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: 10398810
• 负责人: Alison M El Ayadi
• 金额: $ 57.09万
• 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/10398810
• 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; Lead; Longitudinal cohort; Longitudinal cohort study; Maps; 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 and Spirituality; 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; base; care providers; clinical care; clinical development; clinical examination; cohort; contextual factors; evidence base; experience; follow-up; frailty; hazard; hip bone; implementation science; improved; longitudinal design; 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.

摘要 女性生殖器瘘管病是一种使人衰弱的损伤，影响到200万至300万妇女，主要是在撒哈拉以南非洲。 患有瘘管病的妇女有无法控制的尿液和/或粪便渗漏（以及其他身体症状）， 严重受到歧视，精神病发病率很高。初步证据已确定瘘管风险 瘘修补后复发、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， 制定临床干预措施，以减少这些对妇女的不利风险，防止她们再次怀孕， 我们的目标是帮助妇女摆脱瘘管病带来的后果，并改善妊娠结局和生活质量。 为努力改善瘘管病妇女的身体和心理生活质量，我们提议 通过开展一项关于瘘管修补术后不良后果风险的 对乌干达9个设施中800名瘘管修补妇女的纵向队列研究。我们试图找出 修复后瘘管破裂和复发的预测因素（目的1），以确定修复后瘘管破裂和复发的预测因素和特征。 失禁（目标2），并在理论指导的迭代过程中吸引关键利益相关者，以制定路线图 在这种情况下，可能可行和可接受的干预战略（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; 广泛的患者、瘘管和行为特征;招募的女性人数最多（800人） 迄今为止最长的随访时间（3年），用于稳健估计。将在手术时和手术后收集数据。 2周、6周、3个月，此后每季度进行一次，持续3年，通过访谈和管理相结合的方式进行。 患者问卷调查和结构化病历摘要，并根据 护理和必要时根据症状的经验。与主要利益攸关方的深入访谈（n~80， 包括纵向参与者和一系列其他重要角色）， 实施变革理论将帮助我们理解行为的促进者和障碍， 执行目标，为多个层面的潜在干预战略提供信息。 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对修复后瘘管破裂、复发和尿失禁的发生率 生存模式我们的研究结果将为优化修复后结果的咨询和临床护理模式提供信息 用于瘘管修复后的女性。