Publications Collection HAL

  • [hal-03872017] Assessment of atrial fibrillation in European emergency departments: insights from a prospective observational multicenter study
    7 décembre 2022
    Background: The diagnosis and management of atrial fibrillation (AF) in emergency departments (EDs) have not been well described in France, with limited EU research. This study aimed to describe the diagnosis, management, and prognosis of AF patients in French EDs. Methods: A prospective, observational 2-month study in adults diagnosed with AF was conducted at 32 French EDs. Data regarding patient characteristics, diagnosis, and treatment at EDs were collected, with 12-month follow-up. Results: The study included a total of 1369 patients diagnosed with AF at an ED: 279 patients (20.4%) with idiopathic AF (no identified cause of the AF) and 1090 (79.6%) with secondary AF (with a principal diagnosis identified as the cause of AF). Patients were aged 84 years (median) and 51.3% were female. Significantly more idiopathic AF patients than secondary AF patients underwent CHA<inf>2</inf>DS<inf>2</inf>-VASc assessment (67.8% vs. 52.1%,) or echocardiography (21.2% vs. 8.3%), or received an oral anticoagulant and/or antiarrhythmic (62.0% vs. 12.9%). Idiopathic AF patients also had significantly higher rates of discharge to home (36.4% vs. 20.4%) and 3-month cardiologist follow-up (67.0% vs. 41.1%). At 12 months, 96% of patients with follow-up achieved sinus rhythm. The estimated Kaplan-Meier 12-month mortality rate was significantly lower with idiopathic AF than secondary AF (11.9% vs. 34.5%). Conclusions: Patients diagnosed with idiopathic or secondary AF at the ED presented heterogeneous characteristics and prognoses, with those with secondary AF having worse outcomes. Further studies are warranted to optimize patients' initial evaluation in EDs and provide appropriate follow-up.
  • [hal-02405432] Cost-effectiveness of tumor-treating fields added to maintenance temozolomide in patients with glioblastoma: an updated evaluation using a partitioned survival model
    6 décembre 2022
    Purpose: A first cost-effectiveness analysis has raised a strong concern regarding the cost of tumor treatment fields (TTF) added to maintenance temozolomide for patients with glioblastoma. This evaluation was based on effectiveness outcomes from an interim analysis of the pivotal trial, moreover it used a “standard” Markov model. Our objective was to update the cost-effectiveness evaluation using the more flexible potential of the “partitioned survival” model design and using the latest effectiveness data. Methods: We developed the model with three mutually exclusive health states: stable disease, progressive disease, and dead. Good fit parametric models were developed for overall survival and progression free survival and these generated clinically plausible extrapolations beyond the observed data. We adopted the perspective of the French national health insurance and used a 20-year time horizon. Results were expressed as cost/life-years (LY) gained (LYG). Results: The base case model generated incremental benefit of 0.604 LY at a cost of €453,848 which, after 4% annual discounting of benefits and costs, yielded an incremental cost effectiveness ratio (ICER) of €510,273/LYG. Using sensitivity analyses and bootstrapping methods results were found to be relatively robust and were only sensitive to TTF device costs and the modelling of overall survival. To achieve an ICER below €100,000/LYG would require a reduction in TTF device cost of approximately 85%. Conclusions: Using a different type of model and updated survival outcomes, our results show TTF remains an intervention that is not cost-effective, which greatly restrains its diffusion to potentially eligible patients. © 2019, Springer Science+Business Media, LLC, part of Springer Nature.
