its contribution to the quality of health services. Reference to patients' rights in accreditation of healthcare institutions may promote and enhance this concept and contribute to the delivery of care, thereby complementing a lacuna in the law.

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative.

Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.

[Ethics of clinical trials]. / L'éthique des essais thérapeutiques.

TITLE: L'éthique des essais thérapeutiques. ABSTRACT: La pandémie de COVID-19 a conduit certains acteurs reconnus de la médecine à renoncer aux méthodes codifiées de la recherche médicale au profit d'affirmations établies dans l'urgence et sans réelle évaluation scientifique. Autant l'on peut comprendre que certains praticiens recourent à ce qui leur est ainsi proposé, autant cette confusion entre action dans l'urgence et recherche scientifique serait lourde de conséquences si elle venait à se généraliser, et cela à de multiples points de vue : image et rôle de la science, qualité et éthique de la recherche médicale et en fin de compte sort des malades soumis à des traitements mal évalués. Ce sont ces questions qui motivent la mise au point qui suit sur les questions d'éthique associées de longue date aux « essais thérapeutiques ¼, cette procédure rationnelle d'acquisition dans les meilleurs délais d'informations fiables sur les avantages et les risques des traitements dont on envisage l'éventuelle utilisation.

The development of hospital accreditation in low- and middle-income countries: a literature review.

Hospital accreditation has been transferred from high-income countries (HICs) to many low- and middle-income countries (LMICs), supported by a variety of advocates and donor agencies. This review uses a policy transfer theoretical framework to present a structured analysis of the development of hospital accreditation in LMICs. The framework is used to identify how governments in LMICs adopted accreditation from other settings and what mechanisms facilitated and hindered the transfer of accreditation. The review examines the interaction between national and international actors, and how international organizations influenced accreditation policy transfer. Relevant literature was found by searching databases and selected websites; 78 articles were included in the analysis process. The review concludes that accreditation is increasingly used as a tool to improve the quality of healthcare in LMICs. Many countries have established national hospital accreditation programmes and adapted them to fit their national contexts. However, the implementation and sustainability of these programmes are major challenges if resources are scarce. International actors have a substantial influence on the development of accreditation in LMICs, as sources of expertise and pump-priming funding. There is a need to provide a roadmap for the successful development and implementation of accreditation programmes in low-resource settings. Analysing accreditation policy processes could provide contextually sensitive lessons for LMICs seeking to develop and sustain their national accreditation programmes and for international organizations to exploit their role in supporting the development of accreditation in LMICs.

Implementation of duty of candour within neurosurgery: a national survey and framework for improved application in clinical practice.

INTRODUCTION: Statutory duty of candour was introduced in November 2014 for NHS bodies in England. Contained within the regulation were definitions regarding the threshold for what constitutes a notifiable patient safety incident. However, it can be difficult to determine when the process should be implemented. The aim of this survey was to evaluate the interpretation of these definitions by British neurosurgeons. MATERIALS AND METHODS: All full (consultant) members of the Society of British Neurological Surgeons were electronically invited to participate in an online survey. Surgeons were presented with 15 cases and asked to decide in the case of each one whether they would trigger the process of duty of candour. Cases were stratified according to their likelihood and severity. RESULTS: In all, 106/357 (29.7%) members participated in the survey. Responses varied widely, with almost no members triggering the process of duty of candour in cases where adverse events were common (greater than 10% likelihood) and required only outpatient follow-up (7/106; 6.6%), and almost all members doing so in cases where adverse events were rare (less than 0.1% likelihood) and resulted in death (102/106; 96.2%). However, there was clear equipoise in triggering the process of duty of candour in cases where adverse events were uncommon (0.1-10% likelihood) and resulted in moderate harm (38/106; 35.8%), severe harm (57/106; 53.8%) or death (49/106; 46.2%). CONCLUSION: There is considerable nationwide variation in the interpretation of definitions regarding the threshold for duty of candour. To this end, we propose a framework for the improved application of duty of candour in clinical practice.

Civil Money Penalty Enforcement Actions for Quality Deficiencies in Nursing Homes.

