Mid-term evaluation of the surgical management of patulous Eustachian tube dysfunction: a STROBE observational study.

INTRODUCTION: Patulous Eustachian tube (PET) is a condition affecting approximately 0.3% to 6.6% of the population, with autophony being the predominant complain. The management of PET lacks a well-defined standard in the literature as no effective medical treatments have been documented but various surgical options are available. This study aims to report mid-term outcomes following surgical management of PET. MATERIALS AND METHODS: All patients who underwent surgical intervention for PET between September 2017 and June 2022 were enrolled. Data encompassing general demographics, quality of life (GBI), and procedure-specific data were collected. RESULTS: A total of 30 PET cases (in 19 patients) underwent surgical intervention including 9 injections of hyaluronic acid, 13 fat injections, 6 endoscopic shim insertions, 1 cartilage graft, and 1 injection of hydroxy apatite. After an average follow-up of 22 ± 14 months, 16 cases (53%) achieved complete symptom relief, while 8 cases (26.6%) reported partial relief. Additionally, 11(36%) cases required multiple surgeries. No specific surgical technique demonstrated superiority. Quality of life improved in 77% of cases based on 10 out of 13 GBI collected. Recurrence of PET symptoms occurred on average 10.6 ± 9.7 months after initial surgery, with an estimated global risk of 75% at 3 years. Transient serous otitis media was observed in only 4 cases (13.3%). CONCLUSION: Surgical intervention for PET was found to be effective, achieving complete symptom relief in 53% of cases and significantly improving quality of life 2 years post-surgery. However, a substantial portion of cases necessitated one or more re-interventions. The durability of effectiveness appears to diminish over time.

Nationwide Study in France To Predict One Year Major Bleeding and Validate the OAC3-PAD Score in Patients Undergoing Revascularisation for Lower Extremity Arterial Disease.

OBJECTIVE: Antithrombotic strategies are currently recommended for the treatment of lower extremity artery disease (LEAD) but specific scores to assess the risk of bleeding in these patients are scarce. To fill the gap, the OAC3-PAD bleeding score was recently developed and validated in German cohorts. The aim of this study was to determine whether this score performs appropriately in another real world nationwide cohort. METHODS: This 10 year retrospective, multicentre study based on French national electronic health data included patients who underwent revascularisation for LEAD between January 2013 and June 2022. The OAC3-PAD score was calculated and from this, the population was classified into four groups: low, low to moderate, moderate to high and high risk. A binary logistic regression model was applied, with major bleeding occurring at one year (defined using the International Classification of Diseases ICD-10) as the dependent variable. The performance of the OAC3-PAD bleeding score was investigated using a receiver operating characteristic curve. RESULTS: Among 161 205 patients hospitalised for LEAD treatment in French institutions, the one year incidence of major bleeding was 13 672 patients (8.5%). The distribution of the population according to the OAC3-PAD bleeding score was: 88 835 patients (55.1%), 34 369 (21.3%), 27 914 (17.3%), and 10 087 (6.3%) in the low, low to moderate, moderate to high, and high risk groups, respectively; with an incidence of one year major bleeding of 5.0%, 9.8%, 13.2%, and 21.3%. The OAC3-PAD model achieved an AUC of 0.650 to predict one year major bleeding following LEAD repair (95% CI 0.645 - 0.655), with a sensitivity of 0.67 and a specificity of 0.57. CONCLUSION: This nationwide analysis confirmed the accuracy of the OAC3-PAD model to predict one year major bleeding and served as external validation. Although further studies are required, it adds evidence and perspectives to further generalise its use to guide the management of patients with LEAD.

Psychological Distress and Tobacco Use Among Hospital Workers During COVID-19.

