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Abstract：
Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can lead to irreversible organ damage (OD). Data describing the patient burden of OD, as compared with SLE without OD, are limited. Objective: To develop a comprehensive conceptual model describing the burden experienced by patients living with SLE-associated OD. Methods: There were three phases to this qualitative study. First, a targeted literature review was conducted to inform a draft conceptual model. Second, key opinion leaders (KOLs) were interviewed to assess the draft conceptual model and help shape patient interview materials. Third, patients of different demographic backgrounds from across the United States were interviewed individually to gather their perspectives on living with SLE-associated OD. Data from concept elicitation interviews with KOLs and patients were coded and analyzed using NVivo software to identify the key concepts of the overall patient burden of SLE-associated OD. Findings from the KOL and patient interviews were used to finalize the conceptual model. Results: KOLs highlighted that SLE-associated OD carried a higher rate of mortality than SLE alone. Participants with SLE-associated OD (n = 40) experienced detrimental impacts across 4 areas of their lives: physical, cognitive, psychosocial functioning, and economic and work-related well-being. Physical impacts were described by all participants, often affecting their ability to perform everyday tasks. Many also described deterioration of cognitive functioning. Almost all participants experienced emotional impacts and challenges to their relationships and social lives resulting from living with SLE-associated OD. Additionally, SLE-associated OD imposed an economic burden including increased healthcare costs. SLE-associated OD had a more severe and debilitating impact on all aspects of the patient\'s quality of life than SLE prior to OD development, including further limitations in activities of daily living after the development of OD. Discussion: Study findings guided the development of a comprehensive conceptual model that fully represents the patient experience of living with SLE-associated OD, highlighting the additional burden of OD when compared with SLE alone. Conclusions: The conceptual model will inform improvements in disease management, which may result in better patient outcomes and aid development of clinical outcome assessments of disease burden.
摘要：
背景：系统性红斑狼疮（SLE）是一种慢性自身免疫性疾病，可导致不可逆的器官损害（OD）。描述患者OD负担的数据，与无OD的SLE相比，是有限的。目标：建立一个全面的概念模型，描述患有SLE相关OD的患者所承受的负担。方法：本定性研究分为三个阶段。首先,我们进行了有针对性的文献综述,为概念模型草案提供信息.第二,我们采访了关键意见领袖(KOL),以评估概念模型草案,并帮助形成患者访谈材料.第三，对来自美国各地不同人口统计学背景的患者进行了单独访谈,以收集他们对患有SLE相关OD的生活的看法.使用NVivo软件对来自KOL和患者的概念启发访谈的数据进行编码和分析，以确定SLE相关OD的总体患者负担的关键概念。KOL和患者访谈的结果用于最终确定概念模型。结果：KOLs强调SLE相关OD的死亡率高于单用SLE。与SLE相关的OD（n=40）的参与者在他们生活的4个方面经历了有害影响：身体，认知，社会心理功能,以及与经济和工作有关的福祉。所有参与者都描述了物理影响，经常影响他们执行日常任务的能力。许多人还描述了认知功能的恶化。几乎所有参与者都因与SLE相关的OD生活而对他们的关系和社交生活产生了情感影响和挑战。此外,与SLE相关的OD造成了经济负担，包括医疗费用的增加。与OD发生前的SLE相比，与SLE相关的OD对患者生活质量的所有方面都有更严重和令人衰弱的影响，包括OD发展后日常生活活动的进一步限制。讨论：研究结果指导了全面的概念模型的开发，该模型完全代表了与SLE相关的OD生活的患者体验，与单纯SLE相比，突出了OD的额外负担。结论：概念模型将为疾病管理的改进提供信息，这可能会导致更好的患者结局，并有助于制定疾病负担的临床结局评估。
