Search Results (535)

Background: Skin and soft tissue infections (SSTIs) are a major cause of emergency room (ER) visits and hospitalizations. Long-acting lipoglycopeptides (LALs), such as dalbavancin and oritavancin, offer potential for early discharge and outpatient management, especially in patients at risk for methicillin-resistant Staphylococcus aureus (MRSA) or with comorbidities. Methods: We conducted a retrospective observational cohort study from March to December 2024 in an Italian tertiary-care hospital. Adult patients treated in the ER with a single dose of dalbavancin (1500 mg) or oritavancin (1200 mg) for SSTIs were included. Demographic, clinical, and laboratory data were collected. Follow-up evaluations were performed at 14 and 30 days post-treatment to assess outcomes. Results: Nineteen patients were enrolled (median age 59 years; 53% female). Most had lower limb involvement and elevated inflammatory markers. Three patients (16%) were septic. Fourteen patients (74%) were discharged without hospital admission; hospitalization in the remaining cases was due to comorbidities rather than SSTI severity. No adverse drug reactions were observed. At 14 days, 84% of patients had clinical resolution; only 10% had recurrence by day 30, with no mortality nor readmission reported. Conclusions: LALs appear effective and well-tolerated in the ER setting, supporting early discharge and reducing healthcare burden. Broader use may require structured care pathways and multidisciplinary coordination. Full article

Background/Objectives: The number needed to vaccinate (NNV) is a metric commonly used to evaluate the public health impact of a vaccine as it represents the number of individuals that must be vaccinated to prevent one case of disease. Traditional calculations may underestimate vaccine benefits by neglecting indirect effects and duration of protection (DOP), resulting in NNV overestimation. This study evaluated the NNV for the pediatric 20-valent pneumococcal conjugate (PCV20) US immunization program, as compared to PCV13, with a unique approach to NNV. Methods: A multi-cohort, population-based Markov model accounting for indirect effects was employed to calculate the NNV of PCV20 to avert a case of pneumococcal disease, invasive pneumococcal disease (IPD), hospitalized non-bacteremic pneumonia (NBP), ambulatory NBP, and otitis media (OM), as well as to prevent antibiotic-resistant cases and antibiotic prescriptions. Results: The mean NNV over a 25-year time horizon to prevent one case of pneumococcal disease was 6, with NNVs of 854 for IPD, 106 for hospitalized NBP, 25 for outpatient NBP, and 9 for OM, 11 for a course of antibiotic, and 4 for resistant disease. The mean NNV per year decreased over time, reflecting the DOP and increasing indirect effects over time. Conclusions: This study presents a novel approach to NNVs and shows that relatively few vaccinations are required to prevent disease. The decrease in NNV over time highlights the necessity of including DOP and indirect effects in NNV calculations, ensuring a more realistic assessment of a vaccine’s impact. Full article

Background: Several epidemiological studies have indicated that metabolic syndrome (MetS) after renal transplantation is caused by an accumulation of non-immunological risks of renal transplantation, and affects the prognosis of the kidney and the patient by increasing the risk of arteriosclerosis and cardiovascular complications. The incidence of MetS in Japanese renal transplant recipients is 14.9 to 23.8%, but its effects on cardiovascular events and kidney prognosis are not clear. Here, we report the results of a longitudinal study on MetS in renal transplant recipients. Methods: A retrospective cohort study was conducted in 104 stable renal transplant recipients who attended our outpatient department from January 2006 to June 2007 and were diagnosed with MetS at least 6 months after renal transplantation until 31 December 2020, or did not have MetS. The impact of MetS on composite vascular events was examined using multivariate Cox proportional hazards analysis. Results: The hazard ratios for the impact of MetS on composite vascular events diagnosed by NCEP Japan, NCEP Original, NCEP Asia, and IDF criteria on composite vascular events were 2.78 (95% CI: 1.15 to 6.75, p = 0.024), 2.65 (95% CI: 1.04 to 6.80, p = 0.042), 2.37 (95% CI: 0.93 to 6.01, p = 0.070), and 1.91 (95% CI: 0.77 to 4.75, p = 0.164), respectively. P for interaction was used to test the influence of each indicator, but was not statistically significant. Conclusions: MetS is a robust risk factor for graft loss and development of cardiovascular events in Japanese renal transplant recipients, even during long-term follow-up. This finding emphasizes the importance of monitoring and managing MetS in this population to improve long-term outcomes. Full article

