Consideraciones bioéticas en el manejo de la esclerosis lateral amiotrófica: Una aproximación al quehacer fonoaudiológico

Introducción: La esclerosis lateral amiotrófica (ELA) es la forma más común de enfermedad degenerativa de motoneurona en la edad adulta y es considerada una enfermedad terminal. Por lo mismo, el accionar del fonoaudiólogo debe considerar el respeto a los principios bioéticos básicos para garantizar una asistencia adecuada. Objetivo: Conocer aquellas consideraciones bioéticas relacionadas al manejo y estudio de personas con ELA para luego brindar una aproximación hacia el quehacer fonoaudiológico. Método: Se efectuó una búsqueda bibliográfica en las bases de datos PubMed, Scopus y SciELO. Se filtraron artículos publicados desde 2000 hasta junio de 2023 y fueron seleccionados aquellos que abordaban algún componente bioético en población con ELA. Resultados: Aspectos relacionados al uso del consentimiento informado y a la toma de decisiones compartidas destacaron como elementos esenciales para apoyar la autonomía de las personas. Conclusión: Una correcta comunicación y una toma de decisiones compartida son claves para respetar la autonomía de las personas. A su vez, la estandarización de procedimientos mediante la investigación clínica permitirá aportar al cumplimiento de los principios bioéticos de beneficencia y no maleficencia, indispensables para la práctica profesional.

Introduction: Amyotrophic lateral sclerosis (ALS) is the most common form of degenerative motor neuron disease in adulthood and is considered a terminal disease. For this reason, the actions of the speech therapist must consider respect for basic bioethical principles to guarantee adequate assistance. Objective: To know those bioethical considerations related to the management and study of people with ALS to then provide an approach to speech therapy. Methodology: A bibliographic search was carried out in the PubMed, Scopus, and SciELO databases. Articles published from 2000 to June 2023 were filtered and those that addressed a bioethical component in the population with ALS were selected. Results: Aspects related to the use of informed consent and shared decision-making stood out as essential elements to support people's autonomy. Conclusion: Proper communication and shared decision-making are key to respecting people's autonomy. In turn, the standardization of procedures through clinical research will contribute to compliance with the bioethical principles of beneficence and non-maleficence, essential for professional practice.

Outcomes of a Community of Practice on Quebec Speech Language Pathologists' Voice Assessment Practices and Professional Identity

In a context where different protocols for recommended practices in clinical voice assessment exist, while there are gaps in the literature regarding the evidence base supporting assessment procedures and measures, clinicians from regions where a strong community holding expertise in clinical and scientific voice practices lack can struggle to confidently develop their voice assessment practices. In an effort to improve voice assessment practices and strengthen professional identity among speech-language pathologists in Quebec, Canada, a community of practice (CoP) was established, with the aim of promoting knowledge sharing, implementing change in clinical practice, and improving professional identity. Thirty-nine participants took part in the CoP activities conducted over a four-month period, including virtual meetings and in-person workshops. Participants had a high rate of attendance (> 74% participation rate in virtual meetings), and were highly satisfied with their participation and intended to remain involved after the project's end. Statistically significant changes in voice assessment practices were observed post-CoP, regarding probability of performing assessments (p < .001), and perceived importance of assessment for evaluative purposes (p <.001), as well as improvements in assessment specific confidence, specifically for procedure of auditory-perceptual assessment (p < .001) and purpose of aerodynamic assessment (p = .05). Moreover, there was an increase in professional identity post-CoP (p < .001) and participants felt they made significant learnings. The present study highlighted the need to involve SLPs in future research to identify assessments that are relevant to the specific evaluative objectives of SLPs working with voice, and suggests CoPs are an efficient tool for that purpose.

En un contexto en el que existen diferentes protocolos para las prácticas recomendadas en la evaluación vocal clínica, y en el que se presentan vacíos en la literatura respecto a la base de evidencia que respalda los procedimientos y medidas de evaluación, los profesionales de regiones donde no hay una comunidad sólida con experiencia en prácticas vocales clínicas y científicas pueden enfrentar dificultades para desarrollar con confianza sus prácticas de evaluación vocal. Con el propósito de mejorar las prácticas de evaluación vocal y fortalecer la identidad profesional entre los logopedas de Quebec, Canadá, se estableció una comunidad de práctica (CdP). Esta tenía como objetivo fomentar el intercambio de conocimientos, implementar cambios en la práctica clínica y mejorar la identidad profesional. Un total de treinta y nueve participantes se involucraron en las actividades de la CdP, llevadas a cabo durante un período de cuatro meses, que incluyeron reuniones virtuales y talleres presenciales. Los participantes tuvieron una alta tasa de asistencia (> 74% de participación en las reuniones virtuales) y expresaron un alto grado de satisfacción con su participación, manifestando su intención de continuar involucrados después de la finalización del proyecto. Se observaron cambios estadísticamente significativos en las prácticas de evaluación vocal posterior a la CdP, en lo que respecta a la probabilidad de llevar a cabo evaluaciones (p < .001) y la percepción de la importancia de la evaluación con fines evaluativos (p < .001), así como mejoras en la confianza específica en la evaluación, particularmente en el procedimiento de evaluación auditivo-perceptual (p < .001) y el propósito de la evaluación aerodinámica (p = .05). Además, se registró un aumento en la identidad profesional posterior a la CdP (p < .001) y los participantes sintieron que obtuvieron aprendizajes significativos. El presente estudio destacó la necesidad de involucrar a los logopedas en investigaciones futuras, para identificar evaluaciones pertinentes a los objetivos evaluativos específicos de los logopedas que trabajan con la voz, y sugiere que las CdP son una herramienta eficiente con ese propósito.

Hipodermóclise como tecnologia integrativa ao processo infusional em crianças / Hypodermoclysis as an integrative technology for the infusion process in children / Hipodermoclisis como tecnología integradora para el proceso de infusión en niños

Objetivo: Identificar as evidências científicas acerca da efetividade e da segurança da hipodermóclise em comparação à via intravenosa, no processo de infusão de fluidos, para reidratação de crianças até 10 de idade, com leve a moderada desidratação, nos contextos hospitalares e domiciliares. Métodos: Revisão sistemática conduzida conforme as recomendações do Instituto Joanna Briggs®, com protocolo publicado e registrado. A busca foi realizada em cinco recursos informacionais diferentes (bases de dados, literatura cinzenta, referências dos estudos). Todo o processo de seleção foi conduzido por revisores independentes. Resultados: Foram identificados 1410 estudos e dois foram incluídos na análise. Devido a heterogeneidade dos estudos não foi possível a realização da meta-análise. Os desfechos analisados foram volume total de líquido infundido, alteração da desidratação conforme escala de Gorelick e peso, número de tentativas para inserção do cateter, e eventos adversos. Conclusão: Demonstra-se benefícios do uso da hipodermóclise como prática integrativa ao processo de infusão de fluidos em crianças, porém com baixo nível de evidência. Novas pesquisas com alta qualidade metodológica serão promissoras para sua implementação no cuidado ao paciente pediátrico. (AU)

Objective: To identify scientific evidence about the effectiveness and safety of hypodermoclysis compared to the intravenous route, in the fluid infusion process, for rehydration of children up to 10 years of age, with mild to moderate dehydration, in hospital and home settings. Methods: Systematic review conducted according to the recommendations of the Joanna Briggs® Institute, with a published and registered protocol. The search was performed in six databases, five gray literature databases, and references of the included studies. The entire selection process was conducted by independent reviewers. Results: 1410 studies were identified and two were included in the analysis. Due to the heterogeneity of the studies, it was not possible to carry out the meta-analysis. The outcomes analyzed were total volume of fluid infused, change in dehydration according to the Gorelick scale and weight, number of attempts to insert the catheter, and adverse events. Conclusion: Benefits of the use of hypodermoclysis as an integrative practice in the fluid infusion process in children are demonstrated, but with a low level of evidence. New research with high methodological quality will be promising for its implementation in pediatric patient care. (AU)

Objetivo: Identificar evidencia científica sobre la efectividad y seguridad de la hipodermoclisis en comparación con la vía intravenosa, en el proceso de infusión de líquidos, para la rehidratación de niños hasta los 10 años de edad, con deshidratación leve a moderada, en el ámbito hospitalario y domiciliario. Métodos: Revisión sistemática realizada de acuerdo con las recomendaciones del Instituto Joanna Briggs®, con protocolo publicado y registrado. La búsqueda se realizó en seis bases de datos, cinco bases de datos de literatura gris y referencias de los estudios incluidos. Todo el proceso de selección fue realizado por revisores independientes. Resultados: Se identificaron 1410 estudios y se incluyeron dos en el análisis. Debido a la heterogeneidad de los estudios, no fue posible realizar el metanálisis. Los resultados analizados fueron el volumen total de líquido infundido, el cambio en la deshidratación según la escala y el peso de Gorelick, el número de intentos de insertar el catéter y los eventos adversos. Conclusión: Se demuestran los beneficios del uso de la hipodermoclisis como práctica integradora en el proceso de infusión de líquidos en niños, pero con un bajo nivel de evidencia. Nuevas investigaciones con alta calidad metodológica serán prometedoras para su implementación en la atención del paciente pediátrico. (AU)

Utilização da toxina botulínica para o tratamento de cicatriz queloide: revisão de escopo / Use of botulinum toxin for the treatment of keloid scars: scoping review

Introdução: Cicatrizes visíveis podem acarretar agravos, sejam estéticos, psicológicos, funcionais ou sociais, principalmente de grande extensão e volume, como os queloides. A descoberta de novos tratamentos de queloides não é fácil, visto a presença de alguns entraves metodológicos e éticos, sendo uma área pouco explorada. A toxina botulínica tem sido apresentada como alternativa terapêutica em estudos nacionais e internacionais, sendo necessária uma compilação e destaque dos principais estudos que possam subsidiar a prática clínica. Assim, o objetivo foi apresentar uma revisão de escopo sobre a utilização terapêutica da toxina botulínica para o tratamento de cicatrizes queloides. Método: A revisão foi realizada através da estratégia PICO e utilizando o Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Foi realizada nas bases de dados PubMed/ Medline, Biblioteca Virtual em Saúde e SciELO, considerando estudos do período de 2016 até setembro de 2021. Resultados: Foram encontrados 34 artigos no geral relacionados ao tema. Após filtragem e seleção, a revisão foi construída com apoio de 5 artigos. Os estudos variaram entre coorte, relatos de caso, ensaio clínico randomizado e caso-controle. Foi possível observar como principais resultados a ação a curto prazo da toxina botulínica na redução de queloides, maior efetividade na redução dos sintomas e possibilidades de utilização clínica para diferentes populações e manifestações clínicas. Conclusão: O mecanismo de ação da toxina botulínica pode facilitar o tratamento de queloides e redução de sintomas, sendo necessários estudos mais robustos para definição de protocolos cínicos de gestão de cicatrizes.

Introduction: Visible scars can cause problems, whether aesthetic, psychological, functional, or social, mainly of great extension and volume, such as keloids. The discovery of new treatments for keloids is not easy, given the presence of some methodological and ethical obstacles, and it is an area that is little explored. Botulinum toxin has been presented as a therapeutic alternative in national and international studies, requiring a compilation and highlighting of the main studies that can support clinical practice. Thus, the objective was to present a scoping review on the therapeutic use of botulinum toxin for the treatment of keloid scars. Method: The review was carried out using the PICO strategy and using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. It was carried out in the PubMed/ Medline, Virtual Health Library, and SciELO databases, considering studies from 2016 to September 2021. Results: Overall, 34 articles related to the topic were found. After filtering and selection, the review was constructed with the support of 5 articles. The studies varied between cohorts, case reports, randomized clinical trials, and casecontrol. It was possible to observe as main results of the short-term action of botulinum toxin in reducing keloids, greater effectiveness in reducing symptoms, and possibilities of clinical use for different populations and clinical manifestations. Conclusion: The mechanism of action of botulinum toxin can facilitate the treatment of keloids and reduce symptoms, requiring more robust studies to define effective scar management protocols.

Prática baseada em evidências e atuação clínica em linguagem infantil: uma pesquisa online com fonoaudiólogos brasileiros / Evidence-based practice and clinical practice in child language: an online survey with Brazilian speech-language pathologists

RESUMO Objetivo Caracterizar o conhecimento, habilidades, opiniões e principais barreiras percebidas por fonoaudiólogos, da área de linguagem infantil no Brasil, a respeito da prática baseada em evidências (PBE). Método O estudo foi conduzido entre agosto de 2021 e julho de 2022 por meio de um questionário online. Além de dados sociodemográficos e de campo de trabalho, foram considerados 22 itens relacionados à PBE e subdivididos em "conhecimento", "habilidades", "opinião" e "barreiras". Cada item apresentava cinco opções de resposta (discordo totalmente, discordo, não estou decidido, concordo, concordo totalmente). Ao total 122 fonoaudiólogos que atuam na área da linguagem infantil responderam ao questionário. Suas respostas foram descritas pela porcentagem de distribuição de frequência. O tempo de formação e o nível de domínio do inglês foram considerados para comparar o padrão de distribuição das respostas. Resultados Apesar da maioria dos fonoaudiólogos reportar ter aprendido as bases da PBE em sua formação acadêmica, há fragilidades em seu conhecimento e falta de domínio das estratégias de busca e avaliação crítica dos artigos científicos. Ainda que a maioria concorde que a aplicação da PBE é necessária para a prática fonoaudiológica e considere precisar aumentar o uso de evidências científicas em sua prática diária, são apontadas como barreiras a falta de artigos, dificuldades relacionadas à aplicação prática de resultados científicos e falta de apoio coletivo entre os colegas. Conclusão Este estudo alerta a comunidade acadêmica para a urgência de se considerar a PBE no contexto da Fonoaudiologia brasileira.

ABSTRACT Purpose To characterize the knowledge, skills, opinions, and main barriers perceived by speech-language pathologists, in child language in Brazil, regarding evidence-based practice (EBP). Methods The study was conducted between August 2021 and July 2022 using an online questionnaire. In addition to sociodemographic and field data, 22 items related to EBP were considered and subdivided into "knowledge", "skills", "opinion" and "barriers". Each item had five response options (strongly disagree, disagree, not decided, agree, strongly agree). A total of 122 speech-language pathologists who work with child language answered the questionnaire. Their responses were described by the percentage of frequency distribution. The time since graduation and the level of proficiency in English were considered to compare the distribution pattern of the answers. Results Although most speech-language pathologists report having learned the basics of EBP in their academic training, there are weaknesses in their knowledge and lack of mastery of search strategies and critical evaluation of scientific articles. Although most agree that EBP's use is necessary for speech-language practice and consider the need to increase the use of scientific evidence in their daily practice, the lack of articles, difficulties related to the practical application of scientific results and lack of collective support among colleagues are identified as barriers. Conclusion This study alerts the academic community to the urgency of considering EBP in the context of Brazilian Speech-Language Pathology.

Repercussions of the Emergency neurological life support on scientific literature: a bibliometric study / Repercussões do Emergency neurological life support na literatura científica: um estudo bibliométrico

Abstract Background In 2012, the Neurocritical Care Society launched a compilation of protocols regarding the core issues that should be addressed within the first hours of neurological emergencies - the Emergency neurological life support (ENLS). Objective We aim to evaluate this repercussion through a bibliometric analysis. Methods We searched Scopus on October 2022 for articles mentioning ENLS. The following variables were obtained: number of citations; number of citations per year; number of publications per year; year of publication; research type; research subtype; country of corresponding author and its income category and world region; journal of publication and its 5-year impact factor (IF); and section where ENLS appeared. Results After applying eligibility criteria, we retrieved 421 articles, published from 2012 to 2022. The mean number of citations per article was 17.46 (95% Confidence Interval (CI) = 8.20-26.72), while the mean number of citations per year per article was 4.05 (95% CI = 2.50-5.61). The mean destiny journal 5-year IF was 5.141 (95% CI = 4.189-6.093). The majority of articles were secondary research (57.48%; n= 242/421) of which most were narrative reviews (71.90%; n= 174/242). High-Income countries were the most prominent (80.05%; n= 337/421 articles). There were no papers from low-income countries. There were no trials or systematic reviews from middle-income countries. Conclusion Although still low, the number of publications mentioning ENLS is increasing. Articles were mainly published in journals of intensive care medicine, neurology, neurosurgery, and emergency medicine. Most articles were published by authors from high-income countries. The majority of papers were secondary research, with narrative review as the most frequent subtype.

