Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.

BACKGROUND: The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. METHODS: In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2. RESULTS: Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. CONCLUSIONS: RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. CLINICAL TRIALS REGISTRATION: NCT02058589.

Programa informático para minimizar los riesgos en los servicios quirúrgicos / An IT tool for risk management in surgical services

Las acciones ligadas a la atención sanitaria conllevan un riesgo potencial para el paciente, tanto más cuanto más compleja sea dicha actuación. El ámbito quirúrgico es sin duda una de las áreas asistenciales más complejas y el entorno propicio para la existencia de riesgos para el paciente. Los sistemas de registro de eventos adversos son un instrumento de evaluación de la calidad asistencial y permiten determinar factores asociados para implementar acciones preventivas. Nuestra experiencia en un servicio de cirugía general de un hospital universitario consistió en crear una herramienta de registro basado en la vigilancia continua de los eventos del paciente. El objetivo de este trabajo es describir la evolución que ha sufrido nuestra herramienta para ajustarse a sus dos propósitos: registrar información para el aprendizaje y la mejora de la seguridad del paciente, y responsabilizar a los profesionales de la gestión de riesgos y errores, como una tarea más de su actividad diaria. La versión actualizada que presentamos es un programa informático adjunto al sistema de Prescripción Electrónica de la Intranet del hospital, específico del Servicio de Cirugía. Como nueva aportación facilitadora del uso del registro, el diseño es más visual, lo que permite una percepción rápida de las complicaciones, con un código de colores de los diferentes eventos que se presentan en cada paciente, lo que brinda a los cirujanos la máxima utilidad para conocer el estado de las personas hospitalizadas...

[An adverse event continuous surveillance system in surgical services of the autonomous region of Cantabria (Spain)]. / Sistema de vigilancia continua de eventos adversos en los servicios quirúrgicos de Cantabria.

OBJECTIVE: To design a continuous surveillance system for adverse events (AEs) in surgical services in the Autonomous Community of Cantabria. Through homogeneous methodology, this system will provide the information needed to prevent and control AEs and avoid their recurrence. MATERIAL AND METHODS: We performed a prospective study of the population undergoing inpatient surgery in our service. The methodology used was an adapted version of the IDEA (Identification of Adverse Events) project. Surgeons had access to an intranet website and introduced the data by using a personal login. A web application allowed feedback through report-generation. RESULTS: During the pilot phase, limited collection of variables requiring calculations and of those related to location and causality was observed. Assessment of the system indicated the need for simplification to obtain valid and useful information, as well as the need to provide help windows. The system was redesigned with two data input screens and currently allows for automatic report generation of registered AEs. Information was gathered on 70% of the patients and an incidence of 11.2 AEs/100 admissions was found. Of these, 47% were defined as surgical complications. CONCLUSIONS: Establishing a continuous surveillance system for AEs is feasible if professionals participate in the process, data input is easy and feedback from the system is rapid and useful for implementing corrective measures. This system can be considered highly useful for obtaining information on AEs and consequently on the potential areas of improvement in surgical activity in Spanish hospitals.

[Factors related with the performance of a proper hand hygiene]. / Factores asociados a la técnica correcta en la higiene de manos.

OBJECTIVE: To identify factors related with the performance of a proper hand hygiene technique in a hand hygiene campaign. METHODS: We developed two cross-sectional studies on 15 hospital units. The outcome variable was complied HH with proper technique and the exposures variables were care factors (unit, professional group, etc) and other factors related with the HH campaign (training on hand washing). STATISTICAL ANALYSIS: The strength of association was measured using odds ratios (OR) with their 95% confidence interval (CI). Adjusting for confounders was performed using multiple logistic regression. RESULTS: 12% of the observed 1241 hand hygiene were performed with proper technique. The strongest associated factors were ICUS (OR: 4.07 (CI 95% (1.95-8.51)), surgical wards (OR: 3.24 (CI 95% (1.52-6.92), procedures with high risk of contamination (OR: 2,56 CI 95% (1.34-4.70)), and physicians (OR: 2.52 CI 95% (0.93-6.85)). Training increased by 21% the probability of hand hygiene with proper technique for every 10% increase in trained health care workers (OR: 1.21 CI 95% (1.01-1.45). CONCLUSIONS: Hand Washing Training was associated with proper technique especially in surgical services and physicians.

[Impact of a hand hygiene campaign on alcoholic hand rub consumption in a tertiary hospital]. / Impacto de una campaña de mejora de la higiene de manos sobre el consumo de soluciones hidroalcohólicas en un hospital de tercer nivel.

OBJECTIVE: To evaluate the influence of a hand hygiene program on consumption of alcoholic hand rub, and specifically the impact of the development of hand washing training in a tertiary hospital belonging to the Cantabrian Health Service in Spain. METHODS: We performed an ecological study from January 2005 to December 2008. The dependent variable was consumption of alcoholic hand rub (ml/day). As the independent variable, we used the hand hygiene campaign developed by the Cantabrian Health Service. The relationship between alcoholic hand rub consumption and the campaign was evaluated using multiple linear regression. RESULTS AND CONCLUSIONS: The training received in hand hygiene in hospital wards was associated with consumption of alcoholic hand rub, which improved as the campaign became consolidated (in 2008) and showed a positive effect, particularly its training aspects.

Evaluating the impact of a hand hygiene campaign on improving adherence.

We monitored compliance with hand hygiene (HH) by direct observation in 3 hospitals in Cantabria, Spain before and after implementation of an HH informational campaign, separately analyzing the effect of a training program. We report that training plus an informational campaign doubled the probability of HH, whereas the informational campaign without training decreased adherence, acting as a deleterious factor in HH adherence.