Study protocol for the implementation of Centering Patients with Fibroids, a novel group education and empowerment program for patients with symptomatic uterine fibroids.

BACKGROUND: Black women and people with uteri have utilized collectivistic and relational practices to improve health outcomes in the face of medical racism and discrimination for decades. However, there remains a need for interventions to improve outcomes of uterine fibroids, a condition that disproportionately impacts Black people with uteri. Leveraging personalized approaches alongside evidence that demonstrates the positive impact of social and peer support on health outcomes, we adapted from CenteringPregnancy, an evidence based group prenatal care intervention, for the education and empowerment of patients with uterine fibroids. METHODS: The present report provides  an overview of the study design and planned implementation of CPWF in cohorts at Boston Medical Center and Emory University / Grady Memorial Hospital. After receiving training from the Centering Healthcare Institute (CHI), we adapted the 10-session CenteringPregnancy curriculum to an 8-session hybrid group intervention called Centering Patients with Fibroids (CPWF). The study began in 2022 with planned recruitment of six cohorts of 10-12 participants at each institution. We will conduct a mixed methods evaluation of the program using validated survey tools and qualitative methods, including focus groups and 1:1 interviews. DISCUSSION: To date, we have successfully recruited 4 cohorts at Boston Medical Center and are actively implementing BMC Cohort 5 and the first cohort at Emory University / Grady Memorial Hospital. Evaluation of the program is forthcoming.

Fibroids are non-cancerous smooth muscle tumors that disproportionate impact black women and gender expansive people. Our team adapted CenteringPregnancy, a group based model of prenatal care, to an education and empowerment program for peple with fibroids called Centering Patients with Fibroids (CPWF). This paper describes the development and implemation of the program at two academic hospitals serving diverse patients in Boston, Massachusetts and Atlanta, Georgia. To evaluate the successes and challenges of the program, we ask participants to complete surveys to learn more about their experience with having fibroids and also invite them to group feedback sessions or focus groups. We also interview other healthcare providers, team members, and hospital leadership on their knowledge and thoughts about the program. We hope to use the feedback to improve the program and make it available to more people across the country.

Management of Uterine Fibroids and Sarcomas: The Palermo Position Paper.

BACKGROUND: Uterine fibroids are benign monoclonal tumors originating from the smooth muscle cells of the myometrium, constituting the most prevalent pathology within the female genital tract. Uterine sarcomas, although rare, still represent a diagnostic challenge and should be managed in centers with adequate expertise in gynecological oncology. OBJECTIVES: This article is aimed to summarize and discuss cutting-edge elements about the diagnosis and management of uterine fibroids and sarcomas. METHODS: This paper is a report of the lectures presented in an expert meeting about uterine fibroids and sarcomas held in Palermo in February 2023. OUTCOME: Overall, the combination of novel molecular pathways may help combine biomarkers and expert ultrasound for the differential diagnosis of uterine fibroids and sarcomas. On the one hand, molecular and cellular maps of uterine fibroids and matched myometrium may enhance our understanding of tumor development compared to histologic analysis and whole tissue transcriptomics, and support the development of minimally invasive treatment strategies; on the other hand, ultrasound imaging allows in most of the cases a proper mapping the fibroids and to differentiate between benign and malignant lesions, which need appropriate management. CONCLUSIONS AND OUTLOOK: The choice of uterine fibroid management, including pharmacological approaches, surgical treatment, or other strategies, such as high-intensity focused ultrasound (HIFU), should be carefully considered, taking into account the characteristics of the patient and reproductive prognosis.

Evaluating the Effects of Water Balloons on High-Intensity Focused Ultrasound for Treating Uterine Fibroids.

