Nationwide Multicenter Study Research Articles

Development and validation of a prediction rule for estimating gastric cancer risk in the Chinese high-risk population: a nationwide multicentre study

ObjectiveTo develop a gastric cancer (GC) risk prediction rule as an initial prescreening tool to identify individuals with a high risk prior to gastroscopy.DesignThis was a nationwide multicentre cross-sectional study....

Surgical Treatment of Osteoporotic Vertebral Fracture with Neurological Deficit-A Nationwide Multicenter Study in Japan.

Introduction The prevalence of patients with osteoporosis continues to increase in aging societies, including Japan. The first choice for managing osteoporotic vertebral compression fracture (OVF) is conservative treatment. Failure in conservative treatment for OVF may lead to non-union or vertebral collapse, resulting in neurological deficit and subsequently requiring surgical intervention. This multicenter nationwide study in Japan was conducted to comprehensively understand the outcomes of surgical treatments for OVF non-union. Methods This multicenter, retrospective study included 403 patients (89 males, 314 females, mean age 73.8 ± 7.8 years, mean follow-up 3.9 ± 1.7 years) with neurological deficit due to vertebral collapse or non-union after OVF at T10-L5 who underwent fusion surgery with a minimum 1-year follow-up. Radiological and clinical outcomes at baseline and at the final follow-up (FU) were evaluated. Results OVF was present at a thoracolumbar junction such as T12 (124 patients) and L1 (117 patients). A majority of OVF occurred after a minor trauma, such as falling down (55.3%) or lifting objects (8.4%). Short segment fusion, including affected vertebra, was conducted (mean 4.0 ± 2.0 vertebrae) with 256.8 minutes of surgery and 676.1 g of blood loss. A posterior approach was employed in 86.6% of the patients, followed by a combined anterior and posterior (8.7%), and an anterior (4.7%) approach. Perioperative complications and implant failures were observed in 18.1% and 41.2%, respectively. VAS scores of low back pain (74.7 to 30.8 mm) and leg pain (56.8 to 20.7 mm) improved significantly at FU. Preoperatively, 52.6% of the patients were unable to walk and the rate of non-ambulatory patients decreased to 7.5% at FU. Conclusions This study demonstrated that substantial improvement in activity of daily living (ADL) was achieved by fusion surgery. Although there was a considerable rate of complications, fusion surgery is beneficial for elderly OVF patients with non-union.

Outcome After Endovascular Repair of Ruptured Descending Thoracic Aortic Aneurysm: A National Multicentre Study

The purpose of this multicentre study was to analyse the outcome of thoracic endovascular aortic repair (TEVAR) in patients with ruptured descending thoracic aortic aneurysm (rDTAA). This is a nationwide retrospective study including all patients who underwent TEVAR for rDTAA at six major vascular university centres in Sweden between January 2000 and December 2015. Outcome measures were analysed using Kaplan-Meier estimator and multivariable Cox regression. There were 140 patients (age [mean±SD] 74.1±8.8 years; 56% men; aneurysm size 64.8±19mm), with rDTAA. In 53 patients (37.9%), the left subclavian artery was covered, and in 25 patients (17.9%) arch vessel revascularisation was performed. In total, 61/136 patients (45%) had a major complication within 30 days post TEVAR. Stroke (n=20; 14.7%) was the most common complication, followed by paraplegia (n=13; 9.6%) and major bleeding (n=13; 9.6%). TEVAR related complications during follow up included endoleaks 22.1% (30/136; 14 type 1a, six type 1b, 10 not defined). In total, re-interventions (n=31) were required in 27/137 (19.7%) patients. The median follow up time was 17.0 months (range 0-132 months). The Kaplan-Meier estimated survival was 80.0% at one month, 71.7% at three months, 65.3% at one year, 45.9% at three years, and 31.9% at five years. Age (HR 1.03; 95% CI 1.00-1.07; p=.046), history of stroke (HR 2.35; 95% CI 1.19-4.63; p=.014), previous aortic surgery (HR 2.11; 95% CI 1.15-3.87; p=.016) as well as post-operative major bleeding (HR 4.40; 95% CI 2.20-8.81; p=.001), stroke (HR 2.63; 95% CI 1.37-5.03; p=.004), and renal failure (HR 8.25; 95% CI 2.69-25.35; p=.001) were all associated with mortality. This nationwide multicentre study of patients with rDTAA undergoing TEVAR showed acceptable short- but poor long-term survival. Adequate proximal and distal aortic sealing zones are important for technical success. High risk patients and post-operative complications need to be further addressed in an effort to improve outcome.

