Abstract
BACKGROUND: Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM research priority. Difficulties detecting DCM, and changes in DCM, cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically. OBJECTIVE: The study aims to assess the validity of MoveMed, a battery of performance outcome measures performed using a smartphone app, in the measurement of DCM. METHODS: A prospective observational study in decentralized secondary care was performed in England, United Kingdom. Validity and risk of bias were assessed using criteria from the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) manual. Each MoveMed outcome was compared with 2 patient-reported comparators, with a priori hypotheses of convergence or divergence tested against consensus thresholds. The primary outcome was the correlation coefficient between the MoveMed outcome and the patient-reported comparators. The secondary outcome was the percentage of correlations that aligned with the a priori hypotheses. The comparators used were the patient-derived modified Japanese Orthopaedic Association score and the World Health Organization Quality of Life Brief Version questionnaire. Thresholds for convergence or divergence were set at ≥0.3 for convergence, <0.3 for divergence, and >0/<0 for directionality. RESULTS: A total of 27 adults aged 60 (SD 11) years who live with DCM and possess an approved smartphone were included in a preliminary analysis. As expected, MoveMed tests of neuromuscular function correlated most with questionnaires of neuromuscular function (≥0.3) and least with questionnaires of quality of life (<0.3). Furthermore, directly related constructs correlated positively to each other (>0), while inversely related constructs correlated negatively (<0). Overall, 74% (67/90) and 47% (8/17) of correlations (unidimensional and multidimensional, respectively) were in accordance with hypotheses. No risk-of-bias factors from the COSMIN Risk of Bias checklist were recorded. Overall, this was equivalent to "very good" quality evidence of sufficient construct validity in DCM. CONCLUSIONS: MoveMed outcomes and patient-reported questionnaires converge and diverge in accordance with expectations. These findings support the validity of the MoveMed tests in an adult population living with DCM. Criteria from COSMIN provide "very good" quality evidence to support this.