Validation and u.s. Population norms of health-related productivity questionnaire

American Journal of Obstetrics and Gynecology

Chen

et al. 2020

BACKGROUND: Endometriosis-related pain symptoms have a negative impact on health-related quality of life and productivity. In fact, as endometriosis-related symptom severity and the number of symptoms experienced increases, health-related quality of life decreases. Dysmenorrhea and nonmenstrual pelvic pain are prominent symptoms experienced by women with endometriosis and were shown to have improved with the oral, nonpeptide gonadotropin-releasing hormone antagonist, elagolix.

Section: Health-related Productivity Questionnairementioning

confidence: 99%

Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials

Pokrzywinski

American Journal of Obstetrics and Gynecology

Chen

et al. 2020

“…HRPQ is a 9-item questionnaire to assess loss of productivity due to absenteeism and presenteeism [ 23 ] assessed for use in women with endometriosis [ 24 ]. The questionnaire uses skip patterns to ensure that items are applicable to those who work outside the home (e.g.…”

Section: Methodsmentioning

confidence: 99%

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain

Pokrzywinski

Surrey

et al. 2020

J Patient Rep Outcomes

Background Endometriosis 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. Objectives The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain. Methods In 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. Results The 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). Conclusions PROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.

“…Patient-reported outcomes were measured as secondary outcomes in these studies. The present study evaluated change from baseline to each visit during the 6-month treatment period (Months 3 and 6) in workplace and household productivity per the Health-Related Productivity Questionnaire (HRPQ) [19]. Outcomes of patients in the extension period were not evaluated in this analysis.…”

Section: Methodsmentioning

confidence: 99%

Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials

Surrey

Palac

et al. 2019

Patient

BackgroundEndometriosis profoundly impairs women’s workplace and household productivity.ObjectiveThe aim of this study was to evaluate the impact of elagolix on endometriosis-related workplace and household productivity losses.MethodsData were pooled from two phase III trials of women aged 18–49 years with moderate to severe endometriosis-associated pain treated for 6 months with elagolix 150 mg daily (QD), 200 mg twice daily (BID), or placebo. The Health-Related Productivity Questionnaire was administered at baseline, Month 3, and Month 6 to determine workplace and household absenteeism and presenteeism. Productivity changes from baseline were compared between placebo and elagolix doses via analysis of covariance.ResultsWorkplace analyses included 1270 employed women and household analyses included 1565 women. At baseline, women reported average weekly losses of 16 workplace hours, 8.3 household work hours, 45% of scheduled work, and 64% of planned household chores. At Month 6, treatment with elagolix 150 mg QD or 200 mg BID increased productive workplace hours by 1.7 (95% CI 0.1–3.4; p = 0.041) and 5.4 h (95% CI 3.7–7.1; p < 0.001) relative to placebo, corresponding to gains of 5.2% (95% CI 0.7–9.7; p = 0.022) and 14.6% (95% CI 10.0–19.1; p < 0.001) of scheduled work, respectively. Both elagolix doses improved household productivity at Month 6 by 1.7 (95% CI 0.7–2.7) and 3.1 (95% CI 2.1–4.0) hours relative to placebo (both p < 0.001), with increases of 8.8% (95% CI 3.5–14.1; p = 0.001) and 20.4% (95% CI 15.1–25.6; p < 0.001) of planned household work.ConclusionsTreatment with elagolix improved endometriosis-related workplace and household productivity impairments.Trial RegistrationELARIS EM-I (NCT01620528) and ELARIS EM-II (NCT01931670)