High rates of ovarian function preservation after hematopoietic cell transplantation with melphalan-based reduced intensity conditioning for pediatric acute leukemia: an analysis from the Japan Association of Childhood Leukemia Study (JACLS).

Women are at high risk of hypergonadotropic hypogonadism after hematopoietic cell transplantation (HCT). Hypogonadism is universal after irradiation or busulfan. We hypothesized that reduced intensity conditioning (RIC) might protect ovarian function after HCT. We retrospectively reviewed data from patients with acute leukemia treated according to the Japan Association of Childhood Leukemia Study and nationwide multicenter study protocol. We selected 11 female patients with acute leukemia who received first HCT with RIC, had survived for three or more years after HCT, and were aged ≥ 12years at the last follow-up visit. Median age at diagnosis, HCT, and last visit were 8, 10, and 17years. Six patients received HLA-matched bone marrow (BM), two HLA-mismatched BM, and three cord blood. Melphalan was used as conditioning regimen in all patients. At the last visit, six of seven post-pubertal patients at transplantation recovered menstruation, and four of four patients who underwent transplantation at the pre-pubertal began menstruation. Height z scores showed no significant reduction between pre-transplant and post-transplant. No patients received growth hormone treatment. Only one recipient displayed subclinical hypothyroidism. Melphalan-based RIC may be an encouraging option for patients with acute leukemia to avoid ovarian and endocrine dysfunction after HCT.

Various associations of aging and long-term HIV infection with different neurocognitive functions: detailed analysis of a Japanese nationwide multicenter study.

Detailed information of the effects of age and long-term HIV infection on various neurocognitive function have not been fully evaluated yet. In a prospective Japanese nationwide multicenter study of 17 facilities (J-HAND study), 728 HIV-infected individuals completed 14 neuropsychological (NP) tests; Verbal Fluency (VF; category and letter), Digit Span (DS; forward and backward), Trail Making Test (TMT) A-B, Rey-Osterrieth Complex Figure Test (ROCFT; copy, immediate and delayed recall), Story Memory Test (SMT; immediate and delayed recall), Digit Symbol Subset (DSS), and the Grooved Pegboard (GP; dominant and non-dominant). Multivariate analysis identified older age (≥ 50years) to be associated with lower scores in all three ROCFT and GP dominant [odds ratio (OR) [95% confidence interval (CI)] 1.801 (1.217-2.664), 2402 (1.366-3.055), 2.691 (1.720-4.211), and 2.302 (1.145-4.628), respectively], whereas longer time since diagnosis was associated with a lower score in ROCFT (delayed recall) (OR 1.224, 95%CI 1.045-1.434). In VF letter, older age and longer time since diagnosis were associated with a better score [OR (95%CI) 0.449 (0.234-0.861) and 0.831 (0.692-0.997)]. In DSS and TMT-A, longer time since diagnosis was associated with a better score [OR (95%CI): 0.808 (0.670-0.973) and 0.795 (0.665-0.949), respectively]. Older patients in later years since diagnosis are at higher risk of visuospatial and motor impairments despite ART, whereas they are less likely to develop verbal impairment, suggesting that verbal function is relatively resistant to aging and long history of HIV infection under ART. These findings suggest that customtailored supports should be established based on the individual background.

Positive Association Between Helicobacter pylori Infection and Metabolic Syndrome in a Korean Population: A Multicenter Nationwide Study.

