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.

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.

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.

Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial.

OBJECTIVES: Lupus nephritis (LN) is a frequent complication of systemic lupus erythematosus (SLE). Severe (proliferative) forms of LN are treated with induction immunosuppressive therapy (IST), followed by maintenance IST, to target remission and avoid relapses. The optimal duration of maintenance IST is unknown. The WIN-Lupus trial tested whether IST discontinuation after 2‒3 years was non-inferior to IST continuation for two more years in proliferative LN. METHODS: WIN-Lupus was an investigator-initiated multicentre randomised controlled trial. Patients receiving maintenance IST with azathioprine or mycophenolate mofetil for 2-3 years, and hydroxychloroquine, were randomised (1:1) into two groups: (1) IST continuation and (2) IST discontinuation. The primary endpoint was the relapse rate of proliferative LN at 24 months. Main secondary endpoints were the rate of severe SLE flares, survival without renal relapse or severe flare, adverse events. RESULTS: Between 2011 and 2016, 96 patients (out of 200 planned) were randomised in WIN-Lupus: IST continuation group (n=48), IST discontinuation group (n=48). Relapse of proliferative LN occurred in 5/40 (12.5%) patients with IST continuation and in 12/44 (27.3%) patients with IST discontinuation (difference 14.8% (95% CI -1.9 to 31.5)). Non-inferiority was not demonstrated for relapse rate; time to relapse did not differ between the groups. Severe SLE flares (renal or extrarenal) were less frequent in patients with IST continuation (5/40 vs 14/44 patients; p=0.035). Adverse events did not differ between the groups. CONCLUSIONS: Non-inferiority of maintenance IST discontinuation after 2‒3 years was not demonstrated for renal relapse. IST discontinuation was associated with a higher risk of severe SLE flares. TRIAL REGISTRATION NUMBER: NCT01284725.

Molecular characterization of fast-growing melanomas.

BACKGROUND: The rate of growth of primary melanoma is a robust predictor of aggressiveness, but the mutational profile of fast-growing melanomas (FGMM) and the potential to stratify patients at high risk of death has not been comprehensively studied. OBJECTIVE: To investigate the epidemiologic, clinical, and mutational profile of primary cutaneous melanomas with a thickness ≥ 1 mm, stratified by rate of growth. METHODS: Observational prospective study. Deep-targeted sequencing of 40 melanoma driver genes on formalin fixed, paraffin-embedded primary melanoma samples. Comparison of FGMM (rate of growth > 0.5 mm/month) and nonFGMM (rate of growth ≤ 0.5 mm/month). RESULTS: Two hundred patients were enrolled, among wom 70 had FGMM. The relapse-free survival was lower in the FGMM group (P = .014). FGMM had a higher number of predicted deleterious mutations within the 40 genes than nonFGMM (P = .033). Ulceration (P = .032), thickness (P = .006), lower sun exposure (P = .049), and fibroblast growth factor receptor 2 (FGFR2) mutations (P = .037) were significantly associated with fast growth. LIMITATIONS: Single-center study, cohort size, potential memory bias, number of investigated genes. CONCLUSION: Fast growth is linked to specific tumor biology and environmental factors. Ulceration, thickness, and FGFR2 mutations are associated with fast growth. Screening for FGFR2 mutations might provide an additional tool to better identify FGMM, which are probably good candidates for adjuvant therapies.

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.

Predictors of visual function after resection of skull base meningiomas with extradural anterior clinoidectomy.

Skull base meningiomas threatening the optic nerves may require performing an extradural anterior clinoidectomy (EAC) to optimally decompress the optic pathways. The present study evaluated the functional results and morbidity after surgical resection of skull base meningiomas including EAC, focusing on visual acuity (VA) and oculomotricity. Eighty-seven consecutive patients harboring skull base meningiomas who underwent surgical resection that included an EAC between 2003 and 2020 were retrospectively analyzed (86% women, median age 53 years). Decreased visual acuity (DVA) was graded as functional (VA ≥ 5/10) and nonfunctional (VA < 5/10). Statistical analyses were performed on VA and oculomotor nerve (OcN) dysfunction. Ninety surgical procedures were performed. Meningiomas were located at the anterior clinoid process (39%), cavernous sinus (31%), and spheno-orbital (30%) levels. Patients with a preoperative functional vision (normal or functional DVA) had a 90.9% (IC95% = [84.0; 97.8]) probability of preserving it at 6 months and an 84.8% (IC95% = [76.2; 93.5]) probability at last follow-up. Patients with preoperative nonfunctional vision (nonfunctional DVA or blindness) had a 19.0% (IC95% = [2.3; 35.8]) probability of recovery of functional vision at 6 months and a 23.8% (IC95% = [5.6; 42.0]) probability at last follow-up. Preoperative DVA was significantly associated with early postoperative DVA in univariate analyses (p = 0.04). Concerning the OcN, 65% of the patients experienced a postoperative dysfunction, and 78% of those cases recovered. Our study confirms EAC as a useful technical option for skull base meningiomas threatening the optic nerve, especially relevant for patients with preoperative functional vision, and supports early surgical management for these meningiomas.

