1University Hospital Jean Minjoz, Boulevard Fleming, 25030 Besançon, France
2Molecular Cardiology, Maugeri Foundation, Pavia, Italy
3Silesian School of Medicine, Katowice, Poland
Received 14 October 2004; revised 1 February 2005; accepted 3 February 2005; online publish-ahead-of-print 3 May 2005.
* Corresponding author. Tel: +33 381 668 539; fax: +33 381 668 582. E-mail address: jean-pierre.bassand{at}ufc-chu.univ-fcomte.fr
Abstract
Implementing clinical practice guidelines improves outcomes. This has been shown by several large scale registries. However, in spite of this, guidelines are poorly implemented in clinical practice for a wide variety of reasons. We examine the reasons behind the low uptake of guidelines into routine medical practice. Many physicians are simply not aware that guidelines exist; or they do not believe in them; or they simply do not care to implement them. Economic and social factors may also influence uptake of guidelines. It is the role of professional societies to disseminate best scientific knowledge, and ensure optimum implementation of guidelines. This can be achieved through educational activities and CME credit. Close collaboration between the profession, health authorities, and maybe even the industry could improve uptake of clinical practice guidelines, and thereby improve patient outcome.
Key Words: Guidelines Implementation Evidence-based medicine
Although it has been proved that implementing guidelines improve outcomes, many physicians ignore recommendations issued by professional organizations for the care of their patients and rely more on their own impressions rather than on the best evidence for treatment. This could be called impressionist or eminence-based medicine vs. evidence-based medicine. In fact, over the last 30 years, a huge number of clinical randomized trials (CRTs) have been carried out in the field of cardiology, and many have tended to validate and prove the efficacy of different therapeutic methods, drug therapies, diagnostic procedures, or interventions. The information provided by these trials has been completed by registries, meta-analyses, and observational studies. Taken together, the flow of information towards cardiologists has become so abundant that it has become necessary to confront and summarize the available information in easy-to-read documents, presenting the state-of-the-art for management of disease. These documents are usually called guidelines for clinical practice and they are prepared by experts nominated by scientific societies acting in accordance with strict protocols.1 In addition to the main document, which is usually quite extensive, derivative products are also being developed, such as summaries, pocket versions, or PDA downloadable versions of the guidelines: this material is often freely available to the physicians.
This said, guidelines have their own limitations, owing to the very nature of the CRTs that were used as the basis for the recommendation for treatment. Certain subsets of patients are underrepresented or excluded in CRTs. Comparisons between populations of CRTs and registries have often shown large discrepancies, with some patient groups being ignored or underrepresented, particularly women, elderly patients, patients with renal failure, and certain ethnic groups. In acute coronary syndromes, patients included in registries like GRACE2,3 and Euro Heart Survey ACS4 are usually older and sicker and suffer from more co-morbidities than patients included in CRTs such as ASSENT 2 and 3, ESSENCE, and TIMI 11B.58
It is obvious that guidelines implementation effectively improves outcome. In the setting of ST-segment elevation myocardial infarction (MI), German registries have shown that over time, a gradual improvement in the implementation of guidelines impacted positively on vital prognosis.9 In CRUSADE, in the setting of non-ST-segment elevation MI, early revascularization led to better outcome.10 In a Swedish registry, it was shown that revascularization as well as the early prescription of statins improved prognosis of patients with acute coronary syndromes.11 In non-ST-segment elevation MI, the National Registry of Myocardial Infarction 4 (NRMI4) showed that among 60 770 patients, all potential candidates for IIb/IIIa inhibitors, only 25% actually received these inhibitors during the first 24 h after admission, despite a Grade 1A recommendation in this indication. In this registry, early use of IIb/IIIa inhibitors significantly reduced mortality at 9 days, the greater the use, the lower the mortality.12 Many other examples exist in other areas of our discipline.
