Arita Reiko, Minoura Izumi, Morishige Naoyuki, Shirakawa Rika, Fukuoka Shima, Asai Kei, Goto Tateki, Imanaka Takahiro, Nakamura Masatsugu
Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Ophthalmology, Itoh Clinic, Saitama, Japan.
Research and Development Division, Santen Pharmaceutical Co Ltd, Osaka, Japan.
Am J Ophthalmol. 2016 Sep;169:125-137. doi: 10.1016/j.ajo.2016.06.025. Epub 2016 Jun 23.
To develop and validate grading scales for meibomian gland dysfunction (MGD) that allow consistent diagnosis of MGD and are suitable for clinical studies.
Development and validation study of grading scales.
Lid margin and meibomian gland photographs were taken in the multicenter, prospective cross-sectional study for MGD and control subjects. New grading scales for MGD signs (abnormal lid margin findings of vascularity, plugging of gland orifices, lid margin irregularity, lid margin thickening, partial glands, and gland dropout) in both upper and lower eyelids were developed. Three MGD experts, 3 general ophthalmologists, and 3 non-physicians independently tested the scales by evaluating photographs. The levels of interrater and intrarater agreement for each grading scale were estimated with the use of kappa statistics.
Thirty-eight patients with MGD and 20 control subjects were enrolled and photographed. New grading scales were developed using a total of 226 photographs. The interrater kappa values for MGD experts and for general ophthalmologists and non-physicians with reference to an MGD expert ranged from 0.36 to 0.87 (median of 0.66), 0.41 to 0.73 (0.60), and 0.30 to 0.77 (0.59), respectively. Those for intrarater reliability for 2 MGD experts ranged from 0.49 to 0.93 (0.82).
New grading scales for MGD signs were developed and found to have appropriate inter- and intrarater reliabilities for grading MGD. These grading scales are suitable for MGD diagnosis and application to multicenter trials.
开发并验证睑板腺功能障碍(MGD)分级量表,以实现MGD的一致性诊断并适用于临床研究。
分级量表的开发与验证研究。
在一项针对MGD患者和对照受试者的多中心、前瞻性横断面研究中,拍摄睑缘和睑板腺照片。开发了上下眼睑MGD体征(睑缘血管异常、腺管开口堵塞、睑缘不规则、睑缘增厚、部分腺体及腺体缺失)的新分级量表。三位MGD专家、三位普通眼科医生和三位非医生通过评估照片独立测试该量表。使用kappa统计量估计每个分级量表的评分者间和评分者内一致性水平。
纳入38例MGD患者和20例对照受试者并拍摄照片。共使用226张照片开发了新的分级量表。MGD专家、普通眼科医生以及非医生相对于MGD专家的评分者间kappa值分别为0.36至0.87(中位数0.66)、0.41至0.73(0.60)和0.30至0.77(0.59)。两位MGD专家的评分者内信度为0.49至0.93(0.82)。
开发了MGD体征的新分级量表,发现其在MGD分级方面具有适当的评分者间和评分者内信度。这些分级量表适用于MGD诊断及多中心试验应用。