Cross-cultural adaptation and validation of the Hungarian version of the Core Outcome Measures Index for the back (COMI Back)

Abstract

PURPOSE: The Core Outcome Measure Index (COMI) is a short, multidimensional outcome instrument developed for the evaluation of patients with spinal conditions. The aim of this study was to produce a cross-culturally adapted and validated Hungarian version of the COMI Back questionnaire. METHODS: A cross-cultural adaptation of the COMI into Hungarian was carried out using established guidelines. Low back pain patients completed a booklet of questionnaires containing the Hungarian versions of COMI, Oswestry Disability Index (ODI) and WHO Quality of Life-BREF assessment (WHOQOL-BREF). The validation of the COMI included assessment of its construct validity, reliability, and responsiveness. RESULTS: 145 patients participated in the assessment of reliability and 159 surgically treated patients were included in the responsiveness study. Excellent correlation was found between COMI and ODI scores (rho = 0.83, p < 0.01). The COMI showed a very good correlation with the physical subscale of WHOQOL-BREF (rho = -0.75, p < 0.01) and pain (rho = 0.68, p < 0.01). Test-retest analysis showed that Hungarian COMI is a reliable measurement tool (ICC = 0.92) with an acceptable standard error of measurement (SEM = 0.59) and minimum detectable change (MDC = 1.63). Internal responsiveness analysis indicated a large effect size (1.16) for the change in COMI score after lumbar surgery. The area under the ROC curve (AUC) for the COMI score compared with the global outcome of the surgery was 0.87. CONCLUSION: The translation and cross-cultural adaptation of the COMI into the Hungarian language was successful, resulting in a reliable and valid measurement tool with good clinimetric properties.