Smoking and mental disability : A mixed observational study using a diverse sample of medical-social establishments and services / Tabagisme et handicap psychique : étude observationnelle mixte dans un échantillon diversifié d'établissements et de services médico-sociaux.

INTRODUCTION: A multi-center observational study was carried out in ten ESMS, using a mixed methodology (site visits, questionnaire survey, semi-directive group interviews with professionals and individual interviews with users). PURPOSE OF THE RESEARCH: The aim of this article is to describe the management and prevention of smoking in ESMS for people with mental health disorders, and to characterize and identify the smoking behaviors and representations of ESMS users and the professionals working there. RESULTS: The study made it possible to distinguish between ESMS in terms of the organization of smoking areas and tobacco prevention initiatives. It also revealed that 37 percent of respondents among the professionals said they smoked tobacco, with some of them explaining that they smoked with users and sometimes gave them cigarettes. With regard to prevention, there was a consensus among professionals that they should help users who wanted to stop smoking. Professionals were divided, however, on the need for more active prevention, citing the users' freedom and the fact that ESMS are places where people live. Among the users, 47 percent said they were smokers. Of the users who smoked, 55 percent said they wanted to stop. Interviews with the users revealed that twelve of them wanted to quit, with some asking for help and more assistance from professionals. CONCLUSIONS: This report suggests that intervention research could be developed in ESMS for people with mental health disorders, who could benefit from the smoking prevention actions identified in the facilities and services investigated.

Introduction: Une étude observationnelle multicentrique a été réalisée dans dix ESMS et mobilisait une méthodologie mixte (visite des structures, enquête par questionnaires, entretiens semi-directifs collectifs avec des professionnels et individuels avec des usagers). But de l'étude: Cet article vise à décrire la gestion et la prévention du tabagisme dans des établissements et services médico-sociaux (ESMS) accueillant des personnes avec un trouble psychique, et à caractériser et identifier les comportements tabagiques et les représentations de leurs usagers et professionnels. Résultats: L'étude a permis de distinguer les ESMS au regard de l'organisation des espaces du tabagisme et des actions de prévention du tabac. Elle a permis également de constater que 37 % des professionnels qui ont répondu déclaraient fumer du tabac, une partie d'entre eux expliquant fumer avec les usagers et leur donner parfois des cigarettes. Concernant la prévention, un consensus se dégageait chez les professionnels sur le fait d'aider les usagers qui souhaitaient arrêter. Les professionnels étaient cependant divisés à l'égard d'une prévention plus active, invoquant la liberté de l'usager et le fait que les ESMS sont des lieux de vie. 47 % des usagers se disaient fumeurs. 55 % des usagers fumeurs déclaraient vouloir arrêter. Les entretiens avec les usagers ont permis de constater que douze d'entre eux souhaitaient arrêter, une partie réclamant de l'aide et d'être davantage aidés par les professionnels. Conclusions: Cet état des lieux invite à développer des recherches interventionnelles dans les ESMS accueillant des personnes avec un trouble psychique qui pourraient tirer profit des actions de prévention du tabac repérées dans des structures enquêtées.

Improving autonomy support: a collaborative learning experience / Améliorer les pratiques d'accompagnement à l'autonomie en santé : effets d'un dispositif d'apprentissage coopératif

Introduction: The ACESO project, which was part of the Autonomy support in health national experimentation, brought together 21 partners from Ile-de-France. Among these partners, 14 had practices similar to autonomy support. Partners' presupposition was that experimenting a cooperative approach would encourage the empowerment of participants, improve their autonomy support and put into place the conditions necessary for the empowerment of people who would be supported. To help participants to meet this goal, the project leader took on a role as third party whose function was to facilitate the cooperative approach by proposing a framework and a method. Purpose of research: The study aimed to report the effects of this approach on the participants' practices as well as to identify the process for achieving this. Results: The participants' learning enabled them to align themselves with the good practice guidelines collectively constructed within the project. With the project leader's support, they initiated a transformative learning process that allowed them to develop their reflexivity and empowerment. These transformations had repercussions on their teams and structures, through a halo effect. The halo effect varied, in each partner structure, according to the participation and involvement of the project referent and the other members of the structure, in particular managers. Conclusions: This study has highlighted the value of a cooperative approach to facilitate the learning necessary for sustainable practices transformations and the improvement partners autonomy supports. This resulted in gains in autonomy for the autonomy support practitioners and the people they supported.

