Real-world Use Research Articles

Real-World Use of Trazodone in Older Persons in Long Term Care Setting: A Retrospective Study.

Trazodone, an antidepressant drug is also largely used in several medical contexts. Insomnia, behavioral disorders, and anxiety may be underlying symptoms for prescribing trazodone. This cross-sectional study aims to identify reasons for trazodone prescription, assess the efficacy, as well as identify any related side effects in older persons living in long term care facilities (LTCFs). Older adults aged ≥ 60years, at risk of or affected with Covid-19 and enrolled in the GeroCovid Observational study from LTCFs, and using trazodone were included. A structured questionnaire was administered to treating physicians regarding reasons for trazodone prescription, discontinuation, possible adverse events and benefits. Thirty-seven out 74 LTCFs participating in both the GeroCovid and GeroCovid Vax studies completed the questionnaire regarding trazodone use. Of the 427 participants included in this study analysis, we found that 43% had diagnoses of dementia and depression, 33% had dementia, no behavioral and psychological symptoms of dementia (BPSD) and no depression, 14% had dementia with BPSD and no depression, and < 11% had only depression. The main reasons for trazodone prescription included agitation, insomnia, depression and anxiety. Trazodone use was reported as partially or totally effective in more than 90% of participants using the drug. Falls were the most frequent adverse event (30% of participants). Our data suggest that trazodone behaves as an eclectic antidepressant that, in the clinical practice, may also be used for BPSD and insomnia, especially in older people with dementia.

Evaluation of a Novel Mechanical Compression Device.

Venous thromboembolism (VTE) is a leading preventable cause of death in hospitalized patients. Current intermittent pneumatic compression (IPC) devices used to provide external mechanical compression for VTE prevention are associated with a multitude of clinical challenges that often result in subtherapeutic use. A comparative study was conducted of the real-world clinical use of a novel mechanical compression device (MCD) and a current IPC device. The purpose of this quality improvement project was to compare use of the novel MCD and the standard IPC device on three clinical inpatient hospital units. Comparisons were based on the following patient outcome measures: evaluation of wear time, adherence to optimal wear time, evaluation of both patient comfort and device satisfaction, and perceived impact on mobility goals. Nurses' satisfaction with the clinical usability for mobility was also measured. This project used a pre-post design. A convenience sample of 89 surgical patients on the three clinical study units and 63 nursing staff members were recruited for the study. Data were collected using electronic health records, MCD data records, patient surveys, and nursing staff surveys. Data were analyzed using descriptive statistics and independent sample t tests. In the preintervention period, data were collected using the current IPC device. Nursing staff were then trained on use of the MCD. In the postintervention period, the MCDs were used in place of the IPC devices. MCD patients had significantly longer (P ≤ 0.001) wear time (mean, 19.3 hours/day) compared with IPC patients (mean, 12.9 hours/day). MCD patients also reported significantly better sleep (P = 0.04), fewer problems with sweaty legs (P ≤ 0.001), and improved assistance with mobility goals (P ≤ 0.001) than IPC patients. Nursing staff reported significantly improved accuracy of mobility documentation (P ≤ 0.001) with the MCD, but no differences in their perception of patient satisfaction with meeting mobility goals. Use of the MCD device for VTE prophylaxis resulted in actual and perceived improvements from the perspective of both patients and nurses. While these results provide initial data in support of a potentially promising system, more research is needed.

Establishing Medical Intelligence-Leveraging Fast Healthcare Interoperability Resources to Improve Clinical Management: Retrospective Cohort and Clinical Implementation Study.

