Modelo de Treinamento para Inserção de Dispositivos Intrauterinos / Training Model for Intrauterine Device Insertion

RESUMO Introdução Aprender praticando exclusivamente em pacientes é cada vez menos aceitável no ensino médico. O ensino baseado em simulação é uma ferramenta capaz de gerar aquisição de habilidades e competências de forma eficaz e em ambiente controlado, sem causar dano ao paciente. A Ginecologia é uma especialidade médica que depende de treinos bem estruturados, e entre os procedimentos ginecológicos destaca-se a inserção dos dispositivos intrauterinos de cobre. Para aumentar a oferta deste método contraceptivo, é preciso capacitação adequada dos profissionais de saúde. Os simuladores físicos imitam a realidade e auxiliam na aquisição de habilidades e competências, tornando de fundamental importância o ensino baseado em simulação para inserção de dispositivos intrauterinos. Objetivo Desenvolver um modelo de treinamento para aquisição de habilidades na inserção de dispositivos intrauterinos. Método Foi desenvolvido um simulador (modelo de utilidade) para inserção de dispositivos intrauterinos, composto por uma base rígida retangular com 17 cm x 15 cm x 21 cm (A x L x P), com peso de 420 gramas, confeccionada em acrinolitrilabutadieno estireno (ABS). Acoplada a este suporte, existe uma estrutura semiflexível, composta por um protótipo de canal vaginal, com colo uterino e região vulvar semelhantes à anatomia humana, confeccionada em ácido poliático flexível (PLA-FLEX). Foram selecionados 15 médicos residentes de Ginecologia e Obstetrícia para treinamento teórico-prático com o simulador proposto pelo estudo para capacitação em inserção de dispositivo intrauterino de cobre. O simulador utilizado neste estudo foi avaliado e validado por especialistas em Ginecologia e Obstetrícia. Resultados Houve melhora estatisticamente significante dos parâmetros avaliados comparando-se a avaliação inicial (pré-treinamento) e final (pós-treinamento) dos residentes, com homogeneidade no desempenho final. Na avaliação inicial, apenas 40% dos dispositivos ficaram bem posicionados, em contraste com 93,3% de sucesso de inserção após implementado o modelo de treinamento. Conclusão Desenvolveu-se um modelo de treinamento baseado em simulação que contribuiu para a aquisição de habilidades de inserção de dispositivo intrauterino de cobre quando aplicado aos residentes de Ginecologia e Obstetrícia.

ABSTRACT Introduction Learning by practicing exclusively on patients is becoming increasingly unacceptable in medical training. Simulation-based teaching is a tool capable of generating skills and competences efficiently and in a controlled environment, without causing harm to patients. Gynecology is a medical specialty that depends on well-structured training; an important gynecological procedure is the insertion of copper intrauterine devices. In order to increase the supply of this contraceptive method to the population the relevant health professionals need to be adequately trained. Physical simulators imitate reality and assist in skills acquisition. Therefore, structured training based on simulation to teach the insertion of intrauterine devices is of fundamental importance to the teaching of gynecology. Objective To develop a training model for skills acquisition for the insertion of intrauterine devices. Method A simulator (utility model) was developed for the insertion of intrauterine devices, composed of a rigid rectangular base made of acrylonitrile butadiene styrene, measuring 17 cm x 15 cm x 21 cm and weighing 420 g. Attached to this support is a semi-flexible structure made of flexible polylactic acid, composed of a prototype vaginal canal, with a uterine cervix and vulvar region, similar to the human anatomy. Fifteen gynecology and obstetrics residents were selected for theoretical and practical training with the simulator proposed by the study for the training of intrauterine copper device insertion. The simulator used in this study was evaluated by specialists in gynecology and obstetrics, who validated it for use in teaching. Results A statistically significant improvement was found in the evaluated parameters, comparing the initial evaluation and the final evaluation of the residents, whose final performances displayed homogeneity. In the initial evaluation only 40% of the devices were well positioned, in contrast to a 93.3% rate of successfull insertion following implementation of the training model. Conclusion A training model was developed to simulate the performance of copper intrauterine device insertion and contributed to the acquisition of skills for this task when applied to gynecology and obstetrics residents.

