探索系统性硬化症患者的最佳随访:荷兰多中心随机对照试验的研究协议
Eva M Hoekstra1, Sophie I E Liem2, Saad Ahmed2
1Department of Rheumatology, Leiden University Medical Center, Leiden, RC, 2300, The Netherlands. e.m.hoekstra.ana@lumc.nl.
Trials
|February 14, 2026
概括
这项研究调查了定期的门诊诊所访问是否适合替代系统性硬化症 (SSc) 低疾病进展风险患者的密集年度评估. 结果将指导个性化的SSc后续护理.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验设计 临床试验设计
- 医疗服务研究 医疗服务研究
背景情况:
- 目前的系统性硬化症 (SSc) 后续缺乏基于证据的指导方针,依靠专家意见进行年度广泛评估.
- 多学科护理途径改善了患者满意度和结果,但对于低风险的SSc患者来说可能过度.
- 需要根据个体疾病活动和进展风险量身定制的SSc护理.
研究的目的:
- 评估定期门诊随访的非劣势性,与对低风险全身性硬化症患者进行广泛的年度护理途径评估相比.
- 确定常规评估是否是SSc管理中标准化,密集的年度评估的可接受替代方案.
- 为SSc患者的随访制定基于证据的指导方针提供信息.
主要方法:
- 一个多中心,非劣势随机对照试验,涉及250名SSc患者,按疾病进展风险 (低,中等) 分类.
- 低风险或中等风险的患者随机分配到门诊随访 (干预) 或标准年度护理途径 (控制).
- 主要结果:医疗保健利用率;次要结果:疾病进展,患者感知,生活质量. 通过描述性统计和回归进行分析.
主要成果:
- 本部分应在研究结果可用时填写.
- 该研究旨在比较两种后续策略之间的医疗保健利用率和临床结果.
- 结果将表明对特定的SSc患者群体进行不那么密集的随访的可行性和有效性.
结论:
- 这是第一个随机对照试验,用于评估低风险SSc患者的最佳后续策略.
- 研究结果将澄清门诊诊所评估是否是全面年度评估的可行替代方案.
- 这些发现旨在支持建立针对系统性硬化症管理的个性化,基于证据的后续协议.
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