Reducing length of stay after transfemoral transcatheter aortic valve implantation: the FAST-TAVI II trial.

BACKGROUND AND AIMS: The length of stay (LOS) after transcatheter aortic valve implantation (TAVI) remains extremely variable whereas early discharge has been shown to be feasible and safe. The study objective was to evaluate the efficacy and safety of an intervention aimed at reducing LOS after transfemoral TAVI. METHODS: FAST-TAVI II is a prospective, multicentre, cluster, randomized, controlled study including patients with severe symptomatic aortic stenosis, who had transfemoral TAVI. The intervention consisted in a dedicated training programme to implement 10 quality of care measures to reduce LOS with an implementation phase of eight weeks. The primary endpoint was the proportion of patients discharged early within 3 days. Secondary endpoints included: LOS, 30-day mortality and 30-day incidence of readmission for cardiovascular events. RESULTS: During the study period, 969 patients were enrolled in the intervention group and 860 patients in the control group. Mean age was 81.9 ± 6.6 years and mean EuroSCORE II was 4.4 ± 4.5%. Early discharge was achieved in 563 (58.1%) patients in the intervention group vs. 364 (42.3%) patients in the control group (P < .0001). Median LOS was significantly reduced in the intervention group compared to the control group [3 (IQR: 3) vs. 4 days (IQR: 3), P < .0001]. Thirty-day mortality was low and similar in the two groups (0.5% vs. 0.9%, P = .30), as were 30-day readmissions (4.6% vs. 2.8%, P = .28). CONCLUSIONS: The intervention was simple and fast to implement, and was effective and safe to reduce LOS and increase the proportion of patients discharged early after TAVI (NCT04503655).

Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

Impact of Deprivation on the Incidence and Severity of Tuberculosis in Children: A Retrospective Study from 2007 to 2020 in a Tertiary Care Center in Paris, France.

OBJECTIVE: To assess the association between deprivation and the incidence and clinical severity of tuberculosis (TB) in children. STUDY DESIGN: Children ≤18 years old who were admitted for TB between 2007 and 2020 at a tertiary hospital were included in this retrospective study. Deprivation was assessed using the French Deprivation Index. TB severity was assessed using the Wiseman classification. Multivariate analyses were carried out. RESULTS: In total, 222 patients were included. The median age was 10.8 years (IQR 4.5-14.4). TB was considered severe in 126 patients (56.8%), with 50% of the patients included in the 2 most deprived groups. The most-deprived children had a TB incidence that was 58 times greater than that of the least-deprived children (95% CI 28.49-119.40). There was no significant association between deprivation and severity in the multivariable analysis after adjusting for age and circumstances of diagnosis. Deprivation was associated with an increased length of stay in the most-deprived groups (OR 3.79, 95% CI 1.55-10.23). There was a trend toward a greater proportion of symptomatic children in the most-deprived group. CONCLUSIONS: TB incidence and hospital length of stay increased with deprivation levels but not with the severity of TB.

Co-development of a school-based and primary care-based multicomponent intervention to improve HPV vaccine coverage amongst French adolescents (the PrevHPV Study).

INTRODUCTION: Despite various efforts to improve human papillomavirus (HPV) vaccine coverage in France, it has always been lower than in most other high-income countries. The health authorities launched in 2018 the national PrevHPV research programme to (1) co-develop with stakeholders and (2) evaluate the impact of a multicomponent complex intervention aimed at improving HPV vaccine coverage amongst French adolescents. OBJECTIVE: To describe the development process of the PrevHPV intervention using the GUIDance for rEporting of intervention Development framework as a guide. METHODS: To develop the intervention, we used findings from (1) published evidence on effective strategies to improve vaccination uptake and on theoretical frameworks of health behaviour change; (2) primary data on target populations' knowledge, beliefs, attitudes, preferences, behaviours and practices as well as the facilitators and barriers to HPV vaccination collected as part of the PrevHPV Programme and (3) the advice of working groups involving stakeholders in a participatory approach. We paid attention to developing an intervention that would maximise reach, adoption, implementation and maintenance in real-world contexts. RESULTS: We co-developed three components: (1) adolescents' and parents' education and motivation using eHealth tools (web conferences, videos, and a serious video game) and participatory learning at school; (2) general practitioners' e-learning training on HPV using motivational interviewing techniques and provision of a decision aid tool and (3) easier access to vaccination through vaccination days organised on participating middle schools' premises to propose free of charge initiation of the HPV vaccination. CONCLUSION: We co-developed a multicomponent intervention that addresses a range of barriers and enablers of HPV vaccination. The next step is to build on the results of its evaluation to refine it before scaling it up if proven efficient. If so, it will add to the small number of multicomponent interventions aimed at improving HPV vaccination worldwide. PATIENT OR PUBLIC CONTRIBUTION: The public (adolescents, their parents, school staff and health professionals) participated in the needs assessment using a mixed methods approach. The public was also involved in the components' development process to generate ideas about potential activities/tools, critically revise the successive versions of the tools and provide advice about the intervention practicalities, feasibility and maintenance.

