Search Results (4,262)

In 2018, the WHO published a methodology for conducting a point prevalence survey (PPS) of antibiotic use in hospitals. The aim of this study is to report the use of antibiotics in six second-level hospitals in Mexico using this methodology. Methods: A multicenter cross-sectional study based on the 2021–2023 adaptation for Latin American hospitals was conducted in internal medicine, surgery, intensive care unit (ICU), obstetrics and gynecology and pediatrics departments of the IMSS in the western region of the state of Mexico. Results: The overall prevalence of antibiotic use was 61%; the services with the highest prevalence of prescription were general surgery (79%) and the ICU (78%). A total of 846 patients were surveyed; there were no differences in antibiotic use or non-use in terms of gender, surgical procedure and invasive devices, but there were differences in median age and comorbidities. Adherence to guidelines was 53.9%. The three main antibiotics used were third-generation cephalosporins (28%), carbapenems (13%) and glycopeptides (9%); for the type of indication, for CAI and prophylaxis, the rates of use of third-generation cephalosporins were 29.2% and 44.5%, respectively, while for healthcare-associated infections, carbapenems were used (23.9%). By AWaRe group, the watch group was predominant for all types (63.9%), for prophylaxis it was the access group (39.3%), and for HAIs it was the reserve group (4.9%). Full article

Background: Pancreatic ductal adenocarcinoma (PDAC) is associated with a significant percentage of germline pathogenic variants (GPVs). Unlike in the United States, routine universal genetic testing is not performed in Europe. The aim of the study is to evaluate the diagnostic yield of germline genetic testing in all patients with PDAC. Methods: Individuals with newly diagnosed PDAC from three Spanish hospitals were enrolled, regardless of family history. Thirteen known susceptibility genes for PDAC were studied using a multigene panel or whole-exome sequencing. Results: One hundred seventy-nine PDAC patients underwent genetic testing. Fourteen (7.8%) had a GPV or likely pathogenic variant In the genes studied: six in ATM, six in BRCA2, one in PALB2, and one in TP53. Of these, seven (50%) did not meet the clinical criteria for genetic study and would have been classified as sporadic PDAC. Presenting with a personal history of any other neoplasm was associated with some GPV, with an odds ratio (OR) of 3.5 (1.1–11.5). A family history of PDAC and breast cancer was also associated with some GPV, with oRs of 3.7 (1.08–13.6) and 8.5 (2.6–26.6), respectively. None of the patients over 60 years without a relevant family history of malignancies presented a GPV associated with PDAC. Conclusions: In our PDAC cohort, a noteworthy number of GPVs were identified, and half of these patients would have been classified as sporadic based solely on clinical criteria. Genetic testing should always be considered, particularly in patients under 60 years or those with a history of other malignancies, especially where economic resources need optimization. Full article

Background and Objectives: The growing number of colorectal cancer patients has highlighted the importance of surgical education in colorectal surgery. Despite the negative impact of the COVID-19 pandemic on surgical training, recent changes in the Polish surgical training program have increased the number of intestinal procedures required to be completed by residents. This study aims to assess the safety of ileostomy reversal procedures performed by surgical residents. Materials and Methods: A multicenter prospective cohort study, the LILEO study, was conducted from October 2022 until December 2023 across 20 Polish surgical departments. The study included 199 patients who underwent ileostomy reversal and were divided into two groups: 139 patients operated by specialist surgeons and 60 patients operated by surgical residents. The primary outcomes measured were postoperative complications, length of hospital stay (LOS), and 30-day reoperation rate. Secondary outcomes included the severity of perioperative complications assessed using the Clavien–Dindo classification and a focused analysis of loop ileostomy reversal outcomes. Results: The median LOS was significantly shorter in the resident group (5.5 days vs. 6 days, p < 0.05). Although the overall complication rate was lower in the resident group (21.7% vs. 33.1% in the specialist surgeon group), this difference was not statistically significant (p = 0.105). The 30-day reoperation rate was 3.3% in the resident group and 8.6% in the specialist surgeon group (p = 0.179). In terms of severity, minor complications (Clavien–Dindo grades 1 and 2) were more common in the specialist group (p < 0.05). The analysis of loop ileostomy reversals revealed no significant differences in postoperative outcomes between the two groups. Conclusions: Ileostomy reversal procedures performed by surgical residents under supervision are safe and feasible, with outcomes comparable to those performed only by specialist surgeons. These findings support ileostomy reversal as a valuable procedure for developing surgical residents’ skills and do not negatively affect postoperative outcomes. Full article

Background. Previous research has shown that patients with ostomy frequently exhibit a low health-related quality of life (HRQoL). Self-care is a key element that influences their HRQoL. However, the evidence regarding the relationship between these two constructs in patients with ostomy is still not clear. Materials and Methods. This was a secondary analysis of an Italian multicenter, observational, longitudinal study. Participants were recruited from seven outpatient ostomy care clinics in central and northern Italy. The Stoma-Specific Quality of Life Questionnaire (Stoma QoL) and the Ostomy Self-Care Index (OSCI) were administered to the participants. The relationship between self-care and HRQoL was analyzed using structural equation modeling. Results. A total of 521 patients were enrolled. Our results emphasized that self-care is a predictor of HRQoL among people with ostomy. Self-care maintenance and self-care monitoring had a positive effect on HRQoL (self-care maintenance: β = 0.506, p < 0.001; self-care monitoring: β = 0.303, p < 0.001). The model exhibited acceptable fit indices: χ² (151, n= 521) = 516.447, p ≤ 0.001, comparative fit index (CFI) = 0.97, Tucker–Lewis index (TLI) = 0.96, root mean square error of approximation (RMSEA) = 0.068 (90% CI, 0.062–0.075), p < 0.001, and standardized root mean square residual (SRMR) = 0.038. Conclusions. The structural equation model tested the causal relationship between self-care and HRQoL in people with a stoma, demonstrating for the first time that inadequate self-care in patients with ostomy may lead to lower HRQoL. Thus, to enhance HRQoL, interventions should be designed to improve self-care behaviors. Future research should investigate potential mediating variables in the relationship between self-care and HRQoL. Full article

Background: Everolimus at 10 mg daily is approved to treat patients with advanced grade 1/2 neuroendocrine tumors (NETs), although it may lead to significant toxicity. Grade 3 or higher drug-related adverse events and drug discontinuation occur in approximately one-fourth of cases. However, phase I trials have demonstrated that doses from 5 mg daily efficiently inhibit NET cell signaling. Objectives and Methods: This multicenter retrospective study compared the time to treatment failure (TTF) in patients with NETs who received a mean daily dose of 7–10 mg (higher dose [HD]) or ≤6 mg (lower dose [LD]) of everolimus. Results: Ninety-two patients were included: 74 (80%) in the HD group and 18 (20%) in the LD group. At a median follow-up of 4.2 years, the median time to treatment failure (TTF) was 9.2 months for the HD and 7.2 months for the LD groups (p = 0.85). The TTF did not significantly differ between the LD and the HD groups (HR: 1.24; 95% CI: 0.68–2.25; p = 0.47), even after adjusting for age at treatment initiation, the NET grade, and the treatment line. Conclusion: Everolimus doses from 5 to 6 mg/day seem to be equally as effective as higher doses, but lower doses are potentially associated with less toxicity and lower costs. These findings support validation through a randomized clinical trial. Full article

