Prolonged increase in psychotropic drug use among young women following the COVID-19 pandemic: a French nationwide retrospective study.

BACKGROUND: The COVID-19 pandemic has had a significant impact on mental health, with evidence suggesting an enduring mental health crisis. Studies worldwide observed increased usage of antidepressants, anxiolytics, and hypnotics during the pandemic, notably among young people and women. However, few studies tracked consumption post-2021. Our study aimed to fill this gap by investigating whether the surge in the number psychotropic drug consumers in France persisted 2 years after the first lockdown, particularly focusing on age and gender differences. METHODS: We conducted a national retrospective observational study based on the French national insurance database. We retrieved all prescriptions of anxiolytics, hypnotics, and antidepressants dispensed in pharmacies in France for the period 2015-2022. We performed interrupted time series analyses based on Poisson models for five age classes (12-18; 19-25; 26-50; 51-75; 76 and more) to assess the trend before lockdown, the gap induced and the change in trend after. RESULTS: In the overall population, the number of consumers remained constant for antidepressants while it decreased for anxiolytics and hypnotics. Despite this global trend, a long-term increase was observed in the 12-18 and 19-25 groups for the three drug classes. Moreover, for these age classes, the increases were more pronounced for women than men, except for hypnotics where the trends were similar. CONCLUSIONS: The number of people using antidepressants continues to increase more than 2 years after the first lockdown, showing a prolonged effect on mental health. This effect is particularly striking among adolescents and young adults confirming the devastating long-term impact of the pandemic on their mental health.

A Shared-Frailty Spatial Scan Statistic Model for Time-to-Event Data.

Spatial scan statistics are well-known methods widely used to detect spatial clusters of events. Furthermore, several spatial scan statistics models have been applied to the spatial analysis of time-to-event data. However, these models do not take account of potential correlations between the observations of individuals within the same spatial unit or potential spatial dependence between spatial units. To overcome this problem, we have developed a scan statistic based on a Cox model with shared frailty and that takes account of the spatial dependence between spatial units. In simulation studies, we found that (i) conventional models of spatial scan statistics for time-to-event data fail to maintain the type I error in the presence of a correlation between the observations of individuals within the same spatial unit and (ii) our model performed well in the presence of such correlation and spatial dependence. We have applied our method to epidemiological data and the detection of spatial clusters of mortality in patients with end-stage renal disease in northern France.

Risk-Benefit Balance of Simultaneous Gastric Bypass or Sleeve Gastrectomy and Concomitant Cholecystectomy: A Comprehensive Nationwide Cohort of 289,627 Patients.

OBJECTIVE: To assess the relevance of concomitant laparoscopic metabolic bariatric surgery (MBS) and cholecystectomy. BACKGROUND: Because of the massive weight loss it induces, MBS is associated with an increase in the frequency of gallstones. However, no consensus yet exists on the risk-to-benefit ratio of a concomitant cholecystectomy (CC) during MBS to prevent long-term biliary complications. METHODS: This nationwide retrospective cohort research was conducted in 2 parts using information from a national administrative database (PMSI). The 90-day morbidity of MBS with or without CC was first compared in a matched trial (propensity score). Second, we observed medium-term biliary complication following MBS when no CC had been performed during MBS up to 9 years after MBS (minimum 18 months). RESULTS: Between 2013 and 2020, 289,627 patients had a sleeve gastrectomy (SG: 70%) or a gastric bypass (GBP: 30%). The principal indications of CC were symptomatic cholelithiasis (79.5%) or acute cholecystitis (3.6%). Prophylactic CC occurred only in 15.5% of the cases. In our matched-group analysis, we included 9323 patients in each arm. The complication rate at day 90 after surgery was greater in the CC arm [odds ratio=1.3 (1.2-1.5), P <0.001], independently of the reason of the CC. At 18 months, there was a 0.1% risk of symptomatic gallstone migration and a 0.08% risk of biliary pancreatitis. At 9 years, 20.5±0.52% of patients underwent an interval cholecystectomy. The likelihood of interval cholecystectomy decreased from 5.4% per year to 1.7% per year after the first 18 months the whole cohort, risk at 18 months of symptomatic gallstone migration was 0.1%, of pancreatitis 0.08%, and of angiocholitis 0.1%. CONCLUSION: CC during SG and GBP should be avoided. In the case of asymptomatic gallstones after MBS, prophylactic cholecystectomy should not be recommended.

