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1.
BMC Womens Health ; 24(1): 233, 2024 Apr 12.
Article in English | MEDLINE | ID: mdl-38610011

ABSTRACT

BACKGROUND: Uterine fibroids are non-cancerous neoplasms that arise from the uterus affecting over 75% of women. However, there is a disparity with Black women having an increased prevalence of nearly 80%. Black women also experience increased symptom burden, including younger age at the time of diagnosis and increased number and volume of fibroids. Less is known about other ethnoracially diverse women such as Latinas and the potential cultural impacts on fibroid burden and treatment. METHODS: Community engagement studios were conducted to facilitate discussions with stakeholders on their uterine fibroid and menstruation experience. We recruited Black women (n = 6) diagnosed with uterine fibroids and Latinas (n = 7) without uterine fibroids. We held two virtual community engagement studios split by uterine fibroid diagnosis. The studios were not audio recorded and notes were taken by four notetakers. The notes were thematically analyzed in Atlas.ti using content analysis. RESULTS: Participants felt there was a lack of discussion around menstruation overall, whether in the home or school settings. This lack of menstruation education was pronounced when participants had their first menstruation experience, with many unaware of what to expect. This silence around menstruation led to a normalization of painful menstruation symptoms. When it came to different treatment options for uterine fibroids, some women wanted to explore alternative treatments but were dismissed by their healthcare providers. Many participants advocated for having discussions with their healthcare provider about life goals to discuss different treatment options for their uterine fibroids. CONCLUSION: Despite uterine fibroid diagnosis, there is silence around menstruation. Menstruation is a normal biological occurrence and needs to be discussed to help prevent delayed diagnosis of uterine fibroids and possibly other gynecological disorders. Along with increased discussions around menstruation, further discussion is needed between healthcare providers and uterine fibroid patients to explore appropriate treatment options.


Subject(s)
Leiomyoma , Menstruation , Humans , Female , Leiomyoma/complications , Dysmenorrhea , Black People , Hispanic or Latino
2.
Adv Ther ; 40(10): 4127-4133, 2023 10.
Article in English | MEDLINE | ID: mdl-37568061

ABSTRACT

Uterine fibroids (UF) are common benign tumors in women and are an important health concern in the US and globally. UF can severely compromise a woman's quality of life, thus making it an important health issue. In this podcast, a professor of Obstetrics and Gynecology, University of Chicago (Dr. Ayman Al-Hendy) and the CEO of the Fibroid Foundation (Sateria Venable) provide their perspectives on the diagnosis and management of UF, including common treatments (e.g., myomectomy or hysterectomy). They also discuss Relugolix combination therapy for UF, noting who could benefit from this treatment and how it works. Podcast audio available for this article.


Subject(s)
Leiomyoma , Uterine Neoplasms , Pregnancy , Female , Humans , Uterine Neoplasms/drug therapy , Uterine Neoplasms/surgery , Quality of Life , Leiomyoma/drug therapy , Leiomyoma/surgery , Pyrimidinones , Hysterectomy
3.
Am J Obstet Gynecol ; 229(3): 275.e1-275.e17, 2023 09.
Article in English | MEDLINE | ID: mdl-37244458

