Biofield Therapies: Guidelines for Reporting Clinical Trials.

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.

A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g. for a new indication) (ICH-GCP). As per the internationally accepted ICH-GCP guidelines, clinical trials should be conducted strictly per the approved protocol. However, during the lifecycle of a trial, protocol deviations may occur. Under ICH efficacy guidelines, protocol deviations are divided into non-important (minor) or important (major), and the latter can jeopardise the participant's rights, safety or the quality of data generated by the study. Existing guidelines on protocol deviation management do not detail or standardise actions to be taken for participants, investigational products, data or samples as part of a holistic management of important protocol deviations. Herein, we propose guidelines to address the current literature gap and promote the standardisation of actions to address important protocol deviations in clinical trials. The advised actions should complement the existing local institutional review board and national regulatory authority requirements.

Guía de práctica clínica basada en la evidencia sobre intervenciones de prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer. Versión resumida. Octubre de 2023 / Evidence-based clinical practice guide on prevention interventions, advocacy, care of complications and support for families of preterm or low birth weight newborns. Summary version. October 2023

El Instituto Nacional de Salud (INS) coordinó la elaboración de la presente guía de práctica clínica, con apoyo de un equipo multidisciplinario del Sistema Nacional Integrado de Salud (SNIS), y asesoría metodológica de OPS/OMS. El objetivo del documento es contar con recomendaciones informadas en la evidencia para la prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer; y ponerlas a la disponibilidad de los profesionales de la salud, para la atención de la población descrita en esta guía, siendo además una herramienta para los tomadores de decisiones, facilitando su implantación y reduciendo brechas en salud

The National Institute of Health (INS) coordinated the preparation of this clinical practice guide, with the support of a multidisciplinary team from the National Integrated Health System (NHIS), and methodological advice from PAHO/WHO. The aim of the document is to provide informed evidence-based recommendations for prevention, promotion, care of complications and support for the families of premature or low birth weight newborns; and make them available to health professionals, for the care of the population described in this guide, being also a tool for decision makers, facilitating their implementation and reducing health gaps

Guía de práctica clínica basada en la evidencia sobre intervenciones de prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer. Versión completa. Octubre de 2023 / Evidence-based clinical practice guide on prevention interventions, advocacy, care of complications and support for families of preterm or low birth weight newborns. Full version. October 2023

El Instituto Nacional de Salud (INS) coordinó la elaboración de la presente guía de práctica clínica, con apoyo de un equipo multidisciplinario del Sistema Nacional Integrado de Salud (SNIS), y asesoría metodológica de OPS/OMS. El objetivo del documento es contar con recomendaciones informadas en la evidencia para la prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer; y ponerlas a la disponibilidad de los profesionales de la salud, para la atención de la población descrita en esta guía, siendo además una herramienta para los tomadores de decisiones, facilitando su implantación y reduciendo brechas en salud

The National Institute of Health (INS) coordinated the preparation of this clinical practice guide, with the support of a multidisciplinary team from the National Integrated Health System (NHIS), and methodological advice from PAHO/WHO. The aim of the document is to provide informed evidence-based recommendations for prevention, promotion, care of complications and support for the families of premature or low birth weight newborns; and make them available to health professionals, for the care of the population described in this guide, being also a tool for decision makers, facilitating their implementation and reducing health gaps

Desfechos assistenciais na implantação do protocolo minimalista de implante transcateter de válvula aórtica / Care outcomes in the implementation of the minimalist protocol for transcatheter aortic valve implantation

