December 2006
The cons of consensus
by Dr. Christopher Kent
Evidence‑based clinical
practice is defined as "The conscientious, explicit, and judicious use of
the current best evidence in making decisions about the care of individual
patients...(it) is not restricted to randomized trials and metaanalyses. It
involves tracking down the best external evidence with which to answer our
clinical questions." [1]
Despite such a clear
admonition, CCGPP has elected to exclude case studies, while basing
recommendations on the consensus opinions of panel members. Consensus
methods merely formalize the opinions of the participants. Jagoda [2] listed
the characteristics of a formal consensus process:
‑‑ Group of experts
assemble
‑‑ Appropriate
literature reviewed
‑‑ Recommendations not
necessarily supported by scientific evidence
‑‑ Limited by bias and
lack of defined analytic procedures
The selection of
participants will significantly affect the outcome of the process. Sackman
[3] describes a "halo effect" where participants "bask under the warm glow
of a kind of mutual admiration society."
The National Health and
Medical Research Council [4] has made it clear that opinions are not
evidence. "The current levels (of evidence) exclude expert opinion and
consensus from an expert committee as they do not arise directly from
scientific investigation." According to Rosner [5], Bogduk was equally
emphatic: consensus or expert opinion is no longer to be accepted as a form
of evidence.
In contrast, case
studies are gaining respect in the scientific and clinical communities.
Rosner [6] wrote:
"Interestingly, what had been considered to be a lower stratum of evidence
in quality (observational studies) compared to randomized clinical trials
may not be ‑‑ as it has been recently reported ‑‑ that in terms of treatment
effects, estimates from observational studies conducted since 1984 do not
appear to be consistently larger, or qualitatively different from those
obtained in more fastidiously constructed randomized clinical trials. [7]
Indeed, the entire pecking order of the quality of scientific clinical
evidence, as it appears to have been envisioned by conventional wisdom, has
been seriously questioned, such that observations taken in the doctor's
office assume a far greater value in establishing an evidence base with
external as well as internal, validity. [8]
"...What all this is
simply saying is that the entire range of research and clinical experience
needs to be called into play when making a clinical judgment. This would
mean that the 'lowly' case study takes a rightful place in the pantheon of
accumulated evidence supporting a particular type of healthcare
intervention. As David Eisenberg once remarked, Chinese medicine endured
into the 20th century without documentation from clinical trials because it
was substantiated by 3,000 years of case studies. Only 15 percent of what we
regard as modern medicine appears to have been supported by any scientific
evidence at all, [9] and only one percent has been described as sound.
[10]."
Rosner concluded,
"Whoever is seeking documentation of clinical practice needs to be critical
enough to avoid the lure of the gold standard in assessing evidence, so as
not to end up like the three prospectors in 'The Treasure of Sierre Madre'
who, much to their great horror, find that they have come up with fool's
gold."
|
Rank: |
Methodology |
Description |
|
1 |
Systematic reviews
and meta-analyses |
Systematic review:
review of a body of data that uses explicit methods to locate primary
studies, and explicit criteria to assess their quality.
Meta-analysis: A
statistical analysis that combines or integrates the results of
several independent clinical trials considered by the analyst to be
"combinable" usually to the level of re-analysing the original data,
also sometimes called: pooling, quantitative synthesis.
Both are sometimes
called "overviews." |
|
2 |
Randomised
controlled trials (finer distinctions may be drawn within this group
based on statistical parameters like the confidence intervals) |
Individuals are
randomly allocated to a control group and a group who receive a
specific intervention. Otherwise the two groups are identical for any
significant variables. They are followed up for specific end points. |
|
3 |
Cohort studies |
Groups of people
are selected on the basis of their exposure to a particular agent and
followed up for specific outcomes. |
|
4 |
Case-control
studies |
"Cases" with the
condition are matched with "controls" without, and a retrospective
analysis used to look for differences between the two groups. |
|
5 |
Cross sectional
surveys |
Survey or
interview of a sample of the population of interest at one point in
time |
|
6 |
Case reports. |
A report based on
a single patient or subject; sometimes collected together into a short
series |
|
7 |
Expert opinion |
A consensus of
experience from the good and the great. |
|
8 |
Anecdotal |
Something a bloke
told you after a meeting or in the bar. |
An orthodox evidence
hierarchy is shown in the accompanying table [11].
