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[Objectives] To describe the extent, characteristics, and knowledge gaps regarding explicit decision criteria for deprescribing drugs with anticholinergic or sedative properties (Ach/Sed) in older adults., [Design] Scoping review., [Setting and Participants] Original studies, clinical trial protocols, grey literature, and Summaries of Product Characteristics., [Methods] Searches targeting explicit decision criteria for deprescribing Ach/Sed were performed across MEDLINE, EMBASE, CINAHL, and Web of Science, including trial registries (clinicaltrials.gov, ICTRP, EU-CTR, ANZCTR) for pertinent articles, study protocols. Additionally, to encompass non-traditional or 'grey literature' sources, Google searches and relevant agency websites were explored, alongside the summary of product characteristics for Ach/Sed., [Results] The initial literature search identified 8,192 unique data sources. After review, 188 original articles or books, 79 internet sources, and 127 SmPCs were included. Examining these sources for explicit criteria for 154 Ach/Sed, overall, 1,271 explicit criteria guidance for identifying clinical scenarios warranting deprescription of Ach/Sed across 145/154 Ach/Sed were identified. These criteria were identified mainly from qualitative research and Summaries of Product Characteristics. Additionally, 455 criteria-based recommendations suggesting approaches for tapering implementation across 76/154 Ach/Sed were identified, mostly from sources classified as expert opinions. Significant heterogeneity was found across the approaches for tapering Ach/Sed., [Conclusions] This scoping review provides a comprehensive overview of the literature providing guidance for clinical scenarios where Ach/Sed should be deprescribed and highlights the existing knowledge gaps regarding comprehensive guidance on tapering these drugs which warranties future research and development.

The aim of this paper was to review the available evidence on the efficacy and safety of combined or sequential use of PD-1/PD-L1 immune checkpoint inhibitors (ICI) and CAR-T cell therapies in relapsed/refractory (R/R) haematological malignancies. A systematic literature review was performed until 21 November 2022. Inclusion criteria: cohort studies/clinical trials aimed at evaluating the efficacy and/or safety of the combination of CAR-T cell therapy with PD-1/PD-L1 inhibitors in R/R haematological malignancies, which had reported results. Those focusing only on ICI or CAR-T separately or evaluating the combination in other non-hematological solid tumours were excluded. We used a specific checklist for quality assessment of the studies, and then we extracted data on efficacy or efficiency and safety. A total of 1867 articles were identified, and 9 articles were finally included (early phase studies, with small samples of patients and acceptable quality). The main pathologies were B-cell acute lymphoblastic leukaemia (B-ALL) and B-cell non-Hodgkin’s lymphoma (B-NHL). The most studied combination was tisagenlecleucel with pembrolizumab. In terms of efficacy, there is great variability: the combination could be a promising option in B-ALL, with modest data, and in B-NHL, although hopeful responses were received, the combination does not appear better than CAR-T cell monotherapy. The safety profile could be considered comparable to that described for CAR-T cell monotherapy.

The aim of this paper was to review the available evidence on the efficacy and safety of combined or sequential use of PD-1/PD-L1 immune checkpoint inhibitors (ICI) and CAR-T cell therapies in relapsed/refractory (R/R) haematological malignancies. A systematic literature review was performed until 21 November 2022. Inclusion criteria: cohort studies/clinical trials aimed at evaluating the efficacy and/or safety of the combination of CAR-T cell therapy with PD-1/PD-L1 inhibitors in R/R haematological malignancies, which had reported results. Those focusing only on ICI or CAR-T separately or evaluating the combination in other non-hematological solid tumours were excluded. We used a specific checklist for quality assessment of the studies, and then we extracted data on efficacy or efficiency and safety. A total of 1867 articles were identified, and 9 articles were finally included (early phase studies, with small samples of patients and acceptable quality). The main pathologies were B-cell acute lymphoblastic leukaemia (B-ALL) and B-cell non-Hodgkin’s lymphoma (B-NHL). The most studied combination was tisagenlecleucel with pembrolizumab. In terms of efficacy, there is great variability: the combination could be a promising option in B-ALL, with modest data, and in B-NHL, although hopeful responses were received, the combination does not appear better than CAR-T cell monotherapy. The safety profile could be considered comparable to that described for CAR-T cell monotherapy.

[EN] [Abstract] Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. [Objective] The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. [Method] For this purpose, an observational, retrospective, cross-sectional and multicenter study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2,335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analyzed using Student's t-test, Mann-Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analyzed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalized linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis. [Discussion] The results of this clinical study will allow us to focus on specific surgical areas with higher rates of inappropriateness, identify key points of action, [ES] [Resumen] La profilaxis antibiótica quirúrgica es una de las medidas más útiles para la prevención de la infección de la herida quirúrgica. [Objetivo] el objetivo de este proyecto es evaluar la adecuación del uso de profilaxis antibiótica en procedimientos quirúrgicos realizados en centros hospitalarios españoles, tanto de forma global como en función del tipo de cirugía realizada. [Metodología] para ello, se ha diseñado un estudio observacional, retrospectivo, transversal y multicéntrico, donde se recopilarán todas aquellas variables que permitan evaluar la adecuación de la profilaxis antibiótica quirúrgica mediante la comparación del tratamiento prescrito, las recomendaciones recogidas en las guías locales y el documento de consenso de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica y la Asociación Española de Cirujanos. Se tendrán en cuenta la indicación, elección del antimicrobiano, dosis, vía de administración y tiempo de infusión, momento de la administración de la primera dosis, redosificación y la duración de la profilaxis. La muestra estará constituida por pacientes que hayan sido intervenidos de forma programada o urgente, en régimen de hospitalización o ambulatorio, en centros hospitalarios de España. Se ha establecido un tamaño muestral de 2.335 pacientes para estimar con una confianza del 95% y una potencia del 80%, un porcentaje de adecuación que se espera esté en torno al 70%. Las diferencias entre las variables se analizarán mediante la prueba t-Student, U de Mann-Whitney, el test Chi2 o test de Fisher, según proceda. El grado de concordancia entre la profilaxis antibiótica recomendada por las guías de los distintos hospitales y la recomendada en la literatura se analizará mediante el cálculo del indicador Kappa de Cohen. Con el fin de identificar posibles factores que puedan asociarse con diferencias en la adecuación de uso de profilaxis antibiótica, se llevará a cabo un análisis de regresión logística binario y mediant