A qualitative study to develop a patient-reported outcome for dysmenorrhea.

Area of Science:

• Women's Health
• Clinical Trial Methodology
• Patient-Reported Outcomes

Background:

• Dysmenorrhea, characterized by pelvic pain during menstruation, lacks adequate patient-reported outcome measures for clinical trials.
• Existing measures are insufficient for supporting labeling claims related to dysmenorrhea treatments.

Purpose of the Study:

• To develop a novel, comprehensive patient-reported outcome measure for dysmenorrhea.
• To create a tool suitable for use as a primary endpoint in dysmenorrhea clinical trials.

Main Methods:

• Thematic analysis of open-ended interviews with 52 dysmenorrhea patients informed the development of an electronic diary (eDiary).
• Pilot testing with 24 dysmenorrhea patients and cognitive interviews assessed the eDiary's content validity.
• Revisions were made to the eDiary based on patient feedback and pilot study findings.

Main Results:

• Interviews revealed that 98% of participants reported pelvic pain/cramps, impacting their quality of life.
• Pain experiences were consistent between dysmenorrhea and dysmenorrhea with pelvic pain conditions (PPC) subgroups.
• PPC patients experienced pelvic pain throughout the month, unlike those with dysmenorrhea alone.

Conclusions:

• The developed nine-item eDiary is conceptually comprehensive and user-friendly.
• The eDiary assesses menstrual bleeding, pain severity, analgesic use, and impacts on daily activities (work, school, social life, sleep).
• Ongoing psychometric validation will evaluate the eDiary's reliability, validity, and responsiveness.