French Prospective Cohort Study Research Articles

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey

IntroductionChronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent condition affecting approximately 2% of the population. Medical treatment consists long-term use of intranasal corticosteroids and short-term use of oral corticosteroids,...

Evaluation of patients’ expectation and benefits of sublingual Named-Patient Products in the treatment of allergic respiratory diseases: The French ERAPP prospective cohort study

Evaluation of patients’ expectation and benefits of sublingual Named-Patient Products in the treatment of allergic respiratory diseases: The French ERAPP prospective cohort study

Maternal and neonatal outcomes of French prospective multicenter cohort study COVIPREG during the first two COVID-19 waves

BackgroundSARS-CoV-2 infection on pregnant women was the subject of many questions since the COVID-19 pandemic. MethodsWe aim to assess maternal and neonatal outcomes of SARS-CoV-2 infection contracted during 2nd and 3rd trimesters of pregnancy during the first two COVID-19 waves across a prospective French multicenter cohort study. Patients were included between April 2020 and January 2021 in 10 maternity hospitals in Paris area with two groups (i) pregnant women with a positive SARS-CoV-2 nasopharyngeal RT-PCR between [14WG; 37WG[(symptomatic infection), (ii) pregnant women with a negative serology (or equivocal) at delivery and without a positive SARS-CoV-2 nasopharyngeal RT-PCR at any time during pregnancy (G2 group) Main findings2410 pregnant women were included, of whom 310 had a positive SARS-CoV-2 nasopharyngeal RT-PCR and 217 between [14WG; 37WG[. Most infections occurred between 28 and 37 weeks of gestation (56 %). Most patients could be managed as outpatients, while 23 % had to be hospitalized. Among women with a positive RT-PCR, multiparous women were over-represented (OR = 2.45[1.52;3.87]); were more likely to deliver before 37 weeks of gestation (OR = 2.19[1.44;3.24]) and overall cesarean deliveries were significantly increased (OR = 1.53[1.09;2.13]). ConclusionsThis study highlights the maternal, obstetrical, and neonatal burden associated with SARS-CoV-2 infections during the first two pandemic waves before availability of vaccines. Trial registrationNCT04355234 (registration date: 21/04/2020)

Comparative effectiveness of empirical antibiotic treatments in methicillin-susceptible Staphylococcus aureus infective endocarditis: A post hoc analysis of a prospective French cohort study

ObjectivesThe empirical treatment of infective endocarditis is still debated. The aim of this study was to compare the impact of empirical treatment with antistaphylococcal penicillin (ASP) or cefazolin vs. other treatments in methicillin-susceptible Staphylococcus aureus (MSSA) endocarditis. MethodsA post hoc analysis of a prospective cohort study of patients hospitalized in a French reference centre with MSSA endocarditis was conducted between 2013 and 2022. The primary outcome was the duration of bacteraemia under treatment. ResultsOf the 208 patients included, 101 patients (48.6%) were classified in the reference group (ASP or cefazolin) and 107 (52.4%) in the non-reference group. Empirical treatment with ASP/cefazolin was associated with a shorter duration of bacteraemia compared to other treatments (3.6 d vs. 4.6 d, P = 0.01). This difference was not corrected by the addition of an aminoglycoside (3.6 d vs. 4.7 d, P < 0.01). In multivariate analysis, empirical treatment with ASP/cefazolin was associated with a duration of bacteraemia ≤72 h (P = 0.02), whereas endocarditis on native valves (P = 0.01), and intracardiac abscess were associated with longer duration of bacteraemia (P = 0.01). ConclusionsEmpirical treatment of endocarditis with ASP or Cefazolin is more effective than other treatments in MSSA endocarditis, even when the other treatments are combined with aminoglycosides.

