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Review
. 2017 Apr-Jun;64(2):220-227.
doi: 10.29262/ram.v64i2.267.

[The research protocol V: The calculation of sample size]

[Article in Spanish]
Affiliations
Review

[The research protocol V: The calculation of sample size]

[Article in Spanish]
Mario Enrique Rendón-Macías et al. Rev Alerg Mex. 2017 Apr-Jun.

Abstract

Sample size refers to the number of participants to be included in a research study. If the calculation is carried out properly, not only conclusions will be established with statistical support and the potential risks to the subjects included in the investigation will be limited, but also the study can be properly planned to optimize economic and time costs. Calculation of sample size requires information that must be supported by the research protocol. This information includes that the objectives (descriptive study or a study to establish differences between groups) and hypotheses are well elaborated (with magnitude and direction), the scale of measurement of the outcome variable(s) must be defined, and type I error and type II error appropriately identified. This review describes how to specify the requirements needed for sample size calculation, including examples in clinical research designs.

El tamaño de la muestra se refiere al número de participantes que se incluirá en un estudio de investigación. Si se realiza adecuadamente el cálculo, no solamente se establecerán conclusiones con sustento estadístico y se limitarán los riesgos potenciales a los sujetos incluidos en la investigación, sino que además el estudio podrá planearse adecuadamente para optimizar costos económicos y tiempo. Para el cálculo del tamaño de la muestra se requiere información que debe estar sustentada en el protocolo de investigación; dicha información incluye que los objetivos (estudio descriptivo o para establecer diferencias), hipótesis (con magnitud y dirección) y escala de medición de la o las variables de desenlace estén bien planteadas, así como tener considerados los errores tipos I y II. En esta revisión se describe los requerimientos necesarios para el cálculo del tamaño de la muestra, incluyendo ejemplos en diseños de investigación clínica.

Keywords: Measurements, methods and theories; Research; Sample size.

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