Spine Center Division, Department of Research and Development, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland.
Eur Spine J. 2012 Aug;21 Suppl 6(Suppl 6):S737-49. doi: 10.1007/s00586-011-1741-6. Epub 2011 Mar 17.
Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for "function", 92% for "symptom-specific well-being", 100% for "general quality of life", 90% for "social disability", and 98% for "work disability". The intraclass correlation coefficients (ICC(2,1)) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86-0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ''minimum detectable change'' for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4-0.8) with the corresponding full-length reference questionnaires (r = 0.45-0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries.
患者导向的结局问卷对于评估脊柱治疗的治疗成功至关重要。为了进行研究之间和注册中心的比较，有必要对所使用的工具进行标准化。核心结局测量指标（COMI）是一种经过验证的用于脊柱疾病患者的简短多维结局工具，是欧洲脊柱学会脊柱探戈登记处推荐的结局工具；目前，尚无经过验证的意大利语版本。使用既定指南对 COMI 进行了跨文化适应性改编。从瑞士和意大利的五家诊所招募了 96 名慢性背部问题（>3 个月）的门诊患者。他们完成了新翻译的 COMI、罗兰·莫里斯残疾（RM）、形容词疼痛评分、世界卫生组织生活质量（WHOQoL）、欧洲五维健康量表（EQ-5D）和欧洲五维健康量表视觉模拟评分（EQ-VAS）。在一个由 63 名患者组成的亚组中评估了可重复性，这些患者在 1 个月内返回了第二份问卷，并且在 5 分李克特量表转换问题上表示背部状况没有变化。COMI 评分没有地板或天花板效应。在重新测试时，100%的患者在“功能”的每个 COMI 个体域的反应都在一个类别内，92%在“症状特异性幸福感”，100%在“一般生活质量”，90%在“社会残疾”，98%在“工作残疾”。COMI 背部和腿部疼痛项目的组内相关系数（ICC（2,1））分别为 0.78 和 0.82，COMI 综合指数为 0.92（95%CI 0.86-0.95）；这与 RM 的 0.84、WHOQoL 的 0.87、EQ-5D 的 0.79 和 EQ-VAS 的 0.77 相比表现良好。COMI 的测量误差（SEM）为 0.54 分，COMI 的“最小可检测变化”为 1.5 分。大多数 COMI 个体域和 COMI 综合指数的评分与相应的全长参考问卷具有预期的相关性（0.4-0.8）（r = 0.45-0.72）。意大利语 COMI 的可重复性与已发表的德语和西班牙语版本相当。COMI 评分以预期的方式与现有的但明显更长的问卷相关，表明 COMI 具有足够的聚合效度。意大利语 COMI 是一种实用、可靠和有效的工具，可用于讲意大利语的患者，将为国际研究和外科登记处提供价值。