Promoting HPV vaccination at school: a mixed methods study exploring knowledge, beliefs and attitudes of French school staff.

BACKGROUND: HPV vaccine coverage in France remained lower than in most other high-income countries. Within the diagnostic phase of the national PrevHPV program, we carried out a mixed methods study among school staff to assess their knowledge, beliefs and attitudes regarding HPV, HPV vaccine and vaccination in general, and regarding schools' role in promoting HPV vaccination. METHODS: Middle school nurses, teachers and support staff from four French regions participated between January 2020 and May 2021. We combined: (i) quantitative data from self-administered online questionnaires (n = 301), analysed using descriptive statistics; and (ii) qualitative data from three focus groups (n = 14), thematically analysed. RESULTS: Less than half of respondents knew that HPV can cause genital warts or oral cancers and only 18% that no antiviral treatment exists. Almost 90% of the respondents knew the existence of the HPV vaccine but some misunderstood why it is recommended before the first sexual relationships and for boys; 56% doubted about its safety, especially because they think there is not enough information on this topic. Schools nurses had greater knowledge than other professionals and claimed that educating pupils about HPV was fully part of their job roles; however, they rarely address this topic due to a lack of knowledge/tools. Professionals (school nurses, teachers and support staff) who participated in the focus groups were unfavourable to offering vaccination at school because of parents' negative reactions, lack of resources, and perceived uselessness. CONCLUSIONS: These results highlight the need to improve school staff knowledge on HPV. Parents should be involved in intervention promoting HPV vaccination to prevent their potential negative reactions, as feared by school staff. Several barriers should also be addressed before organizing school vaccination programs in France.

Trends in aortic valve replacement for aortic stenosis: a French nationwide study.

AIMS: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce. METHODS AND RESULTS: Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 [106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%)]. The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19). CONCLUSION: The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.

Trends in aortic valve replacement for aortic stenosis: a French nationwide study.

AIMS: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce. METHODS AND RESULTS: Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 [106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%)]. The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19). CONCLUSION: The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.

Health check-ups for the French under-consuming agricultural population: A pilot evaluation of the Instants santé MSA program.

BACKGROUND: The social protection scheme in charge of farmers and agricultural employees (MSA) in France has developed a two-step health promotion program with a nurse appointment followed by a consultation with a doctor of the participant's choosing to reach its under-consuming beneficiaries and enroll them back into a care pathway. Our objective was to carry out a pilot evaluation of this program. METHODS: The evaluation was carried out on the population invited during the second semester of 2017 using data from the program's service providers (date of invitation, of nurse appointment…), regional MSA bodies (consultation voucher), and reimbursement data (other care consumption). Participation rates were calculated overall and by participant characteristics. Medical needs were identified during the nurse appointment and new care pathways were assessed using reimbursement data. Multivariable regression models identified factors associated with participation. RESULTS: 2366 beneficiaries were included in the analysis. 1559 (65.89%) were men and mean age was 52.41 (standard deviation = 14.86). 409 (17.29%) attended the nurse appointment. There was a significant increase in participation with age, in farmers vs. employees (odds ratio = 1.905, 95% confidence interval = 1.393-2.604), and in people living in the most disadvantaged areas (odds ratio = 1.579, 95% confidence interval=1.079-2.312). Participation to the consultation following the nurse appointment was high (62.35%-73.11%). 87.53% of participants had at least one medical need, and new care pathways were more frequent among those who had attended the nurse appointment (55.50% vs. 34.80%, p < 0.0001). CONCLUSIONS: This pilot evaluation shows promising results which need to be confirmed with a national evaluation of the program and longer-term evidence.

