Medication Summary Guides for Vulnerable Populations with Rheumatoid Arthritis

描述（由申请人提供）：类风湿关节炎（RA）是最常见的炎症性关节炎，影响多达1%的美国成年人，并导致严重的残疾，过高的死亡率和经济负担。类风湿性关节炎药物在利弊之间做出了艰难的权衡。因此，RA患者需要彻底了解疾病及其治疗方法，才能做出明智的决定。在过去的十年中，由于治疗的进步，RA患者的健康结果有了显著改善。尽管取得了这一进展，但某些群体在利用和结果方面仍然存在差异。例如，我们记录了不同种族/民族、有限的英语语言能力（LEP）、移民身份和教育程度在疼痛、功能和全球RA状态方面的实质性差异。最后，我们观察到在改善预后方面发挥重要作用的生物制剂的使用差异。总之，这些发现表明，弱势群体患者和医生之间的沟通障碍可能是患者知识、治疗选择、依从性以及最终结果差异的原因。为了解决这类沟通问题，针对患者和临床医生的总结指南已经发表，这些指南提供了RA药物的比较疗效、有效性和危害的证据。然而，这些指南在现实世界中的效用，门诊护理设置不成比例地服务于弱势群体是未知的。虽然我们首先承认，一般来说，了解这些有效的、潜在毒性的药物对于做出明智的治疗决定至关重要，但我们必须确定当前的摘要指南是否满足类风湿关节炎易感患者的需求，如果不能，调整指南以满足这些患者及其风湿病学家的需求，然后，严格测试调整后的指南如何影响沟通和决策。因此，本项目的具体目的是：1)评估目前对类风湿关节炎治疗的知识水平，以及它们在LEP、低文化水平、少数民族或移民身份的类风湿关节炎易感人群中的益处和危害；现行RA摘要指引的可接受性和实用性；决策角色偏好和信息传递方式偏好；2)开发创新的RA总结指南的印刷和视频改编，并为弱势群体提供一种新的决策援助工具；3)开展一项试点随机试验，测试改编的指南和决策辅助工具，并评估开发的工具对患者报告结果的影响。该项目将促进我们目前对障碍的理解，为那些面临最大健康差异风险的患者提供有关类风湿性关节炎药物的有效性、疗效、危害和益处的准确、可解释的循证信息，并为类风湿性关节炎弱势群体成功开发适应性总结指南和创新决策援助。

DESCRIPTION (provided by applicant): Rheumatoid arthritis (RA) is the most common inflammatory arthritis affecting up to 1% of U.S. adults and causes significant disability, excess mortality and economic burden. RA medications pose difficult trade-offs between benefit and harm. Therefore, patients with RA require a thorough understanding of the disease and its treatments to make informed decisions. Over the past decade, health outcomes for persons with RA have improved significantly due largely to advances in treatment. Despite this progress, disparities in utilization and outcomes persist among certain groups. For example, we have documented substantial disparities in pain, function, and global RA status by race/ethnicity, limited English language proficiency (LEP), immigrant status, and education. Finally, we have observed differences in the use of biologic agents that play an important role in improving outcomes. Together, these findings suggest that communication barriers between patients from vulnerable groups and physicians may account for differences in patient knowledge, treatment choices, adherence, and ultimately, outcomes. To deal with such communication problems, summary guides for patients and clinicians that present the evidence on the comparative efficacy, effectiveness, and harms of RA medications have been published. However, the utility of these guides in a real-world, ambulatory care setting that disproportionately serves vulnerable populations is unknown. While at first we acknowledge that, in general, an understanding of these potent, potentially toxic medicines is crucial to making an informed decision about treatment, we must establish whether the current summary guides serve the needs of vulnerable patients with RA, and if not, adapt the guides to meet the needs of such patients and their rheumatologists, and then, rigorously test how the adapted guides affect communication and decision making. Therefore, the specific aims of this project are to: 1) assess current level of knowledge of RA therapies, their benefits and harms among vulnerable populations with RA defined by LEP, low literacy, minority or immigrant status; the acceptability and utility of the current RA summary guides; and preferences for role in decision-making and mode of information delivery; 2) develop innovative print and video adaptations of the RA summary guides and a novel decision aid tool for vulnerable populations; and 3) conduct a pilot randomized trial to test the adapted guides and decision aid tool, and evaluate the impact of the developed tools on patient-reported outcomes over time. This project will advance our current understanding of barriers to providing accurate, interpretable evidence-based information on the effectiveness, efficacy, harms and benefits of RA medications to those patients at greatest risk of health disparities and allow for the successful development of an adapted summary guide and an innovative decision aid for vulnerable populations with RA. PUBLIC HEALTH RELEVANCE: A complex, chronic disease such as rheumatoid arthritis (RA) requires thorough knowledge of the disease and its treatments in order for patients to make informed decisions regarding their care. Despite advances in treatment, some patients continue to have more pain, worse function, and less use of certain drugs; especially patients who are racial or ethnic minorities, those who do not speak English very well, were born outside the U.S., or have less education. The proposed project will advance our current understanding of barriers to providing accurate, interpretable evidence-based information on the effectiveness, efficacy, harms and benefits of RA medications to those patients at greatest risk of poorer outcomes and allow for the successful development of innovative, appropriate summary medication guides and a decision aid tool for vulnerable populations with RA and their rheumatologists.