How a direct connection to engaged individuals makes it possible to understand and characterize health and quality of life

Background and Challenge

• 70% of women experience UF by age 50
• 20-50% experience clinical symptoms that impact daily life
• Pain and heavy menstrual bleeding (HMB) are the most common symptoms

Limited evidence exists about the burden of UF on patients’ lives through prospective, observational studies.

A large pharmaceutical company approached us to conduct a real-world study of women living with UF to:

• Measure the severity of their pain
• Describe the use of medication to treat UF pain, especially among those with heavy periods and more serious pain
• Understand the impact of UF pain on their quality of life, work, and productivity

Approach

Recruitment:

• Using its digital health platform, Evidation recruited, consented, and enrolled 350 women living with UF, HMB, and moderate-to-severe pain for a 4-month prospective study to assess the burden of pain and how this pain is treated.
• We used additional channels including social media and advocacy groups to reach non-Evidation members.

Surveys:

• Participants took daily surveys about their worst UF-associated pain (NRS), the severity of their menstrual bleeding, and their use of pain medication.
• Participants completed a weekly Work Productivity and Activity Impairment Questionnaire (WPAI-UF) to report missed work hours, productivity loss, and activity impairment.
• Additionally, participants took a monthly UFS-QoL-SS scale survey.

Claims Data:

• To track pain medication usage, we looked back at pharmacy claims data for 20 months before the study started, and also during the 4 months of the study period.

Participant Support and Communication:

• Participants received personalized text and email reminders to encourage survey completion.

Results

The company was aware that up to 70% of women face UF by the age of 50, and 20-50% of them have significant symptoms that really disrupt daily life. However, there was a noticeable lack of long-term, real-world studies giving us insight into patients’ experiences of pain due to UF. This study filled that gap in evidence. We found:

• Participants reported significant symptoms and severe pain from UF
• Symptoms often start early in life, however, women aren’t diagnosed for an average of 9 years after symptoms begin
• 65% managed their UF-associated pain with over-the-counter medications and oral contraceptives
• 54% did not receive any treatment for their HMB
• Over 80% did not pursue surgical treatment options for UF Participants experienced significant work impairment
  - 36% reported UF symptoms impaired their productivity during work (presenteeism)
  - 3.3% missed work days due to UF symptoms (absenteeism)

More results available in publication.

Evidation Differentiators

Evidation successfully met the pharmaceutical company’s goals more effectively than traditional methods:

• Low burden digital health platform: Using its platform, Evidation recruited, consented, and enrolled participants from among the Evidation community, an engaged, research-motivated population. This means individuals participate remotely, eliminating the need for inconvenient, frequent in-person visits to a clinic.
• Diverse recruitment channels: In addition to traditional clinic-based recruitment, Evidation recruited participants from channels such as social media and advocacy groups to reach a broader population, including non-Evidation members. This ensured a more diverse and representative study cohort.
• Participant engagement methods: The pharmaceutical company had continuous insight about daily lived experiences of patients and their perceived burden of pain due to Evidation’s ability to maintain participant engagement.