Search

Abstract Background Although moderate physical activity (PA) during cancer treatment has been associated with improved quality of life, reduced side effects, and even lower mortality, many barriers to successful implementation remain. Digital technology has been perceived as an effective lever for overcoming access and motivational issues but few studies have been performed to confirm this assumption. The “VISIO-AJUST” study explored the factors affecting the conditions of adherence to video-conference-based PA programs in patients undergoing cancer treatment. Methods The VISIO-AJUST study was based on a qualitative successive case approach, guided by the principles of the realist evaluation, and applied to two French programs of PA, following three main steps: (1) Identification of factors likely to influence conditions of patients’ adherence; (2) Elaboration and testing of explanatory “Context-Mechanism-Outcome (CMO)” configurations; (3) Refinement of CMO configurations, in order to understand what, how, for whom, and under what circumstances video-conference-based PA programs work. Results Five main CMO configurations were found to be associated with adherence to video-conferencing-based PA programs, promoting (i) accessibility and a supportive environment for adapted physical activity, (ii) a setting conducive to sociability despite distance, (iii) Confidence and security of practice, (iv) a combination of several motivational levers in favor of continuity of effort and progress, (v) regularity of the sessions, progressiveness in the effort and evaluation of progress as a basis for the adoption of a regular physical practice. Conclusion This study provides original insights into the use of videoconferencing to enable patients to improve their PA during cancer treatment. Future research with long-term follow-up would allow for a better understanding of the key conditions promoting sustainable behavior change.

Introduction The prevalence of smoking among pregnant women is the highest in the European region, making smoking cessation a public health priority. In order to address this, pregnant smokers need to be better supported by their healthcare professionals in their attempts to quit smoking. The 5As model, which is a psychosocial intervention, seems to be effective in this specific population. The objective of this review is to identify the factors that act as barriers or facilitators to the implementation of the 5As model within prenatal practices. Methods We conducted a scoping review of the literature on PubMed and Scopus databases, using the terms: ‘smoking cessation’, ‘pregnan*’, and (‘5A’ or ‘5As’). The identified factors were categorized using a theoretical framework of The European Observatory on Health Systems and Policies. Results Among the 43 articles identified in the databases, 13 articles were included in this review. In total, we identified 48 factors. When necessary, we grouped them together, resulting in 12 sub-categories, which in turn were grouped into 9 categories. Those 9 categories were then classified into the 3 levels of the theoretical framework: the clinical level (motivation), the organizational level (healthcare pathway), and the health system level (political environment). Conclusions The factors identified are varied and numerous and are involved in each level of the theoretical framework.

BackgroundMeta-analyses have shown that preexisting mental disorders may increase serious Coronavirus Disease 2019 (COVID-19) outcomes, especially mortality. However, most studies were conducted during the first months of the pandemic, were inconclusive for several categories of mental disorders, and not fully controlled for potential confounders. Our study objectives were to assess independent associations between various categories of mental disorders and COVID-19-related mortality in a nationwide sample of COVID-19 inpatients discharged over 18 months and the potential role of salvage therapy triage to explain these associations.Methods and findingsWe analysed a nationwide retrospective cohort of all adult inpatients discharged with symptomatic COVID-19 between February 24, 2020 and August 28, 2021 in mainland France. The primary exposure was preexisting mental disorders assessed from all discharge information recorded over the last 9 years (dementia, depression, anxiety disorders, schizophrenia, alcohol use disorders, opioid use disorders, Down syndrome, other learning disabilities, and other disorder requiring psychiatric ward admission). The main outcomes were all-cause mortality and access to salvage therapy (intensive-care unit admission or life-saving respiratory support) assessed at 120 days after recorded COVID-19 diagnosis at hospital. Independent associations were analysed in multivariate logistic models. Of 465,750 inpatients with symptomatic COVID-19, 153,870 (33.0%) were recorded with a history of mental disorders. Almost all categories of mental disorders were independently associated with higher mortality risks (except opioid use disorders) and lower salvage therapy rates (except opioid use disorders and Down syndrome). After taking into account the mortality risk predicted at baseline from patient vulnerability (including older age and severe somatic comorbidities), excess mortality risks due to caseload surges in hospitals were +5.0% (95% confidence interval (CI), 4.7 to 5.2) in patients without mental disorders (for a predicted risk of 13.3% [95% CI, 13.2 to 13.4] at baseline) and significantly higher in patients with mental disorders (+9.3% [95% CI, 8.9 to 9.8] for a predicted risk of 21.2% [95% CI, 21.0 to 21.4] at baseline). In contrast, salvage therapy rates during caseload surges in hospitals were significantly higher than expected in patients without mental disorders (+4.2% [95% CI, 3.8 to 4.5]) and lower in patients with mental disorders (-4.1% [95% CI, -4.4; -3.7]) for predicted rates similar at baseline (18.8% [95% CI, 18.7-18.9] and 18.0% [95% CI, 17.9-18.2], respectively). The main limitations of our study point to the assessment of COVID-19-related mortality at 120 days and potential coding bias of medical information recorded in hospital claims data, although the main study findings were consistently reproduced in multiple sensitivity analyses.ConclusionsCOVID-19 patients with mental disorders had lower odds of accessing salvage therapy, suggesting that life-saving measures at French hospitals were disproportionately denied to patients with mental disorders in this exceptional context.

