RESUMO Contexto: Lesões serrilhadas são precursoras de até um terço dos casos de câncer colorretal (CCR) e compartilham características moleculares e epidemiológicas com o CCR de intervalo. Estudos prévios relataram ampla variação na prevalência de pólipos serrilhados e na magnitude da sua relação com adenomas avançados sincrônicos. Objetivo: Descrever a prevalência de pólipos serrilhados colorretais e avaliar sua associação com adenomas avançados sincrônicos. Métodos: O estudo é uma análise retrospectiva de 1208 colonoscopias realizadas em pacientes com idades entre 45 e 75 anos, predominantemente para rastreamento de CCR. Dados sobre a prevalência de subtipos de pólipos serrilhados e de adenomas avançados foram coletados, e análises multivariadas foram realizadas para identificar a associação entre pólipos serrilhados e adenomas avançados sincrônicos. Resultados: A prevalência de pólipos serrilhados clinicamente significativos (PSCS), pólipos serrilhados grandes (PSG) e adenomas sésseis serrilhados (ASS) foi de 11,3%, 6% e 3,7%, respectivamente. PSCS foram associados a adenomas avançados sincrônicos (OR 2,121, IC95% 1,321-3,406), independentemente da localização proximal (OR 2,966, IC95% 1,701-5,170) ou distal (OR 1,945, IC95% 1,081-3,499), enquanto PSG (OR 2,872, IC 95%1,425-5,787) e ASS (OR 5,032, IC95% 2,395-10,576) foram associados a adenomas avançados proximais. Conclusão: A prevalência de PSCS e de adenomas avançados foi semelhante. PSCS é um fator de risco para adenomas avançados, e a força dessa associação é maior para adenomas avançados proximais. PSG e ASS estão associados a adenomas avançados proximais. Contexto (CCR intervalo Objetivo Métodos 120 4 7 anos coletados Resultados PSCS, , (PSCS) (PSG (ASS 113 11 3 11,3% 6 37 3,7% respectivamente OR 2121 2 121 2,121 IC95 1,3213,406, 13213406 1,321 3,406 1 321 406 1,321-3,406) 2966 966 2,966 1,7015,170 17015170 1,701 5,170 701 5 170 1,701-5,170 1945 945 1,945 1,0813,499, 10813499 1,081 3,499 081 499 1,081-3,499) 2872 872 2,872 95%1,4255,787 9514255787 95%1,425 5,787 95 425 787 95%1,425-5,787 5032 032 5,032 2,39510,576 239510576 2,395 10,576 395 10 576 2,395-10,576 proximais Conclusão semelhante 12 (PSCS 11,3 3,7 212 2,12 IC9 3213 1,3213,406 1321340 1321 1,32 3406 3,40 32 40 1,321-3,406 296 96 2,96 7015 1,7015,17 1701517 1701 1,70 5170 5,17 70 17 1,701-5,17 194 94 1,94 0813 1,0813,499 1081349 1081 1,08 3499 3,49 08 49 1,081-3,499 287 87 2,87 4255 95%1,4255,78 951425578 951425 95%1,42 5787 5,78 9 42 78 95%1,425-5,78 503 03 5,03 39510 2,39510,57 23951057 2395 2,39 10576 10,57 39 57 2,395-10,57 11, 3, 21 2,1 1,3213,40 132134 132 1,3 340 3,4 1,321-3,40 29 2,9 1,7015,1 170151 1,7 517 5,1 1,701-5,1 19 1,9 1,0813,49 108134 108 1,0 349 0 1,081-3,49 28 8 2,8 95%1,4255,7 95142557 95142 95%1,4 578 5,7 95%1,425-5,7 50 5,0 3951 2,39510,5 2395105 239 2,3 1057 10,5 2,395-10,5 2, 1,3213,4 13213 13 1, 34 1,321-3,4 1,7015, 17015 51 5, 1,701-5, 1,0813,4 10813 1,081-3,4 95%1,4255, 9514255 9514 95%1, 95%1,425-5, 2,39510, 239510 23 105 10, 2,395-10, 1,3213, 1,321-3, 1,7015 1,701-5 1,0813, 1,081-3, 95%1,4255 951 95%1 95%1,425-5 2,39510 23951 2,395-10 1,3213 1,321-3 1,701- 1,0813 1,081-3 95% 95%1,425- 2,3951 2,395-1 1,321- 1,081- 2,395-