TEMOBIC: Phase II Trial of Neoadjuvant Chemotherapy for Unresectable Anaplastic Gliomas: An ANOCEF Study.

LESSONS LEARNED: Treatment with temozolomide and BCNU was associated with substantial response and survival rates for patients with unresectable anaplastic glioma, suggesting potential therapeutic alternative for these patients. The optimal treatment for unresectable large anaplastic gliomas remains debated. BACKGROUND: The optimal treatment for unresectable large anaplastic gliomas remains debated. METHODS: Adult patients with histologically proven unresectable anaplastic oligodendroglioma or mixed gliomas (World Health Organization [WHO] 2007) were eligible. Treatment consisted of BCNU (150 mg/m2 ) and temozolomide (110 mg/m2 for 5 days) every 6 weeks for six cycles before radiotherapy. RESULTS: Between December 2005 and December 2009, 55 patients (median age of 53.1 years; range, 20.5-70.2) were included. Forty percent of patients presented with wild-type IDH1 gliomas, and 30% presented with methylated MGMT promoter. Median progression-free survival (PFS), centralized PFS, and overall survival (OS) were 16.6 (95% confidence interval [CI], 12.8-20.3), 15.4 (95% CI, 10.0-20.8), and 25.4 (95% CI, 17.5-33.2) months, respectively. Complete and partial responses under chemotherapy were observed for 28.3% and 17% of patients, respectively. Radiotherapy completion was achieved for 75% of patients. Preservation of functional status and self-care capability (Karnofsky performance status [KPS] ≥70) were preserved until disease progression for 69% of patients. Grade ≥ 3 toxicities were reported for 52% of patients, and three deaths were related to treatment. By multivariate analyses including age and KPS, IDH mutation was associated with better prognostic for both PFS and OS, whereas MGMT promoter methylation was associated with better OS. CONCLUSION: The association of BCNU and temozolomide upfront is active for patients with unresectable anaplastic gliomas, but toxicity limits its use.

CD169 and CD64 could help differentiate bacterial from CoVID-19 or other viral infections in the Emergency Department.

The identification of a bacterial, viral, or even noninfectious cause is essential in the management of febrile syndrome in the emergency department (ED), especially in epidemic contexts such as flu or CoVID-19. The aim was to assess discriminative performances of two biomarkers, CD64 on neutrophils (nCD64) and CD169 on monocytes (mCD169), using a new flow cytometry procedure, in patients presenting with fever to the ED during epidemics. Eighty five adult patients presenting with potential infection were included during the 2019 flu season in the ED of La Timone Hospital. They were divided into four diagnostic outcomes according to their clinical records: no-infection, bacterial infection, viral infection and co-infection. Seventy six patients with confirmed SARS-CoV-2 infection were also compared to 48 healthy volunteers. For the first cohort, 38 (45%) patients were diagnosed with bacterial infections, 11 (13%) with viral infections and 29 (34%) with co-infections. mCD169 was elevated in patients with viral infections, with a majority of Flu A virus or Respiratory Syncytial Virus, while nCD64 was elevated in subjects with bacterial infections, with a majority of Streptococcus pneumoniae and Escherichia coli. nCD64 and mCD169 showed 90% and 80% sensitivity, and 78% and 91% specificity, respectively, for identifying patients with bacterial or viral infections. When studied in a second cohort, mCD169 was elevated in 95% of patients with SARS-CoV-2 infections and remained at normal level in 100% of healthy volunteers. nCD64 and mCD169 have potential for accurately distinguishing bacterial and acute viral infections. Combined in an easy and rapid flow cytometry procedure, they constitute a potential improvement for infection management in the ED, and could even help for triage of patients during emerging epidemics.

Risk stratification of adrenal masses by [18 F]FDG PET/CT: Changing tactics.

