Real-world Clinical Setting Research Articles

DeepMonitoring: a deep learning-based monitoring system for assessing the quality of cornea images captured by smartphones.

Smartphone-based artificial intelligence (AI) diagnostic systems could assist high-risk patients to self-screen for corneal diseases (e.g., keratitis) instead of detecting them in traditional face-to-face medical practices, enabling the patients to proactively identify their own corneal diseases at an early stage. However, AI diagnostic systems have significantly diminished performance in low-quality images which are unavoidable in real-world environments (especially common in patient-recorded images) due to various factors, hindering the implementation of these systems in clinical practice. Here, we construct a deep learning-based image quality monitoring system (DeepMonitoring) not only to discern low-quality cornea images created by smartphones but also to identify the underlying factors contributing to the generation of such low-quality images, which can guide operators to acquire high-quality images in a timely manner. This system performs well across validation, internal, and external testing sets, with AUCs ranging from 0.984 to 0.999. DeepMonitoring holds the potential to filter out low-quality cornea images produced by smartphones, facilitating the application of smartphone-based AI diagnostic systems in real-world clinical settings, especially in the context of self-screening for corneal diseases.

Cardiovascular comorbidities among patients with psoriasis: a national register-based study in China

This study aims to illustrate epidemiology of comorbid CVD in the real-world clinical setting of patients with psoriasis in China. We used data of adult patients with psoriasis who were registered in the register of China National Clinical Center for Skin and Immune Diseases between August 2020 and September 2021. Psoriasis was clinically diagnosed following the national guidelines. Univariate and multivariate logistic regression models were used to examine the factors associated with comorbid CVD in patients with psoriasis. Of the 11,560 psoriasis patients (age ≥ 18 years, mean age 41.87 years, 64.88% males), 236 were ascertained with CVD, with the overall prevalence being 2.62%. Multivariate logistic regression analysis suggested that the odds ratio (95% confidence interval) of CVD in psoriasis patients was 2.27 (2.03–2.54) for older age (per 10-year increment), 0.65 (0.48–0.90) for female, 2.07 (1.39–3.06) for obesity (BMI ≥ 28 vs. < 24 kg/m2), 2.55 (1.85–2.52) for smoking, 7.63 (5.86–9.94) for hypertension, 4.27 (3.76–4.85) for diabetes, 1.14 (1.00–1.30) for having a history of drug allergy, 2.27 (1.61–3.20) for having family history of psoriasis, and 1.76 (1.16–2.67) for severe disease (severe vs. mild) with a dose–response relationship (Ptrend < 0.001). In patients with psoriasis, comorbid CVD was associated with smoking, obesity, hypertension, diabetes, history of drug allergy, family history of psoriasis, and the psoriasis severity.

Barriers and facilitators to screening for intimate partner violence at a level 1 trauma center

BackgroundIntimate partner violence (IPV) is a significant public health problem that is associated with substantial health sequelae, including traumatic injury. Surgical professional societies recommend universal intimate partner violence screening in patients presenting after trauma, but this recommendation is not uniformly implemented. We designed and implemented a quality improvement project at our institution in July 2020 to enhance intimate partner violence screening. Although screening rates improved, they remained suboptimal. Therefore, we sought to examine barriers and facilitators to intimate partner violence screening from trauma clinicians’ perspectives. Study DesignWe conducted a qualitative study using in-depth, semistructured interviews to understand the perspectives and experiences of trauma clinicians conducting intimate partner violence screening. A constructivist paradigm informed our study whereby our data collection approaches aimed to understand intimate partner violence screening from the perspectives of those tasked with implementing screening within real-world clinical settings. We used thematic analysis to analyze our data and generate themes related to barriers and facilitators to screening. ResultsWe conducted interviews with 12 resident physicians and 2 advance practice providers. We identified 6 themes, 3 reflecting facilitator themes as (1) standardized education and workflow, (2) benefits of interdisciplinary teamwork, and (3) context of screening, and 3 reflecting barrier themes as (1) lack of time, (2) language misinterpretation, and (3) perceived inappropriateness of universal screening. ConclusionTrauma clinicians described multiple facilitators and barriers to screening for intimate partner violence following traumatic injury, some of which were unique to the trauma setting. Projects seeking to achieve universal screening following traumatic injury may benefit from accounting for these factors when designing interventions.

