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, MPH-

Project Director

• Bryan Comstock, MS- Biostats

• Nick Anderson, PhD-

Bioinformatics

• Brian Bresnahan, PhD- Health

Economist

• Patrick Heagerty, PhD- Biostat

• Judy Turner, PhD-

Psychologist/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

Range

Prev

MR Boden/ 1990

20-60 60-80

44% 93%

MR Stadnik/ 1998

17-60 61-71

52% 80%

MR Weishaupt/

1998

20-50 72-100%

MR Jarvik/ 2001

35-70 91%

Disc Degeneration in Asx

Conceptual Model

Diagnostic Test

Normal

TN: Reassurance

FN: False Reassurance

Abnormal

TP: Anxiety

FP (including incidental): Needless

Anxiety

Conceptual Model

Diagnostic Test

Normal

TN: Reassurance

FN: False Reassurance

Abnormal

TP: Anxiety

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

Diagnostic Test

Normal

TN: Reassurance (TVDT)

FN: False Reassurance

Abnormal

TP: Anxiety

FP (including incidental): Needless

Anxiety

Sox et al

Dx Testing Consequences

Diagnostic Test

Normal

TN: Reassurance (TVDT)

FN: False Reassurance

Abnormal

TP: Anxiety

FP (including incidental): Needless

Anxiety

Probability of any lumbar spine finding >90%

Sox et al

Modic et al

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)

p=0.14

OR*=0.22

1/71

12/166

* Adjusted for imaging severity

Results: Subsequent Narcotic Rx

Within 1 Yr (retrospective pilot)

p=0.01

OR*=0.29

5/71

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

Outcomes Assessment

No Macro with Epi Info

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, MPH-

Project Director

• Bryan Comstock, MS- Biostats

• Nick Anderson, PhD-

Bioinformatics

• Brian Bresnahan, PhD- Health

Economist

• Patrick Heagerty, PhD- Biostat

• Judy Turner, PhD-

Psychologist/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