ABSTRACT Background: Serrated lesions are the precursors of up to one-third of colorectal cancer (CRC) cases and share molecular and epidemiological features with interval CRC. Previous studies have reported wide variation in serrated polyp prevalence and diverse magnitude of its relationship with synchronous advanced adenomas. Objective: Describe the prevalence of serrated polyps and evaluate their association with synchronous advanced adenomas. Methods: The study is a retrospective analysis of 1208 colonoscopies performed in patients aged 45 to 75, predominantly for CRC screening. Data on the prevalence of serrated polyps subsets and advanced adenomas were collected, and multivariate analysis were performed to identify the association between serrated polyps and synchronous advanced adenomas. Results: The prevalence of clinically significant serrated polyps (CSSP), large serrated polyps (LSP), and sessile serrated adenomas (SSA) were 11.3%, 6%, and 3.7%. CSSP were associated with synchronous advanced adenomas (OR 2.121, 95%CI 1.321-3.406), regardless of proximal (OR 2.966, 95%CI 1.701-5.170) or distal (OR 1.945, 95%CI 1.081-3.499) location, while LSP (OR 2.872, 95%CI 1.425-5.787) and SSA (OR 5.032, 95%CI 2.395-10.576) were associated with proximal advanced adenomas. Conclusion: The prevalence of CSSP and advanced adenomas were alike. CSSP is a risk factor for advanced adenomas, and the strength of this association is stronger for proximal advanced adenomas. LSP and SSA are associated with proximal advanced adenomas. Background onethird one third (CRC Objective Methods 120 4 75 screening collected Results CSSP, , (CSSP) LSP, (LSP) (SSA 113 11 3 11.3% 6 6% 37 7 3.7% OR 2121 2 121 2.121 95CI CI 95 1.3213.406, 13213406 1.321 3.406 1 321 406 1.321-3.406) 2966 966 2.966 1.7015.170 17015170 1.701 5.170 701 5 170 1.701-5.170 1945 945 1.945 1.0813.499 10813499 1.081 3.499 081 499 1.081-3.499 location 2872 872 2.872 1.4255.787 14255787 1.425 5.787 425 787 1.425-5.787 5032 032 5.032 2.39510.576 239510576 2.395 10.576 395 10 576 2.395-10.576 Conclusion alike 12 (CSSP (LSP 11.3 3.7 212 2.12 9 3213 1.3213.406 1321340 1321 1.32 3406 3.40 32 40 1.321-3.406 296 96 2.96 7015 1.7015.17 1701517 1701 1.70 5170 5.17 70 17 1.701-5.17 194 94 1.94 0813 1.0813.49 1081349 1081 1.08 3499 3.49 08 49 1.081-3.49 287 87 2.87 4255 1.4255.78 1425578 1425 1.42 5787 5.78 42 78 1.425-5.78 503 03 5.03 39510 2.39510.57 23951057 2395 2.39 10576 10.57 39 57 2.395-10.57 11. 3. 21 2.1 1.3213.40 132134 132 1.3 340 3.4 1.321-3.40 29 2.9 1.7015.1 170151 1.7 517 5.1 1.701-5.1 19 1.9 1.0813.4 108134 108 1.0 349 0 1.081-3.4 28 8 2.8 1.4255.7 142557 142 1.4 578 5.7 1.425-5.7 50 5.0 3951 2.39510.5 2395105 239 2.3 1057 10.5 2.395-10.5 2. 1.3213.4 13213 13 1. 34 1.321-3.4 1.7015. 17015 51 5. 1.701-5. 1.0813. 10813 1.081-3. 1.4255. 14255 14 1.425-5. 2.39510. 239510 23 105 10. 2.395-10. 1.3213. 1.321-3. 1.7015 1.701-5 1.0813 1.081-3 1.4255 1.425-5 2.39510 23951 2.395-10 1.3213 1.321-3 1.701- 1.081- 1.425- 2.3951 2.395-1 1.321- 2.395-