Enabling AI in Radiology: Evaluation of an AI Deployment Process.

Artificial intelligence (AI) is expected to transform healthcare systems and make them more sustainable. Despite the increased availability of AI tools for disease detection, evidence of their impact on healthcare organisations and patient care remains limited. Drawing on previous research underscoring the need for comprehensive evaluations of real-world AI deployments, this paper explores the challenges and opportunities encountered while procuring and implementing AI solutions for radiology. The paper aims to contribute to a better understanding of the complexities surrounding AI deployments in real-world clinical settings through a process evaluation study.

Applying the dissemination and implementation sciences to allergy and immunology: A Work Group Report from the AAAAI Quality, Adherence, and Outcomes Committee

Translating evidence-based practice (EBP) into real-world clinical settings often takes a considerable amount of time and resources. In allergy and immunology, the dissemination and implementation (D&I) sciences facilitate the study of how variations in knowledge, resources, patient populations, and staffing models lead to differences in the clinical care of asthma, allergic disease, and primary immunodeficiency. Despite the need for validated approaches to study how to best apply EBP in the real world, the D&I sciences are underutilized. To address this gap, an American Academy of Allergy, Asthma & Immunology (AAAAI) work group was convened to provide an overview for the role of the D&I sciences in clinical care and future research within the field. For the D&I sciences to be leveraged effectively, teams should be multidisciplinary and inclusive of community and clinical partners, and multimethods approaches to data collection and analyses should be used. Used appropriately, the D&I sciences provide important tools to promote EBP and health equity as well as optimization of clinical practice in allergy and immunology.

Early adopters of doxycycline as post-exposure prophylaxis to prevent bacterial sexually transmitted infections in a real-world clinical setting

ObjectivesDoxycycline as post-exposure prophylaxis (DoxyPEP) is a novel prevention approach which has demonstrated efficacy in preventing bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM) and...

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.

The safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture all adverse events (AE). Active pharmacovigilance strategies are essential for detecting and characterising these AE comprehensively. The aim of this study was to identify and characterise active pharmacovigilance strategies used in real-world clinical settings for patients under systemic antiviral agents, focusing on the frequency of AE and the clinical data sources used. We conducted a systematic review by searching three electronic bibliographic databases targeting observational prospective active pharmacovigilance studies, phase IV clinical trials for post-marketing safety surveillance, and interventional studies assessing active pharmacovigilance strategies, focusing on individuals exposed to systemic antiviral agents. We included 36 primary studies, predominantly using Drug Event Monitoring (DEM), with a minority employing sentinel sites and registries. Human immunodeficiency virus (HIV) was the most common condition, with the majority using DEM. Within the DEM, there was a wide range of incidences of patients experiencing at least one AE, and most of these studies used one or two data sources. Sentinel site studies were less common, with two on hepatitis C virus (HCV) and one on HIV, each relying on one or two data sources. The single study using a registry focusing on HIV therapy reported using just one data source. Patient interviews were the most common data source, followed by medical records and laboratory tests. The quality of the studies was considered 'good' in 18/36, 'fair' in 1/36, and 'poor' in 17/36 studies. DEM was the predominant pharmacovigilance strategy, employing multiple data sources, and appears to increase the likelihood of detecting higher AE incidence. Establishing such a framework would facilitate a more detailed and consistent approach across different studies and settings.

Long-term follow-up study on obstructive hypertrophic cardiomyopathy patients treated with disopyramide: evidences of a notable trend in symptom control within a real-world clinical setting.

