Correlation between unproven therapies and delayed return-to-work for COVID-19-infected healthcare workers.

The objective of this study is to investigate factors influencing the time to return to work (RTW) of HealthCare Workers (HCW) infected with COVID-19 during the initial wave of the pandemic in a southern French university hospital. Data collection of 170 HCW (between March 16 to June 1, 2020) included demographic and professional information, clinical profiles, comorbidities, medical management, therapies and RT-PCR results. The mean time to RTW was 15.6 days. Multivariate analyses revealed that the time to RTW was shorter among laboratory and emergency workers, while it was longer for HCW aged 40 to 49 years, at higher risk of severe illness, with a delayed negative SARS-CoV-2 PCR or those treated with azithromycin and/or hydroxychloroquine. This study highlights diverse factors affecting HCW RTW post-COVID-19 infection, underscoring the importance of exercising caution in administering unproven therapies to HCW during the early stages of a novel infectious pandemic.

Health mediation does not reduce the readmission rate of frequent users of emergency departments living in precarious conditions: what lessons can be learned from this randomised controlled trial?

BACKGROUND: Severe overcrowding of emergency departments (EDs) affects the quality of healthcare. One factor of overcrowding is precariousness, but it has rarely been considered a key factor in designing interventions to improve ED care. Health mediation (HM) aims to facilitate access to rights, prevention, and care for the most vulnerable persons and to raise awareness among healthcare providers about obstacles in accessing healthcare. The primary aim was to determine whether HM intervention for frequent users of EDs (FUED) living in precarious conditions could reduce the readmission rate at 90 days. METHODS: Between February 2019 and May 2022, we enrolled and interviewed 726 FUED in four EDs of southeastern France in this randomised controlled trial. The HM intervention started in the ED and lasted 90 days. In addition to the primary endpoint (first readmission at 90 days), secondary endpoints (readmission at 30 and 180 days, number of hospitalisations at 30, 90, 180 days, admissions for the same reasons as the first admission) were also studied. The outcomes were measured in the ED information systems. Statistical methods included an intention-to-treat analysis and a per-protocol analysis. Comparisons were adjusted for gender, age, ED, and health mediator. RESULTS: 46% of patients reported attending the ED because they felt their life was in danger, and 42% had been referred to the ED by the emergency medical dispatch centre or their GP; 40% of patients were considered to be in a serious condition by ED physicians. The proportion of patients who were readmitted at 90 days was high but did not differ between the control and the HM intervention groups (31.7% vs. 36.3%, p = 0.23). There was no significant difference in any of the secondary outcome measures between the control and HM intervention groups. Per-protocol analysis also showed no significant difference for the primary and secondary endpoints. CONCLUSIONS: This randomised controlled trial did not show that our health mediation intervention was effective in reducing the use of emergency services by FUED living in precarious conditions. Some limitations are discussed: the duration of the intervention (90 days), the long-term effects (> 6 months), the involvement of the ED staff. TRIAL REGISTRATION: Registered on clinicaltrials.gov as NCT03660215 on 4th September 2018.

Drug Efficacy in the Treatment of Antipsychotic-Induced Akathisia: A Systematic Review and Network Meta-Analysis.