Impact of metastatic epidural spinal cord compression (MESCC) and pathological vertebral compression fracture (pVCF) in neurological and survival prognosis

BackgroundMetastatic epidural spinal cord compression (MESCC) and pathological vertebral compression fractures (pVCF) are the most serious debilitating morbidities of spine metastases (SpMs) causing devastating neurological damages. The respective impact of these two metastasis-spreading entities on survival and on neurological damage is debated. MethodsA French prospective cohort study collected 279 consecutive patients presenting with SpMs between January 2017 and 2021. We compared 174 patients with MESCC and 105 patients with pVCF. ResultsThe median Overall Survival (OS) for the MESCC group was 13.4 months (SD 1.5) vs 19.2 months (SD 2.3) for pVCF patients (p = 0.085). Sixty-five patients (23.3 %) were operated on: 49/65 (75.4 %) in the MESCC group and 16/65 (15.2 %) in the pVCF group, p < 0.0001. At 6 months FU, in the MESCC group, 21/44 (45.4 %) of non-ambulatory patients at onset improved to ambulatory status (Frankel D-E) vs 10/13 (76.9 %) in the pVCF group (p = 0.007). In multivariable analysis with the Cox proportional hazard model, good ECOG-PS and SINS Score 7–12 [HR: 6.755, 95 % CI 2.40–19.00; p = 0.001] were good prognostic factors for preserved ambulatory neurological status. However, SpMs diagnosed synchronously with the primary tumor [HR: 0.397, 95 % CI 0.185–0.853; p = 0.018] and MESCC [HR: 0.058, 95 % CI 0.107–0.456; p = 0.007] were independent risk factors for impaired neurological function. ConclusionContrary to pVCF, MESCC causes neurological damage. Nevertheless, neurological recovery remains possible. MESCC and pVCF have no impact on survival. The management of MESCC remains to be clarified and optimized to reduce neurological damage.

Women with severe postpartum hemorrhage have a decreased endogenous thrombin potential before delivery

BackgroundSevere postpartum hemorrhage (PPH), defined as a blood loss ≥1000 mL, is associated with maternal morbidity and mortality. ObjectivesWe aimed at characterizing coagulation properties of predelivery plasmas from pregnant women with thrombin generation assay and hemostatic biomarkers (plasminogen activator inhibitor-1, tissue factor [TF], and thrombomodulin). MethodsA nested case-control study was conducted within the “Study of Biological Determinants of Bleeding Postpartum,” a French prospective cohort study, in order to compare women with severe PPH (cases) and controls matched for age, body mass index, term, and mode of delivery. Plasma was collected at entry in the delivery room, and blood loss was measured objectively. The predelivery endogenous thrombin generation potential (ETP) was measured in plasma using calibrated automated thrombinography and low TF concentration. Hemostatic biomarkers were measured using ELISA kits. ResultsA total of 142 women (71 cases and 71 controls) were investigated. There was no difference in the median lag phase, thrombin peak, and time to peak between cases and controls. However, median predelivery ETP was lower in cases than in controls (2170 vs 2408 nM.min, P < .0001), independently of mode of delivery and PPH etiology. Median plasminogen activator inhibitor-1 and TF levels were higher in cases compared with controls (107.4 vs 68.1 ng/mL, P = .0003; 34.4 vs 27.4 pg/mL, P = .007), whereas thrombomodulin levels did not differ between the 2 groups. ConclusionAmong thrombin generation assay parameters, predelivery ETP levels may have a predictive value for severe PPH.

Prevalence of sleep apnoea in patients with type 1 diabetes and its association with comorbidities and diabetic complications: A French nationwide prospective study.

To investigate sleep apnoea prevalence, factors influencing severity, and associations between sleep apnoea severity and micro-/macrovascular complications in a large population of patients with type 1 diabetes. This French multicentre prospective cohort study was conducted between July 2016 and June 2020. Adults with type 1 diabetes using an insulin pump were eligible. Home care provider nurses collected demographic and clinical data and set up oximetry to determine the oxygen desaturation index (ODI). No, mild-moderate and severe sleep apnoea were defined as ODI <15 events/h, 15 to <30 events/h and ≥30 events/h, respectively. Univariate and multivariate analyses were performed to identify factors associated with sleep apnoea, and associations between sleep apnoea severity and micro-/macrovascular complications were determined using logistic regression. Of 769 participants, 12.4% and 3.4% had mild-to-moderate or severe sleep apnoea, respectively. Factors significantly associated with sleep apnoea on multivariate analysis were age, sex, body mass index (BMI) and hypertension. After adjustment for age, sex and BMI, presence of severe sleep apnoea was significantly associated with macrovascular complications (odds ratio vs. no sleep apnoea: 3.96 [95% confidence interval 1.43-11.11]; P< 0.01), while mild-to-moderate sleep apnoea was significantly associated with presence of diabetic retinopathy (odds ratio 2.09 [95% confidence interval 1.10-3.74]; P< 0.01). Sleep apnoea is a significant comorbidity in patients with type 1 diabetes, especially with respect to diabetic complications. This highlights the need for sleep apnoea screening and management in these individuals.