In obstructive hypertrophic cardiomyopathy (HOCM), disopyramide is used in patients who remain symptomatic despite β-blockers or verapamil. However, effectiveness of disopyramide therapy has not been clearly established due to inconsistent definition of responders and the insufficient length of follow-ups reported in literature. To address these shortcomings, we have conducted a retrospective analysis from detailed databases with long follow-up, from two HCM Referral Centers. 62 symptomatic HOCM patients (43% women, age 52 ± 14 years) with left ventricular (LV) outflow tract gradient (LVOTG) ≥ 50 mmHg at rest or during provocation, were recruited from two Italian Centers. Disopyramide was added as second-line therapy in the patients in whom symptoms persisted despite classic pharmacologic treatment. Patients in NYHA class > II at baseline who reached NYHA class II or I, and patients in NYHA class II at baseline who reached NYHA class I or symptoms stabilization were defined as responders. At follow-up, (mean 4.4 years, IQR 1.1-6.6 years), 47 patients (76%) were responders, whereas 15 (24%) were no-responders. Responders showed larger LV diastolic volume index (LVEDVi) at baseline as compared to no-responders (61 ± 14 vs. 49 ± 16 ml, respectively, p = 0.018), and, at follow-up, reached lower LVOTG than no-responders (43 ± 32 vs. 66 ± 28 mmHg, respectively, p = 0.013), with a LVOTG <50 mmHg more represented in responders than in no-responders (75% vs. 25%, respectively; p = 0.004). No side effects requiring discontinuation of the therapy were recorded. HOCM patients treated with disopyramide as second-line therapy in a quite long-follow-up showed a significant improvement of symptoms, which avoided SRT in up to 70% of them. Moreover, our data suggest that a larger LVEDVi at baseline identify the subgroup of patients who benefit the most from the therapy in terms of symptoms and reduction of LVOTG below 50 mmHg during treatment. We will discuss specific situations where disopyramide may be preferred over myosin inhibition to ensure that effective therapeutic options are fully considered and not prematurely dismissed.

Outcomes and relevance of emergency percutaneous coronary angiography and intervention after resuscitated cardiac arrest: a retrospective study

BackgroundIn patients resuscitated from cardiac arrest and displaying no ST-segment elevation on initial electrocardiogram (ECG), recent randomized trials indicated no benefits from early coronary angiography. How the results of such randomized studies apply to a real-world clinical context remains to be established.MethodsWe retrospectively analyzed a clinical database including all patients 18 yo or older admitted to our tertiary University Hospital from January 2017 to August 2020 after successful resuscitation of out-of-Hospital (OHCA) or In-Hospital (IHCA) cardiac arrest of presumed cardiac origin, and undergoing immediate coronary angiography, regardless of the initial rhythm and post-resuscitation ECG. The primary outcome of the study was survival at day 90 after cardiac arrest. Demographic data, characteristics of cardiac arrest, duration of resuscitation, laboratory values at admission, angiographic data and revascularization status were collected. Comparisons were performed according to the initial ECG (ST-segment elevation or not), and between survivors and non-survivors. Variables associated with the primary outcome were evaluated by univariate and multivariate regression analyses.ResultsWe analyzed 147 patients (130 OHCA and 17 IHCA), including 67 with STEMI and 80 without STEMI (No STEMI). Immediate revascularization was performed in 65/67 (97%) STEMI and 15/80 (19%) no STEMI. Day 90 survival was significantly higher in STEMI (48/67, 72%) than no STEMI (44/80, 55%). In the latter patients, survival was not influenced by the revascularization status. In univariate and multivariate analyses, lower age, a shockable rhythm, shorter durations of no flow and low flow, and a lower initial blood lactate were associated with survival in both STEMI and no STEMI. In contrast, metabolic abnormalities, including lower initial plasma sodium and higher potassium were significantly associated with mortality only in the subgroup of no STEMI patients.ConclusionsOur results, obtained in a real-world clinical setting, indicate that an immediate coronary angiography is not associated with any survival advantage in patients resuscitated from cardiac arrest of presumed cardiac etiology without ST-segment elevation on initial ECG. Furthermore, we found that some early metabolic abnormalities may be associated with mortality in this population, which should deserve further investigation.