Impact of puberty as threshold to differentiate outcome of out-of-hospital cardiac arrest care groups: a nationwide observational study in France.

BACKGROUND: Since 2005, the international guidelines for out-of-hospital cardiac arrest (OHCA) use puberty to differentiate paediatric and adult care. This threshold is mainly relied on the more frequent respiratory aetiologies in children. Hitherto, to the best of our knowledge, no study has compared the characteristics and outcomes of non-pubescent children, adolescents and adult patients with OHCA. In this study, we intended to describe the characteristics, outcome and factors associated with survival of patients who experienced OHCA in the three groups: children, adolescents (pubescent<18 years) and adults (<65 years), to assess the pertinence of the guidelines. METHODS: Data from the French national cardiac arrest registry (2012-2017) were used in this nationwide observational study. Victims of OHCA who were <65 years old were included. The characteristics and outcomes of children and adolescents, and adolescents and adults were compared. Logistic regression was performed in each group to identify factors associated with survival at day 30. RESULTS: We included 934 children, 433 adolescents and 26 952 adults. Respiratory aetiology was more frequent and shockable rhythm less frequent in children compared with adolescents (25.5% vs 17.2%, p=0.025 and 2.4% vs 6.8%, p<0.001, respectively). However, these differences were not observed between adolescents and adults (17.2% vs 14.1%, p=0.266 and 6.8% vs 10%, p=0.055, respectively). Between children and adolescents, and adolescents and adults, there was no significant difference in survival at day 30 (8.6%vs 9.8% and 9.8% vs 8.5%, respectively). For all groups, shockable initial rhythm was a factor of survival. CONCLUSION: Frequency of respiratory aetiologies and shockable rhythm were common in adolescents and adults and different between children and adolescents. These results indicate that puberty as a threshold in international guidelines seems to be relevant.

Predicting Intraoperative Difficulty of Open Liver Resections: The DIFF-scOR Study, An Analysis of 1393 Consecutive Hepatectomies From a French Multicenter Cohort.

OBJECTIVE: The aim of this study was to build a predictive model of operative difficulty in open liver resections (LRs). SUMMARY BACKGROUND DATA: Recent attempts at classifying open-LR have been focused on postoperative outcomes and were based on predefined anatomical schemes without taking into account other anatomical/technical factors. METHODS: Four intraoperative variables were perceived by the authors as to reflect operative difficulty: operation and transection times, blood loss, and number of Pringle maneuvers. A hierarchical ascendant classification (HAC) was used to identify homogeneous groups of operative difficulty, based on these variables. Predefined technical/anatomical factors were then selected to build a multivariable logistic regression model (DIFF-scOR), to predict the probability of pertaining to the highest difficulty group. Its discrimination/calibration was assessed. Missing data were handled using multiple imputation. RESULTS: HAC identified 2 clusters of operative difficulty. In the "Difficult LR" group (20.8% of the procedures), operation time (401 min vs 243 min), transection time (150 vs.63 minute), blood loss (900 vs 400 mL), and number of Pringle maneuvers (3 vs 1) were higher than in the "Standard LR" group. Determinants of operative difficulty were body weight, number and size of nodules, biliary drainage, anatomical or combined LR, transection planes between segments 2 and 4, 4, and 8 or 7 and 8, nonanatomical resections in segments 2, 7, or 8, caval resection, bilioentric anastomosis and number of specimens. The c-statistic of the DIFF-scOR was 0.822. By contrast, the discrimination of the DIFF-scOR to predict 90-day mortality and severe morbidity was poor (c-statistic: 0.616 and 0.634, respectively). CONCLUSION: The DIFF-scOR accurately predicts open-LR difficulty and may be used for various purposes in clinical practice and research.