BACKGROUND AND OBJECTIVES: Civil money penalties (CMP) are fines collected by CMS and then redistributed to states for the sole purpose of improving resident care and quality of life through reinvestment in quality improvement projects. This study examined state variation in civil money penalty enforcement actions for quality of life (QOL) and quality of care (QOC) deficiencies in nursing homes. RESEARCH DESIGN AND METHODS: 2015-2016 cross-sectional CASPER nursing home survey data obtained from the CMS QCOR database were used to explore the pattern of enforcement actions for QOL and QOC deficiencies across states. Fixed effects regression models examined relationships between state-level characteristics, quality deficiencies, and enforcement actions imposed by states. RESULTS: State enforcement actions resulting in a CMP were more likely for QOC deficiencies (M = 0.143, SD = 0.097) than for QOL deficiencies (M = 0.070, SD = 0.056) and states exhibited variability in imposing enforcement actions. The presence of severe QOC deficiencies resulting in actual resident harm contributed to CMP enforcement actions for both QOL and QOC deficiencies. States with primarily for-profit status providers had more enforcement actions. DISCUSSION AND IMPLICATIONS: The variability noted in state enforcement for quality deficiencies actions parallels inconsistencies in state regulatory oversight of nursing homes.

Evaluación del conocimiento sobre gestión de la calidad en el servicio asistencial del Centro Nacional de Genética Médica / Assessment of knowledge on quality management in the care service of the National Center of Genetics Medical

Introducción: El Centro Nacional de Genética Médica traza estrategias para asegurar la calidad de los servicios que se brindan a la Red Nacional de Genética Médica e instituciones del sistema cubano de salud.Objetivo: El objetivo de este trabajo es evaluar el conocimiento de los clientes internos del proceso asistencial, en los requisitos de la norma ISO-NC 9001:2008.Métodos: La evaluación del conocimiento sobre temas de calidad (antes y después de la implementación del Sistema de Gestión de Calidad (SGC) se realizó a través de un cuestionario diseñado a modo de examen. La comparación de los resultados al inicio y al final del período de estudio (mayo de 2012 a mayo de 2018) se realizó a través de un pareamiento por puntaje de propensión. La asociación entre la intervención y el nivel de conocimiento se evaluó por el factor de Bayes. El análisis estadístico se realizó en R 4.0.2.Resultados: En el diagnóstico inicial se obtuvo un 29,35 (percent)de respuestas con un nivel adecuado sobre conocimiento básico del SGC. Las principales irregularidades se identificaron y se aplicaron estrategias como la capacitación continua de los clientes del servicio asistencial y del personal de nuevo ingreso. La evaluación de los resultados al cierre del período arrojó un mayor porcentaje (84,27 (percent) de respuestas positivas con respecto al diagnóstico inicial.Conclusiones: Las estrategias de capacitación implementadas permitieron elevar el nivel de conocimiento del personal del proceso asistencial en el CNGM de un nivel insuficiente a un nivel adecuado…(AU)

Leveraging massive open online courses to expand quality of healthcare education to health practitioners in Rwanda.

Improving the quality of healthcare delivery is increasingly a global health priority. However, quality improvement training opportunities that provide theoretical foundations and basic skills for patient safety and other quality initiatives have been limited or historically out of reach, especially in low-and-middle income countries (LMICs). To address this gap, the Harvard Initiative on Global Health Quality (HIGHQ) created and launched a massive open online course (MOOC) in 2014 focused on patient safety and quality of care using the edX platform. More than 30 000 students from across 195 countries registered for the online course. This paper summarises an innovative educational partnership between the course team and one of these countries, Rwanda, to develop a blended-learning model to bolster participation in this new course among Rwandan healthcare professionals. Although a small country, Rwanda was among the top performing countries for attracting course registrants and was the leading country for the proportion of enrollees who ultimately completed the course. Further, half (21 of 42) of Rwanda's district hospitals opted to appoint a PH555x course facilitator at their site to help lead regular meetings and discussions about the course content at their facility. The majority of Rwandan enrollees were health professionals (63%) and 81% reported that PH555x was their first experience taking an online course. Among those participating in the 'flipped' component at hospital sites, 94% reported that the course helped them to think of specific ways to improve healthcare quality at their facility. In this paper, we describe this innovative public-private educational model, challenges to implementation and lessons learned that may be helpful for future MOOC developers who wish to augment learning opportunities among healthcare professionals in LMICs.