Background and Aims: This work aims to assess the impact of the COVID-19 pandemic on hospital workers' psychological parameters and attitudes toward substance use, before and during the French COVID-19 lockdown. Methods: An online survey was proposed to the staff of the University Hospital of Nice and Sainte-Marie psychiatric hospital in France from May 18 to June 6, 2020 assessing changes in daily habits, psychological distress and changes in substance use, including smoking. Results: A total of 702 respondents (80.3% female) filled out the survey. Overall, most of the workers reported increased stress, irritability, sadness, decreased motivation, and a worse quality of sleep after the beginning of the COVID-19 lockdown. Additionally, hospital workers who were more likely to use tobacco during the COVID-19 lockdown reported increased sadness (OR = 1.23, p < 0.001), loss of motivation (OR = 0.86, p < 0.05), alcohol consumption (OR = 3.12, p < 0.001), lower incomes (OR = 1.69, p < 0.05), living alone (OR = 1.77, p < 0.001) and doing less physical activity (OR = 0.36, p < 0.001). Conclusion: During the first lockdown, significant psychological changes (sadness, distress, irritability) associated with changes in tobacco use and physical activity were reported. Such results should encourage hospital leaders to implement dedicated policies to better accompany hospital workers' psychological distress.

Procalcitonin and C-Reactive Protein/Procalcitonin Ratio as Markers of Infection in Patients With Solid Tumors.

Objectives: The roles of procalcitonin (PCT) and C-reactive protein (CRP) in febrile cancer patients is currently unclear. Our aim was to assess these in febrile patients with solid tumors and to identify cut-off values for ruling out infection. Methods: We retrospectively evaluated patients with solid tumors admitted to hospital due to fever. They were divided into those with Fever with microbiologically documented infection (FMDI), Fever with clinically documented infection (FCDI) and Tumor-related fever (TRF). PCT and CRP levels were compared. Receiver-operating curves were plotted to define the best cut-off values for discriminating between infection-related and cancer-related fever. Results: Between January 2015 to November 2018, 131 patients were recorded (mean age 68 years, 67% male, 86% with metastasis). Patients with FMDI or FCDI had significantly higher baseline levels of PCT and lower CRP/PCT than those with TRF. A PCT cut-off value of 0.52 ng/mL for discriminating between infection and cancer-associated fever yielded 75% sensitivity, 55% specificity, 77% positive predictive value (PPV), and 52% negative predictive value (NPV). A CRP/PCT ratio with a cut-off value of 95 showed 56% sensitivity, 70% specificity, 79% NPV, and 44% PPV. Discussion: PCT is a sensitive marker of sepsis or localized infection in patients with solid tumors, but its specificity is poor. The CRP/PCT ratio improves specificity, thus providing a reliable means of ruling out infection for values above 95.

Colorectal Cancer Risk Following Bariatric Surgery in a Nationwide Study of French Individuals With Obesity.

