CMTP Staff Publications

2010

Coverage with Evidence Development (CED) in the Private Sector: Lessons in Design and Implementation. CMTP Policy Issue Brief. July 2010. Baltimore, MD: the Center for Medical Technology Policy.

Dreyer NA, Tunis SR, Berger M et al. Why observational studies should be among the tools used in comparative effectiveness research. Health Affairs. 2010; 29(10): 1818-1825.

English R, Lebovitz Y, Giffin R. Transforming clinical research in the United States: Challenges and opportunities. 2010. Washington, DC: The National Academies Press.

Hoffman A, Montgomery R, Aubry WM, Tunis SR. How best to engage patients, doctors, and other stakeholders In designing comparative effectiveness studies. Health Affairs. 2010; 29(10):1834-1841.

Mathis, RS (2010). Taming the beloved beast: How medical technology costs are destroying our health care system by Daniel Callahan, a book review. Journal of Health Politics, Policy and Law. In press.

Menon D, McCabe CJ, Stafinski T, et al. Principles of Design of Access with Evidence Development Approaches: A Consensus Statement from the Banff Summit (2010). Pharmacoeconomics. 28(2):109-11.

Mohr, PE & Tunis, SR. Access with Evidence Development: The US Experience (2010). Pharmacoeconomics. 28(2):153-162.

Mohr PE, Tunis SR, Sabharwal R, Montgomery R, Bergthold L. The Comparative Effectiveness Research Landscape in the United States and Its Relevance to the Medicare Program. 2010. Baltimore, MD: Center for Medical Technology Policy.

Mullins CD, Montgomery R, Tunis S. Uncertainty in Assessing Value of Oncology Treatments (2010). The Oncologist. In press, doi: 10.1634/theoncologist.2009-0163.

Mullins CD, Whicher D, Reese E, Tunis S. Generating evidence for CER using pragmatic randomized clinical trials. Pharmcoeconomics, 2010; 28(10):969-976.

Neumann, PJ & Tunis, SR. Medicare and Medical Technology – the Growing Demand for Relevant Outcomes (2010). The New England Journal of Medicine. In press, doi:10.1056/NEJMp0912062.

Sabharwal R, Giffin B, Rangarao S. “What is Comparative Effectiveness Research and What Will it Mean for Patients, Physicians, and Payors?” CMTP Policy Issue Brief. September 2010. Baltimore, MD: the Center for Medical Technology Policy.

Schulman KA, Tunis SR. A policy approach to the development of molecular diagnostic tests. Nature Biotechnology. 2010; 28(11):1-3.

Seidenfeld J, Aubry WM. How the Institute of Medicine (IOM) report on comparative effectiveness research will impact imaging research and practice. Imaging in Medicine. 2010; 2(3): 357-361.

Tunis SR, Benner J, et al. Response to comments on “Comparative Effectiveness Research”. Statistics in Medicine. 2010; 29(19):1999-1997.

Tunis SR, Pearson SD. US moves to improve health decisions. BMJ. 2010; 341:c3615. Doi:10.1136/bmj.c3615.

Woodcock J and Giffin B. CER: Who will do the studies? Health Affairs. 2010; 29(11):2075-2081.

2009

Chalkidou K, Tunis SR, Lopert R, Rochaix L, et al (2009). Comparative effectiveness research and evidence-based health policy: Experience from four countries. Milbank Quarterly. June; 87(2):339-67.

Chalkidou K, Whicher D, Kary W & Tunis SR (2009). Comparative effectiveness research priorities: Identifying critical gaps in evidence for clinical and health policy decision making. Int J Technol Assess Health Care. 25(3):241-248.

Garber AM & Tunis SR (2009). Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. May 7; 360(19):1925-7.

Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, & Schwartz JS (2009). Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. Aug 4;151(3):206-9. Epub 2009 Jun 30.

Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis SR, et al (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. CMAJ. May 12; 180(10):E47-57.

Tunis SR & Whicher D (2009). The National Oncologic PET Registry: Lessons learned for coverage with evidence development. Journal of the American College of Radiology. May 6(5):360-365.

Tunis SR & Seidenfeld J (2009). Evidence making: Developing tools and strategies for comparative effectiveness. Asian Hospital & Healthcare Management. 19:11-16.

Whicher D, Chalkidou K, Dhalla IA, Levin L & Tunis SR (2009). Comparative Effectiveness Research in Ontario, Canada: Producing relevant and timely information for health care decision makers. The Milbank Quarterly. 2009 87 in press.

2008

Douglas PS, Budoff M, Tunis SR, Woodard PK, Justman RA & Honigber R (2008). A New Era for Cardiovascular Imaging? Implications of the Revoked National Coverage Decision for CT Angiography on Future Imaging Reimbursement. JACC Cardiovascular Imaging. May 1(3):398-403.

O’Kane M, Corrigan J, Foote SM, Tunis SR, et al (2008). Crossroads in quality. Health Aff(Millwood). May-Jun: 27(3):749-58.

Tunis SR & Chalkidou K (2008). Coverage with evidence development: A very good beginning, but much to be done. Commentary to Hutton et al. J Clin Oncol. May 1;28(13):2083-4.

2007

Elshaug AG, Hiller JE, Tunis SR & Moss JR (2007). Challenges in Australian policy processes for disinvestment from existing, ineffective health care practices. International Journal of Technology Assessment in Health Care. Oct 23:432-435.

Lindsay MJ, Seigel BA, Tunis SR, et al (2007). The National Oncologic PET Registry: Expanded Medicare coverage for PET under coverage with evidence development. AJR Am J Roentgenol. April 188(4):11-0-13.

Lynn J, Baily MA, Bottrell M, Jennings B, et al (2007). The Ethics of Using Quality Improvement Methods in Health Care. Annals of Internal Medicine. May: 146(9): 666-673.

Tunis, SR (2007). Reflections on Science, Judgment, and Value in Evidence-Based Decision Making: A Conversation with David Eddy. Health Affairs. 26(4): w500-w515.

Tunis SR, Carino TV, Williams RD 2nd & Bach PB (2007). Federal initiatives to support rapid learning about new technologies. Health Aff(Millwood). March-April:26(2):w140-9.

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis SR (2008). Improving the reporting of pragmatic trials: An extension of the CONSORT statement. BMJ. Nov 2008;337:a2390.