Annual national direct and indirect cost estimates of the prevention and treatment of cervical cancer in Brazil.

OBJECTIVE: To estimate the annual direct and indirect costs of the prevention and treatment of cervical cancer in Brazil. METHODS: This cost description study used a "gross-costing" methodology and adopted the health system and societal perspectives. The estimates were grouped into sets of procedures performed in phases of cervical cancer care: the screening, diagnosis and treatment of precancerous lesions and the treatment of cervical cancer. The costs were estimated for the public and private health systems, using data from national health information systems, population surveys, and literature reviews. The cost estimates are presented in 2006 USD. RESULTS: From the societal perspective, the estimated total costs of the prevention and treatment of cervical cancer amounted to USD $1,321,683,034, which was categorized as follows: procedures (USD $213,199,490), visits (USD $325,509,842), transportation (USD $106,521,537) and productivity losses (USD $676,452,166). Indirect costs represented 51% of the total costs, followed by direct medical costs (visits and procedures) at 41% and direct non-medical costs (transportation) at 8%. The public system represented 46% of the total costs, and the private system represented 54%. CONCLUSION: Our national cost estimates of cervical cancer prevention and treatment, indicating the economic importance of cervical cancer screening and care, will be useful in monitoring the effect of the HPV vaccine introduction and are of interest in research and health care management.

Cost-effectiveness analysis of introducing universal human papillomavirus vaccination of girls aged 11 years into the National Immunization Program in Brazil.

OBJECTIVES: To evaluate the impact and cost-effectiveness of introducing universal human papillomavirus (HPV) vaccination into the National Immunization Program (NIP) in Brazil. METHODS: The Excel-based CERVIVAC decision support model was used to compare two strategies: (1) status quo (with current screening program) and (2) vaccination of a cohort of 11-year-old girls. National parameters for the epidemiology and costs of cervical cancer were estimated in depth. The estimates were based on data from the health information systems of the public health system, the PNAD 2008 national household survey, and relevant scientific literature on Brazil. Costs are expressed in 2008 United States dollars (US$), and a 5% discount rate is applied to both future costs and future health benefits. RESULTS: Introducing the HPV vaccine would reduce the burden of disease. The model estimated there would be 229 deaths avoided and 6677 disability-adjusted life years (DALYs) averted in the vaccinated cohort. The incremental cost-effectiveness ratios (ICERs) per DALY averted from the perspectives of the government (US$ 7663), health system (US$ 7412), and society (US$ 7298) would be considered cost-effective, according to the parameters adopted by the World Health Organization. In the sensitivity analysis, the ICERs were most sensitive to variations in discount rate, disease burden, vaccine efficacy, and proportion of cervical cancer caused by types 16 and 18. However, universal HPV vaccination remained a cost-effective strategy in most variations of the key estimates. CONCLUSIONS: Vaccine introduction could contribute additional benefits in controlling cervical cancer, but it requires large investments by the NIP. Among the essential conditions for attaining the expected favorable results are immunization program sustainability, equity in a population perspective, improvement of the screening program, and development of a surveillance system.

