VALIDation of the IBD-Disk Instrument for Assessing Disability in Inflammatory Bowel Diseases in a French Cohort: The VALIDate Study.

BACKGROUND AND AIMS: Inflammatory bowel diseases [IBD] are disabling disorders. The IBD-Disability Index [IBD-DI] was developed for quantifying disability in IBD patients but is difficult to use. The IBD-Disk is a visual adaptation of the IBD-DI. It has not been validated yet. The main objectives were to validate the IBD-Disk and to assess the clinical factors associated with a change in the score and its variability over time. METHODS: From May 2018 to July 2019, IBD patients from three university-affiliated hospitals responded twice to both IBD-Disk and IBD-DI at 3-12 month intervals. Validation included concurrent validity, reproducibility, and internal consistency. Mean IBD-Disk scores were compared according to clinical factors. Variability was assessed by comparing scores between baseline and follow-up visits. RESULTS: A total of 447 patients [71% Crohn's disease, 28% ulcerative colitis] were included in the analysis at baseline and 265 at follow-up. There was a good correlation between IBD-Disk and IBD-DI [r = 0.75, p <0.001]. Reproducibility was excellent [intra-class correlation coefficient = 0.90], as well as internal consistency [Cronbach's α = 0.89]. The IBD-Disk was not influenced by IBD type but was associated with female gender and physician global assessment. Extra-intestinal manifestations, history of resection, elevated C-reactive protein and faecal calprotectin also tended to be associated with higher disability. The IBD-Disk score decreased in patients becoming inactive over time. CONCLUSIONS: This study validated the IBD-Disk in a large cohort of IBD patients, demonstrating that it is a valid and reliable tool for quantifying disability for both CD and UC.

Relative contributions of prenatal complications, perinatal characteristics, neonatal morbidities and socio-economic conditions of preterm infants on the occurrence of developmental disorders up to 7 years of age.

BACKGROUND: To investigate the relative contributions of prenatal complications, perinatal characteristics, neonatal morbidities and socio-economic conditions on the occurrence of motor, sensory, cognitive, language and psychological disorders in a large longitudinal preterm infant population during the first 7 years after birth. METHODS: The study population comprised 4122 infants born at <35 weeks of gestation who were followed for an average of 74.0 months after birth. Developmental disorders, including motor, sensory, cognitive, language and psychological, were assessed at each follow-up visit from 18 months to 7 years of age. The investigated determinants included prenatal complications (prolonged rupture of membranes >24 hours, intrauterine growth restriction, preterm labour and maternal hypertension), perinatal characteristics (gender, multiple pregnancies, gestational age, birth weight, APGAR score and intubation or ventilation in the delivery room), neonatal complications (low weight gain during hospitalization, respiratory assistance, severe neurological anomalies, nosocomial infections) and socio-economic characteristics (socio-economic level, parental separation, urbanicity). Based on hazard ratios determined using a propensity score matching approach, population-attributable fractions (PAF) were calculated for each of the four types of determinants and for each developmental disorder. RESULTS: The percentages of motor, sensory, cognitive, language and psychological disorders were 17.0, 13.4, 29.1, 25.9 and 26.1%, respectively. The PAF for the perinatal characteristics were the highest and they were similar for the different developmental disorders considered (around 60%). For the neonatal and socio-economic determinants, the PAF varied according to the disorder, with contributions of up to 17% for motor and 27% for language disorders, respectively. Finally, prenatal complications had the lowest contributions (between 6 and 13%). CONCLUSIONS: This study illustrates the heterogeneity of risk factors on the risk of developmental disorder in preterm infants. These results suggest the importance of considering both medical and psycho-social follow-ups of preterm infants and their families.

The REFRACT-LYMA cohort study: a French observational prospective cohort study of patients with mantle cell lymphoma.

BACKGROUND: Mantle Cell Lymphoma (MCL) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MCL is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MCL therapies and about associated predictors remains poor. The REFRACT-LYMA Cohort, a multicenter prospective cohort of patients with MCL, is set up to address this limitation. We here describe the study background, design and methods used for this cohort. METHODS/DESIGN: The REFRACT-LYMA Cohort Study aims at including all patients (>18 years old) who are diagnosed with MCL in any stage of the disease and treated in specialized oncology centers in three public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up indefinitely, until refusal to participate in the study, emigration or death. The REFRACT-LYMA follow-up is continuous and collects data on socio-economic status, medical status, MCL therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank. DISCUSSION: To our knowledge, the REFRACT-LYMA Cohort Study is the first prospective cohort of patients with MCL for whom "real-life" medical, epidemiological and QOL data is repeatedly collected together with biological samples during the course of the disease. The integrative cohort at mid-term will be unique at producing a large variety of data that can be used to conceive the most effective personalized therapy for MCL patients. Additionally, the REFRACT-LYMA Cohort puts the medical care of MCL patients in a health and pharmacoeconomic perspective.

Psychometric properties of the French Female Sexual Function Index (FSFI).