Very Preterm Children Gut Microbiota Comparison at the Neonatal Period of 1 Month and 3.5 Years of Life.

Prematurity is a risk factor for dysbiosis of the gut microbiota due to particular birth conditions and frequent prolonged hospitalization of neonates. Although gut microbiota colonization after birth and its establishment during the hospitalization period have been studied in preterm infants, data on gut microbiota following discharge, particularly during early childhood, are scarce. The present study investigated the relationship between gut microbiota at 1 month after birth (hospitalization period) and 3.5 years of age in 159 preterm children belonging to the French EPIFLORE prospective observational cohort study. Analysis using bacterial 16S rRNA gene sequencing showed that the gut microbiota of preterm neonates at 1 month was highly variable and characterized by six distinct enterotypes. In contrast, the gut microbiota of the same children at 3.5 years of age showed less variability, with only two discrete enterotypes. An absence of association between enterotypes at 1 month and 3.5 years of age was observed. While the alpha diversity of gut microbiota significantly increased between 1 month and 3.5 years of age, for both alpha and beta diversities, there was no correlation between the 1-month and 3.5-years time points. Comparison at 3.5 years between children born either preterm (n = 159) or full-term (n = 200) showed no differences in terms of enterotypes, but preterm children harbored a lower Shannon diversity index and a different overall composition of microbiota than full-term children. This study suggests that the characteristics of the early gut microbiota of preterm children are not predictive of the microbial community composition at 3.5 years of age. However, the impact of gestational age is still noticeable on the gut microbiota up to 3.5 years of age.

ID:16561 Non-Permanent Peripheral Nerve Stimulators for Treatment of Postoperative-Related Chronic Pain

Although chronic post-surgical pain may be a relatively new phenomenon, it has become a significant cause of poor quality of life for many people. Almost 90% of adults who had undergone surgery experienced acute pain, and, as a result of suboptimal acute pain management, 74% of those continued to have pain after discharge [1,2]. One French prospective cohort study exemplified that the highest mean chronic pain scores were observed in knee arthroscopy and thoracotomy [1]. Another study found that 58% had chronic post-op pain after a total knee arthroplasty [3].

Neurodevelopment at 5 years of age for preterm-born children according to mode of conception: a cohort study

Preterm delivery is a risk factor for suboptimal neurodevelopment. Pregnancies conceived after medically assisted reproduction-which includes invitro fertilization, with or without intracytoplasmic insemination, and induction of ovulation followed by intrauterine insemination or timed intercourse-have a higher risk of preterm delivery. Few studies have evaluated the outcome at >2 years of age of such preterm-born children. To evaluate neurodevelopmental outcome at 5½ years of age of children born preterm according to the mode of conception (spontaneous vs medically assisted reproduction). A total of 4349 children born between 24 and 34 weeks of gestation who survived to 5½ years of age in the 2011 French prospective national cohort study "EPIPAGE-2" were included: 814 in the medically assisted reproduction group (433 by invitro fertilization, with or without intracytoplasmic insemination, and 381 by induction of ovulation) and 3535 in the spontaneously conceived group. The studied neurodevelopmental outcomes were sensory (hearing and vision) impairments, cerebral palsy, cognition, and developmental coordination disorders. Multivariate analyses were performed with generalized estimating equation models adjusted for gestational age, antenatal steroids, and social characteristics. All analyses were performed following multiple imputation. Sensitivity analyses were performed with the populations of singletons and cases with complete data. No differences in cerebral palsy (adjusted odds ratio, 1.00; 95% confidence interval, 0.67-1.49), neurodevelopmental impairment (adjusted odds ratio, 1.09; 95% confidence interval, 0.82-1.45), or developmental coordination disorders (adjusted odds ratio, 0.75; 95% confidence interval, 0.50-1.12) were found between children born following medically assisted reproduction and children born following spontaneous conception after adjustment for sociodemographic factors. For proportions of children with an intelligence quotient below 1 and 2 standard deviations, there were no differences between those born after medically assisted reproduction and those born after spontaneous pregnancy (respectively, adjusted odds ratio, 0.99; 95% confidence interval, 0.80-1.23 and adjusted odds ratio, 1.14; 95% confidence interval, 0.83-1.56). In subgroup analyses, no differences were observed between children born following induction of ovulation or invitro fertilization and those conceived spontaneously. Sensitivity analyses were consistent with the main results. In this cohort of preterm-born children, there was no evidence of an impact of the mode of conception on neurodevelopmental outcomes at 5½ years of age.