ABSTRACT

BACKGROUND: Few studies have directly compared different surgical procedures for uterine fibroids with respect to long-term health-related quality of life outcomes and symptom improvement. OBJECTIVE: We examined differences in change from baseline to 1-, 2-, and 3-year follow-up in health-related quality of life and symptom severity among patients who underwent abdominal myomectomy, laparoscopic or robotic myomectomy, abdominal hysterectomy, laparoscopic or robotic hysterectomy, or uterine artery embolization. STUDY DESIGN: The COMPARE-UF registry is a multiinstitutional prospective observational cohort study of women undergoing treatment for uterine fibroids. A subset of 1384 women aged 31 to 45 years who underwent either abdominal myomectomy (n=237), laparoscopic myomectomy (n=272), abdominal hysterectomy (n=177), laparoscopic hysterectomy (n=522), or uterine artery embolization (n=176) were included in this analysis. We obtained demographics, fibroid history, and symptoms by questionnaires at enrollment and at 1, 2, and 3 years posttreatment. We used the UFS-QoL (Uterine Fibroid Symptom and Quality of Life) questionnaire to ascertain symptom severity and health-related quality of life scores among participants. To account for potential baseline differences across treatment groups, a propensity score model was used to derive overlap weights and compare total health-related quality of life and symptom severity scores after enrollment with a repeated measures model. For this health-related quality of life tool, a specific minimal clinically important difference has not been determined, but on the basis of previous research, a difference of 10 points was considered as a reasonable estimate. Use of this difference was agreed upon by the Steering Committee at the time when the analysis was planned. RESULTS: At baseline, women undergoing hysterectomy and uterine artery embolization reported the lowest health-related quality of life scores and highest symptom severity scores compared with those undergoing abdominal myomectomy or laparoscopic myomectomy (P<.001). Those undergoing hysterectomy and uterine artery embolization reported the longest duration of fibroid symptoms with a mean of 6.3 years (standard deviation, 6.7; P<.001). The most common fibroid symptoms were menorrhagia (75.3%), bulk symptoms (74.2%), and bloating (73.2%). More than half (54.9%) of participants reported anemia, and 9.4% women reported a history of blood transfusion. Across all modalities, total health-related quality of life and symptom severity score markedly improved from baseline to 1-year with the largest improvement in the laparoscopic hysterectomy group (Uterine Fibroids Symptom and Quality of Life: delta= [+] 49.2; symptom severity: delta= [-] 51.3). Those undergoing abdominal myomectomy, laparoscopic myomectomy, and uterine artery embolization also demonstrated significant improvement in health-related quality of life (delta= [+]43.9, [+]32.9, [+]40.7, respectively) and symptom severity (delta= [-]41.4, [-] 31.5, [-] 38.5, respectively) at 1 year, and the improvement persisted from baseline for uterine-sparing procedures during second (Uterine Fibroids Symptom and Quality of Life: delta= [+]40.7, [+]37.4, [+]39.3 SS: delta= [-] 38.5, [-] 32.0, [-] 37.7 and third year (Uterine Fibroids Symptom and Quality of Life: delta= [+] 40.9, [+]39.9, [+]41.1 and SS: delta= [-] 33.9, [-]36.5, [-] 33.0, respectively), posttreatment intervals, however with a trend toward decline in degree of improvement from years 1 and 2. Differences from baseline were greatest for hysterectomy; however, this may reflect the relative importance of bleeding in the Uterine Fibroids Symptom and Quality of Life, rather than clinically meaningful symptom recurrence among women undergoing uterus-sparing treatments. CONCLUSION: All treatment modalities were associated with significant improvements in health-related quality of life and symptom severity reduction 1-year posttreatment. However, abdominal myomectomy, laparoscopic myomectomy and uterine artery embolization indicated a gradual decline in symptom improvement and health-related quality of life by third year after the procedure.


Subject(s)
Leiomyoma , Uterine Artery Embolization , Uterine Myomectomy , Uterine Neoplasms , Humans , Female , Male , Uterine Myomectomy/methods , Quality of Life , Uterine Neoplasms/surgery , Prospective Studies , Leiomyoma/surgery , Hysterectomy , Treatment Outcome
4.
J Womens Health (Larchmt) ; 32(4): 423-433, 2023 04.
Article in English | MEDLINE | ID: mdl-36637808

ABSTRACT

Objective: To compare 12-month post-treatment health-related quality of life (HR-QoL) and symptom severity (SS) changes among patients with symptomatic uterine fibroids (SUF) not seeking fertility and undergo a hysterectomy, abdominal myomectomy (AM), or uterine artery embolization (UAE). Materials and Methods: The Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF) Registry is a multi-institutional prospective observational cohort study of patients treated for SUF. A subset of 1465 women 31-45 years of age, who underwent either hysterectomy (n = 741), AM (n = 446), or UAE (n = 155) were included in this analysis. Demographics, fibroid history, and symptoms were obtained by baseline questionnaires and at 1 year post-treatment. Results were stratified by all treatments and propensity score weighting to adjust for differences in baseline characteristics. Results: Women undergoing UAE reported the lowest baseline HR-QoL and highest SS scores (mean = 40.6 [standard deviation (SD) = 23.8]; 62.3 [SD = 24.2]) followed by hysterectomy (44.3 [24.3]; 59.8 [SD = 24.1]). At 12 months, women who underwent a hysterectomy experienced the largest change in both HR-QoL (48.7 [26.2]) and SS (51.9 [25.6]) followed by other uterine-sparing treatments. Propensity score weighting revealed all treatments produced substantial improvement, with hysterectomy patients reporting the highest HR-QoL score (92.0 [17.8]) compared with myomectomy (86.7 [17.2]) and UAE (82.6 [21.5]) (p < 0.0001). Similarly, hysterectomy patients reported the lowest SS scores (8.2 [15.1]) compared with myomectomy (16.5 [15.1]) and UAE (19.6 [17.5]) (p < 0.0001). Conclusion: All procedures showed improvement in HR-QoL and reduction in SS score at 12 months, hysterectomy showing maximum improvement. Of importance, at 12 months, patients who underwent either a myomectomy or UAE reported comparable symptom relief and HR-QoL. Clinicaltrials.Gov Identifier: NCT02260752.


