Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial.
BACKGROUND
Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions.


METHODS
We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging.


CONCLUSIONS
If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic.
Department of Radiology, University of Washington, USA; Department of Neurological Surgery, University of Washington, USA; Department of Health Services, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA. Electronic address: jarvikj@uw.edu.
Jeffrey G
JG
Jarvik
Department of Biostatistics, University of Washington, USA; Center for Biomedical Statistics, University of Washington, USA.
Bryan A
BA
Comstock
Department of Radiology, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
Kathryn T
KT
James
Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
Andrew L
AL
Avins
Department of Radiology, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
Brian W
BW
Bresnahan
Department of Family Medicine, Oregon Health Sciences University, Portland, OR, USA; Department of Internal Medicine, Oregon Health Sciences University, Portland, OR, USA; Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, OR, USA; Oregon Institute for Occupational Health Sciences, Oregon Health Sciences University, Portland, OR, USA.
Richard A
RA
Deyo
Department of Radiology, Mayo Clinic, Rochester, MN, USA.
Patrick H
PH
Luetmer
Department of Rehabilitation Medicine, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
Janna L
JL
Friedly
Department of Biostatistics, University of Washington, USA; Center for Biomedical Statistics, University of Washington, USA.
Eric N
EN
Meier
Group Health Research Institute, Seattle, WA, USA.
Daniel C
DC
Cherkin
Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
Laura S
LS
Gold
Department of Rehabilitation Medicine, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
Sean D
SD
Rundell
Department of Radiology, Henry Ford Hospital, Detroit, MI, USA.
Safwan S
SS
Halabi
Department of Radiology, Mayo Clinic, Rochester, MN, USA.
David F
DF
Kallmes
Department of Biostatistics, University of Washington, USA; Center for Biomedical Statistics, University of Washington, USA.
Katherine W
KW
Tan
Department of Psychiatry and Behavioral Sciences, University of Washington, USA; Department of Rehabilitation Medicine, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
Judith A
JA
Turner
Department of Health Services, University of Washington, USA.
Larry G
LG
Kessler
Surgical Outcomes Research Center, University of Washington, Seattle, USA.
Danielle C
DC
Lavallee
Department of Psychiatry and Behavioral Sciences, University of Washington, USA.
Kari A
KA
Stephens
Department of Biostatistics, University of Washington, USA; Center for Biomedical Statistics, University of Washington, USA.
Patrick J
PJ
Heagerty
D003430:Cross-Sectional Studies; D003952:Diagnostic Imaging / Q000379:methods* / Q000706:statistics & numerical data*; D005189:False Positive Reactions; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis* / Q000453:epidemiology* / Q000628:therapy; D008159:Lumbar Vertebrae / Q000503:physiopathology*; D015995:Prevalence; D012107:Research Design
Back pain; Cluster randomized trial; Lumbar imaging; Pragmatic randomized trial; Spine imaging; Stepped wedge design