BackgroundA smoking cessation program for adolescents, TABADO, demonstrated its effectiveness following a controlled trial conducted in 2007/2009. The program is now being scaled up nationally. In order to retain its efficacy across the diversity of contexts in the generalization process, we needed to assess the processes and mechanisms that inform its effects. Theory-driven evaluation is one approach used to address these issues. The aim of the present research is to develop the TABADO program theory. More specifically, we attempt to identify the factors and mechanisms that promote or hinder the enrollment and retention of student smokers in the program.MethodsWe conducted a realist evaluation of the TABADO program through 1) a documentary analysis to construct the initial program theory, and 2) a multiple case study (n = 10) conducted in three regions in France to test and enrich the initial theory with contextual, organizational and mechanistic components. We used the Intervention-Context-Actors-Mechanisms-Outcomes configurations to guide our analysis and to present our results.ResultsOur analysis highlighted 13 mechanisms that foster the enrollment and retention of student smokers in the TABADO program (e.g., being prepared to quit smoking, feeling encouraged in the attempt to quit smoking). To activate these mechanisms, the involvement of various actors is required (e.g., the school nurse, teachers), together with a combination of interventional and contextual factors (e.g., confidentiality, informal speaking time).ConclusionsThese findings allowed us to transform the TABADO program into a new optimized strategy, TABADO2, which is theory-based. Our research helps to explain why adolescent smokers enroll and stay in a school-based smoking cessation program. TABADO2 needs to be considered in a more comprehensive way than the original research-based TABADO, and should be tailored to its implementation context.

Objetivo. En el 2010 se propuso el principio del universalismo proporcional como solución para reducir las desigualdades en materia de salud. Aunque tuvo una gran resonancia, no parece haber sido aplicado ampliamente y no existen directrices sobre cómo aplicarlo. Los dos objetivos específicos de esta revisión sistemática exploratoria fueron: 1) describir el contexto teórico en el que se estableció el universalismo proporcional, y 2) describir cómo los investigadores aplican el universalismo proporcional y las cuestiones metodológicas relacionadas. Métodos. Se buscó en todas las bases de datos de la Web of Science los artículos publicados hasta el 6 de febrero del 2020 que tuvieran como tema universalismo proporcional o sus sinónimos universalismo dirigido o universalismo progresivo. Resultados. Esta revisión de 55 artículos permitió obtener una visión global del universalismo proporcional en cuanto a sus fundamentos teóricos y su aplicación práctica. El principio del universalismo proporcional se basa en las teorías sociales del universalismo y el direccionamiento, y propone vincular estos dos aspectos para lograr una reducción efectiva de las desigualdades en materia de salud. Respecto de su aplicación práctica, las intervenciones basadas en este principio son poco frecuentes y dan lugar a diferentes interpretaciones. Todavía existen muchos desafíos metodológicos y éticos en relación con la concepción y evaluación de las intervenciones relacionadas con el universalismo proporcional, incluida la forma de aplicar la proporcionalidad y la identificación de las necesidades. Conclusión. En esta revisión se llevó a cabo un mapeo de la literatura científica disponible sobre el universalismo proporcional y sus conceptos relacionados. Este principio se basa en teorías sociales. Tal como lo destacaron autores que implementaron intervenciones de universalismo proporcional, su aplicación plantea muchos desafíos, desde el diseño hasta la evaluación. El análisis de las aplicaciones del universalismo proporcional presentado en esta revisión respondió a algunos de ellos, pero los desafíos metodológicos restantes requieren ser abordados en futuras investigaciones.

Abstract Given their inherent complexity, we need a better understanding of what is happening inside the “black box” of population health interventions. The theory-driven intervention/evaluation paradigm is one approach to addressing this question. However, barriers related to semantic or practical issues stand in the way of its complete integration into evaluation designs. In this paper, we attempt to clarify how various theories, models and frameworks can contribute to developing a context-dependent theory, helping us to understand the black box of population health interventions and to acknowledge their complexity. To achieve this goal, we clarify what could be referred to as “theory” in the theory-driven evaluation of the interventional system, distinguishing it from other models, frameworks and classical theories. In order to evaluate the interventional system with a theory-driven paradigm, we put forward the concept of interventional system theory (ISyT), which combines a causal theory and an action model. We suggest that an ISyT could guide evaluation processes, whatever evaluation design is applied, and illustrate this alternative method through different examples of studies. We believe that such a clarification can help to promote the use of theories in complex intervention evaluations, and to identify ways of considering the transferability and scalability of interventions.