OBJECTIVE: In the treatment of uterine fibroids with ultrasound-guided high-intensity focused ultrasound (HIFU), water balloons are considered to be a valuable aid for improving safety and efficiency. However, the water balloons worsen the pathway for acoustic transmission, causing degraded performance both in ultrasound therapy and in ultrasound imaging. This study was aimed at establishing a protocol to evaluate the effects of the water balloon. METHODS: Simulations and experiments were carefully conducted to quantitatively investigate the effects of water ballons on the efficiency of HIFU energy delivery and on the quality of ultrasound guiding images. More specifically, HIFU-induced temperature increases in the focal region, together with spatial resolution, contrast and signal-to-noise ratio in the ultrasound guiding images, were compared under the conditions with and without the water balloon. RESULTS: Experiment results revealed that the use of water balloons led to decreases in temperature up to 10ºC within the focal region in some specific situations, but the quality of the guiding images was relatively less affected. CONCLUSION: The study provided knowledge on what influence the water balloon could have in ultrasound-guided HIFU treatment; it also established a practical and standardized evaluation scheme for further optimizing the water balloon, for example, its material and internal liquid compositions. This study can potentially help improve the efficiency and safety of treating uterine fibroids with ultrasound-guided HIFU systems.

Comparing magnetic resonance imaging and ultrasound in the clinical evaluation of fibroids prior to uterine artery embolization.

PURPOSE: Uterine artery embolization has become established as a frontline treatment for uterine leiomyomata. In planning embolization, preprocedural imaging can further characterize pathology and anatomy, but it may also reveal coexisting diagnoses that have the potential to change clinical management. The purpose of this study is to compare the diagnostic outcomes of ultrasound and MRI performed for patients prior to undergoing embolization. METHODS: The study cohort consisted of 199 patients who underwent uterine artery embolization at a single academic institution between 2013 and 2018. Prior to embolization, all patients had an MRI confirming a leiomyomata diagnosis. Additionally, 118 patients underwent transvaginal ultrasound within five years prior to MRI. MRI findings were analyzed and, when applicable, compared to prior ultrasound impressions to assess for the incidence of new findings. The diagnoses of interest were adenomyosis, hydrosalpinx, predominantly infarcted leiomyomata, and large intracavitary leiomyomata. Data were collected from retrospective chart review and included demographics, symptomology, and imaging reports. RESULTS: 199 patients ultimately underwent embolization for treatment of MRI-confirmed leiomyomata. Of 118 patients who also had an ultrasound within five years prior to their MRI, 26 (22.0%) received a second gynecologic diagnosis based on MRI findings that was not previously seen on ultrasound. Of 81 patients who only had an MRI before embolization, 19 (23.5%) received a second gynecologic diagnosis not previously documented. The most common coexisting pathology was adenomyosis, presenting in 34 (17.1%) patients with leiomyomata, followed by large intracavitary leiomyomata (8, 4.0%), infarcted leiomyomata (7, 3.5%), and hydrosalpinx (6, 3.0%),. CONCLUSIONS: When considering uterine artery embolization for the treatment of symptomatic leiomyomata, preprocedural MRI is superior to ultrasound in detecting coexisting pathologies, including adenomyosis and hydrosalpinx. It can also better characterize leiomyomata, including identifying lesions as intracavitary or infarcted. These findings have the potential to alter clinical management or contraindicate embolization entirely.

Patient Characteristics Associated With Embolization Versus Hysterectomy for Uterine Fibroids: A Systematic Review and Meta-Analysis.

INTRODUCTION: Black and underinsured women in the United States are more likely than their counterparts to develop uterine fibroids (UFs) and experience more severe symptoms. Uterine artery embolization (UAE), a uterine-sparing therapeutic procedure, is less invasive than the common alternative, open hysterectomy. To determine whether demographic disparities persist in UF treatment utilization, we reviewed patient characteristics associated with UAE versus hysterectomy for UF among studies of US clinical practices. METHODS: A systematic literature review was conducted via PubMed, Embase, and CINAHL (PROSPERO CRD42023455051), yielding 1,350 articles (January 1, 1995, to July 15, 2023) that outlined demographic characteristics of UAE compared with hysterectomy. Two readers screened for inclusion criteria, yielding 13 full-text US-based comparative studies specifying at least one common demographic characteristic. Random effects meta-analysis was performed on the data (STATA v18.0). Egger's regression test was used to quantify publication bias. RESULTS: Nine (138,960 patients), four (183,643 patients), and seven (312,270 patients) studies were analyzed for race, insurance status, and age as predictors of treatment modality, respectively. Black race (odds ratio = 3.35, P < .01) and young age (P < .05) were associated with UAE, whereas private insurance (relative to Medicare and/or Medicaid) was not (odds ratio = 1.06, P = .52). Between-study heterogeneity (I2 > 50%) was detected in all three meta-analyses. Small-study bias was detected for age but not race or insurance. CONCLUSIONS AND IMPLICATIONS: Knowledge of demographic characteristics of patients with UFs receiving UAE versus hysterectomy is sparse (n = 13 studies). Among these studies, which seem to be racially well distributed, Black and younger women are more likely to receive UAE than their counterparts.

