Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine

Abstract

Objective To perform the psychometric validation of the Dutch version of the Core Outcome Measures Index (COMI) for the neck. Methods A total of 178 patients, who had an indication for surgery due to degenerative cervical spinal disease, were enrolled in the study. They filled in a baseline booklet containing the Dutch version of the COMI-neck, Likert-scales for neck and arm/shoulder pain, the Neck Disability Index (NDI), the EuroQol-5 dimensions (EQ-5D) and the 12-item Short Form health survey (SF-12). Aside from analyzing construct validity using the Spearman correlation test, test-retest reliability, and responsiveness at 3 months were assessed using the intraclass correlation coefficient (ICC) and the receiver-operating characteristic (ROC) curve, respectively. Results The COMI-neck showed good acceptability with missing data ranging from 0% to 4.5% and some floor/ceiling effects for 3 of the domains at baseline. The COMI-summary score showed good to very good correlation with the EQ5D (ρ=-0.43), the physical component summary of the SF-12 (ρ=-0.47) and the NDI (ρ=0.73). Individual domains showed correlations of -0.28 to 0.85 with the reference questionnaires. Test-retest reliability analysis showed an ICC of 0.91 with a minimal detectable change of 1.7. Responsiveness analysis of the COMI-neck showed an area under 0.79 under the ROC-curve. The standardized response mean for a good outcome was 1.24 and for a poor outcome 0.37. Conclusion The current study shows that the Dutch version of the COMI-neck is a valid, reliable and responsive Patient-Reported Outcome Measure, among patients undergoing surgery for degenerative cervical spinal disorders.

Keywords

• core outcomes measures index
• dutch
• validation