Background: For economic models to be considered fit for purpose, it is vital that their outputs can be interpreted with confidence by clinicians, budget holders and other stakeholders. Consequently, thorough validation of models should be carried out to enhance confidence in their predictions. Here, we present results of external dependent and independent validations of the Core Obesity Model (COM), which was developed to assess the cost-effectiveness of weight management interventions.
Objective: The aim was to assess the external validity of the COM (version 6.1), in line with best practice guidance from the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making.
Methods: For validation, suitable sources and outcomes were identified, and used to populate the COM with relevant inputs to allow prediction of study outcomes. Study characteristics were entered into the COM to replicate either the studies used to develop the model (dependent validation) or those not included in the model (independent validation). The concordance between predicted and observed outcomes was then assessed using established statistical methods and generation of mean error estimates.
Results: For most outcomes, the predictions of the COM showed good linear correlation with observed outcomes, as evidenced by the high coefficients of determination (R values). The independent validation revealed a degree of underestimation in predictions of cardiovascular (CV) disease and mortality, and type 2 diabetes.
Conclusion: The predictions generated by the risk equations used in the COM showed good concordance both with the studies used to develop the model and with studies not included in the model. In particular, the concordance observed in the external dependent validation suggests that the COM accurately predicts obesity-related event rates observed in the studies used to develop the model. However, the impact of existing CV risk, as well as mortality, is a key area for future refinement of the COM. Our results should increase confidence in the estimates derived from the COM and reduce uncertainty associated with analyses using this model.
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http://dx.doi.org/10.1007/s40273-020-00941-3 | DOI Listing |
Comput Biol Med
January 2025
Department of Pharmacy and Yonsei Institute of Pharmaceutical Sciences, Yonsei University, Incheon, Republic of Korea; Department of Pharmaceutical Medicine and Regulatory Science, Yonsei University, Incheon, Republic of Korea; Graduate Program of Industrial Pharmaceutical Science, Yonsei University, Incheon, Republic of Korea; Department of Integrative Biotechnology, Yonsei University, Incheon, Republic of Korea. Electronic address:
Background: Erlotinib is a potent first-generation epidermal growth factor receptor tyrosine kinase inhibitor. Due to its proximity to the upper limit of tolerability, dose adjustments are often necessary to manage potential adverse reactions resulting from its pharmacokinetic (PK) variability.
Methods: Population PK studies of erlotinib were identified using PubMed databases.
Comput Biol Med
January 2025
School of Computer Science, Chungbuk National University, Cheongju 28644, Republic of Korea. Electronic address:
The fusion index is a critical metric for quantitatively assessing the transformation of in vitro muscle cells into myotubes in the biological and medical fields. Traditional methods for calculating this index manually involve the labor-intensive counting of numerous muscle cell nuclei in images, which necessitates determining whether each nucleus is located inside or outside the myotubes, leading to significant inter-observer variation. To address these challenges, this study proposes a three-stage process that integrates the strengths of pattern recognition and deep-learning to automatically calculate the fusion index.
View Article and Find Full Text PDFStem Cells
January 2025
Bioengineering Graduate Program, University of Notre Dame, Notre Dame, 46556 IN, USA.
Myocardial infarction can lead to the loss of billions of cardiomyocytes, and while cell-based therapies are an option, immature nature of in vitro-generated human induced pluripotent stem cell (iPSC)-derived cardiomyocytes (iCMs) is a roadblock to their development. Existing iPSC differentiation protocols don't go beyond producing fetal iCMs. Recently, adult extracellular matrix (ECM) was shown to retain tissue memory and have some success driving tissue-specific differentiation in unspecified cells in various organ systems.
View Article and Find Full Text PDFJ Cereb Blood Flow Metab
January 2025
Departments of Neurology and Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, USA.
Therapeutic drug development for central nervous system injuries, such as traumatic brain injury (TBI), presents significant challenges. TBI results in primary mechanical damage followed by secondary injury, leading to cognitive dysfunction and memory loss. Our recent study demonstrated the potential of carbon monoxide-releasing molecules (CORMs) to improve TBI recovery by enhancing neurogenesis.
View Article and Find Full Text PDFInt J Neuropsychopharmacol
January 2025
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, No.1200 Cailun Road, Shanghai 201203, China.
Objective: This study aims to quantitatively evaluate the efficacy and safety of various treatment regimens for treatment-resistant depression (TRD) across oral, intravenous, and intranasal routes to inform clinical guidelines.
Methods: A systematic review identified randomized controlled trials on TRD, with efficacy measured by changes in the Montgomery-Åsberg Depression Rating Scale (MADRS). We developed pharmacodynamic and covariate models for different administration routes, using Monte Carlo simulations to estimate efficacy distribution.
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