Validation of PROMIS Global-10 compared with legacy instruments in patients with shoulder instability.

BACKGROUND

Outcomes instruments are used to measure patients' subjective assessment of health status. The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 was developed to be a concise yet comprehensive instrument that provides physical and mental health scores and an estimated EuroQol-5 Dimension (EQ-5D) score.

METHODS

A total of 175 prospectively enrolled patients with shoulder instability completed the PROMIS Global-10, EQ-5D, American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Western Ontario Shoulder Instability Index. Spearman correlations between PROMIS scores and the legacy instruments were calculated. Bland-Altman analysis assessed agreement between estimated and actual EQ-5D scores. Floor and ceiling effects were recorded.

RESULTS

Correlation between actual and estimated EQ-5D was excellent-good (0.64/ < 0.0005), but Bland-Altman agreement revealed high variability for estimated EQ-5D scores (95% CI: -0.30 to +0.34). Correlation of PROMIS physical scores was excellent-good with ASES (0.69/ < 0.0005), good with SANE (0.43/<0.0005), and poor with WOSI (0.17/ = 0.13). Correlation between PROMIS mental scores and all legacy instruments was poor.

CONCLUSIONS

PROMIS Global-10 physical function scores show high correlation with ASES but poor correlation with other legacy instruments, suggesting it is an unreliable outcomes instrument in populations with shoulder instability. The PROMIS Global-10 cannot replace actual EQ-5D scores for cost-effectiveness assessment in this population.

LEVEL OF EVIDENCE

Level II, study of diagnostic test.