The author notes, "Many
biomedical discoveries have had to await the development of techniques
capable of dealing with populations in a statistical manner. For instance:
*** Simple observation
may prove that sewing up a torn vein stops patients bleeding to death.
*** In the 1950s,
cohort studies established the link between smoking and lung cancer.
*** Nowadays, to
detect small but important differences in survival rates with different
combinations of drugs for cancer, large multicentre randomised controlled
trials (RCTs) may be needed.
"Techniques which are
lower down the ranking are not always superfluous...it is not that one
method is better: for a given type of question there will be an appropriate
method."
As Sackett wrote,
"External clinical evidence can inform, but can never replace, individual
clinical expertise, and it is this expertise that decides whether the
external evidence applies to the individual patient at all and, if so, how
it should be integrated into a clinical decision. Similarly, any external
guideline must be integrated with individual clinical expertise in deciding
whether and how it matches the patient's clinical state, predicament, and
preferences, and thereby whether it should be applied." [1]
Perhaps Baruss [12]
said it best, "If we are serious about coming to know something, then our
research methods will have to be adapted to the nature of the phenomenon
that we are trying to understand...One may need to draw on the totality of
one's experience and not just on that subset that consists of observations
made through the process of traditional scientific discovery."
It is time for CCGPP to
stop ignoring evidence which does not fit their user‑created, myopic
reality.
References
1. Sackett DL.
Editorial. "Evidence‑based medicine." Spine 1998;23(10):1085.
2. Jagoda A. "Clinical
policies' development and applications." ACEP 2004. http://www.ferne.org
3. Sackman H. "Delphi
Critique." Lexington Books. Lexington,
MA, 1975.
4. "How to use the
evidence: assessment and application of scientific evidence." National
Health and Medical Research Council. Commmonwealth of Australia. 2000.
5. Rosner AL.
"Evidence‑based clinical guidelines for the management of acute low back
pain: Response to the guidelines prepared for the Australian Medical Health
and Research Council." JMPT 2001;24(3):214.
6. Rosner A.
"Reality‑based practice: Prospecting for the elusive gold standard."
Dynamic Chiropractic. February 25, 2002.
7. Benson K, Hartz AJ.
"A comparison of observational studies and randomized controlled trials."
New England Journal of Medicine
2000; 342(25):18781886.
8. Jonas WB. "The
evidence house: How to build an inclusive base for complementary medicine."
Western Journal of Medicine. 2001;175:79‑80.
9. Smith R. "Where is
the wisdom: The poverty of medical evidence." British Medical Journal
1991;303: 798‑799, quoting David Eddy, MD, professor of health policy and
management, Duke University, NC.
10. Rachlis N, Kuschner
C. "Second Opinion: What's Wrong with Canada's Health Care System and How to
Fix It." Collins, Toronto (1989).
11. "Systematic
reviews: what are they and why are they useful?" University of
Sheffield.
http://www.shef.ac.uk/scharr/ir/units/systrev/hierarchy.htm
12. Baruss I:
"Authentic Knowing. The Convergence of Science and Spiritual Aspiration."
Purdue
University Press. West Lafayette, IN. 1996,
pp 40‑41.
(Dr. Christopher
Kent, president of the Council on Chiropractic Practice, is a 1973 graduate
of Palmer College
of Chiropractic. The WCA's "Chiropractic Researcher of the Year" in 1994,
and recipient of that honor from the ICA in 1991, he was also named ICA
"Chiropractor of the Year" in 1998. He is director of research and a
co‑founder of Chiropractic Leadership Alliance. An attorney as well as a
chiropractor, Dr. Kent is a member of the California bar. With Dr. Patrick
Gentempo, Jr., Dr. Kent produces a monthly audio series, "On Purpose,"
covering current events in science, politics and philosophy of vital
interest to the practicing chiropractor. For subscription information call
800‑892‑6463.)