By age 50, half of all women will have uterine fibroids, noncancerous tumors in the uterus that can cause a variety of symptoms. KAI Research, Inc., with funding from the Focused Ultrasound Foundation, InSightec Ltd., and Philips Healthcare, is collaborating with these organizations to build a registry to collect long-term outcomes data among women who receive noninvasive treatment for their fibroids.
Symptomatic fibroids commonly cause bleeding between periods; heavy menstrual bleeding, sometimes with the passage of blood clots; menstrual periods lasting longer than normal; increased frequency of urination; and a sensation of fullness or pressure. Current treatments include watchful waiting, drug and hormone therapy, surgical removal of the fibroids by hysterectomy, and procedures such as magnetic resonance-guided focused ultrasound (“focused ultrasound”).
Focused ultrasound is a noninvasive way to treat uterine fibroids. The physician directs a focused beam of acoustic energy through the patient’s skin to destroy the fibroid without damaging nearby tissue. Researchers and physicians also use focused ultrasound to treat a variety of clinical conditions noninvasively, including breast, liver, and prostate cancer; low back pain; and brain disorders.
While treating fibroids with less invasive methods, such as focused ultrasound, has advantages, the acceptance of this technology has been slow. A primary factor limiting the adoption of focused ultrasound is a lack of widespread reimbursement for the procedure. Despite broad, published evidence supporting the safety and efficacy of focused ultrasound, payers are demanding more long-term outcomes data before they will cover the procedure.
To provide evidence and to help characterize its place in clinical practice and reimbursement policies, the Focused Ultrasound Foundation, InSightec, and Philips Healthcare have embarked on establishing a multisite, international registry titled Registry for Leiomyoma: International Efficacy of Focused Ultrasound (RELIEF). These groups are collaborating with leading physicians to conduct a 3-year observational study to assess such long-term outcomes as symptom relief, need for additional treatments, adverse events, patient satisfaction, and return to normal activities among women who undergo focused ultrasound treatment for fibroids.
In 2012, KAI began assisting with the planning phase for RELIEF. During this planning period, KAI collaborated with the partners to create the study materials and develop the Web portal that will be used to capture incoming data in multiple languages. Once enrollment begins, KAI will lead the overall operational management, monitoring activities, and data management for approximately 20 sites. Additionally, KAI will oversee the routine assessments administered to 1,000 women via the Internet over the course of three years. The resulting database is intended to provide large scale evidence on safety, efficacy, and long-term durability of this treatment.
“MR-guided focused ultrasound is a new and completely noninvasive, uterine-preserving treatment alternative to hysterectomy,” said Principal Investigator Jaron Rabinovici, MD, vice chairman of the Department of Obstetrics and Gynecology at Sheba Medical Center in Israel. “It is our hope that the RELIEF registry will help to accelerate the adoption of this option by providing additional evidence to assure payers that the treatment is not only effective in the short-term but also a long-term solution for women seeking relief from their fibroid symptoms.”
KAI Research, Inc.
Since 1986, KAI Research, Inc., a wholly owned for-profit subsidiary of Altarum Institute, has focused on providing innovative, cost-effective, and practical support to pharmaceutical, biotechnology, academic institutions and government agencies like the National Institutes of Health. KAI has experience in large-scale registries both domestically and internationally. Based on this experience, we have developed innovative and cost-effective strategies to collect registry data, allowing an accurate snapshot of patient clinical information and characteristics as well as health care services and quality over a period of time.
To learn more about our work, please contact KAI at email@example.com.