Background: Autoantibodies against Desmoglein-2 desmosomal protein (anti-DSG2-ab) were identified in Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) by Enzyme-Linked ImmunoSorbent Assay (ELISA); anti-intercalated disk autoantibodies (AIDAs) were identified in myocarditis and (ARVC) by indirect immunofluorescence (IFL). We aim to assess: (1) anti-DSG2-ab specificity in ARVC and myocarditis, (2) accuracy of anti-DSG2-ab detection by ELISA versus AIDA by IFL, and (3) clinical correlates of anti-DSG2-ab in ARVC. Methods: We included 77 patients with ARVC, 91 with myocarditis/dilated cardiomyopathy (DCM), 27 with systemic immune-mediated diseases, and 50 controls. Anti-heart antibodies (AHAs) and AIDAs were assessed by IFL, and anti-DSG2-ab by ELISA (assessed both by optical density, OD, and U/L). Receiving operator curve (ROC) analysis was used to assess ELISA diagnostic accuracy. Results: A relevant proportion (56%) of ARVC patients was anti-DSG2-ab-positive, with higher anti-DSG2-ab levels than controls. Anti-DSG2-ab titer was not different between ARVC and myocarditis/DCM patients (48% anti-DSG-ab positive). Frequency of anti-DSG2 positivity by ELISA was higher in AIDA-positive cases by IFL than AIDA-negative cases (p = 0.039 for OD, p = 0.023 for U/L). In ARVC, AIDA-positive patients were more likely to be AHA-positive (p < 0.001), had pre-syncope (p = 0.025), and abnormalities in cardiac rhythm (p = 0.03) than ARVC AIDA-negative patients, while anti-DSG2-ab positivity did not have clinical correlates. Conclusions: Anti-DG2-ab detection in ARVC and myocarditis/DCM reflects immune-mediated pathogenesis to desmosomal proteins. Higher frequency of anti-DSG2-ab positivity by ELISA by U/L was higher in AIDA-positive cases by IFL than AIDA-negative cases, in keeping with the hypothesis that DSG2 is one of AIDA autoantigens. In ARVC, AIDA status but not anti-DSG2-ab showed distinct clinical correlates, possibly reflecting a wider AIDA autoantigenic spectrum. Full article

Background/Objectives: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved to treat anemia of chronic kidney disease (CKD). The efficacy and safety of roxadustat compared with parenteral erythropoiesis-stimulating agents (ESAs) were evaluated in patients with anemia of CKD receiving peritoneal dialysis (PD). Methods: This analysis pooled data from four phase 3, multicenter, randomized, open-label, active-comparator studies (PYRENEES, SIERRAS, HIMALAYAS, ROCKIES). The primary endpoints evaluated were hemoglobin change from baseline (CFB) to Weeks 28–36 without rescue therapy and hemoglobin CFB to Weeks 28–52 regardless of rescue therapy use. Safety data were reported. Results: This analysis included 422 patients (215 roxadustat, 207 ESA). Hemoglobin CFB to Weeks 28–36 without rescue therapy and hemoglobin CFB to Weeks 28–52 regardless of rescue therapy achieved non-inferiority for roxadustat vs. ESAs. The mean weekly dose of roxadustat was maintained over time (Weeks 1–4, 3.86 mg/kg/week; Weeks 101–104, 3.27 mg/kg/week), whereas the mean weekly ESA dose increased by 24% (Weeks 1–4, 115.70 IU/kg/week; Weeks 101–104, 143.40 IU/kg/week). Fewer patients treated with roxadustat received intravenous iron supplementation and rescue therapy, and patients treated with an ESA required blood transfusions sooner. Roxadustat-treated patients experienced a greater decrease in low-density lipoprotein cholesterol levels relative to baseline vs. ESA-treated patients. Treatment-emergent adverse events were similar in both treatment groups. Major adverse cardiovascular event (MACE), MACE plus unstable angina or congestive heart failure, and all-cause mortality hazard ratios were <1; the lower limit of the 95% CIs was <0.6, and the upper limit was >1.3. Conclusions: Roxadustat was non-inferior to ESAs in correcting and maintaining hemoglobin levels, with stable dosing and a comparable safety profile, in anemic patients receiving PD. Full article

