Efficacy and safety of uncovered self-expandable metal stents for distal malignant biliary obstruction in unresectable non-pancreatic cancer.

Objectives: The efficacy of uncovered self-expandable metal stents (UCSEMS) versus fully covered self-expandable metal stents for distal malignant biliary obstruction remains controversial. Additionally, the heterogeneity of the disease conditions has been indicated in previous studies because pancreatic and non-pancreatic cancers have different characteristics in clinical course. Therefore, the etiology of biliary obstruction necessitates investigations stratified by primary disease. This study aimed to evaluate the outcomes of UCSEMS, specifically for non-pancreatic cancer-induced distal malignant biliary obstruction. Methods: We conducted a single-center retrospective review to evaluate the time to recurrent biliary obstruction and frequency of adverse events (AEs) in patients receiving UCSEMS for unresectable non-pancreatic cancer-induced malignant biliary obstruction. Results: Overall, 32 patients were enrolled in the study between January 2016 and December 2023. The median time to recurrent biliary obstruction was 140 days. AE rates were low at 3.1% for both pancreatitis and cholecystitis, suggesting a potential benefit of UCSEMS in reducing post-procedural AEs. Conclusion: UCSEMS may reduce the risk of post-procedural AEs and should be considered in patients at high risk of post-endoscopic retrograde cholangiopancreatography pancreatitis. However, the patency period may be shorter, necessitating future comparative research with fully covered self-expandable metal stents to determine the optimal stent choice.

Nivel de cumplimiento de metas internacionales de seguridad en un Sanatorio privado 2023 / Level of compliance with international safety goals in a private Sanatorium 2023

La presente investigación pretende evaluar el nivel de cumplimiento de las metas internacionales, que representan el foco principal para la mejora de calidad y seguridad de atención de los pacientes. La seguridad del paciente involucra a todos los estudios, prácticas y acciones promovidas por las instituciones sanitarias para disminuir y eliminar los riesgos de daños innecesarios relacionados con el cuidado de la salud. Metodología: Estudio descriptivo, observacional y transversal. De fuentes primaria y secundaria, Resultados: se abordaron las metas N° 1 la cual consiste en Identificar a los pacientes correctamente y la meta N° 6 la cual se refiere a Reducir el riesgo de lesiones en pacientes como resultado de caídas. En primer lugar, se destaca el cumplimiento en la identificación correcta del paciente y en segunda instancia la mejora del cumplimiento de medidas de prevención de caídas. Conclusión: Esta proximidad de los valores obtenidos genera un aspecto positivo para mejorar la seguridad de los pacientes y que, si bien el cumplimiento de las metas no es el deseado, es cercano al porcentaje planteado. Lo que en definitiva hace a este estudio un antecedente importante en la mejora continua con vista al futuro cercano[AU]

This research aims to evaluate the level of compliance with international goals, which represent the main focus for improving the quality and safety of patient care. Patient safety involves all studies, practices and actions promoted by health institutions to reduce and eliminate the risks of unnecessary harm related to health care. Methodology: Descriptive, observational and transversal study. From primary and secondary sources, Results: goals No. 1 were addressed, which consists of Identifying patients correctly and goal No. 6, which refers to Reducing the risk of injuries in patients as a result of falls. Firstly, compliance with correct patient identification stands out and secondly, improvement in compliance with fall prevention measures. Conclusion: This proximity of the values obtained generates a positive aspect to improve patient safety and that, although the fulfillment of the goals is not as desired, it is close to the proposed percentage. Which ultimately makes this study an important precedent in continuous improvement for the near future[AU]

Esta pesquisa tem como objetivo avaliar o nível de cumprimento das metas internacionais, que representam o foco principal para a melhoria da qualidade e segurança do atendimento ao paciente. A segurança do paciente envolve todos os estudos, e ações promovidas pelas instituições de saúde para reduzir e eliminar os riscos de danos desnecessários relacionados à assistência à saúde. Metodologia: Estudo descritivo, observacional e transversal. De fontes primárias e secundárias, dependendo do indicador e do objetivo para o qual a medição está sendo realizada. Resultados: Nesta pesquisa serão abordadas as metas nº1, que consiste em Identificar corretamente os pacientes e a meta nº 6, que es Reduzir o risco de lesões nos pacientes em decorrência de quedas. Foi realizado nos dois locais. Em primeiro lugar, destaca-se o cumprimento da correta identificação do paciente e, em segundo lugar, a melhoria no cumprimento das medidas de prevenção de quedas. Conclusão: Essa proximidade dos valores obtidos gera um aspecto positivo para melhorar a segurança do paciente e que, embora o cumprimento das metas não seja o desejado, está próximo do percentual proposto. O que acaba por tornar este estudo um precedente importante na melhoria contínua com vista ao futuro próximo.