This being the case, it is hard to understand why guidelines are so poorly adopted. Surveys have shown that a limited part of the target audience actually knows about the existence of guidelines, and even when the physicians are aware that guidelines exist, they do not necessarily put them into medical practice.13 Sometimes physicians feel they are flooded by too much information and a plethora of guidelines.14
Economic constraints within a given healthcare system or hospital could also explain why guidelines are poorly or incompletely put into practice. It is also true that in some instances, physicians do not implement guidelines simply because they do not believe in them. Nihilism on the part of some physicians, even when faced with the best of evidence that a therapeutic option is highly recommended, could also partially explain this attitude.15 This means that treatments with lifesaving potential are under-prescribed for a wide variety of reasons, valid or otherwise. The medical literature abounds with examples. For example, the treatment of risk factors for coronary artery disease (EuroAspire I and II),16,17 which clearly showed that statins, beta-blockers, angiotensin-converting enzyme (ACE)-inhibitors, and antiplatelet agents are not sufficiently prescribed in patients with documented coronary artery disease. Again, this is also the case for IIb/IIIa inhibitors, which are prescribed in only a small proportion of the eligible target population of non-ST-segment elevation MI at a best estimate.12 In this particular case, it would appear that physicians tend to think that these drugs are costly and save only units of CK or nanograms of troponin, whereas in actual fact, IIb/IIIa inhibitors save lives, according to this registry. The medical literature abounds with examples of under-use of procedures or treatment with potentially life-saving effects.1823
In addition, it would even appear that in acute coronary syndromes, there is an inverse relation between the severity of the patient's initial presentation and the level of compliance with the guidelines, i.e. the more severe the initial presentation, the less likely the patient is to receive the most efficacious treatment.24 This has been shown in several reports, in which the sicker patients do not receive the best possible treatment, such as the elderly in CRUSADE10 and patients with advanced kidney disease in APPROACH.15
Equally troublesome is the fact that in routine practice, physicians sometimes rely on results obtained on surrogate endpoints or in unvalidated observations from some clinical trials, as a basis for their treatment strategy. A post hoc analysis of the CAPTIM study showed that when thrombolytic treatment was administered within the first 2 h following onset of symptoms, the result was as good as when patients were transferred for percutaneous coronary intervention (PCI).25 Despite the fact that this was a post hoc analysis, and that the result was only marginally significant, this hypothesis led to the widespread implementation of this strategy without further validation. More troublesome is the case of the so-called facilitated PCI. In some countries, the use of half-dose thrombolytic treatment plus full dose IIb/IIIa inhibitors in the pre-hospital treatment of acute MI during the transportation of the patient to the cathlab is advocated by some and is already being implemented. This approach has never been validated and furthermore has been shown in two large mega-trials to induce excess of bleeding.6,26 This strategy is currently being re-investigated in the pre-hospital setting. However, we cannot assume that it would result in better patient outcome, nor can we assume that the same drawbacks previously observed will not be observed in the ongoing trials.27 This basically means that in certain circumstances, despite the best evidence, physicians continue to rely on their personal experience and on the impression that the therapeutic approach they are going to propose to their patient is the best. Again, this could be called impressionist medicine, or perhaps even eminence-based medicine, and we know that it is detrimental.
The question, therefore, is how to counteract this and make physicians understand that the practice of medicine cannot rely only on the training received in medical school. The volume of information imparted during medical training is an important basis for the future, and we must constantly strive to increase our knowledge and keep abreast of new information. Guidelines should then be regarded as an important source for continuing medical education programmes. Guidelines are not written as an academic exercise for the authors, rather they should be regarded as pivotal educational tools to learn about the evidence provided in support of or against procedures, drugs, and devices used for patients' treatment. Guidelines, therefore, must be implemented, taking into account the particularities of the healthcare system in which a given physician works.
It is true that complete implementation of guidelines might not always be possible, given the various healthcare systems and the differing economic contexts. Variations between countries as regards invasive cardiac procedures and other therapies described in some reports could well be linked to the economic context.2,3,28 So far, the European Society of Cardiology has adopted a policy of describing the best available scientific evidence in its guidelines, and this must remain separate from the economic context. A costbenefit analysis should be performed at the national level.29
It is the responsibility of professional organizations like the European Society of Cardiology to reflect on how best to make guidelines impact on medical practice. This can be achieved by educational activities that provide credit for continuing medical education. It is the responsibility of professionals at the national level to influence reimbursement agencies and governments, to make sure that these guidelines are implemented, with incentives towards medical practice that apply evidence-based medicine in their treatment schemes. Implementation programmes in Europe will have to be planned with the involvement of national societies. In North America, it has already been shown that implementation programmes (Guidelines Applied in Practice, GAP project) have resulted in better care and lead to improved outcomes in patients.30 However, they require enormous investments both in terms of human and financial resources. This could be a common endeavour on the part of the profession, the health authorities, and the industry and deserves further consideration.
Footnotes
The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.
References