Low back pain, an Institute of Medicine priority condition for comparative effectiveness research, is of major public health importance. It is one of the most common reasons for physician visits and an important cause of functional limitation and disability. Imaging is frequently performed as part of the diagnostic evaluation and is an important contributor to the cost of back pain care, which totaled more than $86 billion in 2005. It is well known that, even without back pain, magnetic resonance (MR) imaging of the lumbar spine frequently reveals findings such as disc desiccation or bulging. Patients and their providers may attribute greater importance to these findings, which are often age-related, than they should, because they do not have an appropriate frame of reference in which to interpret the findings. These """"""""incidental"""""""" findings may initiate a cascade of events leading possibly even to surgery, without improving patient outcomes. We propose a pragmatic, randomized controlled trial (RCT) to determine the effectiveness of inserting epidemiological benchmarks into imaging reports at reducing subsequent tests and treatments. Our rationale is that providing a context for both physicians and patients to better interpret imaging findings may reduce concern about incidental findings and reduce unnecessary further diagnostic tests and treatments. Our intervention is simple, inexpensive and easy to deploy. We propose an efficient, novel, cluster randomized design referred to as a """"""""stepped wedge"""""""" design, permitting longitudinal comparisons while controlling for temporal trends. As called for in the Request for Applications, we plan to passively collect primary outcome measures of healthcare utilization both pre- and post-intervention, using robust electronic medical records at our participating sites. We hypothesize that for patients of primary care providers, inserting epidemiological benchmarks in lumbar spine imaging reports will reduce subsequent diagnostic and therapeutic interventions, including MR and CT, opioid prescriptions, spinal injections and surgery. The rationale is that the epidemiologic data may provide a context for both physicians and patients to better interpret imaging findings. The long-term public health significance is high. Not only may this simple, inexpensive intervention substantially reduce unnecessary and expensive care for back pain;thee intervention can easily be generalized to all diagnostic tests, and could become the dominant paradigm for communicating diagnostic information.

Public Health Relevance

The overall goal of our Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE) is to perform a large, pragmatic, randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention - of inserting epidemiological benchmarks into lumbar spine imaging reports - at reducing subsequent tests and treatments. The long-term public health significance is that our simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care not only for back pain, but also for a wide range of other conditions, since it could easily b applied to other diagnostic tests (e.g. other imaging tests, laboratory tests, genetic testing). If our study is positive, adding epidemiologic benchmarks to diagnostic test reporting could become the dominant paradigm for communicating all diagnostic information.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Cooperative Agreement Phase I (UH2)
Project #
1UH2AT007766-01
Application #
8465158
Study Section
Special Emphasis Panel (ZAT1-DB (33))
Program Officer
Khalsa, Partap Singh
Project Start
2012-09-30
Project End
2013-12-31
Budget Start
2012-09-30
Budget End
2013-12-31
Support Year
1
Fiscal Year
2012
Total Cost
$838,162
Indirect Cost
$200,207
Name
University of Washington
Department
Radiation-Diagnostic/Oncology
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Cook, Andrea J; Delong, Elizabeth; Murray, David M et al. (2016) Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials 13:504-12
Juul, Sandra E; Mayock, Dennis E; Comstock, Bryan A et al. (2015) Neuroprotective potential of erythropoietin in neonates; design of a randomized trial. Matern Health Neonatol Perinatol 1:27
Jarvik, Jeffrey G; Comstock, Bryan A; James, Kathryn T et al. (2015) Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials 45:157-63
Lee, Christoph I; Jarvik, Jeffrey G (2014) Patient-centered outcomes research in radiology: trends in funding and methodology. Acad Radiol 21:1156-61
Suri, Pradeep; Boyko, Edward J; Goldberg, Jack et al. (2014) Longitudinal associations between incident lumbar spine MRI findings and chronic low back pain or radicular symptoms: retrospective analysis of data from the longitudinal assessment of imaging and disability of the back (LAIDBACK). BMC Musculoskelet Disord 15:152
Richesson, Rachel L; Hammond, W Ed; Nahm, Meredith et al. (2013) Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory. J Am Med Inform Assoc 20:e226-31