Objectives: To identify clinical, functional, laboratory, and patient-reported parameters associated with medium-term risk of hospitalization or death among older adults attending a multidisciplinary outpatient clinic, and to assess the predictive performance of these measures for individual risk stratification. Methods: In this cohort study, 350 adults aged ≥65 years were assessed at baseline and followed for an average of 8 months. The primary outcome was a composite of hospitalization or all-cause mortality. Parameters assessed included frailty and comorbidity measures, functional parameters, such as gait speed and grip strength, laboratory biomarkers, and patient-reported measures, such as quality of life (QoL, assessed on a Likert scale) and the presence of depressive symptoms. Predictive performance was evaluated using univariable logistic regression and multivariable modeling. Discriminative ability was assessed via area under the ROC curve (AUC), and selected models were internally validated using repeated k-fold cross-validation. Results: Overall, 40 participants (11.4%) experienced hospitalization or death. Traditional clinical risk indicators, including frailty and comorbidity scores, were significantly associated with the outcome. Patient-reported QoL (AUC = 0.74) and Geriatric Depression Scale (GDS) scores (AUC = 0.67) demonstrated useful overall discriminatory ability, with high specificities at optimal cut-offs, suggesting they could act as “red flags” for adverse outcomes. However, the limited sensitivities of individual predictors underscore the need for more comprehensive screening instruments with improved ability to identify at-risk individuals earlier. A multivariable model that incorporated several predictors did not outperform QoL alone (AUC = 0.79), with cross-validation confirming comparable discriminative performance. Conclusions: Patient-reported measures—particularly quality of life and depressive symptoms—are valuable predictors of hospitalization or death and may enhance traditional frailty and comorbidity assessments in outpatient geriatric care. Future work should focus on developing or integrating screening tools with greater sensitivity to optimize early risk detection and guide preventive interventions. Full article

Background and Objectives: The COVID-19 pandemic disrupted cancer care, prompting adaptations to reduce patient exposure while preserving treatment efficacy. This retrospective observational study compared a weekly cisplatin and 5-fluorouracil (5-FU) regimen to the standard monthly regimen for neoadjuvant chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. Materials and Methods: This single-center retrospective study included 91 patients, divided into two cohorts: weekly chemotherapy (n = 30) and standard chemotherapy (n = 61). Treatment assignment was based on hospital policy changes during the pandemic, with weekly outpatient chemotherapy implemented after November 2022 to conserve inpatient resources. All patients received radiotherapy at 50 Gy in 25 fractions. The weekly regimen consisted of cisplatin 20 mg/m² and 5-FU 800 mg/m², administered over 1–2 h weekly, while the standard regimen administered the same doses over four consecutive days on weeks 1 and 5. Primary endpoints were pathologic complete response (pCR), progression-free survival (PFS), and overall survival (OS). Results: The response rates were similar between groups (weekly: 86.7% vs. standard: 90.2%; p = 0.724). The weekly regimen group showed a higher pCR (40.0% vs. 26.2%; p = 0.181) and significantly lower recurrence (26.7% vs. 52.5%; p = 0.020). Mortality was also reduced in the weekly group (6.7% vs. 34.4%; p = 0.004), though the follow-up duration was shorter (10.6 vs. 22.8 months; p < 0.001). Conclusions: In this retrospective observational study, weekly cisplatin and 5-FU demonstrated comparable efficacy to the standard regimen, with potential advantages in reducing recurrence and mortality. This modified approach may be a viable alternative for maintaining oncologic outcomes while minimizing the burden on healthcare systems during pandemic conditions, although prospective validation is needed. Full article

