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PURPOSE Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated. METHODS In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery. RESULTS Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with P < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm ( P < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery. CONCLUSION This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.

Early diagnosis of axial spondyloarthritis (axSpA) remains a challenge due to the lack of specificity of clinical symptoms and variable prevalence of axial imaging findings permitting a definite diagnosis. Power Doppler ultrasonography (PDUS) of the entheses has demonstrated to be a potential useful tool for the classification and diagnostic management of early SpA independently of the phenotype.Objectives To assess the classification value (sensitivity and specificity) of PDUS-defined enthesitis for identifying patients fulfilling Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA (ASAS+) in patients with recent inflammatory back pain (IBP) (the DESIR (DEvenir des Spondylarthropathies Indifférenciées Récentes) cohort).Methods Baseline PDUS was performed at eight entheseal sites, and PDUS enthesitis was defined by the presence of vascularisation at entheseal insertion.Results 402 patients from the DESIR cohort underwent a PDUS evaluation. PDUS enthesitis was detected in 58 (14.4%) patients of whom 40 (14.2%) belonged to the ASAS+ patients and 18 (17%) to the ASAS- patients. The sensitivity of PDUS enthesitis was 13.9% and the specificity was 83.5%, with a positive predictive value of 69% and 26.8% of negative predictive value for meeting ASAS criteria for axSpA. Of the 18 ASAS- patients with positive PDUS, 59% fulfilled Amor’s criteria, 88% European Spondyloarthropathy Study Group criteria and 59% both.ConclusionsIn a cohort of patients with recent IBP, the prevalence of PDUS enthesitis was low (14.4%); however, its specificity for classifying patients as axSpA according to ASAS criteria was high (83.5%). PDUS enthesitis might be of additional value for classifying as patients with axSpA IBP who do not fulfil ASAS criteria.

Objective: To confirm the advantage of in situ reconstruction (ISR) over extra-anatomic reconstruction (EAR) for aortic graft infection and determine the most appropriate conduit including autogenous veins, cryopreserved allografts, and synthetic prosthesis (standard, rifampicin of silver polyesters). Methods: A meta-analysis was conducted with rate of mortality, graft occlusion, amputation, and reinfection. A meta-regression was performed with 4 factors: patients’ age, presence of prosthetic-duodenal fistula (PDF), virulent organisms, or nonvirulent organisms. Results: In situ reconstruction over EAR seems to favor all events. For the 5 conduits used for ISR, according to operative mortality, age of the patients looks to have a positive correlation only for silver polyester and no conduit present any advantage in the presence of PDF. Reinfection seems to be not significantly different for the 5 conduits, and only autogenous veins appear to have a positive correlation with infecting organisms. Conclusion: In situ reconstruction may be considered as first-line treatment. Our results suggest that silver polyesters appear to be most appropriate for older patients, and in order to limit reinfection, autogenous veins are probably the most suitable conduit.

Medical-administrative databases are an important source of big data to assess the epidemiology of diseases and interventions, compare drugs, and investigate rare adverse events. We describe the French national health insurance system databases and the Epidemiology and Safety (EPISAFE) collaboration program in ophthalmology and illustrate the paper with recent studies that used the databases to investigate cataract surgery. The Système national d'information inter-régime de l'assurance maladie (SNIIR-AM) is one of the largest databases of medical and administrative data for a general population, covering nearly 65 million people. The SNIIR-AM database links data for all outpatient-reimbursed health expenditures, hospitalization in all 1,546 French private or public healthcare facilities, and date of death. The use of this database provides information at the scale of the entire country, allowing measurement of the impact of changes in practices and new guidelines. Between 2009 and 2012, a total of 2,717,203 eyes in 1,817,865 patients underwent cataract surgery in France, and the incidence of cataract surgery increased from 9.86 to 11.08/1,000 person-years. The 4-year cumulative risk of retinal detachment was 0.99%, and patients