Risk Factors for High-Arched Palate and Posterior Crossbite at the Age of 5 in Children Born Very Preterm: EPIPAGE-2 Cohort Study.

Introduction:Children born very preterm have an immature sucking reflex at birth and are exposed to neonatal care that can impede proper palate growth.ObjectivesWe aimed to describe the frequency of high-arched palate and posterior crossbite at the age of 5 in children born very preterm and to identify their respective risk factors.MethodsOur study was based on the data from EPIPAGE-2, a French national prospective cohort study, and included 2,594 children born between 24- and 31-week gestation. Outcomes were high-arched palate and posterior crossbite. Multivariable models estimated by generalized estimation equations with multiple imputation were used to study the association between the potential risk factors studied and each outcome.ResultsOverall, 8% of children born very preterm had a high-arched palate and 15% posterior crossbite. The odds of high-arched palate were increased for children with low gestational age (24–29 vs. 30–31 weeks of gestation) [adjusted odds ratio (aOR) 1.76, 95% confidence interval (CI) 1.17, 2.66], thumb-sucking habits at the age of 2 (aOR 1.53, 95% CI 1.03, 2.28), and cerebral palsy (aOR 2.18, 95% CI 1.28, 3.69). The odds of posterior crossbite were increased for children with pacifier-sucking habits at the age of 2 (aOR 1.75, 95% CI 1.30, 2.36).ConclusionsAmong very preterm children, low gestational age and cerebral palsy are the specific risk factors for a high-arched palate. High-arched palate and posterior crossbite share non-nutritive sucking habits as a common risk factor. The oro-facial growth of these children should be monitored.

Fish Consumption and Risk of Rheumatoid Arthritis: Findings from the E3N Cohort Study.

Fish consumption has been thought to reduce the risk of rheumatoid arthritis (RA), but the reported data are conflicting. We aimed to assess the association between fish consumption (overall, lean fish, and oily fish) and the risk of RA. The E3N Study is a French prospective cohort study including 98,995 women since 1990. Dietary data were collected via a validated food frequency questionnaire in 1993. Cox proportional hazards models were used to calculate HRs and 95% CIs for incident RA. Models were adjusted for age and for the main potential confounders including cigarette smoking. Among 62,629 women, 480 incident cases of RA were identified. In the overall population, we did not find a linear association between overall fish consumption and RA risk (p for trend 0.65), but a moderate consumption of fish was associated with a decreased risk of RA (HR 0.74; 95% CI 0.59–0.94 for tertile 2 compared with tertile 1), especially among current or former smokers (HR 0.61; 95% CI 0.44–0.85). Although not statistically significant, a trend towards an inverse association was only found with oily fish consumption (HR 0.81; 95% CI 0.65–1.02), but not with lean fish. Our results suggest that moderate fish consumption could reduce the risk or RA and potentially counterbalance the increased risk of RA induced by smoking. This inverse association might be explained by the omega-3 fatty acid content of oily fish.

Abstract P3-19-01: CANTO RT: The largest prospective multicenter cohort of early breast cancer patients treated with radiotherapy including full DICOM RT data

