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O MINISTRO DE ESTADO DA SAÚDE, no uso das atribuições que lhe conferem os incisos I e II do parágrafo único do art. 87 da Constituição, e Considerando o art. 15, inciso XI, da Lei nº 8.080, de 19 de setembro de 1990 (Lei Orgânica da Saúde), que dispõe sobre a atri- buição da União, dos Estados, do Distrito Federal e dos Municípios de exercer, em seu âmbito administrativo, a elaboração de normas para regular as atividades de serviços privados de saúde, tendo em vista a sua relevância pública; Considerando o art. 16, inciso III, alínea "d", da Lei Orgânica da Saúde, que confere à direção nacional do Sistema Único de Saúde (SUS) a competência para definir e coordenar o sistema de vigilância sanitária; Considerando o art. 16, inciso XII, da Lei Orgânica da Saúde, que confere à direção nacional do Sistema Único de Saúde (SUS) a competência para controlar e fiscalizar procedimentos, produtos e substâncias de interesse para a saúde;Considerando que a gestão de riscos voltada para a qualidade e segurança do paciente englobam princípios e diretrizes, tais como a criação de cultura de segurança; a execução sistemática e estruturada dos processos de gerenciamento de risco; a integração com todos processos de cuidado e articulação com os processos organizacionais do serviços de saúde; as melhores evidências disponíveis; a transparência, a inclusão, a responsabilização e a sensibilização e capacidade de reagir a mudanças; e Considerando a necessidade de se desenvolver estratégias, produtos e ações direcionadas aos gestores, profissionais e usuários da saúde sobre segurança do paciente, que possibilitem a promoção da mitigação da ocorrência de evento adverso na atenção à saúde, resolve
To compare the risks of developing invasive squamous cell cervical cancer associated with screening intervals of 1, 2, and 3 years after a negative cervical smear. We conducted a matched case-control study of invasive squamous cell cervical cancer patients (n = 482) diagnosed between 1983 and 1995 among long-term members of a large health maintenance organization. Controls were matched for age, length of membership, and race (n = 934). Screening interval was time between the last negative cervical smear and the case diagnosis date. The main outcome measure was the relative odds of invasive disease associated with 1-year, 2-year, and 3-year intervals. The odds ratio for a 2-year versus a 1-year interval was 1.72 (95% confidence interval 1.12, 2.64, P =.013) and for a 3-year versus a 1-year interval was 2.06 (95% confidence interval 1.21, 3.50, P =.007). The odds ratio for a 3-year versus a 2-year interval was 1.20 (95% confidence interval 0.65, 2.21, P =.561). Controlling for ever having had an abnormal cervical smear or a previous consecutive negative smear did not substantially change these results. In this large health plan, the relative risks of invasive squamous cell cervical cancer were significantly greater for 2-year and 3-year cervical cancer screening intervals compared with a 1-year interval, but not for a 3-year interval compared with a 2-year interval. Our findings need to be placed in the context of the low absolute risks of developing invasive cervical cancer during the first 3 years after a negative cervical smear before making policy recommendation.
Although contemporary guidelines suggest that the intervals between Papanicolaou tests can be extended to three years among low-risk women with previous negative tests, the excess risk of cervical cancer associated with less frequent than annual screening is uncertain. Among 31,728 women 30 to 64 years of age who had had three or more consecutive negative tests, the prevalence of biopsy-proven cervical intraepithelial neoplasia of grade 2 was 0.028 percent and the prevalence of grade 3 neoplasia was 0.019 percent; none of the women had invasive cervical cancer. According to our model, the estimated risk of cancer with annual Papanicolaou tests for three years was 2 in 100,000 among women 30 to 44 years of age, 1 in 100,000 among women 45 to 59 years of age, and 1 in 100,000 among women 60 to 64 years of age; these risks would be 5 in 100,000, 2 in 100,000, and 1 in 100,000, respectively, if screening were performed once three years after the last negative test. To avert one additional case of cancer by screening 100,000 women annually for three years rather than once three years after the last negative test, an average of 69,665 additional Papanicolaou tests and 3861 colposcopic examinations would be needed in women 30 to 44 years of age and an average of 209,324 additional Papanicolaou tests and 11,502 colposcopic examinations in women 45 to 59 years of age. As compared with annual screening for three years, screening performed once three years after the last negative test in women 30 to 64 years of age who have had three or more consecutive negative Papanicolaou tests is associated with an average excess risk of cervical cancer of approximately 3 in 100,000.
Epidemiological studies based on cervical cytopathology have aroused widespread interest since it was realized that they could be a useful tool for measuring the effectiveness of screening programs and defining practical measures for the prevention of invasive neoplasms and deaths. In the present article, published evidence from screening programs, cohort investigations and case-control studies is reviewed, and possibilities for further analyses and applications are discussed. In particular, when estimates of the relative protections conveyed by Pap smear from various case-control studies conducted on different populations and using different criteria of selection were pooled, a surprisingly close concordance emerged, with overall risk estimates of invasive cervical cancer of 0.42 for women reporting one smear, and of 0.20 for two or more smears in the past. This protection appeared to be long-lasting in a considerable proportion of cases, since the major determinant of invasive cancer risk was the number of previous smears rather than the interval since last smear, and a noticeable residual effect was evident even more than 10 years after the last smear. Besides providing a measure of the effectiveness of cytological screening and helping define the optimal frequency of screening using the limited resources available, case-control studies should permit accurate estimates of the sensitivity of the test and quantify the probability of transition and the duration of various stages of the neoplastic process, i.e., permit a better understanding of the natural history of the disease.