FHIR (Fast Healthcare Interoperability Resources) has been proposed to enable health data interoperability. So far, its applicability has been demonstrated for selected research projects with limited data. This study aimed to design and implement a conceptual medical intelligence framework to leverage real-world care data for clinical decision-making. A Python package for the use of multimodal FHIR data (FHIRPACK [FHIR Python Analysis Conversion Kit]) was developed and pioneered in 5 real-world clinical use cases, that is, myocardial infarction, stroke, diabetes, sepsis, and prostate cancer. Patients were identified based on the ICD-10 (International Classification of Diseases, Tenth Revision) codes, and outcomes were derived from laboratory tests, prescriptions, procedures, and diagnostic reports. Results were provided as browser-based dashboards. For 2022, a total of 1,302,988 patient encounters were analyzed. (1) Myocardial infarction: in 72.7% (261/359) of cases, medication regimens fulfilled guideline recommendations. (2) Stroke: out of 1277 patients, 165 received thrombolysis and 108 thrombectomy. (3) Diabetes: in 443,866 serum glucose and 16,180 glycated hemoglobin A1c measurements from 35,494 unique patients, the prevalence of dysglycemic findings was 39% (13,887/35,494). Among those with dysglycemia, diagnosis was coded in 44.2% (6138/13,887) of the patients. (4) Sepsis: In 1803 patients, Staphylococcus epidermidis was the primarily isolated pathogen (773/2672, 28.9%) and piperacillin and tazobactam was the primarily prescribed antibiotic (593/1593, 37.2%). (5) PC: out of 54, three patients who received radical prostatectomy were identified as cases with prostate-specific antigen persistence or biochemical recurrence. Leveraging FHIR data through large-scale analytics can enhance health care quality and improve patient outcomes across 5 clinical specialties. We identified (1) patients with sepsis requiring less broad antibiotic therapy, (2) patients with myocardial infarction who could benefit from statin and antiplatelet therapy, (3) patients who had a stroke with longer than recommended times to intervention, (4) patients with hyperglycemia who could benefit from specialist referral, and (5) patients with PC with early increases in cancer markers.

Facile Mechanochemical Functionalization of Hydrophobic Substrates for Single-Walled Carbon Nanotube Based Optical Reporters of Hydrolase Activity.

Single walled carbon nanotubes (SWCNT) have recently been demonstrated as modular, near-infrared (nIR) probes for reporting hydrolase activity; however, these have been limited to naturally amphipathic substrate targets used to noncovalently functionalize the hydrophobic nanoparticles. Many relevant substrate targets are hydrophobic (such as recalcitrant biomass) and pose a challenge for modular functionalization. In this work, a facile mechanochemistry approach was used to couple insoluble substrates, such as lignin, to SWCNT using l-lysine amino acid as a linker and tip sonication as the mechanochemical energy source. The proposed coupling mechanism is ion pairing between the lysine amines and lignin carboxylic acids, as evidenced by FTIR, NMR, SEM, and elemental analyses. The limits of detection for the lignin-lysine-SWCNT (LLS) probe were established using commercial enzymes and found to be 0.25 ppm (volume basis) of the formulated product. Real-world use of the LLS probes was shown by evaluating soil hydrolase activities of soil samples gathered from different corn root proximal locations and soil types. Additionally, the probes were used to determine the effect of storage temperature on the measured enzyme response. The modularity of this mechanochemical functionalization approach is demonstrated with other substrates such as zein and 9-anthracenecarboxylic acid, which further corroborate the mechanochemical mechanism.

Characterization of sedation strategies in real-world use of pulsed field ablation: sub-analysis of the EU-PORIA registry

