Abstract
Background: Despite the large negative effect of limb deformity on health-related quality of life (QoL), there exists no patient-reported instrument to quantify this impact. Rather, limb deformity research has been performed using global QoL measurements concurrently with joint-specific and/or arthritis outcome scales, thereby requiring the completion of multiple instruments. Furthermore, joint- and arthritis-specific instruments focus on the impact pain has on function, whereas limb deformities may be pain-free with greater social and functional impairment. The purpose of this study was to validate a patient-reported instrument to quantify limb deformity-related QoL. Materials and Methods: Because of the similarities with regard to pain, function, and body image between limb deformity and scoliosis, the Scoliosis Research Society-30 (SRS-30) spine deformity instrument was modified such that the words back and trunk were replaced with limb to create a novel instrument: the limb deformity-SRS (LD-SRS). Testing for construct validity (both convergent and discriminant), reliability, floor and ceiling effects, and minimal clinically important difference (MCID) was performed in a validation cohort of 62 subjects aged 18 years or older with nonarthritic, unilateral lower extremity deformity. Results: Scale reliability was excellent (test-retest reliability, intraclass correlation coefficient = 0.977; internal consistency, Cronbach's alpha = 0.906), scores were normally distributed, and there were no floor or ceiling effects. There was also robust construct validity: convergent validity testing revealed positive correlations between the LD-SRS and all short-form-36 domains, the American Academy of Orthopaedic Surgeons-Lower Limb Module, and higher scores in those who were postcorrection. Discriminant validity was demonstrated with no correlations between the LD-SRS and subject age, sex, body mass index, surgeon-scored Limb Lengthening and Reconstruction Society-AIM Index, or surgeon-generated deformity measurements. MCID was calculated to be 0.3 (on a 4.0-point scale). Conclusions: The LD-SRS score is a reliable and valid instrument to measure limb deformity-related QoL in patients with nonarthritic lower extremity deformity. It is a valuable tool which allows clinicians to quantify patients' deformity-related QoL with a single instrument, rather than repurposing scales which have been validated for other conditions and have limited applicability to the unique challenges of treating patients with a lower limb deformity. Level of Evidence: Diagnostic, Level 2.
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