PublicationAn m-Health telerehabilitation and health education program on physical performance in patients with hip fracture and their family caregivers: Study protocol for the ActiveHip+ randomized controlled trial.(2022-02-11) Mora-Traverso, Marta; Molina-Garcia, Pablo; Prieto-Moreno, Rafael; Borges-Cosic, Milkana; Cruz Guisado, Victor; Del Pino Algarrada, Rogelio; Moreno-Ramírez, Paz; Gomez-Jurado, Gema; Gomez Tarrias, Consuelo; Hidalgo Isla, Margarita; Jimenez Andrés, Patricia; Linares Gago, Marta; Lirola-Liebanas, Ana; Mesa-Ruiz, Antonio; Muñoz-Garach, Araceli; Salazar-Graván, Susana; Estevez-Lopez, Fernando; Martín-Matillas, Miguel; Ariza-Vega, PatrocinioTelerehabilitation interventions administered via a smartphone may provide new feasible and effective rehabilitation options at home for patients with hip fracture. However, to date, no such interventions have been shown to be effective in the recovery key health outcomes of these patients. The present multicentre randomized controlled trial (RCT) aims to test the effect of the ActiveHip+ m-Health system in the recovery of physical performance, functional level, quality of life, and other health-related outcomes in both patients with hip fracture and their family caregivers. A total of 104 patients older than 65 years, with hip fracture, and their family caregivers will be randomized into the ActiveHip+ rehabilitation (N = 52) or the control group (N = 52). ActiveHip+ is a 12-week smartphone-based rehabilitation program conducted in Granada and Cádiz (Spain) that includes: (1) 24 sessions of physical exercise and 12 sessions of occupational therapy; (2) seven educational modules for patients and for caregivers; and (3) general recommendations in activities of daily living. The control group will receive the usual rehabilitation protocol offered by the Andalusian Public Healthcare System. The primary outcome is the patient's physical performance, while the secondary outcomes are the patient's functional level, quality of life, pain, fear of falling, fitness perception, pre-fracture functional level, emotional status, and caregiver burden. The present project will substantially contribute to the existing knowledge by testing for the first time the efficacy and feasibility of a multidisciplinary m-Health system in the rehabilitation of patients with hip fracture. PublicationPredictive factors of six-week mortality in critically ill patients with SARS-CoV-2: A multicenter prospective study.(2022) Estella, Á; Garcia Garmendia, J L; de la Fuente, C; Machado Casas, J F; Yuste, M E; Amaya Villar, R; Estecha, M A; Yaguez Mateos, L; Cantón Bulnes, M L; Loza, A; Mora, J; Fernández Ruiz, L; Díez Del Corral Fernández, B; Rojas Amezcua, M; Rodriguez Higueras, M I; Díaz Torres, I; Recuerda Núñez, M; Zaheri Beryanaki, M; Rivera Espinar, F; Matallana Zapata, D F; Moreno Cano, S G; Gimenez Beltrán, B; Muñoz, N; Sainz de Baranda Piñero, A; Bustelo Bueno, P; Moreno Barriga, E; Rios Toro, J J; Pérez Ruiz, M; Gómez González, C; Breval Flores, A; de San José Bermejo Gómez, A; Ruiz Cabello Jimenez, M A; Guerrero Marín, M; Ortega Ordiales, A; Tejero-Aranguren, J; Rodriguez Mejías, C; Gomez de Oña, J; de la Hoz, C; Ocaña Fernández, D; Ibañez Cuadros, S; Garnacho Montero, J; Work Group of Infectious Disease (GTEI) de la Sociedad Andaluza de Medicina Intensiva y Unidades coronarias SAMIUCThe objective of the study is to identify the risk factors associated with mortality at six weeks, especially by analyzing the role of antivirals and munomodulators. Prospective descriptive multicenter cohort study. 26 Intensive care units (ICU) from Andalusian region in Spain. Consecutive critically ill patients with confirmed SARS-CoV-2 infection were included from March 8 to May 30. None. Variables analyzed were demographic, severity scores and clinical condition. Support therapy, drug and mortality were analyzed. An univariate followed by multivariate Cox regression with propensity score analysis was applied. 