Abstract Purpose: In this paper, we describe the methodology used, and provide a first characterization of the study population and radiotherapy (RT) data in CANTO-RT (CANcer TOxicities Radiotherapy), the largest available multicenter prospective cohort of early breast cancer (BC) patients treated with RT that aims to identify predictors of development, and persistence of long-term toxicities. Methods: CANTO (NCT01993498) is a French prospective clinical cohort study of 10 150 patients with stage I-III BC from 26 cancer centers. Patients matching all CANTO inclusion and exclusion criteria, who received RT and were still in follow up, in the 10 top recruiting CANTO centers, with a minimum follow up of 3 years, were selected for CANTO-RT. Eligible patients had breast/chest wall +/- lymph node RT with curative intent. Individual full DICOM RT files (CT, RT Structure, RT Dose, RT Plan) were collected, anonymized, structured and analyzed on the CANTO-RT/UNITRAD web platform using AQUILAB Share Place™ and Analytics Dose module. Characteristics of the patients and tumors (including TNM, histology, HER2, estrogen and progesterone receptor) were recorded at baseline. Characteristics of the treatments, skin, lung, cardiovascular, neurological, musculoskeletal toxicities (CTCAE v4.0), QOL (BR23, QLQC30), cosmetic, and oncological outcomes were assessed at diagnosis (baseline), 3-6 (M0), 12 (M12), 36 (M36) and 60 (M60) months after completion of primary surgery, chemotherapy or radiotherapy whichever came last together, with blood, plasma and serum tests. Results: CANTO-RT enrolled 3875 BC patients between June 2012 and February 2017 with a median follow-up of 64 months :1947 (50.2%) left side, 1850 (47.8%) right side and 78 (2%) bilateral BC. The vast majority of patients had hormone receptor-positive tumors 3321 (85.7%) and 553 (14.3%) had human epidermal growth factor 2 (HER2) positive tumors; 2586 (66.7%) had stage pT1 and 2525 (65.2%) pN0 disease; 2087 (53.8%) neoadjuvant or adjuvant chemotherapy, 477 (12.3%) adjuvant trastuzumab and 3138 (81%) adjuvant endocrine therapy. Among 3797 patients with unilateral RT, 3065 (80.4%) had breast conserving surgery, 747 (19.6%) total mastectomy; 2712 (71.5%) sentinel node and 1080 (28.5%) axillary dissection. Tumor bed boost was delivered in 2658 patients (68.5%) and lymph node RT in 1356 patients (35%) including internal mammary chain in 844 patients (21.8%). Most patients 3691 (95.3%) were treated with 3D conformal RT and 184 (4.7%) with intensity-modulated RT. Normofractionated RT (2Gy/fraction) was mostly used (69.9%). Clinical target (breast, chest wall, lymph nodes) and contoured organs at risk (heart, left anterior descending coronary, lung, spinal cord, esophagus, thyroid, brachial plexus, contralateral breast, humeral head) contours and dose/volume histograms were automatically extracted after quality control procedure excluding corrupted files and inconsistencies 36 (1%) (Table 1). Conclusion: CANTO-RT is the largest early breast cancer prospective cohort with full individual clinical and DICOM RT data available. CANTO-RT is a valuable resource, open for collaborative projects, for identification and validation of clinical and dosimetric predictive factors of RT related toxicities. Further long term follow up is ongoing. Table 1.Baseline characteristics of the CANTO RT breast cancer patients.CharacteristicsBreast Cancer Patients [N(%) or Mean (range)]Age at enrolmentMean (range), years56.5 (23.3-85.8)Tumour size (pT)T037 (1)T12586 (66.7)T21058 (27.3)T3177 (4.6)Missing17 (0.4)Nodal status (pN)02525 (65.2)11035 (26.7)2223 (5.8)379 (2)Missing13 (0.3)Tumour histologyInfiltrating Ductal3011 (77.7)Lobular473 (12.2)Others (including mixed)381 (9.8)Missing10 (0.3)Hormone Receptors positiveNegative541 (14)Positive3321 (85.7)Missing13 (0.3)HER2Negative3305 (85.3)Positive553 (14.3)Missing17 (0.4)Type of chemotherapyNo chemotherapy1788 (46.1)Neoadjuvant chemotherapy450 (11.6)Adjuvant chemotherapy1629 (42)Peri-adjuvant chemotherapy (neo + adjuvant)8 (0.2)Hormonal therapyNo730 (18.8)Yes3138 (81)Missing7 (0.2)Herceptin treatmentNo or Not applicable3378 (87.2)Yes477 (12.3)Missing20 (0.5)Type of breast surgerylumpectomy3113 (80.3)Mastectomy734 (18.9)Right lumpectomy and Left mastectomy13 (0.3)Right mastectomy and Left lumpectomy9 (0.2)None6 (0.2)Type of lymph node surgerySentinel node2746 (70.9)Axillary dissection1086 (28)Right sentinel node, Left axillary dissection20 (0.5)Right axillary dissection, left sentinel node12 (0.3)None11 (0.3)Radiation therapyRight Side1850 (47.8)Left Side1947 (50.2)Bilateral78 (2.0)Patients with boostNo or Not applicable1217 (31.4)Yes2658 (68.6)Lymph node levels treatedNone2519 (65)Yes1356 (35)Level 1284 (20.9)Level 2340 (25.1)Level 31072 (79.1)Level 41348 (99.4)Internal mammary chain844 (62.2)Irradiation techniques3D3691 (95.3)IMRT184 (4.7)Fractionation regimensNormofractionation 25-fractions2707 (69.9)Hypofractionation 15-16 fractions166 (4.3)Hypofractionation and Partial breast irradiation51 (1.3)Unspecified fractionation - CTV breast or chest wall not delineated951 (24.5) Citation Format: Thomas Sarrade, Rodrigue Allodji, Youssef Ghannam, Guillaume Auzac, Sibille Everhard, Ophélie Querel, Youlia Kirova, Karine Peignaux, Philippe Guilbert, Claire Charra-Brunaud, Julien Blanchecotte, Rezart Belshi, David Pasquier, Séverine Racadot, Céline Bourgier, Sandrine Ducornet, David Gibon, Fabrice André, Florent De Vathaire, Sofia Rivera. CANTO RT: The largest prospective multicenter cohort of early breast cancer patients treated with radiotherapy including full DICOM RT data [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-19-01.