Importance: Antipsychotic-induced akathisia (AIA) occurs in 14% to 35% of patients treated with antipsychotics and is associated with increased suicide and decreased adherence in patients with schizophrenia. However, no comprehensive review and network meta-analysis has been conducted to compare the efficacy of treatments for AIA. Objective: To compare the efficacy associated with AIA treatments. Data Sources: Three databases (MEDLINE, Web of Science, and Google Scholar) were systematically searched by multiple researchers for double-blind randomized clinical trials (RCTs) comparing active drugs for the treatment of AIA with placebo or another treatment between May 30 and June 18, 2023. Study Selection: Selected studies were RCTs that compared adjunctive drugs for AIA vs placebo or adjunctive treatment in patients treated with antipsychotics fulfilling the criteria for akathisia, RCTs with sample size of 10 patients or more, only trials in which no additional drugs were administered during the study, and RCTs that used a validated akathisia score. Trials with missing data for the main outcome (akathisia score at the end points) were excluded. Data Extraction and Synthesis: Data extraction and synthesis were performed, estimating standardized mean differences (SMDs) through pairwise and network meta-analysis with a random-effects model. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed. Main Outcomes and Measures: The primary outcome was the severity of akathisia measured by a validated scale at the last available end point. Results: Fifteen trials involving 492 participants compared 10 treatments with placebo. Mirtazapine (15 mg/d for ≥5 days; SMD, -1.20; 95% CI, -1.83 to -0.58), biperiden (6 mg/d for ≥14 days; SMD, -1.01; 95% CI, -1.69 to -0.34), vitamin B6 (600-1200 mg/d for ≥5 days; SMD, -0.92; 95% CI, -1.57 to -0.26), trazodone (50 mg/d for ≥5 days; SMD, -0.84; 95% CI, -1.54 to -0.14), mianserin (15 mg/d for ≥5 days; SMD, -0.81; 95% CI, -1.44 to -0.19), and propranolol (20 mg/d for ≥6 days; SMD, -0.78; 95% CI, -1.35 to -0.22) were associated with greater efficacy than placebo, with low to moderate heterogeneity (I2 = 34.6%; 95% CI, 0.0%-71.1%). Cyproheptadine, clonazepam, zolmitriptan, and valproate did not yield significant effects. Eight trials were rated as having low risk of bias; 2, moderate risk; and 5, high risk. Sensitivity analyses generally confirmed the results for all drugs except for cyproheptadine and propranolol. No association between effect sizes and psychotic severity was found. Conclusions and Relevance: In this systematic review and network meta-analysis, mirtazapine, biperiden, and vitamin B6 were associated with the greatest efficacy for AIA, with vitamin B6 having the best efficacy and tolerance profile. Trazodone, mianserin, and propranolol appeared as effective alternatives with slightly less favorable efficacy and tolerance profiles. These findings should assist prescribers in selecting an appropriate medication for treating AIA.

Lifetime sexual violence experienced by women asylum seekers and refugees hosted in high-income countries: Literature review and meta-analysis.

Screening and care for victims of sexual violence (SV) among asylum seekers and refugees (ASRs) living in High-income host countries were prioritized by the WHO in 2020. The lack of stabilized prevalence findings on lifetime SV among ASRs in High-income countries hinders the development of adequate health management. The objective of this study was to determine the lifetime prevalence of SV experienced by ASRs living in High-income countries. We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included in the meta-analysis if the sample consisted exclusively of asylum seekers or refugees over the age of 16 living in High-income countries and if they reported a lifetime prevalence of experienced SV. The results of the meta-analysis were expressed with 95 % confidence intervals (CIs) as estimates of lifetime SV prevalence using a random-effects model. The estimated lifetime prevalence of SV among women ASRs was 44 % (95 % CI, 0.24-0.67) and 27 % (95 % CI, 0.18-0.38) for both sexes. This meta-analysis revealed a high prevalence of SV among ASRs hosted in High-income countries and suggest the importance of developing specific screening and care programs in these host countries.

Incidence of sexual violence among recently arrived asylum-seeking women in France: a retrospective cohort study.

Background: The prevention of sexual violence (SV) occurring shortly after arrival in host countries towards female asylum seekers requires knowledge about its incidence. We aimed to determine the incidence of SV and its associated factors during the past year of living in France among asylum-seeking females who had arrived more than one year earlier but less than two years. Methods: We conducted a retrospective cohort study using a life-event survey of asylum-seeking females who had been registered in southern France by the Office for Immigration for more than one year but less than two. The primary outcome was the occurrence of SV during the past year, weighted by the deviation in age and geographical origin of our sample from all females registered. The nature of SV was noted, and associated factors were explored by a logistic regression model. Findings: Between October 1, 2021, and March 31, 2022, 273 females were included. Eighty-four females experienced SV during the past year of living in France (26.3% weighted [95% CI, 24-28.8]), 17 of whom were raped (4.8% weighted [95% CI, 3.7-6.1]). Being a victim of SV prior to arrival in France (202, 75.7%) was associated with the occurrence of SV after arrival (OR = 4.6 [95% CI, 1.8-11.3]). Lack of support for accommodation was associated with se.xual assault (OR = 2.6 [95% CI, 1.3-5.1]). Interpretation: The months following arrival in a European host country among asylum-seeking females appear to be a period of high incidence of SV; even higher for those who previously experienced SV prior to arrival. Reception conditions without support for accommodation seem to increase exposure to sexual assault. Funding: DGOS-GIRCI.

