Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction.

BACKGROUND

The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains.

PURPOSE

To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction.

STUDY DESIGN

Cohort study (diagnosis); Level of evidence, 2.

METHODS

Initially, 157 patients completed the PROMIS PF CAT, Short Form-36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol-5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen ), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models.

RESULTS

At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF ( = 0.75-0.80, < .01), KOOS-ADL ( = 0.63-0.70, < .01), and KOOS-sport ( = 0.32-0.69, < .01); excellent-good correlation with the EQ-5D ( = 0.60-0.71, < .01); and good correlation with the KOOS-QOL ( = 0.52-0.58, < .01). As expected, there were poor correlations with the MARS ( = 0.00-0.24, < .01) and SF-36 GH ( = 0.16-0.34, < .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments ( = 0.42-0.72, < .01), including the MARS ( = 0.42, < .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different.

CONCLUSION

The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction.