Publications Collection HAL

  • [hal-02544319] Microbiota of interdental space of adolescents according to Risk of Caries: A cross-sectional study protocol
    22 octobre 2021
    Dental caries is a major oral disease resulting from a complex interaction between the commensal microbiota, host susceptibility (heredity, immunity, diseases, etc.) and environmental factors (diet, dental hygiene, etc.). To predict the patient's risk of new carious lesions or progression of existing lesions, the Caries Risk Assessment (CRA) takes account of clinical, biological and behavioural factors. Thus, the CRA can predict whether the patient is at high or low risk of developing caries. The practitioner can thus set up a follow-up adapted to the risk of the patient. However, although bacteria are the main etiological factor of carious lesions, the CRA does not consider bacterial quantification or just focus on the level of S. mutans in the saliva. As the majority of cavities are interproximal in adolescence, the aim of this trial is to identify and quantify the interdental microbiota of adolescents aged from 15 to 17 years with low or high carious risk. So, the quantification of new biomarkers associated with carious lesion could be added to the CRA to improve it.
  • [hal-02624450] Pedagogical Evaluation of Digital Technology to Enhance Dental Student Learning
    22 octobre 2021
    Objective A large number of digital tools supporting students have emerged over recent years which are encouraged in tutoring. A study conducted at the University of Montpellier (France) among 3rd, 4th, and 5th year dentistry students aimed primarily to identify the type of pedagogical support the students preferred according to their discipline. The secondary aim was to evaluate the student satisfaction after establishing a new pedagogical support. Materials and Methods A total of 165 questionnaires were completed. The main questions concerned pedagogical use of information technology and multimedia tools, choice of dentistry disciplines most justifying their use, and pedagogical gaps in these disciplines. Next, a program of pedagogical videos was developed for the most corresponding discipline. A satisfaction survey was finally conducted. Results Nearly 95.7% of students found online classes and E-learning via the virtual learning environment useful, with the most requested type being video. Demand was stronger in conservative dentistry and endodontics (27%), prosthetics (19%), and periodontology (18%). The most apprehended disciplines were endodontics in the 3rd year, endodontics and prosthetics in the 4th year, and prosthetics in the 5th year. Regarding satisfaction, 100% of students appreciated these videos and 99.4% considered they fulfilled expectations. Conclusion All students requested videos, especially for clinical subjects such as endodontics. With digital technology, our world is experiencing a technological revolution resulting in many daily life changes. With students evolving in a digitally saturated society, our ways of learning and teaching need rethinking. Digital technology can help improve learning effectiveness and develop pedagogical practices more adapted to today's students.
  • [hal-03233940] The contribution of teledentistry in detecting tooth erosion in patients with eating disorders
    22 octobre 2021
    Objective The aim of this study was to demonstrate that including a teledentistry consultation in the standard care provided to patients in an eating disorder day hospital could be beneficial, notably for screening for particular pathologies and preventing dental erosion. Methods We included 50 patients from the eating disorders unit of the University Hospital of Montpellier, all of whom underwent a dental examination using asynchronous telemedicine. We recorded the data using teledentistry software for the medical file and an intraoral camera for the clinical videos. Remote diagnosis was performed using the Basic Erosive Wear Examination index. In addition, the participants completed a questionnaire to assess their risk factors for dental pathologies. Results We found dental erosion in 92% of the patients, and 50% had at least one tooth with BEWE 2 or 3 type erosion. Conclusions Despite the fact that there can be wide variety within a group of individuals with similar risk factors, dental telemedicine could promote awareness within this at-risk population, as well as provide personalised prevention advice to each patient. Above all, it would make it possible to treat these patients' lesions at the earliest possible moment, thereby improving their outcomes.
  • [hal-03160007] Quantifying the closeness to a set of random curves via the mean marginal likelihood
    22 octobre 2021
    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.
  • [hal-01722743] Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry
    22 octobre 2021
    In Poland, two proposed amendments to the reimbursement act are currently in preparation ; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers' innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. ARTICLE HISTORY
  • [hal-01722760] Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration
    22 octobre 2021
    Background: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs' benefits and risks. Objective: We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive set of US FDA orphan drug approvals dated between 1/1/2012 and 31/12/2016, and characterize them. Study design: Orphan drug approval documentation was obtained from the US FDA website. Drug Package Inserts (PI) were analyzed to extract information on PRO-related language. Results: Among 178 drugs that met inclusion criteria, 16 (9%) products approved for 16 orphan indications contained PRO language in the Clinical Studies section of the PI. All PRO instruments concerned disease symptoms, and two also referred to patient functioning. The most common PRO instrument was a bleed-specific rating scale for four products approved for the treatment or prevention of bleeding episodes in patients with genetic bleeding disorders. Conclusions: There is a need to implement public incentives for academic development of PRO instruments for rare conditions and for regulatory policies that mandate the collection of PRO endpoints in pivotal trials of orphan drugs.
