The methodological and reporting quality of randomized controlled trials of tyrosine kinase inhibitors for advanced differentiated thyroid cancer: Meta-research study.

INTRODUCTION: Clinical trials on tyrosine kinase inhibitors (TKI) treatment have shown an improvement in overall and progression-free survival in patients with advanced differentiated thyroid cancer. However, it is necessary to evaluate these studies to assess methodological biases and inconsistencies that may impact the effects. OBJECTIVE: To map and assess the methodological quality of randomized clinical trials (RCTs) regarding randomization, allocation concealment, blinding, and selective reporting bias. METHODS: RCTs assessing the efficacy and safety of TKI for the treatment of advanced differentiated thyroid cancer were included. The search was performed in the MEDLINE database. The included RCTs were assessed for the adequacy of the methodological steps, as recommended by the Cochrane Risk of Bias tool. RESULTS: Nine studies were analyzed, of which 77.7% were classified as low risk of bias regarding selective reporting and 33.3% as high risk of reporting bias. The mean time between protocol registration and study publication was approximately 5.11 years. Moreover, 66.7% were classified as low risk of bias for randomization and allocation concealment, and 33.3% did not specify the randomization process and allocation concealment in a way that would allow the identification of occurrences of bias. Concerning blinding of participants and outcome assessors, 77.8% of the RCTs reported adequate blinding and were classified as having a low risk of bias, 11.1% had a high risk of bias, and 11.1% had insufficient information and were classified as having unclear risk of bias. Regarding the blinding of the outcome assessors, 33.3% did the blinding correctly, 11.1% did not blind, and 55.6% did not provide enough information. CONCLUSION: Overall, the assessed RCTs were predominantly at low risk of bias. The critical evaluation of these studies is essential to have confidence in the treatment estimated effect that will support clinical decision-making and provide information to preclude future clinical study flaws.

Empatia e espiritualidade em estudantes e residentes de Medicina / Empathy and spirituality in Medical students and residents

RESUMO Introdução: A empatia tende a diminuir ao longo da formação médica. A relação entre espiritualidade e empatia não tem sido amplamente explorada. Objetivo: Este estudo teve como objetivo correlacionar empatia e religiosidade/espiritualismo por meio de questionário voluntário, entre estudantes e residentes de Medicina. Método: Trata-se de um estudo transversal exploratório por meio de um questionário online para preenchimento voluntário entre estudantes de medicina e residentes, composto por: dados sociodemográficos, questionário de empatia e questões sobre religiosidade/espiritualismo. Resultado: De 1.550 convites, 273 participantes voluntários responderam (17,6%). A maioria era católica (103 - 37,7%), seguida de agnósticos (84 - 30,8%), protestantes e kardecistas (27 - 9,9% cada). A Escala de Empatia de Jefferson apresentou pontuação média de 120,4 (de 90 a 140). Não se constatou correlação entre a crença religiosa e o grau de empatia. Ambos os conceitos não indicaram diferença significativa ao longo do período da educação médica. Conclusão: Empatia e religiosidade/espiritualismo não apresentaram correlação entre estudantes e residentes de Medicina.

ABSTRACT Introduction: Empathy tends to decline throughout the course of medical training. The relationship between spirituality and empathy has not been widely explored. Objective: To correlate empathy and religiosity/spiritualism by means of a voluntary questionnaire applied to medical students and residents. Methods: This is an exploratory cross-sectional study using an online questionnaire completed on a voluntary basis by medical students and residents, consisting of: socio-demographic data, an empathy questionnaire and questions about religiosity/spiritualism. Results: From 1,550 invitations, 273 volunteer participants responded (17.6%). Most were Catholic (103 - 37.7%), followed by agnostics (84 - 30.8%), and Protestants and Kardecists (27 - 9.9% each). The Jefferson Empathy Scale had a mean score of 120.4 (from 90 to 140). Religious belief and degree of empathy did not present any correlation. Neither concept presented significant difference over the course of medical training. Conclusion: Empathy and religiosity/spiritualism did not present any correlation among medical students and residents.

Design thinking como metodologia na elaboração de uma proposta de matriz curricular / Design thinking as a methodology in the elaboration of a curricular structure proposal

Resumo Introdução: A matriz curricular do curso de Medicina pode variar de acordo com o projeto pedagógico de curso (PPC) de cada instituição de ensino superior (IES). Nem sempre a visão da coordenação e do corpo docente do curso de Medicina está alinhada às opiniões dos alunos. Assim, a utilização de uma metodologia para identificar a visão do corpo discente seria fundamental. O design thinking (DT) é um processo que propõe a busca, de forma empática, colaborativa e criativa, de soluções para problemas complexos. Objetivo: Este estudo apresenta o DT como uma metodologia para identificar como os alunos do internato acreditam que deva ser a matriz curricular do primeiro ao quarto ano de um curso de Medicina no estado de São Paulo, e, para tanto, coletaram-se sugestões e pontos que exigiram a reavaliação na matriz original. Método: Realizou-se uma avaliação qualitativa com base no modelo do DT. Os alunos foram divididos em três grupos de cinco alunos, e cada grupo dedicou-se a discutir livremente sobre suas ideias acerca da matriz curricular. Posteriormente, apresentou-se um painel para cada grupo com a separação dos semestres correspondentes - do primeiro ao quarto ano - com post-it representando a matriz curricular vigente do curso de Medicina, e cada grupo teve uma hora para remontar a matriz curricular da maneira que julgasse mais adequado. Resultado: Após a fase de discussão, cada grupo montou sua matriz curricular, e propuseram-se algumas mudanças do ano em que a disciplina era ministrada e a inclusão de algumas matérias. A maioria das sugestões foi julgada procedente e incorporada na matriz curricular. Conclusão: A metodologia do DT contribuiu para a identificação de várias demandas acerca da matriz curricular de uma forma ordenada, empática e colaborativa, levando em consideração a opinião do estudante, sendo, portanto, uma estratégia de planejamento capaz de evidenciar fragilidades e fortalezas do currículo que talvez não fossem percebidas por outras estratégias.

