Preliminary validation of the Review of Musculoskeletal System (ROMS) questionnaire

Background: Measurement of clinical outcomes is necessary to define best practice. It requires a validated tool that can be easily applied as part of clinical practice. We present the preliminary validation of a brief self-reported Review of Musculoskeletal System (ROMS) questionnaire that captures functional limitations due to musculoskeletal problems and other medical and emotional conditions. Methods: Data were derived from a clinical outcomes database (Orthopaedic Minimal Data Set [OrthoMiDaS]) that combines patient-reported data collected as part of routine care and secondary data extracted from electronic medical records. The study utilized 82,873 encounters collected from 24,116 consecutive patients with problems in the upper and lower extremities. In addition to the ROMS, the study used version 2 of the Short Form-12 (SF-12v2), the Penn Shoulder Score (PSS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Fifteen cross-sectional samples were used to evaluate the floor and ceiling effects as well as the construct and content validity. Five longitudinal cohorts were used to measure test-retest reliability and responsiveness. Standard statistical tests were applied. Results: The floor and ceiling effects of the ROMS questionnaire in patients with shoulder, hip, and knee problems ranged from 1.3% to 8.5%. Construct-validity tests confirmed convergent and divergent validity of the ROMS. The tests also justified its additional value when the ROMS was used with joint-specific tools. When measuring test-retest reliability of the ROMS scales, intraclass correlation ranged from 0.80 to 0.90 at approximately one week and from 0.71 to 0.87 at approximately four weeks. Responsiveness of the ROMS was greater than that of the SF-12 and less than that of the jointspecific questionnaires. Conclusions: The ROMS is compatible with routine clinical process and has good psychometric properties in patients with shoulder, hip, and knee disorders. It can be used as a primary outcome tool for large observational studies and can supplement more specific tools in controlled studies. Clinical Relevance: The ROMS was developed as a tool to measure and monitor the clinical status of the musculoskeletal system in a population of patients during and after treatment as well as over time.