RESUMO Objetivo: Relatar o plano de análise estatística (primeira versão) para o estudo Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Métodos: O estudo BaSICS é um ensaio multicêntrico fatorial e randomizado que avaliará os efeitos da administração dos fluidos Plasma-Lyte 148 em comparação com solução salina 0,9% como fluido de escolha em pacientes críticos, assim como os efeitos de uma velocidade de infusão lenta (333mL/hora) em comparação com uma velocidade de infusão rápida (999mL/hora) durante desafios com volume, em importantes desfechos do paciente. O tipo de fluido será mantido cego para os investigadores, pacientes e nas análises. Não será possível, entretanto, ocultar dos investigadores a velocidade de infusão, mas os procedimentos de análise serão mantidos cegos quanto a esse aspecto. Resultados: O estudo BaSICS terá como parâmetro primário a mortalidade em 90 dias, que será testada com utilização de modelos de risco proporcional de Cox de efeitos mistos, considerando os centros de estudo como variável randômica (modelos de fragilidade) ajustada por idade, disfunção de órgãos e tipo de admissão. Os parâmetros secundários importantes incluem terapia de substituição renal até 90 dias, insuficiência renal aguda, disfunção de órgãos nos dias 3 e 7 e dias sem ventilação mecânica em 28 dias. Conclusão: Este artigo fornece detalhes referentes à primeira versão do plano de análise estatística para o estudo BaSICS e orientará a análise do estudo após a conclusão do seguimento.

Abstract Objective: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Methods: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure. Results: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days. Conclusion: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study’s analysis when follow-up is finished.

Abstract Background: Isotretinoin is a synthetic retinoid, derived from vitamin A, with multiple mechanisms of action and highly effective in the treatment of acne, despite common adverse events, manageable and dose-dependent. Dose-independent teratogenicity is the most serious. Therefore, off-label prescriptions require strict criteria. Objective: To communicate the experience and recommendation of Brazilian dermatologists on oral use of the drug in dermatology. Methods: Eight experts from five universities were appointed by the Brazilian Society of Dermatology to develop a consensus on indications for this drug. Through the adapted DELPHI methodology, relevant elements were listed and an extensive analysis of the literature was carried out. The consensus was defined with the approval of at least 70% of the experts. Results: With 100% approval from the authors, there was no doubt about the efficacy of oral isotretinoin in the treatment of acne, including as an adjunct in the correction of scars. Common and manageable common adverse events are mucocutaneous in nature. Others, such as growth retardation, abnormal healing, depression, and inflammatory bowel disease have been thoroughly investigated, and there is no evidence of a causal association; they are rare, individual, and should not contraindicate the use of the drug. Regarding unapproved indications, it may represent an option in cases of refractory rosacea, severe seborrheic dermatitis, stabilization of field cancerization with advanced photoaging and, although incipient, frontal fibrosing alopecia. For keratinization disorders, acitretin performs better. In the opinion of the authors, indications for purely esthetic purposes or oil control are not recommended, particularly for women of childbearing age. Conclusions: Approved and non-approved indications, efficacy and adverse effects of oral isotretinoin in dermatology were presented and critically evaluated.

Abstract: Background: Acne in women is often associated with anxiety and depression, and may persist from adolescence as well as manifest for the first time in adulthood. Genetic and hormonal factors contribute to its etiopathogenesis, and maintenance treatment is required, usually for years, due to its clinical evolution. Objective: To develop a guide for the clinical practice of adult female acne. Methods: A team of five experts with extensive experience in acne conducted a literature review of the main scientific evidence and met to discuss the best practices and personal experiences to develop a guide containing recommendations for the clinical practice of adult female acne. Results: The group of specialists reached consensus on the main guidelines for clinical practice, providing detailed recommendations on clinical picture, etiopathogenesis, laboratory investigation and treatment of adult female acne. Conclusion: Different from teenage acne, adult female acne presents some characteristics and multiple etiopathogenic factors that make its management more complex. This guide provides recommendations for best clinical practices and therapeutic decisions. However, the authors consider that additional studies are needed in order to provide more evidence for adult female acne to be better understood.