INTRODUÇÃO: A abordagem minimalista no implante transcateter da válvula aórtica tornou-se ideal tecnicamente pela redução das comorbidades pré-operatórias e consequentemente, recuperação mais rápida e com menos riscos associados comparados com a cirurgia de troca de válvula aórtica convencional. O conceito de Implante Transcateter de Válvula Aórtica minimalista é definido pela simplificação dos aspectos técnicos como anestesias local/sedação consciente, acesso percutâneo, ecotranstorácico, monitorização em unidade de pós-procedimento anestésico, associados à assistência multidisciplinar, visando simplificar os aspectos da atenção ao paciente, sem perder o foco na segurança da assistência e na obtenção dos melhores desfechos clínicos, assim como na diminuição da internação e custos hospitalares. OBJETIVO: Descrever desfechos assistenciais obtidos na implantação do protocolo minimalista. MÉTODOS Estudo retrospectivo, unicêntrico, realizado em uma Instituição de grande porte especializada em Cardiologia do município de São Paulo. Os dados agregados foram extraídos do laboratório de hemodinâmica da sessão de intervenção Percutânea em Valvopatias, no período de janeiro de 2022 a maio 2023. RESULTADOS Dos 106 procedimentos de Implante Transcateter de Válvula Aórtica realizados no laboratório de hemodinâmica, 94,3% foram minimamente invasivos associados a ações multiprofissional de acordo com o protocolo estabelecidos pelo Heart Team da sessão de Intervenção em Valvopatias. CONCLUSÃO: O Enfermeiro é o profissional essencial na gestão de recursos de materiais específicos, recursos humanos especializados e na mobilização da equipe em assistir e garantir a assistência segura no procedimento minimamente.

Ethics without borders: an analysis of national and international guidelines on ethics in basic medical education.

BACKGROUND: It has been widely recognized that ethics is central to the practice of medicine. Since physicians' identities are heavily influenced by their basic medical training, education in ethics during this period would facilitate their professional development. To enable this, some global and national organizations have published guidelines detailing the aspects of ethics that need to be taught to medical student. However, it is not known how many such guidelines exist and to what extent they concur or differ. AIM: This study aims to identify and examine the content of existing national or international guidelines on the inclusion of ethics in basic medical education, in the English language. By doing so, it hopes to explore and highlight the similarities and differences regarding their pedagogical goals and their prescribed content, thereby contributing to a more holistic understanding on the state of medical ethics education. METHODS: Data collection was performed through systematic searches on Google and on scientific databases. The guidelines that fulfilled the inclusion criteria were thematically analyzed using the method proposed by Braun and Clarke (2006). The resulting themes and sub-themes were grouped and characterized. RESULTS: Thirteen guidelines (ten national and three international) fulfilled the inclusion criteria. Among these, two major approaches can be discerned: value-based and norm-based. Value-based guidelines tend to be more globally applicable, because they endorse more abstract and universal principles. Norm-based guidelines, on the other hand, are more context-specific and have a practical focus. Understanding this distinction could facilitate discussions on different perspectives in ethics education.

A disciplina psicologia do esporte nos cursos de psicologia e educação física / Sports psychology in psychology and physical education courses / La materia psicología del deporte en los cursos de psicología y educación física

Este discute a representatividade da disciplina Psicologia do Esporte nos cursos de Psicologia e Educação Física em instituições de ensino superior reconhecidas pelo MEC e situadas na região Sul do país. Foi realizado um estudo documental, com base nos currículos das Instituições. Os resultados revelaram que no Sul do Brasil 21,02% dos cursos de Psicologia, 41,96% dos cursos de bacharelado em Educação Física e apenas 14,83% dos cursos de licenciatura em Educação Física apresentam a disciplina Psicologia do Esporte em sua grade curricular. Observou-se que a disciplina é ofertada mais frequentemente em regime obrigatório nos cursos de bacharelado em Educação Física. Nos cursos de Psicologia, quando ofertada, costuma ser optativa. Os resultados evidenciam uma maior oferta da disciplina para os estudantes de Educação Física, em relação aos de Psicologia, o que pode estar relacionado ao próprio contexto de surgimento da disciplina e sua popularização no meio acadêmico. Para que esse panorama possa mudar e se possa oferecer uma formação adequada no curso de Psicologia para fomentar essa opção de carreira, há necessidade de se repensar o currículo e o próprio perfil do egresso, de forma a dar mais oportunidade aos estudantes para que conheçam as bases teóricas e os campos de aplicação da Psicologia do Esporte. Tal lacuna pode acarretar a fragilização da disseminação desse conhecimento aos estudantes de graduação e a consequente ocupação do mercado de trabalho.(AU)

