Evaluating the Minimal Clinically Important Difference of EQ-5D-3L in Patients with Degenerative Lumbar Spinal Stenosis: A Swiss Prospective Multi-Center Cohort Study.

Abstract

STUDY DESIGN

Analysis of a prospective, multicenter cohort study

OBJECTIVE

The aim of our study was to compare thresholds of published minimal clinically important differences (MCID) for the 3-level EuroQol-5D health survey (EQ-5D-3L) summary index (range -0.53 to 1.00) with our anchor-based estimate and evaluate how useful these thresholds are in determining treatment success in patients undergoing surgery for degenerative lumbar spinal stenosis (DLSS).

SUMMARY OF BACKGROUND DATA

MCID values for EQ-5D-3L are specific to the underlying disease and only three studies have been published for DLSS patients reporting different values.

METHODS

Patients of the multi-center Lumbar Stenosis Outcome Study (LSOS) with confirmed DLSS undergoing first-time decompression or fusion surgery with 12-month follow-up were enrolled in this study. To calculate MCID we used the Spinal Stenosis Measure (SSM) satisfaction subscale as anchor.

RESULTS

For this study, 364 patients met the inclusion criteria; of these, 196 were very satisfied, 72 moderately satisfied, 43 somewhat satisfied and 53 unsatisfied 12-month after surgery. The MCID calculation estimated for EQ-5D-3L a value of 0.19. Compared to published MCID values (ranging from 0.30 to 0.52), our estimation is less restrictive.

CONCLUSIONS

In patients with LSS undergoing surgery, we estimated an MCID value for EQ-5D-3L summary index of 0.19 with help of the average change anchor-based method, which we find to be the most suitable method for assessing patient change scores.

LEVEL OF EVIDENCE

3.