Background Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties. Methods/design The BRACAVENIR study consists of a prospective, randomized superiority phase II trial with a wait list control group. Participants are childless young female counselees (aged 18–30 years) seen at the oncogenetics department of the Centre Jean Perrin and belonging to HBOC families either with or without BRCA mutations. They will be invited to attend a weekend group session at a spa resort and to participate in short expert conferences and focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (wait list) will enable us to evaluate the intervention’s effect by comparing questionnaire scores between the 6-month time points. The main endpoint is an increase of the Herth Hope Index by at least 1 SD. Secondary endpoints are self-esteem, anxiety trait, anxiety state, coping, and quality of life. With a one-sided α = 0.05 and β = 0.20, 12 participants will be needed by group, plus an additional 2 in anticipation of dropouts. Participants will be randomized 1:1 to the first or the second session so that the groups will be comparable. Discussion The intent of this trial is to bridge the gap on a psychosocial level in these young women with HBOC. A particularity of the design is the use of a waiting list, which should allow for avoiding major bias. The intervention consists of a short session that could be proposed to other young counselees if successful. The results may bring complementary information to facilitate the intervention and also influence the contents of the oncogenetic consultation. Trial registration Ethics committee CPP SUD-EST-6: IRB00008526. Registered on 18 March 2016. ClinicalTrials.gov identifier: NCT02705924. Registered on 2 March 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1642-4) contains supplementary material, which is available to authorized users.

International audience; IMPORTANCE:Postoperative endophthalmitis (POE) often results in severe visual impairment. In clinical studies, an intracameral cefuroxime injection at the end of surgery was found to be effective at reducing the incidence of POE. Two important issues are the retinal safety of cefuroxime and its use for patients with perioperative capsular rupture where the risk of POE is dramatically increased.OBJECTIVE:To assess the effectiveness and retinal safety of an intracameral injection of cefuroxime sodium for the prevention of POE and its possible use in cases of a perioperative capsular rupture of the lens.DESIGN, SETTING, AND PARTICIPANTS:Population-based cohort study of patients 40 years of age or older who underwent cataract surgery at 1 of 1546 French health care facilities, public or private, and whose medical records were obtained from the national administrative database. Data analyses were performed between March and November 2015.MAIN OUTCOMES AND MEASURES:The effectiveness and safety of the prophylactic injection of cefuroxime as measured by the incidence of POE and cystoid macular edema.RESULTS:From January 2010 to October 2014, a total of 3 351 401 eyes of 2 434 008 patients 40 years of age or older (58.9% were women, and the mean [SD] age was 73.9 [9.5] years) underwent cataract surgery; 1941 patients (0.08%) developed POE during the 6 weeks after cataract surgery. The incidence of POE after cataract surgery decreased over the course of the study (0.11%, 0.09%, 0.08%, 0.06%, and 0.05% in 2010, 2011, 2012, 2013, and 2014, respectively [P = .001 for trend]) as the use of cefuroxime prophylactic injections increased (11.1%, 14.4%, 32.8%, 64.8%, and 79.1% in 2010, 2011, 2012, 2013, and 2014, respectively [P = .001 for trend]). After multivariate adjustment, the risk of POE was reduced with the use of cefuroxime (odds ratio, 0.61 [95% CI, 0.56-0.68]). The retinal safety of an injection of cefuroxime, which was assessed by multiadjusted odds of retinal cystoid macular edema, was not increased for patients receiving cefuroxime injections (odds ratio, 0.86 [95% CI, 0.71-1.05]). For patients with a perioperative capsular rupture of the lens (the major risk factor for POE), the incidence of POE was lower for those who received an injection of cefuroxime than for those who did not (0.37% vs 0.51%, respectively [P = .001]), whereas an increased risk of cystoid macular edema was not identified for those who received or did not receive an injection of cefuroxime (5.6% vs 7.3%, respectively [P = .12]).CONCLUSIONS AND RELEVANCE:These data suggest that, in routine practice, the intracameral injection of cefuroxime at the conclusion of cataract surgery is associated with a lower risk of POE and is safe for patients with or without a perioperative capsular rupture. While these data might be used to support the consideration of its routine use to prevent POE, in the absence of a randomized clinical trial, they cannot prove a direct cause-and-effect relationship between the injection of cefuroxime and POE.