Abstract Introduction: The medical school curricular structure may vary according to the educational planning of each higher education institution (HEI). The viewpoint of the coordination and the medical school faculty is not always aligned with the students' opinions. Thus, using a methodology to identify the students' point of view would be essential. Design thinking (DT) is a process that proposes a search, in an empathetic, collaborative, and creative way, for solutions to complex problems. Objectives: To present DT as a methodology to identify how clinical internship students believe the curricular structure from the 1st to the 4th year of a São Paulo state medical school should be, by collecting suggestions and points that require a re-evaluation process of the current curricular structure. Methods: This is a qualitative assessment, which will use the DT model. Students were divided into three groups of five, and each group was committed to having a free discussion on its ideas concerning the curricular structure. Then, a panel was presented to each group, dividing the semesters from the 1st to the 4th year with post-it notes representing the current curricular structure of the medical school, and each group had one hour to reassemble the curricular structure as they deemed appropriate. Results: After the discussion stage, each group assembled its curricular structure. Some changes concerning the year in which the discipline was provided were proposed, and the inclusion of others. Most of the suggestions were considered valid and were incorporated into the curriculum. Conclusions: The DT methodology contributed to the identification of several demands regarding the curricular structure in an orderly, empathetic, and collaborative way, taking into account the students' opinions. It is, therefore, a planning strategy able to evidence weaknesses and strengths of the curriculum that might not have been noticed by the use of other strategies.

Dermatofibrossarcoma na glabela: Uma localização incomum / Dermatofibrosarcoma in glabella: An uncommon location

O dermatofibrossarcoma é um câncer raro que apresenta padrão de crescimento lento e invasão tecidual agressiva. O tratamento para esta condição envolve intervenção cirúrgica com o objetivo de obter margens livres. Neste caso particular, temos um homem de 60 anos que apresentava uma massa na região da glabela que foi extirpada duas vezes sob anestesia local em outro serviço. Os resultados de ambas as biópsias indicaram dermatofibroma. No entanto, o paciente apresentou nova recidiva, que durante a análise imuno-histoquímica da excisão inicial revelou tratar-se de dermatofibrossarcoma. Como resultado, uma ampla excisão foi realizada até que margens negativas fossem obtidas ao exame de congelação. Além disso, um retalho frontal foi empregado no procedimento para reconstrução do defeito cirúrgico. O resultado do tratamento foi considerado bem-sucedido, sem complicações.

Dermatofibrosarcoma is a rare cancer with a slow growth pattern and aggressive tissue invasion. The treatment for this condition involves surgical intervention to achieve clear margins. In this particular case, we have a 60-year-old man who had a mass in the glabella area that was excised twice under local anesthesia at a different facility. The results of both biopsies indicated dermatofibroma. However, the patient experienced a new recurrence, and during the immunohistochemistry analysis of the initial excision, it was revealed to be dermatofibrosarcoma. As a result, a broad excision was performed until negative margins were obtained based on frozen sections. Additionally, a frontal flap was employed to reconstruct the surgical defect. The outcome of the treatment was deemed successful, without complications.

Neck recurrence in papillary thyroid carcinoma.

INTRODUCTION: papillary thyroid carcinoma is a tumor with good prognosis. However, some patients treated present neck recurrence. OBJECTIVE: to evaluate the risk factors for neck recurrence. METHODS: a retrospective study enrolled 89 patients (68 women and 21 men) diagnosed with papillary carcinoma who underwent total thyroidectomy. In 21 patients, neck dissection was performed and 62 patients underwent radioiodinetherapy. Twelve patients relapsed with metastasis in this period with an average of 3.6 years. RESULTS: out of 89 patients, 76.4% were female. Relapse occurred in nine (13.23%) women and three (14.28%) men. The average age of the patients was 44 years in the control group and in patients with relapsed. Eighteen patients (23.37%) in the control group and eight (64.28%) who relapsed had positive lymph nodes at initial diagnosis. The tumor size was significantly larger in the group of patients with cervical recurrence (3.3cm vs. 1.6cm - p=0.008, Student t test), whereas the presence of metastatic lymph nodes at the moment of the first operation was also significant (p=0.004 -Fisher exact test). The tumor size was an independent risk factor for recurrence at the multivariate anaylsis (OR=2.4, IC95%:1.3-4.6 - p=0,007, logistic regression). CONCLUSION: there is an increase in the risk of lymph node recurrence during the follow up of 2.4 folds for each increase of 1cm in the longer nodule diameter.

