Veenstra DL, Piper M, Tunis SR et al. Improving the efficiency and relevance of evidence-based recommendations in the era of whole-genome sequencing: an EGAPP methods update. Genet Med. 2013;15(1):14-24. doi: 10.1038/gim.2012.106. PMID: 22955111
Ramsey SD, Tunis SR, Deverka PA, et al. Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trials (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes. Contemp Clin Trials. 2013;34(1):1-9. doi:10.1016/jcct.2012.09.003. PMID:23000081 {PubMed – in process) PMCID: PMC3525786
Tunis SR. Improving Comparative Effectiveness Research: New methodological standards focus on quality and relevance of research to patents. BMJ. 2012;345:e5160
Kass N, Faden R, Tunis SR. Addressing low-risk comparative effectiveness research in proposed changes to US Federal regulations governing research. JAMA. 2012;307(15):1589-1590. doi:10.1001/jama.2012.491. PMID:22511685
Campbell B, Patrick H; REGISTER GROUP – Tunis SR. International collaboration in the use of registries for new devices and procedures. Br J Surg. 2012;99(6):744-745. doi:10.1002/bjs.8791. PMID: 22508386
Mullins CD, Montgomery R, Tunis SR, et al. Recommendations for clinical trials of off-label drugs used to treat advanced-stage cancer. J Clin Oncol. 2012;30(6):661-666. doi:10.1200/JCO.2011.35.5198. PMID: 22253467
Schwartz S, Lauer M, Tunis SR, et al. Panel discussion 1. Clin Trials. 2012;9(1):13-21. doi:10.1177/1740774511433047. PMID: 22334464
Goddard KA, Knaus WA, Tunis SR, et al. Building the evidence base for decision making in cancer genomic medicine using comparative effectiveness research. Genet Med. 2012; 14(7):633-642. PMID:22516979
Tunis SR, Turkelson CM. Using Health Technology Assessment to Identify Gaps in Evidence and Inform Study Design for Comparative Effectiveness Research. J Clin Oncol. 2012;30(34):4256-4261. doi:10.1200/JCO2012.42.6338.
Basch E, SpencerMR, Tunis SR, et al. Recommendations for Incorporating Patient-Reported Outcomes Into Clinical Comparative Effectiveness Research in Adult Oncology. J Clin Oncol. 2012;30(34); 4249-4255. doi:10.1200/JCO.2012.42.5967. PMID:23071244
Witt CM, Aickin M, Tunis SR, et al. Effectiveness guidance document (EGD) for acupuncture research – a consensus document for conducting trials. BMC Complement Altern Med. 2012;12(1):148. doi 10.1189/1472-6882-12-148. PMID: 22953730.
Chalkidou K, Tunis SR, Whicher DM, Fowler R, Zwarenstein M. The Role for Pragmatic Randomized Controlled Trials (pRCTs) in Comparative Effectiveness Research. Clin Trials. 2012; 9(4): 436-446. doi:10.1177/1740774512450097. PMID: 22752634
Saag KG, Mohr PE, Esmail L, Karkare SU, Moloney RM, Tunis SR, et al. Improving the Efficiency and Effectiveness of Pragmatic Clinical Trials in Older Adults in the United States. Contemp Clin Trials. 2012;33(6) 1211-1216. doi: 10.1016/j.cct.2012.07.002
Witt CM, Manheimer E, Tunis SR, et al. How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain? PLoS ONE. 2012;7(2): e32399. doi:10.1371/journal.pone.0032399.
Gliklich RE, Tunis SR, Mohr PE, Messner DA, Moloney RM, Karkare SU, et al. Incorporating Stakeholder Perspectives in Developing a Translation Table Framework for Comparative Effectiveness Research. J Comp Eff Res. 2012; 1(3), 281-292. doi: 10.2217/cer.12.25.
