EDITORIAL

Guidelines: unity and balance

Wanderley Marques Bernardo^I; António Vaz Carneiro^II; Edmund Chada Baracat^III

^IProfessor de Graduação, Pós-Graduação e Coordenador dos Núcleos de Medicina Baseada em Evidência nas Faculdades de Medicina da Universidade de São Paulo e UNILUS. Coordenador Técnico do Programa Diretrizes AMB/CFM, São Paulo, SP

^IIMD, PhD, FACP - Centro de Estudos de Medicina Baseada na Evidência, Faculdade de Medicina de Lisboa, Portugal

^IIIProfessor Titular de Ginecologia da Faculdade de Medicina da Universidade de São Paulo - USP e Diretor Científico da Associação Médica Brasileira, São Paulo, SP

Around a year ago, I contributed an editorial entitled "Clinical guidelines in Brazilian health system"¹ commenting on the article "Utilization of clinical guidelines by health plan operators in the Brazilian health system",² which was published in this journal and provided an analysis of the implementation of clinical guidelines, especially related to cardiology, in the Brazilian Health System. The authors of the above mentioned article concluded that, in spite of the fact that the use of guidelines in the decision making process was rare, the cardiovascular guidelines were the most frequently used.

Also regarding cardiology, the assessment of the guidelines of the American College of Cardiology and American Heart Association was recently published in the JAMA,³ and the conclusions of such assessment highlighted that the recommendations of these guidelines were largely based on lower levels of evidence or expert opinion. This article also suggests that medical researchers should conduct clinical trials with the purpose of providing those areas of cardiology lacking evidence with information and that physicians should be cautious when considering recommendations that are not based on solid evidence. Finally, the authors of the article added that the guideline writing process should consider the impact of weak evidence on the clinical practice.

Despite being based on a systematic review of the literature, some methodological aspects of the guideline writing process allow the expression of interests in an unbalanced manner, which triggers conflicts. Some of these aspects are: establishment of rates and recommendations lacking support from evidence, failure in recognizing the limits of the scientific information available, failure in identifying the population benefited, disregard of the several different points of view, such as that of the health system, and ambiguous expression of clinical doubt, evidence, and recommendation.

In an oversimplified and tendentious manner, the literature, the media and many opinion makers have attempted to establish a direct critical relation between the results of research, the several interests involved and the health system based solely on the content and method employed in the design of guidelines. However, aspects and elements having the same or a stronger impact on the results of the health care provided to patients by the health system are completely disregarded by such analysis:

Aspects related to the relation between scientific evidence and clinical practice: A countless amount of clinical scenarios have characteristics that hinder their analysis by means of ideally strong study designs; however, on the other hand, several new technologies could be easily tested using adequate study designs although they are imposed by means of uncritical and populist marketing. Furthermore, the local assessments of effectiveness are not even mentioned as the main source of support for the validation of solid evidence in the clinical practice;

Aspects related to the clinical practice: Decisions made by physicians vary a lot and they depend on certain aspects such as work conditions, skills acquired, continuous professional updating, personal expectations, level of experience, and reflexive ability. Knowing the original concepts of evidence-based medicine is essential to make physicians immune against marketing and the owners of knowledge;

Aspects related to the priorities and points of view of the health system managers: International health care programs are flooded with thousands of new options in terms of diagnosis and treatment; however, they do not have the necessary structural conditions and time to develop strategies and establish priorities with regard to the incorporation of these new technologies. With the exclusive focus on the amount of financial resources, the natural trend is reducing criticism to the point that there is no more criticism, resulting in immobilization of decisions, leaving the minorities unprotected, reducing equity, stimulating the need of court decisions, with lack of investments in phase IV research, and looking for answers in a literature that is not related to any health care process;

Aspects related to the point of view of the patients targeted by the recommendations: Knowing how the flow of the decision process will affect the real patient and fulfilling all the different local needs is only possible by listening to and directly or indirectly considering (by means of medical experience) the points of view and conditions of the population involved, including those patients in special situations. Education and relationship processes involving the population may also increase adherence to ethical and evidence-based decisions and reduce the delusion caused by unethical sensationalism based on external interests.

The critical assessment of guidelines whose writing process is not related to these aspects does not contribute to the quality of the health care provided to the patient. On the contrary, criticism focusing exclusively on the method provides arguments to those who do not wish to have an instrument that shows the weaknesses of the scientific evidence used to support many of the current medical practices, or who, due to lack of knowledge, feel that their practice is being restricted.

The design of evidence-based clinical guidelines should be part of a process of health care quality, focused on the implementation, guaranteeing the minimal conditions that will enable appropriate understanding and use of their content and recommendations. This is only feasible with the engagement of all those involved, respecting ethical procedures and focusing on the patient while joining different interests to perform the following actions:

Design of guidelines that take into consideration clinical judgment, knowledge about the best evidence and fulfillment of patients' needs;

Medical education initiatives, providing instruments that facilitate the decision making process, as well as the understanding of the quality of evidence, and the patients' benefits and risks;

Initiatives that promote the education of the population, providing believable information that facilitates adherence to the proposals of decision and to the relationship between patients, physicians, and the health system;

Involvement of the health system managers in the guideline writing process, incorporating the focus on applicability and also on the controlled use of the recommendations, enabling the detection of limitations and benefits;

Alignment of the actions that regulate the health system with the content of the guidelines, valuing efficacy and, mainly, effectiveness, as an instrument to make decisions regarding the recognition of new procedures and treatments.

There is not one single action able to cause the impact expected by all those involved: to reduce conflicts, to rationalize costs, to increase benefits, to decrease risk, and mainly to guarantee equity.

References

• 1. Bernardo WM. Clinical guidelines in brazilian health system. Rev Assoc Med Bras. 2008; 54: 377.
• 2. Escosteguy CC, Portela MC, Lima SML, Ferreira VMB, Vasconcellos MTL, Brito C. Utilização de diretrizes clínicas em cardiologia na saúde suplementar no Brasil. Rev Assoc Med Bras. 2008; 54: 400-5.
• 3. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC Jr. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA 2009; 301: 831-41.

Diretrizes: unidade e equilíbrio

Wanderley Marques Bernardo^I; António Vaz Carneiro^II; Edmund Chada Baracat^III

Publication Dates

• Publication in this collection
  17 Nov 2009
• Date of issue
  2009