SAS - Hospital Universitario Virgen Macarena

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Reporting guidelines and a touch of critical appraisal
(Elsevier, 2023-11-23) Aizpurua-Galdeano, Pilar; Gonzalez-Rodriguez, Paz; Aparicio-Rodrigo, María; Balado-Insunza, Nieves; Perez-Gonzalez, Elena; Ruiz-Canela-Caceres, Juan; Ortega-Paez, Eduardo; [Perez-Gonzalez, E] Hospital Universitario Virgen Macarena, Sevilla, Spain; [Ruiz-Canela-Caceres, J] Atención Primaria, Sevilla, Spain; Comité de Pediatría Basada en la Evidencia de la AEP; Grupo de Trabajo de Pediatría Basada en la Evidencia de la AEPap
The biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.
2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on Complicated Intraabdominal Infections: Diagnostic Imaging of Suspected Acute Cholecystitis and Acute Cholangitis in Adults, Children, and Pregnant People.
(Oxford University Press, 2024-07-04) Bonomo, Robert A; Edwards, Morven S; Abrahamian, Fredrick M; Bessesen, Mary; Chow, Anthony W; Dellinger, E Patchen; Goldstein, Ellie; Hayden, Mary K; Humphries, Romney; Kaye; Potoski , Brian A; Rodriguez-Baño; Sawyer, Robert; Skalweit, Marion; Snydman, David R; Tamma, Pranita D; Donnelly, Katelyn; Loveless, Jennifer; [Rodriguez-Baño] Hospital Universitario Virgen Macarena, University of Seville, Biomedicines Institute of Seville-Consejo Superior de Investigaciones Científicas, Seville, Spain; Infectious Diseases Society of America
This article is part of a clinical practice guideline update on the risk assessment, diagnostic imaging, and microbiological evaluation of complicated intraabdominal infections in adults, children, and pregnant people, developed by the Infectious Diseases Society of America. In this article, the panel provides recommendations for diagnostic imaging of suspected acute cholecystitis and acute cholangitis. The panel's recommendations are based on evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
European Society of Clinical Microbiology and Infectious Diseases/European Committee on infection control clinical guidelines on pre-operative decolonization and targeted prophylaxis in patients colonized by multidrug-resistant Gram-positive bacteria before surgery
(Elsevier, 2024-08-21) Righi, Elda; Mutters, Nico T; Guirao, Xavier; Dolores-Del-Toro, Maria; Eckmann, Christian; Friedrich, Alex W; Giannella, Maddalena; Presterl, Elisabeth; Christaki, Eirini; Cross, Elizabeth L A; Visentin, Alessandro; Sganga, Gabriele; Tsioutis, Constantinos; Tacconelli, Evelina; Kluytmans, Jan; [Dolores-Del-Toro, M] University Hospital Virgen Macarena, Seville, Spain
The aim of these guidelines is to provide recommendations for decolonization and perioperative antibiotic prophylaxis (PAP) in multidrug-resistant Gram-positive bacteria (MDR-GPB) adult carriers before inpatient surgery. These European Society of Clinical Microbiology and Infectious Diseases/European Committee on Infection Control guidelines were developed following a systematic review of published studies targeting methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci, methicillin-resistant coagulase-negative Staphylococci, and pan-drug-resistant-GPB. Critical outcomes were the occurrence of surgical site infections (SSIs) caused by the colonizing MDR-GPB and SSIs-attributable mortality. Important outcomes included the occurrence of SSIs caused by any pathogen, hospital-acquired infections, all-cause mortality, and adverse events associated with the interventions, including resistance development to the agents used and the incidence of Clostridioides difficile infections. The last search of all databases was performed on 1 November 2023. The level of evidence and the strength of each recommendation were defined according to the Grading of Recommendations Assessment, Development, and Evaluation approach. Consensus of a multidisciplinary expert panel was reached for the final list of recommendations. Antimicrobial stewardship considerations were included. The guideline panel reviewed the impact of decolonization, targeted PAP, and combined interventions (e.g. decolonization and targeted PAP) on the risk of SSIs and other outcomes in MDR-GPB carriers, according to the type of bacteria and type of surgery. We recommend screening for S. aureus before high-risk operations, such as cardiothoracic and orthopaedic surgery. Decolonization with intranasal mupirocin with or without a chlorhexidine bath is recommended in patients colonized with S. aureus before cardiothoracic and orthopaedic surgery and suggested in other surgeries. The addition of vancomycin to standard prophylaxis is suggested for MRSA carriers in cardiothoracic surgery, orthopaedic surgery, and neurosurgery. Combined interventions (e.g. decolonization and targeted prophylaxis) are suggested for MRSA carriers undergoing cardiothoracic and orthopaedic surgery. No recommendation could be made regarding screening, decolonization and targeted prophylaxis for vancomycin-resistant enterococci because of the lack of data. No evidence was retrieved for methicillin-resistant coagulase-negative Staphylococci and pan-drug-resistant-GPB. Careful consideration of the laboratory workload and involvement of antimicrobial stewardship and infection control teams are warranted before implementing screening procedures or performing changes in PAP policy. Future research should focus on novel decolonizing techniques, on the monitoring of resistance to decolonizing agents and PAP regimens, and on standardized combined interventions in high-quality studies.
