Multivariate Binary Regression Model Research Articles

Factors associated with adherence to swallowing therapy among patients diagnosed with oropharyngeal dysphagia.

The objective of this study is to assess disparities in adherence to swallowing therapy for clinically diagnosed oropharyngeal dysphagia (OD) patients. Analysis was conducted on data from 600 patients with OD and confirmed impairments in swallowing safety and/or efficiency on a videofluoroscopic swallow study. Patients were classified based on their adherence to treatment sessions, defined as the number of swallow treatment sessions attended. The outcome of treatment adherence was categorized into two groups: those who attended fewer than 50% of the prescribed treatment sessions and those who attended 50% or more of the sessions. Continuous variables were presented as mean ± standard deviation or median ± interquartile range. Categorical variables were compared using Pearson chi-square tests and Fisher's exact test when appropriate. Univariable and multivariable binary logistic regression models were employed to identify factors associated with successful adherence. Approximately 79% adhered to swallowing treatment. We found no significant relationship between adherence and age, sex, race, ethnicity, primary language, marital status, insurance status, occupation, median income, distance, education, OD severity, and diagnosis year (p > 0.05). We found no covariables to be significant predictors to swallowing treatment nonadherence in both univariable and multivariable binary regression models (p > 0.05). The variables analyzed in this study were not significantly associated with nonadherence to swallow therapy. Nevertheless, our study still addressed an important knowledge gap and future studies would benefit from exploring other relevant socioeconomic and disease-related factors. Level 4.

An interdisciplinary integrated specialized one-stop outpatient clinic for idiopathic intracranial hypertension – a comprehensive assessment of patient satisfaction

BackgroundManagement of idiopathic intracranial hypertension (IIH) is complex requiring contributions from multiple specialized disciplines. In practice, this creates considerable organizational and communicational challenges. To meet those challenges, we established an interdisciplinary integrated outpatient clinic for IIH with a central coordination and a one-stop concept. Here, we aimed to evaluate effects of this one-stop concept on subjective patient satisfaction and economic outcome in patients with IIH.MethodsIn a retrospective cohort study, we compared the one-stop era with integrated care (IC, 1-JUL-2021 to 31-DEC-2022) to a reference group receiving standard care (SC, 1-JUL-2018 to 31-DEC-2019) regarding subjective patient satisfaction (assessed by the Vienna Patient Inventory). Multivariable binary linear regression models were used to adjust for confounders.ResultsBaseline characteristics of the IC group (n = 85) and SC group (n = 81) were comparable (female: 90.6% vs. 90.1%; mean age: 33.6 vs. 32.8 years, educational level: ≥9 years of education 60.0% vs. 59.3%; located in Vienna 75.3% vs. 76.5%). Compared to SC, management within IC concept was associated with statistically significantly higher subjective patient satisfaction (beta = 0.93; p < 0.001) with the strongest effects observed in satisfaction with treatment accessibility and availability (beta = 2.05; p < 0.001). Subgroup analyses of patients with migration background and language barrier consistently indicated stronger effects of IC in these groups.ConclusionsInterdisciplinary integrated management of IIH statistically significantly and clinically meaningfully improves patient satisfaction – particularly in socioeconomically underprivileged patient groups. Providing structured central coordination to facilitate and improve access to interdisciplinary management provides means to further improve outcome.

Progression of valve heart disease in a cohort of patients undergoing renal replacement therapy.

Cardiovascular disease is an important cause of death among patients with chronic kidney disease (CKD). Valve calcification is a predictor of cardiovascular mortality and coronary artery disease. To assess heart valve disease frequency, associated factors, and progression in CKD patients. We conducted a retrospective study on 291 CKD patients at Hospital das Clínicas de Pernambuco. Inclusion criteria were age ≥ 18 with CKD and valve disease, while those on conservative management or with missing data were excluded. Clinical and laboratory variables were compared, and patients were categorized by dialysis duration (<5 years; 5-10 years; >10 years). Statistical tests, including chi-square, Fisher's exact, ANOVA, and Kruskal-Wallis, were employed as needed. Simple and multivariate binary regression models were used to analyze valve disease associations with dialysis duration. Significance was defined as p < 0.05. Mitral valve disease was present in 82.5% (240) of patients, followed by aortic valve disease (65.6%; 86). Over time, 106 (36.4%) patients developed valve disease. No significant association was found between aortic, pulmonary, mitral, or tricuspid valve disease and dialysis duration. Secondary hyperparathyroidism was the sole statistically significant factor for mitral valve disease in the regression model (OR 2.59 [95% CI: 1.09-6.18]; p = 0.031). CKD patients on renal replacement therapy exhibit a high frequency of valve disease, particularly mitral and aortic valve disease. However, no link was established between dialysis duration and valve disease occurrence or progression.