Importance: Although bariatric surgery is effective against morbid obesity, the association of this surgery with the risk of colorectal cancer remains controversial. Objective: To assess whether bariatric surgery is associated with altered risk of colorectal cancer among individuals with obesity. Design, Setting, and Participants: This retrospective, population-based, multicenter, cohort study based on French electronic health data included 1 045 348 individuals with obesity, aged 50 to 75 years, and free of colorectal cancer at baseline. All inpatients with obesity having data recorded during a hospital stay between 2009 and 2018 by the French national health insurance information system database were followed up for a mean (SD) of 5.3 (2.1) years for those who did not undergo bariatric surgery and 5.7 (2.2) years for those who underwent bariatric surgery. Two groups of patients comparable in terms of age, sex, body mass index, follow-up, comorbidities, and conditions who did or did not undergo surgery were also obtained by propensity score matching. Exposures: Bariatric surgery (n = 74 131), including adjustable gastric banding, sleeve gastrectomy, gastric bypass; or no bariatric surgery (n = 971 217). Main Outcomes and Measures: Primary outcome was incident colorectal cancer. Standardized incidence ratios were calculated using age-, sex-, and calendar year-matched colorectal cancer incidence among the general French population during the corresponding years. Secondary outcome was incident colorectal benign polyps. Results: Among a total of 1 045 348 patients, the mean (SD) age was 57.3 (5.5) years for the 74 131 patients in the surgical cohort vs 63.4 (7.0) years for the 971 217 patients in the nonsurgical cohort. The mean (SD) follow-up was 6.2 (2.1) years for patients who underwent adjustable gastric banding, 5.5 (2.1) years for patients who underwent sleeve gastrectomy, and 5.7 (2.2) years for patients who underwent gastric bypass. In total, 13 052 incident colorectal cancers (1.2%) and 63 649 colorectal benign polyps were diagnosed. The rate of colorectal cancer was 0.6% in the bariatric surgery cohort and 1.3% in the cohort without bariatric surgery. In the latter cohort, 9417 cases were expected vs 12 629 observed, a standardized incidence ratio of 1.34 (95% CI, 1.32-1.36). In the bariatric surgery cohort, 428 cases were expected and 423 observed, a standardized incidence ratio of 1.0 (95% CI, 0.90-1.09). Propensity score-matched hazard ratios in comparable operated vs nonoperated groups were 0.68 (95% CI, 0.60-0.77) for colorectal cancer and 0.56 (95% CI, 0.53-0.59) for colorectal benign polyp. There were fewer new diagnoses of colorectal cancer after gastric bypass (123 of 22 343 [0.5%]) and sleeve gastrectomy (185 of 35 328 [0.5%]) than after adjustable gastric banding (115 of 16 460 [0.7%]), and more colorectal benign polyps after adjustable gastric banding (775 of 15 647 [5.0%]) than after gastric bypass (639 of 20 863 [3.1%]) or sleeve gastrectomy (1005 of 32 680 [3.1%]). Conclusion and Relevance: The results of this nationwide cohort study suggested that following bariatric surgery, patients with obesity share the same risk of colorectal cancer as the general population, whereas for patients with obesity who do not undergo bariatric surgery, the risk is 34% above that of the general population.

Validation of a rapid and easy-to-perform screening test for neurocognitive impairment in HIV+ patients.

OBJECTIVE: Information Processing Speed (IPS) is one of the earliest cognitive domains impaired in both multiple sclerosis (MS) and HIV-infected patients. Our aim was to study whether the Computerized Speed Cognitive Test (CSCT), an ultra-rapid tool which detects IPS impairment and is already used in MS subjects, could also be useful to screen for HIV-associated neurocognitive disorders (HAND). METHODS: The Neuracog study was an open-label prospective trial conducted in Nice and Cannes hospitals. Each patient performed a wide range of neuropsychological (NP) tests. Patients were defined as no-HAND or HAND. Groups were compared to measure sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CSCT for detecting HAND. RESULTS: Eighty-six subjects were included (26 women, 60 men, mean age: 53.1 years). HAND was diagnosed in 67/86 patients. The CSCT z-score showed a highly significant difference between the no-HAND and the HAND groups (No HAND mean: -0.1, SD: 1.0 versus HAND mean: -1.1, SD: 1.6; p = .002). The sensitivity, specificity, PPV and NPV were 81%, 53%, 86% and 43%, respectively. CONCLUSIONS: The CSCT is an easy-to-perform test allowing detection of mild forms of HAND, to be considered among screening tools for neurocognitive impairment.

Health outcomes of the July 14, 2016 Nice terror attack among hospital-based professionals and students: the « ECHOS de Nice ¼ health survey protocol.

