|
Task
Force 7: Training in Cardiovascular Research
Edmund H. Sonnenblick, MD, FACC - Chairman
Thomas J. Ryan, MD, FACC
Rodman D. Starke, MD, FACC
All cardiology training should be carried out in institutions
in which the opportunity to participate in research
is available. The training site should be one that will
provide an atmosphere of intellectual inquiry and support
of the investigational process.
It is important that every cardiovascular trainee participate
directly in research. Cardiology is a dynamic clinical
field where rapid transfer of knowledge from basic and
clinical research to clinical care will continue to
occur. This pattern will only accelerate in the future.
Cardiovascular research is defined in the broadest terms
possible because recent history makes it abundantly
clear that advances in the care of patients with cardiovascular
disease have come from diverse areas of medical science.
If the clinical cardiologist is to maintain clinical
competence and improve clinical knowledge in step with
the progress of the field, it is crucial that he or
she thoroughly understands the concepts, methods and
pitfalls of the research process.
Every trainee should have direct involvement in the
practical aspects of research, with emphasis on review
of published data, research design, data analysis and
logical deduction. The research experience plays a unique
role in developing the skills in continuing self-education
needed by all cardiovascular specialists. Trainees contemplating
a career in investigative cardiology bear a special
responsibility to prepare effectively to advance understanding
in the broad area of cardiovascular science and especially
the clinical application of new knowledge.
General
Standards
Training
Institution
The training institution must have staff and facilities
for research. Opportunities for research for the trainees
should be available not only within the clinical cardiovascular
division, but also within the basic biomedical science
departments of the institution. Availability of expertise
in epidemiologic methods, outcomes evaluation, biostatistics
and biomedical ethics must be readily available. Optimally,
cardiovascular training should be carried out in a university
teaching hospital or similar institution. Where this
is not feasible, an active ongoing affiliation with
a university is essential.
Preparation
Individual trainees should have, before their appointment,
appropriate preparation in the biologic, epidemiologic
and physical sciences basic to medicine. If additional
course work is desirable and appropriate, it should
be available, and trainees should be encouraged to avail
themselves of it.
Faculty
Faculty of the training program must include several
trainees with proved skill as investigators, demonstrated
by published original research in peer-reviewed journals.
The critical mass of the faculty requires several cardiovascular
investigators, not all of whom need to be clinical cardiologists.
In general, there should be no more than one trainee
per full-time staff member for research training. At
least one full-time faculty member from each training
program should have demonstrated skill as a clinical
investigator.
Content
of Training Program
Research
"Tracks"
Research training will ordinarily take place in one
of three "tracks":
Level
1 = trainees entering the clinical practice of cardiovascular
medicine;
level 2 = trainees planning a commitment to teaching
and clinical investigation;
level 3 = trainees planning a substantive commitment
to basic cardiovascular research.
Clinical
Investigation
Clinical investigation must be carried out under the
supervision of an experienced investigator and according
to approved principles of biomedical ethics and institutional
rules for patient protection. It must be recognized
that clinical research is difficult because of the complexity
of achieving valid scientific conclusions while working
with a diverse population and simultaneously protecting
the interests of each patient.
Components
of Research
The trainee should develop skills in at least the following
areas:
- Literature
study, to ascertain the exact state of knowledge before
undertaking new investigation.
- Formulation
of hypothesis and specific goals, ensuring that the
hypothesis is testable, that the goals are appropriate
and statistical power is achievable.
- Development
of the research plan and the protocol, including study
design, recruitment of subjects, ethical considerations,
informed consent and protection of privacy, data collection
modes, full description of procedures and institutional
approval of human investigation, where appropriate.
- Data
collection, including preparation of routine data
forms.
- Development
of analytic methods or procedural skills, as required,
and particularly the handling of artifacts, missing
data, outliers and statistical inference.
- Presentation
of results, preferably both oral and written, emphasizing
that no investigation is complete until it is reported
in peer-reviewed journals.
- Risk-benefit
analysis, regarding both patient (subject) risk and
benefit and societal risk and benefit.
In the case of multiple center clinical trials, participation
in the full range of special activities outlined here
is required.
The clinician lacking expertise in these areas may be
unable to interpret critical reports bearing directly
on his or her practice. New data may be accepted uncritically
or important advances recognized tardily. The training
program should provide frequent opportunities for faculty
and trainees to review and analyze small- and large-scale
clinical and basic research reports in depth.
Duration
of Research Training
For trainees planning careers in the clinical practice
of cardiovascular medicine (level 1), a minimum of 6
months (and in many instances up to 12 months) should
be devoted to a specific project or projects. For those
planning a substantive commitment to teaching and clinical
investigation (level 2), 1 full year (e.g., 100% of
time for 1 year or 50% of time for 2 years) should be
devoted to clinical research. For those planning a career
in basic research (level 3), 2 to 3 full-time years,
working directly with an experienced mentor, are now
needed in most cases. Such training constitutes only
the beginning of the education of an independent cardiovascular
investigator.
Advanced
Training for Trainees Considering Entering Investigative
Cardiology
Trainees preparing for clinical careers in research
(level 3) need an extensive foundation in scientific
investigation. Some trainees will have obtained thorough
research preparation in combined MD/PhD programs, but
may lack the special skills involved in clinical research
or certain tools that are appropriate to their personal
research goals. These may be obtained in a postdoctoral
research fellowship experience or as part of the cardiology
traineeship.
For full-time training, the trainee should enter the
laboratory of a productive and active scientist, MD
or PhD, in any qualified institution (not necessarily
where he or she is obtaining direct training).
Trainees who aim for a career in investigative cardiology
but who have not had the opportunity to obtain a PhD
or equivalent training at the time they begin their
cardiology traineeships should have the opportunity
and be encouraged to obtain the necessary basic science
course work and laboratory experience necessary for
a productive research career. Current models of this
type of training include the American Heart Association
Clinician Scientist Award and the National Heart, Lung,
and Blood Institute program for clinical scientists
and physician scientists (CIDA).
Teaching
and Manuscript Review
It is important that the trainee be introduced to basic
principles and skills of education because almost all
academic cardiologists devote a significant amount of
time to teaching. It is also useful to provide opportunities
for the critical review and analysis of published manuscripts.
Compensation
Compensation during the often prolonged period of research
training should be sufficient to allow a full-time commitment
to this training.
Evaluation
Evaluation
by the Training Director or Research Sponsor, or Both
Evaluation of a trainee's progress and skills should
be subjective as well as objective, based on agreed
on criteria and standards, and should be ongoing throughout
the training period. The process and documentation currently
required for admittance to the American Board of Internal
Medicine (ABIM) Subspecialty Board Examination serves
as a model for such evaluation. Each trainee's competence
and understanding should be documented at the completion
of training.
Publication
Trainees should be encouraged to publish substantive
results, thereby providing an evaluation by peer-reviewed
journals.
Flexibility
It must be appreciated that the education of future
investigative cardiologists is a continuing process
and that they usually remain in an educational institution
where they are immersed in clinical cardiology. They
often have unique demands that may require altering
the sequence and exposure of clinical training, consistent
with their previous clinical experience. Therefore,
the program director should be afforded latitude in
the assignment of responsibilities for the 3 years of
training while guaranteeing full clinical competence.
Summary
It is vital to the future intellectual health of cardiovascular
medicine and the welfare of patients with cardiovascular
disease that all future cardiologists be familiar with
the principles and tools of research. Training in research
requires the intense involvement of productive and established
investigators. Those trainees preparing for a career
in investigative cardiology require a carefully developed
but flexible educational plan that will permit them
to be successful in their research careers over an extended
period.
Copyright © 1995 American College
of Cardiology
|
