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Nevin Manimala Statistics

Five-year outcomes after surgical versus transcatheter aortic valve replacement with new generation devices from the prospective OBSERVANT studies

Cardiovasc Interv Ther. 2025 Jul 8. doi: 10.1007/s12928-025-01155-0. Online ahead of print.

ABSTRACT

The efficacy and durability of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has been demonstrated in randomized studies, but these findings were not confirmed in several observational studies. This is an analysis of 5706 AS patients who underwent SAVR from 2010 and 2012, and 2989 AS patients who underwent TAVR from 2017 and 2018 from the prospective OBSERVANT I and II studies. TAVR procedures were performed with new-generation devices. Five-year all-cause mortality was the primary outcome of this analysis. Propensity score matching yielded 1008 pairs of TAVR and SAVR patients. The mean EuroSCORE II was comparable between the study cohorts (TAVR 4.7 ± 4.0% and SAVR 4.5 ± 5.7%, p = 0.419). At 5 years, TAVR was associated with higher mortality (44.4% vs. 33.2%, HR 1.36, 95%CI 1.18-1.57, Log-rank test p < 0.001), major adverse cardiac and cerebrovascular events (MACCEs) (49.3% vs. 37.9%, HR 1.32, 95%CI 1.15-1.51, Log-rank test p < 0.001), permanent pacemaker implantation (23.1% vs. 9.3%, HR 2.72, 95%CI 2.14-3.45, Log-rank test p < 0.001) and percutaneous coronary intervention rates (3.7% vs. 1.2%, HR 3.44, 95%CI 1.76-6.71, Log-rank test p < 0.001) compared to SAVR. Age ≤ 80 years, male gender, EuroSCORE II ≤ 4.0%, absence of coronary artery disease and absence of diabetes were associated with higher 5-year mortality after TAVR compared to SAVR. TAVR had a significantly higher 5-year mortality than SAVR both in patients with left ventricular ejection fraction ≤ 50% and > 50%. This observational study from prospective data showed that TAVR using new-generation devices was associated with increased rates of all-cause mortality compared to SAVR at 5 years. These findings should be viewed considering the non-randomized nature of this study and may be attributable to the characteristics of patients selected for TAVR, rather than the procedure itself.

PMID:40627314 | DOI:10.1007/s12928-025-01155-0

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Clinical Trial Simulation in Diabetic Retinopathy: Insights from Patients and Site Staff

Ophthalmol Ther. 2025 Jul 8. doi: 10.1007/s40123-025-01164-5. Online ahead of print.

ABSTRACT

INTRODUCTION: High patient burdens from diabetic retinopathy (DR)-associated vision loss and intravitreal therapy (IVT) support patient experience inclusion in DR trial designs. This trial simulation characterized patient and site staff opinions to improve future nonproliferative DR (NPDR) trial designs.

METHODS: Between March 27 and May 31, 2023, survey data were collected from trial simulation participants. After a preread and trial design animation, study features were simulated followed by a 75-90-min web-assisted telephone interview. Patients with NPDR and trial site staff from the United States, United Kingdom, and Germany were included. The likelihood of patient participation and the challenges faced by site staff in conducting the simulated clinical trial at their study site were assessed using a 1-7 scale. Outcomes were evaluated via thematic analysis and descriptive statistics.

RESULTS: Twenty-two patients aged 36-55 years and mostly female (59.1%), and 16 site staff were interviewed. Mean NPDR duration was 9.3 years; most patients (81.8%) had never participated in a clinical trial. Although eligibility criteria resembled other trials, site staff indicated that restrictive exclusion criteria of the trial simulation could limit recruitment and that endpoints did not match patients’ goals, which mainly focused on saving vision. The proposed 4-5-h on-site visits and 72-week trial length were considered “too long” by 45.5% and 50.0% of patients, respectively. For the 1:2 sham or active treatment allocation ratio, responses were 40.9% neutral, 36.4% positive, and 22.7% negative. Some patients misunderstood that sham injections imitate actual injections, expressing concerns about adverse events. Patients reported IVT-related anxieties, particularly IVT-inexperienced patients. Mean patient trial participation interest score was 4.9/7; 62.5% of site staff were interested in conducting the trial. Some proposed adaptations were implemented in the trial protocol (e.g., offering patient/caregiver transportation).