  • [hal-02987404] Perception of Gingival Bleeding by People and Healthcare Professionals: A Multicentre Study in an Adult French Population
    1 décembre 2022
    Gingival bleeding (GB) is a common sign of gingival inflammation, which indicates the presence of periodontal diseases. This study aimed to describe the perception of French adults about their self-reported GB and answers of healthcare professionals regarding the GB reported by these interviewees. A questionnaire administered by one investigator in each of three public settings of four cities in France from September 2016 to November 2017. Among 794 adults interviewed, 502 (63.2%) reported a GB. Among them, 414 (82.5%) believed that GB is benign, and 309 (61.6%) declared one or more responses. The three main responses were to use mouthwash (29.3%), to change to a soft-bristle toothbrush (20.1%) and to modify the brushing technique (19.3%). Almost half (49.0%) questioned at least one healthcare professional concerning their GB: a dentist (43.0%), a physician (14.1%), and a pharmacist (8.0%). The main response of each healthcare professional was: for dentists: a "prescription of mouthwash", for physicians to say "gingival bleeding is not serious"; and for pharmacists: "to sell a mouthwash". Most of the participants considered their GB as benign and had inappropriate responses, which indicates their lack of knowledge regarding periodontal health. The same conclusions can be drawn for healthcare professionals, as reported by interviewees.
  • [hal-02448042] Nanoparticles as Anti-Microbial, Anti-Inflammatory, and Remineralizing Agents in Oral Care Cosmetics: A Review of the Current Situation.
    29 novembre 2022
    Many investigations have pointed out widespread use of medical nanosystems in various domains of dentistry such as prevention, prognosis, care, tissue regeneration, and restoration. The progress of oral medicine nanosystems for individual prophylaxis is significant for ensuring bacterial symbiosis and high-quality oral health. Nanomaterials in oral cosmetics are used in toothpaste and other mouthwash to improve oral healthcare performance. These processes cover nanoparticles and nanoparticle-based materials, especially domains of application related to biofilm management in cariology and periodontology. Likewise, nanoparticles have been integrated in diverse cosmetic produces for the care of enamel remineralization and dental hypersensitivity. This review summarizes the indications and applications of several widely employed nanoparticles in oral cosmetics, and describes the potential clinical implementation of nanoparticles as anti-microbial, anti-inflammatory, and remineralizing agents in the prevention of dental caries, hypersensitivity, and periodontitis.
  • [inserm-03690975] Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the “My Personal Breast Screening” (MyPeBS) randomised clinical trial
    28 novembre 2022
    Background: The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. Methods: At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants' acceptability and comprehension of the trial, and their experience of risk assessment. Discussion: Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. Trial registration: Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). Clinicaltrials: gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.
  • [hal-01818260] Association of hypovitaminosis D with triceps brachii muscle fatigability among older women: Findings from the EPIDOS cohort
    27 novembre 2022
    Background: Vitamin D affects physical performance in older adults. Its effects on muscles, notably on muscle strength, remain unclear. The objective of this cross-sectional study was to determine whether hypovitaminosis D is associated with triceps brachii muscle fatigability in community-dwelling older women. Methods: A randomized subset of 744 women aged >= 75years from the EPIDOS cohort was categorized into two groups according to triceps brachii muscle fatigability, defined as loss of strength > 5% between two consecutive maximal isometric voluntary contractions. Hypovitaminosis D was defined using consensual threshold values (i.e., serum 25-hydroxyvitamin D concentration [25OHD] <= 10 ng/mL, <= 20 ng/mL, and <= 30 ng/mL). Age, body mass index, comorbidities, use psychoactive drugs, physical activity, first triceps strength measure, hyperparathyroidism, serum concentrations of calcium, albumin and creatinine, season and study centers were used as potential confounders. Results: The prevalence of hypovitaminosis D <= 30 ng/mL was greater among women with muscle fatigability compared with the others (P = .009). There was no between-group difference using the other definitions of hypovitaminosis D. The serum 25OHD concentration was inversely associated with the between-test change in triceps strength (adjusted beta = - 0.09 N, P = .04). Hypovitaminosis D <= 30 ng/mL was positively associated with triceps fatigability (adjusted OR = 3.15, P = .02). Conclusions: Vitamin D concentration was inversely associated with the ability to maintain strength over time in this cohort of community-dwelling older women. This is a relevant new orientation of research toward understanding the involvement of vitamin D in muscle function.