Orbital cellulitis and severe preseptal cellulitis are critical periocular infections with potential vision- and life-threatening implications. The COVID-19 pandemic is hypothesized to have had an influence on their presentation and pathogenesis; however, the real impact remains unclear. In this retrospective multicenter cohort study from January 2017 to December 2022, we analyzed 1285 cases with preseptal or orbital cellulitis in pre-pandemic (2017–2019) and pandemic (2020–2022) cohorts. A notable decrease in hospitalized cases during the pandemic period was observed (97 patients in the pre-pandemic group vs. 54 in the pandemic group, p = 0.004), particularly among individuals aged 30–39 (p = 0.028). Sinusitis remained the leading cause, but odontogenic cases increased (p = 0.025). In addition, microbial diversity decreased during the pandemic, with the effective number of species decreasing from 17.07 to 8.87, accompanied by a rise in antibiotic resistance, notably against erythromycin, oxacillin, penicillin, and metronidazole. While visual outcomes appeared worse in the pandemic group, statistical significance was not reached. These findings suggest that the characteristics, etiology, microbial profiles, resistance patterns, and visual outcomes of orbital and preseptal cellulitis have undergone alterations post-COVID-19 pandemic. Vigilance in clinical management and public health measures is crucial, with further research needed to optimize treatment strategies. Full article

Purpose: Brain metastases (BM) in sarcomas occur rarely and are associated with poor prognosis. This study is a large retrospective cohort describing the demographic and clinical characteristics of these patients, treatment strategies, and survival outcomes. Methods: In total, 81 patients with BM from sarcomas were identified across five sarcoma centers. Demographic data, clinical presentation, and treatment modalities were analyzed. Results: The most common histologies were leiomyosarcoma (12.3%) and undifferentiated pleomorphic sarcoma (12.3%). The median time from sarcoma diagnosis to brain metastases was 1.9 years. Upon presentation, 88.9% of patients with BM from sarcomas were symptomatic with the most common presenting symptom being focal neurological deficits (37.9%) and headaches (22.1%). Higher-grade sarcomas were more likely to metastasize and were usually preceded by metastases to other sites, most commonly the lungs. One-year overall survival was 31% from initial sarcoma diagnosis, and the median time from diagnosis of BM until death was 6.0 months. For treatment, 60 (74.1%) patients had radiation, 39 (48.1%) patients had systemic therapy, and 29 (35.8%) patients had surgery. In a multivariate analysis, surgery (HR 0.30) and chemotherapy (HR 0.23) were found to be significantly correlated with improved survival outcomes. Although radiation as a whole was not found to significantly correlate with survival, improved outcomes were seen with stereotactic radiosurgery (SRS, mOS 11.6 mo) as opposed to whole-brain radiation therapy (WBRT, mOS 8.3 mo). Additionally, patients with leptomeningeal disease were significantly less likely to survive more than one year compared to patients with brain metastases only. Conclusions: Our findings identify that patients with metastatic sarcoma to the brain have poor prognoses, often have concurrent metastasis, and have a median survival of only 6 months. Additionally, our study found that leptomeningeal metastases is a rare presentation with poor survival outcomes. There are various treatment modalities for sarcomas with BM; however, there are no guidelines, unlike in other malignancies. Further research is necessary to evaluate the role of therapeutic measures in terms of type, timing, and outcomes. Full article

In this study, we aimed to integrate a genetic repository with an existing longitudinal national burn database. We set out two primary objectives, namely (1) to develop standard operating procedures for genetic sample collection and storage, DNA isolation, and data integration into an existing multicenter database; and (2) to demonstrate the feasibility of correlating genetic variation to functional outcomes in a pilot study, using the catechol-O-methyltransferase (COMT) gene. Dubbed the worrier/warrior gene, COMT variants have been associated with varying phenotypes of post-traumatic stress, wellbeing, and resilience. Between August 2018 and July 2020, COMT variants were identified for 111 participants from three sites and correlated with their outcome data. We found no association between COMT variants and functional outcomes, likely due to the inadequate sample size. We also asked all potential participants why they consented to or refused genetic analysis. A thematic analysis of responses revealed altruism and personal interest/enthusiasm in the study as top reasons for consenting. Privacy concerns were the most common reason for refusal. In conclusion, we successfully developed standard operating procedures for genetic sample collection and storage, DNA isolation, and data integration into an existing database, and we demonstrated the feasibility of conducting a multicenter collaborative study using a centralized lab location. Full article

