Nationwide Multicenter Study Research Articles

COVID-19 prevalence and mortality in people with epilepsy: A nation-wide multicenter study

BackgroundTo assess the prevalence, severity, and mortality of COVID-19 in people with epilepsy (PWE) and evaluate seizure control in PWE during and after COVID-19. MethodsRetrospective, observational, multicenter study conducted in 14 hospitals. Medical records of randomly selected PWE followed at neurology outpatient clinics were reviewed. Proportion of PWE with a positive test for SARS-CoV-2 during 2020 was calculated. Risk factors associated with COVID-19 and its morbimortality were evaluated. Results2751 PWE were included, mean age 48.8 years (18–99), 72.4% had focal epilepsy, and 35% were drug-refractory. COVID-19 prevalence in PWE was 5.53%, while in the Spanish population was 4.26%. Proportion of admissions to hospital, ICU, and deaths in PWE were 17.1%, 2%, and 4.61% of COVID-19 cases, while in Spanish population were 10.81%, 0.95%, and 2.57%, respectively. A severe form of COVID-19 occurred in 11.8%; dyslipidemia, institutionalization at long-term care facilities, intellectual disability, and older age were associated risk factors. Older age, hypertension, dyslipidemia, cardiac disease, and institutionalization were associated with mortality from COVID-19. Seizure control was stable in 90.1% of PWE during acute COVID-19, while 8.6% reported an increase in seizure frequency. During post-COVID-19 follow-up, 4.6% reported seizure control worsening. ConclusionsCOVID-19 was moderately prevalent in PWE. One out of 5 patients required medical attention and 4.6% died due to COVID-19. Older age, dyslipidemia, institutionalization, and intellectual disability were significant risk factors associated with severe COVID-19. Seizure control remained stable during COVID-19 and throughout long-term follow-up in most PWE who contracted the infection.

Postoperative complications after a transthoracic esophagectomy or a transhiatal gastrectomy in patients with esophagogastric junctional cancers: a prospective nationwide multicenter study.

Esophagogastric junction (EGJ) cancers are resected thorough esophagectomy or gastrectomy, with the incidence of postoperative complications influenced by the chosen procedure. In this prospective nationwide multicenter study, patients with cT2-T4 EGJ cancers were enrolled before surgery. Based on the protocol, surgeons performed a transthoracic esophagectomy (TTE) or a transhiatal gastrectomy (THG) and dissected all lymph nodes prespecified as the standardized procedure. Postoperative complications were correlated with the clinical factors in each procedure. A total of 345 patients were eligible for this study. TTE and THG were performed in 120 and 225 patients, respectively. Complications of Clavien-Dindo ≥ Grade II were found in 115/345 (33.3%) patients. Recurrent laryngeal nerve palsy was found only in the TTE group (p < 0.001). The incidence of other complications was not significantly different between the two groups. High body mass index (BMI) in the TTE group, male sex, and longer esophageal invasion in the THG group were significantly correlated with complications ≥ Grade II (p = 0.049, 0.037, and 0.019, respectively). Anastomotic leakage was most frequently observed (12.2%). Tumor size in the THG group (p = 0.02) was significantly associated with leakage. All six patients with ≥ Grade IV leakage underwent THG, whereas, none of the patients in the TTE group had leakage ≥ Grade IV (2.7% vs. 0%, p = 0.096). Surgical resection should be performed with utmost care, particularly in patients with a high BMI undergoing TTE, and in patients with larger tumors, longer esophageal invasion, or male patients undergoing THG.

