Phenotyping Responses to Optimize the Management of Pain Treatment in Endometriosis

表型反应以优化子宫内膜异位症疼痛治疗的管理

• 批准号: 10372501
• 负责人: Meryl Joseph Alappattu
• 金额: $ 22.88万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10372501
• 关键词: Ablation; Address; Adhesions; Affect; Aftercare; Age; Agonist; American College of Obstetricians and Gynecologists; Anatomy; Behavioral; Caring; Characteristics; Chronic; Clinical; Clinical Practice Guideline; Diagnosis; Diagnostic; Disease; Dysmenorrhea; Economics; Endometrial; Estrogens; Ethnic Origin; Excision; Female Genital Diseases; Foundations; Future; Gold; Gonadotropin Hormone Releasing Hormone; Guidelines; Health; Healthcare; Hemorrhage; Heterogeneity; Infertility; Laparoscopy; Lesion; Measures; Medical; Menarche; National Institute of Child Health and Human Development; Non-Steroidal Anti-Inflammatory Agents; Observational Study; Operative Surgical Procedures; Oral Contraceptives; Ovarian Mass; Pain; Pain intensity; Pain management; Pain quality; Pathogenesis; Patients; Pelvic Pain; Persistent pain; Pharmaceutical Preparations; Pharmacology; Phenotype; Physical activity; Positioning Attribute; Postoperative Pain; Precision Medicine Initiative; Predictive Value; Premenopause; Prevalence; Progestins; Prognosis; Progressive Disease; Provider; Quality of life; Race; Reporting; Risk Factors; Severities; Severity of illness; Sexual Health; Strategic Planning; Subgroup; Symptoms; Therapeutic; Time; Tissues; Treatment Failure; Treatment outcome; United States; Uterine hemorrhage; Uterus; Variant; Woman; Work; aged; base; care seeking; central sensitization; chronic pelvic pain; clinical care; clinical pain; comorbidity; disabling symptom; disease phenotype; dosage; endometriosis; high reward; innovation; novel; opioid therapy; opioid use; pain outcome; pain reduction; pain relief; patient subsets; precision medicine; prospective; psychologic; psychological distress; recruit; reproductive; response; sleep quality; sociodemographic variables; sociodemographics; success; symptom management; symptomatology; treatment response

PROJECT SUMMARY/ABSTRACT Endometriosis is a debilitating and progressive disease that affects 10% of reproductive-aged women. Characterized by the presence of endometrial lesions outside of the uterus, endometriosis is associated with chronic pelvic pain, bleeding, and infertility, with pain being the most debilitating symptom for which patients seek care. Endometriosis results in tremendous economic and healthcare burden and greatly impacts quality of life. Clinical practice guidelines for endometriosis recommend six months of conservative medical treatment for suppression of local or systemic estrogen levels; however, substantial variation exists in the degree of pain relief obtained from pharmacological therapy and some women subsequently require surgical removal of lesions, suggesting that heterogeneity in disease and symptom presentation may underlie treatment response. Further, the mechanisms that predict treatment failure and/or success are poorly characterized, thereby leaving providers in a position of long-term symptom management and with little guidance regarding therapies that may achieve the greatest efficacy. Quantifying this heterogeneity and identifying treatment response characteristics may be a crucial step toward individualizing therapeutic approaches for endometriosis to reduce overall pain burden. In line with the Precision Medicine Initiative, the aims of this prospective observational study are to explore mechanisms associated with treatment response in patients undergoing guideline-based conservative medical therapy for endometriosis, and to characterize associations between phenotypic profiles with pelvic pain severity and pain impact trajectories. Premenopausal women ages 18 to 45 years with clinically suspected endometriosis will be recruited and followed for a period of six months after undergoing conservative treatment according to the American College of Obstetricians and Gynecologists clinical practice guidelines. Heterogeneity in pre- treatment endometriosis symptom presentation will be quantified across the following measures: (1) sociodemographic, (2) clinical, (3) biomedical, (4) pain quality, (5) behavioral, (6) psychological, and (7) functional health. Patients will be followed monthly for six months to assess pelvic pain severity and pain impact. Collectively, these aims have the potential to advance our understanding of phenotypic mechanisms underlying conservative treatment response among women with endometriosis, effects which may serve as a foundation for reducing unnecessary and ineffective medical treatments and lessening the time to proper diagnosis and treatment.

项目摘要/摘要 子宫内膜异位症是一种衰弱和进行性疾病，影响10%的育龄妇女。 以子宫外子宫内膜病变为特征，子宫内膜异位症与 慢性盆腔疼痛、出血和不孕，疼痛是患者寻求的最令人衰弱的症状 关心。子宫内膜异位症造成巨大的经济和医疗负担，并极大地影响生活质量。 子宫内膜异位症的临床实践指南建议对子宫内膜异位症进行6个月的保守治疗 局部或全身雌激素水平的抑制；然而，疼痛缓解的程度存在很大的差异 从药物治疗中获得，一些妇女随后需要手术切除病变， 提示疾病和症状表现的异质性可能是治疗反应的基础。此外， 预测治疗失败和/或成功的机制特征不佳，因此留下了提供者 处于长期症状管理的位置，几乎没有关于可能达到的治疗方法的指导 最大的功效。量化这种异质性并识别治疗反应特征可能是 子宫内膜异位症个体化治疗方法的关键一步，以减轻总体疼痛负担。在……里面 与精确医学计划相一致，这项前瞻性观察研究的目的是探索 接受以指南为基础的保守治疗的患者的治疗反应机制 子宫内膜异位症的治疗，以及表型特征与盆腔疼痛严重程度的关系 以及疼痛冲击轨迹。临床疑似子宫内膜异位症的18至45岁绝经前妇女 在接受保守治疗后，将被招募并跟踪六个月 美国妇产科医师学会临床实践指南。前驱的非均质性 治疗子宫内膜异位症的症状表现将通过以下措施进行量化：(1) 社会人口学，(2)临床，(3)生物医学，(4)疼痛质量，(5)行为，(6)心理，和(7) 功能健康。患者将每月接受为期六个月的随访，以评估骨盆疼痛的严重程度和疼痛影响。 总的来说，这些目标有可能促进我们对潜在的表型机制的理解。 子宫内膜异位症患者保守治疗反应及其影响 减少不必要和无效的治疗，缩短正确诊断和治疗的时间 治疗。