Imaging risk factors for postoperative cerebral infarction in adults with ischemic Moyamoya disease

Objective: To investigate the imaging factors associated with postoperative cerebral infarction in adult patients aged 18 and above with ischemic Moyamoya disease. Methods: The clinical data of adult patients who underwent surgeries for ischemic Moyamoya disease in the Department of Neurosurgery at Peking University International Hospital from October 2015 to October 2020 were retrospectively analyzed. Of the 239 patients, 120 were male and 119 were female, with ages ranging from 18 to 63 (41.7±10.3) years. A total of 239 patients(290 cases) underwent direct and indirect combined revascularization (CR).Gender, age, surgical side, preoperative transient ischemic attack (TIA), presence of old cerebral infarction, and imaging features were compared between the patients with (48 cases) and without (242 cases) cerebral infarction within 1 week after surgery. Multivariate logistic binary regression model was used to analyze the imaging risk factors of postoperative cerebral infarction. Results: Cerebral infarction occurred in 48 cases(16.5%) among the 290 CR group within 1 week after surgery. The proportion of patients with TIA, old cerebral infarction, ICA stenosis, A1 segment stenosis, M1 segment stenosis, abnormal posterior cerebral artery (PCA), and unstable compensation before CR in the cerebral infarction group was higher than that in the non-cerebral infarction group (P<0.05).Preoperative TIA (OR=4.514, 95%CI: 1.920-10.611), old cerebral infarction (OR=2.856,95%CI:1.176-6.936), A1 stenosis (OR=7.027,95%CI:1.877-26.308), M1 stenosis (OR=6.968,95%CI:2.162-22.459), abnormal PCA (OR=4.114,95%CI:1.330-12.728)and unstable compensation (OR=4.488,95%CI:1.194-16.865) were risk factors for cerebral infarction after CR surgery (all P<0.05). Conclusion: Among the imaging factors, TIA, old cerebral infarction, A1 stenosis, M1 stenosis, abnormal PCA and unstable compensation were risk factors for cerebral infarction in adult patients with ischemic Moyamoya disease treated by combined revascularization.

Patient Benefits of Radical Prostatectomy in Certified Prostate Cancer Centers: Comparative Results from the Multicenter IMPROVE Study

Introduction: We investigated differences in treatment outcomes following radical prostatectomy (RP) between certified centers (CCs) and noncertified centers (nCCs) within the IMPROVE study group. Methods: A validated survey assessing various factors, including stress urinary incontinence (SUI) and decision regret (DR), was administered to 950 patients who underwent RP across 19 hospitals (12 CCs and 7 nCCs) at a median follow-up of 15 months after RP (interquartile range: 11–20). The response rate was 74%, with 703 patients participating, including 480 (68%) from CCs. Multivariate binary regression models were used to analyze differences between CCs and nCCs regarding the following binary endpoints: nerve-sparing (NS), positive surgical margins (PSM), SUI (defined as >1 safety pad), complications based on the Clavien-Dindo classification (grade ≥1, grade ≥3) and DR (>15 points indicating critical DR). Results: Considering the multivariate analysis, the rate of NS surgery was lower in CCs than in nCCs (OR = 0.52; p = 0.004). No significant differences were observed in the PSM rate (OR = 1.67; p = 0.051), SUI (OR = 1.03; p = 0.919), and DR (OR = 1.00; p = 0.990). SUI (OR 0.39; p < 0.001) and DR (OR 0.62; p = 0.026) were reported significantly less frequently by patients treated with robotic-assisted RP, which was significantly more often performed in CCs than in nCCs (68.3% vs. 18%; p < 0.001). The total complication rate was 45% lower in CCs (OR = 0.55; p = 0.004), although the number of complications requiring intervention (Clavien-Dindo classification ≥3) did not differ significantly between CCs and nCCs (OR = 2.52; p = 0.051). Conclusion: Within the IMPROVE study group, similarly favorable outcomes after RP were found in both CCs and nCCs, which, however, cannot be transferred to the general treatment landscape of PCA in Germany. Of note, robotic-assisted RP was more often performed in CCs and associated with less SUI and DR, while open prostatectomy was the treatment of choice in low-volume nCCs. Future prospective and region wide studies should also investigate the surgeon caseload and experience as well as a spillover effect of the certification process on nCCs.

Ultrasound in anti-CCP+ at-risk individuals without clinical synovitis: development of a novel 6-joint protocol for feasible risk prediction.