Neck recurrence in papillary thyroid carcinoma / Recidiva cervical no carcinoma papilífero da tireoide

ABSTRACT Introduction: papillary thyroid carcinoma is a tumor with good prognosis. However, some patients treated present neck recurrence. Objective: to evaluate the risk factors for neck recurrence. Methods: a retrospective study enrolled 89 patients (68 women and 21 men) diagnosed with papillary carcinoma who underwent total thyroidectomy. In 21 patients, neck dissection was performed and 62 patients underwent radioiodinetherapy. Twelve patients relapsed with metastasis in this period with an average of 3.6 years. Results: out of 89 patients, 76.4% were female. Relapse occurred in nine (13.23%) women and three (14.28%) men. The average age of the patients was 44 years in the control group and in patients with relapsed. Eighteen patients (23.37%) in the control group and eight (64.28%) who relapsed had positive lymph nodes at initial diagnosis. The tumor size was significantly larger in the group of patients with cervical recurrence (3.3cm vs. 1.6cm - p=0.008, Student t test), whereas the presence of metastatic lymph nodes at the moment of the first operation was also significant (p=0.004 -Fisher exact test). The tumor size was an independent risk factor for recurrence at the multivariate anaylsis (OR=2.4, IC95%:1.3-4.6 - p=0,007, logistic regression). Conclusion: there is an increase in the risk of lymph node recurrence during the follow up of 2.4 folds for each increase of 1cm in the longer nodule diameter.

RESUMO Introdução: o carcinoma papilífero da tireoide é um tumor com bom prognóstico. Entretanto, alguns pacientes tratados evoluem com recidiva cervical. Objetivo: avaliar os fatores de risco para recidiva cervical. Métodos: um estudo retrospectivo arrolou 89 pacientes (68 mulheres e 21 homens) diagnosticados com carcinoma papilífero, submetidos à tireoidectomia total. Em 21 pacientes, realizou esvaziamento cervical e, em 62, radioiodoterapia. Doze pacientes apresentaram recorrência linfonodal no período, com media de 3,6 anos. Resultados: dos 89 pacientes, 76,4% eram mulheres. A falha ocorreu em nove mulheres (13,23%) e três homens (14,28%). A média etária tanto dos pacientes recidivados como do grupo-controle foi de 44 anos. Dezoito pacientes (23,37%) no grupo-controle e oito (64,28%) dentre os que recidivaram tinham linfonodos positivos ao diagnóstico inicial. O tamanho tumoral foi significativamente maior no grupo de pacientes que apresentaram recidiva cervical (3,3 cm vs. 1,6cm - p=0,008, teste t de Student), o mesmo foi observado para a presença de linfonodos metastáticos quando da primeira cirurgia (p=0,004 - teste exato de Fisher). À análise multivariada, o tamanho tumoral foi fator de risco independente de recidiva (OR=2,4, IC95%:1,3-4,6 - p=0,007, regressão logística. Conclusão: para cada aumento de 1cm no maior diâmetro da lesão, há um aumento de 2,4 vezes no risco de recidiva linfonodal ao longo do acompanhamento.

Submandibular gland excision / Ressecção da glândula submandibular

OBJECTIVE: To analyze the value of fine needle aspiration and the rates of postoperative complications in patients undergoing resection of the submandibular gland. METHODS: we analyzed the records of patients treated with resection of the gland from January 1995 to December 2008. The data collected included age, gender, findings on clinical history, surgical procedure, results of fine needle aspiration (FNA), pathological diagnosis and complications. RESULTS: 117 patients were studied, aged 12-89 years (mean 48), 70 women and 47 men. Thirty-nine patients (33.3%) were affected by inflammatory diseases (28 patients with lithiasis), 70 had benign tumors, and malignant tumors, eight. Regarding FNA, the sensitivity and specificity were 85.7% and 100%, respectively. Nine patients (7.7%) had temporary paralysis of the marginal mandibular nerve and one had permanent paralysis. CONCLUSION: resection of the submandibular gland is a safe procedure, with low complication rates.

OBJETIVO: Analisar o valor da punção aspirativa por agulha fina e os índices de complicações pós-operatórias em pacientes submetidos à ressecção da glândula submandibular. MÉTODOS: foram analisados os prontuários de pacientes tratados com a ressecção da glândula, de janeiro de 1995 a dezembro de 2008. Os dados coletados foram: idade, sexo, achados na história clínica, procedimento cirúrgico, resultados da punção por aspiração com agulha fina (PAAF), diagnóstico anatomopatológico e complicações. RESULTADOS: foram estudados 117 pacientes, com idade variando de 12 a 89 anos (média, 48 anos), sendo 70 mulheres e 47 homens. Trinta e nove pacientes (33,3%) foram acometidos por doenças inflamatórias (28 pacientes com litíase), 70 tiveram tumores benignos e oito tumores malignos. A respeito da PAAF, a sensibilidade e especificidade foram de 85,7% e 100%, respectivamente. Nove pacientes (7,7%) tiveram paralisia temporária do nervo mandibular marginal e um apresentou paralisia definitiva. CONCLUSÃO: a ressecção da glândula submandibular é um procedimento seguro, com baixa taxa de complicações.

Validação de metodologia de avaliação da função pulmonar em pacientes submetidos à laringectomia total / Validation of the methodology for the assessment of the pulmonary function in patients submitted to total laryngectomy

