The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination
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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.
Nonsystematic review of the STARD statement.
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.
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.
KEY WORDSdiagnostic accuracy sensitivity specificity
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.
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