Breast cancer is the leading cause of cancer mortality in Brazilian women. The new Brazilian guidelines for early detection of breast cancer were drafted on the basis of systematic literature reviews on the possible harms and benefits of various early detection strategies. This article aims to present the recommendations and update the summary of evidence, discussing the main controversies. Breast cancer screening recommendations (in asymptomatic women) were: (i) strong recommendation against mammogram screening in women under 50 years of age; (ii) weak recommendation for mammogram screening in women 50 to 69 years of age; (iii) weak recommendation against mammogram screening in women 70 to 74 years of age; (iv) strong recommendation against mammogram screening in women 75 years or older; (v) strong recommendation that screening in the recommended age brackets should be every two years as opposed to shorter intervals; (vi) weak recommendation against teaching breast self-examination as screening; (vii) absence of recommendation for or against screening with clinical breast examination; and (viii) strong recommendation against screening with magnetic resonance imaging, ultrasonography, thermography, or tomosynthesis alone or as a complement to mammography. The recommendations for early diagnosis of breast cancer (in women with suspicious signs or symptoms) were: (i) weak recommendation for the implementation of awareness-raising strategies for early diagnosis of breast cancer; (ii) weak recommendation for use of selected signs and symptoms in the current guidelines as the criterion for urgent referral to specialized breast diagnosis services; and (iii) weak recommendation that every breast cancer diagnostic workup after the identification of suspicious signs and symptoms in primary care should be done in the same referral center.
The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.
OBJECTIVE:To assess survival rates and clinical (pretreatment) prognostic factors in patients with clinically localized adenocarcinoma of the prostate. METHODS:Hospital cohort including 258 patients registered in the National Cancer Institute, in the city of Rio de Janeiro, Southeastern Brazil, from 1990 to 1999. Five-and ten-year survival functions were estimated using the KaplanMeier estimator from the histological diagnosis (initial time of follow-up) to death due to prostate cancer (events). Prognostic factors were assessed using hazard ratios (HR) with confidence intervals of 95%, following the Cox's proportional hazards model. The assumption of proportionality of risks was tested using Schoenfeld residuals and the impact of outliers in the model fitness was analyzed using martingale and score residuals. RESULTS:Of 258 patients studied, 46 died during follow-up. The overall fiveyear and ten-year survival rates were 88% and 71%, respectively. A Gleason score higher than 6, PSA levels higher than 40 ng/mL, B2 stage, and white skin color were independent markers of poor prognosis. CONCLUSIONS:Gleason score, digital rectal examination and PSA levels have great predictive power and must be used in pretreatment risk stratification of patients with localized prostate cancer.
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.
The objective of the current article is to present the main challenges for the implementation of the new recommendations for early detection of breast cancer in Brazil, and to reflect on the barriers and the strategies to overcome them. The implementation of evidence-based guidelines is a global challenge, and traditional strategies based only on disseminating their recommendations have proven insufficient for changing prevailing clinical practice. A major challenge for adherence to the new guidelines for early detection of breast cancer in Brazil is the current pattern in the use of mammographic screening in the country, which very often includes young women and a short interval between tests. Such practice, harmful to the population's health, is reinforced by the logic of defensive medicine and the dissemination of erroneous information that overestimates the benefits of screening and underestimates or even omits its harms. In addition, there is a lack of policies and measures focused on early diagnosis of symptomatic cases. To overcome these barriers, changes in the regulation of care, financing, and implementation of shared decision-making in primary care are essential. Audit and feedback, academic detailing, and the incorporation of decision aids are some of the strategies that can facilitate implementation of the new recommendations.
screening actions and early diagnosis in disagreement with the Ministry of Health's recommendations may compromise its effectiveness and entail greater risk to women; it is necessary to improve professional's adherence to screening guidelines, as well as enhance the control and assessment of the health services.
Objetivo: Analisar efeitos de curto prazo da pandemia de COVID-19 no rastreamento, investigação diagnóstica e tratamento de câncer no Brasil. Métodos: Estudo descritivo, utilizando-se dados do Sistema de Informações Ambulatoriais e do Sistema de Informações Hospitalares do SUS, e Sistema de Informação do Câncer. Calculou-se a variação percentual mensal de procedimentos de rastreamento, diagnóstico e tratamento de câncer, em 2019 e 2020, além do tempo esperado para realização dos exames relacionados aos cânceres do colo do útero e mama. Resultados: Em 2020, houve redução de 3.767.686 (-44,6%) exames citopatológicos, 1.624.056 (-42,6%) mamografias, 257.697 (-35,3%) biópsias, 25.172 cirurgias oncológicas (-15,7%) e 552 (-0,7%) procedimentos de radioterapia, comparando-se a 2019. Os intervalos de tempo para realização de exames de rastreamento de câncer do colo uterino e mama foram pouco afetados. Conclusão: Ações de controle do câncer foram afetadas pela pandemia, sendo necessárias estratégias para mitigar efeitos dos atrasos no diagnóstico e tratamento.
OBJETIVO Analisar o impacto da pandemia de covid-19 sobre a mortalidade por câncer e por doenças cardiovasculares (DCV) como causa básica e comorbidade no Brasil e em suas regiões em 2020. MÉTODOS Foram utilizadas as bases de dados de 2019 e 2020 do Sistema de Informações de Mortalidade (SIM), analisando os óbitos ocorridos entre março e dezembro de cada ano que tiveram o câncer e as DCV como causa básica ou como comorbidade. Também foram analisados os óbitos por covid-19 em 2020. Para o cálculo da Razão de Mortalidade Padronizada (RMP) e estimativa do excesso de mortes, os dados de 2019 foram considerados como padrão. RESULTADOS Entre março e dezembro de 2020 ocorreram no Brasil 181.377 mortes por câncer e 291.375 mortes por doenças cardiovasculares, indicando redução de 9,7% e de 8,8%, respectivamente, em relação ao mesmo período do ano anterior. O padrão foi mantido nas cinco regiões brasileiras, com menor variação para o câncer (-8,4% na Região Sul a -10,9% na Região Centro-Oeste). Para as DCV houve uma maior variação, de -2,2% na Região Norte até -10,5 nas regiões Sudeste e Sul. No mesmo período de 2020, essas enfermidades foram classificadas como comorbidade em 18.133 óbitos por câncer e 188.204 óbitos por doenças cardiovasculares, indicando um excesso proporcional, se comparado aos dados de 2019, de 82,1% e 77,9%, respectivamente. Esse excesso foi mais expressivo na Região Norte, com razão de 2,5 entre mortes observadas e esperadas, para as duas condições estudadas. CONCLUSÕES O excesso de óbitos por câncer e DCV como comorbidade em 2020 pode indicar que a covid-19 teve um importante impacto entre pacientes portadores dessas condições.
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