Resumo Antecedentes Em 2012, a Neurocritical Care Society lançou uma compilação de protocolos sobre as questões centrais que devem ser abordadas nas primeiras horas de emergências neurológicas - Emergency neurological life support (ENLS). Objetivo Avaliar a repercussão do ENLS por meio de uma análise bibliométrica. Métodos A base de dados Scopus foi utilizada em outubro de 2022 para a busca por artigos mencionando o ENLS. As seguintes variáveis foram obtidas: número de citações; número de citações por ano; número de publicações por ano; ano de publicação; tipo de pesquisa; país do autor correspondente e sua categoria de renda; revista de publicação e seu fator de impacto de 5 anos (IF); e seção onde o ENLS apareceu. Resultados Os 421 artigos incluídos foram publicados de 2012 a 2022. A média de citações por artigo foi de 17.46 (intervalo de confiança (IC) 95% = 8.20-26.72), enquanto a de citações por ano por artigo foi de 4.05 (IC95% = 2.50-5.61). O IF médio por revista foi de 5.14 (IC95% = 4.19-6.09). A maioria dos artigos era de pesquisa secundária (57.48%; n= 242/421), dos quais a maioria eram revisões narrativas (71.90%; n= 174/242). Os países de alta renda foram os mais prolíficos (80.05%; n= 337/421 artigos). Não houve publicações de países de baixa ou média renda. Conclusão Embora ainda baixo, o número de publicações mencionando o ENLS vem aumentando recentemente. A maioria dos artigos foram publicados em revistas de medicina intensiva, neurologia, neurocirurgia e medicina de emergência. Artigos de pesquisa secundária foram os mais comuns, com revisões narrativas sendo o subtipo mais frequente.

Ações de cuidado e diagnósticos de enfermagem ao paciente com oxigenação por membrana extracorpórea: translação do conhecimento / Acciones de cuidado y diagnósticos de enfermería para pacientes con oxigenación por membrana extracorpórea: traslación del conocimiento / Care actions and nursing diagnoses for patients with extracorporeal membrane oxygenation: knowledge translation

Resumo Objetivo mapear diagnósticos e ações de enfermagem para o cuidado ao paciente adulto com oxigenação por membrana extracorpórea, considerando um protocolo e um sistema informatizado de prescrição e a inclusão de novas ações de cuidados, em um processo de translação do conhecimento à prática clínica. Métodos estudo descritivo e exploratório, com mapeamento cruzado entre um protocolo assistencial e sistema informatizado de um hospital universitário, no período de 2014 a 2018. Foram realizados dois encontros com a chefia de enfermagem e membros do time de oxigenação por membrana extracorpórea para validar as ações. Resultados diagnósticos mais comuns utilizados nos 45 prontuários dos pacientes com oxigenação por membrana extracorpórea foram: Risco de infecção (100%); Ventilação espontânea prejudicada (93,33%); Síndrome do déficit de autocuidado (93,33%). Conclusão e implicações para a prática o mapeamento incluiu 25 novas ações associadas a 14 diagnósticos de enfermagem no sistema informatizado, visando a disseminação do conhecimento e sua aplicação em cuidados reais a pacientes com oxigenação por membrana extracorpórea.

Resumen Objetivo mapear diagnósticos y acciones de enfermería para el cuidado de pacientes adultos con oxigenación por membrana extracorpórea, considerando un protocolo y un sistema de prescripción computarizado y la inclusión de nuevas acciones de cuidado, en un proceso de traslación del conocimiento a la práctica clínica. Métodos estudio descriptivo, exploratorio, con mapeo cruzado entre un protocolo de atención y un sistema informatizado en un hospital universitario, de 2014 a 2018. Posteriormente se realizaron dos reuniones con la gerente de enfermería y miembros del equipo de oxigenación por membrana extracorpórea para validar acciones. Resultados los diagnósticos más frecuentes utilizados en los 45 prontuarios de pacientes con oxigenación por membrana extracorpórea fueron: Riesgo de infección (100%); Deterioro de la ventilación espontánea (93,33%); Síndrome de déficit de autocuidado (93,33%). Conclusión e implicaciones para la práctica el mapeo incluyó 25 nuevas acciones asociadas a 14 diagnósticos de enfermería en el sistema informatizado, con el objetivo de difundir el conocimiento y su aplicación en la atención real al paciente con oxigenación por membrana extracorpórea.

Abstract Objective to map diagnoses and nursing actions for the care of adult patients with extracorporeal oxygenation membrane, considering a protocol and a computerized prescription system and the inclusion of new care actions, in a process of translating knowledge to clinical practice. Methods descriptive and exploratory study, with cross-mapping between a care protocol and a computerized system of at a university hospital, from 2014 to 2018. Two meetings were held with the nursing manager and members of the extracorporeal oxygenation membrane team to validate the actions. Results most common diagnoses used in the 45 medical records of patients with extracorporeal membrane oxygenation were: Risk of infection (100%); Impaired spontaneous ventilation (93.33%); Self-care deficit syndrome (93.33%). Conclusion and implications for practice The mapping included 25 new actions, associated with 14 nursing diagnoses in the computerized system, aiming to disseminate knowledge and its application in real care for patients with extracorporeal oxygenation membrane.

Construction of Evidence Body for Revision of Safety Information on Package Inserts of Chinese Patent Medicines in Post-marketing： Taking Xiaoke'an Capsules as an Example / 中国实验方剂学杂志

ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.