Introdução: Pacientes com câncer de laringe costumam apresentar histórico de tabagismo. Nos pacientes submetidos à tratamento cirúrgico, as complicações pulmonares podem levar à morte no período pós-operatório. Um método com dispositivo extratraqueal padronizado, simples e de baixo custo para a avaliação pulmonar dos pacientes laringectomizados seria muito útil. Objetivo: Validar a metodologia para a avaliação pulmonar em pacientes submetidos à laringectomia total por meio da aplicação de um dispositivo extratraqueal adesivo. Métodos: Participaram deste estudo transversal 50 pacientes submetidos à laringectomia total há pelo menos seis meses como modalidade de tratamento para o câncer de laringe em acompanhamento no Serviço de Cirurgia de Cabeça e Pescoço do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Por meio da anamnese e do prontuário dos pacientes foram obtidos dados demográficos, tabagismo, a presença de doenças respiratórias nos últimos 30 dias, dados acerca do tumor e sobre o tratamento realizado. Os testes de função pulmonar foram utilizados para caracterizar a presença de limitação funcional respiratória e o padrão funcional do paciente laringectomizado. Na intenção de avaliar a reprodutibilidade dos exames realizados, foram utilizados parâmetros com respectivos critérios de aceitação dos exames. Os critérios de reprodutibilidade são indicadores de exatidão. Foi feita a comparação desses parâmetros com 50 exames realizados em pacientes não laringectomizados, no mesmo período com o mesmo equipamento, pareados para idade e gênero. Resultados: Em todos os casos de nosso estudo, uma vedação aérea foi mantida durante todo o procedimento com o uso do dispositivo extratraqueal adesivo. Após a realização dos testes de função pulmonar, encontramos que 44% dos pacientes apresentavam um padrão respiratório normal e 56% alterado. Comparando a frequência e porcentagem dos exames rejeitados entre os laringectomizados e o grupo...

Introduction: Laryngeal cancer patients usually have a smoking history. In patients submitted to laryngectomy, pulmonary complications may lead to death in the post-operative phase. A simple and low-cost method with a standardized extra-tracheal device for the pulmonary assessment of laryngectomized patients would be very useful. Objective: Validate the methodology for pulmonary assessment in patients submitted to total laryngectomy through the application of an adhesive extra-tracheal device. Methods: This transversal study included 50 patients who had been submitted to total laryngectomy at least six months prior to this investigation, as choice of treatment for laryngeal cancer while followed by the Head and Neck Service from Hospital das Clínicas, São Paulo University. Through anamnesis and patients medical records the following information was collected: demographic data, smoking habits, the presence of respiratory diseases in the last 30 days, as well as information about the tumor and the performed treatment. Pulmonary tests were used to characterize the presence of respiratory functional limitation as well as laryngectomized patient's functional standards. Aiming at evaluating the reproducibility of the performed tests, parameters were used with the respective criteria for the acceptance of the tests. The reproducibility criteria are indicators of accuracy. A comparison of these parameters was made with 50 tests performed in non-laryngectomized patients, in the same period with the same equipment, paired up according to age and gender. Results: In all cases of our study, an air-tight seal was maintained through the entire procedure with the use of the adhesive extra-tracheal device. After the performance of pulmonary function tests, 44% of patients presented a normal respiratory standard whereas 56% had an altered one. When comparing the frequency and percentage of the rejected tests between laryngectomized and control...

Fístula faringocutânea após laringectomia total / Pharyngocutaneous fistula following total laryngectomy

A fístula faringocutânea (FFC) é a complicação mais comum após a laringectomia total. OBJETIVOS: Estabelecer a incidência dessa complicação e analisar seus fatores predisponentes. MÉTODO: Este estudo é uma coorte histórica transversal que incluiu 94 pacientes submetidos à laringectomia total. Os seguintes aspectos foram relacionados ao surgimento de FFC: gênero, idade, sítio do tumor, estadiamento patológico conforme o TNM, o tipo de esvaziamento cervical realizado, radioterapia e traqueostomia prévias e o uso de grampeador para fechamento faríngeo. Nos casos de FFC, considerou-se o dia pós-operatório de seu diagnóstico, duração e abordagem terapêutica. RESULTADOS: FFC foi diagnosticada em 20 pacientes (21,3%). Houve incidência significativamente maior na de FFC no estadiamento T4 comparado com T2/T3 (p = 0,03). Os demais aspectos não apresentaram diferença estatística. Entretanto, 40,9% dos pacientes que se submeteram à traqueostomia prévia desenvolveram fístula, contra 21,1% dos pacientes fora dessa condição. CONCLUSÕES: Estadiamento avançado do tumor primário é um fator prognóstico para FFC.

Pharyngocutaneous fistula (PCF) is the most common complication after total laryngectomy. OBJECTIVES: To establish the incidence of this complication and to analyze the predisposing factors. METHOD: This is a cross-sectional study of a historical cohort including 94 patients who underwent total laryngectomy. The following aspects were correlated to the occurrence of PCF: gender, age, tumor site, TNM staging, type of neck dissection, previous radiation therapy, previous tracheotomy, and use of stapler for pharyngeal closure. The following were considered in PCF cases: the day into postoperative care when the fistula was diagnosed, duration of occurrence, and proposed treatment. RESULTS: Twenty (21.3%) patients had PCF. The incidence of PCF was statistically higher in T4 tumors when compared to T2 and T3 neoplasms (p = 0.03). The other analyzed correlations were not statistically significant. However, 40.9% of the patients submitted to tracheostomy previously had fistulae, against 21.1% of the patients not submitted to this procedure. CONCLUSION: Advanced primary tumor staging is correlated with higher incidences of PCF.

Videolaryngostroboscopy and voice evaluation in patients with rheumatoid arthritis.

