DEGREE (if applicable)

Transcription

1 NAME: Jarvik, Jeffrey G. OMB No and (Rev. 10/15 Approved Through 10/31/2018) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. era COMMONS USER NAME (credential, e.g., agency login): jarvikj POSITION TITLE: Professor with Tenure of Radiology, Health Services and Neurological Surgery; Adjunct Professor of Pharmacy and Orthopedics & Sports Medicine EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) Completion Date MM/YYYY FIELD OF STUDY University of California, San Diego BA 12/1981 Biochem and Cell Biol University of California, San Diego MD 06/1987 Medicine Hospital of the University of Pennsylvania Residency 06/1992 Diagnostic Radiology Hospital of the University of Pennsylvania Fellowship 06/1993 Neuroradiology University of Washington MPH 06/1995 Health Services A. Personal Statement As the co-director of the Comparative Effectiveness, Cost and Outcomes Research Center (CECORC) at the University of Washington (UW), I have led or collaborated on multiple observational and randomized controlled trials (RCTs) of devices and procedures. Equally importantly, I have training in health services research and study design. I was a Robert Wood Johnson Clinical Scholar at UW, where I earned my Masters in Public Health. I have focused my research on diagnostic imaging and therapeutic interventions, especially as they relate to the evaluation of low back pain. I am the Principal Investigator (PI) of the Back pain Outcomes using Longitudinal Data- Extended Research (BOLDER) project, a continuation of the $10 million BOLD project funded by the Agency for Healthcare Research and Quality to investigate diagnostic and therapeutic interventions in seniors with back pain. BOLDER partners with large, integrated health systems- Kaiser Northern California, Henry Ford Health System in Detroit, and the Harvard Vanguard/Harvard Pilgrim Health System in Boston. I have extensive experience conducting observational studies and randomized trials of diagnostic and therapeutic interventions of back pain, both as a PI as well as a co-investigator. These projects include the Seattle Lumbar Imaging Project (SLIP), the Longitudinal Assessment of Imaging and Disability of the Back (LAIDBack), the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), and the Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) trial. In addition, I am the PI of the Lumbar Imaging with Reporting of Epidemiology (LIRE) project, part of the NIH Heath Care Systems Collaboratory. LIRE is a large, pragmatic, cluster RCT investigating an intervention to help both patients and clinicians better understand the results of imaging studies for patients with back pain. My over 20 years of experience in conducting RCTs in comparative effectiveness research as well as my recent experience leading a large, pragmatic, cluster RCT puts me in an excellent position discuss pragmatic trials and review lessons learned. a. Jarvik JG, Hollingworth W, Martin B, Gray DT, Emerson SS, Overman S, Robinson D, Staiger T, Wessbecher F, Sullivan SD, Kreuter W, Deyo RA. The Seattle Lumbar Imaging Project: A Randomized Controlled Trial of Rapid MR vs. Radiographs for Patients with Low Back Pain. JAMA; 289(21): , PMID:

2 b. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. Aug 6;361(6):569-79, PMID: c. Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Sullivan SD, Bauer Z, Bresnahan BW, Avins AL, Nedeljkovic SS, Nerenz DR, Standaert C, Kessler L, Akuthota V, Annaswamy T, Chen A, Diehn F, Firtch W, Gerges FJ, Gilligan C, Goldberg H, Kennedy DJ, Mandel S, Tyburski M, Sanders W, Sibell D, Smuck M, Wasan A, Won L, Jarvik JG. A Randomized Trial of Epidural Glucocorticoid Injections for Spinal Stenosis. New England Journal of Medicine, 371(1):11-21, PMID: d. Jarvik JG, Comstock BA, James KT, Avins AL, Bresnahan BW, Deyo RA, Luetmer PH, Friedly JL, Meier EN, Cherkin DC, Gold LS, Rundell SD, Halabi SS, Kallmes DF, Tan KW, Turner JA, Kessler LG, Lavallee DC, Stephens KA, Heagerty PJ. Lumbar Imaging With Reporting Of Epidemiology (LIRE)- Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials Nov;45(Pt B): doi: /j.cct Epub 2015 Oct 19. PMID: B. Positions and Honors Positions and Employment Transitional