Cardiovascular events in perimembranous ventricular septal defect with left ventricular volume overload: a French prospective cohort study (FRANCISCO).

The management of paediatric isolated perimembranous ventricular septal defect (pmVSD) with left ventricle (LV) volume overload but no pulmonary arterial hypertension (PAH) remains controversial. Three therapeutic approaches are considered: watchful waiting, surgical closure, and percutaneous closure. We aim to investigate the long-term outcomes of these patients according to anatomic pmVSD characteristics and treatment strategy. The Filiale de Cardiologie Pediatrique et Congénitale (FCPC) designed the FRANCISCO registry, a long-term prospective nationwide multi-centre observational cohort study sponsored by the French Society of Cardiology, which enrolled, over 2 years (2018–2020), patients older than 1 year who had isolated pmVSD with LV volume overload. Prevalent complications related to pmVSD at baseline were exclusion criteria. Clinical, echocardiographic, and functional data will be collected at inclusion then after 1, 5, and 10 years. A core lab will analyse all baseline echocardiographic data to depict anatomical pmVSD features. The primary outcome is the 5-year incidence of cardiovascular events (infective endocarditis, sub-aortic stenosis, aortic regurgitation, right ventricular outflow tract stenosis, tricuspid regurgitation, PAH, arrhythmia, stroke, haemolysis, heart failure, or death from a cardiovascular event). We plan to enrol 200 patients, given the 10% estimated 5-year incidence of cardiovascular events with a 95% confidence interval of ±5%. Associations linking anatomical pmVSD features and treatment strategy to the incidence of complications will be assessed. The FRANSCICO study will provide the long-term incidence of complications in patients older than 1 year with pmVSD and LV volume overload. The results are expected to improve guidance for treatment decisions.

Childhood Trauma and Perinatal Depression: Data From the IGEDEPP Cohort.

Background: Childhood trauma (CT) is associated with an increased risk of major depressive disorder, but little is known about the impact of CT on depression during pregnancy and the early and late postpartum period. The present study assesses whether CT is associated with perinatal depression, considering different types of CT.Methods: This study used data from the Interaction of Gene and Environment of Depression in PostPartum (IGEDEPP), a French multicenter prospective cohort study, including 3,252 women who completed the Childhood Trauma Questionnaire at the maternity department between November 2011 and June 2016. Depression during pregnancy was assessed retrospectively at the maternity department using DSM-5 criteria. Early- and late-onset postpartum depression were assessed at 2 months and 1 year postpartum, respectively.Results: Among the 3,252 women, 298 (9.2%) reported at least 1 CT. Women with CT had a higher risk of depression (OR = 2.2; 95% CI, 1.7-2.7), anxiety (OR = 2.3; 95% CI, 1.7-3.0), and suicide attempts (OR = 5.4; 95% CI, 3.5-8.4) than women without CT. Perinatal depression was more frequent in women with CT than in women without CT, after adjustment for sociodemographic characteristics and personal history of major depressive episode and consideration of the timing of onset (pregnancy, early or late postpartum) (P < .001). There was a dose effect between the number of CT types and the risk of perinatal depression.Conclusions: These results show that CT is associated with a depressive episode during adulthood, specifically in the perinatal period. These findings may lead to special prenatal care for women abused or neglected during childhood, to better screen and treat perinatal depression.Trial registration: ClinicalTrials.gov identifier: NCT01648816.