RESUMO Objetivo: Levantar dados de prontuário dos pacientes com fratura cervical submetidos a tratamento cirúrgico em um serviço de saúde terciário, para melhor compreensão do cenário atual desse tipo de lesão em nosso meio. Métodos: O estudo realizou o levantamento retrospectivo de casos consecutivos de pacientes com trauma da coluna cervical submetidos ao tratamento cirúrgico durante os anos de 2013 e 2014. Os dados foram submetidos à análise estatística descritiva. Resultados: Cinquenta e dois pacientes foram operados neste serviço entre os anos de 2013 e 2014. Todos os pacientes classificados como Frankel A e B evoluíram com insuficiência respiratória. Quando comparados, os pacientes Frankel A, B e C e Frankel D e E, a taxa de todos os tipos de complicações pós-operatórias foi maior no primeiro grupo, com significância estatística (p < 0,01), exceto a taxa de infecções pós-operatórias (p = 0,717). Além disso, o tempo de internação foi maior no primeiro grupo (p < 0,01). Conclusão: Pacientes com trauma cervical que se apresentem com déficit neurológico na admissão hospitalar devem receber especial atenção, uma vez que a taxa de complicações pós-operatórias e os dias de internação são maiores. Além disso, pacientes Frankel A e B devem ser monitorados em ambiente de terapia intensiva. Nível de Evidência III; Estudo retrospectivo comparativo.

ABSTRACT Objective: To collect data from patients with cervical fracture who were treated surgically in a tertiary health service, in order to better understand the current scenario of this kind of injury in our population. Methods: This retrospective survey examined consecutive cases of patients with cervical spine trauma who received surgical treatment during 2013 and 2014. The data were subjected to descriptive statistical analysis. Results: Fifty-two patients were treated with surgery during 2013 and 2014. All patients classified as Frankel A and B developed respiratory failure. Patients classified as Frankel A, B, and C had significantly higher rates for postoperative complications (p < 0.01) than patients classified as Frankel D and E, except for the rate of postoperative infections (p = 0.717). Hospitalization time was also longer in the first group (p < 0.01). Conclusion: Patients with cervical trauma who present with neurological deficit at hospital admission should receive special attention, since the rate of postoperative complications is higher and hospital stays are lengthier in this group. In addition, patients with Frankel A and B classification should be monitored in an intensive care unit. Level of Evidence III; Retrospective comparative study.

INTRODUÇÃO: A substituição cirúrgica da valva aórtica é o tratamento de eleição para pacientes com estenose aórtica acentuada. Entretanto, o risco cirúrgico aumenta expressivamente com o avançar da idade e com a associação de comorbidades. Recentemente, iniciou-se a experiência com o implante por cateter de biopróteses aórticas no Brasil. Justifica-se, portanto, a criação de um registro nacional para conhecimento dos resultados desse tipo de procedimento em nosso meio. Descrevemos o racional e o desenho do Registro Brasileiro de Implante de Bioprótese Aórtica por Cateter. MÉTODOS: Trata-se de um registro multicêntrico, prospectivo, que incluirá 200 pacientes portadores de estenose valvar aórtica sintomática de alto risco cirúrgico submetidos a implante por cateter de bioprótese valvular aórtica em centros brasileiros. O desfecho primário do estudo é a mortalidade por qualquer causa aos 30 dias, 12 meses e 24 meses. Os desfechos secundários avaliados incluem, entre outros: 1) sucesso técnico do implante da bioprótese; 2) mortalidade cardiovascular aos 30 dias, 12 meses e 24 meses; 3) desfecho combinado de segurança aos 30 dias; e 4) desfecho combinado de eficácia aos 12 meses e 24 meses. CONCLUSÕES: A análise dos resultados desse registro nacional permitirá avaliar os defechos do implante percutâneo de biopróteses aórticas em nosso meio.

BACKGROUND: Surgical replacement of the aortic valve is the therapy of choice for patients with severe aortic stenosis. However, the surgical risk increases dramatically as age advances and with the association of comorbidities. Recently, transcatheter aortic valve implantation has been introduced in Brazil. Therefore, it was important to create a national registry to determine the outcomes of this procedure in our country. The rationale and design of the Brazilian Transcatheter Aortic Valve Implantation Registry is described. METHODS: This is a multicenter prospective registry, including 200 patients with symptomatic aortic valve stenosis and high surgical risk submitted to transcatheter aortic valve implantation in Brazilian institutions. The primary endpoint of the study is all cause mortality at 30 days, 12 and 24 months. Secondary endpoints, among others, are: 1) technical success of transcatheter valve implantation; 2) cardiovascular mortality at 30 days, 12 and 24 months; 3) composite safety endpoint at 30 days; and 4) composite efficacy endpoint at 12 and 24 months. CONCLUSIONS: The analysis of the results of this national registry will enable us to evaluate the outcomes of transcatheter aortic valve implantation in our country.