This study discusses the representativeness of Sports Psychology in Psychology and Physical Education courses at higher education institutions from Southern Brazil. A documentary study was conducted based on the institutions' curricula. Results show that 21.02% of the Psychology major, 41.96% of the bachelor's in Physical Education, and only 14.83% of the license in Physical Education offer Sports Psychology in their curricula. Sports Psychology is most often offered as a compulsory subject in the bachelor's program in Physical Education, whereas Psychology courses offer it mainly as an elective. Physical Education students have greater contact with the discipline when compared with Psychology students, which may be explained by its context of development and popularization in the academic environment. To change this scenario and offer adequate education in the Psychology programs to foster this career option, institutions must rethink their curriculum and the graduate profile itself. This would give students better opportunity to get to know its theoretical bases and fields of application. Such a gap can hinder the dissemination of this knowledge to undergraduate students and the consequent labor market occupation.(AU)

El objetivo de este estudio es discutir la representatividad de la materia Psicología del Deporte en los cursos de Psicología y Educación Física en instituciones de educación superior de la región Sur de Brasil, reconocidas por el Ministerio de Educación (MEC). Se realizó un estudio documental, basado en los planes de estudio de las instituciones. Los resultados revelaron que, en el Sur de Brasil, el 21,02% de los cursos de Psicología, el 41,96% de los cursos de licenciatura en Educación Física y sólo el 14,83% de los cursos de profesorado en Educación tienen la materia Psicología del Deporte en sus planes de estudio. Se observó que la materia Psicología del Deporte se ofrece con mayor frecuencia como asignatura obligatoria en los cursos de licenciatura en Educación Física. Cuando se ofrece en los cursos de Psicología, es una materia optativa. Los resultados muestran una mayor oferta para los estudiantes de Educación Física en comparación con Psicología, lo que puede estar relacionado con el contexto del surgimiento de la Psicología del Deporte como materia y su popularización en el ámbito académico. Para que este escenario cambie y sea posible ofrecer una formación adecuada en el curso de Psicología con el fin de fomentar esta opción de carrera, es necesario repensar el plan de estudios y el perfil del egresado, así los estudiantes tendrán más oportunidades de conocer sus bases teóricas y sus campos de actuación. Tal brecha puede debilitar la difusión de este conocimiento a los estudiantes de grado y la consecuente ocupación en el mercado laboral.(AU)

Processos de reflexividade dos psicólogos do esporte e coaches: um estudo fenomenológico / Reflexivity processes of sport psychologists and coaches: a phenomenological study / Procesos de reflexividad de psicólogos del deporte y coaches: un estudio fenomenológico

O objetivo desta pesquisa é identificar e compreender fenomenologicamente, por meio de relato de Psicólogos de Esporte (PE) e de Coaches, em sua vivência prática, como ocorrem os processos reflexivos em sua atuação, conforme apreendidos a partir de relatos de experiências. O método de investigação escolhido foi a fenomenologia, pois oferece os recursos necessários para tal mergulho junto à experiência reflexiva. A amostra intencional foi delineada por PE e Coaches (profissionais de Educação Física que recorrem ao Coaching) em atividade em esportes de alto rendimento, que tenham atuado ou estejam atuando em modalidades esportivas coletivas e/ou individuais. Realizaram-se nove entrevistas (cinco com PE, quatro com Coaches). O acesso ao objeto desse estudo se deu por meio de entrevistas em profundidade e semiestruturadas, orientadas pela escuta suspensiva. As questões disparadoras foram formuladas com base no Procedimento Estruturado de Reflexão adaptado. Para análise das entrevistas, realizou-se uma síntese de cada relato, seguindo-se de cruzamento intencional. Como resultados, percebeu-se que PE e Coaches trazem algumas similaridades no que se refere aos modos de refletir sobre sua prática. No entanto, as experiências que eles fazem desses processos reflexivos é que podem tomar rumos distintos. Os(as) PE amparam-se na regulamentação da profissão e resguardam-se em seus apontamentos, trazendo suas experiências e reflexões sobre os processos vividos. Os(as) Coaches trazem em suas explanações um trabalho coerente, organizado e compatível com o método do Coaching. Problematizar os processos reflexivos desses profissionais permite diferenciar qualitativa e eticamente suas atuações, possibilitando o fomento multiprofissional no esporte.(AU)