True Costs of Uterine Artery Embolization: Time-Driven Activity-Based Costing in Interventional Radiology Over a 3-Year Period.

PURPOSE: The aim of this study is to uncover potential areas for cost savings in uterine artery embolization (UAE) using time-driven activity-based costing, the most accurate costing methodology for direct health care system costs. METHODS: One hundred twenty-three patients who underwent outpatient UAE for fibroids or adenomyosis between January 2020 and December 2022 were retrospectively reviewed. Utilization times were captured from electronic health record time stamps and staff interviews using validated techniques. Capacity cost rates were estimated using institutional data and manufacturer proxy prices. Costs were calculated using time-driven activity-based costing for personnel, equipment, and consumables. Differences in time utilization and costs between procedures by an interventional radiology attending physician only versus an interventional radiology attending physician and trainee were additionally performed. RESULTS: The mean total cost of UAE was $4,267 ± $1,770, the greatest contributor being consumables (51%; $2,162 ± $811), followed by personnel (33%; $1,388 ± $340) and equipment (7%; $309 ± $96). Embolic agents accounted for the greatest proportion of consumable costs, accounting for 51% ($1,273 ± $789), followed by vascular devices (15%; $630 ± $143). The cost of embolic agents was highly variable, driven mainly by the number of vials (range 1-19) of tris-acryl gelatin particles used. Interventional radiology attending physician only cases had significantly lower personnel costs ($1,091 versus $1,425, P = .007) and equipment costs ($268 versus $317, P = .007) compared with interventional radiology attending physician and trainee cases, although there was no significant difference in mean overall costs ($3,640 versus $4,386; P = .061). CONCLUSIONS: Consumables accounted for the majority of total cost of UAE, driven by the cost of embolic agents and vascular devices.

The impact of fibroid treatments on quality of life and mental health: a systematic review.

Fibroids significantly impact the quality of life (QOL) and mental health of affected women. However, there are limited comparative data on QOL measures after medical, surgical, and radiologic interventions in women with fibroids. This study aimed to assess the current literature evaluating the impact of fibroids on QOL measures using several validated questionnaires for radiologic, medical, or surgical interventions or a combination of interventions before and after treatment. PubMed, PsycINFO, ClinicalTrials.gov, Embase, and Cochrane Library were searched from January 1990 to October 2023 to evaluate the available evidence, and the risk of bias was assessed using Cochrane RoB 2.0 or the Newcastle-Ottawa Scale. The review criteria included randomized controlled trials (RCTs) and observational cohort studies that included premenopausal women with symptomatic uterine fibroids, confirmed by imaging, who underwent an intervention to target fibroid disease. Only reports using validated questionnaires with a numerical baseline (pretreatment) and posttreatment scores were included. The exclusion criteria included perimenopausal or postmenopausal patients, conditions in addition to uterine fibroids that share similar symptoms, or studies that did not focus on QOL assessment. Abstracts were screened, and full texts were reviewed to determine whether studies met the inclusion criteria. A total of 67 studies were included after final review: 18 RCTs and 49 observational studies. All interventions were associated with a significant improvement in uterine fibroid-specific QOL measures, mental health metrics, and a reduction in symptom severity scores after treatment. These data reveal a substantial impact of uterine fibroids on the QOL and mental health of women with fibroids and indicate the metrics that can be used to compare the effectiveness of fibroid treatment options.

