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

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.

Wording wisely: Including prevalence data and evidence based clinical outcomes of spinal and musculoskeletal degeneration in radiology reports

“…There is the need to reduce the knee jerk response to prescribe invasive and expensive treatments solely on the basis of an imaging report that largely describes age related changes. There is an ongoing pragmatic randomized controlled study testing the hypothesis that insertion of epidemiological benchmarks such as prevalence data of asymptomatic individuals into lumbar spine imaging reports may reduce subsequent tests and treatment . Similar trials in a host of degenerative musculoskeletal conditions are urgently needed, for example in meniscus tears, rotator cuff tears, bursitis, labral tears to name a few.…”

The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging

“…We previously published our study protocol, and it is available in Supplement 2 . 13 We designed LIRE to be highly pragmatic (eAppendix 2 in Supplement 1 ) 14 to measure effects in routine care settings. We chose clinic-level cluster randomization because of the strong concern regarding contamination from intervention PCPs to control PCPs.…”

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core

“…15 LIRE randomized 100 primary care clinics within 4 health care systems using a stepped wedge design. 16 At period 0, or baseline, all clinics were receiving the standard imaging report (control intervention).…”