A validation defense of the PROMIS-10 in anterior cervical spine surgery

The Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) has not been validated for use in anterior cervical spine surgery (ACSS). The PROMIS-10 distinctly measures global physical health (GPH) and global mental health (GMH) domains, setting it apart from other patient-reported outcome measures (PROMs). This study aimed to validate the PROMIS-10 and identify minimum clinically important differences (MCIDs) in PROMIS-10 GPH and GMH scores in ACSS.

A prospectively collected quality registry was retrospectively reviewed. PROMIS-10 scores were obtained from patients undergoing ACSS at baseline, 3 months, and 12 months postoperatively. Other validated PROMs assessing quality of life (QOL) were also collected, including the Neck Disability Index (NDI), EuroQol 5-Dimension (EQ-5D) Index, EuroQol visual analog scale (EQ-VAS), and visual analog scales for neck (NP-VAS) and arm pain (AP-VAS). Pearson correlation coefficients assessed the relationship between the PROMIS-10 and other PROMs at baseline (r0) and 12 months (r12), as well as changes from baseline to 12 months (rΔ12). Cronbach's alpha was used to evaluate the internal consistency of PROMIS-10 GPH and GMH at the same time points (α0, α12, and αΔ12). MCIDs were calculated for GPH and GMH using 4 established anchor-based methods, with North American Spine Society patient satisfaction index scores as the anchor.

A total of 700 patients completed baseline and 12-month PROMIS-10 questionnaires. GPH demonstrated moderate to strong correlations with the EQ-5D (r0 = 0.68, r12 = 0.75, rΔ12 = 0.49), NDI (r0 = -0.66, r12 = -0.67, rΔ12 = -0.52), EQ-VAS (r0 = 0.58, r12 = 0.68, rΔ12 = 0.51), NP-VAS (r0 = -0.50, r12 = -0.57, rΔ12 = -0.46), and AP-VAS (r0 = -0.38, r12 = -0.47, rΔ12 = -0.37). GMH had moderate correlations with the EQ-5D (r0 = 0.58, r12 = 0.68, rΔ12 = 0.45), NDI (r0 = -0.49, r12 = -0.54, rΔ12 = -0.37), EQ-VAS (r0 = 0.55, r12 = 0.63, rΔ12 = 0.44), NP-VAS (r0 = -0.32, r12 = -0.45, rΔ12 = -0.31), and AP-VAS (r0 = -0.24, r12 = -0.36, rΔ12 = -0.21). Strong internal consistency reliability was observed in GPH (α0 = 0.71, α12 = 0.78, αΔ12 = 0.60) and GMH (α0 = 0.76, α12 = 0.87, αΔ12 = 0.74). Based on 12-month score changes, MCID thresholds ranged from 4.4 to 10.1 for GPH and 4.7 to 8.6 for GMH. The receiver operating characteristic (ROC) approach was deemed most appropriate for calculating MCIDs.

PROMIS-10 GPH and GMH have strong validity and reliability, with moderate to strong correlations to established PROMs and high internal consistency. Based on the ROC approach, MCID thresholds were 9.05 for GPH and 7.25 for GMH. These findings support the use of the PROMIS-10 in capturing QOL in patients undergoing ACSS.