Abstract Background To reduce social inequities in health, the World Health Organization’s Commission on Social Determinants of Health recommends acting as soon as life begins. In this context, parenting support is promoted as a major lever. The objective of the present research was to develop an intervention theory establishing the conditions for the success of interventions, policies, and organizations supporting parenting in terms of reducing or preventing social inequalities in health for both mother and child in the perinatal period. Methods To meet these objectives, we conducted a realist evaluation based on a multiple-case study. The study evaluated two border towns in Europe. We collected data from three sources: documentary reviews, focus groups and interviews with professionals, and parental questionnaires. Results The main results concerning the fight against social inequalities in health show a true willingness on the part of those involved to carry out universal actions, coordinated between professionals and institutions, in response to the demands of parents; however, the reality on the ground shows the complexity of their implementation and the multiplicity of results. Our middle-range theory showed that to be effective in tackling social inequalities in health, actions must address structural determinants at the macro-systemic level. However, the field of realist evaluation shows that it is first and foremost the actions focused on individual behavior that are implemented. While there is a general political desire to combat social inequalities in health in early childhood, the results show that the strategies in place are potentially not the most effective. Effective support actions would respond to individual strategies; however, current approaches target parents’ behavior, aiming to empower them but without giving them the means to do so. Conclusions This research constitutes a body of knowledge gathered for reflection and action. In particular, any perinatal policy should clearly state among its objectives the intention to reduce social inequalities in health. The policy should also state that it will be evaluated according to the criteria of proportionate universalism, interprofessional coordination, and actions based on the diversity of parents’ needs.

Burnout is frequent among healthcare workers, and sleep problems are suspected risk factors. The sleep health framework provides a new approach to the promotion of sleep as a health benefit. The aim of this study was to assess good sleep health in a large sample of healthcare workers and to investigate its relationship with the absence of burnout among healthcare workers while considering anxiety and depressive symptoms. A cross-sectional Internet-based survey of French healthcare workers was conducted in summer 2020, at the end of the first COVID-19 lockdown in France (March to May 2020). Sleep health was assessed using the RU-SATED v2.0 scale (RegUlarity, Satisfaction, Alertness, Timing, Efficiency, Duration). Emotional exhaustion was used as a proxy for overall burnout. Of 1069 participating French healthcare workers, 474 (44.3%) reported good sleep health (RU-SATED > 8) and 143 (13.4%) reported emotional exhaustion. Males and nurses had a lower likelihood of emotional exhaustion than females and physicians, respectively. Good sleep health was associated with a 2.5-fold lower likelihood of emotional exhaustion and associations persisted among healthcare workers without significant anxiety and depressive symptoms. Longitudinal studies are needed to explore the preventive role of sleep health promotion in terms of the reduction in burnout risk.

Objective. In 2010, the principle of proportionate universalism (PU) has been proposed as a solution to reduce health inequalities. It had a great resonance but does not seem to have been widely applied and no guidelines exist on how to implement it. The two specific objectives of this scoping review were: (1) to describe the theoretical context in which PU was established, (2) to describe how researchers apply PU and related methodological issues. Methods. We searched for all articles published until 6th of February 2020, mentioning “Proportionate Universalism” or its synonyms “Targeted universalism” OR “Progressive Universalism” as a topic in all Web of Science databases. Results. This review of 55 articles allowed us a global vision around the question of PU regarding its theoretical foundations and practical implementation. PU principle is rooted in the social theories of universalism and targeting. It proposes to link these two aspects in order to achieve an effective reduction of health inequalities. Regarding practical implementation, PU interventions were rare and led to different interpretations. There are still many methodological and ethical challenges regarding conception and evaluation of PU interventions, including how to apply proportionality, and identification of needs. Conclusion. This review mapped available scientific literature on PU and its related concepts. PU principle originates from social theories. As highlighted by authors who implemented PU interventions, application raises many challenges from design to evaluation. Analysis of PU applications provided in this review answered to some of them but remaining methodological challenges could be addressed in further research.

Background: The accuracy of surgical scores in predicting in-hospital mortality for nonsurgically treated patients with infective endocarditis (IE) has not yet been explored. Methods: Patients with definite IE who did not undergo valve surgery were selected from the database of seven French administrative areas (Association pour l'Étude et la Prévention de l'Endocardite Infectieuse [AEPEI] Registry, 2008). The patients were scored using (a) six systems specifically devised to predict in-hospital mortality after surgery for IE, (b) three commonly used risk scores for heart surgery, and (c) a risk score for predicting six-month mortality in IE after either surgery or medical therapy. Calibration (Hosmer–Lemeshow test) and discriminatory power (receiver operating characteristic [ROC] analysis) were assessed for each score. Areas under ROC curves were compared one-to-one (Hanley-McNeil method). Results: A total of 192 patients (mean age, 65.2±15.2 years) were considered for analysis. There were 38 (19.8%) in-hospital deaths. Age >70 years (p=0.001), Staphylococcus aureus as causal agent (p=0.05), and severe sepsis (p=0.027) were independent predictors of in-hospital mortality. Despite many differences in the number and type of variables, all but two of the investigated scores showed good calibration (p>0.66). However, discriminatory power was satisfactory (area under ROC curve >0.70) only for three of the scores specific for IE and two of the scores used to predict mortality after cardiac surgery. Conclusions: Among the 10 surgical scores evaluated in this study, five could be adopted to predict in-hospital mortality even for IE patients receiving medical treatment only.

