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 女性生殖器瘘是一种令人衰弱的伤害，影响2至300万妇女，主要是撒哈拉以南非洲。 瘘管的女性尿液和/或粪便（除其他身体症状）是否无法控制 严重的污名化并经历了高精神病发病率。初步证据已经确定了瘘管的风险 瘘管修复后的复发，动荡和妊娠并发症。但是，证据基础 关于导致这些不良结果的因素，严重欠发达，限制了 开发临床干预措施以减少对妇女的不良风险，阻止她们重新 体验瘘管的后果，并改善妊娠结局和生活质量。 为了改善受瘘管影响的女性的身体和心理社会生活质量，我们建议 通过进行瘘管修复后不良后果风险的知识的关键差距 在9个乌干达设施中为800名维修瘘管修复的妇女的纵向队列研究。我们试图确定预测因子 后修复后瘘管崩溃和复发（AIM 1），以识别后修复的预测因子和特征 尿失禁（AIM 2），并让主要利益相关者参与理论引入的迭代过程以开发路线图 干预策略可能在这种情况下是可行的和可以接受的（AIM 3）。 我们的方法通过采用纵向设计克服了对先前研究的局限性；专注于一个 广泛的患者，瘘管和行为特征；并注册最多的女性（800） 迄今为止，最长的随访（3年）进行了强大的估计。数据将在手术时和在 2周，6周，3个月，此后每季度通过面试的组合组合 患者问卷和结构化病历抽象，根据标准进行临床检查 根据症状经历，护理和必要。对主要利益相关者的深入访谈（n〜80， 包括纵向参与者和一系列其他重要角色）在普遍的行为和 实施改变理论将帮助我们了解行为的促进者和障碍 实施目标，以多个级别的潜在干预策略告知潜在的干预策略。 我们的样本量将使我们能够检测到所有结果的最小差异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 关于后修复后瘘管的发生率，违反比例危害脆弱的复发和尿失禁 生存模型。我们的发现将为咨询和临床护理模型提供信息，以优化修复后的结果 适用于瘘管修复后的妇女。