Abstract

To validate the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 for patients who have lateral epicondylitis requiring surgical treatment in comparison with other gold standard patient-reported outcomes. Sixty-two patients with lateral epicondylitis of the elbow were prospectively enrolled before arthroscopic treatment. Inclusion criteria were patients 18years of age or older with a diagnosis of lateral epicondylitis. Each patient completed the PROMIS Global-10, EuroQol 5 Dimension (EQ-5D), American Shoulder and Elbow Surgeons (ASES) assessment form, Mayo Elbow Performance Score (MEPS), and Quick Disabilities of the Arm, Shoulder and Hand Score (QuickDASH). Spearman correlations were calculated. Bland-Altman agreement tests were conducted between estimated EQ-5D scores from the PROMIS-10 and actual EQ-5D scores. Correlation between the PROMIS-10 and the EQ-5D was excellent (0.72, P < .0001). Bland-Altman 95% limits of agreement for estimated EQ-5D scores ranged from 0.33 below to 0.21 above actual EQ-5D scores. Correlation of the PROMIS-10 physical score was good to excellent with MEPS (0.61, P < .0001) and QuickDASH scores (0.64, P < .0001) and good with the ASES (0.58, P < .0001). Correlation of the PROMIS mental scores was good with QuickDASH (0.50, P < .0001) and poor with ASES (0.26, P=.0492) and MEPS (0.37, P= .0038). The PROMIS Global-10 physical scores showed good to excellent correlation with gold standard patient-reported outcome instruments, demonstrating it is a reliable tool for outcome assessment in populations with lateral epicondylitis. Despite the excellent correlation with the EQ-5D, the 95% limit of agreement and high variability among the estimated EQ-5D scores derived from the PROMIS-10 suggests that the PROMIS-10 cannot be used as a substitute for actual EQ-5D scores to derive quality-adjusted life years for economic evaluations and cost-effectiveness research. Level II, development of diagnostic criteria on the basis of consecutive patients.

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