Studies in the Falls Efficacy Scale-International for patients with cervical compressive myelopathy: Reliability, validity, and minimum clinically important difference

Abstract

Context Patients with cervical compressive myelopathy (CCM) often complain of body balance problems, such as fear of falling and bodily unsteadiness. However, no accepted patient-reported outcome measures (PROMs) for this symptomatology exist. The Falls Efficacy Scale-International (FES-I) is one of the most widely used PROMs for evaluating impaired body balance in various clinical fields. Objective To examine reliability, validity, and minimum clinically important difference (MCID) of the FES-I for the evaluation of impaired body balance in patients with CCM. Methods Patients who underwent surgery for CCM were retrospectively reviewed. The FES-I was administered preoperatively and at 1 year postoperatively. Further, cJOA-LE score (subscore for lower extremities in the Japanese Orthopaedic Association score for cervical myelopathy) and stabilometric data, obtained at the same time points of the FES-I administration, were analyzed. Reliability was examined through internal consistency with Cronbach’s alpha. Convergent validity was studied using correlation analysis. The MCID was estimated using anchor- and distribution-based methods. Results Overall, 151 patients were included for analysis. Cronbach’s alpha coefficient was the acceptable value of 0.97 at both baseline and 1 year postoperatively. As for convergent validity, the FES-I had significant correlations with the cJOA-LE score and stabilometric parameters both at baseline and 1 year postoperatively. The MCID calculated using anchor- and distribution-based methods was 5.5 and 10, respectively. Conclusion FES-I is a reliable and valid PROM to evaluate body balance problems for the CCM population. The established thresholds of MCID can help clinicians recognize the clinical significance of changes in patient status.