  • [hal-01818260] Association of hypovitaminosis D with triceps brachii muscle fatigability among older women: Findings from the EPIDOS cohort
    20 octobre 2021
    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
    20 octobre 2021
    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-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
    20 octobre 2021
    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-02547745] An Observational Study of Dyspnea in Emergency Departments: The Asia, Australia, and New Zealand Dyspnea in Emergency Departments Study ( AANZDEM )
    20 octobre 2021
    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.
  • [hal-00799650] Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing.
    20 octobre 2021
    BACKGROUND: The exact overall incidence of sarcoma and sarcoma subtypes is not known. The objective of the present population-based study was to determine this incidence in a European region (Rhone-Alpes) of six million inhabitants, based on a central pathological review of the cases. METHODOLOGY/PRINCIPAL FINDINGS: From March 2005 to February 2007, pathology reports and tumor blocks were prospectively collected from the 158 pathologists of the Rhone-Alpes region. All diagnosed or suspected cases of sarcoma were collected, reviewed centrally, examined for molecular alterations and classified according to the 2002 World Health Organization classification. Of the 1287 patients screened during the study period, 748 met the criteria for inclusion in the study. The overall crude and world age-standardized incidence rates were respectively 6.2 and 4.8 per 100,000/year. Incidence rates for soft tissue, visceral and bone sarcomas were respectively 3.6, 2.0 and 0.6 per 100,000. The most frequent histological subtypes were gastrointestinal stromal tumor (18%; 1.1/100,000), unclassified sarcoma (16%; 1/100,000), liposarcoma (15%; 0.9/100,000) and leiomyosarcoma (11%; 0.7/100,000). CONCLUSIONS/SIGNIFICANCE: The observed incidence of sarcomas was higher than expected. This study is the first detailed investigation of the crude incidence of histological and molecular subtypes of sarcomas.
  • [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
    20 octobre 2021
    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-01911954] Educational outcomes of a new curriculum on interproximal oral prophylaxis for dental students
    20 octobre 2021
    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.
  • [inserm-02544344] Multiple criteria decision analysis approach to consider therapeutic innovations in the emergency department: The methoxyflurane organizational impact in acute trauma pain
    19 octobre 2021
    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-02368200] Medico-economic study of pain in an emergency department: a targeted literature review
    19 octobre 2021
    Background: Pain management in emergency departments is a complex objective. The absence of a care pathway or a high level of activity complicates diagnostic or analgesic therapeutic strategies. Medical innovation can impact both individual practices and the functioning of an emergency department. Objective: We then wanted to understand how medico-economic studies on pain were carried out in an emergency department. Study design: We reviewed the literature of the last 20 years (between 1998 and 2018). Setting: Of 846 titles screened, a total of 268 abstracts qualified for further screening, and 578 titles were excluded. A total of 14 studies qualified for inclusion in the review. Studies on medico-economics in an emergency department are very diverse. None of the methods used are identical; the studies differ in their very nature (prospective, retrospective, cost-effectiveness, etc.) and the determination of emergency room costs differs according to the part of the world studied. In addition, organizational impact is rarely measured, although it is an essential dimension for choosing or not a medical innovation.
  • [hal-01806836] Comparison of three nudge interventions (priming, default option, and perceived variety) to promote vegetable consumption in a self-service buffet setting
    19 octobre 2021
    Background: Dietary choices in out-of-home eating are key for individual as well as for public health. These dietary choices are caused by a wide array of determinants, one of which is automatic decision-making. Nudging is attracting considerable interest due to its understanding and application of heuristic biases among consumers. The aim of this study is to test and compare three nudges in promoting vegetable consumption among test persons in a food lab-based experiment. Methods: The initial sample consisted of 88 participants recruited in Copenhagen, Denmark. Each study participant was randomly assigned to one of the three experiments: priming, default and perceived variety. The priming arm of the experiment consisted of creating a leafy environment with green plants and an odour of herbs. In the default arm of the experiment, the salad was pre-portioned into a bowl containing 200g of vegetables. The third experiment divided the pre-mixed salad into each of its components, to increase the visual variety of vegetables, yet not providing an actual increase in items. Each individual was partaking twice thus serving as her/his own control, randomly assigned to start with control or experimental setting. Results: The default experiment successfully increased the energy intake from vegetables among the study participants (124 kcal vs. 90 kcal in control, p<0.01). Both the priming condition and perceived variety reduced the total energy intake among the study participants (169 kcal, p<0.01 and 124 kcal, p<0.01, respectively), mainly through a decrease in the meat-based meal component. Conclusions: Considerable progress has been made with regard to understanding the use of nudging in promoting a healthier meal composition, including increasing vegetable intake. This study suggests that the nature of a nudge-based intervention can have different effects, whether it is increasing intake of healthy components, or limiting intake of unhealthy meal components. This work has demonstrated that consumer behaviour can be influenced without restricting or providing incentives for behaviour change. The present findings have promising application to the foodservice sector.
  • [inserm-02472475] Topological Modification of Brain Networks Organization in Children With High Intelligence Quotient: A Resting-State fMRI Study
    19 octobre 2021
    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-03375062] Exploring the Determinants of Polypharmacy Prescribing and Dispensing Behaviours in Primary Care for the Elderly-Protocol for a Qualitative Study
    15 octobre 2021
    Polypharmacy is becoming increasingly common, especially among the elderly. It often has a negative connotation, but is sometimes necessary or even desirable, and needed to categorize polypharmacy as appropriate or inappropriate. The challenge is in ensuring that this is considered appropriate when necessary. We aimed to develop an evidence-based intervention to reduce the risks associated with using a systematic approach, involving key stakeholders in prescribing and dispensing drugs to the elderly in primary care. The purpose of this study is to identify the key components which are perceived as influencing these behaviours. It is a qualitative study of general practitioners (GPS) and community pharmacists involved in the care of the elderly. The main inclusion criterion is the geographic location. Qualitative data will be generated from one-on-one, semi-structured interviews and processed for thematic content analysis. Our approach integrates the patient pathway in primary care. It considers the fact that GP and pharmacist behaviours are far from being independent. This study represents the first step in the process of developing an intervention theory which involves a crossover between data from the literature and the knowledge of experts, allowing us to interrogate hypotheses about the influences and mechanisms associated with prescribing and dispensing drugs to the elderly in primary care.
  • [hal-03370370] Use of an antiviral mouthwash as a barrier measure in the SARS-CoV-2 transmission in adults with asymptomatic to mild COVID-19: a multicentre, randomized, double-blind controlled trial
    13 octobre 2021
    Objectives: To determine if commercially available mouthwash with b-cyclodextrin and citrox (bio- flavonoids) (CDCM) could decrease the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary viral load. Methods: In this randomized controlled trial, severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) PCR-positive patients aged 18e85 years with asymptomatic to mild coronavirus disease 2019 (COVID-19) symptoms for <8 days were recruited. A total of 176 eligible patients were randomly assigned (1:1) to CDCM or placebo. Three rinses daily were performed for 7 days. Saliva sampling was performed on day 1 at 09.00 (T1), 13.00 (T2) and 18.00 (T3). On the following 6 days, one sample was taken at 15.00. Quantitative RT-PCR was used to detect SARS-CoV-2. Results: The intention-to-treat analysis demonstrated that, over the course of 1 day, CDCM was significantly more effective than placebo 4 hours after the first dose (p 0.036), with a median percentage (log10 copies/mL) decrease T1eT2 of e12.58% (IQR e29.55% to e0.16%). The second dose maintained the low median value for the CDCM (3.08 log10 copies/mL; IQR 0e4.19), compared with placebo (3.31 log10 copies/mL; IQR 1.18e4.75). At day 7, there was still a greater median percentage (log10 copies/mL) decrease in salivary viral load over time in the CDCM group (e58.62%; IQR e100% to e34.36%) compared with the placebo group (e50.62%; IQR e100% to e27.66%). These results were confirmed by the per-protocol analysis. Conclusions: This trial supports the relevance of using CDCM on day 1 (4 hours after the initial dose) to reduce the SARS-CoV-2 viral load in saliva. For long-term effect (7 days), CDMC appears to provide a modest benefit compared with placebo in reducing viral load in saliva.