Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis

Mohamad Adam Bujang, Tassha Hilda Adnan, Mohamad Adam Bujang, Tassha Hilda Adnan

Abstract

Sensitivity and specificity analysis is commonly used for screening and diagnostic tests. The main issue researchers face is to determine the sufficient sample sizes that are related with screening and diagnostic studies. Although the formula for sample size calculation is available but concerning majority of the researchers are not mathematicians or statisticians, hence, sample size calculation might not be easy for them. This review paper provides sample size tables with regards to sensitivity and specificity analysis. These tables were derived from formulation of sensitivity and specificity test using Power Analysis and Sample Size (PASS) software based on desired type I error, power and effect size. The approaches on how to use the tables were also discussed.

Keywords: Diagnostic; Screening; Type I error.

Figures

[Table/Fig-1]:
[Table/Fig-1]:
Sample size calculation for sensitivity and specificity analysis for prevalence of disease from 5% to 20%.  Prev = prevalence of disease  Ho = Hypothesis null  Ha = Hypothesis alternative N1 = The minimum number of sample size for positive disease  N = The minimum number of sample size requirement for total
[Table/Fig-2]:
[Table/Fig-2]:
Sample size calculation for sensitivity and specificity analysis for prevalence of disease from 30% to 60%. Prev = prevalence of disease  Ho = Hypothesis null  Ha = Hypothesis alternative N1 = The minimum number of sample size for positive disease  N = The minimum number of sample size requirement for total
[Table/Fig-3]:
[Table/Fig-3]:
Sample size calculation for sensitivity and specificity analysis for prevalence of disease from 70% to 90%. Prev = prevalence of disease  Ho = Hypothesis null  Ha = Hypothesis alternative  N1 = The minimum number of sample size for positive disease  N = The minimum number of sample size requirement for total

References

    1. David L Simel, Gregory P Samsa, David B Matchar. Likelihood ratios with confidence: sample size estimation for diagnostic test studies. J Clin Epidmiol. 1991;44(8):763–70.
    1. 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.
    1. Enøe C, Georgiadis MP, Johnson WO. Estimation of sensitivity and specificity of diagnostic tests and disease prevalence when the true disease state is unknown. Prev Vet Med. 2000;45(1-2):61–81.
    1. Netzer NC, Stoohs SA, Netzer CM, Clark K, Strohl KP. Using the Berlin questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999;131:485–91.
    1. Yunus A, Seet W, Mohamad Adam B, Haniff J. Validation of the Malay version of Berlin questionaire to identify Malaysian patients for obstructive sleep apnea. Malaysian Family Physician. 2013;8(1):03–09.
    1. Burgess LJ, Maritz FJ, Le Roux I, Taljaard JJ. Use of adenosine deaminase as a diagnostic tool for tuberculous pleurisy. Thorax. 1995;50(6):672–674.
    1. Premsenthil M, Salowi MA, Bujang MA, Kueh A, Siew CM, Sumugam K, et al. Risk factors and prediction models for retinopathy of prematurity. Malays J Med Sci. 2015;22(5):57–63.
    1. Baeres M, Herkel J, Czaja AJ, Wies I, Kanzler S, Cancado ELR, et al. Liver disease: Establishment of standardised SLA/LP immunoassays: specificity for autoimmune hepatitis, worldwide occurrence, and clinical characteristics. Gut. 2002;51(2):259–64.
    1. [Last accessed on 03 June 2016]
    1. Mohamad AB, Nurakmal B. Sample size guideline for correlation analysis. World Journal of Social Science Research. 2016;3(1):37–46.
    1. Law M, Yang S, Wang H, Babb JS, Johnson G, Cha S, et al. Glioma Grading: Sensitivity, Specificity, and Predictive Values of Perfusion MR Imaging and Proton MR Spectroscopic Imaging Compared with Conventional MR Imaging. AJNR Am J Neuroradiol. 2003;24(10):1989–98.
    1. Choplin NT, Lundy DC. The sensitivity and specificity of scanning laser polarimetry in the detection of glaucoma in a clinical setting. Ophthalmology. 2001;108(5):899–904.
    1. Arroll B, Khin N, Kerse N. Screening for depression in primary care with two verbally asked questions: cross sectional study. BMJ: British Medical Journal. 2003;327(7424):1144–46.
    1. Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994;154(22):2573–81.
    1. Erbel R, Daniel W, Visser C, Engberding R, Roelandt J, Rennollet H. Echocardiography in diagnosis of aortic dissection. The Lancet. 1989;333(8636):457–61.
    1. Nori S, Rius-Díaz F, Cuevas J, Goldgeier M, Jaen P, Torres A, et al. Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: A multicenter study. Journal of the American Academy of Dermatology. 2004;51(6):923–30.
    1. Bujang MA, Ghani PA, Zolkepali NA, Selvarajah S, Haniff J. A comparison between convenience sampling versus systematic sampling in getting the true parameter in a population: explore from a clinical database: The Audit Diabetes Control Management (ADCM) registry in 2009. Proceedings of the International Conference Statistics Sciences Business Engineering. 2009;2012:15.
    1. Bujang MA, Sa’at N, Joys AR, Mohamad Ali M. An audit of the statistics and the comparison with the parameter in the population. AIP Conference Proceedings. 2015;1682:050019.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다