The aim of this study consists in phenomenologically identifying and understanding, by the report of Sport Psychologists (SP) and coaches, in their practical experience, how would be the reflexive processes that take place in their performance, as learned from reports of their experiences. The research method chosen was phenomenology, since it offers the necessary resources for such a dive along with the reflective experience. The intentional sample was outlined by SP and coaches (Physical Education professionals who use coaching) active in high performance sports, who have or are working in collective and/or individual sports. Nine interviews were conducted (five with SP, four with coaches). Access to the object of this study took place by in-depth and semi-structured interviews, guided by suspensive listening. The triggering questions were formulated based on the adapted Structured Reflection Procedure. For the analysis of the interviews, a synthesis of each report was carried out, followed by the intentional crossing. As results, it was noticed that SP and coaches bring some similarities regarding the ways of reflecting on their practice. However, their experiences of these reflective processes are that they can take different directions. The SP are based on the regulation of the profession and guard themselves in their notes, bringing their experiences and reflections on the processes experienced. Coaches bring in their explanations a coherent, organized, and compatible work with the coaching method. Problematizing the reflective processes of these professionals allows to differentiate their actuation qualitatively and ethically, making the multiprofessional phenomenon in sport possible.(AU)

El objetivo de este estudio consiste en identificar y comprender fenomenológicamente, a partir de la experiencia práctica de psicólogos del deporte (PD) y coaches, cómo serían los procesos reflexivos que se llevan a cabo en su rendimiento, tal y como se desprende de los informes de experiencias. El método de investigación elegido fue la fenomenología, ya que ofrece los recursos necesarios junto con la experiencia. La muestra intencional fue delineada por PD y coaches (profesionales de la educación física que utilizan el coaching) activos en deportes de alto rendimiento, que tienen o están trabajando en deportes colectivos e/o individuales. Se realizaron nueve entrevistas (cinco con PD, cuatro con coaches). El acceso al objeto de este estudio fue entrevistas en profundidad y semiestructuradas, guiadas por escuchas suspensivas. Las preguntas se formularon desde el procedimiento de reflexión estructurado adaptado. Para el análisis de las entrevistas, se hizo una síntesis de cada informe, seguida del cruce intencional. Como resultados, se notó que los PD y coaches tienen algunas similitudes con respecto a las formas de reflexionar sobre su práctica. Sin embargo, las experiencias que hacen de estos procesos pueden tomar diferentes direcciones. Los(las) PD se basan en la regulación de la profesión y se protegen en sus notas, aportando sus experiencias y reflexiones sobre los procesos vividos. Los(las) coaches plantean en sus explicaciones un trabajo coherente, organizado y compatible con el método de Coaching. Problematizar los procesos reflexivos de estos profesionales permite diferenciar sus acciones de manera cualitativa y ética, además de posibilitar la promoción multiprofesional en el deporte.(AU)

Advances in pharmacotherapy for rosacea: what is the current state of the art?

INTRODUCTION: Rosacea is a chronic and relapsing facial dermatosis that encompasses a wide spectrum of clinical phenotypes (transient/persistent erythema, telangiectasias, papules/pustules, edema, phymatous changes, and ocular symptoms) often with uncomfortable symptoms such as flushing, pain, burning, edema, and dryness. Current pharmacological treatment includes topical agents, spanning from several conventional (azelaic acid, metronidazole, sodium sulfacetamide) to new ones (brimonidine, oxymetazoline, ivermectine, minocycline), and systemic agents (doxycycline 40 mg modified-release), all Food and Drug Administration approved. AREAS COVERED: The aim of our article is to review the state of art of pharmacological treatment, either as monotherapy or in combination therapy, tailored to the most common rosacea phenotypes (persistent erythema, inflammatory papules/pustules). Other off-label topical or systemic drugs and several adjuvant phytotherapeutic agents are considered. EXPERT OPINION: Combined therapies to target different phenotypes, when present in the same patient, represent one of the major achievements in the management of vascular and inflammatory papules and pustules of rosacea. Future investigations should be addressed to early inflammatory phyma or ocular rosacea, which have actually been neglected. Finally, there is still an ongoing need for therapeutic interventions able to relieve symptoms and social burden, all factors that greatly contribute to improve rosacea quality of life.