Cryoablation versus transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma with lenvatinib from a real-world study.

54 Background: Hepatocellular carcinoma (HCC) is characterized by hypovascularity, the efficacy of transcatheter arterial chemoembolization (TACE) has been suboptimal. This study sought to evaluate and compare the efficacy and safety profiles of cryoablation (CRYO) plus lenvatinib (LEN) against TACE plus LEN for unresectable hepatocellular carcinoma (u-HCC) patients within a real-world clinical practice. Methods: A prospective study was conducted involving 234 patients with u-HCC who underwent treatment with LEN plus either CRYO or TACE at the Fifth Medical Center of the Chinese PLA General Hospital from October 2018 to May 2023. Treatment selection was determined through multidisciplinary discussions among a liver cancer board, weighing the pros and cons. The final decision was made by the patients and clinicians based on consensus. Clinical characteristics were balanced using propensity score matching (PSM). The primary endpoint was overall survival (OS), while secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Tumor response was based on RECIST v1.1 and mRECIST by blinded independent imaging review, AEs by CTCAE v5.0. Results: In this study, 212 (90.6%) were male, with an average age of 56 years. 206 (88%) patients were infected with hepatitis B virus (HBV), and 178 (76.1%) and 77 (32.9%) patients were classified as Child-Pugh A and BCLC B. After PSM, the clinical characteristics were comparable between the CRYO plus LEN and the TACE plus LEN group. Over a median follow-up of 31.8 months, 124 patients (53%) died. The CRYO plus LEN group demonstrated similar OS (24.2 vs. 22.0 months, P = 0.64), PFS (8.7 vs. 11.9 months, P = 0.48), ORR (53.1% vs. 53.1%, P = 1.00), and DCR (86.5% vs. 78.1%, P = 0.19) compared to the TACE plus LEN group after PSM, with consistent results observed before PSM. The two groups exhibited comparable AEs. In addition to similar LEN-related AEs, the most common CRYO-related AEs included 50% elevated ALT, 50% elevated AST, and 38.5% fever, which were consistent with the TACE related AEs. Notably, the incidence of abdominal pain was higher in the TACE plus LEN group compared to the CRYO plus LEN group (7.5% vs. 0.8%, P = 0.021), while pleural effusion was more prevalent in the CRYO plus LEN group than that in the TACE plus LEN group (6.2% vs. 0, P = 0.038). Conclusions: The CRYO plus LEN group exhibited comparable efficacy and well-tolerated safety with TACE plus LEN for u-HCC patients within a real-world clinical setting. It offers a viable alternative for HCC characterized by hypovascularity, presenting a promising therapeutic approach in the clinical management of u-HCC. Clinical trial information: ChiCTR2200058643 .

Factors associated with pathological complete remission after neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a real-world clinical setting.

This study aims to identify factors associated with achieving a pathological complete remission (pCR) in patients with locally advanced rectal cancer (LARC) after neoadjuvant chemoradiotherapy (nCRT). We conducted a cohort analysis of 171 LARC patients who underwent curative resection post-nCRT at the First Affiliated Hospital of Guangxi Medical University between January 2015 and December 2021. The data encompassed clinical and pathological information. Univariate and binary logistic regression multivariate analyses were employed to examine the factors influencing pCR achievement after nCRT. Kappa value tests were utilized to compare clinical staging after nCRT with postoperative pathological staging. Postoperative histopathology revealed that of the 171 patients, 40 (23.4%) achieved TRG 0 grade (pCR group), while 131 (76.6%) did not achieve pCR, comprising 36 TRG1, 42 TRG2, and 53 TRG3 cases. Univariate analysis indicated that younger age (p=0.008), reduced tumor occupation of intestinal circumference (p =0.008), specific pathological types (p=0.011), and lower pre-nCRT CEA levels (p=0.003) correlated with pCR attainment. Multivariate analysis identified these factors as independent predictors of pCR: younger age (OR=0.946, p=0.004), smaller tumor occupation of intestinal circumference (OR=2.809, p=0.046), non-mucinous adenocarcinoma pathological type (OR=10.405, p=0.029), and lower pre-nCRT serum CEA levels (OR=2.463, p=0.031). Clinical re-staging post-nCRT compared to postoperative pathological staging showed inconsistent MRI T staging (Kappa=0.012, p=0.718, consistency rate: 35.1%) and marginally consistent MRI N staging (Kappa=0.205, p=0.001, consistency rate: 59.6%). LARC patients with younger age, presenting with smaller tumor circumferences in the intestinal lumen, lower pre-nCRT serum CEA levels, and non-mucinous adenocarcinoma are more likely to achieve pCR after nCRT. The study highlights the need for improved accuracy in clinical re-staging assessments after nCRT in LARC.

