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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 PDFFixation for Osteochondral Lesions of the Talus Leads to Successful Clinical Outcomes in 9 out of 10 Patients: a Systematic Review.
J ISAKOS
January 2025
Department of Orthopedic Surgery, Amsterdam Movement Sciences, Amsterdam UMC, Location AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; Academic Center for Evidence based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center, Amsterdam UMC, Amsterdam, The Netherlands. Electronic address:
Importance: Osteochondral lesions of the talus (OLT) with an osteochondral fragment are amendable for fixation. Fixation aims to stabilize the osteochondral fragment while retaining the native cartilage. Though fixation for OLT is a promising treatment, no systematic overview of the literature on its efficacy and safety exists.
View Article and Find Full Text PDFImpact of Fatty Acid Supplementation on Migraine Outcomes: A Systematic Review and Meta-analysis.
Nutr Rev
January 2025
Universidad Europea de Madrid, Department of Physiotherapy, Faculty of Medicine, Health and Sports, 28670 Villaviciosa de odón, Madrid, Spain.
Context: Migraines are a prevalent neurological condition that significantly impacts the quality of life. Although narrative reviews and clinical trials suggest the potential effects of fatty acid supplementation as a promising approach for migraine prophylaxis, the findings remain inconsistent.
Objective: The aim was to evaluate the efficacy of fatty acid supplementation on migraine clinical outcomes through a systematic review and meta-analysis.
The management of postamputation pain remains a significant clinical challenge, with existing therapeutic approaches often yielding inconsistent outcomes. Neuromodulation techniques, particularly peripheral nerve stimulation (PNS), have emerged as promising interventions. However, the evidence supporting their effectiveness in treating phantom limb pain (PLP) and residual limb pain (RLP) remains limited.
View Article and Find Full Text PDFUsing a participatory approach to identify priorities to advance LHS implementation at an academic medical center.
Learn Health Syst
January 2025
Introduction: Like many other academic medical centers, the University of Alabama at Birmingham (UAB) aspires to adopt learning health system (LHS) principles and practices more fully. Applying LHS principles establishes a culture where clinical and operational practices constantly generate questions and leverage information technology (IT) and methodological expertise to facilitate systematic evaluation of care delivery, health outcomes, and the effects of improvement initiatives. Despite the potential benefits, differences in priorities, timelines, and expectations spanning an academic medical center's clinical care, administrative operations, and research arms create barriers to adopting and implementing an LHS.
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