Prognostic Impact of Mediastinal Lymph Node Dissection in Octogenarians With Lung Cancer: JACS1303

IntroductionThe prognostic significance of mediastinal lymph node dissection (MLND) in elderly patients with non–small cell lung cancer (NSCLC) remains unclear. This post hoc analysis of a nationwide multicenter cohort study (JACS1303) evaluated the prognostic significance of MLND in octogenarians with NSCLC. Materials and MethodsWe included 622 octogenarians with NSCLC who underwent lobectomy. The median follow-up duration was 41.1 months. We compared survival and perioperative outcomes between patients who did and did not undergo MLND. ResultsIn total, 414 (67%) patients underwent MLND (ND2 group), whereas 208 (33%) did not undergo MLND (ND0-1 group). The disease stage was more advanced in the ND2 group than in the ND0-1 group. Disease-free survival was slightly greater in the ND0-1 group with marginal significance (P= .079). In the matched cohort (N = 228), which mainly consisted of patients with clinical stage I disease (96%), there was no significant difference between the 2 groups regarding overall and disease-free survival (P= .908 and P = .916, respectively). Operative time and blood loss were significantly lower in the ND0-1 group than in the ND2 group in the entire cohort (P< .001 and P = .050, respectively) and in the matched cohort (P = .003 and P= .046, respectively). ConclusionBased on a nationwide prospective database, we found limited prognostic impact of MLND, suggesting that MLND can be omitted for octogenarians with early-stage NSCLC.

Finnish Version of the Eating Assessment Tool (F-EAT-10): A Valid and Reliable Patient-reported Outcome Measure for Dysphagia Evaluation

Our aim was to validate a Finnish version of the Eating Assessment Tool (F-EAT-10) for clinical use and to test its reliability and validity in a multicenter nationwide study. Normative data were acquired from 180 non-dysphagic participants (median age 57.0 years, 62.2% female). Dysphagia patients (n = 117, median age 69.7 years, 53.0% female) referred to fiberoptic endoscopic evaluation of swallowing (FEES) completed F-EAT-10 before the examination and after 2 weeks. Patients underwent the 100-ml water swallow test (WST) and FEES was evaluated using the following three scales: the Yale Pharyngeal Residue Severity Rating Scale, Penetration-Aspiration Scale, and the Dysphagia Outcome Severity Scale. An operative cohort of 19 patients (median age 75.8 years, 57.9% female) underwent an endoscopic operation on Zenker’s diverticulum, tight cricopharyngeal muscle diagnosed in videofluorography, or both. Patients completed the F-EAT-10 preoperatively and 3 months postoperatively. The cut-off score for controls was < 3 (sensitivity 94.0%, specificity 96.1%) suggesting that ≥ 3 is abnormal. Re-questionnaires for test–retest reliability analysis were available from 92 FEES patients and 123 controls. The intraclass correlation coefficient was excellent for the total F-EAT-10 score (0.93, 95% confidence interval 0.91–0.95). Pearson correlation coefficients were strong (p < 0.001) for each of the questions and the total score. Internal consistency as assessed by Cronbach’s alpha was excellent (0.95). Some correlations between findings in FEES and 100-ml WST with F-EAT-10 were observed. The change in subjective symptoms of operative patients paralleled the change in F-EAT-10. F-EAT-10 is a reliable, valid, and symptom-specific patient-reported outcome measure for assessing dysphagia among Finnish speakers.

Neuromyelitis optica spectrum disorders: A nationwide Portuguese clinical epidemiological study

IntroductionNeuromyelitis optica spectrum disorder (NMOSD) is a rare disorder in which astrocyte damage and/or demyelination often cause severe neurological deficits. ObjectiveTo identify Portuguese patients with NMOSD and assess their epidemiological/clinical characteristics. MethodsThis was a nationwide multicenter study. Twenty-four Portuguese adult and 3 neuropediatric centers following NMOSD patients were included. ResultsA total of 180 patients met the 2015 Wingerchuk NMOSD criteria, 77 were AQP4-antibody positive (Abs+), 67 MOG-Abs+, and 36 seronegative. Point prevalence on December 31, 2018 was 1.71/100,000 for NMOSD, 0.71/100,000 for AQP4-Abs+, 0.65/100,000 for MOG-Abs+, and 0.35/100,000 for seronegative NMOSD. A total of 44 new NMOSD cases were identified during the two-year study period (11 AQP4-Abs+, 27 MOG-Abs+, and 6 seronegative). The annual incidence rate in that period was 0.21/100,000 person-years for NMOSD, 0.05/100,000 for AQP4-Abs+, 0.13/100,000 for MOG-Abs+, and 0.03/100,000 for seronegative NMOSD.AQP4-Abs+ predominated in females and was associated with autoimmune disorders. Frequently presented with myelitis. Area postrema syndrome was exclusive of this subtype, and associated with higher morbidity/mortality than other forms of NMOSD. MOG-Ab+ more often presented with optic neuritis, required less immunosuppression, and had better outcome. ConclusionEpidemiological/clinical NMOSD profiles in the Portuguese population are similar to other European countries

PBI-030 - A nation-wide multicentric study on community acquired urinary tract infection among children from a developing country

PBI-030 - A nation-wide multicentric study on community acquired urinary tract infection among children from a developing country

1864P Expertise for management of immune-related adverse events in cancer therapy: Mapping of French practices

Immune checkpoint inhibitors (ICIs) are now a major part of everyday practice in cancer care, responsible for frequent and potentially severe immuno-related adverse events (irAEs). In this nationwide multicenter descriptive study, we report the organization of irAEs management networks within the regional reference centers in France.

Associations of new-onset atrial fibrillation and severe visual impairment in type 2 diabetes: A multicenter nationwide study.

BACKGROUNDMany studies have demonstrated an association between type 2 diabetes mellitus (T2DM) and atrial fibrillation (AF). However, the potential independent contributions of T2DM and AF to the prevalence of visual impairment have not been evaluated.AIMTo determine whether such an association between T2DM and incident AF with visual impairment exists, and if so, the prevalence and magnitude of this association.METHODSWe conducted a nationwide cross-sectional study based on the DM/HT study of the Medical Research Network of the Consortium of Thai Medical Schools. This study had evaluated adult T2DM patients from 831 public hospitals in Thailand in the year 2013. T2DM patients were categorized into two groups: patients without and with incident AF. T2DM patients without AF were selected as the reference group. The association between incident AF and visual impairment among T2DM patients was assessed using multivariate logistic regression.RESULTSA total of 27281 T2DM patients with available eye examination data were included in this analysis. The mean age was 60.7 ± 10.5 years, and 31.2% were male. The incident AF was 0.2%. The prevalence of severe visual impairment in all T2DM patients, T2DM patients without AF, and T2DM patients with incident AF were 1.4%, 1.4%, and 6.3%, respectively. T2DM patients with incident AF were associated with an increased OR of 3.89 (95%CI: 1.17-13.38) for severe visual impairment compared with T2DM patients without AF.CONCLUSIONT2DM patients with incident AF were independently associated with increased severe visual impairment. Therefore, early eye screening should be provided for these high-risk individuals.

Associations of new-onset atrial fibrillation and severe visual impairment in type 2 diabetes: A multicenter nationwide study

Associations of new-onset atrial fibrillation and severe visual impairment in type 2 diabetes: A multicenter nationwide study

Examining the Clinical Prognosis of Critically Ill Patients with COVID-19 Admitted to Intensive Care Units: A Nationwide Saudi Study.

Backgroundand Objectives: COVID-19 is a novel infectious disease caused by a single-stranded RNA coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We aimed to conduct a nationwide multicenter study to determine the characteristics and the clinical prognostic outcome of critically ill COVID-19 patients admitted to intensive care units (ICUs). Materials and Methods: This is a nationwide cohort retrospective study conducted in twenty Saudi hospitals. Results: An analysis of 1470 critically ill COVID-19 patients demonstrated that the majority of patients were male with a mean age of 55.9 ± 15.1 years. Most of our patients presented with a shortness of breath (SOB) (81.3%), followed by a fever (73.7%) and a cough (65.1%). Diabetes and hypertension were the most common comorbidities in the study (52.4% and 46.0%, respectively). Multiple complications were observed substantially more among non-survivors. The length and frequency of mechanical ventilation use were significantly greater (83%) in the non-survivors compared with the survivors (31%). The mean Sequential Organ Failure Assessment (SOFA) score was 6 ± 5. The overall mortality rate of the cohort associated with patients that had diabetes, hypertension and ischemic heart disease was 41.8%. Conclusion: Age; a pre-existing medical history of hypertension, diabetes and ischemic heart disease; smoking cigarettes; a BMI ≥ 29; a long mechanical ventilation and ICU stay; the need of ventilatory support; a high SOFA score; fungal co-infections and extracorporeal membrane oxygenation (ECMO) use were key clinical characteristics that predicted a high mortality in our population.

