Clinical Outcomes (Epidemiology) Track

The Epidemiology and Outcomes Program is supported, in part, by a training grant from the NIH. Fellows in the program spend 4 years in training – two years of research training leading to an advanced degree and two years of clinical training leading to Board eligibility in gastroenterology and Hepatology. The program takes advantage of unique and considerable institutional strengths in epidemiology and digestive disease research. A diverse, experienced, multidisciplinary faculty has been assembled to provide trainees with expert guidance in epidemiology, biostatistics, health policy, and outcomes research.

Overview

The goal of the program is to train independent researchers who will improve our understanding of the magnitude, etiology, impact and treatment of digestive and liver diseases, and who will assume leadership roles in GI epidemiology and outcomes research. To accomplish that goal, the program includes the following features:

  1. Formal advanced training in epidemiologic methods and biostatistics to provide a strong foundation in research design and analytic techniques.
  2. A full 2-year period of coursework culminating in an advanced degree, either MPH or MSCR in epidemiology
  3. Emphasis on design, execution, analysis and publication of research projects to enhance the ability of the trainee to conceptualize and think through research problems with increasing independence.
  4. Mentors to guide the developing investigator
  5. An integrative core curriculum designed to develop additional skills necessary for an academic career

Minorities are encouraged to apply. To be eligible for Training Grant support, applicants must be U.S. citizens or permanent residents.

Training Faculty

The faculty members listed below participate in training fellows in the digestive disease epidemiology training program. Trainees may elect other members of the medical school and public health school faculty to serve as their preceptors.

Robert Sandler, MD, MPH, is the director of the training program and director of the NIH-funded Digestive Disease Research Center, the Center for Gastrointestinal Biology and Disease. His research has concerned the epidemiology of a number of chronic gastrointestinal conditions including individuals at higher risk to develop gastrointestinal malignancies, diverticulosis, irritable bowel syndrome, gastric cancer, inflammatory bowel disease, constipation, colon adenomas and microscopic colitis. His current research is focused on diverticulosis, microscopic colitis and patient reported outcomes in IBD.

John Baron, MD, MS, received a Master’s degree in statistics from Yale and was a doctoral student in mathematical statistics at Stanford before receiving a medical degree from the University of Michigan. He was a longtime faculty member at Dartmouth where he established an international reputation as a clinical and cancer epidemiologist. He is perhaps best known for his work in colorectal cancer chemoprevention with important papers in the New England Journal. He teaches the course on clinical trials in the Department of Epidemiology.

Sidney Barritt, MD, MSCRjoined the GI faculty after serving as a trainee on this award. He is a transplant hepatologist with a special interest in nonalcoholic fatty liver disease. He has mentored several past fellows.

Seth Crockett, MD, MPHis a former trainee in this program. His research concerns the epidemiology, screening and prevention of GI cancers. His particular interest is the serrated pathway to colon cancer and its precursor lesions. He directs the epidemiology course for UNC Medical Students.

Evan Dellon, MD MPH, joined the UNC faculty in 2008 after obtaining an MPH degree on this training grant. He is currently funded by an R01 from the NIH. He is the Director of the UNC Center for Esophageal Diseases and Swallowing, and his major research interest is in eosinophilic esophagitis. In particular, he has active investigations in both etiologic and clinical epidemiology on this topic.

Donna Evon, PhD, is a clinical psychologist with research interests in identifying and understanding psychological, social and behavioral factors associated with hepatitis C, antiviral treatment initiation, and treatment outcomes. Her research also includes developing psychosocial interventions to improve access to care, coping with treatment-related side effects and the stress of antiviral treatment, medication adherence, and persistence on antiviral therapy regimens. She is an expert in qualitative research and patient reported outcomes.

Michael Fried, MD, directs the liver program at UNC. He has been involved with clinical and laboratory studies of hepatitis C since 1990 when he served for three years as a medical staff fellow in the Liver Diseases Section of the National Institutes of Health. Dr Fried has been the principal investigator on numerous Phase I, II and III clinical trials of various antiviral agents for chronic hepatitis B and hepatitis C. Since his appointment to UNC in 1998, Dr. Fried has received funding from the NIH for investigator-initiated research and has been funded by a K24 Mid-Career Investigator Award.