Objectives Lyme disease may be considered by rheumatologists in patients with recent-onset arthritis, even in the absence of suggestive symptoms. The aim of this study was to determine the diagnostic impact of routine Lyme serology in a French cohort of patients with recent-onset arthritis affecting at least 2 joints. Methods We performed an ancillary study of a French prospective multicentre cohort established to monitor clinical, biological and radiographic data in patients with inflammatory arthritis in at least 2 joints, lasting for 6 weeks to 6 months. Borrelia IgM and IgG antibodies were sought routinely at baseline, using ELISA tests, independently from the physician's strategy for detecting a spirochetal infection. We recorded the proportion of patients with a final diagnosis of Lyme arthritis and evaluated the diagnostic performance of Lyme serology in this particular context. The clinical and biological characteristics of patients according to the Lyme serology results were analysed. Results Of 810 patients, 657 (81.1%) were negative for IgM and IgG antibodies, 91 (11.2%) had only IgM antibodies, 49 (6%) had only IgG antibodies, and 13 (1.6%) had IgG and IgM antibodies. Thus, 7.6% had IgG positivity, consistent with exposure to Borrelia infection. IgG positivity was significantly more prevalent in the North and North-East regions of France (χ2=14.6, p

International audience; BackgroundSkin-sparing mastectomy (SSM) with immediate breast reconstruction (IBR) is increasingly used in invasive breast cancer. However, adjuvant chemotherapy (CT) and radiotherapy (RT) can increase the rate of local complications.ObjectiveThe aim of this study was to assess the morbidity of SSM–IBR after neoadjuvant CT and RT.MethodsA French prospective pilot study of women aged 18–75 years with invasive breast cancer requiring mastectomy after CT and RT. Reconstruction was performed using autologous latissimus dorsi flap with or without prosthesis. The primary endpoint was the skin necrosis rate within 6 months, while secondary endpoints included pathological complete response rate (pCR) and global morbidity.ResultsAmong 94 patients included in this study, 83 were analyzed (mean age 45.2 ± 9.5 years, T1 23.6 %, T2 55.6 %, T3 18.1 %). All but one patient received anthracyclines and taxanes, and all patients received RT (49.3 ± 5.2 Gy) before SSM–IBR. Prostheses were used for IBR in 32 patients (mean volume 256 ± 73 mm3). Five patients had necrosis (≤2 cm2, 2–10 cm2 and >10 cm2, in three, one, and one cases, respectively), and they all recovered without revision surgery. Among 50 patients who underwent upfront mastectomy, 36 % achieved pCR.ConclusionsSSM–IBR performed after CT and RT is safe, with an acceptable local morbidity rate. Long-term data are needed to evaluate recurrence rates.

Objective To study the contribution of routine viral screening tests in patients with early rheumatoid arthritis (RA) or a potential for progressing to RA. Methods Eight hundred thirteen patients with swelling of at least 2 joints for at least 6 weeks and a symptom duration of less than 6 months in the ESPOIR cohort were screened for parvovirus B19 (IgG and IgM anti–parvovirus B19 antibodies), hepatitis B virus (HBV; hepatitis B surface antigen), hepatitis C virus (HCV; anti-HCV antibodies), and human immunodeficiency virus (HIV; anti–HIV-1 and -2 antibodies). Results Parvovirus B19 testing was performed in 806 patients and showed longstanding immunity in 574 (71.2%) and no antibodies in 223 (27.7%). Among the 9 remaining patients (7 IgG positive/IgM positive, 1 IgG negative/IgM positive, and 1 IgG indeterminate/IgM positive), only 2 (0.25%; 95% confidence interval [95% CI] 0–0.99%) had a positive polymerase chain reaction test for parvovirus B19; these patients (women ages 34 and 40 years) had no extraarticular signs. HIV seroprevalence was 0.12% (n = 1 of 813; 95% CI 0.01–0.8%) and HCV seroprevalence was 0.86% (n = 7 of 808, 95% CI 0.38–1.86%). HCV-related arthritis was diagnosed in 4 patients (0.5%). HCV-seropositive patients had significantly higher transaminase levels than the other patients (P = 0.001), with no significant differences for the other laboratory data. HBV seroprevalence was 0.12% (n = 1 of 808; 95% CI 0.01–0.8%); the positive HBV status was known before study inclusion, and the patient had no diagnosis of HBV-related arthritis. Finally, routine viral testing identified 2 patients with parvovirus B19 infection and 3 with HBV infection (0.6%; 95% CI 0.2–1.5%). Cost was €85.05 per patient (total €68,720). Conclusion Routine serologic testing did not contribute substantially to the diagnosis in this context.