Introduction: Le projet ACESO, participant à l'expérimentation nationale des dispositifs d'accompagnement à l'autonomie en santé (AAS), a rassemblé 21 partenaires franciliens parmi lesquels 14 portaient des pratiques qui empruntent à l'accompagnement. Son présupposé était qu'en expérimentant une démarche coopérative favorisant l'empowerment des partenaires, ceux-ci amélioreraient leurs pratiques d'accompagnement et mettraient notamment en place les conditions nécessaires à l'empowerment des personnes accompagnées. Pour les y aider, le porteur de projet a tenu un rôle de tiers dont la fonction était de faciliter la démarche coopérative en proposant un cadre et une méthode. But de l'étude: L'étude visait à rendre compte des effets de cette démarche sur les pratiques des partenaires, ainsi qu'à identifier le processus pour y parvenir. Résultats: Les apprentissages réalisés ont permis aux partenaires de se donner des balises de bonnes pratiques construites collectivement au sein du projet (valeurs, principes et postures). Avec le soutien du tiers, ils ont initié un processus d'apprentissage transformationnel développant leur réflexivité et leur empowerment. Ces transformations ont eu des répercussions sur leurs équipes et structures, par effet de halo. Ce dernier a varié, dans chaque structure partenaire, en fonction de la participation et de l'implication du référent-projet et des membres de la structure, en particulier la direction. Conclusion: Cette étude met en évidence l'intérêt d'une démarche coopérative pour faciliter l'apprentissage nécessaire aux transformations durables des pratiques et l'amélioration des pratiques de partenaires d'un collectif apprenant. Dans le cas de l'AAS, ceci s'est traduit par des gains d'autonomie pour les accompagnants et les personnes accompagnées.

Spatial determinants of excess all-cause mortality during the first wave of the COVID-19 epidemic in France.

BACKGROUND: The first wave of the COVID-19 pandemic in France was associated with high excess mortality, and anecdotal evidence pointed to differing excess mortality patterns depending on social and environmental determinants. In this study we aimed to investigate the spatial distribution of excess mortality during the first wave of the COVID-19 pandemic in France and relate it at the subnational level to contextual determinants from various dimensions (socioeconomic, population density, overall health status, healthcare access etc.). We also explored whether the determinants identified at the national level varied depending on geographical location. METHODS: We used available national data on deaths in France to calculate excess mortality by department for three age groups: 0-49, 50-74 and > 74 yrs. between March 1st and April 27th, 2020. We selected 15 variables at the department level that represent four dimensions that may be related to overall mortality at the ecological level, two representing population-level vulnerabilities (morbidity, social deprivation) and two representing environmental-level vulnerabilities (primary healthcare supply, urbanization). We modelled excess mortality by age group for our contextual variables at the department level. We conducted both a global (i.e., country-wide) analysis and a multiscale geographically weighted regression (MGWR) model to account for the spatial variations in excess mortality. RESULTS: In both age groups, excess all-cause mortality was significantly higher in departments where urbanization was higher (50-74 yrs.: ß = 15.33, p < 0.001; > 74 yrs.: ß = 18.24, p < 0.001) and the supply of primary healthcare providers lower (50-74 yrs.: ß = - 8.10, p < 0.001; > 74 yrs.: ß = - 8.27, p < 0.001). In the 50-74 yrs. age group, excess mortality was negatively associated with the supply of pharmacists (ß = - 3.70, p < 0.02) and positively associated with work-related mobility (ß = 4.62, p < 0.003); in the > 74 yrs. age group our measures of deprivation (ß = 15.46, p < 0.05) and morbidity (ß = 0.79, p < 0.008) were associated with excess mortality. Associations between excess mortality and contextual variables varied significantly across departments for both age groups. CONCLUSIONS: Public health strategies aiming at mitigating the effects of future epidemics should consider all dimensions involved to develop efficient and locally tailored policies within the context of an evolving, socially and spatially complex situation.

