Experiencia quirúrgica en el Centro Especializado en Tratamiento de Enfermedades de la Piel (CETEP) del Centro Hospitalario Pereira Rossell, desde 1996 hasta 2019

Los tumores cutáneos presentan una alta prevalencia en dermatología en el mundo, siendo los benignos más frecuentes que los malignos; sin embargo, estos últimos son más estudiados debido a su morbimortalidad. El objetivo principal de este estudio fue conocer los principales diagnósticos y técnicas quirúrgicas correspondientes desarrolladas en el Centro de Tratamiento de Enfermedades de la Piel (CETEP) entre 1996 y 2019, evaluando aspectos clínicos y demográficos. Se realizó un estudio retrospectivo y observacional que incluyó todo paciente con lesión cutánea y posterior resolución quirúrgica de la misma. En la muestra analizada (N 6.659) hubo un predominio del sexo femenino (68%) y la media de edad fue 53 ± 21 años. Los pacientes residían mayoritariamente en Montevideo (58%). Los tumores benignos fueron los más frecuentes (41%), seguidos de los malignos (28%), dentro de éstos: carcinoma basocelular (CBC) 66%, carcinoma espinocelular (CEC) 21% y melanoma (MM) 5%. Las técnicas quirúrgicas realizadas fueron cirugías convencionales (57%), principalmente losange (93%), seguidas de procedimientos de cirugía dermatológica (42%), predominando biopsias (52%) y afeitado con electrocoagulación (23%). Se destaca que el CETEP resolvió un número mayor de pacientes de centros externos que del propio Centro Hospitalario Pereira Rossell (CHPR): 59% no CHPR vs 41% CHPR. En conclusión, este trabajo proporcionó información nacional sobre la epidemiología de distintos tumores cutáneos, así como las técnicas quirúrgicas más utilizadas en su resolución. Además, estableció la importancia de la cirugía dermatológica y la capacidad del CETEP en dar respuesta a pacientes propios tanto como referenciados desde otros centros del sistema público.

Cutaneous tumors have a high prevalence in dermatology worldwide, with benign tumors being more common than malignant ones. Nevertheless, the latter are more extensively studied due to their associated morbidity and mortality. The main objective of this study was to identify the primary diagnoses and corresponding surgical techniques developed at the Center for the Treatment of Skin Diseases (CETEP) between 1996 and 2019, while assessing clinical and demographic aspects. A retrospective, observational study was conducted, including all patients with cutaneous lesions and subsequent surgical resolution of the same. In the analyzed sample (N 6659), there was a predominance of females (68%), and the mean age was 53 ± 21 years. The majority of patients resided in Montevideo (58%). Benign tumors were the most prevalent (41%), followed by malignant tumors (28%), with the latter comprising basal cell carcinoma (BCC) at 66%, squamous cell carcinoma (SCC) at 21%, and melanoma (MM) at 5%. The performed surgical techniques included conventional surgeries (57%), primarily using the lozenge method (93%), followed by dermatologic surgery procedures (42%), with a predominance of biopsies (52%) and shave excision with electrocoagulation (23%). It is noteworthy that CETEP resolved a greater number of patients from external centers than from its own hospital, Pereira Rossell Hospital Center (CHPR). 59% non-CHPR vs. 41% CHPR. In conclusion, this study provided national information on the epidemiology of various cutaneous tumors, as well as the most commonly employed surgical techniques in their resolution Furthermore, it emphasized the importance of dermatologic surgery and highlighted the capacity of CETEP to respond to both its own patients and those referred from other centers within the public healthcare system.

Os tumores da pele apresentam alta prevalência na dermatologia em todo mundo, sendo os tumores benignos mais frequentes que os malignos, porém estes últimos são mais estudados devido à sua morbidade e mortalidade. O objetivo principal deste estudo foi conhecer os principais diagnósticos e correspondentes técnicas cirúrgicas desenvolvidas no Centro de Tratamento de Doenças da Pele (CETEP) no período 1996-2019, avaliando aspectos clínicos e demográficos. Foi realizado um estudo retrospectivo e observacional, que incluiu todos os pacientes com lesões cutâneas e com posterior tratamento cirúrgico. Foram estudados 659 pacientes com predomínio do sexo feminino (68%) e média de idade de 53 ± 21 anos. A maioria dos pacientes residiam em Montevidéu (58%). Os tumores benignos foram os mais frequentes (41%), seguidos dos tumores malignos (28%), entre estes: carcinoma basocelular (CBC) 66%, carcinoma espinocelular (CEC) 21% e melanoma (MM) 5%. As técnicas cirúrgicas realizadas foram cirurgias convencionais (57%), principalmente em forma de cunha (93%), seguidas de procedimentos cirúrgicos dermatológicos (42%), predominando biópsias (52%) e shaving com eletrocoagulação (23%). Destaca-se que o CETEP atendeu um número maior de pacientes de centros externos do que do próprio Centro Hospitalar Pereira Rossell (CHPR): 59% não-CHPR vs. 41% CHPR. Concluindo, este trabalho forneceu informações sobre a epidemiologia dos diferentes tumores de pele no país, bem como as técnicas cirúrgicas mais utilizadas no seu tratamento. Além disso, estabeleceu a importância da cirurgia dermatológica e a capacidade do CETEP de atender os pacientes do hospital e também os que foram encaminhados de outros centros da rede pública.

Scale development and validation of perimenopausal women disability index in the workplace

BACKGROUND@#Menopausal disorders include obscure symptomatology that greatly reduce work productivity among female workers. Quantifying the impact of menopause-related symptoms on work productivity is very difficult because no such guidelines exist to date. We aimed to develop a scale of overall health status for working women in the perimenopausal period.@*METHODS@#In September, 2021, we conducted an Internet web survey which included 3,645 female workers aged 45-56 years in perimenopausal period. We asked the participants to answer 76 items relevant to menopausal symptomatology, that were created for this study and performed exploratory and confirmatory factor analyses for the scale development. Cronbach's alpha, receiver operating characteristic analysis, and logistic regression analysis were used to verify the developed scale.@*RESULTS@#Approximately 85% participants did not have menstruation or disrupted cycles. Explanatory factor analysis using the maximum likelihood method and Promax rotation identified 21 items with a four-factor structure: psychological symptoms (8 items, α = 0.96); physiological symptoms (6 items, alpha = 0.87); sleep difficulty (4 items, alpha = 0.92); human relationship (3 items, alpha = 0.92). Confirmatory factor analyses found excellent model fit for the four-factor model (RMSR = 0.079; TLI = 0.929; CFI = 0.938). Criterion and concurrent validity were confirmed with high correlation coefficients between each of the four factors, previously validated menopausal symptom questionnaire, and Copenhagen Burnout Inventory scales, respectively (all ps < 0.0001). The developed scale was able to predict absenteeism with 78% sensitivity, 58% specificity, and an AUC of 0.727 (95%CI: 0.696-0.757). Higher scores of each factor as well as total score of the scale were more likely to be associated with work absence experience due to menopause-related symptoms even after adjusting for Copenhagen Burnout Inventory subscales (all ps < 0.0001).@*CONCLUSION@#We found that the developed scale has high validity and reliability and could be a significant indicator of absenteeism for working women in perimenopausal period.

Inhibition of lipopolysaccharide-induced NF-κB maintains osteogenesis of dental pulp and periodontal ligament stem cells

Abstract Dental pulp stem cells (DPSCs) and periodontal ligament stem cells (PDLSCs) can differentiate into osteoblasts, indicating that both are potential candidates for bone tissue engineering. Osteogenesis is influenced by many environmental factors, one of which is lipopolysaccharide (LPS). LPS-induced NF-κB activity affects the osteogenic potencies of different types of MSCs differently. This study evaluated the effect of LPS-induced NF-κB activity and its inhibition in DPSCs and PDLSCs. DPSCs and PDLSCs were cultured in an osteogenic medium, pretreated with/without NF-κB inhibitor Bay 11-7082, and treated with/without LPS. Alizarin red staining was performed to assess bone nodule formation, which was observed under an inverted light microscope. NF-κB and alkaline phosphatase (ALP) activities were measured to examine the effect of Bay 11-7082 pretreatment and LPS supplementation on osteogenic differentiation of DPSCs and PDLSCs. LPS significantly induced NF-κB activity (p = 0.000) and reduced ALP activity (p = 0.000), which inhibited bone nodule formation in DPSCs and PDLSCs. Bay 11-7082 inhibited LPS-induced NF-κB activity, and partially maintained ALP activity and osteogenic potency of LPS-supplemented DPSCs and PDLSCs. Thus, inhibition of LPS-induced NF-κB activity can maintain the osteogenic potency of DPSCs and PDLSCs.

Vigilancia activa en cáncer de próstata en un grupo de pacientes asistidos en el Centro Docente Asociado de Oncología Médica Rivera: Cooperativa Médica de Rivera (COMERI) / Active surveillance in prostate cancer in a group of patients assisted at the Rivera Associated Teaching Center for Medical Oncology: Rivera Medical Cooperative (COMERI) / Vigilância ativa do câncer de próstata em um grupo de pacientes atendidos no Rivera Associated Teaching Center for Medical Oncology: Rivera Medical Cooperative (COMERI)

Introducción: En Uruguay el cáncer de próstata ocupa el primer lugar en incidencia y el tercer lugar en mortalidad en el hombre. La mayoría de estos cánceres se diagnostican en estadios precoces. Hoy en día, para pacientes con adenocarcinoma de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, la vigilancia activa es una opción adecuada. Objetivos: Describir una población de pacientes con cáncer de próstata de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, en vigilancia activa en COMERI. Material y métodos: Estudio descriptivo, observacional, retrospectivo. Se incluyeron pacientes con cáncer de próstata de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, tratados entre 2010 y 2018 en COMERI. Se recopilaron datos en el sistema de registro clínico electrónico. Resultados: Se incluyeron 33 pacientes, la mediana de edad al diagnóstico fue de 74 años. Todos los pacientes fueron sometidos a controles clínicos y determinación de PSA cada 3 meses. El tacto rectal se realizó en forma anual. El tiempo mediano de vigilancia activa fue de 33 meses. Durante el seguimiento, se observaron pocas variaciones en los valores de PSA. El 21% de los pacientes fue sometido a una nueva biopsia durante el seguimiento activo, y en todos los casos, el Gleason se mantuvo incambiado. Ningún paciente abandonó la modalidad de vigilancia activa. Conclusión: En nuestro entorno, la vigilancia activa se considera una opción terapéutica válida para pacientes altamente seleccionados con cáncer de próstata de muy bajo riesgo, bajo riesgo o riesgo intermedio favorable, y es bien aceptada por ellos.

Introduction: In Uruguay, prostate cancer ranks first in incidence and third in mortality among men. The majority of these cancers are diagnosed at early stages. Nowadays, active surveillance is an appropriate option for patients with adenocarcinoma of very low risk, low risk, or favorable intermediate risk. Objectives: To describe a population of patients with prostate cancer of very low risk, low risk, or favorable intermediate risk under active surveillance at COMERI. Materials and Methods: Descriptive, observational, retrospective study. Patients with prostate cancer of very low risk, low risk, or favorable intermediate risk treated between 2010 and 2018 at COMERI were included. Data were collected from the electronic clinical registry system. Results: Thirty-three patients were included, with a median age at diagnosis of 74 years. All patients underwent clinical monitoring and PSA determination every 3 months. Digital rectal examination was performed annually. The median time of active surveillance was 33 months. During follow-up, there were few variations in PSA values. 21% of patients underwent a repeat biopsy during active surveillance, and in all cases, the Gleason score remained unchanged. No patient discontinued active surveillance. Conclusion: In our setting, active surveillance is considered a valid therapeutic option for highly selected patients with prostate cancer of very low risk, low risk, or favorable intermediate risk, and it is well accepted by them.