Importance of previous hospital stays on the risk of hospital re-admission in older adults: a real-life analysis of the PAERPA study population.

BACKGROUND: consideration of the first hospital re-admission only and failure to take account of previous hospital stays, which are the two significant limitations when studying risk factors for hospital re-admission. The objective of the study was to use appropriate statistical models to analyse the impact of previous hospital stays on the risk of hospital re-admission among older patients. METHODS: an exhaustive analysis of hospital discharge and health insurance data for a cohort of patients participating in the PAERPA ('Care Pathways for Elderly People at Risk of Loss of Personal Independence') project in the Hauts de France region of France. All patients aged 75 or over were included. All data on hospital re-admissions via the emergency department were extracted. The risk of unplanned hospital re-admission was estimated by applying a semiparametric frailty model, the risk of death by applying a time-dependent semiparametric Cox regression model. RESULTS: a total of 24,500 patients (median [interquartile range] age: 81 [77-85]) were included between 1 January 2015 and 31 December 2017. In a multivariate analysis, the relative risk (95% confidence interval [CI]) of hospital re-admission rose progressively from 1.8 (1.7-1.9) after one previous hospital stay to 3.0 (2.6-3.5) after five previous hospital stays. The relative risk [95%CI] of death rose slowly from 1.1 (1.07-1.11) after one previous hospital stay to 1.3 (1.1-1.5) after five previous hospital stays. CONCLUSION: analyses of the risk of hospital re-admission in older adults must take account of the number of previous hospital stays. The risk of death should also be analysed.

A functional-model-adjusted spatial scan statistic.

This paper introduces a new spatial scan statistic designed to adjust cluster detection for longitudinal confounding factors indexed in space. The functional-model-adjusted statistic was developed using generalized functional linear models in which longitudinal confounding factors were considered to be functional covariates. A general framework was developed for application to various probability models. Application to a Poisson model showed that the new method is equivalent to a conventional spatial scan statistic that adjusts the underlying population for covariates. In a simulation study with single and multiple covariate models, we found that our new method adjusts the cluster detection procedure more accurately than other methods. Use of the new spatial scan statistic was illustrated by analyzing data on premature mortality in France over the period from 1998 to 2013, with the quarterly unemployment rate as a longitudinal confounding factor.

Spatial analysis of hypospadias cases in northern France: taking clinical data into account.

BACKGROUND: Strong evidence for a causal role of environmental factors in a congenital anomaly is still difficult to produce. The collection of statistical data is crucial for gaining a better understanding of the epidemiology and pathophysiology of these anomalies. We aimed to evaluate spatial variations in hypospadias within our region and it's association to socioeconomic and ecological factors, taking clinical data into account. METHODS: All boys with hypospadias born in northern France and seen in Lille University Medical Center (Lille, France) between 1999 and 2012 were included in the analysis. We retrospectively collected geographic data, clinical data (especially known confounding factors associated with an elevated risk of hypospadias), and demographic, socio-economic and ecological data. We analyzed the entire study population and subsequently the subset of boys lacking confounding factors. RESULTS: The study sample of 975 cases of hypospadias over the 13-year period resulted in an incidence of 25.4/10,000 male births, and was characterized by significant spatial heterogeneity (p < 0.005) and autocorrelation (p < 0.001). We detected two high-incidence clusters that differed with regard to their land use. After the exclusion of 221 patients with confounding factors, two high-incidence clusters with significant disease risks (1.65 and 1.75, respectively; p < 0.001) and a significant difference in land use (p < 0.001) again appeared. The first cluster contained a higher median [interquartile range] proportion of artificialized land (0.40 [0.22;0.47]) than the remaining "neutral areas" (0.19 [0.08;0.53]) did (p < 0.001). Conversely, the second cluster contained a higher median proportion of rural land (0.90 [0.78;0.96]) than the "neutral areas" (0.81 [0.47;0.92]) did (p < 0.001). The median deprivation index was significantly lower in the urban cluster (0.47 [0.42;0.55]) and significantly higher in the rural cluster (0.69 [0.56;0.73]) (p < 0.001). CONCLUSIONS: Our results evidenced the heterogeneous spatial distribution of cases of hypospadias in northern France. We identified two clusters with different environmental and social patterns - even after the exclusion of known confounding factors.

