Translational Research and Medical Education: Preparing Students to Interface Research and Patient Care Templeton Smith Class of 2012, WVU SoM tsmith65@mix.wvu.edu Scott Cottrell, Ed.D. scottrell@hsc.wvu.edu Terry Stratton, Ph.D. terry.stratton@uky.edu James Shumway, Ph.D. jshumway@hsc.wvu.edu 2010 SGEA Annual Meeting Small Group Discussion April 16, 2010 1:00-2:30 P.M. Objectives To better understand translational research (TR) and identify strategies to prepare medical students for their roles in translational research through: • Identifying and discussing elements of TR that medical students should be expected to understand and apply; • Identifying TR learning outcomes essential to complying with Liaison Committee on Medical Education (LCME) Standard ED-17-A; and • Discussing optimal methods of teaching and assessing TR-related learning outcomes. Outline I. Foundation of LCME Standard ED-17-A A. Historical context of TR B. Define TR II. LCME and Standard ED-17-A III. Identify and discuss TR learning objectives that fulfill the LCME Standard ED-17-A IV. Discuss how to teach and assess these learning objectives in a medical school curriculum V. Identify and discuss TR learning objectives beyond those applicable to LCME Standard ED-17-A Foundation of LCME Standard ED-17-A Historical Context Of 101 articles, published between 1979-83 in six major basic science journalsa promising novel therapeutic or preventive therapies:1 – 1:4 technologies resulted in a published randomized trial – < 1:10 entered routine clinical use within 20 years of the basic science index publication – By 2002, only ONE had had major clinical impact a. Science, Nature, Cell, Journal of Experimental Medicine, Journal of Clinical Investigation, and Journal of Biological Chemistry NIH Roadmap for Medical Research • Launched in September 2004 • Address “roadblocks” to research • Re-engineer how biomedical research is conducted by: – Overcoming “specific hurdles” – Closing defined gaps in knowledge – Catalyzing translational research http://nihroadmap.nih.gov/aboutroadmap.asp Association of American Medical Colleges (AAMC): Translational Research Translational research (2003): – Identifies clinically relevant questions raised in the interpretation of results from animal and molecular or cellular research; – Targets questions raised by epidemiologic studies or clinical trials; and – Addresses data from basic research, clinical or population studies resulting from advances in genetics and genomics.3 Translational Research Translational Research • While the goals of TR mirror those of traditional clinical research, the former focuses on expediting their clinical application4 by improving communication and reinforcing its bidirectionality among basic scientific research, clinical research, patient care, and healthcare policy.5, 6 • TR strives to foster new therapeutic insights by enabling clinical research and medical observations to elucidate scientific research and strategic approaches for their clinical implimentation.7 Translational Research Translational Research • Translational research “fosters the multidirectional and multidisciplinary integration of basic research, patientoriented research, and population-based research, with the long-term aim of improving the health of the public.” • Types of translational research – T1 research catalyzes translation between basic research and patient-oriented research. – T2 research facilitates the movement between patient-oriented research and population-based research. – T3 research promotes interaction between laboratory-based research and population-based research. Rubio et al.8 Translational Research Translational Research Figure 1 Model for translational research, as proposed by the Evaluation Committee of the Association for Clinical Research Training.8 • T1 research seeks to foster new or improved scientific understanding or patient care. • T2 research facilitates improved patient outcomes, optimization of medical practices, and improved community health. • T3 research promotes further scientific understanding of human health and disease. Teaching Medical Students TR Despite teaching the latest scientific advancements in the classroom, medical school curricula have struggled to prepare students for incorporating such new scientific discoveries into their future practices.9, 10, 11 Translational Research LCME Accrediting authority for medical education programs leading to the M.D. degree in the U.S. and Canada • Standard ED-17-A Translational Research LCME Standard ED-17-A • “The curriculum must introduce students to the basic principles of clinical and translational research, including how such research is conducted, evaluated, explained to patients, and applied to patient care. ” Translational Research LCME Standard ED-17-A • Medical educators must now modify their schools’ current curricula accordingly. • However, the standard does not specify any required criteria, and only minimal suggestions as to how to address this standard, thus leaving much to the discretion of medical educators. Results of Discussion on How to Satisfy LCME Standard ED-17-A Translational Research General Information • N=6 • 2 Ph.D., 1 Ed.D, 1 M.A., 1 M.H.A, 1 unknown • TR knowledge • • • • 1 very knowledgeable 2 somewhat knowledgeable 2 not knowledgeable 1 unknown • None have participated in TR studies or unknown. Translational Research Basic Principals of TR TR Learning Outcome E R I 1. Concisely define translational research. 2. Identify the relationship between translational research, translational medicine, clinical research, and evidence-based medicine. 3. Understand the purpose(s) of each translational research phase (T1, T2, T3). 4. Understand how translational research will influence medical practice. 5. Describe how translational research can enhance the development of improved medicinal therapies. 6. Understand the NIH Roadmap. 7. Identify social and economic trends that contributed to the development of translational research as a research discipline. 8. Identify which medical disciplines may most easily assimilate into a framework of translational research. 9. Understand the relationship between translational research and the prevention of disease. 10. Examine the relationship between translational research and public health. 11. Identify classic examples of translational research and their medical consequences. 5 Please do not publish results without permission of T. Smith (templeton.smith.iii@gmail.com). 1 6 4 4 2 1 4 2 2 2 2 5 1 5 1 4 2 3 3 3 3 E – essential R – relevant I – irrelevant “Know how such research is conducted Translational Research …” TR Learning Outcome E R I 1. Identify ethical issues specific to translational research and their implications. 2. Understand how translational research is funded. 3. Understand the benefits of interdisciplinary collaboration between basic, clinical and community-based research. 4. Understand the methodology of each translational research phase (T1, T2, T3). 5. Utilize translational research resources and literature to help identify potential translational research studies. 6. Derive clinically relevant questions aligned with basic and community-based research findings. 7. Propose an appropriate translational research study design to address a medical question. 8. Participate in an existing translational research study as a graduation requirement for the M.D. degree. 9. Conduct an original translational research project as a graduation requirement for the M.D. degree. 6 1 3 2 2 3 1 2 4 2 3 5 1 2 3 1 2 2 2 2 4 Please do not publish results without permission of T. Smith (templeton.smith.iii@gmail.com). 1 E – essential R – relevant I – irrelevant “Know how Translational such research is … Research evaluated … ” E R I TR Learning Outcome 1. Assess the strengths and limitations of study designs of translational 4 2 research studies. 4 1 2. Interpret ethical issues specific to translational research. 3. Propose strategies to identify health issues and disparities in a 3 3 community. 4. Interpret how a translational research study may influence patient care 5 1 and/or healthcare policy. Please do not publish results without permission of T. Smith (templeton.smith.iii@gmail.com). E – essential R – relevant I – irrelevant “Know how such research is …explained to patients, and applied to patient care.” Translational Research TR Learning Outcome E R I 1. Summarize evidence from the literature on a clinical problem that informs patient care decisions. 2. Synthesize and articulate conclusions of translational research to a research or medical colleague using an appropriate lexicon. 3. Synthesize and articulate conclusions of translational research to a patient or patient proxy using an appropriate lexicon. 4. Assess a patient’s understanding of one’s explanations of translational research conclusions. 5. Present results of translational research to research or medical colleagues using appropriate visual aids. 6. Incorporate translational research findings into patient care decisions. 7. Identify how clinical observations may precipitate basic, clinical, or community-based research. Please do not publish results without permission of T. Smith (templeton.smith.iii@gmail.com). 4 2 3 3 4 1 5 1 1 5 4 2 4 1 E – essential R – relevant I – irrelevant Translational Research Comments • “Communicate (2, 3, 4); Knowledge (1); Skill/Behavior (5, 6)” What methods can validly assess Translational Research specific TR knowledge and skills? • Simulations or OSCEs with secretly expert patients (M.D., R.N., etc.), who can evaluate the encounter and the student’s technique, unbeknownst to the student. • Have students critique grants and classify types of TR. • Have students suggest appropriate tests (PCR, FISH, etc.) to solve simulated clinical problems and narrow a differential diagnosis. • Have students reflect on potential opportunities for TR in their patient portfolios. • Utilize journal clubs to teach TR. • Integrate TR studies into lecture. • Have students identify health disparities in the community. References Translational Research 1. Contopoulos-Ioannidis D, Ntzani E, Ioannidis J. Translation of highly promising basic science research into clinical applications. Am J Med. 2003;114:477-84. 2. National Institutes of Health. NIH Roadmap: Accelerating Medical Discovery to Improve Health <http://nihroadmap.nih.gov/aboutroadmap.asp>. Accessed 14 Oct. 2009. 3. Association of American Medical Colleges. Information technology enabling clinical research. Washington, D.C.: Association of American Medical Colleges; 2003. 4. Littman BH, Di Mario L, Plebani M. What’s next in translational medicine? Clin Scien. 2007;112:217-27. 5. Kleinman MS, Mold JW. Defining the Components of the Research Pipeline. Clin and Transl Sci. 2009;2:312-14. 6. Crist TB, Schafer AI, Walsh RA. Translating basic discoveries into better health care: the APM’s recommendations for improving translational research. Am J Med. 2004;116:431-4. 7. Cosmatos D, Chow S-C (eds). Translational Medicine: Strategies and Statistical Methods. New York: CRC Press, 2009. 8. Rubio DM, Schoenbaum EE, Lee LS, Schteingart DE, Marantz PR, Anderson KE, Platt LD, Baez A, Esposito K. Defining translational research: implications for training. Acad Med. 2010;85:407-5. 9. Report IV – Contemporary issues in medicine: basic science and clinical research. AAMC Medical School Objectives Project. 2001. 10. NIH Roadmap for Medical Research. <http://nihroadmap.nih.gov/overview.asp>. Accessed October 14, 2009. 11. Westfall JM, Mold J, Fagnan L. Practice-based research – “Blue Highways” on the NIH roadmap. JAMA. 2007;297:403-6. Thank You!