Background/Objectives: Clostridioides difficile infection (CDI) is a major cause of infectious diarrhea in the inpatient and community setting. Real-world data outside the strict environment of randomized controlled trials (RCTs) are needed to improve the quality of evidence. The aim of this study was to compare different clinical outcomes of CDI patients treated with fidaxomicin with those treated with vancomycin using a representative patient population in the United States of America (USA). Methods: Comprehensive real-world data were analyzed for this retrospective observational study, provided by the TriNetX database, an international research network with electronic health records from multiple USA healthcare providers. This includes in- and outpatients treated with fidaxomicin (FDX) or vancomycin (VAN) for CDI between 01/2013 and 12/2023. The following cohorts were compared: (i) patients treated with fidaxomicin within 10 days following CDI diagnosis (FDX group) vs. (ii) patients treated with vancomycin within 10 days following CDI diagnosis (VAN group). Outcomes analysis between the two cohorts was performed after propensity score matching and included event risk and Kaplan–Meier survival analyses for the following concomitant diseases/events occurring during an observational period of 12 months following CDI diagnosis: death, sepsis, candidiasis, infections caused by vancomycin-resistant enterococci, inflammatory bowel disease, cardiovascular disease, psychological disease, central line-associated blood stream infection, surgical site infection, and ventilator-associated pneumonia. Results: Following propensity score matching, 2170 patients were included in the FDX group and VAN groups, respectively. The event risk analysis demonstrated improved outcomes of patients treated with FDX compared to VAN in 6 out of the 10 events that were analyzed. The highest risk ratio (RR) and odds ratio (OR) were found for sepsis (RR: 3.409; OR: 3.635), candidiasis (RR: 2.347; OR: 2.431), and death (RR: 1.710; OR: 1.811). The Kaplan–Meier survival analysis showed an overall survival rate until the end of the 12-month observational period of 87.06% in the FDX group and 78.49% in the VAN group (log-rank p < 0.001). Conclusions: Our comparative event risk analysis demonstrated improved outcomes for patients treated with FDX compared to VAN in most of the observed events and underlines the results of previously conducted RCTs, highlighting the beneficial role of FDX compared to VAN. Further big data analyses from other industrialized countries are needed for comparison with our observations. Full article

Background: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3) Abbott left ventricular assist device (LVAD), it is unknown how the role of the LVAD outpatient clinic may affect the long-term survival after hospital discharge. Our objective is to share our standardized protocol for outpatient care, to describe the role of the LVAD outpatient clinic in postoperative long-term care after LVAD implantation, and to report survival. Methods: We retrospectively reviewed all patients implanted with HM3 LVAD in our institute between September 2015 and January 2025. Patients who received HeartWare Ventricular Assist Device (HVAD) and HeartMate 2 LVAD devices were excluded from our study, to ensure a homogenous cohort focusing on the latest and the only currently used LVAD device generation. We included a total of 48 patients. After LVAD patients are discharged from our center, they are followed in our outpatient clinic in 3-month intervals. During visits, bloodwork, EKG, wound inspection, and echocardiography are performed in addition to LVAD analysis. The role of the outpatient clinic is to detect early signs of deterioration or problems and act accordingly to prevent serious complications. Results: Thirty-three patients (68.7%) are still alive in 2025; two patients (4.2%) had a successful heart transplantation; and thirty-one patients (64.5%) are still on LVAD support. There were 210 total patient years of support. The mean time on device is 4.4 years. During the follow-up period we noticed 15 deaths (31.3%). Notably, there was no technical device-related death. Kaplan–Meier analysis estimated an overall survival rate of 97.9%, 92.8%, 83.7%, and 51.1% at 1, 2, 4, and 8 years, respectively. Conclusion: Strict control of patients after discharge in an outpatient clinic is essential for the long-term survival of these patients. A well-structured outpatient program is of utter importance to avoid LVAD-related complications and should be a cornerstone for the treatment, especially in non-transplant centers. Full article