International audience; STUDY DESIGN: Cross-cultural adaptation and reliability study. OBJECTIVE: To translate, evaluate the reliability and cross-culturally adapt the Skin Management Needs Assessment Checklist (SMnac), a questionnaire evaluating the knowledge on pressure ulcer (PU) prevention measures in persons with spinal cord injury (SCI). SUBJECTS: 138 persons with SCI, mean age 45.9 years, mean time since injury 94 months. MATERIAL AND METHOD: The study was carried out in two stages. First, the questionnaire went through a forward-backward translation process and was cross-culturally adapted, according to a validated methodology for self-reported measures. Then, the test-retest reliability was evaluated on a population of persons with SCI. RESULTS: The standardized back-translation and cross-cultural adaptation led to the revised Smack grid, with the addition of seven items representing an update of PU prevention measures. The reliability was excellent (intraclass correlation coefficient: 0.899). CONCLUSION: The revised SMnac is an adaptation of the SMnac, including therapeutic education frameworks and the latest PU prevention practices. It appears to be a reliable tool for assessing the knowledge and benefits of PU prevention in persons with SCI. Further studies are needed to explore its validity and responsiveness to change.

Objective.To evaluate the seroprevalence of hepatitis B (HBV) and C (HCV) in patients living in France with recent-onset polyarthritis suggesting rheumatoid arthritis.Methods.The 813 patients in the ESPOIR cohort were screened for anti-HCV antibodies and HBs antigen.Results.Seroprevalence was 0.86% for HCV (n = 7) and 0.12% for HBV (n = 1). HCV-related arthritis was diagnosed in 4 (0.5%) patients; no patient had HBV-related arthritis. HCV-seropositive patients had significantly higher transaminase levels (ALAT, 41.5 IU vs 23.2 IU, p = 0.02; and ASAT, 39.2 IU vs 21.8 IU, p = 0.001) but only 2 patients had ASAT or ALAT levels > 40 IU. No significant differences were found for anti-CCP antibodies, C-reactive protein, erythrocyte sedimentation rate, or other test. HCV seroprevalence was significantly higher in the subgroup with history of blood transfusion than in other patients (3.7% vs 0.42%, p = 0.02). Two of the 7 HCV positive patients and the single patient with confirmed hepatitis B infection were born in areas with higher prevalence of viral hepatitis (Togo, Senegal, Vietnam). Positive hepatitis status was known before study inclusion in 4 of the 7 HCV-positive patients and in the HBV-positive patient.Conclusion.The prevalence of HBV and HCV in a population of patients with recent-onset polyarthritis suggestive of RA was not greater than expected based on data from the general population in the same geographic area. Routine HBV and HCV serological testing did not contribute substantially to the diagnosis of recent-onset polyarthritis. Although advisable before initiating immunosuppressive or hepatotoxic drugs, serological testing for HCV and HBV is unnecessary in routine diagnostic evaluation of recent-onset polyarthritis.

Objective : To investigate the expression of adrenomedullin (AM) in benign and malignant ovarian tissues and its correlation with estrogen receptors (ERs) mRNA status. Study design : Ovarian carcinoma cell lines, normal ovaries, serous cysts and cancers were analyzed using real-time polymerase chain reaction (PCR) in order to quantify adrenomedullin and ERs mRNAs expression. Some ovarian samples were submitted to laser-capture microdissection to determine the differential expression of target genes in epithelium and stroma. Results : Ovarian cancer cells express adrenomedullin mRNA for both the ligand and receptor and produce the peptide. In tumors, the ERα/β ratio was higher than in other tissues. Correlations were found between ERα and ERβ mRNA and adrenomedullin mRNA expression in tumors. Conclusion : Adrenomedullin may be involved in both normal and malignant tissue growth through both vascular and growth factor effects. Because of the correlations with ERs status, there is emerging evidence that ovarian cancer is endocrine-related.