Results Summary

What was the research about?

Uterine fibroids are growths in the uterus that are not cancer. They are one of the most common and costly health problems in women of childbearing age. Fibroids are most common in women aged 35 to 45. More research is needed to know the benefits and risks of these treatments.

In this study, the research team compared the health records for women who received one of three treatments. All three of these treatments try to save as much of the uterus as possible. The research team wanted to learn how well the treatments delayed new or recurring symptoms and helped patients avoid follow-up treatments. The three treatments were

  • Endometrial ablation. This is surgery to destroy a thin layer of the lining of the uterus (called the endometrium) to stop bleeding caused by uterine fibroids. This treatment is the most common of the three.
  • Myomectomy. This is surgery to remove uterine fibroids (also called myomas).
  • Uterine artery embolization. This is surgery to block the flow of blood to uterine fibroids. This treatment causes the fibroids to shrink.

What were the results?

  • New or recurring symptoms. All three treatments worked about the same to prevent or delay new or recurring symptoms.
  • Having follow-up treatments: Both uterine artery embolization and myomectomy were somewhat better than endometrial ablation at helping patients avoid follow-up treatments.

Who was in the study?

The research team looked at electronic medical records and insurance claims for 12,234 patients who received treatment for uterine fibroids. The average patient age was 44.

What did the research team do?

The research team used information from two large national data networks. The team looked at records for patients who had uterine fibroids and received one of the three treatments between January 1, 2005, and December 31, 2011. The electronic medical records and insurance claims had no information that could identify the patients. The research team used at least two years of health record data for each patient.

The research team worked with women who had uterine fibroids, doctors, and health insurers to plan the study. This group helped make sure the research focused on what was most important to them.

What were the limits of the study?

This study used treatment information from electronic medical records and insurance claims. Sometimes there are problems in using this information for health research. For example, some information was missing. Also, different electronic records recorded information in different ways. Finally, the records didn’t give reasons for why patients had certain treatments. These limits are common in studies that use electronic medical records and insurance claims.

Future studies could track patients who are currently getting treatment for uterine fibroids. The studies could look at information not often noted in medical records. This information could include patients’ reasons for choosing certain treatments.

How can people use the results?

Women with uterine fibroids and their doctors may consider using the results from this study when they talk about treatment options.

Final Research Report

View this project's final research report.

More to Explore...

Related PCORI Dissemination and Implementation Project

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

The awardee made the following revisions in response to peer review:

  • The awardee provided additional details on the use of complete case analysis to account for missing data on race and other variables for a substantial number of participants. The awardee also noted in the study limitations that because of the large amount of missing data, particularly for race, planned subgroup analyses on racial differences in uterine fibroid treatment could not occur.
  • The awardee described the management of loss to follow-up. The study required all patients in the analytic data set to have had at least two years of follow-up data which the awardee used as the focus for its primary analyses. The awardee performed additional analyses using all follow-up data after first removing patients who were lost to follow-up.
  • The awardee clarified the membership of the stakeholder advisory group, which included individuals who had experience with uterine fibroids and others who held roles with nonprofit advocacy groups for uterine fibroid awareness.
  • The awardee revised its description of adherence to PCORI’s Methodology Standards. The awardee provided more detail in additional text that addresses handling of standards RQ-4 (Identify and assess participant subgroups); IR-1 (Specify plans for data analysis); IR-5 (Provide sufficient information in reports to allow for assessments of the study’s internal and external validity); and all standards for prevention and handling of missing data.

Conflict of Interest Disclosures

Project Information

Priscilla Velentgas, MS, PhD*
Outcome Sciences, Inc.
$1,147,733 *
10.25302/5.2018.CE.12114430
Comparing Patient-Centered Outcomes after Treatment for Uterine Fibroids

Key Dates

May 2013
May 2017
2013
2017

Study Registration Information

*Richard Gliklich, MD was the original principal investigator for this project.

Final Research Report

View this project's final research report.

Related PCORI Dissemination and Implementation Project

Multi-Component Implementation of Shared Decision Making for Uterine Fibroids Across Socioeconomic Strata

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: November 30, 2022