495 patients were enrolled, but 73 of them were excluded for incomplete data. Thus, 422 patients were included in the final analysis. Median age was 63 years and 305 (72.3%) were men. ICU mortality: 144/422 34%; 14 days mortality: 81/422 (19.2%); 28 days mortality: 121/422 (28.7%); 6-week mortality 152/422 36.5%. By multivariable Cox proportional analysis, factors independently associated with 42-day mortality were age, APACHE II score, SOFA score at ICU admission >6, Lactate dehydrogenase at ICU admission >470U/L, Use of vasopressors, extrarenal depuration, %lymphocytes 72h post-ICU admission 6, Lactate dehydrogenase at ICU admission >470U/L, Use of vasopressors, extrarenal depuration, %lymphocytes 72h post-ICU admission 470U/L, Use of vasopressors, extrarenal depuration, %lymphocytes 72h post-ICU admission Age, APACHE II, SOFA>value of 6 points, along with vasopressor requirements or renal replacement therapy have been identified as predictor factors of mortality at six weeks. Administration of corticosteroids showed no benefits in mortality, as did treatment with tocilizumab. Lopinavir/ritonavir administration is identified as a protective factor. Publication[Recommendations for the management of critically ill patients with COVID-19 in Intensive Care Units].(2021-09-16) Vidal-Cortés, P; Díaz Santos, E; Aguilar Alonso, E; Amezaga Menéndez, R; Ballesteros, M Á; Bodí, M A; Bordejé Laguna, M L; Garnacho Montero, J; García Sánchez, M; López Sánchez, M; Martín-Loeches, I; Ochagavía Calvo, A; Ramírez Galleymore, P; Alcántara Carmona, S; Andaluz Ojeda, D; Badallo Arébalo, O; Barrasa González, H; Borges Sa, M; Castellanos-Ortega, Á; Estella, Á; Ferrer Roca, R; Fraile Gutiérrez, V; Fuset Cabanes, M; Giménez-Esparza Vich, C; González Iglesias, C; Hernández-Tejedor, A; Igeño Cano, J C; Iglesias Posadilla, D; Jiménez Rivera, J J; Llanos Jorge, C; Llompart-Pou, J A; López Camps, V; Lorencio Cárdenas, C; Marcos Neira, P; Martín Delgado, M C; Martín-Macho González, M; Martín Villén, L; Nuvials Casals, X; Ortiz Suñer, A; Quintana Díaz, M; Rascado Sedes, P; Recuerda Núñez, M; Del Río Carbajo, L; Rodríguez Aguirregabiria, M; Rodríguez Oviedo, A; Seijas Betolaza, I; Soriano Cuesta, C; Suberviola Cañas, B; Vera Ching, C; Vidal González, Á; Zapata Fenor, L; Zaragoza Crespo, RThe COVID-19 pandemic has led to the admission of a high number of patients to the ICU, generally due to severe respiratory failure. Since the appearance of the first cases of SARS-CoV-2 infection, at the end of 2019, in China, a huge number of treatment recommendations for this entity have been published, not always supported by sufficient scientific evidence or with methodological rigor necessary. Thanks to the efforts of different groups of researchers, we currently have the results of clinical trials, and other types of studies, of higher quality. We consider it necessary to create a document that includes recommendations that collect this evidence regarding the diagnosis and treatment of COVID-19, but also aspects that other guidelines have not considered and that we consider essential in the management of critical patients with COVID-19. For this, a drafting committee has been created, made up of members of the SEMICYUC Working Groups more directly related to different specific aspects of the management of these patients. PublicationOrthohepevirus C infection as an emerging cause of acute hepatitis in Spain: First report in Europe.(2022-02-12) Rivero-Juarez, Antonio; Frias, Mario; Perez, Ana Belen; Pineda, Juan Antonio; Reina, Gabriel; Fuentes-Lopez, Ana; Freyre-Carrillo, Carolina; Ramirez-Arellano, Encarnación; Alados, Juan Carlos; Rivero, Antonio; HEPAVIR and GEHEP-014 Study GroupsHepatitis E virus (HEV) was considered the only member of the Hepeviridae family with zoonotic potential. Nevertheless, this consideration has been reassessed owing to several reported cases of acute and chronic hepatitis linked to the Orthohepevirus C genus. Because the circulation of Orthohepevirus C in rodents has been described worldwide, the risk of zoonotic transmission is plausibly global. Orthohepevirus C RNA was retrospectively evaluated in 2 cohorts of patients in Spain. The first cohort included patients with acute hepatitis without etiological diagnosis after screening for hepatotropic virus infection. The second cohort included patients diagnosed with acute HEV infection, defined as positivity for anti-HEV-IgM antibodies and/or detectable HEV RNA in serum. Cohort 1 comprised 169 patients (64.4% male, median age 43 years) and cohort 2 comprised 98 individuals (68.3% male, median age 45 years). Of the individuals included in Cohort 1, two (1.18%; 