Predicting Heart Failure Survival with Machine Learning: Assessing My Risk

This study investigates the application of machine learning techniques for heart disease prediction using a comprehensive dataset of 918 patients. The research employs multiple algorithms, including Logistic Regression, Random Forest, Support Vector Machine (SVM), and Neural Networks, to develop predictive models based on 11 clinical features. The dataset, compiled from five independent sources, underwent thorough preprocessing and was split into training (70%) and test (30%) sets. Model performance was evaluated using accuracy, precision, recall, F1-score, and ROC-AUC metrics. Results demonstrate consistently high performance across all models, with the SVM achieving the highest overall performance (accuracy: 88.41%, precision: 89.76%, recall: 90.85%, F1-score: 90.30%, ROC-AUC: 94.97%). Key predictors identified include age, maximum heart rate, and ST depression (Oldpeak). The study's findings have significant implications for clinical practice, offering the potential for rapid, objective heart disease risk assessment. The consistent performance across different model architectures provides flexibility for implementation in various healthcare settings. Limitations include potential data collection variability and gender imbalance in the dataset. Future research directions include developing more sophisticated neural networks, incorporating additional data types, and conducting prospective studies to validate model performance in real-world clinical settings. This research contributes to the growing body of evidence supporting the use of machine learning in medical diagnostics. The developed models enhance early detection and risk stratification of heart disease, potentially improving patient outcomes through timely interventions.

Efficacy and Safety of Escalating the Dose of Oral Semaglutide from 7 to 14mg: A Single-Center, Retrospective Observational Study.

The efficacy and safety of oral semaglutide, the first glucagon-like peptide1 receptor agonist available in tablet form for the treatment of type2 diabetes, were established in the phase3a PIONEER program. However, evidence regarding the titration of oral semaglutide in real-world clinical settings remains insufficient. This study aimed to elucidate the therapeutic advantages of escalating the dose of oral semaglutide from 7 to 14mg through clinical data analysis. This retrospective observational study was conducted at a single center in Japan, focusing on adults with type2 diabetes who were initiated on 14mg oral semaglutide. The primary endpoint was the alteration in HbA1c levels 24weeks after the initial prescription of 14mg oral semaglutide. Secondary endpoints included changes in metabolic parameters and the incidence of adverse events. Data from 66 patients who met the inclusion criteria were analyzed. The mean change in HbA1c levels from baseline to 24weeks following dose escalation was - 0.5 ± 0.8% [from 7.4 ± 1.0% at baseline to 7.0 ± 0.9% at 24weeks (p < 0.01)]. Moreover, a significant reduction in body weight of - 2.0 ± 4.4kg was observed at 24weeks [from 90.0 ± 20.5kg at baseline to 88.2 ± 21.4kg at 24weeks (p < 0.01)], with 41% of patients achieving at least a 3% reduction compared to baseline. Gastrointestinal disorders emerged as the most prevalent adverse event (10.6%), particularly nausea (7.6%), although predominantly of mild or moderate severity, with no instances of serious adverse events necessitating drug discontinuation. Escalating the dose of oral semaglutide to 14mg could be an effective approach for enhancing glycemic control and managing body weight in individuals with type2 diabetes.

Development of thresholds and a visualization tool for use of a blood test in routine clinical dementia practice.

