Lumbar Imaging with Reporting of Epidemiology (LIRE) Jeffrey (Jerry) Jarvik, M.D., M.P.H. Director, Comparative Effectiveness, Cost and Outcomes Research Center Bryan A. Comstock, MS Operations Director, Center for Biomedical Statistics Brian Bresnahan, PhD Health Economist, Dept. of Radiology Nick Anderson, PhD Associate Director, Bioinformatic Core, ITHS
Key People UW Non-UW • Jerry Jarvik, MD, MPH- PI • Rick Deyo, MD, MPH-OHSU • Katie James, PA-C, MPH- • Dan Cherkin, PhD-GHRI Project Director • Rene Hawkes- GHRI • Bryan Comstock, MS- Biostats • Safwan Halabi, MD-HFHS • Nick Anderson, PhD- • Dave Nerenz, PhD- HFHS Bioinformatics • Dave Kallmes, MD- Mayo • Brian Bresnahan, PhD- Health • Jyoti Pathak, PhD- Mayo Economist • Patrick Luetmer, MD- Mayo • Patrick Heagerty, PhD- Biostat • Andy Avins, MD, MPH-KPNC • Judy Turner, PhD- Psychologist/Pain expert
Disclosures • Physiosonix (ultrasound company) – Founder/stockholder • Healthhelp (utilization review) – Consultant • Springer: Evidence-based Neuroradiology – Co-Editor • GE Healthcare: CER Advisory Board (past) – Consultant
Background and Rationale • Lumbar spine imaging frequently reveals incidental findings • These findings may have an adverse effect on: – Subsequent healthcare utilization – Patient health related quality of life
Prevalence of Disc Degeneration s LBP Modality Author/ Age Prev Year Range MR Boden/ 20-60 44% 1990 60-80 93% MR Stadnik/ 17-60 52% 1998 61-71 80% MR Weishaupt/ 20-50 72-100% 1998 MR Jarvik/ 35-70 91% 2001
Disc Degeneration in Asx
Conceptual Model TN: Reassurance Normal FN: False Reassurance Diagnostic Test TP: Anxiety Abnormal FP (including incidental): Needless Anxiety
Conceptual Model TN: Reassurance Normal FN: False Reassurance Diagnostic Test TP: Anxiety Abnormal FP (including LIRE incidental): Needless target Anxiety
Therapeutic Value of Diagnostic Test (Sox et al Ann Int Med 1981) • Pts with non-cardiac chest pain randomized to ECG+CPK vs. no tests • Pts getting tests showed less short term disability • Conclusion: testing can directly improve HRQOL via reassurance
Natural History of Low Back Pain and Radiculopathy- Modic et al: Radiology 2005: 235;297 • 246 subjects from primary care and ER w/in 2 wks sx – 150 LBP / 96 radiculopathy – Random allocation • imaging info (115) • no imaging info (131)
SF-36 General Health p=0.07 *p=0.001
Conclusion from Modic et al: Radiology 2005 • Effect of imaging likely mediated through anxiety produced by findings • Testing can directly worsen HRQOL
Dx Testing Consequences Sox et al TN: Reassurance (TVDT) Normal FN: False Reassurance Diagnostic Test TP: Anxiety Abnormal FP (including incidental): Needless Anxiety
Dx Testing Consequences Sox et al TN: Reassurance (TVDT) Normal FN: False Reassurance Diagnostic Test Modic et al TP: Anxiety Abnormal FP (including incidental): Needless Anxiety Probability of any lumbar spine finding >90%
Martin Roland, Maurits van Tulder Disc degeneration: Approximately 80%-100% of people without back pain have this, so finding may not be related to patient ’ s pain.
Lumbar Spine Macro The following findings are so common in people without low back pain that while we report their presence, they must be interpreted with caution and in the context of the clinical situation (Reference-Jarvik et al, Spine 2001): Finding (prevalence in pts without low back pain) Disc degeneration (91%) Disc signal Loss (83%) Disc height loss (56%) Disc bulge (64%) Disc protrusion (32%) Annular fissure (38%)
Support for Clinical Decision Support • Blackmore et al, JACR 2011 – Used evidence-based decision support tool – Showed sustained decrease of • 23% for lumbar spine MR for LBP • 23% for brain MRI for headache • 27% for sinus CT
LIRE Preliminary Data • Starting 12/2005, we made the macro available to insert into reports • Arbitrary for which patients the macro was incorporated • 2/~10 attendings used the macro • Not randomized, but arbitrary
Hypothesis • The benchmark information will influence subsequent management of primary care patients with LBP – Fewer subsequent imaging tests – Fewer referrals for minimally invasive pain treatment – Fewer referrals to surgery – Less narcotic use
Results: Subsequent Imaging Within 1 Yr (retrospective pilot) 12/166 1/71 p=0.14 OR*=0.22 * Adjusted for imaging severity
Results: Subsequent Narcotic Rx Within 1 Yr (retrospective pilot) 37/166 p=0.01 5/71 OR*=0.29
Possible Confounding by Severity • Arbitrary assignment of macro shouldn ’ t be related to severity • Controlled for age, race, insurance status, deg severity by imaging (>mod central or foraminal sten, extrusion)
LIRE, The RCT A pragmatic, cluster randomized trial
Proposed Study Flow Primary Care Clinics With LBP Patients Randomize Clinics Macro with No Macro Epi Info with Epi Info Outcomes Outcomes Assessment Assessment
LIRE Sites • Kaiser Permanente • Group Health Northern California Research Institute/GHC – Dan Cherkin, PhD – Andy Avins, MD MPH • Mayo Clinic Health • Henry Ford Health System – Dave Kallmes, MD System – Safwan Halabi, MD
4+1 Working Groups and Leaders 1. Refinement of benchmark text Jerry Jarvik 2. Implementation of cluster randomization Bryan Comstock, MS 3. Spine intervention intensity measure Brian Bresnahan 4. Electronic data capture Nick Anderson 5. Katie ’ s WG of 1: IRB, Protocols, Subcontr
LIRE, the RCT UH2 Aims/Working Groups • Aim 1/WG1: Refine the information to be included in the radiology report so that it is specific for imaging modality and patient age.
WG1- Refining the Message • Have identified the most recent literature • Abstracted prevalence data that is modality and age specific • On target to finish by ~March 2013
Aim/Working Group 2 Bryan Comstock- Biostatistician, Center for Biomedical Statistics, UW • Develop site-specific deployment methods for the stepped wedge, cluster randomization scheme.
Choice of Study Design
Stepped Wedge Design
Stepped Wedge Design • A one-way cluster, randomized crossover design • Temporally spaces the intervention • Assures that each participating clinic eventually receives the intervention
Advantages of SW Design • Controls for external temporal trends • Assures all sites receive intervention • Participation more palatable for interventions viewed as desirable
WG2- Progress • Sites have identified clinics (units of randomization) and number of primary care providers at each clinic. • Working with site health system programmers for placement and timing of benchmark info
Aim/Working Group 3 Brian Bresnahan, PhD- Health Economist • Develop/validate a composite measure of spine intervention intensity-a single metric of overall intensity of resource utilization for spine care
Aim/WG 3 (cont.) • Will convert CPT codes to RVUs as our primary metric of back-related utilization • Will validate CPT conversion by directly pulling RVUs from one site • Will explore RVU as proxy metric by examining correlation with disability, pain and HRQOL in BOLD registry
Aim/WG 3 Progress • Working with site programmers to pull CPT and RVU data • Already established data pulls for 2 sites • Have initial BOLD data for RVU-PRO analysis
Aim/Working Group 4 Nick Anderson, PhD- Bioinformatics Core, ITHS • Develop/validate electronic data methods and tools to capture outcomes of interest (subsequent diagnostic testing, opioid prescriptions, spinal injections, spine surgeries).
Aim 4 Progress • Already established data pulls from 2 sites for BOLD (Kaiser N. CA and Henry Ford) • Working with site programmers for direct EMR pulls • Considering using VDW at HMORN sites
Key Aspects of Pragmatic Trial • Broad inclusion criteria • Waiver of consent • Simple, easily implementable intervention • Passive collection of outcomes
Key Challenge- IRB Waiver of Consent • KPNC, HFHS and GHC/GHRI- – Initial conversations with IRBs reason for optimism for waiver • Mayo- greater challenge • UW- full committee review
Key Challenge- IRB Consolidation • KPNC likely willing to cede to another HMORN site (GHRI) • HFHS has apparently never ceded (there ’ s always a first time…) • Mayo- greater challenge • UW- has cooperative agreement with GHRI
Key People UW Non-UW • Jerry Jarvik, MD,MPH- PI • Rick Deyo, MD, MPH-OHSU • Katie James, PA-C, MPH- • Dan Cherkin, PhD-GHRI • Rene Hawkes- GHRI Project Director • Bryan Comstock, MS- Biostats • Safwan Halabi, MD-HFHS • Nick Anderson, PhD- • Dave Nerenz, PhD- HFHS Bioinformatics • Dave Kallmes, MD- Mayo • Brian Bresnahan, PhD- Health • Jyoti Pathak, PhD- Mayo Economist • Patrick Luetmer, MD- Mayo • Patrick Heagerty, PhD- Biostat • Andy Avins, MD MPH-KPNC • Judy Turner, PhD- Psychologist/Pain expert
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