Jerry Jarvik, MD, MPH, Principal Investigator, LIRE Trial
The NIH Collaboratory Demonstration Project, Lumbar Imaging with Reporting of Epidemiology (LIRE), has completed enrollment as of September 30, 2016. LIRE is a pragmatic, cluster-randomized trial testing the effectiveness of inserting epidemiologic benchmarks into lumbar spine imaging reports for reducing subsequent tests and treatments for back pain. Given the rate of age-related, incidental imaging findings in individuals without back pain, many follow-up interventions for back pain based on imaging results are unnecessary. With back pain as one of the most common reasons for doctor visits, this inexpensive intervention has the potential for a large public health impact. The trial will continue to follow subjects for up to 2 years after enrollment using data from the electronic health record, but no new subjects will be enrolled.
Congratulations to the LIRE study team on this important milestone!
In the systematic review, the researchers found that imaging findings of spine degeneration are present in high proportions of asymptomatic individuals, and these findings increase with age. Thus, many degenerative features found on spine imaging are likely part of normal aging. Given that advanced imaging is increasingly used in the evaluation of patients with lower back pain, knowing the prevalence of degenerative findings in asymptomatic individuals can help clinicians and patients when interpreting imaging findings.
The LIRE pragmatic trial is testing the insertion of these epidemiologic benchmarks into lumbar spine imaging reports with the goal of reducing subsequent tests and treatments, including MRI and CT, opioid prescriptions, spinal injections, or surgery.
A new article published in the journal Trials provides a look at how the Pragmatic–Explanatory Continuum Indicator Summary, or PRECIS, rating system can be applied to clinical trials designs in order to examine where a given study sits on the spectrum of explanatory versus pragmatic clinical trials.
The PRECIS-2 criteria are used to rate study designs as more or less “pragmatic” according to multiple domains that include participant eligibility, recruitment methods, setting, organization, analysis methods, primary outcomes, and more. In this context, “pragmatic” refers to trials that are designed to study a therapy or intervention in a “real world” setting similar or identical to the one in which the therapy will actually be used. Pragmatic trials stand in contrast to explanatory trials, which are typically designed to demonstrate the safety and efficacy of an intervention under highly controlled conditions and in carefully selected groups of participants, but which may also be difficult to generalize to larger or more varied populations.
PRECIS-2 Wheel. Kirsty Loudon et al. BMJ 2015;350:bmj.h2147. Copyright 2015 by British Medical Journal Publishing Group. Used by permission.
Clinical trials are almost never wholly “explanatory” or wholly “pragmatic.” Instead, many studies exist somewhere on a spectrum between these two categories. However, understanding how these different attributes apply to trials can help researchers design studies that are optimally fit for purpose, whether that purpose is to describe a biological mechanism (as in an explanatory trial) or to show how effective an intervention is when used across a broad population of patients (as in a pragmatic trial).
In their article in Trials, authors Karin Johnson, Gila Neta, and colleagues applied PRECIS-2 criteria to 5 pragmatic clinical trials (PCTs) being conducted through the NIH Collaboratory. Each trial was found to rate as “highly pragmatic” across the multiple PRECIS-2 domains, highlighting the tool’s potential usefulness in guiding decisions about study design, but also revealing a number of challenges in applying it and interpreting the results.
Study authors Johnson and Neta will be discussing their findings during the NIH Collaboratory’s Grand Rounds on Friday, January 22, 2016 (an archived version of the presentation will be available the following week).
Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016;17(1):32. doi: 10.1186/s13063-016-1158-y. PMID: 26772801. PMCID: PMC4715340.
You can read more about the NIH Collaboratory PCTs featured as part of this project at the following links:ABATE (Active Bathing to Eliminate Infection)
LIRE (A pragmatic trial of Lumbar Image Reporting with Epidemiology)
PPACT (Collaborative Care for Chronic Pain in Primary Care)
STOP-CRC (Strategies & Opportunities to Stop Colon Cancer in Priority Populations)
TIME (Time to Reduce Mortality in End-Stage Renal Disease)
Additional Resources
An introductory slide set on PCTs (by study author Karin Johnson) is available from the Living Textbook:
Introduction to Pragmatic Clinical Trials
The University of Colorado Denver - Anschutz Medical Campus publishes an electronic textbook on pragmatic trials:
Pragmatic Trials: A workshop Handbook
LIRE is studying the effect of inserting epidemiologic benchmarks for common imaging findings into lumbar spine imaging reports being delivered to primary care physicians. The primary goal is to measure whether the intervention reduces subsequent spine-related tests and treatments. All outcomes are captured passively through the electronic health record. The authors state that if successful, such a low-cost intervention could potentially be applied to diagnostic tests for other conditions. LIRE has a projected sample size of more than 160,000 patients across an estimated >2000 primary care physicians at 4 health systems. Enrollment will continue through 2016.
“LIRE is a pragmatic cluster randomized trial of a minimal-risk intervention that we believe can serve as a model for future pragmatic trials.”
(Jarvik JG, et al. Contemp Clin Trials 2015)
One of the NIH Collaboratory’s initial Demonstration Projects, the Lumbar Image Reporting with Epidemiology (LIRE) study, has begun randomization in early April. The LIRE trial is designed to test whether insertingadditional epidemiological information into the lumbar spine imaging reports of patients being treated for lower back pain can help both doctors and patients to better understand and interpret the reports. This in turn could help doctors avoid subjecting patients to unnecessary tests and procedures.
LIRE is a cluster randomized trial, which means that instead of randomizing individual patients, whole clinics (one at the Henry Ford Health System in Detroit; one at Group Health Cooperative in Seattle, with more to follow) are randomly assigned to provide either the experimental treatment or the control treatment to patients.
Cluster-randomized trials offer a number of advantages, including the avoidance of certain kinds of bias that can effect the outcome of a study, but they also raise special issues that can require careful consideration.
The principal investigator of the LIRE trial is Dr. Jeffrey Jarvik of the University of Washington. You can read more about the LIRE trial here.