Metodología para la confección de la guía de tratamiento integral del cáncer de pulmón, en Villa Clara / Methodology to prepare a comprehensive treatment guideline for lung cancer in Villa Clara

RESUMEN Introducción: En Cuba, la Estrategia Nacional de Control del Cáncer recomienda contextualizar las guías clínicas de diagnóstico y tratamiento a las condiciones específicas de cada provincia e institución sanitaria. Objetivo: Describir la metodología para la elaboración de la guía de diagnóstico y tratamiento del cáncer de pulmón en Villa Clara. Métodos: Se realizó una búsqueda bibliográfica en la Biblioteca Cochrane de revisiones sistemáticas y en la base de datos PubMed, en el periodo de 2007-2017. Se consultaron, además, las principales guías nacionales e internacionales relacionadas con el tratamiento del cáncer de pulmón. Se utilizó el consenso de expertos como sistemática de trabajo para la elaboración y validación de la guía. Resultados: Se estructuró un documento final en seis apartados (estadísticas de cáncer de pulmón, prevención y epidemiología, diagnóstico y tratamiento, seguimiento, conducta en la recidiva local y progresión de la enfermedad); con anexos relacionados con la pesquisa, descripción clínica, esquemas de tratamiento, instrumentos de calidad de vida e indicadores. La guía se encuentra implementada en hospitales y policlínicos de la provincia, desde el año 2013, y fue actualizada en 2017. Conclusiones: Esta guía fomenta la valoración multidisciplinaria de los pacientes, orienta a la Atención Primaria de Salud en la aplicación del algoritmo para la atención integral a los enfermos y el desarrollo de los ensayos clínicos con inmunoterapias, e incorpora indicadores de evaluación de desempeño en la red de atención médica.

ABSTRACT Introduction: the National Cancer Control Strategy, in Cuba, recommends contextualizing clinical guidelines for the diagnosis and treatment of the specific conditions in each health institution and province. Objective: to describe the methodology for the preparation of a diagnosis and treatment guideline for lung cancer in Villa Clara. Methods: a bibliographic search was carried out in the Cochrane Library of systematic reviews and in PubMed database, in 2007-2017. The main national and international guidelines related to the treatment of lung cancer were also consulted. The consensus of experts was used as a work system for the guideline preparation and validation. Results: a final document was structured in six sections (lung cancer statistics, prevention and epidemiology, diagnosis and treatment, follow-up, conduct in local recurrence and disease progression); with annexes related to the research, clinical description, treatment schemes, quality of life instruments and indicators. The guideline has been implemented in hospitals and polyclinics in the province since 2013, and was updated in 2017. Conclusions: this guideline promotes the multidisciplinary assessment of patients, guides Primary Health Care in the application of the algorithm for comprehensive care of patients and the development of clinical trials with immunotherapies, as well as incorporates performance evaluation indicators in the health care network.

Protocolos de asistencia para los periodos preconcepcional, prenatal, parto, puerperio, a la persona recién nacida y lactancia materna en situación de bajo riesgo en Primer Nivel de Atención / Assistance protocols for the pre-conceptional, prenatal, childbirth, puerperium, newborn and breastfeeding periods in low-risk situations at First Level of Care