Water safe Worcester: student-led drowning prevention in an adolescent underserved population.

Adolescents aged 15 to 19 years have the second highest fatal drowning rate of any age group, second only to toddlers aged 12 to 36 months. This risk is amplified in black, indigenous, and people of color (BIPOC), and those of low socioeconomic status. Worcester, MA is a diverse city with over 40% of residents identifying as BIPOC and 20% living below the poverty line. The city has multiple natural bodies of water available for recreation, putting Worcester residents, particularly adolescents, at high risk of drowning. It is known that swimming lessons provided to adolescents significantly improve their swimming skills, however many programs are tailored to young children and are not appropriate for adolescents. Students from the University of Massachusetts T.H. Chan Medical School (UMass Chan), in collaboration with community partners, developed a water safety and swim education program tailored to Worcester adolescents as a means for an age-appropriate swim experience and education, community engagement, and injury prevention. Water Safe Worcester (WSW) was established as a city-wide injury prevention program that included swim lessons offered by medical students at the Central Community Branch YMCA in Worcester, MA. Instructors included UMass Chan medical students, graduate students, and staff. Adolescent YMCA members were invited to participate in lessons free of charge. Lessons were 90 min and emphasized a 3-fold approach: (1) expand knowledge of water safety and what to do in an emergency, (2) increase swimming skills, and (3) reduce fear of water. The overall attendance for the 2023 spring and summer sessions offered was 73 students, including multiple swimmers who attended more than one session. A total of 12 volunteers participated, which included 9 first-year medical students, one PhD student, one research assistant, and one surgery resident from UMass Chan. WSW demonstrated promising outcomes during its swim education classes, suggesting that WSW is a successful model to promote water safety, reduce the risk of drowning, and expand access to life-saving skills to Worcester's at-risk adolescents. This program serves as a critical step toward health equity while also providing an avenue for public health and injury prevention exposure for medical students.

Polypharmacy and high-alert medications in patients with nasally placed feeding tube on admission and at hospital discharge: Multicenter cross-sectional study.

Background: Polypharmacy and the use of high-alert medications in patients with nasally placed feeding tube (NPFT) increase the risks of drug related problems. Objective: Characterize drugs prescribed to patients with NPFT and compare the rates of polypharmacy and high-alert medication use at admission and hospital discharge. Design and setting: Multicenter cross-sectional study with 327 participants. Methods: Data of patients with NPFT were obtained from the medical records and recorded in an electronic data collection tool. Mean number of drugs, polypharmacy and number of high-alert medications prescribed on admission and at discharge were compared using Wilcoxon or McNemar's tests. Generalized Estimating Equations analyzed the relationship between polypharmacy and high-alert medications according to age and time point. Primary reason for hospital admission, level of consciousness, severity of comorbid diseases and patient care complexity were also assessed. Results: Most patients were male, older people, hospitalized for circulatory system diseases and had at least one comorbidity. On admission, a significant number of patients were alert (59.9%), at high risk for death (43.1%) and high dependent on nursing care (35.4%). Additionally, 92% patients were on polypharmacy on admission, versus 84.7% at hospital discharge (p = 0,0011). The occurrence of polypharmacy was independent of age (p = 0.2377). >17% of all drugs prescribed were high-alert medications, with no statistically significant difference between admission and discharge (p = 0,3957). There was no statistical evidence that the use of high-alert medications increases with age (n = 0,5426). Conclusions: These results support the planning of multidisciplinary qualified actions for patients using NPFT.

Intraperitoneal Irrigation Chemotherapy with Lobaplatin in Locally Advanced Gastric Cancer: A Special Type of Abdominal Chemotherapy.

BACKGROUND: This study evaluated the safety and efficiency of intraperitoneal irrigation chemotherapy with lobaplatin for the treatment of advanced gastric cancer (GC). METHODS: A total of 56 locally advanced GC patients (experimental group) who received intraoperative intraperitoneal irrigation chemotherapy in addition to undergoing radical D2 surgery were matched 1:1 based on 8 covariates to 56 patients without drug treatment (control group). Clinical data were collected and analyzed. RESULT: The two groups were well balanced in basic characteristics and had comparable clinical indices. All patients had similar time to first flatus (2.8 ± 0.3 vs. 2.9 ± 0.3 d, P = 0.076), time to first oral intake (3.5 ± 3.4 vs. 4.1 ± 4.6 d, P = 0.439), and duration of postoperative hospitalization (9.1 ± 3.2 vs. 9.6 ± 4.0 d, P = 0.446). There were no significant differences in postoperative complications including anastomotic and duodenal stump leakage, abdominal and anastomotic bleeding, seroperitoneum, and incision infection between the experimental and control groups (P > 0.05). The rates of chemotherapy-related side effects including allergic reaction, neurotoxicity, diarrhea, and nausea/vomiting were also similar between the two groups, and there were no abnormalities in leukocyte and platelet levels and liver and renal function during the first 5 days after surgery. CONCLUSION: Intraperitoneal irrigation chemotherapy with lobaplatin is safe for patients with advanced gastric cancer.

Safety of Gonadal Tissue-Derived Mesenchymal Stem Cell Therapy in Geriatric Dogs with Chronic Disease.

Ensuring the safety of mesenchymal stem cell (MSC) therapy is a fundamental requirement in clinical practice. This study aimed to assess the safety of using gonadal tissue-derived MSCs (n = 10) compared to the commonly utilized adipose tissue-derived MSCs (n = 9) in geriatric dogs with chronic diseases. All participants received allogeneic MSC therapy, and no allergic reactions due to allogeneic cell immunogenicity were noted. Both groups showed no adverse changes in physical exams or hematological parameters before and after therapy. Importantly, there were no instances of tumor formation or growth post-treatment in either group. The findings demonstrated that dogs treated with gonadal tissue-derived MSCs experienced no clinical adverse effects. However, clinical adverse effects were reported in one case of adipose tissue-derived MSC therapy. Despite limitations in monitoring beyond one year and constraints due to a small and diverse patient group, this pioneering study validates the safe use of gonadal tissue-derived MSCs in aged companion animals. It underscores the potential of utilizing tissues from neutering procedures to advance regenerative medicine and expand cell banks and therapy options for companion animals.

The Kinetics of Inflammation-Related Proteins and Cytokines in Children Undergoing CAR-T Cell Therapy-Are They Biomarkers of Therapy-Related Toxicities?

CD19-targeted CAR-T cell therapy has revolutionized the treatment of relapsed/refractory (r/r) pre-B acute lymphoblastic leukemia (ALL). However, it can be associated with acute toxicities related to immune activation, particularly cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Cytokines released from activated immune cells play a key role in their pathophysiology. This study was a prospective analysis of proinflammatory proteins and cytokines in children treated with tisagenlecleucel. Serial measurements of C-reactive protein, fibrinogen, ferritin, IL-6, IL-8, IL-10, IFNγ, and TNFα were taken before treatment and on consecutive days after infusion. The incidence of CRS was 77.8%, and the incidence of ICANS was 11.1%. No CRS of grade ≥ 3 was observed. All complications occurred within 14 days following infusion. Higher biomarker concentrations were found in children with CRS grade ≥ 2. Their levels were correlated with disease burden and CAR-T cell dose. While cytokine release syndrome was common, most cases were mild, primarily due to low disease burden before lymphodepleting chemotherapy (LDC). ICANS occurred less frequently but exhibited various clinical courses. None of the toxicities were fatal. All of the analyzed biomarkers rose within 14 days after CAR-T infusion, with most reaching their maximum around the third day following the procedure.

Methotrexate, Tofacitinib, and Biologic Disease-Modifying Antirheumatic Drug Safety and Effectiveness Among Patients with Rheumatoid Arthritis in Japan: CorEvitas Registry Observational Study.

