Patient-centered research in uterine fibroids

“Both hysterectomy and myomectomy are reasonable options,” said Wanda Nicholson, MD, MPH, MBA, a professor of ob/gyn at the University of North Carolina in Chapel Hill.

Wanda Nicholson, MD, MPH, MBA

Nicholson spoke on the COMPARE-UF Experience at the 2021 Fibroid Summit, sponsored by The Fibroid Foundation and the Campion Fund. She is 1 of 8 principal investigators of the project, with her clinical site being the University of North Carolina (UNC) Medical Center in Chapel Hill.

“In 2015, COMPARE-UF Experience convened a group of principal investigators from across the United States with similar, as well as distinct differences, in our clinical perspectives on uterine fibroids, the type of patients we provided care to and the indications for surgical interventions for uterine fibroids,” Nicholson told Contemporary OB/GYN.

Among the components of an effective physician/patient relationship are understanding patient needs and the legacy of patient fear, plus being educated on all treament options.

The COMPARE-UF Experience evaluates the effectiveness of surgical options, with patient-centered, health-related quality of life as the primary outcome of interest.

“Prior clinical trials comparing surgical interventions, such as hysterectomy, myomectomy and ablation, or the surgical approach, like abdominal or minimally invasive, have centered on traditional clinical outcomes, including blood loss, surgical complications and length of hospital stay,” Nicholson said.

The COMPARE-UF Experience incorporates both traditional clinical outcomes and health-related quality of life. “The collaboration between our patient advisory board and team of investigators was one of the unique and important aspects of the endeavour,” said Nicholson, who also serves as director of Diabetes and Obesity Core at the Center for Women’s Health Research at the UNC.

The project encompasses all key stakeholders: advocacy groups, the life sciences industry, clinicians and professional societies, federal agencies, and payer and health systems.

Patient enrollment began in November 2015 and was completed in March 2019. Among the 3,097 women undergoing UF procedures, 42% were Black, 40% were aged 40 or older and 16% were age 35.

The 7 procedues captured were hysterectomy, myomectomy, laparoscopic radiofrequency (RF) ablation, endometrial ablation, uterine artery embolization, magnetic resonance (MR)-guided focused ultrasound and progestin-releasing intrauterine device (IUD).

Of the patient cohort, 46% had myomectomy (14% abdominal, 19% laparoscopic/robotic, 13% abdominal) and 38% hysterectomy.

Women undergoing hysterectomy or myomectomy had a significant 30+ point increase in health-related quality of life scores (higher scores = better quality of life) and a significant reduction of 30 to 40 points in symptom severity (lower score = less severity of symptoms) at 1-year post surgery.

“These improvements in quality of life and symptom severity were observed for both abdominal and minimally invasive surgery,” Nicholson said.

In addition, both Black and White women achieved equal improvement in quality of life and symptom severity at 1-year post procedure.

“Future studies that provide longer follow up will help to further inform patient counseling and decision making for fibroid therapy,” Nicholson said.

One of the future goals of COMPARE-UF Experience is to secure additional funding so that existing patients can be monitored for the next 3 to 5 years to assess long-term quality of life.

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Disclosure

Nicholson received support for her role in COMPARE from the Patient-Centered Outcomes Research Institute (PCORI) and the Agency for Health Care Research and Quality (AHRQ).