Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.
PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26.
Clear definitions of outcomes following trichiasis surgery are critical for planning program evaluations and for identifying ways to improve trichiasis surgery. Eyelid contour abnormality is an important adverse outcome of surgery; however, no standard method has been described to categorize eyelid contour abnormalities.
METHODOLOGY/PRINCIPAL FINDINGS: A classification system for eyelid contour abnormalities following surgery for trachomatous trichiasis was developed. To determine whether the grading was reproducible using the classification system, six-week postoperative photographs were reviewed by two senior graders to characterize severity of contour abnormalities. Sample photographs defining each contour abnormality category were compiled and used to train four new graders. All six graders independently graded a Standardization Set of 75 eyelids, which included a roughly equal distribution across the severity scale, and weighted kappa scores were calculated. Two hundred forty six-week postoperative photographs from an ongoing clinical trial were randomly selected for evaluating agreement across graders. Two months after initial grading, one grader regraded a subset of the 240 photographs to measure longer-term intra-observer agreement. The weighted kappa for agreement between the two senior graders was 0.80 (95% CI: 0.71-0.89). Among the Standardization Set, agreement between the senior graders and the 4 new graders showed weighted kappa scores ranging from 0.60-0.80. Among 240 eyes comprising the clinical trial dataset, agreement ranged from weighted kappa 0.70-0.71. Longer-term intra-observer agreement was weighted kappa 0.86 (95% CI: 0.80-0.92).
CONCLUSIONS/SIGNIFICANCE: The standard eyelid contour grading system we developed reproducibly delineates differing levels of contour abnormality. This grading system could be useful both for helping to evaluate trichiasis surgery outcomes in clinical trials and for evaluating trichiasis surgery programs.
明确沙眼性倒睫手术后的结果定义对于规划项目评估和确定改善倒睫手术的方法至关重要。眼睑轮廓异常是手术的一个重要不良结果；然而，尚未描述用于对眼睑轮廓异常进行分类的标准方法。
方法/主要发现：开发了一种用于描述手术后眼睑轮廓异常的分类系统。为了确定使用分类系统进行分级是否具有可重复性，由两名高级分级员对术后 6 周的照片进行了回顾，以评估轮廓异常的严重程度。编译了定义每个轮廓异常类别的示例照片，并用于培训 4 名新分级员。所有 6 名分级员独立对包含大致均匀分布在严重程度范围内的 75 个眼睑的标准化集进行了分级，并计算了加权 Kappa 评分。从正在进行的临床试验中随机选择了 246 周术后的 246 张照片，以评估分级员之间的一致性。初次分级两个月后，一名分级员对 240 张照片中的一部分进行了再次分级，以衡量长期的观察者内一致性。两名高级分级员之间的加权 Kappa 一致性为 0.80（95%CI：0.71-0.89）。在标准化集中，高级分级员和 4 名新分级员之间的一致性显示加权 Kappa 评分在 0.60-0.80 之间。在包含临床试验数据集的 240 只眼中，一致性的加权 Kappa 值在 0.70-0.71 之间。长期的观察者内一致性为加权 Kappa 0.86（95%CI：0.80-0.92）。
结论/意义：我们开发的标准眼睑轮廓分级系统可重复性地描述了不同程度的轮廓异常。该分级系统可用于帮助评估临床试验中的倒睫手术结果，也可用于评估倒睫手术项目。
