Elaboración e implementación de un protocolo para la Hora Dorada de recién nacidos prematuros utilizando ciencia de la implementación / Elaboration and implementation of a protocol for the Golden Hour of premature newborns using an Implementation Science lens / Elaboração e implementação de protocolo para Hora Ouro do recém-nascido prematuro utilizando ciência da implementação

Objetivo: describir el proceso de diseño e implementación de un protocolo de atención para la primera hora de vida del recién nacido prematuro. Método: investigación participativa, que utilizó el marco de la ciencia de la implementación y los dominios del Consolidated Framework for Implementation Research. Estudio realizado en un hospital escuela del sureste de Brasil, con la participación del equipo multidisciplinario y de los gestores. El estudio se organizó en seis etapas, mediante del ciclo de mejora continua (Plan, Do, Check, Act): diagnóstico situacional; elaboración del protocolo; capacitaciones; implementación del protocolo; relevamiento de barreras y facilitadores; seguimiento y revisión del protocolo. Los datos fueron analizados mediante estadística descriptiva y análisis de contenido. Resultados: el primer protocolo de la Hora Dorada de la institución fue organizado por el equipo multidisciplinario a partir de un enfoque colectivo y dialógico. El protocolo priorizó la estabilidad cardiorrespiratoria, la prevención de hipotermia, hipoglucemia e infección. Después de cuatro meses de capacitación e implementación, el protocolo fue evaluado como una intervención de calidad, necesaria para el servicio, de bajo costo y de poca complejidad. La principal sugerencia de mejora fue realizar actividades educativas frecuentes. Conclusión: la implementación generó cambios e inició un proceso de mejora de la calidad de la atención neonatal, es necesario que la capacitación sea continua para lograr mayor adherencia y mejores resultados.

Objective: describe the process of designing and implementing a care protocol for the first hour of life of premature newborns. Method: a participatory research study using an implementation science framework, the Consolidated Framework for Implementation Research (CFIR) was employed to determine drivers and facilitators of implementation success of the Golden Hour protocol for newborns at a large university hospital in southeastern Brazil. A multi-professional team, including first line providers and managers participated in six stages of quality improvement: situational diagnosis; protocol elaboration; training protocol implementation; barrier and facilitator assessment; and protocol monitoring and review. Qualitative and monitoring data collected across these six stages were analyzed using descriptive statistics and content analysis. Results: the institution's Golden Hour protocol was organized by the multi-professional team based on a collective and dialogical approach. The protocol prioritized the infant's cardiopulmonary stability, as well as prevention of hypothermia, hypoglycemia and infection. After four months of implementation, the care team was evaluated the protocol as a good quality intervention, necessary for the service, low-cost and not very complex. One suggested improvement recommended was to carry out refresher training to address staff turnover. Conclusion: implementation of the Golden Hour protocol introduced an appropriate and feasible neonatal care quality improvement process, which requires periodic refresher training to ensure greater adherence and better neonatal results.

Objetivo: descrever o processo de elaboração e implementação de protocolo assistencial para a primeira hora de vida do recém-nascido prematuro. Método: pesquisa participativa, que utilizou referencial da ciência da implementação e os domínios do Consolidated Framework for Implementation Research. Estudo realizado em hospital universitário no sudeste do Brasil, com participação da equipe multiprofissional e gestores. O estudo foi organizado em seis etapas, por meio do ciclo de melhoria contínua (Plan, Do, Check, Act): diagnóstico situacional; elaboração do protocolo; treinamentos; implementação do protocolo; levantamento de barreiras e facilitadores; monitoramento e revisão do protocolo. Os dados foram analisados por estatística descritiva e análise de conteúdo. Resultados: o primeiro protocolo Hora Ouro da instituição foi organizado pela equipe multiprofissional a partir de uma abordagem coletiva e dialógica. O protocolo priorizou a estabilidade cardiorrespiratória, prevenção de hipotermia, de hipoglicemia e de infecção. Após treinamento e implementação por quatro meses, o protocolo foi avaliado como uma intervenção de qualidade, necessária ao serviço, de baixo custo e pouco complexa. A principal sugestão de melhoria foi realizar ações educativas frequentes. Conclusão: a implementação provocou mudanças e iniciou um processo de melhoria da qualidade da assistência neonatal, sendo necessária a manutenção dos treinamentos para maior adesão e melhores resultados.