Impact of follow-up by peer support workers on mental health service users' global functioning and self-stigmatisation.

OBJECTIVES: The introduction of the first French professional peer support workers training program. (« Médiateurs de santé pairs en santé mentale ¼) led to a series of evaluations. After a number of qualitative studies demonstrating benefits of peer support for all stakeholders, our objective was to evaluate its direct effects for users by focusing on repeated quantitative measures: global functioning and self-stigma scores. The hypothesis was that peer support would improve the former and decrease the latter. METHOD: The procedure was based on a one-year follow-up of two groups of mental health service users. Both groups received usual care, either with or without additional peer support. All of them were asked to respond to three questionnaires at the beginning of the study and 6 and 12 months later: a sociodemographic and clinical questionnaire, a global functioning scale and a self-stigmatization scale. Samples included 85/64/35 participants at the three stages for the PHM group, and 205/157/105 for the control group. RESULTS: Peer support improved global functioning. Nevertheless, it had no impact on self-stigmatization scores which remained rather low throughout the observational period. CONCLUSIONS: Despite difficulties concerning follow-up of service users during the course of the study and the reluctance to integrate a new profession based on experiential knowledge, it appears that the hope of recovery can improve global functioning of people with mental disorders. The reasons for low self-stigmatization and its stability over time remain to be explored.

Conditions for the Successful Integration of an eHealth Tool "StopBlues" Into Community-Based Interventions in France: Results From a Multiple Correspondence Analysis.

BACKGROUND: For over a decade, digital health has held promise for enabling broader access to health information, education, and services for the general population at a lower cost. However, recent studies have shown mixed results leading to a certain disappointment regarding the benefits of eHealth technologies. In this context, community-based health promotion represents an interesting and efficient conceptual framework that could help increase the adoption of digital health solutions and facilitate their evaluation. OBJECTIVE: To understand how the local implementation of the promotion of an eHealth tool, StopBlues (SB), aimed at preventing psychological distress and suicide, varied according to local contexts and if the implementation was related to the use of the tool. METHODS: The study was nested within a cluster-randomized controlled trial that was conducted to evaluate the effectiveness of the promotion, with before and after observation (NCT03565562). Data from questionnaires, observations, and institutional sources were collected in 27 localities where SB was implemented. A multiple correspondence analysis was performed to assess the relations between context, type of implementation and promotion, and use of the tool. RESULTS: Three distinct promotion patterns emerged according to the profiles of the localities that were associated with specific SB utilization rates. From highest to lowest utilization rates, they are listed as follows: the privileged urban localities, investing in health that implemented a high-intensity and digital promotion, demonstrating a greater capacity to take ownership of the project; the urban, but less privileged localities that, in spite of having relatively little experience in health policy implementation, managed to implement a traditional and high-intensity promotion; and the rural localities, with little experience in addressing health issues, that implemented low-intensity promotion but could not overcome the challenges associated with their local context. CONCLUSIONS: These findings indicate the substantial influence of local context on the reception of digital tools. The urban and socioeconomic status profiles of the localities, along with their investment and pre-existing experience in health, appear to be critical for shaping the promotion and implementation of eHealth tools in terms of intensity and use of digital communication. The more digital channels used, the higher the utilization rates, ultimately leading to the overall success of the intervention. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04464-2.