Internship, Mercy Hospital and Medical Center, San Diego, CA Residency- Radiology, Hospital of the University of Pennsylvania Assistant Instructor, Radiology, Hospital of the University of Pennsylvania Fellowship- Neuroradiology, Radiology, Hospital of the University of Pennsylvania Acting Instructor, Radiology, University of Washington Assistant Professor, Radiology, University of Washington Adjunct Assistant Professor, Dept. of Health Associate Professor, Dept. of Radiology, Dept. of Neurological Surgery and Adjunct Health Professor, Departments of Radiology and Neurological Surgery and Adjunct Health Section Chief, Neuroradiology, Department of Radiology, University of Washington Adjunct Professor, Orthopedics and Sports Medicine Medicare Coverage Advisory Committee(MEDCAC): Panel Member, 2006-Present Professor, Department of Health Services Electronic Data Methods (EDM) Forum Steering Committee (AcademyHealth/AHRQ) Professor with Tenure, Departments of Radiology, Neurological Surgery and Health Other Experience and Professional Memberships NHS R&D Health Technology Assessment Programme: Referee/Panelist Director, UW Comparative Effectiveness, Cost and Outcomes Research Center (CECORC) Medicare Coverage Advisory Committee (MCAC, now MEDCAC): Panel Member Assistant Editor: American Journal of Roentgenology Associate Editor: Radiology Advisory Board Member: Spine: An international journal for the study of the spine Association of University Radiologists-GE Radiology Research Academic Fellowship: Board of Review Editorial Board Member: Associate Editorial Board, Cochrane Back Review Group, Patient Centered Outcomes Research Institute: Scientific Reviewer (Cycles 1 and 3) American Society of Neuroradiology: Chair, Committee for Evidence Based Medicine Associate Member: Editorial Board, Spine: An international journal for the study of the spine NIH/NIAMS- Ad Hoc Grant Reviewer Medicare Coverage Advisory Committee (MCAC): Guest Panelist - Vertebroplasty and Kyphoplasty coverage decision Associate Editor: American Journal of Neuroradiology Radiology Alliance for Health Services Research, President ACRIN (ACR Imaging Network) Advisory Committee: Member

3 Honors 1981 Phi Beta Kappa: University of California, San Diego 1981 Magna Cum Laude: BA, University of California, San Diego Robert Wood Johnson Clinical Scholar, University of Washington GE-AUR Radiology Research Fellow (GERRAF) Award 2010 Hyman R. Senturia Lecturer, Washington University, St. Louis 2013 Ralph Heinz Memorial Lecture, Duke University, Durham, NC 2014 Edward H. Smith Annual Lecture, U Mass Medical School, Worcester, MA 2015 Achievement Award, Radiology Alliance for Health Services Research, AUR, 2015 C. Contribution to Science 1. I have focused my career on the promotion of effectiveness research in general and randomized controlled trials (RCTs) in particular for the field of radiology. My first R01 was an RCT, the Seattle Lumber Imaging Project (SLIP). As Principal Investigator (PI), I led a team comparing a new rapid MR of the lumbar spine with plain films as an initial imaging test for patients with low back pain. We demonstrated that the MR arm was equivalent to plain films with respect to health outcomes but much more expensive. In addition to being one of the first RCTs of a diagnostic imaging test for back pain, our study helped curtail the dissemination of an expensive technology that did not provide health benefits. We published our primary results in JAMA (see Section A). a. Jarvik JG. Fundamentals of Clinical Research for Radiologists: The Research Framework. American Journal of Roentgenology 176: , No PMCID available. b. Hollingworth W, Gray DT, Martin BI, Sullivan SD, Deyo RA, Jarvik JG. Rapid Magnetic Resonance Imaging for Diagnosis of Cancer-Related Low Back Pain. J. General Internal Med.;18(4):303-12, PMID: c. Jarvik JG, Maravilla KR, Haynor DR, Levitz M, Deyo RA. Rapid magnetic resonance imaging vs. plain radiology in patients with low back pain: initial results of a randomized study. Radiology 204: , PMID: d. Jarvik JG, Deyo RA, Koepsell TD. Screening magnetic resonance images versus plain films for low back pain: a randomized trial of effects on patient outcomes. Academic Radiology 