To investigate, in anti-CCP antibody-positive individuals with musculoskeletal symptoms but no clinical synovitis (CCP+ at-risk), the additional value of US for the prediction of inflammatory arthritis. Furthermore, to define a concise US protocol for feasible risk prediction. Demographic and clinical data were collected in 417 CCP+ at-risk (Leeds CCP cohort) with a baseline US scan assessing synovitis and bone erosions in 36 joints, and a follow-up duration ≥24 months. Multivariable binary regression models for inflammatory arthritis development at 24 months evaluated routine clinical variables associated with inflammatory arthritis alone ('clinical' model) and combined with a 36-joint US scanning protocol ('clinical-US extended' model). A 'clinical-US short' model was also developed. At 24 months, 92/417 (22.1%) CCP+ at-risk developed inflammatory arthritis (median time 7 months, interquartile range 3-12). The 'clinical-US extended' model performed better than the 'clinical' model [area under the curve (AUC) 0.788 vs AUC 0.731, respectively, P < 0.001] with an odds ratio for inflammatory arthritis development of 3.18 (95% CI 1.80-5.63) for US synovitis and 2.54 (95% CI 1.21-5.37) for bone erosions. The 'clinical-US short' model, which retained the wrists, knees and MTP5 joints, performed better (AUC 0.782) than the 'clinical' model (P < 0.001) and similarly (difference in Akaike information criteria <2) to the 'clinical-US extended' model. US provides valuable information for predicting progression to inflammatory arthritis in CCP+ individuals both alone and in addition to clinical variables. US synovitis was associated with a 3-fold increase risk of inflammatory arthritis development. A concise US protocol of six joints provides clinically feasible risk prediction in CCP+ at-risk.

Use of the Geriatric Nutritional Risk Index to Assess Risk for Postoperative Complications Following Posterior Cervical Decompression/Fusion.

Posterior cervical decompression with or without fusion (PCD/F) is used to manage degenerative spinal conditions. Malnutrition has been implicated for poor outcomes in spine surgery. The aim of this study was to assess the ability of the Geriatric Nutritional Risk Index (GNRI) as a risk calculator for postoperative complications in patients undergoing PCD/F. The 2006 to 2018 American College of Surgeons National Surgery Quality Improvement Program Database was queried for patients undergoing PCD/F. Nutritional status was categorized as normal (GNRI greater than 98), moderately malnourished (GNRI 92-98), or severely malnourished (GNRI less than or equal to 92). Complications within 30 days of surgery were compared among the groups. Preoperative data that were statistically significant (P < 0.05) upon univariate χ2 analysis were included in the univariate then multivariate binary regression model to calculate adjusted ORs. All ORs were assessed at the 95% CI. Of the 7597 PCD/F patients identified, 15.6% were severely malnourished and 19.1% were moderately malnourished. Severe and moderate malnourishment were independent risk factors for mortality (OR = 3.790, 95% CI 2.492-5.763, P < 0.001; OR = 2.150, 95% CI 1.351-3.421, P = 0.011). Severe malnourishment was an independent risk factor for sepsis/septic shock (OR = 3.448, 95% CI 2.402-4.948, P < 0.001). In elderly patients undergoing PCD/F, severe malnutrition, as defined by the GNRI, was an independent risk factor for mortality and sepsis/septic shock. The GNRI may be more useful than other indices for risk stratification in elderly patients because it accounts for confounding variables such as hydration status and paradoxical malnourishment in obese patients.

High-risk TP53 mutations predict poor primary treatment response of patients with head and neck squamous cell carcinoma.

Head and neck squamous cell carcinoma (HNSCC) poses a diagnostic and therapeutic challenge worldwide and is associated with a poor survival rate. Due to the variability in the efficacy of treatments for HNSCC, new predictive biomarkers of therapy outcomes are needed. Recently, we developed an algorithm that employs the mutational profile of TP53 as an independent prognostic factor in HNSCC. In this study, we investigated its role as a predictive biomarker of treatment outcomes in HNSCC patients. We also tested the usefulness of two classification systems for TP53 mutational landscapes. Clinical and genomic data were retrieved from The Cancer Genome Atlas database. We built a multivariate stepwise backward binary regression model to assess the role of TP53 mutations in predicting therapeutic outcomes. Cases harbouring high-risk-of-death mutations reported an odds ratio of 3.301 for stable or progressive disease compared to wild-type cases, while no significant difference in treatment outcomes was found between cases with low-risk-of-death mutations and wild-type TP53. Our analysis found that older patients with a history of alcohol consumption had a higher risk of stable/progressive disease. This study improves current evidence on the role of TP53 mutations in treatment response in HNSCC patients.