RESUMO CONTEXTO: Desde 2012, uma nova técnica para ressecção de pólipos grandes tem sido descrita, a ressecção da mucosa endoscópica sob imersão d’água (REMS). Algumas vantagens que surgem desta técnica são evitar a injeção na camada submucosa e a maior chance de captura completa do pólipo. Objetivo - Há poucos estudos com REMS no Brasil. Nosso objetivo é avaliar a segurança e a eficácia da técnica em um centro brasileiro. MÉTODOS: Esta série de casos foi conduzida de fevereiro a dezembro de 2020. Pólipos colorretais maiores que 9 mm sem sinais endoscópicos de invasão de submucosa foram ressecados utilizando RMES. RESULTADOS: Vinte e quatro pólipos foram ressecados com RMES em 24 pacientes diferentes. O tamanho médio dos pólipos era de 19 mm, variando de 12 a 35 mm. Todas as lesões foram ressecadas e 66% (16/24) foram ressecadas em monobloco. Na análise histológica, a maioria era adenoma (70.8%) e apenas uma havia invasão profunda da submucosa. CONCLUSÃO: O uso de REMS é um procedimento seguro e factível. Com o aumento de dados relativos ao procedimento, esta parece ser uma excelente ferramenta na prevenção do câncer colorretal e sua aplicabilidade deve ser encorajada para fora dos centros de referência.

ABSTRACT BACKGROUND: Since 2012, a new technique for resection of large polyps has been described, the underwater endoscopic mucosal resection (UEMR). Some advantages that emerge from it is the needless of injection in submucosal layer and a greater chance of complete capture of the polyp. OBJECTIVE: There are few studies of UEMR in Brazil. The aim of this study is to evaluate the safety and efficacy of this technique in one Brazilian center. METHODS: This case series was conducted from February to December of 2020. Colorectal polyps greater than 9 mm without features of deep submucosal invasion were resected using UEMR. RESULTS: Twenty-four large polyps were resected with the UEMR approach from 24 patients. The mean size of the polys was 19 mm, ranging from 12 to 35 mm. All lesions were successful resected and 66% (16/24) were resected en bloc. In histologic analyses, most of them were adenomas (70.8%) and only one had deep submucosal invasion. There were no cases of acute complications, such perforation or acute bleeding. CONCLUSION: The UEMR is a safe and feasible procedure. With the emerging data on the procedure, it seems to be a wonderful tool in preventing colorectal cancer and its applicability and scope should be encourage to surpass reference centers.

Abstract Introduction: Patient safety is a serious public health with serious implications on morbidity, mortality, and quality of life of patients, in addition to negatively affecting the public image of healthcare institutions and professionals. It requires further investigation, especially in specialties lacking published data, such as endoscopy. Objective: To analyze patient safety incidents reported in a gastrointestinal endoscopy unit of a tertiary hospital in southern Brazil. Methods: This retrospective, cross-sectional study quantitatively described patient safety incidents related to endoscopic procedures. The sample consisted of reports of incidents that occurred from 2015 to 2017. The data were descriptively analysed, and the study was approved by the relevant research ethics committee. Results: Overall, 42,863 endoscopic procedures were performed and 167 reports were submitted in the period, accounting for a prevalence of incidents of 0.38%. Most incidents did not result in unnecessary harm to patients (76.6%). The most prevalent incidents were those related to patient identification, followed by those related to pathology exams, exam reports, gastrointestinal perforations, skin lesions, falls and medication errors. The rate of adverse events (harm to patient) in patients undergoing any endoscopic procedure was 0.06%. Conclusions: The incidence of unnecessary harm (adverse event) associated with any endoscopic procedure was relatively low in this study. However, the identification of reported incidents is crucial for evaluating and improving the quality of care provided to patients.