95% CI 0.2-3.8) had detectable Orthohepevirus C RNA in serum. In Cohort 2, of the 98 included patients, 58 showed detectable HEV RNA, while 40 only showed positivity for IgM antibodies. Among those bearing only IgM antibodies, Orthohepevirus C RNA was detected in 1 (2.5%; 95% CI 0.06-13.1) individual. All strains were consistent with genotype C1. The infection resulted in mild self-limiting acute hepatitis in 2 patients. Infection caused severe acute hepatitis in the remaining patient who died as a result of liver and renal failure. We described 3 cases of Orthohepevirus C in patients with acute hepatitis, resulting in the first description of this infection in Europe. The prevalence obtained in our study suggests that Orthohepevirus C could be an emerging disease in Europe. We describe the first cases of acute hepatitis related to rat hepatitis E virus in Europe. The prevalence found in our study suggest that rat hepatitis E virus could be considered an emerging disease in Europe. PublicationConsensus of the ambulatory surgery commite section of the Spanish Association of Surgeons on the role of ambulatory surgery in the SARS-CoV-2 pandemic(Elsevier espana slu, 2022-03-01) Morales-Garcia, Dieter; Docobo-Durantez, Fernando; Capitan Vallvey, J. M.; Manuel Suarez-Grau, Juan; Eugenia Campo-Cimarras, Maria; Gonzalez-Vinagre, Salustiano; Antonio Hidalgo-Grau, Luis; Puigcercos-Fuste, J. M.; Zaragoza-Fernandez, Cristobal; Valera-Sanchez, Zoraida; Vega-Ruiz, Vicente; Grp Trabajo CIRUGIA-AEC-COVID-19; [Morales-Garcia, Dieter] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Docobo-Durantez, Fernando] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Capitan Vallvey, J. M.] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Manuel Suarez-Grau, Juan] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Eugenia Campo-Cimarras, Maria] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Gonzalez-Vinagre, Salustiano] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Antonio Hidalgo-Grau, Luis] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Puigcercos-Fuste, J. M.] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Zaragoza-Fernandez, Cristobal] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Valera-Sanchez, Zoraida] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Vega-Ruiz, Vicente] Asociac Espanola Cirujanos, Secc Cirugia Mayor Ambulatoria, Madrid, Spain; [Morales-Garcia, Dieter] Hosp Univ Marques de Valdecilla, Inst Invest IDIVAL, Santander, Spain; [Docobo-Durantez, Fernando] Asociac Andaluza de Cirujanos, Com Cient, Andalucia, Spain; [Capitan Vallvey, J. M.] Hosp Univ Jaen, Jaen, Spain; [Manuel Suarez-Grau, Juan] Hosp Riotinto, Huelva, Spain; [Eugenia Campo-Cimarras, Maria] Hosp Txagorritxu, Vitoria, Spain; [Gonzalez-Vinagre, Salustiano] Hosp Univ Santiago, Santiago De Compostela, Spain; [Antonio Hidalgo-Grau, Luis] Hosp Mataro, Barcelona, Spain; [Puigcercos-Fuste, J. M.] Hosp Dos de Mayo, Barcelona, Spain; [Zaragoza-Fernandez, Cristobal] Hosp Gen Univ Valencia, Valencia, Spain; [Valera-Sanchez, Zoraida] Hosp Univ Virgen Macarena, Seville, Spain; [Vega-Ruiz, Vicente] Hosp Univ Puerto Real, Cadiz, SpainThe current situation of the SARS-CoV-2 pandemic has paralyzed non-urgent and/or oncological surgery in many hospitals in our country with what it means for the health of citizens who are awaiting a surgical procedure. Outpatient Surgery can afford more than 85% of the surgical procedures that are performed in a surgical department and is presented as a feasible and safe alternative at the present time since it does not require admission and decreases clearly the risk of infection. In addition, it is the tool that should be generalized to solve the accumulation of patients on the waiting list that the pandemic is generating, so it seems appropriate that the Ambulatory Surgery section of the Spanish Association of Surgeons present a series of recommendations for the implementation of outpatient surgery in these exceptional circumstances that we have to live. (C) 2021 AEC. Published by Elsevier Espana, S.L.U. All rights reserved. PublicationExperience with the potassium binder patiromer in hyperkalaemia management in heart failure patients in real life.