Annual national direct and indirect cost estimates of the prevention and treatment of cervical cancer in Brazil

OBJECTIVE: To estimate the annual direct and indirect costs of the prevention and treatment of cervical cancer in Brazil. METHODS: This cost description study used a "gross-costing" methodology and adopted the health system and societal perspectives. The estimates were grouped into sets of procedures performed in phases of cervical cancer care: the screening, diagnosis and treatment of precancerous lesions and the treatment of cervical cancer. The costs were estimated for the public and private health systems, using data from national health information systems, population surveys, and literature reviews. The cost estimates are presented in 2006 USD. RESULTS: From the societal perspective, the estimated total costs of the prevention and treatment of cervical cancer amounted to USD $1,321,683,034, which was categorized as follows: procedures (USD $213,199,490), visits (USD $325,509,842), transportation (USD $106,521,537) and productivity losses (USD $676,452,166). Indirect costs represented 51% of the total costs, followed by direct medical costs (visits and procedures) at 41% and direct non-medical costs (transportation) at 8%. The public system represented 46% of the total costs, and the private system represented 54%. CONCLUSION: Our national cost estimates of cervical cancer prevention and treatment, indicating the economic importance of cervical cancer screening and care, will be useful in monitoring the effect of the HPV vaccine introduction and are of interest in research and health care management. .

Seroprevalence of human papillomavirus 6, 11, 16, and 18 in young primiparous women in Sao Paulo, Brazil.

INTRODUCTION: Data on epidemiology of HPV infection are needed for the development of human papillomavirus (HPV) vaccine recommendations, especially in countries where HPV vaccination is not yet included in public vaccination programs. The aim of this study was to determine the prevalence of serum antibodies to HPV types 6, 11, 16, and 18 and associated factors among young women after birth of the first child. METHODS: This cross-sectional study was carried out in a large public maternity hospital in Sao Paulo, Brazil. Three hundred one women aged 15 to 24 years who gave birth to their first child were recruited between 43 and 60 days after delivery. Seroprevalence was performed using a type-specific enzyme-linked immunosorbent assay based on HPV Late protein 1 viruslike particles. The association of seroreactivity with these 4 HPV types with selected demographic and behavioral factors was assessed by Generalized Linear Model analysis. RESULTS: Fifty-eight (19.3%) women (95% confidence interval, 15.0%-24.2%) had antibodies to any of the 4 viruslike particles tested. The overall seroprevalence rates of the HPV types were: HPV16, 9.0%; HPV18, 7.0%; and HPV 6+11, 7.7%, which are targeted by the HPV prophylactic vaccines. In the multivariate analysis, only age (inversely, P = 0.044 for trend) and previous sexually transmitted disease (P = 0.008) were 2 factors independently associated with HPV seropositivity. CONCLUSIONS: These data offer additional information on the epidemiology of HPV in a group of young Brazilian women after first delivery and contribute to establish a baseline of HPV seroprevalence against which post-HPV vaccine era seroprevalence can be compared.

Opportunity for catch-up HPV vaccination in young women after first delivery.

BACKGROUND: Early age at first delivery has been identified as a risk factor for high-risk HPV-type infection and cervical cancer development. METHODS: A cross-sectional study was carried out in a large public maternity hospital in São Paulo, Brazil. During June 2006 to February 2007, 301 women aged 15-24 years who gave birth to their first child were recruited between 43 and 60 days after delivery. Detection of HPV DNA in cervical specimens was performed using a standardised PCR protocol with PGMY09/11 primers. The association of selected factors with HPV infection was assessed by using a Generalised Linear Model. RESULTS: HPV DNA was detected in 58.5% (95% CI 52.7% to 64.0%) of the enrolled young women. The most common types of HPV found were: HPV16, HPV51, HPV52, HPV58 and HPV71. The overall prevalence of HPV types targeted by the HPV prophylactic vaccines was: HPV 16-12.0%, HPV 18- 2.3% and HPV 6 and 11 4.3%. In the multivariate analysis, only age (inversely, p for trend=0.02) and smoking habits were independently associated with HPV infection. CONCLUSIONS: The findings show that these young primiparous women had high cervical HPV prevalence, suggesting that this is a high-risk group for cervical cancer development. Nevertheless, 17.3% were positive for any of the four HPV types included in HPV vaccines (HPV6, 11, 16 or 18), with 13.3% positive for HPV 16 or 18 and only 1.0% having both vaccine related-oncogenic HPV types. Thus, young primiparous women could benefit from catch-up HPV vaccination programmes.

