Which treatments for uterine fibroids have the best results?
The study included patients with uterine fibroids having 1 of the procedures of interest occurring from January 1, 2005, to December 31, 2011, with the first instance being designated as the index procedure. The study then followed patients for a minimum of 2 years in the electronic medical record a...
| Main Authors: | , , |
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| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
[Washington, D.C.]
Patient-Centered Outcomes Research Institute (PCORI)
2018, [2018]
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| Series: | Final research report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | The study included patients with uterine fibroids having 1 of the procedures of interest occurring from January 1, 2005, to December 31, 2011, with the first instance being designated as the index procedure. The study then followed patients for a minimum of 2 years in the electronic medical record and claims data to look for new or recurrent symptoms and subsequent procedures. We created a Stakeholder Participation Council (SPC) with 17 diverse stakeholders (eg, patients/patient advocates, physicians, payers) to provide continuous input on the research process and interpretation and dissemination of the study findings. RESULTS: The study included a total of 8687 patients in Q-EMR and 3547 patients in COMPASS. Due to the relatively small sample size of the COMPASS data, we based the comparative analyses on the Q-EMR data only. Endometrial ablation was the most common index procedure in Q-EMR. BACKGROUND: Uterine fibroids are one of the leading causes of morbidity in reproductive-aged women. Because treatment options for symptomatic fibroids involve significant trade-offs, the lack of evidence on treatment effectiveness limits the ability of patients and their physicians to make informed treatment decisions. OBJECTIVES: The first objective of this study was to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures. The second objective of this study was to evaluate the effect stakeholder participation had on the research process. METHODS: This was a retrospective database study of patients with uterine fibroids. The study used 2 data sources: Quintiles Electronic Medical Record System (Q-EMR) linked to Truven MarketScan claims and the COMparative effectiveness and PAtient Safety and Surveillance (COMPASS) Research Network. Patients who had uterine artery embolization as their index procedure had a lower risk of new or recurrent symptoms after the index procedure and a lower risk of having a subsequent procedure during the study period compared with patients who underwent endometrial ablation. Myomectomy patients had a lower risk of having a subsequent procedure than patients who received endometrial ablation. CONCLUSIONS: This research provides additional evidence about expectations for the durability of symptom relief and time to subsequent procedures among women with uterine fibroids that may be helpful to women and their health care providers when making treatment choices. Overall, the SPC provided critical input that shaped the study design, data analysis, and dissemination plan for key findings |
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| Physical Description: | 1 PDF file (100 pages) illustrations |