Abstract Background/Introduction With the introduction of pulsed field ablation (PFA) to treat patients with atrial fibrillation (AF), there has been interest in studying workflow and sedation strategies to better understand how this new technology can be integrated into clinical practice. Purpose Characterize the use of general anesthesia (GA) versus deep sedation during real-world use of the pentaspline PFA catheter to treat AF. Methods EU-PORIA is an all-comer AF registry enrolling consecutive patients treated with the pentaspline PFA catheter at seven high-volume centers in Europe. Patients were treated based on institutional standard of care. During follow-up, any episode of atrial tachycardia (AT) or AF lasting longer than 30 seconds was considered an arrhythmia recurrence. Results EU-PORIA enrolled 1233 patients, of which 250 ablation cases were performed under GA and 983 cases were performed with deep sedation. Six out of the 7 participating centers employed a single sedation strategy (2 GA; 4 deep sedation), with one center doing a mix of both sedation and GA. The patient population treated with GA had fewer female patients (30% vs 40%; p=0.04), a lower prevalence of hypertension (43% vs 57%; p&amp;lt;0.01), and fewer paroxysmal AF patients (54% vs 62%; p&amp;lt;0.01). The ablation strategy was performed based on operator’s discretion. In the GA group, 72% of patients received a pulmonary vein isolation (PVI)-only ablation approach versus 90% of patients in the sedation group (p&amp;lt;0.01). The most common additional lesion set performed was posterior wall isolation which accounted for 23% and 7% of cases in the GA and sedation groups, respectively (p&amp;lt;0.01). Procedure times and fluoroscopy times were significantly shorter in the sedation group versus the GA group (51 [36-84] min vs 75[60-90] min; 13 [8-19] min vs 19 [15-26] min; p&amp;lt;0.01 for both). Mapping was used in 60% of cases in the GA group versus only 26% of cases in the sedation group. Overall, there were no differences in the incidence of serious adverse events, and no difference in chronic treatment success. At 1-year follow-up, 74.8% of patients (187/250) in the GA group and 73.8% of patients (725/983) in the sedation group were free from recurrent AF/AT. Conclusion(s) In this registry, the use of deep sedation for AF ablation with the pentaspline PFA catheter demonstrated a safety and efficacy profile consistent with those procedures performed under GA. The majority of the deep sedation procedures were PVI-only and performed in a less progressed AF disease state. It is worth noting that there may be certain patient populations and center restrictions where GA will remain the necessary approach for AF ablation. This characterization of real-world use warrants further evaluation to understand optimal sedation strategies that can be used with PFA technologies.

ETL vs ELT: Evolving Approaches to Data Integration

This article explores the evolution of data integration approaches, focusing on the transition from Extract, Transform, Load (ETL) to Extract, Load, Transform (ELT) methodologies. It examines the characteristics, advantages, and challenges of both approaches in the context of modern data management requirements. The article discusses the factors driving the shift towards ELT, including cloud adoption, big data growth, real-time analytics demands, and the rise of data lake architectures. Additionally, it presents best practices for implementing ELT, covering areas such as data cataloging, version control, data quality checks, performance optimization, and security compliance. Through analysis of industry trends and real-world use cases, the article provides insights into why organizations are increasingly adopting ELT frameworks and the considerations involved in this transition.

Twelve-Month Real-World Use of an Advanced Hybrid Closed-Loop System Versus Previous Therapy in a Dutch Center For Specialized Type 1 Diabetes Care.

Complexity of glucose regulation in persons with type 1 diabetes (PWDs) necessitates increased automation of insulin delivery (AID). This study aimed to analyze real-world data over 12 months from PWDs who started using the MiniMed 780G (MM780G) advanced hybrid closed-loop (aHCL) AID system at the Diabeter clinic, focusing on glucometrics and clinical outcomes. Persons with type 1 diabetes switching to the MM780G system were included. Clinical data (e.g. HbA1c, previous modality) was collected from Diabeter's electronic health records and glucometrics (time in range [TIR], time in tight range [TITR], time above range [TAR], time below range [TBR], glucose management indicator [GMI]) from CareLink Personal for a 12-month post-initiation period of the MM780G system. Outcomes were age-stratified, and the MM780G system was compared with previous use of older systems (MM640G and MM670G). Longitudinal changes in glucometrics were also evaluated. A total of 481 PWDs were included, with 219 having prior pump/sensor system data and 334 having monthly longitudinal data. After MM780G initiation, HbA1c decreased from 7.6 to 7.1% (P < .0001) and the percentage of PWDs with HbA1c <7% increased from 30% to 50%. Glucose management indicator and TIR remained stable with mean GMI of 6.9% and TIR >70% over 12 months. Age-stratified analysis showed consistent improvements of glycemic control across all age groups, with older participants achieving better outcomes. Participants using recommended system settings achieved better glycemic outcomes, reaching TIR up to 77% and TTIR up to 55%. Use of MM780G system results in significant and sustained glycemic improvements, consistent across age groups and irrespective of previous treatment modalities.