Joseph Galanko, PhD, is the biostatistician for the Center for Gastrointestinal Biology and Disease and for the Data Management Center for the Crohn’s and Colitis Foundation. He is also the consulting biostatistician for the Clinical Nutrition Research Unit. He previously served as the consulting biostatistician for Gastroenterology.

Paul Hayashi, MD, MPH, joined the UNC faculty in 2006 and is currently an Associate Professor of Medicine and Medical Director of Liver Transplantation. After completion of a fellowship in gastroenterology at the University of California Davis, he did two additional hepatology fellowships, one in clinical research at the NIH and another in transplant hepatology at the University of Colorado. He was a transplant hepatologist at Saint Louis University prior to coming to UNC. Dr. Hayashi is interested in clinical outcomes research, particularly liver transplant outcomes, drug induced liver disease, organ allocation and hepatocellular carcinoma.

Hans Herfarth, MD, PhDis a gastroenterologist with clinical and research interest and expertise in inflammatory bowel disease. He is the past chair of the Crohn’s and Colitis Foundation Clinical Alliance. He was the PI for “Merit-UC: methotrexate response in treatment of ulcerative colitis” a randomized, double blind, prospective trial that is investigating the efficacy of methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (U01DK092239).

Michael Kappelman, MD, MPH, is a pediatric gastroenterologist with interests in epidemiology, pharmacoepidemiology, and health services research in the area of inflammatory bowel disease (IBD). He joined the UNC faculty after completing fellowships in pediatric gastroenterology and pediatric health services research at Harvard Medical School and a Master’s in Public Health in Clinical Effectiveness at the Harvard School of Public Health. His current work is focused on analyzing the utilization of resources and economic impact of IBD, and studying the quality of care in this patient population.

Millie Long, MD, MPH, received an MPH while a fellow in this program. She is currently the training director in the GI Division. She is chair of the Crohn’s and Colitis Foundation Clinical Alliance. During her fellowship she also completed board certification in Preventive Medicine. Her research interest is in preventive care aspects of inflammatory bowel disease. She has authored seminal papers on the risk of malignancy associated with IBD therapies.

Jennifer Lund, PhDis a graduate of the program. She is an assistant professor in the Department of Epidemiology with a focus on pharmacoepidemiology. She has special expertise working with large administrative databases to address issues in comparative effectiveness.

Anne Peery, MD, MSCRis graduate of the program. She is currently supported on a K23 award from the NIH. Her research focus is on diverticular disease and she has written original research on this topic as well as serving as an author of guidelines from the AGA. She has also served as the lead author of a paper periodically published by our group on the burden of GI disease.

David Ransohoff, MD was the founding director of the Translational and Clinical Research Curriculum at UNC. The curriculum provides a non-degree two-year training program for a group of carefully selected trainees, each of whom is committed to a career as a clinical investigator. Dr. Ransohoff’s research has concerned clinical epidemiology methodology with important contributions to our understanding of asymptomatic gallstones, colorectal cancer screening and recently the application of clinical epidemiology principles to biomarker research.

Nicholas Shaheen, MD, MPH, is a gastroenterologist who received a Master’s in Public Health in Epidemiology from UNC’s School of Public Health as a previous trainee in this program. He is the current GI Division Chief. His research is in the areas of Barrett’s esophagus, esophageal adenocarcinoma, and gastroesophageal reflux disease.  His current work seeks to better define the risk factors for Barrett’s esophagus and esophageal adenocarcinoma. He is supported by an R01 and a Mid-Career Investigator (K24) Award. Healthcare utilization issues are especially important in GERD, and a major focus of his work has been the utilization of endoscopy and other healthcare expenditures related to GERD and Barrett’s esophagus.

Til Stürmer, MD, PhDis the newly appointed chair of the Department of Epidemiology at UNC. He has a dual focus in epidemiologic methods and clinical epidemiology. His research in epidemiologic methods includes the development of more efficient matching strategies in genetic epidemiology, measurement error correction methods in case-control studies, the value of propensity scores for pharmacoepidemiologic studies, and the novel integration of ideas from measurement error correction and propensity score analysis to improve control for confounding by medication-use choices using data from validation studies.

The faculty on this application are unusually interactive. Figure 1 indicates shared publications between fellows and faculty during the past 10 years.  

Figure 1. Collaboration between faculty and trainees*

     Faculty-Trainee Collaboration

*The nodes represent current faculty and present/past fellows (past 10 years). The size of the node is proportional to the number of publications with a trainee. The colors represent interest groups: red (esophageal), yellow (colonic), blue (liver), green (IBD). Collaborations are represented by connecting lines. Publications are limited to papers written by a trainee within one year of fellowship completion. Created using VOSviewer software

Core curriculum

The organized didactic program is based in the School of Public Health. Trainees are expected to obtain an MPH or an MSCR. Most trainees currently obtain an MSCR, in a special degree program developed specifically by our School of Public Health for clinicians.  This program emphasizes course work developing skills necessary for the successful clinician researcher (such as study design and data analysis), while reducing content less pertinent to them, such as traditional observational epidemiology and environmental exposure work.  Trainees who enter with an MPH can take advanced coursework.

In order to complete the 36 credit hour degree requirements, students must master a defined set of competencies including:

  1. Clinical research study design: Identify testable research hypotheses. Develop appropriate study designs with minimal bias; identify appropriate target populations.
  2. Fundamentals of data analysis: Develop appropriate data analysis plans for research hypotheses; implement basic statistical analyses including multivariable regression. Understand sample size and power calculations.
  3. Grant proposal development: Develop a proposal for clinical/translational research suitable for submission to the National Institutes of Health or research foundation.
  4. Interdisciplinary collaboration: Demonstrate knowledge of team science. Develop skills for collaboration with research methodologists, including biostatisticians.
  5. Project oversight and management: Demonstrate skills to implement a research project, including hiring of appropriate team members, developing and managing budget, overseeing project, ethics approvals, and regulatory reviews.
  6. Oral and written presentation: Effectively present research findings orally to peers, lay persons, and the media. Write clearly and succinctly for scientific publication and research proposals.
  7. Professional development: Demonstrate knowledge of the academic research environment, sources of research support, and professional advancement. Demonstrate the use of strategies to improve professional effectiveness, such as time management, leadership, and management skills.

Duration and sequence of training

The training includes an initial year of clinical GI training. Fellows are appointed to the T32 in their second year. During the summer semester, fellows are introduced to the research, educational and clinical opportunities available at UNC through a series of seminars from training grant faculty geared to this purpose. They meet with their academic advisor to choose specific course work for the coming academic year. They attend research presentations by the training faculty at the Digestive Disease Epidemiology Conference and meet with training faculty to explore mutual interests and to identify a research project. Trainees begin courses in biostatistics and epidemiologic methods during the fall semester of the second year. Course work and seminars continue in the spring semester of the second year. During the third year the trainees complete the remainder of the courses required to satisfy the MPH or MSCR degree. In addition to the required courses, fellows select advanced courses or tutorials pertinent to their research. During the spring semester of the 3rd year, trainees complete additional clinical training so that they are board-eligible at the end of the year based on ACGME requirements. During the spring semester they complete their masters paper and final coursework so that they can graduate in May.

The fourth year is a ‘flex’ year where fellows participate in research and write papers, but also have the opportunity to obtain advanced clinical training. Past trainees have completed advanced clinical training in liver transplant, IBD and esophageal diseases.

Stipends, Insurance, Tuition, Fees, Travel, Research Expenses

The training program is funded by an Institutional National Research Service Award from the NIH. As such, the program abides by the rules established for these awards.

Stipends are established by the NIH. The current annual stipend for postdoctoral trainees is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree.

Trainees are provided with approximately $8,850 per year in research funds to cover cost of health insurance, malpractice insurance (only if the nature of the research training requires such special insurance), training-related supplies, and professional memberships.  Trainees are provided with office space equipped with a personal computer and printer. 

Trainees are provided $1,000 in travel funds to cover cost of one national meeting per year.

Trainees are provided with approximately $4,500 per year to cover cost of full-time tuition and fees in our School of Public Health.

As part of the general MD fellowship program through the Match, our epidemiology track is equivalent to the ‘clinical outcomes’ option.