Publications Collection HAL

  • [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
    30 juin 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-01911954] Educational outcomes of a new curriculum on interproximal oral prophylaxis for dental students
    29 juin 2022
    Objective The aim of this study was to evaluate the effectiveness of a preclinical oral prophylaxis education program by examining the effectiveness of the teaching module on changes to the students' attitudes towards their individual hygiene behaviors with interdental brushes (IDBs). Methods As being part of a new didactic program on oral interproximal prophylaxis, all preclinical third-year students (n = 96) enrolled in the 2014/15 academic year received theoretical, pre-clinical, and clinical lessons on interproximal prophylaxis. The evaluation of educational outcomes was linked to observed changes in students' hygiene behaviors using interdental brushes. Knowledge, skills, attitudes, satisfaction, competence and performance were also explored. The evaluation interviews were recorded at each recall, i.e., 1 week, 1 month, 3 months and 1 year after baseline. Results Motivation to use IDBs is clearly related to the perception of the effectiveness of the brushes and the perception of bleeding reduction. At one week, 89.6% of subjects reported using IDBs. Individual use decreased significantly from one week to one month (-26%, p = 0.006) while a non-significant upward trend occurred between one month and three months. Among students reporting usage of IDBs at 1 year (20.8%), only 2.0% used IDBs daily. Most students would recommend IDBs to other people at the beginning (69.8%). However, this share dropped to 50% at 3 months. IDB-users prescribed more than non-users.
  • [hal-03707340] PHAREO study: Perceived and observed accessibility to therapeutic drugs used for treating patients with inherited bleeding disorders
    29 juin 2022
    What is known and objective: The dispensing of clotting factor concentrates in hospital pharmacies imposes accessibility constraints on patients and their caregivers, thereby increasing the disease burden. Very few studies have addressed these issues so far in terms of individual perceptions and actual difficulties. The PHAREO study aims to report patient's perception of treatment accessibility and evaluate spatial accessibility. Methods: The PHAREO study is an observational survey based on a questionnaire specifically designed for the study purpose in collaboration with patients' representatives in the second demographic and economic French region. Results and discussion: We collected 293 responses (participation rate of 64.1%) which show that 89.8% of respondents were either very or rather satisfied with regard to access to treatment. However, respondents reported difficulties in accessing the hospital pharmacy. The data also showed that 79.2% of respondents tended to over-estimate travel time which was reported above their acceptable threshold for 39.2% of them. The main determinants of dissatisfaction were parental burden (OR 2.5 [1.3; 4.8], p = 0.008) and waiting time at the hospital pharmacy (OR 1.5 [1.1;2.0], p = 0.016, per 10 min increase). What is new and conclusion: The PHAREO study provides subjective and objective data regarding satisfaction levels of persons with haemophilia and other coagulation deficiencies, with a high representativeness rate for patients on prophylaxis (87.5%). Both respondents and hospital pharmacists pled for an evolution of the current dispensing circuit to improve access to treatment and reduce the burden for patients. Currently, the community pharmacists are apart from the dispensing circuit. The authors propose improvements in the pathway of care for patients and their caregivers by including the community pharmacists alongside the hospital pharmacists in a centralized coordination scheme.
  • [hal-01753107] Hemispheric Differences in White Matter Microstructure between Two Profiles of Children with High Intelligence Quotient vs. Controls: A Tract-Based Spatial Statistics Study
    28 juin 2022
    Objectives: The main goal of this study was to investigate and compare the neural substrate of two children's profiles of high intelligence quotient (HIQ). Methods: Two groups of HIQ children were included with either a homogeneous (Hom-HIQ: n = 20) or a heterogeneous IQ profile (Het-HIQ: n = 24) as defined by a significant difference between verbal comprehension index and perceptual reasoning index. Diffusion tensor imaging was used to assess white matter (WM) microstructure while tract-based spatial statistics (TBSS) analysis was performed to detect and localize WM regional differences in fractional anisotropy (FA), mean diffusivity, axial (AD), and radial diffusivities. Quantitative measurements were performed on 48 regions and 21 fiber-bundles of WM. Results: Hom-HIQ children presented higher FA than Het-HIQ children in widespread WM regions including central structures, and associative intra-hemispheric WM fasciculi. AD was also greater in numerous WM regions of Total-HIQ, Hom-HIQ, and Het-HIQ groups when compared to the Control group. Hom-HIQ and Het-HIQ groups also differed by their hemispheric lateralization in AD differences compared to Controls. Het-HIQ and Hom-HIQ groups showed a lateralization ratio (left/right) of 1.38 and 0.78, respectively. Conclusions: These findings suggest that both inter-and intra-hemispheric WM integrity are enhanced in HIQ children and that neural substrate differs between Hom-HIQ and Het-HIQ. The left hemispheric lateralization of Het-HIQ children is concordant with their higher verbal index while the relative right hemispheric lateralization of Hom-HIQ children is concordant with their global brain processing and adaptation capacities as evidenced by their homogeneous IQ.