Prevalência do HPV em mulheres rastreadas para o câncer cervical / Prevalence of genital HPV infection among women screened for cervical cancer

OBJETIVO: Analisar a prevalência da infecção genital por papilomavírus humano (HPV) de alto risco por faixa etária e fatores associados. MÉTODOS: Estudo transversal com amostra de 2.300 mulheres (15-65 anos) que buscaram rastreamento para o câncer cervical entre fevereiro de 2002 e março de 2003 em São Paulo e Campinas, estado de São Paulo. Aplicou-se questionário epidemiológico e realizou-se coleta cervical para citologia oncológica e teste de captura híbrida II. As análises estatísticas empregadas foram teste de qui-quadrado de Pearson e análise multivariada pelo método forward likelihood ratio. RESULTADOS: A prevalência total da infecção genital por HPV de alto risco foi de 17,8 por cento, distribuída nas faixas etárias: 27,1 por cento (<25 anos), 21,3 por cento (25-34 anos), 12,1 por cento (35-44 anos), 12,0 por cento (45-54 anos) e de 13,9 por cento (55-65 anos). Participantes com maior número de parceiros sexuais durante a vida apresentaram maior freqüência da infecção. Relacionamento estável, idade de 35 a 44 anos e ex-fumantes foram associados à proteção da infecção. A infecção genital por HPV de alto risco ocorreu em 14,3 por cento das citologias normais, em 77,8 por cento das lesões escamosas de alto grau e nos dois (100 por cento) casos de carcinoma. CONCLUSÕES: A prevalência da infecção genital por HPV de alto risco na amostra estudada foi alta. Houve predomínio de casos abaixo dos 25 anos e tendência a um novo aumento após os 55 anos, com maior freqüência naqueles com maior número de parceiros sexuais durante a vida.

OBJECTIVE: To assess the prevalence of high-risk genital human papillomavirus (HPV) infection by age group and risk factors associated. METHODS: Cross-sectional study in a sample of 2,300 women (15-65 years old) who self-referred to cervical cancer screening in Sao Paulo and Campinas, Southeastern Brazil, between February 2002 and March 2003. An epidemiological questionnaire was applied and cervical specimens were obtained for cytology and hybrid capture II test (HCII) for HPV detection. Statistical analysis included Pearson Chi-square and unconditional multiple logistic regression model (forward likelihood ratio). RESULTS: High-risk genital HPV infection prevalence in this sample was 17.8 percent and age distribution was as follows: 27.1 percent (<25 years), 21.3 percent (25-34 years), 12.1 percent (35-44 years), 12.0 percent (45-54 years) and 13.9 percent (55-65 years). Subjects with the highest number of lifetime sexual partners had the highest rates of genital HPV infection. To be living with a partner, aged 35 to 44 years, and former smokers were protective factors. High-risk genital HPV infection was 14.3 percent in normal cytology, 77.8 percent in high grade squamous intraepithelial lesions and in the two cases (100 percent) of cervical cancer. CONCLUSIONS: High-risk HPV prevalence was high in the sample studied. The highest prevalence of HPV infection was seen in women under 25 years old and then a new increase was seen over the age of 55 and the highest rates were found among those with many sexual partners during their lifetime.

[Prevalence of genital HPV infection among women screened for cervical cancer]. / Prevalência do HPV em mulheres rastreadas para o câncer cervical.