COVID-19 vaccines are one of the best tools to limit the spread of the virus. However, vaccine hesitancy is increasing worldwide, and France is one of the most hesitant countries. From the beginning of the COVID-19 vaccination campaign, health care workers (HCW) have been prioritized in the vaccination strategy but were also hesitant. This study was conducted to identify and understand the determinants of COVID-19 vaccination intention in the French context, with a view to promoting HCW vaccination. A qualitative study using individual semi-structured interviews of HCWs was carried out at the beginning of the vaccination campaign (January to April 2021) in a French university hospital. Interviews indicated that the vaccination intention of HCWs was influenced by confidence in the proposed vaccines, past experience with vaccines and disease, the opinions and vaccination status of others, and media handling of information related to COVID-19 vaccination. Improving HCW vaccination intention regarding COVID-19 vaccines could be achieved through the dissemination of clear, reassuring, scientific information. Information should be disseminated by HCWs and vaccination experts and adapted to local contexts. To improve the level of confidence and vaccination uptake through a compliance effect, it would be useful to promote positive COVID-19 vaccination experiences and increased rates of immunization.

Summary: Background: Opinion polls on vaccination intentions suggest that COVID-19 vaccine hesitancy is increasing worldwide; however, the usefulness of opinion polls to prepare mass vaccination campaigns for specific new vaccines and to estimate acceptance in a country's population is limited. We therefore aimed to assess the effects of vaccine characteristics, information on herd immunity, and general practitioner (GP) recommendation on vaccine hesitancy in a representative working-age population in France. Methods: In this survey experiment, adults aged 18–64 years residing in France, with no history of SARS-CoV-2 infection, were randomly selected from an online survey research panel in July, 2020, stratified by gender, age, education, household size, and region and area of residence to be representative of the French population. Participants completed an online questionnaire on their background and vaccination behaviour-related variables (including past vaccine compliance, risk factors for severe COVID-19, and COVID-19 perceptions and experience), and were then randomly assigned according to a full factorial design to one of three groups to receive differing information on herd immunity (>50% of adults aged 18–64 years must be immunised [either by vaccination or infection]; >50% of adults must be immunised [either by vaccination or infection]; or no information on herd immunity) and to one of two groups regarding GP recommendation of vaccination (GP recommends vaccination or expresses no opinion). Participants then completed a series of eight discrete choice tasks designed to assess vaccine acceptance or refusal based on hypothetical vaccine characteristics (efficacy [50%, 80%, 90%, or 100%], risk of serious side-effects [1 in 10 000 or 1 in 100 000], location of manufacture [EU, USA, or China], and place of administration [GP practice, local pharmacy, or mass vaccination centre]). Responses were analysed with a two-part model to disentangle outright vaccine refusal (irrespective of vaccine characteristics, defined as opting for no vaccination in all eight tasks) from vaccine hesitancy (acceptance depending on vaccine characteristics). Findings: Survey responses were collected from 1942 working-age adults, of whom 560 (28·8%) opted for no vaccination in all eight tasks (outright vaccine refusal) and 1382 (71·2%) did not. In our model, outright vaccine refusal and vaccine hesitancy were both significantly associated with female gender, age (with an inverted U-shaped relationship), lower educational level, poor compliance with recommended vaccinations in the past, and no report of specified chronic conditions (ie, no hypertension [for vaccine hesitancy] or no chronic conditions other than hypertension [for outright vaccine refusal]). Outright vaccine refusal was also associated with a lower perceived severity of COVID-19, whereas vaccine hesitancy was lower when herd immunity benefits were communicated and in working versus non-working individuals, and those with experience of COVID-19 (had symptoms or knew someone with COVID-19). For a mass vaccination campaign involving mass vaccination centres and communication of herd immunity benefits, our model predicted outright vaccine refusal in 29·4% (95% CI 28·6–30·2) of the French working-age population. Predicted hesitancy was highest for vaccines manufactured in China with 50% efficacy and a 1 in 10 000 risk of serious side-effects (vaccine acceptance 27·4% [26·8–28·0]), and lowest for a vaccine manufactured in the EU with 90% efficacy and a 1 in 100 000 risk of serious side-effects (vaccine acceptance 61·3% [60·5–62·1]). Interpretation: COVID-19 vaccine acceptance depends on the characteristics of new vaccines and the national vaccination strategy, among various other factors, in the working-age population in France. Funding: French Public Health Agency (Santé Publique France).

