Santa Casa e Asilo dos Pobres, Batatais, Brazil.
Eur Spine J. 2012 Jul;21(7):1273-82. doi: 10.1007/s00586-011-2100-3. Epub 2011 Dec 15.
The use of patient-orientated questionnaires is of utmost importance in assessing the outcome of spine surgery. Standardisation, using a common set of outcome measures, is essential to aid comparisons across studies/in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders. This study aimed to produce a Brazilian-Portuguese version of the COMI.
A cross-cultural adaptation of the COMI into Brazilian-Portuguese was carried out using established guidelines. 104 outpatients with chronic LBP (>3 months) were recruited from a Public Health Spine Medical Care Centre. They completed a questionnaire booklet containing the newly translated COMI, and other validated symptom-specific questionnaires: Oswestry Disability Index (ODI) and Roland Morris disability scale (RM), and a pain visual analogue scale. All patients completed a second questionnaire within 7-10 days to assess reproducibility.
The COMI summary score displayed minimal floor and ceiling effects. On re-test, the responses for each individual domain of the COMI were within 1 category in 98% patients for the domain 'function', 96% for 'symptom-specific well-being', 97% for 'general quality of life', 99% for 'social disability' and 100% for 'work disability'. The intraclass correlation coefficients (ICC(2,1)) for COMI pain and COMI summary scores were 0.91-0.96, which compared favourably with the corresponding values for the RM (ICC, 0.99) and ODI (ICC, 0.98). The standard error of measurement for the COMI was 0.6, giving a "minimum detectable change" (MDC95%) of approximately 1.7 points i.e., the minimum change to be considered "real change" beyond measurement error. The COMI scores correlated as hypothesised (Rho, 0.4-0.8) with the other symptom-specific questionnaires.
The reproducibility of the Brazilian-Portuguese version of the COMI was comparable to that of other language versions. The COMI scores correlated in the expected manner with existing but longer symptom-specific questionnaires suggesting good convergent validity for the COMI. The Brazilian-Portuguese COMI represents a valuable tool for Brazilian study-centres in future multicentre clinical studies and surgical registries.
使用以患者为中心的问卷对于评估脊柱手术的结果至关重要。通过使用一套共同的结局测量标准进行标准化，有助于促进研究/注册之间的比较。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。本研究旨在制作 COMI 的巴西葡萄牙语版本。
根据既定指南，对 COMI 进行跨文化适应，转化为巴西葡萄牙语。从一家公立脊柱医疗保健中心招募了 104 名慢性腰痛（>3 个月）的门诊患者。他们填写了一本包含新翻译的 COMI 以及其他经过验证的症状特异性问卷的问卷手册：Oswestry 残疾指数（ODI）和 Roland Morris 残疾量表（RM）以及疼痛视觉模拟量表。所有患者在 7-10 天内完成第二次问卷以评估可重复性。
COMI 综合评分显示出最小的地板和天花板效应。在重新测试时，COMI 中每个单独领域的反应在 98%的患者中处于第 1 类，在“功能”领域为 96%，在“症状特异性幸福感”领域为 97%，在“一般生活质量”领域为 97%，在“社会残疾”领域为 99%，在“工作残疾”领域为 100%。COMI 疼痛和 COMI 综合评分的组内相关系数（ICC（2,1））为 0.91-0.96，与 RM（ICC，0.99）和 ODI（ICC，0.98）的相应值相比表现良好。COMI 的测量误差为 0.6，即大约 1.7 点的“最小可检测变化”（MDC95%），这是超出测量误差之外被认为是“真实变化”的最小变化。COMI 评分与其他症状特异性问卷的相关性与假设一致（Rho，0.4-0.8）。
COMI 的巴西葡萄牙语版本的可重复性与其他语言版本相当。COMI 评分与现有的但更长的症状特异性问卷以预期的方式相关，表明 COMI 具有良好的收敛效度。巴西葡萄牙语 COMI 为巴西研究中心在未来的多中心临床研究和手术登记中提供了一种有价值的工具。
