Establishing the content validity of the Sexual Arousal, Interest, and Drive Scale and the Hypogonadism Energy Diary.
OBJECTIVE
The aim of this qualitative analysis was to establish the content validity of two new patient-reported outcome (PRO) measures: Sexual Arousal, Interest, and Drive Scale (SAID) and Hypogonadism Energy Diary (HED).


METHODS
Four separate qualitative studies were conducted with 125 men with hypogonadism (mean age: 53 years, 85% adult onset). Study 1 used focus groups/interviews to identify important and relevant concepts related to the experience of hypogonadism and its treatment in men primarily with adult-onset hypogonadism. Study 2 tested items generated for assessments of low sex drive and low energy. Study 3 used interviews to confirm in men with early-onset hypogonadism that low sex drive and low energy were also important and relevant symptoms. Study 4 tested final versions of the two PROs and determined equivalency of paper-based and electronic versions of the two PROs.


RESULTS
Of the concepts emerging in Studies 1 and 3, low sex drive and low energy were the symptoms most often spontaneously mentioned. Coding of transcripts from Studies 1 and 3 led to the generation of items for the SAID and HED. After item testing (Studies 2 and 4), the final SAID included five items pertaining to arousal, interest in sex and sex drive with a 7-day recall period and the final HED included two items (energy, tired/exhausted) to be administered three times per day.


CONCLUSIONS
The SAID and HED have content validity established according to regulatory guidance and, therefore, the potential to provide the patient perspective of treatments for hypogonadism.
Eli Lilly and Company, Indianapolis, IN, USA.
R P
RP
Hayes
J
J
Henne
K S
KS
Kinchen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001143:Arousal / Q000502:physiology*; D017144:Focus Groups; D006801:Humans; D007006:Hypogonadism / Q000503:physiopathology*; D053609:Lethargy; D007989:Libido / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D036301:Qualitative Research; D011795:Surveys and Questionnaires; D055815:Young Adult