Development of a Smart Mobile Data Module for Fetal Monitoring in E-Healthcare.

The fetal heart rate (FHR) is a marker of fetal well-being in utero (when monitoring maternal and/or fetal pathologies) and during labor. Here, we developed a smart mobile data module for the remote acquisition and transmission (via a Wi-Fi or 4G connection) of FHR recordings, together with a web-based viewer for displaying the FHR datasets on a computer, smartphone or tablet. In order to define the features required by users, we modelled the fetal monitoring procedure (in home and hospital settings) via semi-structured interviews with midwives and obstetricians. Using this information, we developed a mobile data transfer module based on a Raspberry Pi. When connected to a standalone fetal monitor, the module acquires the FHR signal and sends it (via a Wi-Fi or a 3G/4G mobile internet connection) to a secure server within our hospital information system. The archived, digitized signal data are linked to the patient's electronic medical records. An HTML5/JavaScript web viewer converts the digitized FHR data into easily readable and interpretable graphs for viewing on a computer (running Windows, Linux or MacOS) or a mobile device (running Android, iOS or Windows Phone OS). The data can be viewed in real time or offline. The application includes tools required for correct interpretation of the data (signal loss calculation, scale adjustment, and precise measurements of the signal's characteristics). We performed a proof-of-concept case study of the transmission, reception and visualization of FHR data for a pregnant woman at 30 weeks of amenorrhea. She was hospitalized in the pregnancy assessment unit and FHR data were acquired three times a day with a Philips Avalon® FM30 fetal monitor. The prototype (Raspberry Pi) was connected to the fetal monitor's RS232 port. The emission and reception of prerecorded signals were tested and the web server correctly received the signals, and the FHR recording was visualized in real time on a computer, a tablet and smartphones (running Android and iOS) via the web viewer. This process did not perturb the hospital's computer network. There was no data delay or loss during a 60-min test. The web viewer was tested successfully in the various usage situations. The system was as user-friendly as expected, and enabled rapid, secure archiving. We have developed a system for the acquisition, transmission, recording and visualization of RCF data. Healthcare professionals can view the FHR data remotely on their computer, tablet or smartphone. Integration of FHR data into a hospital information system enables optimal, secure, long-term data archiving.

Potentially inappropriate medication prescribing is associated with socioeconomic factors: a spatial analysis in the French Nord-Pas-de-Calais Region.

Background: potentially inappropriate medication (PIM) prescribing is common in older people and leads to adverse events and hospital admissions. Objective: to determine whether prevalence of PIM prescribing varies according to healthcare supply and socioeconomic status. Methods: all prescriptions dispensed at community pharmacies for patients aged 75 and older between 1 January  and 31 March 2012 were retrieved from French Health Insurance Information System of the Nord-Pas-de-Calais Region for patients affiliated to the Social Security scheme. PIM was defined according to the French list of Laroche. The geographic distribution of PIM prescribing in this area was analysed using spatial scan statistics. Results: overall, 65.6% (n = 207,979) of people aged 75 years and over living in the Nord-Pas-de-Calais Region were included. Among them, 32.6% (n = 67,863) received at least one PIM. The spatial analysis identified 16 and 10 clusters of municipalities with a high and a low prevalence of PIM prescribing, respectively. Municipalities with a low prevalence of PIM were characterised by a high socioeconomic status whereas those with a high prevalence of PIM were mainly characterised by a low socioeconomic status, such as a high unemployment rate and low household incomes. Markers of healthcare supply were weakly associated with high or low prevalence clusters. Conclusion: significant geographic variation in PIM prescribing was observed in the study territory and was mainly associated with socioeconomic factors.

Design and synthesis of a novel series of [1-(4-hydroxy-benzyl)-1H-indol-5-yloxy]-acetic acid compounds as potent, selective, thyroid hormone receptor ß agonists.