Predicting outcomes in children with congenital anomalies of the kidney and urinary tract.

Congenital anomalies of the kidney and urinary tract (CAKUT) are the most frequent causes of childhood chronic kidney disease (CKD). Using a large CAKUT cohort, we sought to identify the predictors of CKD and to develop a prediction model that informs a risk-stratified clinical pathway. This was a retrospective cohort study including cases with multicystic dysplastic kidneys (MCDK), unilateral kidney agenesis (UKA), kidney hypoplasia (KH), and posterior urethral valves (PUV). We identified risk factors for CKD (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m2) and tested their performance in an adjusted multivariate binary regression model. Prediction probability scores for CKD were used to separate cases likely to develop complications from those not needing specialist follow-up. We identified 452 eligible cases of CAKUT with 22% developing CKD. Strongest associations with CKD included primary diagnosis (OR 3.5, 95% CI 2.6-4.6), preterm delivery (OR 2.3, 95% CI 1.2-4.4), non-kidney anomalies (OR 1.8, 95% CI 1.1-3), first eGFR<90 (OR 8.9, 95% CI 4.4-18.1), small kidney size (OR 9, 95% CI 4.9-16.6), and additional kidney anomalies (OR 1.6, 95% CI 1.2-2.8). PUV (OR 4.7, 95% CI 1.5-15.3), first eGFR <90 (OR 4.4, 95% CI 2-9.7), and kidney length to body length ratio <7.9 (OR 4.2, 95% CI 1.9-9.2) were independent predictors of CKD. The regression model had a prediction accuracy of 80% and a prediction probability c-statistic of 0.81. Using a large combined CAKUT cohort we identified risk factors for CKD. Our prediction model provides the first steps towards a risk-stratified clinical pathway. A higher resolution version of the Graphical abstract is available as Supplementary information.

Risk of adverse newborn outcomes among women who experienced physical and psychological intimate partner abuse during pregnancy in Ghana's northern region

BackgroundIntimate partner violence (IPV) is common worldwide. However, the health effects of exposure to IPV during pregnancy are significantly more severe. We investigated the relationship between exposure to IPV during pregnancy and the risk of preterm and low birthweight births among women in Ghana's northern region. MethodsWe recruited 402 postnatal women aged 15–49 years from five selected public health facilities in the Tamale Metropolis of the northern region of Ghana. Using Kobo Collect, information on a wide range of factors, including exposure to IPV during the last pregnancy and pregnancy outcomes, was collected electronically. Multiple logistic regression analyses were conducted in Stata to determine the associations between prenatal exposure to IPV and binary measures of gestational age at birth and birthweight. ResultsOverall, 35.1% (95% CI: 30.5, 39.9) of the respondents experienced IPV during their recent pregnancy; 6.7% (95% CI: 4.6, 9.6) experienced physical IPV; and 34.8% (95% CI: 30.3, 39.6) experienced psychological IPV. The prevalence of preterm and low birthweight deliveries was 18.9% (95% CI: 15.4, 23.1) and 9.0% (95% CI: 6.5, 12.2), respectively. Prenatal exposure to IPV was linked to poor newborn outcomes by multivariable binary regression models. Women who suffered IPV during their last pregnancy were three times more likely to deliver low birthweight babies (AOR = 3.12: 95% CI: 1.42, 6.84). Exposed women were also about twice as likely to deliver prematurely, although this association was not statistically significant (AOR = 1.81; 95% CI: 0.97, 3.38). ConclusionExposure to IPV during pregnancy increases a woman's risk of delivering prematurely and having a low birthweight baby. IPV screening should be a regular part of ANC, so that pregnant women who are experiencing IPV can be monitored and supported to avoid adverse outcomes for their babies.

Epidemiology of infection, transmission and COVID-19 outcomes among mental health users and workers in a comprehensive network of long-term mental health facilities: Retrospective observational population-base study.

A high Coronavirus Disease 19 (COVID-19) morbidity and mortality have been reported among users and workers of long-term care facilities. The main objective of this work was to explore the prevalence and temporal pattern of COVID-19 in comprehensive network of long-term mental health facilities in Spain. Secondly, we aimed to estimate the effect of having a severe mental health diagnosis on prevalence and COVID-19 outcomes. A cohort of 2552 participants were followed-up over a one-year. Sociodemographic and clinical data related to COVID-19 were recollected using a proforma. Frequency analyses were used to determine the prevalence of COVID-19 disease. Multivariable binary regression models sequentially adjusted by gender and age were employed to explore the potential role of severe mental health diagnosis on COVID-19 outcomes. Workers had higher risk of testing positive than mental health users (odds ratio [OR] 1.57 [95% CI 1.01-2.43; p<0.05] who presented an equivalent risk of testing positive after accounting for age and gender (OR 1.62 [95% CI 0.98-2.66; p=0.06]. The significant lower prevalence of COVID-19 among mental health users could be explained by the measures implemented to prevent COVID-19 as well as by the possible role that antipsychotic treatment could play in the prevention of SARS-CoV-2 infection.

