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Injecting Tighter Regulation: Implications of the TGA's Clampdown on Cosmetic Injectables Advertising.
J Law Med
November 2024
Sydney Health Law, Sydney Law School, University of Sydney.
Recently, the Therapeutic Goods Administration (TGA) updated its guidance on cosmetic injectables advertising. The updates confirm that all direct or indirect advertising of cosmetic injectable products, including botulinum toxins or dermal fillers, is prohibited in Australia. While some commentators have lamented these updates, they present no changes to the law.
View Article and Find Full Text PDFIdentify the underlying true model from other models for clinical practice using model performance measures.
BMC Med Res Methodol
January 2025
School of Mathematical Sciences, Xiamen University, Xiamen, 361005, People's Republic of China.
Objective: To assess whether the outcome generation true model could be identified from other candidate models for clinical practice with current conventional model performance measures considering various simulation scenarios and a CVD risk prediction as exemplar.
Study Design And Setting: Thousands of scenarios of true models were used to simulate clinical data, various candidate models and true models were trained on training datasets and then compared on testing datasets with 25 conventional use model performance measures. This consists of univariate simulation (179.
Overlooked and underpowered: a meta-research addressing sample size in radiomics prediction models for binary outcomes.
Eur Radiol
January 2025
Laboratory of Key Technology and Materials in Minimally Invasive Spine Surgery, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Objectives: To investigate how studies determine the sample size when developing radiomics prediction models for binary outcomes, and whether the sample size meets the estimates obtained by using established criteria.
Methods: We identified radiomics studies that were published from 01 January 2023 to 31 December 2023 in seven leading peer-reviewed radiological journals. We reviewed the sample size justification methods, and actual sample size used.
Prospective validation of ORACLE, a clonal expression biomarker associated with survival of patients with lung adenocarcinoma.
Nat Cancer
January 2025
Cancer Research UK Lung Cancer Centre of Excellence, University College London Cancer Institute, London, UK.
Human tumors are diverse in their natural history and response to treatment, which in part results from genetic and transcriptomic heterogeneity. In clinical practice, single-site needle biopsies are used to sample this diversity, but cancer biomarkers may be confounded by spatiogenomic heterogeneity within individual tumors. Here we investigate clonally expressed genes as a solution to the sampling bias problem by analyzing multiregion whole-exome and RNA sequencing data for 450 tumor regions from 184 patients with lung adenocarcinoma in the TRACERx study.
View Article and Find Full Text PDFAlkaline phosphatase decline and pain response as predictors of overall survival benefit in patients treated with radium-223: a post hoc analysis of the REASSURE study.
Br J Cancer
January 2025
Mayo Clinic, Rochester, MN, USA.
Background: Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (Ra) treatment, but their association with treatment outcomes is unclear.
Methods: For patients with metastatic castration-resistant prostate cancer treated with Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2).
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