Investigating Pathways to Optimal Reproductive Outcomes Among Women with Rheumatic Diseases

研究患有风湿病的女性获得最佳生殖结果的途径

• 批准号: 10478252
• 负责人: Mehret Birru Talabi
• 金额: $ 16.84万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10478252
• 关键词: Address; Adherence; Affect; Age; Antirheumatic Agents; Belief; Biological; Caring; Child; Clinic; Clinic Visits; Clinical; Clinical Trials; Conceptions; Conduct Clinical Trials; Contraceptive methods; Data; Decision Aid; Decision Making; Development; Diagnosis; Disease; Family Planning; Female; Fetal Development; Fibrinogen; Foundations; Fright; Funding; Future; Growth; Gynecologist; Health; Health Professional; Health Services; Hormones; Inflammatory Arthritis; Information Services; Intervention; Knowledge; Lead; Learning; Longitudinal cohort; Maternal Mortality; Medical; Mentors; Mentorship; Modeling; Morbidity - disease rate; Online Systems; Outcome; Outpatients; Pamphlets; Pathway interactions; Patients; Pharmaceutical Preparations; Positioning Attribute; Pregnancy; Pregnancy Outcome; Premature Birth; Primary Care Physician; Prospective cohort; Research Personnel; Rheumatism; Rheumatology; Risk; Risk Factors; Scientific Inquiry; Services; Severities; Source; Spontaneous abortion; Surveys; Symptoms; Testing; Time; Vulnerable Populations; Woman; Women' s Group; Women' s Health; Work; acceptability and feasibility; activity marker; adverse pregnancy outcome; behavioral health; career; career development; clinically relevant; cohort; effectiveness implementation study; effectiveness trial; experience; fetal; health literacy; healthy pregnancy; high risk; improved; medication compliance; medication safety; mortality; novel; patient oriented; perinatal outcomes; pilot trial; pragmatic implementation; pregnant; preservation; prevent; prospective; reproductive; reproductive outcome; rheumatologist; service gap; shared decision making; skills; stillbirth; therapy development; trend; unintended pregnancy; young woman

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.

摘要 妊娠是风湿病妇女及其子女发病和死亡的主要原因; 因此，一个患有风湿性疾病的女性可能做出的最重要的决定之一是，是否和/或何时 她想怀孕然而，我的基础工作发现，这些妇女中的许多人无法使 因为她们的信息需求没有得到满足。为了应对这一紧迫和 紧急病人的需要，我将开发一种新颖的，面向病人的决策援助称为MyVoice，以帮助妇女作出 在风湿病临床环境中知情的妊娠决定和增加计划生育护理 (Aim 1）。我将在风湿病诊所试用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效果试验的基础 评估MyVoice是否增加了妇女的疾病特异性生殖知识和计划生育护理 并最终改善其下游生殖结果。 风湿性疾病妇女不良妊娠和围产期结局的主要预测因素之一 在受孕和怀孕期间是活动性疾病。我之前的研究表明有些女性 在怀孕期间经历活动性疾病，因为他们决定不坚持怀孕兼容的抗- 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、探索性的风湿性疾病年轻女性队列， 依从性受到关键的时变和时不变上游风险因素的影响（即，怀孕意向， 生殖知识、症状严重程度、计划生育护理收据）。在随后的R 01研究中，我将 评估这些上游因素如何导致健康或不利的生殖结果-因此，定位我， 确定可能改善生殖结果的干预措施的新目标。我将继续保持并扩大这一点 在我的职业生涯中，我的研究对象可以作为额外假设和科学探究的来源。 80%的风湿性疾病患者是女性，其中许多人在生育年龄时， 因此，我的目标与风湿病患者和从业者高度临床相关。K23 项目将产生新的知识，可用于提高弱势群体的生殖成果， 一群妇女和她们的孩子。这些目标也将帮助我实现我的职业目标， 开发一套技能，包括以患者为中心的干预开发，进行临床试验， 实际实施、队列创建和高级增长曲线建模，以评估随时间变化的风险 在我提议的队列中。我的项目提供了两个不同但互补的路径的初步数据 R 01融资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，以促进我过渡到一个独立的成果研究者在风湿病学。