CONTEXT: [18 F]FDG PET/CT improves adrenal tumour characterization. However, there is still no consensus regarding the optimal imaging biomarkers of malignancy. OBJECTIVES: To assess the performance of Tumour standardized uptake value (SUV)max :Liver SUVmax for malignancy-risk and to build and evaluate a prediction model. DESIGN/METHODS: The cohort consisted of consecutive patients with adrenal masses evaluated by [18 F]FDG PET/CT. The gold standard for malignancy was based on histology or a multidisciplinary consensus in nonoperated cases. The performance of the previously reported cut-off for Tumour SUVmax :Liver SUVmax (>1.5) was evaluated in this independent cohort. Additionally, a predictive model of malignancy was built from the training cohort (previous study) and evaluated in the validation cohort (current study). RESULTS: Sixty-four patients were evaluated; 28% of them had a Cushing's syndrome. Fifty-four adrenal masses were classified as benign and 10 as malignant (including 7 adrenocortical carcinomas). Compared to benign masses, malignant lesions were larger in size, had higher unenhanced densities and higher [18 F]FDG uptake. CT-derived anthropometric parameters did not differ between benign and malignant masses. A tumour SUVmax :Liver SUVmax  > 1.5 showed a good diagnostic performance: Se = 90.0%/Sp = 92.6%/PPV = 69.2%/NPV = 98.0% and accuracy = 92.2%. A predictive model based on tumour size and tumour-to-liver uptake SUVmax ratio for malignancy-risk was validated and provides a complementary approach to the ratio. CONCLUSIONS: Tumour SUVmax :Liver SUVmax uptake ratio is a useful biomarker for diagnosis of adrenal masses. Another tactic would be to calculate with the model an individual risk of malignancy and integrate this information into a shared decision-making process.

Systematic review and meta-analysis of endovascular versus open repair for common femoral artery atherosclerosis treatment.

BACKGROUND: Encouraging recent reports on endovascular treatment of common femoral artery (CFA) atherosclerotic disease has rendered the question regarding the place of this technique evermore pertinent and legitimizes the performance of randomized trials. The present comprehensive review focused on the early and midterm outcomes to help assess the benefit/risk balance of endovascular vs open repair for CFA treatment. METHODS: Embase and Medline searches were conducted according to the PRISMA (Preferred Reporting Items for Systematic review and Meta-Analyses) standards to identify studies from 2000 to 2018 reporting on endovascular repair (ER), open surgery (OS), and comparisons of both techniques for CFA atherosclerosis treatment. The outcomes measured were 30-day mortality, morbidity, reintervention rates, midterm patency, late reintervention, and restenosis rates. RESULTS: Twenty-eight studies were eligible: 14 OS (1920 patients), 12 ER (1900 patients), and 2 comparative randomized trials (197 patients). The meta-analysis of the comparative studies revealed no differences in 30-day mortality or reintervention rates but improved 30-day morbidity after ER. At 1 year, the primary patency rates did not differ between ER and OS, nor did the late reintervention rate. In the noncomparative studies, with a mean follow-up period of 23.8 months for ER and 66 months for OS, the restenosis rate was 14.4% and 4.7%, respectively. The reported stent fracture rate was 3.6%. In the ER cohort, the overall primary patency at 1, 2, and 3 years was 81.9%, 77.8%, and 75.1%, respectively. For the OS cohort, the overall primary patency rate at 1, 2, and 3 years was 93.4%, 91.4%, and 90.5%, respectively. CONCLUSIONS: Despite expectations, our analysis of the reported data suggests that the perioperative mortality is not in favor of ER; however, the perioperative morbidity showed an advantage for ER compared with OS. Also, although comparable in the first year, the long-term primary patency rate was much greater after OS. At present, the place of ER for CFA treatment still requires further definition. Additional clarification of the indications and more research are both required to determine the optimal endovascular technology and femoral bifurcation reconstruction with stenting.

Defect in the nuclear pore membrane glycoprotein 210-like gene is associated with extreme uncondensed sperm nuclear chromatin and male infertility: a case report.

