The NERI Hypogonadism Screener: psychometric validation in male patients and controls

OBJECTIVE: Hypogonadism (HG) is a clinical disorder consisting of reduced testosterone (T) levels and characteristic signs and symptoms of low T. Current instruments used to assess hypogonadal symptoms in men lack adequate measurement properties. To present data on the quantitative validation of a new self-report instrument (HG Screener) developed to identify men with symptoms of HG. DESIGN: This is a psychometric validation study conducted at 16 clinical sites across the Unites States. Subjects completed two visits separated by 2-4 weeks. PATIENTS: One hundred and thirty-one men (82 hypogonadal patients with total T≤10·4 nmol/l and 49 controls with total T>10·4 nmol/l) aged 21-75 years were enrolled. MEASUREMENTS: Self-reported assessments including the HG Screener (at both visits) along with seven validated questionnaires. RESULTS: The results of a factor analysis identified five functional factors or domains. The resulting instrument contains 25 items consisting of 18 functional items in five core domains (sexual function, mood, memory, sleep function and fatigue) and seven physical symptom items. Overall, the new instrument was found to have strong psychometric properties, including acceptable discriminant, construct and content validity, as well as good internal consistency and test-retest reliability. CONCLUSIONS: A new screening tool (HG Screener) for identifying men with HG has been developed and validated according to FDA standards. This new instrument possesses acceptable psychometrics and is available for clinical or research use.