NTRK1 gene-related congenital insensitivity to pain with anhidrosis: a nationwide multicenter retrospective study.

Congenital insensitivity to pain with anhidrosis (CIPA) is a rare autosomal recessive disease resulting from mutations in the NTRK1 gene encoding the neurotrophic tyrosine kinase-1 receptor. In this multicenter observational retrospective study, we investigated CIPA patients identified from French laboratories sequencing the NTRK1 gene, and seven patients were identified. Patients originated from France (2), Suriname (2), Mali (1), Kazakhstan (1), and Algeria (1). Mean age of patients was 9.8years (4-20), four patients were female (57%), infant developmental milestones were delayed in four cases (57%), and four patients had a family history of consanguinity (57%). Mean age at diagnosis was 4.8months (3-6), and all patients presented with pain insensitivity, anhidrosis, intellectual disability, self-mutilation, febrile episodes, impaired temperature perception, and autonomous nervous system impairment. Patients also showed an assortment of associated findings, including hyperactivity (86%), emotional lability (86%), joint deformities (71%), bone fractures (57%), abnormal sense of touch, vibration and position (50%), skin, hair and nails abnormalities (28%), and hypothermia episodes (28%). Two patients died at age 9 and 12years from infection. In three cases, nerve conduction studies showed absent lower limbs sensory nerve action potentials. In one case, sensory nerve biopsy showed complete absence of unmyelinated fibers. Nine NTRK1 pathogenic variants were found, including three newly described mutations. This nationwide study confirms that NTRK1 gene-related CIPA is an extremely rare disorder and expands the genotypic spectrum of NTRK1 mutations.

Demographic, psychosocial and health disparities between living and deceased renal allograft recipients in Switzerland.

Living donor renal transplantation is widely performed in Switzerland with a superior long-term outcome and lower waiting time compared with deceased renal transplantation. However the chances of receiving a living donor kidney transplant are not the same for all transplant candidates. The current study aimed to identify psychosocial and demographic characteristics that predict lower access to living kidney donation in Switzerland. The study was a nationwide multicentre study nested within the Swiss Transplant Cohort Study. Pre-transplant demographic, psychosocial and health characteristics of 1126 deceased and 859 living renal transplant recipients were compared using logistic regression analysis. Transplant candidates with higher age (odds ratio [OR] per 10 years 0.67, 95% confidence interval [CI] 0.60&ndash;0.74), lower education (OR 0.46, 95% CI 0.36&ndash;0.59), a work capacity of less than 50% (OR 0.48, 95% CI 0.35&ndash;0.66), single or formerly married (OR 0.38, 95% CI 0.26&ndash;0.53 / OR 0.37, 95% CI 0.26&ndash;0.53) or with a higher hospital depression score (OR per 5 points 0.61, 95% CI 0.50&ndash;0.74) were less likely to receive an allograft from a living donor. In some regions of Switzerland candidates were more likely to undergo living transplantation than in other regions. No association was found with gender or income. Interventions to increase access to kidney transplantation from living donors should target transplant candidates of older age, lower education, lower working capacity and not living in a committed relationship. The observed regional differences suggest that additional determinants of living donation may play a role such as population and health professional attitudes toward living donation.

