The Pivot Mandu is an innovative device featuring a leak-tight adjustable 3D balloon spacer, incorporating inner mesh support, an outer e-PTFE layer, and a compliant balloon in the middle layer with a specialized detachable system. To assess its feasibility, proof of concept was rigorously evaluated through bench testing and survival porcine animal experiments. The results demonstrated successful remote inflation of the balloon system, with the balloon spacer exhibiting sustained patent and functional integrity over an extended observation period of up to 6 months. A noteworthy feature of the newly designed 3D balloon spacer is its capability for easy size adjustment during procedures, enhancing its adaptability and practicality in clinical settings. This three-layered 3D balloon spacer, with its established long-term patency, exhibits highly encouraging outcomes that hold promise in overcoming the current limitations of spacer devices for heart valve diseases. Given the compelling results from preclinical investigations, the translation of the Pivot Mandu into human trials is strongly warranted.
High temperatures accelerate bolting and shorten the vegetative phase, thereby reducing the marketable yield in lettuce(Lactuca sativa L.). Using the KNOU lettuce core collection (KLC; n = 288), which represents major horticultural types, we integrated genome-wide association studies (GWAS) with genotyping-by-target-sequencing (GBTS), a multiplex target amplicon sequencing approach, to develop compact SNP marker panels for breeding-relevant prediction of reproductive timing. The KLC was genotyped via genotyping-by-sequencing (GBS; 97,528 SNPs) and phenotyped across two spring-to-summer seasons to analyze cumulative temperature to bolting (CTTB) and cumulative temperature to anthesis (CTTA) under protected cultivation conditions, revealing broad variation and high heritability (H = 0.79 and 0.74, respectively). Multi-model GWAS consistently identified a major hotspot on chromosome 7 for both traits, whereas additional loci showed trait- and year-specific effects. A lead SNP on chromosome 7 was validated by KASP, confirming a consistent allelic effect across genetic backgrounds. GWAS-supported loci were converted into compact GBTS panels (CTTB-only, CTTA-only, and pooled), and their ability to predict genomic estimated breeding values (GEBVs) was evaluated via repeated 5-fold cross-validation. The pooled panel achieved the highest predictive performance for CTTB (up to R2 = 0.41 with random forest and R2 = 0.37 with RR-BLUP), outperforming the CTTB-only panel. In contrast, CTTA prediction was more moderate (up to R2 = 0.32). Overall, this GWAS-to-GBTS panel strategy provides a practical basis for low-cost, early selection of reproductive timing in lettuce breeding.
Background: Understanding physical activity (PA) patterns in older adults is crucial for effectively promoting adherence to PA guidelines. However, measuring PA can be challenging because it involves a balance between ease of administration and accuracy of data collection. The primary objective of this study was to analyze PA levels in older Korean adults using both self-reported and objective accelerometer measures, and the secondary objective was to investigate the factors associated with adherence to PA guidelines. Methods: Using data from the Korea National Health and Nutrition Examination Survey (KNHANES VII-2) 2017, we assessed 425 older adults who provided both self-reported and accelerometer data. Adherence to PA guidelines was evaluated using two different thresholds for the accelerometer data, each applied both strictly and with a tolerance of one to two minutes when defining a 10-minute bout. Results: Self-reported data indicated a 34% adherence rate, whereas accelerometer-based rates ranged from 16% to 62.8%, depending on the cutoff values and tolerance settings. Bland-Altman analyses demonstrated notable differences between subjective and objective measurements. In terms of correlates, the questionnaire data highlighted factors such as education and household income, whereas the accelerometer-based findings emphasized sex, age, hypertriglyceridemia, and low high-density lipoprotein cholesterol. Conclusions: This study revealed substantial discrepancies in both moderate-to-vigorous PA adherence estimates and significant predictors when comparing self-reported surveys to accelerometer data among older adults. For estimating population-level adherence, in the absence of accelerometer cutoff values established by a specialized lab, both self-reported data and accelerometer measurements offer unique insights. Meanwhile, when analyzing the factors influencing PA adherence, accelerometer data may be preferable, as subjective biases in self-report can affect the observed correlates in statistical results.
1 August 2025 in Journal of Mechanical Science and Technology
Null hypothesis significance testing (NHST) in medical research is increasingly being supplemented by estimation statistics, focusing on effect sizes (ESs) and confidence intervals (CIs). This study evaluates the expression of ESs and CIs for binary outcomes. A utilitarian framework is proposed, emphasizing the number of beneficiaries and the impact level. To evaluate clinical significance, minimal clinically important risk difference (MCIRD) is proposed based on event magnitude (EM). Within this framework, risk difference (RD) is introduced as the primary measure. To assess the performance of RD, we compared its statistical power against other measures (risk ratio, RR; odds ratio, OR; Cohen’s h) in individual study scenarios, and visual information conveyance in meta-analysis scenarios. RDs maintain statistical power in comparison to other measures in individual studies. They provide clarity on the true impact of clinical interventions without compromising statistical integrity. Meta-analytic results indicate that using RDs directly enhances transparency, uncovers heterogeneity, and addresses misaligned assumptions. This approach, by quantifying clinical effectiveness under a utilitarian perspective, facilitates the applicability of research to patient care and encourages shared decision-making. The study advocates for reporting baseline risks (BRs) with RDs and recommends a standardized presentation of these statistics. In a utilitarian perspective, adopting RD as the preferred ES can foster a transparent, patient-focused research ethos. This aids in accurately presenting the magnitude and variability of treatment effects, offering a new direction in methodology.
17 July 2026 in Journal of Biopharmaceutical Statistics
1. In clinical trial design, sample size determination (SSD) plays a critical role, as it directly impacts both cost and statistical power to detect treatment effects. An appropriate sample size en...