The association of γδT lymphocytes with cystic leukomalacia in premature infants.

Periventricular leukomalacia (PVL) is an essential cause of cerebral palsy in preterm infants, and cystic PVL (cPVL) is the most severe form of the disease. The pathogenesis of cPVL is complex, and immune imbalances and inflammatory responses may play an essential role in it. This study aimed to investigate the correlation between peripheral blood lymphocyte subsets, especially γδT cells with the pathogenesis of cPVL in preterm infants. Peripheral blood from preterm infants with GA < 32 weeks and BW < 1,500 g was used in this study and was collected at 34 weeks corrected gestational age and within 24 h after the diagnosis with cranial MRI or cranial ultrasound. The infants were divided into cPVL groups and control groups. Flow cytometry was used to detect peripheral blood γδT, CD3+, CD4+, CD8+, and the proportion of total lymphocytes. Multiplex cell assays were used to detect the concentration of extracellular serum cytokines IL-6, IL-2, IL-8, IL-17A, IL-10, IL-1RA, eotaxin (CCL11), MCP-1 (CCL2), CXCL1, G-CSF, and IFNγ. A follow-up visit was carried out when the patient was 3 years old. After correcting for confounding factors, the proportion of peripheral blood γδT in the cPVL group was significantly lower than that in the control group (β: 0.216; 95% CI: 0.058-0.800, P < 0.022). Peripheral blood γδT (AUC: 0.722, P=0.006) and multivariate binary regression model (AUC: 0.865, P < 0.000) have good diagnostic values for cPVL. Peripheral blood γδT has some predictive power for neurodevelopmental outcomes in preterm infants (AUC: 0.743, P = 0.002). It seems that peripheral blood γδT cells are inversely correlated with cPVL, which is not only a risk factor for cPVL disease but also neurodevelopmental outcomes in preterm infants. However, the causality of cPVL and various lymphocytes is unclear and needs further study.

Level of women-friendly care provision among mothers in immediate post-partum period at public hospitals of Southeast Ethiopia: a cross-sectional study

BackgroundThe women-friendly care approach focuses on women’s rights to have access to quality care for themselves as individuals, as mothers, and for their infants. However, access to quality health services is not guaranteed for many women, particularly in low and middle-income countries. Hence, this study aimed to assess the level of women-friendly care provision and associated factors among mothers in the immediate post-partum period at public hospitals of Bale Zone, Southeast Ethiopia 2021.MethodsAn institutional-based cross-sectional survey was employed among mothers in the immediate post-partum period in public hospitals of Bale Zone from March 1–30, 2021. A total of 363 mothers were recruited by systematic random sampling technique in this study. Data was collected through pre-tested structured questionnaires. A 21-verified questionnaire was used to measure the outcome variable. The data were entered into Epi Data version 4.6.2.0 and exported to the statistical package of social science version 26.0 for analysis. A variable with a P value of less than 0.25 in the bi-variable binary logistic regression model was transferred to a multivariable binary logistics regression model. Hosmer and Lemeshow’s goodness of fit model was checked. Adjusted odds ratio with 95% confidence intervals were used to estimate the strength of association between the outcome variable and independent variables. A p-value less than 0.05 was considered as significantly associated.ResultsThe level of women-friendly care provision among mothers in immediate post-partum at public hospitals of Bale Zone was found to be 61% [95% confidence interval (55.73–66.04)]. Being prim para mother [Adjusted odds ratio = 1.88(1.07–3.33)], having planned pregnancy [Adjusted odds ratio = 1.94(1.04–3.63)] and staying at a health facility after delivery [Adjusted odds ratio = 4.8(1.71–13.39)] were found to be statistically significant predictors of level of women-friendly care provision.ConclusionThe women-friendly care provision among mothers in the immediate post-partum period in this study area was found to be low against most of the pre-existing findings. Strong counseling on planned pregnancy and staying at a health facility after delivery is recommended.

