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Background: A nudge corresponds to any procedure that influences choice architecture, without using persuasion or financial incentives. Nudges are effective in increasing vaccination with heterogeneous levels of acceptability.Objective: To evaluate the effectiveness and acceptability of a nudge promoting influenza vaccination for general practice trainees, also called residents.Methods: The hypothesis was that a reminder would be efficient and accepted and that prior exposure to a nudge increases its acceptability. Residents were randomly divided into three parallel experimental arms: a nudge group, a no-nudge group and a control group in order to evaluate the Hawthorne effect. The nudge consisted of providing a paper form for the free delivery of the vaccine and contacts for occupational health services.Results: The analysis included 161 residents. There was a strong consensus among the residents that it is very acceptable to nudge their peers and patients. Acceptability was better with residents exposed to the nudge and with residents included in step 1 (Hawthorne effect). The nudge did not increase vaccination coverage.Conclusion: The failure of this nudge highlights the importance of matching an intervention to the population's needs. The experimental approach is innovative in this context and deserves further attention.Clinicaltrials.gov Pre-registration: NCT03768596. [ABSTRACT FROM AUTHOR]

Background: The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients.Main Body: This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources.Conclusion: Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level. [ABSTRACT FROM AUTHOR]

Objective: Quality of life (QoL) is still assessed using paper-based and fixed-length questionnaires, which is one reason why QoL measurements have not been routinely implemented in clinical practice. Providing new QoL measures that combine computer technology with modern measurement theory may enhance their clinical use. The aim of this study was to develop a QoL multidimensional computerized adaptive test (MCAT), the SQoL-MCAT, from the fixed-length SQoL questionnaire for patients with schizophrenia.Methods: In this multicentre cross-sectional study, we collected sociodemographic information, clinical characteristics (i.e., duration of illness, the PANSS, and the Calgary Depression Scale), and quality of life (i.e., SQoL). The development of the SQoL-CAT was divided into three stages: (1) multidimensional item response theory (MIRT) analysis, (2) multidimensional computerized adaptive test (MCAT) simulations with analyses of accuracy and precision, and (3) external validity.Results: Five hundred and seventeen patients participated in this study. The MIRT analysis found that all items displayed good fit with the multidimensional graded response model, with satisfactory reliability for each dimension. The SQoL-MCAT was 39% shorter than the fixed-length SQoL questionnaire and had satisfactory accuracy (levels of correlation >0.9) and precision (standard error of measurement <0.55 and root mean square error <0.3). External validity was confirmed via correlations between the SQoL-MCAT dimension scores and symptomatology scores.Conclusion: The SQoL-MCAT is the first computerized adaptive QoL questionnaire for patients with schizophrenia. Tailored for patient characteristics and significantly shorter than the paper-based version, the SQoL-MCAT may improve the feasibility of assessing QoL in clinical practice. [ABSTRACT FROM AUTHOR]

This paper assesses the impact of eligibility for a free means-tested complementary health insurance plan, called Couverture Maladie Universelle Complémentaire (CMUC), on doctor visits. We use information on the selection rule to qualify for the plan to identify the effect of eligibility and adopt a regression discontinuity approach. Our sample consists of low-income individuals enrolled in the Health Insurance Fund and recipients of social benefits from the Family Allowance Fund of an urban area in Northern France. Our findings do not show significant impacts of the CMUC threshold on the number of doctor visits within the full sample. Among the subsample of adults under 30 years old, however, eligible individuals are more likely to see a specialist and have, on average, significantly more specialist visits than non-eligible individuals. This specific impact of the CMUC cut-off point among young adults may be explained by the fact that young adults are less likely to be covered by a complementary health insurance plan when they are not recipients of the CMUC plan. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

At the request of French Regulatory Authorities, a new formulation of Levothyrox® was licensed in France in 2017, with the objective of avoiding the stability deficiencies of an existing licensed formulation. Before launching the new formulation, an average bioequivalence (ABE) trial was conducted, having enrolled 204 subjects and selected for interpretation a narrow a priori bioequivalence range of 0.90-1.11. Bioequivalence was concluded. In a previous publication, we questioned the ability of an ABE trial to guarantee the switchability within patients of the new and old levothyroxine formulations. It was suggested that the two formulations should be compared using the conceptual framework of individual bioequivalence. The present paper is a response to those claiming that, despite the fact that ABE analysis does not formally address the switchability of the two formulations, future patients will nevertheless be fully protected. The basis for this claim is that the ABE study was established in a large trial and analyzed using a stringent a priori acceptance interval of equivalence. These claims are questionable, because the use of a very large number of subjects nullifies the implicit precautionary intention of the European guideline when, for a Narrow Therapeutic Index drug, it recommends shortening the a priori acceptance interval from 0.80-1.25 to 0.90-1.11. [ABSTRACT FROM AUTHOR]

Background/objectives: Monitoring of processed products at the brand level was implemented in Austria, France and Romania on the basis of the Oqali methodology during the Joint Action on Nutrition and Physical Activity (JANPA) to compare the nutritional quality of the food offering. The objective of this paper is to present the results obtained during this study.Subjects/methods: Collected data were those available on product packaging. In total, 2155 soft drinks and 943 breakfast cereals were classified in a standardised list of product families and analysed in a harmonised way. For each product family, mean values for sugar, fat, saturated fat, salt and dietary fibres were compared between countries. Common products across countries were also studied.Results: For all the studied nutrients, significant differences were observed between countries, with a higher sugar content for Romania in regular carbonated and non-carbonated beverages containing fruits, regular lemonades and regular tonics and bitters (together with Austria for tonics), for France in fruit beverages with more than 50% fruit, and for Austria in low-sugar beverages containing tea. For France, higher nutrient contents were also observed for sugar in chocolate-flavoured cereals, filled cereals and cornflakes, and other plain cereals (at a similar level as Romania for cornflakes), and for saturated fats in honey/caramel cereals and crunchy mueslis. These differences were explained by a different food offering in the three countries, but also by differences in nutrient contents for common products. This study also showed high variability of the nutrient content within a product family, suggesting a real potential for product reformulation.Conclusions: National tools, at the branded products level, are essential to monitor the nutritional quality of the food offering, and to follow up on processed food reformulations. [ABSTRACT FROM AUTHOR]

Background: Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS).Methods: We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required).Results: The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total.Conclusion: With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS. [ABSTRACT FROM AUTHOR]

Background: The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression.Methods/design: This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements).Discussion: The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression.Trial Registration: ClinicalTrials.gov, Identifier NCT02376491 . Registered on 17 February 2015 at http://clinicaltrials.gov . [ABSTRACT FROM AUTHOR]

Objective: The clinical symptoms of schizophrenia are associated with serious social, quality of life and functioning alterations. Typically, data on health utilities are not available in clinical studies in schizophrenia. This makes the economic evaluation of schizophrenia treatments challenging. The purpose of this article was to provide a mapping function to predict unobserved utility values in patients with schizophrenia from the available clinical and socio-demographic information.Methods: The analysis was performed using data from EuroSC, a 2-year, multi-centre, cohort study conducted in France (N = 288), Germany (N = 618), and the UK (N = 302), totalling 1208 patients. Utility was calculated based on the EQ-5D questionnaire. The relationships between the utility values and the patients' socio-demographic and clinical characteristics (Positive and Negative Syndrome Scale--PANSS, Calgary Depression Scale for Schizophrenia--CDSS, Global Assessment of Functioning--GAF, extra-pyramidal symptoms measured by Barnes Akathisia Scale-BAS, age, sex, country, antipsychotic type) were modelled using a random and a fixed individual effects panel linear model.Results: The analysis demonstrated the prediction ability of the used parameters for estimating utility measures in patients with schizophrenia. Although there are small variations between countries, the same variables appear to be the key predictors. From a clinical perspective, age, gender, psychopathology, and depression were the most important predictors associated with the EQ-5D.Conclusion: This paper proposed a reliable, robust and easy-to-apply mapping method to estimate EQ-5D utilities based on demographic and clinical measures in schizophrenia. [ABSTRACT FROM AUTHOR]