INTRODUCTION: Few validated questionnaires are available in French to assess sexual function. The aim of this study was thus to validate a French version of the Female Sexual Function Index (FSFI) in a sample of French women. METHODS: In this prospective monocentric and cross-sectional study, an already existing French version of the FSFI, was back-translated and compared to the original version. It was then randomly distributed to 800 women attending Gynecology consultation at Nantes University Hospital in April 2012. Various statistical analyzes were used to test the psychometric properties of the French FSFI. RESULTS: 512 questionnaires were completed. Mean FSFI summary score was 25.2. Intraclass correlation coefficients were superior to 0.75 and Cronbach's coefficients superior to 0.8 similarly to the original version. Variance analysis revealed significant differences in summary score between premenopausal and postmenopausal women and according to the marital status. Convergent validity was excellent (100%) and discriminant validity was satisfactory (89.5%). The factorial structure corresponded to the original version with six retrieved dimensions. CONCLUSIONS: Our study demonstrated similar or adequate psychometric properties of the French version of the FSFI compared to the original English version.

Global determinants of mortality in under 5s: 10 year worldwide longitudinal study.

OBJECTIVE: To assess at country level the association of mortality in under 5s with a large set of determinants. DESIGN: Longitudinal study. SETTING: 193 United Nations member countries, 2000-09. METHODS: Yearly data between 2000 and 2009 based on 12 world development indicators were used in a multivariable general additive mixed model allowing for non-linear relations and lag effects. MAIN OUTCOME MEASURE: National rate of deaths in under 5s per 1000 live births RESULTS: The model retained the variables: gross domestic product per capita; percentage of the population having access to improved water sources, having access to improved sanitation facilities, and living in urban areas; adolescent fertility rate; public health expenditure per capita; prevalence of HIV; perceived level of corruption and of violence; and mean number of years in school for women of reproductive age. Most of these variables exhibited non-linear behaviours and lag effects. CONCLUSIONS: By providing a unified framework for mortality in under 5s, encompassing both high and low income countries this study showed non-linear behaviours and lag effects of known or suspected determinants of mortality in this age group. Although some of the determinants presented a linear action on log mortality indicating that whatever the context, acting on them would be a pertinent strategy to effectively reduce mortality, others had a threshold based relation potentially mediated by lag effects. These findings could help designing efficient strategies to achieve maximum progress towards millennium development goal 4, which aims to reduce mortality in under 5s by two thirds between 1990 and 2015.

Validation of the French national health insurance information system as a tool in vaccine safety assessment: application to febrile convulsions after pediatric measles/mumps/rubella immunization.

In the French national health insurance information system (SNIIR-AM), routine records of health claimed reimbursements are linked to hospital admissions for the whole French population. The main focus of this work is the usability of this system for vaccine safety assessment programme. Self-controlled case series analyses were performed using an exhaustive SNIIR-AM extraction of French children aged less than 3 years, to investigate the relationship between MMR immunization and children hospitalizations for febrile convulsions, a well-documented rare adverse event, over 2009-2010. The results suggest a significant increase of febrile convulsions during the 6-11 days period following any MMR immunization (IRR=1.49, 95% CI=1.22, 1.83; p=0.0001) and no increase 15-35 days post any MMR immunization (IRR=1.03, 95% CI=0.89, 1.18; p=0.72). These results are in accordance with other results obtained from large epidemiologic studies, which suggest the usability of the SNIIR-AM as a relevant database to study the occurrence of adverse events associated with immunization. For future use, results associated with risk of convulsion during the day of vaccination should nevertheless be considered with particular caution.

Corruption kills: estimating the global impact of corruption on children deaths.

BACKGROUND: Information on the global risk factors of children mortality is crucial to guide global efforts to improve survival. Corruption has been previously shown to significantly impact on child mortality. However no recent quantification of its current impact is available. METHODS: The impact of corruption was assessed through crude Pearson's correlation, univariate and multivariate linear models coupling national under-five mortality rates in 2008 to the national "perceived level of corruption" (CPI) and a large set of adjustment variables measured during the same period. FINDINGS: The final multivariable model (adjusted R(2)= 0.89) included the following significant variables: percentage of people with improved sanitation (p.value<0.001), logarithm of total health expenditure (p.value = 0.006), Corruption Perception Index (p.value<0.001), presence of an arid climate on the national territory (p = 0.006), and the dependency ratio (p.value<0.001). A decrease in CPI of one point (i.e. a more important perceived corruption) was associated with an increase in the log of national under-five mortality rate of 0.0644. According to this result, it could be roughly hypothesized that more than 140000 annual children deaths could be indirectly attributed to corruption. INTERPRETATIONS: Global response to children mortality must involve a necessary increase in funds available to develop water and sanitation access and purchase new methods for prevention, management, and treatment of major diseases drawing the global pattern of children deaths. However without paying regard to the anti-corruption mechanisms needed to ensure their proper use, it will also provide further opportunity for corruption. Policies and interventions supported by governments and donors must integrate initiatives that recognise how they are inter-related.