Long-term safety of mepolizumab for up to ∼10 years in patients with severe asthma: open-label extension study

Objectives Long-term safety monitoring of mepolizumab is necessary to support real-world use for the treatment of severe asthma. This Long-Term Access Program assessed the safety and benefit:risk of mepolizumab in pediatric, adolescent, and adult patients with severe asthma. Materials and methods This was a multicenter, Phase IIIb safety, open-label extension study of multiple prior studies assessing mepolizumab in addition to standard of care (Aug 2015 − Aug 2022). Adults/adolescents (≥12 years of age) received mepolizumab 100 mg subcutaneously (SC) every 4 weeks until mepolizumab was commercialized. Pediatric patients (6–11 years of age) received mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) every 4 weeks. Safety was assessed every 4 weeks and benefit:risk every 12 weeks. Results Of the 514 patients enrolled, 57% were female and the mean age was 51.1 (standard deviation: 14.9) years; 24 (5%) patients were 6–17 years of age. Total cumulative mepolizumab exposure across all mepolizumab studies included in this analysis was 1500.59 patient-years; median exposure was 2.03 (range, 0.08 to 9.97) years. Overall, 37 (7%) patients experienced on-treatment serious adverse events (SAEs): 34/502 (7%) in the 100 mg SC group and 3/7 (43%) in the 40 mg SC pediatric group. Two patients experienced SAEs considered to be treatment-related by the investigator. Infections were the most common SAEs of special interest (9 [2%] patients). Physician-assessed benefit:risk of mepolizumab supported continued treatment over the study period. Conclusions This long-term safety analysis of mepolizumab was consistent with previous reports, with no emerging safety concerns; most patients had a favorable benefit:risk up to ∼10 years. Clinical trial identifier NCT00244686 (GSK ID 201956)

Anonymity Unmasked The Role of Cryptocurrencies in Global Money Laundering

This research paper examines the intersection of cryptocurrencies and financial crime, particularly focusing on money laundering. It examines how these digital assets are employed in illicit financial activities, investigates the methodologies used to obscure transaction trails, evaluates regulatory responses to these risks, and presents practical case studies highlighting the real-world criminal use of cryptocurrency. The study, covering data from 2020 to 2024, combines a thorough review of existing literature with empirical analysis of blockchain transactions and case studies. The novelty of this study is the use of blockchain analysis methods for monitoring cryptocurrency transactions in the blockchain and detecting criminal money laundering techniques. It also examines how the criminals use mixers to exponentially expand the transaction trail and hide the money flow. Our analysis reveals that cryptocurrencies are often viewed as tools for anonymity but the underlying technology provides tracking of transactions, albeit with challenges, particularly when advanced techniques such as coin mixers, privacy coins, and decentralized exchanges are used. Case studies, including high-profile hacks, highlight the complexities of tracing illicit funds and challenges faced by law enforcement agencies. Despite efforts by global regulatory bodies, regulations on digital assets vary significantly around the world, allowing criminals to exploit jurisdictions with lax regulations for their illicit activities. The study concludes that cryptocurrencies pose notable risks of money laundering, advancement in digital forensic tools, enhanced regulatory measures, and greater international cooperation are essential to address these risks. This research contributes to the understanding of money laundering through cryptocurrencies and underscores the need for continuous improvement of regulation and technology to ensure finance remains safe in the age of innovation.

Data Analytics to Support Policy Making for Noncommunicable Diseases: Scoping Review.

