Matsudaira Ko, Oka Hiroyuki, Oshima Yasushi, Chikuda Hirotaka, Taniguchi Yuki, Matsubayashi Yoshitaka, Kawaguchi Mika, Sato Emiko, Murano Haruka, Laurent Thomas, Tanaka Sakae, Mannion Anne F
Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, Faculty of Medicine, The University of Tokyo, Tokyo, Bunkyo-ku, Japan.
Department of Pain Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.
BMC Musculoskelet Disord. 2018 Mar 2;19(1):71. doi: 10.1186/s12891-018-1986-x.
The patient-rated Core Outcome Measures Index (COMI) assesses the multidimensional impact of back problems on the sufferer. The brevity and comprehensibility of the tool make it practical for use in clinical and research settings. Although the COMI has been cross-culturally adapted in various languages worldwide, there is currently no Japanese version. The aim of this study was to develop a Japanese version of the COMI by: (1) performing a cross-cultural adaptation of the English version and (2) evaluating the psychometric properties of the Japanese version of the COMI in Japanese volunteers with chronic back problems.
The English version of the COMI was cross-culturally adapted for the Japanese language using established guidelines. The pre-final version was pilot-tested in five Japanese-speaking patients with low back pain (LBP) and a history of spine surgery. The psychometric properties of the Japanese COMI were tested in a group of 1052 individuals with chronic LBP (LBP ≥3 months), aged 20-69 years, who were recruited through a web-based survey. The psychometric properties that were evaluated included convergent and known-group validity, using the following reference questionnaires: EuroQol 5 Dimension, Roland Morris Disability Questionnaire, Short Form 8™ Health Survey, and the Keele STarT Back Screening Tool.
The pre-final version of the cross-culturally adapted Japanese COMI was completed without any major problems of understanding or acceptability. For the evaluation of its psychometric properties, tests for convergent validity showed moderate correlations between COMI items and the respective reference questionnaires for symptom-specific well-being [- 0.33--0.48] and disability domains [0.48] and strong correlations (> 0.5) for the other domains and the COMI summary score. The analysis of known-group validity showed a linear trend for the COMI score in relation to prognostic risk (P < 0.001).
The Japanese COMI retained conceptual equivalence to the original using comprehensible and acceptable Japanese expressions. We developed a Japanese version of the COMI that displayed qualities that support its convergent and known-group validity. The availability of a Japanese version of the COMI should allow for improved documentation of the care provided to patients with back problems.
患者自评核心结局指标指数（COMI）评估背部问题对患者的多维度影响。该工具的简洁性和易理解性使其在临床和研究环境中具有实用性。尽管COMI已在全球范围内以多种语言进行了跨文化改编，但目前尚无日语版本。本研究的目的是通过以下方式开发COMI的日语版本：（1）对英文版进行跨文化改编；（2）评估COMI日语版本在患有慢性背部问题的日本志愿者中的心理测量特性。
使用既定指南将COMI英文版进行跨文化改编以适应日语。预终版在5名有下腰痛（LBP）且有脊柱手术史的日语患者中进行了预测试。通过基于网络的调查招募了1052名年龄在20 - 69岁之间、患有慢性LBP（LBP≥3个月）的个体，对日语COMI的心理测量特性进行了测试。评估的心理测量特性包括收敛效度和已知组效度，使用以下参考问卷：欧洲五维健康量表、罗兰·莫里斯残疾问卷、简短健康调查问卷8™以及基尔STarT背部筛查工具。
跨文化改编后的日语COMI预终版在理解或可接受性方面没有出现任何重大问题。对于其心理测量特性的评估，收敛效度测试显示COMI项目与针对特定症状幸福感[-0.33 - -0.48]和残疾领域[0.48]的相应参考问卷之间存在中度相关性，而在其他领域与COMI总分之间存在强相关性（>0.5）。已知组效度分析显示COMI得分与预后风险呈线性趋势（P < 0.001）。
日语COMI使用易懂且可接受的日语表达，在概念上与原版保持等效。我们开发的COMI日语版本展现出支持其收敛效度和已知组效度的特性。COMI日语版本的可用性应有助于改善对背部问题患者所提供护理的记录。
