Abstract
BackgroundEndometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials.ObjectivesThe study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.MethodsIn a phase III double-blind, placebo-controlled clinical trial (NCT01620528), women aged 18–49 years with moderate-to-severe endometriosis-related pain were randomized to elagolix 150 mg once daily, elagolix 200 mg twice daily, or placebo for 6 months. PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6. Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness were evaluated.ResultsThe analysis included 871 women, mean age 31.5 years. Internal consistency supported a single concept (Cronbach’s alpha 0.93). For the 238 patients with no change in PGIC at month 1, the intraclass correlation coefficient for the PROMIS Fatigue T-score was 0.7 and paired t-test statistically significant (2.84, p = 0.0049). Correlations with other measures were expected to be fairly low as concepts were not redundant. The PROMIS Fatigue discriminated among known groups with mean scores of 55.3, 62.3, and 65.8 at month 3 (PGIC improvement, no change, worsening, respectively). Statically significant discrimination, and change score responsiveness, were seen using clinically relevant anchors (dysmenorrhea and NMPP) at months 3 and 6 between responders and non-responders. Anchor-based (PGIC) responsiveness showed significant improvement from baseline to months 3 and 6 (p < 0.0001).ConclusionsPROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.
Highlights
Endometriosis is a common problem in women of reproductive age and has impacts on healthrelated quality of life and productivity
Items include (1) “I feel fatigued”; (2) “I have trouble starting things because I am tired”; (3) “How run-down did you feel on average”; (4) “How fatigued were you on average?”; (5) “How much were you bothered by your fatigue on average?”; (6) “To what degree did your fatigue interfere with your physical functioning”
The mean Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue T-score at baseline was 63.3 (7.7). Sample characteristics This analysis included the 871 participants enrolled in the EM-I trial who received at least one dose of study treatment or placebo (Table 1)
Summary
Endometriosis is a common problem in women of reproductive age and has impacts on healthrelated quality of life and productivity. In addition to pain and bleeding, fatigue is experienced by 50%–87% of women with endometriosis and is considered by women to be one of the most burdensome symptoms [3,4,5]. Due to these symptoms, and their association with infertility, endometriosis has far-reaching consequences on a woman’s health-related quality of life, interfering with marital and sexual relationships, social life, employment, physical activities, and psychological function [4,5,6,7,8,9,10,11]. The Patient-Reported Outcome Measurement Information System (PROMIS), includes fatiguerelated item banks and several fatigue short forms that have been developed and assessed for performance in chronic conditions [15]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