Subject(s)
Leiomyoma , Quality of Life , Uterine Artery Embolization , Uterine Myomectomy , Uterine Neoplasms , Female , Humans , Hysterectomy , Leiomyoma/surgery , Prospective Studies , Registries , Treatment Outcome , Uterine Artery Embolization/psychology , Uterine Myomectomy/psychology , Uterine Neoplasms/surgery
5.
BMJ Surg Interv Health Technol ; 4(Suppl 1): e000094, 2022.
Article in English | MEDLINE | ID: mdl-36393887

ABSTRACT

Objectives: The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum data set for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by a study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved. Results: Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data. Conclusions: The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.

6.
J Womens Health (Larchmt) ; 31(3): 415-424, 2022 03.
Article in English | MEDLINE | ID: mdl-34101502

ABSTRACT

Background: Quality of life (QOL) and psychological health has been reported to be decreased among women with gynecological conditions such as uterine fibroids (UFs). Materials and Methods: Women enrolled in the Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry, receiving procedural therapy for symptomatic UFs, were eligible for this analysis if they completed a series of health-related QOL surveys administered at three time points (baseline, 6-12 weeks postprocedure, and 1 year postprocedure; n = 1486). Ethical approval for this study was obtained at each recruiting site and the coordinating center (NCT02260752, clinicaltrials.gov). Results: More than 26% (n = 393) of women reported moderate anxiety/depression on the baseline anxiety/depression domain of the Euro-QOL 5-dimension instrument. At both the 6-12 weeks and 1-year postprocedural follow-up, there was significant improvement in the UF QOL symptom severity score (p < 0.001, p < 0.001), the total UF symptom QOL score (p < 0.001, p < 0.001), and the Euro-QOL 5-dimension visual analog scale (p < 0.001, p = 0.004) compared with the preprocedural baseline scores. The reporting of anxiety/depression decreased by 66.4% among women who were at baseline, whereas 5.6% of women previously reporting no anxiety/depression reported anxiety/depression at the 1-year follow-up. Conclusion: UF symptoms were more severe among women reporting anxiety/depression at baseline. At the 1-year follow-up, health-related QOL scores improved among all women and the prevalence of anxiety/depression decreased in most, but not all women, whereas severity of anxiety/depression worsened in a small percentage of women (5.6%). Overall, these results suggest that UF treatment improves symptoms of anxiety/depression associated with symptomatic UFs.


Subject(s)
Leiomyoma , Uterine Neoplasms , Anxiety/epidemiology , Depression/epidemiology , Female , Humans , Leiomyoma/complications , Leiomyoma/epidemiology , Leiomyoma/surgery , Quality of Life , Surveys and Questionnaires , Uterine Neoplasms/complications , Uterine Neoplasms/epidemiology , Uterine Neoplasms/surgery
7.
J Racial Ethn Health Disparities ; 9(4): 1184-1191, 2022 08.
Article in English | MEDLINE | ID: mdl-34013445

ABSTRACT

BACKGROUND: Uterine fibroids are non-cancerous neoplasms of the uterus. Women of color, including non-Hispanic Black/African American women and Hispanic/Latinas, have a higher uterine fibroid prevalence, incidence, and disease burden compared to non-Hispanic White women. Therefore, understanding ethnoracial factors in the diagnosis and treatment of uterine fibroids in women of color is critical. This study provides insight on the ethnoracial factors and cultural barriers experienced by women of color in the management and treatment of uterine fibroids. METHODS: Women were recruited via The Fibroid Foundation, a nonprofit that provides uterine fibroid support and education. Women who were interested completed an online screening survey. Eligible participants were interviewed via phone. Transcribed audio recordings were qualitatively analyzed using the principles of grounded theory. RESULTS: Forty-seven women of reproductive age who were diagnosed with uterine fibroids and received U.S.-based care participated in a semi-structured interview exploring experiences with uterine fibroid diagnosis and management. Twenty-eight women self-identified as Black, Latina, or other ethnicity. Women of color reported fibroid symptoms that significantly disrupted their work and home life. Women of color also reported perceptions that their race/ethnicity impacted their uterine fibroid treatment, including negative interpersonal provider-patient interactions. These perceptions engendered feelings of skepticism towards the medical system based on historical injustices and/or their own negative experiences and led some to go without longitudinal care. CONCLUSION: Cultural and familial factors have significant impact on uterine fibroid diagnosis and management. Greater attention to culturally sensitive care and potential bias reduction in the treatment of uterine fibroids should be a priority.


Subject(s)
Leiomyoma , Uterine Neoplasms , Black People , Cost of Illness , Female , Humans , Leiomyoma/therapy , Uterine Neoplasms/therapy , Uterus
8.
J Patient Exp ; 8: 23743735211049655, 2021.
Article in English | MEDLINE | ID: mdl-34692992

ABSTRACT

Uterine fibroids are noncancerous tumors associated with significant morbidity among symptomatic patients. While medical and surgical treatments have expanded, hysterectomy remains common. We interviewed women diagnosed with uterine fibroids (n = 47) to explore their experiences and recommendations for shared decision-making. A majority were non-Hispanic Black, highly educated (51.1%), and had graduate degrees (40.4%). Participants with both positive and negative provider experiences expressed a desire for a more proactive therapeutic approach, including a presentation by their provider of the spectrum of medical and surgical treatment options, and greater provider recognition of the impact of symptoms on quality of life. Women advocated for expanded shared decision-making that acknowledged their contribution to their own treatment plan and felt early screening and improved patient/provider education of uterine fibroid symptoms would facilitate greater congruence between treatment approaches and patient goals. Perceptions of insufficient input into their treatment plans frequently served as a barrier to care-seeking and treatment acceptance among women with uterine fibroid symptoms. Improved discussion of treatment options in the context of the unique symptom burden and values of the patient may facilitate greater provider trust and acceptance of uterine fibroid treatment.

10.
J Womens Health (Larchmt) ; 30(3): 355-366, 2021 03.
Article in English | MEDLINE | ID: mdl-33524308

ABSTRACT

Background: To evaluate differences in the proportion of uterine fibroid (UF) treatments that are uterine-sparing between Black women and White women and identify factors that could explain disparities. Methods: Women at age 18-54 years who were enrolled from 10 clinical sites in the United States into the Comparing Options for Management: Patient-Centered Results for UFs (COMPARE-UF) treatment registry completed questionnaires before their UF procedure. UF symptoms and quality of life were assessed by questionnaires. Details on UF imaging and treatment (hysterectomy, myomectomy, or uterine artery embolization [UAE]) were collected from each patient's medical record. Random-effects logistic regression was used to assess the association between race and the odds of having a uterine-sparing procedure versus hysterectomy. Subgroup analyses compared each uterine-sparing procedure with hysterectomy. Results: In this cohort of 1141 White women and 1196 Black women, Black women tended to be younger (median 41.0 vs. 42.0 years) and report worse symptoms, pain, and function on every scale compared with White women. Black women were more likely to have had a prior UF treatment compared with White women (22.8% vs. 14.6%). White women had more hysterectomies (43.6% vs. 32.2%) and myomectomies (50.9% vs. 50.2%) versus Black women. Black women had more UAEs (15.1% vs. 4.7%) than White women. After adjusting for clinical site and other variables, Black women had greater odds than White women of having a myomectomy (odds ratio [OR] = 2.41, 95% confidence interval [CI] = 1.63-3.56) or a UAE versus hysterectomy (OR = 4.24, 95% CI = 2.41-7.46). Conclusion: In these participants, Black women were more likely to schedule a uterine-sparing UF treatment and a nonsurgical UF treatment than their White counterparts; this may not be true for all women. Longer comparative effectiveness studies are needed to inform women about the durability of UF treatments. Greater understanding of factors influencing treatment selection is needed as are studies that include women without access to tertiary care centers. Clinical Trial Registration: Clinicaltrials.gov, NCT02260752 (enrollment start: November 2015).