Smoking in psychiatry: realities and implications for its management / Le tabagisme en psychiatrie : réalités et implications pour sa prise en charge

OBJECTIVE: This study looks at tobacco use among persons with psychiatric disorders and its management in public psychiatric units in France. METHODS: A thematic analysis based on semi-directive interviews with 10 patients and 9 caregivers was carried out. RESULTS: Patients use tobacco to deal with their emotions and mood swings. However, mental health professionals, who only focus on mental disorders and addictions that have a direct impact on behaviors, disregard smoking addiction. Moreover, tobacco is sometimes integrated into the way services operate. However, it would be too simplistic to reduce the issue of smoking cessation to a matter of goodwill of caregivers. The structural dimension of smoking was evident, particularly in psychiatric hospitals, where it was an important bargaining chip and activity. CONCLUSIONS: Patients desire to receive individualized smoking-cessation interventions. This underlines the relevance of a public health intervention co-construction that goes beyond simply prescribing nicotine substitutes. This intervention should take into account characteristics of tobacco consumption among psychiatric patients, and the need to offer such interventions when patients are stabilized. In the meantime, psychiatric caregivers should be encouraged to engage in shared decision-making processes with patients for tobacco-use reduction and cessation.

Objectif: Cette étude s'intéresse à la place du tabagisme dans la vie des personnes porteuses de troubles psychiques et à sa prise en charge chez les patients des secteurs de psychiatrie publique en France. Méthode: L'analyse thématique est basée sur des entretiens semi-directifs menés auprès de 10 patients et 9 soignants. Résultats: Le tabac est vécu par les patients comme une modalité de gestion émotionnelle en lien avec leurs vicissitudes psychiques. Pour autant, les professionnels de la psychiatrie, se centrant sur les troubles psychiques et les addictions ayant un impact sur le comportement, se sentent peu concernés par cette addiction. Le tabac est d'ailleurs parfois intégré au mode de fonctionnement des services. Toutefois, réduire la question du sevrage tabagique à la bonne volonté des soignants serait simplificateur. La dimension structurelle du tabagisme ressortait notamment à l'hôpital psychiatrique, où il constituait une monnaie d'échange et une activité importante. Conclusions: L'individualisation de la prise en charge du sevrage tabagique, souhaitée par les patients, souligne la pertinence d'une co-construction d'une intervention de santé publique dépassant la seule prescription de substituts nicotiniques. Cette intervention devra tenir compte des caractéristiques de la consommation de tabac des patients pris en charge en psychiatrie, de la nécessité qu'elle soit proposée à un moment où leur état est stable, tout en accompagnant les soignants de psychiatrie pour favoriser leur engagement dans un processus de décision partagée des objectifs à atteindre en termes de consommation tabagique et de temporalité du processus de sevrage.

Estimation of the Width of Uncertainty in Care Consumption and Costs When Using Common Data Collection Tools in Economic Evaluations: A Benchmark for Sensitivity Analyses.

OBJECTIVES: This study aimed to evaluate the uncertainty related to the use of common collection tools to assess costs in economic evaluations compared with an exhaustive administrative database. METHODS: A pragmatic study was performed using preexisting cost-effectiveness studies. Patients were probabilistically matched with themselves in the French National Health Data System (Système National des Données de Santé [SNDS]), and all their reimbursed hospital and ambulatory care data during the study were extracted. Outcomes included the ratio of the number of each type of resources consumed using trial data (case report forms for ambulatory care and local hospital data for hospital care) versus the SNDS and the ratio of corresponding costs. Mean ratios and 95% confidence intervals (CIs) were calculated using bootstrapping. The impact of the collection tool on the result of the economic evaluation was calculated with the difference in costs between the 2 treatment arms with both collection methods. RESULTS: Five cost-effectiveness studies were included in the analysis. A total of 397 patients had the SNDS hospital data, and 321 had ambulatory care data. Common collection tools underestimated hospital admissions by 13% (95% CI 8-20), corresponding costs by 5% (95% CI 2-14), and ambulatory acts by 41% (95% CI 33-51), with large variations in costs depending on the study. There was no change in the economic conclusion in any study. CONCLUSIONS: The use of common collection tools underestimates healthcare resource consumption and its associated costs, particularly for ambulatory care. Our results could provide useful evidence-based estimates to inform sensitivity analyses' parameters in future cost-effectiveness analyses.

Socioeconomic Status of Newborns and Hospital Efficiency: Implications for Hospital Payment Methods.