Helicobacter pylori (H. pylori) infection causes extra-gastrointestinal as well as gastric diseases. This analytical cross-sectional study was performed to investigate the association between H. pylori infection and metabolic syndrome in a Korean population. Anthropometric and metabolic data, as well as anti-H. pylori IgG antibodies, were measured in 21,106 subjects who participated in a health checkup between January 2016 and June 2017. The classification of metabolic syndrome followed the revised National Cholesterol Education Program criteria. After excluding subjects with a history of H. pylori eradication therapy, or gastric symptoms, the seropositivity of H. pylori was 43.2% in 15,195 subjects. H. pylori-positive participants had significantly higher body mass index (BMI), waist circumference, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and lower high-density lipoprotein (HDL-C) than did seronegative participants (P < 0.05). After adjusting for confounders, high TC, low HDL-C, and high LDL-C were associated with H. pylori seropositivity. Finally, the prevalence of metabolic syndrome was higher in H. pylori-seropositive subjects than in negative ones (27.2% vs. 21.0%, P < 0.05), and H. pylori seropositivity increased the likelihood of metabolic syndrome (OR 1.19, 95% CI 1.09-1.31, P < 0.001) after adjusting for sex, age, BMI, smoking, residence, household income, and education level. However, the association between H. pylori seropositivity and metabolic syndrome disappeared in those ≥ 65years old. H. pylori infection plays an independent role in the pathogenesis of metabolic syndrome in Koreans under 65years old.

Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan.

The virological efficacy and safety of the direct-acting antiviral (DAA) regimen consisting of daclatasvir, asunaprevir, and beclabuvir (DCV/ASV/BCV) for patients chronically infected with hepatitis C virus (HCV) genotype 1 have not been previously evaluated in Japanese real-world settings. In a Japanese nationwide multicenter study, the rate of sustained virologic response (SVR) and safety were analyzed in 91 patients who started the DCV/ASV/BCV regimen between November 2016 and July 2017. SVR rates were compared based on baseline patient characteristics. More than 60% of patients had a history of failure to achieve SVR with interferon (IFN)-free DAA therapy. Overall, 50 of 91 patients (54.9%) achieved SVR. Multivariate analysis identified a history of failure with IFN-free DAA therapy and pretreatment HCV RNA levels as factors significantly associated with treatment failure. Whereas the SVR rate in patients without a history of IFN-free DAA therapy was 91.7% (33 of 36 patients), it was only 30.9% (17 of 55 patients) among patients with a history of IFN-free DAA therapy. The rate of discontinuation due to an adverse event was 4.4%. Many patients treated with the DCV/ASV/BCV regimen have a history of a failure to achieve SVR with previous IFN-free DAA therapy. SVR rate was not as high as that in pre-approval clinical trial of this regimen in IFN-free DAA-naïve patients. In addition, most patients with a history of failure with IFN-free DAA therapy, particularly the DCV/ASV regimen, showed resistance to this regimen.

Qualitative versus quantitative lumbar spinal stenosis grading by machine learning supported texture analysis—Experience from the LSOS study cohort

