Autorité de Sûreté Nucléaire

This work presents a new vision of patient safety and offers practical suggestions and recommendations to prepare the safe healthcare of the future.

BACKGROUND: Guidelines aim to support evidence-informed practice but are inconsistently used without implementation strategies. Our prior scoping review revealed that guideline implementation interventions were not selected and tailored based on processes known to enhance guideline uptake and impact. The purpose of this study was to update the prior scoping review. METHODS: We searched MEDLINE, EMBASE, AMED, CINAHL, Scopus, and the Cochrane Database of Systematic Reviews for studies published from 2014 to January 2021 that evaluated guideline implementation interventions. We screened studies in triplicate and extracted data in duplicate. We reported study and intervention characteristics and studies that achieved impact with summary statistics. RESULTS: We included 118 studies that implemented guidelines on 16 clinical topics. With regard to implementation planning, 21% of studies referred to theories or frameworks, 50% pre-identified implementation barriers, and 36% engaged stakeholders in selecting or tailoring interventions. Studies that employed frameworks (n=25) most often used the theoretical domains framework (28%) or social cognitive theory (28%). Those that pre-identified barriers (n=59) most often consulted literature (60%). Those that engaged stakeholders (n=42) most often consulted healthcare professionals (79%). Common interventions included educating professionals about guidelines (44%) and information systems/technology (41%). Most studies employed multi-faceted interventions (75%). A total of 97 (82%) studies achieved impact (improvements in one or more reported outcomes) including 10 (40% of 25) studies that employed frameworks, 28 (47.45% of 59) studies that pre-identified barriers, 22 (52.38% of 42) studies that engaged stakeholders, and 21 (70% of 30) studies that employed single interventions. CONCLUSIONS: Compared to our prior review, this review found that more studies used processes to select and tailor interventions, and a wider array of types of interventions across the Mazza taxonomy. Given that most studies achieved impact, this might reinforce the need for implementation planning. However, even studies that did not plan implementation achieved impact. Similarly, even single interventions achieved impact. Thus, a future systematic review based on this data is warranted to establish if the use of frameworks, barrier identification, stakeholder engagement, and multi-faceted interventions are associated with impact. TRIAL REGISTRATION: The protocol was registered with Open Science Framework ( https://osf.io/4nxpr ) and published in JBI Evidence Synthesis.

CONTEXT: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany. METHODS: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies' websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts. FINDINGS: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities' successful operation. CONCLUSIONS: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system.

OBJECTIVE: To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. DESIGN: A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways. SETTING AND PARTICIPANTS: Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. MAIN OUTCOME MEASURE: Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways. RESULTS: Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke). CONCLUSIONS: Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.

BACKGROUND: Hospitals in European countries apply a wide range of quality improvement strategies. Knowledge of the effectiveness of these strategies, implemented as part of an overall hospital quality improvement system, is limited. METHODS/DESIGN: We propose to study the relationships among organisational quality improvement systems, patient empowerment, organisational culture, professionals' involvement with the quality of hospital care, including clinical effectiveness, patient safety and patient involvement. We will employ a cross-sectional, multi-level study design in which patient-level measurements are nested in hospital departments, which are in turn nested in hospitals in different EU countries. Mixed methods will be used for data collection, measurement and analysis. Hospital/care pathway level constructs that will be assessed include external pressure, hospital governance, quality improvement system, patient empowerment in quality improvement, organisational culture and professional involvement. These constructs will be assessed using questionnaires. Patient-level constructs include clinical effectiveness, patient safety and patient involvement, and will be assessed using audit of patient records, routine data and patient surveys. For the assessment of hospital and pathway level constructs we will collect data from randomly selected hospitals in eight countries. For a sample of hospitals in each country we will carry out additional data collection at patient-level related to four conditions (stroke, acute myocardial infarction, hip fracture and delivery). In addition, structural components of quality improvement systems will be assessed using visits by experienced external assessors. Data analysis will include descriptive statistics and graphical representations and methods for data reduction, classification techniques and psychometric analysis, before moving to bi-variate and multivariate analysis. The latter will be conducted at hospital and multilevel. In addition, we will apply sophisticated methodological elements such as the use of causal diagrams, outcome modelling, double robust estimation and detailed sensitivity analysis or multiple bias analyses to assess the impact of the various sources of bias. DISCUSSION: Products of the project will include a catalogue of instruments and tools that can be used to build departmental or hospital quality and safety programme and an appraisal scheme to assess the maturity of the quality improvement system for use by hospitals and by purchasers to contract hospitals.