UNLABELLED: Arthritis may affect the larynx and produce symptoms such as hoarseness and vocal fatigue. OBJECTIVE: This paper aimed to evaluate the laryngeal manifestations of rheumatoid arthritis. METHODS: This is prospective study assessed 27 patients with rheumatoid arthritis with the aid of videolaryngostroboscopy, auditory-perceptual analysis of the speech using the GIRBAS scale, acoustic analysis and the Voice Handicap Index questionnaire. RESULTS: Nineteen patients had laryngeal complaints, the main ones being intermittent dysphonia and sensation of a foreign body in the throat. The most frequent laryngoscopical finding was overlapping arytenoids. Three patients had low pitch, nine patients had mild dysphonia and roughness. Median acoustic measures were: F0, 198.39 Hz; Jitter, 0.815; Shimmer, 4.915; and NHR, 0.144. Regarding the Voice Handicap Index, the median score was zero in all domains. There was a statistically significant correlation between voice complaints and the domains of this index. Functional classes were significantly correlated to: overlapping arytenoids (p = 0.001), PPQ (p = 0.0257), Shimmer (p = 0.0295), APQ (p = 0.0195), and the VHI physical (p = 0.0227) and total domains (p = 0.0425). CONCLUSION: Laryngeal complaints were reported by 70.4% of the patients and laryngoscopical alterations were observed in 48% of the subjects. Voice acoustic evaluation and self-perception were altered.

Videolaringoestroboscopia e avaliação vocal em pacientes portadores de artrite reumatoide / Videolaryngostroboscopy and voice evaluation in patients with rheumatoid arthritis

A artrite pode afetar a laringe com rouquidão e fadiga vocal. OBJETIVO: Avaliar as manifestações laríngeas da artrite reumatoide. MÉTODOS: Estudo prospectivo de 27 pacientes com artrite reumatoide por meio de videolaringoestroboscopia, avaliação perceptivo-auditiva da voz por meio da escala GIRBAS, análise acústica e questionário do Índice de desvantagem vocal. RESULTADOS: Queixas laríngeas foram descritas por 19 pacientes, principalmente disfonia intermitente e sensação de corpo estranho na garganta. O achado laringoscópico mais frequente foi o cavalgamento das aritenoides. Três pacientes apresentaram pitch considerada grave. Nove tiveram o grau de disfonia e rugosidade discretos. As medianas das medidas acústicas foram: F0, 198,39 Hz; Jitter, 0,815; Shimmer, 4,915; e NHR, 0,144. Em relação ao índice de desvantagem vocal, a mediana foi zero para todos os domínios. Existiu significância estatística relacionando a queixa vocal com todos os domínios desse índice. A classe funcional teve relação estatisticamente significante com: cavalgamento de aritenoides (p = 0,001), PPQ (p = 0,0257), Shimmer (p = 0,0295), APQ (p = 0,0195) e com o domínio físico e total do IDV (p = 0,0227 e p = 0,0425). CONCLUSÃO: Queixa laríngea foi referida por 70,4% dos pacientes e alterações laringoscópicas foram verificadas em 48%. A avaliação acústica da voz e a autopercepção mostraram-se alterados.

Arthritis may affect the larynx and produce symptoms such as hoarseness and vocal fatigue. OBJECTIVE: This paper aimed to evaluate the laryngeal manifestations of rheumatoid arthritis. METHODS: This is prospective study assessed 27 patients with rheumatoid arthritis with the aid of videolaryngostroboscopy, auditory-perceptual analysis of the speech using the GIRBAS scale, acoustic analysis and the Voice Handicap Index questionnaire. RESULTS: Nineteen patients had laryngeal complaints, the main ones being intermittent dysphonia and sensation of a foreign body in the throat. The most frequent laryngoscopical finding was overlapping arytenoids. Three patients had low pitch, nine patients had mild dysphonia and roughness. Median acoustic measures were: F0, 198.39 Hz; Jitter, 0.815; Shimmer, 4.915; and NHR, 0.144. Regarding the Voice Handicap Index, the median score was zero in all domains. There was a statistically significant correlation between voice complaints and the domains of this index. Functional classes were significantly correlated to: overlapping arytenoids (p = 0.001), PPQ (p = 0.0257), Shimmer (p = 0.0295), APQ (p = 0.0195), and the VHI physical (p = 0.0227) and total domains (p = 0.0425). CONCLUSION: Laryngeal complaints were reported by 70.4% of the patients and laryngoscopical alterations were observed in 48% of the subjects. Voice acoustic evaluation and self-perception were altered.

[Pharyngocutaneous fistula following total laryngectomy]. / Fístula faringocutânea após laringectomia total.

UNLABELLED: Pharyngocutaneous fistula (PCF) is the most common complication after total laryngectomy. OBJECTIVES: To establish the incidence of this complication and to analyze the predisposing factors. METHOD: This is a cross-sectional study of a historical cohort including 94 patients who underwent total laryngectomy. The following aspects were correlated to the occurrence of PCF: gender, age, tumor site, TNM staging, type of neck dissection, previous radiation therapy, previous tracheotomy, and use of stapler for pharyngeal closure. The following were considered in PCF cases: the day into postoperative care when the fistula was diagnosed, duration of occurrence, and proposed treatment. RESULTS: Twenty (21.3%) patients had PCF. The incidence of PCF was statistically higher in T4 tumors when compared to T2 and T3 neoplasms (p = 0.03). The other analyzed correlations were not statistically significant. However, 40.9% of the patients submitted to tracheostomy previously had fistulae, against 21.1% of the patients not submitted to this procedure. CONCLUSION: Advanced primary tumor staging is correlated with higher incidences of PCF.

[Neck dissection complications]. / Complicações dos esvaziamentos cervicais.

