Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial

Una E. Makris, Todd C. Edwards, Danielle C. Lavallee, Zoya Bauer, Bryan A. Comstock, Jeffrey G. Jarvik, Donald L. Patrick, Mahshid Lotfi, Janna L. Friedly

Research output: Contribution to journalArticle

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Abstract

STUDY DESIGN.: Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. OBJECTIVE.: To re-evaluate 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 LESS trial were re-analyzed 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). While 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 re-analysis 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.Level of Evidence: 2

Original languageEnglish (US)
JournalSpine
DOIs
StateAccepted/In press - Apr 19 2016

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Epidural Injections
Spinal Stenosis
Steroids
Lidocaine
Adrenal Cortex Hormones
Confidence Intervals
Weights and Measures
Surveys and Questionnaires
Sickness Impact Profile
Clinical Trials

ASJC Scopus subject areas

  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial. / Makris, Una E.; Edwards, Todd C.; Lavallee, Danielle C.; Bauer, Zoya; Comstock, Bryan A.; Jarvik, Jeffrey G.; Patrick, Donald L.; Lotfi, Mahshid; Friedly, Janna L.

In: Spine, 19.04.2016.

Research output: Contribution to journalArticle

Makris, Una E. ; Edwards, Todd C. ; Lavallee, Danielle C. ; Bauer, Zoya ; Comstock, Bryan A. ; Jarvik, Jeffrey G. ; Patrick, Donald L. ; Lotfi, Mahshid ; Friedly, Janna L. / Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial. In: Spine. 2016.
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title = "Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial",
abstract = "STUDY DESIGN.: Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. OBJECTIVE.: To re-evaluate 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 LESS trial were re-analyzed 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). While 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 re-analysis 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.Level of Evidence: 2",
author = "Makris, {Una E.} and Edwards, {Todd C.} and Lavallee, {Danielle C.} and Zoya Bauer and Comstock, {Bryan A.} and Jarvik, {Jeffrey G.} and Patrick, {Donald L.} and Mahshid Lotfi and Friedly, {Janna L.}",
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AU - Makris, Una E.

AU - Edwards, Todd C.

AU - Lavallee, Danielle C.

AU - Bauer, Zoya

AU - Comstock, Bryan A.

AU - Jarvik, Jeffrey G.

AU - Patrick, Donald L.

AU - Lotfi, Mahshid

AU - Friedly, Janna L.

PY - 2016/4/19

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N2 - STUDY DESIGN.: Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. OBJECTIVE.: To re-evaluate 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 LESS trial were re-analyzed 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). While 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 re-analysis 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.Level of Evidence: 2

AB - STUDY DESIGN.: Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. OBJECTIVE.: To re-evaluate 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 LESS trial were re-analyzed 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). While 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 re-analysis 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.Level of Evidence: 2

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