该iBLAD研究:在瘤治疗期间患者报告的膀癌的结果:一个多中心国家随机对照试验
Gry Assam Taarnhøj1, Christoffer Johansen2,3, Andreas Carus4,5
1Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark. gry.assam.taarnhoej@regionh.dk.
Journal of patient-reported outcomes
|October 9, 2023
概括
这项研究发现,患者报告的结果 (PROs) 并没有改善治疗完成或减少接受化疗或免疫治疗的膀癌 (BC) 患者的住院治疗. 观察到高度的合规性,但缺乏实时警报限制了PROs的影响.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 医疗信息学 医疗信息学
背景情况:
- 患者报告结果 (PROs) 在医疗保健中越来越多地使用.
- 它们对特定癌症诊断的影响,如膀癌 (BC),仍未得到充分研究.
- 这项研究研究了在接受医疗瘤治疗 (MOT) 的局部晚期或转移性BC患者的PRO.
研究的目的:
- 评估在膀癌患者的化疗或免疫治疗期间积极使用PROs的临床影响.
- 为了在这个患者群体中比较PROs与标准护理的结果.
- 确定PRO是否影响治疗完成,住院和整体存活率.
主要方法:
- 一项随机对照试验 (RCT) 涉及228名患有局部晚期或转移性BC的患者.
- 患者被随机分配到使用带有症状预警算法的PRO的干预臂 (IA) 或接受标准护理的控制臂 (CA).
- 同一级终点包括住院和治疗完成率;二级终点包括整体生存率和生活质量.
主要成果:
- 在IA (51%) 和CA (56%) 之间,治疗完成率没有显著差异.
- 住院率没有显著差异 (IA:41%与CA:32%).
- 总体存活时间在各组之间是可比的,IA的中位数为22.3个月,CA的中位数为23.1个月.
结论:
- 积极使用PROs在接受MOT的膀癌患者中没有显示出显著的临床益处.
- 观察到患者和临床医生的高度遵从性,但缺少实时警报响应是关键限制.
- 未来的研究应该考虑实时预警系统,以潜在地提高PRO在瘤学的有效性.
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