Predictive value of autoantibody testing for validating self-reported diagnoses of rheumatoid arthritis in the Women's Health Initiative.

Rheumatoid arthritis (RA) research using large databases is limited by insufficient case validity. Of 161,808 postmenopausal women in the Women's Health Initiative, 15,691 (10.2%) reported having RA, far higher than the expected 1% population prevalence. Since chart review for confirmation of an RA diagnosis is impractical in large cohort studies, the current study (2009-2011) tested the ability of baseline serum measurements of rheumatoid factor and anti-cyclic citrullinated peptide antibodies, second-generation assay (anti-CCP2), to identify physician-validated RA among the chart-review study participants with self-reported RA (n = 286). Anti-CCP2 positivity had the highest positive predictive value (PPV) (80.0%), and rheumatoid factor positivity the lowest (44.6%). Together, use of disease-modifying antirheumatic drugs and anti-CCP2 positivity increased PPV to 100% but excluded all seronegative cases (approximately 15% of all RA cases). Case definitions inclusive of seronegative cases had PPVs between 59.6% and 63.6%. False-negative results were minimized in these test definitions, as evidenced by negative predictive values of approximately 90%. Serological measurements, particularly measurement of anti-CCP2, improved the test characteristics of RA case definitions in the Women's Health Initiative.