OBJECTIVE: To assess the prevalence of high-risk genital human papillomavirus (HPV) infection by age group and risk factors associated. METHODS: Cross-sectional study in a sample of 2,300 women (15-65 years old) who self-referred to cervical cancer screening in Sao Paulo and Campinas, Southeastern Brazil, between February 2002 and March 2003. An epidemiological questionnaire was applied and cervical specimens were obtained for cytology and hybrid capture II test (HCII) for HPV detection. Statistical analysis included Pearson Chi-square and unconditional multiple logistic regression model (forward likelihood ratio). RESULTS: High-risk genital HPV infection prevalence in this sample was 17.8% and age distribution was as follows: 27.1% (<25 years), 21.3% (25-34 years), 12.1% (35-44 years), 12.0% (45-54 years) and 13.9% (55-65 years). Subjects with the highest number of lifetime sexual partners had the highest rates of genital HPV infection. To be living with a partner, aged 35 to 44 years, and former smokers were protective factors. High-risk genital HPV infection was 14.3% in normal cytology, 77.8% in high grade squamous intraepithelial lesions and in the two cases (100%) of cervical cancer. CONCLUSIONS: High-risk HPV prevalence was high in the sample studied. The highest prevalence of HPV infection was seen in women under 25 years old and then a new increase was seen over the age of 55 and the highest rates were found among those with many sexual partners during their lifetime.

O Desempenho da colposcopia através do índice de Reid / The colposcopic performance through Reid's index

A colposcopia representa uma precisa colaboração na detecção das lesões precursoras do câncer do colo uterino. Como é baseada em interpretações subjetivas do colposcopista, esta técnica sofre as mesmas críticas que a interpretação do exame de Papanicolaou e do exame da biópsia, por problemas de baixa reprodutibilidade. O índice colposcópico de Reid (ICR) é um método objetivo que tem como finalidade estabelecer padrões de gravidade de uma lesão pré-maligna do colo uterino detectada por exame de colposcopia. O índice categoriza quatro achados colposcópicos a serem considerados: margem da lesão, reação ao ácido acético, características dos vasos e impregnação com solução de lugol. O ICR pode predizer a classificação histológica da doença cervical e permite a diferenciação entre baixo grau e alto grau da lesão cervical. Com estes parâmetros, o uso do índice permite que o examinador formule a impressão colposcópica e realize a biópsia na região mais alterada do colo uterino.

[Serological detection of anti HPV 16/18 and its association with pap smear in adolescents and young women]. / Detecção sorológica de anti-HPV 16 e 18 e sua associação com os achados do Papanicolaou em adolescentes e mulheres jovens.

OBJECTIVE: Verify the relation between HPV 16/18 antibodies and the association with cervical cytology findings in adolescents and young women. METHODS: A cross sectional study with 541 healthy and sexually active women from 15 to 25 years of age was carried on from September to November 2000. At gynecological examination, a cervical sample on liquid-base for cytology-testing and a blood sample for ELISA identification of HPV 16 and 18 antibodies were collected and sent to a reference laboratory in Belgium. Statistical analysis estimated the prevalence and prevalence ratio with a 95% confidence interval. RESULTS: Of these young women, 150 (27.7%) were seropositive: 79 (14.6%) to HPV 16 antibody; 35 (6.4%) to HPV 18 antibody and 36 (6.6%) to both HPV 16/18 antibodies. Cytological abnormalities were detected in 107 cases (20.5%): 63 presented with atypical squamous cells of undetermined significance (ASCUS), 41 were suggestive of low grade squamous intra-epithelial lesion (LGSIL) and 3 of high grade squamous intra-epithelial lesion (HGSIL). Prevalence of abnormal cytology with a positive serology was only 1.75 times that of prevalence of abnormal cytology with a negative serology. Detection of abnormal cytology was not correlated with positive serology. CONCLUSION: Results of this study indicate a high prevalence of HPV 16 and 18 in young healthy women which showed no relation to the abnormal findings of cytology smears.

