Long Term Effectiveness of Uterine Sparing Fibroid Treatments

保留子宫肌瘤治疗的长期有效性

• 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
• 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

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.

在黑人妇女和妇女中，子宫肌瘤(肌瘤或UF)的终生累积发病率为80%。 白人女性的比例约为70%。UF是美国最常见的子宫切除术原因，可能会导致严重的 需要输血的月经出血(S)、盆腔疼痛、排尿和肠道问题、不孕不育和 严重损害生活质量(QOL)。虽然子宫切除术的替代方案包括 肌瘤摘除(肌瘤摘除)，子宫动脉栓塞术(UAE)，子宫内膜消融术(EA)，以及 射频消融(RFA)，存在着严重的知识鸿沟，阻碍了 循证临床指南，以选择适当的UF治疗。先前对UF治疗的研究已经 几个关键缺陷，包括有限的跟踪时间(两年)和未能评估重要的混杂因素， 如术前肌瘤特征、基线生活质量和妊娠意向。两个多站点注册表 有了统一的数据，比较-UF(肌瘤切除术，EA和UAE患者)和ULTA(RFA患者)，有 解决关键证据差距和显著改善对UF妇女的护理的能力。 该项目将由Compare-UF/ULTRA调查员(MPI)领导，并延长700人的后续行动 比较-UF和ULTRA参与者接受过长达10年的保留子宫肌瘤治疗 在索引程序之后。绝经后的长期随访对评估其持久性至关重要。 症状改善和子宫切除或其他子宫手术的比率 治疗。目前，接受COMPARE-UF/UTA治疗的妇女只在治疗后接受1-3年的随访； 本次建议追加跟进，将对临床决策产生重大影响，提供相关数据 在种族多样性(&gt；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对未来生育的自我报告愿望。在女性中 接受过四种保留子宫手术中的一种(肌瘤摘除术、电切术、子宫动脉栓塞术和射频消融术)，经验证 手术前的问卷将每年重复一次，直到手术后10年，以实现 以下：目标1：比较子宫肌瘤症状和生活质量从术前到10年的变化 术后四种保留子宫的手术方式：子宫肌瘤剔除术、电切术、子宫动脉栓塞术和射频消融术。目标2：比较 指数治疗后长达10年的治疗失败率和持续时间 肌瘤摘除术、电针、阿联酋和射频消融术。目标3：确定预测术后临床疗效的基线因素 肌瘤切除术、EA、UAE和RFA，以及患者和提供者的输入，创建了一个临床预测工具(肌瘤 治疗计算器)，支持知情决策。我们的初步数据显示 这些参与者的积极参与。这个项目是一个有时间限制的机会，使用了两个精心设计的 使用经过验证的调查问卷和意愿收集的全面基线信息的纵向队列 产生立即应用于临床护理的结果。