Objectives: Persistent Human Papillomavirus (HPV) infection in the cervix and the preinvasive lesions it causes are significant risk factors for cervical cancer. Therefore, a treatment strategy is necessary to facilitate the clearance of HPV and prevent the progression of preinvasive lesions without causing cervical tissue destruction. This study aimed to evaluate the effectiveness of a vaginal adsorbent gel composed of a hydroxyethyl cellulose matrix formulation containing dispersed silicon dioxide, antioxidant sodium selenite, deflamin, and citric acid in patients with HPV infection. Methods: The study was designed as a retrospective cohort study and involved 449 women infected with HPV. For the purposes of the study, the patients were divided into two groups: the treatment group (TG) comprised 207 patients who used the vaginal gel daily for a period of three months, while the control group (CG), consisting of 242 patients, received no treatment under an “active surveillance” protocol. The study’s endpoints encompassed the domains of cytology, histology, and HPV clearance. Results: The regression rate of smear pathologies was 24.8% in the control group and 29.0% in the group using the vaginal adsorbent gel. In the first year, the histological regression rate in cervical biopsies was 49.3% in the treatment group and 19.4% in the control group, with a significant difference between groups (p < 0.001). Moreover, the clearance rate of HPV types was found to be significantly higher in the group using the vaginal adsorbent gel. Conclusions: The findings of this study suggest that the outpatient treatment approach can effectively prevent the oncogenic progression of cervical dysplasia. This alternative method has been shown to be efficacious in preventing the progression of cervical dysplasia and promoting regression. Furthermore, the efficacy of this gel in eradicating HPV has been demonstrated within a 12-month period. Full article

Background/Objectives: The main objective of the study is to assess the clinical utility of microbial cell-free DNA (mcfDNA) in neutropenic patients diagnosed with acute myeloid leukemia (AML) undergoing chemotherapy in the outpatient setting. Neutropenia is a common complication in this patient cohort and enhances the risk of fatal opportunistic bacterial and fungal infections. Accurate and timely diagnosis of these infections in outpatient asymptomatic individuals is critical. Methods: Fourteen patients were studied in this prospective observational case series. Traditional blood cultures (BCs) were obtained when clinically indicated and blood samples were collected for plasma mcfDNA metagenomic sequencing up to two times a week at outpatient oncology appointments. Results were compared in identifying potential infectious agents. Results: BCs identified pathogens in only two patients, despite several cases where infection was suspected. In contrast, mcfDNA testing detected pathogens in 11 of the 14 patients, including bacteria, such as Staphylococcus aureus, and invasive fungi, such as Candida and Aspergillus species, and Pneumocystis jirovecii. Conclusions: In the outpatient setting, mcfDNA surveillance offers a more reliable method for detecting pathogens. This approach identified actionable microbiologic results in immunocompromised individuals who did not meet standard clinical criteria for suspicion of infection. Further research is required to confirm the potential of mcfDNA surveillance in an outpatient setting to guide more accurate treatment decisions, reduce extensive clinical investigations, and improve neutropenic patient outcomes. Full article

Background/Objectives: Two-dimensional echocardiography (2D echo) is widely used for assessing left ventricular ejection fraction (LVEF). This single-center comparative study aims to evaluate the accuracy of LVEF measurements obtained using the AI-assisted handheld ultrasound device Kosmos against cardiac magnetic resonance (CMR), the current gold standard. Methods: A total of 49 adult patients undergoing clinically indicated CMR were prospectively enrolled. AI-based LVEF measurements were compared with CMR using the Wilcoxon signed-rank test, Pearson correlation, multivariable linear regression, and Bland–Altman analysis. All analyses were performed using STATA v18.0. Results: Median LVEF was 57% (CMR) vs. 55% (AI-Echo), with no significant difference (p = 0.51). Strong correlation (r = 0.99) and minimal bias (1.1%) were observed. Conclusions: The Kosmos AI-based autoEF algorithm demonstrated excellent agreement with CMR-derived LVEF values. Its speed and automation make it promising for bedside assessment in emergency departments, intensive care units, and outpatient clinics. This study aims to fill the gap in current clinical evidence by evaluating, for the first time, the agreement between LVEF measurements obtained via Kosmos’ AI-assisted autoEF and those from cardiac MRI (CMR), the gold standard for ventricular function assessment. This comparison is critical for validating the reliability of portable AI-driven echocardiographic tools in real-world clinical practice. However, these findings derive from a selected population at a single Italian center and should be validated in larger, diverse cohorts before assuming global generalizability. Full article