Detecção sorológica de anti-HPV 16 e 18 e sua associação com os achados do papanicolaou em adolescentes e mulheres jovens / Serological detection of anti HPV 16/18 and its association with pap smear in adolescents and young women

OBJETIVO: Verificar a taxa de anticorpos neutralizantes anti-HPV 16 e/ou 18, e a sua associação com os achados da citologia oncológica do colo uterino em adolescentes e mulheres jovens. MÉTODOS: Foram incluídas, neste estudo transversal, 541 mulheres de 15 a 25 anos de idade, saudáveis, sexualmente ativas, que apresentaram exame ginecológico normal, no período de setembro a novembro de 2000. Foi obtida uma amostra cervical para citologia em meio líquido e uma amostra de sangue para identificação dos anticorpos anti-HPV 16 e/ou 18, por meio do método ELISA. As amostras foram encaminhadas para um laboratório de referência na Bélgica. Para análise estatística, foram estimadas a prevalência e a razão de prevalência (RP), com intervalo de confiança de 95 por cento. RESULTADOS: Entre as mulheres incluídas, 150 (27,7 por cento) apresentaram resultados positivos da sorologia sendo: 79 (14,6 por cento) por anticorpos anti-HPV 16, 35 (6,4 por cento) anti-HPV 18 e 36 (6,6 por cento) anti-HPV 16 e 18. Foram detectadas anormalidades citológicas em 107 casos (20,5 por cento), sendo 63 classificadas como atipias celulares de significado indeteminado (ASCUS), 41 casos sugestivos de lesões de baixo (LSIL) e três casos sugestivos de lesões de alto grau (HSIL). A prevalência de citologias anormais quando a sorologia foi positiva foi apenas 1,75 vez a prevalência de citologias positivas observadas com sorologia negativa. Nesta amostra não houve evidência de associação entre os resultados anormais da citologia e a positividade da sorologia. CONCLUSAO: O resultado deste estudo indica uma alta prevalência de sorologia positiva para o HPV 16 e 18 em mulheres jovens sadias sem relação com os achados anormais da colpocitologia.

Idade e prevalência da infecção genital por papilomavírus humano de alto risco em mulheres submetidas a rastreamento para o câncer cervical / Age and prevalence of high risk human papilomavirus genital infection in women submitted to cervical cancer screening

Introdução: A relação causal entre infecção genital por papilomavírus humano (HPV) de alto risco e o câncer do colo uterino está bem estabelecida; porém, há controvérsias em diferentes populações quanto a prevalência e a distribuição da infecção em relação a idade. Objetivos: Caracterizar, pela Capturta Híbrida II (CHII), a prevalência da infecção genital por HPV de alto risco e sua estratificação por idade. Verificar a associação da infecção com fatores de risco, resultados da citologia oncológica (CO), da colposcopia e da biópsia cervical. Casuística e Métodos: Em estudo transversal estudou-se 2300 mulheres (15-65 anos) que buscaram rastreamento para o câncer cervical. Aplicou-se questionário epidemiológico e foi feita a coleta da CO e da CHII, no caso de alteração em um destes exames ou ambosindicou-se colposcopia e, nos casos anormais, procedeu-se á biópsia cervical. Resultados: A prevalência da infecção genitalpor HPV de alto risco em toda amostra foi de 17,8 por cento: 27 por cento (<25 anos), 21 por cento (25-34 anos), 12 por cento (35-54 anos) e de 14 por cento (55-65 anos). Participantes com maior número de parceiros sexuais durante a vida apresentaram uma maior chance de infecção, relacionamento estável, idade entre 30 a 54 anos e ser ex-fumante foram fatores associados à proteção da infecção. Encontrou-se 204 (8,8 por cento) CO anormais e uma relação direta entre severidade do diagnóstico citológico e infecção por HPV de alto risco, 14,3 por cento em citologia normal, 78 por cento em lesão escamosa de alto grau, 100 por cento nos esfregaços compatíveis com carcinoma. Foram histologicamente confirmados: 10 casos de neoplasia intra-cervical grau 2/3 (NIC2/3) entre as mulheres infectadas por HPV, com citologia normal; 4NIC 2/3 e 3 carcinomas em mulheres com ambos os testes positivos. Conclusão: A prevalência da infecção genital por HPV de alto risco foi alta, seguindo uma curva na qual se observou novo aumento da prevalência após os 55 anos