CONCLUSIONS: Insights gained from respondent feedback in this simulation may inform future DR clinical trial design, potentially enhancing recruitment rates and patient experience.

PMID:40627309 | DOI:10.1007/s40123-025-01164-5

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Transitional care after hospitalization for sepsis in Germany- results from the population-based AVENIR cohort study

Infection. 2025 Jul 8. doi: 10.1007/s15010-025-02589-7. Online ahead of print.

ABSTRACT

PURPOSE: Sepsis survivorship is associated with significant long-term morbidity, mortality and health care utilization. Transitional care between inpatient and follow-up care is crucial, but insufficiently understood. We investigated health care utilization in sepsis survivors 90 days post-discharge, comparing translational care during 2016-2019 vs. 2020 in the first year of the pandemic.

METHODS: This retrospective cohort study used nationwide health claims data of the “AOK- die Gesundheitskasse”. Sepsis patients with inpatient treatment in 2016-2019 were identified using explicit ICD-10 codes for sepsis and codes for organ dysfunction. A second sepsis patient cohort was identified in 2020, which included also explicitly defined sepsis patients as well as patients with COVID-19 and Influenza with evidence of organ dysfunction. Among survivors, health care utilization in the 90 days post-discharge was assessed and first health service provider contacts were visualized using Sankey diagrams.

RESULTS: Among 234,874 sepsis survivors in 2016-2019, 94.4% were treated by a general practitioner, 47.7% had ≥ 1 hospital readmission and 42.8% of patients had ≥ 1 emergency treatment 90 days post-sepsis. Nearly all patients had prompt health service provider contacts in that time frame, with physicians in the outpatient sector being the most common first and second health service provider contacts. In the 2020 cohort (n = 69,432 survivors), more patients died without follow-up contact. Additionally, the latency to the first and second health service provider contacts were elevated compared to 2016-2019.

DISCUSSION: Sepsis survivors receive early, high-frequency follow-up care in the inpatient and outpatient sector. This may be an opportunity to implement early screening for sequelae and targeted therapies.

PMID:40627302 | DOI:10.1007/s15010-025-02589-7

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Vision Transformers-Based Deep Feature Generation Framework for Hydatid Cyst Classification in Computed Tomography Images

J Imaging Inform Med. 2025 Jul 8. doi: 10.1007/s10278-025-01602-7. Online ahead of print.

ABSTRACT

Hydatid cysts, caused by Echinococcus granulosus, form progressively enlarging fluid-filled cysts in organs like the liver and lungs, posing significant public health risks through severe complications or death. This study presents a novel deep feature generation framework utilizing vision transformer models (ViT-DFG) to enhance the classification accuracy of hydatid cyst types. The proposed framework consists of four phases: image preprocessing, feature extraction using vision transformer models, feature selection through iterative neighborhood component analysis, and classification, where the performance of the ViT-DFG model was evaluated and compared across different classifiers such as k-nearest neighbor and multi-layer perceptron (MLP). Both methods were evaluated independently to assess classification performance from different approaches. The dataset, comprising five cyst types, was analyzed for both five-class and three-class classification by grouping the cyst types into active, transition, and inactive categories. Experimental results showed that the proposed VIT-DFG method achieves higher accuracy than existing methods. Specifically, the ViT-DFG framework attained an overall classification accuracy of 98.10% for the three-class and 95.12% for the five-class classifications using 5-fold cross-validation. Statistical analysis through one-way analysis of variance (ANOVA), conducted to evaluate significant differences between models, confirmed significant differences between the proposed framework and individual vision transformer models ( p < 0.05 ). These results highlight the effectiveness of combining multiple vision transformer architectures with advanced feature selection techniques in improving classification performance. The findings underscore the ViT-DFG framework’s potential to advance medical image analysis, particularly in hydatid cyst classification, while offering clinical promise through automated diagnostics and improved decision-making.

PMID:40627295 | DOI:10.1007/s10278-025-01602-7

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Noninvasive Multimodal Imaging and Its Role in Diagnosing Skin Lesions in Dermatology: A Systematic Review and Meta-Analysis

Am J Clin Dermatol. 2025 Jul 8. doi: 10.1007/s40257-025-00958-4. Online ahead of print.

ABSTRACT

BACKGROUND: Multimodal noninvasive imaging is a novel technique in dermatology. Its purpose is to overcome the limitations of unimodal techniques. This is done by combining higher resolution images with deeper imaging depth and/or tissue specificity within a single device for improvement of diagnosis and management of skin lesions.

OBJECTIVE: Our aim was to systematically review multimodal imaging devices currently used in dermatology clinics and their diagnostic accuracy of skin lesions.

METHODS: A comprehensive search was conducted in October 2022 for studies on multimodal imaging technologies in vivo, in human subjects, used in dermatology. An additional search was made in March 2024. Four databases were selected: MEDLINE, Embase, CENTRAL, and Web of Science. This review was registered with the international Prospective Register of Systematic Reviews (PROSPERO record number CRD42022364864). The search strategy used Medical Subject Headings (MeSH) and keywords from two concepts: Multimodal Imaging and Dermatological Conditions. Reference lists were also searched for relevant studies. Selected studies included multimodal techniques in neoplastic, inflammatory, and pigmentary skin disorders. Ex vivo imaging, non-human studies, and non-clinical settings were excluded. Data extraction and quality assessment were performed using QUADAS and STARD criteria. Data extraction was conducted by one researcher and then reviewed by an additional researcher. A third researcher resolved any disagreements. The statistical analysis involved diagnostic accuracy meta-analysis, subgroup comparisons (multimodal vs single modal, multimodal vs multimodal), and SROC curves. The primary outcomes were the diagnostic accuracy, sensitivity, and specificity of multimodal imaging devices in diagnosing dermatological conditions.

RESULTS: The analysis included 92 studies, predominantly case reports or series (83.7%), with basal cell carcinoma (BCC) being the most frequently imaged lesion (11.8%). The studies had a moderate risk of bias (QUADAS score: 0.6) with histology as the reference test in most cases. Meta-analysis showed multimodal devices have high sensitivity and specificity for BCC diagnosis. These results indicate reliable diagnostic accuracy.

CONCLUSIONS: In a clinical setting, multimodal imaging can be useful to perform bedside diagnosis and management of skin lesions.

PMID:40627274 | DOI:10.1007/s40257-025-00958-4

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What are the Main Diagnoses in Hospitalized Patients in Madagascar ? A Sentinel Surveillance in 18 Hospitals from 2014 to 2018

J Epidemiol Glob Health. 2025 Jul 8;15(1):95. doi: 10.1007/s44197-025-00392-z.

ABSTRACT

BACKGROUND: In Madagascar, a sentinel surveillance system was set up in 18 hospitals since 2014 and was managed by the Ministry of Public Health and the Institut Pasteur de Madagascar. In order to improve the access to appropriate health care in Madagascar, the main clinical diagnoses in hospitalized patients were analyzed.

METHODS: At hospitalization of a patient, each unit involved in the sentinel surveillance recorded the clinical diagnosis through an e-health platform. Data from September 2014 to July 2018 were analyzed. Morbidity and annual incidence of diseases according to ICD-10 were reported.

RESULTS: A total of 140,789 inpatients information was recorded. The median age was 28.2 years (IQR: 18.3; 45.3). 21.6% of the children < 15 years suffered from communicable diseases. The hospital morbidity was 4.01% for malaria, 0.84% for tuberculosis, 0.09% for HIV/AIDS and 0.05% for plague. The hospital morbidity of non-communicable diseases was higher compared to communicable diseases with 7.8%, 7.1% and 3.1% for “Diseases of the circulatory system”, “Injury, poisoning and certain other consequences of external causes” and “Mental and behavioural disorders”, respectively. “Pregnancy, childbirth and puerperium” represented 20.5% of the hospitalized patients.

CONCLUSIONS: The e-health platform enabled continuous and standardized data collection. Communicable diseases affect mainly children < 15 years. Non-communicable diseases are on the rise and need more attention by national health authorities. A number of hospitalizations could be prevented by a better health care management at the community-based health care level and by implementation of a Universal Health Coverage (UHC) in Madagascar.

PMID:40627272 | DOI:10.1007/s44197-025-00392-z

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S100a8 and s100a9 are elevated in aortic wall from patients with moderate-and-severe obstructive sleep apnea syndrome

Sleep Breath. 2025 Jul 8;29(4):236. doi: 10.1007/s11325-025-03400-5.

ABSTRACT

PURPOSE: Obstructive sleep apnea (OSA) is associated with systemic inflammation and cardiovascular disease, including atherosclerosis. S100A8 and S100A9 are pro-inflammatory proteins involved in atherogenesis, but their expression in the aortic walls of OSA patients remains unknown. This study aimed to determine the relationship between OSA severity and S100A8/S100A9 expression in aortic tissue from patients undergoing coronary artery bypass grafting (CABG).

METHODS: This study included 46 patients who underwent CABG. OSA severity was assessed using the WatchPAT™ home sleep apnea test, classifying patients into control and mild (0 < AHI < 15), and moderate to severe (AHI ≥ 15) OSA groups. Aortic wall samples were collected intraoperatively, and S100A8 and S100A9 expression was evaluated using immunohistochemistry. Statistical analysis compared protein expression across OSA severity groups.

RESULTS: Patients with moderate-to-severe OSA exhibited higher S100A8 and S100A9 expression in aortic tissue compared to control and mild OSA groups. The difference was statistically significant for S100A9 (p < 0.01), while S100A8 showed a non-significant increasing trend (p = 0.073).

CONCLUSION: This study provides novel evidence that S100A8 and S100A9 are overexpressed in the aortic walls of patients with moderate-to-severe OSA. These findings suggest a potential role for these proteins in OSA-related vascular inflammation and atherosclerosis. Further research is needed to explore their potential as biomarkers or therapeutic targets in OSA-related cardiovascular disease.

PMID:40627268 | DOI:10.1007/s11325-025-03400-5

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Pharmacy cost groups for the German morbidity-based risk compensation scheme

Eur J Health Econ. 2025 Jul 8. doi: 10.1007/s10198-025-01809-z. Online ahead of print.

ABSTRACT

INTRODUCTION: To ensure fair competition and prevent risk selection by sickness funds, Germany employs a morbidity-based risk-adjustment scheme, primarily using diagnostic data to record insured persons’ morbidity. However, concerns about the manipulability and quality of diagnostic coding have sparked discussions. This study proposes and evaluates an alternative risk-adjustment model based on pharmaceutical data, assessing its potential as an extension or an alternative to the diagnosis-based status quo.

METHODS: We adapted an existing pharmacy-based model to German conditions and simulated various models. In order to create comparability to the status quo, we constructed a representative sample for the German statutory health insurance (SHI), using claims data of about 4.5 million insured persons. We evaluated the sample by assessing the standardized differences of the weighted means of the relevant covariates. For a quantitative assessment of the models we used the coefficients of determination (R2), Cumming’s Predictive Measure (CPM), and the mean absolute prediction error (MAPE). Under- and overcompensation within different risk groups were also analysed.

