Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

ABSTRACT:

Aim

The aim of this study was to perform psychometric testing and estimate minimal important change (MIC) of two new patient-reported outcome (PRO) instruments - Sexual Arousal, Interest and Drive Scale (SAID) and Hypogonadism Energy Diary (HED).

Methods

New PRO instruments were administered immediately after screening (Time 1, test-retest subset only) and immediately prior to both randomisation (Time 2) and end-point (Time 3) to men participating in a randomised clinical trial comparing the effect of testosterone solution 2% (TS) and placebo on serum total testosterone. Psychometric analyses included reliability, validity and responsiveness. Total scores for both PRO instruments were transformed to a 0-100 scale.

Results

Study participants (n = 694) were 80% age ≤ 65

SUBMITTER: Hayes RP 

PROVIDER: S-EPMC5089588 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature