Abstract
Clinical guidelines are traditionally drafted by expert consensus. The benefits of mammographic screening have been questioned in recent years, owing to biases detected in the clinical trials that popularized its widespread use. Meanwhile, growing body of evidence on harms associated with mammographic screening also required a new approach, taking into account the uncertainties on the benefits and a balance between the gains and possible harms from screening. This article discusses the development of the new guidelines for early detection of breast cancer in Brazil, with details on the drafting methods and implications for the new recommendations. The new methodology features systematic literature reviews, assessment of the validity of the evidence, and the balance between each intervention's risks and benefits, ensuring greater transparency, reproducibility, and validity in the drafting process. The new guidelines also include recommendations for cases with suspicious signs and symptoms. The authors provide a detailed discussion of the advantages of the approach as compared to the traditional expert consensus model, as well as the methods' limitations and disadvantages. They also address the implications of various decisions, such as choices on study designs, screening effectiveness outcomes, definition of overdiagnosis, and methods for calculation.
Highlights
Clinical guidelines essentially aim to assist evidence-based decision-making, both for health professionals and health system users and policymakers
The Brazilian Ministry of Health has made an effort in recent years to produce clinical guidelines and replace the country’s hegemonic model, based mainly on expert opinions and narrative literature reviews
The 2004 consensus did not recommend teaching breast self-examination, it maintained the traditional recommendation of annual screening with clinical breast examination in women 40 years or older 6. The evidence for this recommendation is very weak 11, other similar recommendations are found in the guidelines of developing countries in Latin America, Africa, and Asia 3,10,12,13, generally including women under 50 years in the target population. Indirect criteria, such as a younger population age structure than in Europe and North America, less access to mammography, and lower accuracy of this exam in young women, as well as habitually later tumor detection in these countries, are the justifications usually presented for this recommendation of annual screening with clinical examination
Summary
Clinical guidelines essentially aim to assist evidence-based decision-making, both for health professionals and health system users and policymakers. The Brazilian Ministry of Health has made an effort in recent years to produce clinical guidelines and replace the country’s hegemonic model, based mainly on expert opinions and narrative literature reviews. This effort resulted in the creation of the so-called “Clinical Protocols and Treatment Guidelines”, which have succeeded both in increasing the country’s prevailing quality standard for guidelines and the publication of a wide range of guidelines on diverse themes in a short space of time, generally broad enough to cover a major portion of the line of care for each respective disease. This article aims to present the development process of the new guidelines for early detection of breast cancer in Brazil, with details on the methods used and their implications for the new recommendations
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