Clinical Evidence Mapping of Chinese Patent Medicines Combined with Western Medicine in Treatment of Hypertension / 中国实验方剂学杂志

ObjectiveTo systematically collect， analyze， and evaluate the randomized controlled trials （RCT） of Chinese patent medicine combined with western medicine in the treatment of hypertension， map the evidence， and provide reference for the future clinical research and formulation of guidelines and policies. MethodThe relevant articles were retrieved from China Biology Medicine disc， China National Knowledge Infrastructure （CNKI）， VIP， Wanfang Data， PubMed， Embase， and Cochrane Library with the time interval from inception to December 31， 2022. The RCT of Chinese patent medicines combined with western medicine in the treatment of hypertension were included. The research characteristics and methodological quality were analyzed and evaluated. ResultA total of 330 RCTs of treating hypertension with Chinese patent medicines combined with Western medicine were included in this study， all of which were published in Chinese. These RCTs involved 88 Chinese patent medicines and 37 788 patients， and 46% of RCT had the sample size ≥100 patients. Eighty-seven percent of RCT showed the study period within 3 months. All the interventions in the RCTs were Chinese patent medicine + western medicine vs western medicine. Among the evaluation indicators， blood pressure， response rate， TCM syndrome score， endothelial cell function， and safety were mainly concerned. In terms of methodological quality， most articles did not mention the generation of random sequences， allocation concealment， or blinding method. The blinding evaluation of outcomes showed low risks of bias， and there was insufficient information to judge whether there was selective bias or other bias. ConclusionThere were many Chinese patent medicines used in combination with western medicine in the treatment of hypertension， and they were mainly taken orally. The existing RCT had problems such as small sample size， unclear clinical value positioning， imperfect design failing to reflect the value of Chinese patent medicines， unreasonable measurement indicators， and non-standard measurement methods. Future research should solve the above problems， improve the research quality， value， and authenticity， and enhance the reliability and extension of evidence.

GRADE Clinical Study Evidence Evaluation and Expert Consensus on Antihypertensive Chinese Patent Medicines Combined with Western Medicines for Treatment of Hypertension / 中国实验方剂学杂志

ObjectiveTo evaluate the quality of research and evidence related to antihypertensive Chinese patent medicines combined with western medicines for the treatment of hypertension， synthesize and update the evidence， form expert consensus， and provide evidence for clinical decision-making. MethodThe databases of China National Knowledge Infrastructure （CNKI）， WanFang Data Knowledge Service Platform （WanFang）， Vip Chinese Science and Technology Journal Database （VIP）， Chinese Biomedical Literature Service System （Sinomed）， National Library of Medicine （PubMed）， Cochrane Library， Web of Science， and US Clinical Trials Registry were searched for randomized controlled trials of antihypertensive Chinese medicine combined with western medicine for the treatment of hypertension from database construction to July 31， 2022. The quality of the literature was evaluated using the bias risk assessment tool in Cochrane Handbook 6.3. Evidence synthesis of main outcome indicators was performed using R software. The Grading of Recommendations Assessment， Development， and Evaluation profiler （GRADEprofiler） 3.6 was employed to evaluate the quality of evidence. Expert consensus was formed based on the Delphi method after two rounds of voting. Result64 pieces of literature were included， and the results of literature quality evaluation and risk of bias showed that 70.31% （45/64） of the studies indicated some risks， and 29.69% （19/64） indicated high risks. Compared with conventional western medicines， the combination of Chinese patent medicines with western medicines can significantly lower systolic pressure （SBP） and diastolic pressure （DBP）， increase the effective rate of antihypertensive， reduce the incidence of adverse reactions， endothelin-1， and traditional Chinese medicine syndrome scores. Egger's test showed that Songling Xuemaikang capsules reduced SBP and DBP. Tianma Gouteng granules reduced SBP and DBP and increased the effective rate of antihypertensive， and Xinmaitong capsules reduced SBP and increased the effective rate of antihypertensive， without significant publication bias. Songling Xuemaikang capsules increased the effective rate of antihypertensive， and Xinmaitong capsules decreased DBP， with significant publication bias. The results of the GRADE evidence quality evaluation showed that most evidence was at grades B and C. Finally， four strong recommendations and 14 weak recommendations were formed. ConclusionCompared with conventional western medicines for the treatment of hypertension， antihypertensive Chinese patent medicines combined with western medicines have advantages in reducing blood pressure and improving drug use safety， but they are mostly weak recommendations in terms of efficacy， and more high-quality evidence is needed.

Evaluation of GRADE Clinical Research Evidence of Chinese Patent Medicine Combined with Western Medicine in Treatment of Hypertension with Dyslipidemia / 中国实验方剂学杂志

