Back pain Outcomes using Longitudinal Data (BOLD): Lessons for LIRE - - PowerPoint PPT Presentation

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Back pain Outcomes using Longitudinal Data (BOLD): Lessons for LIRE - - PowerPoint PPT Presentation

Jan 05, 2023 344 likes •738 views

Back pain Outcomes using Longitudinal Data (BOLD): Lessons for LIRE (and Other Pragmatic Trials) Jeffrey (Jerry) Jarvik, M.D., M.P.H. Professor of Radiology and Neurological Surgery Adjunct Professor Health Services and Pharmacy Director,

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Back pain Outcomes using Longitudinal Data (BOLD): Lessons for LIRE (and Other Pragmatic Trials)

Jeffrey (Jerry) Jarvik, M.D., M.P.H.

Professor of Radiology and Neurological Surgery Adjunct Professor Health Services and Pharmacy Director, Comparative Effectiveness, Cost and Outcomes Research Center (CECORC) University of Washington

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Disclosures

  • Physiosonix (ultrasound company)

–Founder/stockholder

  • Healthhelp (utilization review)

–Consultant

  • Evidence-based Neuroradiology (Springer)

–Co-Editor

  • AHRQ: R01 HS019222-01
  • NIH 1UH2AT007766-01

Acknowledgements-BOLD

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Key People

UW

  • Jerry Jarvik, MD,MPH- PI
  • Katie James, PA-C, MPH-Proj

Dir

  • Bryan Comstock, MS- Biostats
  • Nick Anderson, PhD-

Biomedical Informatics

  • 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
  • Heidi Berthoud MPH- 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
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Inappropriate Imaging

  • 30-40% of imaging studies in the

U.S. may be inappropriate

Picano E. Sustainability of medial imaging. BMJ. 2004;328:578-580

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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

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Prevalence of Disc Degeneration in Normals

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%

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Disc Degeneration

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Back pain Outcomes using Longitudinal Data (BOLD)

  • CER for seniors with back pain
  • AHRQ funded- part of $1.1 billion

American Recovery and Reinvestment Act (ARRA)

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BOLD CHOICE (Clinical and Health Outcomes Initiative in CE)

  • Overall goal: establish registry to evaluate

effectiveness, safety, and cost-effectiveness of interventions for pts > 65 with back pain

  • Setting: HMO Research Network
  • Sites

– Kaiser Northern CA: Andy Avins – Henry Ford Health System Detroit: Dave Nerenz – Harvard Pilgrim/Vanguard Boston: Srdj Nedeljkovic

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BOLD CHOICE: 3 Aims

  • 1. Establish BOLD registry
  • 2. Conduct observational cohort

study of early imaging

  • 3. Conduct RCT of epidural steroid

injections plus local anesthetic (LA)

  • vs. LA alone
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BOLD Aim 1: Registry Measures

  • 1) Roland-Morris Questionnaire
  • 2) 0-10 pain NRS-avg pain past 7d
  • 3) pain interference with activity (BPI)
  • 4) patient expectation re recovery
  • 5) PHQ-4 Depression/Anxiety
  • 6) EQ-5D
  • 7) Brief fall screen
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BOLD Aim 2: Early Imaging Cohort

  • Observational cohort
  • Compare early to no early imaging in

elderly with new visit for LBP

  • Outcomes: Disability (RMDQ), pain,

subsequent resource utilization

  • Propensity score matching to control for

variables that affect receiving imaging

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BOLD Aim 2: Early Imaging Cohort

  • Observational cohort
  • Compare early to no early imaging in

elderly with new visit for LBP

  • Outcomes: Disability (RMDQ), pain,

subsequent resource utilization

  • Propensity score matching to control for

variables that affect receiving imaging

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Lumbar Imaging with Reporting of Epidemiology (LIRE) Proposed Study Flow

Primary Care Clinics With LBP Patients Randomize Clinics Macro with prevalence info Outcomes Assessment- Resource Utilization No macro with prevalence info Outcomes Assessment- Resource Utilization

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LIRE Primary Aim

  • To determine whether inserting age-

specific prevalence of imaging findings among asymptomatic subjects into lumbar spine imaging reports decreases back-related interventions (imaging, injections, surgeries, etc.) over the subsequent year

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GHC Test Template

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Intervention Text

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Stepped Wedge Design

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Stepped Wedge Design

  • A one-way cluster, randomized crossover

design

  • Temporally spaces the intervention
  • Assures that each participating clinic

eventually receives the intervention

  • Within site comparison controls for

between site differences (eg- CPT coding)

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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

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Site Characteristics

Site # Primary Care Clinics # PCPs # Patients # Back Pain Visits (2011) # L- spine Imaging exams Kaiser PNCA 17 1096 2,430,000 149,300 44790 Henry Ford 26 230 187,000 23,900 7170 Group Health 24 303 347,000 37,700 11310 Mayo Clinic 61 269 1,500,000 106,700 32010 Total 128 1,898 4,464,000 317,600 95,280

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LIRE Aims/Working Groups and Leaders

1. Refinement of benchmark text

Jerry Jarvik, MD MPH

2. Implementation of cluster randomization

Bryan Comstock, MS

3. Spine intervention intensity measure

Brian Bresnahan, PhD

4. Electronic data capture

Nick Anderson, PhD

5. IRB, Protocols, Subcontracts

Katie James, PA, MPH

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LIRE Aims/Working Groups and Leaders

1. Refinement of benchmark text

Jerry Jarvik, MD MPH

2. Implementation of cluster randomization

Bryan Comstock, MS

3. Spine intervention intensity measure

Brian Bresnahan, PhD

4. Electronic data capture

Nick Anderson, PhD

5. IRB, Protocols, Subcontracts

Katie James, PA, MPH

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LIRE Aim 3

  • Develop/validate a composite

measure of spine intervention intensity-a single metric of overall intensity of resource utilization for spine care

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Aim 3 Progress

  • Working with site programmers to

pull CPT data

  • Already established data pulls for 2

sites

  • Constructed density plots of CPT

–For QC checks –Compare site use of codes

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BOLD: CPT Code Frequencies By Site

Site 1 Site 2 Site 3

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BOLD: Density Plot of Radiology CPT Code Frequencies By Site for QC

  • Site 1

Site 2 Site 3

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BOLD: Density Plot of Surgery CPT Code Frequencies By Site

Site 1 Site 2 Site 3

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Aim 3 (cont.)

  • Converted CPT codes to RVUs as
  • ur primary metric of back-related

utilization

–Used total RVU (tech + pro) –Did not use geographic adjuster –Use 2012 values using CMS look-up files

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Converting CPTs to RVUs

  • Validate CPT conversion by

directly pulling RVUs from one site

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Example RVU Values

HCPCS DESCRIPTION TOTAL 2012 RVUs 72100 X-ray exam of lower spine 1.07 99214 Office/outpatient visit level 4 2.26 72131 CT lumbar spine w/o dye 6.27 72148 MRI lumbar spine w/o dye 11.31 63047 Laminectomy 32.89

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CPT Proportion of RVUs

0.00% 2.00% 4.00% 6.00% 8.00% 10.00% 12.00% 99214 99233 99223 99213 99285 72148 99215 G0202

Site 1

Office level IV Subsequent hospital care Initial hospital care Office level III ED visit MR Lspine Office level V Screening mammo dig

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Challenges

  • CPT counts seem to differ by site

–Step wedge design helps to address this since before-after comparison is within site –Using only back-related RVUs improves accuracy/reliability using algorithm developed by Martin et al at Dartmouth

  • Different pharmacy data systems (e.g.

not all sites have Rx filled data)

–Within-system comparisons will be valid

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Challenges

  • System differences will always be present

in large pragmatic trials

  • When do pragmatic trials become meta-

analysis of parallel trials?

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Key People to Thank

UW

  • Katie James, PA-C, MPH-Proj

Dir

  • Bryan Comstock, MS- Biostats
  • Nick Anderson, PhD-

Biomedical Informatics

  • 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
  • Heidi Berthoud. MPH- 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