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Rigorous New Approach to Constructing a Gold Standard for Validating New Diagnostic Criteria, as Exemplified by the Eosinophilia-Myalgia Syndrome
Phillip A. Hertzman, MD;
Daniel J. Clauw, MD;
Joseph Duffy, MD;
Thomas A. Medsger, Jr, MD;
Alvan R. Feinstein, MD
Arch Intern Med. 2001;161:2301-2306.
Background Constructing diagnostic criteria, a common problem in clinical medicine,
is particularly difficult for diseases that lack a pathognomonic "gold standard."
To develop an improved strategy for constructing such criteria, we used the
eosinophilia-myalgia syndrome as an example. The goal, for research classifications,
was to construct validated clinically sensible criteria and to develop improved
methods that can be used for other disorders.
Methods Using a "pattern-based" approach with data from several separate sources,
a committee of investigators first prepared and informally tested criteria
for the diagnosis of eosinophilia-myalgia syndrome. A gold standard challenge
set of reports of cases and noncases was independently generated and separately
validated by an external panel of clinical experts. The criteria were then
tested using the gold standard set, and interobserver variability and diagnostic
accuracy were determined.
Results Interobserver variability showed the following mean proportionate agreements:
98.7% for the presence of specific criteria elements, 99% to 100% for diagnosis,
and 97% to 98% for diagnostic pattern.  Values were correspondingly
high. Diagnostic accuracy showed sensitivity at 88%, specificity at 97%, and
overall accuracy at 92%.
Conclusions The proposed criteria are accurate and reproducible, and can be used
in future clinical investigations of the eosinophilia-myalgia syndrome. The
new strategy and methods developed for this challenge can be valuable for
solving analogous problems in constructing criteria for other clinical disorders.
From the Los Alamos Medical Center, Los Alamos, NM (Dr Hertzman); Division
of Rheumatology, Immunology, and Allergy, Department of Medicine, Georgetown
University School of Medicine, Washington, DC (Dr Clauw); Division of Rheumatology,
Department of Internal Medicine, Mayo Clinic, Rochester, Minn (Dr Duffy);
Division of Rheumatology and Clinical Immunology, Department of Medicine,
University of Pittsburgh School of Medicine, Pittsburgh, Pa (Dr Medsger);
and Department of Internal Medicine and Epidemiology, Yale University School
of Medicine, New Haven, Conn (Dr Feinstein).
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