Los presentes protocolos han sido creado con la finalidad de proporcionar al personal que labora dentro del Sistema Nacional Integrado de Salud (SNIS), la información necesaria para brindar la Atención de Primer Nivel adecuada a la mujer en etapa de preconcepción, embarazo, a su familia y la comunidad en sus áreas de responsabilidad, generando de esta manera las condiciones para que toda mujer en etapa de embarazo pueda tener un parto respetado así como su hijo o hija pueda recibir un Cuidado Cariñoso y Sensible, por medio de una alta gama de servicios y la sensibilización a partir de la educación prenatal, que permita tener la información necesaria para la búsqueda de atención oportuna en los establecimientos de salud, también hace prevalecer los derechos y obligaciones de las mujeres gestantes que hacen uso del establecimiento, de tal manera que garantice la seguridad de la mujer y del bebé por nacer. Este documento establece las responsabilidades de cada nivel de atención, las acciones de promoción, educación prenatal y atención clínica por parte del personal de salud. Además, incluye los instrumentos necesarios para el seguimiento, monitoreo y supervisión por las instancias correspondientes. Este conjunto de acciones permitirá la adecuada implementación de la Ley Nacer con Cariño para un Parto Respetado y un Cuidado Cariñoso y Sensible para el Recién Nacido (en adelante la Ley) y por tanto garantizando la reducción de la morbimortalidad materna y neonatal

These protocols have been created with the purpose of providing the personnel who work within the National Integrated Health System, the necessary information to provide adequate First Level Care to women in the preconception, pregnancy, and family stages. and the community in their areas of responsibility, thus creating the conditions so that every pregnant woman can have a respected birth, as well as her son or daughter can receive Affectionate and Sensitive Care, through a wide range of services. and sensitization based on prenatal education, which allows having the necessary information to seek timely care in health establishments, also makes the rights and obligations of pregnant women who use the establishment prevail, in such a way as to guarantee the safety of the woman and the unborn baby. This document establishes the responsibilities of each level of care, promotion actions, prenatal education, and clinical care by health personnel. In addition, it includes the necessary instruments for follow-up, monitoring and supervision by the corresponding instances. This set of actions will allow the adequate implementation of the Born with Affection Law for a Respectful Childbirth and Affectionate and Sensitive Care for the Newborn (hereinafter the Law) and therefore guaranteeing the reduction of maternal and neonatal morbidity and mortality

Protocolos de asistencia para los períodos preconcepcional, prenatal, parto y puerperio de bajo riesgo perinatal / Assistance Protocols for the Preconception, Prenatal, Childbirth and Postpartum periods of Low Perinatal Risk

Los presentes protocolos tienen por objeto, establecer los criterios y pautas en el Sistema Nacional Integrado de Salud. SNIS, para vigilar y atender la salud en la preconcepción, embarazo, parto, puerperio y recién nacido de bajo riesgo con base a la Ley Nacer con Cariño para un Parto Respetado y un Cuidado Cariñoso y Sensible para el Recién Nacido, y promueven la efectividad y la seguridad de la atención; sistematizando practicas sanitarias que han demostrado ser seguras, eficaces y menos costosas. Los mismos deben ser aplicados en todos los niveles de atención, para lograr la reducción de la morbilidad y mortalidad materna perinatal

The purpose of these protocols is to establish the criteria and guidelines in the National Integrated Health System. SNIS, to monitor and care for health in pre-conception, pregnancy, childbirth, puerperium and low-risk newborns based on the Born with Affection Law for a Respectful Childbirth and Affectionate and Sensitive Care for the Newborn, and promote effectiveness and safety of care; systematizing sanitary practices that have proven to be safe, effective and less expensive. They must be applied at all levels of care, to achieve the reduction of perinatal maternal morbidity and mortality

Strengthening the quality of clinical trials of acupuncture: a guideline protocol.

