Research Policy
A. Objective.
Trainees in Clinical Cardiac
Electrophysiology should understand the design and interpretation of research
studies, and the responsible use of informed consent. They should be able to critically assess the
medical literature with regard to new therapies and techniques. A meaningful research experience, tailored to
the needs of the individual trainee, is required.
B. Teaching
method.
All electrophysiology faculty
participate in clinical research, with one (Dr. Steiner) designated as the
Director of Electrophysiologic Research.
The trainee will be exposed to some of this research, including
participation in multi-center studies as well as original research. Self-study and conferences represent other
teaching methods.
C. Content.
1. The
design of various types of research studies.
2. Interpretation
of research studies, including basic statistics (confidence intervals, tests of
statistical significance, linear correlation, multi-variate analysis,
meta-analysis, and decision analysis).
3. FDA
requirements for informed consent and protection of human subjects.
D. Educational
materials.
1. Fellow's
Teaching Notebook.
2. Clinical
material: Clinical Cardiac
Electrophysiology is a new and rapidly changing field. Clinical research can be incorporated into
the daily routine.
E. Evaluation.
Even for trainees headed for a career
in private practice, we require a minimum research exposure since we feel this
is a scholarly activity that will make the clinical practitioner of Cardiac
Electrophysiology critically aware of how the scientific basis of the field is
advanced. The trainee is evaluated as
part of the tutorial process, which is tailored in part to the research
interests of the trainee. The resident
has the opportunity to evaluate this part of the curriculum every six months in
writing.
The principle faculty in Clinical
Cardiac Electrophysiology are heavily invested in
patient care, but are still committed to performing some clinical
research. The faculty and trainees have
from 1/2 to 1 day weekly of protected time for research. There are other potential research mentors in
our medical center, especially those in
F.
Selected recent Trainee Research
1.
Multicenter
trials: warfarin vs. an investigational thrombin inhibitor for
sroke prevention in atrial fibrillation (SPORTIF V, RE-LY); registry of cardiac
resynchronization therapy (RESTORE-US); risk factors for sudden cardiac death
in ICD patients (SERF); investigation of RV-LV timing in an investigational
CRT-D device (INSYNC III).
2.
Single or
limited center studies: studies of the
organization of atrial activity in atrial fibrillation, from surface and
intra-cardiac recordings (in collaboration with CREARE, INC.).
3.
DHMC studies:
Accelerated dosing of sotalol in atrial fibrillation, conservative management
of cardiac tamponade complicating electrophysiologic procedures, assessing
sinus node function post autonomic blockade in patients with syncope of
undetermined etiology.