Immunosuppressive tumor microenvironment and uterine fibroids: Role in collagen synthesis.

Uterine fibroids (UF), also called uterine leiomyoma, is one of the most prevalent uterine tumors. UF represents a serious women's health global problem with a significant physical, emotional, and socioeconomic impact. Risk factors for UF include racial disparities, age, race, hormonal factors, obesity, and lifestyle (diet, physical activity, and stress. There are several biological contributors to UF pathogenesis such as cellular proliferation, angiogenesis, and extracellular matrix (ECM) accumulation. This review addresses tumor immune microenvironment as a novel mediator of ECM deposition. Polarization of immune microenvironment towards the immunosuppressive phenotype has been associated with ECM deposition. Immunosuppressive cells include M2 macrophage, myeloid-derived suppressor cells (MDSCs), and Th17 cells, and their secretomes include interleukin 4 (IL-4), IL-10, IL-13, IL-17, IL-22, arginase 1, and transforming growth factor-beta (TGF-ß1). The change in the immune microenvironment not only increase tumor growth but also aids in collagen synthesis and ECM disposition, which is one of the main hallmarks of UF pathogenesis. This review invites further investigations on the change in the UF immune microenvironment as well as a novel targeting approach instead of the traditional UF hormonal and supportive treatment.

Efficacy of uterine artery embolization (UAE) for uterine fibroids according to FIGO classification: a single-center experience.

OBJECTIVE: This study aims to retrospectively evaluate the outcomes of uterine artery embolization (UAE) for uterine fibroids (UFs), specifically submucosal UFs, according to the International Federation of Gynecology and Obstetrics (FIGO) classification of UFs. MATERIALS AND METHODS: Forty-two patients with symptomatic UFs underwent UAE with Embosphere® between July 2016 and November 2021. MRI was performed before, at 3 and 6 months after the UAE. At each examination, the volume of UF was measured, and the percentage volume reduction rate (VRR) was calculated. The technical success rate (TSR), symptom improvement rate (SIR), regrowth rate (RR) after 6 months, and adverse events (AEs) were examined; VRR was compared between patients with submucosal UFs (FIGO types 0-2, group A), those with submucosal contacts (FIGO type 3, group B), and those without submucosal UFs (FIGO types 4-7, group C). Statistical analysis was performed on the difference in VRR between groups A, B, and C at 3 and 6 months after UAE. The relationship with hormone levels before UAE and VRR was evaluated. RESULTS: Thirty-seven of the 42 patients were evaluated. Overall, VRR was 37.0% at 3 months and 52.1% at 6 months; TSR, SIR, and RR were 100%, 95.2%, and 5.4%, respectively; VRR at 6 months was 80.7% for group A (n = 7), 57.8% for group B (n = 13), and 37.1% for group C (n = 17). Significant differences were found between A and C (p < 0.001) and B and C (p = 0.023). Hormone levels before UAE had no effect on VRR. There was no significant AEs other than grade 3 pulmonary embolism in one patient. CONCLUSION: UAE was effective for submucosal FIGO types 0-3. UAE was especially useful as an option for FIGO type 3 with a low protrusion rate that is difficult to treat with transcervical resection.

Outcome prediction for symptomatic patients with fibroids who underwent uterine artery embolization.

PURPOSE: To predict the clinical outcome of symptomatic patients with uterine leiomyomas who underwent uterine artery embolization (UAE), based on clinical and radiological features. METHODS: Patients with symptomatic uterine leiomyomas who underwent UAE from March 2010 to September 2019 were consecutively included in this retrospective study. Patients with persistent or recurrent symptoms and those who needed repeated UAE, myomectomy, or hysterectomy following the initial treatment were considered to have a poor outcome after UAE. The total and enhancing volume of the dominant leiomyoma in each location and uterine volume were obtained before and after UAE. Univariate and multivariate Cox proportional hazard analyses were used to evaluate the parameters that could predict poor outcome. RESULTS: A total of 116 patients (mean age, 45 ± 5 years) were included. Forty-six patients (46/116, 39.7%) showed poor outcome. Cox regression analysis showed higher hazard of poor outcome for younger patients vs. older patients (HR: 0.92, p-value: 0.01), patients with adenomyosis vs. patients without adenomyosis (HR: 2.47, p-value < 0.01), patients with adenomyosis thickness > 2.5 cm before UAE vs. patients without adenomyosis (HR: 4.2, p-value < 0.01) and for patients with intramural fibroid enhancement volume > 440 cm3 compared to patients with no intramural fibroids (p-value: 0.06). Multivariate Cox regression analysis including age, the thickness of adenomyosis, and intramural leiomyoma volume of enhancement before UAE was chosen as the best model to predict the outcome. CONCLUSIONS: Pretreatment clinical and MRI features could identify patients with a higher risk for poor outcome after UAE.

