Long Term Effectiveness of Uterine Sparing Fibroid Treatments

保留子宫肌瘤治疗的长期有效性

基本信息

批准号：
10656850
负责人：
Vanessa Jacoby
金额：
$ 63.48万
依托单位：
HENRY FORD HEALTH SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10656850
关键词：
Ablation Address Affect African American Aftercare Age Anemia Black race Blood Transfusion Blood flow Caring Characteristics Clinical Clinical effectiveness Cohort Studies Comparative Effectiveness Research Data Decision Making Development Diabetes Mellitus Effectiveness Endometrial Endometrium Enrollment Excision Failure Fertility Fibroid Tumor Functional disorder Future Goals Guidelines Hemorrhage Hysterectomy Image Impairment Incidence Infertility Intention Intestines Knowledge Location Longitudinal cohort Longterm Follow-up Menopausal Status Menopause Morbidity - disease rate Online Systems Outcome Pain Participant Patient Self-Report Patient-Focused Outcomes Patients Pelvic Pain Pelvis Population Postmenopause Predictive Factor Pregnancy Premenopause Procedures Provider Psychometrics Quality of life Questionnaires Race Radiofrequency Interstitial Ablation Recurrence Registries Reporting Reproductive History Research Personnel Retreatment Risk Selection for Treatments Site Standardization Statistical Methods Statistical Models Symptoms Testing Time Tissues Treatment Effectiveness Treatment Failure United States Uterine Fibroids Uterine myomectomy Uterus Woman Work adverse pregnancy outcome black women clinical care clinical decision-making clinical predictors cohort common treatment comorbidity comparative effectiveness data harmonization ethnic diversity evidence base flexibility follow-up improved indexing individual patient longitudinal design novel patient engagement patient oriented precision medicine predictive tools preservation pressure prevent racial diversity risk prediction success symptomatic improvement tumor urinary

项目摘要

The lifetime cumulative incidence of uterine leiomyomas (fibroids or UF) is >80% among Black women and ~70% in White women. UF are the most common reason for hysterectomy in the U.S. and can cause heavy menstrual bleeding requiring blood transfusion(s), pelvic pain, urinary and bowel problems, infertility, and substantial impairment of quality of life (QOL). While alternatives to hysterectomy are available including myomectomy (fibroid removal), uterine artery embolization (UAE), endometrial ablation (EA), and radiofrequency ablation (RFA), there are significant knowledge gaps that preclude the development of evidence-based clinical guidelines to select an appropriate UF treatment. Prior studies of UF treatments have several key deficits including limited follow-up time (<2 years) and failure to assess important confounders, such as pre-procedure fibroid characteristics, baseline QOL, and pregnancy intention. Two multisite registries with harmonized data, COMPARE-UF (Myomectomy, EA and UAE patients) and ULTRA (RFA patients), have the capacity to address critical evidence gaps and significantly improve care for women with UF. This project will be led by COMPARE-UF/ULTRA investigators (MPIs) and extend the follow-up of 700 COMPARE-UF and ULTRA participants who have had a uterine-sparing fibroid treatment for up to 10 years after the index procedure. Long term follow-up through menopause is critical to assess the durability of symptom improvement and the rates of hysterectomy or other uterine procedures following the index treatment. Currently, women in COMPARE-UF/ULTRA are followed only for 1-3 years post treatment; the additional follow-up in this proposal, will have a major impact on clinical decision-making, provide relevant data in a racially diverse (>40% Black) population, and include detailed imaging information (UF size, number and location), and self-reported desire for future fertility obtained prior to the index fibroid treatment. Among women who have undergone one of four uterine-sparing procedures (myomectomy, EA, UAE and RFA), validated questionnaires from pre-procedure will be repeated annually up to 10 years post-procedure, to achieve the following: Aim 1: Compare changes in fibroid symptoms and quality of life from pre-procedure up to 10 years post-procedure among four uterine-sparing procedures: myomectomy, EA, UAE, and RFA. Aim 2: Compare the rate of and time until treatment failure up to 10 years after the index treatment among participants who had myomectomy, EA, UAE, and RFA. Aim 3: Identify baseline factors that predict clinical effectiveness after myomectomy, EA, UAE, and RFA and with patient and provider input, create a clinical prediction tool (Fibroid Treatment Calculator) that supports informed decision-making. Our preliminary data demonstrate ongoing active engagement of these participants. This project is a time-limited opportunity that uses two well-designed longitudinal cohorts with comprehensive baseline information collected with validated questionnaires and will yield results for immediate application in clinical care.

黑人女性和女性中子宫肌瘤（肌瘤或 UF）的终生累积发病率 >80% 白人女性中约占 70%。在美国，UF 是子宫切除术的最常见原因，可导致严重的子宫切除术。需要输血的月经出血、盆腔疼痛、泌尿和肠道问题、不孕症以及生活质量（QOL）严重受损。虽然子宫切除术的替代方案包括子宫肌瘤切除术（子宫肌瘤切除术）、子宫动脉栓塞术（UAE）、子宫内膜消融术（EA）和射频消融（RFA）方面，存在重大知识差距，阻碍了射频消融术的发展选择合适的超滤治疗的循证临床指南。先前对超滤治疗的研究几个关键缺陷，包括有限的随访时间（<2年）和未能评估重要的混杂因素，例如术前肌瘤特征、基线生活质量和怀孕意愿。两个多站点注册表根据统一数据，COMPARE-UF（子宫肌瘤切除术、EA 和 UAE 患者）和 ULTRA（RFA 患者）解决关键证据差距并显着改善对 UF 女性护理的能力。该项目将由 COMPARE-UF/ULTRA 研究人员 (MPI) 领导，并对 700 名患者进行随访接受保留子宫肌瘤治疗长达 10 年的 COMPARE-UF 和 ULTRA 参与者在索引过程之后。绝经期的长期随访对于评估其持久性至关重要症状改善以及遵循该指数的子宫切除术或其他子宫手术的比率治疗。目前，接受 COMPARE-UF/ULTRA 治疗的女性仅在治疗后随访 1-3 年；这本提案的额外后续工作，将对临床决策产生重大影响，提供相关数据在种族多样化（>40% 黑人）人群中，并包括详细的成像信息（UF 大小、数量和位置），以及在指数肌瘤治疗之前获得的自我报告的对未来生育能力的渴望。在女性中接受过四种保留子宫手术（子宫肌瘤切除术、EA、UAE 和 RFA）之一的经验证的手术前的调查问卷将每年重复一次，直至手术后 10 年，以实现目标 1：比较术前至 10 年间肌瘤症状和生活质量的变化四种保留子宫手术的术后：子宫肌瘤切除术、EA、UAE 和 RFA。目标 2：比较接受指标治疗后 10 年内治疗失败的比率和直至治疗失败的时间子宫肌瘤切除术、EA、UAE 和 RFA。目标 3：确定预测临床效果的基线因素子宫肌瘤切除术、EA、UAE 和 RFA，并根据患者和提供者的意见，创建临床预测工具（肌瘤治疗计算器）支持明智的决策。我们的初步数据表明正在进行这些参与者的积极参与。该项目是一个限时的机会，使用两个精心设计的纵向队列，具有通过验证问卷收集的全面基线信息，并将产生可立即应用于临床护理的结果。