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.
Professional Abstract
Objective
To compare symptom relief and subsequent procedures required after use of three uterus-conserving treatments for uterine fibroids: endometrial ablation, myomectomy, and uterine artery embolization.
Study Design
| Design Elements | Description |
|---|---|
| Design | Observational: cohort study |
| Population | Medical records and insurance claims of 12,234 patients who received treatment for uterine fibroids |
| Interventions/ Comparators |
|
| Outcomes | Occurrence of new or recurrent symptoms, 2-year risk of new or recurrent symptoms, occurrence of subsequent procedures, 2-year risk of subsequent procedures |
| Timeframe | A minimum of 2-year follow-up for study outcomes |
This retrospective cohort study of patients with uterine fibroids compared the occurrence of new or recurrent symptoms, two-year risk of new or recurrent symptoms, occurrence of subsequent procedures, and two-year risk of subsequent procedures for three different uterus-conserving treatments: endometrial ablation, myomectomy, and uterine artery embolization. The study excluded a fourth treatment from the analysis—magnetic resonance imaging-guided focused ultrasound ablation—because less than 1 percent of the patients received this treatment.
The research team analyzed electronic medical record and claims data from two data networks: Quintiles Electronic Medical Records (Q‐EMR) linked to Truven MarketScan claims data and the COMparative effectiveness and PAtient Safety and Surveillance (COMPASS) Research Network. Both networks draw from a wide variety of health systems and settings across the nation and provide a sample similar to the US population. The analysis included 8,687 patients from the Q‐EMR data and 3,547 patients from the COMPASS data with a diagnostic code for uterine fibroids and a treatment of interest between January 1, 2005, and December 31, 2011. The research team reviewed at least two years of electronic medical record data for each patient. The analysis included only women ages 18 to 55 with two years of follow-up data after initial treatment. The mean patient age was 44. Due to the relatively small sample size in the COMPASS data, the comparative analyses used only the Q-EMR data.
A 17-member stakeholder-participation council including patients, doctors, insurers, and others provided input that helped shape the study design and data analysis.
Results
The three treatments worked similarly to prevent or delay new or recurrent symptoms. However, uterine artery embolization and myomectomy appeared to lower the risk of needing subsequent procedures when compared to endometrial ablation.
- Occurrence of new or recurrent symptoms. There was no difference in the likelihood of having new or recurrent symptoms within two years for patients who had uterine artery embolization (Odds Ratio [OR]: 0.90; 95% Confidence Interval [CI]: 0.66, 1.24) or myomectomy (OR: 1.03; 95% CI: 0.82, 1.30) compared with endometrial ablation.
- Two-year risk of new or recurrent symptoms. There was no difference in the risk of having new or recurrent symptoms during the two-year study period for patients who had uterine artery embolization (Hazard Ratio [HR]: 0.88; 95% CI: 0.73, 1.07) or myomectomy (HR: 0.92; 95% CI: 0.81, 1.05) compared with endometrial ablation.
- Occurrence of subsequent procedures. Patients who had uterine artery embolization (OR: 0.59; 95% CI: 0.38, 0.94) or myomectomy (OR: 0.68; 95% CI: 0.50, 0.92) were less likely to have subsequent procedures within two years of their first procedure than patients who had endometrial ablation.
- Two-year risk of subsequent procedures. Patients who had uterine artery embolization (HR: 0.61; 95% CI: 0.43, 0.86) or myomectomy (HR: 0.74; 95% CI: 0.60, 0.92) were at lower risk of having subsequent procedures during the two-year study period than patients who had endometrial ablation.
Limitations
Limitations in the data set may affect interpretation of results. For example, there were inconsistencies in how information was coded, and some information was missing because it was not originally intended for research purposes. Also, the data lacked information on why patients chose certain treatments and information on the size or location of patients’ fibroids, which would affect treatment decisions and outcomes. The subgroups did not have sufficient sample sizes to conduct adequate subgroup analyses. In particular, race was missing for 27 percent of patients in the Q-EMR data. These limitations are relatively common in research using data from electronic medical records and insurance claims.
Conclusions and Relevance
Compared with endometrial ablation, both uterine artery embolization and myomectomy appeared to lower the likelihood of having a subsequent procedure to treat uterine fibroids. Doctors and patients may consider using these results to help make treatment decisions.
Future Research Needs
Future research could continue to examine the outcomes of different uterus-conserving treatments for patients with uterine fibroids. Collecting data in real time that includes information missing from the medical records in this study (such as size or location of fibroids) could add to the body of evidence.
Final Research Report
View this project's final research report.
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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
Key Dates
Study Registration Information
*Richard Gliklich, MD was the original principal investigator for this project.