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01.
medRxiv (Medicine) 2026-06-25

Psychometric Evaluation of the Snakebite Severity Score (SSS) in a Multinational Randomized Clinical Trial

Authors:
Perez de Souza↗J. V↗Nkenguye↗Chappell↗Platts-Mills↗T. F↗Nickenig Vissoci↗J. R↗Gerardo↗C. J↗

Background: Snakebite envenomation (SBE) is a World Health Organization recognized neglected tropical disease (NTD) affecting 1.8 million annually. Currently SBE research lacks standardized, patient-centered outcome measures, hindering comparability and clinical relevance. The Snakebite Severity Score (SSS) is a composite endpoint developed to assess symptom severity across multiple body systems. The present study evaluates the psychometric properties of the SSS using data from the BRAVO Phase 2b clinical trial of varespladib-methyl. Methods: A secondary analysis was conducted using data from the BRAVO clinical trial (NCT04996264), a randomized, double-blind, placebo-controlled Phase 2b study evaluating varespladib-methyl. Patients aged [≥]5 years with symptomatic SBE were enrolled from emergency departments in India and the US. The SSS and modified versions (6-item and 3-item) were administered at baseline and at multiple follow-up time points: 3, 6, and 9 hours post-envenomation, and on days 2, 3, 7, 14, and 28. Psychometric analyses included descriptive statistics, intraclass correlation coefficients (ICC) for reliability, principal component analysis (PCA) for internal structure, and correlations with patient-reported outcomes (PSFS, PGIC, NPRS) and clinician-rated CGI-I for external validity. Results: Ninety-five participants were analyzed (varespladib: n=45; placebo: n=50). The 6-item SSS demonstrated strong reliability (ICC = 0.8 at Days 7-14) and consistent internal structure across subscores. PCA confirmed multidimensionality, with distinct contributions from local wound, nervous system, hematological, and other subscales. External validity was supported through moderate to strong correlations with PGIC, NPRS, and CGI-I, particularly for applications capturing symptom variation over time (AUC, mean scores). The 6-item SSS captured symptom severity more robustly than the 3-item version. Conclusion: The SSS is a reliable and valid multidimensional composite endpoint for assessing clinical severity in SBE. Applications that integrate symptom change over time demonstrate better external validity and are preferable. Findings support SSS use in clinical research to standardize and improve outcome assessment in SBE.

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02.
medRxiv (Medicine) 2026-06-18

Evaluating Deep-Learning Based Quantification of Breast Arterial Calcification on Mammography for Cardiovascular Risk Assessment

Authors:
Singh↗Platt↗Bussey↗Heacock↗Verdone↗Chen↗Reynolds↗H. R↗Yu↗Shen↗Bredella↗M. A↗…

Purpose: To develop and evaluate a deep learning model for automated quantification of breast arterial calcification (BAC) on screening mammography and to assess whether AI-derived BAC burden predicts major adverse cardiovascular events (MACE) in women. Methods: In this retrospective study, 202,006 women who underwent screening mammography without history of MACE were included. A BAC segmentation model was trained on an expert-annotated dataset using a multi-task U-Net with a ResNet-18 encoder to detect and segment BAC. BAC burden was quantified as area (mm{superscript 2}) from model-generated masks using DICOM pixel spacing and categorized by tertiles into low, intermediate, and high. The PREVENT score and incident MACE were identified from electronic health records. Cox proportional hazards models were developed to evaluate AI-derived BAC burden and PREVENT score alone, and combined models for 5 - and 10-year cardiovascular risk prediction. Results: Among 202,006 women (mean age 54.8{+/-}11.7 years), 23.1% had AI-detected BAC, and 7,701 (3.8%) developed incident MACE during a median follow - up of 7.5 years. On the geographically held-out test set, the BAC model achieved an AUROC of 0.97, Dice score of 0.6678, and Pearson correlation of 0.961 between AI-derived and manually annotated BAC burden. BAC burden increased with age and was higher among women who developed MACE. Five - year MACE incidence increased across BAC categories from 1.5% in women without BAC to 6.9% in those with high BAC burden. BAC burden alone showed modest prediction of MACE, with 5-year and 10-year AUROCs of 0.661 and 0.650, respectively, while PREVENT achieved AUROCs of 0.781 and 0.771. Adding BAC to PREVENT produced minimal improvement in discrimination. Conclusion: Deep learning-based BAC quantification from routine mammography is feasible, accurate, and associated with future cardiovascular risk. Although BAC added little to PREVENT for overall discrimination, it may serve as a scalable opportunistic imaging biomarker to identify women at elevated cardiovascular risk and support preventive care.

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03.
medRxiv (Medicine) 2026-06-25

Sources and transmission dynamics of Campylobacter and Shigella using culture-independent molecular methods in Tanzania (SCAT): a protocol for a prospective observational cohort study

Authors:
Mbelele↗P. M↗Katengu↗Wettstone↗E. G↗Pholwat↗Elwood↗Ahmed↗Guga↗G. W↗Temu↗Habiye↗…

Introduction: Enteric infections caused by Shigella and Campylobacter species are associated with acute diarrhea as well as enteric dysfunction leading to chronic malnutrition and poor child development. However, interventional studies to reduce exposure to these pathogens have been ineffective, and evidence that identifies putative sources and species transmission dynamics between humans, animals and the environment is scarce. Because isolation of these organisms from both human and environmental samples is challenging, studies using molecular detection may help reduce this substantial knowledge gap and lead to targeted interventions to reduce the burden of disease. Methods and analysis: This longitudinal cohort study will enroll 100 index infants as well as their families in Haydom, Tanzania. Families will be followed for one year, with collection of stool samples monthly and during incident diarrhea from all household members. Additionally, we will sample from the index child's environment, including domestic animal stools, drinking water, milk, porridge, flies, and soil. All samples will undergo nucleic acid extraction and quantitative PCR for Campylobacter and Shigella. Serial serologic tests will also be performed to identify seroconversion to these pathogens. Associations between pathogen detection from the environment and household members and detection in index children will be estimated, and the temporal patterning of infection cases will be analyzed using transmission models. Ethics and dissemination: This trial has been approved by the Tanzanian National Institute for Medical Research and the University of Virginia Institutional Review Board.

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