Introdução: No Uruguai, o câncer de próstata ocupa o primeiro lugar em incidência e o terceiro lugar em mortalidade entre os homens. A maioria desses cânceres é diagnosticada em estágios precoces. Atualmente, para pacientes com adenocarcinoma de risco muito baixo, baixo risco ou risco intermediário favorável, a vigilância ativa é uma opção adequada. Objetivos: Descrever uma população de pacientes com câncer de próstata de risco muito baixo, baixo risco ou risco intermediário favorável sob vigilância ativa em COMERI. Material e métodos: Estudo descritivo, observacional, retrospectivo. Foram incluídos pacientes com câncer de próstata de risco muito baixo, baixo risco ou risco intermediário favorável, tratados entre 2010 e 2018 em COMERI. Os dados foram coletados no sistema de registro clínico eletrônico. Resultados: Foram incluídos 33 pacientes, com mediana de idade no diagnóstico de 74 anos. Todos os pacientes foram submetidos a controles clínicos e determinação de PSA a cada 3 meses. O toque retal foi realizado anualmente. O tempo médio de vigilância ativa foi de 33 meses. Durante o acompanhamento, houve poucas variações nos valores de PSA. 21% dos pacientes foram submetidos a uma nova biópsia durante a vigilância ativa, e em todos os casos, o Gleason permaneceu inalterado. Nenhum paciente abandonou a modalidade de vigilância ativa. Conclusão: Em nosso ambiente, a vigilância ativa é considerada uma opção terapêutica válida para pacientes altamente selecionados com câncer de próstata de risco muito baixo, baixo risco ou risco intermediário favorável, e é bem aceita por eles.

Directrices para presentación de informes de ensayos clínicos sobre intervenciones con inteligencia artificial: extensión CONSORT-AI / Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension / Diretrizes para relatórios de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão CONSORT-AI

resumen está disponible en el texto completo

ABSTRACT The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

RESUMO A declaração CONSORT 2010 apresenta diretrizes mínimas para relatórios de ensaios clínicos randomizados. Seu uso generalizado tem sido fundamental para garantir a transparência na avaliação de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence) é uma nova diretriz para relatórios de ensaios clínicos que avaliam intervenções com um componente de IA. Ela foi desenvolvida em paralelo à sua declaração complementar para protocolos de ensaios clínicos, a SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 29 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão CONSORT-AI inclui 14 itens novos que, devido à sua importância para as intervenções de IA, devem ser informados rotineiramente juntamente com os itens básicos da CONSORT 2010. A CONSORT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA está inserida, considerações sobre o manuseio dos dados de entrada e saída da intervenção de IA, a interação humano-IA e uma análise dos casos de erro. A CONSORT-AI ajudará a promover a transparência e a integralidade nos relatórios de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente a qualidade do desenho do ensaio clínico e o risco de viés nos resultados relatados.

Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI / Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension / Diretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI

resumen está disponible en el texto completo

ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.

Pedículo Renal: Análisis de sus Variantes / Renal Pedicle: Analysis of their Variants

Testut & Latarjet (1980), Bouchet & Cuilleret (1986), Latarjet & Liard (2005) y Rouvière & Delmas (2005) describen las relaciones intrínsecas del pedículo renal (PR) a partir de dos planos coronales, siendo la PER el elemento que limita entre ambos. Trivedi et al. (2011) demostró relaciones entre los elementos del PR que no coinciden con las descripciones aportadas por dichos autores.Conocer las posibles variantes en las relaciones intrínsecas del PR es de suma importancia en prácticas quirúrgicas como el trasplante renal (García de Jalón Martínez et al., 2003; Batista Hernández et al., 2010). Por lo tanto, el objetivo del presente trabajo fue analizar las variables relaciones entre los elementos que conforman el PR en la región yuxtahiliar del riñón. Se estudiaron 23 PR, formolizados al 10 % y provistos por el Equipo de Disección de la Segunda Cátedra de Anatomía de la Universidad de Buenos Aires. Se clasificaron los PR en dos grupos. En el Grupo I, las afluentes de origen de la vena renal (AOVR) se hallaban en el mismo plano coronal. En el grupo II, las AOVR se encontraban en diferentes planos coronales. Cada grupo fue subdividido en distintos patrones. Los patrones I y II, de mayor incidencia, fueron asociados al grupo I y los patrones III, IV y V al grupo II. En el patrón I, las AOVR eran anteriores a la pelvis renal (PER) y posteriores a la arteria prepiélica (APP). En el patrón II, las AOVR eran anteriores a la PER y a la APP. Los patrones I y II conforman el grupo I y presentaron mayor número de incidencia en nuestra investigación. Existen también variantes que inciden con menor frecuencia que dichos patrones, estas comprenden el grupo II de la clasificación planteada en el presente trabajo.

SUMMARY: Testut & Latarjet (1980), Bouchet & Cuilleret (1986), Latarjet & Liard (2005) y Rouvière & Delmas (2005) describe the intrinsic relationships of the renal pedicle (PR) from two coronal planes, the renal pelvis (PER) being the element that limits between both. Trivedi et al. (2011) showed relationships between the elements of the RP that do not coincide with the descriptions provided by these authors. Knowing the possible variants in the intrinsic relationships of the RP is of the utmost importance in surgical practices such as renal transplantation (García de Jalón Martínez et al., 2003). Therefore, the objective of this study is to analyze the variable relationships between the elements that make up the RP in the juxtahilar region of the kidney. 23 RP were studied, formalized at 10 % and provided by the Dissection Team of the Second Chair of Anatomy of the University of Buenos Aires. PRs were classified into two groups. In Group I, the tributaries of origin of the renal vein (RVOA) were in the same coronal plane. In group II, the AOVRs were in different coronal planes. Each group was subdivided into different patterns. Patterns I and II, with the highest incidence, were associated with group I and patterns III, IV and V with group II. In pattern I, the VROA were anterior to the renal pelvis (PER) and posterior to the prepelvic artery (PPA). In pattern II, AOVRs were prior to PER and APP. Patterns I and II make up group I and presented a higher number of incidence in our investigation. There are also variants that occur less frequently than these patterns, these comprise group II of the classification proposed in this work.

Evaluación de la formación de biopelículas en aislamientos bacterianos y fúngicos por el método semicuantitativo de microtitulación con cristal violeta y el cualitativo de agar con rojo Congo / Assessment of biofilms formation of bacterial and fungal isolates using qualitative Congo red agar and semiquantitative crystal violet microtiter methods

Introducción. El 65 % de las infecciones humanas son producidas por bacterias o levaduras, cuya capacidad de formar biopelículas las hace más resistentes a los antimicrobianos y antifúngicos. Objetivo. Determinar la capacidad de formación de biopelículas en aislamientos bacterianos y fúngicos por medio de los métodos cuantitativo de microtitulación con cristal violeta y cualitativo de cultivo en agar con rojo Congo. Materiales y métodos. Con el método cuantitativo, se utilizaron los medios de cultivo infusión cerebro-corazón, tripticasa de soya y Müeller-Hinton para aislamientos bacterianos; para levaduras, se usaron caldo infusión cerebro-corazón y Sabouraud dextrosa. Para el método cualitativo de cultivo en agar, se utilizaron los mismos medios de cultivo más una solución con 3 % de rojo Congo y 10 % de dextrosa. Cómo método de referencia, se utilizó la propuesta de Stepanovic et al. Resultados. Se evaluaron 103 aislamientos bacterianos y 108 de levaduras. No es recomendable sustituir el caldo infusión cerebro-corazón por los caldos tripticasa de soya y Müeller-Hinton en el método cuantitativo, para evaluar la formación de biopelículas en los aislamientos bacterianos. El medio Sabouraud dextrosa, en caldo y agar, puede sustituir al de infusión de cerebro-corazón para evaluar la formación de biopelículas en levaduras, tanto por el método cuantitativo como por el cualitativo. Conclusión. El estudio de las biopelículas en el laboratorio de microbiología, a partir del método cualitativo de cultivo en agar con rojo Congo, es un procedimiento sencillo, rápido y de bajo costo, que proporciona información útil para el diagnóstico y la terapéutica de infecciones persistentes causadas por bacterias y levaduras.

Introduction. Sixty-five percent of human infections are caused by bacteria or yeasts able to form biofilms. This feature makes them more resistant to antimicrobials and antifungals. Objective. To determine biofilm formation capacity of bacterial and fungal isolates by quantitative crystal violet microtiter and qualitative Congo red agar methods. Materials and methods. Brain-heart infusion, trypticase soy broth and Müeller-Hinton culture media were used in bacterial isolates for the quantitative method; brain-heart infusion broth and Sabouraud dextrose were used for yeasts. The same culture media plus 3% Congo red and 10% dextrose were used to apply the qualitative method in agar. The proposal by Stepanovic, et al. was used as a reference method. Results. We evaluated 103 bacterial isolates and 108 yeasts isolates. We did not recommend substitute brain-heart infusion broth for trypticase soy and Müeller-Hinton broths for biofilm formation assessment in bacterial isolates using the quantitative method. Sabouraud dextrose medium, both broth and agar, can replace brain-heart infusion to assess biofilm formation in yeasts, quantitatively and qualitatively. Conclusion. The study of biofilms in the microbiology laboratory, using Congo red agar qualitative method, is a simple, fast, and inexpensive procedure that provides precise information for the diagnosis and treatment of persistent infections caused by bacteria and yeasts.

Arterias sigmoideas: bases para una nueva clasificación / Sigmoid arteries: bases for a new classification

Las arterias sigmoideas son ramas de la arteria mesentérica inferior e irrigan al colon sigmoideo. Se originan del tronco de las arterias sigmoideas. Esta es la descripción más frecuente según los autores consultados. El objetivo fue analizar las variaciones en el origen y distribución de las arterias sigmoideas mediante disección. Se utilizaron 13 preparados cadavéricos formolizados al 10 %. Se disecó la cavidad abdominal para identificar a las arterias sigmoideas. Se evidenció su bifurcación paralela al colon sigmoideo. Se lo delimitó mediante reparos palpables. Patrón I: 4 casos (30,8 %). Variante de la arcada sigmoidea como rama colateral de la arteria mesentérica inferior. Tipo Ia: 1 caso (25 %). Sin asociaciones. Tipo Ib: 1 caso (25 %). Asociada al tronco sigmoideo. Tipo Ic: 2 casos (50 %). Asociada a arterias sigmoideas accesorias. Patrón II: 6 casos (46,2 %). Variante del tronco común entre arteria cólica izquierda y arterias destinadas al colon sigmoideo. Tipo IIa: 3 casos (50 %). Sin asociaciones. Tipo IIb: 2 casos (33,3 %). Asociado al tronco sigmoideo. Tipo IIc: 1 caso (16,7 %). Asociado a arterias sigmoideas accesorias. Patrón III: 3 casos (23 %). Variante clásica. Se definió por la ausencia del tronco común con la arteria cólica izquierda y de la arcada sigmoidea. Tipo IIIa: 2 casos (66,7 %). Un número variable de arterias sigmoideas nacen como ramas colaterales de la arteria mesentérica inferior, sin asociarse al tronco sigmoideo. Tipo IIIb: 1 caso (33,3 %). La arteria cólica izquierda emite como rama colateral la primera arteria sigmoidea y se asocia al tronco sigmoideo. 1. El patrón II es el prevalente en este trabajo (46,2 %). 2. La variante clásica no es la predominante en esta investigación (23 %). 3. La arcada sigmoidea tiene 53,8 % de incidencia.

SUMMARY: The sigmoid arteries are branches of the inferior mesenteric artery and supply the sigmoid colon. They originate from the trunk of the sigmoids. This is the most frequent description according to the consulted authors. The objective is to analyze the variations in the origin and distribution of the sigmoid arteries through dissection. 13 cadaveric preparations formalized at 10 % and instruments were used. The abdominal cavity was dissected to identify the sigmoid arteries. Its bifurcation parallel to the sigmoid colon is evident. It is delimited by palpable repairs. Pattern I: 4 cases (30.8 %). Variant of the sigmoid arcade as a collateral branch of the inferior mesenteric artery. Type Ia: 1 case (25 %). No associations. Type Ib: 1 case (25 %). Associated with the sigmoid trunk. Type Ic: 2 cases (50 %). Associated with accessory sigmoid arteries. Pattern II: 6 cases (46.2 %). Variant of the common trunk between the left colic artery and arteries destined for the sigmoid colon. Type IIa: 3 cases (50 %). No associations. Type IIb: 2 cases (33.3 %). Associated with the sigmoid trunk. Type IIc: 1 case (16.7 %). Associated with accessory sigmoid arteries. Pattern III: 3 cases (23 %). Classic variant. It was defined by the absence of the common trunk with the left colic artery and the sigmoid arcade. Type IIIa: 2 cases (66.7 %). A variable number of sigmoid arteries arise as collateral branches of the inferior mesenteric artery, without being associated with the sigmoid trunk. Type IIIb: 1 case (33.3 %). The left colic artery gives off the first sigmoid artery as a collateral branch and is associated with the sigmoid trunk. 1. Pattern II is the most prevalent in this study (46.2 %). 2. The classic variant is not the predominant one in this research (23 %). 3. The sigmoid arcade has a 53.8 % incidence.

Antimicrobial Activities of Mangrove Species in Southeast Asia: A Systematic Review (Aktiviti Antimikrob Spesies Bakau di Asia Tenggara: Tinjauan Sistematik) / Jurnal Sains Kesihatan Malaysia

@#Antimicrobial resistance in Southeast Asia is a macro-level health dilemma that may cause substantial casualties annually. Fortunately, Southeast Asian mangroves are potent reservoirs of bioactive compounds with antimicrobial properties in correlation to their traditional usage. Hence, this study aimed to systematically review studies concerning antimicrobial activities of mangroves in Southeast Asia as well as provide a technological overview of its prospective use in pharmaceutical industry applications through patents. Through the PRISMA protocol, the search for peerreviewed studies originated from Southeast Asia and published between 2010 to 2022 were conducted over databases such as CORE, Google Scholar, PubMed (MedLine), Science Direct, Semantic Scholar, Scopus, and Web of Science. Additionally, a patent search was also performed on the Espacenet Patent Search, Google Patents, National Institute of Industrial Property, and United States Patent and Trademark Office. The studies and patents were collated on Mendeley Reference Manager as well as tabulated and assessed on Microsoft Office Excel 2016. After the four-phase screening, 59 studies and one patent regarding antimicrobial activities of Southeast Asian mangroves passed the criteria for the systematic review. It was inferred that Southeast Asia constitutes potentially most species-diverse mangroves with highly varied antimicrobial properties and can form synergism with drugs. The existing studies and patents may provide enlightenment on the future path of studies and inventions which must be continually substantiated in animal and clinical experiments for prospective pharmaceutical industry use. In this way, mangroves can be conserved while antimicrobial resistance and anthropogenic activities can be lowered.

Safety attitudes, burnout and well-being among healthcare workers during the COVID-19 pandemic: an Indo-Pacific regional cross-sectional study

INTRODUCTION@#The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented impact in Asia and has placed significant burden on already stretched healthcare systems. We examined the impact of COVID-19 on the safety attitudes among healthcare workers (HCWs), as well as their associated demographic and occupational factors, and measures of burnout, depression and anxiety.@*METHODS@#A cross-sectional survey study utilising snowball sampling was performed involving doctors, nurses and allied health professions from 23 hospitals in Singapore, Malaysia, India and Indonesia between 29 May 2020 and 13 July 2020. This survey collated demographic data and workplace conditions and included three validated questionnaires: the Safety Attitudes Questionnaire (SAQ), Oldenburg Burnout Inventory and Hospital Anxiety and Depression Scale. We performed multivariate mixed-model regression to assess independent associations with the SAQ total percentage agree rate (PAR).@*RESULTS@#We obtained 3,163 responses. The SAQ total PARs were found to be 35.7%, 15.0%, 51.0% and 3.3% among the respondents from Singapore, Malaysia, India and Indonesia, respectively. Burnout scores were highest among respondents from Indonesia and lowest among respondents from India (70.9%-85.4% vs. 56.3%-63.6%, respectively). Multivariate analyses revealed that meeting burnout and depression thresholds and shifts lasting ≥12 h were significantly associated with lower SAQ total PAR.@*CONCLUSION@#Addressing the factors contributing to high burnout and depression and placing strict limits on work hours per shift may contribute significantly towards improving safety culture among HCWs and should remain priorities during the pandemic.

A literature review and clinical consensus guidelines on the management of Bullous Pemphigoid

@#Bullous pemphigoid (BP) is the most common autoimmune blistering disease primarily characterized by tense blisters and occasionally with urticarial plaques, affecting the skin and mucous membranes. These are caused by autoantibodies against BP180 and BP230 which target antigens on the basement membrane zone. The diagnosis relies on the integration of clinical, histopathological, immunopathological, and serological findings. The management depends on the clinical extent and severity. We present in this article a literature review and the clinical consensus guidelines of the Immunodermatology Subspecialty Core Group of the Philippine Dermatological Society in the management of BP.

Practice and perceptions of pediatric residents in a Tertiary Government Hospital on mental healthcare as part of general practice

Objective@#This study aimed to describe mental health practice patterns, perceptions, perceived responsibility, confidence, barriers, and supports of pediatric residents in a tertiary government hospital to arrive at recommendations in enhancing their mental health competencies.@*Methodology@#As part of needs and baseline assessment within an existing collaboration, written self-administered questionnaires were distributed among pediatric residents of the hospital. Frequency of answers were tallied to see clustering and trends. RESULTS: Most of the 37 Pediatric residents had positive perceptions i.e. 78.83% - 83.78% and planned to incorporate all aspects mental healthcare in their future practice as consultants i.e. 89.19 %- 97.29 %. However, they did not get to practice or apply it as much during training. All respondents perceived that diagnosing the neurodevelopmental disorders of Autism Spectrum, Attention Deficit and Hyperactivity, Intellectual Disability and Learning was their responsibility. When it came to confidence in diagnosing other psychiatric disorders less than half to 3/5 (45.9%- 64/9%) were confident or very confident in doing so. Approximately three fifths (56.75% -67.56%) of them were confident in managing neurodevelopmental disorders. There was an even lower proportion i.e. one fourth (16.21% - 32.43%) of pediatric residents who were confident in managing other psychiatric disorders. Time was the most often perceived barrier while more exposure and training were the supportive factors for integrating mental healthcare into practice.@*Conclusion@#With such positive perceptions already in place, programs to improve knowledge and skills can be developed to increase confidence, focusing on diagnosing and managing psychiatric conditions. Target areas as guided by this research can be on how to use screening tools and psychotropics, diagnosing anxiety and behavioral addictions, and managing psychosis and trauma. These should be incorporated in a time-efficient manner into usual patient interviews. Training and added exposure can be utilized in the short-term as well as institutionalization of collaboration, liaison, and feedback systems in the future.

Tying it all together: Case of Autism Spectrum Disorder with paraphilic activities

@#Autism Spectrum Disorder (ASD) is a phenotypically heterogenous group of neurodevelopmental syndromes characterized by a wide range of impairments in socialcommunication and restricted and repetitive behaviors. (1) The majority of individualswith ASD go through puberty and experience the same physical and psychosexual aspectsof sexual development as their peers. However, there are notable problems with regardsto sexuality especially at the start of puberty when the development of social skillscannot keep up with the increasing social demands, and the difficulties of formingromantic and sexual relationships become evident. (2)The case presented here is a 26-year-old male with a history of engaging in paraphilicactivities that showed the complexities of ASD (Asperger Syndrome) in their sexualbehavior.PJPCASE REPORTTYING IT ALL TOGETHER:CASE OF AUTISM SPECTRUM DISORDER WITH PARAPHILIC ACTIVITIESMELANIE TONGOL, MDTHE MEDICAL CITYDEPARTMENT OF PSYCHIATRY34 · PJP 2023 · Volume 4 (1-2) · ISSN 2980-4884CASE PRESENTATIONChief ComplaintJay was a 26-year-old Filipino male, Christian,single, seeking consult for intrusive thoughts withthemes of bondage & discipline, dominance& submission and sadism &masochism (BDSM).History of Present IllnessJay described himself as curious, ambitious, andpeculiar. Despite trying to be sociable andextroverted, he had difficulty connecting withfriends and he often ended up alone. This hasbeen a recurring experience since childhood.Five years prior to consult, Jay’s excitement washyped, as a female chatmate opened up thetopic of BDSM.He shared his long-term fantasies of tying up agirl and subjecting her to pain, humiliation andsexual stimulation, which was never realizedgiven his Christian belief that it was wrong.After meeting someone who shared his hiddendesires, he was able to muster the strength to liveout his fantasies and met with the said chatmate.They planned their BDSM roles and restrictions,with Jay as the dominant and the chatmate assubmissive. On the day of their meeting, Jaypacked ropes in his bag, as he remembered hispast fascination with them when he was still aboy scout. he met his chatmate at the deliveryarea of a mall and there began his string of novel sexual pursuits. He started binding herhands and legs behind her. Both lying on thefloor, fully clothed, he kept on tying her as if hewas in a trance. Merely having his partner

Acceptance, knowledge, and experiences of Pediatric Hematologists in the Philippines on newborn screening for hemoglobinopathies

Background@#Hemoglobinopathies as a group is one of the most common conditions confirmed through the newborn screening (NBS) program of the Philippines. This led to the increased participation of pediatric hematologists in the NBS program.@*Objective@#The aim of the study was to assess newborn screening acceptance and knowledge of pediatric hematologists using an online questionnaire.@*Method@#Members of the Philippine Society of Pediatric Hematology (PSPH), who are practicing pediatric hematologists in the Philippines, were invited to answer an online questionnaire.@*Results@#Sixty members of the PSPH (65.2%) answered the survey. All the respondents are familiar with the newborn screening program. Fifty-seven respondents (95 %) have already managed a case of hemoglobinopathy identified through the newborn screening program. Differences in the approach to management and level of confidence with diagnostic test result interpretation have been noted. General themes of their concerns include being unaware of the protocol, concerns on delays in confirmatory tests, request for guidelines on follow-up, and incongruence of results with clinical picture.@*Conclusion@#The information collected may be used to develop strategies to better equip our pediatric hematologists and assist the PSPH standardize management protocols for hemoglobinopathies.

Telegenetics services in a tertiary hospital: Utility and patient satisfaction

Background@#Telegenetics has been a very useful platform to continue the different services offered by the clinical genetics team especially during the COVID-19 pandemic, when this mode of care had been maximized.@*Objective@#This paper aimed to present the process of telegenetics in a tertiary hospital and the feedback for this service through patient satisfaction surveys. @*Methods@#Telegenetics consultation is divided into three phases: pre-consultation, consultation, and post-consultation. Patient satisfaction in the delivery of genetics services were obtained through a survey answered by patients/caregivers after telegenetics consultation. Ratings of patient satisfaction on telegenetics consultation during the pandemic (September 2020 to February 2021) were compared from that of face-to-face consultations before the pandemic (September 2019 to February 2020).@*Results@# In 2020, there were a total of 1,228 consultations made via telegenetics. Of which, 319 consultations were for the metabolic service, 138 for dysmorphology, 207 for genetic counseling, and 564 for dietary counseling. New patients comprised 13.84% of the consultations and 86.16% were from follow-up patients. In 2021, there were a total of 3,124 consultations made via telegenetics. Of which, 617 consultations were for the metabolic service, 688 for dysmorphology, 961 for genetic counseling, and 858 for dietary counseling. New patients comprised 12.93% of the consultations and 87.07% were from follow-up patients. Over a period of 6 months, pre-pandemic (face-to-face consultation) and pandemic (telegenetics) patient satisfaction survey results showed no significant difference on the results for both new patient consultations and follow-up patient consultations that is a standard satisfactory rating of at least 3 (satisfactory) on customer satisfaction by more than 70% of the respondents. @*Conclusion@#Patient satisfaction ratings on the utility of telegenetics was comparable to that of face-to-face consultations. Its use has shown benefits like cost-effectiveness, time efficiency, improved accessibility, and psychological benefits as some patients fear a hospital setting during the pandemic. It also has limitations like possible technical difficulties during consultations and limited opportunity for physical examination, establishing rapport, and exploring psychosocial issues. Hence it is important to consider the possibility of a telegenetics consultation as an alternative to a face-to-face consultation.

Anesthetic management of a patient with acquired angioedema submitted to broncofibroscopy: a case report

Abstract Acquired angioedema with C1 inhibitor deficiency (AAE-C1INH) is a very rare condition of bradykinin-mediated angioedema. One of its major complications is potentially life-threatening, laryngeal edema. We report a 53-year-old woman with AAE-C1INH proposed for an elective broncofibroscopy. The direct stimulation caused by broncofibroscopy poses a high risk of angioedema, thus presenting an anesthetic challenge. Due to the risk of death, it is essential to adopt preventive measures. Short-term prophylaxis was performed, and the acute treatment was readily available. A well-structured multidisciplinary periprocedural plan makes it possible to safely approach the airway, in a remote area of the hospital.

Peroneus Longus Tendon Graft to Reconstruct the Posterolateral Corner of the Knee / Enxerto do tendão fibular longo na reconstrução do canto posterolateral do joelho

Abstract The posterolateral corner is critical to knee stability. Neglected injuries have a direct impact on the prognosis due to residual instability, chronic pain, deformities, and failure to repair other structures. Several techniques are used to reconstruct the posterolateral corner, often with autologous ischiotibial grafts or homologous grafts. An option little used for knee ligament reconstructions is the peroneus longus tendon graft. Although reported as a good alternative for anterior cruciate ligament reconstruction, we found no case using a peroneus longus tendon graft for posterolateral corner reconstruction. Here, we describe the case of a patient who underwent a non-anatomical reconstruction of the posterolateral corner using a peroneus longus tendon graft. The patient underwent surgical procedures for ligament reconstruction and correction of the deformity caused by a failed graft, but his knee remained unstable. During the preoperative planning, it was decided to reconstruct the posterolateral corner with an ipsilateral peroneus longus tendon graft. Studies have shown that the peroneus longus tendon graft does not increase ankle morbidity, and that its length and diameter favor ligament reconstruction. Thus, the present article highlights the importance of the proper diagnosis of ligament injuries in the acute phase, and describes a new technique for posterolateral corner reconstruction that must be included in the surgeon's body of knowledge, increasing the amount of technical options.

Resumo O canto posterolateral tem grande importância na estabilidade do joelho. Sua lesão pode ser negligenciada, o que tem um impacto direto no prognóstico e resulta em instabilidade residual, dor crônica, deformidades e falha do reparo de outras estruturas. Existem diversas técnicas de reconstrução do canto posterolateral e o uso de enxertos autólogos dos isquiotibiais ou homólogos são as mais comuns. Uma opção pouco utilizada para reconstruções ligamentares no joelho é o enxerto do tendão fibular longo. Apesar de descrito como boa opção na reconstrução do ligamento cruzado anterior, não foi encontrado nenhum caso de uso do enxerto do tendão fibular longo na reconstrução do canto posterolateral. Neste artigo, descrevemos o caso de um paciente submetido a reconstrução não anatômica do canto posterolateral com uso do enxerto do tendão fibular longo. O paciente foi submetido a procedimentos cirúrgicos para reconstrução ligamentar e correção de deformidade ocasionada pela falha do enxerto, mas manteve instabilidade ligamentar. No planejamento pré-operatório, optou-se pela reconstrução do canto posterolateral com enxerto do tendão fibular longo ipsilateral. Estudos evidenciaram que o enxerto do tendão fibular longo não provoca aumento de morbidadeem relação aotornozelo abordado, bem comoseapresenta com comprimento e diâmetro favoráveis à reconstrução ligamentar. Dessa forma, este artigo aponta para a importânciadodiagnóstico correto das lesões ligamentaresnafase aguda,e para uma nova técnica na reconstrução do canto posterolateral, que deve fazer parte do arsenal de conhecimentos do cirurgião, pois aumenta as opções de técnicas.

Translation and cross-cultural adaptation of the knowledge translation planning template for the brazilian context / Traducción y adaptación intercultural de la plantilla de planificación para la traducción de conocimiento al contexto brasileño / Tradução e adaptação transcultural da ferramenta knowledge translation planning template para o contexto brasileiro

ABSTRACT Objective: to translate, cross-culturally adapt, and validate the content of the Knowledge Translation Planning Template, a research dissemination planning tool, into Brazilian Portuguese. Method: this is a methodological study, sequentially divided into six stages: initial translation, translation synthesis, back-translation, judges' committee, pre-test, and approval of the adapted version by the instrument author. The judge's committee assessed content validity using the modified Kappa and Content Validity Index. The test was conducted with teachers and students from a Federal University of Santa Catarina graduate program. Results: the process of translating and back-translating the tool showed no discrepancies in terms of meaning. The committee was composed of seven judges who carried out semantic, cultural, and conceptual evaluations and made notes on the translation of the content. At this stage, the content validity showed excellent values for the Content Validity Index and modified Kappa, with 0.99 and 0.816, respectively. The tool was tested with 30 teachers and postgraduate students, where 90% of the respondents considered the tool to be sufficiently comprehensive and that all the items were relevant to the purpose of the instrument. In the last stage, the documents were analyzed together with the author of the original tool and the final version was approved. Conclusion: the Modelo de Planejamento de Tradução do Conhecimento results from a careful translation process, cross-cultural adaptation, and tool content validation. This has resulted in a tool that is applicable and understood by the target audience, which shows consistency in the equivalence of translation and cross-cultural adaptation for Brazil.

RESUMEN Objetivo: realizar la traducción, adaptación transcultural y validar el contenido de la Plantilla de Planificación para la Traducción del Conocimiento para el idioma portugués de Brasil. Método: estudio metodológico que siguió seis etapas: traducción inicial, síntesis de la traducción, retrotraducción, comité de expertos, pretest y aprobación de la versión adaptada por la autora de la herramienta. Em el comité de expertos, la validez del contenido se calculó mediante el índice de validez de contenido y el Kappa modificado. El pre-test se realizó con profesores y estudiantes de un programa de postgrado en la Universidad Federal de Santa Catarina. Resultados: el proceso de traducción y retrotraducción de la herramienta no mostró discrepancias en términos de significado. El comité estuvo formado por siete expertos que evaluaron los aspectos semánticos, culturales y conceptuales y realizaron observaciones sobre la traducción del contenido. En esta etapa, la validez de contenido mostró valores excelentes para el Índice de Validez de Contenido y el Kappa modificado, con 0,99 y 0,816 respectivamente. La herramienta se probó con 30 profesores y estudiantes de posgrado, donde el 90% de los encuestados consideraron que la herramienta era lo suficientemente completa y que todos los elementos eran pertinentes para el propósito de la herramienta. En la fase final, se analizaron los documentos junto con la autora de la herramienta original y se aprobó la versión final. Conclusión: el "Modelo de Planejamento de Tradução do Conhecimento" es el resultado de un proceso riguroso de traducción, adaptación transcultural y validación de contenido de la herramienta. El resultado fue una herramienta aplicable y comprensible para el público destinatario, y que muestra coherencia en la equivalencia de la traducción y la adaptación transcultural para Brasil.

RESUMO Objetivo: realizar a tradução, adaptação transcultural e validar o conteúdo da Knowledge Translation Planning Template para língua portuguesa do Brasil. Método: estudo metodológico, que seguiu seis etapas: tradução inicial, síntese da tradução, retrotradução, comitê de juízes, pré-teste e aprovação da versão adaptada pela autora da ferramenta. No comitê de juízes a validade do conteúdo foi calculada por meio do Índice de Validade de Conteúdo e Kappa modificado. O pré-teste foi realizado com docentes e discentes de um programa de pós-graduação da Universidade Federal de Santa Catarina. Resultados: o processo de tradução e retrotradução da ferramenta não apresentou discrepâncias em termos de significado. O comitê foi composto por sete juízes que realizaram avaliação semântica, cultural, conceitual e realizaram apontamentos quanto à tradução do conteúdo. Nesta etapa, a validade de conteúdo apresentou valores excelentes de Índice de Validade de Conteúdo e Kappa modificado, com 0,99 e 0,816 respectivamente. A ferramenta foi testada com 30 docentes e discentes de pós-graduação, onde 90% dos respondentes consideraram a ferramenta suficientemente abrangente, e que todos os itens são relevantes ao propósito da ferramenta. Na última etapa, os documentos foram analisados em conjunto com a autora da ferramenta original e a versão final foi aprovada. Conclusão: o Modelo de Planejamento de Tradução do Conhecimento é resultado de um processo criterioso de tradução, adaptação transcultural e validação de conteúdo da ferramenta. Isso gerou uma ferramenta aplicável e compreendida pelo público-alvo, a qual apresenta consistência na equivalência da tradução e adaptação transcultural para o Brasil.

Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI / Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension / Diretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI

resumen está disponible en el texto completo

ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.