Diagnostic test validation: cochlear hydrops analysis masking procedure in Ménière's disease.

Objective: To determine the diagnostic value of the cochlear hydrops analysis masking procedure (CHAMP) in patients with definite Ménière's disease.

Study Design: Prospective validation study for a diagnostic test, study phase 2.

Setting: Tertiary referral centers.

Patients: Subjects with definite Ménière's disease (Group 1), differential diagnosis (Group 2: another audiovestibular diseases or neurologic disorders), and normal hearing (Group 3) were included. Sample sizes were calculated.

Interventions: Study test (CHAMP) was compared with the current clinical criterion standard described by the guidelines of the American Academy of Otolaryngology-Head and Neck Surgery.

Main Outcome Measure: Sensitivity, specificity, and other indicators of diagnostic validation.

Results: One hundred ten cases completed the follow-up, and their results are presented. Sensitivity at 31.3% and specificity at 100% were found in subjects with definite Ménière's disease, features that are more helpful in confirming the diagnosis than in rejecting it. Group 1 showed significantly shorter latency delays than Groups 2 and 3 (p < 0.001).

Conclusion: If definite Ménière's disease is suspected, an abnormal result confirms the diagnosis; however, a normal result does not rule out the Ménière's disease diagnosis.