Clinical Research Awareness in Neurology and Neurosurgery Residency Workshop

Clinical Research Awareness in Neurology and Neurosurgery Residency Workshop Summary
December 11 - 12, 2006
Washington, DC

Introduction

The purpose of the workshop, organized by NINDS/NIH, was to discuss possible ways to develop a program to enhance clinical research awareness in neurology and neurosurgery residency training programs, including ways to implement, sustain and measure success of such a program.

Background

Individual Neurology and Neurosurgery training programs vary widely in the degree of resources available for training in research. As our knowledge for diagnosis and treatment of neurologic diseases has expanded and the rules and regulations for training programs by both the ACGME and the Residency Review Committees (RRCs) have also increased, there is a need to take a fresh look at how trainees are taught and view clinical research. Currently, the neurology and neurosurgery RRCs require scholarship from all residents: "The responsibility for establishing and maintaining an environment of inquiry and scholarship rests with the faculty, and an active research component must be included in each program."

Discussion

The initial panel discussion focused on the current state of affairs from the standpoint of the NINDS, the RRC, program directors, and trainees. The panel discussed NINDS concerns for clinical research in areas of recruitment for trials, participation in trials, and also implementation of trial results. The current RRC requirements for research in the training programs allow significant variation from program to program. The possibility of two separate tracks for residents, those going into academics and those going into clinical practice, was presented, with truly separate tracks and different types of mentoring. It was suggested that the clinical track could require exposure to research methodology, review of personal clinical experience, attendance at regional and national meetings, local academic competitions, and publications of case reports or topical reviews. From the program director and trainee standpoints, many concerns were raised, including unfunded mandates to develop additional teaching courses without sufficient resources, both financial and personnel, the absence of time to add anything else into training programs and resident schedules which are already stretched maximally, the viewpoint that involving yourself in clinical research projects/trials as a trainee may have little learning value and reward. After the panel presentations, there was a lively discussion with many viewpoints shared. A variety of institutions were represented including those that are purely clinical with active research program, those with strong NINDS-funded research programs in their departments or institutions, and those in between. Departments of varying sizes and geographic distribution were also represented. Some institutions have clearly established resident research programs in which residents are required to do clinical research projects from beginning to publication. Others encourage resident attempts to publish or do clinical research but did not have a significant number of, if any, possible mentors for doing clinical research. All programs had curriculum that included review of clinical research, current and past, most consistently covered in a regular journal club where recent literature is reviewed. There was clearly an interest in approaches that attempt to enhance clinical research awareness in residency training, but no clear measurements of effectiveness exist to determine which approaches are most successful. Input from trainees at this workshop clearly indicated that the assumptions made by those teaching may not reflect the view of those being taught.

A review of recent publications by the AAMC and from other specialties revealed general concern about the lack of training or ineffectiveness of current training with regard to clinical research in both medical schools and residency programs. Although some of this focused on training clinicians to perform clinical research, much of it focused on training clinicians to consider clinical research as part of the potential care for all patients. Furthermore, it was pointed out that clinicians must first have a basic understanding of research methods, be facile in interpreting results from trials, and develop an awareness of ongoing clinical research. (AAMC Task Force II on Clinical Research and Committee on Incorporating Research in Psychiatry Residency Training). Involving all trainees (medical students and residents) in performing actual clinical research as the solution may not be practical or effective. The AAMC recommended that specific requirements for education in translational and clinical research be developed, and then met by medical students and trainees prior to graduation/completion of training. Discussion among participants raised the concerns of unfunded mandates from oversight committees without clear guidance or consensus.

Several breakout sessions were held during the remainder of the workshop: 1) developing ways that research awareness could be a part of a training program in neuroscience, 2) possible incentives for developing and then maintaining a clinical research awareness initiative, 3) possible outcome measurements to see if programs are effective, and 4) methods to accomplish integration of clinical research awareness programs including potential roadblocks.

