Migowski Arn, Stein Airton Tetelbom, Ferreira Camila Belo Tavares, Ferreira Daniele Masterson Tavares Pereira, Nadanovsky Paulo
Instituto Nacional de Câncer José Alencar Gomes da Silva, Rio de Janeiro, Brasil.
Instituto Nacional de Cardiologia, Rio de Janeiro, Brasil.
Cad Saude Publica. 2018 Jun 21;34(6):e00116317. doi: 10.1590/0102-311X00116317.
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.
临床指南传统上是通过专家共识制定的。近年来，由于在推广其广泛使用的临床试验中发现存在偏差，乳腺钼靶筛查的益处受到了质疑。与此同时，越来越多关于乳腺钼靶筛查相关危害的证据也要求采用一种新方法，要考虑到益处的不确定性以及筛查的获益与可能危害之间的平衡。本文讨论了巴西乳腺癌早期检测新指南的制定情况，详细介绍了起草方法以及新建议的影响。新方法的特点包括系统的文献综述、证据有效性评估以及每种干预措施的风险与益处之间的平衡，确保起草过程具有更高的透明度、可重复性和有效性。新指南还包括针对有可疑体征和症状病例的建议。作者详细讨论了该方法与传统专家共识模式相比的优势，以及该方法的局限性和缺点。他们还探讨了各种决策的影响，例如研究设计的选择、筛查有效性结果、过度诊断的定义以及计算方法等。