BACKGROUND: The terror attack of July 14, 2016, in Nice, France, resulted in 86 deaths, including children, and several hundred wounded, with a major psychological impact on the population. Hospital staff had to cope with exceptional circumstances which made them vulnerable to detrimental effects on their own health. This paper describes the method that was selected for the survey entitled "ECHOS de Nice 14 Juillet" which aimed to assess the impact of the attack on the psychological, psycho-traumatic and somatic health condition of the Nice University and Lenval hospital staff who were directly or indirectly exposed to the attack, and also to describe the support and care facilities they were offered. METHOD: ECHOS de Nice 14 juillet is an observational, cross-sectional, multicentre study focusing on all the hospital staff and students of both institutions, i.e. 10,100 persons in June 2017. A web-based questionnaire based on the model developed by Santé Publique France (IMPACTS and ESPA 13 novembre 2015) was adapted to the contexts of the healthcare professionals and students employed in these healthcare institutions in Nice and published on line from June 21 to October 30, 2017. The paper describes the tools that were used to meet the aims of the study, i.e. identification of exposure categories ('civilian' exposure for those present during the attack and/or 'professional' exposure); indicators of psychological impact (anxiety, depression, burnout, compassion fatigue, suicidal states, tobacco and alcohol use, self-medications), psycho-traumatic and somatic impact; professional and social impact. Lastly, awareness of availability and use of psychological support and care-follow-up facilities by professionals were investigated. Respondents could include extensive qualitative comments on the various themes explored in the questionnaire, with text analysis complementing that of quantitative data. DISCUSSION: The benefits and limitations of the selected methodology are discussed, in view of contributing useful information to help anticipate and manage health issues among hospital staff who have been victims of traumatic events.

Preventive effect of bariatric surgery on type 2 diabetes onset in morbidly obese inpatients: a national French survey between 2008 and 2016 on 328,509 morbidly obese patients.

BACKGROUND: The association between bariatric surgery (BS) and the prevention of type 2 diabetes (T2D) and its complications in patients with obesity has been rarely addressed in large, nationwide database studies. OBJECTIVE: To estimate the preventive effect of BS against T2D and its vascular complications in patients with obesity without co-morbidity at baseline. SETTING: All French public and private hospitals. METHODS: Data were extracted from the French National Health Service database between 2008 and 2016. All patients with obesity aged 18- to 60-years old, free of T2D and major co-morbidities, and with at least 1 year of follow-up were analyzed. Patients who had undergone gastric bypass (GB), sleeve gastrectomy (SG), or adjustable gastric banding (AGB) were included in the BS group, and patients with obesity with no history of BS were considered as controls. RESULTS: Of 328,509 patients with obesity, 102,627 had BS. Between 2009 and 2016, 9.7% (31,946/328,509) of patients had a diagnosis of T2D associated with morbid obesity, 13.2% of the control group versus 2.0% of the BS group (P < .001). BS was associated with favorable 8-year T2D event-free survival estimates of 92.3% in the BS group against 58.2% in the control group. The hazard ratio for the diagnosis of T2D was .18 (95% confidence interval, .17-.19) for the BS group versus controls, after adjustment on age, sex, body mass index, and baseline differences. A significant difference was found between the type of bariatric procedure (P < .001) with more T2D after AGB (4.5%) than after GB (1.2%) or SG (0.9%). T2D complications were more common in controls (P < .001) with multiple T2D complications occurring in 1% of patients in the control group and .1% in the BS group (P < 0.001). GB and SG were more effective than AGB. CONCLUSIONS: This nationwide study shows that BS reduces the new onset of T2D in patients with obesity by 82%. SG and GB give comparable results and both are more effective than AGB.

Anemia and Bariatric Surgery: Results of a National French Survey on Administrative Data of 306,298 Consecutive Patients Between 2008 and 2016.

BACKGROUND: Bariatric surgery (BS) has grown exponentially in France, and long-term anemia due to micronutrient deficiencies has become common. OBJECTIVES: The objective of this study was to assess the long-term risk of anemia after BS and to investigate the factors associated with the occurrence of this complication. MATERIALS AND METHODS: Data from the French National Health Service database on patients who had undergone gastric bypass (GB), sleeve gastrectomy (SG), or adjustable gastric banding (AGB), between 2008 and 2016 were extracted. Only patients with a primary intervention were considered. RESULTS: Data from 306,298 patients (143.733 SG, 79.188 GB, and 36.413 AGB) were analyzed. Overall, 12.930 of them (5.0%) had a diagnosis of anemia due to micronutrient deficiencies as main diagnosis or related diagnosis at time of a hospital stay between 2008 and 2016. In multivariate analysis, GB surgery, female gender, age younger than 52 years, and 25-OH vitamin D deficiency were positively associated with the occurrence of anemia whereas hospital procedural volume was negatively associated. The risk to be diagnosed with anemia after BS was 13.0% after a GB, 5.6% after a SG and 4.0% after an AGB (Log-rank p < 0.0001). The hazard ratio for anemia after GB compared to SG was 2.0 (95% CI 1.9-2.1), adjusted for age and gender. CONCLUSION: In France, between 2008 and 2016, 5% of patients had anemia after BS. The risk to develop anemia was 2-fold higher after a GB than after a SG. Young women should be particularly aware of this long-term risk.

Generating and characterizing the mechanical properties of cell-derived matrices using atomic force microscopy.

Mechanical interaction between cells and their surrounding extracellular matrix (ECM) controls key processes such as proliferation, differentiation and motility. For many years, two-dimensional (2D) models were used to better understand the interactions between cells and their surrounding ECM. More recently, variation of the mechanical properties of tissues has been reported to play a major role in physiological and pathological scenarios such as cancer progression. The 3D architecture of the ECM finely tunes cellular behavior to perform physiologically relevant tasks. Technical limitations prevented scientists from obtaining accurate assessment of the mechanical properties of physiologically realistic matrices. There is therefore a need for combining the production of high-quality cell-derived 3D matrices (CDMs) and the characterization of their topographical and mechanical properties. Here, we describe methods that allow to accurately measure the young modulus of matrices produced by various cellular types. In the first part, we will describe and review several protocols for generating CDMs matrices from endothelial, epithelial, fibroblastic, muscle and mesenchymal stem cells. We will discuss tools allowing the characterization of the topographical details as well as of the protein content of such CDMs. In a second part, we will report the methodologies that can be used, based on atomic force microscopy, to accurately evaluate the stiffness properties of the CDMs through the quantification of their young modulus. Altogether, such methodologies allow characterizing the stiffness and topography of matrices deposited by the cells, which is key for the understanding of cellular behavior in physiological conditions.

Is the psychological impact of genetic testing moderated by support and sharing of test results to family and friends?

Receiving the results of genetic tests for a breast and ovarian cancer susceptibility can be a stressful experience. Here we studied the effects of social support (SS) and the sharing of test results on the psychological impact of BRCA1/2 test result disclosure. We also compared carriers and non-carriers on sharing, SS and psychological impact. Five-hundred and twenty-two unaffected women were followed prospectively for 2 years after receiving their test results. Psychological impact was measured on the impact of event scale. Multivariate multi-level models were used, and all the analyses were stratified depending on mutation status (carriers vs non-carriers). Two weeks after receiving their BRCA1/2 results, carriers had shared their test results less frequently than non-carriers (p < 0.01). Sharing test results was not significantly associated with psychological impact. Availability of SS was significantly associated with better psychological adjustment across time among carriers (p < 0.01), but not among non-carriers. For female BRCA1/2 mutation carriers, the importance of SS should be stressed, and possible ways of enlisting people in their entourage for this purpose should be discussed in the context of clinical encounters.

Development of a scale for assessing respondents' perceptions of health research questionnaires (the REP-HQ Scale).

