Semin Reprod Med 2003; 21(1): 009-016
DOI: 10.1055/s-2003-39990
Copyright © 2003 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel.: +1(212) 584-4662

Evidence-Based Medicine for Diagnostic Questions

Johannes L.H. Evers1 , Jolande A. Land1 , Ben W. Mol2
  • 1Department of Obstetrics and Gynaecology, Research Institute GROW, Academisch ziekenhuis Maastricht and Maastricht University, Maastricht, The Netherlands
  • 2Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands
Further Information

Publication History

Publication Date:
12 June 2003 (online)

ABSTRACT

When searching the medical care literature for evidence on a diagnostic test, three questions should be addressed each time a study is found: (1) Is this evidence about a diagnostic test valid? (2) Does the test accurately discriminate between patients who do and patients who do not have a specific disorder? (3) Can the test be applied to this patient who is right now sitting in front of me? We will discuss hysterosalpingography (HSG) as an example of a valid and accurate diagnostic test to be applied in a general population of subfertile couples to assess tubal patency (specificity 0.83). HSG is an unreliable test for diagnosing tubal occlusion however (sensitivity 0.65). If HSG were normal, other investigations could be pursued and diagnostic laparoscopy (LS) only performed if conception had not occurred by a later date. If HSG were abnormal, LS would be needed to confirm or exclude tubal occlusion. Patients with risk factors for pelvic or tubal disease, including an abnormal Chlamydia antibody test (CAT) and those showing abnormalities at pelvic examination, should proceed directly to LS because they are significantly more likely to have pelvic pathology. A completely different issue would be HSG as a prognostic test for the occurrence of pregnancy. In theory, the occurrence of pregnancy may be considered a gold standard; however, in reproductive medicine, with so many causes of subfertility other than tubal pathology, a diagnostic test for one single disorder, if normal, will never be able to accurately predict the eventual occurrence of pregnancy.

