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Comparing patient-centered outcomes after treatment for uterine fibroids
Investigator (PI): Velentgas, Priscilla
Performing Organization (PO): (Current): IQVIA / (617) 475-6500
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2017
Record Source/Award ID: PCORI/CE-12-11-4430
Funding: Total Award Amount: $1,087,995
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Uterine fibroids are common, benign tumors that can cause severe symptoms in women of childbearing age. They affect African American women more than women of other races. More than $4 billion is spent each year treating fibroids in the United States. Even though fibroids are common and can cause severe symptoms, there is little scientific evidence about which treatment options are better than others. Treatment options include hysterectomy, which is the surgical removal of the uterus; other types of surgical procedures that do not involve removing the uterus; and medications. In 2010, we asked many different types of stakeholders to prioritize research questions related to the treatment of fibroids. These questions provide the basis for our proposed study. Objectives: Through a process that incorporates the perspectives of many stakeholders, we will focus on three objectives: (1) we will estimate how long treatment effects (that is, relief from symptoms) last for treatments other than hysterectomy. We will estimate this by measuring how many subsequent procedures women have after the first treatment and examining whether this is affected by the types of symptoms a woman is experiencing, her demographic characteristics, or the severity of her disease; (2) we will estimate how long treatment effects last for all treatments (including hysterectomy), as measured by the return of symptoms after the initial treatment. Again, we will look at whether this is affected by symptom type, patient characteristics, and severity of disease; and (3) we will examine how having stakeholders involved in the research process affects the study results and interpretation. Methods: We will use two existing data sets for this study. First, we will analyze a database of electronic medical records that are linked to insurance data. More than 13,000 patients in this database have a diagnosis of uterine fibroids. For these patients, we will be able to analyze patient demographics, diagnoses and symptoms, treatments, and laboratory results. Second, we analyze electronic medical records from a network of health systems. More than 20,000 women in this database have a diagnosis of uterine fibroids. For these patients, we will be able to examine records from hospitals as well as other settings, such as clinics or physician offices. We will use appropriate biostatistical methods for these analyses. To examine the impact of stakeholder participation, we will analyze the data using the researchers' original plans, analyze the data again using a plan modified with stakeholder suggestions, and compare the results. We will engage stakeholders throughout the study to help us refine the research plan and decide how to communicate the results. Projected patient outcomes: The main outcome will be length of treatment effect after various treatments for fibroids. We selected this outcome based on a prioritization process that incorporated the perspectives of multiple stakeholders.
MeSH Terms:
  • Databases, Factual
  • Electronic Health Records
  • Female
  • Humans
  • Insurance, Health /statistics & numerical data
  • Leiomyoma /*therapy
  • * Outcome Assessment, Health Care
  • Patient-Centered Care /*organization & administration
  • Time Factors
  • United States
Country: United States
State: Massachusetts
Zip Code: 02138
UI: 20143198
Project Status: Completed
Record History: ('2017: Project extended to 2017.',)