The design, synthesis, and structure activity relationships for a novel series of indoles as potent, selective, thyroid hormone receptor ß (TRß) agonists is described. Compounds with >50× binding selectivity for TRß over TRα were generated and evaluation of compound 1c from this series in a model of dyslipidemia demonstrated positive effects on plasma lipid endpoints in vivo.

Mortality of people suffering from mental illness: a study of a cohort of patients hospitalised in psychiatry in the north of France.

BACKGROUND: The mortality of people suffering from psychiatric illnesses is far higher than that of the general population, all categories of diagnosis combined; mortality statistics can be used as an index of quality of care. The aim of this study was to assess the all-cause mortality in psychiatric patients covering all diagnostic groups. METHODS: The living or deceased status of 4,417 patients of majority age hospitalised in a public mental health establishment between 2004 and 2007 were requested from French National Institute for Statistics and Economic Studies on 1st January 2011. The cause of death of those people who had died was obtained from French National Institute for Health and Medical Research and comparative standardized mortality ratios (SMR) were established from the population in a region of northern France of the same age in 2006. RESULTS: The study population was made up of 54% men and 46% women, median age 41 and 45 years old, respectively. Four hundred and seventy-three people died during the period studied. The SMR were 421 for men (95% CI 378-470) and 330 for women (95% CI 281-388). The highest SMRs were found in patients aged 35-54, with a 20-time higher mortality risk than the general population of the same age. CONCLUSION: Our study confirms the considerably higher mortality in psychiatric patients than in general population, particularly in mean age and mostly due to an unnatural cause.

Outpatient management of primary spontaneous pneumothorax: a prospective study.

We prospectively assessed the safety and cost saving of a small-bore drain based procedure for outpatient management of first episodes of primary spontaneous pneumothorax. Patients were managed by observation alone or insertion of an 8.5-F "pig-tail" drain connected to a one-way valve, according to size and clinical tolerance of the pneumothorax. All patients were reassessed after 4 h, on the first working day after discharge and on day 7. Patients still exhibiting air leak on day 4 underwent thoracoscopy. The primary end-point was complete lung re-expansion at day 7. 60 consecutive patients entered the study. 48 (80%) met the definition of large pneumothorax. The success rate was 83%. The 1-year recurrence rate was 17%. 36 (60%) patients were discharged after 4 h and 50% had full outpatient management. No severe complication was observed. The mean ± SD length of hospitalisation was 2.3 ± 3.1 days. This policy resulted in about a 40% reduction in hospital stay-related costs. The present study supports the use of a single system combined with a well-defined management algorithm including safe discharge criteria, as an alternative to manual aspiration or chest tube drainage. This approach participates in healthcare cost-savings.

