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Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency.
Clin Pharmacol Ther
January 2025
Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this.
View Article and Find Full Text PDFFactors Associated with Nonspecialist Quality of Delivery within a Family Strengthening Intervention in Rwanda: a Parallel Latent Growth Model.
Prev Sci
January 2025
Boston College School of Social Work, 140 Commonwealth Ave, Chestnut Hill, Boston, MA, 02467, USA.
In task-shared, mental health, and psychosocial support interventions, monitoring the quality of delivery (fidelity and competence) of nonspecialist providers is critical. Quality of delivery is frequently reported in brief, summary statistics, and while both fidelity and competence scores tend to be high, rarely have factors associated with quality of delivery in low-resource, mental health, and psychosocial support interventions been examined using inferential statistics. Understanding both modifiable and non-modifiable predictors of quality of delivery is important for adapting training and supervision approaches throughout intervention delivery.
View Article and Find Full Text PDFGender Differences in the Association Between Anxiety and Interoceptive Insight.
Eur J Neurosci
January 2025
Translational Neuromodeling Unit, University of Zurich and ETH Zurich, Zurich, Switzerland.
Anxiety is one of the most common and debilitating mental health disorders, and is related to changes in interoception (perception of bodily states). While anxiety is more prevalent in women than men, gender differences in interoception-anxiety associations are often overlooked. Here, we examined gender-specific relationships between anxiety and interoception in the breathing domain, utilising multicentre data pooled from four study sites (N = 175; 51% women).
View Article and Find Full Text PDFUnlabelled: A small behavioral literature on individuals with autism spectrum disorder (ASD) has shown that they can be impaired when navigating using map-based strategies (i.e., memory-guided navigation), but not during visually guided navigation.
View Article and Find Full Text PDFProb-sparse self-attention extraction of time-aligned dynamic functional connectivity for ASD diagnosis.
Heliyon
January 2025
School of Computer Science and Technology, Shandong Technology and Business University, Yantai, China.
Dynamic functional connectivity (DFC) has shown promise in the diagnosis of Autism Spectrum Disorder (ASD). However, extracting highly discriminative information from the complex DFC matrix remains a challenging task. In this paper, we propose an ASD classification framework PSA-FCN which is based on time-aligned DFC and Prob-Sparse Self-Attention to address this problem.
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