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患者报告的结果 - - 缺失的环节,以推进轻链 (AL) 氨基粉症的临床研究

Tobias Dittrich¹, Lina Weinert², Anita D'Souza³

¹Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg University, Heidelberg, Germany; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg University, Heidelberg, Germany.

|May 24, 2025

系统性轻链（AL）淀粉样变常导致多器官功能障碍和显著的疾病负担。临床评估可能无法全面反映疾病及治疗对患者的影响。患者报告结局（PROs）有助于弥补这一空白。尽管已有证据表明，PROs在既定的心脏分期系统之外具有额外的预测价值，但其在AL淀粉样变常规管理中的整合仍有限。本文综述了PROs在预后判断和治疗评估中的价值，以及其作为临床试验终点的当前应用情况。我们还讨论了实际操作中的若干问题，包括测量工具的选择与实施、数据解读与报告方式。最后，我们提出了将PROs整合到常规AL淀粉样变管理中的实施路径，重点关注合适的电子化PRO（ePRO）平台选择与实施策略。我们倡导建立数据共享框架和协调一致的研究议程。通过填补证据空白并优先考虑患者视角，PROs有望推动AL淀粉样变的临床管理与科学研究。关键词：AL淀粉样变；患者报告结局；电子化患者报告结局；临床试验终点；预后评估；治疗监测；患者中心化护理

系统性轻链（AL）淀粉样变常导致多器官功能障碍和显著的疾病负担。临床评估可能无法全面反映疾病及治疗对患者的影响。患者报告结局（PROs）有助于弥补这一空白。尽管已有证据表明，PROs在既定的心脏分期系统之外具有额外的预测价值，但其在AL淀粉样变常规管理中的整合仍有限。本文综述了PROs在预后判断和治疗评估中的价值，以及其作为临床试验终点的当前应用情况。我们还讨论了实际操作中的若干问题，包括测量工具的选择与实施、数据解读与报告方式。最后，我们提出了将PROs整合到常规AL淀粉样变管理中的实施路径，重点关注合适的电子化PRO（ePRO）平台选择与实施策略。我们倡导建立数据共享框架和协调一致的研究议程。通过填补证据空白并优先考虑患者视角，PROs有望推动AL淀粉样变的临床管理与科学研究。关键词：AL淀粉样变；患者报告结局；电子化患者报告结局；临床试验终点；预后评估；治疗监测；患者中心化护理

关键词:

在AL氨基粉症症.人权问题人权问题在这个过程中,PRO PRO PRO.

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