We developed a multimarker blood test result interpretation tool for the clinical dementia practice, including phosphorylated (P-)tau181, amyloid-beta (Abeta)42/40, glial fibrillary acidic protein (GFAP), and neurofilament light (NfL). We measured the plasma biomarkers with Simoa (n=1199), applied LASSO regression for biomarker selection and receiver operating characteristics (ROC) analyses to determine diagnostic accuracy. We validated our findings in two independent cohorts and constructed a visualization approach. P-tau181, GFAP, and NfL were selected. This combination had area under the curve (AUC)=83% to identify amyloid positivity in pre-dementia stages, AUC=87%-89% to differentiate Alzheimer's or controls from frontotemporal dementia, AUC=74%-76% to differentiate Alzheimer's or controls from dementia with Lewy bodies. Highly reproducible AUCs were obtained in independent cohorts. The resulting visualization tool includes UpSet plots to visualize the stand-alone biomarker results and density plots to visualize the biomarker results combined. Our multimarker blood test interpretation tool is ready for testing in real-world clinical dementia settings. We developed a multimarker blood test interpretation tool for clinical dementia practice. Our interpretation tool includes plasma biomarkers P-tau, GFAP, and NfL. Our tool is particularly useful for Alzheimer's and frontotemporal dementia diagnosis.

Precision Antiplatelet Therapy after Percutaneous Coronary Intervention (Precision PCI) Registry - Informing optimal antiplatelet strategies.

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor (clopidogrel, prasugrel, or ticagrelor) is indicated after percutaneous coronary intervention (PCI) to reduce the risk of atherothrombotic events. Approximately 30% of the US population has a CYP2C19 no-function allele that reduces the effectiveness of clopidogrel, but not prasugrel or ticagrelor, after PCI. We have shown improved outcomes with the integration of CYP2C19 genotyping into clinical care to guide the selection of prasugrel or ticagrelor in CYP2C19 no-function allele carriers. However, the influence of patient-specific demographic, clinical, and other genetic factors on outcomes with genotype-guided DAPT has not been defined. In addition, the impact of genotype-guided de-escalation from prasugrel or ticagrelor to clopidogrel in patients without a CYP2C19 no-function allele has not been investigated in a diverse, real-world clinical setting. The Precision Antiplatelet Therapy after Percutaneous Coronary Intervention (Precision PCI) Registry is a multicenter US registry of patients who underwent PCI and clinical CYP2C19 testing. The registry is enrolling a diverse population, assessing atherothrombotic and bleeding events over 12 months, collecting DNA samples, and conducting platelet function testing in a subset of patients. The registry aims to define the influence of African ancestry and other patient-specific factors on clinical outcomes with CYP2C19-guided DAPT, evaluate the safety and effectiveness of CYP2C19-guided DAPT de-escalation following PCI in a real-world setting, and identify additional genetic influences of clopidogrel response after PCI, with the ultimate goal of establishing optimal strategies for individualized antiplatelet therapy that improves outcomes in a diverse, real-world population.

Clinical utility of diffusion MRI-derived measures of cortical microstructure in a real-world memory clinic setting.

To investigate cortical microstructural measures from diffusion MRI as "neurodegeneration" markers that could improve prognostic accuracy in mild cognitive impairment (MCI). The prognostic power of Amyloid/Tau/Neurodegeneration (ATN) biomarkers to predict progression from MCI to AD or non-AD dementia was investigated. Ninety patients underwent clinical evaluation (follow-up interval 32 ± 18 months), lumbar puncture, and MRI. Participants were grouped by clinical stage and cerebrospinal fluid Amyloid and Tau status. T1-structural and diffusion MRI scans were analyzed to calculate diffusion metrics related to cortical columnar structure (AngleR, ParlPD, PerpPD+), cortical mean diffusivity, and fractional anisotropy. Statistical tests were corrected for multiple comparisons. Prognostic power was assessed using receiver operating characteristic (ROC) analysis and related indices. A progressive increase of whole-brain cortical diffusion values was observed along the AD continuum, with all A+ groups showing significantly higher AngleR than A-T-. Investigating clinical progression to dementia, the AT biomarkers together showed good positive predictive value (with 90.91% of MCI A+T+ converting to dementia) but poor negative predictive value (with 40% of MCI A-T- progressing to a mix of AD and non-AD dementias). Adding whole-brain AngleR as an N marker, produced good differentiation between stable and converting MCI A-T- patients (0.8 area under ROC curve) and substantially improved negative predictive value (+21.25%). Results support the clinical utility of cortical microstructure to aid prognosis, especially in A-T- patients. Further work will investigate other complexities of the real-world clinical setting, including A-T+ groups. Diffusion MRI measures of neurodegeneration may complement fluid AT markers to support clinical decision-making.