Mortality of patients with solid and haematological cancers presenting with symptoms of COVID-19 with vs without detectable SARS-COV-2: a French nationwide prospective cohort study.

BackgroundOver 30 million COVID-19 cases have been diagnosed worldwide from late 2019. Among frail persons, cancer patients are at high risk of death from COVID-19.MethodsThe French prospective cohort ONCOVID-19 enrolled patients with solid or haematological tumour, receiving anticancer treatment and presenting with clinical symptoms suggestive of COVID-19. COVID-19 was confirmed through detectable SARS-CoV2 by RT-PCR (repeated twice if negative first) and/or specific CT-scan. The study aims to assess the 28-day mortality rate after the first COVID test.ResultsFrom March 1st to May 21st 2020, 23 French cancer centres and hospitals enrolled 1230 cancer patients with suspicion of COVID-19, including 1162 (94.5%) matching the inclusion criteria. We identified 425 (36.6%) COVID-19 positive patients including 155 (13.3%) diagnosed with CT-scan only, while 737 (63.4%) patients were COVID-19 negative. Death at day-28 occurred in 116/425 (27.8%) COVID-19 positive patients, and in 118/737 (16.3%) COVID-19 negative patients (p < 0·0001). With a median follow-up of 2.1 (1.6–2.4) months, 310 (26.7%) deaths were reported including 143 (33.6%) in the COVID-19 positive population, and 167 (22.7%) in the COVID-19 negative patients. Male gender, age, metastatic disease, immunosuppressive treatments, lymphopenia, COVID-19 diagnosis and diabetes were independent risk factors for death.ConclusionPatients with solid and haematological cancers presenting COVID-19 symptoms with SARS-CoV-2 RT-PCR confirmed or not are both at high-risk of early mortality. COVID-19 is reported as the cause of death in 50% of COVID-19 positive patients with cancer.Clinical trial registrationThis trial is registered with ClinicalTrials.gov, number NCT04363632.

Is a treat-to-target approach to lipid-lowering therapy appropriate in patients with chronic kidney disease? A prospective French cohort study.

Whereas European guidelines recommend adjusting lipid-lowering therapy (LLT) to meet prespecified targets ('treat-to-target') for low-density lipoprotein cholesterol (LDL-C), other guidelines do not ('fire and forget'). In a large observational prospective cohort, we sought to evaluate which strategy could be associated with better cardiovascular outcomes in chronic kidney disease (CKD). In CKD-REIN, patients (CKD stages 3 and 4) on LLT were categorized according to achievement of LDL-C targets for high and very high cardiovascular risk (< 2.6 and < 1.8mmol/L, respectively) at baseline. Primary outcome was fatal/non-fatal atheromatous cardiovascular disease (CVD). Secondary outcomes were non-atheromatous CVD, atheromatous or non-atheromatous CVD, and major adverse cardiovascular events. The population comprised 1521 patients (68 ± 12years, 31% women, mean estimated glomerular filtration rate [eGFR] 35mL/min/1.73m2). Overall, 523 (34%) met their LDL-C targets at baseline. Median follow-up was 2.9years (interquartile range 2.2-3.0). Incidence rates per 100 patient-years were 6.2% (95% confidence interval [CI] 5.5-7.0) for atheromatous CVD, 9.2% (8.3-10.1) for non-atheromatous CVD, 15.2% (14.0-16.4) for atheromatous/non-atheromatous CVD, and 6.3% (5.5-7.1) for major adverse cardiovascular events. Corresponding rates in patients who achieved targets were 6.6%, 9.8%, 16.1%, and 6.3%, respectively. Target achievement was not associated with risk of fatal/non-fatal atheromatous CVD (adjusted hazard ratio 1.04, 95% CI 0.76-1.44, p = 0.77) or fatal/non-fatal atheromatous or non-atheromatous CVD (0.98, 0.78-1.23, p = 0.91). These findings do not appear to support a treat-to-target approach in CKD patients on LLT, and may favor the hypothesis of an advantage of fire-and-forget. Randomized trials are needed to confirm this theory.