  • [hal-02309648] Malnutrition according to ESPEN definition predicts long-term mortality in general older population: Findings from the EPIDOS study-Toulouse cohort
    27 novembre 2022
    BACKGROUND: The European Society of Clinical Nutrition and Metabolism (ESPEN) has developed a consensus definition of malnutrition. This study aimed to determine the prevalence of malnutrition according to the ESPEN definition in otherwise healthy community-dwelling older women and to explore its value for predicting long-term mortality in this population. METHODS: This prospective population-based cohort study included 181 women (age ≥75 years) from a subsample of the EPIDémiologie de l'OStéoporose (EPIDOS) study participants from Toulouse. Inclusion criteria were the availability of the data on variables required to apply the ESPEN definition and survival after 7 years of follow-up. Primary outcome was mortality at 12-year follow-up; main covariates were malnutrition assessment according to the ESPEN consensus and its components (unintentional weight loss, BMI, and FFMI). Body composition was assessed by dual-energy X-ray absorptiometry at baseline and at 7-year follow-up. Kaplan-Meier survival curves and adjusted Cox regressions were performed. Analysis was adjusted for age, hypertension, diabetes mellitus, and coronary heart disease as potential confounders. RESULTS: Complete data were available for 179 of the 181 women in the EPIDOS-Toulouse cohort (83.1 ± 2.2 years) and 13 (7.3%) fulfilled the ESPEN definition for malnutrition at 7-year follow-up. Malnutrition was associated with increased risk of mortality (adjusted HR = 4.4 [95%CI: 1.7-11.3]). Among the ESPEN components, only BMI was associated with increased mortality (adjusted HR=0.6 [95%CI: 0.4-0.9]). CONCLUSIONS: Although malnutrition prevalence according to the ESPEN definition was relatively low (7.3%) in this sample of otherwise healthy community-dwelling older French women, malnutrition was associated with 4.4-fold higher mortality risk at 12-year follow-up.
  • [hal-02547745] An Observational Study of Dyspnea in Emergency Departments: The Asia, Australia, and New Zealand Dyspnea in Emergency Departments Study ( AANZDEM )
    23 novembre 2022
    Objectives: The objective was to describe the epidemiology of dyspnea presenting to emergency departments (EDs) in the Asia-Pacific region, to understand how it is investigated and treated and its outcome. Methods: Prospective interrupted time series cohort study conducted at three time points in EDs in Australia, New Zealand, Singapore, Hong Kong, and Malaysia of adult patients presenting to the ED with dyspnea as a main symptom. Data were collected over three 72-hour periods and included demographics, comorbidities, mode of arrival, usual medications, prehospital treatment, initial assessment, ED investigations, treatment in the ED, ED diagnosis, disposition from ED, in-hospital outcome, and final hospital diagnosis. The primary outcomes of interest are the epidemiology, investigation, treatment, and outcome of patients presenting to ED with dyspnea. Results: A total of 3,044 patients were studied. Patients with dyspnea made up 5.2% (3,105/60,059, 95% confidence interval [CI] = 5.0% to 5.4%) of ED presentations, 11.4% of ward admissions (1,956/17,184, 95% CI = 10.9% to 11.9%), and 19.9% of intensive care unit (ICU) admissions (104/523, 95% CI = 16.7% to 23.5%). The most common diagnoses were lower respiratory tract infection (20.2%), heart failure (14.9%), chronic obstructive pulmonary disease (13.6%), and asthma (12.7%). Hospital ward admission was required for 64% of patients (95% CI = 62% to 66%) with 3.3% (95% CI = 2.8% to 4.1%) requiring ICU admission. In-hospital mortality was 6% (95% CI = 5.0% to 7.2%). Conclusion: Dyspnea is a common symptom in ED patients contributing substantially to ED, hospital, and ICU workload. It is also associated with significant mortality. There are a wide variety of causes however chronic disease accounts for a large proportion.