Mohr PE. Looking at Comparative Effectiveness Research from Medicare’s Perspective. J Manag Care Pharm. 2012; 18(4-a): S5- S8. ISSN 1083-4087. PMID; 22578211
Brixner D, Oderda G, Mohr PE, Dubois R, Cannon E. Three Perspectives on the Impact of Comparative Effectiveness Research on Decision Making. J Manag Care Pharm. 2012; 18(4-a), s01-s17. ISSN 1083-4087.
Tunis SR, Messner DA, Mohr PE, Gliklich RE, and Dubois RW. A translation table for patient-centered comparative effectiveness research — Guidance to improve the value of research for clinical and health policy decision making. J Comp Eff Res. 2012;1(3), 259-262. ISSN 2042-6305. doi:10.2217/cer.12.22.
Messner, DA, Tunis, SR. Current and Future State of FDA-CMS Parallel Reviews. Clin Pharmacol Ther. 2012;91(3), 383-385. doi:10.1038/clpt.2011.350. PMID: 22343814
Deverka PA, Lavallee DM, Desai PJ, Esmail LC, Tunis SR, et al. Stakeholder Participation in Comparative Effectiveness Research: Defining a Framework for Effective Engagement. J Comp Eff Res. 2012;1(2), 181–194. PMID: 22707880 [PubMed] PMCID: PMC3371639.
Bekelman JE, Deye JA, Vikram B, Tunis SR, et al. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials. Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance. Int J Radiat Oncol Biol Phys. 2012;83(3) 782-790. doi:10.1016/j.ijrobp.2011.12.080. PMID: 22425219 [PubMed - indexed for MEDLINE] PMCID: PMC3361528
Esmail LC, Roth J, Deverka PA. Getting our priorities straight: a novel framework for stakeholder-informed prioritization of cancer genomics research. Genet Med. 2012; [Epub ahead of print]. doi:10.1039/gim.2012.103. PMID23037935
Deverka PA, Schuly SD, Ishibe N, et al. Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies. Gene Med. 2012;14(7):656-662. PMID:22481130
Thariani R, Deverka PA, Esmail LC, et al. Prioritization in comparative effectiveness research: the CANCERGEN Experience. Med Care. 2012;50(5):388-393. doi:10.1097/MLR.0b013e3182422a3b. PMID:22274803 [Pubmed – indexed for MEDLINE] PMCID: PMC3469160
Shermock KM, Tandon S, Srgen PJ, Lavallee DC, Clarke W, Streiff MB. Comparative performance of two methods that assess the quality of international normalized ratio measures. Clin Biochem. 2012;45(7-8):530-534. doi:10.1016/j.clinbiochem.2012.01.032. PMID: 22342920
Deverka PA, Lavallee DC, Desai PJ, et al. Facilitating CER in cancer genomics: evaluating stakeholder perceptions of the engagement process. J Comp Effect Res. 2012; 1(4):359-370. doi:10.2217/cer.12.36
Ramsey SD, Veenstra D, Tunis SR, Garrison L, Crowley JJ, Baker LH. How Comparative Effectiveness Research Can Help Advance ‘Personalized medicine’ In Cancer Treatment. Health Affairs 2011, 30 (12).doi: 10.377/hlthaff.2010.0637.
Bekelman JE, Deye JA, Vikram B, Tunis SR et al. (in press) Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials. Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance. International Journal of Radiation Oncology. 2011
Tiglao MR, Phurrough S, Mullins CD, Abernethy AP, Tunis SR. Development of effectiveness guidance documents (EGDs) as a stakeholder-driven process for informing study designs for comparative effectiveness research (CER). J Clin Oncol 29: 2011 (suppl: abstr e16617). Submission to ASCO.
Tunis S, Berenson R, Phurrough S, Mohr PE. Improving the Quality and Efficiency of the Medicare Program Through Coverage Policy. Urban Institute 2011: http://www.urban.org/url.cfm?ID=412392
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.
Mohr PE & Tunis SR. Access with Evidence Development: The US Experience (2010). Pharmacoeconomics. 28(2):153-162.
Mullins CD, Montgomery R, Tunis SR. Uncertainty in Assessing Value of Oncology Treatments (2010). The Oncologist. doi: 10.1634/theoncologist.2010-S1-58.
Mullins CD, Whicher D, Reese E, Tunis SR. 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 2010; 362:377-379.
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. Center for Medical Technology Policy. Baltimore, MD. September 2010
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.
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.
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. Prepared for the Medicare Payment Advisory Committee. Center for Medical Technology Policy. Baltimore, MD. May 31, 2009.
Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis SR, 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. Milbank Quarterly, 87: 585-606. doi: 10.1111/j. 1468-0009.209.00572x
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.
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.
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.
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.
Tunis SR and Chalkidou K. Coverage with Evidence Development: A Good Start, Much to Do. Int J Tech Assessment in Healthcare, 2007
Tunis SR and Pearson SD. Coverage Options for Promising Technologies: Medicare’s ‘coverage with evidence development’. Health Affairs 2006; 25(5):1218-1230.
Woolf SJ, Chan ECY, Harris R, Sheridan SL, Braddock CH, Kaplan RM, Krist A, O’Connor AM, Tunis SR. Promoting informed choice: transforming healthcare to dispense knowledge for decision making. Ann Internal Med 2005;143(4):293-300.
Majumdar SR, Ross-Degnan D, Farraye FA, Lee M, Kemp JA, LeCates RF, Henning JA, Tunis SR, Schrammel P. Controlled Trial of Interventions to Increase Testing and Treatment for Helicobacter pylori and Reduce Medication Use in Patients with Chronic Acid-Related Symptoms. Alimentary Pharmacology & Therapeutics 2005;21(8):1029-1039.
Tunis SR. A Clinical Research Strategy To Support Shared Decision Making. Health Affairs 2005;24:180-184.
McClellan MB, Tunis SR. Implantable cardioverter-defibrillators. N. Engl. J. Med. 2005;352:2025. [letter].
McClellan MB, Tunis SR. Medicare Coverage of ICDs. N. Engl. J. Med. 2005;352:222-224.
Tunis SR. Medicare coverage for technological innovations. N. Engl. J. Med. 2004;351:720. [letter].
Tunis SR. Why Medicare Has Not Established Criteria for Coverage Decisions. N. Engl. J. Med. 2004;350:2196-2198.
Tunis SR. Economic Analysis in Healthcare Decisions. American Journal of Managed Care 2004;10:301-304.
Carino T, Sheingold S, Tunis SR. Using clinical trials as a condition of coverage. Lessons from the National Emphysema Treatment Trial. Clinical Trials 2004;1:1-14.
Kessler L, Ramsey SD, Tunis SR, Sullivan S. Clinical use of medical devices in the “Bermuda Triangle” between CMS, FDA and NIH. Health Affairs (Millwood) 2004;23(1):200-207.
Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003:290:1624-1632.
Tunis SR, Kang JL. Improvements in Medicare coverage of new technology. Health Aff (Millwood). 2001;20:83-85.
Tunis SR, Sheinhait MA, Schmid C, Bishop BA, Ross SD. The efficacy of lansprozole compared to histamine-2 receptor antagonists in healing gastric ulcers: a meta-analysis. Clinical Therapeutics 1997:19(4):743-757.
Hayward RSA, Wilson, MC, Tunis SR, Guyatt GH. Practice guidelines: what are internists looking for? J Gen Intern Med 1996:11:176-178.
Weingarten S, Stone E, Hayward R, Tunis SR. The adoption of preventive care practice guidelines by primary care physicians: do actions match intentions? ? J Gen Intern Med 1995: 10(3):138-44.
Steinberg EP, Tunis SR, Shapiro D. Insurance Coverage for Experimental Technology. Health Affairs. 1995: Winter: 143-158.
Oxman AD, Sackett DL, Guyatt GH; for the Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature: I. How to get started, JAMA. 1993;270: 2093-2095. [S Tunis listed as a contributor to this article.]
