Developing a New Reference Standard: Is Validation Necessary?

Gold, Rachel; Reichman, Melissa; Greenberg, Edward; Ivanidze, Jana; Elias, Elliott; Tsiouris, Apostolos J.; Comunale, Joseph P.; Johnson, Carl E.; Sanelli, Pina C.

doi:10.1016/j.acra.2010.05.021

« Previous Next »Academic Radiology
Volume 17, Issue 9 , Pages 1079-1082, September 2010

Developing a New Reference Standard:

Is Validation Necessary?

Rachel Gold, BA
- New York College of Osteopathic Medicine, Old Westbury, NY
- Address correspondence to: R.G.
Melissa Reichman, MD
- Department of Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065
Edward Greenberg, MD
- Department of Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065
Jana Ivanidze, MD
- Ludwig Maximilians University of Munich, Munich, Germany
Elliott Elias, MD, MPH
- Boston University School of Medicine, Boston, MA
Apostolos J. Tsiouris, MD
- Department of Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065
Joseph P. Comunale, MD
- Department of Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065
Carl E. Johnson, MD
- Department of Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065
Pina C. Sanelli, MD, MPH
- Department of Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065
- Department of Public Health, Weill Cornell Medical College, New York Presbyterian Hospital, 525 East 68th Street, Starr 8A, New York, NY 10065

Received 30 October 2009; accepted 25 May 2010.

Rationale and Objectives

A gold standard is often an imperfect diagnostic test, falling short of achieving 100% accuracy in clinical practice. Using an imperfect gold standard without fully comprehending its limitations and biases can lead to erroneous classification of patients with and without disease. This will ultimately affect treatment decisions and patient outcomes. Therefore, validation is essential before implementing a reference standard into practice. Performing a comprehensive validation process is discussed, along with its advantages and challenges. The different types of validation methods are reviewed. An example from our work in developing a new reference standard for vasospasm diagnosis in aneurysmal subarachnoid hemorrhage patients is provided.

Conclusion

Employing a new reference standard may result in a definitional shift of the disease and classification scheme of patients; therefore, it is important to also assess the impact of a new reference standard on patient outcomes and its clinical effectiveness.

Key Words: Vasospasm, validation, gold standard

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This publication was made possible by Grant Number 5K23NS058387-02 from the National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NINDS or NIH.

Conflict of interest: None.

PII: S1076-6332(10)00305-3

doi:10.1016/j.acra.2010.05.021

« Previous Next »Academic Radiology
Volume 17, Issue 9 , Pages 1079-1082, September 2010

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