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.

在黑人妇女中，子宫平滑肌瘤（肌瘤或UF）的寿命累积发生率> 80％ 白人妇女〜70％。 UF是美国子宫切除术的最常见原因，可能会导致沉重 月经出血需要输血，骨盆疼痛，尿和肠问题，不育和 大大损害生活质量（QOL）。虽然可以接受子宫切除术的替代方法 肌瘤切除术（肌瘤去除），子宫动脉栓塞（UAE），子宫内膜消融（EA）和 射频消融（RFA），存在明显的知识差距，排除了发展的发展 基于证据的临床指南，以选择适当的UF治疗。对UF治疗的先前研究 几个关键赤字，包括有限的随访时间（<2年）和未能评估重要的混杂因素， 例如疗程肌瘤特征，基线QOL和妊娠意图。两个多站点登记处 使用统一的数据，比较 - UF（肌瘤，EA和阿联酋患者）和Ultra（RFA患者）具有 解决关键证据差距并显着改善UF女性的护理能力。 该项目将由比较/UF/Ultra调查人员（MPI）领导，并扩展了700的随访 比较已接受子宫疗程的肌瘤治疗长达10年的UF和超级参与者 索引程序之后。通过更年期的长期随访对于评估耐用性至关重要 症状改善以及子宫切除术或其他子宫手术的发生率 治疗。目前，在治疗后1 - 3年仅遵循比较/Ultra的妇女；这 该提案的其他随访，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％的黑人）中，包括详细的成像信息（UF大小，数字和数字 位置），以及在肌纤维治疗之前获得对未来生育能力的渴望。在女性中 经过四个子宫占主体手术之一（肌瘤切除术，EA，阿联酋和RFA）之一，已验证 预科前的问卷将每年重复到后期10年，以实现 以下：AIM 1：比较肌瘤症状的变化和从预科前期10年的生活质量 四个子宫分类手术的后期治疗：肌瘤切除术，EA，阿联酋和RFA。目标2：比较 在索引治疗后长达10年的治疗失败的率和时间之间 肌瘤切除术，EA，阿联酋和RFA。目标3：确定可预测临床有效性之后临床有效性的基线因素 肌瘤切除术，EA，阿联酋和RFA以及患者和提供者的输入，创建一个临床预测工具（肌瘤 治疗计算器）支持明智的决策。我们的初步数据证明了正在进行的 这些参与者的积极参与。该项目是一个时间限制的机会，使用了两个精心设计的 纵向人群，并附有综合的基线信息，并将 立即应用临床护理的产量结果。