- •Uterine fibroids (UFs) are the most common type of benign uterine tumor; patients experience a high symptom burden that affects their health-related quality of life and activities of daily living. There is currently a need for a concise measure of cardinal UF symptoms, which is appropriate for use in clinical trials.
- •The bleeding and pelvic discomfort (BPD) scale was derived from the symptom severity scale of the Uterine Fibroid Symptom and Quality of Life questionnaire to obtain a patient-centric symptom endpoint for clinical trial use. Patient exit interviews confirmed the cardinal UF symptoms included in the BPD; its psychometric properties were found to be good, including reliability, known-groups validity, and ability to detect change.
- •The meaningful change threshold for the BPD, derived based on anchor-based methods supported by patient input, can be used to assess whether a patient is a responder to treatment, that is, experiences a relevant and meaningful improvement.
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