Abstract Background An international workshop on population health intervention research (PHIR) was organized to foster exchanges between experts from different disciplines and different fields. This paper aims to summarize the discussions around some of the issues addressed: (1) the place of theories in PHIR, (2) why theories can be useful, and (3) how to choose and use the most relevant of them in evaluating PHIR. Methods The workshop included formal presentations by participants and moderated discussions. An oral synthesis was produced by a rapporteur to validate, through an expert consensus, the key points of the discussion and the recommendations. All discussions were recorded and have been fully transcribed. Results The following recommendations were generated through a consensus in the workshop discussions: (i) The evaluation of interventions, like their development, could be improved through better use of theory. (ii) The referenced theory and framework must be clarified. (iii) An intervention theory should be developed by a partnership of researchers and practitioners. (iv) More use of social theory is recommended. (v) Frameworks and a common language are helpful in selecting and communicating a theory. (vi) Better reporting of interventions and theories is needed. Conclusion Theory-driven interventions and evaluations are key in PHIR as they facilitate the understanding of mechanisms of change. There are many challenges in developing the most appropriate theories for interventions and evaluations. With the wealth of information now being generated, this subject is of increasing importance at many levels, including for public health policy. It is, therefore, timely to consider how to build on the experiences of many different disciplines to enable the development of better theories and facilitate evidence-based decisions.

Abstract Background An international workshop on population health intervention research (PHIR) was organized to foster exchanges between experts from different disciplines and different fields. Aims This paper aims to summarize the discussions around one of the issues addressed: the place or role of pilot studies in PHIR. Pilot studies are well-established in biomedical research, but the situation is more ambiguous for PHIR, in which a pilot study could refer to different purposes. Methods The workshop included formal presentations of participants and moderated discussions. An oral synthesis was carried out by a rapporteur to validate by expert consensus the key points of the discussion and the recommendations. All discussions have been recorded and fully transcribed. Discussion PHIR generally addresses complex interventions. Thus, numerous tasks may be required to inform the intervention and test different aspects of its design and implementation. While in clinical research the pilot study mainly concerns the preparation of the trial, in PHIR the pilot study focuses on the preparation of both the intervention and the trial. In particular, pilot studies in PHIR could be used for viability evaluation and theory development. Recommendations from the workshop participants The following recommendations were generated by consensus from the workshop discussions: i) terms need to be clarified for PHIR; ii) reporting and publication should be standardized and transparency should be promoted; iii) the objectives and research questions should drive the methods used and be clearly stated; iv) a pilot study is generally needed for complex intervention evaluation and for research-designed programs; and v) for field-designed programs, it is important to integrate evaluability assessments as pilot studies . Conclusion Pilot studies play an important role in intervention development and evaluation. In particular, they contribute to a better understanding of the mechanisms of intervention and the conditions of its applicability and transferability. Pilot studies could therefore facilitate evidence-based decisions about design and conduct of main studies aimed to generate evidence to inform public health policy.

Abstract Background Evaluation of complex interventions (CI) is challenging for health researchers and requires innovative approaches. The objective of this work is to present the main methods used to evaluate CI. Methods A systematic review of the scientific literature was conducted to identify methods used for the evaluation of CI. We searched MEDLINE via PubMed databases for articles including an evaluation or a pilot study of a complex intervention, published in a ten-year period. Key-words of this research were (“complex intervention*” AND “evaluation”). Results Among 445 identified articles, 100 research results or protocols were included. Among them, 5 presented 2 different types of design in the same publication, thus our work included 105 designs. Individual randomized controlled trials (IRCT) represented 21.9% (n = 23) of evaluation designs, randomized clinical trials adaptations 44.8% (n = 47), quasi -experimental designs and cohort study 19.0% (n = 20), realist evaluation 6.7% (n = 7) and other cases studies and other approaches 8.6% (n = 9). A process/mechanisms analysis was included in 80% (n = 84) of these designs. Conclusion A range of methods can be used successively or combined at various steps of the evaluation approach. A framework is proposed to situate each of the designs with respect to evaluation questions. The growing interest of researchers in alternative methods and the development of their use must be accompanied by conceptual and methodological research in order to more clearly define their principles of use.

Abstract Background Population health intervention research raises major conceptual and methodological issues. These require us to clarify what an intervention is and how best to address it. This paper aims to clarify the concepts of intervention and context and to propose a way to consider their interactions in evaluation studies, especially by addressing the mechanisms and using the theory-driven evaluation methodology. Main text This article synthesizes the notions of intervention and context. It suggests that we consider an “interventional system”, defined as a set of interrelated human and non-human contextual agents within spatial and temporal boundaries generating mechanistic configurations – mechanisms – which are prerequisites for change in health. The evaluation focal point is no longer the interventional ingredients taken separately from the context, but rather mechanisms that punctuate the process of change. It encourages a move towards theorization in evaluation designs, in order to analyze the interventional system more effectively. More particularly, it promotes theory-driven evaluation, either alone or combined with experimental designs. Conclusion Considering the intervention system, hybridizing paradigms in a process of theorization within evaluation designs, including different scientific disciplines, practitioners and intervention beneficiaries, may allow researchers a better understanding of what is being investigated and enable them to design the most appropriate methods and modalities for characterizing the interventional system. Evaluation methodologies should therefore be repositioned in relation to one another with regard to a new definition of “evidence”, repositioning practitioners’ expertise, qualitative paradigms and experimental questions in order to address the intervention system more profoundly.

This article describes supplementary tables and figures associated with the research paper entitled “Impact of referral bias on prognostic studies outcomes: insights from a population-based cohort study on infective endocarditis”. The aforementioned paper is a secondary analysis of data from the EI 2008 cohort on infective endocarditis and aimed at characterising referral bias. A total of 497 patients diagnosed with definite infective endocarditis between January 1st and December 31st 2008 were included in EI 2008. Data were collected from hospital medical records by trained clinical research assistants. Patients were divided into three groups: admitted to a tertiary hospital (group T), admitted to a non-tertiary hospital and referred secondarily to a tertiary hospital (group NTT) or admitted to a non-tertiary hospital and not referred (group NT). The pooled (NTT+T) group mimicked studies recruiting patients in tertiary hospitals only. Two different starting points were considered for follow up: date of first hospital admission and date of first admission to a tertiary hospital if any (hereinafter referred to as “referral time”). Referral bias is a type of selection bias which can occur due to recruitment of patients in tertiary hospitals only (excluding those who are admitted to non-tertiary hospitals and not referred to tertiary hospitals). This bias may impact the description of patients’ characteristics, survival estimates as well as prognostic factors identification. The six tables presented in this paper illustrate how patients’ selection (population-based sample [pooled (NT+NTT+T) group] versus recruitment in tertiary hospitals only [pooled (NTT+T) group]) might impact Hazards Ratios values for prognostic factors. Crude and adjusted Cox regression analyses were first performed to identify prognostic factors associated with 3-month and 1-year mortality in the whole sample using inclusion as the starting point. Analyses were then performed in the pooled (NTT+T) group first using inclusion as the starting point and finally using referral time as the starting point. Figures 1 to 3 illustrate how HR increase with time for covariates that were considered as time-varying covariates (covariate*time interaction).

Introduction Adolescence is a sensitive life stage during which tobacco, alcohol and cannabis are used as ways to learn and adopt roles. There is a great deal of interest in substance use (SU) prevention programmes for young people that work to change representations of these products and help with mobilisation of life skills. Unfortunately, few existing programmes are evidence-based.In France, a programme called Expériences Animées (EA, Animated Experiences) has been developed, inspired by life skills development programmes that have been proven to be successful. The EA programme uses animated short movies and talks with high school and secondary school pupils about the use of psychoactive substances and addictions. By allowing life skills mobilisation and modifying representations and beliefs about SU, it is aimed at delaying initiation of use of psychoactive substances, preventing adolescents from becoming regular consumers, reducing the risks and harms related to the use of these substances and opening the way for adapted support measures.We are interested in understanding how, under what circumstances, through which mechanisms and among which adolescents the EA programme works. Therefore, we have developed the ERIEAS study (‘Evaluation Réaliste de l’Intervention Expériences Animées en milieu Scolaire’; Realist Evaluation of the EA Intervention in Schools).Methods and analysis EA will be conducted in 10 schools. A multi-case approach will be adopted with the aim of developing and adjusting an intervention theory. The study comes under the theory-driven evaluation framework. The investigation methodology will include four stages: (i) elaboration of a middle-range theory; (ii) data collection for validating/adjusting the theory; (iii) data analysis; and (iv) refinement and adjustment of the middle-range theory and definition of the programme’s key functions.Ethics and dissemination The study will provide evidence-based results to health authorities to help in the rollout of health promotion strategies in schools. It will provide knowledge about the strategic configurations most suitable for leading to life skills mobilisation and change young people’s representations about SU. The project will be carried out with full respect of current relevant legislation (eg, the Charter of Fundamental Rights of the European Union) and international conventions (eg, Helsinki Declaration). It follows the relevant French legislation of the research category on interventional research protocol involving the human person. The protocol was approved by the Comité et Protection des Personnes (CPP), that is, Committee for the Protection of Persons CPP SUD-EST VI n°: AU 1525 and was reported to the Agence Française de Sécurité Sanitaire des Produits de Santé (ANSM) that is, the French National Agency for the Safety of Health Products. It is in conformity with reference methodology MR003 of Bordeaux University Hospital (CNIL n° 2 026 779 v0).Trial registration detailsThis research has been registered on ClinicalTrials.gov (No. NCT04110626).The research project is registered in the European database ID-RCB (No. 2019-A01003-54).