Clinical reasoning is a core competency in medical practice. No study has explored clinical reasoning occurring before a clinical encounter, when physicians obtain preliminary information about the patient, and during the first seconds of the observation phase. This paper aims to understand what happens in emergency physicians' minds when they acquire initial information about a patient, and when they first meet a patient. The authors carried out in-depth interviews based on the video recordings of emergency situations filmed in an "own-point-of-view-perspective". 15 expert emergency physicians were interviewed between 2011 and 2012. Researchers analysed data using an interpretive approach based on thematic analysis and constant comparison. Almost all participants used a few critical pieces of information to generate hypotheses even before they actually met the patient. Pre-encounter hypotheses played a key role in the ensuing encounter by directing initial data gathering. Initial data, collected within the first few seconds of the encounter, included the patient's position on the stretcher, the way they had been prepared, their facial expression, their breathing, and their skin colour. Physicians also rapidly appraised the seriousness of the patient's overall condition, which determined their initial goals, i.e. initiating emergency treatment or pursuing the diagnostic investigation. The study brings new insights on what happens at the very beginning of the encounter between emergency physicians and patients. The results obtained from an innovative methodological approach open avenues for the development of clinical reasoning in learners. [ABSTRACT FROM AUTHOR]

This paper focusses on coping strategies employed by children and adolescents with diagnosed short stature, assesses the impact of socio-demographic and clinical characteristics on coping, examines the relationship between coping and health related quality of life (QoL) and investigates the role of coping strategies in mediating the relationship between height and QoL. Coping with a disease (CODI) and quality of life in short stature youth (QoLISSY-QoL) questionnaires were completed by 137 short-statured children and adolescents between 8 and 18 years, participating in the crosssectional European QoLISSY study. Clinical and socio-demographic data were collected to examine differences in coping via variance and regression analyses, associations between CODI and QoLISSY were inspected using correlation and mediation analyses. Most frequently employed coping strategies in the CODI were 'Acceptance' and 'Wishful Thinking', with 'Emotional Reaction' used least. Significant effects of age, diagnosis and treatment status on coping strategies were detected. CODI scales 'Acceptance' and 'Distance' were associated with higher QoLISSY-QoL scores, 'Emotional Reaction' and 'Wishful Thinking' with lower scores. Coping strategies predicted 60 % of the QoLISSY-QoL variance. Relationships between height deviation and QoLISSY-QoL were mediated by the coping strategies of 'Wishful Thinking' and 'Distance'. Findings suggest that coping efforts vary with socio-demographic and clinical characteristics, that protective coping strategies in terms of QoL can be identified and that coping mediates the relationship between short stature and QoL. Future longitudinal research should focus on the adaptive function of coping in relation to QoL over time. [ABSTRACT FROM AUTHOR]

Introduction: Endovascular treatment of large, wide-necked intracranial aneurysms with coils is associated with low rates of initial angiographic occlusion and high rates of recurrence. The Pipeline™ Embolization Device has shown high rates of complete occlusion in uncontrolled clinical series. Methods: The study is a prospective, controlled, randomized, multicenter, phase 2 open-label trial. Intention-to-treat population includes age ≥18, unruptured saccular aneurysm located in the intra-dural area, neck diameter ≥4 and ≤10 mm, sac diameter ≥7 mm and ≤20 mm, 'dome/neck' ratio is ≥1, diameter of the parent artery ≥2 mm and ≤5 mm, and no prior treatment of the aneurysm. Site can only participate if five patients have been previously treated with the Pipeline device. The primary end point of the study is complete occlusion of the aneurysm on angiogram performed 12 months after the endovascular procedure. Complete aneurysm occlusion is defined as the absence of visible blood flow, grade 1 according to the Raymond scale for the standard procedure group and grade 4 according to the grading scale of Kamran for the flow diverter group. Results: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up. Conclusion: This paper details the trial design of the French EVIDENCE phase 2 trial, a blinded, controlled randomized trial of wide-neck intra-dural aneurysms amenable to either traditional endovascular strategy or flow diversion with Pipeline device. [ABSTRACT FROM AUTHOR]

Objectives: In this paper, we introduce a method that aims at describing components of medical activities that are performed by a medical team, including physicians and nurses, during patients' management in an ICU (intensive care unit). This method is based on formal task analyses developed in cognitive ergonomics. Our ultimate aim is to build a method covering the observation and the representation of collective activities during patients' management, which should be re-usable by the team members in order to prepare themselves for accreditation.Methods: This method comprises two main steps:--the formal observations of medical staff's activities that occur during patient management,--a representation of the findings with regard to an ontology and a temporal flowchart, which describes actors and events related to patient management.Results: This paper describes field studies performed in ICUs. This method has been used for analyzing the management of 24 cases of neurological and multiple traumas. We have represented the different actions of the medical team members (clinicians, nurses and outside medical consultants).Conclusion: The results allow us to identify the specific features of these complex and time-constrained situations, especially about the strong collaborative activities between members of the patient-care teams, especially the interaction between information management and medical actions. [ABSTRACT FROM AUTHOR]

Modafinil, a wake-promoting compound now used worldwide in sleep medicine, was initially regarded as a sedative compound because mice were so quiet with respect to locomotion after receiving it that this behavioral state was qualified as sedation. In the early 1980's when modafinil was first assessed by polysomnography in a cat in our laboratory, surprisingly, the cat spent the whole night awake without even one minute of sleep! This initial observation resulted subsequently in a series of basic and clinical studies in order to define the pharmacological profile of modafinil and its mode of action and, notably, to identify the brain targets by which modafinil acts to promote wakefulness. These studies were undertaken using pharmacologic approach coupled with the Cerveau isolé (brain transection) preparation, c-fos labelling and knockout mouse models. It was also in this context that we have developed a purified polyclonal antibody against modafinil. We expected that using immunohistochemistry with this antibody would allow us to localize the brain distribution of modafinil dosing. Surprisingly, we found discrete modafinil immunoreactive neuronal populations in several brain areas of modafinil-naive cats, rodents and humans. The most numerous and intensely labeled modafinil-immunoreactive neurons characterized by granular staining were found in the basal forebrain. They shared the regional location with cholinergic and aspartate-containing neurons but did not colocalize with them. In summary, we here present a newly identified neuronal population located in the basal forebrain that has never previously been published and suggests that these modafinil-immunoreactive neurons might be involved in forebrain functions such as sleep-wake control and cognition. This paper briefly reviews our journey with modafinil research and presents new unpublished experimental data. [ABSTRACT FROM AUTHOR]

Background: As a result of the ban on lead in gasoline on 2nd January 2000, the French population's exposure to lead has decreased in recent years. However, because of the acknowledged harmful cognitive effects of lead even at low levels, lead exposure remains a major public health issue. In France, few biomonitoring data are available for exposure to lead in pregnant women and newborn. The purpose of the perinatal component of the French human biomonitoring (HBM) program was to describe levels of various biomarkers of exposure to several environmental pollutants, including lead, among mother-baby pairs. In this paper, we aimed to describe the distribution of cord blood lead levels (CBLL) in French mother-baby pairs, and to estimate the contribution of the main lead exposure risk factors to these levels.Method: A total of 1968 mother-baby pairs selected from the participants of the perinatal component of the French HBM program were included in the study on lead. Lead levels were analyzed in cord blood collected at child delivery by inductively coupled plasma-mass spectrometry (ICP-MS). The data collected included biological sample, socio-demographic characteristics, environmental and occupational exposure, and information on dietary factors.Results: CBLL were quantified for 99.5% of the sample. The CBLL geometric mean was 8.30 μg/l (95% CI [7.94-8.68]) with a 95th percentile of 24.3 μg/l (95% CI [20.7-27.1]). Factors significantly associated with CBLL were tap water consumption, alcohol consumption, shellfish consumption, vegetable consumption, bread consumption, smoking, and the mother being born in countries where lead is often used.Conclusion: This study provides the first reference value for CBLL in a random sample of mother-baby pairs not particularly exposed to high levels of lead (24.3 μg/l). A substantial decrease in CBLL over time was observed, which confirms the decrease of exposure to lead among the general population. CBLL observed in this French study were in the range of those found in recent surveys conducted in other countries. [ABSTRACT FROM AUTHOR]