INTRODUCTION AND OBJECTIVE: This paper provides an overview of the DUQuE (Deepening our Understanding of Quality Improvement in Europe) project, the first study across multiple countries of the European Union (EU) to assess relationships between quality management and patient outcomes at EU level. The paper describes the conceptual framework and methods applied, highlighting the novel features of this study. DESIGN: DUQuE was designed as a multi-level cross-sectional study with data collection at hospital, pathway, professional and patient level in eight countries. SETTING AND PARTICIPANTS: We aimed to collect data for the assessment of hospital-wide constructs from up to 30 randomly selected hospitals in each country, and additional data at pathway and patient level in 12 of these 30. MAIN OUTCOME MEASURES: A comprehensive conceptual framework was developed to account for the multiple levels that influence hospital performance and patient outcomes. We assessed hospital-specific constructs (organizational culture and professional involvement), clinical pathway constructs (the organization of care processes for acute myocardial infarction, stroke, hip fracture and deliveries), patient-specific processes and outcomes (clinical effectiveness, patient safety and patient experience) and external constructs that could modify hospital quality (external assessment and perceived external pressure). RESULTS: Data was gathered from 188 hospitals in 7 participating countries. The overall participation and response rate were between 75% and 100% for the assessed measures. CONCLUSIONS: This is the first study assessing relation between quality management and patient outcomes at EU level. The study involved a large number of respondents and achieved high response rates. This work will serve to develop guidance in how to assess quality management and makes recommendations on the best ways to improve quality in healthcare for hospital stakeholders, payers, researchers, and policy makers throughout the EU.

Safety in healthcare is a constantly moving target. As standards improve and concern for safety grows, we come to regard an increasing number of events as patient safety issues. In this respect, healthcare differs from almost all other safety-critical industries. What we regard as harm in, for instance, civil aviation remains the same whatever advances may occur in aviation technology or practice. In contrast, innovation and improving standards in healthcare alter our conceptions of both harm and preventability. In the 1950s, many complications of healthcare were recognised, at least by some, but largely viewed as the inevitable consequences of medical intervention.1 Over time, certain types of incidents come to be seen as both unacceptable and potentially preventable. The clearest example in recent times is healthcare-associated infections, which in the 1980s were still regarded as unfortunate, but inevitable. With increased understanding of underlying processes, mechanisms of transmission and methods of prevention, coupled with major public and regulatory pressure, such infections are now seen as patient safety issues.2 The list of ‘never events’ put forward in various countries, such as wrong-site surgery, is similarly an assertion that certain types of failure cannot be tolerated.3 In the last 10 years, as more types of harm have come to be regarded as preventable, the perimeter of patient safety has expanded. We could now include pressure ulcers, …

BACKGROUND: The quality of palliative care is the foremost preoccupation of clinicians, decision-makers, and managers as well as patients and families. Major input from healthcare professionals is required to develop indicators for the quality of palliative care, but the involvement of patients and families is also recognized as essential, even though this is rarely achieved in practice. AIM: The objectives of this study were to identify (1) convergences and divergences in the points of view of different stakeholders (patients, families, healthcare professionals) relative to key elements of the quality of palliative care and (2) avenues for refining existing indicators of quality of palliative care. DESIGN: Cross-sectional qualitative study. SETTING/PARTICIPANTS: There were six settings: two hospital-based palliative care units, one hospice, and three other medical units where a mobile palliative care team intervene. Semi-structured interviews were conducted among 61 patients, families, healthcare professionals, and managers. RESULTS: Four major dimensions of quality of care are deemed critical by patients, their families, and professionals: comprehensive support for the patients themselves, clinical management, involvement of families, and care for the imminently dying person and death. Differences exist between various stakeholders regarding perceptions of some dimensions of quality of care. Avenues for improving current quality of care indicators are identified. CONCLUSION: Our study results can be used to refine or develop quality indicators that truly mirror the points of view of patients and their families and of healthcare professionals.

Healthcare systems across the world are experiencing increased financial, organizational and social pressures attributable to a range of critical issues including the challenge of ageing populations. Health systems need to adapt, in order to sustainably provide quality care to the widest range of patients, particularly those with chronic and complex diseases, and especially those in vulnerable and low-income groups. We report on a workshop designed to tackle such issues under the auspices of ISQua, with representatives from Argentina, Australia, Canada, Columbia, Denmark, Emirates, France, Ireland, Jordan, Qatar, Malaysia, Norway, Oman, UK, South Africa and Switzerland. We discuss some of the challenges facing healthcare systems in countries ageing rapidly, to those less so, and touch on current and future reform options.

