Quality of patient- and proxy-reported outcomes for children with impairment of the lower extremity: A systematic review using the COnsensus-based Standards for selection of health Measurement INstruments methodology.

Background: Patient-reported outcome measures have become crucial in the clinical evaluation of patients. Appropriate selection, in a young population, of the instrument is vital to providing evidence-based patient-centered healthcare. This systematic review applies the COnsensus-based Standards for selection of health Measurement INstruments methodology to provide a critically appraised overview of patient-reported outcome measures targeted at pediatric orthopedic patients with lower limb impairment. Method: A systematic search of electronic databases was performed to identify original studies reporting the development and/or validation of patient-reported outcome measures evaluating children with impairment of the lower extremity. Data extraction, quality assessment, and risk of bias evaluation were performed following the COnsensus-based Standards for selection of health Measurement INstruments guidelines and Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. Results: A total of 6919 articles were screened. Thirty-three studies were included, reporting evidence on the measurement properties of 13 different patient-reported outcome measures and 20 translations. Four studies reported on content validity and patient-reported outcome measure development. The methodological quality of studies on structural validity, content validity, or patient-reported outcome measure development was mostly rated as "doubtful" or "very good." The quality of evidence on measurement properties varied noticeably, with most studies needing to perform improve their methodological quality to justify their results. Conclusion: This review provides an extensive overview of all available patient-reported outcome measures for patients with lower extremity impairment within pediatric orthopedics. We cautiously advise the use of four patient-reported outcome measures. However, the scarce availability of research on content validity and patient-reported outcome measure development highlights an area for future research endeavors to improve our knowledge on the currently available patient-reported outcome measures. Level of evidence: Diagnostic level 1.