After the two meiotic divisions, haploid round spermatids undergo dramatic changes to become mature spermatozoa. One of the main transformations consists of compacting the cell nucleus to confer the sperm its remarkable hydrodynamic property and to protect its DNA from the oxidative stress it will encounter during its reproductive journey. Here, we studied an infertile subject with low sperm count, poor motility and highly abnormal spermatozoa with strikingly large heads due to highly uncondensed nuclear sperm DNA. Whole-exome sequencing was performed on the subject's DNA to identify the genetic defect responsible for this severe sperm anomaly. Bioinformatics analysis of exome sequence data uncovered a homozygous loss of function variant, ENST00000368559.7:c.718-1G>A, altering a consensus splice site expected to prevent the synthesis of the nucleoporin 210 like (NUP210L) protein. High-resolution mass spectrometry of sperm protein extracts did not reveal any NUP210L peptide sequence in the patient's sperm, contrary to what was observed in control donors, thus confirming the absence of NUP210L in the patient's sperm. Interestingly, homozygous Nup210l knock-out mice have been shown to be infertile due to a reduced sperm count, a high proportion of round-headed sperm, other head and flagella defects and a poor motility. NUP210L is almost exclusively expressed in the testis and sequence analogy suggests that it encodes a nuclear pore membrane glycoprotein. The protein might be crucial to regulate nuclear trafficking during and/or before spermiogenesis, its absence potentially impeding adequate nuclear compaction by preventing the entry of histone variants/transition proteins/protamines into the nucleus and/or by preventing the adequate replacement of core histones. This work describes a new gene necessary for male fertility, potentially improving the efficiency of the genetic diagnosis of male infertility. The function of NUP210L still remains to be resolved and its future investigation will help to understand the complex mechanisms necessary for sperm compaction.

Assessing the experience of the quality of care of patients living with multiple sclerosis and their caregivers: The MusiCare questionnaire.

BACKGROUND AND PURPOSE: Patients with a chronic illness, such as multiple sclerosis (MS), and their natural caregivers have a specific experience of healthcare and health services. These experiences need to be assessed to evaluate the quality of care. Our objective was to develop a French-language questionnaire to evaluate the quality of care as experienced by MS patients and their natural caregivers. METHODS: Eligible patients had been diagnosed with MS according to the McDonald criteria. Eligible caregivers were individuals designated by the patients. The MusiCare questionnaire was developed in two standard phases: (i) item generation, based on interviews with patients and caregivers; and (ii) validation, consisting of validity, reliability, external validity, reproducibility, and responsiveness measures. RESULTS: In total, 1088 patients (n = 660) and caregivers (n = 488) were recruited. The initial 64-item version of MusiCare was administered to a random subsample (n = 748). The validation process generated a 35-item questionnaire. Internal consistency and scalability were satisfactory. Testing of the external validity revealed expected associations between MusiCare scores and sociodemographic and clinical data. The questionnaire showed good reproducibility and responsiveness. CONCLUSIONS: The availability of a reliable and validated French-language self-report questionnaire probing the experience of the quality of care for MS will allow the feedback of patients and caregivers to be incorporated into a continuous healthcare quality-improvement strategy.

Clinical validation of immunoassay HemosIL® AcuStar HIT-IgG (PF4-H) in the diagnosis of Heparin-induced thrombocytopenia.

Heparin induced thrombocytopenia (HIT) is a life and limb-threatening complication of heparin exposure. The misdiagnosis of this disease can have major consequences on the patients. The objective of this study was to evaluate a diagnostic strategy that combines the 4Ts score with the result of HemosIL® AcuStar HIT-IgG (PF4-H) to confirm the diagnosis of HIT. Citrated plasmas from 1300 patients with suspicion of HIT were analyzed with a fully automated quantitative chemiluminescent immunoassay (HemosIL® AcuStar HIT-IgG (PF4/H)). If the IgG anti-PF4/H antibodies were positive (cut-off, 1 U/mL), HIT diagnosis was confirmed using functional tests. In total, 1300 samples of consecutive patients were enrolled, 94 (7.2%) of which gave positive results in HemosIL® AcuStar-IgG. HIT was diagnosed in 65 out of these patients, corresponding to a prevalence of 5%. Using ROC curve analysis, patients were divided into three groups according to their titer of antibodies. Higher values of the IgG (PF4-H) were associated with increased probability of HIT, and the diagnostic specificity was greatly increased using the combination of a 4Ts score > 3 and a positive titer ≥ 3.25 U/mL. Importantly, the diagnostic specificity is 100% when the titer is > 12.40 U/mL. We demonstrated that higher values of Anti PF4/H Antibodies were associated with a high probability of having HIT. A titer of HemosIL® IgG (PF4-H) > 12.40 U/mL has a specificity of 100% which should no require a functional test to confirm the diagnosis of HIT.