Background/Objectives: Achieving disease control is the main goal in asthmatic patients in order to prevent future risks and exacerbations. There are several clinical guidelines that set different definitions of asthma control, and these differences may affect management and treatment in many patients. Our aim was to describe asthma control patterns according to the Global Initiative for Asthma (GINA) 2023 in patients considered to have uncontrolled asthma as per previous GINA 2010 guidelines. Methods: A total of 1299 patients from the COAS study were analyzed. The COAS study was a cross-sectional multicenter study conducted in routine clinical practice that included patients with uncontrolled asthma according to GINA 2010. These patients were then re-classified using the now updated GINA 2023 asthma control criteria. Results: After applying GINA 2023 control criteria, previously uncontrolled patients were now classified as having controlled asthma in 24.3% of cases and partially controlled asthma in 16.3% of cases. Only 59.4% maintained their previous diagnosis of uncontrolled asthma. ACT in the uncontrolled patients remained similar after re-classification, as did the percentage of active smokers, respiratory allergy, rhinitis, and lung function. Conclusions: Changes in clinical guideline criteria affect the definition of asthma control. When excluding pulmonary function abnormalities in GINA 2023 asthma control criteria, the percentage of controlled patients greatly increased. Full article

Background and Objectives: Lung nodules detected by chest computed tomography (CT) often require invasive biopsies for definitive diagnosis, leading to unnecessary procedures for benign lesions. A blood-based biomarker test that predicts lung cancer risk in CT-detected nodules could help stratify patients and direct invasive diagnostics toward high-risk individuals. Methods: In this multicenter, single-blinded clinical trial, we evaluated a test measuring plasma levels of p53, anti-p53 autoantibodies, CYFRA 21-1, and anti-CYFRA 21-1 autoantibodies in patients with CT-detected lung nodules. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated, and subgroup analyses by gender, age, and smoking status were performed. A total of 1132 patients who had CT-detected lung nodules, including 885 lung cancer cases and 247 benign lesions, were enrolled from two academic hospitals in South Korea. Results: The test demonstrated a sensitivity of 78.4% (95% CI: 75.7–81.1) and specificity of 93.1% (95% CI: 90.0–96.3) in predicting lung cancer in CT-detected nodules. The PPV was 97.6%, and the NPV was 54.6%. Performance was consistent across gender (sensitivity 79.3% in men and 76.8% in women) and age groups, with a specificity of 93.4% in men and 92.7% in women. Stage I lung cancer was detected with a sensitivity of 80.6%. Conclusions: The Lung Cancer test based on 9G technology presented here offers a non-invasive method for stratifying lung cancer risk in patients with CT-detected nodules. Its integration into clinical practice could reduce unnecessary interventions and foster earlier detection. Full article

Background: Endoscopic Submucosal Dissection (ESD) has become the standard therapy for early malignant lesions in the gastrointestinal tract and has shown as good oncological surgery results. Approximately 30% of ESDs do not meet the criteria for oncological curability, and upfront surgery is indicated. Hence, about 40% of patients with an indication for surgery are advised against surgery because of comorbidities and an advanced age. Methods: We performed a multicenter retrospective cohort study on the long-term outcomes of non-curative ESDs, performed between 2009 and May 2024, without additional tumor therapy. The primary outcome was the recurrence of malignancy, either local malignancy or lymph node metastasis during follow-up, or death. We compared the outcomes between two cohorts: after non-curative ESD (ncESD) and after curative ESD (cESD). Results: A total of 374 ESDs were analyzed in this study. Overall, the technical success rate was 91%, and the oncological curative resection criteria were met in 70.9% of patients. Severe complications occurred in 5% of cases without procedure-associated mortality. In the ncESD group, 20% (7/35) of patients had a recurrence of malignancy primarily due to positive horizontal margins in the resection specimens, and 3 out of 35 died due to a non-oncological reason during the follow-up (mean length 36.6 months). In the cESD group, 3% (1/33) of patients had tumor recurrence, and 1 patient died because of a non-oncological reason. The tumor recurrence rate between the cohorts was significant (p = 0.017), and overall mortality did not show significance (p = 0.33). Conclusions: Especially in the elderly and multimorbid patients, the recommendation to perform rescue surgery after non-curative ESD remains challenging. Residual malignancy rates in surgical resection specimens are low, recurrence rates of malignancy are low, and mortality rates for non-oncological reasons are high in this population. There is a need for more data for the individualization of patient management after non-curative ESD. Full article

Background: The Supportive and Palliative Care Indicators Tool (SPICT) was developed for identifying, in a timely manner, patients who may benefit from supportive and palliative care for better treatment review, care-plan discussion, and end-of-life care. Although the SPICT has been validated in different languages and for patients living in different settings, it has not been validated for patients receiving home-based medical care (HBMC), or in the context of using traditional Chinese characters. Objectives: The present study aimed to validate the Taiwanese version of the SPICT (SPICT-TW) and to measure its ability to predict six-month mortality in patients who received HBMC in Taiwan. Methods: Seven HBMC agents (five clinics and two hospitals) participated in this validation study. We recruited 129 patients aged ≥ 50 years who had been consistently receiving HBMC for >two months. Results: The results revealed that the SPICT-TW demonstrated similar reliability and validity compared to other language versions of the SPICT. It may be an appropriate tool for healthcare professionals to detect, in a timely manner, the needs for palliative care in older people who receive home healthcare. Furthermore, we found that a combination of four general indicators and one clinical indicator in the SPCIT-TW has the best prediction ability at predicting six-month mortality in these HBMC recipients. This multi-center study validated the SPICT-TW among HBMC recipients in Taiwan. Conclusions: The SPICT-TW demonstrated high reliability and validity through the Kuder–Richardson 20, an intraclass correlation coefficient, Cohen’s kappa, and receiver operating characteristic analysis, supporting its potential as a practical tool for identifying older adults at risk of dying within six months who have not yet received palliative care but may benefit from it. Full article

(1) Background: Metastatic L-type sarcomas (liposarcoma and leiomyosarcoma) are rare and have a poor prognosis. Trabectedin is an effective agent that can be used after anthracyclines. This study was designed to evaluate the real-life effectiveness and safety of trabectedin. (2) Methods: A retrospective multicenter study was conducted on patients who were treated with trabectedin for metastatic L-type sarcomas at ten tertiary oncology centers between 2015 and 2023. The objective response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), and overall survival (OS) were evaluated in the cohort. Cox regression analysis was used to determine prognostic factors for survival. (3) Results: A total of 98 patients (52% liposarcoma and 48% leiomyosarcoma) were included in the study. The median treatment line was three (range: 1 to 6). Thirteen patients (13.3%) underwent local treatment due to oligoprogression, and dose reduction was required in seventeen patients (17.3%) due to toxicity. The ORR and DCR were 16% and 42%, respectively. The median TTF was 3 months, and the median OS was 10 months. In univariate analysis, a significantly longer median TTF was observed in patients who underwent local treatment (p = 0.008), obtained objective responses (p < 0.001), and underwent dose reduction (p = 0.002). No statistical differences were observed according to the histologic subtype and metastatic site. In the multivariate analysis for OS, it was found that obtaining an objective response was a good prognostic factor (p = 0.003), while the presence of liver metastases was associated with a poor prognosis (p = 0.016). (4) Conclusion: Trabectedin is a suitable option for L-type sarcoma after doxorubicin-based treatments. Survival was not worse in patients who underwent dose reduction. The use of local therapies simultaneously with trabectedin can be effective. Full article