RESUMO CONTEXTO: O papel de infecção por Helicobacter pylori no infiltrado eosinofílico duodenal ainda é pouco compreendido. Um aumento no número de eosinófilos duodenais tem sido associado a dispepsia funcional. OBJETIVO: Avaliar a influência do H. pylori na contagem de eosinófilos duodenais e o papel do infiltrado eosinofílico duodenal na dispepsia funcional. MÉTODOS: Indivíduos H. pylori positivo e negativo foram incluídos. Ambos os grupos, compreendendo dispépticos funcionais pelos critérios de Roma III (casos) e indivíduos sem sintomas gastrointestinais (controles), foram submetidos à endoscopia digestiva alta para pesquisa de H. pylori, efetuada por histopatologia e teste de urease. Eosinófilos na mucosa duodenal foram contabilizados em cinco campos de maior aumento, selecionados randomicamente nas lâminas de biópsia endoscópicas. RESULTADOS: Trinta e nove indivíduos H. pylori positivo (média de idade 40,5 e 69,2% mulheres) e 24 H. pylori negativos (média de idade 37,3 e 75% mulheres) foram incluídos. A influência da infecção por H. pylori foi observada na contagem de eosinófilos, que foi maior nos positivos: mediana 13,2 vs 8,1 (P=0,005). Quando analisados pacientes de acordo com sintomas, os casos (média de idade 39,6 e 71,4% mulheres) e controles (média de idade 38,7 e 71,4% mulheres), apresentaram semelhante contagem de eosinófilos duodenais: mediana 11,9 e 12,6, respectivamente (P=0,19). CONCLUSÃO: Não demonstramos associação da contagem de eosinófilos duodenais com dispepsia duodenal, mas encontramos associação com infecção por H. pylori.

ABSTRACT BACKGROUND: The role of Helicobacter pylori infection on eosinophilic infiltration in duodenal mucosa is poorly studied. An increase in the number of eosinophils in duodenum has been associated with functional dyspepsia. OBJECTIVE: To evaluate the influence of H. pylori infection on duodenal eosinophil count and the role of eosinophilic infiltrate of duodenum in functional dyspepsia. METHODS: Positive and negative H. pylori individuals were included. Both functional dyspeptic patients according to Rome III criteria (cases) and individuals without gastrointestinal symptoms (controls) were enrolled. They were submitted to upper endoscopy and H. pylori infection was verified by gastric histopathology and urease test. Eosinophils in the duodenal mucosa were counted in five high-power fields, randomly selected on slides of endoscopic biopsies. RESULTS: Thirty-nine H. pylori positive (mean age 40.5 and 69.2% women) and 24 negative patients (mean age 37.3 and 75% women) were included. The influence of the infection was observed in the duodenal eosinophil count, which was higher in infected individuals: median 13.2 vs 8.1 in non-infected individuals (P=0.005). When we analyzed patients according to symptoms, cases - mean age 39.6; 71.4% women - and controls - mean age 38.7; 71.4% women - had similar duodenal eosinophil count: median 11.9 and 12.6 respectively (P=0.19). CONCLUSIONS: We did not demonstrate association of duodenal eosinophil count with functional dyspepsia but found association with H. pylori infection.