(2022-06-24) Esteban-Fernández, Alberto; Ortiz Cortés, Carolina; López-Fernández, Silvia; Recio Mayoral, Alejandro; Camacho Jurado, Francisco Javier; Gómez Otero, Inés; Molina, María; Almenar Bonet, Luis; López-Vilella, RaquelHyperkalaemia (HK) is common in heart failure (HF) patients, related to renal dysfunction and medical treatment. It limits medical therapy optimization, which impacts prognosis. New potassium (K) binders help control HK, allowing better medical management of HF. A retrospective multicentre register included all outpatients with HF and HK (K ≥ 5.1 mEq/L) treated with patiromer according to current recommendations. We evaluated analytic and clinical parameters before starting the treatment and at 7, 30 and 90 days, as well as adverse events related to patiromer and treatment optimization. We included 74 patients (71.6% male) with a mean age of 70.8 years (SD 9.2). Sixty-seven patients (90.5%) presented HK in the previous year. Forty patients (54.1%) underwent down-titration of a renin-angiotensin-aldosterone inhibitor (RAASi) or a mineralocorticoid receptor antagonist (MRA), and 27 (36.5%) stopped any of them due to HK. Initial K was 5.5 mEq/L (SD 0.6), with a significantly reduction at 7 days (4.9 mEq/L (SD 0.8); P In a real-life cohort of patients with HF, patiromer reduced and maintained K levels during 3 months of follow-up. The most common adverse events were hypomagnesaemia and gastrointestinal disturbances. Patiromer helps optimize medical treatment, increasing the percentage of patients treated with RAASi and MRA at target doses. At the end of follow-up, natriuretic peptides values and hospital visits were reduced, suggesting the benefit of optimizing HF medical treatment. PublicationPatient-Reported Outcome Measures in Real-World Atopic Dermatitis Studies in Spain: A Systematic Review.(2022-02-10) Armario-Hita, J C; Artime, E; Vidal-Vilar, N; Huete, T; Díaz-Cerezo, S; Moro, R M; Lizán, L; Frutos, F J Ortiz deAtopic dermatitis (AD) is a chronic inflammatory skin disease with symptoms such as pruritus that can be a major burden for patients. Patient-reported outcomes (PRO) complement clinician-reported outcomes in AD. This systematic review aims to identify and describe patient-reported outcome measures (PROM) used in observational studies of AD over the last decade in Spain. Eighteen PROM were identified to measure 13 different PRO that assess multiple aspects of the disease, including symptoms and disease severity, impact on daily activities and on work productivity/functioning, psychosocial impact, patient empowerment, and health-related quality of life (HRQoL). HRQoL, symptoms (particularly pruritus), and anxiety/depression were the most frequently assessed PRO, and the Dermatology Quality of Life Index, the Visual Analogue Pruritus Scale, and the Hospital Anxiety and Depression Scale were the most frequently used PROM, respectively. The growing number of observational studies on AD including PROM in Spain suggests that PRO are becoming increasingly important in the management of AD. PublicationSeroprevalence and immunological memory against SARS-CoV-2 in lung cancer patients: the SOLID study.(2022) Provencio, Mariano; Rodríguez-Abreu, Delvys; Ortega, Ana L; Serrano, Gloria; Aguado, Carlos; Franco, Fernando; Gutierrez, Vanesa; López Vivanco, Guillermo; Guirado, María; Benítez, Gretel; Estival, Anna; Calvo, Virginia; Jiménez, Beatriz; Arasanz, Hugo; Coves, Juan; Majem, Margarita; Massutí, Bartomeu; Vázquez, Sergio; Juan-Vidal, Oscar; Collazo-Lorduy, Ana; Gozálvez, Clara L; Del Barco, Edel; Rosero, Adriana; Bosch-Barrerra, Joaquim; Moreno, María A; Mielgo-Rubio, Xabier; Villa, José C; López-Martin, Ana; Córdoba, Juan F; de Asís Aparisi, Francisco; Zafra, Marta; Mosquera, Joaquín; Pérez Altozano, Javier; Nadal, Ernest; Catot, Silvia; Balsalobre, José; de Portugal, Teresa; Martín, Paloma; Cuesta de Juan, Susanaa; Cobo, ManuelAt present, we did not find any articles that studied seroprevalence and its persistence several months later in lung cancer patients in the setting of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Most patients with coronavirus disease 2019 (COVID-19) go on to develop antibodies (Abs) against viral proteins. However, it is not known how long these Abs last nor whether cancer treatments could affect the duration of immune response. This prospective, longitudinal, multicenter serological study in the setting