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Abstract BackgroundIn 2022, the World Health Organization highlighted the alarming state of oral health (OH) worldwide and urged action to include OH in initiatives on noncommunicable diseases. The population needs improved OH skills and attitudes and an adequate level of OH literacy (OHL) and general health literacy (HL). The implementation of health promotion actions in the workplace, which is a part of most people’s lives, appears to be an opportunity. In France, civil servants have several socioprofessional levels and represent an excellent model with results transposable to the population. ObjectiveThis study aimed at determining the OHL and HL level of civil servants in France in order to implement specific prevention actions in their workplaces. MethodsA cross-sectional study of French civil servants was conducted in France from October 2023 to February 2024. Participants completed three validated questionnaires in French: (1) a questionnaire on OH knowledge, (2) the Oral Health Literacy Instrument, French version (OHLI-F; this is composed of reading comprehension and numeracy sections) to assess the OHL level, and (3) the Short Test of Functional Health Literacy in Adults, French version (s-TOFHLA-F) to assess the HL level. The scores for OH knowledge, the OHLI-F, and the s-TOFHLA-F were reported as means (SD) and the 95% CI. These scores were classified into 3 categories: adequate (75-100), marginal (60-74) and inadequate (0-59). ANOVA and binary logistic regression were performed. The OHLI-F reading comprehension and OHLI-F numeracy scores were compared using the Welch 2-sample tt ResultsA total of 1917 persons completed the 3 questionnaires, with adequate levels of OHL (n=1610, 84%), OH knowledge (n=1736, 90.6%), and HL (n=1915, 99.9%). The scores on the s-TOFHLA-F (mean 98.2, SD 2.8) were higher than the OHLI-F (mean 80.9, SD 7.9) and OH knowledge (mean 87.6, SD 10.5). The OHLI-F was highly correlated with OH knowledge (P

Background: Care pathways are useful for optimizing patient or disease management. However, in practice, the implementation of this concept remains below its potential. Probably because it is a complex intervention in complex systems. In such cases, modeling is beneficial. Thus, facilitating the representation of care pathways can go through the formalization of a standardizable part. Indeed, certain structural elements of care pathways are systematically present, whatever the area of healthcare. The objective of the present study will be to identify and develop a list of these key factors, called “invariant determinants of care pathways”. Methods: This qualitative study will adopt a descriptive design. Semi-structured interviews will be conducted with different types of health experts: practitioners, academics, and institutional representatives. An interview guide was designed in 3 research sections: identifying the main key elements of the care pathway concept, defining the main determinants considered as pathway invariants, projecting the interviewee into a broader perspective of systemic pathway description. Once collected, data will be anonymized, transcribed and analyzed according to a thematic approach. The analysis report will follow the COREQ checklist. This research project has been validated by the ethics committee of Lyon (n°2022-05-19-003). Discussion: The results of our research will enable us to use a systems approach to gain a better understanding of the concept of care pathways and, in the longer term, to model these pathways. This study will make it possible to identify and characterize the invariant determinants of care pathways. However, although these factors are systematically present, their influence on the care pathway varies. Methods for calculating the power of impact will be used to assess this variability. Then, for a more exhaustive approach, specific factors known as variant determinants will be identified. Determining the invariant and variant determinants will enable each care pathway to be modelled.

BackgroundDiabetes affects millions of people worldwide, making them more vulnerable to infections, including seasonal influenza. It is therefore particularly important for those suffering from diabetes to be vaccinated against influenza each year. However, influenza vaccination coverage remains low in this population. This review primarily aims to identify the determinants of influenza vaccination in people with diabetes (T1D or T2D). Secondly, it aims to assess main recommendations for influenza vaccination, vaccine effectiveness, vaccination coverage, and how education and pharmacists can encourage uptake of the vaccine in the diabetic population.MethodsA scoping review was conducted in January 2022 to systematically review evidence on influenza vaccination in people with diabetes using data from PubMed, Science Direct, and EM Premium with terms such as “Diabetes mellitus,” “Immunization Programs,” “Vaccination,” and “Influenza Vaccines.” Quality assessment and data extraction were independently conducted by two authors. Disagreements between the authors were resolved through discussion and consensus, and if necessary, by consulting a third author.ResultsOf the 333 records identified, 55 studies met the eligibility criteria for inclusion in this review. Influenza vaccination was recommended for people ≥6 months. Despite effectiveness evidence showing a reduction in mortality and hospitalizations in people with diabetes vaccinated vs. non-vaccinated ones, very few studies reported a coverage rate ≥ 75%, which is WHO’s target objective. Determinants such as advanced age, presence of comorbidities and healthcare givers’ advice were associated with increased vaccination uptake. On the contrary, fear of adverse reactions and concerns about vaccine effectiveness were significant barriers. Finally, education and pharmacists’ intervention played a key role in promoting vaccination and increasing vaccination uptake.ConclusionInfluenza vaccination coverage in people with diabetes remains low despite recommendations and evidence on vaccine effectiveness. Motivators and barriers as well as several socio-demographic and clinical factors have been identified to explain this trend. Efforts are now needed to increase the number of diabetics vaccinated against influenza, mainly through education and the involvement of healthcare givers.

