Fatigue in Primary Biliary Cholangitis: Factors Associated With Severity and Persistence as Future Therapeutic Targets (RU SOMACROSS)

原发性胆汁性胆管炎的疲劳：与作为未来治疗目标的严重性和持久性相关的因素（RU SOMACROSS）

• 批准号: 460374844
• 负责人: Professor Dr. Christoph Schramm
• 金额: --
• 依托单位: I. Medizinische Klinik und Poliklinik
• 依托单位国家: 德国
• 项目类别: Research Units
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/460374844?language=en
• 关键词: Fatigue; Primary; Biliary; Cholangitis; Factors

Fatigue is a common symptom and the major ‘unmet need’ in the management of patients with primary biliary cholangitis (PBC). There are few prospective studies that address the development of PBC-associated fatigue over time and histologic grades. At the same time, few biological and psychosocial risk factors and mechanisms have been identified that could explain the development and maintenance of fatigue in PBC. In order to identify patients at risk for severe fatigue at an early stage, prospective studies that apply a comprehensive approach, synthesizing perspectives and integrating potential biomedical and psychological risk factors of fatigue are needed. It is the overall aim of our project to identify factors that determine the course and severity of fatigue as the main unmet clinical need in PBC, and to target these factors within deliverable interventions, in order to improve quality of life for our patients. In a cross-sectional part of our prospective twelve-month cohort study, we aim to simultaneously examine clinically relevant biomedical and psychosocial factors, and systematically assess and compare associations and interactions between these factors and fatigue in n = 240 patients with PBC (a patient group severely affected by fatigue) and n = 240 patients with PSC (a control cholestatic liver disease group much less affected by fatigue). In a prospective part, we will longitudinally monitor these variables to identify factors that determine the severity of fatigue over time. In order to complement our quantitative data by evidence other than self-report, we will embed an experimental study and qualitative interviews in a subsample of n = 48 patients with newly diagnosed PBC. Both approaches represent a valuable opportunity for an in-depth exploration of mechanisms of fatigue perception, development and maintenance. By applying a mixed method approach within a prospective design, we will gain innovative knowledge on the predictive role of biomedical and psychosocial risk factors for fatigue that are amenable to change. This will enhance our understanding of the aetiology of PBC-fatigue and enable the design of interventions to reduce fatigue. In terms of the overall aims of RU SOMACROSS, we will contribute to the development of a disease-overarching multivariable prediction model for persistent somatic symptoms, which will facilitate a common understanding of chronic symptoms across diseases and medical disciplines.

疲劳是原发性胆管炎（PBC）患者的常见症状和主要“未满足的需求”。很少有前瞻性研究，解决了PBC相关的疲劳随着时间的推移和组织学分级的发展。与此同时，很少有生物和心理社会的危险因素和机制已被确定，可以解释PBC疲劳的发展和维持。为了在早期阶段识别有严重疲劳风险的患者，需要采用综合方法，综合观点并整合疲劳的潜在生物医学和心理风险因素的前瞻性研究。我们项目的总体目标是确定确定疲劳的病程和严重程度的因素，作为PBC中主要未满足的临床需求，并在可交付的干预措施中针对这些因素，以提高患者的生活质量。在我们为期12个月的前瞻性队列研究的横断面部分，我们的目标是同时检查临床相关的生物医学和心理社会因素，并系统评估和比较这些因素与n = 240例PBC患者疲劳之间的关联和相互作用（受疲劳严重影响的患者组）和n = 240例PSC患者（受疲劳影响小得多的对照胆汁淤积性肝病组）。在前瞻性部分，我们将纵向监测这些变量，以确定随着时间的推移，疲劳的严重程度的因素。为了补充我们的定量数据的证据以外的自我报告，我们将嵌入一个实验研究和定性访谈的子样本n = 48例新诊断的PBC患者。这两种方法代表了一个宝贵的机会，深入探索疲劳的感知，发展和维护的机制。通过在前瞻性设计中应用混合方法，我们将获得关于生物医学和心理社会风险因素对疲劳的预测作用的创新知识。这将增强我们对PBC疲劳病因的理解，并使干预措施的设计能够减少疲劳。在RU SOMACROSS的总体目标方面，我们将致力于开发持续性躯体症状的疾病总体多变量预测模型，这将有助于跨疾病和医学学科对慢性症状的共同理解。