INTRODUCTION: The evolution of disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) has improved patient prognosis. However, more real-world safety/effectiveness data comparing methotrexate (MTX), tofacitinib, tumor necrosis factor inhibitors (TNFi), and non-TNFi biologic DMARDs (bDMARDs) are warranted. METHODS: The CorEvitas RA Japan registry was used to identify patients with rheumatologist-diagnosed RA who initiated MTX/tofacitinib/TNFi/non-TNFi bDMARDs. Safety outcomes included incidence of major adverse cardiovascular events (MACE), total cardiovascular disease, total serious infections, total herpes zoster, and total malignancies (excluding non-melanoma skin cancer). Effectiveness outcomes included change from baseline (Δ) in Clinical Disease Activity Index (CDAI) and proportion of patients achieving a minimum clinically important difference (MCID) in CDAI at month 6. Adjusted regression models were fit; marginal means were estimated. RESULTS: Overall, 1972 patients were included in the safety cohort: MTX (N = 298); tofacitinib (N = 253); TNFi (N = 663); non-TNFi (N = 758). Mean follow-up time was 3.8, 2.9, 3.0, and 2.9 years for MTX, tofacitinib, TNFi, and non-TNFi, respectively. Adjusted incidence rates (IRs, patients with events/100 patient-years [95% confidence intervals]) for MACE and total cardiovascular disease, respectively, were numerically lower for MTX (0.34 [0, 0.83]; 0.42 [0, 0.92]) and TNFi (0.09 [0, 0.27]; 0.61 [0.15, 1.07]) versus tofacitinib (0.48 [0, 1.20]; 2.30 [0.38, 4.22]) and non-TNFi (0.77 [0.35, 1.19]; 1.28 [0.73, 1.82]). Serious infections were numerically higher for non-TNFi (4.47 [3.38, 5.56]); herpes zoster was higher for tofacitinib (7.41 [4.52, 10.29]), versus other groups. IRs for malignancies were comparable between groups. Mean ΔCDAI and rates of achieving MCID in CDAI at month 6 were generally greater with tofacitinib versus other groups. CONCLUSION: Some variations in incidence of safety outcomes were observed between treatments, while certain effectiveness outcomes favored tofacitinib. Sample size variation between groups and low number of safety events limited the analysis. Further studies are warranted to investigate observed differences. CLINICALTRIALS: GOV: NCT05572567.

What did we catch? Predictors of infection after tissue expander-based breast reconstruction in a safety-net system.

BACKGROUND: Infection is a common complication following tissue expander (TE)-based breast reconstruction. Few studies have examined risk factors specifically in the unique populations encountered at safety-net hospitals. The purpose of this study was to identify predictors of TE infection at Harris Health safety-net hospitals, which serve the third most populous county in the United States. METHODS: A retrospective review was performed to evaluate women over the age of 18 years who underwent TE placement at two safety-net hospitals from October 2015 to November 2022. Demographic information, medical history, operative details, and postoperative course were recorded for each individual TE. The primary outcome was TE infection, for which univariate and multivariate analysis was conducted. The secondary outcome was the time to onset of TE infection, for which a Kaplan-Meier analysis was undertaken. RESULTS: There were 279 patients, totaling 372 breasts, meeting the inclusion criteria. The TE infection rate was 23%. Increased body mass index (BMI), diabetes, use of acellular dermal matrix (ADM), and prolonged surgical drain use were all significantly associated with TE infection in univariate and multivariate analysis. Similarly, BMI ≥30 kg/m2, diabetes, and ADM use were also associated with earlier onset of TE infection. CONCLUSIONS: This study demonstrated similar TE infection rates at our safety-net hospitals compared with previously reported literature. To optimize the quality of care for patients in safety-net institutions, these risk factors must be addressed in the context of the unique challenges encountered in these settings.

In Pursuit of Optimal Outcomes: A Framework for Quality Standards in Immune Effector Cell Therapy.