RESULTS: The sample closely matched SHI data (overall effect size after matching < 0.0001). Substituting diagnostic data with pharmacy cost groups (PCGs) showed comparable model quality, but worsened under- and overcompensation for groups vulnerable to risk selection. Conversely, integrating PCGs into the status quo improved nearly all performance measures.

CONCLUSION: Introducing pharmacy-based models into the German risk compensation scheme demonstrates significant potential. Extending the current model with PCGs enhances statistical performance, improves morbidity measurement, and offers a viable approach to mitigate coding manipulation incentives.

PMID:40627257 | DOI:10.1007/s10198-025-01809-z

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The Relationship Between Prediabetes and Peripheral Neuropathy-A Systematic Review and Meta-Analysis

Eur J Neurol. 2025 Jul;32(7):e70283. doi: 10.1111/ene.70283.

ABSTRACT

AIMS: The present systematic review and meta-analysis study aimed to investigate the putative relationship between pre-diabetes and neuropathy.

METHODS: Original studies that assessed the association of pre-diabetes patients with neuropathy disorders in humans without setting and country were selected. The methodological quality of the included articles was evaluated using NHLBI quality assessment tools for observational studies. The meta-analysis was conducted using the relevant effect sizes to compare outcomes and the random-effects restricted model. An I2 value > 50% and a p < 0.05 indicated substantial heterogeneity. Galbraith plot is demonstrated for heterogeneity. Egger’s and Begg’s test was used to evaluate publication bias. A non-parametric trim-and-fill analysis of publication bias was used to assess the number of missing studies.

RESULTS: According to the standardized mean difference (SMD) of included articles, there was a statistically significant association between pre-diabetes and the occurrence of peripheral neuropathy in the increasing neuropathy assessment metrics (e.g., Impaired unilateral vibration perception, Neuropathic pain, Sensory nerve dysfunction) 0.23[0.14; 0.33] and in decreasing neuropathy assessment metrics (e.g., corneal nerve fiber density, corneal nerve fiber length, warm threshold, cold threshold) -1.04[-1.05; -0.57].

CONCLUSION: Policymakers should give special attention to preventive strategies and effective lifestyle interventions for these patients to reduce the risk of neuropathy and its consequences.

PMID:40626353 | DOI:10.1111/ene.70283

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Normative study of the Taiwanese version of the Montreal Cognitive Assessment (MoCA) in community-dwelling individuals in Taiwan

J Chin Med Assoc. 2025 Jul 8. doi: 10.1097/JCMA.0000000000001265. Online ahead of print.

ABSTRACT

BACKGROUND: The Montreal Cognitive Assessment (MoCA) may not be appropriately interpreted in Taiwan because of the lack of large-scale normative data. Moreover, examinees’ demographic characteristics may influence their MoCA scores. However, previous studies have not adequately adjusted for these effects. This study aimed to use regression-based methods to establish demographically adjusted MoCA norms.

METHODS: Participants were recruited from six hospitals and neighboring communities from all geographic areas of Taiwan. Multiple regression analyses were conducted to quantify the effects of age, education, and sex on MoCA total and domain scores, resulting in correction equations and adjusted cutoff scores.

RESULTS: A total of 2,310 cognitively healthy participants were included in the analysis. Age and education significantly affected the total and all domain scores. Sex affected naming, language, and abstract thinking domain scores. Correction equations and corresponding cutoffs were proposed for MoCA total and domain scores to support more precise clinical interpretations.

CONCLUSION: This study provides regression-adjusted norms for the MoCA, improving its accuracy and clinical utility in Taiwan. An adjusted total MoCA score of 23 points is recommended as the cutoff for identifying potential cognitive impairment, with domain-specific cutoffs further supporting individualized interpretation.

PMID:40626349 | DOI:10.1097/JCMA.0000000000001265