Protocolización de estudios clínicos multicéntricos en la era digital. ¿Tiene utilidad la centralización de datos por un data-manager? / Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

Introducción En los estudios multicéntricos la protocolización de los datos es una fase crítica que puede generar sesgos, sobre todo en estudios clínicos con presupuesto limitado. El objetivo es analizar la concordancia y la confiabilidad de los datos obtenidos en un estudio multicéntrico clínico entre la protocolización del centro de origen y la protocolización centralizada mediante un data-manager. Método Estudio clínico multicéntrico de prevalencia nacional sobre un carcinoma familiar infrecuente, realizándose una doble protocolización de los datos: a)en el centro de origen, y b)centralizada con un data-manager. La concordancia se analiza para el global de los datos y para los dos subgrupos del proyecto: a)grupo a estudio (carcinoma familiar; protocolizan 30 investigadores) y b)grupo control (carcinoma esporádico; protocolizan 4). Las diferencias interobservador se evalúan mediante el índice de Kappa de Cohen. Resultados Se incluyen 689 pacientes: 252 del grupo a estudio y 437 del grupo control. Respecto al análisis de concordancia del estadio tumoral, se han objetivado un 2,5% de discordancias, siendo alta la concordancia entre protocolizadores (Kappa=0,931). Respecto a la valoración del riesgo de recidiva, las discordancias fueron del 7% de los casos, siendo alta la concordancia (Kappa=0,819). Respecto a la clasificación ecográfica TIRADS, las discordancias son del 6,9% y la concordancia es alta (Kappa=0,922). Se han detectado un 4,6% de errores de transcripción. Conclusiones En los estudios multicéntricos clínicos la protocolización centralizada de los datos por un data-manager parece presentar resultados similares a la protocolización directa en la base de datos en el centro de origen. (AU)

Introduction In multicenter studies, the protocolization of data is a critical phase that can generate biases. The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data-manager. Methods National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (i)center of origin; and (ii)centralized by a data manager. The concordance between the data is analyzed for the global data and for the two groups of the project: (i)study group (familiar carcinoma, 30 researchers protocolize); (ii)control group (sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. Results The study includes a total of 689 patients with carcinoma: 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa=0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa=0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa=0.922). Also, 4.6% of transcription errors were detected. Conclusions In multicenter clinical studies, the centralized data protocolization by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin. (AU)

Hodgkin lymphoma associated vanishing bile duct syndrome treated successfully with a brentuximab based regimen.

We report a combination therapy to successfully treat a patient with Hodgkin's lymphoma complicated by vanishing bile duct syndrome. Our patient was in his 20s and presented with jaundice, emesis, B symptoms and diffuse lymphadenopathy along with cholestatic liver injury prompting a liver biopsy, which revealed this diagnosis, after the exclusion of other aetiologies. Our treatment regimen incorporated brentuximab along with other more conventional agents which attempted to maximise therapeutic efficacy while minimising the consequences of hepatotoxicity on the treatment protocol. Although this patient's treatment course was complicated because of neutropenic infections, the patient achieved a complete metabolic response and is now more than 1 year off therapy.

Study protocol for safety and efficacy of all-oral shortened regimens for multidrug-resistant tuberculosis: a multicenter randomized withdrawal trial and a single-arm trial [SEAL-MDR].