IntroductionThe healthcare pathway is at the heart of public health organization concerns, but communication between the various players can be an obstacle. This work, produced by a French transdisciplinary team, offers a methodological approach based on formalized consensus to elaborate a glossary of healthcare pathways. A two-steps procedure was elaborated, including a double rounded Delphi method to formalize expert consensus, and two groups of experts: a workgroup and a review group.MethodsThe workgroup provided a list of words or expressions that, in their opinion, described, evaluated or compared the healthcare pathways for patients, caregivers or regulators. The review group checked this list and added or deleted words or expressions. Then, definitions were added by the workgroup based into account three dimensions: official, academic and from the field. The review group validated the definitions and provided complementary proposals if needed.ResultsAfter pooling the list of words proposed by each of the six members of the working group, 417 words/expressions were ranked. After the two rounds of evaluation, 294 words/expressions were rated “appropriate” and were analyzed by the review group. This group, after two rounds of evaluation, agreed on 263 words/expressions that were transmitted to the working group who defined them. These definitions were rated by the review group. The first round of evaluation established 195 definitions as being appropriated whereas 68 definitions were amended by the review group.ConclusionThis glossary supports transdisciplinary communication, reduces the extent of variations in practice and optimizes decision-making. International debate on all aspects might be strengthened by an improved understanding of the concept of health pathway.

BackgroundOral health is a fundamental human right and is inseparable and indivisible from overall health and well-being. Oral Health Literacy (OHL) has been proved to be fundamental to promoting oral health and reducing oral health inequalities. To our knowledge, no OHL instrument to evaluate OHL level is currently validated in French language despite the fact it is the fifth most widely spoken languages on the planet. The Oral health literacy Instrument (OHLI) appears to be the most interesting OHL instrument to adapt into French because it is already available in English, Spanish, Russian, Malaysian, and it contains both reading comprehension and numeracy sections. Its psychometric properties have been rated as adequate.ObjectiveThe aim of this study was to translate and adapt cross-culturally the OHLI into French, to evaluate its psychometric properties and to compare its results to oral health knowledge.MethodThis study followed and applied well-established processes of translation, cross-cultural adaptation and validation, based on the recommendations of the World Health Organization guidelines and on the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) study design checklist for patient-reported outcomes. Two psychometric assessments were planned, the comparison of OHLI-F scores according to education level and frequency of dental visits, and the test–retest reliability of the OHLI-F.ResultsA total of 284 participants answered the OHLI-F. The OHLI-F scores were significantly different between participants with different levels of education and frequency of dental visits (p

Background: Health technology assessment (HTA) bodies across Europe rely on explicit factors for decision making. However, additional undefined factors play a role. This mixed-methods research aimed to identify the implicit factors involved in HTA deliberative processes in five European countries, and to analyze their impact on decision making. Methods: Between February and May 2021, semi-structured interviews (n = 20) were conducted with HTA experts of three different profiles (chair, advisor, and committee member) from France, Germany, Italy, Spain, and the United Kingdom. The degree of influence of a set of implicit factors and attributes that play a role in the HTA deliberative process, as previously identified in a systematic literature review, was scored by the experts. Experts were also asked to make recommendations on ways of improving the deliberative process. A qualitative analysis and descriptive statistics of quantitative variables are reported. Results: Most (18/20) experts concurred that implicit factors play a role in the HTA deliberative process. Recommendations for improving the process fell into three categories: transparency, methodology improvement, and stakeholder involvement. The results suggest a need for 1) increased external involvement HTA and 2) development of a methodology to mitigate the influence of implicit factors in the deliberative process. This could be achieved by updating the current frameworks to acknowledge these implicit factors and by developing methods to address them.

Background: Proton-pump inhibitors (PPI) are frequently used in the emergency and general practice settings in several clinical presentations linked to acute upper gastro-intestinal tract disorders as abdominal or chest pain without recommendations. Objective: The aim of this scoping review was to assess pain reduction, diagnostic performance, and safety in the first 24 h-management in primary care or emergency medicine. Methods: Search was realized by 2 independent reviewers in PubMed, Embase, and Web of Science following PRISMA-ScR guidelines. Only original articles or systematic reviews in English were included. Studies about chronic and/or bleeding conditions, therapeutic cocktails and studies without pain evaluation were excluded. Two methodologies were used for bias estimation. Results: From 4442 titles, 79 full-text articles were assessed, and 9 were included. There is no strong evidence supporting the use of PPI as a first line analgesic or diagnostic test in acute syndromes linked to acute upper gastro-intestinal tract disorder. A small effect in pain reduction was retrieved in patients with low pain scores. A poor additional value in patients with gastric reflux, and a low specificity compared to other diagnostic tests were observed. A short-term PPI administration appears to be safe with low risk of serious allergic reactions, and poor adverse effects (moderate evidence). Conclusion: Although PPIs may contribute to the multimodal analgesia in acute settings, with few and/or minor side effects, no recommendation can be drawn for their use as a primary analgesic. Data regarding the relevance of the PPI test are much less clear, no data regarding care pathways are available.