ObjectiveTo evaluate the effect of antihypertensive and lipid-regulating Chinese patent medicine combined with conventional Western medicine in the treatment of hypertension with dyslipidemia. To carry out the evidence synthesis of clinical research and provide evidence-based evidence support for clinical decision-making. MethodThe databases including China National Knowledge Infrastructure （CNKI），Wanfang Data Knowledge Service Platform （WF），VIP，SinoMed，Embase，PubMed，Web of Science （WOS），and the Cochrane Library were searched for randomized controlled trials （RCT） of all listed Chinese patent medicines in the treatment of hypertension with dyslipidemia from the establishment of the databases to April 15，2023. The literature was screened and extracted，and the risk of bias tool 2.0 （RoB2） was used to assess the quality and risk of bias of the methodology. Revman 5.4.1 software was used to analyze the outcome indicators. Grading of Recommendations Assessment，Development and Evaluation （GRADE） was applied to assess the quality of evidence formed by clinical research data. The inclusion and recommendation of Chinese patent medicines in the National Drug Catalogue for Basic Medical Insurance，Work-related Injury Insurance and Maternity Insurance （2022） and domestic guidelines and consensus were searched to form a bubble chart. ResultA total of 15 studies were included. The evaluation of the methodological quality of each study showed that the risk of bias stemmed from the lack of blinding and allocation concealment，and low sample size. The comprehensive analysis of clinical studies showed that Dengzhan Shengmai capsules combined with rosuvastatin and amlodipine besylate，Yindan Xinnaotong capsules combined with simvastatin and levamlodipine tablets，Xiaoshuan Tongluo capsules combined with nifedipine controlled release tablets and pravastatin sodium tablets，Xinshubao capsules combined with atorvastatin calcium tablets and irbesartan，Wenyading capsules combined with enalapril，and Jiangzhining tablets combined with conventional Western medicines were all superior to conventional Western medicines used in the control group in improving systolic blood pressure （SBP），diastolic blood pressure （DBP），cholesterol （TC），triglyceride （TG），low density lipoprotein cholesterol （LDL-C），and high density lipoprotein cholesterol （HDL-C）. There was no significant difference in the incidence of adverse reactions between the two groups. The GRADE evaluation of the main outcome indicators showed that the evidence quality of SBP and incidence of adverse reactions was graded as B，that of DBP as C，and that of total TC，TG，LDL-C，and HDL-C as D. The evaluation of Chinese patent medicines covered by medical insurance and recommended by guidelines and consensus showed that Yindan Xinnaotong soft capsules，Dengzhan Shengmai capsules and Xiaoshuan Tongluo capsules belonged to class B drugs of medical insurance，and were recommended for 7，6 and 3 times in the guidelines and consensus，respectively. ConclusionCompared with simple medicine treatment，Chinese patent medicine combined with conventional Western medicine has more advantages in improving blood pressure and blood lipid，and shows higher safety. Among them，Yindan Xinnaotong soft capsules，Dengzhan Shengmai capsules and Xiaoshuan Tongluo capsules have stronger clinical applicability and economy. All the trials included in this article adhered to the principle of randomization and reported the outcome measures. However，the quality of evidence in related clinical studies was low. In terms of trial design，large-sample，multi-center，blinded randomized controlled trials based on the consolidated standards of reporting trials （CONSORT） statement are still needed for comprehensive trial designs and reporting，to further improve the GRADE quality evaluation and guideline formulation under the guidance of evidence-based medicine，so as to provide higher quality evidence-based research evidence for clinical decision-making.

Drug Selection and Evaluation in Medical Institutions： A Scoping Review / 中国实验方剂学杂志

ObjectiveBy analyzing the current situation of drug selection and evaluation in medical institutions in the world，we aim to understand the development of relevant selection methods and tools，provide reference basis for drug selection in traditional Chinese medicine （TCM） medical institutions，and promote the optimization of drug catalogs in TCM medical institutions. MethodBased on the method of scoping review，the eight databases were systematically searched，the included documents were screened，extracted and analyzed，and the research results were graphically displayed. ResultA total of 23 articles were included in this study，including 13 in Chinese and 10 in English，involving 23 methods or tools related to drug selection. Of the 14 methods or tools from Chinese medical institutions，the earliest one was published in 2012，and five were published in 2022. The published methods or tools involved different levels of hospitals，different drug varieties，different evaluation angles，etc.，such as the drug selection methods of one county hospital and one township hospital， methods and tools for different types of drugs such as antibacterial drugs，ibuprofen preparations，proton pump inhibitors and hypoglycemic drugs used in pediatric intensive care units， Chinese patent medicine selection tools， tools for evaluation from the perspective of pharmacoeconomics， and universal tools for selecting domestic medical institutions. The nine drug selection tools of foreign medical institutions were from the European，American，Asian and African countries. It was first published in 1955. The contents included the formulation standards that medical institutions should follow for drug prescription sets，the management formulation and update of hospital prescription sets，and drug evaluation tools. ConclusionOn the whole，the drug selection methods and institutional methods of foreign medical institutions developed earlier than those in China. In recent years，Chinese medical institutions have paid high attention to drug selection and released various types of drug selection tools. However，the standardization should be further improved in the future.

Evidence-based evaluation of the global cancer-associated thromboembolism risk assessment tools / 中国药房

OBJECTIVE To evaluate the global cancer-associated thromboembolism risk assessment tools based on evidence- based methods， and to provide methodological reference and evidence-based basis for constructing a specific tool in China. METHODS A comprehensive search was conducted on 6 databases， including CNKI， Wanfang data， VIP， CBM， PubMed， and Embase， as well as on the websites of NCCN， ASCO， ESMO and so on with a deadline of June 30， 2022. Furthermore， a supplementary search was conducted in January 2023. The essential characteristics and methodological quality of included risk assessment tools were described and analyzed qualitatively， focusing on comparing each assessment stratification ability. RESULTS Totally 14 risk assessment tools were included in the study， with a sample size of 208-18 956 cases and an average age distribution of 53.1-74.0 years. The applicable population included outpatient cancer student@sina.com patients， lymphoma patients， and multiple myeloma patients，etc. The common predictive factors were body mass index， venous thromboembolism history， and tumor site. All tools had undergone methodological validation， with 9 presented in a weighted scoring format. Only seven tools were used simultaneously for specificity， sensitivity， negative predictive value （NPV）， positive predictive value （PPV） and area under the curve （AUC） or C statistical analysis. CONCLUSIONS The risk of bias in constructing existing tools is high， and the heterogeneity of tool validation results is significant. The overall methodological quality must be improved， and its risk stratification ability must also be investigated. There are still certain limitations in clinical practice in China.

Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework / 中国实验方剂学杂志

ObjectiveTo establish the clinical comprehensive evaluation index system for Chinese patent medicine（CPM） based on Evidence and Value：Impact on DEcisionMaking（EVIDEM） framework， so as to promote the scientific， systematic and standardized implementation of clinical comprehensive evaluation of CPM. MethodThe clinical comprehensive evaluation index system was determined through literature review， semi-structured interview and Delphi method， and the weights of each index were clarified by analytic hierarchy process（AHP）. ResultThe recovery rates of both rounds of expert consultation were 100%， and the authority coefficient of experts was 0.90 and 0.905， respectively. Kendall's coordination coefficients（W） of the second- and third-level indicators in the first-round consultation were 0.320 and 0.283（P<0.001）， and in the second round were 0.411 and 0.351， respectively（P<0.001）. The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators， 13 second-level indicators and 28 third-level indicators. Among the first-level indicators， the weights of effectiveness， safety， economy， innovation， suitability and accessibility were 37.34%， 32.68%， 11.85%， 5.87%， 5.79% and 6.47%， respectively. ConclusionThis study has constructed a universal clinical comprehensive evaluation index system for CPM， and the domain and criteria are introduced and interpreted in detail， which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM， but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

Descending necrotizing mediastinitis: a clinical analysis based on 10 years of published data in China / 口腔疾病防治

Objective@#To investigate the clinical characteristics, diagnosis, treatment, and prognosis of descending necrotizing mediastinitis (DNM) to provide a reference for the early diagnosis and timely treatment of DNM.@*Methods@#Data on DNM in China was electronically retrieved from the core databases and comprehensively reviewed from June 2012 to June 2023. The infection, pathogenic microorganisms, main symptoms, comorbidities and treatment methods of DNM were analyzed.@*Results@#The data of a total of 781 DNM patients, with an average age of (52.97 ± 5.64) years, were retrieved, including 554 males and 227 females. Odontogenic source, tonsillitis, pharyngeal abscess, sialoadenitis, upper respiratory tract infection, foreign body injury, or iatrogenic traumatic procedures are common causes. Among these, odontogenic infection is the most common source. Streptococcus sp. (n = 217) and Staphylococcus sp. (n = 82) were most isolated, followed by Klebsiella pneumoniae and Pseudomonas aeruginosa (equally n = 59). A total of 69.4% (542/781) of DNM patients recruited in this study were discovered to have various comorbidities, and more than one-third of these patients (n = 185) had diabetes. Of the broad antibiotics, carbapenem was most frequently used as treatment, and vancomycin was the most frequently coadministered. The mediastinal drainage approach varies widely, and the optimal regimen is still unknown. Seventy-two patients were treated with video-assisted thoracoscopic/mediastinoscopic surgical drainage, 22 patients were treated with percutaneous catheter drainage, 30 underwent the transcervical approach, and 40 underwent thoracotomy. A total of 617 patients who were selected underwent the appropriate combined operation for surgical drainage according to the specific location of the infected focus. The overall mortality rate of all 781 DNM patients included was 11.2%.@*Conclusion@#The most effective diagnosis and treatment of DNM is a high degree of clinical vigilance followed by prompt and adequate drainage with intensive care, including hemodynamic monitoring, nutritional support, computer tomographic scanning repeated as necessary, and combined use of systemic antibiotics.

Meta-analysis of Distribution Frequency of Traditional Chinese Medicine Syndrome in Primary Osteoporosis / 中国实验方剂学杂志

ObjectiveTo systematically evaluate the distribution of traditional Chinese medicine（TCM） syndromes of primary osteoporosis（POP） in China by using evidence-based medicine methods， and to understand the distribution law of the syndromes. MethodChina National Knowledge Infrastructure（CNKI）， VIP Chinese Science and Technology Journal Database（VIP）， WanFang Data Knowledge Service Platform（WanFang） and China Biology Medicine（CBM） were searched to obtain representative literature， and each database was searched from the 1994 World Health Organization defined diagnostic criteria for osteoporosis until May 1， 2023. Two researchers independently screened literature according to the criteria， extracted data， and cross-checked them. Meta analysis was conducted using R4.1.3， and subgroup analysis was performed. ResultA total of 56 Chinese papers were included， involving 14 415 patients. After standardized classification of syndromes， 11 articles were excluded， and Meta analysis results of the ultimately included 45 Chinese articles showed that the distribution frequencies of liver-kidney Yin deficiency syndrome， spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome in 12 723 patients were 27%［95% confidence interval（CI） 0.24-0.31］， 32%（95% CI 0.29-0.36）， 36%（95% CI 0.30-0.42）. Subgroup analysis showed that there was a statistically significant difference in the distribution of the three TCM syndromes in the north and south（P<0.05）. In addition， the incidence of TCM syndrome fractures in different types of POP was 15%（95% CI 0.09-0.24） for liver-kidney Yin deficiency syndrome， 20%（95% CI 0.12-0.30） for spleen-kidney Yang deficiency syndrome， and 31%（95% CI 0.25-0.39） for kidney deficiency and blood stasis syndrome. ConclusionThe distribution of syndromes in POP patients is mainly kidney deficiency， accompanied by liver and spleen dysfunction. Liver-kidney Yin deficiency syndrome， spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome are all the main syndromes of POP and osteoporotic fractures， and kidney deficiency and blood stasis syndrome is most closely related to the development of osteoporotic fractures. The reference standards for syndrome determination among the included studies are inconsistent， and in the future， it is necessary to focus on their determination standards to obtain consensus research results， at the same time， conduct large-scale syndrome research to obtain representative research results， providing a basis for clinical practice and research.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine（Part 4）： Evidence Retrieval and Evaluation / 中医杂志

The retrieval and evaluation of evidence is the basis for the development of clinical practice guidelines for Chinese patent medicine. As traditional Chinese medicine has a different development trajectory and utilization characteristics from modern medicine， there is certain differences in terms of evidence composition， retrieval and integration.This paper discussed multi-source body of evidence on Chinese patent medicine based on modern evidence-based medicine and ancient medical literature， and summarized the retrieval strategy as well as the possible problems and solving methods. For different types of evidence on Chinese patent medicine， the corresponding evaluation tools have been recommended， and the order to integrate the evidence based on the quality of the evidence from high to low is suggested. Finally， a multi-source based evidence retrieval-evaluation-integration scheme for Chinese patent medicine has been formed， which will provide a methodological reference for practitioners in the development of clinical practice guidelines for Chinese patent medicine.