INTRODUCTION: The urgent need for new treatments for multidrug-resistant tuberculosis (MDR-TB) and pre-extensively drug-resistant tuberculosis (pre-XDR-TB) is evident. However, the classic randomized controlled trial (RCT) approach faces ethical and practical constraints, making alternative research designs and treatment strategies necessary, such as single-arm trials and host-directed therapies (HDTs). METHODS: Our study adopts a randomized withdrawal trial design for MDR-TB to maximize resource allocation and better mimic real-world conditions. Patients' treatment regimens are initially based on drug resistance profiles and patient's preference, and later, treatment-responsive cases are randomized to different treatment durations. Alongside, a single-arm trial is being conducted to evaluate the potential of sulfasalazine (SASP) as an HDT for pre-XDR-TB, as well as another short-course regimen without HDT for pre-XDR-TB. Both approaches account for the limitations in second-line anti-TB drug resistance testing in various regions. DISCUSSION: Although our study designs may lack the internal validity commonly associated with RCTs, they offer advantages in external validity, feasibility, and ethical appropriateness. These designs align with real-world clinical settings and also open doors for exploring alternative treatments like SASP for tackling drug-resistant TB forms. Ultimately, our research aims to strike a balance between scientific rigor and practical utility, offering valuable insights into treating MDR-TB and pre-XDR-TB in a challenging global health landscape. In summary, our study employs innovative trial designs and treatment strategies to address the complexities of treating drug-resistant TB, fulfilling a critical gap between ideal clinical trials and the reality of constrained resources and ethical considerations. TRAIL REGISTRATION: Chictr.org.cn, ChiCTR2100045930. Registered on April 29, 2021.

Medication Abortion: A Comprehensive Review.

This chapter provides an overview of evidence-based guidelines for medication abortion in the first trimester. We discuss regimens, both FDA-approved and other clinical-based protocols, and will briefly discuss novel self-managed abortion techniques taking place outside the formal health care system. Overview of patient counseling and pain management are presented with care to include guidance on "no touch" regimens that have proven both feasible and effective. We hope that this comprehensive review helps the health care community make strides to increase access to abortion in a time when reproductive health care is continuously restricted.

Implementation of the ERAS protocol in gynecology and oncogynecology - evaluation of a pilot study.

OBJECTIVE: To describe the implementation process and evaluate the success of compliance with the recommended ERAS protocol in the Czech healthcare system. METHODS: The study included 163 patients from March to September 2022, a total of 7 months. Patients were divided into three groups according to the type of surgery. Clinical protocol: Oncogynecology, hysterectomy and laparoscopy. The implementation was realized in three phases (preparation, implementation of the protocol itself and evaluation). RESULTS AND CONCLUSIONS: The cumulative adherence rate was 90% or more in all three groups. Based on the pilot results at our department, we evaluated the ERAS concept as a well-implemented tool for gynaecological departments in the Czech healthcare system.

Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective.

Obesity, which is defined as having a body mass index of 30 kg/m2 or greater, has been recognized as a serious health problem that increases the risk of many comorbidities (eg, heart disease, stroke, and diabetes) and mortality. The high prevalence of individuals who are classified as obese calls for additional considerations in clinical trial design. Nevertheless, gaining a comprehensive understanding of how obesity affects the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of drugs proves challenging, primarily as obese patients are seldom selected for enrollment at the early stages of drug development. Over the past decade, model-informed drug development (MIDD) approaches have been increasingly used in drug development programs for obesity and its related diseases as they use and integrate all available sources and knowledge to inform and facilitate clinical drug development. This review summarizes the impact of obesity on PK, PD, and the efficacy of drugs and, more importantly, provides an overview of the use of MIDD approaches in drug development and regulatory decision making for patients with obesity: estimating PK, PD, and efficacy in specific dosing scenarios, optimizing dose regimen, and providing evidence for seeking new indication(s). Recent review cases using MIDD approaches to support dose selection and provide confirmatory evidence for effectiveness for patients with obesity, including pediatric patients, are discussed. These examples demonstrate the promise of MIDD as a valuable tool in supporting clinical trial design during drug development and facilitating regulatory decision-making processes for the benefit of patients with obesity.

Optimizing Antimicrobial Treatment Schedules: Some Fundamental Analytical Results.

This work studies fundamental questions regarding the optimal design of antimicrobial treatment protocols, using pharmacodynamic and pharmacokinetic mathematical models. We consider the problem of designing an antimicrobial treatment schedule to achieve eradication of a microbial infection, while minimizing the area under the time-concentration curve (AUC), which is equivalent to minimizing the cumulative dosage. We first solve this problem under the assumption that an arbitrary antimicrobial concentration profile may be chosen, and prove that the ideal concentration profile consists of a constant concentration over a finite time duration, where explicit expressions for the optimal concentration and the time duration are given in terms of the pharmacodynamic parameters. Since antimicrobial concentration profiles are induced by a dosing schedule and the antimicrobial pharmacokinetics, the 'ideal' concentration profile is not strictly feasible. We therefore also investigate the possibility of achieving outcomes which are close to those provided by the 'ideal' concentration profile, using a bolus+continuous dosing schedule, which consists of a loading dose followed by infusion of the antimicrobial at a constant rate. We explicitly find the optimal bolus+continuous dosing schedule, and show that, for realistic parameter ranges, this schedule achieves results which are nearly as efficient as those attained by the 'ideal' concentration profile. The optimality results obtained here provide a baseline and reference point for comparison and evaluation of antimicrobial treatment plans.

[Clinical protocol: audiological assessment of infants in Russian Federation. Part I]. / Protokol audiologicheskogo obsledovaniya detei pervogo goda zhizni v Rossiiskoi Federatsii. Chast' I.

The clinical protocol of audiological assessment in infants was prepared by the workgroup of Russian pediatric audiologists from different regions. The goal of the protocol is unification approaches to audiological diagnosis of the infants. The protocol has been developed according the evidence based medicine principles, by reviewing current scientific publications on the topic and taking into account the order of providing medical services and other clinical practice guidelines. When direct evidence was not available, both indirect evidence and consensus practice were considered in making recommendations. This guideline is not intended to serve as a standard to dictate precisely how the child should be diagnosed. This guideline is meant to provide the evidence base from which the clinician can make individualized decisions for each patient. The first part of the protocol covers following sections: equipment, staff requirements, timing of the diagnostics, case history and risk factors, preparing the child for the appointment, sedation and general anesthesia, otoscopy, tympanometry and acoustic reflex, otoacoustic emissions, skin preparing, electrode montage, choosing the stimulators, auditory brainstem responses on broadband and narrow-band stimuli, on bone conducted stimuli, auditory steady-state responses, masking, combined correction factors.

A protocol of Chinese expert consensuses for the management of health risk in the general public.

Introduction: Non-communicable diseases (NCDs) represent the leading cause of mortality and disability worldwide. Robust evidence has demonstrated that modifiable lifestyle factors such as unhealthy diet, smoking, alcohol consumption and physical inactivity are the primary causes of NCDs. Although a series of guidelines for the management of NCDs have been published in China, these guidelines mainly focus on clinical practice targeting clinicians rather than the general population, and the evidence for NCD prevention based on modifiable lifestyle factors has been disorganized. Therefore, comprehensive and evidence-based guidance for the risk management of major NCDs for the general Chinese population is urgently needed. To achieve this overarching aim, we plan to develop a series of expert consensuses covering 15 major NCDs on health risk management for the general Chinese population. The objectives of these consensuses are (1) to identify and recommend suitable risk assessment methods for the Chinese population; and (2) to make recommendations for the prevention of major NCDs by integrating the current best evidence and experts' opinions. Methods and analysis: For each expert consensus, we will establish a consensus working group comprising 40-50 members. Consensus questions will be formulated by integrating literature reviews, expert opinions, and an online survey. Systematic reviews will be considered as the primary evidence sources. We will conduct new systematic reviews if there are no eligible systematic reviews, the methodological quality is low, or the existing systematic reviews have been published for more than 3 years. We will evaluate the quality of evidence and make recommendations according to the GRADE approach. The consensuses will be reported according to the Reporting Items for Practice Guidelines in Healthcare (RIGHT).

Effectiveness of the Unified Protocol for the transdiagnostic treatment of emotional disorders in online and group format in Argentina: study protocol for a randomized controlled trial.

