Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.
Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
Scand J Pain. 2020 Jul 28;20(3):483-490. doi: 10.1515/sjpain-2019-0156.
Background and aims The Core Outcome Measures Index (COMI) is a short, self-reported questionnaire for assessing important outcomes in patients with low back pain (LBP). The present study was conducted to explore the responsiveness and longitudinal validity of the Persian COMI (COMI-P) in patients with non-specific chronic LBP. Methods In this prospective cohort study of patients with non-specific chronic LBP receiving physiotherapy, patients completed a booklet containing the COMI-P, Persian Functional Rating Index (FRI-P), and a visual analogue scale (VAS) for pain before and after the end of ten-sessions of physiotherapy. Patients also completed a global rating of change scale (GRCS) at the end of the physiotherapy. Responsiveness was examined by means of internal responsiveness methods [t-test, standard effect size (SES); standardized response mean (SRM), and Guyatt responsiveness index (GRI)] and external responsiveness methods [correlation with external criteria and receiver operating characteristics (ROC) curve]. Results Fifty patients with a mean age of 50.62 ± 13.8 years participated. The paired t-test showed significant changes in COMI-P scores (p < 0.001). The effect sizes for COMI-P were large (range 0.96-1.23). The score changes for the COMI-P revealed significant correlations with FRI-P (r = 0.67, p < 0.001), the VAS (r = 0.65, p < 0.001), and the GRCS (r = 0.34, p = 0.02). The COMI-P change scores showed excellent correlation with the dichotomized smallest detectable change (SDC) criterion (r = 0.83, p < 0.001). The ROC area under the curve for the COMI-P based on the dichotomized SDC criterion was perfect. The minimal clinically important change was estimated 2.15 points (sensitivity 94% and specificity 100%). Conclusions The COMI-P appears to have responsiveness and longitudinal validity in detecting changes after physiotherapy for non-specific chronic LBP. An improvement of 2.15 points in COMI-P total score is required to be interpreted as minimally clinically important change in individual patients.
核心结局测量指标（COMI）是一种简短的、自我报告的问卷，用于评估腰痛（LBP）患者的重要结局。本研究旨在探讨非特异性慢性 LBP 患者中 Persian COMI（COMI-P）的反应度和纵向有效性。
在这项接受物理治疗的非特异性慢性 LBP 患者的前瞻性队列研究中，患者在物理治疗结束前和结束后填写了包含 COMI-P、 Persian 功能评定指数（FRI-P）和疼痛视觉模拟量表（VAS）的小册子。患者还在物理治疗结束时填写了总体变化评分量表（GRCS）。通过内部反应度方法（t 检验、标准效应量（SES）；标准化反应均值（SRM）和 Guyatt 反应度指数（GRI））和外部反应度方法（与外部标准的相关性和受试者工作特征（ROC）曲线）来评估反应度。
50 名平均年龄为 50.62±13.8 岁的患者参与了研究。配对 t 检验显示 COMI-P 评分有显著变化（p<0.001）。COMI-P 的效应量较大（范围 0.96-1.23）。COMI-P 的评分变化与 FRI-P（r=0.67，p<0.001）、VAS（r=0.65，p<0.001）和 GRCS（r=0.34，p=0.02）显著相关。COMI-P 变化评分与二分最小可检测变化（SDC）标准具有极好的相关性（r=0.83，p<0.001）。基于二分 SDC 标准的 COMI-P 的 ROC 曲线下面积为完美。最小临床重要变化估计为 2.15 分（敏感性 94%，特异性 100%）。
COMI-P 似乎具有在检测非特异性慢性 LBP 患者物理治疗后的变化方面的反应度和纵向有效性。COMI-P 总分提高 2.15 分被认为是个体患者的最小临床重要变化。