Abstract Background In 2009, the World Health Organization’s Commission on Social Determinants of Health set out its recommendations for action, which included establishing equity from early childhood onwards by enabling all children and their mothers to benefit from a comprehensive package of quality programmes. In order to address social inequalities in health, it is recommended that action be taken from early childhood, and actions providing support for parenting are an effective lever in this respect. The aim of this review of systematic reviews is to analyse, on the one hand, the components and characteristics of effective interventions in parenting support and, on the other, the extent to which the reviews took into account social inequalities in health. Methods A total of 796 reviews were selected from peer-reviewed journals published between 2009 and 2016 in French or English. Of these, 21 reviews responding to the AMSTAR and selected ROBIS criteria were retained. These were analysed in relation to the consideration they gave to social inequalities in health according to PRISMA-equity. Results The reviews confirmed that parenting support programmes improved infants’ sleep, increased mothers’ self-esteem and reduced mothers’ anger, anxiety and stress levels. The mainly authors noted that the contexts in which the interventions had taken place were described either scantly or not at all, making it difficult to evaluate them. Only half of the reviews had addressed the question of social inequalities in health. In particular, there had been little research conducted on the relational aspect and the social link. Conclusion In terms of addressing social inequalities in perinatal health, the approach remains both modest and reductive. Understanding how, for whom and in what conditions interventions operate is one way of optimising their results. Further research is needed to study the interactions between the interventions and their contexts.

It can be assumed that higher SARS-CoV-2 infection risk is associated with higher COVID-19 vaccination intentions, although evidence is scarce. In this large and representative survey of 6007 adults aged 18–64 years and residing in France, 8.1% (95% CI, 7.5–8.8) reported a prior SARS-CoV-2 infection in December 2020, with regional variations according to an East–West gradient (p < 0.0001). In participants without prior SARS-CoV-2 infection, COVID-19 vaccine hesitancy was substantial, including 41.3% (95% CI, 39.8–42.8) outright refusal of COVID-19 vaccination. Taking into account five characteristics of the first approved vaccines (efficacy, duration of immunity, safety, country of the vaccine manufacturer, and place of administration) as well as the initial setting of the mass vaccination campaign in France, COVID-19 vaccine acceptance would reach 43.6% (95% CI, 43.0–44.1) at best among working-age adults without prior SARS-CoV-2 infection. COVID-19 vaccine acceptance was primarily driven by vaccine characteristics, sociodemographic and attitudinal factors. Considering the region of residency as a proxy of the likelihood of getting infected, our study findings do not support the assumption that SARS-CoV-2 infection risk is associated with COVID-19 vaccine acceptance.

Abstract Background Evidence-based decision-making and practice are pivotal in public health. However, barriers do persist and they relate to evidence properties, organisations and contexts. To address these major knowledge transfer (KT) issues, we need to rethink how knowledge is produced and used, to enhance our understanding of decision-making processes, logics and mechanisms and to examine the ability of public health services to integrate research findings into their decisions and operations. This article presents a realist evaluation protocol to assess a KT scheme in prevention policy and practice at local level in France. Methods/design This study is a comparative multiple case study, using a realist approach, to assess a KT scheme in regional health agencies (ARS) and regional non-profit organisations for health education and promotion (IREPS), by analysing the configurations contexts/mechanisms/outcomes of it. The KT scheme assessed is designed for the use of six reviews of systematic reviews concerning the following themes: nutrition, alcohol, tobacco smoking, physical activity, emotional and sexual life and psychosocial skills. It combines the following activities: supporting the access to and the adaptation of scientific and usable evidences; strengthening professionals’ skills to analyse, adopt and use the evidences in the course of their practices and their decision-making process; facilitating the use of evidence in the organisations and processes. RAMESE II reporting standards for realist evaluations was used. Discussion The aims of this study are to experiment and characterise the factors related to the scheme’s ability to enable public health stakeholders to address the challenges of KT and to integrate scientific knowledge into policy and practice. We will use the realist approach in order to document the parameters of successful KT strategies in the specific contexts of preventive health services in France, while seeking to determine the transferability of such strategies.

Staphylococcus aureus induces severe infective endocarditis (IE) where embolic complications are a major cause of death. Risk factors for embolism have been reported such as a younger age or larger IE vegetations, while methicillin resistance conferred by the mecA gene appeared as a protective factor. It is unclear, however, whether embolism is influenced by other S. aureus characteristics such as clonal complex (CC) or virulence pattern. We examined clinical and microbiological predictors of embolism in a prospective multicentric cohort of 98 French patients with monomicrobial S. aureus IE. The genomic contents of causative isolates were characterized using DNA array. To preserve statistical power, genotypic predictors were restricted to CC, secreted virulence factors and virulence regulators. Multivariate regularized logistic regression identified three independent predictors of embolism. Patients at higher risk were younger than the cohort median age of 62.5 y (adjusted odds ratio [OR] 0.14; 95% confidence interval [CI] 0.05–0.36). S. aureus characteristics predicting embolism were a CC30 genetic background (adjusted OR 9.734; 95% CI 1.53–192.8) and the absence of pIB485-like plasmid-borne enterotoxin-encoding genes sed, sej, and ser (sedjr; adjusted OR 0.07; 95% CI 0.004–0.457). CC30 S. aureus has been repeatedly reported to exhibit enhanced fitness in bloodstream infections, which might impact its ability to cause embolism. sedjr-encoded enterotoxins, whose superantigenic activity is unlikely to protect against embolism, possibly acted as a proxy to others genes of the pIB485-like plasmid found in genetically unrelated isolates from mostly embolism-free patients. mecA did not independently predict embolism but was strongly associated with sedjr. This mecA-sedjr association might have driven previous reports of a negative association of mecA and embolism. Collectively, our results suggest that the influence of S. aureus genotypic features on the risk of embolism may be stronger than previously suspected and independent of clinical risk factors.