Subject(s)
Leiomyoma , Uterine Myomectomy , Uterine Neoplasms , Adolescent , Adult , Black or African American , Female , Humans , Hysterectomy , Leiomyoma/surgery , Middle Aged , Quality of Life , Uterine Neoplasms/surgery , Young Adult
11.
Fertil Steril ; 113(3): 618-626, 2020 03.
Article in English | MEDLINE | ID: mdl-32192594

ABSTRACT

OBJECTIVE: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL. DESIGN: Prospective cohort study. SETTING: Eight clinical sites throughout the United States. PATIENT(S): A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy as part of Comparing Options for Management: Patient-Centered Results for Uterine Fibroids. INTERVENTION(S): None. MAIN OUTCOME MEASURE (S): Self-reported HRQOL measures including Uterine Fibroid Symptom Quality of Life, the European QOL 5 Dimension Health Questionnaire, and the visual analog scale at baseline and 1-year after hysterectomy or myomectomy. RESULT (S): Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients. There were no differences in baseline HRQOL. After adjustment for baseline differences between groups, compared with myomectomy, patients' HRQOL (95% confidence interval [CI], 5.4, 17.2) and symptom severity (95% CI, -16.3, -8.8) were significantly improved with hysterectomy. When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy. There was little difference in HRQOL (95% CI, 0.1 [-9.5, 9.6]) or symptom severity (95% CI, -3.4 [-10, 3.2]) between abdominal hysterectomy and abdominal myomectomy. CONCLUSION (S): HRQOL improved in all women 1 year after hysterectomy or myomectomy. Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients. When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches.


Subject(s)
Hysterectomy , Leiomyoma/surgery , Quality of Life , Uterine Myomectomy , Uterine Neoplasms/surgery , Adult , Cohort Studies , Comparative Effectiveness Research , Female , Follow-Up Studies , Humans , Hysterectomy/adverse effects , Hysterectomy/rehabilitation , Hysterectomy/statistics & numerical data , Leiomyoma/epidemiology , Leiomyoma/psychology , Middle Aged , Pregnancy , Prospective Studies , Surveys and Questionnaires , Treatment Outcome , Uterine Artery Embolization/adverse effects , Uterine Artery Embolization/rehabilitation , Uterine Artery Embolization/statistics & numerical data , Uterine Myomectomy/adverse effects , Uterine Myomectomy/rehabilitation , Uterine Myomectomy/statistics & numerical data , Uterine Neoplasms/epidemiology , Uterine Neoplasms/psychology
12.
Implement Sci ; 14(1): 88, 2019 09 02.
Article in English | MEDLINE | ID: mdl-31477140

ABSTRACT

BACKGROUND: Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. METHODS: We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. DISCUSSION: This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. TRIAL REGISTRATION: Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.


Subject(s)
Decision Support Techniques , Leiomyoma/therapy , Patient Participation/methods , Patient Preference , Adolescent , Adult , Communication , Cultural Characteristics , Decision Making , Female , Health Knowledge, Attitudes, Practice , Humans , Middle Aged , Self Efficacy , Young Adult
13.
Obstet Gynecol ; 134(2): 261-269, 2019 08.
Article in English | MEDLINE | ID: mdl-31306318

ABSTRACT

OBJECTIVE: To compare short-term health-related quality of life (HRQOL) 6-12 weeks after hysterectomy or myomectomy for the treatment of symptomatic leiomyomas. METHODS: We conducted a prospective comparative effectiveness analysis of data. In an existing multisite registry, we compared 6-12-week postsurgical HRQOL using the disease-specific Uterine Fibroid Symptom Quality of Life and the generic EuroQoL 5-Dimension Health Questionnaire, in women from the ages of 18-54 years with documented leiomyomas undergoing hysterectomy or myomectomy. Propensity score weighting was used to adjust for confounding, and analyses were also stratified by route of surgery. RESULTS: A total of 1,295 patients (727 with hysterectomy and 568 with myomectomy) enrolled from registry initiation in November 2015 until June 2018 met inclusion criteria. At baseline, leiomyoma-specific HRQOL (44.0±25.4 and 50.2±25.3, P<.01), symptom severity (60.7±23.6 and 51.7±24.6, P<.01), and generic HRQOL (69.3±20.4 and. 73.4±18.9, P<.01) were significantly different between the hysterectomy compared with myomectomy groups, respectively. Differences were eliminated by propensity adjustment. Substantial improvement in HRQOL measures were seen in both groups at 6-12 weeks, with the mean propensity-adjusted symptom severity score 4 points lower in hysterectomy patients (mean difference -4.6; 95% CI -7.0 to -2.3), compared with myomectomy patients. Hysterectomy patients had better scores on the concern and self-consciousness subscales compared with myomectomy patients. When stratified by surgical route, these two subscale findings were similar between minimally invasive hysterectomy and minimally invasive myomectomy. Symptom severity scores did not differ after abdominal myomectomy compared with abdominal hysterectomy, but subscale scores on activity and energy/mood were higher with myomectomy. CONCLUSION: Both hysterectomy and myomectomy were associated with substantial improvement in HRQOL at short-term follow-up, with small but statistically significant differences in symptom severity and certain subscales. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02260752.