Early chest CT abnormalities to predict the subsequent occurrence of chronic lung allograft dysfunction.

INTRODUCTION: Chronic lung allograft dysfunction (CLAD) can take two forms: bronchiolitis obliterans syndrome (BOS) or restrictive allograft syndrome (RAS). The aim was to determine if chest-CT abnormalities after lung transplantation (LTx) could predict CLAD before respiratory functional deterioration. MATERIALS AND METHODS: This monocentric retrospective study analyzed consecutive patients who underwent LTx from January 2015 to December 2018. Initial CT post-LTx (CTi) and a follow-up CT at least 9 months post-LTx (CTf) were reviewed. CLAD was defined as a persistent respiratory functional decline (> 20% of basal FEV1) outside acute episode. A Cox regression was performed in univariate, then in multivariate analysis (including features with p < 0.01 in univariate or of clinical importance) to determine risk factors for CLAD. Subgroup analyses were made for BOS, RAS, and death. RESULTS: Among 118 LTx patients (median (min-max) 47 (18-68) years), 25 developed CLAD during follow-up (19 BOS). The median time to CLAD since LTx was 570 days [150-1770]. Moderate pulmonary artery stenosis (30-50%) was associated with the occurrence of CLAD on CTi (hazard ratio HR = 4.6, CI [1.6-13.2]) and consolidations and pleural effusion on CTf (HR = 2.6, CI [1.3-4.9] and HR = 4.5, CI [1.5-13.6] respectively). The presence of mosaic attenuation (HR = 4.1, CI [1.4-12.5]), consolidations (HR = 2.6, CI [1.3-5.4]), and pleural effusions (p = 0.01, HR = 5.7, CI [1.4-22.3]) were risk factors for BOS on CTf. The consolidations (p = 0.029) and pleural effusions (p = 0.001) were risk factors for death on CTf. CONCLUSIONS: CTi and CTf in the monitoring of LTx patients could predict CLAD. Moderate pulmonary artery stenosis, mosaic pattern, parenchyma condensations, and pleural effusions were risk factors for CLAD. CRITICAL RELEVANCE STATEMENT: There is a potential predictive role of chest CT in the follow-up of LTx patients for chronic lung allograft dysfunction (CLAD). Early chest CT should focus on pulmonary artery stenosis (risk factor for CLAD in this study). During the follow-up (at least 9 months post-LTx), parenchymal consolidations and pleural effusions were shown to be risk factors for CLAD, and death in subgroup analyses. KEY POINTS: • Pulmonary artery stenosis (30-50%) on initial chest-CT following lung transplantation predicts CLAD HR = 4.5; CI [1.6-13.2]. • Pleural effusion and consolidations 1 year after lung transplantation predict CLAD and death. • Early evaluation of lung transplanted patients should evaluate pulmonary artery anastomosis.

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial.

Importance: Bacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date. Objective: To evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth. Design, Setting, and Participants: The AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks' gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022. Interventions: Participants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV. Main Outcomes and Measures: Overall rate of preterm birth before 37 weeks' gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted. Results: Among 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87). Conclusion and Relevance: In this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group. Trial Registration: ClinicalTrials.gov Identifier: NCT02288832.

Diagnostic value of a urine test in pregnancy of unknown location.

BACKGRO: Pregnancy of unknown location (PUL) is a term used when there is a positive pregnancy test but no sonographic evidence for an intrauterine pregnancy (IUP) or ectopic pregnancy (EP). This term is a classification and not a final diagnosis. OBJECTIVE: This study aimed to evaluate the diagnostic value of the Inexscreen test on the outcome of patients with pregnancies of unknown location. STUDY DESIGN: In this prospective study, a total of 251 patients with a diagnosis of pregnancy of unknown location at the gynecologic emergency department of the La Conception Hospital, Marseille, France, between June 2015 and February 2019 were included. The Inexscreen (semiquantitative determination of intact human urinary chorionic gonadotropin) test was performed on patients with a diagnosis of pregnancy of unknown location. They participated in the study after information and consent collection. The main outcome measures (sensitivity, specificity, predictive values, and the Youden index) of Inexscreen were calculated for the diagnosis of abnormal pregnancy (nonprogressive pregnancy) and ectopic pregnancy. RESULTS: The sensitivity and specificity of Inexscreen for the diagnosis of abnormal pregnancy in patients with pregnancy of unknown location were 56.3% (95% confidence interval, 47.0%-65.1%) and 62.8% (95% confidence interval, 53.1%-71.5%), respectively. The sensitivity and specificity of Inexscreen for the diagnosis of ectopic pregnancy in patients with pregnancy of unknown location were 81.3% (95% confidence interval, 57.0%-93.4%) and 55.6% (95% confidence interval, 48.6%-62.3%), respectively. The positive predictive value and negative predictive value of Inexscreen for ectopic pregnancy were 12.9% (95% confidence interval, 7.7%-20.8%) and 97.4% (95% confidence interval, 92.5%-99.1%), respectively. CONCLUSION: Inexscreen is a rapid, non-operator-dependent, noninvasive, and inexpensive test that allows the selection of patients at high risk of ectopic pregnancy in case of pregnancy of unknown location. This test allows an adapted follow-up according to the technical platform available in a gynecologic emergency service.

Multimodality therapy for lung cancer invading the chest wall: A study of the French EPITHOR database.

OBJECTIVES: According to a nation-based study, we intend to report the data of the patients operated on for lung cancer invading the chest wall, taking into consideration the completion of induction chemotherapy (Ind_CT), induction radiochemotherapy (Ind_RCT) or no induction therapy (0_Ind). MATERIALS AND METHODS: All patients with a primary lung cancer invading the chest wall who underwent radical resection from 2004 to 2019 were included. Superior sulcus tumors were excluded. RESULTS: Overall, 688 patients were included: 522 operated without induction therapy, 101 with Ind_CT and 65 with Ind_RCT. Postoperative 90-day mortality was 10.7% in the 0_Ind group, 5.0% in the Ind_CT group, 7.7% in the Ind_RCT group (p = 0.17). Incomplete resection rate was 14.0% in the 0_Ind group, 6.9% in the Ind_CT group, 6.2% in the Ind_RCT group (p = 0.04). In the 0_Ind group, 70% of the patients received adjuvant therapies. Overall survival (OS) analysis disclosed the best long-term outcomes in the Ind_RCT group (5-year OS probability: 56.5% versus 40.0% and 40.5% for 0_Ind and Ind_CT groups, respectively; p = 0.035). At multivariable analysis, Ind_RCT (HR = 0.571; p = 0.008), age > 60 years old (HR = 1,373; p = 0.005), male sex (HR = 1.710; p < 0.001), pneumonectomy (HR = 1.368; p = 0.025), pN2 status (HR = 1.981; p < 0.001), ≥3 resected ribs (HR = 1.329; p = 0.019), incomplete resection (HR = 2.284; p < 0.001) and lack of adjuvant therapy (HR = 1.959; p < 0.001) were associated with OS. Ind_CT was not associated with survival (HR = 0.848; p = 0.257). CONCLUSION: Induction chemoradiation therapy seems to improve survival. Therefore, the present results should be confirmed by a prospective randomized trial testing the benefit of induction radiochemotherapy for NSCLC invading the chest wall.

Radiomics model to classify mammary masses using breast DCE-MRI compared to the BI-RADS classification performance.