L'évaluation des projets d'accompagnement à l'autonomie en santé : pourquoi privilégier une approche pragmatiste ?

INTRODUCTION: In connection with article 92 of the last Health Act, twenty-eight projects are being tested nationwide with a view to demonstrate the value of support to gain autonomy in health. These projects will be assessed on a case-by-case basis according to their specific situations. However, with the possible generalization of this type of programs, it was also necessary to assess them against the same frame of reference. METHOD: To this end, a participatory approach was conducted with their coordinators to identify a single evaluation framework, even though these projects were very heterogeneous. RESULTS: This development process led to the identification of a common intervention logic that made it possible, in the aftermath, to define support for autonomy in health, i.e. to set out the conditions under which a health intervention may be used. A pragmatic vision guided the production of the evaluation framework which articulates four dimensions (individual empowerment, enabling environment, collective empowerment, organizational empowerment) composed of 21 criteria and presented as inseparable. DISCUSSION: According to this logic, the process of empowering individuals, as an objective of interventions, cannot be pursued if it is not embedded in practices that are consistent with the values inherent to the original intention. This also calls for the effects of the empowerment of supported persons to be granted as much importance as the processes of the interventions and the learning processes of individuals and organizations.

Fruits and vegetables at home (FLAM): a randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France.

BACKGROUND: Fruits and Vegetables (FV) consumption is considered a marker of social inequalities in health since it is considerably decreased in disadvantaged populations. The main objective of this trial was to evaluate the impact of vouchers for FV purchase on the consumption of FV among children living in disadvantaged families in a French urban district. METHODS: The FLAM study was a controlled randomized intervention trial, performed in Saint-Denis (North suburbs of Paris). The study group (intervention or control) was randomly attributed to parent-child pairs at inclusion. The intervention group received vouchers exchangeable for FV over a 1 year period. Nutritional education through workshops was available for both groups. FV consumption was assessed through face-to-face food frequency questionnaires. Participants who reported eating less than 3.5 FV per day were considered low FV consumers. RESULTS: A total of 92 parent-child pairs were included, in which 45 were allocated to the intervention group and 47 to the control group. Amongst them, 64 completed the final follow-up questionnaire (30% lost to follow-up). After one year, the proportion of low FV consumers in children was significantly lower in the intervention group (29.4%) compared to the control group (66.7%, p = 0.005). Overall, 82% of the vouchers were used by the families. CONCLUSIONS: This study found a decreased proportion of small consumers in children after 1 year of distribution of FV vouchers compared to the control group. FV vouchers could be an effective lever to increase FV consumption among children from disadvantaged households. TRIAL REGISTRATION: ClinicalTrials.gov identifier no. NCT02461238 .

[Methodological approaches to the evaluation of Local Health Contracts and their capacity to reduce social inequalities in health]. / Repères méthodologiques pour l'évaluation des Contrats Locaux de Santé et de leur capacité à réduire les inégalités sociales de santé.

INTRODUCTION: Local health contracts are a promising tool to reduce social and geographical inequalities in health. They are optimally effective when they are designed to mobilize the resources of various sectors to target the essential, upstream determinants of inequalities. METHODS: We propose a checklist of their capacities to achieve this goal, comprising two parts. RESULTS: the targets and objectives of each action (what needs to be changed to achieve what long-term results?); and the strategies and modalities of intervention to address the issue of how to act. An example of application to a sample of first-generation contracts in the Ile-de-France region is presented, showing the importance attributed to the health system rather than to the inhabitants' living conditions. DISCUSSION: The authors discuss the limits of a working tool that does not address either the conditions of implementing actions according to territories or regional governance.

[How do general practitioners promote a more equitable access for patient education?]. / Comment les médecins généralistes favorisent-ils l'équité d'accès à l'éducation thérapeutique pour leurs patients.