Management of Patients with Suspected or Confirmed Antibiotic Allergy: Executive Summary of Guidelines from the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Allergy and Clinical Immunology (SEAIC), the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Intensive Medicine and Coronary Care Units (SEMICYUC).
(Esmon Publicidad, 2022-09-02) Paño-Pardo, J R; Moreno-Rodilla, E; Cobo-Sacristan, S; Cubero-Saldaña, J L; Periañez-Parraga, L; Del Pozo-Leon, J L; Retamar-Gentil, P; Rodriguez-Oviedo, A; Torres-Jaen, M J; Vidal-Cortes, P; Colas-Sanz, C; [Retamar-Gentil, P] Hospital Universitario Virgen Macarena, Sevilla, Spain; [Retamar-Gentil, P] Instituto de Biomedicina de Sevilla (IBiS), Sevilla, Spain; [Torres-Jaen, M.J] Hospital Regional Universitario de Málaga-HRUM, Málaga, Spain; [Torres-Jaen, M.J] Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain
Suspected or confirmed antibiotic allergy is a frequent clinical circumstance that influences antimicrobial prescription and often leads to the avoidable use of less efficacious and/or more toxic or costly drugs than first-line antimicrobials. Optimizing antimicrobial therapy in patients with antibiotic allergy labels has become one of the priorities of antimicrobial stewardship programs in several countries. These guidelines aim to make recommendations for the systematic approach to patients with suspected or confirmed antibiotic allergy based on current evidence. An expert panel (11 members of various scientific societies) formulated questions about the management of patients with suspected or confirmed antibiotic allergy. A systematic literature review was performed by a medical librarian. The questions were distributed among panel members who selected the most relevant references, summarized the evidence, and formulated graded recommendations when possible. The answers to all the questions were finally reviewed by all panel members. A systematic approach to patients with suspected or confirmed antibiotic allergy was recommended to improve antibiotic selection and, consequently, clinical outcomes. A clinically oriented, 3-category risk-stratification strategy was recommended for patients with suspected antibiotic allergy. Complementary assessments should consider both clinical risk category and preferred antibiotic agent. Empirical therapy recommendations for the most relevant clinical syndromes in patients with suspected or confirmed ß-lactam allergy were formulated, as were recommendations on the implementation and monitoring of the impact of the guidelines. Antimicrobial stewardship programs and allergists should design and implement activities that facilitate the most appropriate use of antibiotics in these patients.
SEOM clinical guidelines for cancer anorexia-cachexia syndrome (2023)
(Springer, 2024-06-01) Soria -Rivas, Ainara; Escobar-Alvarez, Yolanda; Blasco-Cordellat, Ana; Majem-Tarruella, Margarita; Molina-Mata, Kevin; Motilla-de-la-Camara, Marta; Del-Mar-Muñoz-Sanchez, Mª; Zafra-Poves, Marta; Beato-Zambrano, Carmen; Cabezon-Gutierrez, Luis; [Beato-Zambrano, C] Hospital Univ. Virgen Macarena, Seville, Spain
Cancer-related anorexia-cachexia syndrome (CACS) is a debilitating condition afflicting up to 80% of advanced-stage cancer patients. Characterized by progressive weight loss, muscle wasting, and metabolic abnormalities, CACS significantly compromises patients' quality of life and treatment outcomes. This comprehensive review navigates through its intricate physiopathology, elucidating its stages and diagnostic methodologies. CACS manifests in three distinct stages: pre-cachexia, established cachexia, and refractory cachexia. Early detection is pivotal for effective intervention and is facilitated by screening tools, complemented by nutritional assessments and professional evaluations. The diagnostic process unravels the complex interplay of metabolic dysregulation and tumor-induced factors contributing to CACS. Management strategies, tailored to individual patient profiles, encompass a spectrum of nutritional interventions. These include dietary counseling, oral nutritional supplements, and, when necessary, enteral nutrition and a judicious use of parenteral nutrition. Specific recommendations for caloric intake, protein requirements, and essential nutrients address the unique challenges posed by CACS. While pharmacological agents like megestrol acetate may be considered, their use requires careful evaluation of potential risks. At its core, this review underscores the imperative for a holistic and personalized approach to managing CACS, integrating nutritional interventions and pharmacological strategies based on a nuanced understanding of patient's condition.