There is an emerging need for evidence-based approaches harnessing large amounts of health care data and novel technologies (such as artificial intelligence) to optimize public health policy making. The aim of this review was to explore the data analytics tools designed specifically for policy making in noncommunicable diseases (NCDs) and their implementation. A scoping review was conducted after searching the PubMed and IEEE databases for articles published in the last 10 years. Nine articles that presented 7 data analytics tools designed to inform policy making for NCDs were reviewed. The tools incorporated descriptive and predictive analytics. Some tools were designed to include recommendations for decision support, but no pilot studies applying prescriptive analytics have been published. The tools were piloted with various conditions, with cancer being the least studied condition. Implementation of the tools included use cases, pilots, or evaluation workshops that involved policy makers. However, our findings demonstrate very limited real-world use of analytics by policy makers, which is in line with previous studies. Despite the availability of tools designed for different purposes and conditions, data analytics is not widely used to support policy making for NCDs. However, the review demonstrates the value and potential use of data analytics to support policy making. Based on the findings, we make suggestions for researchers developing digital tools to support public health policy making. The findings will also serve as input for the European Union-funded research project ONCODIR developing a policy analytics dashboard for the prevention of colorectal cancer as part of an integrated platform.

Asia-Pacific Real-World Evolocumab Use, LDL-C Reduction, Physician Goals, and Patient Perceptions: HALES Observational Study.

Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia-Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia-Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval. The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2). Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2mmol/L (123.7mg/dL), patients had a median percent change in LDL-C of - 60.8% at 1-6months. Goal achievement increased from 7.9% to 69.8% for < 1.8mmol/L (< 70mg/dL) and 4.4% to 57.8% for < 1.4mmol/L (< 55mg/dL) from baseline to 12months. In the one-time data collection, more patients had ≥ 1.8mmol/L (≥ 70mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk. Real-world, Asia-Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations. Graphical abstract available for this article.·.

Real-world clinical outcomes of tixagevimab/cilgavimab in the Omicron outbreak in China: baseline characteristics and interim analysis of the CLEAR study

PurposeThis study aimed to investigate the real-world use and clinical outcomes of tixagevimab/cilgavimab in China during the Omicron outbreak in late 2022.MethodsThis observational, real-world study included patients who received tixagevimab/cilgavimab from July 9 to December 30, 2022, in Hainan, China. Here, we report the baseline and characteristics and interim analysis results of the clinical outcomes in those receiving at least one dose of tixagevimab/cilgavimab (300 mg) for pre-exposure prophylaxis.ResultsAmong 248 subjects who received tixagevimab/cilgavimab, 229 subjects were included in this analysis. Until March 28, 2023, the median follow-up was 95 days. The mean age of the subjects was 44.4 ± 15.9 years, 11.8% were ≥ 65 years, and 41.5% were male. Fifty-eight (25.3%) subjects had comorbidities, 16.2% subjects had key immune compromised conditions. Seventy-two (32.6%) patients had laboratory-confirmed SARS-CoV-2 infection and/or received healthcare within three months; 71/72 (98.6%) had mild disease, and one (1.4%) was moderate. No COVID-19-related intensive care unit (ICU) admissions, extracorporeal membrane oxygenation utilizations, or death occurred. Two (0.9%) patients required hospitalization. One (0.4%) serious adverse event occurred, which was considered unrelated to tixagevimab/cilgavimab.ConclusionAmong Chinese patients receiving prophylactic tixagevimab/cilgavimab, the incidence of COVID-19-related hospitalization, ICU admission, or death was low during the Omicron surge. Further randomized controlled trials with larger sample sizes are needed to determine the effectiveness of tixagevimab/cilgavimab in preventing severe COVID-19 outcomes.Trial registrationThe study was registered with clinicaltrial.gov (NCT05917951).

