Optimizing Lupus Management in Pregnancy

优化妊娠期狼疮管理

• 批准号: 8989276
• 负责人: Megan E.B. Clowse
• 金额: $ 21.27万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2017-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8989276
• 关键词: Optimizing; Lupus; Management; Pregnancy

 DESCRIPTION (provided by applicant): Over half of pregnancies in women with lupus are complicated by miscarriage, preterm birth, or preeclampsia, most commonly in women with significant lupus activity. The guiding principle of lupus management is thus to use the safest available medications to prevent flares during pregnancy. Data supporting this principle are scarce, however, and based on small cohorts. Limitations in the data have also prevented identification of the best treatment strategies for women with varying risks. The goal of this proposal is to identify strategies that optimize pregnancy outcomes using comparative effectiveness approaches. The first method will be a patient- level meta-analysis based on datasets from published lupus pregnancy cohorts; 8 of the largest cohorts have already demonstrated interest. By stratifying pregnancies by lupus activity, prior renal disease, and maternal race, this analysis will yield new data about optimal medication therapies to control lupus and improve pregnancy outcomes. The second method, a decision analysis, will assess potential cost and pregnancy benefits of optimal lupus management. These two aims will offer new data to guide lupus management. Integrating this knowledge into daily practice, however, will be a challenge. For example, current best practices, like continuing hydroxychloroquine (HCQ) in lupus pregnancy, have not yet moved from expert clinics to daily practice. An exploratory aim will use mixed methods to ask community rheumatologists to identify strategies and tools that would enable them to integrate expert recommendations into daily practice. An essential goal is to develop an active Patient Advisory Council (PAC), comprising primarily mothers with lupus, to guide Dr. Clowse in these and future projects. This PAC will be integrated into many aspects of this proposal. Dr. Clowse, a national leader in clinical management of rheumatologic disease in pregnancy, seeks to build new methodology skills to move her research forward. To this end, this proposal outlines a program of research projects, apprenticeships, mentoring, and course work in statistics, comparative effectiveness, and patient-centered outcomes methods. With the primary mentorship of Gillian Sanders-Schmidler, PhD, Director of Duke University's AHRQ-funded Evidence-Based Practice Center, Dr. Clowse will build strong meta- analysis skills. She will practice decision analysis with co-mentor Evan Myers, MD, MPH, lead author for numerous women's health decision analyses and guidelines for AHRQ. At project completion, Dr. Clowse will have the skills, the data, and the stakeholder partnerships needed to drive innovation in the management of lupus in pregnancy.

 描述(由申请人提供)：超过一半的狼疮妇女妊娠合并流产、早产或先兆子痫，最常见的是有明显狼疮活动的妇女。因此，狼疮治疗的指导原则是使用最安全的可用药物来防止怀孕期间的红斑。然而，支持这一原则的数据很少，而且是基于小样本。数据的局限性也阻碍了为具有不同风险的妇女确定最佳治疗策略。这项提案的目标是确定使用比较有效性方法优化妊娠结局的战略。第一种方法将是基于已发表的狼疮妊娠队列的数据集的患者水平的荟萃分析；8个最大的队列已经表现出兴趣。通过根据狼疮活动、既往肾脏疾病和母亲种族对怀孕进行分层，这项分析将产生关于控制狼疮和改善妊娠结局的最佳药物治疗的新数据。第二种方法，决策分析，将评估最佳狼疮治疗的潜在成本和妊娠收益。这两个目标将为指导狼疮治疗提供新的数据。然而，将这些知识融入日常实践将是一个挑战。例如，目前的最佳实践，如在狼疮妊娠中继续使用羟基氯喹(HCQ)，尚未从专家诊所进入日常实践。一个探索性的目标是使用混合方法要求社区风湿病医生确定战略和工具，使他们能够将专家建议整合到日常实践中。一个基本的目标是发展一个积极的患者咨询委员会(PAC)，主要由患有狼疮的母亲组成，以指导Clowse博士在这些和未来的项目中。这项帐委会将纳入这项建议的多个方面。克劳斯博士是妊娠期风湿病临床管理领域的全国领导者，她试图建立新的方法学技能来推动她的研究。为此，本提案概述了统计学、比较有效性和以患者为中心的结果方法方面的研究项目、学徒制度、指导和课程工作。在杜克大学AHRQ资助的循证实践中心主任Gillian Sanders-Schmidler博士的主要指导下，Clowse博士将建立强大的荟萃分析技能。她将与共同导师、医学博士、公共卫生硕士Evan Myers一起练习决策分析，Evan Myers是AHRQ许多女性健康决策分析和指南的主要作者。在项目完成时，Clowse博士将拥有推动妊娠期狼疮管理创新所需的技能、数据和利益相关者伙伴关系。