Validity of the Early Functional Ability scale (EFA) among critically ill patients undergoing early neurological rehabilitation

BackgroundA reliable assessment of the functional abilities of patients after severe brain damage is crucial for valid prognostication and treatment decisions, but most clinical scales are of limited use among this specific group of patients.AimThe present study investigates the usefulness of the Early Functional Ability (EFA) scale, which determines the functional abilities of severely impaired patients.MethodsCritically ill patients consecutively admitted to early neurological rehabilitation were screened for eligibility. We assessed the correlation between the EFA scale and (i) the Early Rehabilitation Barthel Index (ERBI), and (ii) the Coma Recovery Scale-Revised (CRS-R). The 1-year outcome on the Glasgow Outcome Scale-extended (GOSE) was used to examine the predictive validity. Demographical and medical variables were entered into univariate and multivariate binary regression models to identify independent predictors of 1-year outcome.ResultsTwo hundred fifty-seven patients (168 men) with a median age of 62 years (IQR = 51–75) were enrolled. The correlation of the EFA scale with the CRS-R was high but low with the ERBI upon admission. Multivariate regression analysis yielded the vegetative subscale of the EFA scale as the only independent predictor for the 1-year outcome of patients admitted to early neurological rehabilitation.ConclusionsThis study shows a high correlation of the EFA scale with the CRS-R but a weak correlation with the ERBI in patients with low functional abilities. With improving patient abilities, these correlations were partly reversed. Thus, the EFA scale is a useful tool to assess the functional abilities and the prognosis of critically ill patients adequately and may be more feasible than other scales.

Magnetic resonance imaging has a limited role in investigating odynophagia if examination is normal: A binary logistic regression analysis of 484 patients presenting to a tertiary head and neck clinic.

Investigation of head and neck cancers places a significant burden on the National Health Service and effective resource allocation is of perpetual importance. Existing risk calculators are designed to stratify the likelihood of underlying malignancy according to symptoms, but are less relevant in secondary care as they do not integrate clinical examination findings (e.g. naso-endoscopy). We looked to evaluate the utility of magnetic resonance imaging (MRI) in investigating patients with unilateral odynophagia and a normal clinical examination. A retrospective analysis was conducted over a 54-month period; 484 consecutively-recruited adult patients who underwent MRI of the neck for suspected malignancy were included. Imaging reports, case notes, and histopathology results were reviewed. Patients with previously diagnosed/treated malignancy, undergoing surveillance, or those with pathology of the salivary glands, oral cavity or thyroid gland, were excluded. A multivariate binary logistical regression model was performed to calculate the odds ratios and probabilities of malignancy for each presenting symptom, with and without negative nasoendoscopy findings. The overall incidence of malignancy within the cohort was 173/484 patients (35.7%; 95% CI 31.5%-40.2%) with no cases of malignancy in patients presenting with odynophagia and a normal nasoendoscopy (0/39). The presence of a neck lump was significantly associated with malignancy, (odds ratio [OR] 2.03, p = .001; 95% CI 1.59-2.58), as was dysphagia (OR 1.52, p = .009; 95% CI 1.11-2.11). Conversely, globus was found to have an inverse association (OR 0.41, p < .001; 95% CI 0.24-0.70). New patients presenting with odynophagia alone and normal endoscopy or globus have a low likelihood of underlying malignancy, justifying reassurance and follow-up in the event of persistent symptoms. Contrariwise, patients with a neck lump, dysphagia, odynophagia and multiple concurrent aerodigestive tract symptoms, or an abnormal endoscopy have a high likelihood of underlying malignancy and should be investigated accordingly.

Ibrutinib improves survival compared with chemotherapy in mantle cell lymphoma with central nervous system relapse

