背景:免疫球蛋白A肾病(IgAN)是一种可导致进行性肾脏疾病的肾脏疾病。目前,缺乏对IgAN患者所经历的症状和影响的全面概述,这将有助于为临床试验中使用的符合目的临床结局评估(COA)的选择或发展提供信息.这项研究的目的是建立成人和儿童IgAN患者体验的概念模型,包括疾病体征和症状,治疗副作用,以及对运作和福祉的影响。
方法:本研究包括对诊断为IgAN的成人和儿童的定性研究的系统评价和主题分析。通过期刊文章的电子数据库搜索确定了数据源(MEDLINE,Embase,PsycINFO;2021年6月),手工搜索会议记录,患者倡导团体网站,灰色文学非英语文章被排除在外。识别数据(患者/护理人员报价,作者总结,和对患者经历的解释)是从文章中提取的。提取的数据进行定性分析,由ATLAS协助。tiv7.代码被应用于数据;概念(即,症状)被确定,named,和精致。通过将相关概念分组到域中,开发了一个概念模型。
结果:总计,确定了五个来源进行分析:两篇期刊文章,两个在线的病人故事选集,和一个患者组织赞助的“患者之声”会议报告。概念模型症状领域包括肿胀/浮肿(水肿),疼痛/疼痛/不适,疲劳,体重增加,睡眠问题,泌尿问题,还有肠胃问题.影响领域包括情感/心理健康,日常生活的身体功能/活动,社会功能,工作/学校,和关系。
结论:对已发表的定性文献的二次分析允许开发一种描述IgAN患者经历的新型概念模型;然而,它的深度受到缺乏可用文献的限制。建议进一步的定性研究来完善和/或确认概念和领域,确定它们之间的任何关系,并探索对患者最有意义的结果。完善的模型将提供一个有用的工具来通知选择,发展,和/或COAs的修订,用于未来的IgAN临床试验。
BACKGROUND: Immunoglobulin A nephropathy (IgAN) is a kidney disorder that can lead to progressive kidney disease. Currently, there lacks a comprehensive overview of the symptoms and impacts experienced by those living with IgAN that would help inform the selection or development of fit-for-purpose clinical outcome assessments (COA) to be used in clinical trials. The aim of this study was to develop a conceptual model of the adult and pediatric patient experience of IgAN, including disease signs and symptoms, treatment side effects, and impact on functioning and well-being.
METHODS: This study comprised a systematic
review and thematic analysis of qualitative studies with adults and children diagnosed with IgAN. Data sources were identified through an electronic database search of journal articles (MEDLINE, Embase, PsycINFO; June 2021), hand-searching of conference proceedings, patient advocacy group websites, and gray literature. Non-English articles were excluded. Identified data (patient/caregiver quotes, author summaries, and interpretations of patient experiences) were extracted from articles. Extracted data were qualitatively analyzed, aided by ATLAS.ti v7. Codes were applied to data; concepts (i.e., symptoms) were identified, named, and refined. A conceptual model was developed by grouping related concepts into domains.
RESULTS: In total, five sources were identified for analysis: two journal articles, two online anthologies of patient stories, and one patient organization-sponsored \"Voice of the Patient\" meeting report. Conceptual model symptom domains included swelling/puffiness (edema), pain/aches/discomfort, fatigue, weight gain, sleep problems, urinary problems, and gastrointestinal problems. Impact domains included emotional/psychological well-being, physical functioning/activities of daily living, social functioning, work/school, and relationships.
CONCLUSIONS: Secondary analysis of published qualitative literature permitted development of a novel conceptual model depicting the patient experience of IgAN; however, its depth is limited by a lack of available literature. Further qualitative research is recommended to refine and/or confirm the concepts and domains, determine any relationships between them, and explore the outcomes that are most meaningful to patients. The refined model will provide a useful tool to inform the selection, development, and/or amendment of COAs for use in future IgAN clinical trials.