Lumbar Imaging with Reporting of Epidemiology (LIRE)

Transcription

1 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

2 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

3 Disclosures Physiosonix (ultrasound company) Founder/stockholder Healthhelp (utilization review) Consultant Springer: Evidence-based Neuroradiology Co-Editor GE Healthcare: CER Advisory Board (past) Consultant

4 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

5 Prevalence of Disc Degeneration s LBP Modality Author/ Year MR MR MR MR Boden/ 1990 Stadnik/ 1998 Weishaupt/ 1998 Jarvik/ 2001 Age Range Prev % 93% % % % %

6 Disc Degeneration in Asx

7 Conceptual Model Diagnostic Test Normal Abnormal TN: Reassurance FN: False Reassurance TP: Anxiety FP (including incidental): Needless Anxiety

8 Conceptual Model Diagnostic Test Normal Abnormal TN: Reassurance FN: False Reassurance TP: Anxiety FP (including incidental): Needless Anxiety LIRE target

9 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

10 Natural History of Low Back Pain and Radiculopathy- Modic et al: Radiology 2005: 235; subjects from primary care and ER w/in 2 wks sx 150 LBP / 96 radiculopathy Random allocation imaging info (115) no imaging info (131)

11 SF-36 General Health p=0.07 *p=0.001

12 Conclusion from Modic et al: Radiology 2005 Effect of imaging likely mediated through anxiety produced by findings Testing can directly worsen HRQOL

13 Dx Testing Consequences Diagnostic Test Normal Abnormal TN: Reassurance (TVDT) FN: False Reassurance TP: Anxiety FP (including incidental): Needless Anxiety Sox et al

14 Dx Testing Consequences Diagnostic Test Normal Abnormal TN: Reassurance (TVDT) FN: False Reassurance TP: Anxiety Sox et al FP (including incidental): Needless Anxiety Probability of any lumbar spine finding >90% Modic et al

15 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.

16 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%)

17 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

18 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

19 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

20 Results: Subsequent Imaging Within 1 Yr (retrospective pilot) 12/166 1/71 p=0.14 OR*=0.22 * Adjusted for imaging severity

21 Results: Subsequent Narcotic Rx Within 1 Yr (retrospective pilot) 5/71 p= /166 OR*=0.29

22 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)

23 LIRE, The RCT A pragmatic, cluster randomized trial

24 Proposed Study Flow Primary Care Clinics With LBP Patients Randomize Clinics Macro with Epi Info No Macro with Epi Info Outcomes Assessment Outcomes Assessment

25 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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27 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

28 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.

29 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

30 Aim/Working Group 2 Bryan Comstock- Biostatistician, Center for Biomedical Statistics, UW Develop site-specific deployment methods for the stepped wedge, cluster randomization scheme.

31 Choice of Study Design

32 Stepped Wedge Design

33 Stepped Wedge Design A one-way cluster, randomized crossover design Temporally spaces the intervention Assures that each participating clinic eventually receives the intervention

34 Advantages of SW Design Controls for external temporal trends Assures all sites receive intervention Participation more palatable for interventions viewed as desirable

35 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

36 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

37 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

38 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

39 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).

40 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

41 Key Aspects of Pragmatic Trial Broad inclusion criteria Waiver of consent Simple, easily implementable intervention Passive collection of outcomes

42 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

43 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

44 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

45 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?

46 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: