Patient Perspective in Endometriosis and Clinical Trial Barriers
Author(s)
Mulvihill E1, Bates D2, Nash R3, Drakeley S3, Sternbach N4
1Oracle Life Sciences, St. Louis, MO, USA, 2Oracle Life Sciences, Webster, NY, USA, 3Oracle Life Sciences, Austin, TX, USA, 4Oracle Life Sciences, Malvern, PA, USA
Presentation Documents
OBJECTIVES: Endometriosis is an under reported disease, of unknown etiology. While endometriosis is actively being studied, barriers prevent participation in clinical trial research. Our previous work showed that endometriosis patients can provide meaningful and significant input on trial design leading to important and impactful adjustments, improvements to the study, and reduced participation barriers. This study characterized the US adult endometriosis population on disease burden and willingness to participate in clinical studies.
METHODS: We analyzed data from 2022 US National Health and Wellness Survey (NHWS), a self-administered, nationally-representative, cross-sectional online survey. Women (aged 18-50) never experienced endometriosis (n=13,693) were compared to those diagnosed with endometriosis (n=410); diagnosed medication users (UseRx, n=139) were compared to nonmedication users (NoRx, n=271). Peri/menopausal women were excluded. Variables included sociodemographic and health characteristics, PAM, GAD-7, PHQ-9, RAND-36, past 6-month HCRU, and attitudes towards clinical trials.
RESULTS: Endometriosis patients were White (59.8%), Hispanic (21.0%), African American (9.0%), college educated (45.6%), and insured (88.8%); 41.0% saw a gynecologist in the past six months. Diagnosed patients scored lower (worse) in all RAND-36 domains compared to those without endometriosis, higher rate of score 5+ on PHQ-9 and GAD-7 (PHQ-9: 72.9% vs 60.6%; GAD-7:69.8% vs 59.4%) and tended to lack reliable transportation (22.9% vs 16.5%). UseRx reported greater severe severity of the disease (69.1% vs 24.4%), fewer indicated PAM level 4 and higher HCRU (ER visits: 36.7% vs 26.9%; Hospitalized: 23.7% vs 14.4%) compared to NoRx. Despite burden, almost half (48.8%) of endometriosis patients were willing to participate in a clinical trial, with UseRx more willing than NoRx (51.1% vs. 47.6%).
CONCLUSIONS: Women with high endometriosis disease burden are willing to participate in clinical trials. Clinical trial designers should consider the voiced needs of these patients, acknowledging depression, anxiety, lack of reliable transportation, lower activation in managing their health, and willingness to discontinue current medication.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 6, S1 (June 2024)
Code
PT45
Topic
Patient-Centered Research, Study Approaches
Topic Subcategory
Patient Engagement, Patient-reported Outcomes & Quality of Life Outcomes, Surveys & Expert Panels
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Reproductive & Sexual Health