OBJECTIVE: To develop a scale for assessing Respondents' Perceptions of Health Research Questionnaires (the REP-HQ Scale) and test this scale psychometrically. STUDY DESIGN AND SETTING: A scale was drawn, based on detailed content analysis of patients' free comments, which were collected prospectively in a 2-year cohort study (n=228). The questionnaire corresponding to this scale was subsequently completed by a cohort of female BRCA1/2 carriers/noncarriers not affected by cancer, who had been followed up for 5 years since test result disclosure (n=246). Principal component analysis, Cronbach's alpha coefficient, and Pearson's correlations were used in the statistical analyses. RESULTS: The perceived effects that emerged from the respondents' responses were analyzed and classified under the headings: "Useful medical information," "Usefulness of research," and "Labeling intrusion." Cronbach's alpha coefficients on the three dimensions were 0.75, 0.64, and 0.56, respectively. Carriers obtained lower scores than noncarriers on the first dimension (P=0.005) and on the overall score (P=0.002). CONCLUSIONS: The REP-HQ scale is the first generic tool to be developed for assessing participants' perceptions about the effects of health research questionnaires. Further testing is now required to confirm the validity of the findings obtained here by applying this tool in other settings.

Spontaneous disclosure of BRCA1/2 genetic test results to employers: a French prospective study.

The aim of this study was to examine the patterns of disclosure of BRCA1/2 genetic test results to employers by unaffected carriers. In a national prospective cohort study on unaffected BRCA1/2 mutation carriers, disclosure to employers was assessed prospectively, using self-administered questionnaires, up to 2 years after their test results were delivered by cancer geneticists. Kaplan-Meier curves and Cox-regression analysis were used to assess the factors associated with time to disclosure to the employer. Mean age of the 146 women BRCA1/2 carriers who were employed when their test results were delivered was 37.1 years (range: 19-57). At the end of the second year of follow-up, 47 of them (32.2%) had disclosed their results to their employers; median time to disclosure was 6 months. Reasons spontaneously expressed were first to inform the employer that medical surveillance/surgery was necessary for cancer risk management although these carriers did not actually have cancer. After multivariate adjustment on age, women with a lower educational level (HRadj=2.00, P=0.026) and those who had undergone prophylactic surgery during the 2 years of follow-up (HRadj=2.18, P=0.019) had disclosed their BRCA status to their employers earlier and more frequently. One-third of the female carriers not affected by breast/ovarian cancer disclosed their BRCA1/2 genetic test results spontaneously to their employers, mainly to inform them that they were disease-free but required medical surveillance or a surgical intervention to reduce the risk of cancer.

BRCA1/2 carriers: their childbearing plans and theoretical intentions about having preimplantation genetic diagnosis and prenatal diagnosis.

PURPOSE: To assess the impact of BRCA1/2 test results on carriers' reproductive decision-making and the factors determining their theoretical intentions about preimplantation genetic diagnosis (PGD) and prenatal diagnosis (PND). METHODS: Unaffected BRCA1/2 mutation carriers of childbearing age (N = 605; 449 women; 151 men) were included at least 1 year after the disclosure of their test results in a cross-sectional survey nested in a national cohort. Multivariate adjustment was performed on the data obtained in self-administered questionnaires. RESULTS: Response rate was 81.0%. Overall, 32.5% and 50% said that they would undergo PGD/PND, respectively, at a theoretical next pregnancy, whereas only 12.1% found termination of pregnancy (TOP) acceptable. Theoretical intentions toward PGD did not depend on gender/age, but were higher among those with no future childbearing plans (adjusted odds ratio (AOR) 95% confidence interval (CI): 3.5 (1.9-6.4)) and those having fewer relatives with cancer (AOR 1.5 95% CI (1.0-2.3)). Greater TOP acceptability was observed among males and those with lower educational levels; 85.4% of respondents agreed that information about PGD/PND should be systematically delivered with the test results. CONCLUSIONS: The closer to reproductive decision-making BRCA1/2 carriers are, i.e., when they are more likely to be making future reproductive plans, the less frequently they intend to have PGD. Carriers' theoretical intentions toward PND are discussed further.