Introduction: Because the current instruments used for assessing hypogonadal symptoms in men lack sufficient measurement properties, this quantitative validation study was undertaken of a new self-report instrument (HG Screener). The HG Screener was created to identify men with symptoms of hypogonadism (HG), which is a clinical disorder caused by lowered testosterone levels and characteristic signs and symptoms associated with those low testosterone levels.
Methods: There were 16 clinical sites involved in this psychometric validation study that included 131 men. Of the men, 82 were hypogonadal (total T ≤ 10.5 nmol/L) and 49 were controls (total T > 10.4 nmol/L); they were between the ages of 21 and 75.
Men participating in the study had 2 visits (separated by 2 to 4 weeks). Each visit involved filling out the HG Screener, as well as 7 other validated questionnaires.
Results: Through factor analysis, 5 functional factors or domains were identified. The final screening instrument has 25 items:
This new HG Screener has strong psychometric properties, in addition to good internal consistency. This study also showed that the HG Screener has good test-retest reliability.
Conclusions: The HG Screener is now available for clinical or research use after being validated by FDA standards.
Commentary by Glenn R. Cunningham MD