Immune Effector Cell (IEC) therapy represents a transformative advancement in oncology, leveraging the immune system to combat various malignancies. This manuscript outlines a comprehensive framework for establishing and maintaining quality standards in IEC therapy amidst rapid scientific and clinical advancements. We emphasize the integration of structured process measures, robust quality assurance, and meticulous outcome evaluation to ensure treatment efficacy and safety. Key components include multidisciplinary expertise, stringent accreditation protocols, and advanced data management systems, which facilitate standardized reporting and continual innovation. The collaborative effort among stakeholders-ranging from patients and healthcare providers to regulatory bodies-is crucial in delivering high-quality IEC therapies. This framework aims to enhance patient outcomes and cement the role of IEC therapy as a cornerstone of modern oncology, promoting continuous improvement and adherence to high standards across the therapeutic spectrum.

Efficacy and Safety of Bone Wax Application at Different Time Points to Reduce Postoperative Blood Loss in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

OBJECTIVE: In addition to the surface hemorrhage of cancellous bone after large-area osteotomy, the intramedullary hemorrhage after the reamed knee joint is also a major cause of postoperative bleeding after total knee arthroplasty (TKA). This study evaluated the efficacy and safety of bone wax application at different time points of prone hemorrhage to reduce perioperative blood loss. METHODS: From August 2023 to December 2023, 150 patients undergoing primary unilateral TKA were included in this prospective, randomized controlled trial, patients were randomly divided into three groups: group A, after autogenous osteotomy plug was used to fill the femoral medullary cavity, the residual space was sealed with bone wax and the exposed cancellous bone surface around the prosthesis was coated with bone wax after the prosthesis adhesion; group B, only the exposed cancellous bone surface around the prosthesis was coated with bone wax; and group C, no bone wax was used. The primary outcome was total perioperative blood loss. Secondary outcomes included occult blood loss, postoperative hemoglobin reduction, blood transfusion rate, lower limb diameter, and knee function, while length of hospital stay was recorded. Tertiary outcomes included the incidence of postoperative related adverse events. RESULTS: The total blood loss in group A (551.5 ± 224.5 mL) and group B (656.3 ± 267.7 mL) was significantly lower than that in group C (755.3 ± 248.3 ml, p < 0.001), and the total blood loss in group A was also lower than that in group B (p < 0.05). There were also significant differences in the reduction of hemoglobin level and hidden blood loss among the three groups (p < 0.05). However, there was no significant improvement in postoperative lower limb swelling, knee joint activity and hospitalization time; there was no significant difference in the incidence of complications such as thromboembolism. CONCLUSION: The use of bone wax in TKA can safely and effectively reduce perioperative blood loss and hemoglobin drop rate, and multiple use at time points during the operation when blood loss is prone to occur can produce more significant hemostatic effect.

Stop the Line: Interventions to Prevent Retained Surgical Items.

The surgical team works collaboratively to prevent the occurrence of retained surgical items (RSIs). The purpose of this quality improvement project was to increase compliance with facility policies and improve teamwork skills to prevent the occurrence of RSIs. The project team implemented an evidence-based communication protocol, updated hospital network policies, introduced just-in-time job aids, and facilitated leader support through a daily huddle to address identified practice gaps. The TeamSTEPPS Teamwork Attitudes Questionnaire was used to measure the change in staff members' attitudes about teamwork before and after project implementation. Additional process and outcome measures included the number of near misses and actual RSIs, compliance with the daily huddle, and completion of the communication training. Results included improved perceived teamwork attitude scores and zero reports of actual RSI events over 7.5 weeks.

Which Is More Suitable for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer, PD-L1 Inhibitors Versus PD-1 Inhibitors? A Systematic Review and Network Meta-Analysis.