Purpose: To investigate and compare the reproducibility and accuracy of qualitative ratings and quantitative texture analysis (TA) in detection and grading of lumbar spinal stenosis (LSS) in magnetic resonance imaging (MR) scans of the lumbar spine.Materials and methods: From a nationwide multicenter and multidisciplinary lumbar stenosis outcome study (LSOS) register 82 patients, undergoing MR scans of the lumbar spine due to clinical indication of spinal claudication, with a single level central or lateral severe LSS were included. In total 343 transaxial T2-weighted images of the lumbar spine were included from one to five levels (L1 to S1) per patient. One expert radiologist serving as reference standard rated LSS grade according to a standard four-point (normal to severe) as well as to an eight-point Schizas grading scale. DICOM data were then rescaled to a defined pixel size. Two independent readers performed qualitative ratings analogous to expert reader in addition to TA of spinal canals by manually placing two regions of interest (ROI) per image reflecting qualitative scales: (1) dural sac only (2) inner contour of the spinal canal including epidural fat and bilateral recesses. Interreader agreements of qualitative and quantitative parameters were assessed by Cohen’s Kappa (κ) and intraclass correlation (ICC), respectively. TA feature reduction was performed by ICC threshold > 0.75. Remaining features were analyzed with machine learning algorithms (Weka 3 tool) for correlation with LSS grades using 10-fold cross validation.Results: Qualitative ratings showed only moderate reproducibility for both LSS classification systems but high correlation with cut-off cross-sectional area (CSA) <130mm² for severe spinal stenosis. In quantitative TA of both ROIs, machine learning analysis with a decision tree classifier revealed higher performances for LSS grading compared to qualitative assessments using the reference CSA cut-off, respectively.Conclusion: Qualitative LSS grading independent of classification system shows moderate reproducibility. TA with machine learning offers highly reproducible quantitative parameters that increase accuracy for severe LSS detection with minor impact of grading score and CSA border definition.

The prevalence of childhood psychopathology in Turkey: a cross-sectional multicenter nationwide study (EPICPAT-T)

Aim: The aim of this study was to determine the prevalence of childhood psychopathologies in Turkey.Method: A nation-wide, randomly selected, representative population of 5830 children (6–13 years-old) enrolled as a 2nd,3rd or 4th grade student in 30 cities were evaluated for presence of a psychiatric or mental disorder by a Sociodemographic Form, Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime Version (K-SADS-PL), and DSM-IV-Based Screening Scale for Disruptive Behavior Disorders in Children and Adolescents scales. Impairment criterion was assessed via a 3 point-Likert scale by the parent and the teacher independently.Results: Overall prevalence of any psychopathology was 37.6% without impairment criterion, and 17.1% with impairment criterion. Attention-deficit hyperactivity disorder was the most frequent diagnosis, followed by anxiety (19.5% and 16.7% without impairment, 12.4% and 5.3% with impairment, respectively). Lower education level and presence of a physical or psychiatric problem of the parents were independent predictors of any psychopathology of the offspring.Conclusion: This is the largest and most comprehensive epidemiological study to determine the prevalence of psychopathologies in children and adolescents in Turkey. Our results partly higher than, and partly comparable to previous national and international studies. It also contributes to the literature by determining the independent predictors of psychopathologies in this age group.

Abnormal T-cell phenotype in episodic angioedema with hypereosinophilia (Gleich syndrome): Frequency, clinical implication, and prognosis

Episodic angioedema with eosinophilia (EAE) (Gleich syndrome) is a raredisorder consisting of recurrentepisodes of angioedema, hypereosinophilia, and frequent elevated serum IgM level. We conducted a retrospective multicenter nationwide study regarding the clinical spectrum and therapeutic management of patients with EAE in France. A total of 30 patients with a median age at diagnosis of 41years (range, 5-84) were included. The median duration of each crisis was 5.5days (range, 1-90), with swelling affecting mainly the face and the upper limbs. Total serum IgM levels were increased in 20 patients (67%). Abnormal T-cell immunophenotypes were detected in 12 patients (40%), of whom 5 (17%) showed evidence of clonal T-cell receptor gamma locus gene (TRG) rearrangement. The median duration of follow-up was 53months (range, 31-99). The presence of an abnormal T-cell population was the sole factor associated with a shorter time to flare (hazard ratio, 4.15; 95% confidence interval, 1.18-14.66; P=.02). At last follow-up, 3 patients (10%) were able to have all treatments withdrawn and 11 (37%) were in clinical and biologic remission with less than 10mg of prednisone daily. EAE is a heterogeneous condition that encompasses several disease forms. Although patients usually respond well to glucocorticoids, those with evidence of abnormal T-cell phenotype have a shorter time to flare.

A nationwide multicenter study in patients with unresectable hepatocellular carcinoma treated with lenvatinib in real world practice in Japan.