AbstractCentral nervous system (CNS) relapse of mantle cell lymphoma (MCL) is a rare phenomenon with dismal prognosis, where no standard therapy exists. Since the covalent Bruton tyrosine kinase (BTK) inhibitor ibrutinib is effective in relapsed/refractory MCL and penetrates the blood–brain barrier (BBB), on behalf of Fondazione Italiana Linfomi and European Mantle Cell Lymphoma Network we performed a multicenter retrospective international study to investigate the outcomes of patients treated with ibrutinib or chemoimmunotherapy. In this observational study, we recruited patients with MCL with CNS involvement at relapse who received CNS-directed therapy between 2000 and 2019. The primary objective was to compare the overall survival (OS) of patients treated with ibrutinib or BBB crossing chemotherapy. A propensity score based on a multivariable binary regression model was applied to balance treatment cohorts. Eighty-eight patients were included. The median age at study entry was 65 years (range, 39-87), 76% were males, and the median time from lymphoma diagnosis to CNS relapse was 16 months (range, 1-122). Patients were treated with ibrutinib (n = 29, ibrutinib cohort), BBB crossing chemotherapy (ie, high-dose methotrexate ± cytarabine; n = 29, BBB cohort), or miscellaneous treatments (n = 30, other therapy cohort). Both median OS (16.8 vs 4.4 months; P = .007) and median progression-free survival (PFS) (13.1 vs 3.0 months; P = .009) were superior in the ibrutinib cohort compared with the BBB cohort. Multivariable Cox regression model revealed that ibrutinib therapeutic choice was the strongest independent favorable predictive factor for both OS (hazard ratio [HR], 6.8; 95% confidence interval [CI], 2.2-21.3; P < .001) and PFS (HR, 4.6; 95% CI, 1.7-12.5; P = .002), followed by CNS progression of disease (POD) >24 months from first MCL diagnosis (HR for death, 2.4; 95% CI, 1.1-5.3; P = .026; HR for death or progression, 2.3; 95% CI, 1.1-4.6; P = .023). The addition of intrathecal (IT) chemotherapy to systemic CNS-directed therapy was not associated with superior OS (P = .502) as the morphological variant (classical vs others, P = .118). Ibrutinib was associated with superior survival compared with BBB-penetrating chemotherapy in patients with CNS relapse of MCL and should be considered as a therapeutic option.

Longitudinal Study Reveals Long-Term Proinflammatory Proteomic Signature After Ischemic Stroke Across Subtypes.

Background:Inflammation contributes both to the pathogenesis of stroke and the response to brain injury. We aimed to identify proteins reflecting the acute-phase response and proteins more likely to reflect proinflammatory processes present before stroke by broadly profiling inflammation-related plasma proteins in a longitudinal ischemic stroke study.Methods:Participants were from a Swedish ischemic stroke cohort (SAHLSIS [Sahlgrenska Academy Study on Ischemic Stroke], n=600 cases and n=600 controls). Plasma levels of 65 proteins including chemokines, interleukins, surface molecules, and immune receptors were measured once in controls and at 3× in cases: during the acute phase, after 3 months, and for a subgroup (n=223) at 7-year follow-up. Associations between proteins and ischemic stroke or subtype were investigated in multivariable binary regression models corrected for age, sex, vascular risk factors, and multiple testing.Results:In the acute phase, 48 proteins were significantly and independently associated with ischemic stroke (false discovery rate adjusted P<0.05). At 3-month follow-up, 51 proteins and at 7-year follow-up 50 proteins were associated with ischemic stroke. The majority of proteins were upregulated in cases compared with controls (n=34 at all time points) and the most upregulated were CXCL5 (CXC chemokine ligand 5) and OSM (oncostatin M). Generally, large artery and cardioembolic stroke had the highest protein levels. However, several interesting subtype-specific differences were also detected at each time point.Conclusions:We found inflammation-related proteins that were differentially regulated in ischemic stroke cases compared with controls only in the acute phase and others that remained elevated also at later time points. This latter group of proteins could reflect underlying pathophysiological processes of relevance. Future studies both in terms of disease risk and prognostication are warranted.

QT Interval Prolongation Is a Novel Predictor of 1-Year Mortality in Patients With COVID-19 Infection.

BackgroundQT interval prolongation is common in critically ill patients and is associated with increased mortality. However, the predictive value of a prolonged corrected QT interval (QTc) for myocardial injury and long-term mortality among patients hospitalized with COVID-19 infection is not well known.PurposeTo evaluate the association of prolonged QTc with myocardial injury and with 1-year mortality among patients hospitalized with COVID-19 infection.Materials and MethodsA total of 335 consecutive patients hospitalized with COVID-19 infection were prospectively studied. All patients underwent a comprehensive echocardiographic evaluation within 48 h from admission. Using the Bazett formula, the QTc interval was calculated from the first ECG tracing recorded at the ER. QTc ≥ 440 ms in males and ≥450 ms in females was considered prolonged. Patients with elevated cardiac biomarkers and/or echocardiographic signs of myocardial dysfunction were considered to have myocardial injury. The predictive value of QTc prolongation for myocardial injury was calculated using a multivariate binary regression model. One-year mortality rate of patients with and without QTc prolongation was compared using the log-rank test, and a multivariate Cox regression model adjusting for multiple covariates was performed to evaluate the 1-year mortality risk.ResultsOne-hundred and nine (32.5%) patients had a prolonged QTc. Compared to patients without QTc prolongation, patients with prolonged QTc were older (70 ± 14.4 vs. 62.7 ± 16.6, p < 0.001), had more comorbidities, and presented with a more severe disease. Prolonged QTc was an independent predictor for severe or critical disease (adjusted HR 2.14, 95% CI 1.3–3.5; p = 0.002) and myocardial injury (adjusted HR 2.07, 95% CI 1.22–3.5; p = 0.007). One-year mortality of patients with prolonged QTc was higher than those with no QTc prolongation (40.4% vs. 15.5; p < 0.001). Following adjustment to multiple covariates including myocardial injury and disease severity, QTc prolongation was found to be associated with increased 1-year mortality risk (HR 1.69, 95% CI 1.06–2.68, p = 0.027).ConclusionProlonged QTc is associated with disease severity, myocardial injury and 1-year mortality among patients hospitalized with COVID-19 infection.