BACKGROUND: Recent advanced in radiomics analysis could help to identify breast cancer among benign mammary masses. The aim was to create a radiomics signature using breast DCE-MRI extracted features to classify tumors and to compare the performances with the BI-RADS classification. MATERIAL AND METHODS: From September 2017 to December 2019 images, exams and records from consecutive patients with mammary masses on breast DCE-MRI and available histology from one center were retrospectively reviewed (79 patients, 97 masses). Exclusion criterion was malignant uncertainty. The tumors were split in a train-set (70%) and a test-set (30%). From 14 kinetics maps, 89 radiomics features were extracted, for a total of 1246 features per tumor. Feature selection was made using Boruta algorithm, to train a random forest algorithm on the train-set. BI-RADS classification was recorded from two radiologists. RESULTS: Seventy-seven patients were analyzed with 94 tumors, (71 malignant, 23 benign). Over 1246 features, 17 were selected from eight kinetic maps. On the test-set, the model reaches an AUC = 0.94 95 CI [0.85-1.00] and a specificity of 33% 95 CI [10-70]. There were 43/94 (46%) lesions BI-RADS4 (4a = 12/94 (13%); 4b = 9/94 (10%); and 4c = 22/94 (23%)). The BI-RADS score reached an AUC = 0.84 95 CI [0.73-0.95] and a specificity of 17% 95 CI [3-56]. There was no significant difference between the ROC curves for the model or the BI-RADS score (p = 0.19). CONCLUSION: A radiomics signature from features extracted using breast DCE-MRI can reach an AUC of 0.94 on a test-set and could provide as good results as BI-RADS to classify mammary masses.

Systematic Review and Meta-Analysis of Ex-Situ and In-Situ Fenestrated Stent-Grafts for Endovascular Repair of Aortic Arch Pathologies.

PURPOSE: To gain insight into safety and efficacy of in situ and ex-situ fenestration techniques for total endovascular arch repair. The term ex-situ fenestration is referring to physician-modified stent-graft technique where fenestration is performed on a back table. METHODS: Electronic search was conducted according to PRISMA (Preferred Reporting Items for Systematic review and Meta-analyses) guidelines from 2000 to 2020. The main outcomes measured were 30-day mortality, stroke, aortic-related mortality, and reintervention rates. RESULTS: Fifteen studies were eligible: 7 ex-situ fenestration (189 patients) and 8 in-situ fenestration (149 patients). In ex-situ group, dissection was the main pathology treated and proximal sealing zones were Z0 or 1 in 53.5% of patients. In in-situ group, dissection and aneurysm were equally represented in around 40% of cases and proximal sealing zones were Z0 or 1 in 46.5% of patients. Cumulative 30-day all-cause mortality was similar in both groups: 3.8% (95% confidence interval [CI]: 1.7%-8.2%) and 3.8% (95% CI: 1.6%-8.9%), respectively, in ex-situ and in-situ groups and stroke rate of 2.8% (95% CI: 1.1%-7%) and 5.3% (95% CI: 2.6%-10.5%). After a 11.1 ± 2.6 months mean follow-up for ex-situ and 16.7 ± 2.3 months for in-situ group, there were 5.2 and 1.4 reinterventions per 100 patients-years, respectively, for ex-situ and in situ groups. Aortic-related mortality rates of, respectively, 3.2% (95% CI: 1.3%-7.4%) and 2.6% (95% CI: 0.9%-7.3%) were noted in ex-situ and in situ groups. CONCLUSION: The reported data show favorable short-term results of both ex-situ and in-situ fenestration techniques with low mortality and strokes rates. However, durability is still questionable given the lack of long-term data. Both options may have their place in arch repair beyond the spectrum of emergent and urgent cases, on condition that results stand the test of time. CLINICAL IMPACT: In situ and ex-situ fenestration techniques have been initially developed to overcome emergency or as a bail out techniques however giving the promessing favorable short term results indications of these techniques may be extended to elective patients ineligible to customized stent-grafts and possibly in the futur to more elective cases as an option for total endovascular arch repair.

High-level burnout in physicians and nurses working in adult ICUs: a systematic review and meta-analysis.