REFERENCES

  • 1 Feinstein A R. Basic biomedical science and the destruction of the pathophysiologic bridge from bench to bedside.  Am J Med . 1999;  107 461-467
  • 2 Guyatt G, Rennie D, and The Evidence-Based Medicine Working Group. Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. Chicago: AMA Press 2002
  • 3 Lijmer J G, Mol B W, Heisterkamp S. et al . Empirical evidence of design-related bias in studies of diagnostic tests.  JAMA . 1999;  282 1061-1066
  • 4 Knottnerus J A, Van Weel C, Muris J WM. Evaluation of diagnostic procedures.  BMJ . 2002;  324 477-480
  • 5 Royal College of Obstetricians & Gynaecologists. The Initial Investigation and Management of the Infertile Couple: Evidence-Based Clinical Guideline No 2. London: RCOG Press 1998
  • 6 Forsey J P, Caul E O, Paul I D, Hull M GR. Chlamydia trachomatis, tubal disease and the incidence of symptomatic and asymptomatic infection following hysterosalpingography.  Hum Reprod . 1990;  5 444-447
  • 7 Watson A, Vandekerckhove P, Lilford R, Vail A, Brosens I, Hughes E. A meta-analysis of the therapeutic role of oil soluble contrast media at hysterosalpingography: a surprising result?.  Fertil Steril . 1994;  61 470-477
  • 8 Spring D B, Barkan H E, Pruyn S C. Potential therapeutic effects of contrast materials in hysterosalpingography: a prospective randomized clinical trial. Kaiser Permanente Infertility Work Group.  Radiology . 2000;  214 53-57
  • 9 Mol B W, Swart P, Bossuyt P M, van Beurden M, van der Veen F. Reproducibility of the interpretation of hysterosalpingography in the diagnosis of tubal pathology.  Hum Reprod . 1996;  11 1204-1208
  • 10 Glatstein I Z, Sleeper L A, Lavy Y. et al . Observer variability in the diagnosis and management of the hysterosalpingogram.  Fertil Steril . 1997;  67 233-237
  • 11 Haynes R B, Wilczynski N, McKibbon K A, Walker C J, Sinclair J C. Developing optimal search strategies for detecting clinically sound studies in MEDLINE.  J Am Med Inform Assoc . 1994;  1 447-458
  • 12 Swart P, Mol B W, Van der Veen F, Van Beurden M, Redekop W K, Bossuyt P MM. The accuracy of hysterosalpingography in the diagnosis of tubal pathology: a meta-analysis.  Fertil Steril . 1995;  64 486-491
  • 13 Rice J P, London S N, Olive D L. Reevaluation of hysterosalpingography in infertility investigation.  Obstet Gynecol . 1986;  67 718-721
  • 14 Loy R A, Weinstein F G, Seibel M M. Hysterosalpingography in perspective: the predictive value of oil-soluble versus water-soluble contrast media.  Fertil Steril . 1989;  51 170-172
  • 15 Bossuyt P M, Lijmer J G, Mol B W. Randomised comparisons of medical tests: sometimes invalid, not always efficient.  Lancet . 2000;  356 1844-1847
  • 16 Sackett D L, Haynes R B. The architecture of diagnostic research.  BMJ . 2002;  324 539-541
  • 17 Sackett D L, Richardson W S, Rosenberg W, Haynes R B. Evidence-Based Medicine: How to Practice and Teach EBM. New York: Churchill Livingstone 1997
  • 18 Duff D E, Fried A M, Wilson E A, Haack D G. Hysterosalpingography and laparoscopy: a comparative study.  Am J Radiol . 1983;  141 761-763
  • 19 Swolin K, Rosencrantz M. Laparoscopy versus hysterosalpingography in sterility investigations, a comparative study.  Fertil Steril . 1972;  23 270-273
  • 20 Keirse M J, Vandervellen R. A comparison of hysterosalpingography and laparoscopy in the investigation of infertility.  Obstet Gynecol . 1972;  41 685-688
  • 21 Hull M G, Glazener C M, Kelly N J. et al . Population study of causes, treatment, and outcome of infertility.  BMJ . 1985;  291 1693-1697
  • 22 Collins J A. Diagnostic assessment of the infertile female partner.  Curr Probl Obstet Gynecol Fertil . 1988;  11 7-42
  • 23 Greenhalgh T. How to read a paper: the basics of evidence based medicine. London: BMJ Publishing Group 1997
  • 24 Land J A, Evers J L, Goossens V J. How to use chlamydia antibody testing in subfertility patients.  Hum Reprod . 1998;  13 1094-1098
  • 25 Maas J W, Evers J L, ter Riet G, Kessels A G. Pregnancy rate following normal versus abnormal hysterosalpingography findings: a meta-analysis.  Gynecol Obstet Invest . 1997;  43 79-83
  • 26 Mol B W, Collins J A, Burrows E A, van der Veen F, Bossuyt P M. Comparison of hysterosalpingography and laparoscopy in predicting fertility outcome.  Hum Reprod . 1999;  14 1237-1242
  • 27 Dabekausen Y A, Evers J L, Land J A, Stals F S. Chlamydia trachomatis antibody testing is more accurate than hysterosalpingography in predicting tubal factor infertility.  Fertil Steril . 1994;  61 833-837
  • 28 Mol B W, Dijkman B, Wertheim P, Lijmer J, van der Veen F, Bossuyt P M. The accuracy of serum chlamydial antibodies in the diagnosis of tubal pathology: a meta-analysis.  Fertil Steril . 1997;  67 1031-1037
  • 29 Sackett D L, Haynes R B, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. Boston: Little, Brown 1985
  • 30 Johnson N P, Taylor K, Nadgir A A, Chinn D J, Taylor P J. Can diagnostic laparoscopy be avoided in routine investigation for infertility?.  Br J Obstet Gynaecol . 2000;  107 174-178
    >