UNLABELLED: Because of the proximity of vital structures, certain complications are inherent to neck dissection (ND) for the treatment of patients with squamous cell carcinoma of the upper aerodigestive tract. AIM: To establish the incidence of complications of ND. METHODS: A cross-sectional retrospective study of patient registries. ND with curative intention was evaluated in 480 patients with squamous cell carcinoma of the upper aerodigestive tract from January 1995 to December 2008 to identify perioperative complications. RESULTS: Considering the total quantity of dissected neck sides, 413 radical ND and 295 selective ND were studied, of which 220 were supraomohyoid ND and 75 were jugular ND, totaling 708 sides. There were no deaths. The most frequent complication was marginal mandibular nerve injury (5.5%), followed by accessory nerve injury (5.1%). However, in 18 out of 21 cases this nerve was sacrificed for oncological completeness. CONCLUSIONS: There were no perioperative deaths. Nerves were the most commonly injured structures; the marginal mandibular branch is injured most (5.5%).

Complicações dos esvaziamentos cervicais / Neck dissection complications

Devido à proximidade de estruturas vitais, certas complicações são inerentes ao esvaziamento cervical (EC) para o tratamento de pacientes portadores de carcinoma epidermoide das vias aerodigestivas superiores. OBJETIVO: Determinar a incidência de complicações dos EC. MÉTODOS: Estudo retrospectivo transversal de avaliação de prontuários. Entre janeiro de 1995 e dezembro de 2008, foram avaliados EC com finalidade curativa em 480 pacientes portadores de carcinoma espinocelular das vias aerodigestivas superiores, sendo estudada a ocorrência de complicações perioperatórias. RESULTADOS: Considerando o número total de lados esvaziados, foram estudados 413 EC radicais e 295 EC seletivos, dos quais 220 foram EC supraomo-hioideos e 75 foram EC jugulares, totalizando 708 lados avaliados. Não houve óbito. A complicação mais frequente foi a lesão do nervo mandibular marginal (5,5 por cento), seguida da lesão do nervo acessório (5,1 por cento), contudo, destes, em 18/21 casos o nervo foi sacrificado por razões de radicalidade oncológica. CONCLUSÕES: Não houve óbito no período peroperatório. As lesões mais comuns são nervosas, com maior incidência de lesão do nervo mandibular marginal (5,5 por cento).

Because of the proximity of vital structures, certain complications are inherent to neck dissection (ND) for the treatment of patients with squamous cell carcinoma of the upper aerodigestive tract. AIM: To establish the incidence of complications of ND. METHODS: A cross-sectional retrospective study of patient registries. ND with curative intention was evaluated in 480 patients with squamous cell carcinoma of the upper aerodigestive tract from January 1995 to December 2008 to identify perioperative complications. RESULTS: Considering the total quantity of dissected neck sides, 413 radical ND and 295 selective ND were studied, of which 220 were supraomohyoid ND and 75 were jugular ND, totaling 708 sides. There were no deaths. The most frequent complication was marginal mandibular nerve injury (5.5 percent), followed by accessory nerve injury (5.1 percent). However, in 18 out of 21 cases this nerve was sacrificed for oncological completeness. CONCLUSIONS: There were no perioperative deaths. Nerves were the most commonly injured structures; the marginal mandibular branch is injured most (5.5 percent).

Valor de predição para malignidade dos aspectos macroscópicos do nódulo tireoidiano / Predictive value for malignancy of the thyroid nodule macroscopically

Introdução: A punção aspirativa por agulha fina (PAAF) é um método de alta acurácia no diagnóstico pré-operatório dos nódulos tireoidianos, mas o "padrão folicular" segue sendo um fator de falha. Por outro lado, a utilidade do exame intra-operatório de congelação é controversa. Aspectos macroscópicos dos nódulos tireoidianos podem aumentar a acurácia diagnóstica pré e intra-operatória da PAAF e a biópsia de congelação. Objetivo: Avaliar os aspectos macroscópicos do espécime cirúrgico na tomada de decisão frente à doença nodular da glândula tireoide. Método: Durante 2007, 85 pacientes submetidos a tratamento cirúrgico por doença nodular tireoidiana foram avaliados por estudo prospectivo e os aspectos macroscópicos de 125 nódulos foram comparados aos achado histopatológicos. Resultados: Foi observado que o padrão de crescimento recente, a presença de aderências da tireoide, a ausência de hemorragia, a presença de necrose e a má delimitação do nódulo tiveram significado estatístico no resultado de doença maligna. Conclusão: Padrão de crescimento, aderências da tireoide, necrose e a má delimitação do nódulo são fatores indicativos de malignidade, enquanto a presença de hemorragia é fator protetor.

Introduction: The fine needle aspiration (FNA) is a method of high accuracy in the preoperative diagnosis of thyroid nodules, but the "follicular" remains a factor of failure. Furthermore, the usefulness of intraoperative examination of freezing is controversial. Macroscopic aspects of thyroid nodules may increase the diagnostic accuracy of preoperative and intraoperative FNA biopsy and freezing. Objective: To evaluate the macroscopic aspects of the surgical specimen in the decision facing the nodular disease of thyroid gland. Methods: During 2007, 85 patients underwent surgical treatment for thyroid nodular diseases were evaluated by prospective and macroscopic aspects of 125 nodules were compared with histopathological findings. Results: We found that the pattern of recent growth, the presence of adhesions of the thyroid, absence of hemorrhage, necrosis and poor demarcation of the nodule had statistical significance in the outcome of malignant disease. Conclusion:Pattern of growth, thyroid adhesions, necrosis and poor demarcation of the nodule are predictors of malignancy, while the presence of hemorrhage is a protective factor.

