Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair

确定预防女性生殖器瘘修复术后不良后果的机会

• 批准号: 10561711
• 负责人: Alison M El Ayadi
• 金额: $ 56.9万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10561711
• 关键词: Accounting; Address; Affect; Africa South of the Sahara; Attention; Behavior; Behavioral; Behavioral Sciences; Cervical spinal cord injury; Characteristics; Clinical; Coitus; Communities; Counseling; Data; Development; Economics; Enrollment; Exposure to; Extravasation; Face; Family; Feces; Female genitalia; Fistula; Genital; Genitalia; Health; Iatrogenesis; Incidence; Incontinence; Individual; Infection; Injury; Intervention; Interview; Joints; Knowledge; Longitudinal cohort; Longitudinal cohort study; Medical Records; Methods; Modeling; Morbidity - disease rate; Obstructed labor; Operative Surgical Procedures; Outcome; Pain; Participant; Patients; Personal Satisfaction; Physical Examination; Population; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Prevention; Process; Quality of life; Questionnaires; Recurrence; Religion; Reporting; Research; Research Infrastructure; Resolution; Risk; Risk Factors; Role; Sample Size; Sampling; Severities; Site; Stigmatization; Structure; Survival Analysis; Symptoms; Testing; Theory of Change; Time; Translating; Translations; Trauma; Uganda; Urinary Incontinence; Urine; Validation; Walking; Woman; Women' s Health; Work; acceptability and feasibility; adverse outcome; care providers; clinical care; clinical development; clinical examination; cohort; contextual factors; evidence base; experience; follow-up; frailty; hazard; hip bone; implementation science; improved; intervention mapping; longitudinal design; marginalization; member; nerve damage; physical symptom; prevent; psychosocial; recruit; repaired; secondary infertility; social; sociodemographics; standard of care; stillbirth; study population; theories

ABSTRACT Female genital fistula is a debilitating injury that affects 2 to 3 million women, mostly in sub-Saharan Africa. Women with fistula have uncontrollable leakage of urine and/or feces (among other physical symptoms), are heavily stigmatized, and experience high psychiatric morbidity. Preliminary evidence has identified risk of fistula recurrence, incontinence, and pregnancy complications following fistula repair. However, the evidence base regarding the factors contributing to these adverse outcomes is severely underdeveloped, limiting the development of clinical interventions to reduce these adverse risks to women, preventing them from re- experiencing the consequences of fistula, and to improve pregnancy outcomes and quality of life. In an effort to improve the physical and psychosocial quality of life for women affected by fistula, we propose to address the critical gaps in knowledge on risk of adverse outcomes following fistula repair by conducting a longitudinal cohort study of 800 women repaired for fistula in 9 Ugandan facilities. We seek to identify predictors of post-repair fistula breakdown and recurrence (Aim 1), to identify predictors and characteristics of post-repair incontinence (Aim 2), and to engage key stakeholders in a theory-guided iterative process to develop a roadmap of intervention strategies likely to be feasible and acceptable within this setting (Aim 3). Our approach overcomes limitations to prior research through employing a longitudinal design; focusing on a broad range of patient, fistula, and behavioral characteristics; and enrolling the largest number of women (800) with the longest follow-up (3 years) to date for robust estimation. Data will be collected at time of surgery and at 2 weeks, 6 weeks, 3 months, and quarterly thereafter for 3 years through a combination of interview-administered patient questionnaire and structured medical record abstraction, with clinical exams conducted per standard of care and as necessary based on symptom experiences. In-depth interviews with key stakeholders (n~80, including longitudinal participants and a range of other important roles) guided by prevalent behavior and implementation change theories will help us to understand facilitators and barriers of behavior and implementation targets to inform potential intervention strategies at multiple levels. Our sample size will allow us to detect a minimum difference in effect of 20% for all outcomes. Analyses will describe estimate the individual and joint-effects of patient, fistula, fistula repair, and post-repair characteristics on incidence of post-repair fistula breakdown and recurrence and incontinence using proportional hazards frailty survival models. Our findings will inform counseling and clinical care models for optimizing post-repair outcomes for women following fistula repair.

抽象的 女性生殖器瘘管病是一种使人衰弱的损伤，影响着 2 至 300 万女性，其中大部分集中在撒哈拉以南非洲地区。 患有瘘管的女性会出现无法控制的尿液和/或粪便渗漏（以及其他身体症状）， 遭受严重污名化，精神疾病发病率很高。初步证据已确定存在瘘管风险 瘘管修复术后复发、失禁和妊娠并发症。然而，证据基础 关于导致这些不良结果的因素的研究严重不足，限制了 制定临床干预措施以减少这些对妇女不利的风险，防止她们再次 体验瘘管的后果，并改善妊娠结局和生活质量。 为了改善受瘘管病影响的妇女的身心生活质量，我们建议： 通过开展一项关于瘘管修复术后不良后果风险的知识来弥补这一关键差距 对乌干达 9 个设施中 800 名接受瘘管修复的妇女进行的纵向队列研究。我们寻求确定预测因素 修复后瘘管破裂和复发（目标 1），以确定修复后的预测因素和特征 失禁（目标 2），并让主要利益相关者参与理论指导的迭代过程以制定路线图 在此背景下可能可行且可接受的干预策略（目标 3）。 我们的方法通过采用纵向设计克服了先前研究的局限性；专注于一个 广泛的患者、瘘管和行为特征；招收的女性人数最多（800 人） 迄今为止最长的随访（3年）以进行稳健的估计。数据将在手术时和 2周、6周、3个月以及此后每季度一次，持续3年，通过面试相结合的方式进行 患者调查问卷和结构化病历摘要，并根据以下标准进行临床检查 护理并根据症状经验进行必要的护理。与主要利益相关者（n~80， 包括纵向参与者和一系列其他重要角色）以普遍行为和 实施变革理论将帮助我们理解行为的促进因素和障碍，以及 实施目标为多个层面的潜在干预策略提供信息。 我们的样本量将使我们能够检测到所有结果的最小效果差异为 20%。分析将 描述估计患者、瘘管、瘘管修复和修复后特征的个体和联合效应 使用比例风险脆弱性研究修复后瘘管破裂、复发和失禁的发生率 生存模型。我们的研究结果将为咨询和临床护理模型提供信息，以优化修复后的结果 适用于瘘管修复术后的女性。