  • [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
    26 juin 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.
  • [hal-03493041] Standardized healthcare pathway in intrauterine growth restriction and minimum evidence-based care
    26 juin 2022
    Introduction: Fetal growth restricted fetuses are less likely to receive evidence-based care; a previous work demonstrated an improvement in neonatal prognosis when fetuses with intrauterine growth restriction (IUGR) received minimum evidence based-care. Objective: The objective of the study was to evaluate the impact of a standardized healthcare pathway on the implementation of the recommended clinical practice in the antenatal management of IUGR fetuses, in comparison to a traditional pathway. The quality of the implementation of practice has been defined whether or not minimum evidence-based care (MEC), defined according to the recommendations of the French college of gynecologists and obstetricians (CNGOF), has been implemented. Study design: From a historical cohort of 31,052 children, born at the Femme Mère Enfant Hospital (Lyon, France) between January 1st, 2011 and December 31st, 2017, we selected the population of IUGR fetuses. We compared the rate of MEC between the IUGR fetuses followed-up in the traditional healthcare pathway versus the IUGR fetuses followed-up in a standardized healthcare pathway between 2015 and 2017. Results: A total of 245 IUGR were tracked between 2015 and 2017. Over this period, 120 fetuses were followed within the traditional pathway and 125 within the IUGR pathway. The standardized pathway resulted in a higher rate of MEC (86,4%) when compared to IUGR fetuses followed-up in the traditional pathway (27,5% (OR* 20 (95 % CI 10.0-39.7). Among early-onset IUGR: 31 % received MEC in the traditional pathway versus 83 % in the standardized pathway (p<0.001). Among late-onset IUGR: 22 % received MEC in the traditional pathway versus 92 % in the standardized pathway (p<0.001). The provided care in the standardized pathway resulted in an increase of complete antenatal corticosteroid therapy (92,8 %) when compared to the traditional pathway (50.0 %; p<0.001) and a reduction of the rate of caesarean sections before labor for non-reassuring fetal heart rate (15 %) when compared to the traditional pathway (41.3 % p=0.007). Conclusion: The standardized pathway improves the implementation of the local recommendations in the management of early- and late-onset IUGR. This study is the first to suggest a standardized care pathway in prenatal medicine. A medico-economic study could estimate the health care savings that such a pathway would provide by allowing a medical management in accordance with the recommendations.
  • [inserm-02472475] Topological Modification of Brain Networks Organization in Children With High Intelligence Quotient: A Resting-State fMRI Study
    26 juin 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-02461727] Perception, préférences et consommation alimentaires chez les personnes âgées atteintes de la maladie d'Alzheimer
    26 juin 2022
    La prise en charge de la dénutrition chez les patients âgés Alzheimer est au cœur des préoccupations des praticiens et implique une adaptation de l’alimentation, laissant trop souvent oublier l’importance capitale de l’aliment comme source de plaisir. Comprendre les mécanismes perceptifs menant à l’appréciation des aliments est donc essentiel pour mieux appréhender les préférences des malades, les intégrer dans la construction des repas et favoriser la consommation. Ne plus voir l’alimentation des personnes atteintes de maladie d’Alzheimer seulement à l’échelle nutritionnelle mais à l’échelle du repas, avec l’ensemble de ses composantes sociales, psychologiques et physiologiques, tel est le défi de demain pour accompagner au mieux les malades et qu’ils retrouvent le plaisir de manger.
