Slides - NIH Collaboratory

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
Jerry Jarvik, MD, MPH- PI
Katie James, PA-C, MPHProject Director
Bryan Comstock, MS- Biostats
Nick Anderson, PhDBioinformatics
Brian Bresnahan, PhD- Health
Economist
Patrick Heagerty, PhD- Biostat
Judy Turner, PhDPsychologist/Pain expert
•
•
•
•
•
•
•
•
•
Non-UW
Rick Deyo, MD, MPH-OHSU
Dan Cherkin, PhD-GHRI
Rene Hawkes- GHRI
Safwan Halabi, MD-HFHS
Dave Nerenz, PhD- HFHS
Dave Kallmes, MD- Mayo
Jyoti Pathak, PhD- Mayo
Patrick Luetmer, MD- Mayo
Andy Avins, MD, MPH-KPNC
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/
Year
Age
Prev
Range
MR
20-60
60-80
17-60
61-71
20-50
44%
93%
52%
80%
72-100%
35-70
91%
MR
MR
MR
Boden/
1990
Stadnik/
1998
Weishaupt/
1998
Jarvik /
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
incidental): Needless
Anxiety
LIRE
target
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)
p=0.01
5/71
OR*=0.29
37/166
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
Epi Info
No Macro
with Epi Info
Outcomes
Assessment
Outcomes
Assessment
LIRE Sites
• Kaiser Permanente
Northern California
– Andy Avins, MD
MPH
• Henry Ford Health
System
– Safwan Halabi, MD
• Group Health
Research
Institute/GHC
– Dan Cherkin, PhD
• Mayo Clinic Health
System
– Dave Kallmes, 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
Jerry Jarvik, MD,MPH- PI
Katie James, PA-C, MPHProject Director
Bryan Comstock, MS- Biostats
Nick Anderson, PhDBioinformatics
Brian Bresnahan, PhD- Health
Economist
Patrick Heagerty, PhD- Biostat
Judy Turner, PhDPsychologist/Pain expert
•
•
•
•
•
•
•
•
•
Non-UW
Rick Deyo, MD, MPH-OHSU
Dan Cherkin, PhD-GHRI
Rene Hawkes- GHRI
Safwan Halabi, MD-HFHS
Dave Nerenz, PhD- HFHS
Dave Kallmes, MD- Mayo
Jyoti Pathak, PhD- Mayo
Patrick Luetmer, MD- Mayo
Andy Avins, MD MPH-KPNC
Questions for Audience
1. Any experience with using RVUs as a metric
for patient reported outcomes?
2. We want to collect pain NRS from the
clinical record. What experience with
missing data do people have for clinically
collected variables, such as the BPI?
3. What experience do people have with
getting HMORN and non-HMORN sites to
cooperatively review protocols?
Health Care Systems
Research Collaboratory Grand Rounds:
Lumbar Imaging with Reporting of Epidemiology
Jeffrey (Jerry) Jarvik, M.D., M.P.H.
Bryan A. Comstock, MS
Brian Bresnahan, PhD
Nick Anderson, PhD
January 25, 2013
A Virtual Home for Knowledge about Pragmatic Clinical Trials using
Health Systems: www.theresearchcollaboratory.org