BACKGROUND: In this network meta-analysis (NMA), the efficiency and safety of PD-1 inhibitors + chemotherapy and PD-L1 inhibitors + chemotherapy were compared in the first-line therapy of patients with extensive-stage small cell lung cancer (ES-SCLC). METHODS: We searched research databases, conference abstracts, and trial registries and subsequently chose relevant studies and extracted dates. The NMA was conducted to estimate the efficiency and safety of the PD-1 inhibitors + chemotherapy and PD-L1 inhibitors + chemotherapy on overall survival (OS), progression-free survival (PFS), overall remission rate (ORR), and adverse events (AEs). Studies were assessed for quality. Subgroup analyses were used to evaluate study heterogeneity. RESULTS: We included six randomized trials with a total of 3163 patients. Direct comparisons showed that patients who received either PD-1 inhibitors + chemotherapy (HR: 0.71, 95% CI: 0.57-0.87) or PD-L1 inhibitors + chemotherapy (HR: 0.74, 0.61-0.89) demonstrated significantly longer OS than those who received placebo + chemotherapy. The results of the NMA showed that no significant differences in OS (HR 0.96 95% CI: 0.72-1.3), PFS (HR 0.83, 95% CI: 0.51-1.4), and ORR (OR 1.3 95% CI: 0.66-2.5) were observed for PD-1 inhibitors + chemotherapy compared with PD-L1 inhibitors + chemotherapy, but the Bayesian ranking revealed that patients receiving PD-1 inhibitors + chemotherapy tended to have longer OS, PFS benefit, and better treatment response than patients receiving PD-L1 inhibitors + chemotherapy. In terms of safety, no significant difference was observed in their safety profiles. CONCLUSION: In comparison to placebo + chemotherapy, PD-L1 inhibitors + chemotherapy and PD-1 inhibitors + chemotherapy significantly improved survival for ES-SCLC. According to the available data, PD-L1 inhibitors + chemotherapy and PD-1 inhibitors + chemotherapy had equivalent efficacy and safety; however, the level of evidence of this type of comparison is limited.

Ratanjot (Alkanna tinctoria L.) Root Extract, Rich in Antioxidants, Exhibits Strong Antimicrobial Activity against Foodborne Pathogens and Is a Potential Food Preservative.

Natural and sustainable plant-based antioxidants and antimicrobials are highly desirable for improving food quality and safety. The present investigation assessed the antimicrobial and antioxidant properties of active components from Alkanna tinctoria L. (herb) roots, also known as Ratanjot root. Two methods were used to extract active components: microwave-assisted hot water (MAHW) and ethanolic extraction. MAHW extract yielded 6.29%, while the ethanol extract yielded 18.27%, suggesting superior Ratanjot root extract powder (RRP) solubility in ethanol over water. The ethanol extract showed significantly higher antioxidant activity than the MAHW extract. Gas Chromatography-Mass Spectrometry analysis revealed three major phenolic compounds: butanoic acid, 3-hydroxy-3-methyl-; arnebin 7, and diisooctyl pthalate. The color attributes (L*, a*, b*, H°ab, C*ab) for the ethanolic and MAHW extracts revealed significant differences (p < 0.05) in all the above parameters for both types of extracts, except for yellowness (b*) and chroma (C*ab) values. The ethanol extract exhibited antimicrobial activity against 14 foodborne bacteria, with a significantly higher inhibitory effect against Gram-positive bacteria (Listeria monocytogenes and Staphylococcus aureus) than the Gram-negative bacteria (Salmonella enterica serovar Typhimurium and Escherichia coli). The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) were both 25 mg/mL for the Gram-negative bacteria, while the MIC and MBC concentrations varied for Gram-positive bacteria (0.049-0.098 mg/mL and 0.098-0.195 mg/mL) and the antimicrobial effect was bactericidal. The antimicrobial activities of RRP extract remained stable under broad temperature (37-100 °C) and pH (2-6) conditions, as well as during refrigerated storage for 30 days. Application of RRP at 1% (10 mg/g) and 2.5% (25 mg/g) levels in a cooked chicken meatball model system prevented lipid oxidation and improved sensory attributes and retarded microbial growth during refrigerated (4 °C) storage for 20 days. Furthermore, the RRP extract was non-toxic when tested with sheep erythrocytes and did not inhibit the growth of probiotics, Lacticaseibacillus casei, and Lactiplantibacillus plantarum. In conclusion, the study suggests that RRP possesses excellent antimicrobial and antioxidant activities, thus making it suitable for food preservation.

Health Technology Assessment of Cardiopulmonary Bypass Circuit with and without Phosphorylcholine Coating: A Retrospective Study on Safety and Efficiency in Cardiac Surgery.