SEOM-GEM clinical guidelines for cutaneous melanoma (2023)
(Springer, 2024-05-14) Marquez-Rodas, Ivan; Muñoz-Couselo, Eva; Rodriguez-Moreno, Juan F; Arance-Fernandez, Ana Mª; Berciano-Guerrero, Miguel Angel; Campos-Balea, Begoña; de la Cruz-Merino, Luis; Espinosa-Arranz, Enrique; Garcia-Castaño, Almudena; Berrocal-Jaime, Alfonso; [Berciano-Guerrero, M.A] Hospitales Universitarios Regional y Virgen de la Victoria (HURyVV), Málaga, Spain; [de la Cruz-Merino, L] Biomedicine Institute of Seville (IBIS)/CSIC, Clinical Oncology Department, University Hospital Virgen Macarena and School of Medicine, University of Seville, Seville, Spain
Cutaneous melanoma incidence is rising. Early diagnosis and treatment administration are key for increasing the chances of survival. For patients with locoregional advanced melanoma that can be treated with complete resection, adjuvant-and more recently neoadjuvant-with targeted therapy-BRAF and MEK inhibitors-and immunotherapy-anti-PD-1-based therapies-offer opportunities to reduce the risk of relapse and distant metastases. For patients with advanced disease not amenable to radical treatment, these treatments offer an unprecedented increase in overall survival. A group of medical oncologists from the Spanish Society of Medical Oncology (SEOM) and Spanish Multidisciplinary Melanoma Group (GEM) has designed these guidelines, based on a thorough review of the best evidence available. The following guidelines try to cover all the aspects from the diagnosis-clinical, pathological, and molecular-staging, risk stratification, adjuvant therapy, advanced disease therapy, and survivor follow-up, including special situations, such as brain metastases, refractory disease, and treatment sequencing. We aim help clinicians in the decision-making process.
SEOM-GEMCAD-TTD clinical guidelines for the adjuvant treatment of colon cancer (2023)
(Elsevier, 2024-11) Pericay, Carles; Montagut, Clara; Reina, Juan Jose; Melian, Marcos; Alcaide, Julia; Tarazona, Noelia; Ruiz-Casado, Ana; Gonzalez-Flores, Encarnacion; Graña, Begoña; Gravalos, Cristina; [Reina, J.J] Hospital University, Virgen Macarena, Seville, Spain; [Alcaide, J] Hospital University, Regional y Virgen de la Victoria, Málaga, Spain; [Gonzalez-Flores, E] Hospital University, Virgen de las Nieves, Granada, Spain
Colorectal cancer (CRC) has a 5-year overall survival rate of over 60%. The decrease in the rate of metastatic disease is due to screening programs and the population's awareness of healthy lifestyle. Similarly, advancements in surgical methods and the use of adjuvant chemotherapy have contributed to a decrease in the recurrence of resected disease. Before evaluating a patient's treatment, it is recommended to be discussed in a multidisciplinary tumor board. In stage II tumors, the pathologic characteristics of poor prognosis must be known (T4, number of lymph nodes analyzed less than 12, lymphovascular or perineural invasion, obstruction or perforation, poor histologic grade, presence of tumor budding) and it is mandatory to determine the MSI/MMR status for avoiding administering fluoropyridimidines in monotherapy to patients with MSI-H/dMMR tumors. In stage III tumors, the standard treatment consists of a combination of fluoropyrimidine (oral or intravenous) with oxaliplatin for 6 months although the administration of CAPOX can be considered for 3 months in low-risk tumors. Neoadjuvant treatment is not consolidated yet although immunotherapy is achieving very good preliminary results in MSI-H patients. The use of ctDNA to define the treatment and monitoring of resected tumors is only recommended within studies. These guidelines are intended to help decision-making to offer the best management of patients with non-metastatic colon cancer.
Executive summary: Guidelines for the diagnosis and treatment of septic arthritis in adults and children, developed by the GEIO (SEIMC), SEIP and SECOT
(Elsevier, 2024-04-02) Benito, Natividad; Martinez-Pastor, Juan Carlos; Lora-Tamayo, Jaime; Ariza, Javier; Baeza, Jose; Belzunegui-Otano, Joaquin; Cobo, Javier; Del-Toro, Maria-Dolores; Fontecha, Cesar G; Font-Vizcarra, Lluis; Horcajada, Juan P; Morata, Laura; Murillo, Oscar; Nolla, Joan M; Nuñez-Cuadros, Esmeralda; Pigrau, Carlos; Portillo, Maria Eugenia; Rodriguez-Pardo, Dolors; Sobrino-Diaz, Beatriz; Saavedra-Lozano, Jesus; [Del-Toro, M.D] Hospital Universitario Virgen Macarena, Instituto de Biomedicina de Sevilla (IBIS)/CSIC, Universidad de Sevilla, Seville, Spain; [Nuñez-Cuadros, E] Hospital Regional Universitario de Málaga, Spain; [Sobrino-Diaz, B] Hospital Regional Universitario de Málaga, IBIMA, Málaga, Spain
Infection of a native joint, commonly referred to as septic arthritis, is a medical emergency because of the risk of joint destruction and subsequent sequelae. Its diagnosis requires a high level of suspicion. These guidelines for the diagnosis and treatment of septic arthritis in children and adults are intended for use by any physician caring for patients with suspected or confirmed septic arthritis. They have been developed by a multidisciplinary panel with representatives from the Bone and Joint Infections Study Group (GEIO) belonging to the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Paediatric Infections (SEIP) and the Spanish Society of Orthopaedic Surgery and Traumatology (SECOT), and two rheumatologists. The recommendations are based on evidence derived from a systematic literature review and, failing that, on the opinion of the experts who prepared these guidelines. A detailed description of the background, methods, summary of evidence, the rationale supporting each recommendation, and gaps in knowledge can be found online in the complete document.
SEOM-GOTEL clinical guidelines on diffuse large B cell lymphoma (2022).