Objectives Deliberative processes in Health Technologies Assessment (HTA) result in recommendations that determine the reimbursement of medicines, diagnostics or devices. These processes are governed by explicit criteria, but are also influenced by implicit factors. The objective of this work was to identify the implicit factors influencing HTA deliberative processes in 5 European countries (France, Germany, Italy, Spain and the UK).Methods A systematic review of literature published between 2009 and 2019 was conducted. The search was performed in Pubmed, The Cochrane Database of Systematic Reviews, Google Scholar and Center for Reviews and Dissemination. The ISPOR database was searched manually.Results Out of 100 eligible publications, 8 articles were selected for data extraction and analysis. The implicit factors in the HTA deliberative process most frequently mentioned in the identified literature are value judgments, biases, preferences and subjectivity. 5 out of the 8 articles highlight the need to further improve the transparency of the process, and 3 provide recommendations on how to address the influence of implicit factors on the HTA deliberative process through a framework.Conclusion Even in countries with a long HTA history, evidence on implicit factors is scarce. Some methods have been recommended for addressing these factors. Further research is required to characterize the implicit factors in the HTA deliberative process at a country level and explore potential ways to mitigate the influence of these factors on the HTA deliberative process.

BackgroundApproximately 800 million people, representing 11% of the world’s population, are affected by mental health problems. The COVID-19 pandemic exacerbated problems and triggered a decline in well-being, with drastic increase in the incidence of conditions such as anxiety, depression, and stress. Approximately 20,000 mental health apps are listed in mobile app stores. However, no significant evaluation of mental health apps in French, spoken by approximately 300 million people, has been identified in the literature yet. ObjectiveThis study aims to review the mental health mobile apps currently available on the French Apple App Store and Google Play Store and to evaluate their quality using Mobile App Rating Scale–French (MARS-F). MethodsScreening of mental health apps was conducted from June 10, 2022, to June 17, 2022, on the French Apple App Store and Google Play Store. A shortlist of 12 apps was identified using the criteria of selection and assessed using MARS-F by 9 mental health professionals. Intraclass correlation was used to evaluate interrater agreement. Mean (SD) scores and their distributions for each section and item were calculated. ResultsThe highest scores for MARS-F quality were obtained by Soutien psy avec Mon Sherpa (mean 3.85, SD 0.48), Evoluno (mean 3.54, SD 0.72), and Teale (mean 3.53, SD 0.87). Mean engagement scores (section A) ranged from 2.33 (SD 0.69) for Reflexe reussite to 3.80 (SD 0.61) for Soutien psy avec Mon Sherpa. Mean aesthetics scores (section C) ranged from 2.52 (SD 0.62) for Mental Booster to 3.89 (SD 0.69) for Soutien psy avec Mon Sherpa. Mean information scores (section D) ranged from 2.00 (SD 0.75) for Mental Booster to 3.46 (SD 0.77) for Soutien psy avec Mon Sherpa. Mean Mobile App Rating Scale subjective quality (section E) score varied from 1.22 (SD 0.26) for VOS – journal de l’humeur to 2.69 (SD 0.84) for Soutien psy avec Mon Sherpa. Mean app specificity (section F) score varied from 1.56 (SD 0.97) for Mental Booster to 3.31 (SD 1.22) for Evoluno. For all the mental health apps studied, except Soutien psy avec Mon Sherpa (11/12, 92%), the subjective quality score was always lower than the app specificity score, which was always lower than the MARS-F quality score, and that was lower than the rating score from the iPhone Operating System or Android app stores. ConclusionsMental health professionals assessed that, despite the lack of scientific evidence, the mental health mobile apps available on the French Apple App Store and Google Play Store were of good quality. However, they are reluctant to use them in their professional practice. Additional investigations are needed to assess their compliance with recommendations and their long-term impact on users.

Human papillomaviruses (HPVs) are responsible for one of the most common sexually transmitted diseases in the world, and their oncogenic role has been well demonstrated in genital, anal, and oropharyngeal areas. However, a certain distrust and a lack of knowledge about this vaccine are perceptible among French adolescents and their parents. Thus, health professionals and, more particularly, pharmacists appear to be key persons to promote HPV vaccination and restore confidence in the target population. The present study aims to assess the knowledge, attitudes, and practices regarding HPV vaccination among pharmacists, particularly in boys, following the 2019 recommendation to vaccinate them. The present study was designed as a cross-sectional, quantitative, and descriptive survey that was conducted from March to September 2021 among pharmacists in France. 215 complete questionnaires were collected. Gaps in knowledge were found, only 21.4% and 8.4% obtained a high level of knowledge related to, respectively, HPV and vaccination. Pharmacists were confident in the HPV vaccine (94.4%), found it safe and useful, and felt that the promotion of the vaccine was part of their role (94.0%). However, only a few have already advised it, which they justify due to a lack of opportunity and forgetfulness. Faced with this, training, computerized reminders, or supportive materials could be implemented to improve the advice and thus the vaccination coverage. Finally, 64.2% were in favor of a pharmacy-based vaccination program. In conclusion, pharmacists are interested in this vaccination and the role of promoter. However, they need the means to facilitate this mission: training, computer alerts, supportive materials such as flyers, and the implementation of vaccination in pharmacies.