BACKGROUND: Phosphorylcholine has emerged as a potential adjunctive agent in cardiopulmonary bypass (CPB) circuits. Phosphorylcholine serves as a coating for the CPB circuit, potentially enhancing biocompatibility and reducing thrombotic events. However, its impact on specific patient populations and procedural outcomes remains underexplored. MATERIALS AND METHODS: In this retrospective study, we analyzed data from 60 patients who underwent cardiac surgery with CPB, comprising 20 cases each of coronary artery bypass grafting (CABG), mitral valve repair, and aortic valve replacement. The patient cohort was divided into two groups-30 patients whose CPB circuits were coated with phosphorylcholine (phosphorylcholine-coated group) and 30 patients who did not receive phosphorylcholine supplementation or circuit coating. Both groups underwent surgery with identical CPB circuit designs. We assessed the absence of adverse events, safety, and efficacy parameters, including blood loss, clotting, and the structural integrity of the CPB circuit. Additionally, we measured changes in mean albumin levels (g/dL), mean platelet counts (×109/L), and antithrombin III (ATIII) levels before and after CPB. RESULTS: The retrospective analysis revealed an absence of adverse events in both groups. In the phosphorylcholine-coated group compared to the non-phosphorylcholine-coated group, there was a notable difference in the delta change in mean albumin levels (0.87 ± 0.1 vs. 1.65 ± 0.2 g/dL, p-value 0.021), mean platelet counts (42.251 ± 0.121 vs. 54.21 ± 0.194 × 109/L, p-value 0.049), and ATIII levels (16.85 ± 0.2 vs. 31.21 ± 0.3 p-value 0.017). There was a notable reduction in the perioperative consumption of human complex units after CPB (3 vs. 12, p-value 0.019). CONCLUSIONS: Both groups, phosphorylcholine and non-phosphorylcholine, demonstrated the absence of adverse events and that the systems are safe for iatrogenic complication. Our findings suggest that the use of phosphorylcholine coating on the CPB circuit, in the absence of supplementary phosphorylcholine, in cardiac surgery is associated with favorable changes in mean albumin levels, mean platelet counts, and ATIII levels. Further research is warranted to elucidate the full extent of phosphorylcholine's impact on patient outcomes and CPB circuit performance.

Immunosuppressive Induction Therapy Using the Antithymocyteglobulin Grafalon: A Single-Center Non-Interventional Study.

Background: Induction therapy with depleting antibodies in the setting of liver transplantation (LT) is discussed controversially to this day. The rabbit antithymocyteglobulin (ATG) Thymoglobulin (rATG) was introduced as early as 1984 and was frequently used as a standard regime for induction therapy after LT. There are no public reports characterizing Grafalon (ATG-F), a novel ATG, as an induction agent after LT. Objectives: The aim of this observational non-interventional study was to investigate the safety and efficacy of Grafalon induction therapy and characterize its clinical effects in the setting of LT. Methods: A cohort of 80 patients undergoing deceased donor LT at the Medical University of Vienna and receiving Grafalon as part of the clinical standard immunosuppressive regimen was prospectively included between March 2021 and November 2022. Patients were monitored closely for leukocytopenia and thrombocytopenia during the first postoperative week and followed up for incidence and severity of biopsy-proven acute rejection (BPAR), overall survival, and bacterial infections in the first year after LT. Results: The incidences of thrombocytopenia and leukocytopenia following Grafalon treatment peaked on postoperative day four, with 64% and 31%, respectively. However, there were no cases of severe leukocytopenia after the first postoperative week. Induction therapy with Grafalon resulted in a rate of localized bacterial infections and bacteremia of 28% and 21%, respectively. The rate of BPAR was 12.5% in the first year after LT; the one-year survival rate in this cohort was 90%. Conclusions: Overall, this study provides evidence of the safety and efficacy of Grafalon as an induction agent. Further studies investigating the potential long-term effects of Grafalon, as well as comparison studies with different immunosuppressive regimens, are needed in order to draw further conclusions.

Pregnancy Recommendations Solely Based on Preclinical Evidence Should Be Integrated with Real-World Evidence: A Disproportionality Analysis of Certolizumab and Other TNF-Alpha Inhibitors Used in Pregnant Patients with Psoriasis.

