Before conducting a scientific study, a power analysis is performed to determine the sample size required to test an effect within allowable probabilities of Type I error (α) or Type II error (β). The power of a study is related to Type II error by 1-β. Most scientific studies set α=0.05 and power=0.80 as minimums. More conservative study designs will decrease α or increase power, which will require a larger sample size. The third and final parameter required for a power analysis is the effect size (ES). ES is a measure of the strength of the observation in the outcome of interest (ie, the dependent variable). ES must be estimated from pilot studies or published values. A small ES will require a larger sample size than a large ES. It is possible to detect statistically significant findings even for very small ES, if the sample size is sufficiently large. Therefore, it is also essential to evaluate whether ES is sufficiently large to be clinically meaningful.
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http://dx.doi.org/10.1097/BSD.0000000000001079 | DOI Listing |
Clin Trials
January 2025
Department of Biostatistics, University of Florida, Gainesville, FL, USA.
Introduction: The sequential parallel comparison design has emerged as a valuable tool in clinical trials with high placebo response rates. To further enhance its efficiency and effectiveness, adaptive strategies, such as sample size adjustment and allocation ratio modification can be employed.
Methods: We compared the performance of Jennison and Turnbull's method and the Promising Zone approach for sample size adjustment in a two-phase sequential parallel comparison design study.
Pharmaceutics
January 2025
Division of Clinical Pharmacology, Department of Medicine, School of Medicine, The Johns Hopkins University, Baltimore, MD 21287, USA.
Long-acting and extended-release drug delivery strategies have greatly improved treatment for a variety of medical conditions. Special populations, specifically infants, children, young people, and pregnant and postpartum women, could greatly benefit from access to these strategies but are often excluded from clinical trials. We conducted a systematic review of all clinical studies involving the use of a long-acting intramuscular injection or implant in infants, children, young people, and pregnant and postpartum people.
View Article and Find Full Text PDFPharmaceutics
December 2024
Clinical Pharmacology Unit, San Giovanni di Dio e Ruggi d'Aragona University Hospital, 84131 Salerno, Italy.
Highly active antiretroviral therapy has led to a significant increase in the life expectancy of people living with HIV. The trade-off is that HIV-infected patients often suffer from comorbidities that require additional treatment, increasing the risk of Drug-Drug Interactions (DDIs), the clinical relevance of which has often not been determined during registration trials of the drugs involved. Therefore, it is important to identify potential clinically relevant DDIs in order to establish the most appropriate therapeutic approaches.
View Article and Find Full Text PDFPlants (Basel)
January 2025
Departamento de Fitotecnia, Instituto de Horticultura, Universidad Autónoma Chapingo, km 38.5 Carretera México-Texcoco, Chapingo 56230, Estado de México, Mexico.
A synthetic variety (SV) of maize may not become stable if the sample size representing each parental line (m) is small. This research aimed to evaluate the effect of m on the inbreeding coefficient (IC) of the SV (FSynL) and on the stability of its genetic constitution. An SV formed by randomly mating l unrelated lines whose inbreeding coefficient is F was considered, and a random sample was taken from the genotypic array of the progeny produced by selfing a parental line A1A2 (GA) This sample was visualized as a set of g groups of four plants whose genotypes are all four of the GA and e represented the number of plants that failed to form a group.
View Article and Find Full Text PDFNutrients
January 2025
Department of Physiology and Aging, College of Medicine, University of Florida, Gainesville, FL 32611, USA.
Background/objectives: Time-restricted eating (TRE) has been associated with beneficial effects for inflammation and oxidative stress; however, the effects of TRE on inflammation and oxidative stress in the aging population have not been explored.
Methods: This secondary analysis tested the effects of TRE on pro-inflammatory (hs-CRP [high-sensitivity C-reactive protein], IL-1β [interleukin 1 beta], IL-6 [interleukin 6], TNF-α [tumor necrosis factor alpha]) and oxidative stress (8-isoprostane) biomarkers in ten overweight older adults (mean age = 77.1 ± 6.
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