BackgroundThe global burden of disease attributes 20% of deaths to poor nutrition. Although hundreds of nutrition-related mobile apps have been created, and these have been downloaded by millions of users, the effectiveness of these technologies on the adoption of healthy eating has had mixed ObjectiveThe aim of this study was to review which nutrition-related mobile apps are currently available on the French market and assess their quality. MethodsWe screened apps on the Google Play Store and the French Apple App Store, from March 10 to 17, 2021, to identify those related to nutritional health. A shortlist of 15 apps was identified, and each was assessed using the French version of the Mobile App Rating Scale: 8 dietitians and nutritionists assessed 7 apps, and the remaining apps were randomly allocated to ensure 4 assessments per app. Intraclass correlation was used to evaluate interrater agreement. Means and standard deviations of scores for each section and each item were calculated. ResultsThe top scores for overall quality were obtained by Yazio - Régime et Calories (mean 3.84, SD 0.32), FeelEat (mean 3.71, SD 0.47), and Bonne App (mean 3.65, SD 0.09). Engagement scores ranged from a mean of 1.95 (SD 0.5) for iEatBetter: Journal alimentaire to a mean of 3.85 (SD 0.44) for FeelEat. Functionality scores ranged from a mean of 2.25 (SD 0.54) for Naor to a mean of 4.25 (SD 0.46) for Yazio. Aesthetics scores ranged from a mean of 2.17 (SD 0.34) for Naor to a mean of 3.88 (SD 0.47) for Yazio. Information scores ranged from a mean of 2.38 (SD 0.60) for iEatBetter to a mean of 3.73 (SD 0.29) for Yazio. Subjective quality scores ranged from a mean of 1.13 (SD 0.25) for iEatBetter to a mean of 2.28 (SD 0.88) for Compteur de calories FatSecret. Specificity scores ranged from a mean of 1.38 (SD 0.64) for iEatBetter to a mean of 3.50 (SD 0.91) for FeelEat. The app-specific score was always lower than the subjective quality score, which was always lower than the quality score, which was lower than the rating from the iOS or Android app stores. ConclusionsAlthough prevention and information messages in apps regarding nutritional habits are not scientifically verified before marketing, we found that app quality was good. Subjective quality and specificity were associated with lower ratings. Further investigations are needed to assess whether information from these apps is consistent with recommendations and to determine the long-term impacts of these apps on users.

Abstract Background Thanks to advancements in medical care, a majority of patients with sickle cell disease (SCD) worldwide live beyond 18 years of age, and therefore, patients initially followed in paediatric departments are then transferred to adult departments. This paediatric-adult care transition is a period with an increased risk of discontinuity of care and subsequent morbidity and mortality. During this period, the patient will have to manage new interlocutors and places of care, and personal issues related to the period of adolescence. To take into consideration all these aspects, an interesting approach is to use the whole system approach to the patient, as presented in the biopsychosocial approach. The aim of this trial is to evaluate the impact of the proposed biopsychosocial paediatric-adult transition programme. Methods The DREPADO study is a multicentre randomised control trial comparing a control group (Arm A) to an interventional group with a paediatric-adult transition programme based on a biopsychosocial approach (Arm B). To be included, patients should have the SS, SC, or Sβ form of sickle cell disease and be aged between 16 and 17 years. The randomisation in a 1:1 ratio assigns to Arm A or B. The primary outcome is the number of hospital admissions and emergencies for complications in the index hospital, in the 2 years after the first consultation in the adult department of care. Secondary outcomes consider the quality of life, but also include coping skills such as sense of self-efficacy and disease knowledge. To provide patient and parent knowledge and coping skills, the transition programme is composed of three axes: educational, psychological, and social, conducted individually and in groups. Discussion By providing self-care knowledge and coping skills related to SCD and therapeutics, helping empower patientsin relation to pain management and emotions, and facilitating the relationship to oneself, others, and care in Arm B of the DREPADO study, we believe that the morbidity and mortality of patients with SCD may be reduced after the proposed paediatric-adult transition programme. Trial registration ClinicalTrials.gov, ID: NCT03786549; registered on 17 December 2018; https://clinicaltrials.gov/.

The fast spread of COVID-19 is related to the highly infectious nature of SARS-CoV-2. The disease is suggested to be transmitted through saliva droplets and nasal discharge. The saliva quantification of SARS-CoV-2 in real-time PCR from asymptomatic or mild COVID-19 adults has not been fully documented. This study analyzed the relationship between salivary viral load on demographics and clinical characteristics including symptoms, co-morbidities in 160 adults diagnosed as COVID-19 positive patients recruited between September and December 2020 in four French centers. Median initial viral load was 4.12 log10 copies/mL (IQR 2.95–5.16; range 0–10.19 log10 copies/mL). 68.6% of adults had no viral load detected. A median load reduction of 23% was observed between 0–2 days and 3–5 days, and of 11% between 3–5 days and 6–9 days for the delay from onset of symptoms to saliva sampling. No significant median difference between no-symptoms vs. symptoms patients was observed. Charge was consistently similar for the majority of the clinical symptoms excepted for headache with a median load value of 3.78 log10 copies/mL [1.95–4.58] (P < 0.003). SARS-CoV-2 RNA viral load was associated with headache and gastro-intestinal symptoms. The study found no statistically significant difference in viral loads between age groups, sex, or presence de co-morbidity. Our data suggest that oral cavity is an important site for SARS-CoV-2 infection and implicate saliva as a potential route of SARS-CoV-2 transmission.