(Springer, 2023-06-08) Guma, Josep; Palazon-Carrion, Natalia; Rueda-Dominguez, Antonio; Sequero, Silvia; Calvo, Virginia; Garcia-Arroyo, Ramon; Gomez-Codina, Jose; Llanos, Marta; Martinez-Banaclocha, Natividad; Provencio, Mariano; [Palazon-Carrion, N] Hospital Universitario Virgen de la Macarena, Seville, Spain; [Rueda-Dominguez, A] Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain; [Sequero, S] Hospital Universitario San Cecilio, Granada, Spain
Diffuse large B-cell lymphoma is the most frequent histological subtype of NHL and the paradigm for the management of aggressive lymphoma. An excisional or incisional lymph node biopsy evaluated by an experienced hemopathologist is recommended to establish the diagnosis. Twenty years following its introduction, R-CHOP remains the standard first-line treatment. No modification of this scheme (increased chemotherapy dose intensity, new monoclonal antibodies, or the addition of immunomodulators or anti-target agents) has significatively improved the clinical outcomes, whereas therapy for recurrence or progression is evolving rapidly. The irruption of CART cells, polatuzumab vedotin, tafasitamab, and CD20/CD3 bispecific antibodies are changing the natural history of relapsed patients and will challenge R-CHOP as the benchmark for newly diagnosed patients.
Let's talk about sex: consensus guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology: clinical recommendations after pelvic radiotherapy.
(Springer, 2024-07-24) Gil-Haro, Beatriz; Cordoba-Largo, Sofía; Rodriguez-Rodriguez, Isabel; Lozano-Martin, Eva Maria; Couselo-Paniagua, Maria Luz; Martinez-Montesinos, Irene; Belinchon-Olmeda, Belen; Vicente-Ruiz, Paula; Cerrolaza-Pascual, Maria; Payano-Hernandez, Stephanyie; Rey-Baltar-Oramas, Dolores; Martinez-Casares, Nieves; Barahona-Orpinell, Manel; [Vicente-Ruiz,P] Virgen Macarena University Hospital, Seville, Spain.; [Barahona Orpinell,M] Puerto Real University Hospital, Cadiz, Spain.; Spanish Radiation Oncology Society
Purpose: This consensus statement was developed by the GINECOR working group on behalf of the Spanish Society of Radiation Oncology (SEOR) to address the management of sexual health in patients with gynaecological cancer following pelvic radiotherapy. Methods: A modified two-round online Delphi study was conducted with the participation of an expert panel composed of radiation oncologists, nurses, and a gynaecologist. The panel evaluated aspects related to diagnosis, treatment, and follow-up of sexual health issues. The GRADE criteria were applied to assess the level of agreement and support evidence-based recommendations. Results: The resulting consensus recommendations focus on both diagnosis and treatment, emphasizing the use of patient-reported outcome measures (PROMs). Key recommendations include the systematic evaluation of genitourinary, gastrointestinal, and sexual symptoms, as well as the implementation of pharmacological treatments (e.g., vaginal lubricants, hormone therapy) and mechanical options (e.g., vaginal dilators, vibrators). These guidelines reflect both current scientific evidence and expert clinical experience. Conclusion: This consensus statement presents a comprehensive, multidisciplinary approach aimed at improving the sexual health and quality of life of patients with gynaecological cancers after pelvic radiotherapy. It provides specific, actionable recommendations and highlights the importance of regular, patient-centered assessment and specialized care in the management of sexual health concerns in this patient population.
Monitoring of the oncological process for lung cancer in Spain: an expert consensus report.
(Doyma, 2025-04-22) de Castro, Javier; Alonso-Fernández, Patricia; Castrodeza, José Javier; Gayete, Ángel; Hernando, Florentino; Martínez-Olmos, José; Massuti, Bartomeu; Paz-Ares, Luis; Sisó-Almirall, Antoni; Vicente, David; Molins, Laureano; [Martínez-Olmos,J] Escuela Andaluza de Salud Pública (EASP), Andalucía, Spain.
Introduction: Continuous monitoring of the oncological process is essential for identifying inefficiencies and areas of improvement, enabling better resource allocation in the care of lung cancer patients. Objective: The objective is to define key indicators and identify critical variables for monitoring lung cancer care, aiming to improve early detection, reduce delays in diagnosis and treatment, and enhance biomarker research, ensuring timely and effective treatments for all patients. Methods: A multidisciplinary expert group conducted a consensus process based on a review of national guidelines and initiatives related to lung cancer care. The experts defined relevant indicators and identified variables for monitoring overall care, addressing delays, and improving biomarker research. The feasibility of incorporating these indicators into existing information systems was also assessed. Results: The proposed indicators provide a structured approach for assessing lung cancer care and outcomes. Their inclusion in healthcare information systems would improve the monitoring and evaluation of care quality and patient outcomes. Additionally, these indicators would also promote interoperability and continuous patient care across different centers and regions, allowing informed decision-making in the improvement of healthcare processes by those responsible for healthcare management. Conclusions: The adoption of standardized indicators for lung cancer care monitoring can drive continuous improvement in healthcare processes. Implementing these indicators in information systems will enable better resource allocation, timely and effective treatment, and enhanced coordination among healthcare providers, ultimately improving patient outcomes.
