Abstract
Much of clinical research is aimed at assessing causality. However, clinical research can also address the value of new medical tests, which will ultimately be used for screening for risk factors, to diagnose a disease, or to assess prognosis. In order to be able to construct research questions and designs involving these concepts, one must have a working knowledge of this field. In other words, although traditional clinical research designs can be used to assess some of these questions, most of the studies assessing the value of diagnostic testing are more akin to descriptive observational designs, but with the twist that these designs are not aimed to assess causality, but are rather aimed at determining whether a diagnostic test will be useful in clinical practice. This chapter will introduce the various ways of assessing the accuracy of diagnostic tests, which will include discussions of sensitivity, specificity, predictive value, likelihood ratio, and receiver operator characteristic curves.
Research is what I’m doing when I don’t know what I’m doing.
Wernher von Braun http://www.brainyquote.com/quotes/authors/w/wernher_von_braun.html
Prediction is very difficult, especially about the future.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Bayes T. An essay towards solving a problem in the doctrine of chances. Philos Trans R Soc Lond B Biol Sci. 1763;53:370–418.
Ledley RS, Lusted LB. Reasoning foundations of medical diagnosis; symbolic logic, probability, and value theory aid our understanding of how physicians reason. Science. 1959;130:9–21.
Redwood DR, Borer JS, Epstein SE. Whither the ST segment during exercise. Circulation. 1976;54:703–6.
Rifkin RD, Hood Jr WB. Bayesian analysis of electrocardiographic exercise stress testing. N Engl J Med. 1977;297:681–6.
McGinn T, Wyer PC, Newman TB, Keitz S, Leipzig R, For GG, et al. Tips for learners of evidence-based medicine: 3. Measures of observer variability (kappa statistic). CMAJ. 2004;171:1369–73. PMC527344.
Green DM, Swets JM. Signal detection theory and psychophysics. New York: Wiley; 1966.
Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA, Breathing Not Properly Multinational Study, I. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002;347:161–7. doi:10.1056/NEJMoa020233.
Fagan TJ. Letter: Nomogram for Bayes theorem. N Engl J Med. 1975;293:257. doi:10.1056/NEJM197507312930513.
Miller DD, Shaw LJ. Coronary artery disease: diagnostic and prognostic models for reducing patient risk. J Cardiovasc Nurs. 2006;21:S2–16; quiz S17–9.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Glasser, S.P. (2014). Research Methodology for Studies of Diagnostic Tests. In: Glasser, S. (eds) Essentials of Clinical Research. Springer, Cham. https://doi.org/10.1007/978-3-319-05470-4_14
Download citation
DOI: https://doi.org/10.1007/978-3-319-05470-4_14
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-05469-8
Online ISBN: 978-3-319-05470-4
eBook Packages: MedicineMedicine (R0)