364 Background: Lenvatinib(LEN) has been approved as a single agent for patients with unresectable hepatocellular carcinoma (u-HCC) since Mar 2018 in Japan. A few results from a large sample size cohort of LEN therapy in real world practice has been reported. Therefore, we performed a retrospective nationwide multicenter study. Methods: A total of 116 u-HCC patients received LEN from March 2018 at 14 sites in Japan were registered. Tumour assessments in accordance with RECICT ver1.1 and modified RECIST were done using dynamic CT or MRI within 4-8 weeks and every 6-8 weeks thereafter. Adverse events (AEs) were graded according to the CTCAE ver4.0. Results: Median age was 72 (46-91)years, 88 (75.9%) patients were male, and median body weight was 60 (30-94) kg. The baseline liver function was Child-Pugh class A in 106 (91.4%) patients. Seventy-three (62.9%) patients were BCLC stage C. As the 2nd-line therapy (after sorafenib), 28 (24.1%) patients received LEN and 17 (14.7%) patients did as the 3rd-line (after regorafenib). Median observation time was 2.5 months and one patient died from HCC progression. The imaging findings of 49 (42.2%) patients were evaluated at 4-8weeks. Based on mRECIST, CR was shown in 3 (6.1%), PR in 14 (28.6%), SD in 23 (46.9%), and PD in 6 (12.2%). In the 3 patients, target lesions of liver showed PR, however bone metastases had progressed. [overall response rate (ORR) 34.7%, disease control rate (DCR) 81.6%]. ORR and DCR of tyrosine kinase inhibitor (TKI) naïve patients (n = 26) were 34.6% and 80.8%, while those of TKI experienced (n = 23) were 34.8% and 82.6%. The most common any-grade AEs were hypertension (52.0%), diarrhoea (32.1%), decreased appetite (63.5%) and fatigue (49.4%). Hand-food skin reaction (HFSR) was observed in 28% of patients. Conclusions: The efficacy of LEN therapy in real world practice in Japan was similar to the phase 3 clinical trial, even though elderly patients with lower body weight were included in this study. The incidence of HFSR during LEN in real world practice was lower than that of the sorafenib group in the phase 3 trial of LEN. Decrease appetite and fatigue must be carefully monitored and managed during LEN therapy.

Simplified disease activity changes in real-world practice: a nationwide observational study of seropositive rheumatoid arthritis patients with moderate-to-high disease activity.

Background/AimsThe objective of this study was to compare changes in the simplified disease activity index (SDAI) between biologic (b) and conventional (c) disease-modifying antirheumatic drugs (DMARD) users with seropositive rheumatoid arthritis (RA) in daily clinical practice.MethodsThis was a nationwide multicenter observational study. Patients who had three or more active joint counts and abnormal inf lammatory marker in blood test were enrolled. The selection of DMARDs was determined by the attending rheumatologist. Clinical parameters, laboratory findings, and Health Assessment Questionnaire (HAQ) scores were obtained at baseline and at 6 and 12 months. Serial SDAI changes and clinical remission rate at 6 and 12 months were assessed.ResultsA total of 850 patients participated in this study. The mean baseline SDAI score in bDMARD group was higher than that in cDMARD group (32.08 ± 12.98 vs 25.69 ± 10.97, p < 0.0001). Mean change of SDAI at 12 months was –19.0 in the bDMARD group and –12.6 in the cDMARD group (p < 0.0001). Clinical remission rates at 12 months in bDMARD and cDMARD groups were 15.4% and 14.6%, respectively. Patient global assessment and HAQ at 12 months were also significantly improved in both groups. Multivariate logistic regression showed that baseline HAQ score was the most notable factor associated with remission.ConclusionsThere was a significant reduction in SDAI within 12 months after receiving DMARDs in Korean seropositive RA patients irrespective of bDMARD or cDMARD use in real-world practice. Clinical remission was achieved in those with lower baseline HAQ scores.