Chitin-glucan improves important pathophysiological features of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most frequent and debilitating conditions leading to gastroenterological referrals. However, recommended treatments remain limited, yielding only limited therapeutic gains. Chitin-glucan (CG) is a novel dietary prebiotic classically used in humans at a dosage of 1.5-3.0 g/d and is considered a safe food ingredient by the European Food Safety Authority. To provide an alternative approach to managing patients with IBS, we performed preclinical molecular, cellular, and animal studies to evaluate the role of chitin-glucan in the main pathophysiological mechanisms involved in IBS. AIM: To evaluate the roles of CG in visceral analgesia, intestinal inflammation, barrier function, and to develop computational molecular models. METHODS: Visceral pain was recorded through colorectal distension (CRD) in a model of long-lasting colon hypersensitivity induced by an intra-rectal administration of TNBS [15 milligrams (mg)/kilogram (kg)] in 33 Sprague-Dawley rats. Intracolonic pressure was regularly assessed during the 9 wk-experiment (weeks 0, 3, 5, and 7) in animals receiving CG (n = 14) at a human equivalent dose (HED) of 1.5 g/d or 3.0 g/d and compared to negative control (tap water, n = 11) and positive control (phloroglucinol at 1.5 g/d HED, n = 8) groups. The anti-inflammatory effect of CG was evaluated using clinical and histological scores in 30 C57bl6 male mice with colitis induced by dextran sodium sulfate (DSS) administered in their drinking water during 14 d. HT-29 cells under basal conditions and after stimulation with lipopolysaccharide (LPS) were treated with CG to evaluate changes in pathways related to analgesia (µ-opioid receptor (MOR), cannabinoid receptor 2 (CB2), peroxisome proliferator-activated receptor alpha, inflammation [interleukin (IL)-10, IL-1b, and IL-8] and barrier function [mucin 2-5AC, claudin-2, zonula occludens (ZO)-1, ZO-2] using the real-time PCR method. Molecular modelling of CG, LPS, lipoteichoic acid (LTA), and phospholipomannan (PLM) was developed, and the ability of CG to chelate microbial pathogenic lipids was evaluated by docking and molecular dynamics simulations. Data were expressed as the mean ± SEM. RESULTS: Daily CG orally-administered to rats or mice was well tolerated without including diarrhea, visceral hypersensitivity, or inflammation, as evaluated at histological and molecular levels. In a model of CRD, CG at a dosage of 3 g/d HED significantly decreased visceral pain perception by 14% after 2 wk of administration (P < 0.01) and reduced inflammation intensity by 50%, resulting in complete regeneration of the colonic mucosa in mice with DSS-induced colitis. To better reproduce the characteristics of visceral pain in patients with IBS, we then measured the therapeutic impact of CG in rats with TNBS-induced inflammation to long-lasting visceral hypersensitivity. CG at a dosage of 1.5 g/d HED decreased visceral pain perception by 20% five weeks after colitis induction (P < 0.01). When the CG dosage was increased to 3.0 g/d HED, this analgesic effect surpassed that of the spasmolytic agent phloroglucinol, manifesting more rapidly within 3 wk and leading to a 50% inhibition of pain perception (P < 0.0001). The underlying molecular mechanisms contributing to these analgesic and anti-inflammatory effects of CG involved, at least in part, a significant induction of MOR, CB2 receptor, and IL-10, as well as a significant decrease in pro-inflammatory cytokines IL-1b and IL-8. CG also significantly upregulated barrier-related genes including muc5AC, claudin-2, and ZO-2. Molecular modelling of CG revealed a new property of the molecule as a chelator of microbial pathogenic lipids, sequestering gram-negative LPS and gram-positive LTA bacterial toxins, as well as PLM in fungi at the lowesr energy conformations. CONCLUSION: CG decreased visceral perception and intestinal inflammation through master gene regulation and direct binding of microbial products, suggesting that CG may constitute a new therapeutic strategy for patients with IBS or IBS-like symptoms.

Bone Marrow Adiposity Alterations in Postmenopausal Women With Type 2 Diabetes Are Site-Specific.

Context: Bone marrow adiposity (BMAT) alterations in patients with type 2 diabetes mellitus (T2DM) may contribute to adverse bone effects. Objective: Characterization of BMAT content and composition in patients with well-controlled T2DM. Methods: This cross-sectional study included 2 groups of postmenopausal women: one with T2DM and the other without. The proton density fat fraction (PDFF) of the lumbar spine and proximal femur, comprising the femoral head, neck, and diaphysis, was assessed using chemical shift-based water-fat separation imaging (WFI). Magnetic resonance imaging with spectroscopy (1H-MRS) was performed in a subgroup of participants to confirm the PDFF measurements and determine the apparent lipid unsaturation level (aLUL) at the L3 vertebrae and femoral neck. The association of imaging-based PDFFs and aLUL between diabetes groups was investigated by adjusting for confounding factors using a linear mixed model. Results: Among 199 participants, patients with T2DM (n = 29) were significantly heavier (P < .001) and had a higher bone mineral density (BMD) (P < .001 for all sites) than nondiabetic patients (n = 170). When PDFFs were compared after adjusting for age, body mass index (BMI), and BMD, the femoral head WFI-based PDFF was lower in patients with T2DM (mean [standard error] 88.0% [0.7] vs 90.6% [0.3], P < .001). Moreover, the aLUL at the L3 vertebrae was lower in patients with T2DM (n = 16) than in without (n = 97) (mean [standard error] 3.9% [0.1] vs 4.3% [0.1], P = .02). Conclusion: The content and composition of BMAT are modified in postmenopausal women with T2DM and these changes occur at specific sites.