Background Several innovative drugs liable to lead to changes in healthcare organization are or soon will be available for the management of hemophilia. Analyzing their implementation can shed further light on healthcare decision-making, to anticipate changes and risk of breakdown in the patient’s care pathway. Methods Multiple criteria decision analysis (MCDA), based on ISPOR recommendations, was used to assess the organizational impact of innovation in hemophilia care management. The MCDA process designed for this specific context involved ten French experts in hemophilia care management (physicians, nurses, pharmacist, physiotherapist and psychologist) in the hemophilia care center of Chambéry, in the Rhône-Alpes Region of France. This pilot study involved seven steps: (i) defining the decision problem; (ii) selecting and structuring criteria; (iii) assessing the relative weight of each criterion with software-assisted simulation based on pairwise comparisons of different organizational change scenarios; (iv) measuring the performance of the selected innovations; (v) scoring alternatives; (vi) calculating aggregate scores; (vii) discussion. The endpoint was to determine the expected overall organizational impact on a 0–100 scale. Results Seven organizational criteria were selected. "Acceptability for patient/caregiver/association" was the most heavily weighted. Factor VIII by subcutaneous route obtained the highest aggregate score: i.e., low impact on care organization (88.8 out of 100). The innovation with strongest organizational impact was gene therapy (27.3 out of 100). Conclusion This approach provided a useful support for discussion, integrating organizational aspects in the treatment decision-making process, at healthcare team level. The study needs repeating in a few years’ time and in other hemophilia centers.

Invasive meningococcal disease (IMD) remains a significant health concern due to its unpredictable nature and its rapid progression. Even if occurrence of IMD is strictly monitored by a national surveillance network, no information on long-term sequelae is reported, making it difficult to assess the entire clinical burden of IMD in France. The aim of this scoping review was to analyze the epidemiology and the clinical burden of IMD in France by reporting the main epidemiological parameters, and by describing the clinical consequences and the care pathway of patients. The process of the review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension to the Scoping Reviews guidelines. In France, the incidence of IMD cases has been fluctuating over time, characterized by an overall downward trend linked to a decrease in Sg B cases and the introduction of mandatory vaccination against Sg C. Sg W cases increased in recent years (from 5% to 21% in 2019). The case fatality rate remained constant (6–12.9%). The most frequently reported sequelae were severe neurological disorder, epilepsy, and anxiety. However, data on sequelae and care pathways were scarce. Further research should concentrate on providing robust identification of sequelae and the subsequent impact on quality of life, as well as on the organization of optimal care and support for patients and their families.

Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all relevant stakeholders to navigate. In this review, we will elaborate on the importance of collaborations and harmonization across different stakeholders, to expedite the market access of promising ATMPs. Manufacturers of ATMPs should proactively establish collaborations with other stakeholders throughout the whole lifecycle of ATMPs, from early research to post-market activities. This covered engagements with (1) external developers (i.e., not-for-profit organizations and commercial players) to obtain complementary knowledge, technology, or infrastructures, (2) patient groups and healthcare providers to highlight their roles as active contributors, and (3) decision-makers, such as regulators, health technology assessment (HTA) agencies, and payers, to communicate the uncertainties in evidence package, where parallel consultation will be a powerful strategy. Harmonization between decision-makers is desired at (1) regulatory level, in terms of strengthening the international standardization of regulatory framework to minimize discrepancies in evidence requirements for market authorization, and (2) HTA level, in terms of enhancing alignments between regional and national HTA agencies to narrow inequity in patient access, and cross-border HTA cooperation to improve the quality and efficiency of HTA process. In conclusion, manufacturers and decision-makers shared the common goals to safeguard timely patient access to ATMPs. Collaboration and harmonization will be increasingly leveraged to enable the value delivery of ATMPs to all stakeholders.

BackgroundIn the recent decades, the number of apps promoting health behaviors and health-related strategies and interventions has increased alongside the number of smartphone users. Nevertheless, the validity process for measuring and reporting app quality remains unsatisfactory for health professionals and end users and represents a public health concern. The Mobile Application Rating Scale (MARS) is a tool validated and widely used in the scientific literature to evaluate and compare mHealth app functionalities. However, MARS is not adapted to the French culture nor to the language. ObjectiveThis study aims to translate, adapt, and validate the equivalent French version of MARS (ie, MARS-F). MethodsThe original MARS was first translated to French by two independent bilingual scientists, and their common version was blind back-translated twice by two native English speakers, culminating in a final well-established MARS-F. Its comprehensibility was then evaluated by 6 individuals (3 researchers and 3 nonacademics), and the final MARS-F version was created. Two bilingual raters independently completed the evaluation of 63 apps using MARS and MARS-F. Interrater reliability was assessed using intraclass correlation coefficients. In addition, internal consistency and validity of both scales were assessed. Mokken scale analysis was used to investigate the scalability of both MARS and MARS-F. ResultsMARS-F had a good alignment with the original MARS, with properties comparable between the two scales. The correlation coefficients (r) between the corresponding dimensions of MARS and MARS-F ranged from 0.97 to 0.99. The internal consistencies of the MARS-F dimensions engagement (ω=0.79), functionality (ω=0.79), esthetics (ω=0.78), and information quality (ω=0.61) were acceptable and that for the overall MARS score (ω=0.86) was good. Mokken scale analysis revealed a strong scalability for MARS (Loevinger H=0.37) and a good scalability for MARS-F (H=0.35). ConclusionsMARS-F is a valid tool, and it would serve as a crucial aid for researchers, health care professionals, public health authorities, and interested third parties, to assess the quality of mHealth apps in French-speaking countries.