In this paper the author examines the proposition that heterogeneity in individual frailty leads to autocorrelation in cohort mortality rates. A simple model is used to construct analytic expressions for the covariance of cohort mortality rates at different ages under a number of alternative assumptions about the stochastic process generating shocks in mortality. The model then is used to construct a procedure that uses correlations in cohort mortality rates to estimate the extent of heterogeneity in a population without relying on strong assumptions about the distribution of frailty or the shape of the underlying hazard. The procedure then is used to show that cohort mortality data from France are consistent with a generalized random-effects model in which frailty is gamma-distributed. [ABSTRACT FROM AUTHOR]

This paper analyzes short-run fluctuations in national time series of vital events for France in the period 1740 to 1909. Fertility, mortality, and nuptiality form a simultaneous system which interacts with economic and meteorological conditions. In the short run, the demographic variables are endogenous. Economic and meteorological conditions are exogenous. Our indicator of economic conditions is the price of wheat, the principal food crop. Biometric models of fertility and empirical research on the biologically-based interrelations of fertility and mortality provide insight into the expected timing of events. We combine these results with empirical research on the effects of nutrition on fertility and mortality, research in medical biometeorology, and French historical demographic and economic research to formulate our model. The resultant distributed lag system is estimated. We find that the economic/nutritional effects are more likely to be statistically significant in predicting the time path of vital events than are the demographic variables or the effects of meteorological conditions. [ABSTRACT FROM AUTHOR]

In this paper we question whether prior cross-national differences in food attitudes still exist and if so, to what extent. Due to societal evolutions such as sedentarism and globalization, international variations in food attitudes may not be as pronounced as currently believed. A cross-sectional web-based survey was carried out in the United States, the United Kingdom, France and Belgium. A total of 2167 respondents (52% women; mean age = 39.0 years, SD = 11.4) participated. To successfully combat obesity, a joint approach focusing on food choice and physical activity is required; therefore we included behavioral measures by means of choice tasks for these two important drivers. Further, the extent to which respondents subscribe to the unhealthy = tasty intuition, together with health and taste interest were investigated. Socio-demographic information and self-reported heights and weights were also incorporated. Logistic regressions were fitted with weight status as the dependent variable and the attitudinal and behavioral measures as independent variables. Our findings indicate that having a higher interest in healthy eating decreases the chance of being overweight (odds = 0.88) and believing that unhealthy food is tasty significantly increases the chance of being obese by 1.18 times. Overall, we find that food attitudes have largely converged across the countries we investigated. [ABSTRACT FROM AUTHOR]

The public-health community views mandatory Front-of-Pack (FOP) nutrition labels and nutritional taxes as promising tools to control the growth of food-related chronic diseases. This paper uses household scanner data to propose an ex-ante evaluation and comparison of these two policy options for the fromage blanc and dessert yogurt market. In most markets, labelling is voluntary and firms display fat labels only on the FOP of low-fat products to target consumers who do not want to eat fat. We here separately identify consumer preferences for fat and for FOP fat labels by exploiting an exogenous difference in legal labelling requirements between these two product categories. Estimates of demand curves are combined with a supply model of oligopolistic price competition to simulate policies. We find that a feasible ad valorem fat tax dominates a mandatory FOP-label policy from an economic perspective, but both are equally effective in reducing average fat purchases. [ABSTRACT FROM AUTHOR]

Background: In this paper, we report the results of risk attitudes elicitation of a French general practitioners national representative sample (N=1568).Methods: Willingness to take risks in four different domains (daily life, financial matters, own health and patient health) was collected through a large-scale telephone interview of GPs using self-reported 11-point Likert scale questions.Results: We uncover some specificities of the GPs population regarding their attitudes towards risk. In particular, we detect an important positive gap between their willingness to take risks in the domain of their own health and in the domain of the heath of their patients. This "patient-regarding" risk aversion is discussed with respect to its important consequences regarding medical behavior bias.Conclusions: We confirm the self-other discrepancy found in the medical literature on physicians' behaviors and emphasize the utility of the study and measures of personality traits such as "risk attitudes" for the medical professions and for the population they address. [ABSTRACT FROM AUTHOR]

Context: Some patients in palliative care units request euthanasia regardless of legislation. Although studies have explored the reasons for these requests, little is known about the subjective, relational, and contextual repercussions for the patient. Objectives: The aim of this study is to understand the purpose of euthanasia requests from the patient's viewpoint and their personal and practical impact. Methods: We conducted in-depth interviews with patients requesting euthanasia, their family members, and health care providers in 11 French palliative care units. A thematic analysis of the data was performed. Results: In total, 18 patients were interviewed within 48 h of the request being made; 1 week later, 9 patients were interviewed again. Five main themes emerged: assuming the possibility of transgressing the forbidden, a call for unbearable suffering to be recognized, encouragement to change clinical practice, reclaiming a sense of freedom over medical constraints, and imagining a desirable future for oneself. Conclusions: A request for euthanasia appears to be a willful means to remove oneself from the impasse of an existence paralyzed by suffering. It creates a space for discussion, which promotes negotiation with patients on care practices and therapeutics, and strengthens patients' sense of autonomy. Investigating the relationship between the evolution of euthanasia requests within the palliative care setting could be beneficial. It is important to encourage health care professionals to adopt a readiness to listen by interacting with patients in a way that is not momentarily action-oriented but rather focused on proactive discussion. [ABSTRACT FROM AUTHOR]

Background: Schizophrenia has a variety of clinical profiles, disabilities and outcomes requiring responsive management and the devotion of considerable resources. The primary objective of the European Schizophrenia Cohort (EuroSC) is to relate the types of treatment and methods of care to clinical outcome. Secondary objectives include the assessment of treatment needs in relation to outcome, the calculation of resource consumption associated with different methods of care, and the identification of prognostic factors.Method: EuroSC is a naturalistic follow-up of a cohort of people aged 18 to 64 years, suffering from schizophrenia and in contact with secondary psychiatric services. The study was done in nine European centres, in France (N = 288), Germany (N = 618), and Britain (N = 302). Participants were interviewed at 6-monthly intervals for a total of 2 years. This initial paper describes the methods used and presents clinical and social baseline data.Results: The clinical and socio-demographic differences between patients from the different countries were small. However, patients from Britain were considerably more likely than their continental counterparts to have a history of homelessness, rooflessness or imprisonment, even when social and clinical differences between the samples were controlled.Conclusions: The samples were largely similar in clinical terms. Thus, the social differences between the samples seem likely to be due more to the societal context and may reflect relatively benign situations in the continental locations of our study. [ABSTRACT FROM AUTHOR]