Derechos humanos y salud mental en Andalucía: protección de los derechos humanos de las personas con trastorno mental en el marco de la Convención de Derechos de las Personas con Discapacidad
(Consejería de Salud y Bienestar Social, 2012) Bono del Trigo, Águila; Navarro Matillas, Bibiana; Suess, Amets; Grupo de trabajo Derechos Humanos y Salud Mental
Este informe presenta los resultados del grupo de trabajo Derechos Humanos y Salud Mental, creado en el marco del Plan Integral de Salud Mental de Andalucía. Analiza el cumplimiento de los artículos expresados en la Convención de las Naciones Unidas sobre los Derechos de las Personas con Discapacidad y plantea tanto ejemplos de situaciones de vulneración de esos derechos como medidas de protección que mejoren su garantía. Para luchar contra el estigma y promover la recuperación hay que conocer y proteger los derechos de las personas con trastorno mental y garantizar que las prácticas profesionales no los vulneran, siendo el primer paso la toma de conciencia de que esta vulneración pueda estar ocurriendo en la atención que se presta desde los servicios sanitarios y de apoyo social.
Assessing the value of moderate‐to‐severe atopic dermatitis treatment using multi‐criteria decision analysis (MCDA)
(Wiley, 2024-01-01) Pereyra-Rodriguez, Jose Juan; Poveda, José Luis; Rivero, Alvaro; Serra-Baldrich, Esther; Silvestre, Juan Francisco; Armario-Hita, José Carlos; Calleja, Miguel Angel; Carrascosa, Jose Manuel; Florez, Angeles; Herranz, Pedro; Comellas, Marta; Ortiz de Frutos, Francisco Javier; [Pereyra-Rodríguez,JJ] Dermatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.; [Armario-Hita,JC] Dermatology Department, Hospital Universitario de Puerto Real, University of Cádiz, Cádiz, Spain.; [Carrascosa,JM] Pharmacy Department, Hospital Universitario Virgen Macarena, Sevilla, Spain.
The increased understanding of atopic dermatitis (AD) pathophysiology has shed light on the underlying immunologic mechanisms and spurred the development of novel, more precisely targeted therapies. As new agents become available, assessing their added value is advisable. Yet the value of novel health interventions sometimes remains largely unmeasured and inadequately understood. Value assessment is challenging since it involves assessing the extent to which it meets current unmet needs. Therefore, it is necessary to establish the most relevant health outcomes from different stakeholders' perspectives.
Cosibelimab in advanced cutaneous squamous cell carcinoma (CSCC): Longer-term efficacy and safety results from pivotal study
(Elsevier, 2024) Munoz-Couselo, E.; Montaudie, H.; Berciano-Guerrero, M. A.; Alamo-De-La-Gala, M. D. C.; Charles, J.; Quereux, G.; Nardin, C.; Yaya-Tur, R.; Dalle, S.; Beylot-Barry, M.; Ladwa, R.; McGrath, M.; Brungs, D.; Harris, D.; Shue, H.; Tazbirkova, A.; Fourie, S. J.; Malan, D. R.; Oliviero, J.; Clingan, P.; Checkpoint Therapeutics, Inc
Background: Cosibelimab is a high-affinity, fully human monoclonal antibody that directly binds to programmed death ligand-1 (PD-L1) and blocks its interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors to restore an anti-tumor immune response. Cosibelimab also has a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (ADCC) as an additional mechanism of anti-tumor immunity. Efficacy and safety data from a pivotal study (NCT03212404) supported a biologics license application for cosibelimab for the treatment of patients (pts) with advanced CSCC (metastatic [mCSCC] or locally advanced [laCSCC]) who are not candidates for curative surgery or radiation. Here, we present new longer-term follow-up data from the pivotal study. Methods: Pts with mCSCC (Group [Gp] 1) and laCSCC (Gp 2) were treated with cosibelimab 800 mg Q2W. The primary endpoint was objective response rate (ORR; complete response + partial response) by independent central review (ICR) assessed by Gp. The safety analysis included all CSCC pts treated with at least one dose and includes a third Gp of pts with mCSCC treated with cosibelimab 1200 mg Q3W (Gp 3). Results: As of the 31 March 2023 data cutoff, 192 pts were enrolled and treated (78 in Gp 1, 58 in Gp 2 and 56 in Gp 3), and 109 pts were eligible for long-term efficacy assessment (78 in Gp 1 and 31 in Gp 2). With a median duration of follow-up of 29.3 months (range: 0.4-52.0) for Gp 1 and 24.1 months (range: 2.8-37.3) for Gp 2, ORR per ICR was 50.0% (95% CI: 38.5-61.5) and 54.8% (95% CI: 36.0-72.7), respectively.The complete response rate was 12.8% and 25.8% for Gp 1 and 2, respectively. Median duration of response has not been reached in either Gp, with a probably of maintaining response at 24 months of 72.1% and 80.2% for Gp 1 and 2, respectively. The most common adverse events (AEs) by any grade (Gr) were fatigue (22.9%), anemia (20.3%), constipation (16.1%) and diarrhea (15.1%); Gr 3 were anemia (5.2%) and lipase increased (3.1%). 3.6% of pts experienced a Gr 3 immune-related AE (no Gr 4). Conclusions: Cosibelimab demonstrates robust objective response and complete response rates in advanced CSCC, with manageable safety and notable low rates of overall and severe immune-related AEs.
