Evaluating the implementation of community engagement guidelines (EVALUA GPS project): a study protocol.

INTRODUCTION: The EVALUA GPS project aims to evaluate the impact of the implementation of the National Institute for Health Care and Excellence (NICE) guideline 'Community engagement: improving health and well-being and reducing health inequalities' adapted to the Spanish context. METHODS AND ANALYSIS: Phase I: A tool will be designed to evaluate the impact of implementing the recommendations of the adapted NICE guideline. The tool will be developed through a review of the literature on implementation of public health guidelines between 2000 and 2021 and an expert's panel consensus. PHASE II: The developed tool will be implemented in 16 community-based programmes, acting as intervention sites, and 4 controls through a quasi-experimental pre-post study. Phase III: A final online web tool, based on all previously collected information, will be developed to support the implementation of the adapted NICE guidelines recommendations in other contexts and programmes. DATA COLLECTION AND ANALYSIS: Data will be collected through surveys and semistructured interviews. Quantitative and qualitative data will be analysed to identify implementation scenarios, changes in community engagement approaches, and barriers and facilitators to the implementation of the recommendations. All this information will be further synthesised to develop the online tool. ETHICS AND DISSEMINATION: The proposed research has been approved by the Clinical Research Ethics Committee of Aragon. Results will be presented at national and international conferences and published in peer-reviewed open access journals. The interactive online tool (phase III) will include examples of its application from the fieldwork.

Recommended Best Practices in Freeze Dryer Equipment Performance Qualification: 2022.

Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as "shelf surface uniformity"), equipment capability, and performance metrics of the freeze dryer essential to the pharmaceutical Quality by Design paradigm. Specific guidelines for performing shelf temperature mapping, freeze dryer equipment limit testing (the capability curve), and condenser performance metrics have been provided. Concerning shelf temperature mapping and equipment capability measurements, the importance of paying attention to the test setup and the use of appropriate testing tools are stressed. In all the guidelines provided, much attention has been paid to identifying the balance between obtaining useful process knowledge, logistical challenges associated with testing in the production environment vs that at laboratory scale, and the frequency of the testing necessary to obtain such useful information. Furthermore, merits and demerits of thermal conditions maintained on the cooled surfaces of the freeze dryer condenser have been discussed identifying the specific influence of the condenser surface temperature on the process conditions using experimental data to support the guidelines. Finally, guidelines for systematic leak rate testing criteria for a freeze dryer are presented. These specific procedural recommendations are based on calculations, measurements, and experience to provide useful process and equipment knowledge.

Recommended Guideline for Uniform Reporting of Neonatal Resuscitation: The Neonatal Utstein Style.

Clinical research on neonatal resuscitation has accelerated over recent decades. However, an important methodologic limitation is that there are no standardized definitions or reporting guidelines for neonatal resuscitation clinical studies. To address this, the International Liaison Committee on Resuscitation Neonatal Life Support Task Force established a working group to develop the first Utstein-style reporting guideline for neonatal resuscitation. The working group modeled this approach on previous Utstein-style guidelines for other populations. This reporting guideline focuses on resuscitation of newborns immediately after birth for respiratory failure, bradycardia, severe bradycardia, or cardiac arrest. We identified 7 relevant domains: setting, patient, antepartum, birth/preresuscitation, resuscitation process, postresuscitation process, and outcomes. Within each domain, relevant data elements were identified as core versus supplemental. Core data elements should be collected and reported for all neonatal resuscitation studies, while supplemental data elements may be collected and reported using standard definitions when possible. The Neonatal Utstein template includes both core and supplemental elements across the 7 domains, and the associated Data Table provides detailed information and reporting standards for each data element. The Neonatal Utstein reporting guideline is anticipated to assist investigators engaged in neonatal resuscitation research by standardizing data definitions. The guideline will facilitate data pooling in meta-analyses, enhancing the strength of neonatal resuscitation treatment recommendations and subsequent guidelines.

Protocolos de atención quirúrgica en el donante vivo y el receptor de trasplante renal / Surgical care protocols in the living donor and kidney transplant recipient

En El Salvador las enfermedades crónicas no transmisibles se han incrementado progresivamente en las últimas décadas, actualmente ocupan un lugar relevante en la ocurrencia de morbilidad y mortalidad en la población. El aparecimiento de nuevos casos, sumado a la alta cifra de los ya existentes, ha producido un incremento en la demanda de servicios de salud, tanto de atenciones ambulatorias, como de hospitalizaciones. Como parte esencial de este esfuerzo y con participación de especialistas del MINSAL y del ISSS, se han actualizado los protocolos médicos para el trasplante de riñón que fueron elaborados en el año 2019. EL presente documento contiene la inclusión de nuevos criterios, con los que se ha actualizado el contenido técnico, en relación con los procedimientos médicos que regirán la realización de los procesos de trasplante renal en la red de hospitales del SNIS, involucrados en la donación y trasplante con donantes vivos y que proporcionarán a pacientes que los reciban, la oportunidad de una mejor calidad de vida