Abstract Objectives - To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals. - To compare the evolution of the SARS-CoV-2 nasal and salivary viral load according to the presence or absence of antivirals in the mouthwash. Trial design This is a multi-center, randomised controlled trial (RCT) with two parallel arms (1:1 ratio). Participants Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France). Intervention and comparator Eligible participants will be allocated to one of the two study groups. Intervention group: patients perform a tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®) for a period of 7 days. Control group: patients perform a tri-daily mouthwash with a placebo mouthwash for a period of 7 days. Main outcomes Primary Outcome Measures: Change from Baseline amount of SARS-CoV-2 in salivary samples at 4 and 9 hours, 1, 2, 3, 4, 5 and 6 days. Real-time PCR assays are performed to assess salivary SARS-CoV 2 viral load. Secondary Outcome Measures: Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 6 days. Real-time PCR assays are performed to assess nasal SARS-CoV-2 viral load. Randomisation Participants meeting all eligibility requirements are allocated to one of the two study arms (mouthwash with β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®) in a 1:1 ratio using simple randomisation with computer generated random numbers. Blinding (masking) Participants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes will be blinded to group assignment. Numbers to be randomised (sample size) Both the intervention and control groups will be composed of 103 participants, so the study will include a total of 206 participants. Trial Status The current protocol version is 6, August 4th, 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. As of October 2, 2020, forty-two participants have been included. Trial registration This trial was registered on 20 April 2020 at www.clinicaltrials.gov with the number NCT04352959 . Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.” The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).”

Objectives: Inclusion of patient preference (PP) data in decision making has been largely discussed in recent years. Healthcare decision makers—regulatory and health technology assessment (HTA)—are more and more conscious of the need for a patient-centered approach to decide on optimal allocation of scarce money, time, and technological resources. This literature review aims to examine the use of and recommendations for the integration of PP in decision making.Methods: A literature search was conducted through PubMed/Medline in May 2019 to identify publications on PP studies used to inform benefit–risk assessments (BRAs) and HTAs and patient-centered projects and guidelines related to the inclusion of PPs in health policy decision making. After title and abstract screening and full-text review, selected publications were analyzed to retrieve data related to the collection, use, and/or submission of PPs informing BRA or HTA as well as attempts and initiatives in recommendations for PPs integration in decision-making processes.Results: Forty-nine articles were included: 24 attempts and pilot project discussions and 25 PP elicitation studies. Quantitative approaches, particularly discrete choice experiments, were the most used (24 quantitative elicitation studies and 1 qualitative study). The objective of assessing PPs was to prioritize outcome-specific information, to value important treatment characteristics, to provide patient-focused benefit–risk trade-offs, and to appraise the patients' willingness to pay for new technologies. Moreover, attempts and pilot projects to integrate PPs in BRAs and HTAs were identified at the European level and across countries, but no clear recommendations have been issued yet. No less than seven public and/or private initiatives have been undertaken by governmental agencies and independent organizations to set guidance targeting improvement of patients' involvement in decision making.Conclusion: Despite the initiatives undertaken, the pace of progress remains slow. The use of PPs remains poorly implemented, and evidence of proper use of these data in decision making is lacking. Guidelines and recommendations formalizing the purpose of collecting PPs, what methodology should be adopted and how, and who should be responsible for generating these data throughout the decision-making processes are needed to improve and empower integration of PPs in BRA and HTA.

Background Organizational aspect is rarely considered in healthcare. However, it is gradually seen as one of the key aspects of the decision-making process as well as clinical and economic dimensions. Our primary objective was to identify criteria already used to assess the organizational impact of medical innovations. Our secondary objective was to structure them into an inventory to support decision-makers to select the relevant criteria for their complex decision-making issues. Materials and methods A search using the Medline database was conducted in June 2019. The records published between January, 1990 and December, 2018 were identified. The publications cited by the authors of the included articles and the websites of health technology assessment agencies, units or learned societies identified during the search were also consulted. The identified criteria were structured in an inventory. Results We selected 107 records of a wide range of evidence mostly published after the 2000s. We identified 636 criteria that we classified into five categories: people, task, structure, technology, and surroundings. Conclusion Criteria selection is a crucial step in any multi-criteria decision analysis (MCDA). This work is the first step in the development of a validated MCDA method to assess the organizational impact of medical innovations.

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.

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. Keywords: Interdental microbiota, Adolescent, Dental caries, Carious risk

The aim of this study was to determine whether self-collected pure saliva (SCPS) is comparable to nasopharyngeal (NP) swabs in the quantitative detection of SARS-CoV-2 by RT-PCR in asymptomatic, mild patients with confirmed COVID-19. Thirty-one patients aged from 18 to 85 years were included between 9 June and 11 December 2020. A SCPS sample and a NP sample were taken for each patient. Quantitative PCR was performed to detect SARS-CoV-2 viral load. Results of SCPS vs. NP samples testing were compared. Statistical analyses were performed. Viral load was significantly correlated (r = 0.72). The concordance probability was estimated at 73.3%. In symptomatic adults, SCPS performance was similar to that of NP swabs (Percent Agreement = 74.1%; p = 0.11). Thus, the salivary test based on pure oral saliva samples easily obtained by noninvasive techniques has a fair agreement with the nasopharyngeal one in asymptomatic, mild patients with a confirmed diagnosis of COVID-19.