Balloon Dilatation of the Pylorus After Gastric Pull-up in a Single Centre

Background: The mainstay of intended curative treatment for esophagus cancer is surgery. Symptoms of gastric outlet obstruction can occur in some patients postoperatively. Some of these patients require alleviating treatment which may include balloon dilatation of the pylorus. The aim of this study was to investigate the use for balloon dilatation of the pylorus following esophagectomy in patients treated for carcinoma of the esophagus with intent to cure. Methods: A retrospective study of 120 patients who underwent esophagectomy with gastric pull-up at Aarhus University Hospital, Denmark, between January 2017 and December 2018 and were followed until December 2020. Primary outcome was number of postoperative balloon dilatations of the pylorus. Results: A total of 63 patients (53%) went through at least 1 balloon dilatation of the pylorus, 40 (63%) needed more than 1 dilatation. The median time between esophagectomy and first dilatation was two months. There was a strong association between squamous cell carcinoma and postoperative dilatation compared to adenocarcinoma (OR=4.13). An association was also seen between ex-smokers and postoperative dilatation compared to non-smokers (OR=3.95). Conclusions: More than fifty percent of the patients needed postoperative balloon dilatation. The need for dilatations was strongest between the second and the ninth postoperative month. A nationwide multicentre study of gastric pull-up patients is needed in the future to develop clinical tools to assess the need for pyloric dilatation.

A nationwide survey on central nervous system multiple myeloma in Japan: analysis of prognostic and treatment factors that impact survival.

This nationwide multicentre retrospective study was performed to analyze clinical features that predict the prognosis of central nervous system invasion in multiple myeloma (CNS-MM, approximately 1% of MM). Overall, of the 77 adult patients with CNS-MM identified between 2005 and 2016, those diagnosed at MM diagnosis (n=3) had longer overall survival (OS) than those diagnosed at relapse (n=74; median: 48·5 vs 2·7months). Therefore, we compared the relapsed MM with CNS-MM in patients with any treatment (n=60). Multivariate analyses revealed that lenalidomide treatment [hazard ratio (HR) 0·27, P=0·003], intrathecal chemotherapy (IT; HR 0·54, P=0·05), and radiation therapy (RTx; HR 0·33, P<0·001) for CNS-MM had a positive effect on longer OS. These factors were used to develop a scoring system combining the number of treatments with lenalidomide, IT, and RTx (0, 1, 2, 3). The OS of CNS-MM patients was stratified based on these factors, with a median OS of 1·1, 4·5, and 7·5months for patients with zero, one, two to three favourable features, respectively (0 vs 1, P=0·0002; 1 vs 2-3, P=0·08). Multimodal treatment including lenalidomide in addition to conventional IT and RTx can improve OS.

The association between age at diagnosis of type 2 diabetes and albuminuria in Chinese adults: A nationwide population study.

Type 2 diabetes is increasingly diagnosed at a younger age worldwide and in China. Limited data are available regarding the association between age at diabetes diagnosis and risks of albuminuria. This study sought to examine the independent effect of age at diagnosis of type 2 diabetes on the risk of albuminuria. We used data from a nationwide multicenter study with 207 961 participants in mainland China. Age, sex, and study site were matched for 31 366 screen-detected type 2 diabetes cases and 31 366 normal controls. Age, sex, study site, and diabetes duration were matched for 7490 self-reported type 2 diabetes cases and 7490 normal controls. Risks of having albuminuria in matched type 2 diabetes vs controls were examined using multivariable logistic regression analysis in strata of age at diabetes diagnosis. Although the absolute rate of albuminuria is higher in older adults, the odds ratio of albuminuria in type 2 diabetes vs matched controls decreased with increasing age at diagnosis. For participants with diabetes diagnosed at an age of <50, 50 to 59, 60 to 69, or ≥70 years, the multivariable adjusted risk of albuminuria increased by 81%, 60%, 45%, and 33% for screen-detected diabetes, and 135%, 121%, 90%, and 58% for self-reported diabetes compared with their normal controls, respectively. A younger age at diagnosis of type 2 diabetes is associated with a more significantly elevated risk of albuminuria than an older age at diagnosis in Chinese adults.

Morning Surge in Blood Pressure and Stroke Events in a Large Modern Ambulatory Blood Pressure Monitoring Cohort: Results of the JAMP Study.

Morning Surge in Blood Pressure and Stroke Events in a Large Modern Ambulatory Blood Pressure Monitoring Cohort: Results of the JAMP Study.

