Abstract
BACKGROUND: Previous neck-specific patient-reported outcome measures (PROMs) have tended to measure both symptoms and disability. This multi-staged study developed and evaluated a neck-specific PROM focusing on functional disability. METHODS: This study integrated findings from systematic reviews on neck-specific outcome measures, patient interviews, qualitative studies on neck disability, and iterative item testing to develop a 10-item measure of neck-related disability (ND10). Content validity was assessed by classifying items using the International Classification of Functioning, Disability and Health (ICF) and perspective linking. Patients (n = 78) with neck pain completed cognitive interviews, exploring items of the Neck Disability Index (NDI) and ND10, and completed structured questions related to literacy and relevance. Test-retest reliability and internal consistency were evaluated using intraclass correlation coefficients, Bland Altman graphs, and Cronbach's alpha. Concurrent convergent validity was evaluated by comparing the ND10 to the NDI, Single Assessment Numeric Evaluation (SANE), and Disabilities of the Arm, Shoulder and Hand (DASH). Known group validity was determined by comparing ND10 scores from patients, who rated their neck as more or less than 1/2 of "normal" on the SANE, using t-tests. RESULTS: The ND10 requires respondents to make rational judgements about their neck-related body function and disability. It has high internal consistency (0.94) and re-test reliability (0.87; SEM = 3.2/100; MDC = 7.5); and no re-test bias (mean re-test difference of 0.6). It followed expected correlation patterns, being highly correlated with related multi-item PROMs (r = 0.85-0.91), and moderately correlated to the single-item SANE. More patients agreed that the ND10 was easily readable than did so for the NDI (84% vs 68%; p < 0.05). All the PROMs distinguished the patients who perceived themselves as being abnormal/normal defined by a dichotomized SANE (p < 0.01). CONCLUSION: The ND10 is reliable and valid for measuring neck-related functional disability. Longitudinal and cross-cultural translation studies are needed to support future use.