BACKGROUND: Carcinogenic risks of internal exposures to alpha-emitters (except radon) are poorly understood. Since exposure to alpha particles-particularly through inhalation-occurs in a range of settings, understanding consequent risks is a public health priority. We aimed to quantify dose-response relationships between lung dose from alpha-emitters and lung cancer in nuclear workers. METHODS: We conducted a case-control study, nested within Belgian, French, and UK cohorts of uranium and plutonium workers. Cases were workers who died from lung cancer; one to three controls were matched to each. Lung doses from alpha-emitters were assessed using bioassay data. We estimated excess odds ratio (OR) of lung cancer per gray (Gy) of lung dose. RESULTS: The study comprised 553 cases and 1,333 controls. Median positive total alpha lung dose was 2.42 mGy (mean: 8.13 mGy; maximum: 316 mGy); for plutonium the median was 1.27 mGy and for uranium 2.17 mGy. Excess OR/Gy (90% confidence interval)-adjusted for external radiation, socioeconomic status, and smoking-was 11 (2.6, 24) for total alpha dose, 50 (17, 106) for plutonium, and 5.3 (-1.9, 18) for uranium. CONCLUSIONS: We found strong evidence for associations between low doses from alpha-emitters and lung cancer risk. The excess OR/Gy was greater for plutonium than uranium, though confidence intervals overlap. Risk estimates were similar to those estimated previously in plutonium workers, and in uranium miners exposed to radon and its progeny. Expressed as risk/equivalent dose in sieverts (Sv), our estimates are somewhat larger than but consistent with those for atomic bomb survivors.See video abstract at, http://links.lww.com/EDE/B232.

OBJECTIVE: To assess whether there is a relationship between having quality as an item on the board's agenda, perceived external pressure (PEP) and the implementation of quality management in European hospitals. DESIGN: A quantitative, mixed method, cross-sectional study in seven European countries in 2011 surveying CEOs and quality managers and data from onsite audits. PARTICIPANTS: One hundred and fifty-five CEOs and 155 quality managers. SETTING: One hundred and fifty-five randomly selected acute care hospitals in seven European countries (Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey). Main outcome measure(s) Three constructs reflecting quality management based on questionnaire and audit data: (i) Quality Management System Index, (ii) Quality Management Compliance Index and (iii) Clinical Quality Implementation Index. The main predictor was whether quality performance was on the executive board's agenda. RESULTS: Discussing quality performance at executive board meetings more often was associated with a higher quality management system score (regression coefficient b = 2.53; SE = 1.16; P = 0.030). We found a trend in the associations of discussing quality performance with quality compliance and clinical quality implementation. PEP did not modify these relationships. CONCLUSIONS: Having quality as an item on the executive board's agenda allows them to review and discuss quality performance more often in order to improve their hospital's quality management. Generally, and as this study found, having quality on the executive board's agenda matters.

The considerable rise of computed tomography (CT) procedures over the past few decades has urged responsible authorities and researchers to evaluate the risk of carcinogenesis in the population in relation to the radiation dose delivered to the patient. A single patient undergoing CT may receive a radiation equivalent dose that varies between about 2 mSv (head ) to about 20 mSv (CT-based coronary angiography). Whereas the latter represents a substantial dose delivered to one patient it is, however, population-wise far below the area of the so-called low doses, i.e. 50 mSv in children and 100 mSv in adults. While at effective doses above 50 mSv the risk of cancer induction increases linearly with dose, this dose-response relation has not been demonstrated at doses below 50 mSv. Below 50 mSv no convincing epidemiological evidence for cancer risk exists. Calculations on this risk are based on scientifically questionable, if not invalid, extrapolations of data from higher doses. However, the failure to demonstrate that a risk of cancer exists does not mean that there is no risk. This paper summarizes the data mentioned in various articles from recent literature discussing cancer risks due to CT and puts the results of these studies in perspective of current scientific knowledge in the field of radiation protection. For this we follow the lead of the ICRP and UNSCEAR. Furthermore, we review the strategies and efforts of various national and international bodies and manufacturers of CT apparatus to lower the radiation dose to the patient.

