Establishing minimum clinically important difference for patient-reported outcome measures in patients undergoing lateral lumbar interbody fusion.

Abstract

The minimum clinically important difference (MCID) has not been established in lateral lumbar interbody fusion (LLIF). Our study aims to establish MCID for patient-reported outcome measures (PROMs) of physical function and pain for LLIF through anchor-based and distribution-based approaches. Patients undergoing LLIF with preoperative and 6-month postoperative Oswestry Disability Index (ODI) scores were identified. PROMs of Patient-Reported Outcome Measurement Information System Physical Function (PROMIS-PF), 12-Item Short Form Physical Component Score (SF-12 PCS), Veterans RAND 12-Item Short Form Physical Component Score (VR-12 PCS), visual analog scale (VAS) back, and VAS leg were collected at preoperative and 6-month postoperative time points. Anchor-based MCID calculations were average change, minimal detectable change, change difference, receiver operating characteristic curve, and cross-sectional analysis using ODI as the anchor. Distribution-based calculations were standard error of measurement, reliable change index, effect size, and 0.5 ∗ ΔSD. Fifty patients were included. Anchor-based approaches MCID ranges were PROMIS-PF 1.1-9.6, SF-12 PCS 6.4-16.5, VR-12 PCS 5.9-12.9, VAS Back 1.4-4.6, and VAS Leg 1.3-4.3. The area under curve for receiver operating characteristics (ROC) analysis ranged from 0.63 to 0.71. Distribution-based MCID ranges were PROMIS-PF 1.4-4.5, SF-12 PCS 1.9-12.7, VR-12 PCS 2.0-6.6, VAS Back 0.4-1.4, and VAS Leg 0.5-2.0. MCID thresholds varied widely depending on the calculation method. The closest to (0,1) ROC approach was the most clinically appropriate MCID calculation. The corresponding MCID values for LLIF were PROMIS-PF at 7.8, SF-12 PCS at 6.4, VR-12 PCS at 9.3, VAS Back at 4.6, and VAS Leg at 4.3.