Predicting risk factors of postoperative hypocalcemia after total thyroidectomy: is safe discharge without supplementation possible? A large cohort study.

PURPOSE: With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia after total thyroidectomy. The aim of this study was to investigate whether serum calcium and/or PTH levels can predict post-thyroidectomy hypoparathyroidism. METHODS: From January to December 2014, 477 consecutive patients undergoing total thyroidectomy were included. Corrected calcemia and PTH were systematically performed on postoperative day 1/(POD1). Symptomatic patients were treated on POD1 or POD2 with calcium and vitamin D. RESULTS: Sixty-eight patients (14.25%) were treated for postoperative hypocalcemia. No patients with calcemia ≥ 2.16 mmol/l and PTH ≥ 1.9 pmol/l were supplemented and therefore were safely discharged on POD1 (specificity = 100%). All patients with calcemia ≤ 1.89 mmol/l were treated regardless the PTH values (n = 10) (specificity = 100%). For calcium value between 1.9 and 2.16 mmol/l with a PTH > 4.7 pmol/l, nobody was treated. With a calcemia between 1.9 and 2.16 mmol/l and a PTH > 1.9 pmol/l, 44 patients did not develop any symptom. ROC curve analysis showed that combination of Cac = 2.16 mmol/l and iPTH = 4.7 pmol/l provided a sensitivity of 97.06% and a specificity of 76.53% (p < 0.0001). We therefore propose an algorithm that would allow to 70% of patients could have been discharged on POD1 without risk of hypocalcemia or overtreatment. CONCLUSION: Combination of corrected calcemia and PTH on POD1 can efficiently predict hypocalcemia and be integrated into clinical practice for personalizing lengths of hospitalization and appropriate treatment. TRIAL REGISTRATION: ClinicalTrials.gov PRS. Unique Identifying number or registration ID: NCT04372225.

Delayed post-pancreatectomy hemorrhage and bleeding recurrence after percutaneous endovascular treatment: risk factors from a bi-centric study of 307 consecutive patients.

PURPOSE: Delayed post-pancreatectomy hemorrhage (PPH) is still one of the most dreaded complications after pancreatic surgery. Its management is now focused on percutaneous endovascular treatments (PETs). METHODS: Between 2013 and 2019, 307 patients underwent pancreatic resection. The first endpoint of this study was to determine predictive factors of delayed PPH. The second endpoint was to describe the management of intra-abdominal abscesses (IAA). The third endpoint was to identify risk factors of bleeding recurrence after PET. Patients were divided into two cohorts: A retrospective analysis was performed ("cohort 1," "learning set") to highlight predictive factors of delayed PPH. Then, we validated it on a prospective maintained cohort, analyzed retrospectively ("cohort 2," "validation set"). Second and third endpoints studies were made on the entire cohort. RESULTS: In cohort 1, including 180 patients, 24 experienced delayed PPH. Multivariate analysis revealed that POPF diagnosis on postoperative day (POD) 3 (p=0.004) and IAA (p=0.001) were independent predictive factors of delayed PPH. In cohort 2, association of POPF diagnosis on POD 3 and IAA was strongly associated with delayed PPH (area under the curve [AUC] 0.80; 95% confidence interval [CI] [0.59-0.94]; p=0.003). Concerning our second endpoint, delayed PPH occurred less frequently in patients who underwent postoperative drainage procedure than in patients without IAA drainage (p=0.002). Concerning our third endpoint, a higher body mass index (BMI) (p=0.027), occurrence of postoperative IAA (p=0.030), and undrained IAA (p=0.011) were associated with bleeding recurrence after the first PET procedure. CONCLUSION: POPF diagnosis on POD 3 and intra-abdominal abscesses are independent predictive factors of delayed PPH. Therefore, patients presenting an insufficiently drained POPF leading to intra-abdominal abscess after pancreatic surgery should be considered as a high-risk situation of delayed PPH. High BMI, occurrence of postoperative IAA, and undrained IAA were associated with recurrence of bleeding after PET.

Nomograms for predicting adverse obstetric outcome in IVF pregnancy: A preliminary study.