  • [inserm-03356480] Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial
    23 novembre 2022
    Background: Colorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France. Methods: We will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention's sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory. Discussion: Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening).
  • [hal-02975784] A Time-Dependent Propensity Score Matching Approach to Assess Epinephrine Use on Patients Survival Within Out-of-Hospital Cardiac Arrest Care
    21 novembre 2022
    Background: Epinephrine effectiveness and safety are still questioned. It is well known that the effect of epinephrine varies depending on patients' rhythm and time to injection.Objective: We aimed to assess the association between epinephrine use during out-of-hospital cardiac arrest (OHCA) care and patient 30-day (D30) survival.Methods: Between 2011 and 2017, 27,008 OHCA patients were included from the French OHCA registry. We adjusted populations using a time-dependent propensity score matching. Analyses were stratified according to patient's first rhythm. After matching, 2837 pairs of patients with a shockable rhythm were created and 20,950 with a nonshockable rhythm.Results: Whatever the patient's rhythm (shockable or nonshockable), epinephrine use was associated with less D30 survival (odds ratio [OR] 0.508; 95% confidence interval [CI] 0.440-0.586] and OR 0.645; 95% CI 0.549-0.759, respectively). In shockable rhythms, on all outcomes, epinephrine use was deleterious. In nonshockable rhythms, no difference was observed regarding return of spontaneous circulation and survival at hospital admission. However, epinephrine use was associated with worse neurological prognosis (OR 0.646; 95% CI 0.549-0.759).Conclusions: In shockable and nonshockable rhythms, epinephrine does not seem to have any benefit on D30 survival. These results underscore the need to perform further studies to define the optimal conditions for using epinephrine in patients with OHCA.
  • [hal-03610803] Teledentistry and forensic odontology: Cross-sectional observational comparative pilot study
    3 novembre 2022
    Forensic dentistry is the branch of forensic science concerned with the study of teeth and jaws. To facilitate the work of experts, new comparative identification tools are emerging, with digital techniques such as the intra-oral camera, which are revolutionising current techniques in forensic dentistry. Objective: The aim of this study is to evaluate the diagnostic quality of the post-mortem odontogram carried out remotely via a video of the oral cavity using an intra-oral camera. The gold standard is the post-mortem odontogram obtained via the standard identification technique during the clinical examination. Materials and methods: 25 deceased patients were included in the study and the data were collected in the Forensic Medicine and Thanatology Department at the University Hospital of Montpellier. The protocol was divided into three stages: the gold standard consultation, the recording of videos with the Soprocare® camera, and the remote analysis of the images obtained. The gold standard consultation and the remote analysis were carried out by two separate dental surgeons responsible for completing a clinical file, used to establish the odontogram of the deceased patient. Results: The study was carried out on 25 deceased subjects, between 13 May and 12 June 2019. Our sample was composed of 68% men and 32% women. A sensitivity threshold of 0.97 was observed for the performance of the odontogram, i.e., for all the teeth actually present in the mouth for all subjects in the study, 97% of them were identified with the videos taken using the intraoral camera. The examination with the intra-oral camera demonstrated a good diagnostic performance in the detection of missing teeth with a PPV of 97.9% and a NPV of 98.2%. Practitioner became more skilled at recording the videos with the intra-oral camera. One can therefore note an ease in the handling of this digital tool, which gradually improved with the number of subjects included in the study CONCLUSIONS: The Soprocare® intraoral camera has an acceptable diagnostic validity in establishing the odontogram of the deceased. It enables fundamental elements to be detected with optimal efficiency. However, several points still need to be improved, in order to make the use of the camera during data collection as easy and efficient as possible.