ABSTRACT Aim To analyze the influence of the -31 C/T polymorphism of the interleukin-1β gene on Helicobacter pylori eradication therapy success in patients with functional dyspepsia. Methods Functional dyspepsia was diagnosed according to the Rome III criteria. All patients underwent upper gastrointestinal endoscopy, and gastric biopsies were obtained at screening and 12 months after randomization (last follow-up visit). Urease test and histological examination were performed to define the H. pylori status. Patients received twice-daily amoxicillin, clarithromycin and omeprazole for 10 days. Genotyping of the interleukin-1beta -31 C/T polymorphism (rs1143627) was performed using polymerase chain reaction-restriction fragment length polymorphism. Results One hundred forty-nine patients received treatment with triple therapy for H. pylori eradication. Only one patient was lost to follow-up, and adherence to study medication was 94.6%. A total of 148 patients (mean age 46.08 ± 12.24 years; 81.8% women) were evaluated for the influence of the interleukin-1beta -31 C/T polymorphism on the outcome of H. pylori eradication therapy. After treatment, bacteria were eradicated in 87% of patients (129/148). Genotype frequencies of the polymorphism were as follows: CC, 38/148 (25.7%); CT, 71/148 (47.9%); and TT, 39/148 (26.4%). Successful eradication rate was 78.9%, 94.4% and 82.1% for the CC, CT and TT genotypes, respectively. The CT genotype was significantly associated with successful H. pylori eradication (p= 0.039). Conclusion This study suggests that the CT genotype of the interleukin-1beta -31 C/T polymorphism plays a role in the successful eradication of H. pylori among patients with functional dyspepsia.

Abstract Functional dyspepsia and lactose intolerance (adult-type hypolactasia, ATH) are common conditions that may coexist or even be confounded. Their clinical presentation can be similar, however, lactose intolerance does not form part of the diagnostic investigation of functional dyspepsia. Studies on the association between functional dyspepsia and ATH are scarce. This study aimed to evaluate whether ATH is associated with symptoms of functional dyspepsia. Patients fulfilling the Rome III diagnostic criteria for functional dyspepsia underwent genetic testing for ATH. Dyspeptic symptoms were evaluated and scored according to a validated questionnaire. The diagnostic criteria for ATH was a CC genotype for the -13910C/T polymorphism, located upstream of the lactase gene. The mean scores for dyspeptic symptoms were compared between patients with ATH and those with lactase persistence. A total of 197 functional dyspeptic patients were included in the study. Mean age was 47.7 years and 82.7% patients were women. Eighty-eight patients (44.7%) had a diagnosis of ATH. Abdominal bloating scores were higher in ATH patients compared to the lactase persistent patients (P=0.014). The remaining dyspeptic symptom scores were not significantly different between the two groups. The study results demonstrate an association between ATH and bloating in patients with functional dyspepsia.

RESUMO Contexto Recentemente, uma grande variedade de estudos tem investigado e até mesmo sugerido a presença de Helicobacter pylori como um importante fator no desenvolvimento de eventos restritos ou não ao trato gastrointestinal. A relação já bem estabelecida entre virulência bacteriana e risco aumentado para úlcera péptica ou adenocarcinoma gástrico não parece estar tão elucidada quando se comparam alterações de marcadores inflamatórios, como a proteína C-reativa, com a presença do patógeno. Objetivo O objetivo deste estudo foi avaliar a presença da infecção por H. pylori, a virulência bacteriana e os níveis séricos de proteína C-reativa em indivíduos diagnosticados com dispepsia funcional. Métodos Foram incluídos neste estudo, prospectivamente, 489 indivíduos dispépticos. Os pacientes deveriam preencher os critérios clínicos de Roma III para o diagnóstico de dispepsia funcional sem apresentar doença orgânica evidenciada a partir da endoscopia. A infecção bacteriana foi estabelecida por histologia e pelo teste rápido da urease. Os níveis de proteína C-reativa foram quantificados através de imunonefelometria e o status para a presença da CagA dos indivíduos infectados por H. pylorifoi determinado por ensaio imunoenzimático. Resultados A taxa de prevalência de H. pylori foi de 66.3% e o fator de virulência CagA foi detectado em aproximandamente 43% das amostras positivas. Adicionalmente, denotou-se uma associação entre o consumo deIlex paraguariensis (chimarrão) e a prevalência do patógeno. Um importante efeito da infecção bacteriana na inflamação apenas foi observado localmente, no epitélio gástrico. Conclusão Não foi evidenciada resposta sistêmica ao patógeno aferido através dos níveis de proteína C-reativa, independentemente do status para CagA. Por outro lado, o consumo de chimarrão pode ser sugerido como um fator cultural possivelmente relacionado à transmissão de H. pylori.

