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.

摘要