Spinal fractures in patients with Diffuse idiopathic skeletal hyperostosis:A nationwide multi-institution survey

BackgroundDiffuse idiopathic skeletal hyperostosis (DISH) increases the spine's susceptibility to unstable fractures that can cause neurological deterioration. However, the detail of injury is still unclear. A nationwide multicenter retrospective study was conducted to assess the clinical characteristics and radiographic features of spinal fractures in patients with DISH. MethodsPatients were eligible for this study if they 1) had DISH, defined as flowing ossification along the anterolateral aspect of at least four contiguous vertebral bodies, and 2) had an injury in the ankylosing spine. This study included 285 patients with DISH (221 males, 64 females; mean age 75.2 ± 9.5 years). ResultsThe major cause of injury was falling from a standing or sitting position; this affected 146 patients (51.2%). Diagnosis of the fracture was delayed in 115 patients (40.4%). Later neurological deterioration by one or more Frankel grade was seen in 87 patients (30.5%). The following factors were significantly associated with neurological deficits: delayed diagnosis (p = 0.033), injury of the posterior column (p = 0.021), and the presence of ossification of the posterior longitudinal ligament (OPLL) (p < 0.001). The majority of patients (n = 241, 84.6%) were treated surgically, most commonly by conventional open posterior fixation (n = 199, 69.8%). Neurological improvement was seen in 20.0% of the conservatively treated patients, and in 47.0% of the patients treated surgically. ConclusionsMinor trauma could cause spinal fractures in DISH patients. Delayed diagnosis, injury of the posterior column, and the presence of OPLL were significantly associated with neurological deterioration. Patients with neurological deficits or unstable fractures should be treated by fixation surgery.

Profile of treatment-related complications in women with clinical stage IB-IIB cervical cancer: A nationwide cohort study in Japan.

ObjectiveTo examine clinico-pathological factors associated with surgical complications and postoperative therapy for clinical stage IB-IIB cervical cancer.MethodsThis nationwide multicenter retrospective study examined women with clinical stage IB-IIB cervical cancer who underwent radical hysterectomy plus pelvic and/or para-aortic lymphadenectomy between 2008–2009 at 87 institutions of the Japanese Gynecologic Oncology Group (n = 693). Multivariate models were used to identify independent predictors of perioperative grade 3–4 complications and bladder dysfunction.ResultsThe overall intraoperative and postoperative complication rates were 3.3% and 9.8%, respectively. Clinical stage was not associated with perioperative complications (P = 0.15). Radiotherapy-based adjuvant therapy was significantly associated with an increased risk of postoperative complications (radiotherapy alone: adjusted-odds ratio [OR] 3.19, 95% confidence interval [CI] 1.46–6.99, P = 0.004; radiotherapy plus chemotherapy: adjusted-OR 3.26, 95%CI 1.66–6.41, P = 0.001), whereas chemotherapy was not (P = 0.45). Nerve-sparing surgery significantly reduced the risk of postoperative bladder dysfunction (adjusted-OR 0.57, 95%CI 0.37–0.90, P = 0.02) whereas adjuvant chemotherapy increased the risk of bladder dysfunction (adjusted-OR 2.06, 95%CI 1.16–3.67, P = 0.01). Among women receiving adjuvant chemotherapy, nerve-sparing radical hysterectomy significantly reduced the risk of bladder dysfunction (15.0% versus 32.9%, OR 0.31, 95%CI 0.14–0.68, P = 0.004). After propensity score matching, survival outcomes were similar with both types of adjuvant therapy (radiotherapy-based versus chemotherapy, P>0.05).ConclusionOur study highlighted two distinct complication profiles of adjuvant therapy after radical hysterectomy for clinical stage IB-IIB cervical cancer, with radiotherapy increasing grade 3–4 adverse events and chemotherapy increasing bladder dysfunction. In this setting, nerve-sparing surgery may be useful if chemotherapy is being considered for adjuvant therapy.

