Skip to main content
Log in

The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination

  • Original Article
  • Published:
Journal of General Internal Medicine Aims and scope Submit manuscript

Summary

Objective

The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test.

Setting

Nonsystematic review of the STARD statement.

Interventions

Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus.

Measurements and Main Results

The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians.

Conclusions

The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Bossuyt PM, Reitsma JB, Bruns DE, et al., for the STARD Group. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD Initiative. Clinical Chem. 2003;49:1–6.

    Article  CAS  Google Scholar 

  2. Bossuyt PM, Reitsma JB, Bruns DE, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin Chem. 2003;49:7–18.

    Article  PubMed  CAS  Google Scholar 

  3. Rennie D. Improving reports of studies of diagnostic tests. The STARD initiative. J Am Med Assoc. 2003;289:89–90.

    Article  Google Scholar 

  4. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting randomized controlled trials: the CONSORT statement. J Am Med Assoc. 1996;276:637–9.

    Article  CAS  Google Scholar 

  5. Guyatt G, Rennie D. Users’ Guides to the Medical Literature. Chicago, IL: AMA; 2002.

    Google Scholar 

  6. Moons KG, Harrell FE. Sensitivity and specificity should be de-emphasized in diagnostic accuracy studies. Acad Radiol. 2003;10:670–2.

    Article  PubMed  Google Scholar 

  7. Williams JW, Simel DL, Roberts L, Samsa G. Clinical evaluation for sinusitis: the value of a good history and physical examination. Ann Intern Med. 1992;117:705–10.

    PubMed  Google Scholar 

  8. Begg CB. Biases in the assessment of diagnostic tests. Stat Med. 1987;6:411–23.

    Article  PubMed  CAS  Google Scholar 

  9. Rutjes AW, Reitsma JB, Vandenbroucke JP, Glas AS, Bossuyt PM. Case-control and two-gate designs in diagnostic accuracy studies. Clin Chem. 2005;51:1335–41.

    Article  PubMed  CAS  Google Scholar 

  10. Rao G, Fisch L, Srinivasan S, et al. Simel DL, Rennie D, eds. Does this Patient have Parkinson’s Disease? J Am Med Assoc. 2003;289:347–53.

    Google Scholar 

  11. Bachmann LM, Puhan MA, Riet G, Bossuyt PM. Sample sizes of studies on diagnostic accuracy: literature survey. Br J Med. 2006;332:1127–9.

    Article  Google Scholar 

  12. Simel DL, Samsa GP, Matchar DB. Likelihood ratios with confidence: sample size estimation for diagnostic test studies. J Clin Epidemiol. 1991;44(8):763–70.

    Article  PubMed  CAS  Google Scholar 

  13. Harrell FE, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating and measuring and reducing errors. Stat Med. 1996;15:361–87.

    Article  PubMed  Google Scholar 

  14. Simel DL, Halvorsen RA, Feussner JR. Quantitating bedside diagnosis: clinical evaluation of ascites. J Gen Intern Med. 1988;3:423–8.

    Article  PubMed  CAS  Google Scholar 

  15. Turnbull JM. Is listening for abdominal bruits useful in the evaluation of hypertension? J Am Med Assoc. 1995;274:1299–301.

    Article  CAS  Google Scholar 

  16. Hasselblad V, Hedges LV. Meta-analysis of screening and diagnostic tests. Psychol Bull. 1995;117:167–78.

    Article  PubMed  CAS  Google Scholar 

  17. Scherer K, Bedlack RS, Simel DL. Simel DL, Rennie D, eds. Does This Patient Have Myasthenia Gravis? J Am Med Assoc. 2005;293:1906–14.

  18. Simel DL, DeLong ER, Feussner JR, Matchar DB. Intermediate, indeterminate, and uninterpretable diagnostic test results. Med Decis Mak. 1987;7:107–14.

    Article  CAS  Google Scholar 

  19. Holleman DR, Simel DL. Quantitative assessments from the clinical examination: how should clinicians integrate the numerous results? J Gen Intern Med. 1997;12:165–71.

    PubMed  Google Scholar 

Download references

Funding

The authors received no funding for the preparation of this manuscript.

Conflict of Interest

The authors have no financial conflict of interest with this manuscript. Drs. Simel and Rennie are the editors of the “Rational Clinical Examination Series” published in the Journal of the American Medical Association. Drs. Rennie and Bossuyt were members of the original STARD Steering Group.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to David L. Simel MD MHS.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Simel, D.L., Rennie, D. & Bossuyt, P.M.M. The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination. J GEN INTERN MED 23, 768–774 (2008). https://doi.org/10.1007/s11606-008-0583-3

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11606-008-0583-3

KEY WORDS

Navigation