Robotic urologic applications of the hinotori™ Surgical Robot System

ObjectiveTo assess the safety and effectiveness of urological tumor surgeries using the hinotori™ Surgical Robot System (hinotori) in a real-world clinical setting. MethodsAll surgeries including procedures of robot-assisted radical prostatectomy (RARP), robot-assisted partial nephrectomy (RAPN), robot-assisted radical nephrectomy (RARN), robot-assisted nephroureterectomy (RANU), robot-assisted adrenalectomy (RAA), and robot-assisted radical cystectomy with intracorporeal urinary diversion (RARC+ICUD) for urological tumors with hinotori and da Vinci surgical system (da Vinci) from January 2022 through September 2023 were enrolled. We evaluated the safety and effectiveness of surgery using hinotori compared using da Vinci. ResultsRobotic surgeries using hinotori were performed in a total of 91 cases, comprising 42 cases of RARP, 18 cases of RAPN, six cases of RARN, 10 cases of RANU, 13 cases of RAA, and two cases of RARC+ICUD. No major intraoperative complications were observed in any cases using hinotori. No major postoperative complications occurred in any of the cases. No case experienced unrecoverable equipment error during surgery. Meanwhile, robotic surgeries using da Vinci were performed in a total of 277 cases that included 126 cases of RARP, 94 cases of RAPN, 12 cases of RARN, 10 cases of RANU, 20 cases of RAA and 15 cases of RARC+ICUD. Major intraoperative complications occurred two cases. Major postoperative complications occurred in seven cases. Seven cases required transfusion. One case underwent conversion to open surgery. During the study period, no case experienced an unrecoverable equipment error. Surgical outcomes for cases with hinotori were comparable to those with da Vinci. ConclusionsThis study demonstrated that hinotori is a safe and feasible tool for robotic surgeries in the field of urology.

Identifying digital biomarkers of illness activity and treatment response in bipolar disorder with a novel wearable device (TIMEBASE): protocol for a pragmatic observational clinical study.

Bipolar disorder is highly prevalent and consists of biphasic recurrent mood episodes of mania and depression, which translate into altered mood, sleep and activity alongside their physiological expressions. The IdenTifying dIgital bioMarkers of illnEss activity and treatment response in BipolAr diSordEr with a novel wearable device (TIMEBASE) project aims to identify digital biomarkers of illness activity and treatment response in bipolar disorder. We designed a longitudinal observational study including 84 individuals. Group A comprises people with acute episode of mania (n = 12), depression (n = 12 with bipolar disorder and n = 12 with major depressive disorder (MDD)) and bipolar disorder with mixed features (n = 12). Physiological data will be recorded during 48 h with a research-grade wearable (Empatica E4) across four consecutive time points (acute, response, remission and episode recovery). Group B comprises 12 people with euthymic bipolar disorder and 12 with MDD, and group C comprises 12 healthy controls who will be recorded cross-sectionally. Psychopathological symptoms, disease severity, functioning and physical activity will be assessed with standardised psychometric scales. Physiological data will include acceleration, temperature, blood volume pulse, heart rate and electrodermal activity. Machine learning models will be developed to link physiological data to illness activity and treatment response. Generalisation performance will be tested in data from unseen patients. Recruitment is ongoing. This project should contribute to understanding the pathophysiology of affective disorders. The potential digital biomarkers of illness activity and treatment response in bipolar disorder could be implemented in a real-world clinical setting for clinical monitoring and identification of prodromal symptoms. This would allow early intervention and prevention of affective relapses, as well as personalisation of treatment.