Association Between COVID-19 and Self-Harm: Nationwide Retrospective Ecological Spatiotemporal Study in Metropolitan France.

Background: The COVID-19 pandemic has not been associated with increases in suicidal behavior at the national, regional, or county level. However, previous studies were not conducted on a finer scale or adjusted for ecological factors. Objective: Our objective was to assess the fine-scale spatiotemporal association between self-harm and COVID-19 hospitalizations, while considering ecological factors. Methods: Using the French national hospital discharge database, we extracted data on hospitalizations for self-harm of patients older than 10 years (from 2019 to 2021) or for COVID-19 (from 2020 to 2021) in metropolitan France. We first calculated monthly standardized incidence ratios (SIRs) for COVID-19 between March 2020 and December 2021, using a Besag, York, and Mollié spatiotemporal model. Next, we entered the SIRs into an ecological regression in order to test the association between hospital admissions for self-harm and those for COVID-19. Lastly, we adjusted for ecological variables with time lags of 0 to 6 months. Results: Compared with a smoothed SIR of ≤1, smoothed SIRs from 1 to 3, from 3 to 4, and greater than 4 for COVID-19 hospital admissions were associated with a subsequent increase in hospital admissions for self-harm, with a time lag of 2 to 4 months, 4 months, and 6 months, respectively. Conclusions: A high SIR for hospital admissions for COVID-19 was a risk factor for hospital admission for self-harm some months after the epidemic peaks. This finding emphasizes the importance of monitoring and seeking to prevent suicide attempts outside the epidemic peak periods.

Detectability of use errors in summative usability tests of medical devices: Impact of the test environment.

The regulations on summative usability evaluations of medical devices (MDs) emphasize that the test environment must have sufficient ecological validity for generalization to real-life use. Here, we examined the influence of environmental fidelity (a component of ecological validity) on the detectability of MD use errors. A total of 140 participants participated in a summative usability evaluation of an anaphylactic shock auto-injector device under either a high-fidelity condition or a condition acceptable from the manufacturer's perspective, lower-fidelity condition. The numbers of errors detected in each condition were compared by applying descriptive statistics and logistic and Poisson multivariate regressions. We found that the level of fidelity did not influence the overall number of use errors detected but did influence the detection of certain use errors. To optimize the test environment and increase the detection of use errors, each environmental feature's role in the test task should first be examined.

Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP® DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study.

BACKGROUND: Irritable bowel syndrome (IBS), defined according to the Rome IV diagnostic criteria, is a chronic functional gastrointestinal disorder characterized by recurrent abdominal pain related to altered bowel habits. First-line recommended treatments are limited to combining drugs targeting predominant symptoms, particularly pain (antispasmodics), constipation (laxatives), and diarrhea (loperamide), yielding only a limited therapeutic gain. GASTRAP® DIRECT is a class IIa medical formulation composed of a combination of chitin-glucan and simethicone indicated for the symptomatic treatment of gas-related gastrointestinal disorders by combining different mechanisms of action. AIM: To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP® DIRECT treatment in patients with IBS. METHODS: In this prospective, multicenter, open-label trial, 120 patients with IBS received three sticks of GASTRAP® DIRECT (1.5 g/d of chitin-glucan and 0.75 mg/d of simethicone) per day for 4 weeks. The primary endpoint was the responder rate, defined as the number of patients whose abdominal pain score decreased by ≥ 30% from baseline to week (W) 4. The analysis was performed using the per-protocol set. Cardinal symptoms, impact of global symptoms on daily life, change in stool consistency, and improvement in defecatory disorders were evaluated. RESULTS: Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 ± 2.4 vs 2.9 ± 2.0, P < 0.0001). Similar improvements were observed for bloating [8.0 ± 1.7 vs 4.7 ± 2.9, P < 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 ± 2.1 vs 4.4 ± 3.1, P < 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 ± 2.0 vs 4.6 ± 2.9, P < 0.0001; 54% (95%CI: 44-64) responders]. Stool consistency improved in most patients (90% and 57% for patients with liquid and hard stools, respectively). Overall, 42% of patients with defecatory disorders reported very much/considerable improvements by W2. No severe adverse event occurred, and tolerability was rated "good" or "very good" by 93% of patients. CONCLUSION: GASTRAP® DIRECT is safe and well tolerated, alleviating IBS symptoms rapidly in 2 weeks. This open-label study suggests that the combination of chitin-glucan and simethicone could be beneficial in patients with IBS.