Biópsia aspirativa por agulha fina de adenopatia cervical guiada por ultra-sonografia / Aspiration biopsy by fine needle of cervical adenopathy guided by ultrasonography

Introdução: A punção aspirativa por agulha fina (PAAF) é considerada uma opção diagnóstica em substituição à remoção do linfonodo a céu aberto. Entretanto, o diagnóstico obtido é frequentemente insuficiente clinicamente. Objetivo: Avaliar a acurácia diagnóstica da PAAF guiada por ultra-sonografia (USG) na abordagem da adenopatia cervical. Método: Estudo de série consecutiva de 186 pacientes que foram submetidos à PAAF guiada por USG de adenopatia cervical retrospectivo. O diagnóstico final foi determinado pelo exame histopatológico da biópsia por excisão do linfonodo, quando realizada ou pelo seguimento clínico por mais de um ano. Sensibilidade, especificidade, valores preditivos e acurácia foram avaliados. Resultados: No total, houve 54 diagnósticos de malignidade, cinco de tuberculose e 127 de linfadenite crônica inespecífica. A sensibilidade, especificidade, valores preditivos dos testes negativo e positivo e acurácia da PAAF foram respectivamente 79,5%, 99,1%, 88,2%, 98,3% e 91,4%. Conclusão: Enquanto a PAAF positiva é altamente preditivas do diagnóstico histológico final, o resultado negativo deve ser interpretado com cautela.

Introduction: The fine needle aspiration biopsy (FNAB) is deemed to be a diagnostic option replacing the lymph nodes open dissection. Nevertheless, the diagnosis obtained is frequently insufficient clinically. Objective: To evaluate the accuracy of FNAB diagnostic guided by ultrasonography (USG) in the cervical adenopathy approach. Methods: Consecutive series study of 186 patients who were submitted to retrospective USG-guided FNAB of cervical adenopathy. The final diagnosis was determined by the biopsy histopathological exam by excision of the lymph node when applied or clinical follow-up for more than one year. Sensitivity, specialty, predictive values and accuracy were evaluated. Results: There was a total of 54 malignancy diagnosis, five of tuberculosis and 127 of nonspecific chronic lymphadenitis. The sensitivity, specificity, predictive values of the negative and positive tests and FNAB accuracy were respectively of 79.5%, 99.1%, 88.2%, 98.3% and 91.4%. Conclusion: As the positive FNAB is highly predictive of the final histological diagnosis, the negative result must be carefully interpreted.

Fatores de risco para metástases à distância no câncer de cabeça e pescoço / Risk factors for distant metastasis in head and neck cancer

OBJETIVO: Identificar os fatores de risco para o desenvolvimento de metástase à distância (MD) entre pacientes com câncer de cabeça e pescoço cirurgicamente tratados. MÉTODOS: Realizou-se estudo retrospectivo de 253 pacientes entre janeiro de 1997 e dezembro de 2002. Deles, 10 desenvolveram MD durante o seguimento. Foram avaliados: gênero, idade, sítio primário, classificação TNM, nível de doença linfonodal e presença de invasão extracapsular macro ou microscópica. RESULTADOS: A média de sobrevida para pacientes com MD, a partir da finalização do tratamento oncológico, foi de 16 meses (com desvio-padrão de 2,256 meses). A presença de invasão extracapsular macro (risco relativo = 14,429) e microscópica (RR = 17,471) e os estadiamentos patológicos avançados cervical (RR = 4,409) e do tumor primário (RR = 2,929) apresentaram significado estatístico como fatores de risco para MD. CONCLUSÃO: Os fatores de risco para o surgimento de MD foram: invasão extracapsular macro e microscópica, presença de linfonodo positivo à avaliação histopatológica e tumor primário avançado.

OBJECTIVE: To identify risk factors for the development of distant metastasis (MD) among patients with head and neck squamous cell carcinoma (SCC) surgically treated. METHODS: A retrospective study of 253 patients from January, 1997 to December, 2002 was performed. Out of them, 10 patients presented DM during the follow up. The following aspects were analyzed: gender, age, tumor primary site, TNM classification, cervical lymph node status, and the presence of extracapsular spread - gross or microscopic. RESULTS: The survival average for the patients with DM, after finishing the oncological treatment, was 16 months (standard deviation = 2.256). The presence of both gross extracapsular spread (Odd ratio = 14.429) and the microscopic one (OR = 17.471) and the both the neck advanced pathological staging (OR = 4.409) and the primary tumor staging (RR = 2.929) presented statistical significance as risk fators for the occurrence of DM. CONCLUSION: The risk factors for DM were: microscopic and gross extracapsular spread, the pathological presence of positive neck lymph node and advanced primay tumor.

Fatores prognósticos e impacto da comorbidade na laringectomia fronto-lateral / Prognostic factors and comorbidity impact upon the frontolateral laryngectomy

OBJETIVO: Avaliar sobrevida, impacto da comorbidade, complicações e fatores de falha da laringectomia como tratamento de tumores malignos glóticos. MÉTODOS: Foram analisadas 38 pacientes com tumor glótico sob estadiamento clínico T1b/T2N0M0 submetidos à laringectomia fronto-lateral com reconstrução, de janeiro de 1995 a dezembro de 2006. Foram avaliados os resultados oncológicos, comorbidades (através da escala Adult Comorbidity Evaluation - 27 ACE-27) e complicações, sendo correlacionados com dados demográficos e características do tumor. RESULTADOS: Oito pacientes apresentaram recidiva local e foram resgatados cirurgicamente. Complicações não foram verificadas em 33 pacientes. Não houve diferença significativa das sobrevidas global em cinco anos e livre de doença ao considerarem-se as diferentes categorias de comorbidades. Somente o envolvimento patológico das margens mostrou diferenças significativas na sobrevida global (p=0,0033) e sobrevida livre de doença (p<0,0001). CONCLUSÃO: A sobrevida global em cinco anos foi de 67,6 por cento e a sobrevida livre de doença de 73,7 por cento; a comorbidade não representou fator prognóstico independente; o índice de complicações pós-operatórias foi de 13,2 por cento e somente o envolvimento patológico das margens mostrou diferenças significativas na sobrevida global e livre de doença.

