Abordaje terapéutico integral de la hipertensión arterial. Recomendaciones para Centroamérica y el Caribe / Comprehensive Therapeutic Approach to Hypertension. Recommendations for Central America and the Caribbean

Las guías clínicas latinoamericanas de hipertensión arterial (HTA), elaboradas a la medida de las necesidades de los países de Centro y Sudamérica deben ser aplicadas y conocidas por la mayoría de los médicos latinoamericanos. El conocimiento e implementación de las guías es uno de los mayores desafíos de las sociedades de hipertensión del área latinoamericana tales como la Sociedad Centroamericana y del Caribe de Hipertensión Arterial (SCCH), la Sociedad latinoamericana de Hipertensión (LASH) y La Sociedad Interamericana de Cardiología (SIAC). En el año 2020, la SIAC publicó su posicionamiento sobre las guías vigentes de hipertensión arterial debido a la necesidad de estandarizar la evaluación, diagnóstico, tratamiento y control de la HTA, estableciendo recomendaciones que deberían adoptarse en todos los países de América Latina, encaminadas a optimizar el manejo del riesgo cardiovascular y conseguir una mejora sustancial en la disminución de eventos y mortalidad cardiovascular. El presente documento pretender reforzar las propuestas de la guía LASH y el posicionamiento de la SIAC en relación con el abordaje terapéutico y recomendaciones de tratamiento farmacológico de la HTA, con la finalidad de que se logre un mejor control de HTA en el área Centroamericana y del Caribe y, consecuentemente, mejorar el pronóstico de las enfermedades cardiovasculares en el área. (AU)

Latin American hypertension guidelines, tailored to the needs of countries of Central and South America, should be applied and known by most Latin American physicians. The knowledge and implementation of the Guidelines is one of the greatest challenges of hypertension societies in Latin America such as the Central American and Caribbean Society of Arterial Hypertension (SCCH), the Latin American Society of Hypertension (LASH) and the Inter-American Society of Cardiology (SIAC). In 2020, the Inter-American Society of Cardiology (SIAC) published its position on the current Guidelines for Arterial Hypertension due to the need to standardize the evaluation, diagnosis, treatment and control of hypertension, establishing recommendations that should be adopted in all Latin American countries, aimed at optimizing the management of cardiovascular risk and achieving a substantial improvement in the reduction of cardiovascular events and mortality. This document intends to reinforce all proposals by the LASH guidelines and the position of the SIAC in relation to the therapeutic approach and pharmacological recommendations for patients with hypertension (HT), in order to achieve better HT control in the Central American and Caribbean area, and the consequently prognosis improvement of cardiovascular disease in the area. (AU)

Reglas y consejos para ser un buen revisor por pares de manuscritos científicos / Tips and guidelines for being a good peer reviewer

La publicación es el medio clave por el cual la ciencia se difunde. El propósito de las revistas científicas es publicar artículos novedosos y de calidad. Los editores de las revistas evalúan el contenido de los manuscritos sometiéndolos a un proceso denominado «revisión por pares» (peer review), considerado hoy en día el estándar de oro para garantizar la adecuada publicación de los artículos científicos. Un informe de revisión por pares crítico y bien elaborado es un tesoro, tanto para el autor como para el editor. En el presente manuscrito examinaremos los aspectos clave de la revisión por pares. Comenzaremos explicando en qué consiste exactamente este proceso y desde cuándo existe, para después aclarar por qué es tan importante. Luego argumentaremos por qué deberíamos querer ser evaluadores de artículos científicos. Repasaremos cuáles son las reglas fundamentales para llevar a cabo una buena revisión de un manuscrito y en qué aspectos de este nos deberíamos centrar. Posteriormente veremos qué formato debe tener un informe de revisión por pares y cómo redactar sus distintos apartados, así como las opciones de su dictamen final. Dedicaremos especial atención a comentar los aspectos éticos y los errores más frecuentes que se comenten en la evaluación de manuscritos. Finalmente, reconoceremos cuáles son las limitaciones fundamentales de la revisión por pares y terminaremos proponiendo algunas sugerencias para su mejora. Nuestro objetivo final no es otro que estimular a los investigadores –y autores– a dar un paso más y acometer el reto de ser revisores de manuscritos científicos.(AU)

Publication is the key means by which science spreads. The purpose of scientific journals is to publish novel and quality articles. The editors of the journals evaluate the content of the manuscripts by submitting them to a process called «peer review», considered today the gold standard to guarantee the adequate publication of scientific articles. A well-crafted and critical peer-review report is a treasure for both authors and editors. In the present manuscript we will examine the key aspects of the peer review process. We will begin by explaining what exactly this process consists of and since when it has existed, and then clarifying why it is so important. Then we will argue why we should want to be reviewers of scientific papers. We will then review what are the fundamental rules to carry out a good review of a manuscript and what aspects of it we should focus on. Later we will see what format a peer review report should have and how to write its different sections, as well as the options for its final resolution. We will pay special attention to commenting on the ethical aspects and the most frequent errors that are made in the evaluation of manuscripts. Finally, we will recognize what the fundamental limitations of peer review are, and we will end by proposing some suggestions for their improvement. Our ultimate goal is to stimulate researchers –and authors– to go one step further and undertake the challenge of being peer reviewers of scientific manuscripts.(AU)

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.

Respiratory management in the premature neonate.

INTRODUCTION: Advances in neonatal care have made possible the increased survival of extremely preterm infants. Even though there is widespread recognition of the harmful effects of mechanical ventilation on the developing lung, its use has become imperative in the management of micro-/nano-preemies. There is an increased emphasis on the use of less-invasive approaches such as minimally invasive surfactant therapy and non-invasive ventilation that have been proven to result in improved outcomes. AREAS COVERED: Here, we review the evidence-based practices surrounding the respiratory management of extremely preterm infants including delivery room interventions, invasive and non-invasive ventilation approaches, and specific ventilator strategies in respiratory distress syndrome and bronchopulmonary dysplasia. Adjuvant relevant respiratory pharmacotherapies used in preterm neonates are also discussed. EXPERT OPINION: Early use of non-invasive ventilation and use of less invasive surfactant administration are key strategies in the management of respiratory distress syndrome in preterm infants. Ventilator management in bronchopulmonary dysplasia must be tailored according to the individual phenotype. There is strong evidence to start caffeine early to improve respiratory outcomes, but evidence is lacking on the use of other pharmacological agents in preterm neonates, and an individualized approach has to be considered for their use.

Targeting adverse effects of antiseizure medication on offspring: current evidence and new strategies for safety.

INTRODUCTION: For women with epilepsy of reproductive age, antiseizure medications (ASMs) are associated with an increased risk of offspring malformations. There are safety concerns for most anti-seizure medications in the perinatal period, and there is a clear need to identify safe medications. ASMs must transport through biological barriers to exert toxic effects on the fetus, and transporters play essential roles in trans-barrier drug transport. Therefore, it is vital to understand the distribution and properties of ASM-related transporters in biological barriers. AREAS COVERED: This study reviews the structure, transporter distribution, and properties of the blood-brain, placental, and blood-milk barrier, and summarizes the existing evidence for the trans-barrier transport mechanism of ASMs and standard experimental models of biological barriers. EXPERT OPINION: Ideal ASMs in the perinatal period should have the following characteristics: 1) Increased transport through the blood-brain barrier, and 2) Reduced transport of the placental and blood-milk barriers. Thus, only low-dose or almost no antiseizure medication could enter the fetus's body, which could decrease medication-induced fetal abnormalities. Based on the stimulated structure and molecular docking, we propose a development strategy for new ASMs targeting transporters of biological barriers to improve the perinatal treatment of female patients with epilepsy.

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.

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

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.

[Current evidence for various inpatient psychotherapy programs in the treatment of psychoses-A narrative review article]. / Aktuelle Evidenz verschiedener stationärer Psychotherapieprogramme in der Behandlung von Psychosen ­ ein narrativer Übersichtsartikel.

BACKGROUND: The analysis of the efficacy of evidence-based psychotherapy for patients with psychotic disorders has mostly been carried out in the outpatient field. In the inpatient field the efficacy is sometimes difficult to assess due to different healthcare systems. OBJECTIVE: The aim of this narrative review is to summarize international guidelines and meta-analyses on the efficacy of inpatient psychotherapeutic treatment strategies for patients with psychotic disorders. Based on this, recommendations for disorder-specific ward concepts for acute and postacute fields are formulated. METHODS: The German S3 guidelines, international guidelines, current meta-analyses and primary studies on psychological interventions in the treatment of psychotic disorders were included. Based on the results, recommendations for the inpatient psychotherapeutic treatment in various phases of treatment were formulated (acute phase and postacute phase). RESULTS: In the acute phase a combination of cognitive behavioral therapy (CBTp) in the individual setting and family interventions in the group setting as well as metacognitive training (MCT acute) is effective and recommended. In the postacute phase, in addition to individual and group CBTp and family interventions, psychoeducation, social skills training and cognitive remediation have been shown to be effective and are recommended. DISCUSSION: The suggested recommendations for concrete interventions in various treatment phases and the evidence base are critically discussed and recommendations for the structure of wards are presented.

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.

Gene Therapy for High Grade Glioma: The Clinical Experience.

INTRODUCTION: High-grade gliomas (HGG) are the most common malignant primary brain tumors in adults, with a median survival of ~18 months. The standard of care (SOC) is maximal safe surgical resection, and radiation therapy with concurrent and adjuvant temozolomide. This protocol remains unchanged since 2005, even though HGG median survival has marginally improved. AREAS COVERED: Gene therapy was developed as a promising approach to treat HGG. Here, we review completed and ongoing clinical trials employing viral and non-viral vectors for adult and pediatric HGG, as well as the key supporting preclinical data. EXPERT OPINION: These therapies have proven safe, and pre- and post-treatment tissue analyses demonstrated tumor cell lysis, increased immune cell infiltration, and increased systemic immune function. Although viral therapy in clinical trials has not yet significantly extended the survival of HGG, promising strategies are being tested. Oncolytic HSV vectors have shown promising results for both adult and pediatric HGG. A recently published study demonstrated that HG47Δ improved survival in recurrent HGG. Likewise, PVSRIPO has shown survival improvement compared to historical controls. It is likely that further analysis of these trials will stimulate the development of new administration protocols, and new therapeutic combinations that will improve HGG prognosis.

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

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.