Lymphoma-associated hemophagocytic syndrome: a retrospective, single-center study of 86 patients.

To explore the clinical features, treatment, and prognosis of patients with lymphoma-associated hemophagocytic syndrome (LAHS) in a real-world clinical setting. We retrospectively examined LAHS patients diagnosed at our center between January 2016 and August 2023, focusing primarily on their clinical features, therapeutic approaches, overall response rate (ORR), and overall survival (OS). A combination of univariate and multivariate analyses was conducted to identify potential prognostic factors. A total of 86 patients diagnosed with LAHS were included to evaluate clinical characteristics and prognostic factors. Patients with T/NK cell lymphoma had a higher probability of developing hemophagocytic syndrome (HPS) during the clinical process than those with B cell lymphoma. The median survival time was 55 days for all patients, and 47 and 81 days for the T/NK cell LAHS and B cell LAHS cohorts, respectively (P = 0.025). Among the patients evaluated, the ORR was 42.2%. Patients starting with anti-lymphoma treatment had a better, albeit not significant, ORR than those beginning with anti-HPS treatment. In the univariate analysis, T/NK cell LAHS (P = 0.027), HPS onset at relapse (P = 0.036), higher baseline plasma EBV-DNA levels (> 4,000 copies/mL, P = 0.034), and treatments including cytokine adsorption and ruxolitinib (P < 0.001 and P = 0.017, respectively) were potentially associated with worse OS, while corticosteroid therapy benefited OS. In the multivariate analysis, T/NK cell LAHS (adjusted hazard ratio (aHR) = 2.007), cytokine adsorption therapy (aHR = 4.547), and corticosteroid therapy (aHR = 0.118) were independently associated with mortality. T/NK cell lymphoma was the main cause of LAHS and carried a worse prognosis. Whether anti-lymphoma or anti-HPS treatment should start first still requires prospective studies with larger sample sizes. The key point in controlling HPS is to block the cytokine storm promptly. Corticosteroid therapy is both effective and accessible and should be used early and in sufficient quantities.

One-year Efficacy and Safety of Dulaglutide in Patients with Type 2 Diabetes and Chronic Kidney Disease: A Retrospective Study of Asian Patients

PurposeDulaglutide is a long-acting glucagon-like peptide-1 receptor agonist that is not cleared by the kidneys and has proven efficacy and safety in patients with diabetic kidney disease. We aimed to evaluate the 1-year efficacy of dulaglutide in patients with diabetic kidney disease who have used the drug for more than 1 year. MethodsThis retrospective, observational study comprised 131 patients with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2 who had received dulaglutide for more than one year between June 2016 and May 2023. The primary outcome measures were changes in glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and body weight from baseline to the 12-month follow-up, with assessments performed at six-month intervals. Subgroup analyses were conducted based on age, sex, baseline body mass index, FPG, and HbA1c, and insulin administration at baseline and last follow-up. FindingsThe mean age was 60.0 ± 10.2 years, and 61.1% of the participants were males. Baseline HbA1c, FPG, and body weight were 9.1% (76.0 mmol/mol), 186.8 mg/dL, and 79.3 kg, respectively. Dulaglutide significantly reduced HbA1c, FPG, and body weight from baseline to the 12-month follow-up (mean ± standard error: –1.2 ± 0.1%, –34.8 ± 6.9 mg/dL, and –2.3 ± 0.5 kg, respectively; P < 0.001). Subgroup analysis revealed significant differences in HbA1c reduction based on baseline HbA1c. ImplicationsDulaglutide exhibited sustained glucose-lowering and weight-reduction effects during the initial 1 year of treatment in patients with diabetic kidney disease. Altogether, dulaglutide could serve as a favorable long-term therapeutic option for patients with diabetic kidney disease in real-world clinical settings.