Subject(s)
Hysterectomy/statistics & numerical data , Leiomyoma/surgery , Quality of Life , Uterine Myomectomy/statistics & numerical data , Uterine Neoplasms/surgery , Adult , Female , Humans , Middle Aged , Minimally Invasive Surgical Procedures , Postoperative Period , Prospective Studies , Surveys and Questionnaires
14.
Am J Obstet Gynecol ; 219(1): 95.e1-95.e10, 2018 07.
Article in English | MEDLINE | ID: mdl-29750955

ABSTRACT

BACKGROUND: Uterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare. OBJECTIVE: The purpose of this study was to design and establish a uterine fibroid registry based in the United States to provide comparative effectiveness data regarding uterine fibroid treatment. STUDY DESIGN: We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered REsults for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality in collaboration with the Patient-Centered Outcomes Research Institute. COMPARE-UF was designed to help answer critical questions about treatment options for women with symptomatic uterine fibroids. Women who undergo a procedure for uterine fibroids (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal, and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance-guided focused ultrasound, or progestin-releasing intrauterine device insertion) at 1 of the COMPARE-UF sites are invited to participate in a prospective registry with 3 years follow up for postprocedural outcomes. Enrolled participants provide annual follow-up evaluation through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes, and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. RESULTS: We built a network of 9 clinical sites across the United States with expertise in the care of women with uterine fibroids to capture geographic, racial, ethnic, and procedural diversity. Of the initial 2031 women who were enrolled in COMPARE-UF, 42% are self-identified as black or African American, and 40% are ≤40 years old, with 16% of participants <35 years old. Women who undergo myomectomy comprise the largest treatment group at 46% of all procedures, with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all procedures. Hysterectomy is the second most common treatment within the registry at 38%. CONCLUSION: In response to priorities that were identified by our patient stakeholders, the initial aims within COMPARE-UF will address how different procedures that are used to treat uterine fibroids compare in terms of long-lasting symptom relief, potential for recurrence, medical complications, improvement in quality of life and sexual function, age at menopause, and fertility and pregnancy outcomes. COMPARE-UF will generate evidence on the comparative effectiveness of different procedural options for uterine fibroids and help patients and their caregivers make informed decisions that best meet an individual patient's short- and long-term preferences. Building on this infrastructure, the COMPARE-UF team of investigators and stakeholders, including patients, collaborate to identify future priorities for expanding the registry, such as assessing the efficacy of medical therapies for uterine fibroids. COMPARE-UF results will be disseminated directly to patients, providers, and other stakeholders by traditional academic pathways and by innovative methods that include a variety of social media platforms. Given demographic differences among women who undergo different uterine fibroid treatments, the assessment of comparative effectiveness for this disease through clinical trials will remain difficult. Therefore, this registry provides optimized evidence to help patients and their providers better understand the pros and cons of different treatment options so that they can make more informed decisions.


Subject(s)
Leiomyoma/therapy , Patient Outcome Assessment , Registries , Uterine Neoplasms/therapy , Adolescent , Adult , Endometrial Ablation Techniques , Female , High-Intensity Focused Ultrasound Ablation , Humans , Hysterectomy , Intrauterine Devices, Medicated , Magnetic Resonance Imaging , Middle Aged , Progestins/administration & dosage , Quality of Life , Radiofrequency Ablation , Surgery, Computer-Assisted , Treatment Outcome , Uterine Artery Embolization , Uterine Myomectomy , Young Adult
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