Multiple air pollutant exposure is associated with higher risk of all-cause mortality in dialysis patients: a French registry-based nationwide study.

Background: Little is known about the effect of combined exposure to different air pollutants on mortality in dialysis patients. This study aimed to investigate the association of multiple exposures to air pollutants with all-cause and cause-specific death in dialysis patients. Materials and methods: This registry-based nationwide cohort study included 90,373 adult kidney failure patients initiating maintenance dialysis between 2012 and 2020 identified from the French REIN registry. Estimated mean annual municipality levels of PM2.5, PM10, and NO2 between 2009 and 2020 were combined in different composite air pollution scores to estimate each participant's exposure at the residential place one to 3 years before dialysis initiation. Adjusted cause-specific Cox proportional hazard models were used to estimate hazard ratios (HRs) per interquartile range (IQR) greater air pollution score. Effect measure modification was assessed for age, sex, dialysis care model, and baseline comorbidities. Results: Higher levels of the main air pollution score were associated with a greater rate of all-cause deaths (HR, 1.082 [95% confidence interval (CI), 1.057-1.104] per IQR increase), regardless of the exposure lag. This association was also confirmed in cause-specific analyses, most markedly for infectious mortality (HR, 1.686 [95% CI, 1.470-1.933]). Sensitivity analyses with alternative composite air pollution scores showed consistent findings. Subgroup analyses revealed a significantly stronger association among women and fewer comorbid patients. Discussion: Long-term multiple air pollutant exposure is associated with all-cause and cause-specific mortality among patients receiving maintenance dialysis, suggesting that air pollution may be a significant contributor to the increasing trend of CKD-attributable mortality worldwide.

How do territorial characteristics affect spatial inequalities in the risk of coronary heart disease?

BACKGROUND: Cardiovascular diseases remain the leading cause of death and disabilities worldwide, with coronary heart diseases being the most frequently diagnosed. Their multifactorial etiology involves individual, behavioral and territorial determinants, and thus requires the implementation of multidimensional approaches to assess links between territorial characteristics and the incidence of coronary heart diseases. CONTEXT AND OBJECTIVES: This study was carried out in a densely populated area located in the north of France with multiple sources of pollutants. The aim of this research was therefore to establish complex territorial profiles that have been characterized by the standardized incidence, thereby identifying the influences of determinants that can be related to a beneficial or a deleterious effect on cardiovascular health. METHODS: Forty-four variables related to economic, social, health, environment and services dimensions with an established or suspected impact on cardiovascular health were used to describe the multidimensional characteristics involved in cardiovascular health. RESULTS: Three complex territorial profiles have been highlighted and characterized by the standardized incidence rate (SIR) of coronary heart diseases after adjustment for age and gender. Profile 1 was characterized by an SIR of 0.895 (sd: 0.143) and a higher number of determinants that revealed favorable territorial conditions. Profiles 2 and 3 were characterized by SIRs of respectively 1.225 (sd: 0.242) and 1.119 (sd: 0.273). Territorial characteristics among these profiles of over-incidence were nevertheless dissimilar. Profile 2 revealed higher deprivation, lower vegetation and lower atmospheric pollution, while profile 3 displayed a rather privileged population with contrasted territorial conditions. CONCLUSION: This methodology permitted the characterization of the multidimensional determinants involved in cardiovascular health, whether they have a negative or a positive impact, and could provide stakeholders with a diagnostic tool to implement contextualized public health policies to prevent coronary heart diseases.