Objectives: Hospitals and medical centers are producing more and more data that need to be processed. Those data are confidential, heterogeneous, and limited to the geographic site where they have been produced. Unless properly anonymized, they cannot be distributed on wide area networks.Methods: Grid technologies allow the globalization of storage and processing resources, and enable large-scale experimentations on distributed data. They constitute a promising tool to treat the different data and analyze the knowledge they contain, while offering secured access and high-performance computing capacities to the different users. Our aim is to evaluate the possibilities of grid technologies for handling medical data.Results and Conclusions: In this paper, we focus on a breast cancer diagnosis assistance tool, based on distributed and incremental knowledge construction and a content-based image retrieval system. We analyze the different scenarios of uses of such a tool. We further propose an algorithm that indexes mammographic images for content-based query purposes. This algorithm is tested on images of different resolutions in order to reduce the indexation time and we analyze its performance with experiments on the grid. [ABSTRACT FROM AUTHOR]

Objectives: To propose a novel approach of incorporating ambient intelligence in the health grid security architecture.Methods: Security concerns are severely impeding the grid community effort in spreading its wings in health applications. In this paper, we have proposed a high level approach to incorporate ambient intelligence for health grid security architecture and have argued that this will significantly improve the current state of the grid security paradigm with an enhanced user-friendly environment. We believe that the time is right to shift the onus of traditional security mechanisms onto the new technologies. The incorporation of ambient intelligence in the security architecture of a grid will not only render a security paradigm robust but also provide an attractive vision for the future of computing by bringing the two worlds together.Results: In this article we propose an evolutionary approach of utilizing smart devices for grid security architecture. We argue that such an infrastructure will impart unique features to the existing grid security paradigms by offering fortified and relentless monitoring. This new security architecture will be comprehensive in nature but will not be cumbersome for the users due to its typical characteristics of not prying into their lives and adapting to their needs.Conclusions: We have identified a new paradigm of the security architecture for a health grid that will not only render a security mechanism robust but will also provide the high levels of user-friendliness. As our approach is a first contribution to this problem, a number of other issues for future research remain open. However, the prospects are fascinating. [ABSTRACT FROM AUTHOR]

This paper examines parents' experiences of medical decision-making and coping with having a critically ill baby in the Neonatal Intensive Care Unit (NICU) from a cross-cultural perspective (France vs. U.S.A.). Though parents' experiences in the NICU were very similar despite cultural and institutional differences, each system addresses their needs in a different way. Interviews with parents show that French parents expressed overall higher satisfaction with the care of their babies and were better able to cope with the loss of their child than American parents. Central to the French parents' perception of autonomy and their sense of satisfaction were the strong doctor-patient relationship, the emphasis on medical certainty in prognosis versus uncertainty in the American context, and the "sentimental work" provided by the team. The American setting, characterized by respect for parental autonomy, did not necessarily translate into full parental involvement in decision-making, and it limited the rapport between doctors and parents to the extent of parental isolation. This empirical comparative approach fosters a much-needed critique of philosophical principles by underscoring, from the parents' perspective, the lack of "emotional work" involved in the practice of autonomy in the American unit compared to the paternalistic European context. Beyond theoretical and ethical arguments, we must reconsider the practice of autonomy in particularly stressful situations by providing more specific means to cope, translating the impersonal language of "rights" and decision-making into trusting, caring relationships, and sharing the responsibility for making tragic choices. [ABSTRACT FROM AUTHOR]

Background Little is known about the prevalence of hypoglycaemia in older people with diabetes. However, the HbA1c goal is ≥8% for institutionalised patients with treatments that can cause hypoglycaemia. Purpose We aimed to assess the prevalence of hypoglycaemia with continuous glucose monitoring and to evaluate the link with HbA1C in older institutionalised patients with diabetes taking potentially hypoglycaemia-inducing drugs. Design Prospective, multicentre study carried out in six geriatric care centres in the Côte d'Or region of France between January 2019 and July 2020. Settings, subjects and methods A FreeStyle Libre Pro® (FSLP) was worn for up to 14 days in blinded mode in 42 patients taking at least one potentially hypoglycaemia-inducing antidiabetic drug. Results Two hundred and forty-two hypoglycaemic events were detected in 79% (n  = 33) of patients wearing the FSLP. One or more hypoglycaemic event was detected in 100% of patients with HbA1C < 7% and in 79% of patients with HbA1C ≥ 8% (P  = 0.02). The time spent in hypoglycaemia was higher in patients with HbA1C < 7% than those with HbA1C ≥ 8% (P  = 0.015). Time spent <54 mg/dl was detected in 45% of patients. Conclusions We report a very high prevalence of hypoglycaemia, with a significant proportion of severe hypoglycaemia, in older institutionalised patients with diabetes taking potentially hypoglycaemia-inducing drugs. Having HbA1C < 7% exposes patients to a higher risk of hypoglycaemia, but this risk remains also high in patients with HbA1C ≥ 8%. In this population, continuous glucose monitoring could be considered an effective tool to detect hypoglycemia, which is associated with increased risk of cardiovascular events, falling, fractures, cognitive impairment and mortality. [ABSTRACT FROM AUTHOR]

Clinical trials for the treatment of schizophrenia now often include cognitive assessments in addition to clinical ratings of symptoms. Recently, these trials have included cross-national assessments. It is not clear if translated psychological tests produce consistent results across different languages. This paper presents the results of a study of the comparability of the results of cognitive assessments in different English-speaking countries and a number of countries where tests were translated into other languages. Performance on tests of executive functioning, verbal and visuo-spatial learning and memory, language skills, psychomotor speed, and vigilance was compared across the first episode patients with schizophrenia (n=301) assessed in six different languages (English, French, Finnish, German, Hebrew, and Afrikaans), including two different countries where patients were assessed in English and other languages: Canada (French) and South Africa (Afrikaans). The variance in performance across the sites tested in English was as large as the variance between English and non-English speakers when all tests were considered. Performance differences across English and other languages were found only for executive functions, vigilance, and psychomotor speed, with executive functioning differences nonsignificant when education was considered. No differences were found between English and non-English speakers in Canada. These results suggest that the translation of tests of memory and verbal skills can lead to consistent results across translated versions of the tests. Differences between countries were greater than differences between languages, suggesting the need to consider representativeness of patient samples in terms of local educational attainment. In general, these data support the validity of cross-national neuropsychological assessments. [Copyright &y& Elsevier]

Background: Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. Methods: This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self‐reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self‐reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision‐making, or deficient consideration of pain). Results: Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94‐7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57‐12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision‐making. Conclusions: Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions. [ABSTRACT FROM AUTHOR]

Background: The use of a 'do not interrupt' vest during medication administration rounds is recommended but there have been no controlled randomized studies to evaluate its impact on reducing administration errors. We aimed to evaluate the impact of wearing such a vest on reducing such errors. The secondary objectives were to evaluate the types and potential clinical impact of errors, the association between errors and several risk factors (such as interruptions), and nurses' experiences. Methods: This was a multicenter, cluster, controlled, randomized study (March–July 2017) in 29 adult units (4 hospitals). Data were collected by direct observation by trained observers. All nurses from selected units were informed. A 'Do not interrupt' vest was implemented in all units of the experimental group. A poster was placed at the entrance of these units to inform patients and relatives. The main outcome was the administration error rate (number of Opportunities for Error (OE), calculated as one or more errors divided by the Total Opportunities for Error (TOE) and multiplied by 100). Results: We enrolled 178 nurses and 1346 patients during 383 medication rounds in 14 units in the experimental group and 15 units in the control group. During the intervention period, the administration error rates were 7.09% (188 OE with at least one error/2653 TOE) for the experimental group and 6.23% (210 OE with at least one error/3373 TOE) for the control group (p = 0.192). Identified risk factors (patient age, nurses' experience, nurses' workload, unit exposition, and interruption) were not associated with the error rate. The main error type observed for both groups was wrong dosage-form. Most errors had no clinical impact for the patient and the interruption rates were 15.04% for the experimental group and 20.75% for the control group. Conclusions: The intervention vest had no impact on medication administration error or interruption rates. Further studies need to be performed taking into consideration the limitations of our study and other risk factors associated with other interventions, such as nurse's training and/or a barcode system. Trial registration: The PERMIS study protocol (V2–1, 11/04/2017) was approved by institutional review boards and ethics committees (CPP Ile de France number 2016-A00211–50, CNIL 21/03/2017, CCTIRS 11/04/2016). It is registered at ClinicalTrials.gov (registration number: NCT03062852, date of first registration: 23/02/2017). [ABSTRACT FROM AUTHOR]

