Validation of the Ménière's Disease Patient-Oriented Symptom-Severity Index.

OBJECTIVE: To validate a disease-specific, health-related quality-of-life instrument for people with active, unilateral, cochleovestibular Ménière's disease (MD).

DESIGN: Prospective, blinded, randomized cohort study using a 16-item instrument, the Ménière's Disease Patient-Oriented Symptom-Severity Index (MDPOSI), version 2.

SETTING: Four clinical sites, including 3 university hospitals and 1 private practice.

PARTICIPANTS: Sixty-one adult participants in a clinical trial of a new treatment modality (the Meniett device) at 4 medical centers.

INTERVENTION: The MDPOSI was administered at baseline and at 2 and 4 months after the use of the Meniett device or the placebo.

MAIN OUTCOME MEASURES: Each item, domain, and overall MDPOSI score was compared with self-reported cumulative frequency of definitive attacks of vertigo at baseline and 2 and 4 months later.

RESULTS: The MDPOSI global score, domain scores, and 13 of 16 items were significantly associated with the frequency of vertigo (gold standard) as noted on the daily symptom report card.

CONCLUSIONS: The MDPOSI is a valid and reliable instrument to evaluate the impact of MD on patients' disease-related quality of life, and it is responsive to change in the status of the disorder. The MDPOSI is suitable for use in clinical practice and clinical research in people with MD.