Precise Clinical Positioning of Chinese Patent Medicine in Paradigm of "Target Spectral Effect of Prescription"： A Case Study of Qizhi Tongluo Capsules / 中国实验方剂学杂志

The clinical value of Chinese patent medicine is the core direction of the development of the traditional Chinese medicine industry. The precise clinical positioning determines the way to prove the value of the drug， and is a key link to highlight the clinical value. This paper presented a case study of clinical positioning for Chinese patent medicine， namely Qizhi Tongluo capsules， and the key technical framework of precise clinical positioning of Chinese patent medicine， which was manifested as a comparison of prescription target spectral effect， discovery of core value of prescription， and confirmation of clinical positioning trial. The technical framework was designed to address a range of issues in the realm of precise clinical positioning. Before the clinical positioning trial， based on the multi-component， multi-target， and multi-phenotype data of prescription and clinical indication， the multi-omics network analysis technology was used to identify the core value of the traditional Chinese medicine varieties and predict the potential clinical advantages. Then， based on the predicted clinical advantages， reasonable efficacy indicators were selected， and the clinical efficacy was judged and verified by dynamic and flexible innovative clinical trials to improve the success rate of clinical positioning. This research paradigm integrates "omics technology" with "evidence-based" principles and follows the "precise evidence-based" concept. This research aims to provide a new strategy and method for the precise medication and positioning of Chinese patent medicine with traditional Chinese medicine characteristics after being put into the market and provide more technical thinking for traditional Chinese medicine to move towards precise medicine.

La gestión para la evaluación de las competencias en la formación del profesional de Cultura Física

La evaluación, como categoría didáctica en el proceso de enseñanza-aprendizaje de la carrera Licenciatura en Cultura Física y Deporte, enfrenta desafíos que obligan a los diferentes colectivos pedagógicos a proyectar acciones que le permitan una visión contextualizada e integral de la misma. La unidad del sistema de influencias educativas es una necesidad para la evaluación formativa, compartida, personalizada, centrada en evidencias de conocimiento, de producto y de desempeño en la formación y desarrollo de competencias en esta Carrera. El objetivo del trabajo es valorar el proceso evaluativo integrador de las competencias, en los estudiantes de la Práctica Laboral Investigativa de tercer año, de la Carrera de licenciatura en Cultura Física y Deporte, a través de la disciplina principal integradora Formación Laboral Investigativa. Para ello, se aplicaron métodos de investigación empíricos, como el análisis de documentos, la entrevista y la observación. Los resultados permitieron fundamentar una propuesta metodológica que potencie la evaluación integradora, sobre la base el enfoque integral físico-educativo, en el proceso de estudio. El diseño de los resultados fue de tipo experimental, en su variante pre-experimento. La aplicación parcial de la propuesta validó su pertinencia y contribuyó de forma favorable al mejoramiento del desempeño profesional y humano de los que participan.

A avaliação, como categoria didática no processo de ensino-aprendizagem do curso de Bacharelado em Cultura Física e Esporte, enfrenta desafios que obrigam os diferentes coletivos pedagógicos a planejar ações que permitam uma visão contextualizada e integral da mesma. A unidade do sistema de influências educacionais é uma necessidade para a avaliação formativa, compartilhada e personalizada, focada na evidência de conhecimento, produto e desempenho na formação e no desenvolvimento de competências nesse curso de graduação. O objetivo do estudo é avaliar o processo de avaliação integrativa das competências dos alunos do terceiro ano do Estágio de Pesquisa no Bacharelado em Cultura Física e Esporte, por meio da principal disciplina integrativa do Estágio de Pesquisa. Para isso, foram aplicados métodos de pesquisa empírica, como análise de documentos, entrevista e observação. Os resultados permitiram fundamentar uma proposta metodológica que aprimora a avaliação integrativa, com base na abordagem físico-educacional integral, no processo de estudo. O desenho dos resultados foi experimental, em sua variante pré-experimental. A aplicação parcial da proposta validou sua relevância e contribuiu favoravelmente para a melhoria do desempenho profissional e humano dos envolvidos.

Evaluation, as a didactic category in the teaching-learning process of the Bachelor's Degree in Physical Culture and Sports, faces challenges that force the different pedagogical groups to project actions that allow a contextualized and comprehensive vision of it. The unity of the system of educational influences is a necessity for formative, shared, personalized evaluation, focused on evidence of knowledge, product and performance in the training and development of competencies in this Career. The objective of the work is to assess the integrative evaluative process of the competencies, in the students of the third-year Investigative Work Practice, of the Bachelor's Degree in Physical Culture and Sports, through the main integrative discipline Investigative Work Training. To achieve this, empirical research methods were applied, such as document analysis, interviews and observation. The results allowed to base a methodological proposal that enhances the integrative evaluation, based on the comprehensive physical-educational approach, in the study process. The design of the results was experimental, in its pre-experiment variant. The partial application of the proposal validated its relevance and contributed favorably to the improvement of the professional and human performance of those who participate.