Sall Kenneth, Foulks Gary N, Pucker Andrew D, Ice Karen L, Zink Richard C, Magrath George
Lexitas Pharma Services, Inc, Durham, NC, USA.
University of Louisville (Retired), Louisville, KY, USA.
Clin Ophthalmol. 2023 Mar 7;17:757-767. doi: 10.2147/OPTH.S398843. eCollection 2023.
Validation of the novel Lexitas modified NEI scale for use in assessment of corneal fluorescein staining.
A series of 18 illustrations and 14 clinical photographs depicting varying severity levels of corneal fluorescein staining were assessed by 3 independent examiners. Regions of the cornea were graded for staining severity based on 3 different grading scales: the original NEI staining scale (density-based scoring; 0-3 scale), a structured version of the NEI scale (dot-count scoring; 0-3 scale), and the Lexitas modified NEI staining scale (0-4 scale with half-point increments). Kappa statistics (simple and weighted) were computed to determine intra-examiner image grading repeatability for each examiner over 2 separate assessments. Inter-examiner assessment reliability utilized the scores from the first read of each examiner, and pairs of examiners to compute kappa statistics.
Data was analyzed from the scores provided by the examiners from each gradable corneal region on 32 images (18 illustrations and 14 photographs) for a total of 154 corneal regions across the 3 grading scales for each validation run. The mean intra-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.67/0.72, 0.91/0.94, 0.80/0.92 for the graded illustrations, and 0.83/0.88, 0.76/0.85, 0.77/0.88 for the graded photographs, respectively. The mean inter-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.59/0.65, 0.86/0.90, and 0.78/0.91 for the graded illustrations, and 0.80/0.88, 0.84/0.89, 0.69/0.88 for the graded photographs, respectively.
The expanded scale of the Lexitas modified NEI staining scale demonstrated a high degree of reliability and repeatability of grading assessments within and across individual examiners, comparing favorably with the original NEI staining scale. A future investigation into the in-office utility of the Lexitas modified NEI staining scale is warranted.
验证用于评估角膜荧光素染色的新型Lexitas改良NEI量表。
由3名独立检查者对一系列18幅插图和14张临床照片进行评估,这些图像描绘了不同严重程度的角膜荧光素染色情况。根据3种不同的分级量表对角膜区域的染色严重程度进行分级:原始NEI染色量表(基于密度评分;0 - 3级量表)、NEI量表的结构化版本(点计数评分;0 - 3级量表)以及Lexitas改良NEI染色量表(0 - 4级量表,以半分递增)。计算kappa统计量(简单和加权),以确定每位检查者在2次单独评估中对图像分级的可重复性。检查者间评估可靠性利用每位检查者首次读取的分数,并通过成对检查者来计算kappa统计量。
对检查者提供的来自32幅图像(18幅插图和14张照片)中每个可分级角膜区域的分数进行分析,每次验证运行中,在3种分级量表下共有154个角膜区域。使用NEI密度、NEI点计数和Lexitas改良NEI染色量表时,分级插图的检查者内简单/加权kappa值平均分别为0.67/0.72、0.91/0.94、0.80/0.92,分级照片的分别为0.83/0.88、0.76/0.85、0.77/0.88。使用NEI密度、NEI点计数和Lexitas改良NEI染色量表时,分级插图的检查者间简单/加权kappa值平均分别为0.59/0.65、0.86/0.90、0.78/0.91,分级照片的分别为0.80/0.88、0.84/0.89、0.69/0.88。
Lexitas改良NEI染色量表的扩展量表在个体检查者内部和之间的分级评估中显示出高度的可靠性和可重复性,与原始NEI染色量表相比具有优势。有必要对Lexitas改良NEI染色量表在门诊的实用性进行进一步研究。