The role of bronchoscopy in patients with SARS-CoV-2 pneumonia.
(2021-07-12) Arenas-De Larriva, Marisol; Martín-DeLeon, Roberto; Urrutia Royo, Blanca; Fernández-Navamuel, Iker; Gimenez Velando, Andrés; Nuñez García, Laura; Centeno Clemente, Carmen; Andreo García, Felipe; Rafecas Codern, Albert; Fernández-Arias, Carmen; Pajares Ruiz, Virginia; Torrego Fernández, Alfons; Rajas, Olga; Iturricastillo, Gorane; Garcia Lujan, Ricardo; Comeche Casanova, Lorena; Sánchez-Font, Albert; Aguilar-Colindres, Ricardo; Larrosa-Barrero, Roberto; García García, Ruth; Cordovilla, Rosa; Núñez-Ares, Ana; Briones-Gómez, Andrés; Cases Viedma, Enrique; Franco, José; Cosano Povedano, Javier; Rodríguez-Perálvarez, Manuel Luis; Cebrian Gallardo, Jose Joaquin; Nuñez Delgado, Manuel; Pavón-Masa, María; Valdivia Salas, Maria Del Mar; Flandes, Javier
The role of bronchoscopy in coronavirus disease 2019 (COVID-19) is a matter of debate. This observational multicentre study aimed to analyse the prognostic impact of bronchoscopic findings in a consecutive cohort of patients with suspected or confirmed COVID-19. Patients were enrolled at 17 hospitals from February to June 2020. Predictors of in-hospital mortality were assessed by multivariate logistic regression. A total of 1027 bronchoscopies were performed in 515 patients (age 61.5±11.2 years; 73% men), stratified into a clinical suspicion cohort (n=30) and a COVID-19 confirmed cohort (n=485). In the clinical suspicion cohort, the diagnostic yield was 36.7%. In the COVID-19 confirmed cohort, bronchoscopies were predominantly performed in the intensive care unit (n=961; 96.4%) and major indications were: difficult mechanical ventilation (43.7%), mucus plugs (39%) and persistence of radiological infiltrates (23.4%). 147 bronchoscopies were performed to rule out superinfection, and diagnostic yield was 42.9%. There were abnormalities in 91.6% of bronchoscopies, the most frequent being mucus secretions (82.4%), haematic secretions (17.7%), mucus plugs (17.6%), and diffuse mucosal hyperaemia (11.4%). The independent predictors of in-hospital mortality were: older age (OR 1.06; p Bronchoscopy may be indicated in carefully selected patients with COVID-19 to rule out superinfection and solve complications related to mechanical ventilation. The presence of haematic secretions in the distal bronchial tract may be considered a poor prognostic feature in COVID-19.
A multicenter randomized clinical trial to evaluate the efficacy of telemonitoring in patients with advanced heart and lung chronic failure. Study protocol for the ATLAN_TIC project.
(Elsevier, 2020-01-09) Hernandez-Quiles, Carlos; Bernabeu-Wittel, Máximo; Garcia-Serrano, Maria Del Rocio; Vergara-Lopez, Salvador; Perez-de-Leon, Jose Antonio; Ruiz-Cantero, Alberto; Lopez-Jimeno, Wilfredo; Quero-Haro, Manuel; Terceño-Rodriguez, Eusebio; Garcia-Jimenez, Remedios; Baron-Franco, Bosco; Ollero-Baturone, Manuel
Using technologies of information and communication (TICs) is emerging in medical assistance. TICs application for medical assistance is promising. Its applicability in advanced heart and/or respiratory failure is still controversial because studies have shown methodological weakness which could put in danger their conclusions. Our objective is to evaluate efficacy of the application of home monitoring biological parameters in a multi-level model of coordinated clinical care for patients with chronic diseases with advanced heart (HF) and/or respiratory failure (RF) in comparison with conventional clinical care. /Design: Multicentric, phase III, randomized, parallel groups, controlled clinical trial. Patients with advanced HF and/or RF were eligible to participate. Patients received medical assistance by a multi-level model of coordinated clinical care with or without home monitoring. Follow up was performed until 180 days after inclusion. Primary efficacy outcome was defined as the percentage of patients with hospitalization/emergency room visits. Secondary efficacy outcomes were hospital admissions, admissions to hospital emergencies and Primary Care Emergencies, number of days of hospital stay, total cost per patient in euros, mortality, change in functional status, quality of life, assistance and technology devices. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruits patients per arm is set at 255, a total of 510 patients. This trial could provide some knowledge about the real impact of home monitoring for patients with advanced HF and/or RF within a multi-level model of integrated care.
Key considerations on the potential impacts of the COVID-19 pandemic on antimicrobial resistance research and surveillance.
