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This article introduces randomized clinical trials and basic concepts of statistical inference. We present methods for calculating the sample size by outcome type and the hypothesis to be tested, together with the code in the R programming language. We describe four methods for adjusting the original sample size for interim analyses. We sought to introduce these topics in a simple and concrete way, considering the mathematical expressions that support the results and their implementation in available statistical programs; therefore, bringing health students closer to statistics and the use of statistical programs, which are aspects that are rarely considered during their training.
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http://dx.doi.org/10.17843/rpmesp.2023.402.12217 | DOI Listing |
JMIR Biomed Eng
August 2025
Cardiovascular Center and Divisions of Cardiology and Hospital Medicine, Department of Internal Medicine, National Taiwan University Hospital, No.7, Chung Shan S Rd, Taipei, 100225, Taiwan, 886 2-2312-3456.
Background: Photoplethysmography (PPG) signals captured by wearable devices can provide vascular age information and support pervasive and long-term monitoring of personal health condition.
Objective: In this study, we aimed to estimate brachial-ankle pulse wave velocity (baPWV) from wrist PPG and electrocardiography (ECG) from smartwatch.
Methods: A total of 914 wrist PPG and ECG sequences and 278 baPWV measurements were collected via the smartwatch from 80 men and 82 women with average age of 63.
Stroke
September 2025
Department of Neurology, Yale School of Medicine, New Haven, CT (L.H.S.).
Preclinical stroke research faces a critical translational gap, with animal studies failing to reliably predict clinical efficacy. To address this, the field is moving toward rigorous, multicenter preclinical randomized controlled trials (mpRCTs) that mimic phase 3 clinical trials in several key components. This collective statement, derived from experts involved in mpRCTs, outlines considerations for designing and executing such trials.
View Article and Find Full Text PDFCirc Cardiovasc Interv
September 2025
Keele Cardiovascular Research Group, Keele University, United Kingdom (M.A.M., R.B.).
Background: Evidence informing clinical guidelines assumes that all transcatheter aortic valve implantation (TAVI) devices have similar effectiveness, in other words, displaying a class effect across TAVI valves. We aimed to assess the comparative effectiveness of different TAVI platforms relative to other TAVI counterparts or surgical aortic valve replacement (SAVR).
Methods: MEDLINE/Embase/CENTRAL were searched from inception until April 2025, for randomized controlled trials comparing outcomes with different commercially available TAVI devices relative to other TAVI counterparts or SAVR.
Circ Genom Precis Med
September 2025
Clinical Pharmacology and Precision Medicine, William Harvey Research Institute, London, United Kingdom (W.J.Y., M.M.S., J.R., S.v.D., H.R.W., A.T., P.B.M.).
Background: There is a higher prevalence of heart rate corrected QT (QTc) prolongation in patients with diabetes and metabolic syndrome. QT interval genome-wide association studies have identified candidate genes for cardiac energy metabolism, and experimental studies suggest that polyunsaturated fatty acids have direct effects on ion channel function. Despite this, there has been limited study of metabolite concentration relationships with QT intervals.
View Article and Find Full Text PDFPeriodontol 2000
September 2025
Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
This systematic review and meta-analysis aimed to evaluate the long-term clinical outcomes of regenerative procedures compared with access flap surgery for the treatment of intrabony defects, with a minimum follow-up period of 5 years. A systematic review protocol following PRISMA guidelines was conducted. Both electronic and manual searches were conducted to identify randomized clinical trials (RCTs) on regenerative treatment of deep intrabony defects (≥3 mm) with a follow-up of at least 5 years.
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