ABSTRACT Background Recently, a great variety of studies aimed to investigate and even suggestHelicobacter pylori as an important key factor in gastrointestinal and non-gastrointestinal events development. The well-established relationship between bacterial virulence and increased risk for peptic ulcer or gastric carcinoma is not so clear when comparing inflammation markers alterations, such C-reactive protein, with the pathogen. Objective The objective of this study was to evaluate the presence of H. pylori, bacterial virulence and C-reactive protein serum levels in individuals diagnosed with functional dyspepsia. Methods Were prospectively included in this study 489 dyspeptic individuals. They fulfill Rome III clinical criteria for the diagnosis of functional dyspepsia with no organic disease at endoscopy. The bacterial infection was established by histology and urease rapid test. The levels of serum C-reactive protein were obtained by immunonefelometry and CagA status ofH. pylori positive individuals was determined through an imunoenzimatic assay. Results Prevalence rate of H. pylori was 66.3% and virulence factor CagA was detected in nearly 43% of positive samples. In addition, it has been noticed an association between Ilex paraguariensis(yerba maté) consumption and pathogen's prevalence. An important effect of bacterial infection on inflammation was only observed in gastric epithelium. Conclusion No systemic response to the pathogen, measured through C-reactive protein levels, was observed, regardless of CagA status. Otherwise, the intake of yerba maté should be considered as a cultural factor possibly related toH. pylori's transmission.

CONTEXTO: Estudos de farmacovigilância têm por objeto a detecção, avaliação, compreensão e prevenção dos riscos dos efeitos adversos dos medicamentos ou qualquer outro possível problema relacionado com medicamento. A alfainterferona (IFN) está sendo produzida por Bio-Manguinhos/Fiocruz e utilizada no tratamento da hepatite C crônica no âmbito do Sistema Único de Saúde (SUS). OBJETIVO: Conhecer o perfil de segurança e efetividade deste IFN em uma amostra de pacientes brasileiros com hepatite crônica pelo vírus C genótipos 2 e 3, em Porto Alegre, RS, Brasil. MÉTODO: Trata-se de uma coorte de pacientes com hepatite crônica pelo vírus C genótipos 2 e 3 tratados com IFN e ribavirina e acompanhados em um serviço ambulatorial especializado no sul do Brasil. Os eventos adversos foram coletados e classificados de acordo com a gravidade em entrevistas mensais estruturadas. Para medida de eficácia foi avaliada a carga viral do HCV antes, ao final e 24 semanas após o término do tratamento. RESULTADOS: Foram acompanhados 141 pacientes no período do estudo, sendo 52,5% do sexo feminino com média de idade de 52 anos. Os eventos adversos mais frequentes foram fadiga (84%), cefaleia (79%) e mialgia (75%). Ocorreram 13 interrupções de tratamento por eventos adversos, sendo nove destes considerados eventos adversos graves. A resposta virológica ao final do tratamento foi de 54,6% e 24 semanas após de 39,7%, considerando todos os pacientes que iniciaram o tratamento. CONCLUSÃO: O produto produzido por Bio-Manguinhos possui eficácia e um perfil de eventos adversos e de resposta virológica sustentada comparáveis aos encontrados na literatura. Este é o primeiro estudo de farmacovigilância realizado com o produto brasileiro. Estes dados serão úteis para planejamento e gestão do tratamento desta doença no Brasil.