PURPOSE: The prevalence of burnout in intensive care unit (ICU) professionals is difficult to establish due to the variety of survey instruments used, the heterogeneity of the targeted population, the design of the studies, and the differences among countries regarding ICU organization. METHODS: We performed a systematic review and meta-analysis examining the prevalence of high-level burnout in physicians and nurses working in adult ICUs, including only studies that use the Maslach Burnout Inventory (MBI) as a tool to evaluate burnout and involving at least 3 different ICUs. RESULTS: Twenty-five studies with a combined population of 20,723 healthcare workers from adult ICUs satisfied the inclusion criteria. Combining 18 studies including 8187 ICU physicians, 3660 of them reported a high level of burnout (prevalence 0.41, range 0.15-0.71, 95% CI [0.33; 0.5], I2 97.6%, 95% CI [96.9%; 98.1%]). The heterogeneity can be at least in part explained by the definition of burnout used and the response rate as confirmed by the multivariable metaregression done. In contrast, there was no significant difference regarding other factors such as the study period (before or during the coronavirus disease 2019 (COVID-19) pandemic), the income of the countries, or the Healthcare Access and Quality (HAQ) index. Combining 20 studies including 12,536 ICU nurses, 6232 of nurses were reporting burnout (prevalence 0.44, range 0.14-0.74, [95% CI 0.34; 0.55], I2 98.6% 95% CI [98.4%; 98.9%]). The prevalence of high-level burnout in ICU nurses for studies performed during the COVID-19 pandemic was higher than that reported for studies performed before the COVID-19 pandemic (0.61 [95% CI, 0.46; 0.75] and 0.37 [95% CI, 0.26; 0.49] respectively, p = 0.003). As for physicians, the heterogeneity is at least in part explained by the definition used for burnout using the MBI but not by the number of participants. When compared, the prevalence of high-level burnout was not different between ICU physicians and ICU nurses. However, the proportion of ICU nurses with a high level of emotional exhaustion was higher than for ICU physicians (0.42 [95% CI, 0.37; 0.48] and 0.28 [0.2; 0.39], respectively, p = 0.022). CONCLUSION: According to this meta-analysis, the prevalence of high-level burnout is higher than 40% in all ICU professionals. However, there is a great heterogeneity in the results. To evaluate and to compare preventive and therapeutic strategies, there is the need to use a consensual definition of burnout when using the MBI instrument.

The introduction of a universal transvaginal cervical length screening program is associated with a reduced preterm birth rate.

BACKGROUND: Midtrimester sonographic short cervix is a good predictor of preterm birth in singleton pregnancies. OBJECTIVE: This study aimed to assess the impact of implementing a universal transvaginal cervical length screening program on preterm birth rate. STUDY DESIGN: This study consisted of 2 parts: a before-and-after multicenter study and a study on the ECHOCOL ("echo"="ultrasound" and "col"="cervix" in French) prospective cohort. We compared the rate of preterm birth before and after the introduction of universal cervical length screening at the time of midtrimester anatomy ultrasound. The multicenter before-and-after regional study included all women with a singleton pregnancy who gave birth after 24 weeks' gestation in the South East of France from January 1, 2012 to April 30, 2018. In parallel, the ECHOCOL cohort study was prospectively conducted from May 2015 to July 2018, including 17 maternity hospitals in the South East region of France. In case of asymptomatic short cervix <25 mm, treatments offered included 200 mg of vaginal progesterone, or cerclage, or a pessary until 34 weeks' gestation. RESULTS: We observed a significant decrease rate of preterm birth between periods A and B after multivariate analysis. (respectively, 5.8% vs 5.6%; adjusted odds ratio, 0.92; 95% confidence interval, 0.89-0.95; P<.0001). In parallel, the percentage of cervical length screening significantly increased from 28.9% in period A to 52.9% in period B (odds ratio, 2.76; 95% confidence interval, 2.71-2.80; P<.0001). Among the 3468 patients of the ECHOCOL prospective cohort, 38 (1.1%) asymptomatic short cervices were detected, and 192 patients gave birth prematurely (11 with an asymptomatic short cervix and 181 without). In the ECHOCOL cohort, a marked but statistically insignificant tendency toward a reduced rate of preterm birth before 37 weeks of gestation was observed (from 5.8% to 5.5%; adjusted odds ratio, 0.72; 95% confidence interval, 0.51-1.03; P=.068). CONCLUSION: This study showed a significantly lower rate of preterm birth after the implementation of a universal cervical length screening and treating policy during the second trimester of pregnancy. The clinical trial was registered under NCT02598323.

Plasma levels of E-selectin are associated with retinopathy in sickle cell disease.