Use of Nalmefene in Routine Practice: Results from a French Prospective Cohort Study and a National Database Analysis.

AimsTwo complementary studies were used to assess the real-life use of nalmefene in alcohol-dependent patients and its impact on alcohol use health status.MethodsUSE-PACT was a prospective cohort study designed to evaluate the real-life effectiveness of nalmefene in the management of alcohol dependence, as assessed by total alcohol consumption (TAC) and number of heavy drinking days (HDD) at 1 year. USE-AM was a cohort study using data from the French nationwide claims database and was used to evaluate the external validity of the population in the prospective study.ResultsOverall, 256 of 700 new nalmefene users enrolled in the USE-PACT study had valid data at 1 year. After 1 year, patients treated with nalmefene showed a mean ± SD reduction from baseline in TAC (−41.5 ± 57.4 g/day) and number of HDD (−10.7 ± 11.7 days/4 weeks). Patients took a mean ± SD of 20.0 ± 12.0 tablets/4 weeks (median of 1 tablet/day) for the first 3 months and then reduced the dose. The proportion of patients who no longer took nalmefene gradually increased from 5% at 1 month to 52% at 1 year. The USE-AM study identified 486 patients with a first reimbursement for nalmefene in 2016; baseline characteristics confirmed external validity of the USE-PACT study. Overall, 46.3% of initial USE-AM prescriptions were made by GPs; most (91.8%) patients stopped treatment during follow-up. However, 15.2% of patients resumed treatment after stopping.ConclusionsIn this analysis of French routine practice, patients with alcohol dependence treated with nalmefene showed reduced alcohol consumption, and nalmefene was generally well tolerated.

The long-run effects of war on health: Evidence from World War II in France.

We investigate the effects of early-life exposure to war on adult health outcomes including cancer, hypertension, angina, infarction, diabetes and obesity. We combine data from the French prospective cohort study E3N on women employed in the French National Education with historical data on World War II. To identify causal effects, we exploit exogenous spatial and temporal variation in war exposure related to the German invasion of France during the Battle of France. The number of French military casualties at the level of the postcode area serves as main measure of exposure. Our results suggest that exposure to the war during the first 5 years of life has significant adverse effects on health in adulthood. A 10 percent increase in the number of deaths per 100,000 inhabitants in the individual's postcode area of birth increases the probability of suffering from any of the health conditions considered in this study by 0.08 percentage points. This is relative to a mean of 49 percent for the sample as a whole.

Cardiac rehabilitation in patients older than 75 years : Results from the French cohort of EU-CaRE study

The benefits of exercise based cardiac rehabilitation (CR) have been documented in elderly patients. The EUCaRE project included elderly patients (> 65 years) in 7 European countries, however in France, patient > 75 years were considered as elderly. To compare the results of CR in patients aged ≤ or > 75 years old. The prospective French cohort study from EU-CaRE study included 220 consecutive elderly patients (65+ years old) with coronary artery disease and/or heart valve replacement undergoing CR. All patients underwent cardiopulmonary exercise test (CPET) at baseline, at the end of CR and after 1 year of follow up. Of 217 patients with complete data, 71 were older than 75 years (32.72 %). Demographic characteristics, cardiac risk factors and comorbidities were similar between the 2 groups except for age, and the mean BMI that was lower in the > 75 years group. Rate of residential vs. ambulatory and the mean time from index event to start CR were comparable between older and ≤ 75 years (73.3 % vs. 67.6 % ; P = 0.385 and 18.8 ± 13 I vs. 20.9 ± 16 days ; P = 0.689, respectively). CPET results are displayed in the Table 1 . We found that the gain of exercise capacity after CR is similar between the two groups ( P = ns), with a same sustainability at one year. Patients older than 75 years improved functional capacity after CR similarly to youngers and should not be excluded if they are able to perform an exercise training program.