Detection of Nonadherence to Antihypertensive Treatment by Measurements of Serum Drug Concentrations.

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Prospective nationwide multicentre cohort study of the clinical significance of autoimmune features in idiopathic interstitial pneumonias

BackgroundSome patients with idiopathic interstitial pneumonia (IIP) show autoimmune features. Interstitial pneumonia with autoimmune features (IPAF) was recently proposed as a research concept in these patients. However, retrospective studies reported...

Clinical features and outcome of Guillain\u2013Barre syndrome in Saudi Arabia: a multicenter, retrospective study

BackgroundGuillain–Barre syndrome (GBS) is an inflammatory polyradiculoneuropathy characterized by rapidly evolving weakness and areflexia, reaching nadir within 4 weeks. Data on the characteristic of GBS in Saudi Arabia are limited. This study aimed to describe the clinical, electrophysiological, and laboratory characteristics and outcome of a multicenter cohort of patients with GBS.MethodsThis is a retrospective multicenter nationwide study. Patients who had GBS, identified through Brighton Criteria, between January 2015 and December 2019 were included. Data collected included demographics, clinical features, cerebrospinal fluid profile, reported electrophysiological patterns, treatment, and outcome. Reported GBS subtypes were compared using chi-square, Fisher's exact, or Mann–Whitney U tests, as appropriate.ResultsA total of 156 patients with GBS were included (men, 61.5%), with a median age of 38 (interquartile range, 26.25–53.5) years. The most commonly reported antecedent illnesses were upper respiratory tract infection (39.1%) and diarrhea (27.8%). All but two patients (98.7%) had weakness, 64.1% had sensory symptoms, 43.1% had facial diplegia, 33.8% had oropharyngeal weakness, 12.4% had ophthalmoplegia, and 26.3% needed mechanical ventilation. Cytoalbuminological dissociation was observed in 69.1% of the patients. GBS-specific therapy was administered in 96.8% of the patients, of whom 88.1% had intravenous immunoglobulin, and 11.9% had plasmapheresis. Approximately half of the patients were able to walk independently within 9 months after discharge, and a third regained the ability to walk independently thereafter. Death of one patient was caused by septicemia. Acute inflammatory demyelinating polyradiculoneuropathy was the most commonly reported GBS subtype (37.7%), followed by acute motor axonal neuropathy (29.5%), and acute motor-sensory axonal neuropathy (19.2%).ConclusionThe clinical and laboratory characteristics and outcome of GBS in the Arab population of Saudi Arabia are similar to the international cohorts. The overall prognosis is favorable.

Incidence and clinical characteristics of acute rheumatic fever in Turkey: Results of a nationwide multicentre study.

To evaluate the incidence and clinical features of acute rheumatic fever (ARF) in Turkey, following the revised Jones criteria in 2015. This multicentre study was designed by the Acquired Heart Diseases Working Group of the Turkish Pediatric Cardiology and Pediatric Cardiac Surgery Association in 2016. The data during the first attack of 1103 ARF patients were collected from the paediatric cardiologists between 1 January 2016 and 31 December 2016. Turkey National Institute of Statistics records of 2016 were used for the determination of ARF incidence with regard to various cities and regions separately. The estimated incidence rate of ARF was 8.84/100 000 in Turkey. The ARF incidence varied considerably among different regions. The highest incidence was found in the Eastern Anatolia Region as 14.4/100 000, and the lowest incidence was found in the Black Sea Region as 3.3/100 000 (P < 0.05). Clinical carditis was the most common finding. The incidence of clinical carditis, subclinical carditis, polyarthritis, aseptic monoarthritis, polyarthralgia and Sydenham's Chorea was 53.5%, 29.1%, 52.8%, 10.3%, 18.6% and 7.9%, respectively. The incidences of clinical carditis, subclinical carditis, polyarthritis and polyarthralgia were found to be significantly different among different regions (P < 0.05). The findings of this nationwide screening of ARF suggest that Turkey should be included in the moderate-risk group.