基于电子患者报告的结果,测试免疫检查点抑制剂患者的护理模式:随机二期受控试验的协议
André Manuel da Silva Lopes1, Sara Colomer-Lahiguera1, Célia Darnac1,2
1Institute of Higher Education and Research in Healthcare, Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.
JMIR research protocols
|October 18, 2023
概括
使用患者报告结果 (PROs) 的远程患者监测可以加快在接受免疫检查点抑制剂 (ICI) 的癌症患者中检测与免疫相关的不良事件 (IrAEs). 这种数字护理模式旨在改善症状管理和患者的治疗结果.
科学领域:
- 在瘤学瘤学.
- 数字健康数字健康
- 患者报告的结果
背景情况:
- 及时检测来自免疫检查点抑制剂 (ICI) 的严重症状免疫相关不良事件 (IRAE) 对患者管理至关重要.
- 通过患者报告结果 (PROs) 进行远程监测,可以减少症状发作和临床检测之间的延迟.
研究的目的:
- 用PRO数据评估远程患者监测模型对检测症状IRAE的时间的影响.
- 评估对干预时间,IRAE严重程度,生活质量,自我有效性和6个月整体存活率的影响.
主要方法:
- 198名接受ICI的癌症患者被随机分配到数字护理模型或6个月的常规护理.
- 患者使用电子应用程序进行每周问卷调查 (FACT-G,PROMIS自我效率),干预组使用PRO-CTCAE进行症状跟踪.
- 护士使用标准化选算法来管理通过应用程序报告的新症状或恶化的症状.
主要成果:
- 积极招聘发生在2021年11月至2023年11月期间.
- 预计试验结果将在2024年第一季度发表,并将在国际会议上发表.
结论:
- 这项试验开创了PRO数据的使用,直接为ICI患者提供常规护理.
- 它通过收集更广泛的日常自我报告的症状数据来解决先前研究的局限性.
- 这些发现可能会激发关于远程诊断和治疗相关症状的管理及其对患者的影响的讨论.
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