OBJECTIVES: Studies have shown a consistent impact of socioeconomic status at birth for both mother and child; however, no study has looked at its impact on hospital efficiency and financial balance at birth, which could be major if newborns from disadvantaged families have an average length of stay (LOS) longer than other newborns. Our objective was therefore to study the association between socioeconomic status and hospital efficiency and financial balance in that population. METHODS: A study was carried out using exhaustive national hospital discharge databases. All live births in a maternity hospital located in mainland France between 2012 and 2014 were included. Socioeconomic status was estimated with an ecological indicator and efficiency by variations in patient LOS compared with different mean national LOS. Financial balance was assessed at the admission level through the ratio of production costs and revenues and at the hospital level by the difference in aggregated revenues and production costs for said hospital. Multivariate regression models studied the association between those indicators and socioeconomic status. RESULTS: A total of 2 149 454 births were included. LOS was shorter than the national means for less disadvantaged patients and longer for the more disadvantaged patients, which increased when adjusted for gestational age, birth weight, and severity. A 1% increase in disadvantaged patients in a hospital's case mix significantly increased the probability that the hospital would be in deficit by 2.6%. CONCLUSIONS: Reforms should be made to hospital payment methods to take into account patient socioeconomic status so as to improve resource allocation efficiency.

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States.

Hepatocellular carcinoma (HCC) is the leading cause of death in patients with cirrhosis. Patients outside clinical trials seldom benefit from evidence-based monitoring. The objective of this study was to estimate the cost-effectiveness of complying with HCC screening guidelines. The economic evaluation compared surveillance of patients with cirrhosis as recommended by the guidelines ("gold-standard monitoring") to "real-life monitoring" from the health care system perspective. A Markov model described the history of the disease and treatment course including current first-line curative treatment: liver resection, radiofrequency ablation (RFA), and liver transplantation. Transition probabilities were derived mainly from two French cohorts, CIRVIR and CHANGH. Costs were computed using French and U.S. tariffs. Effectiveness was measured in life years gained (LYG). An incremental cost-effectiveness ratio (ICER) was calculated for a 10-year horizon and tested with one-way and probabilistic sensitivity analyses. The cost difference between the two groups was $648 ($87,476 in the gold-standard monitoring group vs. $86,829 in the real-life monitoring group) in France and $11,965 ($93,795 vs. $81,829) in the United States. Survival increased by 0.37 years (7.18 vs. 6.81 years). The ICER was $1,754 per LYG in France and $32,415 per LYG in the United States. The health gain resulted from earlier diagnosis and access to first-line curative treatments, among which RFA provided the best value for money. CONCLUSION: Our results indicate that gold-standard monitoring for patients with cirrhosis is cost-effective, attributed to a higher probability of benefiting from a curative treatment and so a higher survival probability. (Hepatology 2017;65:1237-1248).

Determinants of long-term outcome in ICU survivors: results from the FROG-ICU study.

BACKGROUND: Intensive care unit (ICU) survivors have reduced long-term survival compared to the general population. Identifying parameters at ICU discharge that are associated with poor long-term outcomes may prove useful in targeting an at-risk population. The main objective of the study was to identify clinical and biological determinants of death in the year following ICU discharge. METHODS: FROG-ICU was a prospective, observational, multicenter cohort study of ICU survivors followed 1 year after discharge, including 21 medical, surgical or mixed ICUs in France and Belgium. All consecutive patients admitted to intensive care with a requirement for invasive mechanical ventilation and/or vasoactive drug support for more than 24 h following ICU admission and discharged from ICU were included. The main outcome measure was all-cause mortality at 1 year after ICU discharge. Clinical and biological parameters on ICU discharge were measured, including the circulating cardiovascular biomarkers N-terminal pro-B type natriuretic peptide, high-sensitive troponin I, bioactive-adrenomedullin and soluble-ST2. Socioeconomic status was assessed using a validated deprivation index (FDep). RESULTS: Of 1570 patients discharged alive from the ICU, 333 (21%) died over the following year. Multivariable analysis identified age, comorbidity, red blood cell transfusion, ICU length of stay and abnormalities in common clinical factors at the time of ICU discharge (low systolic blood pressure, temperature, total protein, platelet and white cell count) as independent factors associated with 1-year mortality. Elevated biomarkers of cardiac and vascular failure independently associated with 1-year death when they are added to multivariable model, with an almost 3-fold increase in the risk of death when combined (adjusted odds ratio 2.84 (95% confidence interval 1.73-4.65), p < 0.001). CONCLUSIONS: The FROG-ICU study identified, at the time of ICU discharge, potentially actionable clinical and biological factors associated with poor long-term outcome after ICU discharge. Those factors may guide discharge planning and directed interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT01367093 . Registered on 6 June 2011.

