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/ p < 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/ p < 0.0005), good with SANE (0.43/ p<0.0005), and poor with WOSI (0.17/ p = 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.