BACKGROUND: The vascular endothelium is markedly disrupted in sickle cell disease (SCD) and is the converging cascade of the complex pathophysiologic processes linked to sickle cell vasculopathy. Circulating endothelial activation and/or apoptotic markers may reflect this endothelial activation/damage that contributes to the pathophysiology of the SCD vascular complications. METHODS: Plasmatic levels of circulating endothelial cells (CECs), E-selectin, progenitor's endothelial cells (EPCs), and circulating extracellular vesicles (EVs) were evaluated in 50 SCD patients, 16 with vasculopathy. The association between these markers and the occurrence of disease-related microvascular injuries of the eye (retinopathy), kidney (nephropathy), and skin (chronic active ulcers) was explored. RESULTS: Among the endothelial activation markers studied, only higher plasma levels of E-selectin were found in SCD patients with vasculopathy (p = .015). Increased E-selectin levels were associated with retinopathy (p < .001) but not with nephropathy or leg ulcers. All patients, at steady state, with or without vasculopathy, did not display a high count of CEC and EPC, markers of endothelial injury and repair. We did not show any significant differences in EVs levels between vasculopathy and not vasculopathy SCD patients. CONCLUSIONS: Further studies will be required to determine whether the E-selectin could be used as an early biomarker of retinopathy sickle cell development.

Health status of recently arrived asylum seekers in their host country: results of a cross-sectional observational study.

BACKGROUND: The World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. There is no recent data on the health status of only asylum seekers who have recently arrived in their Western host country. The purpose of this study was to determine the health status of asylum seekers and search for explanatory factors for this health status. METHODS: This cross-sectional observational study screened the mental and somatic health of adult asylum seekers who had arrived in France within the past 21 days and went to the Marseille single center between March 1 and August 31, 2021. In order to study the explanatory factors of the asylum seekers' health status, a multivariate analysis was performed using a logistic regression model to predict the health status. Factors taken into account were those significantly associated with outcome (level < 0.05) in univariate analysis. RESULTS: In total, 419 asylum seekers were included and 96% CI95%[93;97.3] had at least one health disorder. Concerning mental health, 89% CI95% [85.1;91.4] had a mental disorder and in terms of somatic health exclusively, 66% CI95% [61.4;70.6] had at least one somatic disorder. Women were more likely to have a somatic disease OR = 1.80 [1.07; 3.05]. We found a statistically significant association between the presence of at least one disorder and sleeping in a public space OR = 3.4 [1.02;11.28] p = 0.046. This association is also found for mental disorders OR = 2.36 [1.16;4.84], p = 0.018. CONCLUSIONS: Due to the high prevalence of health disorders our study found, asylum seekers are a population with many care needs when they arrive in their host country. The main factors linked to a poor health status seem to be related to a person's sex, geographical origin and sleeping in a public space.

Unrelated Cord Blood Transplantation in Children, Adolescents, and Young Adults with Acute Leukemia or Myelodysplastic Syndrome: A Retrospective Comparative Study from the French Society for Bone Marrow Transplantation and Cellular Therapy Between Real-World Data and Previously Reported Results of a Randomized Clinical Trial.

We previously reported results of a French randomized clinical trial (RCT) comparing the risk of transplantation failure (including transplant-related mortality [TRM], engraftment failure, and autologous recovery) in single and double unrelated cord blood (UCB) transplantation in children and young adults with hematologic malignancies. We concluded that single-UCB transplantation with an adequate cell dose is the standard of care, leading to a 70% two-year overall survival (OS). It remains unclear, however, whether RCT participants have better outcomes than comparable patients not treated in the setting of a clinical trial. We compared the characteristics and outcomes of RCT participants (n = 137) to a Francophone population-based registry of patients (real-world [RW] group) fulfilling the eligibility criteria used in our RCT and transplanted with 1 or 2 UCB units after a myeloablative conditioning (MAC) regimen between March 2015 (end of inclusion in the RCT) and February 2019 (n = 141). The primary endpoint was the 2-year cumulative incidence (CI) of transplantation strategy failure as defined in our RCT. The 2 groups were comparable in terms of age, disease distribution, hematologic status at transplantation, follow-up, and HLA compatibility. Patients in the RW group were more likely to be transplanted with a single-unit UCB (87.9% versus 49.6%, P< .001) and to receive a radiation-free regimen (39.0% versus 60.6%, P< .001). The 2-year CI of transplantation strategy failure, TRM, and the 2-year probability of OS were similar between the 2 groups, although the relapse risk was higher in the RW group (31.2% ± 7.7% versus 20.4% ± 6.8%, P= .01), resulting in a significantly lower disease-free survival (DFS) (59.2% ± 8.4% versus 69.3% ± 8.0%, P= .047). This difference remained statistically significant only in the group of patients with acute lymphoid leukemia (ALL) who did not receive the conditioning regimen recommended by the RCT (fludarabine 75 mg/m2, total body irradiation 12 Gy, cyclophosphamide 120 mg/kg). The results of our RCT appear to be reproducible in real-world conditions, provided that the same cord blood selection criteria and conditioning regimen are used.

