Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2009
Diagnostic test validation: cochlear hydrops analysis masking procedure in Ménière's disease.
Клиническое исследование II фазыСтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Ordóñez-Ordóñez Leonardo Elías, Rojas-Roncancio Eveling, Hernández-Alarcón Víctor, Jaramillo-Safón Rafael, Prieto-Rivera Jose, Guzmán-Durán Jose, Lora-Falquez Jose, Escobar Marcela, Angulo-Martínez Esther Sofía
Аннотация
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.
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.