Oxman AD, Cook DJ, Guyatt GH; for Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature. VI. How to Use an Overview. JAMA. 1994; 272: 1367-1371. [S Tunis listed as a contributor to this article.]
Levine M, Walter S, Lee H, Haines T, Holbrook A, Moyer V; for the Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature. IV. How to Use an Article About Harm. JAMA. 1994; 271: 1615-1619. [S Tunis listed as a contributor to this article.]
Jaeschke R, Guyatt G, Sackett DL; for the Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature. III. How to Use an Article About a Diagnostic Test. B. What are the Results and Will They Help Me in Caring for My Patients? JAMA. 1994;271: 703-707. [S Tunis listed as a contributor to this article.]
Jaeschke R, Guyatt G, Sackett DL; for the Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature: III. How to Use an Article About a Diagnostic Test. A. Are the Results of the Study Valid? JAMA. 1994;271: 389-391. [S Tunis listed as a contributor to this article.]
Guyatt GH, Sackett DL, Cook DJ; for the Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature: II. How to Use an Article About Therapy or Prevention. B. What Were the Results and Will They Help Me in Caring for My Patients? JAMA. 1994;271: 59-63. [S Tunis listed as a contributor to this article.]
Guyatt GH, Sackett DL, Cook, DJ; for the Evidence-Based Medicine Working Group. Users’ Guides to the Medical Literature: II. How to Use an Article About Therapy or Prevention. A. Are the Results of the Study Valid? JAMA. 1993; 270-2598-2601. [S Tunis listed as a contributor to this article.]
Rubin HR, Wu AW, Tunis SR. Warning – Inhaling Tabasco Products Can be Hazardous to your health. W Journal Med, 1994 [letter].
Wilson MC, Hayward RSA, Tunis SR, Bass EB, Guyatt G. Users’ guides to the medical literature: VIII. How to use clinical practice guidelines B. What are the recommendations and will they help you in caring for your patients. JAMA 1995: 274(20):1630-1632.
Hayward RSA, Wilson MC, Tunis SR, Bass EB, Guyatt G. Users’ guides to the medical literature: VIII. How to use clinical practice guidelines A. Are the recommendations valid. JAMA 1995:274:570-574.
Wilson MC, Tunis SR, Hayward RSA, Kern DE, Howard DM, Bass EB. Primary care physicians’ attitudes toward clinical practice guidelines. J Gen Intern Med. 1993: 6:114-118.
Tunis SR, Wilson MC, Hayward RSA, Rubin HR, Bass EB, Steinberg EP. Internists’ attitudes toward clinical practice guidelines. Ann Int Med. 1994;120:956-963.
Tunis SR, Hayward RSA, Wilson MC. Attitudes about guidelines. Ann Int Med 1994:121(9):725-6 [lettter].
Steinberg EP, Bass EB, Tunis SR. Interventional management of peripheral vascular disease: what did we learn in Maryland and where do we go from here? Radiology. 1993;186:639-642.
Hayward RSA, Wilson MC, Tunis SR, Bass EB, Haynes RB. More informative abstracts of articles describing clinical practice guidelines. Ann Intern Med. 1993;118:731-737.
Tunis SR, Bass EB, Klag MJ, Steinberg EP. Variation in Utilization of Procedures Used for Treatment of Peripheral Arterial Disease: A Look at Patient Characteristics. Arch Int Med. 1993;153:991-998.
Tunis SR, Bass EB, Steinberg EP. The use of angioplasty, bypass surgery, and amputation in the management of peripheral vascular disease. N. Engl. J. Med. 1991 [letter].
Tunis SR, Bass EB, Steinberg EP. The use of angioplasty, bypass surgery, and amputation in the management of peripheral vascular disease. N. Engl. J. Med. 1991;325:556-562.
Showstack J, Garnick D, Rosenfeld K, Luft H, Shaffarzick R, Tunis SR, Fowles J. Episode‑of‑care physician payment: a study of coronary artery bypass graft surgery. Inquiry. 1987;24:376‑383.