Adverse events associated with tezepelumab: a safety analysis of clinical trials and a pharmacovigilance system

ABSTRACT Background Tezepelumab is the first asthma biologic approved by the FDA that is not restricted by biomarker phenotypes. To date, there have been no studies reporting adverse events (AEs) associated with the real-world use of tezepelumab. Research design and methods This study included a comprehensive evaluation of AE reports related to tezepelumab since its approval (4th quarter of 2021 to 1st quarter of 2024) using the FAERS database, and compared with the currently reported clinical trial results (ClinicalTrials.gov). Results A total of 2153 reports of tezepelumab-related AEs were extracted. 256 preferred terms (PTs) of adverse reactions involving 27 system organ classes were identified. Significant AEs that were not reported on the drug label, such as ‘dyspnea,’ ‘body temperature,’ and ‘tongue pruritus,’ were reported. The median time to onset (TTO) of tezepelumab-related AEs was 35 days.The most frequent AEs in different sexes were ‘arthralgia’ and ‘dyspnea,’ with differences in signal strength ranking between the sexes. Conclusions This study represents the largest report to date on tezepelumab-related AEs, providing valuable insights into the potential side effects of tezepelumab. This work is crucial for the broader clinical application of this novel biologic and improving outcomes for patients with severe asthma.

Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019).

Real-world data from multinational observational studies are required to better understand the role and performance of isavuconazole in real-world practice in Europe. A retrospective medical record review was conducted at 16 sites in Europe (France, Germany, Italy, Spain, and the United Kingdom). Eligible records were from patients aged ≥ 18years at the time of isavuconazole initiation and received at least one dose of isavuconazole for suspected or confirmed invasive aspergillosis (IA) or invasive mucormycosis (IM) during the eligibility period (October 15, 2015 to June 30, 2019). Data were descriptively analysed. Success rates, overall survival, and times to these events were descriptively analysed. Data were abstracted from 218 patients (201, IA; 17, IM) who received isavuconazole as monotherapy (initiated as infusion, 52%; oral, 46%). Isavuconazole was initiated as primary therapy in 92 patients (42.2%) and salvage therapy in 121 patients (55.5%) (unknown for five patients). Mean (standard deviation) age was 56.8 (15.6) years, 66% were men and 62% had at least three comorbidities, most frequently haematologic malignancy (62%). Estimated clinical response rate at week 24 was 54.5% (95% confidence interval [CI], 38.2-66.5%) for primary treatment and 73.5% (95% CI, 62.7-81.1%) for salvage therapy. Overall, 45 patients (21%) experienced at least one adverse event (AE). Serious AEs were experienced by 37 patients (17%), with seven related to isavuconazole; five patients (2.3%) discontinued isavuconazole monotherapy due to the serious AE. A total of 137 patients (63%) died, with 17 deaths (12.4%) related to their invasive fungal infection, 11 of whom initiated isavuconazole as salvage therapy. This study adds to the growing body of evidence that whether used as first-line therapy or after the failure of other antifungal therapies, isavuconazole appears to have a promising clinical response and a good safety profile as an antifungal agent in patients with varied underlying conditions.

Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe

Background: Although data on patients treated with pembrolizumab are available from clinical trials and single-country real-world reports, to our knowledge no multi-country real-world studies have investigated the use of pembrolizumab as an adjuvant treatment for stage III melanoma. Methods: We used the European Melanoma Registry (EUMelaReg), a disease entity-based registry specific for melanoma, to examine treatment and outcomes for adult patients with stage III melanoma with lymph node involvement who had complete resection and received adjuvant treatment with pembrolizumab. The primary objectives were to describe the demographic and clinical characteristics of the included patients as well as time on adjuvant pembrolizumab treatment (TOT), real-world recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) from adjuvant pembrolizumab initiation. Secondary objectives were time to next treatment (TTNT) after adjuvant use of pembrolizumab, next-line therapy for stage III and unresectable stage IV melanoma and overall survival (OS) from initiation of pembrolizumab. Results: Patients were stratified according to age, sex, BRAF status, number of positive lymph nodes and disease substage. Median TOT was 11.1 (9.2–11.5) months, median RFS was 29.6 [18.7–not reached (NR)] months and median DMFS was 32.4 (22.7–NR) months. TTNT was 29.9 (22.2–NR) months, while median OS was not reached. Conclusions: The results of this study offer insights into the real-world use of pembrolizumab as an adjuvant therapy for melanoma in Europe.

Predictive biomarkers for low-dose IL-2 therapy efficacy in systemic lupus erythematosus: a clinical analysis

BackgroundLow-dose IL-2 (Ld-IL2) has shown favorable therapeutic effects in systemic lupus erythematosus (SLE) therapy. However, previous clinical trials reported an SLE Responder Index-4 (SRI-4) response rate of 65.52%-68%, with approximately half failing to achieve the primary endpoint by week 24. Our study aims to determine the real-world use of Ld-IL2 and to identify determinants of its effectiveness in SLE.MethodsWe pooled data from 342 SLE patients undergoing sequential Ld-IL2 treatment, with 314 persisting for over 3 months were included in effectiveness and prediction analyses. All patients were categorized into responder (n = 136) and non-responder group (n = 178) according to SRI-4. Lupus Low Disease Activity State (LLDAS) was also analyzed to validate our results.ResultsRash, lower complement 3 (C3), and renal involvement including urine protein, urine occult blood and urine casts emerged as prominent predictors of achieving SRI-4. Adjusting for baseline values using the ratio of change to baseline revealed significant differences in CD4 + T cell immune profiles between responders and non-responders. ROC analysis confirmed a satisfactory performance of rash, renal involvement, percentage change of CD4 + T cells, and C3 in predicting SRI-4, yielding an AUC of 0.933. LLDAS analysis showed that hematological involvements and lower CLA + Treg were potent predictive markers in LLDAS attainment. Conversely, renal involvement failed to have significant association in achieving LLDAS. The analysis of background therapy in SLE patients showed that MMF was more likely to reach the SRI-4 response with the combination of Ld-IL2.ConclusionsThese findings uncovered the predictors of Ld-IL2 treatment efficacy in SLE patients and provided guidance to physicians for rational utilization.

Task-Based Language Teaching: A Systematic Review of Research and Applications

Task-Based Language Teaching (TBLT) has gained widespread recognition as an effective approach in language education, emphasizing meaningful communication and real-world language use. TBLT focuses on learners completing tasks that mirror authentic language use, promoting both linguistic and communicative competence. Despite its popularity, challenges in implementation, teacher training, and resource availability have raised questions about its effectiveness across different educational contexts. This systematic review aims to evaluate the research and applications of TBLT, analyzing its impact on language proficiency, student engagement, and instructional outcomes. The review includes qualitative and quantitative studies from various contexts, ranging from primary to higher education, as well as English as a Foreign Language (EFL) and English as a Second Language (ESL) settings. The findings reveal that TBLT enhances language acquisition, particularly in developing speaking and listening skills, and fosters greater learner autonomy. However, successful implementation requires adequate teacher training and institutional support. Challenges such as curriculum alignment and assessment remain significant obstacles in some educational environments. Despite these issues, TBLT consistently promotes higher levels of student engagement and motivation. In conclusion, TBLT offers considerable benefits for language learning, but its success is highly dependent on contextual factors such as teacher preparedness and curriculum flexibility. Further research is needed to explore long-term outcomes and effective strategies for overcoming implementation barriers.

Real-World Use of Ruxolitinib in Patients With Myelofibrosis and Anemia or Thrombocytopenia at Diagnosis.

Ruxolitinib is approved for treatment of myelofibrosis. We evaluated ruxolitinib in patients with anemia (hemoglobin &lt;10 g/dL) or thrombocytopenia (platelet count ≤100×109/L) at diagnosis. This was a retrospective, secondary analysis of a Cardinal Health Oncology Provider Extended Network medical chart review of adults with myelofibrosis diagnosed between 2012-2016 who received first-line ruxolitinib. 176 patients received first-line ruxolitinib and were included in this analysis. At diagnosis, 120 patients had hemoglobin concentrations &lt;10 g/dL and 59 had a platelet count ≤100×109/L. Most patients (95%) with thrombocytopenia also had anemia. Median time of observation after diagnosis was 21.4 months. Among patients with anemia or thrombocytopenia, ruxolitinib dose at end of study was ≥10 mg twice daily (bid) in 88.3% and 83.1%, respectively. Ruxolitinib treatment was ongoing in 76.1% of patients overall and was rarely discontinued for anemia or thrombocytopenia (n=2 total, 1.1%). Per the treating physician, 79.7% of patients had improved symptoms and 62.7% improved spleen size. Most patients with myelofibrosis and anemia or thrombocytopenia at diagnosis tolerated and maintained a ruxolitinib dose ≥10 mg bid for nearly 2 years, resulting in clinical benefit. This real-world evidence supports observations from prospective clinical trials of ruxolitinib in myelofibrosis.

Operational Google-Earth-Engine Workflow to Monitor Irrigated Areas in a Semi-Arid Climate

Abstract. Sustainable water resources management relies on advanced hydrological models calibrated from long-term satellite observations of water cycles. Monitoring water resources from Earth-observing satellites is enabled by cloud computing environments like Google Earth Engine (GEE) that support easy processing and analysis of archived data. While there are different satellite-based indicators of water resources availability, this paper focuses on mapping irrigated areas for each summer harvest season. The paper presents an automated workflow to extract yearly irrigated areas from imagery made public by Landsat and Sentinel-2. This method uses a normalised difference vegetation index (NDVI) to identify fields that exhibit higher vegetation greenness than their surroundings and are potentially being irrigated. As a first step, Google Earth Engine was used to create a seasonal maximum NDVI composite on which a grid-based thresholding algorithm was applied to identify irrigated areas in different parts of a catchment. The irrigated areas were then refined using morphological image processing and a quality-control step was conducted with ancillary datasets such as the most recent landuse classification, evapotranspiration data and crop phenology information. Finally, real-world use cases are presented to demonstrate the ability of satellite remote sensing to provide critical information on irrigation practices over the last 4 decades at the catchment scale.

Terminology of medicines used to control seizure disorders: 2024 ILAE Recommendations and profile of real-world term use

Background. The International League Against Epilepsy (ILAE) has provided recommendations on the terminology of medicines for control of seizure disorders, which should be adapted into different languages.Objective: to evaluate the usage profile of terms describing the effects of medicines used in patients with epilepsy.Material and methods. The search query analysis systems Google Trends and Yandex Wordstat as well as PubMed/MEDLINE, Google Scholar and eLibrary databases were used to evaluate the general public and professional usage profile, respectively.The following terms in Russian and English were studied: “antiepileptic”, “antiepileptic drug”, “antiseizure”, “antiseizure drug”. In order to ascertain a prevailing opinion within professional and patient communities, a questionnaire survey was conducted on the public online resources of the non-profit partnership “The Association of Epileptologists and Patients” carried out via the cloud-based cross-platform social media as well as instant messaging service Telegram and the social media platform VK.Results. In the English-speaking internet segment, the term “antiepileptic” is used more than 5 times frequently than “antiseizure” by the general public. Conversely, in the Russian-language segment, the term “antiseizure” is almost 2.5 times more common. The term “antiepileptic” is more prevalent in scientific community in both segments. This finding aligns with the profile of terminology usage observed among epileptologists and epilepsy patients. The questionnaire survey results revealed that 56.42% of 179 respondents were in favor of the terms “antiepileptic drug”, “AED” and “antiepileptic therapy”, whereas as few as 17.32% of those endorsed the ILAE-proposed terminology.Conclusion. In light of the established practice of terminology use in both professional scientific community and among practicing epileptologists and epileptic patients, as well as the differences in the semantics of English- and Russian-language terms and the identified lack of precision in the ILAE definition of epilepsy, it can be concluded that for the Russian-speaking population, the terms “antiepileptic drug”, “AED” are more preferable rather than the terms “antiseizure medication”, “ASM”. Additionally, it is preferable to use the terms “convulsive ictus” and “epileptic ictus” due to negative connotation with term “seizure” in Russian. The terms “antiseizure” and “antiepileptic” should not be regarded as mutually exclusive in the context of treatment that has a direct impact on epilepsy course. Finally, it is necessary to further refine epilepsy definition and classification.