Validity of the Japanese core outcome measures index (COMI)-neck for cervical spine surgery: a prospective cohort study

Validity of the Japanese core outcome measures index (COMI)-neck for cervical spine surgery: a prospective cohort study
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DOI:
10.1007/s00586-020-06657-4
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发表时间:
2020-11-19
影响因子:
2.8
通讯作者:
Matsudaira, Ko
Matsudaira, Ko
中科院分区:
医学3区
文献类型:
--
作者:
Oshima, Yasushi;Nagata, Kosei;Matsudaira, Ko

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目的探讨颈椎手术患者核心结局指标-颈(COMI-颈)日本版的心理测量学特性。方法选择2017年4月至12月因脊柱疾病行颈椎手术的患者177例。患者报告结局(PRO)包括EuroQOL、颈部残疾指数和治疗满意度。为了解决问卷评分是否与基于预定义假设的其他结局相关,测量了COMI颈和其他PRO之间的相关性(斯皮尔曼等级相关系数)。使用受试者工作特征(ROC)曲线和7分制Likert治疗结果满意度量表计算COMI汇总评分的最小临床重要差异(MCID)。为了评估可重复性,另一组59名患有慢性颈部疼痛的志愿者被要求回答COMI颈部两次,间隔7-14天。结果术前术后COMI综合评分均无下限或上限效应。每个主要利益中心领域和主要利益中心总得分与参考问卷得分的假设程度相关(ρ = 0.40-0.79)。根据满意度(包括“非常满意”和“满意”)的ROC曲线,COMI总分的曲线下面积和MCID分别为0.78和2.1。COMI总分的组内相关系数和最小可检测变化(MDC 95%)分别为0.97和0.77。结论日语版COMI-Neck量表适用于日语颈椎病患者。
Purpose To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Neck (COMI-Neck) in patients undergoing cervical spine surgery. Methods A total of 177 patients undergoing cervical spine surgery for spinal disorders from April to December 2017 were enrolled. Patient-reported outcomes (PROs) included EuroQOL, Neck Disability Index, and treatment satisfaction. To address whether the questionnaire's scores relate to other outcomes based on a predefined hypothesis, the correlations between the COMI-Neck and the other PROs were measured (Spearman's rank correlation coefficients). The minimum clinically important difference (MCID) of the COMI summary score was calculated using the receiver operating characteristic (ROC) curve with a 7-point Likert scale of satisfaction with the treatment results. To assess reproducibility, another group of 59 volunteers with chronic neck pain were asked to reply to the COMI-Neck twice with an interval of 7-14 days. Results The COMI summary score showed no floor or ceiling effects preoperatively or postoperatively. Each of the COMI domains and the COMI summary score correlated to the hypothesized extent with the scores of the reference questionnaires (rho = 0.40-0.79). According to the ROC curve with satisfaction (including "very satisfied" and "satisfied"), the area under the curve and MCID of the COMI summary score were 0.78 and 2.1. The intraclass correlation coefficient and the minimum detectable change (MDC 95%) of the COMI summary score were 0.97 and 0.77. Conclusion The Japanese version of the COMI-Neck is valid and reliable for Japanese-speaking patients with cervical spinal disorders.