(Oxford University Press, 2021-03-27) Rodriguez-Baño, Jesus; Rossolini, Gian Maria; Schultsz, Constance; Tacconelli, Evelina; Murthy, Srinivas; Ohmagari, Norio; Holmes, Alison; Bachmann, Till; Goossens, Herman; Canton, Rafael; Roberts, Adam P; Henriques-Normark, Birgitta; Clancy, Cornelius J; Huttner, Benedikt; Fagerstedt, Patriq; Lahiri, Shawon; Kaushic, Charu; Hoffman, Steven J; Warren, Margo; Zoubiane, Ghada; Essack, Sabiha; Laxminarayan, Ramanan; Plant, Laura; Plan Nacional de I+D+i 2013–2016 and the Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades; Instituto de Salud Carlos III; German Federal Ministry of Education and Research
Antibiotic use in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) patients during the COVID-19 pandemic has exceeded the incidence of bacterial coinfections and secondary infections, suggesting inappropriate and excessive prescribing. Even in settings with established antimicrobial stewardship (AMS) programmes, there were weaknesses exposed regarding appropriate antibiotic use in the context of the pandemic. Moreover, antimicrobial resistance (AMR) surveillance and AMS have been deprioritised with diversion of health system resources to the pandemic response. This experience highlights deficiencies in AMR containment and mitigation strategies that require urgent attention from clinical and scientific communities. These include the need to implement diagnostic stewardship to assess the global incidence of coinfections and secondary infections in COVID-19 patients, including those by multidrug-resistant pathogens, to identify patients most likely to benefit from antibiotic treatment and identify when antibiotics can be safely withheld, de-escalated or discontinued. Long-term global surveillance of clinical and societal antibiotic use and resistance trends is required to prepare for subsequent changes in AMR epidemiology, while ensuring uninterrupted supply chains and preventing drug shortages and stock outs. These interventions present implementation challenges in resource-constrained settings, making a case for implementation research on AMR. Knowledge and support for these practices will come from internationally coordinated, targeted research on AMR, supporting the preparation for future challenges from emerging AMR in the context of the current COVID-19 pandemic or future pandemics.
Interplay between IncF plasmids and topoisomerase mutations conferring quinolone resistance in the Escherichia coli ST131 clone: stability and resistance evolution
(Springer, 2021-11-17) Rodriguez-Martinez, Jose-Manuel; Lopez-Cerero, Lorena; Garcia-Duque, Ana; Rodriguez-Bano, Jesus; Pascual, Alvaro; [Rodriguez-Martinez, Jose-Manuel] Univ Seville, Dept Microbiol, Avda Sanchez Pizjuan S-N, Seville 41009, Spain; [Lopez-Cerero, Lorena] Univ Seville, Dept Microbiol, Avda Sanchez Pizjuan S-N, Seville 41009, Spain; [Garcia-Duque, Ana] Univ Seville, Dept Microbiol, Avda Sanchez Pizjuan S-N, Seville 41009, Spain; [Rodriguez-Bano, Jesus] Univ Seville, Dept Microbiol, Avda Sanchez Pizjuan S-N, Seville 41009, Spain; [Pascual, Alvaro] Univ Seville, Dept Microbiol, Avda Sanchez Pizjuan S-N, Seville 41009, Spain; [Rodriguez-Martinez, Jose-Manuel] Univ Seville, Hosp Univ Virgen Macarena, CSIC, Inst Biomed Sevilla IBiS, Seville, Spain; [Lopez-Cerero, Lorena] Univ Seville, Hosp Univ Virgen Macarena, CSIC, Inst Biomed Sevilla IBiS, Seville, Spain; [Rodriguez-Bano, Jesus] Univ Seville, Hosp Univ Virgen Macarena, CSIC, Inst Biomed Sevilla IBiS, Seville, Spain; [Pascual, Alvaro] Univ Seville, Hosp Univ Virgen Macarena, CSIC, Inst Biomed Sevilla IBiS, Seville, Spain; [Rodriguez-Martinez, Jose-Manuel] Inst Salud Carlos III, Red Espanola Invest Patol Infecciosa REIPI, Madrid, Spain; [Lopez-Cerero, Lorena] Inst Salud Carlos III, Red Espanola Invest Patol Infecciosa REIPI, Madrid, Spain; [Rodriguez-Bano, Jesus] Inst Salud Carlos III, Red Espanola Invest Patol Infecciosa REIPI, Madrid, Spain; [Pascual, Alvaro] Inst Salud Carlos III, Red Espanola Invest Patol Infecciosa REIPI, Madrid, Spain; [Lopez-Cerero, Lorena] Hosp Univ Virgen Macarena, Unidad Enfermedades Infecciosas Microbiol & Med P, Seville, Spain; [Rodriguez-Bano, Jesus] Hosp Univ Virgen Macarena, Unidad Enfermedades Infecciosas Microbiol & Med P, Seville, Spain; [Pascual, Alvaro] Hosp Univ Virgen Macarena, Unidad Enfermedades Infecciosas Microbiol & Med P, Seville, Spain; Plan Nacional de I + D + i 2013-2016 - Joint Programming Initiative on Antimicrobial Resistance, JPIAMR; Instituto de Salud Carlos III - Joint Programming Initiative on Antimicrobial Resistance, JPIAMR; Subdireccion General de Redes y Centros de Investigacion Cooperativa, Ministerio de Economia, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI); European Development Regional Fund "A way to achieve Europe," Operative program Intelligent Growth 2014-2020
