128 S.B. Goldin

Funding

Most surgical education research is conducted without the benefit of research grants. There are, however, several organizations that do have funding available for research. This includes the ASE with their Center for Excellence in Surgical Education,Research andTraining (CESERT) program. Information for this program can be found at www.surgicaleducation.com. Other sources include the National Board of Medical Examiners, the Agency for Health Care Research and Quality, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Surgeons.

Conclusions

Educational research is grounded in the same fundamentals as empirical benchtop research. Likewise, the principles of EBM clearly apply to educational research, with the goal of enhancing teaching and learning by using teaching methods backed up by evidence of their usefulness. Clinicians should consider becoming involved with educational research for a variety of reasons that all can contribute to career advancement. Educational research can clearly be done even with increased clinical demands that are becoming the norm. Academicians should study what they know and do daily, which includes teaching.Most academic surgeons are involved with daily educational activities, and a small amount of innovation may be what is required to take their reflections upon their daily activities to the next level. Conducting and then implementing the results of educational research can be immensely satisfying to the educator. In addition, it can promote and improve the academic surgical profession, which encompasses all three aspects of the academic mission including patient care,research,and education.Educational research projects provide evidence that improve teaching and ultimately lead to better patient care. Proper implementation of an educational research project with collaboration of experts

in study design, database management, and statistics among others can lead to a successful academic career, and hopefully allow one to turn their tricycle into a three-wheeled high power all-terrain vehicle.

Acknowledgment I would like to thank Monika Wahi for her critical reading and contributions to this manuscript.

Selected Readings

Trochim WM, Donnelly JP. Research Methods Knowledge Base. 3rd ed. Atomic Dog Publishing. http://www.socialresearchmethods.net/kb/. 2007.

Fink A. The Survey Kit. 2nd ed. Thousand Oaks: Sage Publications; 2003.

Gall MD, Gall JP, Borg WR. Educational Research: An Introduction. 8th ed. Columbus: Allyn and Bacon; 2006.

Capella J, Kasten SJ, Steinemann S, Torbeck L. Guide for Research in Surgical Education. Woodbury: Cine-Med; 2010.

Centre for Evidence Based Medicine. http://www.cebm.net. Accessed January 2011.

132 D.P. Foley

administrators would rather see the surgeon generating clini- cal revenue by performing surgery instead of doing experi- ments in the laboratory. At the divisional level, one may be frowned upon when asking for financial divisional support to develop a research program while the partners shoulder his or her clinical work load. In many areas of surgery, “medical competitors” perform similar types of research. However, medical competitors do not suffer the same limitations in developing their research programs, as do surgeons.

Another challenge facing surgeons is that sustainable research requires funding, and sources of funding have decreased over recent years. Success rates for attaining funding from the National Institutes of Health have also decreased. Based on data from the NIH the success rate of R01equivalent grants has decreased from 31% in 1998 to 22% in

2010. The average age of receiving a R01 grant increased from 39 in 1990 to 43 in 2007. In addition, basic science tech- nology has become significantly more complex in recent years, making it more challenging for the surgical scientist to stay up-to-date while maintaining a clinical surgical practice.

Fortunately, there has been an influx of other research opportunities for surgeons that are more closely related to patient disease states and outcomes. One of those areas that continue to evolve is translational research. Translational research involves identifying and defining a clinical problem at the bedside, developing a hypothesis that can be tested in the laboratory setting,and then completing the loop by bring- ing those research findings back to the clinical setting for testing and improvement in clinical care. It focuses on directly linking laboratory discoveries and clinical care. Some exam- ples include: (1) the evaluation of biopsies from donated human livers with microarrays to determine if a specific expression profile predicts allograft failure or other compli- cations after liver transplantation; (2) the identification of diagnostic biomarkers for human hepatocellular carcinoma by using mass spectroscopy; or (3) the determination of whether doxycycline administration reduces protease expres- sion in human aortic aneurysm tissue.

Chapter 9.  Translational Research and New Approaches 133

In 2005, the National Cancer Institute (NCI) established the Translational Research Working Group (TRWG) to con- duct a discussion with a broader cancer research community and develop recommendations about how the NCI can best organize its investment to further translational research. The group defined translational research as research that “trans- forms scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce can- cer incidence, morbidity, and mortality.” Those participating in translational research will form the bridge between the “bench and the bedside.” For instance, the discovery of novel gene targets, a promising molecule, or a candidate protein biomarker of a specific disease identified in the basic science laboratory can lead to increased partnerships and collabora- tion with the government, industry, or academia. It can also lead more quickly to intervention development and Phase I or II clinical trials.1

Why is translational research a viable career choice for aspiring academic surgical scientists? One reason is the fact that as surgeons we perform surgery to remove tumors, to treat organ failure, and remove organs with intractable inflammatory disease. We are unique in that we are able to see pathology in the human in vivo setting and correlate these intraoperative findings with clinical symptoms, signs, and postoperative outcomes. With adequate informed con- sent from the patient, we are able to safely biopsy organs, and correlate clinical and intraoperative findings with molecular and protein analyses from the biopsy tissue. We have access to tumor bank tissue and analysis of that tissue is another viable area of research where one can study molecular signa- tures that may impact response to therapy and overall patient outcomes. Opportunities have also expanded to include the use of clinical databases whereby both retrospective and pro- spective analyses are performed to answer patient-related research questions. In addition, the use of animal surgical models that are similar to clinical situations allows for the testing of novel treatment modalities for the treatment of disease.

134 D.P. Foley

Another reason to pursue translational research is the recent increase in funding opportunities. In order to build national clinical and translational research capability, the

National Institutes of Health’s National Center for Research

Resources (NCRR) launched the Clinical and Translational Science Award (CTSA) Program in 2006. The program sup- ports a national consortium of medical research institutions designed to transform how biomedical research is conducted. The goals are to speed the translation of laboratory discover- ies into treatments for patients, to engage communities in clinical research efforts, and to train a new generation of clinical and translational researchers. Currently, there are 55 institutions that are part of the CTSA consortium including 28 states and the District of Columbia. In addition, the NIH has increased the emphasis of clinical significance in grant proposals. Historically, basic science grant applications that resulted in funding could focus on cellular and molecular pathways and mechanisms without overemphasizing a potential transitional impact on clinical outcomes in the near future. There is now a shift towards a greater emphasis on clarifying how a research proposal addresses an important problem or a critical barrier to patient care. Studying human tissue samples and correlating these findings with disease states or treatment for a given disease allows for direct application to clinical care.

There are multiple new technologies that have been devel- oped over recent years to study the human body’s response to disease at the cellular level. These findings can be corre- lated with clinical outcomes and subsequently used to predict response to a specific therapy or simply to identify of a novel biomarker for a particular disease. Some of these strategies include genomics, proteomics, and metabolomics.These tech- nologies allow for the molecular examination of tissue or blood to unravel the basic biological responses to disease. The remainder of this chapter will focus on each of these strategies and various examples of how this technology can lead to a better understanding of the body’s response to mul- tiple disease states.