FUNDAMENTO: Indicadores de qualidade (IQ) em cirurgia cardíaca são importantes instrumentos de avaliação da assistência médica em centros hospitalares. OBJETIVO: Avaliar os IQ da cirurgia de revascularização miocárdica (CRVM) isolada em centro terciário cardiológico. MÉTODOS: Foram avaliados 144 pacientes consecutivos submetidos a CRVM isolada entre outubro de 2005 e março de 2007: 108 pacientes eram do sexo masculino (75%), com média de idade de 65±11 anos e EuroSCORE de 4±3. Os IQ avaliados foram: intervalo de tempo entre a marcação e a realização da cirurgia (TMC); taxa de cancelamento (TxC) decorrentes de problemas ligados à infra-estrutura hospitalar; tempo de permanência hospitalar (TPH); mortalidade operatória (MO) e taxa de reinternação hospitalar por infecção em ferida cirúrgica (TxRH). RESULTADOS: O TMC (n=98) foi de 4±3 dias (mediana de 4 dias) e a TxC foi zero. A MO observada de 4,9% (Intervalo de Confiança [IC] 95% = 2,2 - 9,87%) foi menor do que a MO esperada de 5,1% (IC 95% = 1,4% a 14,37%), mas sem significância estatística (p=0,65). A área sob a curva ROC do EuroSCORE para MO observada foi de 0,702 (IC 95% = 0,485 - 0,919). O TPH foi de 11±9 dias. A área sob a curva ROC do EuroSCORE para TPH foi de 0,764 (IC 95% = 0,675 - 0,852). A TxRH observada foi de 2,1%. CONCLUSÃO: A avaliação dos IQ demonstrou que, em um centro com baixo número anual de CRVM, os resultados alcançados foram compatíveis com o perfil de risco da população envolvida.

BACKGROUND: Quality indicators (QI) for cardiac surgery are important instruments for measuring healthcare quality in hospital centers and allow comparison with high-quality healthcare centers. OBJECTIVE: To evaluate QIs in isolated myocardial revascularization procedures (CABG) performed at a tertiary cardiology center. METHODS: One hundred and forty-four consecutive patients who had undergone isolated CABG were evaluated between October 2005 and March 2007. One hundred and eight patients were men (75%), the mean age was 65±11, and the EuroSCORE was 4±3. The following QIs were measured: time elapsed between the surgery date-setting appointment and the actual day of the CABG (TDC); surgery cancellation rate (SCR) due to problems in hospital infrastructure; length of hospital stay (LOS); operative mortality (OM) and rate of readmission (RHR) for infection in the surgical wound. RESULTS: The TDC (n=98) was 4±3 days (median: 4 days) and the SCR was zero. The OM recorded of 4.9% (95% confidence interval [CI] = 2.2 - 9.87%) was lower than the expected OM of 5.1% (95% CI = 1.4% to 14.37%), but with no statistical significance (p=0.65). The area under the ROC curve of the EuroSCORE for the OM was 0.702 (95% CI = 0.485 - 0.919). LOS was 11±9 days. The area under the ROC curve of the EuroSCORE for the LOS was 0.764 (95% CI = 0.675 - 0.852). The RHR recorded was 2.1%. CONCLUSION: The measurement of the QIs showed that, in a medical center with a low annual volume of CABG, the results were compatible with the risk profile of the population involved.

O pioderma gangrenoso pode apresentar-se como manifestação paraneoplásica. Relata-se um caso de pioderma gangrenoso, da variante bolhosa, acompanhado de bicitopenia, em que foi evidenciado, por meio de mielograma, biópsia de medula óssea e cariótipo, padrão compatível com síndrome mielodisplásica, subtipo citopenia refratária com displasia de multilinhagens. Foi tratado com dapsona, obtendo cicatrização das lesões. O pioderma gangrenoso pode associar-se a doenças sistêmicas, devendo a síndrome mielodisplásica ser considerada nos casos acompanhados de citopenias. Portanto, o pioderma gangrenoso pode ser um marcador cutâneo de doença sistêmica de prognóstico reservado.

Pyoderma gangrenosum can present as a cutaneous manifestation of paraneoplastic syndromes. A case of bullous pyoderma gangrenosum associated with bicytopenia is described. During the complementary investigation, myelogram, bone marrow biopsy and karyotype were performed, and showed a pattern consistent with myelodysplastic syndrome. The patient was treated with dapsone with improvement. Pyoderma gangrenosum can be a manifestation of systemic diseases. The possibility of myelodysplastic syndrome should always be considered in patients with pyoderma gangrenosum associated with cytopenia. Pyoderma gangrenosum could indicate poorer prognosis in patients with systemic diseases.