FOLFIRINOX for locally advanced pancreatic cancer: Results and prognostic factors of subset analysis from a nation-wide multicenter observational study in Japan

BackgroundFOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil, leucovorin) treatment significantly improved overall survival in the recent phase III study and became a standard therapy for metastatic pancreatic cancer. However, treatment for locally advanced pancreatic cancer is still controversial. We conducted subset analyses from a nation-wide multicenter observational study in Japan to evaluate the tolerability and efficacy of FOLFIRINOX in patients with locally advanced pancreatic cancer and to investigate independent prognostic factors with pre-treatment variables. MethodsThe study included 66 patients with unresectable locally advanced pancreatic cancer from 27 institutions in Japan who received FOLFIRINOX as first-line treatment between December 20, 2013 and December 19, 2014 and surveyed until December 2015. ResultsThe median age was 63 with the Eastern Cooperative Oncology Group performance status of 0 or 1. Major Grade 3 or 4 adverse events included neutropenia (64%), leukopenia (33%), febrile neutropenia (15%), and diarrhea (15%). Severe adverse event occurred in 14 patients (11%) without fatal event. The median overall survival and progression-free survival times were 18.5 and 7.6 months, respectively. The objective response rate 15.2% and the disease control rate was 81.9%. A high modified Glasgow prognostic score (mGPS, ≥1) (95%CI 1.96–12.5) and female (95%CI 0.20–0.97) were identified as independent poor prognostic factors. ConclusionsFirst-line FOLFIRINOX treatment for locally advanced pancreatic cancer seems to be effective with acceptable toxicities. A high mGPS may be associated with poor survival in patients with locally advanced pancreatic cancer who receive FOLFIRINOX. This study was registered at the UMIN Clinical Trials Registry (UMIN000014658).

Mapping of Lymph Node Metastasis From Oesophagogastric Junction Tumours: A Prospective Nationwide Multi-Centre Study

Mapping of Lymph Node Metastasis From Oesophagogastric Junction Tumours: A Prospective Nationwide Multi-Centre Study

A Multicenter Investigation of Caring Behaviors and Burnout Among Oncology Nurses in China.

Job burnout could negatively affect nursing care provided. However, little is known about burnout and caring behaviors among oncology nurses in China. The aims of this study were to investigate the status of burnout and caring behaviors among oncology nurses in China, to examine the relationship between them, and to identify factors that affect caring behaviors. A nationwide multicenter study was performed in 6 public cancer hospitals in June 2016. Data were collected through an online survey with instruments of a sociodemographic and occupational characteristics questionnaire, the Caring Behavior Inventory, and the Maslach Burnout Inventory. Descriptive statistics, independent-samples t tests or 1-way analysis of variance, Pearson correlation analyses, and multiple regression analyses were applied. A total of 3100 oncology nurses were invited to participate; 3014 valid questionnaires were returned. The percentages of oncology nurses experiencing high levels of emotional exhaustion, depersonalization, or diminished personal accomplishment were 30.16%, 19.97%, and 47.28%, respectively. Caring Behavior Inventory scores were significantly and negatively correlated with emotional exhaustion, depersonalization, and diminished personal accomplishment. Depersonalization, diminished personal accomplishment, level of family concern, and original nursing degree level showed significant negative influence on caring behaviors. Burnout (depersonalization and diminished personal accomplishment), family concern, and original nursing degree were negatively related to oncology nurses' caring behaviors. Initiatives in oncology nursing in China are needed that focus on improving job burnout and emphasize humanistic oncology nursing care, such as caring nurses' personal factors, creating a harmonious working environment, strengthening coping skills, and building a caring organizational culture.

Multiple sclerosis with atypical MRI presentation: Results of a nationwide multicenter study in 57 consecutive cases