  • [hal-03833967] Knowledge, Attitudes and Practices Related to Medication, Antibiotics, and Vaccination among Public Service Population: National Survey Conducted in France
    31 octobre 2022
    Medication, antibiotics, and immunization are three major and cost-effective medical interventions but their use is balanced. Knowledge, attitudes and practices (KAP) are a cornerstone. This retrospective study aims at analyzing KAP related to these concerns among the public service population in order to establish the basis for the implementation of selective preventive actions. From a cross-sectional anonymous online questionnaire-based survey among the insurees of a French mutual organization (Union Prévention Santé pour la Fonction publique, UROPS), 33 questions related to medication, antibiotics and vaccination were extracted to evaluate KAP. New variables were constituted: levels of knowledge, antibiotic misuse, proactive behavior and vaccinophobia. Multiple correspondence analysis was performed to identify respondents’ homogenous groups. In addition, bivariate statistical comparisons were provided and logistic regressions were carried out to identify determinants of these new variables. Public service population (workers and retired) were highly exposed to polymedication (8.7% vs. 24.4%, p < 0.0001), hypnotics overtake (24.3% vs. 18.4%, p < 0.0001), and misuse antibiotics (33.2% vs. 22.6%, p < 0.0001) despite good levels of knowledge. Proportions of vaccinophobia was low (0.8% vs. 1.7%, p < 0.0001). However, workers have different KAP than retired, without shared determinants in the 3 health domains studied. Respondents were proactive (85.8% vs. 81.6%, p < 0.0001), used multiple sources of trustworthy information and seems to be ready for the delegation of health tasks. Thus, preventive actions related to antibiotics and polymedication should be a priority in vaccination education for mutual organizations such as UROPS. Studying their insurees longitudinally could be interesting to highlight the impact of selective prevention on behaviors, through trusted health professionals (general practitioners, pharmacists…)
  • [hal-03834681] Association between location of out-of-hospital cardiac arrest, on-scene socioeconomic status, and accessibility to public automated defibrillators in two large metropolitan areas in Canada and France
    31 octobre 2022
    Aim To compare walking access times to automated external defibrillators (AEDs) between area-level quintiles of socioeconomic status (SES) in out-of-hospital cardiac arrest (OHCA) cases occurring in 2 major urban regions of Canada and France. Methods This was an international, multicenter, retrospective cohort study of adult, non-traumatic OHCA cases in the metropolitan Vancouver (Canada) and Rhône County (France) regions that occurred between 2014 and 2018. We calculated area-level SES for each case, using quintiles of country-specific scores (Q5=most deprived). We identified AED locations from local registries. The primary outcome was the simulated walking time from the OHCA location to the closest AED (continuous and dichotomized by a 3-minute 1-way threshold). We fit multivariate models to analyze the association between OHCA-to-AED walking time and outcomes (Q5 vs. others). Results A total of 6,187 and 3,239 cases were included from the Metro Vancouver and Rhône County areas, respectively. In Metro Vancouver Q5 areas (vs. Q1-Q4), areas, AEDs were farther from (79% over 400m from case vs. 67%, p<0.001) and required longer walking times to (97% above 3min vs. 91%, p<0.001) cases. In Rhône Q5 areas, AEDs were closer than in other areas (43% over 400m from case vs. 50%, p=0.01), yet similarly poorly accessible (85% above 3min vs. 86%, p=0.79). In multivariate models, AED access time ≥ 3min was associated with decreased odds of survival at hospital discharge in Metro Vancouver (odds ratio 0.41, 95% CI [0.23-0.74], p=0.003). Conclusions Accessibility of public AEDs was globally poor in Metro Vancouver and Rhône, and even poorer in Metro Vancouver’s socioeconomically deprived areas.