BACKGROUND: The Unified Protocol (UP) is a transdiagnostic intervention based on emotional regulation for the treatment of emotional disorders. Its application in individual and group formats has been studied worldwide, obtaining similar results to specific protocols but with a lower drop-out rate and improving the cost-benefit ratio, since a larger number of patients can benefit from it. Moreover, the inclusion of digital technologies in psychotherapy aims to improve the accessibility of treatments, especially since the pandemic of COVID-19 that forced the implementation of treatments through teletherapy increasing its use. To date, no studies have been carried out in Argentina on the application of the UP in a group format and through teletherapy. The aim of the present study is to evaluate the efficacy of the UP in a group format and through teletherapy in the Argentine population. METHODS: A parallel-group, controlled, randomized trial, with pre-post and repeated follow-up measures intergroup design will be conducted. One hundred eighty patients will be randomized to one of the following conditions: an online, group-based UP intervention or a waiting list. The Beck Depression Inventory-II and the Beck Anxiety Inventory will be used to compare primary outcomes and the Beck Hopelessness Scale, Difficulties in Emotion Regulation Scale, Positive Affect and Negative Affect Scale, and Multicultural Quality of Life Index will be administered for secondary outcomes at baseline, post-intervention, and 3 months follow-up. Ad-hoc questionnaires will be used to assess patients' experiences and treatment satisfaction. DISCUSSION: The purpose of this trial is to evaluate the efficacy of the online and group application of the UP in the Argentine population, as well as to evaluate the patient's experience and satisfaction with the treatment. It is expected that the findings of this study will be useful in reducing anxious and depressive symptomatology, will allow us to adapt the UP to our culture, and will improve accessibility to treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05275322. Registered on 11 March 2022.

Early Seroma Treatment Protocol Based on US-Guided Aspiration in DTI Prepectoral Reconstruction: A Prospective Study.

INTRODUCTION: Seroma is a common complication after prepectoral prosthetic breast reconstruction with ADM, leading to wound dehiscencse, infection, and even loss of reconstruction at last. A new ultrasound (US) guided follow-up protocol has been applied to compare primary and secondary complications incidence and their treatment, and evaluate the effect of precocious seroma detection and its evacuation in reducing secondary complications. METHODS: We enrolled 406 patients from January 1st, 2021 to July 1st, 2023 who underwent mastectomy and 1-stage prepectoral reconstruction with ADM. Experimental group counted 96 patients, whom have been treated as protocol fashion, therefore with multiple US-guided evaluations and eventual evacuations along with postoperative period; control group (310 patients) has exclusively been clinically evaluated. RESULTS: Seroma incidence detected rate among experimental group, after 1-year follow-up, was 32.2%, compared to 16.8% in control cohort, additionally no other secondary complications were detected in the first group. Referring to the wound dehiscence incidence, a statistically significant higher frequency was observed in control group compared with treatment 1 (21.2% vs. 0%; P = .0027). CONCLUSIONS: Seroma and correlated secondary complications may lead to additional surgeries, higher sanitary costs and even reconstructive failure. With a seriated US follow-up protocol application, the surgeon could promptly manage and treat seroma, decreasing additional complications rate, particularly wound dehiscence. LEVEL OF EVIDENCE: III.

Academy of Breastfeeding Medicine Clinical Protocol #21: Breastfeeding in the Setting of Substance Use and Substance Use Disorder (Revised 2023).

Background: The Academy of Breastfeeding Medicine (ABM) revised the 2015 version of the substance use disorder (SUD) clinical protocol to review the evidence and provide updated literature-based recommendations related to breastfeeding in the setting of substance use and SUD treatments. Key Information: Decisions around breastfeeding are an important aspect of care during the peripartum period, and there are specific benefits and risks for substance-exposed mother-infant dyads. Recommendations: This protocol provides breastfeeding recommendations in the setting of nonprescribed opioid, stimulant, sedative-hypnotic, alcohol, nicotine, and cannabis use, and SUD treatments. Additionally, we offer guidance on the utility of toxicology testing in breastfeeding recommendations. Individual programs and institutions should establish consistent breastfeeding approaches that mitigate bias, facilitate consistency, and empower mothers with SUD. For specific breastfeeding recommendations, given the complexity of breastfeeding in mothers with SUD, individualized care plans should be created in partnership with the patient and multidisciplinary team with appropriate clinical support and follow-up. In general, breastfeeding is recommended among mothers who stop nonprescribed substance use by the time of delivery, and they should continue to receive ongoing postpartum care, such as lactation support and SUD treatment. Overall, enhancing breastfeeding education regarding substance use in pregnancy and lactation is essential to allow for patient-centered guidance.

Vasoespasmo en microcirugía: revisión de la literatura y recomendaciones para su manejo / Vasospasm in microsurgery: literature review and clinical recommendations

Introducción y objetivo: Los colgajos libres microquirúrgicos se han convertido en una herramienta indispensable en Cirugía Reconstructiva. El vasoespasmo es una entidad que puede producir fallo del colgajo. El objetivo de este trabajo es evaluar las distintas medidas terapéuticas para la prevención y tratamiento del vasoespasmo y proponer un algoritmo de manejo para esta complicación. Material y método: Revisión bibliográfica de estudios de diseño experimental o cuasi experimental que evalúen el efecto de distintas intervenciones para la prevención y el tratamiento del vasoespasmo. Resultados: Incluimos 31 estudios experimentales, de los cuales 5 analizan intervenciones no farmacológicas y 26 intervenciones farmacológicas. Todos los estudios experimentales fueron realizados en modelos animales. Dentro de las intervenciones no farmacológicas estudiadas, la adventicetomía y el adecuado control de la hemostasia mostraron ser medidas efectivas para la prevención del vasoespasmo. Dentro de las intervenciones farmacológicas tópicas, la lidocaína, la papaverina, el sulfato de magnesio al 10% y el verapamilo demostraron consistentemente su efectividad en la prevención y tratamiento del vasoespasmo. Dentro de las intervenciones farmacológicas sistémicas, la pentoxifilina y la prostaglandina E1 fueron las más efectivas para el manejo del vasoespasmo. Otros fármacos mostraron evidencia controvertida: nifedipino, nicardipino y prostaglandina E1 (todos de aplicación tópica); nicardipino, nifedipino y verapamilo (todos de aplicación sistémica). Conclusiones: La evidencia actual respecto a la efectividad de medidas orientadas al manejo del vasoespasmo en microcirugía se basan principalmente en estudios animales. El algoritmo de manejo del vasoespasmo que presentamos se sustenta en la experiencia clínica acumulada y la mejor evidencia actualmente disponible...

Background and objective: Microsurgical free flaps have become an indispensable tool in Reconstructive Surgery. Vasospasm is an entity that can cause flap failure. Our objective is to evaluate the different therapies for vasospasm prevention and treatment and to propose a management algorithm for this complication. Methods: Bibliographic review of studies of experimental or quasi-experimental design that assesed the effect of interventions for the prevention and treatment of vasospasm. Results: Thirty one experimental studies were included, of which 5 analyzed non-pharmacological interventions and 26 pharmacological interventions. All experimental studies were performed in animal models. Among the non-pharmacological interventions studied, adventicetomy and adequate control of hemostasis proved to be effective measures for the prevention of vasospasm. Within topical pharmacological interventions, lidocaine, papaverine, 10% magnesium sulfate, and verapamil consistently demonstrated their effectiveness in the prevention and treatment of vasospasm. Within the systemic pharmacological interventions, pentoxifylline and prostaglandin E1 were the most effective interventions for the management of vasospasm. Other drugs showed controversial evidence: nifedipine, nicardipine and prostaglandin E1 (topicallys); nicardipine, nifedipine and verapamil (systemics). Conclusions: The current evidence regarding the effectiveness of measu-res aimed at managing vasospasm in microsurgery is based mainly on animal studies. The vasospasm management algorithm presented is based on accumulated clinical experience and the best currently available evidence. Having this therapeutic strategy makes it possible to standardize management in clinical practice for rapid decision-making. Level of evidence 5c Therapeutic.(AU)

Protocolo de manejo de pacientes con enfermedad pulmonar obstructiva crónica tras agudización en urgencias / Protocol for the management of patients with chronic obstructive pulmonary disease after exacerbation in the emergency department

En la enfermedad pulmonar obstructiva crónica el síndrome de agudización (SAE) es un episodio de inestabilidad clínica por agravamiento de la limitación espiratoria al flujo aéreo o del proceso inflamatorio subyacente. La gravedad del SAE depende de la estratificación del riesgo basal y la intensidad del episodio agudo. La Atención Primaria es el epicentro del circuito asistencial del SAE, pero puede extenderse al Servicio de Urgencias Extrahospitalarias y al propio hospital dependiendo de la situación clínica, del nivel de gravedad, de la disponibilidad de pruebas complementarias y de los recursos terapéuticos necesarios para cada paciente. El registro de los datos clínicos, antecedentes, factores desencadenantes, tratamiento y evolución de los episodios previos de SAE en la historia clínica electrónica son un aspecto esencial para ajustar el tratamiento actual y prevenir la aparición de futuros episodios (AU)

In chronic obstructive pulmonary disease, an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an episode of clinical instability due to the worsening of expiratory airflow limitation or of the underlying inflammatory process. The severity of AECOPD depends on baseline risk stratification and the intensity of the acute episode. Primary Care is the epicenter of the AECOPD care circuit, but it can be extended to the out-of-hospital emergency department and the hospital itself depending on the clinical situation, the level of severity, the availability of complementary tests, and the therapeutic resources required for each patient. Recording clinical data, history, triggering factors, treatment, and evolution of previous episodes of AECOPD in the electronic medical record is an essential aspect to adjust current treatment and prevent the occurrence of future episodes (AU)

Implantación de un programa de mininefrolitotomía percutánea ambulatoria: presentación del protocolo y resultados iniciales / Initial results of the implementation of an ambulatory mini percutaneous nephrolithotomy program

Objetivo Presentar nuestro protocolo de nefrolitotomía percutánea ambulatoria y evaluar los resultados iniciales del programa. Material y métodos Se analiza la implantación clínica del protocolo con los 30 primeros casos de mininefrolitotomía percutánea ambulatoria realizados en nuestro centro entre abril de 2021 y septiembre de 2022. Se recogen datos demográficos, variables perioperatorias, complicaciones y necesidad de atención médica no planificada, stone-free rate, tipología litiásica y parámetros de satisfacción con el proceso de cirugía mayor ambulatoria. Resultados Con una edad media de 60,2±11,6 años se intervinieron un total de 30 pacientes que cumplían los criterios de inclusión. El tamaño medio de la litiasis fue de 15mm [rango: 5-20]. No se registró ninguna complicación intraoperatoria. Todos los pacientes excepto uno fueron dados de alta el mismo día de la intervención, según lo planificado. El mes posterior al alta, la tasa de complicaciones, reconsulta a urgencias o reingreso hospitalario ha sido del 0%. La stone-free rate a los 3 meses ha sido del 83%. La satisfacción global de todo el proceso perioperatorio, valorada a través del cuestionario EVAN-G, fue de 124,3 puntos sobre un máximo de 150, equivalente a un 78,6% de grado de satisfacción. Conclusión La mininefrolitotomía percutánea en régimen ambulatorio puede instaurarse como una opción de asistencia en centros con experiencia en endourología, una unidad establecida de cirugía mayor ambulatoria y mediante una selección estricta de los pacientes. Nuestros resultados iniciales muestran un perfil de seguridad adecuado y un grado de satisfacción global elevado de los pacientes intervenidos en esta modalidad (AU)

Objective To present our program for ambulatory mini percutaneous nephrolithotomy and evaluate its initial results. Material and methods We analyzed the implementation of the protocol into the clinical practice with the first 30 outpatient mini percutaneous nephrolithotomy cases performed in our center between April 2021 and September 2022. Demographic characteristics, perioperative variables, complications and need for unplanned health care, stone-free rate, stone type and patient satisfaction with the major ambulatory surgery process were collected. Results A total of 30 patients with a mean age of 60.2±11.6 years who met the inclusion criteria underwent surgery. The mean stone size was 15mm [range: 5-20]. No intraoperative complications were recorded. All patients except one were discharged the same day of surgery as planned. In the month following discharge, the rate of complications, emergency department revisits or hospital readmissions rates were 0%. Stone-free-rate at 3 months was 83%. Overall satisfaction with the whole perioperative process was assessed with the EVAN-G questionnaire, obtaining 124.3 points out of a maximum of 150, which is equivalent to a 78.6% level of satisfaction. Conclusion Ambulatory mini percutaneous nephrolithotomy can be implemented as a treatment option in centers with experience in endourology, an established major ambulatory surgery unit, and strictly selected patients. Our initial results show an adequate safety profile and high overall satisfaction perceived by patients undergoing the ambulatory approach (AU)

Can vitamin B6 alleviate the adverse reactions of quadruple anti-Helicobacter pylori regimen? : randomized controlled trial.

BACKGROUND: Vitamin B6 is an essential water-soluble vitamin for humans. It is often used to prevent a variety of neuropathies, relieve vomiting, and relieve symptoms such as hand and foot neuritis. AIM: To evaluate whether vitamin B6 can alleviate the adverse reactions caused by the quadruple anti-Helicobacter pylori treatment regimen containing minocycline and metronidazole. METHODS: In this randomized controlled trial, 280 patients with H. pylori infection were randomly placed into one of two treatment groups-the conventional treatment group and the vitamin B6 supplement treatment group-for 2 weeks. The primary endpoint was the total incidence of adverse reactions up to 2 weeks after treatment initiation. The study was designed according to CONSORT Medicinal Interventions. And it was registered with Chinese Clinical Trial Registry under the number ChiCTR2100053833. RESULTS: In terms of efficacy, vitamin B6 does not affect the efficacy of conventional regimen. In the vitamin B6 supplement treatment group, the incidence of adverse reactions was 56.92%, which was significantly lower than the 74.62% observed in the conventional treatment group. In addition, the severity of adverse reactions was also significantly reduced. The proportion of moderate to severe central nervous system symptoms decreased from 58.7 to 14.63%. And, the proportion of moderate to severe gastrointestinal reactions decreased from 33.33 to 0%. We speculate that the mechanism of vitamin B6 of reducing adverse reaction may be related to the production of GABA in the brain. CONCLUSIONS: Vitamin B6 can alleviate adverse reactions of the quadruple anti-H. pylori regimen containing minocycline and metronidazole.

Efficacy and safety of front-line treatment regimens for Waldenstrom macroglobulinaemia: a systematic review and meta-analysis.

Rituximab-based chemo-immunotherapy is currently the standard first-line treatment for Waldenstrom macroglobulinaemia (WM), while ibrutinib has emerged as an alternative. In the absence of randomised trials (RCTs) comparing these regimens, the optimal first-line treatment for WM remains uncertain. In this systematic review and meta-analysis, we sought to assess the efficacy and safety of first-line treatment regimens for WM. We searched key databases from January 2007 to March 2023, including phase II and III trials, including treatment-naïve WM patients treated with rituximab-based regimens or ibrutinib. Response rates, progression-free survival (PFS), overall survival (OS), and toxicities were evaluated. Four phase III and seven phase II trials were included among 736 unique records. Pooled response rates from all comparative and non-comparative trials were 46%, 33% and 26% for bendamustine rituximab (BR), bortezomib-dexamethasone, cyclophosphamide, rituximab (BDRC) and ibrutinib rituximab (IR), respectively. Two-year pooled PFS was 89%, 81% and 82% with BR, BDRC and IR, respectively. Neuropathy was more frequent with bortezomib, while haematologic and cardiac toxicities were more common with chemo-immunotherapy and ibrutinib-based regimens respectively. Our findings suggest that BR yields higher response rates than bortezomib or ibrutinib-based combinations. RCTs comparing BR against emerging therapies, including novel Bruton Tyrosine Kinase Inhibitors, are warranted.