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

摘要 女性生殖器瘘是一种使人衰弱的伤害，影响到200万至300万妇女，主要发生在撒哈拉以南非洲地区。 患有瘘管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)， 严重污名化，精神疾病发病率高。初步证据已确定有发生瘘管的风险 瘘管修补术后复发、大小便失禁和妊娠并发症。然而，证据基础 关于造成这些不利结果的因素严重不发达，限制了 开发临床干预措施，以减少这些对妇女的不利风险，防止她们再次 体验瘘管的后果，并改善妊娠结局和生活质量。 为了改善患有瘘管病的妇女的身体和心理社会生活质量，我们建议 通过开展一项关于瘘管修补术后不良后果风险的知识缺口 乌干达9家医疗机构800名接受瘘管修补术的妇女的纵向队列研究。我们试图找出预测因素 修复后瘘破裂和复发的预测(目标1)，以确定修复后的预测因素和特征 大小便失禁(目标2)，并让关键利益攸关方参与理论指导的迭代过程，以制定路线图 在这一背景下可能可行和可接受的干预策略(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 范围广泛的患者、瘘管和行为特征；招募的女性人数最多(800人) 具有迄今为止稳健估计的最长跟踪时间(3年)。数据将在手术时和在 2周、6周、3个月，此后3年每季度进行一次面谈--实施 患者问卷和结构化病历摘要，临床检查按照 根据症状经验进行护理和必要时的护理。与关键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) 实施变革理论将帮助我们理解行为的促进者和障碍，以及 实施目标，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效果差异为20%。分析将 描述评估患者、瘘管、瘘管修复和修复后特征的个体和联合影响 应用比例危险度评价修复术后瘘口破裂、复发和尿失禁的发生率 生存模式。我们的发现将为优化修复后结果的咨询和临床护理模式提供参考 适用于瘘管修补后的女性。

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.