  • [hal-03829874] Chemical vs. natural toothpaste: which formulas for which properties? A scoping review
    27 octobre 2022
    Introduction. The proliferation of the oral care industry has made it more challenging for shoppers to zero in on the best possible toothpaste for their preventative requirements. It also makes the toothpaste's various components safer. Objective. The researchers set out to evaluate the state of information about the biological properties and cytotoxicity of adult toothpaste so that they might make some informed recommendations. Methods. A scoping review of research published between 2015 and 2020 according to PRISMA guidelines was performed. Results. In vitro clinical trials account for 44% of the papers, in vivo clinical trials for 25%, systematic reviews for 19%, and metaanalyses for 12%. They have active chemical components that have been shown to be antimicrobial, anti-inflammatory, or desensitizing. Herbal toothpaste has these characteristics and is very secure to use. Toothpaste with sodium lauryl sulfate has been found to be harmful. Conclusions. Scientists have investigated the biological effects of a wide range of chemically active compounds and plant extracts. Herbal toothpaste, it has been discovered, is both efficient and secure. Companies making toothpaste should be required to clearly label the product's qualities, active ingredients, and potentially harmful ingredients on the packaging.
  • [hal-03160007] Quantifying the closeness to a set of random curves via the mean marginal likelihood
    25 octobre 2022
    In this paper, we tackle the problem of quantifying the closeness of a newly observed curve to a given sample of random functions, supposed to have been sampled from the same distribution. We define a probabilistic criterion for such a purpose, based on the marginal density functions of an underlying random process. For practical applications, a class of estimators based on the aggregation of multivariate density estimators is introduced and proved to be consistent. We illustrate the effectiveness of our estimators, as well as the practical usefulness of the proposed criterion, by applying our method to a dataset of real aircraft trajectories.
  • [inserm-03690872] A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy – including photon and proton therapy – for the treatment of radioresistant tumors: the ETOILE trial
    18 octobre 2022
    Background: Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy transfer radiation (including photons and protons) and may therefore beneficiate from a carbon ion therapy. Despite encouraging results obtained in phase I/II trials compared to historical data with photons, the spread of carbon ions has been limited mainly because of the absence of randomized medical data. The French health authorities stressed the importance of having randomized data for carbon ion therapy. Methods: The ETOILE study is a multicenter prospective randomized phase III trial comparing carbon ion therapy to either advanced photon or proton radiotherapy for inoperable or macroscopically incompletely resected (R2) radioresistant cancers including sarcomas and adenoid cystic carcinomas. In the experimental arm, carbon ion therapy will be performed at the National Center for Oncological Hadrontherapy (CNAO) in Pavia, Italy. In the control arm, photon or proton radiotherapy will be carried out in referent centers in France. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival and local control, toxicity profile, and quality of life. In addition, a prospective health-economic study and a radiobiological analysis will be conducted. To demonstrate an absolute improvement in the 5-year PFS rate of 20% in favor of carbon ion therapy, 250 patients have to be included in the study. Discussion: So far, no clinical study of phase III has demonstrated the superiority of carbon ion therapy compared to conventional radiotherapy, including proton therapy, for the treatment of radioresistant tumors. Trial registration: ClinicalTrials.gov identifier: NCT02838602 . Date of registration: July 20, 2016. The posted information will be updated as needed to reflect protocol amendments and study progress.
  • [inserm-03246094] Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study)
    18 octobre 2022
    INTRODUCTION: Adherence to secondary preventive medications is often suboptimal in patients with stroke, exposing them to an increased risk of recurrent cerebral and/or cardiovascular events. Effective actions in the long term to improve adherence to medication are needed. The study will evaluate the efficacy of a collaborative multiprofessional patient-centred intervention conducted by a pharmacist on adherence to secondary preventive medication in stroke survivors. METHODS AND ANALYSIS: This is a multicentre cluster-randomised controlled trial. Two groups of 91 patients (intervention vs standard care) will be recruited. The clinical pharmacist intervention targeting secondary preventive medication will consist of three parts over 1 year: (1) an individual semi-structured interview at hospital discharge; (2) follow-up telephone interviews at 3, 6 and 9 months after discharge; and (3) a final individual semi-structured interview 1 year after discharge. Information on patient follow-up will be shared with the general practitioner and the community pharmacist by sending a report of each interview. The primary outcome is adherence to medication during the 12 months after hospital discharge, assessed using a composite endpoint: the medication possession ratio associated with a self-administered questionnaire. ETHICS AND DISSEMINATION: The local ethics committee, the national committee for use of personal data in medical research and the national data protection agency approved the study. The sponsor has no role in study design; collection, analysis and interpretation of data; or report writing. DISCUSSION: This pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events. TRIAL REGISTRATION NUMBER: NCT02611440.
