在抗脂综合征诊断中整合抗酸/抗原蛋白抗体检测:一个多域,基于专家感知的健康技术评估
Michele Cioffi1,2, Valentina Oddone1,2, Massimo Radin1,2
1University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-Net, ERN-Reconnect and RITA-ERN Member) with Nephrology and Dialysis Unit and Center of Immuno-Rheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, ASL Città di Torino, San Giovanni Bosco Hub Hospital, 10154 Turin, Italy.
抗氨酸氨酸/原氨酸 (aPS/PT) 抗体检测显示出对诊断抗脂综合征 (APS) 的前景,特别是在血清阴性患者中. 专家认为aPS/PT测试是安全,有效和公平的,支持其整合到诊断算法中.
科学领域:
- 免疫学 免疫学 免疫学
- 临床诊断 临床诊断 临床诊断
- 卫生技术评估 卫生技术评估
背景情况:
- 抗脂综合征 (APS) 诊断依赖于临床标准和特定的自身抗体.
- 一部分APS患者,特别是患有全身性红斑狼 (SLE) 患者,尽管临床怀疑,但仍然是血清阴性.
- 抗氨酸氨酸/原氨酸 (aPS/PT) 抗体正在成为APS的潜在诊断生物标志物.
研究的目的:
- 评估实施aPS/PT抗体测试的临床,伦理和组织影响.
- 与APS目前的诊断实践相比,评估专家对aPS/PT测试的看法.
主要方法:
- 采用健康技术评估 (HTA) 框架,评估安全性,有效性,公平性,伦理性和组织影响.
- 对50名抗脂综合征 (APS) 专家进行了一项调查.
- 计算Z分数是为了将当前的诊断场景 (AS IS) 与将aPS/PT测试 (TO BE) 集成的场景进行比较.
主要成果:
- 综合的aPS/PT测试场景 (TO BE) 在所有五个HTA领域的得分明显高于标准实践.
- 在感知诊断疗效 (ΔZ = +2.65) 和安全性 (ΔZ = +2.03) 方面,最显著的改善是注意到的.
- 感知到的诊断效果与公平性 (r = 0.70) 和道德影响 (r = 0.67) 有很强的相关性.
结论:
- 专家认为,aPS/PT测试的增加是APS诊断的重大进展,特别是在血清阴性SLE患者中.
- 该试验始终被评为安全,临床有用,公平,易于在常规工作流程中实施.
- 有利的HTA概况支持进一步的前性评估和潜在的整合到未来的APS诊断算法.
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