Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas

"In randomized controlled clinical trials, treatment efficacy is considered as its capability to produce beneficial effects. Efficacy of an experimental treatment is usually established comparing its effectiveness respect to a placebo or comparing with the effect of an active control treatment....

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Autor Principal: Monterrey P.A.
Formato: Artículo (Article)
Lenguaje:Inglés (English)
Publicado: Universidad de La Habana 2017
Materias:
Acceso en línea:https://repository.urosario.edu.co/handle/10336/22192
id ir-10336-22192
recordtype dspace
spelling ir-10336-221922020-06-03T22:15:02Z Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas Monterrey P.A. Meta-analysys Non-inferiority Non-inferiority margin P-values distribution T-test Test power "In randomized controlled clinical trials, treatment efficacy is considered as its capability to produce beneficial effects. Efficacy of an experimental treatment is usually established comparing its effectiveness respect to a placebo or comparing with the effect of an active control treatment. The first stage to determine effectiveness of a new treatment is placebo-controlled trial, and, as a second stage, a superiority trial will compare new treatment with a treatment uniformly accepted as a standard one. Sometimes the use of a placebo control is considered unethical; in such a case, a non-inferiority trial may be appropriate. In non-inferiority the new treatment dont need to be superior to a control, it is enough that it doesn't be unacceptably worse and additionally to be better than placebo. This assert rules the construction of non-inferiority hypothesis, which is based in a non-inferiority margin; in its determination is necessary to consider both statistical reasoning and clinical judgement. The possibility to claim incorrectly non-inferiority is one of the methodological flaws in non-inferiority studies and is related with the determination of non-inferiority margin. Two samples t-test is the statistical criteria to analyze non-inferiority hypothesis when mean value is the parameter to measure treatments efficacy. The objective of present report was to obtain and to characterize the p-value probability distribution for t-test in non-inferiority designs and to establish the relationship between this distribution and test's power function, as a result a characterization of the effect of sample size and non-inferiority margin over test sensibility was obtained, in addition an application of p-value distribution to meta-analysis was done introducing a criteria to analyze the effect of a particular study in results integration." 2017 2020-05-25T23:55:44Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 2574306 https://repository.urosario.edu.co/handle/10336/22192 eng info:eu-repo/semantics/openAccess application/pdf Universidad de La Habana instname:Universidad del Rosario reponame:Repositorio Institucional EdocUR
institution EdocUR - Universidad del Rosario
collection DSpace
language Inglés (English)
topic Meta-analysys
Non-inferiority
Non-inferiority margin
P-values distribution
T-test
Test power
spellingShingle Meta-analysys
Non-inferiority
Non-inferiority margin
P-values distribution
T-test
Test power
Monterrey P.A.
Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
description "In randomized controlled clinical trials, treatment efficacy is considered as its capability to produce beneficial effects. Efficacy of an experimental treatment is usually established comparing its effectiveness respect to a placebo or comparing with the effect of an active control treatment. The first stage to determine effectiveness of a new treatment is placebo-controlled trial, and, as a second stage, a superiority trial will compare new treatment with a treatment uniformly accepted as a standard one. Sometimes the use of a placebo control is considered unethical; in such a case, a non-inferiority trial may be appropriate. In non-inferiority the new treatment dont need to be superior to a control, it is enough that it doesn't be unacceptably worse and additionally to be better than placebo. This assert rules the construction of non-inferiority hypothesis, which is based in a non-inferiority margin; in its determination is necessary to consider both statistical reasoning and clinical judgement. The possibility to claim incorrectly non-inferiority is one of the methodological flaws in non-inferiority studies and is related with the determination of non-inferiority margin. Two samples t-test is the statistical criteria to analyze non-inferiority hypothesis when mean value is the parameter to measure treatments efficacy. The objective of present report was to obtain and to characterize the p-value probability distribution for t-test in non-inferiority designs and to establish the relationship between this distribution and test's power function, as a result a characterization of the effect of sample size and non-inferiority margin over test sensibility was obtained, in addition an application of p-value distribution to meta-analysis was done introducing a criteria to analyze the effect of a particular study in results integration."
format Artículo (Article)
author Monterrey P.A.
author_facet Monterrey P.A.
author_sort Monterrey P.A.
title Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
title_short Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
title_full Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
title_fullStr Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
title_full_unstemmed Distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
title_sort distribución del valor p para la prueba t en estudios de no-inferioridad con muestras paralelas
publisher Universidad de La Habana
publishDate 2017
url https://repository.urosario.edu.co/handle/10336/22192
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score 11,828437