Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 166 Gumiro, Bundang-gu, Sungnam, 463-707, Republic of Korea.
Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Hospital, 101 Daehangno, Jongno-gu, Seoul, 110-744, Republic of Korea.
Eur Spine J. 2018 Nov;27(11):2804-2813. doi: 10.1007/s00586-018-5759-x. Epub 2018 Sep 17.
To translate and cross-culturally adapt the Core Outcome Measures Index (COMI) into the Korean language and to test the psychometric properties of the Korean COMI in patients with degenerative lumbar spine diseases.
A cross-cultural adaptation of the COMI into Korean was carried out using established guidelines. A total of 117 patients with lumbar spinal diseases were recruited from the spinal center of a tertiary care teaching institution and completed a baseline questionnaire including the newly translated COMI, the visual analog scale for back pain and for leg pain, the Oswestry Disability Index (ODI), and the EuroQOL-5 dimensions (EQ-5D). Within 2 weeks after the first assessment, 83 (71%) completed a second COMI questionnaire and a transition question (no change, slight change, moderate change, a lot of change) by phone to assess reproducibility.
COMI summary scores displayed 1.7% floor effects and no ceiling effect. For construct validity, each COMI item and COMI summary score well correlated with its corresponding reference questionnaire. Therefore, the predefined hypotheses for the construct validities of each COMI item (ρ > 0.4 with the corresponding questionnaire) and the COMI summary score (ρ > 0.6 with both ODI and EQ-5D) were confirmed. Intraclass correlation coefficients of each COMI item and summary score ranged from 0.93 to 0.98. Therefore, the hypothesis for reliability (ICC > 0.8) was confirmed.
The present study highlights that the Korean version of the COMI is a reliable and valid outcome tool for use in Korean-speaking patients with degenerative lumbar spinal disease. These slides can be retrieved under Electronic Supplementary Material.
将核心结局测量指标（COMI）翻译并跨文化适应为韩语，并在退行性腰椎疾病患者中检验韩国 COMI 的心理测量特性。
使用既定指南对 COMI 进行韩语跨文化适应性改编。共招募了来自三级教学机构脊柱中心的 117 名腰椎疾病患者，他们完成了基线问卷，包括新翻译的 COMI、腰背腿痛视觉模拟量表、Oswestry 残疾指数（ODI）和欧洲五维健康量表（EQ-5D）。在首次评估后 2 周内，通过电话，83 名（71%）患者完成了第二次 COMI 问卷和转换问题（无变化、稍有变化、中度变化、有很大变化），以评估可重复性。
COMI 综合评分显示 1.7%的地板效应和无天花板效应。对于结构效度，每个 COMI 项目和 COMI 综合评分都与相应的参考问卷有很好的相关性。因此，每个 COMI 项目（与相应问卷的 ρ>0.4）和 COMI 综合评分（与 ODI 和 EQ-5D 的 ρ>0.6）的结构效度的预定假设得到了证实。每个 COMI 项目和综合评分的组内相关系数范围为 0.93 至 0.98。因此，可靠性的假设（ICC>0.8）得到了证实。
本研究强调，韩国版 COMI 是一种可靠且有效的结局工具，可用于韩国退行性腰椎疾病患者。这些幻灯片可以在电子补充材料中检索。