CONTEXT: Pharmacovigilance studies aim to detect, assess, understand and prevent risks of adverse effects of medications or any other possible drug related problem. Alpha interferon is being produced by Bio-Manguinhos/Fiocruz, Rio de Janeiro, RJ, Brazil and used in the treatment of chronic hepatitis C at Brazilian National Health System. OBJECTIVE: To study the safety profile and effectiveness of alpha interferon in a sample of Brazilian patients with chronic hepatitis C genotypes 2 and 3, in Porto Alegre, RS, Brazil. METHOD: We followed a cohort of chronic hepatitis C genotypes 2 and 3 patients treated with alpha interferon plus ribavirin in a specialized outpatient clinic in southern Brazil. Adverse events were collected and classified according to severity in monthly structured interviews. To measure effectiveness, hepatitis C viral load was evaluated before, at the end and 24 weeks after the treatment. RESULTS: We followed 141 patients during the study period, of which 52.5% were female with mean age of 52 years. The most frequent adverse events were fatigue (84%), headache (79%) and myalgia (75%). There were 13 treatment interruptions due to adverse events, 9 of those considered serious adverse events. Virological response at end of treatment was 54.6% and after 24 weeks 39.7%, considering all patients who started treatment. CONCLUSION: The product produced by Bio-Manguinhos has similar efficacy and adverse event and sustained virological response profiles comparable to those found in the literature. This is the first study of pharmacovigilance performed with the Brazilian product. These data will be useful for planning and management of this disease in Brazil.

CONTEXTO: Questionários validados são ferramentas essenciais para serem utilizados em estudos epidemiológicos. No momento não existem questionários diagnósticos de Roma III traduzidos para português. OBJETIVO: Validar a versão em português do Questionário Diagnóstico de Roma III para Dispepsia Funcional. MÉTODOS: O questionário foi traduzido seguindo as recomendações de Roma III. Cento e nove pacientes consecutivos com dispepsia funcional responderam ao questionário. O grupo controle foi composto por 100 doadores de sangue consecutivos, sem problemas digestivos. Consistência interna, reprodutibilidade, sensibilidade, validade discriminante e análise de conteúdo foram avaliadas. RESULTADOS: O coeficiente αde Cronbach foi de 0,92. O questionário mostrou reprodutibilidade: os pacientes responderam-no de forma semelhante em duas ocasiões distintas e suas respostas foram substancialmente semelhantes (P = 1,00). O questionário foi capaz de demonstrar alterações quando elas ocorreram (P<0,01). Dois gastroenterologistas "cegos" concordaram que o questionário avalia a dispepsia funcional adequadamente. Quando comparadas as respostas entre pacientes e controles, o questionário mostrou que 5,3% dos controles e 91,2% dos pacientes tinham sintomas de dispepsia funcional (P<0,01). CONCLUSÃO: O Questionário Diagnóstico de Roma III para Dispepsia Funcional está pronto para ser utilizado em pesquisas clínicas em países lusófonos, como foi validado com sucesso para o português.

CONTEXT: Validated questionnaires are essential tools to be utilized in epidemiological research. At the moment there are no Rome III diagnostic questionnaires translated to Portuguese. OBJECTIVE: To validate the Portuguese version of the Rome III Diagnostic Questionnaire for Functional Dyspepsia. METHODS: The questionnaire has been translated following the Rome III recommendations. Hundred and nine consecutive patients with functional dyspepsia answered the questionnaire. The control group comprised 100 healthy consecutive blood donors, without digestive problems. Internal consistency, reproducibility, responsiveness, discriminate validity and content analysis were evaluated. RESULTS: Cronbach's α coefficient was 0.92. The questionnaire showed reliability: the patients answered it in a similar way on two distinct occasions and their responses were substantially very similar (P = 1.00). The questionnaire was able to demonstrate changes when they occur (P<0.01). Two "blinded" gastroenterologists agreed that the questionnaire adequately evaluated Functional Dyspepsia. When we compared the answers between patients and controls, the questionnaire showed that 5.3% of controls had Functional Dyspepsia symptoms compared with 91.2% of the patients (P<0.01). CONCLUSION: The Rome III Diagnostic Questionnaire for Functional Dyspepsia is ready to be used in clinical researches in lusophone countries, as it has been successfully validated in Portuguese.