INTRODUCTION: Acupuncture has been accepted in many Western countries and clinical trials have been increasing recently. However, the problems of insufficient and low-quality evidence remain, and substantially hinder the development of acupuncture clinical trials. We therefore aim to develop a guideline to strengthen the quality of acupuncture clinical trials, in accordance with WHO handbook for guideline development and the Reporting Items for practice Guidelines in HealThcare. The guideline will help to improve the quality of acupuncture clinical trials. METHODS AND ANALYSIS: We will search for studies on the quality of acupuncture clinical trials using PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database, The Cochrane Library, the WHO and Health Technology Assessment websites, and other sources. We will also check reference lists and contact experts in the field. We will systematically evaluate the quality of acupuncture clinical trials, and extract and summarise the quality problems and countermeasures of such trials. We will also systematically review clinical trial quality control manuals and systems and formulate research questions on quality control in acupuncture clinical trials. Finally, we will develop the guideline and establish a comprehensive quality control system to ensure high quality acupuncture clinical trials. We will also evaluate the guideline and will update the guideline to reflect new scientific evidence. ETHICS AND DISSEMINATION: Ethics committee approval and informed consent are not required for developing guideline because only published data will be used, however, we will interview the patients, the ethics committee approval has been got from West China Hospital of Sichuan Unversity (Number: 2021-1188). We will publish all manuscripts arising from this research and present the findings at conferences. GUIDELINE REGISTRATION NUMBER: IPGRP-2021CN093.

Guía de práctica clínica basada en la evidencia para el abordaje del paciente adulto crítico con Covid-19. Versión completa / Evidence-based clinical practice guideline for the management of critically ill adult patients with Covid-19. Complete version

La presente guía de práctica clínica es un esfuerzo realizado por profesionales del Sistema Integrado de Salud (SNIS) coordinado por el Instituto Nacional de Salud (INS) ante la amenaza de la COVID-19 considerada una infección potencialmente mortal causada por el virus SARS-Cov2 y que actualmente representa un desafío sanitario mundial. Actualmente, la enfermedad COVID-19 es un problema prioritario; por tal razón, se ha generado este documento como herramienta de apoyo a los profesionales de la salud en su práctica diaria

This clinical practice guideline is an effort carried out by professionals from the Integrated Health System (SNIS) coordinated by the National Institute of Health (INS) in the face of the threat of COVID-19, considered a life-threatening infection caused by the SARS-Cov2 virus. and that currently represents a global health challenge. Currently, the COVID-19 disease is a priority problem; For this reason, this document has been generated as a support tool for health professionals in their daily practice

Guía de práctica clínica basada en la evidencia para el abordaje del paciente adulto crítico con Covid-19. Versión Resumida / Evidence-based clinical practice guideline for the management of critically ill adult patients with Covid-19. Summary version

La presente guía de práctica clínica es un esfuerzo realizado por profesionales del Sistema Integrado de Salud (SNIS) coordinado por el Instituto Nacional de Salud (INS) ante la amenaza de la COVID-19 considerada una infección potencialmente mortal causada por el virus SARS-Cov2 y que actualmente representa un desafío sanitario mundial. Actualmente, la enfermedad COVID-19 es un problema prioritario; por tal razón, se ha generado este documento como herramienta de apoyo a los profesionales de la salud en su práctica diaria

This clinical practice guideline is an effort carried out by professionals from the Integrated Health System (SNIS) coordinated by the National Institute of Health (INS) in the face of the threat of COVID-19, considered a life-threatening infection caused by the SARS-Cov2 virus. and that currently represents a global health challenge. Currently, the COVID-19 disease is a priority problem; For this reason, this document has been generated as a support tool for health professionals in their daily practice

BRAF mutation testing for patients diagnosed with stage III or stage IV melanoma: practical guidance for the Australian setting.