INTRODUCTION: Over the past 20 years, the use of fluoroscopy to guide urologic surgical interventions has been constantly growing. Thus, in their daily practice, urologists and other operating room (OR) staff are exposed to X-radiation increasingly frequently. This raises questions as to the risks they encounter and the actions needed to reduce them. OBJECTIVE: Evaluate X-ray dose exposure in the members of the surgical team and determine urologist radioprotection knowledge and practices. MATERIALS AND METHODS: A prospective bicenter study was conducted within AFUF (French urology resident association) and in association with The French Nuclear Safety Authority/The Institute for Radiological Protection and Nuclear Safety (ASN/IRSN). Radiation exposure was measured on 12 operators using dosimeters (seven per operator), in staff-occupied locations in the OR using ionization chambers, and on anthropomorphic phantoms. A survey was used to gather information on radiation knowledge and safety practices of the AFUF members. RESULTS: Annual whole-body radiation doses were low (0.1-0.8 millisieverts [mSv], mostly at around 0.3 mSv), and equivalent doses were low for the fingers (0.7-15 mSv, mostly at around 2.5 mSv), and low for the lens of the eye (0.3-2.3 mSv, mostly at around 0.7 mSv). In percutaneous nephrolithotomy, extremity doses were lower when the patient was placed in dorsal decubitus compared with ventral decubitus. Pulsed fluoroscopy reduced radiation dose exposure by a factor of 3 compared with continuous fluoroscopy with no image quality loss. Radiation safety practices were poor: only 15% of urologists wore dosimeters and only 5% had been trained in the handling of X-ray generators. CONCLUSION: In the present study, radiation exposure for urologists was low, but so was knowledge of radiation safety and optimization practices. This absence of training for radiation safety and reduction, teamed with novel techniques involving long fluoroscopy-guided interventions, could result in unnecessarily high exposure for patients and OR personnel.

Over the past two decades technical advances and improvements have made computed tomography (CT) a valuable and essential tool in the array of diagnostic imaging modalities. CT uses ionizing radiation (X-rays) which may damage DNA and increase the risk of carcinogenesis. This is especially pertinent in pediatric CT as children are more radiosensitive and have a longer life expectancy than adults. The purpose of this paper is to review and elucidate the potential harmful effects of ionizing radiation in terms of solid cancer induction from pediatric CT scanning. In the light of scientific and technical developments, we will also discuss the possible strategies and ongoing efforts to reduce CT radiation exposure in pediatric patients. In this context, we will not ignore the fact that a well-justified CT scan may exceed its risk and have a favorable impact.

Within the last ten years there has been increasing interest in tritium behaviour and distribution in the environment. This is based partly on empirical findings that tritium discharged mostly as HTO can become transformed into organic forms in environmental samples. An international workshop was convened in France in 2012 to gather the scientific community interested in organically bound tritium to share their experience and to establish a current state of knowledge. This paper summarises the outcome of the workshop, which aimed to improve skills concerning OBT (Organically Bound Tritium) determination, transfer and behaviour in the environment. In order to improve OBT measurement credibility, it was decided to conduct and promote OBT analysis through inter-laboratory exercises. This practice will reduce uncertainty in OBT analysis results, providing better OBT model validation data and public dose assessments.

QUALITY PROBLEM: There is no simple tool to assess compliance with common national and European directives, guidance and professional advice on the management of healthcare institutions. Despite evidence of unacceptable variations in the protection of patient and staff safety little attention has been given to harmonizing the way services are organized and managed. INITIAL ASSESSMENT: Existing systems which define organizational standards, or assess compliance with them, are not in a position to extend this activity into or across national borders in Europe. Certification, accreditation and licensing programmes are too variable to provide a common basis for consistent assessment. Consensual standards would inevitably be minimal if they were to achieve acceptance by all or a majority of member state governments; they would not be standards for excellence or help the majority of organizations to improve performance. PROPOSED SOLUTION: This paper proposes the development of a framework and measurement tool, initially for hospitals, which could be used for self-assessment or peer review to demonstrate compliance with European legislation, guidance and public expectations without infringing national responsibilities. A common code of management practice could be developed through a process similar to that adopted for clinical practice guidelines by the European commission-funded project on appraisal of guidelines research and evaluation. CONCLUSIONS: In practice, the legal relationships between member states and intergovernmental organizations inhibit the harmonization of management practice across-borders. Faster progress to higher levels of performance would be achieved by voluntary, non-regulatory cooperation of enthusiasts to define, measure and improve the quality of healthcare in European hospitals.

