Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm

Journal of Patient-Reported Outcomes

Table 5 FSDS-DAO versus specified PRO measures (evaluable mITT sample)

Comparator	Spearman’s rank correlation coefficient
Comparator	End of baseline placebo self-dosing (N = 323)	End of double-blind study-drug use (N = 309)
FSFI total	− 0.65^b	− 0.66^b
FSFI desire	− 0.58^b	− 0.63^b
FSFI arousal	− 0.59^b	− 0.64^b
FSFI lubrication	− 0.44^b	− 0.41^b
FSFI orgasm	− 0.43^b	− 0.55^b
FSFI satisfaction	− 0.67^b	− 0.66^b
FSFI pain	− 0.17^c	− 0.22^b
GAQ Q1 (satisfaction with arousal)	− 0.46^b	− 0.57^b
GAQ Q2 (satisfaction with desire)	− 0.45^b	− 0.56^b
GAQ Q3 (benefit from study drug)	− 0.41^b	− 0.54^b
WITS-9 total	− 0.55^b	− 0.64^b
Number of SSEs per month^a	− 0.42^b	− 0.32^b

FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm; FSFI = Female Sexual Function Index; GAQ = General Assessment Questionnaire; mITT = modified intent-to-treat; PRO = patient-reported outcome; Q = Question; SSEs = satisfying sexual events; WITS = Women's Inventory of Treatment Satisfaction
^aN = 314 at end of baseline and 267 at end of double-blind treatment
^bP < 0.001
^cP < 0.01