Validation and Important Differences for the Sarcoidosis Assessment Tool
Validation and Important Differences for the Sarcoidosis Assessment Tool
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DOI：
10.1164/rccm.201410-1785oc
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发表时间：
2015-04-01
影响因子：
24.7
通讯作者：
Victorson, David E.
中科院分区：
文献类型：
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作者：
Judson, Marc A.;Mack, Michael;Victorson, David E.
目的：结节病评估工具(SAT)是一种针对结节病的特殊评估工具，在一项肺和皮肤结节病治疗试验中应用。我们探讨了SAT的表现特征及其与标准临床测量的相关性，以验证其是一种有用的临床结节病特异性PRO。方法：SAT分析侧重于基线和第16周的评估。除了SAT，参与者还接受了临床和医生评估，以及作为锚定变量的额外PRO，并与-SAT进行了比较。信度用Cronbachα系数进行评估。使用Spearman相关系数来评估SAT评分与临床和其他预防措施之间的关联。临床和PRO“锚”变量评估之间的变化被分类为改善、稳定或恶化。已知组相邻类别之间的平均差异和检测变化能力分析的平均变化被审查以获得适当的临床重要差异估计。测量和主要结果：分析了173名患者的结果。每个SAT模块在基线和变化方面都反映了适当的锚定变量。每个模块的克朗巴赫系数至少为0.87。此外，我们成功地为每个SAT模块建立了临床上重要的差异范围。结论：我们证明了SAT是一种可靠和一致的结节病特异性PRO。它具有出色的内部一致性和可靠性。已经为SAT模块建立了一系列临床上重要的差异。
Rationale: Patient-reported outcome (PRO) measures have been developed to measure symptoms and other aspects of health-related quality of life.Objectives: The Sarcoidosis Assessment Tool (SAT), a sarcoidbsis-specific PRO, was administered in a lung and skin sarcoidosis treatment trial. We explored SAT performance characteristics and correlation with standard clinical measurements to validate it as a useful clinical sarcoidosis-specific PRO.Methods: The SAT analyses focused On baseline and Week 16 assessments. Besides the SAT, participants underwent clinical and physician assessments plus additional PROs that were used as anchor variables and were compared with the-SAT. Reliability was-evaluated by using Cronbach alpha coefficient. Spearman correlation coefficients Were used to evaluate the association between SAT scores with clinical and other PRO measures. Changes between assessments in the clinical and PRO "anchor" variables were classified as improved, stable, or worsened. Mean differences between adjacent categories of the known groups and mean changes from the ability to detect change analyses were reviewed for appropriate clinically important difference estimates.Measurements and Main Results: Results from 173 patients were analyzed. Each SAT module reflected appropriate anchor variables at baseline and in terms of change. The Cronbach a for each of these modules was at least 0.87. In addition, we successfully established a clinically important difference range for each SAT module.Conclusions: We demonstrated that the SAT is a reliable and consistent sarcoidosis-specific PRO. It has excellent internal consistency and reliability. A range of clinically important differences has been established for the SAT modules.