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.

Introduction: The appraisal of medicines is often a complex and iterative process. We compared the health technology assessment (HTA) process in England and France taking as a case study the example of ixazomib for multiple myeloma. Methods: We undertook an analysis of eight relevant published documents identifed from the websites of the French and English HTA bodies (HAS and NICE, respectively). We analyse patients’ availability of ixazomib resulting in the different stages of the appraisal process. Results: We identified differences in the assessment, one of these being the use of an appraisal scope in England allowing the differentiation of populations and comparators according to previously approved treatments. Ixazomib became available earlier in France as part of an early access programme, but the availability was soon discontinued for newly eligible patients following an HAS determination that Ixazomib yielded no additional benefit. This opinion resulted in long pricing discussions. In England, despite the absence of an early access programme and following a process that included cost-effectiveness evaluation combined with pricing discussions, the medicine was fairly rapidly recommended for use. Conclusions: Differences in the HTA process may result in appreciable differences in time from marketing authorisation to health service adoption of newly licensed drugs.

Background: The Trump administration’s ‘American Patients First’ blueprint proposes to reduce drug prices in the USA by increasing drug prices abroad, ex USA. The possibility of the Trump administration to raise drug prices ex USA through legal action via the WTO and bilateral negotiations with foreign trade partners was reviewed. Methods: A literature review was conducted through PUBMED, EMBASE, Media and grey literature to consolidate publications of the Trump administrations’ policies and strategies towards foreign countries and drug prices. Results: The Trump administration has withdrawn from and halted major multilateral agreements including the TPP, Paris Agreement, TTIP, UNESCO, NAFTA (now USMCA), and NATO. The Trump administration has been successful in bilateral negotiations for pharmaceuticals’ pricing, as seen with Japan, South Korea, Germany, and Mexico and Canada. Conclusion: The objective of raising prices abroad is attainable. Action through the WTO is unlikely, due to its nondiscriminatory principle. Bilateral trade negotiation have proven more promising. In this bilateral framework, financial security and military protection are strong assets for the USA to levy higher drug prices abroad. Although raising drug prices ex USA is possible, further questions as to whether this will directly translate into lower drug prices for American patients are raised.

Nutrition is recognized as an essential component in the prevention of a number of chronic diseases, including periodontal disease. Based on these considerations, a better understanding is required regarding how the diet, and more particularly the intake of macronutrients and micronutrients, could impact the potential relationship between nutrition and periodontal diseases, periodontal diseases and chronic diseases, nutrition and chronic diseases. To overcome this complexity, an up-to-date literature review on the nutriments related to periodontal and chronic diseases was performed. High-sugar, high-saturated fat, low-polyols, low-fiber and low-polyunsaturated-fat intake causes an increased risk of periodontal diseases. This pattern of nutrients is classically found in the Western diet, which is considered as an ‘unhealthy’ diet that causes cardiovascular diseases, diabetes and cancers. Conversely, low-sugar, high-fiber and high-omega-6-to-omega-3 fatty acid ratio intake reduces the risk of periodontal diseases. The Mediterranean, DASH, vegetarian and Okinawa diets that correspond to these nutritional intakes are considered as ‘healthy’ diets, reducing this risk of cardiovascular diseases, diabetes and cancers. The role of micronutrients, such as vitamin D, E, K and magnesium, remains unclear, while others, such as vitamin A, B, C, calcium, zinc and polyphenols have been shown to prevent PDs. Some evidence suggests that probiotics and prebiotics could promote periodontal health. Periodontal and chronic diseases share, with a time delay, nutrition as a risk factor. Thus, any change in periodontal health should be considered as a warning signal to control the dietary quality of patients and thus reduce the risk of developing chronic diseases later on.

Background: Healthcare systems worldwide adapt to patients’ needs and expectations, following social evolutions. Pharmaceutical practice has shifted towards activities such as therapeutic education. Such new missions require to prioritize human and social sciences, which now play a predominant role in training. Objective: This work consists of assessing the contribution of human and social sciences to the field of pharmacy, with a twofold focus on practice and training. Method: A literature review was carried out according to the PRISMA guidelines focusing on the last 10 years. Selected full texts were read and analyzed to elicit the contribution of human and social sciences to pharmacy. Results: Overall 36 articles were included. Three specific topics were identified during an inductive process of full text analysis: public health policy, patient care, and interprofessional collaboration. Conclusions: Although human and social sciences are essential to the evolution of the pharmacist profession, their impact on health care costs remains difficult to evaluate. Moreover, teaching human and social sciences can prove difficult to standardize. Such approaches must be supported and organized by governments and universities with a view of upscaling practices.