This retrospective cohort study evaluated characteristics, treatment patterns, and clinical outcomes in adults with locally advanced/metastatic urothelial carcinoma (la/mUC) receiving first-line (1L) systemic treatment with or without avelumab 1L maintenance (1LM) between January 2020 and July 2023. The index date was the first date with a claim for 1L systemic therapy after a la/mUC diagnosis. Patients with continuous health plan enrollment for ≥6 months before and ≥1 month after the index date were identified from Carelon Research’s Healthcare Integrated Research Database. Of 2820 patients receiving 1L treatment, 37.0% received platinum-based chemotherapy (PBC); 39.0%, immuno-oncology (IO) monotherapy; and 24.0%, other therapies. Renal disease and other comorbidities influenced 1L regimen choice. Healthcare resource utilization (HCRU) and costs were reported for patients receiving second-line (2L) treatment. HCRU was high in 32.8% of patients (926 of 2820) who received 2L treatment. Median all-cause direct medical costs per patient per month were USD 15,859, USD 19,781, USD 11,346, and USD 9516 for 1L PBC, 1L PBC + avelumab 1LM, 1L IO monotherapy, and 1L other therapies, respectively. Most direct healthcare costs were attributed to all-cause outpatient visits. Full article

Background/Objectives: Gait abnormalities in advanced knee osteoarthritis (KOA) are characterized by decreased stride length, walking speed, and cadence. Total knee arthroplasty (TKA) is intended to improve temporal–spatial gait parameters; however, the extent and timing of functional recovery remain under investigation. To assess changes in stride length, walking speed, and cadence following TKA in short- and long-term perspectives, and to compare outcomes with a non-operated KOA cohort. Methods: A prospective observational study was conducted involving 46 patients with unilateral KOA (grades III–IV, Kellgren–Lawrence scale) who underwent cemented TKA via a medial parapatellar approach. Group I (n = 34) was assessed one day prior to surgery and six weeks postoperatively. Group II (n = 12), a follow-up subset, was reassessed 1.5 years postoperatively. Group III (n = 34) served as a non-operated control group, assessed only preoperatively. Temporal–spatial gait parameters were evaluated under standardized conditions using a two-dimensional video analysis (Kinovea^® software version 0.8.27). Stride length (m) and walking speed (m/s) were assessed during continuous walking along a 15 m corridor, with at least three valid gait cycles averaged per trial. Cadence (steps/min) was determined during a one-minute walk and verified frame-by-frame. No structured outpatient physiotherapy was provided; all patients followed a standardized in-hospital rehabilitation protocol. Results: In Group I, the mean stride length increased from 0.40 ± 0.10 m to 0.42 ± 0.10 m (p = 0.247), walking speed improved from 0.41 ± 0.027 m/s to 0.47 ± 0.022 m/s (p = 0.063), and cadence increased significantly from 72.9 ± 7.8 to 77.1 ± 8.6 steps/min (p = 0.044). In Group II, the mean stride length rose from 0.39 ± 0.10 m to 0.52 ± 0.09 m (p < 0.001), walking speed improved from 0.44 ± 0.02 m/s to 0.69 ± 0.01 m/s (p < 0.001), and cadence increased from 73.7 ± 8.8 to 103.6 ± 7.4 steps/min (p < 0.001). Compared to the control group (Group III: stride length 0.42 ± 0.09 m; walking speed 0.41 ± 0.02 m/s; cadence 73.9 ± 7.9 steps/min), Group II demonstrated superior values across all parameters (p < 0.001 for each comparison). No significant correlations were observed between BMI and gait outcomes. Conclusions: Total knee arthroplasty resulted in progressive improvement in temporal–spatial gait parameters. While early postoperative gains were limited, substantial functional restoration was observed at long-term follow-up, emphasizing the importance of extended recovery monitoring in post-TKA evaluation. Full article