Understanding geographic variations in psychiatric inpatient admission rates: width of the variations and associations with the supply of health and social care in France.

BACKGROUND: Inpatient care accounts for the majority of mental health care costs and is not always beneficial. It can indeed have detrimental consequences if not used appropriately, and is unpopular among patients. As a consequence, its reduction is supported by international recommendations. Varying rates of psychiatric inpatient admissions therefore deserve to draw attention of researchers, clinicians and policy makers alike as such variations can challenge quality, equity and efficiency of care. In this context, our objectives were first to describe variations in psychiatric inpatient admission rates across the whole territory of mainland France, and second to identify their association with characteristics of the supply of care, which can be targeted by dedicated health policies. METHODS: Our study was carried out in French psychiatric sectors' catchment areas for the year 2012. Inpatient admission rates per 100,000 adult inhabitants were calculated using data from the national psychiatric discharge database. Their variations were described numerically and graphically. We then carried out a negative binomial regression to identify characteristics of the supply of care (public and private care, health and social care, hospital and community-based care, specialised and non-specialised care) which were associated with these variations while adjusting our analysis for other relevant factors, in particular epidemiological differences. RESULTS: Considerable variations in inpatient admission rates were observed between psychiatric sectors' catchment areas and were widespread on the French territory. Institutional characteristics of the hospital to which each sector was linked (private non-profit status, specialisation in psychiatry and participation to teaching activities and to emergency care) were associated with inpatient admission rates. Similarly, an increase in the availability of community-based private psychiatrists was associated with a decrease in the inpatient admission rate while an increase in the capacity of housing institutions for disabled individuals was associated with an increase in this rate. CONCLUSIONS: Our results advocate for a homogenous repartition of health and social care for mental disorders in lines with the health needs of the population served. This should apply particularly to community-based private psychiatrists, whose heterogeneity of repartition has often been underscored.

Gender and access to professorships in academic medical settings in France.

CONTEXT: Previous studies, mainly originating from North America, suggest that women are less likely than men to obtain professorships in academic medical settings. However, research providing a comprehensive picture of such gender disparities in other national contexts and addressing associated contextual factors is lacking. OBJECTIVES: Our objectives were to assess gender differences in access to professorships in academic medical settings in France, to determine their evolution across regions and medical specialties and over time, and to identify the factors associated with the likelihood of a professor being a woman. METHODS: We carried out a national administrative cohort study of all new professors appointed during 1989-2015 in all medical specialties in the whole of France. We first conducted a descriptive analysis of the percentage of professorships awarded to women and its variations by time, region and specialty. We then ran a logistic regression model to determine factors significantly associated with the likelihood of a professor being a woman. RESULTS: Between 1989 and 2015, 3950 professors were appointed, of whom fewer than one in five were women. Female professors consistently represented a minority in all French regions and specialties over the study period. Although a small increase was observed over the years, women never represented more than 29% of newly appointed professors. After adjustments for other factors, the likelihood of a professor being a woman was significantly higher in specialties with a higher percentage of women among hospital practitioners, in regions with higher numbers of appointed professors and in recent years. CONCLUSIONS: Gender inequalities in career evolution exist in academic medical settings in France and have continued over time despite moderate improvements. Increased awareness based on scientific evidence is a first step towards reducing such inequalities.

Geographic variations in involuntary care and associations with the supply of health and social care: results from a nationwide study.

