The NERI Hypogonadism Screener: Psychometric Validation in Male Patients and Controls
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:
- 18 functional items in 5 core domains. Those domains are: sexual function, mood, memory, sleep function, and fatigue).
- 7 physical symptom 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.
Male hypogonadism is characterized by signs and symptoms of androgen deficiency and the presence of low testosterone levels. Diagnosis can therefore be challenging, given the subjectivity of a patient’s physical symptoms. Previous screening tools have had poor specificity.
The HG Screener is a self-assessment tool created to better identify hypogonadal men. A psychometric validation study was performed at 16 clinical sites with 131 men and twenty five key functional factors and physical symptoms subsequently were identified.
This questionnaire was validated according to FDA standards in both a qualitative study as well as a secondary quantitative, psychometric study in hypogonadal patients and age-matched controls. The HG Screener was found to be reliable with very high internal consistency. Further validation studies are still needed to determine its diagnostic accuracy in patients with other co-morbidities, such as depression and metabolic syndrome. This useful diagnostic tool is currently available for both clinical and research use. It has not been validated to assess testosterone replacement therapy.