Professional Documents
Culture Documents
Current opinion
0195-668X/03/$ - see front matter 2003 Published by Elsevier Ltd on behalf of The European Society of Cardiology.
doi:10.1016/S0195-668X(03)00438-X
credible. This task is facilitated by the fact that major both the reduction in relative risk, as well as the
medical journals, which publish these studies, require absolute risk reduction in the total population who would
them to fulfil high standards as regards study design and be candidates for the therapy being studied.4 Thus, two
statistical methodology. Furthermore, it is important to studies may show a 33% reduction in relative risk of
be vigilant about potential sources of bias in the study: mortality, but in one, the mortality could be reduced
patient selection, their allocation to the randomized from 6% to 4% while in the other, from 30% to 20%. Both
arms, equivalent treatment except for the therapy being studies might well show the same level of statistical
tested, drop-outs/crossovers, definition of endpoints and significance, but clearly, the latter has a significantly
their evaluation when the study ends. Studies least sus- more compelling treatment benefit.
ceptible to such biases are those that are conducted in
many centres, not just one or a few; use proper ran- Guidelines and conflict of interest
domization schemes; apply methods to assure that
patient profiles and their therapies are similar for Expert guidelines are expected to be objective, impartial
patients assigned to the randomized arms; verify that the and independently derived. Sponsorship from organiz-
drop-outs/crossovers (between study arms) are within ations that stand to gain from recommendations favour-
the limits defined in the study design; and ensure that able to their products threatens to undermine such
independent Endpoint Review Committee and Data objectivity. Given the profitability of industry, such
Safety and Monitoring Board (DSMB) have evaluated study neutrality is needed. In this respect it is important that
compliance and endpoints. The DSMB also serves to verify Task Forces are not developed by a selected group of
that there have been no unacceptable patient safety experts of a specific field but rather they provide a
issues, e.g., complications beyond those anticipated by balanced representation of clinical cardiologists, allied
the study. professionals, epidemiologists, pharmacologists and
A further means of evaluating the credibility of the patients associations. It is expected that through the
outcome is to examine whether the study results are involvement of such a composite panel of stakeholders,
consistent with those of other trials of the same therapy guidelines will provide a more objective evaluation of
in similar populations. For instance, there are by now a treatment options.
multitude of studies in post myocardial infarction Professional societies like the European Society of
patients. By selecting studies on patients with similar Cardiology and particularly those with influences on
characteristics, such as time from onset of symptoms, medical practice, should adopt rigorous standards with
and extent of myocardial damage as expressed by left regard to industry sponsorship.
ventricular ejection fraction, it is possible to obtain a
good estimate of the prognosis of such patients, both From evidence based guidelines to clinical
from a standpoint of natural history, and under various practice
medical therapies. A therapy that gives results con-
sistent with those from other studies in similar situations After the exercise of comparing clinical trials and ranking
obviously reinforces the credibility of the data and the benefit of the various treatments is concluded,
strengthens the recommendation provided by the guidelines are ready to be implemented in clinical prac-
guidelines. tice. The implementation phase is a most important
Of course, large-scale controlled and randomized step in the educational effort of scientific societies.
study designs such as those that have provided important There may be obstacles to successful implemen-
answers regarding the management of coronary artery tation related to the complexity of dissemination and
disease or congestive heart failure cannot be applied adoption5,6 of the guidelines. Recently, new factors are
to all cardiac diseases, especially if they are rare, for further complicating the applicability of guidelines in
instance, hypertrophic cardiomyopathy or long QT syn- medical practice.
drome. The level of evidence governing management New therapies, which improve patient prognosis and
decisions can often be derived only from non- quality of life, come at a price often quite high and
randomized, retrospective and observational data and are directly contrary to the limitations in health
sometimes only from expert opinions. expenditures stipulated by our governments. As per the
It is most important that the European Society of Hippocratic Oath, physicians have a clear obligation to do
Cardiology takes responsibility for selecting the best what is in the best interest of our patients. If a new
available experts to develop a consensus. therapy is found to provide substantial benefit for the
patient, they feel compelled to make every effort to
Compelling magnitude of treatment effect provide him/her with that benefit. However, physicians
are increasingly obliged to operate under strong econ-
The second prerequisite for data to be introduced into omic pressure and therefore, despite being aware of the
Guidelines is that the magnitude of the benefit should recommendations for optimal patient management, may
have true clinical (not just statistical) significance. Here, not receive the financial support to offer these treat-
it is important to take into account the significance of the ments to the majority of patients. This situation is not
outcome of the study, i.e. vis-a-vis other established only frustrating, but it also raises the issue of the legal
data or studies in the population tested. For instance, in implications for the physicians when not adhering to
an all-cause mortality trial, it is important to examine recommendations.7 As a result, the question of whether
the development of guidelines should include the con- the guidelines created under such circumstances might
cept of affordability of a medical therapy has recently be interpreted by the health administration as a sign of
been raised. As previously anticipated, the official pos- our lack of confidence in the validity and strength of the
ition of the ESC is in disagreement with this approach, data itself. That in turn will diminish the impact of the
and it will therefore not be adopted in ESC guidelines, for work of researchers and of the investigators involved in
the reasons indicated below. clinical trials. Conversely, maintaining the focus on the
First of all, the guidelines produced by the ESC are medical/scientific evaluation of new data will direct the
endorsed and implemented in a variety of different health authorities in their deliberations on a proper
countries. It is therefore impossible to provide an accu- allocation of funds for medical care. In particular, the
rate economic assessment that would be simultaneously inclusion of the magnitude of benefit of a tested therapy
applicable in a set of healthcare systems as profoundly as a key criterion for its recommendation in Guidelines
different as those present in the 47 ESC member will aid these authorities in setting out priorities for
countries. allocating funds to new therapies or indications.
Furthermore, we believe that as discussed in the ESC In conclusion, ESC Guidelines will continue to be pro-
document on the legal implications of guidelines,7 guide- duced with the primary aim of assessing the quality of
lines should be regarded as educational tools that help science and the strength of evidence of clinical studies.
physicians formulate their clinical judgements and make They are an important tool of communication between
their independent therapeutic choices. European cardiologists and healthcare providers that will
As discussed in a previous ESC statement8 the guide- eventually decide on the affordability of novel thera-
lines of the ESC have no formal legal power: before they pies in the individual countries. It is in fact the responsi-
become enforceable by national health authorities, they bility of health care authorities in the member states to
need to be endorsed and translated by national societies. put guidelines in the economic context of a specific
In this process, annotations may be needed to adapt healthcare system and to decide which therapies and
guidelines to each individual country. which investigations will be reimbursed in each individual
In this regard, most of the member societies of the ESC country.
have announced that they would consider the possibility
of discontinuing all further individual guidelines develop-
ment, and instead, adapt and endorse the guidelines of References
the ESC, translating them into the local language where
1. Packer M. Current role of beta-adrenergic blockers in the management
necessary. of chronic heart failure. Am J Med 2001;110(7A):8194.
Although the economic considerations certainly need 2. Mahon NG, Young JB, Mc Kenna WJ. Beta adrenergic blockers in
to be addressed, this is not the role of the physicians chronic congestive cardiac failure: a call for action. Eur J Intern Med
called upon to prepare a document that is essentially 2002;13:96100.
3. Echt D, Liebson P, Mitchell B et al. Mortality and morbidity in patients
aimed at translating the results of clinical trials into receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia
recommendations for clinical practice, based on their Suppression Trial (CAST). N Engl J Med 1991;324:7818.
scientific merit. Within the individual countries there are 4. Myerburg R, Mitrani R, Interian A et al. Interpretation of outcomes of
people in responsible positions in their respective gov- antiarrhythmic clinical trials. Design features and population impact.
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5. Bassand JP. Improving the quality and dissemination of guidelines: the
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What they require from us as physicians is clarity and 6. Cabana MD, Rand CS, Powe NR et al. Why don't physicians follow
consensus on the validity and strength of the data sup- clinical practice guidelines? A framework for improvement. JAMA
porting a new medical indication or therapy. If members 1999;282:145865.
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The legal implications of medical guidelines a Task Force of the
to influence their judgments on the validity and strength European Society of Cardiology. Eur Heart J 1999;20:11527.
of such data, they would be diverging from their real 8. Bassand JP, Ryden L. Guidelines: making the headlines or confined to
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