Concepts in sample size determination

Investigators involved in clinical, epidemiological or translational research, have the drive to publish their results so that they can extrapolate their findings to the population. This begins with the preliminary step of deciding the topic to be studied, the subjects and the type of study design....

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Main Author: Umadevi K Rao
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2012-01-01
Series:Indian Journal of Dental Research
Subjects:
Online Access:http://www.ijdr.in/article.asp?issn=0970-9290;year=2012;volume=23;issue=5;spage=660;epage=664;aulast=Rao
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author Umadevi K Rao
author_facet Umadevi K Rao
author_sort Umadevi K Rao
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description Investigators involved in clinical, epidemiological or translational research, have the drive to publish their results so that they can extrapolate their findings to the population. This begins with the preliminary step of deciding the topic to be studied, the subjects and the type of study design. In this context, the researcher must determine how many subjects would be required for the proposed study. Thus, the number of individuals to be included in the study, i.e., the sample size is an important consideration in the design of many clinical studies. The sample size determination should be based on the difference in the outcome between the two groups studied as in an analytical study, as well as on the accepted p value for statistical significance and the required statistical power to test a hypothesis. The accepted risk of type I error or alpha value, which by convention is set at the 0.05 level in biomedical research defines the cutoff point at which the p value obtained in the study is judged as significant or not. The power in clinical research is the likelihood of finding a statistically significant result when it exists and is typically set to >80%. This is necessary since the most rigorously executed studies may fail to answer the research question if the sample size is too small. Alternatively, a study with too large a sample size will be difficult and will result in waste of time and resources. Thus, the goal of sample size planning is to estimate an appropriate number of subjects for a given study design. This article describes the concepts in estimating the sample size.
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spelling doaj.art-2d5c8b034a914a53bb1c7e88cbca0f4b2022-12-21T17:56:55ZengWolters Kluwer Medknow PublicationsIndian Journal of Dental Research0970-92901998-36032012-01-0123566066410.4103/0970-9290.107385Concepts in sample size determinationUmadevi K RaoInvestigators involved in clinical, epidemiological or translational research, have the drive to publish their results so that they can extrapolate their findings to the population. This begins with the preliminary step of deciding the topic to be studied, the subjects and the type of study design. In this context, the researcher must determine how many subjects would be required for the proposed study. Thus, the number of individuals to be included in the study, i.e., the sample size is an important consideration in the design of many clinical studies. The sample size determination should be based on the difference in the outcome between the two groups studied as in an analytical study, as well as on the accepted p value for statistical significance and the required statistical power to test a hypothesis. The accepted risk of type I error or alpha value, which by convention is set at the 0.05 level in biomedical research defines the cutoff point at which the p value obtained in the study is judged as significant or not. The power in clinical research is the likelihood of finding a statistically significant result when it exists and is typically set to >80%. This is necessary since the most rigorously executed studies may fail to answer the research question if the sample size is too small. Alternatively, a study with too large a sample size will be difficult and will result in waste of time and resources. Thus, the goal of sample size planning is to estimate an appropriate number of subjects for a given study design. This article describes the concepts in estimating the sample size.http://www.ijdr.in/article.asp?issn=0970-9290;year=2012;volume=23;issue=5;spage=660;epage=664;aulast=RaoEpidemiologysample sizestatistics
spellingShingle Umadevi K Rao
Concepts in sample size determination
Indian Journal of Dental Research
Epidemiology
sample size
statistics
title Concepts in sample size determination
title_full Concepts in sample size determination
title_fullStr Concepts in sample size determination
title_full_unstemmed Concepts in sample size determination
title_short Concepts in sample size determination
title_sort concepts in sample size determination
topic Epidemiology
sample size
statistics
url http://www.ijdr.in/article.asp?issn=0970-9290;year=2012;volume=23;issue=5;spage=660;epage=664;aulast=Rao
work_keys_str_mv AT umadevikrao conceptsinsamplesizedetermination