Treatment for pregnant women with psoriasis is limited by the lack of information typically related to clinical trials. While anti-tumor necrosis factor (TNF) drugs offer therapeutic benefits, their safety during pregnancy is a concern. Notably, certolizumab is comparatively safer than adalimumab, etanercept, infliximab, and golimumab according to the current recommendations. Thus, this study aimed to conduct a pharmacovigilance comparative analysis of maternal and neonatal outcomes associated with certolizumab versus other anti-TNF drugs by using data from EudraVigilance. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with an anti-TNF drug and related to the pregnant patients with psoriasis from 2009 and 2023, focusing our analysis on the specific pregnancy outcomes and fetal/neonatal disorders. The most common pregnancy-related adverse event was spontaneous abortion, predominantly related to adalimumab and certolizumab. Certolizumab was also reported in cases of caesarean section, gestational diabetes, abortion, fetal death, fetal distress syndrome, pre-eclampsia, and premature separation of placenta. Generally, the findings from our study depicted a safety profile that overlapped for each anti-TNF drug, both in maternal/neonatal outcomes and other adverse events, suggesting no substantial differences between treatments. We advocate for further investigations before making concrete recommendations.

Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 Trial.

BACKGROUND: The recently approved AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) demonstrated high efficacy against RSV-related disease in ≥60-year-olds. METHODS: This ongoing phase 3 study in ≥60-year-olds evaluates immune persistence until 3 years after RSVPreF3 OA vaccination. Here, we describe interim results on humoral and cell-mediated immunogenicity, reactogenicity, and safety until 1 year post-dose 1. RESULTS: In total, 1653 participants were vaccinated. One month post-dose 1, neutralization titers increased 10.5-fold (RSV-A) and 7.8-fold (RSV-B) vs pre-dose 1. Titers then declined to levels 4.4-fold (RSV-A) and 3.5-fold (RSV-B) above pre-dose 1 at month 6 and remained 3.1-fold (RSV-A) and 2.3-fold (RSV-B) above pre-dose 1 levels after 1 year. RSVPreF3-binding immunoglobulin G levels and CD4+ T-cell frequencies showed similar kinetics. Solicited administration-site and systemic adverse events (mostly mild to moderate and transient) were reported by 62.2% and 49.5% of participants. Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related. CONCLUSIONS: One RSVPreF3 OA dose elicited cell-mediated and RSV-A- and RSV-B-specific humoral immune responses that declined over time but remained above pre-dose 1 levels for at least 1 year. The vaccine was well tolerated with an acceptable safety profile. Clinical Trials Registration. NCT04732871 (ClinicalTrials.gov).

Respiratory syncytial virus (RSV) is a major cause of illness and hospitalization in older adults. An RSV vaccine for older adults developed by GSK was recently approved. The vaccine was well tolerated and provided protection against RSV disease in adults aged ≥60 years during at least 1 RSV season. In this ongoing study, we are evaluating the magnitude and durability of the immune response, as well as vaccine safety, until 3 years after vaccination of adults aged ≥60 years from 5 countries. Here, we report the results of an interim analysis until 1 year after vaccination with 1 dose. In total, 1653 participants were vaccinated. We found that the vaccine induced a strong immune response that was evident 1 month after vaccination, after which it declined but persisted for at least 1 year. Study participants most often reported pain at the injection site, muscle pain, tiredness, and headache as adverse reactions, which were mostly mild to moderate and of short duration. One serious adverse reaction was considered related to the vaccine. The long-term immune response that was observed in this study is consistent with the vaccine providing protection during at least 1 RSV season.

Use of Simulation for Improving Quality and Patient Safety.

Healthcare systems have been challenged to reduce errors, improve patient outcomes, and enhance the quality of care provided. Simulation can support patient safety and risk management by improving medical and nursing education, knowledge, skills, and behavior. This engaging experiential teaching method helps healthcare professionals identify and correct potential sources of error in their practice and has also improved safety and clinical outcomes.

Technology-Related Safety Events in Primary and Community Care Settings: A Scoping Review.

This scoping review assesses the current knowledge on technology-related safety events in primary and community care settings, focusing on patient safety and harm. Utilizing Arksey and O'Malley's methodological framework, a comprehensive literature search was conducted across various databases, yielding 17 relevant articles. The review highlighted predominant safety event issues, such as technology limitations, incorrect data, and software malfunctions, and identified essential risk mitigation strategies. Consultation with healthcare leaders reinforced these findings and revealed additional organizational challenges, emphasizing the need for continuous monitoring, reporting, and analyzing of HIT-related safety concerns. The findings suggest that while safety events in non-acute settings share similarities with those in acute care, they require specific attention and further research.