Evidence map›Paper›PMID 27105466›Full record

Trial reportSpine2017

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

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Spine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Epidural Steroid Injections for Low Back Pain: A Narrative Review.International journal of environmental research and public health · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Una E MakrisDepartment of Internal Medicine, Division of Rheumatic Diseases, UT Southwestern Medical Center and Dallas VAMC, Dallas, TX.
Todd C EdwardsDepartment of Health Services, Seattle, WA.
Danielle C LavalleeDepartment of Surgery, Seattle, WA.
Zoya BauerDepartment of Radiology, Seattle, WA.
Bryan A ComstockDepartment of Biostatistics, Seattle, WA.
Jeffrey G JarvikDepartment of Health Services, Seattle, WA.
Donald L PatrickDepartment of Health Services, Seattle, WA.
Mahshid LotfiPatient Advisor, CERTAIN Patient Voices, Seattle, WA.
Janna L FriedlyDepartment of Rehabilitation Medicine, Seattle, WA.
The University of Texas Southwestern Medical Center · USUniversity of Washington · USCancer Research And Biostatistics · USSeattle University · US

Funding

UT Southwestern Center for Translational Medicine (UL1/KL2/TL1)UL1TR001105 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2013 to 2017
$24.5M
Back pain Outcomes using Longitudinal Data (BOLD)R01HS019222 · AHRQ · UNIVERSITY OF WASHINGTON · PI JARVIK, JEFFREY G · 2010 to 2010
$9.9M
UT Southwestern Center of Patient-Centered Outcomes Research (PCOR)R24HS022418 · AHRQ · UT SOUTHWESTERN MEDICAL CENTER · PI HALM, ETHAN A · 2013 to 2017
$5.0M
UT Southwestern Center for Translational Medicine (UL1/KL2/TL1KL2TR001103 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2013 to 2017
$4.0M
AHRQ HHS R01 HS019222AHRQ HHS R24 HS022418NCATS NIH HHS KL2 TR001103NCATS NIH HHS UL1 TR001105
6 · The paper itself

Abstract

STUDY

designSecondary analysis of lumbar epidural steroid injections for spinal stenosis randomized controlled trial data.

objectiveTo 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.

methodsOutcomes 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.

resultsAt 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.

conclusionResults 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. LEVEL OF EVIDENCE: 2.

Indexed as

Adrenal Cortex HormonesAgedAged, 80 and overAnesthetics, LocalDisability EvaluationDouble-Blind MethodDrug Therapy, CombinationFemaleGlucocorticoidsHumansInjections, EpiduralLidocaineLow Back PainLumbar VertebraeMaleMiddle AgedAdrenal Cortex HormonesAnesthetics, LocalGlucocorticoidsLidocaine

Identifiers

PMID27105466
PMCPMC5071103
OpenAlexW2337468911

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.