Prediction of non-perfusion volume ratio for uterine fibroids treated with ultrasound-guided high-intensity focused ultrasound based on MRI radiomics combined with clinical parameters.

BACKGROUND: Prediction of non-perfusion volume ratio (NPVR) is critical in selecting patients with uterine fibroids who will potentially benefit from ultrasound-guided high-intensity focused ultrasound (HIFU) treatment, as it reduces the risk of treatment failure. The purpose of this study is to construct an optimal model for predicting NPVR based on T2-weighted magnetic resonance imaging (T2MRI) radiomics features combined with clinical parameters by machine learning. MATERIALS AND METHODS: This retrospective study was conducted among 223 patients diagnosed with uterine fibroids from two centers. The patients from one center were allocated to a training cohort (n = 122) and an internal test cohort (n = 46), and the data from the other center (n = 55) was used as an external test cohort. The least absolute shrinkage and selection operator (LASSO) algorithm was employed for feature selection in the training cohort. The support vector machine (SVM) was adopted to construct a radiomics model, a clinical model, and a radiomics-clinical model for NPVR prediction, respectively. The area under the curve (AUC) and the decision curve analysis (DCA) were performed to evaluate the predictive validity and the clinical usefulness of the model, respectively. RESULTS: A total of 851 radiomic features were extracted from T2MRI, of which seven radiomics features were screened for NPVR prediction-related radiomics features. The radiomics-clinical model combining radiomics features and clinical parameters showed the best predictive performance in both the internal (AUC = 0.824, 95% CI 0.693-0.954) and external (AUC = 0.773, 95% CI 0.647-0.902) test cohorts, and the DCA also suggested the radiomics-clinical model had the highest net benefit. CONCLUSIONS: The radiomics-clinical model could be applied to the NPVR prediction of patients with uterine fibroids treated by HIFU to provide an objective and effective method for selecting potential patients who would benefit from the treatment mostly.

The Costs of Implementing a Conversation Aid for Uterine Fibroids in Multiple Health Care Settings.

BACKGROUND: Health care organizations considering adopting a conversation aid (CA), a type of patient decision aid innovation, need information about the costs of implementation. OBJECTIVES: The aims of this study were to: (1) calculate the costs of introducing a CA in a study of supported implementation in 5 gynecologic settings that manage individuals diagnosed with uterine fibroids and (2) estimate the potential costs of future clinical implementation efforts in hypothetical settings. RESEARCH DESIGN: We used time-driven activity-based costing to estimate the costs of CA implementation at multiple steps: integration with an electronic health record, preimplementation, implementation, and sustainability. We then estimated costs for 2 disparate hypothetical implementation scenarios. SUBJECTS AND DATA COLLECTION: We conducted semistructured interviews with participants and examined internal documentation. RESULTS: We interviewed 41 individuals, analyzed 51 documents and 100 emails. Overall total implementation costs over ∼36 months of activities varied significantly across the 5 settings, ranging from $14,157 to $69,134. Factors influencing costs included size/complexity of the setting, urban/rural location, practice culture, and capacity to automate patient identification. Initial investments were substantial, comprising mostly personnel time. Settings that embedded CA use into standard workflows and automated identification of appropriate patients had the lowest initial investment and sustainability costs. Our estimates of the costs of sustaining implementation were much lower than initial investments and mostly attributable to CA subscription fees. CONCLUSION: Initiation and implementation of the interventions require significant personnel effort. Ongoing costs to maintain use are much lower and are a small fraction of overall organizational operating costs.