Our research is designed to understand how and under what conditions general practitioners contribute to equitable access to patient education (PE).We conducted a survey based on interactionist sociology in a sample of 32 doctors. These practitioners worked in the context of health networks and health care centres and were also involved in the PE resource centre for the Île-de-France region, thereby providing a favourable setting for our study, also reflected by the fact that one-half of practitioners were aware of the importance of or had been trained in PE.Doctors stress that their engagement in the patient-doctor relationship does not depend on the patient's psycho-social characteristics. Their educational practice nevertheless appears to be influenced by their a priori judgement of these characteristics. Based on their judgement, some clinicians develop practices that seem to promote better access for their socially underprivileged patients. This process is facilitated by several dynamics described in this article.The results of this research open up opportunities for office-based physicians and PE development structures to facilitate better access to PE for all patients.

[Health literacy and patient education interventions: a review]. / Interventions en littératie en santé et éducation thérapeutique : une revue de la littérature.

INTRODUCTION: Low health literacy (HL) is an obstacle to therapeutic patient education (TPE), especially for people in a vulnerable situation, who are also at greater risk of chronic illnesses and their complications. It therefore seems essential to rethink TPE programmes in order to ensure greater equity based on analysis of the characteristics of HL interventions and their possible relationships with TPE. METHODS: A scoping review of the literature was performed from November 2014 to January 2016 using the following search engines: MEDLINE/PubMed, EMBASE, PsycINFO, ERIC, OpenGrey, SUDOC, thèses.fr and BDSP and the following search terms: ?health literacy?, ?Littératie en santé?, ?literacy?, ?Littératie?, ?numeracy?, ?numératie?, ?compétence en santé? combined with the keywords: ?programme?, ?program?, ?intervention?, ?méthode?, ?method?, ?technique?, ?outil?, ?tool?. RESULTS: After selecting forty out of 206 studies, interventions were classified into two main types of specific interventions to promote comprehension of resources intended for patients and generally complex interventions designed to support and improve HL skills. DISCUSSION: While the level of health literacy has an impact on TPE programme accessibility, TPE programmes need to be made more accessible and TPE must constitute an opportunity to address health literacy needs via its own specific modalities. Creating partnerships between social/educational and health settings might be an effective strategy to strengthen the interrelationships between HL and TPE, as might training that prepares caregivers-educators to improve patient HL. CONCLUSION: Interrelationships between HL and TPE are possible. Research should question the pedagogical modalities to be used to adapt TPE programs to the HL.

Are disparities of waiting times for breast cancer care related to socio-economic factors? A regional population-based study (France).

The increasing number of breast cancer cases may induce longer waiting times (WT), which can be a source of anxiety for patients and may play a role in survival. The aim of this study was to examine the factors, in particular socio-economic factors, related to treatment delays. Using French Cancer Registry databases and self-administered questionnaires, we included 1,152 women with invasive non-metastatic breast cancer diagnosed in 2007. Poisson regression analysis was used to identify WTs' influencing factors. For 973 women who had a malignant tissue sampling, the median of overall WT between the first imaging procedure and the first treatment was 44 days (9 days for pathological diagnostic WT and 31 days for treatment WT). The medical factors mostly explained inequalities in WTs. Socio-economic and behavioral factors had a limited impact on WTs except for social support which appeared to be a key point. Better identifying the factors associated with increase in WTs will make it possible to develop further interventional or prospective studies to confirm their causal role in delay and at last reduce disparities in breast cancer management.

Promoting physical activity in a low-income neighborhood of the Paris suburb of Saint-Denis: effects of a community-based intervention to increase physical activity.

BACKGROUND: Physical activity (PA) is a key factor for facing the increasing prevalence of obesity and overweight, and should be part of every public health programs. In this context, a community-based public health program promoting PA was developed in a low-income neighborhood of the city of Saint-Denis (France). METHODS: This work aimed at assessing the effectiveness of a 2-year PA promotion program. A quasi-experimental study was carried out using a pre/post design, with an assessment before (2013) and after (2015) the program. The interviewees were selected using a stratified random cluster sampling. The primary outcome was the proportion of participants practicing sufficient PA (WHO guidelines), and was measured using the RPAQ questionnaire. External interventions (on both neighborhood environment and inhabitants) were listed. RESULTS: We collected 199 questionnaires at baseline and 217 in 2015. There was a majority of women in both samples: 64.3 % in 2013 and 58.2 % in 2015. The average age of participants was 38.1 years (+/-1.1) and 40.6 (+/-1.1) respectively. The proportion of people practicing sufficient PA was modified from 48.1 % in 2013 to 63.5 % in 2015 (p = 0.001). This was mainly driven by women whose level of PA, increased from 40.3 % to 60.3 % (p = 0.002), reaching the average national French estimation of PA level among adults (63.5 %). CONCLUSIONS: This work showed a significant increase of the proportion of people practicing PA in a disadvantaged neighborhood where a community-based program promoting PA was developed. Simultaneous external interventions contributed to the results, showing the necessity of synergic interventions to reach efficiency.