BACKGROUND: Involuntary psychiatric care remains controversial. Geographic disparities in its use can challenge the appropriateness of the care provided when they do not result from different health needs of the population. These disparities should be reduced through dedicated health policies. However, their association with the supply of health and social care, which could be targeted by such policies, has been insufficiently studied. Our objectives were therefore to describe geographic variations in involuntary admission rates across France and to identify the characteristics of the supply of care which were associated with these variations. METHODS: Involuntary admission rate per 100,000 adult inhabitants was calculated in French psychiatric sectors' catchment areas using 2012 data from the national psychiatric discharge database. Its variations were first described numerically and graphically. Several factors potentially associated with these variations were then considered in a negative binomial regression with an offset term accounting for the size of catchment areas. They included characteristics of the supply of care (public and private care, health and social care, hospital and community-based care, specialised and non-specialised care) as well as adjustment factors related to epidemiological characteristics of the population of each sector's catchment area and its level of urbanization. Such variables were extracted from complementary administrative databases. Supply characteristics associated with geographic variations were identified using a significance level of 0.05. RESULTS: Significant variations in involuntary admission rates were observed between psychiatric sectors' catchment areas with a coefficient of variation close to 80%. These variations were associated with some characteristics of the supply of health and social care in the sectors' catchment areas. Notably, an increase in the availability of community-based private psychiatrists and the capacity of housing institutions for disabled individuals was associated with a decrease in involuntary admission rates while an increase in the availability of general practitioners was associated with an increase in those rates. CONCLUSIONS: There is evidence of considerable variations in involuntary admission rates between psychiatric sectors' catchment areas. Our results provide lines of thoughts to reduce such variations, in particular by supporting an increase in the availability of upstream and downstream care in the community.

Thirty-day Readmission Rates and Associated Factors: A Multilevel Analysis of Practice Variations in French Public Psychiatry.

BACKGROUND: Inpatient psychiatric readmissions are often used as an indicator of the quality of care and their reduction is in line with international recommendations for mental health care. Research on variations in inpatient readmission rates among mental health care providers is therefore of key importance as these variations can impact equity, quality and efficiency of care when they do not result from differences in patients' needs. AIMS OF THE STUDY: Our objectives were first to describe variations in inpatient readmission rates between public mental health care providers in France on a nationwide scale, and second, to identify their association with patient, health care providers and environment characteristics. METHODS: We carried out a study for the year 2012 using data from ten administrative national databases. 30-day readmissions in inpatient care were identified in the French national psychiatric discharge database. Variations were described numerically and graphically between French psychiatric sectors and factors associated with these variations were identified by carrying out a multi-level logistic regression accounting for the hierarchical structure of the data. RESULTS: Significant practice variations in 30-day inpatient readmission rates were observed with a coefficient of variation above 50%. While a majority of those variations was related to differences within sectors, individual patient characteristics explained a lower part of the variations resulting from differences between sectors than the characteristics of sectors and of their environment. In particular, an increase in the mortality rate and in the acute admission rate for somatic disorders in sectors' catchment area was associated with a decrease in the probability of 30-day readmission. Similarly, an increase in the number of psychiatric inpatient beds in private for-profit hospitals per 1,000 inhabitants in sectors' catchment area was associated with a decrease in this probability, which also varied with overall sectors' case-mix characteristics and with the level of urbanisation of the area. DISCUSSION: The extent of the variations and the factors associated with it question the adequacy of care and suggest that some of them may be unwarranted. Our findings should however be interpreted in consideration of several limits inherent to data quality and availability as we relied on information from administrative databases. While we considered a wide range of factors potentially associated with variations in 30-day readmissions, our model indeed only explained a limited part of the variations resulting from differences between sectors. IMPLICATIONS FOR HEALTH POLICIES: Our findings underscored that practice variations in psychiatry are a reality that merits the full attention of decision makers as they can impact the quality, equity and efficiency of care. A specific data system should be established to monitor practice variations in routine to promote transparency and accountability. IMPLICATIONS FOR FURTHER RESEARCH: Few associations were found between variations in 30-day inpatient readmissions and the supply of care. The routine collection of detailed organizational characteristics of health care providers at a national level should be supported to facilitate additional research work, both in France and in other contexts.