Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial.
METHODS
Secondary analysis of lumbar epidural steroid injections for spinal stenosis randomized controlled trial data.


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.


BACKGROUND
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 corticosteroid + lidocaine 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 corticosteroid + lidocaine 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 (corticosteroid + lidocaine: -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 patient-prioritized 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.


CONCLUSIONS
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 corticosteroid + lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone for older adults with lumbar spinal stenosis.


METHODS
2.
Department of Internal Medicine, Division of Rheumatic Diseases, UT Southwestern Medical Center and Dallas VAMC, Dallas, TX.
Una E
UE
Makris
Department of Health Services, Seattle, WA.
Todd C
TC
Edwards
Department of Surgery, Seattle, WA.
Danielle C
DC
Lavallee
Department of Radiology, Seattle, WA.|Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA.
Zoya
Z
Bauer
Department of Biostatistics, Seattle, WA.
Bryan A
BA
Comstock
Department of Health Services, Seattle, WA.|Department of Radiology, Seattle, WA.|Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA.
Jeffrey G
JG
Jarvik
Department of Health Services, Seattle, WA.
Donald L
DL
Patrick
Patient Advisor, CERTAIN Patient Voices, Seattle, WA.
Mahshid
M
Lotfi
Department of Rehabilitation Medicine, Seattle, WA.|Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA.
Janna L
JL
Friedly
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007268:Injections, Epidural; D008012:Lidocaine / Q000008:administration & dosage / Q000627:therapeutic use*; D017116:Low Back Pain / Q000188:drug therapy*; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D013130:Spinal Stenosis / Q000188:drug therapy*; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000779:Anesthetics, Local; D005938:Glucocorticoids; D008012:Lidocaine