MEDICAL DEVICE & DIAGNOSTICS OUTCOMES RESEARCH: ISSUES & GOOD RESEARCH PRACTICES (in progress )

Medical Device & Diagnostics Outcome Research: Issues & Good Research Practices (THE BOOK)

Co-editors

• Stacey Ackerman, MSE, PhD, Vice President, Covance Health Economics & Outcomes Services, San Diego, CA 92037-1468 USA 
  Email: stacey.ackerman@covance.com
• G. Scott Gazelle, MD, MPH, PhD, Director, Institute for Technology Assessment Director, Clinical Research Support Office Associate Professor of Radiology, Harvard Medical School Associate Professor, Health Policy & Management, Harvard School of Public Health, Boston, MA, USA
  Email:scott@mgh-ita.org

Medical Device & Diagnostics Methodological Issues & Good Outcomes Research Practices – Research Differentiation Section Working Group

Section Editor:
Jenifer Ehreth PhD, Director, Economic Affairs, Alexion International
Email: JeniferEhreth@wanadoo.fr

Section Authors:

• Steve E. Phurrough, MD MPA, Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Center for Medicare and Medicaid Services, Baltimore, MD 21244
  Email: Steve.Phurrough@cms.hhs.gov
• David Parker PhD, Vice President, Covance, Gaithersburg, MD
  Email: david.parker@covance.com
• Jonathan Cook PhD, Health Services Research Unit, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, UK
  Email: j.a.cook@abdn.ac.uk
• Marcel Dijkgraaf PhD, Senior Researcher, Academic Medical Center - University of Amsterdam,  Amsterdam, The Netherlands
  Email: m.g.dijkgraaf@amc.uva.nl

Medical Device & Diagnostics Methodological Issues & Good Outcomes Research Practices – Evidence Hierarchy Section Working Group

Section Editor:
Eric Faulkner MPH, Senior Director, RTI Health Solutions, Research Triangle Park, NC, USA
Email: efaulkner@rti.org

Section Authors:

• A. Mark Fendrick MD, Associate Professor, University of Michigan Medical Center,  Ann Arbor, MI, USA
  Email: amfen@umich.edu
• Clifford Goodman PhD, Vice President, The Lewin Group, Falls Church, VA, USA
  Email: clifford.goodman@lewin.com
• Bryan Luce MBA PhD, Senior Vice President, Science Policy, United BioSource Corporation Bethesda, MD, USA
  Email: byan.luce@unitedbiosource.com
• Gregory de Lissovoy PhD, MPH, Senior Research Scientist, UBC Health Care Analytics Group, Bethesda, MD
  Email: greg.delissovoy@unitedbiosource.com
• Helmut Wenzel PhD, Director, Appli Heath Economics – Integrated Healthcare Diagnostics, Roche Diagnostics, Mannheim, Germany
  Email: helmut.wenzel@roche.com
• Randel Richner BSN, MPH, NEOCURE
  E-Mail: richner@neocuregroup.com
• Rod Taylor, MSc, PhD, Associate Professor in Health Services Research, University of Exeter, Peninsula Medical School, Exeter, UK, E-Mail: rod.taylor@pms.ac.uk

Medical Device & Diagnostics Methodological Issues & Good Outcomes Research Practices - Clinical Outcomes Section Working Group

Section Editor:
David W. Polly, Jr, MD, Professor and Chief of Spine Surgery, Department of Orthopedic Surgery, University of Minnesota, Minneapolis,  Attending Surgeon Twin Cities Spine Center, Minneapolis, MN, USA
E-mail: pollydw@umn.edu

Section Authors:

• Rod Taylor MSc, PhD, Senior Reader in Public Health & Epidemiology & Director of MSC HTA Programme, Department of Public Health & Epidemiology, University of Birmingham, Edgbaston, UK, Birmingham, UK
  E-mail r.s.taylor@bham.ac.uk
• Michael Yaszemski MD, PhD, Professor of Orthopedic Surgery and Biomedical Engineering, Director, Tissue Engineering and Polymeric Biomaterials Laboratory, Chair, Division of Spine Surgery, Department of Orthopedic Surgery, Mayo Clinic College of Medicine,  Rochester, MN , USA
  E-Mail: Yaszemski.Michael@mayo.edu
• Jeffrey (Jerry) G. Jarvik, MD MPH, Professor of Radiology and Neurosurgery, Adjunct Professor Health Services Chief of Neuroradiology; Co-Director, Radiology Health Services Research Section Director, Comparative Effectiveness, Cost and Outcomes Research Center Box 357115, 1959 NE Pacific St., University of Washington Seattle, WA, 98195 phone (206) 598-3271; fax (206) 598-8475 Email: jarvikj@u.washington.edu
• Ruth Carlos, University of Michigan, Email: rcarlos@umich.edu
• John Eng, Johns Hopkins, Email: jeng@jhmi.edu
• Rita Peeters, Clinical Research Director, Medtronic, The Netherlands, Email: rita.peeters@medtronic.com

Medical Device & Diagnostics Methodological Issues & Good Outcomes Research Practices - Economic Outcomes Section Working Group

Chair:
Seema Sonnad, PhD, Associate Professor, Dept of Surgery, University of Pennsylvania, Philadelphia, PA USA
Email: seema.sonnad@uphs.upenn.edu

Section Authors:

• Uwe Siebert MD, Professor of Public Health, Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment UMIT –University of Health Sciences, Medical Informatics and Technology Eduard, Wallnoefer Zentrum I, 6060 Hall, Austria
  Email: uwe.siebert@umit.at
• Frank Papatheofanis MD, MPH, PhD, Associate Professor of Radiology and Economics, UCSD, San Diego, CA, USA 
  Email: fpapath@ucsd.edu

Medical Device & Diagnostics Methodological Issues & Good Outcomes Research Practices - Patient Reported Outcomes Section Working Group

Section Editor:
Erin Sullivan MPH, PhD, Director, Reimbursement & Outcomes Planning, Boston Scientific, Natick, MA USA
Email: erin.sullivan@bsci.com

Section Authors:

• Nancy Leidy PhD, President and CEO, The MEDTAP Institute at UBC, Bethesda, MD, USA
  Email: leidy@medtap.com
• Susan Mathias MPH, Vice President, Ovation Research Group, San Francisco, CA, USA
  Email: smathias@ovation.org
• Bruce Crawford MPH, MA, Director, Patient Reported Outcomes and Regulatory Consulting-Operations Di, Mapi Values Boston, MA, USA
  Email: bruce.crawford@mapivalues.com
• Sahar Dawisha, M.D., Medical Officer , Detail to CDRH/OIVD/ DCTD (Center for Devices and Radiological Health, Office of In Vitro Diagnostics, Division of Chemistry and Toxicology Devices), Rockville, MD, USA
  Email: sahar.dawisha@fda.hhs.gov

Facilitator

Marilyn Dix Smith RPh, PhD, Founding Executive Director, ISPOR, Lawrenceville, NJ USA
Email: mdsmith@ispor.org