When analyzing the randomized controlled trial, we may employ various statistical methods to adjust for baseline measures. Depending on the method chosen to adjust for baseline measures, inferential results can vary. We investigate the Type 1 error and statistical power of tests comparing treatment outcomes based on parametric and nonparametic methods. We also explore the increasing levels of correlation between baseline and changes from the baseline, with or without underlying normality. These methods are illustrated and compared via simulations.
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http://dx.doi.org/10.1016/j.cct.2014.01.002 | DOI Listing |
PLoS One
January 2025
Department of Neurology, University of Virginia, Charlottesville, Virginia, United States of America.
We examine the efficacy of the Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP), an intervention that involves one-on-one individualized support from a dementia care coordinator for a dementia care partner, compared to an active control group. At least once monthly contact is made from a dementia care coordinator to the dementia care partner by telephone, video conferencing, email, or in-person support at clinical visits for the person with dementia. In this pilot randomized unblinded control trial of ICECaP, n = 61 (n = 90 randomized) care partners completed 12-months of the ICECaP intervention and n = 69 (n = 92 randomized) care partners received routine clinical support (controls) in an outpatient memory care clinic at an academic medical center, from which the participants were recruited.
View Article and Find Full Text PDFPLoS One
January 2025
Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
Background: Cinnamon has been studied as a possible way to control blood glucose and serum cholesterol levels. However, there are no well-conducted randomized controlled trials that can accurately measure the lipid and glucose-lowering effects of Cinnamomum zeylanicum (C. zeylanicum) extract.
View Article and Find Full Text PDFJ Clin Endocrinol Metab
January 2025
The University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
Context: Trabecular bone score (TBS), a gray-level texture index derived from lumbar spine (LS) dual-energy x-ray absorptiometry (DXA) scans, is decreased in patients with diabetes and is associated with increased fracture risk, independent of areal bone mineral density (aBMD), but potentially influenced by abdominal fat tissue.
Objective: Evaluate effect of romosozumab (210 mg monthly) for 12 months followed by alendronate (70 mg weekly) for 24 months vs alendronate alone (70 mg weekly) for 36 months on LS aBMD and TBS in women with type 2 diabetes (T2D) enrolled in the ARCH study.
Methods: This post hoc analysis included women from ARCH who had T2D at baseline and LS DXA scans at baseline and ≥1 postbaseline visit (romosozumab-to-alendronate, n = 165; alendronate-to-alendronate, n = 195).
J Diabetes Investig
January 2025
Department of Diabetes, Endocrinology and Metabolism, Center Hospital, National Center for Global Health and Medicine, Tokyo, Japan.
Aim: To determine the epidemiological characteristics and risk factors for heart failure (HF) among Japanese patients with type 2 diabetes.
Methods: A retrospective cohort analysis, using J-DREAMS database, was conducted from December 2015 to January 2020 with type 2 diabetes. The primary objectives were to describe patient characteristics stratified by HF history at baseline and new HF events during follow-up.
Int J Cancer
January 2025
Department of Medical Oncology, Shanghai East Hospital of Tongji University, Shanghai, China.
This study aimed to assess the efficacy and safety of three dosing regimens of JMT103 in patients with bone metastases from solid tumors. Eligible patients were randomly assigned to receive JMT103 subcutaneously, 120 mg every 4 weeks (Cohort 1), 120 mg every 8 weeks (Cohort 2), or 180 mg every 8 weeks (Cohort 3) for up to 49 weeks. The primary endpoint was change from baseline to Week 13 in creatinine-adjusted urinary N-telopeptide (uNTx/Cr).
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