Prospective Multicenter Preliminary Validation of Limb Deformity-modified Scoliosis Instruments in Pediatric Patients With Limb Deformity.

INTRODUCTION

There are few disease-specific patient-reported outcome measures (PROMs) for use in pediatric limb deformity (LD), with authors instead relying on generic PROMs such as the Pediatric Outcomes Data Collection Instrument (PODCI) to assess treatment outcomes from the patient's perspective. The purpose of this study was to perform preliminary validation of 2 disease-specific PROMs in pediatric patients with LD.

METHODS

LD modifications were created by substituting the word "limb" for "back" in the Early Onset Scoliosis Questionnaire (EOSQ, ages 10 and younger) and the Scoliosis Research Society (SRS, ages 11 to 18) survey, creating the LD-EOSQ and LD-SRS instruments. Children were preoperatively administered the age-appropriate LD-PROMs (n=34 LD-EOSQ; n=30 LD-SRS) and PODCI questionnaires. LD-PROMs were assessed for construct (convergent and discriminant) validity, floor and ceiling effects, content validity, and minimal clinically important difference.

RESULTS

Both LD-EOSQ and LD-SRS demonstrated excellent preliminary convergent validity with similar PODCI domains and discriminant validity with demographic information, deformity data, and LLRS-AIM scores. There were minimal floor or ceiling effects. Content validity was achieved in 100% of LD-EOSQ surveys and more than 80% of LD-SRS surveys. Minimal clinically important difference was 0.4 for LD-EOSQ and 0.3 for LD-SRS.

CONCLUSIONS

The LD-EOSQ for patients aged 10 and under and LD-SRS for patients aged 11 to 18 demonstrated preliminary validity and reliability in the pediatric LD population. These measures provide more information specifically related to familial impact in younger children and self-image and mental health in adolescents compared to the PODCI and should be further evaluated for use in these patients.

LEVEL OF EVIDENCE

Level II-diagnostic. Prospective cross-sectional cohort design.