Mannion A F, Vila-Casademunt A, Domingo-Sàbat M, Wunderlin S, Pellisé F, Bago J, Acaroglu E, Alanay A, Pérez-Grueso F S, Obeid I, Kleinstück F S
Spine Center Division, Department of Research and Development, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland.
Spine Research Unit, Vall d'Hebron Institute of Research, Barcelona, Spain.
Eur Spine J. 2016 Aug;25(8):2638-48. doi: 10.1007/s00586-015-4292-4. Epub 2015 Oct 30.
The Core Outcome Measures Index for the back (COMI-back) is a very brief instrument for assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability). However, it might be expected to be less responsive than a disease-specific instrument when evaluating specific pathologies. In patients with adult spinal deformity, we compared the performance of COMI-back with the widely accepted SRS-22 questionnaire.
At baseline and 12 months after non-operative (N = 121) and surgical (N = 83) treatment, patients (175 F, 29 M) completed the following: COMI-back, SRS-22, Oswestry Disability Index (ODI) and SF-36 PCS. At 12 months' follow-up, patients also indicated on a 15-point Global Rating of Change Scale (GRCS) how their back problem had changed relative to 1 year ago. Construct validity for the COMI-back was assessed by the correlation between its scores and those of the comparator instruments; responsiveness was assessed with receiver operating characteristics (ROC) analysis of COMI-back change scores versus the criterion 'treatment success' (dichotomized GRCS).
Baseline values for the COMI-back showed significant (p < 0.0001) correlations with SRS-22 (r = -0.85), ODI (r = 0.83), and SF-36 PCS (r = -0.82) scores; significantly worse scores for all measures were recorded in the surgical group. The correlation between the change scores (baseline to 12 months) for COMI and SRS-22 was 0.74, and between each of these change scores and the external criterion of treatment success were: COMI-back, r = 0.58; SRS-22, r = -0.58 (each p < 0.0001). The ROC areas under the curve for the COMI-back and SRS-22 change scores were 0.79 and 0.82, respectively.
Both baseline and change scores for the COMI-back correlated strongly with those of the SRS-22, and differed significantly in surgical and non-operative patients, suggesting good construct validity. With the "change in the back problem" serving as external criterion, COMI-back showed similar external responsiveness to SRS-22. The COMI-back was well able to detect important change. Coupled with its brevity, which minimizes patient burden, these favourable psychometric properties suggest the COMI-back is a suitable instrument for use in registries and can serve as a valid instrument in clinical studies emerging from such data pools.
背部核心结局指标指数（COMI-back）是一种非常简短的工具，用于评估对背部问题患者（疼痛、功能、特定症状的健康状况、生活质量、残疾）重要的主要结局。然而，在评估特定病理情况时，预计它的反应性可能不如针对特定疾病的工具。在成人脊柱畸形患者中，我们比较了COMI-back与广泛接受的SRS-22问卷的性能。
在非手术（N = 121）和手术（N = 83）治疗的基线和12个月后，患者（175名女性，29名男性）完成了以下内容：COMI-back、SRS-22、Oswestry残疾指数（ODI）和SF-36身体功能量表（PCS）。在12个月的随访中，患者还在15分的总体变化评定量表（GRCS）上指出其背部问题相对于1年前有何变化。通过COMI-back得分与比较工具得分之间的相关性评估COMI-back的结构效度；通过对COMI-back变化得分与“治疗成功”标准（二分法GRCS）进行受试者操作特征（ROC）分析来评估反应性。
COMI-back的基线值与SRS-22（r = -0.85）、ODI（r = 0.83）和SF-36 PCS（r = -0.82）得分显示出显著（p < 0.0001）相关性；手术组所有测量指标的得分均显著更差。COMI和SRS-22变化得分（基线至12个月）之间的相关性为0.74，这些变化得分与治疗成功的外部标准之间的相关性分别为：COMI-back，r = 0.58；SRS-22，r = -0.58（均p < 0.0001）。COMI-back和SRS-22变化得分的曲线下ROC面积分别为0.79和0.82。
COMI-back的基线得分和变化得分均与SRS-22的得分高度相关，并且在手术和非手术患者中存在显著差异，表明具有良好的结构效度。以“背部问题的变化”作为外部标准，COMI-back显示出与SRS-22相似的外部反应性。COMI-back能够很好地检测出重要变化。再加上其简短性，可将患者负担降至最低，这些良好的心理测量特性表明COMI-back是适用于登记处的工具，并且可以作为从此类数据库中产生的临床研究中的有效工具。
