Validation of PROMIS Physical Function Instruments in Patients With an Orthopaedic Trauma to a Lower Extremity.

OBJECTIVES: To evaluate the reliability, convergent validity, known-groups validity, and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility Computer Adaptive Test (CAT) and PROMIS Physical Function 8a Short Form. DESIGN: Prospective cohort study. SETTING: Two Level-I trauma centers. PATIENTS: Eligible adults with an isolated lower extremity trauma injury receiving treatment were approached consecutively (n = 402 consented at time 1, median = 80 days after treatment). After 6 months, 122 (30.3%) completed another assessment. INTERVENTION: Cross-sectional and longitudinal monitoring of patients. MAIN OUTCOME MEASUREMENTS: Floor and ceiling effects, reliability (marginal reliability and Cronbach's alpha), convergent validity, known-groups discriminant validity (weight-bearing status and fracture severity), and responsiveness (Cohen's d effect size) were evaluated for the PROMIS Mobility CAT, PROMIS Physical Function 8a Short Form, and 5 other measures of physical function. RESULTS: PROMIS PFSF8a and Foot and Ankle Ability Measure Activities of Daily Living Index had ceiling effects. Both PROMIS measures demonstrated excellent internal consistency reliability (mean marginal reliability 0.94 and 0.96; Cronbach's alpha = 0.96). Convergent validity was supported by high correlations with other measures of physical function (r = 0.70-0.87). Known-groups validity by weight-bearing status and fracture severity was supported as was responsiveness (Mobility CAT effect size = 0.81; Physical Function Short Form 8a = 0.88). CONCLUSIONS: The PROMIS Mobility CAT and Physical Function 8a Short Form demonstrated reliability, convergent and known-groups discriminant validity, and responsiveness in a sample of patients with a lower extremity orthopaedic trauma injury.

Longitudinal Validation of the PROMIS Physical Function Item Bank in Upper Extremity Trauma.

OBJECTIVES: To evaluate the reliability, validity, and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (UE-CAT) and the 8-item Physical Function short form (PF-SF8a) for monitoring outcomes after musculoskeletal injuries in upper extremity trauma patients. DESIGN: Prospective cohort study. SETTING: Two Level-I trauma centers. PATIENTS: Eligible consecutive patients were approached and 424 consented at time 1 (median 9.7 weeks posttreatment). After 6 months, 132 patients (43% of the 307 eligible) completed follow-up measures. INTERVENTION: Cross-sectional and longitudinal monitoring of upper extremity trauma patients treated with or without surgery. MAIN OUTCOME MEASUREMENTS: Reliability, validity, and responsiveness of the UE-CAT and PF-SF8a. Internal consistency reliability, convergent validity correlations, and discriminant validity (by fracture severity and dominant/nondominant extremity groups) were calculated for PROMIS and non-PROMIS forms. Floor and ceiling effects were also examined at both assessment occasions. Responsiveness was evaluated using random-intercept mixed effects models and effect sizes. RESULTS: PROMIS measures had excellent reliability, correlated well with legacy measures, and were responsive to treatment. CONCLUSIONS: PROMIS measures had good statistical properties. In addition to the known advantages of PROMIS, such as lower patient burden and the ability to assess the broadest range of functioning, our data demonstrated that for patients with upper extremity limitations, a region-specific measure such as the UE-CAT may perform more favorably than an overall/full body physical function measure.