Randomized Controlled Trial

. 2015 Nov;45(Pt B):157-163.

doi: 10.1016/j.cct.2015.10.003. Epub 2015 Oct 19.

Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial

Jeffrey G Jarvik¹, Bryan A Comstock², Kathryn T James³, Andrew L Avins⁴, Brian W Bresnahan³, Richard A Deyo⁵, Patrick H Luetmer⁶, Janna L Friedly⁷, Eric N Meier², Daniel C Cherkin⁸, Laura S Gold⁹, Sean D Rundell⁷, Safwan S Halabi¹⁰, David F Kallmes⁶, Katherine W Tan², Judith A Turner¹¹, Larry G Kessler¹², Danielle C Lavallee¹³, Kari A Stephens¹⁴, Patrick J Heagerty²

Affiliations

¹ 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.
² Department of Biostatistics, University of Washington, USA; Center for Biomedical Statistics, University of Washington, USA.
³ Department of Radiology, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
⁴ Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
⁵ 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.
⁶ Department of Radiology, Mayo Clinic, Rochester, MN, USA.
⁷ Department of Rehabilitation Medicine, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
⁸ Group Health Research Institute, Seattle, WA, USA.
⁹ Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
¹⁰ Department of Radiology, Henry Ford Hospital, Detroit, MI, USA.
¹¹ 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.
¹² Department of Health Services, University of Washington, USA.
¹³ Surgical Outcomes Research Center, University of Washington, Seattle, USA.
¹⁴ Department of Psychiatry and Behavioral Sciences, University of Washington, USA.

PMID: 26493088
PMCID: PMC4674321
DOI: 10.1016/j.cct.2015.10.003

Randomized Controlled Trial

Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial

Jeffrey G Jarvik et al. Contemp Clin Trials. 2015 Nov.

. 2015 Nov;45(Pt B):157-163.

doi: 10.1016/j.cct.2015.10.003. Epub 2015 Oct 19.

Authors

Affiliations

¹ 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.
² Department of Biostatistics, University of Washington, USA; Center for Biomedical Statistics, University of Washington, USA.
³ Department of Radiology, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
⁴ Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
⁵ 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.
⁶ Department of Radiology, Mayo Clinic, Rochester, MN, USA.
⁷ Department of Rehabilitation Medicine, University of Washington, USA; Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
⁸ Group Health Research Institute, Seattle, WA, USA.
⁹ Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA.
¹⁰ Department of Radiology, Henry Ford Hospital, Detroit, MI, USA.
¹¹ 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.
¹² Department of Health Services, University of Washington, USA.
¹³ Surgical Outcomes Research Center, University of Washington, Seattle, USA.
¹⁴ Department of Psychiatry and Behavioral Sciences, University of Washington, USA.

PMID: 26493088
PMCID: PMC4674321
DOI: 10.1016/j.cct.2015.10.003

Abstract

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/design: 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.

Discussion: 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.

Keywords: Back pain; Cluster randomized trial; Lumbar imaging; Pragmatic randomized trial; Spine imaging; Stepped wedge design.

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**Figure 2**
Pragmatic-Explanatory Continuum Indicator Summary (PRECIS)

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References

1. Jarvik JJ, Hollingworth W, Heagerty P, Haynor DR, Deyo RA. The Longitudinal Assessment of Imaging and Disability of the Back (LAIDBack) Study: baseline data. Spine. 2001;26(10):1158–1166. - PubMed
1. Jensen MC, Brant-Zawadzki MN, Obuchowski N, Modic MT, Malkasian D, Ross JS. Magnetic resonance imaging of the lumbar spine in people without back pain [see comments] N Engl J Med. 1994;331(2):69–73. - PubMed
1. Brinjikji W, Luetmer PH, Comstock B, Bresnahan BW, Chen LE, Deyo RA, Halabi S, Turner JA, Avins AL, James K, et al. Systematic Literature Review of Imaging Features of Spinal Degeneration in Asymptomatic Populations. AJNR Am J Neuroradiol. 2014 - PMC - PubMed
1. Jarvik JG, Gold LS, Comstock BA, Heagerty PJ, Rundell SD, Turner JA, Avins AL, Bauer Z, Bresnahan BW, Friedly JL, et al. Association of early imaging for back pain with clinical outcomes in older adults. JAMA. 2015;313(11):1143–1153. - PubMed
1. Graves JM, Fulton-Kehoe D, Jarvik JG, Franklin GM. Health care utilization and costs associated with adherence to clinical practice guidelines for early magnetic resonance imaging among workers with acute occupational low back pain. Health Serv Res. 2014;49(2):645–665. - PMC - PubMed

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Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial

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Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial

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