Identification of Future Research Needs in the Comparative Management of Uterine Fibroid Disease. A Report on the Priority-Setting Process, Preliminary Data Analysis, and Research Plan. Effective Health Care Program Research Report Number 30

摘要

In 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) was signed into law. Section 1013 of MMA authorized the Agency for Healthcare Research and Quality (AHRQ) to conduct and support research on comparative effectiveness and clinical effectiveness, and to disseminate the findings of that research to stakeholders. AHRQ organized the Effective Health Care (EHC) Program to meet the requirements of Section 1013. The legislation also required that the needs of Medicare, Medicaid, and the Childrens Health Insurance Program drive AHRQs research priorities. The primary goals of Section 1013 are to develop valid scientific evidence about the comparative effectiveness of different treatments and appropriate clinical approaches to difficult health care problems and to make this information easily accessible to decisionmakers. The conduct of new research in areas where existing scientific evidence is insufficient to inform health care decisions is an important step to meet the goals of Section 1013. As part of the EHC program and Section 1013 of MMA, the AHRQ Effective Healthcare , DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Program developed an evidence =generation focused task order designed to revisit the current state of evidence-based research gaps in a priority population condition area of gynecological health as identified in prior AHRQ evidence based-practice center systematic reviews. AHRQ has funded this project to develop a prioritized research agenda and protocol to study the clinical and/or comparative effectiveness of uterine fibroid disease diagnosis, management, care coordination, and treatment. Uterine fibroids (leiomyomata) are the most common noncancerous tumors in women of childbearing age and the second most common reason women of reproductive age undergo surgery. Uterine fibroids, which result in more than 200,000 hysterectomies every year, have no known cause and limited treatment options. In the United States it is estimated that approximately 1 percent of women with employer-provided insurance have clinically significant uterine fibroids, and the direct costs associated with treating uterine fibroids are more than $1 billion annually. Treatment options for symptomatic uterine fibroids include watchful waiting; nonprocedural treatments (medical therapies) such as hormonal therapies, oral contraceptives, and nonsteroidal anti-inflammatory drugs; and a number of procedural treatments ranging from surgical or incisional such as hysterectomy or myomectomy, to nonsurgical (also called nonincisional or minimally invasive) such as uterine artery embolization and magnetic resonance image-guided focused ultrasound.