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KMID : 1094020150320010073
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Journal of Veterinary Clinics
2015 Volume.32 No. 1 p.73 ~ p.77
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Sample Size Requirements in Diagnostic Test Performance Studies
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Pak Son-Il
Oh Tae-Ho
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Abstract
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There has been increasing attention on sample size requirements in peer reviewed medical literatures. Accordingly, a statistically-valid sample size determination has been described for a variety of medical situationsincluding diagnostic test accuracy studies. If the sample is too small, the estimate is too inaccurate to be useful. Onthe other hand, a very large sample size would yield the estimate with more accurate than required but may be costlyand inefficient. Choosing the optimal sample size depends on statistical considerations, such as the desired precision,statistical power, confidence level and prevalence of disease, and non-statistical considerations, such as resources, costand sample availability. In a previous paper (J Vet Clin 2012; 29: 68-77) we briefly described the statistical theorybehind sample size calculations and provided practical methods of calculating sample size in different situations fordifferent research purposes. This review describes how to calculate sample sizes when assessing diagnostic testperformance such as sensitivity and specificity alone. Also included in this paper are tables and formulae to helpresearchers for designing diagnostic test studies and calculating sample size in studies evaluating test performance. For complex studies clinicians are encouraged to consult a statistician to help in the design and analysis for an accuratedetermination of the sample size.
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KEYWORD
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sample size, diagnostic test, accuracy, sensitivity, specificity
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