Patient priority weighting of the roland morris disability questionnaire does not change results of the lumbar epidural steroid injections for spinal stenosis trial

Objective. To reevaluate whether outcomes for older adults receiving epidural steroid injections with or without corticosteroid improve after using patient-prioritized Roland-Morris Disability Questionnaire (RDQ) items. Summary of Background Data. Epidural corticosteroid injections are commonly used to treat lumbar spinal stenosis symptoms, despite limited evidence for their effectiveness in clinical trials. It is unclear whether evaluating patient-prioritized outcomes would alter results of a large clinical trial. Methods. Outcomes from the trial of lumbar epidural corticosteroid injections for spinal stenosis (LESS) trial were reanalyzed using RDQ, Sickness Impact Profile (SIP) weights assigned to the RDQ items, and patient-prioritized RDQ items. Differences between corticosteroidlidocaine versus lidocaine-alone groups and 95% confidence intervals (CI) were calculated using analysis of covariance with adjustment for baseline values of the RDQ and recruitment site. Results. At 6 weeks, both the corticosteroidlidocaine group and the lidocaine-alone group had improvement in the RDQ scores (RDQ, RDQ using SIP weights, patient-prioritized RDQ) as compared with baseline scores (corticosteroidlidocaine: -4.2 points, -4.1 points, 4.2; lidocaine-alone: -3.1 points, -2.9 points, and -3.1 points, respectively). However, there was no significant between-group difference in the RDQ or patientprioritized RDQ (average treatment effect -1.0 points, 95% CI -2.1 to 0.1, P=0.07; -1.0 points, 95% CI -2.0 to 0.1, P=0.08, respectively). Although the between-group difference of RDQ using SIP weights was statistically significant (average treatment effect -1.1, 95% CI -2.2 to -0.1, P=0.04), this was not clinically important. Conclusion. Results of the LESS trial did not substantively differ based on reanalysis of data using RDQ with SIP weights or patient-prioritized RDQ outcomes. This provides additional evidence that epidural injection of corticosteroidlidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone for older adults with lumbar spinal stenosis.