Investigating Pathways to Optimal Reproductive Outcomes Among Women with Rheumatic Diseases

摘要 怀孕是患有风湿病的妇女及其子女发病和死亡的主要原因； 因此，患有风湿病的女性可能做出的最重要的决定之一是是否和/或何时 她希望怀孕。然而，我的基础工作发现，其中许多女性无法 由于她们的信息需求未得到满足，因此她们在怀孕期间做出了明智的决定。为了满足这个即时和 患者有紧急需求，我将开发一种新颖的、面向患者的决策辅助工具，名为 MyVoice，帮助女性做出决策 在风湿病临床环境中做出明智的妊娠决定并增强计划生育护理的接受度 （目标 1）。我将在风湿病诊所试点 MyVoice，以评估其可行性、可接受性和实施情况 潜力（目标 2）。这项工作将作为未来混合实施-有效性试验的基础 评估 MyVoice 是否可以增加女性特定疾病的生殖知识和计划生育护理 接收，并最终改善其下游的繁殖结果。 患有风湿性疾病的女性不良妊娠和围产期结局的主要预测因素之一 是受孕时和怀孕期间的活动性疾病。我之前的工作表明一些女性可能 在怀孕期间经历活动性疾病，因为他们决定不坚持妊娠相容的抗 风湿病药物；他们担心他们的药物可能会对胎儿发育产生不利影响。在目标 3 中，我将 建立一个纵向的、探索性的年轻女性风湿性疾病队列，以评估药物治疗的效果 依从性受到关键的时变和时不变上游危险因素（即怀孕意图、 生殖知识、症状严重程度、计划生育护理收据）。在随后的 R01 研究中，我将 评估这些上游因素如何导致健康或不良的生殖结果——从而使我能够 确定可增强生殖结果的干预措施的新目标。我将维护并扩展这个 我的职业生涯中的队列作为额外假设和科学探究的来源。 百分之八十的风湿病患者是女性，其中许多人处于生育年龄 被确诊；因此，我的目标与风湿病患者和从业者具有高度的临床相关性。这个K23 项目将产生新知识，可用于增强弱势群体的生殖结果 一群妇女和她们的孩子。这些目标还将帮助我通过以下方式实现我的职业目标 开发一套技能，包括以患者为中心的干预开发、临床试验的进行、 实际实施、队列创建和先进的增长曲线建模来评估随时间变化的风险 我提出的队列中的因素。我的项目为两条不同但互补的路径提供了初步数据 R01 资金。我优秀的导师团队将支持我成功完成目标和职业生涯 发展里程碑，以促进我向风湿病学独立成果研究员的过渡。

ABSTRACT Pregnancy is a major cause of morbidity and mortality among women with rheumatic diseases and their children; thus, one of the most important decisions that a woman with a rheumatic disease may make is if and/or when she wishes to conceive. However, my foundational work has found that many of these women are unable to make informed decisions around pregnancy because their information needs are unmet. To meet this immediate and urgent patient need, I will develop a novel, patient-facing decision aid called MyVoice to help women to make informed pregnancy decisions and augment family planning care receipt in the rheumatology clinical setting (Aim 1). I will pilot MyVoice in rheumatology clinics to assess its feasibility, acceptability, and implementation potential (Aim 2). This work will serve as the foundation for a future hybrid implementation-effectiveness trial to evaluate if MyVoice increases women’s disease-specific reproductive knowledge and family planning care receipt, and ultimately improves their downstream reproductive outcomes. One of the major predictors of adverse pregnancy and perinatal outcomes among women with rheumatic diseases is active disease at the time of conception and during pregnancy. My prior work suggests that some women may experience active disease during pregnancy because they decide not to adhere to pregnancy-compatible anti- rheumatic drugs; they fear that their medications might adversely affect fetal development. In Aim 3, I will develop a longitudinal, exploratory cohort of young women with rheumatic diseases to evaluate how medication adherence is influenced by key time-varying and time-invariant upstream risk factors (i.e., pregnancy intentions, reproductive knowledge, symptom severity, family planning care receipt). In a subsequent R01 study, I will assess how these upstream factors lead to healthy or adverse reproductive outcomes-- thus, positioning me to identify novel targets for interventions that may enhance reproductive outcomes. I will maintain and expand this cohort over my career to serve as a source of additional hypotheses and scientific inquiry. Eighty percent of patients with rheumatic diseases are women, many of whom are reproductive-age when they are diagnosed; thus, my Aims are highly clinically relevant to rheumatology patients and practitioners. This K23 project will generate new knowledge that may be used to enhance the reproductive outcomes of a vulnerable group of women and their children. These Aims will also help me to meet my career objectives through development of a skill set that includes patient-centered intervention development, conduct of clinical trials, practical implementation, cohort creation, and advanced growth curve modeling to evaluate time-varying risk factors in my proposed cohort. My project provides preliminary data for two distinct but complementary paths to R01 funding. My outstanding mentorship team will support the successful completion of my Aims and career development milestones, to facilitate my transition to an independent outcomes researcher in rheumatology.