[Oral health status, supply of oral and dental care among Senegalese children: a review of available data]. / État de santé, offre et recours aux soins bucco-dentaires chez les enfants sénégalais?: synthèse des données disponibles.

INTRODUCTION: Oral and dental diseases are a major public health problem due to their high prevalence and their impact on general health. OBJECTIVE: This article reviews the oral health status and oral health care supply and uptake in children. METHOD: The available literature were reviewed. The Medline and Embase databases, and the Senegal Ministry of Health and Social Action and National Agency of Statistics and Demography (ANSD) websites were consulted. A total of 7 articles, 3 PhD theses and 8 reports were selected for analysis. The review was supplemented by interviews. RESULTS: Overall, children have poor oral health status. Health care supply is insufficient (1 dentist/38,000 residents) and poorly distributed (mostly in the capital) with unequal oral health care uptake. CONCLUSION: This systematic review of the literature revealed a lack of reliable data on the oral health of children. It also concluded on a generally poor oral health status.

[Overview of French public policies promoting health-enhancing physical activity]. / Panorama des politiques publiques françaises de promotion de l'activité physique bénéfique pour la santé.

Although multiple strategies are used to promote physical activity, they do not cover all sectors. This configuration also raises the question of the harmonization of these national public policies and the existence of intersectoral coordination mechanisms. .

[Analysis of hospital outpatient care of a rare disease: cystic fibrosis]. / Analyse de la prise en charge hospitalière ambulatoire de la mucoviscidose.

INTRODUCTION: Following the generalization of neonatal screening, the French CF Care Network has become structured around 45 qualified centres, the French CF Society, 2 national expertise centres, the Patient Registry and the National Protocol of CF Care in collaboration with the Vaincre Ia Mucoviscidose patient association. This organization and progress in treatment have resulted in the outpatient follow-up of a growing number of patients. Since 2010, the CF Network representatives have been conducting an assessment of outpatient follow-up to identify difficulties in complying with national and international clinical practice guidelines. METHODS: Two complementary quantitative and qualitative approaches were used to characterize and quantify the activities carried out by professionals in 8 centres both for outpatient visits and patient care coordination. RESULTS: Two thirds of the 1,4 75 patients followed in the centres were managed over the period, less than half (40%) of them attended outpatient visits, but all of them were concerned by care coordination activities, whether or not they were related to the visit. The core team (doctor, nurse, physio-therapist) is not mobilized at each scheduled outpatient visit as recommended. Professionals devote 40% less time for follow-up in adult centres than in paediatric centres, all activities included. The multidisciplinary outpatient visit process is complicated by the lack of available resources and the unsuitability of certain premises. DISCUSSION: With a constantly growing number of patients, CF centres are struggling to comply with good clinical practice and meet the specific needs of adult patients and transplant recipients. An upgrade of professional resources and an update of the National Protocol appear to be necessary.

Do gender differences affect the doctor-patient interaction during consultations in general practice? Results from the INTERMEDE study.