3:S28-31, PMID: Funded by the Veteran s Administration Epidemiology Research and Information Center (ERIC) grant, I was the PI of a longitudinal cohort study examining the prevalence of imaging findings in patients without back pain and the incidence of back pain and new imaging findings. This project, the Longitudinal Assessment of Imaging and Disability of the Back (LAIDBack) Project, found a high prevalence of several imaging findings in patients without back pain, but also identified findings that were likely clinically more important. This work helped inform appropriateness guidelines for spine imaging. a. Deyo RA, Jarvik JG, Chou R. Low Back Pain in Primary Care. British Medical Journal 349:g4266, PMID: b. Jarvik JG and Deyo RA. Diagnostic Evaluation of Low Back Pain, With Emphasis on Imaging. Annals of Internal Medicine;137: , PMID: c. Jarvik JG, Hollingworth W, Heagerty P, Haynor, D, Boyko, E, Deyo RA. 3-Year Incidence of Low Back Pain in an Initially Asymptomatic Cohort: Clinical and Imaging Risk Factors. Spine. Jul; 30(13):1541-8, PMID: As PI of a subproject that was part of a Multi-disciplinary Clinical Research Center (MCRC) funded by the NIH/NIAMS, our group designed and performed a RCT comparing surgical to non-surgical treatment for carpal tunnel syndrome, with all patients undergoing MR of the median nerve to determine its ability to predict surgical benefit. We found that surgery was superior to non-surgical treatment and that MR had a modest ability to predict a favorable surgical outcome. a. Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. Sep 26;374(9695): , PMID: b. Jarvik JG, Comstock BA, Heagerty PJ, Haynor DR, Fulton-Kehoe D, Kliot M, Franklin GM. Magnetic Resonance Imaging vs. Electrodiagnostic Studies in Patients with Suspected Carpal Tunnel Syndrome: Predicting Symptoms, Function and Surgical Benefit at 1 year. J Neurosurg. Mar; 108(3): , PMID:

4 c. Jarvik JG, Yuen E, Haynor DR, Bradley CM, Fulton-Kehoe D, Smith-Weller T, Wu R, Kliot M, Kraft G, Wang L, Erlich V, Heagerty PJ, Franklin GM. MR Nerve Imaging in a Prospective Cohort of Patients with Suspected Carpal Tunnel Syndrome. Neurology; 58(11): , PMID: I served as a mentor for and collaborator with David Kallmes for the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), funded by NIAMS/NIH. INVEST was the first blinded RCT to compare vertebroplasty with a control intervention (paravertebral lidocaine injections) for the treatment of osteoporotic vertebral fractures. We demonstrated that there was no clinically meaningful difference in 4- week pain and functional outcomes between the two types of injections. The New England Journal of Medicine published our primary results in tandem with a study from Australia that had similar results. The results of this somewhat controversial work have influenced coverage and policy decisions on both the state and federal level nationally as well as internationally. a. Comstock BA, Sitlani C, Jarvik JG, Heagerty PJ, Turner J, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient reported outcomes through 1 year. Radiology, 269(1): , PMID: b. Kallmes DF, Comstock BA, Gray LA, Heagerty PJ, Hollingworth W, Turner JA, Stout L, Jarvik JG. Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial. AJNR Am J Neuroradiol. Jun;30(6):1203-5, Epub 2009 Feb 26. PMID: Recently I have focused on pragmatic studies, both randomized trials and observational studies. I was PI of a $10 million grant from AHRQ, the Back pain Outcomes using Longitudinal Data (BOLD) project, that included a large observational cohort of older adults with back pain as well as a RCT comparing epidural injections of glucocorticoids and lidocaine with lidocaine alone for spinal stenosis, the Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) trial, led by my mentee, Janna Friedly. We published these results in the New England Journal of Medicine. Using the BOLD cohort for an observational study, we found that older adults who underwent early imaging had no better outcomes than patients who did not get early imaging but did have markedly greater resource use. We published these results in JAMA. I am currently PI of on-going pragmatic trial that is part of the NIH Collaboratory and examines the ability of inserting benchmark prevalence data into spine imaging reports to decrease subsequent health resource use. The Lumbar Imaging with Reporting of Epidemiology (LIRE) study is a pragmatic, cluster randomized, cross-over RCT that uses a stepped-wedge design. We will complete data collection in a. Jarvik JG, Gold LS, Comstock BA, Heagerty PJ, Rundell SD, Turner JA, Avins AL, Bauer Z, Bresnahan BW, Friedly JL, James K, Kessler L, Nedeljkovic SS, Nerenz DR, Shi X, Sullivan SD, Chan L, Schwalb JM, Deyo RA. Association of early imaging for back pain with clinical outcomes in older adults. JAMA, Mar 17;313(11): , PMID: b. McCullough BJ, Johnson GR, Martin BI, Jarvik JG, Lumbar MR Imaging and Reporting Epidemiology: Do Epidemiological Data in Reports Affect Clinical Management? Radiology. Radiology, March, 262: , PMID: c. Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, Major Medical Complications, and Charges Associated with Surgery for Lumbar Spinal Stenosis in Older Adults. JAMA. Apr;303(13): , PMID: Complete List of Published Work in MyBibliography (139 citations): scending D. Research Support Ongoing Research Support UH3 AR (Jarvik-Principal Investigator(PI)) 01/01/ /31/ Calendar NIH/NIAMS A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE) The goal of this project is to determine the effectiveness of inserting epidemiological benchmarks into imaging reports at reducing subsequent tests and treatments. 1 R01 HS (Jarvik- PI) 09/30/ /29/2016 AHRQ NCE

5 Back Pain Outcomes using Longitudinal Data-Extension of Research (BOLDER) The goal of this project is to leverage existing infrastructure to collect long term follow-up to address important knowledge gaps among older adults with back pain. K12 HS (Sullivan-PI, Jarvik-Mentor) 8/1/2014-7/31/2019 AHRQ UW Patient-Centered Outcomes Research Institutional Mentored Career Development Program (K12) The goal of this program is to develop early career scientists in PCOR evidence development, evaluation and implementation. AT the completion of their training, Scholars will have cutting edge PCOR skills and grounding in implementation and dissemination science. (Lavallee-PI; Jarvik- Co-Investigator(CoI)) 9/15/2014-9/14/2017 Comparing Engagement Techniques for incorporating Patient Input in Research Prioritization The goal of this project is to inform researchers on how surveys, focus groups, and online methods compare for involving patients in research prioritization activities. R21 AR (Flum-PI; Jarvik-CoI) 7/1/2015-6/30/2017 NIH Understanding Non-Response in Spine Fusion Surgery The goal of this project is to identify and address factors which may improve spine fusion surgery outcomes. (Thompson-PI; Jarvik-CoI) 1/1/ /31/2019 Patient-Centered Research for Standards of Outcomes in Diagnostic Tests (PROD) The goal of this project is to develop guidelines that will identify which patient-centered outcomes are most important to include in evaluations of tests. Completed Research Support Within Past 3 Years UW AM01 (Sullivan-PI; Jarvik-CoI) 8/21/13-1/20/15 OHSU/AHRQ Flow-thru Pain Management Injection Therapies for Low-Back Pain The Pacific Northwest Evidence-based Practice Center (EPC) evaluated Pain Management Injection Therapies for Low Back Pain. This summary is focused on injection therapies used in the treatment of low-back pain. R01 HS (Jarvik-PI) 9/30/10-9/29/13 AHRQ Back pain Outcomes using Longitudinal Data (BOLD) This $10 million project built infrastructure to study low back pain in older adults. The goals were:1) construct a registry of older adults with back pain; 2) perform a RCT evaluating epidural steroid injections for patients with spinal stenosis; 3) perform an observational cohort study of early imaging in older adults with back pain. UH2 AT (Jarvik-PI) 9/30/ /31/2013 NIH/NCCAM A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE) The goal of this project is to determine the effectiveness of inserting epidemiological benchmarks into imaging reports at reducing subsequent tests and treatments. CE (Friedly-PI; Jarvik-CoI) 07/01/ /30/2016 Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis To build on the existing infrastructure of our AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial).