Oregon Health and Science University, Portland, OR, USA.
Innovaderm Research Inc., Montreal, QC, Canada.
Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21.
The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) is a standardized severity assessment for use in clinical trials and registries for atopic dermatitis (AD).
To investigate the reliability, validity, responsiveness and within-patient meaningful change of the vIGA-AD.
Data were analysed from adult patients with moderate-to-severe AD in the BREEZE-AD1 (N = 624 patients; NCT03334396), BREEZE-AD2 (N = 615; NCT03334422) and BREEZE-AD5 (N = 440; NCT03435081) phase III baricitinib clinical studies.
Across studies, test-retest reliability for stable patients showed moderate-to-good agreement [range of Kappa values for Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD), 0·516-0·639; for Eczema Area and Severity Index (EASI), 0·658-0·778]. Moderate-to-large correlations between vIGA-AD and EASI or body surface area (range at baseline, 0·497-0·736; Week 16, 0·716-0·893) supported convergent validity. Known-groups validity was demonstrated vs. EASI and PGI-S-AD (vIGA-AD for severe vs. moderate EASI categories at baseline, P < 0·001). Responsiveness was demonstrated vs. EASI (P < 0·001 for much improved vs. improved and improved vs. stable). Anchor- and distribution-based methods supported a vIGA-AD change of -1·0 as clinically meaningful. These findings are limited to populations defined by the studies' inclusion and exclusion criteria.
The vIGA-AD demonstrated sufficient reliability, validity, responsiveness and interpretation standards for use in clinical trials. What is already known about this topic? A description of the development of the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) has been published previously. What does this study add? The current study validates the vIGA-AD by demonstrating appropriate test-retest reliability, convergent validity, known-groups validity and responsiveness across three baricitinib clinical studies. In addition, a 1-point change was identified as a clinically meaningful patient-perceived change minimal clinically important difference in the vIGA-AD. What are the clinical implications of the work? The vIGA-AD is a measure for investigator assessment of atopic dermatitis suitable for use in clinical research.
经过验证的特应性皮炎研究者全球评估（vIGA-AD™）是一种标准化的严重程度评估方法，用于特应性皮炎（AD）的临床试验和注册。
调查 vIGA-AD 的可靠性、有效性、反应性和患者内有意义的变化。
对来自中度至重度 AD 成年患者的 BREEZE-AD1（N=624 例患者；NCT03334396）、BREEZE-AD2（N=615 例；NCT03334422）和 BREEZE-AD5（N=440 例；NCT03435081）三项 III 期巴瑞替尼临床研究的数据进行了分析。
在三项研究中，稳定患者的重测信度显示出中度至良好的一致性[患者整体严重程度印象-特应性皮炎（PGI-S-AD）的 Kappa 值范围为 0.516-0.639；湿疹面积和严重程度指数（EASI）为 0.658-0.778]。vIGA-AD 与 EASI 或体表面积（基线时的范围，0.497-0.736；第 16 周，0.716-0.893）之间的中度至大相关性支持了其收敛效度。与 EASI 和 PGI-S-AD 相比，已知组的有效性得到了证明（vIGA-AD 对基线时严重和中度 EASI 类别的比较，P<0.001）。与 EASI 相比，vIGA-AD 显示出了良好的反应性（与改善相比，明显改善和改善的 P<0.001，与稳定相比）。基于锚点和分布的方法支持 vIGA-AD 变化-1.0 作为临床有意义的变化。这些发现仅限于研究纳入和排除标准定义的人群。
vIGA-AD 在临床试验中具有足够的可靠性、有效性、反应性和解释标准。
关于这个主题已经知道些什么？
特应性皮炎研究者全球评估（vIGA-AD™）的开发描述以前已经发表过。
本研究有何新发现？
目前的研究通过在三项巴瑞替尼临床试验中证明了适当的重测信度、收敛效度、已知组的有效性和反应性，验证了 vIGA-AD。此外，在 vIGA-AD 中，1 分的变化被确定为患者感知的有临床意义的变化，即最小临床重要差异。
这项工作的临床意义是什么？
vIGA-AD 是一种适合于临床研究的研究者评估特应性皮炎的方法。