OBJECTIVE: To evaluate the survival rates, comorbidity impact, complications, and treatment failure facts. METHODS: 38 patients clinically staged as T1b / T2N0M0 glottic tumors were analyzed. They underwent frontolateral laryngectomy with reconstruction, from January, 1995 to December, 2006. The oncological outcome, comobidity (through the Adult Comorbidity Evaluation -27 ACE-27 scale) and complications were studied and correlated to the demographic data and tumor characteristics. RESULTS: Eight patients presented local recurrence being surgically salvaged. Complications were not observed in 33 patients. There was no significant difference on the global and free of disease 5-year survival regarding the diverse comorbidity categories. Only the pathological margins spread of the tumor presented significant difference on the global (p=0.0033) and free 0f disease survival (p<0.0001). CONCLUSION: The 5-year global survival was 67.6 percent whereas the free of disease survival was 73.7 percent; the comorbidity did not represent independent prognostic factor; the postoperative complications rate was 13.2 percent; and only the pathological margin spread showed significant difference on the global and free of disease survival rates.

[Risk factors for distant metastasis in head and neck cancer]. / Fatores de risco para metástases à distância no câncer de cabeça e pescoço.

OBJECTIVE: To identify risk factors for the development of distant metastasis (MD) among patients with head and neck squamous cell carcinoma (SCC) surgically treated. METHODS: A retrospective study of 253 patients from January, 1997 to December, 2002 was performed. Out of them, 10 patients presented DM during the follow up. The following aspects were analyzed: gender, age, tumor primary site, TNM classification, cervical lymph node status, and the presence of extracapsular spread - gross or microscopic. RESULTS: The survival average for the patients with DM, after finishing the oncological treatment, was 16 months (standard deviation = 2.256). The presence of both gross extracapsular spread (Odd ratio = 14.429) and the microscopic one (OR = 17.471) and the both the neck advanced pathological staging (OR = 4.409) and the primary tumor staging (RR = 2.929) presented statistical significance as risk fators for the occurrence of DM. CONCLUSION: The risk factors for DM were: microscopic and gross extracapsular spread, the pathological presence of positive neck lymph node and advanced primay tumor.

Tumores primários múltiplos em pacientes com câncer de cabeça e pescoço / Multiple primary tumors in patients with head and neck cancer

Introdução: O diagnóstico de tumores primários múltiplos (TPM) leva a problemas terapêuticos e é considerado um fator prognóstico. Objetivo: determinar o risco de pacientes com câncer de cabeça e pescoço desenvolverem TPM e seu impacto na sobrevida. Métodos: 232 pacientes foram estudados retrospectivamente. O primeiro tumor identificado na região da cabeça e pescoço foi considerado o tumor índice. Gênero, idade, sítio do tumor índice, estádio patológico, sítio dos TPM, intervalo entre a ocorrência do índice e dos tumores subseqüentes e o prognóstico foram considerados. Resultados: 26 pacientes (11,2%) foram diagnosticados como apresentando TPM: duplo, n=23; e triplo, n=3. A relação masculino:feminino foi 7,6:1 e a média de idade, 63 anos. Treze pacientes apresentaram tumor índice estadiado clinicamente como I/II, enquanto os demais 13 foram classificados como III/IV. Houve seis segundos tumores sincrônicos (23,1%) e 20 metacrônicos (76,9%). As localizações mais comuns do segundo tumor foram cavidade oral e a orofaringe (23,1% cada). Dezoito segundos tumores (69,2%) ocorreram dentro da área de cabeça e pescoço. A sobrevida global a cinco anos foi 47,04% para o grupo com TPM e de 56,15% para o grupo sem tal condição. Conclusão: TPM são um fator prognóstico para pacientes com CEC de cabeça e pescoço.

Introdution: The diagnosis of multiple primary tumors (MPT) lead to therapeutic problems and is considered a prognostic factor. Objective: To determine risk of developing MPT and their impact upon survival of head and neck cancer patients. Methods: 232 patients were retrospectively studied. The first tumor identified in the head and neck region was considered the index tumor. Gender, age, the site of the index tumor, pathological staging, site of the multiple primary malignancies, the interval between occurrence of index and subsequent tumors, and the prognosis were considered. Results: 26 patients (11.2%) were diagnosed as having MPT: double, n=23; and triple, n=3. The male:female ratio was 7.6:1 and the mean age was 63. Thirteen patients presented index tumor staged as I/II, whereas the remaining 13 were classified as stage III/IV. There were 6 synchronous second malignancies (23.1%) and 20 metachronous (76.9%). The most common localization of the second tumors was oral cavity and oropharynx (23.1% each). Eighteen second tumors (69.2%) were localized within the head and neck area. The 5-year survival rates for the group with MPT was 47.04% and without MPT 56.15%. Conclusion: The MPT was a prognostic factor for patients with head and neck SCC.