The Escherichia coli ST131 H30-Rx subclone vehicles CTX-M-15 plasmids and mutations in gyrA and parC conferring multidrug resistance successfully in the clinical setting. The aim of this study was (1) to investigate the relationship of specific topoisomerase mutations on the stability of IncF (CTX-M producing) plasmids using isogenic E. coli mutants and (2) to investigate the impact of the IncF-type plasmids present in the E. coli clone ST131 on the evolution of quinolone resistance. E. coli ATCC 25922 (background strain) and derived mutants encoding specific QRDR substitutions were used. Also, NGS-characterized IncFIA and IncFIB plasmids (encoding CTX-M genes) were included. Plasmid stability was evaluated by sequential dilutions into Luria broth medium without antibiotics for 7 days. Mutant frequency to ciprofloxacin was also evaluated. Moderate differences in the IncF plasmids stability were observed among E. coli ATCC 25922 and isogenic mutants. Under our experimental conditions, the fluctuation of bacteria harboring plasmids was less than 0.5-log((10)) in all cases. In the mutant frequency tests, it was observed that the presence of these IncF plasmids increased this value significantly (10-1000-fold). Quinolone resistance substitutions in gyrA or parC genes, frequently found associated with E. coli clone ST131, do not modify the stability of ST131-associated IncFIA and IncFIB plasmids under in vitro conditions. IncF-type plasmids present in E. coli clone ST131 facilitate the selection of resistance to quinolones. These results are consistent with the clinical scenario in which the combination of resistance to quinolones and beta-lactams is highly frequent in the E. coli clone ST131.
Does Online Search Behavior Coincide with Candida auris Cases? An Exploratory Study.
(MDPI AG, 2019-06-04) Saris, Katja; Meis, Jacques F; Rodriguez-Baño, Jesus ; Tacconelli, Evelina; van-de-Belt, Tom H; Voss, Andreas; European Union Seventh Framework Programme; EPI-Net COMBACTE-MAGNET
Candida auris is an emerging multidrug resistant infectious yeast which is challenging to eradicate and despite available laboratory methods is still difficult to identify especially in less developed countries. To limit the rapid spread of C. auris, quick and accurate detection is essential. From the perspective of disease surveillance, additional methods of tracking this yeast are needed. In order to increase global preparedness, we explored the use of online search behavior to monitor the recent global spread of C. auris. We used Google Trends to assess online search behavior on C. auris from January 2016 until August 2018. Weekly Google Trends results were counted as hits and compared to confirmed C. auris cases obtained via publications and a global expert network of key opinion leaders. A total of 44 countries generated a hit, of which 30% (13/44) were confirmed known cases, 34% (15/44) were missed known cases, 34% (15/44) were hits for unknown cases, and 2% (1/44) were confirmed unknown cases. Conclusions: Google Trends searches is rapidly able to provide information on countries with an increased search interest in C. auris. However, Google Trends search results do not generally coincide with C. auris cases or clusters. This study did show that using Google Trends provides both insight into the known and highlights the unknown, providing potential for surveillance and tracking and hence aid in taking timely precautionary measures.
Gender differences in quality of life in adults with long-standing type 1 diabetes mellitus.
(BioMed Central Ltd., 2020-07-17) Castellano-Guerrero, Ana Maria; Guerrero, Raquel; Ruiz-Aranda, Desiree; Perea, Sofia; Pumar, Alfonso; Relimpio, Federico; Mangas, Miguel Angel; Losada, Fernando; Martinez-Brocca, Maria Asuncion; Instituto de Salud Carlos III and co-funded by European Union (ERDF/ESF)
To assess gender differences in Quality of life (QoL) and in sociodemographic, clinical and psychological factors associated with impaired QoL in adults with long-standing type 1 diabetes mellitus (DM1). Cross-sectional evaluation in a random cohort of DM1 adult patients from a tertiary care hospital. QoL was evaluated using translated and validated self-administered Diabetes QoL questionnaire (Es-DQoL), and results transformed into a 0-100 scale. Psychological assessment included a planned psychological interview and self-reported questionnaires (Beck Depression Inventory II, State-Trait Anxiety Inventory Form Y, Fear of hypoglycaemia Scale, Medical Outcomes Study Social Support Survey). A total of 312 patients (51.6% male; 38.2 ± 12.7 years; HbA1c 7.5 ± 1.1% (58.5 ± 14.2 mmol/mol); 20.4 ± 12.0 years of DM1) were included in the analysis. Male and female subgroups showed similar sociodemographic and diabetes-related features and comparable social support. Among female patients, higher frequency of depression [31.7% (IC95% 26.2-40.8) vs. 14.9% (IC95% 10.1-20.8), p Adult women with long-standing DM1 showed lower QoL probably related to higher frequency and severity of psychopathological syndromes. Depressive and anxious symptoms and, among women, exposure to glycemic excursions were identified as modifiable, QoL-related variables. Educational, technological and psychological interventions are needed in order to improve QoL in DM1 patients.

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