Quintiles study to examine uterine fibroid treatments effectiveness in real-world practice
By Mia Burns
The Patient-Centered Outcomes Research Institute has granted the contract research organization Quintiles a research award to compare the effectiveness of treatments for uterine fibroids, a common condition affecting women of childbearing age. The study is part of a portfolio of patient-centered research that addresses PCORI’s national research priorities. The goal is to provide patients and their caregivers with information that will help them make better-informed care decisions. Associate Web Editor Mia Burns interviewed Richard Gliklich, MD, president, Quintiles Outcome, the real-world and late phase division of Quintiles.
Q: Can uterine fibroids affect fertility?
A: Uterine fibroids can affect fertility. Fibroids are associated with some cases of infertility, and they may contribute to adverse reproductive outcomes, including miscarriage, preterm birth, and an increased risk of cesarean delivery. However, there is some uncertainty about the association between fibroids and adverse reproductive outcomes due to the limited number of long-term studies in this area. In addition, there is a lack of evidence on the effect of some uterus-conserving treatment options on fertility.
Q: Is part of the study’s objectives to find treatment options other than surgery and full hysterectomies?
A: The study’s objective is to provide evidence about current treatment options to help patients and providers make more informed treatment decisions. The study will examine uterus-conserving procedures, such as myomectomy, uterine artery embolization; MR guided focused ultrasound, and endometrial ablation, as well as hysterectomy. In our discussion with stakeholders, patients and providers expressed a strong demand for alternatives to hysterectomy, either to preserve future childbearing potential or for other reasons. However, the selection of uterus-conserving treatment options is complicated by the lack of information on long-term outcomes. In this study, we will compare the effectiveness of uterus-conserving options, both against each other and against hysterectomy, in terms of relative durability of symptom relief and relative likelihood of subsequent procedures. Both of these outcomes were cited as the top research priorities during the stakeholder-driven priority-setting project that we conducted for the Agency for Healthcare Research and Quality in 2010.
Q: What is the current standard of treatment for uterine fibroids?
A: Several treatment options exist for uterine fibroid disease. However, there is almost no evidence on the relative effectiveness of these options, and, as a result, there are no treatment guidelines. Treatment decisions vary depending on symptom severity and patient preferences, with desire for future childbearing a major factor.
Q: What are some of the reasons why African-American women may be affected more than women of other ethnicities?
A: Studies to date have found that African-American women consistently develop symptomatic fibroids at younger ages and may have more severe symptoms. However, little is known about why African-American women are affected more than women of other ethnicities. In fact, little is known about the etiology and natural history of the disease generally. Additional research is needed in this area.
Q: Is Quintiles looking to identify treatment plans that would be less expensive?
A: This study is not designed to compare the costs of the various treatment options. However, by providing evidence to support informed treatment decisions, the study may help patients avoid the need for subsequent procedures, which would in turn reduce the costs of managing the disease.
Posted: August 2013