In El Salvador, chronic noncommunicable diseases have increased progressively in recent decades, currently occupying a relevant place in the occurrence of morbidity and mortality in the population. The appearance of new cases, added to the high number of existing ones, has produced an increase in the demand for health services, both for outpatient care and hospitalizations. As an essential part of this effort and with the participation of MINSAL and ISSS specialists, the medical protocols for kidney transplantation that were prepared in 2019 have been updated. This document contains the inclusion of new criteria, with which has updated the technical content, in relation to the medical procedures that will govern the performance of kidney transplant processes in the SNIS network of hospitals, involved in donation and transplantation with living donors and that will provide patients who receive them, the opportunity of a better quality of life

Key Elements of Enhanced Recovery after Total Joint Arthroplasty: A Reanalysis of the Enhanced Recovery after Surgery Guidelines.

Recent guidelines have produced a consensus statement for perioperative care in hip and knee replacement. However, there is still a need for reanalysis of the evidence and recommendations. Therefore, we retrieved and reanalyzed the evidence of each recommended components of enhanced recovery after surgery (ERAS) based on the guidelines of total joint arthroplasty. For each one, we included for the highest levels of evidence and those systematic reviews and meta-analyses were preferred. The full texts were analyzed and the evidence of all components were summarized. We found that most of the recommended components of ERAS are supported by evidence, however, the implementation details of each recommended components need to be further optimized. Therefore, implementation of a full ERAS program may maximize the benefits of our clinical practice but this combined effect still needs to be further determined.

Expert Witness Testimony in Spine Surgery: A Review of Guidelines and Recommendations From Professional Organizations.

BACKGROUND: Most professional spine societies have enacted formal guidelines for spine surgeons providing expert witness services. However, there is significant heterogeneity in existing recommendations, with most societies providing information that is limited in detail and scope. OBJECTIVE: To provide a review of guidelines published by professional spine societies for spine surgeons serving as expert witnesses. METHODS: The Gale Directory Library, PubMed, and the grey literature were queried for national or international professional societies related to spine surgery. The search was focused on societies in the United States and North America, but also included well recognized international organizations in the field of spine surgery. Included societies with publicly available guidelines regarding expert witness services were extracted for 4 domains: (1) qualifications, (2) preparations, (3) testimony, and (4) compensation as well as the presence of a professional compliance program, defined as any official subcommittee aimed toward investigating claims of unethical behavior. RESULTS: Although most professional spine societies share general themes with respect to expert witness guidelines, important differences exist. Of the 26 societies included, 10 included publicly available guidelines: 4 of which were general neurosurgery societies, 2 general orthopedic surgery, and 4 spine specific. Three societies included the guidelines on all 4 domains (ie, qualifications, preparations, testimony, and compensation), and 2 societies included only 1 of the 4 domains. Eight societies possess a professional compliance program. CONCLUSION: There remains a paucity in expert witness guidelines provided by professional spine societies. Although existing recommendations are useful, there is a lack of standardized and comprehensive materials for spine surgeons providing expert witness testimony to reference. Moving forward, joint committees comprising surgeons, attorneys, and patient stakeholders may help improve the guidelines.

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines.

The recent centennial anniversary of R.E. Montgomery's seminal published description of "a form of swine fever" disease transmitted from wild African pigs to European domestic pigs is a call to action to accelerate African Swine Fever (ASF) vaccine research and development. ASF modified live virus (MLV) first-generation gene deleted vaccine candidates currently offer the most promise to meet international and national guidelines and regulatory requirements for veterinary product licensure and market authorization. A major, rate-limiting impediment to the acceleration of current as well as future vaccine candidates into regulatory development is the absence of internationally harmonized standards for assessing vaccine purity, potency, safety, and efficacy. This review summarizes the asymmetrical landscape of peer-reviewed published literature on ASF MLV vaccine approaches and lead candidates, primarily studied to date in the research laboratory in proof-of-concept or early feasibility clinical safety and efficacy studies. Initial recommendations are offered toward eventual consensus of international harmonized guidelines and standards for ASF MLV vaccine purity, potency, safety, and efficacy. To help ensure the successful regulatory development and approval of ASF MLV first generation vaccines by national regulatory associated government agencies, the World Organisation for Animal Health (WOAH) establishment and publication of harmonized international guidelines is paramount.

Guía para la Implementación y funcionamiento de las Maternidades Nacer con Cariño / Guide for the Implementation and operation of Born with Love Maternity Hospitals

El presente documento es una guía que proporciona herramientas para la autogestión y autoevaluación, tanto a las maternidades como al personal que desarrolla sus actividades en ellas a fin de adherirse al cumplimiento de la Ley Nacer Con Cariño para un Parto Respetado y un Cuidado Cariñoso y Sensible para el Recién Nacido (LNCC), del cual surge el modelo de atención Maternidades Nacer con Cariño (MNCC) como marco macro previo a la implementación de cualquier tipo de acciones estratégicas en instituciones donde nacen personas. Incluye conceptos básicos de la atención materno infantil con un enfoque de derechos que facilita la transición de un modelo médico hegemónico a un modelo biopsicosocial, centrado en la familia. Además, ofrece elementos que permitirán el análisis objetivo de cada área relacionada con las MNCC y su personal, fomentando una mejora en la cultura organizacional como en la interacción personal de salud y los/as usuarios/as

This document is a guide that provides tools for self-management and self-assessment, both to maternity hospitals and to the personnel who carry out their activities in them, in order to adhere to compliance with the Born With Sweetie Law for a Respectful Childbirth and Affectionate and Sensitive Care for the Newborn , from which the Maternity Born with Love care model arises as a macro framework prior to the implementation of any type of strategic actions in institutions where people are born. It includes basic concepts of maternal and child care with a rights-based approach that facilitates the transition from a hegemonic medical model to a biopsychosocial model, centered on the family. In addition, it offers elements that will allow the objective analysis of each area related to the and its personnel, promoting an improvement in the organizational culture as well as in the personal interaction of health and the users

Cuidados de enfermagem ao utente com ostomia respiratória: avaliação de conhecimentos / Nursing care to the respiratory ostomy patient: knowledge assessment

A ostomia respiratória é comumente realizada eletivamente nos serviços de medicina intensiva em utentes críticos que necessitam de assistência ventilatória prolongada, sendo o procedimento cirúrgico realizado com mais frequência em utentes graves entubados. Apesar de vários estudos indicarem os benefícios deste procedimento, surgem frequentemente complicações decorrentes do mesmo e que carecem de enfermeiros devidamente formados e capazes de responder adequadamente perante situações críticas. Objetivos: Identificar os procedimentos em que os enfermeiros apresentam maior deficit de conhecimentos no cuidado a utentes com ostomia respiratória; Avaliar os conhecimentos dos enfermeiros acerca dos cuidados de enfermagem na manutenção de utentes com ostomia respiratória; Analisar a relação entre os conhecimentos dos enfermeiros e as suas variáveis sociodemográficas. Métodos: Foi realizado um estudo observacional transversal e analítico, aplicando-se o instrumento de recolha de dados a 85 enfermeiros dos Serviços de Medicina Intensiva e Serviços de Internamento, através do preenchimento de um questionário. A análise estatística dos dados recolhidos foi efetuada a partir do software SPSS. Resultados: A maioria da amostra pertence à faixa etária dos 31-40 anos, são do sexo feminino, exercem funções há mais de 18 anos, maioritariamente no SMI, em que os que possuem Especialidade indicam que a área mais prevalente é a de Enfermagem Médico- Cirúrgica. Concluiu-se que os procedimentos em que os enfermeiros apresentam maior deficit de conhecimentos no cuidado a utentes com ostomia respiratória são os que se relacionam com a identificação do local específico para a realização das diferentes ostomias respiratórias, com a frequência de limpeza da cânula interna, de troca do penso do estoma e com a pressão que deve ser mantida no cuff. A amostra apresenta níveis médios e altos de conhecimentos sobre a temática, embora se saliente que uma pequena minoria ainda apresenta conhecimentos mínimos. Relativamente à relação entre os conhecimentos dos enfermeiros e as variáveis sociodemográficas e profissionais, concluiu-se que existe relação estatística significativa entre a idade, o local adequado para a realização da ostomia respiratória, os parâmetros de deglutição, hidratação e nutrição; entre o sexo e a aspiração de secreções, a limpeza da cânula e a alimentação do utente; entre o tempo de exercício profissional e a humidificação das vias aéreas e o método de aspiração de secreções; entre o Serviço em que desempenha funções e a técnica da ostomia respiratória, a aspiração de secreções, a limpeza da cânula, os cuidados ao estoma e a pressão do cuff e entre a Especialidade e os parâmetros de deglutição, hidratação e nutrição, a alimentação do utente e a comunicação do utente. Conclusão: O investimento na formação profissional e especializada dos enfermeiros, com respetiva atualização periódica de procedimentos e protocolos ajustados a cada procedimento, com o propósito de uniformizar e garantir procedimentos especializados de alta qualidade, resultará em benefícios para os utentes sujeitos a ostomias respiratórias e, em consequência para as instituições de saúde protocoladas.

Respiratory ostomy is commonly performed electively in intensive care units in critical patients who need prolonged ventilatory assistance, and the surgical procedure is performed more frequently in severely intubated patients. Although several studies indicate the benefits of this procedure, complications often arise from it and that lack of properly trained nurses capable of responding adequately to critical situations. Objectives: To identify the procedures in which nurses present a greater deficit of knowledge in the care of users with respiratory ostomy; To evaluate nurses' knowledge about nursing care in the maintenance of patients with respiratory ostomy; To analyze the relationship between nurses' knowledge and their sociodemographic variables. Methods: A cross-sectional and analytical observational study was carried out, applying the data collection instrument to 85 nurses from the Intensive Care Services and Inpatient Services, by completing a questionnaire. Statistical analysis of the collected data was performed using the SPSS software. Results: Most of the sample belongs to the age group of 31-40 years old, are female, have been working for more than 18 years, mostly in the SMI, in which those with a Specialty indicate that the most prevalent area is Medical Nursing-Surgical. It was concluded that the procedures in which nurses present a greater deficit of knowledge in the care of users with respiratory ostomy are those related to the identification of the specific place to perform the different respiratory ostomies, with the frequency of cleaning the internal cannula, of changing the stoma dressing and with the pressure that must be maintained in the cuff. The sample has medium and high levels of knowledge on the subject, although it should be noted that a small minority still has minimal knowledge. Regarding the relationship between nurses' knowledge and sociodemographic and professional variables, it was concluded that there is a statistically significant relationship between age, the appropriate place for performing the respiratory ostomy, swallowing, hydration and nutrition parameters; between sex and aspiration of secretions, cleaning the cannula and feeding the user; between the time of professional practice and the humidification of the airways and the method of aspiration of secretions; between the service in which it performs its functions and the technique of respiratory ostomy, aspiration of secretions, cleaning the cannula, care of the stoma and the pressure of the cuff and between the Specialty and the parameters of swallowing, hydration and nutrition, feeding the user and user communication. Conclusion: Investment in professional and specialized training of nurses, with the respective periodic updating of procedures and protocols adjusted to each procedure, with the purpose of standardizing and guaranteeing high quality specialized procedures, will result in benefits for users undergoing respiratory ostomies and, consequently for the protocoled health institutions.

A brief guideline for studies of phase-separated biomolecular condensates.

Cells are exquisitely compartmentalized to achieve precise spatiotemporal regulation of myriad processes and pathways. Phase separation offers one way to achieve territorial organization in the cellular context, via the creation of membrane-less organelles (MLOs). MLOs formed through phase separation are associated with numerous critical biological functions. Although hundreds of publications on related topics are produced each year, robust criteria for the determination of biologically meaningful phase separation are yet to be well established. Here we present some principles and propose a few guidelines for phase-separation studies in biology. Specifically, we provide an in-depth experiment pipeline for phase-separation studies, including mechanisms of the molecular driving forces, ways to correlate in vivo and in vitro observations, and strategies to relate the phase-separation phenomenon to biological functions. We also intend to contribute to streamlining the aforementioned diagnostic criteria by further stressing a few common caveats in the field.

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.

Documento Técnico: Manual de control de calidad externo de baciloscopia para el diagnóstico bacteriológico de la tuberculosis / Technical Document: Manual of external quality control of smear microscopy for the bacteriological diagnosis of tuberculosis

El documento contiene las directrices y métodos estandarizados para evaluar la calidad y confiabilidad de la baciloscopia que realizan los laboratorios de TB a nivel nacional

An overview of the pharmacological options for pediatric obsessive-compulsive disorder.

INTRODUCTION: Childhood and adolescence represent critical stages for the development of obsessive-compulsive disorder (OCD). According to recent guidelines and meta-analyses, selective serotonin reuptake inhibitors (SSRIs) should be considered as the first-line pharmacological option for pediatric OCD presenting mild-to-moderate symptoms, and second-generation antipsychotic augmentation therapy should be regarded for resistant cases. AREAS COVERED: The present paper provides an overview of the most recent evidence that should guide clinicians on the choice of the appropriate first-line drugs and augmentation strategies for pediatric OCD, while considering their adverse effects and attrition rates. Additionally, this paper highlights the gaps of the literature on this topic and the future directions of research. EXPERT OPINION: The current literature on the pharmacological treatments of pediatric OCD reveals a series of gaps, mainly deriving from the limited data available in this population that requires special attention, while considering the specificity of its developmental trajectory. Although controversy still exists on whether psychotropic compounds should be used in children, scientific evidence is available on the detrimental effects of untreated OCD in this critical period of the life span.