OBJECTIVE: The aim of the study was to ascertain whether disagreement between GPs and patients on advice given on nutrition, exercise and weight loss is related to patient-doctor gender discordance. Our hypothesis is that a patient interacting with a physician of the same gender may perceive more social proximity, notably on health care beliefs and may be more inclined to trust them. METHODS: The analysis used the Intermede project's quantitative data collected via mirrored questionnaires at the end of the consultation. Multilevel logistic regressions were carried out to explore associations between patient-doctor gender discordance and their disagreement on advice given during the consultation adjusted on patients' and physicians' characteristics. The sample consists of 585 eligible patients and 27 GPs. RESULTS: Disagreement on advice given on nutrition was observed less often for female concordant dyads: OR = 0.25 (95% CI = 0.08-0.78), and for female doctors-male patients dyads: OR = 0.24 (95% CI = 0.07-0.84), taking the male concordant dyads as reference. For advice given on exercise, disagreement was found less often for female concordant dyads OR = 0.38 (95% CI = 0.15-0.98) and an interdoctor effect was found (P < 0.05). For advice given on weight loss, the probability of disagreement was significantly increased (OR: 2.87 95% CI = 1.29-6.41) when consultations consisted of female patient and male GP. CONCLUSION: Patient-doctor gender concordance/discordance is associated with their agreement/disagreement on advice given during the consultation. Physicians need to be conscious that their own demographic characteristics and perceptions might influence the quality of prevention counseling delivered to their patients.

[Reviewing the shared strategy health bill: further measures to meet the structural challenges of the health system]. / Orientations du projet de loi de santé : aller plus loin pour «?répondre aux défis structurels du système de santé?¼

This article reviews the draft health bill entitled "Federate health professionals around a shared strategy", currently submitted for consultation in the context of the national health strategy in France. This bill comprises innovative measures for prevention and health care in France. In particular, it is designed to develop, strengthen and structure the prevention sector, especially in children and young people. It is also designed to organize health care trajectories and acquire the necessary tools to promote their development. However, the bill sometimes presents limited ambitions in terms of objectives and means. In particular, the project comprises almost none of the necessary actions on the social determinants of health. Overall, the orientations of this bill represent a first major step towards a health policy in France beyond the field of health care. However, we must remain vigilant concerning application of these orientations in the process of elaboration of the bill and its related regulations, and implementation of the national health strategy.

A recall program for the outcome of conventional root canal treatment performed in a teaching hospital.

OBJECTIVES: This study investigated the long-term survival and the prognostic factors of endodontic treatments performed in a dental teaching hospital. The aim was to calculate the probabilities of success or failure according to the follow-up extent and to assess the time allowed for a complete periapical healing. MATERIALS AND METHODS: A cohort of 185 teeth were re-examined 1-4 years after treatment. The outcome was assessed on the basis of radiographic and clinical criteria as success, uncertain or failure. A survival analysis using the Cox model was used (i) to explore tooth survival and periapical healing over the time and (ii) to highlight the predictive factors of treatment outcome. RESULTS: After 2 years, the appearance of an apical periodontitis remained lower than 3.5%, whereas only 22.8% of periapical healed cases were notified. The prognosis factors are: (i) for teeth with initial healthy periapical conditions, coronal leakage (p = 0.002) with the higher risk of failure (RR = 19.77), absence of correspondence filling length/shaping = 0.026), type of teeth (p = 0.041) and (ii) for teeth with apical periodontitis, number of root canals (p = 0.000,91), correspondence filling length/shaping length (p = 0.017) and over-filling (p = 0.09). New periapical lesions or tooth loss were recorded after 2 years. Half of the successful cases of periapical healing were observed during the follow-up from 2-4 years. CONCLUSIONS: This longitudinal study shows that coronal leakage is responsible for late failure and that periapical healing is long to achieve. Therefore, endodontic treatments may require a follow-up of over 2 years.

Determinants of maternal and household social inequalities of dental caries among Senegalese children in the Department of Pikine.

Introduction: the problematic of social Inequalities in oral health remains a global concern; it constitutes evidence of social injustice. The present work aims to study the determinants of maternal and household social inequalities of children´s dental caries in Pikine. Methods: cross-sectional epidemiological survey has been conducted in the department of Pikine, Senegal on 315 children aged 3 to 9 and their mothers. The clinical data on children´s caries have been obtained by clinical examination and the socio-economic data by a questionnaire submitted to mothers. Pearson chi-square and trend tests as well as a logistic model were used in the data analysis. Results: the prevalence of dental caries in children was 64.8% and the mixed decayed, filled, missing (DFM) index was 2.5 (±2.7). The trend test showed significant inequalities in the prevalence of dental caries according to level of studies (p<0.001), profession (p<0.010) and contacts frequency (p<0.001) of mothers; the level of wealth (p<0.001) and structure (p<0.005) of households. According to the logistic regression model, the level of secondary or university education [OR (IC 95%) = 0.59 (0.33'>OR (IC 95%) = 0.59 (0.33-0.93)] or social network dynamism [OR (IC 95%) = 0.32(0.15'>OR (IC 95%) = 0.32(0.15-0.67)] of mothers; as well as wealthy families [OR (IC 95%) = 0.23(0.08'>OR (IC 95%) = 0.23(0.08-0.64) were associated to fewer risks of dental caries among children. Conclusion: some socio-economic characteristics of the mother and the household social conditions are identified as determinants of dental caries social inequalities in Children. Proportionate universalism may be a good approach to reduce this problematic in Pikine.