BackgroundThe recent 2017 modification have increased the sensitivity of McDonald criteria for MS. Nevertheless, some MS patients with atypical MRI findings have been identified, leading to prolonged delay to diagnosis and high costs to look for alternative diagnoses. ObjectiveTo describe a series of MS patients with atypical MRI presentation. Material and methodsPatients with atypical MS were identified through a nationwide retrospective study. We established a five groups classification: tumefactive demyelinating lesion (TDL)-onset MS, acute disseminated encephalomyelitis (ADEM)-like MS, cavitary MS and leukodystrophy-like MS. All the patients meeting our radiological criteria for atypical MS were included. ResultsA total of 57 patients met the inclusion criteria. 7 cases were classified in the TDL-onset group, 10 in the ADEM-like group, 26 in the cavitary group and 14 in the leukodystrophy-like group. Overall risk of conversion to MS after an isolated TDL was around 30% at five years. Patients in the TDL-onset and ADEM-like groups globally presented an acute onset and a relapsing-remitting evolution. Conversely, patients in the cavitary and leukodystrophy- groups largely evolved with a progressive and severe course. ConclusionA significant number of MS patients can have a striking atypical presentation and may be misdiagnosed. This preliminary analysis helps to refine the spectrum of atypical MS patients.

Klebsiella pneumoniae and Klebsiella oxytoca meningitis in infants. Epidemiological and clinical features

BackgroundThe incidence of meningitis caused by Klebsiella pneumoniae (Kp) and Klebsiella oxytoca (Ko) in high-income countries is unknown, and no series have been published to date. MethodsWe conducted a nationwide multicenter observational study in France between 2006 and 2016. All children from the French national registry for paediatric bacterial meningitis under the age of 1 year and hospitalized for Kp or Ko meningitis were included. Virulence factors of four Klebsiella spp. strains were explored by whole genome sequencing. ResultsOf 1859 cases of meningitis in children under the age of 1 year, 13 cases (0.7%) of Klebsiella spp. meningitis (nine for Kp meningitis and four for Ko meningitis) were registered in the French national registry. Three of the patients died and 50% of the survivors had developmental delays. ConclusionsPrematurity, low birth weight, and congenital anomalies of the urinary tract appear to be risk factors for Klebsiella spp. meningitis as well as virulence factors of the strain.

Can We Jump Out of the Periodic Circles of Hope and Disappointment in the Anterior Cruciate Ligament Reconstruction Using Synthetic Ligament? A Nationwide Multicenter Study by the China Artificial Ligament Study Group (CALSG)

Background: The application of synthetic ligaments for theanterior cruciate ligament (ACL) reconstruction was never untroubled. Their history was commented as Periodic cycles of hope and disappointment. Currently, their long-term clinical outcome was still controversial despite satisfactory short and mid-term results. If we want to spare us from another disappointment, we have to clarify the long-term rate of adverse events and the fundamental reason for failure. Methods: The national multicenter research was backed by the China Artificial Ligament Study Group (CALSG). The ACL reconstruction using synthetic ligaments between July 2004 and December 2010 were screened. The adverse events consisted of cumulative failure and complications. For failure cases, the symptoms, the clinical outcomes, the reason for failure, and the activity level were investigated. Findings: A total of 1705 cases from 20 centers were screened with 1393 cases included. And 1146 cases fulfilled evaluation at meanly 87 months postoperative. Adverse events were confirmed in 83 cases with the rate of 7.2% (83/1146). Among them, the cumulative failure was confirmed in 36 cases; complications in 32 cases; cumulative failure combined with complications in 15 cases. Generally, the cumulative failure rate was 4.5% (51/1146), and the complication rate was 4.1% (47/1146). For failure cases, the bone tunnel position was evaluated in 49 of them. The bone tunnel malposition, an error caused by the surgeon, was confirmed in 32 cases with the constituent ratio of 65.3% (32/49); trauma in 25 cases with the constituent ratio of 49.0% (25/51); screw loosening in 8 cases with the constituent ratio of 15.7% (8/51). Conclusion: Currently, the failure rate of ACL reconstruction using synthetic ligament was 4.5% at meanly 87 months postoperative. Bone tunnel malposition was the primary cause of failure. We need to pay attention to the technique error when ACL reconstruction using synthetic ligaments failed, instead of merely blaming the graft. Funding Statement: China Artificial Ligament Study Group Declaration of Interests: The authors state no conflict reported. Ethics Approval Statement: KY2017-334 (Huashan Hospital Institutional Review Board)