  • [inserm-02472475] Topological Modification of Brain Networks Organization in Children With High Intelligence Quotient: A Resting-State fMRI Study
    18 octobre 2022
    The idea that intelligence is embedded not only in a single brain network, but instead in a complex, well-optimized system of complementary networks, has led to the development of whole brain network analysis. Using graph theory to analyze resting-state functional MRI data, we investigated the brain graph networks (or brain networks) of high intelligence quotient (HIQ) children. To this end, we computed the "hub disruption index κ," an index sensitive to graph network modifications. We found significant topological differences in the integration and segregation properties of brain networks in HIQ compared to standard IQ children, not only for the whole brain graph, but also for each hemispheric graph, and for the homotopic connectivity. Moreover, two profiles of HIQ children, homogenous and heterogeneous, based on the differences between the two main IQ subscales [verbal comprehension index (VCI) and perceptual reasoning index (PRI)], were compared. Brain network changes were more pronounced in the heterogeneous than in the homogeneous HIQ subgroups. Finally, we found significant correlations between the graph networks' changes and the full-scale IQ (FSIQ), as well as the subscales VCI and PRI. Specifically, the higher the FSIQ the greater was the brain organization modification in the whole brain, the left hemisphere, and the homotopic connectivity. These results shed new light on the relation between functional connectivity topology and high intelligence, as well as on different intelligence profiles.
  • [hal-02178772] Factors associated with virological rebound in HIV-positive sub-Saharan migrants living in France after traveling back to their native country -ANRS-VIHVO 2006-2009 study
    18 octobre 2022
    In France, around 25% of the estimated number of people living with HIV are migrants, of whom three quarters are from sub-Saharan Africa (SSA). Our objective was to determine factors associated with virological rebound (VR) at the occasion of a transient stay to the country of origin. HIV-positive migrants from SSA participating to the ANRS-VIHVO adherence study between 2006 and 2009, on effective ART with controlled pre-travel HIV-1 plasma viral load (VL), were included. Outcome was VR, defined as VL ≥ 50 copies/ml at the post-travel visit during the week following the return to France. Among 237 persons (61.6% female, median age 41 years (IQR, 35–47), median time on ART 4.2 years (IQR, 2.2–7.1), 27 (11.4%) experienced VR. The main purpose of the travel was to visit family and median time spent abroad was 5.3 weeks (IQR, 4.1–8.8). The travel was extended longer than anticipated by at least 1 week in 42 individuals (17.7%). In multivariable logistic model, risk factors for VR were male sex [adjusted OR (aOR) 5.1; 95% CI 1.6–16.2)], no employment in France (aOR 2.0; 1.2–3.5), self-reported non-adherence during the trip (aOR 14.9; 4.9–45.9) and PI-containing regimen (aOR 4.6; 1.2–17.6). In another analysis not including self-reported adherence, traveling during Ramadan while respecting the fast (aOR 3.3; 1.2–9.6) and extension of the stay (aOR 3.0; 1.1–7.8) were associated with VR. Virological rebound was partly explained by structural barriers to adherence such as extension of the travel and inadequate management of Ramadan fasting. Individuals’ journeys should be carefully planned with health care providers.