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TAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator.
Trials
January 2025
Department of Electrical and Computer Engineering, Princeton University, Princeton, 08544, NJ, USA.
Background: Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.
Methods: To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD).
How does BMI correlate with menarche onset? Evidence from the Italian HBSC cross-sectional study.
BMC Womens Health
January 2025
Post Graduate School of Public Health, University of Siena, Siena, 53100, Italy.
Menarche is an important period in a female's life; its time of onset may depend on various factors and could correlate with the development of diseases in adulthood. Our study aims to investigate the relationship between body mass index and age at onset of menarche; METHODS: We used a unique standardized national dataset on adolescent girls participating in the Italian Health Behaviour in School-aged Children Study. Two independent nationally representative survey datasets: one on 15-year-olds (n = 6505, year 2017/2018) and one on 11-year-olds (n = 6548, year 2013/2014) were analysed.
View Article and Find Full Text PDFEffectiveness of rotavirus vaccine following introduction in the childhood immunization program in Northeast India.
Indian J Med Microbiol
January 2025
Department of Microbiology, RIMS, Lamphelpat, Imphal - 795004, Manipur, India. Electronic address:
Background: Rotavirus diarrhoea is a major cause of mortality and morbidity in children under five years of age. The WHO has recommended vaccination against this agent especially in countries with high mortality rates. As India accounts for almost a quarter of worldwide rotaviral diarrhoea cases, the government has introduced indigenously manufactured vaccines in the national immunization schedule which has been implemented in four phases.
View Article and Find Full Text PDFEarly-life Exposure to Tobacco Smoke and the Risk of Idiopathic Pulmonary Fibrosis: A Population-based Cohort Study.
Ann Am Thorac Soc
January 2025
Hangzhou Medical College, Hangzhou, China;
Rationale: Tobacco smoking is a well-established risk factor for idiopathic pulmonary fibrosis (IPF), yet the influence of early-life tobacco exposure on future IPF risk remains poorly understood.
Objectives: To test the hypothesis that early-life tobacco exposure may elevate the risk of developing IPF, with this effect potentially modified by genetic susceptibility to IPF and mediated through accelerated biological aging.
Methods: Using data from over 430,000 participants in the UK Biobank, we performed a prospective cohort study to examine the associations of maternal smoking around birth and age of smoking initiation with IPF risk.
The politicisation of vaccines and its influence on Brazilian caregivers' opinions on childhood routine vaccination.
Cien Saude Colet
January 2025
Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo. São Paulo SP Brasil.
Progressive declines in vaccination coverage have been recorded in Brazil in recent years. The COVID-19 pandemic has introduced even more challenges to this scenario. Considering the pandemic as an event, the scope of this article was to analyze the politicization of vaccines from the perspective of caregivers of young children.
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