[Healthy volunteers' protection around the world]. / VolREthics - Une initiative internationale de l'Inserm pour définir la protection des volontaires sains.

Healthy volunteers participating in biomedical research benefit from varying levels of protection in different parts of the world since they are too rarely identified as a specific subset of study participants with specific vulnerabilities and risks. These differences in protection can lead to unfair and ethically unacceptable situations. Healthy volunteers are subject to a number of risks, not only regarding the respect of their rights and of their health but they are also at risk of being exploited because of their financial situation, educational level and motivations. In the end, the scientific validity of the studies may also be called into question. Through its work, the VolREthics (Volunteers in Research and Ethics) initiative, set up by the Inserm ethics committee, outlines the ethical issues raised by the involvement of healthy volunteers in biomedical research, and highlights the need to improve their protection worldwide. Healthy volunteers are essential to scientific progress and society, and their potential vulnerabilities must be recognized and taken into account.

Title: VolREthics - Une initiative internationale de l'Inserm pour définir la protection des volontaires sains. Abstract: Les volontaires sains qui participent aux recherches biomédicales sont très rarement identifiés comme un groupe spécifique. Pourtant, de par leur vulnérabilité et les risques potentiels auxquels ils sont exposés, ils ne bénéficient que d'un niveau de protection qui reste variable selon les régions du monde. Il en résulte différents risques, non seulement pour le respect de leurs droits, de leur santé, mais également pour la validité scientifique des recherches. L'initiative internationale VolREthics (pour volontaires sains en recherche et éthique, ou Volunteers in Research and Ethics), lancée par le comité d'éthique de l'Inserm, a mis en évidence les questions éthiques soulevées par la participation des volontaires sains dans la recherche biomédicale. Elle insiste également sur la nécessité d'améliorer la protection de ces volontaires lors des recherches menées à travers le monde.

Causes of inappropriate hospital days: development and validation of a French assessment tool for rehabilitation centres.

OBJECTIVE: To develop and validate a list of criteria to assess the causes of inappropriate hospital days for patients admitted to rehabilitation centres and sub-acute care units. DESIGN: The tool was developed by a multidisciplinary panel of 33 experts, using a formalized consensus method. It collects both the needs of patients (distinguishing healthcare needs (9 criteria) and accommodation needs (9 criteria)) and the reasons for inappropriateness (19 criteria). Inappropriate days were identified using the tool to assess appropriateness of hospital days validated previously. Reliability was studied by measuring agreement between two independent simultaneous ratings. SETTING: The validation study was performed on a randomized sample of 576 hospital days from 22 wards in France. MAIN OUTCOME MEASURES: Inter-rater reliability was evaluated using the κ-statistic and prevalence-adjusted and bias-adjusted kappa (PABAK). RESULTS: For patient accommodation needs, the inter-rater reliability was estimated by a κ-value of 0.80 (95% confidence interval (95% CI) 0.66-0.92) and a PABAK of 0.80 (95% CI 0.63-0.91). There was good agreement on the reasons for inappropriateness, with κ-values from 0.30 to 0.60 and PABAK from 0.46 to 0.69. The κ-coefficient varied from 0.33 to 0.49 for the assessment of patient healthcare needs, with PABAK ranging from 0.49 to 0.72. CONCLUSIONS: The instrument is suitable and valid to assess the causes of inappropriate hospital days in rehabilitation centres and sub-acute care units. The study showed that the tool can be easily used by healthcare workers, which makes it useful for quality improvement.