Targeted therapy (BRAF inhibitor plus MEK inhibitor) is now among the possible treatment options for patients with BRAF mutation-positive stage III or stage IV melanoma. This makes prompt BRAF mutation testing an important step in the management of patients diagnosed with stage III or IV melanoma; one that can help better ensure that the optimal choice of systemic treatment is initiated with minimal delay. This article offers guidance about when and how BRAF mutation testing should be conducted when patients are diagnosed with melanoma in Australia. Notably, it recommends that pathologists reflexively order BRAF mutation testing whenever a patient is found to have American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) stage III or IV melanoma (i.e., any metastatic spread beyond the primary tumour) and that patient's BRAF mutation status is hitherto unknown, even if BRAF mutation testing has not been specifically requested by the treating clinician (in Australia, Medicare-subsidised BRAFV600 mutation testing does not need to be requested by the treating clinician). When performed in centres with appropriate expertise and experience, immunohistochemistry (IHC) using the anti-BRAF V600E monoclonal antibody (VE1) can be a highly sensitive and specific means of detecting BRAFV600E mutations, and may be used as a rapid and relatively inexpensive initial screening test. However, VE1 immunostaining can be technically challenging and difficult to interpret, particularly in heavily pigmented tumours; melanomas with weak, moderate or focal BRAFV600E immunostaining should be regarded as equivocal. It must also be remembered that other activating BRAFV600 mutations (including BRAFV600K), which account for ∼10-20% of BRAFV600 mutations, are not detected with currently available IHC antibodies. For these reasons, if available and practicable, we recommend that DNA-based BRAF mutation testing always be performed, regardless of whether IHC-based testing is also conducted. Advice about tissue/specimen selection for BRAF mutation testing of patients diagnosed with stage III or IV melanoma is also offered in this article; and potential pitfalls when interpreting BRAF mutation tests are highlighted.

Quality assessment of conventional and traditional oriental medicine clinical practice guidelines for knee osteoarthritis using AGREE II instrument.

INTRODUCTION: Knee osteoarthritis is a degenerative disease and its prevalence tends to increase. Clinical practice guidelines (CPGs) are evidence-based recommendations for treatment that help policymakers, practitioners, and patients make more appropriate and efficient decisions during the course of management. This study aimed to evaluate the quality of knee osteoarthritis CPGs using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. METHOD: The retrieval engines and websites were utilized from January 2010 to December 2020. The search words were "Clinical practice guideline" OR "Critical practice guideline" OR "guideline∗" AND "Osteoarthritis." The quality of the CPGs was independently examined by four appraisers using the AGREE II instrument. Consequently, the selected CPGs were graded as Classes A, B, and C according to the level of recommendation. RESULT: In this study, 13 CPGs for knee osteoarthritis were selected and evaluated qualitatively using the AGREE II instrument. The overall quality percentage score was as follows: clarity of presentation, 72.6%, scope and purpose, 62.6%, rigor of development, 54.2%, stakeholder investment, 50.5%, editorial independence, 46.5%, applicability, 22.5%. CONCLUSION: Auxiliary materials for the treatment process of knee OA should be supplemented in future revised versions for quality improvement of knee OA CPGs. Also, more evidence should be accumulated to support the recommendation of traditional oriental medical treatments in the clinical field. From the perspective of integrative medicine, along with conventional pharmacological treatment, exercise, weight loss, and acupuncture can be combined together in clinical situations.

An exploration of potential output measures to assess efficiency and productivity for labour and birth in Australia.

BACKGROUND: In maternity services, as in other areas of healthcare, increasing emphasis is placed on improving "efficiency" or "productivity". The first step in any efficiency and productivity analysis is the selection of relevant input and output measures. Within healthcare quantifying what is produced (outputs) can be difficult. The aim of this paper is to identify a potential output measure, that can be used in an assessment of the efficiency and productivity of labour and birth in-hospital care in Australia and to assess the extent to which it reflects the principles of woman-centred care. METHODS: This paper will survey available perinatal and maternal datasets in Australia to identify potential output measures; map identified output variables against the principles of woman-centred care outlined in Australia's national maternity strategy; and based on this, create a preliminary composite outcome measure for use in assessing the efficiency and productivity of Australian maternity services. RESULTS: There are significant gaps in Australia's maternity data collections with regard to measuring how well a maternity service is performing against the values of respect, choice and access; however safety is well measured. Our proposed composite measure identified that of the 63,215 births in Queensland in 2014, 67% met the criteria of quality outlined in our composite measure. CONCLUSIONS: Adoption in Australia of the collection of woman-reported maternity outcomes would substantially strengthen Australia's national maternity data collections and provide a more holistic view of pregnancy and childbirth in Australia beyond traditional measure of maternal and neonate morbidity and mortality. Such measures to capture respect, choice and access could complement existing safety measures to inform the assessment of productivity and efficiency in maternity care.