Fibroids and Fertility.

Uterine fibroids significantly impact women's reproductive health, influencing fertility potential and pregnancy outcomes. Their growth, often facilitated by hormonal influences like estrogen and progesterone, can cause considerable disruptions in the uterus, leading to symptoms and complications that impact the quality of life and reproductive prospects of women.This article provides an exhaustive discussion of uterine fibroids, including pathophysiology, their impact on endometrial function, receptivity, fertility, and pregnancy outcomes, and the management of infertility in patients with uterine fibroids. It underlines the critical role of uterine fibroids in women's reproductive health, emphasizing the importance of effective diagnosis and treatment to promote fertility and improve pregnancy outcomes.

Leiomyoma Fistulization After Uterine Artery Embolization.

BACKGROUND: Uterine artery embolization (UAE) has been used to treat symptomatic uterine leiomyomas since 1995. This case report describes a rare complication of UAE, with delayed recognition, ultimately requiring definitive hysterectomy. CASE: A 53-year-old women with symptomatic leiomyomas underwent imaging demonstrating an enlarged (16.9×11.3×11.5 cm) uterus with multiple leiomyomas. She underwent UAE and, over the subsequent 3 months, and had five emergency department visits for abdominal pain and dysuria. Pelvic magnetic resonance imaging (MRI) 4 months postprocedure showed nodular mural enhancement of the right anterior bladder dome, and cystoscopy demonstrated irregular tissue on the right dome of the bladder. The patient ultimately underwent total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, partial cystectomy with reconstruction, and omental flap for bladder necrosis and leiomyoma fistulization. CONCLUSION: Bladder necrosis and leiomyoma fistulization are rare complications of UAE that can present with pelvic pain, hematuria, and recurrent bladder stones. Computed tomography and MRI can be useful tools in evaluating for complications, but clinicians should have a low threshold to use cystoscopy to directly visualize potential abnormalities identified on imaging. Patients with complex cases with suspected post-UAE complications warrant referral to tertiary care centers for a multidisciplinary approach.

Assessment of Uterine Fibroid Knowledge and Educational Interests Among Health Care Professionals.

BACKGROUND: Uterine fibroid diagnosis and management can be delayed by a lack of access to care. To combat this barrier, this study aimed to determine gaps in knowledge and investigate areas of education interest. METHODS: Obstetrics-gynecology, family medicine, and internal medicine resident and attending physicians received an electronic survey via RedCap. Descriptive statistics were performed in Mintab and Excel. RESULTS: Seventy of the 316 physicians (22%) who received the survey completed it. Most participants answered questions regarding diagnosis timing, instruments for validated reported outcomes, and risk factors incorrectly. Seventy-six percent of respondents desired more education about treatment options and guidelines. DISCUSSION: This study provides insight regarding current knowledge of uterine fibroids and areas of educational interest among different physicians.

Nuevo paradigma en la cirugía del mioma: reparación uterina / New paradigm in fibroid surgery: Uterine repair

Los miomas uterinos son una patología frecuente que afecta fundamentalmente a mujeres en su tercera y cuarta década de su vida. La mayoría son asintomáticos. Sin embargo, algunos pueden tener una importante repercusión clínica o en la fertilidad de la paciente. Recientemente se han producido cambios relevantes en el diagnóstico y manejo de esta entidad. En este manuscrito se pretende resumir dichos cambios abordados en el 1er Congreso Nacional de la Sociedad Española para el estudio de las Miomas y Endometriosis.(AU)

Uterine fibroids are a frequent pathology that mainly affects women in their third and fourth decade of life. Most are asymptomatic. However, some may have a significant clinical impact or on the fertility of the patient. Recently there have been relevant changes in the diagnosis and management of this entity. This paper aims to summarize these changes discussed at the 1 st National Congress of the Spanish Society for the Study of Fibroids and Endometriosis.(AU)