Sample size calculation for diagnostic test studies
Keywords:
sample size, diagnostic test, sensitivity, specificityAbstract
The method of sample size calculation for diagnostic test studies is based on the primary objective of the study. The prevalence of disease is an important factor to calculate the required sample size for estimating and testing sensitivity and specificity. In the case of the prevalence of disease, it was equal to 0.50 and the required sample size for estimating and testing sensitivity and specificity will be the same. On the other hand, if the prevalence of disease is not equal to 0.50, the sample size calculation would be use both sample size formulas for estimating and testing sensitivity and specificity. In this article, the author described a concept of diagnostic testing, for sample size calculation to estimate or test sensitivity and specificity, as well as illustrating the use through applied examples and presenting the sample size table for different parameters.
References
Petrie A, Sabin C. Medical statistics at a glance. 3rd ed. West Sussex: WileyBlackwell; 2009. p. 115-7.
Portney LG, Watkins MP. Foundations of clinical research: applications to practice. 3rd ed. New Jersey: Julie Levin Alexander; 2009. p. 619-58.
A n t o n i s a m y B , P r e m k u m a r P S , Christopher S. Principles and practice of biostatistics. 1st ed. New Delhi: Elsevier; 2017. p. 213-26.
Jones S, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J 2003;20(5):
-8.
Peat J, Barton B, Elliott E. Statistics workbook for evidence-based health care. 1 st ed. West Sussex: WileyBlackwell; 2008. p. 147-53.
Lwanga SK, Lemeshow S. Sample size determination in health studies: a practical manual. 1st ed. Geneva: World Health Organization; 1991. p. VII-VIII.
Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med 1996;3(9):895-900.
Daly LE, Bourke GJ. Interpretation and uses of medical statistics. 5th ed. Oxford: Blackwell Science; 2000. p. 269-95.
Li J, Fine J. On sample size for sensitivity and specificity in prospective diagnostic accuracy studies. Stat Med 2004; 23(16):2537-50.
Chow SC, Shao J, Wang H. Sample size calculations in clinical research. 2nd ed. New York: Chapman & Hall/CRC; 2008. p. 1-47.
Machin D, Campbell MJ, Tan SB, et al. Sample size tables for clinical studies. 3rd ed. West Sussex: Wiley-Blackwell; 2009. p. 1-13. 12. Monette DR, Sullivan TJ, DeJong CR. Applied social research: a tool for the
human services. 8th ed. Belmont, CA: Brooks/Cole, Cengage Learning; 2011. p. 134-62.
Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform 2014;48:193-204.
Connell FA, Koepsell TD. Measures of gain in certainty from a diagnostic test. Am J Epidemiol 1985;121(5):744-53.
Arkin CF, Wachtel MS. How many patients are necessary to assess test performance?. JAMA 1990;263(2):275-8.
Kent S, Wanzek J, Yun J. Screening in the upper elementary grades: Identifying fourth-grade students at-risk for failing the state reading assessment. Assess Eff Interv 2018;1:1-13.
Monette DR, Sullivan TJ, DeJong CR. Applied social research: a tool for the human services. 8th ed. Belmont, CA: Brooks/Cole, Cengage Learning; 2011. p. 425.
Lemeshow S, Hosmer Jr DW, Klar J, et al. Adequacy of sample size in health studies. 1st ed. Chichester: John Wiley & Sons Ltd.; 1990. p. 1-8.
Asadoorian OM, Kantarelis D. Essentials of inferential statistics. 4th ed. Oxford: University Press of America, Inc.; 2005. p.94.
Machin D, Campbell MJ, Tan SB, et al. Sample size tables for clinical studies. 3rd ed. West Sussex: Wiley-Blackwell; 2009. p. 122-5.
