Abstract
The aim of this paper is to provide a theoretical background for performing and reading systematic reviews of diagnostic studies. We first discuss items for assessment of methodological quality in diagnostic studies and then present methods on how to incorporate these quality measures in systematic reviews. The items of internal validity determine whether the presented results of the individual studies are unbiased and can be trusted. Items of external validity determine to what extent the results are applicable outside the population in which the study was performed. The issues concern the adequacy of the study population, the performance and interpretation of the diagnostic tests and the presentation of the results. Several methods exist for incorporation of issues of methodological quality into systematic reviews, such as subgroup analyses, meta-regression analysis, and methodological scores. Publications of diagnostic studies should provide sufficient information to enable assessment of the methodological quality. Furthermore, publication of results of subgroup analyses should be promoted. Methodological criteria lists might help to improve the quality of systematic reviews of diagnostic research. With the items of methodological quality in mind the general practitioner might be better equipped to critically read and interpret diagnostic reviews.
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References
Ransohoff DF, Feinstein AR. Problems of spectrum and bias in evaluating efficacy of diagnostic tests. N Engl J Med 1978; 299: 926–930.
Diamond GA, Forrester JS. Analysis of probability as an aid in clinical diagnosis of coronary artery disease. N Engl J Med 1979; 300: 1350–1358.
Hlatky MA, Mark DB, Harrell FE, Lee KL, Califf RM, Pryor DB. Rethinking sensitivity and specificity. Am J Cardiol 1987; 59: 1195–1198.
Panzer RJ, Suchman AL, Griner PF. Workup bias in prediction research. Med Decis Making 1987; 7: 115–119.
Knottnerus JA. Diagnostic prediction rules: Principles, requirements, and pitfalls. Primary Care 1995; 22: 341–363.
Miettinen OS, Caro JJ. Foundations of medical diagnosis: What actually are the parameters involved in Bayes' theorem? Stat Med 1994; 13: 201–209.
Van der Schouw YT, Verbeek ALM, Ruijs SHJ. Guidelines for the assessments of new diagnostic tests. Invest Radiol 1995; 30: 334–340.
Moons KGM, van Es GA, Deckers JW, Habbema JDF, Grobbee DE. Limitations of sensitivity, specificity, likelihood ratio, and Bayes' theorem in assessing diagnostic probabilities: A clinical example. Epidemiology 1997; 8: 12–17.
Begg CB. Biases in the assessment of diagnostic tests. Stat Med 1987; 6: 411–423.
Jaeschke R, Guyatt GH, Sackett DL. Users' guide to the medical literature. III How to use an article about a diagnostic test. A: Are the results of the study valid? JAMA 1994; 271: 389–391.
Jaeschke R, Guyatt GH, Sackett DL. Users' guide to the medical literature III How to use an article about a diagnostic test. B: What are the results and will they help me in caring for my patients? JAMA 1994; 271: 703–707.
Sheps SB, Schechter MT. The assessments of diagnostic tests: A survey of current medical research. JAMA 1984; 252: 2418–2422.
Mulrow CD, Linn WD, Gaul MK, Pugh JA. Assessing quality of diagnostic test evaluation. J Gen Int Med 1989; 4: 288–295.
Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology. A Basic Science for Clinical Medicine, 2nd edn., Boston: Little Brown, 1991.
Reid MC, Lachs MS, Feinstein AR. Use of methodological standards in diagnostic test research. Getting better but still not good. JAMA 1995; 274: 645–651.
Irwig L, Macaskill P, Glasziou P, Fahey M. Meta-analytic methods for diagnostic test accuracy. J Clin Epidemiol 1995; 48: 119–130.
Greenhalgh T. How to read a paper: Papers that report diagnostic or screening tests. Br Med J 1997; 315: 540–543.
Knottnerus JA, Leffers P. The influence of referral patterns on the characteristics of diagnostic tests. J Clin Epidemiol 1992; 45: 1143–1154.
Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA 1999; 282: 1061–1066.
Muris JWM, Starmans R, Fijten GH, Crebolder HFJM, Schouten HJA, Knottnerus JA. Non-acute abdominal complaints in general practice: Diagnostic value of signs and symptoms. Br J Gen Pract 1995; 45: 313–316.
Knottnerus JA, Dinant GJ. Medicine based evidence, a prerequisite for evidence based medicine. Br Med J 1997; 315: 1109–1110.
Devillé W, Buntinx F, van der Windt DAWM, et al. Didactic guidelines for conducting systematic reviews of studies evaluating the accuracy of diagnostic tests. In: Knottnerus JA (ed.), The Evidence Base of Diagnosis. London: BMJ Publishing Group, 2001.
Hoogendam A, Buntinx F, Vet HC de. The diagnostic value of digital rectal examination in primary care screening: A meta-analysis. Family Practice 1999; 16: 621–626.
Hoogen HM van der, Koes BW, Eijk JT van, Bouter LM. On the accuracy of history, physical examination and erythrocyte sedimentation rate in diagnosing low back pain in general practice. A criteria-based review of the literature. Spine 1995; 20: 318–327.
Greenland S. Invited commentary: A critical look at some popular meta-analytic methods. Am J Epidemiol 1994; 140: 290–296.
Jüni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA 1999; 282: 1054–1060.
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de Vet, H., van der Weijden, T., Muris, J. et al. Systematic reviews of diagnostic research. Considerations about assessment and incorporation of methodological quality. Eur J Epidemiol 17, 301–306 (2001). https://doi.org/10.1023/A:1012751326462
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DOI: https://doi.org/10.1023/A:1012751326462