BackgroundAspecific scoring systems are used to predict the risk of death postsurgery in patients with infective endocarditis (IE). The purpose of the present study was both to analyze the risk factors for in‐hospital death, which complicates surgery for IE, and to create a mortality risk score based on the results of this analysis. Methods and ResultsOutcomes of 361 consecutive patients (mean age, 59.1±15.4 years) who had undergone surgery for IE in 8 European centers of cardiac surgery were recorded prospectively, and a risk factor analysis (multivariable logistic regression) for in‐hospital death was performed. The discriminatory power of a new predictive scoring system was assessed with the receiver operating characteristic curve analysis. Score validation procedures were carried out. Fifty‐six (15.5%) patients died postsurgery. BMI >27 kg/m2 (odds ratio [OR], 1.79; P=0.049), estimated glomerular filtration rate 55 mm Hg (OR, 1.78; P=0.032), and critical state (OR, 2.37; P=0.017) were independent predictors of in‐hospital death. A scoring system was devised to predict in‐hospital death postsurgery for IE (area under the receiver operating characteristic curve, 0.780; 95% CI, 0.734–0.822). The score performed better than 5 of 6 scoring systems for in‐hospital death after cardiac surgery that were considered. ConclusionsA simple scoring system based on risk factors for in‐hospital death was specifically created to predict mortality risk postsurgery in patients with IE.

Symptomatic neurological complications (NC) are a major cause of mortality in infective endocarditis (IE) but the impact of asymptomatic complications is unknown. We aimed to assess the impact of asymptomatic NC (AsNC) on the management and prognosis of IE.From the database of cases collected for a population-based study on IE, we selected 283 patients with definite left-sided IE who had undergone at least one neuroimaging procedure (cerebral CT scan and/or MRI) performed as part of initial evaluation.Among those 283 patients, 100 had symptomatic neurological complications (SNC) prior to the investigation, 35 had an asymptomatic neurological complications (AsNC), and 148 had a normal cerebral imaging (NoNC). The rate of valve surgery was 43% in the 100 patients with SNC, 77% in the 35 with AsNC, and 54% in the 148 with NoNC (p

To update the epidemiology of S. aureus bloodstream infection (SAB) in a high-income country and its link with infective endocarditis (IE).All consecutive adult patients with incident SAB (n = 2008) were prospectively enrolled between 2009 and 2011 in 8 university hospitals in France.SAB was nosocomial in 54%, non-nosocomial healthcare related in 18% and community-acquired in 26%. Methicillin resistance was present in 19% of isolates. SAB Incidence of nosocomial SAB was 0.159/1000 patients-days of hospitalization (95% confidence interval [CI] 0.111-0.219). A deep focus of infection was detected in 37%, the two most frequent were IE (11%) and pneumonia (8%). The higher rates of IE were observed in injecting drug users (IE: 38%) and patients with prosthetic (IE: 33%) or native valve disease (IE: 20%) but 40% of IE occurred in patients without heart disease nor injecting drug use. IE was more frequent in case of community-acquired (IE: 21%, adjusted odds-ratio (aOR) = 2.9, CI = 2.0-4.3) or non-nosocomial healthcare-related SAB (IE: 12%, aOR = 2.3, CI = 1.4-3.5). S. aureus meningitis (IE: 59%), persistent bacteremia at 48 hours (IE: 25%) and C-reactive protein > 190 mg/L (IE: 15%) were also independently associated with IE. Criteria for severe sepsis or septic shock were met in 30% of SAB without IE (overall in hospital mortality rate 24%) and in 51% of IE (overall in hospital mortality rate 35%).SAB is still a severe disease, mostly related to healthcare in a high-income country. IE is the most frequent complication and occurs frequently in patients without known predisposing conditions.

According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk.Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health insurance systems (07/01/08-12/31/09) with a follow-up of up to 30 months.Lipid-lowering drug-naive diabetic patients initiating fibrate or statin monotherapy were identified. Patients at high cardiovascular risk were then selected: patients with a diagnosis of diabetes and hypertension, and > 50 (men) or 60 (women), but with no history of cardiovascular events. The composite endpoint comprised myocardial infarction, stroke, amputation, or death.Of the 31,652 patients enrolled, 4,058 (12.8%) received a fibrate. Age- and gender-adjusted annual event rates were 2.42% (fibrates) and 2.21% (statins). The proportionality assumption required for the Cox model was not met for the fibrate/statin variable. A multivariate model including all predictors was therefore calculated by dividing data into two time periods, allowing Hazard Ratios to be calculated before (HR < 540) and after 540 days (HR > 540) of follow-up. Multivariate analyses showed that fibrates were associated with an increased risk for the endpoint after 540 days: HR < 540 = 0.95 (95% CI: 0.78-1.16) and HR > 540 = 1.73 (1.28-2.32).Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy.