Background:
In addition to the need for more well designed and well executed clinical
research, there is an increasing awareness that the ability of physicians, other
health care providers, and health care organizations, to appraise, interpret and
synthesize evidence from clinical research will be the key to improving the
efficiency of health care, controlling costs, and improving outcomes. Several
landmark papers set many observers and critics of health care delivery on a
mission to promote, what is now known as, “evidence based medicine”.
First, in the 1980’s, using large administrative databases, Wennberg and others
found that there was great variability in the amount and type of health care
provided to patients with the same condition, in different areas of the country.
This disparity was shown to result in large differences in the cost of care with little
difference in outcomes. When others investigated the level of evidence to
recommend one treatment over another, they found that for a variety of
conditions, the research needed to determine the best therapy was inadequate,
both in terms of quantity and quality. (Altman, 1992)
In 1991, Guyatt et al. introduced the term “evidence based medicine” into the
parlance. The ideal physician is one who can figure out the best course of action
for an individual patient by evaluating the risks and benefits of all of the
alternatives and then incorporating the patient’s unique characteristics and
preferences into a coherent plan. This is a very tall order for a number of
reasons.
Evaluating risks and benefits depends on there being a body of unbiased, high
quality research relevant to the patient’s condition. It requires that the physician
have the time and knowledge to do a thorough literature search, to retrieve all of
the available information. He or she must have the background in research
methodology to evaluate the quality of the research, especially recognizing
potential sources of bias. The physician must be able to evaluate whether the
subjects in a particular study or compilation of studies are similar enough to his
or her own patients so that the results are applicable. The physician must have
the ability to extract from all the reported results, the actual level of benefit or
harm that can be expected, on average, of the contemplated treatment compared
to a different treatment or no treatment at all.
Because this all requires a very special set of skills that are not comprehensively
taught in medical school or residency training, and because, synthesizing
evidence is a very laborious procedure that takes a lot of time, most clinicians
rely on a combination of anecdotal experience, information from drug company
representatives, textbooks and online services that purport to have up-to-date
evidence based recommendations. They often also rely on the opinions of
respected colleagues in their communities, and for a select group of problems,
practice guidelines developed by a panels of experts convened by medical
societies and other interested organizations.
All of these methods, for coming to a clinical decision about what type of
evaluation or intervention is the best in a particular situation, have serious flaws.
Anecdotal experience and advice from drug company representatives are known
to come with severe biases. Textbooks are often filled with opinion based on
anecdotal experience, and non-systematic evaluation of the medical literature.
The information is also likely to be several years old and out of date. On line
services are probably more up to date but do not necessarily rely on a systematic
review of the medical literature and do not quantify the level of evidence that
underlies each of their recommendations. Guidelines developed by medical
societies are supposed to report the level of evidence used to formulate the
guideline and how strongly the committee recommends a particular course of
action, based on level of evidence and a consideration of the consequences of
not following the recommendation. However, it has been shown that most
clinical guidelines, published so far, do not meet high standards for the synthesis
and reporting of evidence-based recommendations. This is because, even
people who are enlisted to write the guidelines, can come to the table with their
own biases, may have a limited background in research methodology, and be
unfamiliar with quantitative techniques for combining the results of several
studies.
It is with this background that we have decided to design and evaluate a faculty
development course, directed at teachers of physicians in residency training. The
purpose of this course is to introduce principles of research design and analysis,
literature search tools and how to critique and interpret the medical literature, so
that these educators can transmit these skills to young doctors in training and
embark on clinical research from a solid base of knowledge. We envision that
this training will inspire a smaller group of physicians, who have a special
interest, to enter graduate programs in epidemiology, biostatistics and
translational research. The aim is to build and perpetuate a cadre of clinical
scholars who will both do the high quality research and insist that others do high
quality research. They will have the necessary skills to serve on committees that
write clinical guidelines used by health care providers all over the globe, to
improve care.
Methods:
1. The first step in this process is to interview key professionals to gain
insight into what clinical faculty should know about study design, bias and
statistical inference, in order to be effective teachers, researchers and
consumers of the medical literature.
2. Develop a course outline based on step 1.
3. Hold focus groups with clinical faculty members to discuss the course
outline and determine how the concepts could be approached to maximize
the appeal to the target audience.
4. Develop approximately ten 1-hour modules addressing the main areas
contained in revised outline.
5. Pilot the course to a group of clinical faculty at St. Joseph Mercy Health
System, offering 20 hours of continuing medical education credit.
6. Pretest and post-test the group.
7. Hold a focus group of participants to determine how to improve the
course.
8. Revise the modules based on 9 and 10 above.
9. Publish the revised modules for the use of other ASA chapters.
10. Offer the course for a fee, on a yearly basis, to raise money for the
chapter.
11. Use as a template to develop courses for other professionals like nurses,
engineers, pharmacists, veterinarians, and others.