Considered to be a major portal of entry for infectious agents, the oral cavity is directly associated with the evolutionary process of SARS-CoV-2 in its inhalation of ambient particles in the air and in expectorations. Some new generations of mouth rinses currently on the market have ingredients that could contribute to lower the SARS-CoV-2 viral load, and thus facilitate the fight against oral transmission. If chlorhexidine, a usual component of mouth rinse, is not efficient to kill SARS-CoV-2, the use of a mouth rinses and/or with local nasal applications that contain β-cyclodextrins combined with flavonoids agents, such as Citrox, could provide valuable adjunctive treatment to reduce the viral load of saliva and nasopharyngeal microbiota, including potential SARS-CoV-2 carriage. We urge national agencies and authorities to start clinical trials to evaluate the preventive effects of βCD-Citrox therapeutic oral biofilm rinses in reducing the viral load of the infection and possibly disease progression.

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.

Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan drug approval documentation was obtained from the EMA website. PRO-related language was extracted from the Summaries of Product Characteristics (SmPCs). Data were compared to a previously published analysis of the FDA approvals from the same time period. Results: Out of 60 approvals that met the inclusion criteria, 12 products approved by the EMA for 13 (21.7%) orphan indications contained PRO language in the Clinical Studies section of the SmPC. Twelve SmPCs contained PRO instruments based on symptoms, five of which also concerned patient functioning. Eight approvals included PRO claims related to quality of life (QoL) most commonly in cancer treatment. Conclusion: The rate of PRO claims was lower for orphan drugs specifically than for all drug approvals by the EMA. However, in accordance with previous findings, the EMA appeared more inclined to grant PRO claims including health-related QoL than the FDA.

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, preclinical, 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. DISCUSSION AND PUBLIC HEALTH IMPLICATIONS:The implementation of a module on interdental hygiene practices in the oral health program is strongly recommended. However, corrective measures should be considered regarding the organization and frequency of recall periods in order to improve the performance of the curriculum.

Background: In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medical innovations. That is why health technology assessment is subject to an increasing interest at national level for management and approval decisions. This article provides an overview of the assessment and diffusion of medical innovation in France. Method: The data are extracted from French authorities or organisations websites and documents and from French legislative texts. In addition, regarding discussion, a search in MEDLINE database was carried out. Results: An overview of the assessment and diffusion of medical innovation in France is given by presenting the different types of medical innovations according to French health system definition (I); introducing French authorities participating to health technology assessment and describe assessment procedures of medical innovations (II); and giving details about market access process of innovative health product in France (III). Key opportunities and challenges of medical innovation assessment and diffusion in France are discussed at the end of this article. Conclusion: In France, medical innovation is considered as a crucial component for quality of care and performance of healthcare system. The aim of health technology assessment is to promote a secure and timely access to innovation for patients. Nevertheless, it appears necessary to improve regulatory mechanisms.

Le service de Santé des Armées assure le soutien sanitaire des forces armées déployées en opération extérieure. Afin d'assurer la même qualité de soin sur le théâtre et en Métropole, le Service de Santé des Armées réalise la stérilisation des dispositifs médicaux réutilisables par ses propres moyens. Le pharmacien militaire en mission sur place provient de différents horizons: laboratoire de biologie médicale, recherche, ravitaillement sanitaire, pharmacie hospitalière ou encore officine pour certains réservistes. Une formation à la pratique de la stérilisation en situation d'isolement est donc nécessaire afin d'assurer une uniformité des connaissances. Notre travail s'est articulé en deux temps: détermination des besoins et des modalités de formation adaptés, puis construction de la formation proprement dite. Cette formation doit être accessible à un public dispersé géographiquement dont les niveaux d'expertise en stérilisation sont disparates. Le module ''préparation opérationnelle à la stérilisation en Opération Extérieure '' réalisé permet d'actualiser et d'uniformiser les connaissances des pharmaciens déployés. Il est composé de 11 sous-modules couvrant les différents aspects de la stérilisation en Opération Extérieure. Une évaluation, à l'aide de questions à choix multiples (QCM), est nécessaire pour vérifier le niveau de connaissance et de compréhension à la fin de la formation. Un taux de bonne réponse de 75% est demandé pour valider la formation. Le contenu de la formation a été approuvé par les référents nationaux en stérilisation et est d'ores et déjà disponible sur la plateforme de formation e-learning de l'Ecole du Val de Grace.

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.

Adolescence is closely associated with a high risk of caries. The identification of specific bacteria in an oral microniche, the interdental space of the molars, according to carious risk can facilitate the prediction of future caries and the anticipation of the progression or stabilization of caries in adolescents. A cross-sectional clinical study according to the bacteriological criteria of interdental healthy adolescents and carious risk factors—low and high—using a real-time polymerase chain reaction technique was conducted. The presence of 26 oral pathogens from the interdental microbiota of 50 adolescents aged 15 to 17 years were qualitatively and quantitatively analyzed. Bacteria known to be cariogenic (Bifidobacterium dentium, Lactobacillus spp., Rothia dentocariosa, Streptococcus cristatus, Streptococcus mutans, Streptococcus salivarius, Streptococcus sobrinus, and Streptococcus wiggsiae) did not present differences in abundance according to carious risk. Periodontal bacteria from the red complex are positively correlated with carious risk. However, only 3 bacteria—S. sobrinus, E corrodens and T. forsythia—presented a significant increase in the highest group. Estimating the risk of caries associated with bacterial factors in interdental sites of molars in adolescents contributes to the better definition of carious risk status, periodicity and intensity of diagnostic, prevention and restorative services.