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  • Research on the Comparative Management of Uterine Fibroid Disease

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Abstract - Draft – Jan. 19, 2010

Research on the Comparative Management of Uterine Fibroid Disease

Topic Abstract

Background: Uterine fibroids (leiomyomata) are the most common, non-cancerous tumors in women of childbearing age and the second most common reason women of childbearing age undergo surgery. Despite the prevalence and possible complications of uterine fibroids, the currently available evidence-based literature is insufficient to provide information about the burden, etiology, natural history, and recurrence of disease; choice and timing of existing therapeutic interventions and new technological advances (radiological, medical, and surgical); and care coordination and longitudinal management of the disease process itself. The lack of evidence makes it difficult for decision-makers to draw conclusions about the relative benefits, harms, or costs of treatments and to select appropriate treatments.

Objectives: The purpose of this project is to develop a research plan to study the clinical effectiveness and/or comparative effectiveness of uterine fibroid disease, its diagnosis, management, care coordination, and treatment approaches. The specific objectives of the project are:

  1. Develop a consultative partnership with multiple stakeholders including key technical experts to identify clinical problems for which new research will inform treatment decisions for patients and providers.
  2. Identify, in partnership with stakeholders, clinically- or policy-relevant research questions related to the burden of uterine fibroid disease, natural history, clinical symptoms and presentation, medical and surgical management, care coordination and short-term and longitudinal outcomes of uterine fibroid disease for select fibroid subtypes.
  3. Prepare a white paper describing the research development process and the components and requirements for the development of a prioritized prospective clinical research agenda.
  4. Design, in partnership with stakeholders, researchers, and AHRQ, a research protocol and comprehensive analytic plan to evaluate major research questions using various approaches for a multi-center prospective study of the comparative effectiveness of diagnosis, management, care coordination, and/or treatment of uterine fibroids.
  5. Conduct a preliminary analysis of existing data to inform the protocol development and assess the prioritized comparative effectiveness research questions identified by stakeholders.
  6. Disseminate, in collaboration with AHRQ and its resources, the project findings to stakeholder partners and other stakeholder groups.

Expected Outputs: White paper and study protocol

Expected Date of Project Completion: November 2010

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