Each breakout session met separately then presented to the larger group with significant discussion. Proposed solutions include having a steward or mentor for enhancing clinical research awareness in every training program or developing the means of sharing such a person with other programs. Possible methodologies included utilizing resources already or soon to be available such as the Evidence-based Medicine Tool Kit being developed by the AAN and incorporating research methodology understanding into this tool kit. Teaching modules could be designed and distributed to improve research training in journal clubs, which are already in place at virtually all programs.

Each resident and each program must be given appropriate incentives to encourage the teaching of clinical research awareness and to make it successful. Certifications could be issued to those who successfully develop competence in appropriate interpretation of the literature, as well those who demonstrate a basic understanding of the systems based practice of clinical research. Certifications could be made available from the NIH, from the RRC, or other organizations such as the AAN. Certification could be obtained through examinations or successful participation in clinical research. Other incentives could include money for travel or registration at meetings built into training program budgets or through national organizations. Some training programs send their residents who are presenting research, but this would be another reason or way to fund residents going to meetings. Specific money for those doing the mentoring or for research nurses or coordinators in programs would also serve as incentives, but there are currently no sources for this type of funding. A suggestion was made of funding model programs in training programs that are "underserved" in the area of clinical research through a granting mechanism from NIH or national organizations like AAN. If this were to occur, clear outcome measurements would need to be developed to measure the success of such programs.

Potential outcome measurements recommended included number of publications of residents with faculty, although this might look primarily at those residents actually doing research, unless the publications are reviews or case reports. Measurement of participation in research by departments as well as participation in or referral of patients to research by residents after they leave a program that has instituted a clinical research awareness training program would also be a way to look at effectiveness of the program. In-service examinations and board examinations could also include questions that would look at knowledge of basic research principles.

There were some concerns voiced in the main group about training programs that provide separate tracks for those interested in becoming researchers and those more interested in clinical practice. There was concern that one track might appear to be "favored" and it might actually push residents who are not going to do research away from learning about the importance of and valuing the ability to understand and utilize clinical research - further separating the clinician from the researcher. Concern about professional identity and the effect of admitting personal or community equipoise about a clinical issue was raised, as well as the professional identity of the trainees themselves - their identity as a worker versus as a student.

Reccomendations/Conclusions

The final recommendations of the workshop were based on the agreed upon goal of having all neurologists and neurosurgeons have a higher awareness of research, which must begin in training. Residency programs will need to modify the curriculum and the content related to research, in order to ensure that residents are taught basic principles of research. Furthermore, it is desirable to heighten awareness of research in the hopes of encouraging consideration of research as part of clinical care for future patients, even by those physicians who choose not to directly participate in clinical research. It is essential that these modifications in training be directed to all residents, not just those who will go into research. It should occur at all residency programs, not just those who are successful at NIH-funded research. This training should absolutely not become an onerous burden to the residents, faculty, or the individual institutions and there must be buy-in from Chairs, Program Directors, other faculty and residents.

The workshop concluded with a consensus that this a major concern in the area of clinical neurosciences. The results of this workshop with the statement of the problem and possible solutions will be presented at a variety of national venues for both neurologists and neurosurgeons. Efforts by other organizations along these lines will also be reviewed. Consideration of possible survey of practicing physicians and trainees to see the scope of the problem, possible other solutions, and if the proposed solutions seem viable.

Next steps to address this problem then might include:

1. an initiative from national organizations, such as the AAN or Society of Neurologic Surgeons
2. an RFP or RFA from the NIH for developing model programs within residency training programs
3. a program through the Clinical Research Collaboration/NINDS program that would target resident awareness of research

Participants

Steering Committee

Richard T. Benson, M.D., Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Ted M. Burns, M.D.
Associate Professor
Department of Neurology
University of Virginia

Laurie Gutmann, M.D.
Program Director
Division of Extramural Research
Clinical Trials
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Brett Kissela, M.D.
Associate Professor
Department of Neurology
University of Cincinnati

Lori Schuh, M.D.
Department of Neurology
Henry Ford Hospital

Katie Woodbury-Harris
Health Scientist Administrator
Scientific Review Branch
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Participants

Cynthia L. Bodkin, M.D.
Clinical Neurophysiology Fellow
Department of Neurology
Mayo Clinic Jacksonville

Allison Brashear, M.D.
Professor and Chair
Department of Neurology
Wake Forest University School of Medicine

Ian J. Butler, M.D.
Professor of Pediatrics and Neurology
Department of Pediatrics
University of Texas Medical School at Houston

Donna Chen, M.D., M.P.H.
Assistant Professor
Center for Biomedical Ethics
University of Virginia

Howard B. Dickler, M.D.
Director for Clinical Research
Division of Biomedical and Health Sciences Research
Association of American Medical Colleges

Elana Farace, Ph.D.
Associate Professor
Director of Clinical Research
Department of Neurosurgery
Hershey Medical Center
Pennsylvania State University

Jacqueline A. French, M.D.
Professor of Neurology
Assistant Dean for Clinical Trials
Department of Neurology
Hospital of the University of Pennsylvania

Karen L. Furie, M.D., M.P.H.
Associate Professor
Stroke Service
Department of Neurology
Massachusetts General Hospital

Robert C. Griggs, M.D.
Professor and Chair of Neurology
Department of Neurology
University of Rochester School of Medicine and Dentistry

Robert E. Harbaugh, M.D., F.A.C.S.
Professor and Chairman
Department of Neurosurgery
Hershey Medical Center
Pennsylvania State University

Katherine A. Henry, M.D.
Associate Professor
Department of Neurology
New York University School of Medicine

Ronald M. Kanner, M.D.
Chairman
Department of Neurology
North Shore Long Island Jewish Health System

Walter J. Koroshetz, M.D.
Deputy Director-NINDS (as of January 2007)
Associate Chief
Neurology Service
Massachusetts General Hospital

Dennis M. Landis, M.D.
Chairman
Department of Neurology
Case Western Reserve University School of Medicine
University Hospitals of Cleveland
As of January 1, 2007:
Professor and Chairman
Department of Neurology
Baylor College of Medicine

Sung B. Lee, M.D.
Chair
Consortium of Neurology Residents and Fellows
Neurocritical Care and Stroke Program
Department of Neurology

Anne S. Lindblad, Ph.D.
Principal Investigator
CRC Operations Center
National Institute of Neurological Disorders and Stroke
National Institutes of Health

John Loeser, M.D.
Professor
Departments of Neurological Surgery and Anesthesiology
University of Washington

Christopher Nolte, M.D., M.S.Chair-Elect of the Consortium of Neurology Residents and Fellows
Department of Neurology
Mayo Clinic Jacksonville

Irene Hegeman Richard, M.D.
Associate Professor
Departments of Neurology and Psychiatry
University of Rochester School of Medicine and Dentistry

Susan K. Rodmyre
Associate Director, Education
Center for Education and Science
American Academy of Neurology

Noah Rosen, M.D.
Director of Headache Fellowship
Department of Neurology
Thomas Jefferson University

Thomas R. Swift, M.D.
President
American Academy of Neurology
Department of Neurology
Professor Emeritus, Former Chair
Department of Neurology
Medical College of Georgia

NINDS Staff Members

Robin Conwit, M.D.
Program Director
NINDS Clinical Trials
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Wendy R. Galpern, M.D., Ph.D.
Program Director
Clinical Trials
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Deborah Hirtz, M.D.
Program Director
Clinical Trials
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Scott Janis, Ph.D.
NINDS Clinical Trials
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Story Landis, Ph.D.
Director
National Institute of Neurological Disorders and Stroke
National Institutes of Health

John K. Lynch, D.O., M.P.H.
Program Director
Office of Minority Health and Research
National Institute of Neurological Disorders and Stroke
National Institutes of Health

John R. Marler, M.D.
Associate Director, Clinical Trials
Division of Extramural Research
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Audrey S. Penn, M.D.
Deputy Director
National Institute of Neurological Disorders and Stroke
National Institutes of Health