Background: The etiology of the central nervous system (CNS) tumors remains largely unknown. The role of pesticide exposure has been suggested by several epidemiological studies, but with no definitive conclusion.Objective: To analyze associations between occupational pesticide exposure and primary CNS tumors in adults in the CERENAT study.Methods: CERENAT is a multicenter case-control study conducted in France in 2004-2006. Data about occupational pesticide uses-in and outside agriculture-were collected during detailed face-to-face interviews and reviewed by experts for consistency and exposure assignment. Odds ratios (ORs) and 95% confidence intervals (95% CI) were estimated with conditional logistic regression.Results: A total of 596 cases (273 gliomas, 218 meningiomas, 105 others) and 1 192 age- and sex-matched controls selected in the general population were analyzed. Direct and indirect exposures to pesticides in agriculture were respectively assigned to 125 (7.0%) and 629 (35.2%) individuals and exposure outside agriculture to 146 (8.2%) individuals. For overall agricultural exposure, we observed no increase in risk for all brain tumors (OR 1.04, 0.69-1.57) and a slight increase for gliomas (OR 1.37, 0.79-2.39). Risks for gliomas were higher when considering agricultural exposure for more than 10 years (OR 2.22, 0.94-5.24) and significantly trebled in open field agriculture (OR 3.58, 1.20-10.70). Increases in risk were also observed in non-agricultural exposures, especially in green space workers who were directly exposed (OR 1.89, 0.82-4.39), and these were statistically significant for those exposed for over 10 years (OR 2.84, 1.15-6.99).Discussion: These data support some previous findings regarding the potential role of occupational exposures to pesticides in CNS tumors, both inside and outside agriculture. [ABSTRACT FROM AUTHOR]

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Aim: Although well documented in randomised trials, the efficacy of prophylaxis against respiratory syncytial virus (RSV) in real-word conditions is less studied. The objective was to assess the impact of partial versus full RSV prophylaxis for acute respiratory infections (ARIs) and ARI-related hospital admissions in preterm children.Methods: This study included children born preterm in 2011 in France who were eligible for RSV prophylaxis and received at least one palivizumab dose from October 2011 to March 2012. Full prophylaxis was defined as receiving at least one palivizumab dose for each month of RSV exposure in the community. Children with full and partial prophylaxis were matched, and odds of ARIs and ARI-related hospital admission were compared by logistic regression.Results: Full prophylaxis concerned 861/1083 (80%) children. As compared with full prophylaxis, partial prophylaxis was not associated with ARI occurrence (odds ratio OR 1.3, 95% confidence interval CI 0.9-1.9) but was significantly associated with ARI-related hospital admission during the RSV epidemic (OR 1.9, 95% CI 1.2-2.9).Conclusion: During the 2011-2012 RSV epidemic, hospital admission rates were higher for preterm children with partial than full RSV prophylaxis. Improving compliance could help alleviate the burden of RSV on healthcare systems. [ABSTRACT FROM AUTHOR]

Background: The effects of surgical site infections (SSI) after glioblastoma surgery on patient outcomes are understudied. The aim of this retrospective multicenter study was to evaluate the impact of SSI on the survival of glioblastoma patients. Methods: Data from SSI cases after glioblastoma surgeries between 2009 and 2016 were collected from 14 French neurosurgical centers. Collected data included patient demographics, previous medical history, risk factors, details of the surgical procedure, radiotherapy/chemotherapy, infection characteristics, and infection management. Similar data were collected from gender- and age-paired control individuals. Results: We used the medical records of 77 SSI patients and 58 control individuals. 13 were excluded. Our analyses included data from 64 SSI cases and 58 non-infected glioblastoma patients. Infections occurred after surgery for primary tumors in 38 cases (group I) and after surgery for a recurrent tumor in 26 cases (group II). Median survival was 381, 633, and 547 days in patients of group I, group II, and the control group, respectively. Patients in group I had significantly shorter survival compared to the other two groups (p < 0.05). The one-year survival rate of patients who developed infections after surgery for primary tumors was 50%. Additionally, we found that SSIs led to postoperative treatment discontinuation in 30% of the patients. Discussion: Our findings highlighted the severity of SSIs after glioblastoma surgery, as they significantly affect patient survival. The establishment of preventive measures, as well as guidelines for the management of SSIs, is of high clinical importance. [ABSTRACT FROM AUTHOR]

Over the past decade, improvements in medical treatment and revascularization techniques have been beneficial for patients with peripheral artery disease in the late stage of critical limb ischemia (CLI). We evaluated the putative reduction in the number of major amputees in the Cohorte des Patients ARTeriopathes (COPART) cohort over time. Patients were selected from this multicenter cohort, from 2006 to 2016, for CLI according to Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease II criteria. Patients included before and after 2011 were compared. Patients were followed for 1 year. Primary outcome was the rate of major amputations. Secondary outcomes were minor amputations, deaths from all causes, cardiovascular deaths; 989 patients were included, 489 before 2011 and 450 after 2011. There was a significant decrease in rates of major amputation after 2011 (17% vs 25%), confirmed in multivariate analysis (odds ratio [OR]: 1.5 [1.1-2.2]), an increase in revascularization, particularly distal angioplasty (OR: 2.7 [1.7-4.4]) and increased statin intake (OR: 1.6 [1.1-2.1]). For secondary outcomes, there was no significant difference. Limb prognosis of CLI patients has improved over the past decade, possibly due to more revascularizations, particularly distal ones, and increased statin use. [ABSTRACT FROM AUTHOR]

Study Question: Do IVF, IUI or female infertility (i.e. endometriosis, polycystic ovary syndrome [PCOS] and primary ovarian insufficiency [POI]) lead to an increased risk of congenital anomalies in singletons?Summary Answer: After multivariable adjustments, the increased risks of congenital defects associated with IUI were no longer significant, but the underlying maternal infertility presented a potential emental risk, in addition to the risk associated with IVF.What Is Known Already: Most epidemiological studies suggest that singletons born from ART have a higher risk of birth defects, specifically musculoskeletal, cardiovascular and urogenital disorders. However, most of these studies were established on data obtained at birth or in the neonatal period and from relatively small populations or several registries. Moreover, to our knowledge, female infertility, which is a potential confounder, has never been included in the risk assessment.Study Design, Size, Duration: Using data from the French National Health System database, we conducted a comparative analysis of all singleton births (deliveries ≥22 weeks of gestation and/or >500 g of birthweight) in France over a 5-year period (2013-2017) resulting from fresh embryo or frozen embryo transfer (fresh-ET or FET from IVF/ICSI cycles), IUI and natural conception (NC). Data were available for this cohort of children at least up to early childhood (2.5 years old).Participants/materials, Setting, Methods: A total of 3 501 495 singleton births were included (3 417 089 from NC, 20 218 from IUI, 45 303 from fresh-ET and 18 885 from FET). Data were extracted from national health databases and used to identify major birth defects. Malformations were classified according to the 10th revision of the International Classification of Disease. To analyse the effect of mode of conception, multivariable analyses were performed with multiple logistic regression models adjusted for maternal age, primiparity, obesity, smoking, history of high blood pressure or diabetes and female infertility.Main Results and the Role Of Chance: In our cohort of children, the overall prevalence of congenital malformations was 3.78% after NC, 4.53% after fresh-ET, 4.39% after FET and 3.91% after IUI (132 646 children with major malformations). Compared with infants conceived naturally, children born after fresh-ET and after FET had a significantly higher prevalence of malformations, with an adjusted odds ratio (aOR) of 1.15 [95% CI 1.10-1.20, P < 0.0001] and aOR of 1.13 [95% CI 1.05-1.21, P = 0.001], respectively. Among the 15 relevant subgroups of malformations studied, we observed a significantly increased risk of eight malformations in the fresh-ET group compared with the NC group (i.e. musculoskeletal, cardiac, urinary, digestive, neurological, cleft lip and/or palate and respiratory). In the FET group, this increased risk was observed for digestive and facial malformations. The overall risk of congenital malformations, and the risk by subtype, was similar in the IUI group and the NC group (overall risk: aOR of 1.01 [95% CI 0.94-1.08, P = 0.81]). In addition, there was an overall independent increase in the risk of congenital defects when the mothers were diagnosed with endometriosis (1.16 aOR [95% CI 1.10-1.22], P < 0.0001), PCOS (1.20 aOR [95% CI 1.08-1.34], P = 0.001) or POI (1.52 aOR [95% CI 1.23-1.88], P = 0.0001). Chromosomal, cardiac and neurological anomalies were more common in the three maternal infertility groups.Limitations, Reasons For Caution: Male infertility, the in vitro fertilization method (i.e. in vitro fertilization without or with sperm injection: conventional IVF vs ICSI) and embryo stage at transfer could not be taken into account. Furthermore, residual confounding cannot be excluded as well as uncertainties regarding the diagnostic criteria used for the three female infertilities. Findings for specific malformations should be interpreted with caution because the number of cases was small in some sub-groups (potentially due to the Type I error or multiple testing).Wider Implications Of the Findings: In this large study, after multivariable maternal adjustments, a moderately increased risk of defects subsisted after IVF, while those associated with IUI were no longer significant. In addition, our results showed that underlying maternal infertility could contribute to the increased risk of defects associated with IVF. These novel findings highlight the importance of taking into account the ART treatment methods and the type of infertility.Study Funding/competing Interest(s): This work was supported by the National Agency of Biomedicine. The authors have no competing interests to disclose.Trial Registration Number: NA. [ABSTRACT FROM AUTHOR]

Objective: To describe the trajectories of pain, dyspnea, fever, confusion, agitation and fatigue of nursing home residents' (NHRs) after a transfer to the emergency department (ED). Design: Observational multicenter study. Setting: 17 EDs in France. Participants: 751 NHRs presenting to EDs over four non-consecutive weeks (one week per season) in 2016. Measurements: Trajectories of symptoms (binary variables) including pain, dyspnea, fever, agitation, confusion and fatigue at four times: before ED transfer, during the transfer, in the ED and after discharge. Results: Group-based multi-trajectory modelling was performed to identify groups of NHRs following similar trajectories of symptoms evolution after a transfer to ED. Five groups were identified. In group 1 (n=190), NHRs presented with confusion and a rising prevalence of fatigue. In group 2 (n=212), NHRs presented with a highly prevalent but declining pain. In group 3 (n=158), NHRs presented with similar peaking pain prevalence, rising confusion and fatigue, and a high but stable agitation prevalence. In group 4 (n=144), NHRs presented with a highly prevalent but declining dyspnea, rising then declining fever, rising confusion, and a high and fluctuating fatigue prevalence. In group 5 (n=47), NHRs presented with a highly prevalent but declining fever, rising then declining dyspnea, stable and high both fatigue and pain prevalence, stable and low prevalence of confusion. Conclusion: Symptom alleviation in NHRs transferred to ED was better achieved in those with pain, fever or dyspnea rather than in those with confusion, agitation and fatigue. NHRs' resilience through the stress of an ED transfer could be predicted by comorbidity and functional abilities, challenged by acute conditions representing various levels of stress intensity, and evaluated on the course of non-specific symptoms. NHRs' resilience is key to estimate the appropriateness of an ED transfer and should facilitate advance care planning regarding NHRs' hospitalizations. [ABSTRACT FROM AUTHOR]

Background: The objective of this work was to analyse the prevalence trends of multimorbidity among European community-dwelling adults.Methods: A temporal series study based on waves 1, 2, 4, 5, 6 and 7 of the Survey of Health, Ageing and Retirement in Europe (SHARE) was conducted, and community-dwelling participants aged 50+ (n = 274,614) from 15 European countries were selected for the period 2004-2017. Prevalence, adjusted by age, Average Annual Percentage Change (APC) and 95% confidence interval (95% CI) were all calculated. Trend analyses were realised by period, age groups and groups of diseases.Results: The results showed a large variability in the prevalence of multimorbidity in adults aged 50 and over among European countries. Increase in the prevalence of multimorbidity in the countries of central Europe (Austria, Belgium, Czech Republic, France, Germany and Switzerland) and Spain in both sexes, and in the Netherlands among men. Stability was observed in northern and eastern European countries. Musculoskeletal and neurodegenerative groups showed more significant changes in the trend analyses.Conclusions: This information can be useful for policy makers when planning health promotion and prevention policies addressing modifiable risk factors in health. [ABSTRACT FROM AUTHOR]

Importance: Clinical guidelines for the early management of acute heart failure in the emergency department (ED) setting are based on only moderate levels of evidence, with subsequent low adherence to these guidelines.Objective: To test the effect of an early guideline-recommended care bundle on short-term prognosis in older patients with acute heart failure in the ED.Design, Setting, and Participants: Stepped-wedge cluster randomized trial in 15 EDs in France of 503 patients 75 years and older with a diagnosis of acute heart failure in the ED from December 2018 to September 2019 and followed up for 30 days until October 2019.Interventions: A care bundle that included early intravenous nitrate boluses; management of precipitating factors, such as acute coronary syndrome, infection, or atrial fibrillation; and moderate dose of intravenous diuretics (n = 200). In the control group, patient care was left to the discretion of the treating emergency physician (n = 303). Each center was randomized to the order in which they switched to the "intervention period." After the initial 4-week control period for all centers, 1 center entered in the intervention period every 2 weeks.Main Outcomes and Measures: The primary end point was the number of days alive and out of hospital at 30 days. Secondary outcomes included 30-day all-cause mortality, 30-day cardiovascular mortality, unscheduled readmission, length of hospital stay, and kidney impairment.Results: Among 503 patients who were randomized (median age, 87 years; 298 [59%] women), 502 were analyzed. In the intervention group, patients received a median (interquartile range) of 27.0 (9-54) mg of intravenous nitrates in the first 4 hours vs 4.0 (2.0-6.0) mg in the control group (adjusted difference, 23.8 [95% CI, 13.5-34.1]). There was a significantly higher percentage of patients in the intervention group treated for their precipitating factors than in the control group (58.8% vs 31.9%; adjusted difference, 31.1% [95% CI, 14.3%-47.9%]). There was no statistically significant difference in the primary end point of the number of days alive and out of hospital at 30 days (median [interquartile range], 19 [0- 24] d in both groups; adjusted difference, -1.9 [95% CI, -6.6 to 2.8]; adjusted ratio, 0.88 [95% CI, 0.64-1.21]). At 30 days, there was no significant difference between the intervention and control groups in mortality (8.0% vs 9.7%; adjusted difference, 4.1% [95% CI, -17.2% to 25.3%]), cardiovascular mortality (5.0% vs 7.4%; adjusted difference, 2.1% [95% CI, -15.5% to 19.8%]), unscheduled readmission (14.3% vs 15.7%; adjusted difference, -1.3% [95% CI, -26.3% to 23.7%]), median length of hospital stay (8 d in both groups; adjusted difference, 2.5 [95% CI, -0.9 to 5.8]), and kidney impairment (1% in both groups).Conclusions and Relevance: Among older patients with acute heart failure, use of a guideline-based comprehensive care bundle in the ED compared with usual care did not result in a statistically significant difference in the number of days alive and out of the hospital at 30 days. Further research is needed to identify effective treatments for acute heart failure in older patients.Trial Registration: ClinicalTrials.gov Identifier: NCT03683212. [ABSTRACT FROM AUTHOR]

Background/objective: The COVID-19 crisis has been increasing the burden of healthcare workers in acute care geriatric facilities. These workers have been dealing with drastic changes in the care they provide to their residents including cancelation of group activities and communal dining and even restrictions of activities outside rooms. Healthcare workers have also been devoting more time and energy to perform COVID-related medical duties. Geriatric facilities have been facing shortages in equipment and supplies, as well as staffing shortages. Finally, healthcare workers have been facing challenges regarding their personal safety and that of their families. Consequently, we hypothesized the presence of high levels of burnout among healthcare workers during the COVID-19 crisis.Methods: To evaluate burnout in healthcare workers in French acute care geriatric facilities, we used an online survey based on the Oldenburg Burnout Inventory. Eighty-four healthcare workers answered the survey, during April of 2020.Results: Analysis demonstrated that they were experiencing medium levels of burnout, exhaustion, and disengagement.Conclusion: This level of burnout reflected their fatigue, loss of energy, and/or feelings of being overextended and exhausted. Considering the expected cumulative impact of various stressors, the medium level of burnout observed has come as a surprise to us and might actually be considered as relatively good news. Nevertheless, no level of burnout is negligible and has wide ranging negative consequences. [ABSTRACT FROM AUTHOR]

Background: One of the major challenges in treating OSA is to achieve adequate CPAP adherence. Telemonitoring has the potential to provide individualized management and early recognition of problems during treatment.Research Question: What is the effect of a multimodal telemonitoring intervention on treatment adherence, quality of life, and functional status in symptomatic patients with OSA and low cardiovascular risk?Study Design and Methods: In a multicenter, randomized controlled trial, patients newly diagnosed with OSA were randomly assigned to multimodal telemonitoring for 6 months vs usual care (UC). Telemonitoring consisted of built-in electronic alert algorithms for early adjustment of CPAP treatment in case of side effects, leaks, or persistent residual events. The primary outcome was CPAP adherence (in hours per night). Secondary outcomes included daily symptoms such as fatigue and sleepiness, and quality of life measured by using self-reported questionnaires.Results: A total of 206 patients with OSA and a median age of 50.6 years (interquartile range [IQR], 42.1; 58.1 years) were included in the study; they were predominantly male (63%) with a median BMI of 30.6 kg/m2 (IQR, 26.8; 35.1 kg/m2) and a median apnea-hypopnea index of 45.2 events/h (IQR, 34.0; 60.0 events/h). Of these, 102 received UC and 104 received telemonitoring. After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 h per night in the telemonitoring group and 5.08 ± 2.44 h per night in the UC group; P = .30) or in percentage of patients adherent to treatment (> 4 h usage per night, > 70% nights; 64% in the telemonitoring group vs 72% in the UC group; P = .24). There was no significant difference between the groups in effect size of improvement in fatigue and sleepiness.Interpretation: In patients with severe OSA and low cardiovascular risk, multimodal telemonitoring did not increase CPAP adherence. For both the telemonitoring and UC groups, similar improvements in daytime symptoms were achieved.Trial Registry: ClinicalTrials.gov; No.: 01796769; URL: www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Background: Supervised injection facilities have been set-up in many countries to curb the health risks associated with unsafe injection practices. These facilities have, however, been met with vocal opposition, notably in France. As harm reduction policies can only succeed to the extent that people agree with them, this study mapped French people's opinions regarding the setting-up of these facilities.Method: A sample of 318 adults--among them health professionals--were presented with 48 vignettes depicting plans to create a supervised injection facility in their town. Each vignette contained three pieces of information: (a) the type of substance that would be injected in the facility (amphetamines only, amphetamines and cocaine only, or amphetamines, cocaine and heroin), (b) the type of staff who would be working in the facility (physicians and nurses, specially trained former drug users, specially trained current drug users, or trained volunteers recruited by the municipality), and (c) the staff members' mission (to be present and observe only, technical counselling about safe injection, counselling about safe injection and hygiene, or counselling and encouragement to follow a detoxification program).Results: Through cluster analysis, three qualitatively different positions were found: Not very acceptable (20%), Depends on staff and mission (49%), and Always acceptable (31%). These positions were associated with demographic characteristics--namely gender, age and political orientation.Conclusion: French people's positions regarding supervised injection facilities were extremely diverse. One type of facility would, however, be accepted by a large majority of people: supervised injection facilities run by health professionals whose mission would be, in addition to technical and hygienic counselling, to encourage patrons to enter detoxification or rehabilitation programs. [ABSTRACT FROM AUTHOR]

Aim: To describe maternal employment and the socio-economic status of the household up to 8 years after the very preterm birth of a child, according to the presence and type of motor or cognitive impairment.Method: A total of 1885 families from the French EPIPAGE cohort of children who were born very preterm between 1997 and 1998 were included. Motor and cognitive impairments were identified in children between the ages of 2 and 8 years in 770 families and were classified according to type. The 1115 families with children born very preterm without these impairments were considered the reference group.Results: Mothers of children with severe motor or cognitive impairments were less often working at 5 years after the birth than the reference mothers (21% and 30% vs 57%; p<0.001). Those working before birth returned to work less often and those not working started to work less often after the birth than did reference mothers. At 8 years, mothers of children with severe impairments reported financial difficulties more often than mothers of children without impairments.Interpretation: Despite a fairly protective regulatory framework in France, families of infants born very preterm with severe motor or cognitive impairments are socially underprivileged. Measures to maintain an acceptable standard of living for these families and their children are needed. [ABSTRACT FROM AUTHOR]

Background: Minimal data are available on the clinical activity of general practitioners (GPs) in Africa.Objective: To describe the health problems managed by GPs in Mali as compared with France where epidemiological transition is already advanced.Methods: A retrospective, multicenter study, conducted in five Malian Community Health Centers. We compared their consultation data to those of the ECOGEN (Eléments de la COnsultation en médecine GENérale) study conducted in 128 French general practices, after data standardization for age and sex.Results: Malian and French databases included 19 068 and 19 341 consultations, respectively. Patients had an average of 1.2 health problems managed per consultation in Mali, versus 2.2 in France. They were dominated by infections (51.3%) in Mali, including malaria (24.9%), pneumonia (9.0%) and gastrointestinal infections (5.0%). In comparison with French GPs, Malian GPs more frequently managed cardiovascular (20.2% versus 13.5%), respiratory (15.0% versus 12.4%) and digestive (13.3% versus 7.8%) problems, and less frequently musculoskeletal (3.1% versus 12.6%), endocrine/metabolic (1.5% versus 10.7%) and psychological (0.2% versus 8.2%) problems. The main activity performed by French GPs was prevention (11.0%), which was nominal in Mali. Apart from hypertension, which accounted for 18.9% of the health problems managed in Mali, chronic conditions were less often managed by Malian GPs than by French GPs (12.3% versus 39.6%).Conclusions: Africa is currently at the crossroads where chronic conditions carried with the epidemiological transition are progressing, while the burden of communicable diseases is still overwhelming. Along with the enhancing medicalization of primary care in Mali, the transition of practices is just emerging. [ABSTRACT FROM AUTHOR]

Background: Guidelines that detail preventive measures against Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type b, and influenza are published annually in France to decrease the risk of severe infections in immunocompromised patients. We aimed at describing adherence to these guidelines by GPs in the management of their asplenic patients in France between 2013 and 2016. Method: We conducted a multicenter retrospective study between January 2013 and December 2016 in three French hospitals: asplenic adults were identified and their GPs were questioned. A descriptive analysis was performed to identify the immunization coverage, type and length of antibiotic prophylaxis, number of infectious episodes, and education of patients. Results: 103 patients were finally included in this study: only 57% were adequately vaccinated against Streptococcus pneumoniae or Neisseria meningitidis, 74% against Haemophilus influenzae type b, and 59% against influenza. Only 24% of patients received a combination of all four vaccinations. Two-thirds of patients received prophylactic antibiotics for at least 2 years. Overall, this study found that 50% of splenectomized patients experienced at least one pulmonary or otorhinolaryngological infection, or contracted influenza. Conclusions: These data match those reported in other countries, including Australia and the United Kingdom, meaning a still insufficient coverage of preventive measures in asplenic patients. Improved medical data sharing strategies between healthcare professionals, along with educational measures to keep patients and physicians up to date in the prevention of infections after splenectomy would improve health outcomes of asplenic patients. [ABSTRACT FROM AUTHOR]

Background: Cancer-incidence and mortality-trend analyses require appropriate statistical modelling. In countries without a nationwide cancer registry, an additional issue is estimating national incidence from local-registry data. The objectives of this study were to (i) promote the use of multidimensional penalized splines (MPS) for trend analyses; (ii) estimate the national cancer-incidence trends, using MPS, from only local-registry data; and (iii) propose a validation process of these estimates.Methods: We used an MPS model of age and year for trend analyses in France over 1990-2015 with a projection up to 2018. Validation was performed for 22 cancer sites and relied essentially on comparison with reference estimates that used the incidence/health-care ratio over the period 2011-2015. Alternative estimates that used the incidence/mortality ratio were also used to validate the trends.Results: In the validation assessment, the relative differences of the incidence estimates (2011-2015) with the reference estimates were <5% except for testis cancer in men and < 7% except for larynx cancer in women. Trends could be correctly derived since 1990 despite incomplete histories in some registries. The proposed method was applied to estimate the incidence and mortality trends of female lung cancer and prostate cancer in France.Conclusions: The validation process confirmed the validity of the national French estimates; it may be applied in other countries to help in choosing the most appropriate national estimation method according to country-specific contexts. MPS form a powerful statistical tool for trend analyses; they allow trends to vary smoothly with age and are suitable for modelling simple as well as complex trends thanks to penalization. Detailed trend analyses of lung and prostate cancers illustrated the suitability of MPS and the epidemiological interest of such analyses. [ABSTRACT FROM AUTHOR]

Background: Current data suggest that COVID-19 is less frequent in children, with a milder course. However, over the past weeks, an increase in the number of children presenting to hospitals in the greater Paris region with a phenotype resembling Kawasaki disease (KD) has led to an alert by the French national health authorities.Methods: Multicentre compilation of patients with KD in Paris region since April 2020, associated with the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ('Kawa-COVID-19'). A historical cohort of 'classical' KD served as a comparator.Results: Sixteen patients were included (sex ratio=1, median age 10 years IQR (4·7 to 12.5)). SARS-CoV-2 was detected in 12 cases (69%), while a further three cases had documented recent contact with a quantitative PCR-positive individual (19%). Cardiac involvement included myocarditis in 44% (n=7). Factors prognostic for the development of severe disease (ie, requiring intensive care, n=7) were age over 5 years and ferritinaemia >1400 µg/L. Only five patients (31%) were successfully treated with a single intravenous immunoglobulin (IVIg) infusion, while 10 patients (62%) required a second line of treatment. The Kawa-COVID-19 cohort differed from a comparator group of 'classical' KD by older age at onset 10 vs 2 years (p<0.0001), lower platelet count (188 vs 383 G/L (p<0.0001)), a higher rate of myocarditis 7/16 vs 3/220 (p=0.0001) and resistance to first IVIg treatment 10/16 vs 45/220 (p=0.004).Conclusion: Kawa-COVID-19 likely represents a new systemic inflammatory syndrome temporally associated with SARS-CoV-2 infection in children. Further prospective international studies are necessary to confirm these findings and better understand the pathophysiology of Kawa-COVID-19. Trial registration number NCT02377245. [ABSTRACT FROM AUTHOR]

Background: Hypoxia is common during daily nursing procedures (DNPs) routinely performed on mechanically ventilated patients. The impact of automated ventilation on the incidence and severity of blood oxygen desaturation during DNPs remains unknown.Methods: A prospective randomized controlled crossover trial was carried out in a French intensive care unit to compare blood oxygen pulse saturation (SpO2) during DNPs performed on patients mechanically ventilated in automated and conventional ventilation modes (AV and CV, respectively). All patients with FiO2 ≤ 60% and without prone positioning or neuromuscular blocking agents were included. Patients underwent two DNPs on the same day using AV (INTELLiVENT-ASV®) and CV (volume control, biphasic positive airway pressure, or pressure support ventilation) in a randomized order. The primary outcome was the percentage of time spent with SpO2 in the acceptable range of 90-95% during the DNP.Results: Of the 265 included patients, 93% had been admitted for a medical pathology, the majority for acute respiratory failure (52%). There was no difference between the two periods in terms of DNP duration, sedation requirements, or ventilation parameters, but patients had more spontaneous breaths and lower peak airway pressures during the AV period (p <  0.001). The percentage of time spent with SpO2 in the acceptable range during DNPs was longer in the AV period than in the CV period (48 ± 37 vs. 43 ± 37, percentage of DNP period; p = 0.03). After adjustment, AV was associated with a higher number of DNPs carried out with SpO2 in the acceptable range (odds ratio, 1.82; 95% CI, 1.28 to 2.6; p = 0.001) and a lower incidence of blood oxygen desaturation ≤ 85% (adjusted odds ratio, 0.50; 95% CI, 0.30 to 0.85; p = 0.01).Conclusion: AV appears to reduce the incidence and severity of blood oxygen desaturation during daily nursing procedures (DNPs) in comparison to CV.Trial Registration: This study was registered in clinical-trial.gov ( NCT03176329 ) in June 2017. [ABSTRACT FROM AUTHOR]

Background: With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated.Methods: Using a 2 × 2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2 years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2 min with guidance, 4-min blind, or 4 min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3.Discussion: This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4 min.Trial Registration: ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019. [ABSTRACT FROM AUTHOR]

Using quantitative and qualitative research designs, respectively, two studies investigated why countries make different health technology assessment (HTA) drug reimbursement recommendations. Building on these, the objective of this study was to (a) develop a conceptual framework integrating the factors explaining these decisions, (b) explore their relationship and (c) assess if they are congruent, complementary or discrepant. A parallel convergent mixed methods design was used. Countries included in both previous studies were selected (England, Sweden, Scotland and France). A conceptual framework that integrated and organised the factors explaining the decisions from the two studies was developed. Relationships between factors were explored and illustrated through case studies. The framework distinguishes macro-level factors from micro-level ones. Only two of the factors common to both studies were congruent, while two others reached discrepant conclusions (stakeholder input and external review of the evidence processes). The remaining factors identified within one or both studies were complementary. Bringing together these findings contributed to generating a more complete picture of why countries make different HTA recommendations. Results were mostly complementary, explaining and enhancing each other. We conclude that differences often result from a combination of factors, with an important component relating to what occurs during the deliberative process. [ABSTRACT FROM AUTHOR]

Background: Acne vulgaris has increased in women over the past 10 years; it currently affects 20-30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone's efficacy in order to establish it as an alternative to cyclines.Methods: Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months.Discussion: The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage.Trial Registration: ClinicalTrials.gov: NCT03334682. Registered on 7 November 2017. [ABSTRACT FROM AUTHOR]