Calibration and Validation of a PREMIUM-DT Item Bank to Measure the Experience of Drug Therapy for Patients with Severe Mental Illness.

The aim of this study was to (1) calibrate an item bank to measure patients' experience of drug therapy for adult patients with SMIs and (2) develop computerized adaptive testing (CAT) to improve its use in routine practice. This is a cross-sectional, multicentric study involving 541 patients with schizophrenia, bipolar disorder, and major depressive disorder. Analyses based on classical test and item response theories were performed. After 7 highly inter-correlated items and 4 items with low factor loadings were removed, the remaining 26 items were sufficiently unidimensional (RMSEA = 0.069, CFI = 0.969, TLI = 0.963) and showed adequate fit to the generalized partial credit model. There was no differential item functioning by gender, age, care setting, or diagnosis from moderate- to large-magnitude. The mean score was 46.0 ± 16.9 and was significantly higher for patients reporting good medication adherence. The resulting PREMIUM-DT item bank has strong psychometric properties, and CAT facilitates widespread use in clinical settings (an average of 8 items administered, corresponding to a reliability of >0.90). Our results suggest that practical information and information about the side effects of psychotropic treatments and how to cope with them should be targeted as a priority to improve patients' experience of drug therapy.

Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial.

Importance: Reducing the use of coercion in mental health care is crucial from a human rights and public health perspective. Psychiatric advance directives (PADs) are promising tools that may reduce compulsory admissions. Assessments of PADs have included facilitation by health care agents but not facilitation by peer workers. Objective: To determine the efficacy of PADs facilitated by peer workers (PW-PAD) in people with mental disorders. Design, Setting, and Participants: A multicenter randomized clinical trial was conducted in 7 French mental health facilities. Adults with a DSM-5 diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who had a compulsory admission in the past 12 months and the capacity to consent were enrolled between January 2019 and June 2020 and followed up for 12 months. Interventions: The PW-PAD group was invited to fill out a PAD form and meet a peer worker who was trained to assist in completing and sharing the form with relatives and psychiatrists. Main Outcomes and Measures: The primary outcome was the rate of compulsory admission at 12 months after randomization. The overall psychiatric admission rate, therapeutic alliance, quality of life, mental health symptoms, empowerment, and recovery outcomes were also investigated. Results: Among 394 allocated participants (median age, 39 years; 39.3% female; 45% with schizophrenia, 36% bipolar I disorder, and 19% schizoaffective disorder), 196 were assigned to the PW-PAD group and 198 to the control group. In the PW-PAD group, 27.0% had compulsory admissions compared with 39.9% in the control group (risk difference, -0.13; 95% CI, -0.22 to -0.04; P = .007). No significant differences were found in the rate of overall admissions, therapeutic alliance score, and quality of life. Participants in the PW-PAD group exhibited fewer symptoms (effect size, -0.20; 95% CI, -0.40 to 0.00), greater empowerment (effect size, 0.30; 95% CI, 0.10 to 0.50), and a higher recovery score (effect size, 0.44; 95% CI, 0.24 to 0.65), compared with those in the control group. Conclusions and Relevance: Peer worker-facilitated PADs are effective in decreasing compulsory hospital admissions and increasing some mental health outcomes (self-perceived symptoms, empowerment, and recovery). Involving peer workers in the completion of PADs supports the current shift of mental health care from substitute decision-making to supported decision-making. Trial Registration: ClinicalTrials.gov Identifier: NCT03630822.