Background: Severe scoliosis can lead to chronic low back pain (cLBP) and may progress in adulthood. While day-time bracing is commonly used to alleviate pain and improve function, the role of night-time bracing remains unclear. This study aimed to assess the six-month effectiveness of a custom-made night-time brace in reducing pain in adults with scoliosis, compared to a prefabricated brace worn for 2–4 h during the day. Methods: A retrospective cohort study was conducted at a tertiary outpatient clinic specializing in spinal deformities. Adults with scoliosis (≥30° Cobb) and cLBP were divided into two groups: the study group used a custom-made night-time thoracolumbosacral orthosis (TLSO), while the control group wore a prefabricated brace (Peak) for 2–4 h daily. Pain and functional outcomes were assessed at baseline and after six months. Results: The study group included 25 women (mean age, 62.3 ± 9.5 years; Cobb angle, 60.4 ± 17.7°) who wore the night-time brace for an average of 7.2 ± 2.2 h per night. The control group comprised 20 women (mean age, 67.8 ± 10.5 years; Cobb angle, 61.9 ± 12.6°). At six months, the worst pain significantly improved in the TLSO group compared to the Peak group (F = 6.32, p = 0.0158). However, no statistically significant differences were observed between groups for back pain, leg pain, Core Outcome Measures Index (COMI), or Oswestry Disability Index (ODI). Conclusions: Night-time bracing shows interesting results on pain at six months in adults with severe scoliosis and back pain. These preliminary results open a new perspective that needs further verification and will help design more robust studies to verify what we found and identify the population more responsive to this approach. Full article

Background: Although the value of point-of-care ultrasound (PoCUS) is well-established for specific diseases and in the hands of trained users, its broader impact on overall ED efficiency is not yet fully known. This study aims to evaluate the association of early PoCUS, performed within 1 h of presentation, with ED patient flow, healthcare resource utilization, and quality of care in adults with non-traumatic abdominal pain. Method: This retrospective cohort study included 44,863 adult patients (≥18 years) presenting with non-traumatic abdominal pain from January 2021 to December 2023. Patients were grouped into PoCUS and no-PoCUS categories, with a subgroup analysis for those receiving PoCUS within 1 h, to evaluate ED LOS, and costs for different ED dispositions. Outcomes measured included hospital LOS, costs, mortality, and ICU admission. Results: The mean age of the subjects was 44.4 ± 17.9 years, and 61.2% were female. PoCUS was performed in 39.7% of cases, with 69.6% of these conducted within one hour. Additionally, 30.5% underwent CT. The PoCUS group had a significantly shorter ED LOS compared to the no-PoCUS group among patients admitted to general wards (p < 0.001), but not in outpatient dispositions (p = 0.282) or ICU admissions (p = 0.081). Subgroup analysis of patients receiving PoCUS within 1 h showed a significantly shorter LOS for both outpatient dispositions (p < 0.001) and general ward admissions (p < 0.001), with no effect on ICU admissions (p = 0.869). The presence or absence of CT did not alter these findings. Multivariable analysis indicated that patients who received PoCUS within one hour alone at index visit and admitted after an unscheduled return visit had lower initial ED costs (−9436.1 TWD, p < 0.001) and shorter ED LOS (−11.59 min, p < 0.001) than patients admitted directly at the index visit, with no significant increase in total resource utilization or adverse outcomes after return visits. Conclusions: PoCUS, especially when performed within one hour, was associated with reduced ED LOS and healthcare resource utilization for both outpatient dispositions and inpatient admissions without compromising patient safety or quality of care. Full article

Background: Psychological impacts of the coronavirus disease 2019 (COVID-19) pandemic on individuals with chronic medical conditions remain understudied. Chronic kidney disease (CKD) is one of the chronic conditions associated with an increased risk of severe COVID-19 outcomes. The aim of this study was to define the psychological burden of individuals with CKD during the COVID-19 pandemic. Methods: In this cross-sectional study, 219 individuals with CKD were recruited from the Nephrology Outpatient Unit at the University Hospital Essen, Germany, and completed anonymous surveys incorporating validated psychological assessment tools for generalized anxiety (GAD-7) and depressive symptoms (PHQ-2), along with self-generated items addressing COVID-19-specific concerns and behavioral changes. These participants were propensity score matched with controls from the general German population. Results: Individuals with CKD exhibited lower levels of generalized anxiety and depressive symptoms compared to the general population. However, they reported significantly greater risk perceptions regarding the likelihood of experiencing symptoms, a severe disease course, and death from COVID-19. COVID-19-related fear and associated behavioral changes were more frequently reported among CKD patients. Adherent and dysfunctional safety behaviors predominated among the CKD cohort. Conclusions: This study underscores psychological challenges faced by individuals with CKD during the COVID-19 pandemic. The increased risk perceptions and fears of severe disease and mortality from COVID-19 emphasize the need for mental health interventions aimed at improving coping strategies alongside physical health management in this vulnerable population. Full article