  • [inserm-02544344] Multiple criteria decision analysis approach to consider therapeutic innovations in the emergency department: The methoxyflurane organizational impact in acute trauma pain
    25 juin 2022
    BACKGROUND: Acute trauma pain is poorly managed in the emergency department (ED). The reasons are partly organizational: ED crowding and rare trauma care pathways contribute to oligoanalgesia. Anticipating the organizational impact of an innovative care procedure might facilitate the decision-making process and help to optimize pain management. METHODS: We used a multiple criteria decision analysis (MCDA) approach to consider the organizational impact of methoxyflurane (self-administered) in the ED, introduced alone or supported by a trauma care pathway. A MCDA experiment was designed for this specific context, 8 experts in emergency trauma care pathways (leading physicians and pharmacists working in French urban tertiary hospitals) were recruited. The study involved four steps: (i) Selection of organizational criteria for evaluating the innovation's impact; (ii) assessment of the relative weight of each criterion; (iii) choice of appropriate scenarios for exploring the organizational impact of MEOX under various contexts; and (iv) software-assisted simulation based on pairwise comparisons of the scenarios. The final outcome measure was the expected overall organizational impact of methoxyflurane on a 0-to-100 scale (score >50: positive impact). RESULTS: Nine organizational criteria were selected. "Mean length of stay in the ED" was the most weighted. Methoxyflurane alone obtained 59 as a total score, with a putative positive impact for eight criteria, and a neutral effect on one. When a trauma care pathway was introduced concomitantly, the impact of methoxyflurane was greater overall (score: 75) and for each individual criterion. CONCLUSIONS: Our model highlighted the putative positive organizational impact of methoxyflurane in the ED-particularly when supported by a trauma care pathway-and the relevance of expert consensus in this particular pharmacoeconomic context. The MCDA approach could be extended to other research fields and healthcare challenges in emergency medicine.
  • [hal-02061308] Cosmetic whitening and lightening products: scientific, cultural and regulatory aspects
    25 juin 2022
    Background: This topic concerns cosmetic whitening and lightening products of the skin which are widely used in almost the regions of the world. Indeed, it is a booming market leading the development of parallel market with products that can cause serious damage to health. Purpose: We took stock of ingredients with whitening and lightening properties. We also explored the socio-cultural aspects of the different populations using these products. Methods: It has been shown that this practice, called voluntary depigmentation, associated with the use of these products not only concerns individuals with hyperpigmentation but also those with hypopigmentation in order to standardize the color of their skin. The various effects claimed by these products, whitening, brightening, or the combination of the two are often classified as similar in the consumer's head. These products have in fact, a slight lightening and non-whitening effect on the skin due to the low percentage of active ingredients added to the cosmetic formula. Results: The real depigmenting molecules are, for their part, for the vast majority reserved for the pharmaceutical. Moreover, their use in the treatment of certain diseases requires appropriate medical monitoring. Nevertheless, these same molecules are also contained in products that are often misused and /or counterfeited in some countries with disastrous consequences caused by voluntary depigmentation and encouraged for the most part by media still very influential. Conclusion: It is very important to inform health professional about side effects of these products. The development of global public heath campaigns becomes an urgency in order to educate population especial in some country.
  • [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
    25 juin 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.
  • [hal-03695022] Oral-Hygiene-Related Mobile Apps in the French App Stores: Assessment of Functionality and Quality
    15 juin 2022
    Mobile health apps can contribute to increased quality of individual oral hygiene behaviors. This study provides an overview and an evaluation of quality of oral-hygiene-related mobile apps currently available in Google Play Store and the French Apple App. A shortlist of nine apps was assessed by 10 oral health professionals using the Mobile App Rating Scale. Intraclass correlation was used to evaluate interrater agreement. Best quality scores were obtained by Oral-B (3.4 ± 0.97), Colgate Connect (3.20 ± 0.63), and Preventeeth (3.10 ± 1.1) and worst ones by Mimizaur se brosse les dents (1.80 ± 0.79) and Kolibree (2.30 ± 0.82). The subjective quality scores ranged from 2.62 ± 0.61 (Oral-B) to 1.5 ± 0.61 (MSD). Specificity of the content ranged from 3.46 ± 0.84 (Preventeeth) to 1.78 ± 0.47 (Mimizaur se brosse les dents). Thus, even if oral health professionals positively evaluated the quality of oral-hygiene-related mobile apps, they are less assertive concerning their impact on the user’s knowledge, attitudes, and intentions to change, as well as the likelihood of actual change in the oral hygiene behavior. Further investigations are needed to assess whether information from these apps is consistent with oral hygiene recommendations and to determine the long-term impacts of these apps.