PURPOSE: Epidemiological studies of the French uranium miners and the plutonium workers at the Mayak nuclear facility have provided excess relative risk (ERR) estimates per unit absorbed lung dose from alpha radiation. The aim of this paper was to review these two studies and to derive values of the relative biological effectiveness (RBE) of alpha particles for the induction of lung cancer. MATERIALS AND METHODS: We examined and compared the dosimetry assumptions and methodology used in the epidemiological studies of uranium miners and the plutonium workers. Values of RBE were obtained by comparing risk coefficients including comparison of lifetime risks for a given population. To do this, preliminary calculations of lifetime risks following inhalation of plutonium were carried out. RESULTS AND CONCLUSIONS: Published values of risk per unit dose following inhalation of radon progeny and plutonium were in agreement despite the very different dose distributions within the lungs and the different ways the doses were calculated. Values of RBE around 10-20 were obtained by comparing ERR values, but with wide uncertainty ranges. Comparing lifetime risks gave similar values (10, 19 and 21). This supports the use of a radiation weighting factor of 20 for alpha particles for radiation protection purposes.

The International Commission on Radiological Protection (ICRP) has recently published two reports on radon exposure; Publication 115 on lung cancer risks from radon and radon progeny and Publication 126 on radiological protection against radon exposure. A specific graded approach for the control of radon in workplaces is recommended where a dose assessment is required in certain situations. In its forthcoming publication on Occupational Intakes of Radionuclides (OIR) document, Part 3, effective dose coefficients for radon and thoron will be provided. These will be calculated using ICRP reference biokinetic and dosimetric models. Sufficient information and dosimetric data will be given so that site-specific dose coefficients can be calculated based on measured aerosol parameter values. However, ICRP will recommend a single dose coefficient of 12 mSv per working level month (WLM) for inhaled radon progeny to be used in most circumstances. This chosen reference value was based on both dosimetry and epidemiological data. In this paper, the application and use of dose coefficients for workplaces are discussed including the reasons for the choice of the reference value. Preliminary results of dose calculations for indoor workplaces and mines are presented. The paper also briefly describes the general approach for the management of radon exposure in workplaces based both on ICRP recommendations and the European directive (2013/59/EURATOM).

Protection of the population and of workers from exposure to radon is a unique challenge in radiation protection. Many coordinated actions and a variety of expertise are needed. Initially, a National Radon Action Plan (NRAP) has been developed and implemented by some countries, while it is currently recommended by international organizations (e.g., World Health Organization) and required by international regulations, such as the European Council Directive 2013/59/Euratom and the International Basic Safety Standards on Radiation Protection and Safety of Radiation Sources, cosponsored by eight international organizations. Within this framework, the Heads of the European Radiological Protection Competent Authorities (HERCA) have organized activities aimed at sharing experiences to contribute toward the development and implementation of effective NRAPs. Two workshops were held in 2014 and 2015, the latter on radon in workplaces. As a follow-up to these, an online event took place in March 2021, and a second specific workshop on NRAP is planned for June 2022. These workshops were attended by experts from the competent authorities of European countries, relevant national and international organizations. The experience of several countries and the outcomes from these workshops have highlighted the need for adequate indicators of the effectiveness and progress of the actions of NRAPs, which could also be useful to implement the principle of optimization and the graded approach in NRAPs. In this paper, the activities of HERCA to support the development and implementation of effective NRAPs are described and some examples of effectiveness indicators are reported, including those already included in the NRAP of some European countries.

El Nuevo Management Público se ha constituido en el principal referente a la hora de construir políticas educativas a nivel mundial. Sin embargo, diversos estudios han mostrado que el managerialismo promovido por este modelo, se vincula fuertemente con la promoción del autoritarismo como modo de gestión. Chile ha sido considerado un caso emblemático de implementación del Nuevo Management Público en educación. Este artículo aborda cómo el managerialismo constituye a la posición del director de escuela en el caso chileno mediante el análisis de dos políticas educativas recientes: el Marco para la Buena Enseñanza y el Liderazgo Directivo, y la reciente Ley que fortalece las facultades de los directores de los establecimientos educacionales en materia de convivencia escolar. Como se podrá apreciar, los resultados confirman que los límites entre managerialismo y autoritarismo resultan difusos. Esto debería preocupar a investigadores y gestores políticos, considerando la amplia difusión de los modelos manageriales.