QT interval prolongation is a novel predictor of one year morality in patients with coronavirus disease-19 infection

Funding AcknowledgementsType of funding sources: None.BackgroundQT interval prolongation is common in critically ill patients and is associated with increased mortality. However, the predictive value of a prolonged corrected QT interval (QTc) for myocardial injury and long-term mortality among patients hospitalized with COVID-19 infection is not well known.PurposeTo evaluate the association of prolonged QTc with myocardial injury and with 1-year mortality among patients hospitalized with COVID-19 infection.MethodsA total of 335 consecutive patients hospitalized with COVID-19 infection were prospectively studied. All patients underwent a comprehensive echocardiographic evaluation within 48 hours from admission. Using the Bazett formula, the QTc interval was calculated from the first ECG tracing recorded at the ER. QTc ≥440 msec in males and ≥450 msec in females was considered prolonged. Patients with elevated cardiac biomarkers and/or echocardiographic signs of myocardial dysfunction were considered to have myocardial injury. The predictive value of QTc prolongation for myocardial injury was calculated using a multivariate binary regression model. One-year mortality rate of patients with and without QTc prolongation was compared using the log-rank test, and a multivariate Cox regression model adjusting for multiple covariates was performed to evaluate the 1-year mortality risk.ResultsOne-hundred and nine (32.5%) patients had a prolonged QTc. Compared to patients without QTc prolongation, patients with prolonged QTc were older (70±14.4 vs 62.7±16.6, p <0.001), had more comorbidities, and presented with a more severe disease. Prolonged QTc was an independent predictor for myocardial injury (adjusted HR 2.07, 95% CI 1.22-3.5; p=0.007). One-year mortality of patients with prolonged QTc was higher than those with no QTc prolongation (40.7% vs 16.9; p <0.001, adjusted HR 1.85[1.2-2.84]; p=0.005). Compared to patient without QTc prolongation and no myocardial injury, the adjusted 1-year mortality risk was highest in patients with prolonged QTc and myocardial injury (HR 6.63, 95% CI 2.28-19.3; p=0.001), followed by patients with QTc prolongation without myocardial injury (HR 6.12 95% CI 1.83-20.49; p=0.003), and patients with myocardial injury without QTc prolongation (HR 4.95 95% CI 1.83-20.49.; p=0.003).ConclusionProlonged QTc is an independent risk factor for both myocardial injury and 1-year mortality among patients hospitalized with COVID-19 infection.

Decline of Humoral Responses 6 Months after Vaccination with BNT162b2 (Pfizer-BioNTech) in Patients on Hemodialysis.

This study analyzed binding and neutralizing antibody titers up to 6 months after standard vaccination with BNT162b2 (two doses of 30 µg each) in SARS-CoV-2 naïve patients (n = 59) on hemodialysis. Humoral vaccine responses were measured before and 6, 12, and 24 weeks after the first vaccination. A chemiluminescent immunoassay (CLIA) was used to quantify SARS-CoV-2 IgG against the spike glycoprotein. SARS-CoV-2 neutralizing activity was tested against the wild-type virus. A multivariable binary regression model was used to identify risk factors for the absence of humoral immune responses at 6 months. At week 6, vaccine-specific seroconversion was detected in 96.6% of all patients with median anti-SARS-CoV-2 IgGs of 918 BAU/mL. At weeks 12 and 24, seroconversion rates decreased to 91.5% and 79.7%, and corresponding median binding antibody titers declined to 298 BAU/mL and 89 BAU/mL, respectively. Neutralizing antibodies showed a decay from 79.6% at week 6 to 32.8% at week 24. The risk factor with the strongest association for vanishing immune responses was low serum albumin (p = 0.018). Regarding vaccine-specific humoral responses 6 months after the standard BNT162b2 vaccination schedule, SARS-CoV-2 naïve patients receiving hemodialysis must be considered at risk of becoming infected with SARS-CoV-2 and being infectious.