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2019, Number 6

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Acta Pediatr Mex 2019; 40 (6)

Diagnostic accuracy research

Díaz-García L, Medina-Vera I, García-de la Puente S, González-Garay A, Murata C

Language: Spanish
References: 18
Page: 342-357
PDF size: 261.93 Kb.


ABSTRACT

Background: Diagnostic test studies can be distinguished in five stages, corresponding to different objectives. We focus on Phase III, known as diagnostic accuracy research.
Objective: To provide physicians and other health professionals with an up-to-date introduction to basic concepts and statistical tools in diagnostic accuracy studies.
Description: A diagnostic accuracy study is carried out to determine if the test of interest distinguishes in a daily clinical situation the subjects who have and do not have the disease among the patients with suspicion of the disease. To achieve this objective, selecting a valid reference standard, avoiding characteristic bias in this phase, identifying parameters that quantify the accuracy of the diagnosis and performing appropriate statistical analyzes are of crucial importance.
Conclusions: This research phase must be clearly differentiated within the diagnostic study both for the use of information and for diagnostic accuracy studies. In particular, it is important to notice that the usefulness of the information in Phase II and Phase III is very different. Users of diagnostic tests should know how to correctly apply local data so that the results generated by the index test are appropriate for their clinical context.


REFERENCES

  1. Sackett DL, Haynes RB. The architecture of diagnostic research. BMJ 2002; 324: 539-541

  2. Haynes RB, You JJ. The architecture of diagnostic research. In: Knottnerus JA, Buntinx F, editors. The Evidence Base of Clinical Diagnosis. Theory and methods of diagnostic research, 2nd Ed. OX, UK: BMJ Books, 2009, p.20-41

  3. Jaeschke R, Guyatt G, Sackett D.L. Users' Guides to the Medical Literature. III. How to use an article about a diagnostic test. Are the results of the study valid? JAMA 1994; 271: 389-391.

  4. Knottnerus JA, Buntinx F, van Weel C. General introduction: evaluation of diagnostic procedures. In: Knottnerus JA, Buntinx F, editors. The Evidence Base of Clinical Diagnosis. Theory and methods of diagnostic research, 2nd Ed. OX, UK: BMJ Books, 2009, p.1-19

  5. Knottnerus JA, Muris JW. Assessment of the accuracy of diagnostic tests: the cross-sectional study. In: Knottnerus JA, Buntinx F, editors. The Evidence Base of Clinical Diagnosis. Theory and methods of diagnostic research, 2nd Ed. OX, UK: BMJ Books, 2009, p.42-62

  6. Irwig LM, Bossuyt PMM, Glasziou PP, Gatsonis C, Lijmer J. Designing studies to ensure that estimates of test accuracy will travel. In: Knottnerus JA, Buntinx F, editors. The Evidence Base of Clinical Diagnosis. Theory and methods of diagnostic research, 2nd Ed. OX, UK: BMJ Books, 2009, p.96-117

  7. Smith AF. Diagnostic value of serum-creatine-kinase in a Coronary-Care Unit. Lancet 1967;2(7508):178-182

  8. U.S. Centers for Disease Control and Prevention. Principles of epidemiology in public health practice. In: An introduction to applied epidemiology and biostatistics. 3rd ed. Self Study Course SS1000, Lesson 3. https://www.cdc.gov/ csels/dsepd/ss1978/lesson3/section1.html Accessed 11 July 2019.

  9. Habbema JF, Eijkemans R, Krijnen P, Knottnerus JA. Analysis of data on the accuracy of diagnostic tests. In: Knottnerus JA, Buntinx F, editors. The Evidence Base of Clinical Diagnosis. Theory and methods of diagnostic research, 2nd Ed. OX, UK: BMJ Books, 2009, p.118-145

  10. Wilson MC, Henderson MC, Smetana GW. Chapter 5. Evidence- Based Clinical Decision Making. In: Henderson MC, Tierney LM Jr, Smetana GW, editors. The Patient History. An Evidence-Based Approach to Differential Diagnosis, 2nd Ed. NY, USA: LANGE medical book, McGraw Hill, 2012, p.27-32

  11. Simel DL, Sama GP, Matchar DB. Likelihood ratios with confidence: sample size estimation for diagnostic test studies. J Clin Epidemiol 1991;44(8):763-770

  12. A dictionary of epidemiology. Sixth ed. Oxford, UK. International Epidemiological Association, Inc. Oxford University Press; 2014. Parameter; p209

  13. Arkin CF, Wachtel MS. How many patients are necessary to assess test performance? JAMA 1990;263(2):275-278

  14. Obuchowski NA. Sample size calculations in studies of test accuracy. Stat Meth Med Res 1998;7:371-392

  15. Flahault A, Cadilhac M, Thomas G. Sample size should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol 2005;58:859–62

  16. Bachmann LM, Puhan MA, ter Riet G, Bossuyt PM. Sample sizes of studies on diagnostic accuracy: literature survey. BMJ 2006;332(7550):1127-9

  17. Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform 2014;48:193-204

  18. Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L, Irwig L, Levine D, Reitsma JB, de Vet HC, Bossuyt PM. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open 2016;6(11):e012799. doi: 10.1136/bmjopen-2016-012799.




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