BACKGROUND: In a previous study, we showed that the obstetric complication rate after in vitro fertilization (IVF) pregnancy was 40%. The main objective of our study was to determine maternal prognosis factors that influence the IVF pregnancy outcome. METHODS: We conducted an observational retrospective monocentric study between January 2014 and January 2018. Pregnancy over 22 gestational weeks (GW) obtained after IVF in our infertility clinic was included. Maternal characteristics and pregnancy outcome were collected. RESULTS: Data from 498 IVF pregnancies were analyzed. The most significant maternal prognosis factors for obstetric complications were maternal age above 40 years (OR 3,0 [95% IC 1,30-7,09], P = 0,010), twin pregnancies (3.8 [95% IC 1.49-9.99], P = .005), daily maternal smoking above 10 cigarettes (7.1 [95% IC 1.22-41.74], P = .029), maternal obesity (2.2 [95% IC 1.19-4.07], P = .012), endometriosis stages III and IV (6.4 [95% IC 1.52-27.04], P = .011), and history of ovarian hyperstimulation syndrome (OHSS) in early pregnancy (5.7 [95% IC 1.29-24.74], P = .021). Risk increase was independent of pregnancy type (singleton or twin) and allowed the elaboration of 2 nomograms. CONCLUSIONS: Our study showed a link between some maternal factors and increase in obstetric complications after IVF. Screening of these factors during preconceptional visit is essential to identify at high-risk pregnancies and adapt their monitoring.

Performance Assessment for Total Laparoscopic Hysterectomy in the Operating Room: Validity Evidence of a Procedure-specific Rating Scale.

STUDY OBJECTIVE: The technical conduct of total laparoscopic hysterectomy (LH) is critical to surgical outcomes. This study explored the validity evidence of an objective scale specific to the assessment of technical skills (H-OSATS) for 7 tasks of an LH with salpingo-oophorectomy procedure performed in the operating room. DESIGN: Observational cohort study. SETTING: Two academic hospitals in Marseille and Montpellier, France. PATIENTS: Three groups of operators (novice, intermediate, and experienced surgeons) were video recorded during their live performances of LH on a simple case. For each group, a dozen unedited videos were obtained for the following tasks: division of the round ligament, division of the infundibulopelvic ligament, creation of the bladder flap, opening of the posterior peritoneum, division of the uterine vessels, colpotomy, and closure of the vault. INTERVENTIONS: Two qualified raters blindly assessed each video using the H-OSATS rating scale. Inter-rater reliability and test-retest reliability were calculated as measures of internal structure. In a separate round of evaluations, the raters provided a global competent/noncompetent decision for each performance. As a measure of consequential validity, a pass/fail score was set for each task using the contrasting group method. MEASUREMENTS AND MAIN RESULTS: Three tasks (creation of the bladder flap, colpotomy, and closure of the vault) displayed sound validity evidence: a meaningful total score difference among the 3 groups of experience as well as between the intermediate and experienced surgeons, reliability outcomes of >0.7, and a pass/fail score with a theoretical false-positive rate of <10%. CONCLUSION: The validity evidence of the H-OSATS rating scale differed for separate evaluations of the 7 tasks. Three tasks (i.e., creation of the bladder flap, colpotomy, and closure of the vault) revealed sound validity evidence, including at the level of the attending surgeon, whereas other tasks were more consistent with low-stakes formative evaluation standards.

Technical feasibility and correlations between shear-wave elastography and histology in kidney fibrosis in children.

BACKGROUND: Ultrasound elastography has been suggested for assessing organ fibrosis. OBJECTIVE: To study the feasibility of shear-wave elastography in children with kidney disease and the correlation between elasticity and kidney fibrosis in order to reduce the indications for kidney biopsy and its complications. MATERIALS AND METHODS: Four operators measured kidney elasticity in children with kidney diseases or transplants, all of whom also had a renal biopsy. We assessed the feasibility and the intraobserver variability of the elasticity measurements for each probe used and each kidney explored. Then we tested the correlation between elasticity measurements and the presence of fibrosis. RESULTS: Overall, we analyzed 95 children and adolescents, 31 of whom had renal transplant. Measurements with the convex probe were possible in 100% of cases. Linear probe analysis was only possible for 20% of native kidneys and 50% of transplants. Intraobserver variabilities ranged from moderate to high, depending on the probe and kidney studied. Elasticity was higher with the linear probe than with the convex probe (P<0.001 for left kidney and P=0.03 for right kidney). Measurements did not differ from one kidney to another in the same child. Elasticity and fibrosis were both higher in transplant patients (P=0.02 with convex probe; P=0.01 with linear probe; P=0.04 overall). There was no correlation between elasticity and fibrosis. CONCLUSION: Of the devices used in this work, kidney elastography was more accurately analyzed with a convex probe. Our study did not identify any correlation between elasticity and kidney fibrosis.