ARD:干燥反应评估工具(STAR)的开发和初步验证:用于评估原发性干燥综合征治疗效果的共识综合评分

2022-07-07 MedSci原创 MedSci原创

候选STAR是一个综合反应指数,在一个工具中包含所有主要疾病特征,旨在用作原发性干燥综合征 RCT的主要终点。候选STAR对变化表现出良好的敏感性。

目的

今天仍然没有批准用于原发性干燥综合征(pSS)患者的疾病缓解抗风湿药物。其中一种原因是当前用作主要终点的结果测量有重大局限性,例如,高安慰剂反应率、未评估对症状或全身活动以及重要特征。该研究的目的在于开发原发性干燥综合征(pSS)的综合反应指数:干燥反应评估工具(STAR)

方法

为了开发STARNECESSITY(原发性干燥综合征的新临床终点:基于患者分层的介入试验)联盟使用了基于9项随机对照试验(RCT)的数据驱动方法和涉及78名专家和20 名患者的共识技术。基于对利妥昔单抗试验和文献的重新分析,德尔福(Delphi一种结构化的沟通技术或方法,最初是作为一种依赖专家小组的系统、交互式预测方法而开发的 )小组确定了一组核心领域及其各自的结果测量。

向专家组提出了结合这些领域的STAR选项以供选择和改进。对于每个STAR选项,通过九个RCT中的C指数估计对变化的敏感性。专家组进行了德尔福讨论以确定STAR。对于最终投票前剩余的选项,对RCT进行了荟萃分析。

结果

德尔福小组确定了五个核心领域(全身活动、患者症状、泪腺功能、唾液腺功能和生物学参数),并选择了结合这些领域的227STAR选项来测试对变化的敏感性。在两轮德尔福之后,对剩余的20个选项进行了荟萃分析。然后根据计量特性和临床相关性通过最终投票选出候选STAR

结论

候选STAR是一个综合反应指数,在一个工具中包含所有主要疾病特征,旨在用作 pSS RCT的主要终点。严谨和一致的开发过程确保了其表面和内容的有效性。候选STAR对变化表现出良好的敏感性,并将由NECESSITY联盟在专门的RCT中进行前瞻性验证。

出处:

Seror R, Baron G, Camus M on behalf of the NECESSITY WP5 - STAR development working group, et al. Development and preliminary validation of the Sjögren’s Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren’s syndrome. Annals of the Rheumatic Diseases 2022;81:979-989.

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    2022-07-07 ms5000000518166734

    学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习

    0

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