of SARS-CoV-2 infection was carried out in 50 Spanish hospitals. Eligibility criterion was the diagnosis of any lung cancer. The determination of anti-SARS-CoV-2 IgG Abs was performed by qualitative immuno-enzymatic assay using enzyme-linked immunosorbent assay (ELISA) kit from NovaLisa whose Abs target the recombinant antigen N of the nucleocapsid of SARS-CoV-2. The first Ab determination was performed between April 21 and June 3, 2020. The second Ab determination was performed in all previously seropositive patients, between September 10 and November 20, 2020. Study objectives were to prospectively determine seroprevalence in unselected lung cancer patients during the first wave of the pandemic; the persistence of immunity; protection or lack thereof against reinfection; and the influence of treatments on maintenance or loss of immunity. Of 1,500 patients, 128 were seropositive, overall prevalence of 8.5% seropositivity [95% confidence interval (CI): 7.2-10.1%]. Seventy-five percent were in active cancer treatment. Forty-seven point seven percent of IgG positive participants had experienced a symptomatic illness suspected of being infected with SARS-CoV-2 (95% CI: 38.8-56.6%). A second determination was performed on average 4.5 months later [interquartile range (IQR), 4.0-5.0 months] and obtained for 104 of the initially seropositive patients (81%), it could not be obtained in 24 patients, the majority due to death caused by disease progression (73%). In the second determination, IgG was not detected in 30.8% of patients. The severity of the infection, the need for hospitalization (P=0.032) and the presence of symptoms at diagnosis (P=0.02) were associated with persistence of immunity in the second determination. No variables or treatments received were associated with Abs loss. Immunity against SARS-CoV-2 does not appear to be compromised by treatment and persists beyond 4 months. Neither do mortality rates appear to be particularly high in this unselected population. ClinicalTrials.gov identifier: NCT04407143. PublicationDesign and implementation of an online tool for managing the availability of high-cost perishable medicines.(2022-09-02) Galisteo, Myriam Gallego; Puerto, Javier Romero; Bautista, Maria José Martínez; Navarro, Jorge Díaz; Elcuaz, Rosa Seisdedos; Galisteo, Juan Gallego; Rubio, Alberto Villa; de Juan, María Del Carmen Jiménez; Andrades, Ana Ganfornina; Cantero, Marcelo Domínguez; Morales, José Carlos Roldán; Ramos, Jaime Cordero; García, Alfonso Sánchez; Ortiz, Carlos Núñez; Álvarez, José Ramón ÁvilaDue to their impact on healthcare systems, the sustainability and optimization of high-cost drugs is an issue of concern for several countries. Different strategies have been implemented such as centralized purchasing to optimize budgetary resources. However, there is still a need for a mechanism to optimize these drugs further. We conducted this prospective multicenter intervention study in five hospitals in the Andalusian Public Health System of Cádiz (Spain) between July 2019 and September 2021. We developed an online website (Farmastock) and implemented it to determine the availability of high-cost, low-use, and near-expiry medicines in each hospital. We used a simple analysis using operational variables to assess the project intervention's savings impact on managing these high-cost drugs. The implementation of Farmastock in Cádiz resulted in savings of 675,757.52 € for the Andalusian Public Health System, with 238 medicines transferred out of the 373 available. Of these medicines offered, the most considerable percentage were medicines used for pathologies with high clinical instability and accounted for nearly 80% of the medicines optimized by the tool. Farmastock allowed the Andalusian Public Health System to make substantial financial savings by not making new purchases of high-cost drugs available in other centers of this health network that were not being used. Therefore, this tool is a very efficient measure to contribute to the sustainability of the APHS and could be implemented in more hospitals soon. PublicationShorter Time to Discontinuation Due to Treatment Failure in People Living with HIV Switched to Dolutegravir Plus Either Rilpivirine or Lamivudine Compared with Integrase Inhibitor-Based Triple Therapy in a Large Spanish Cohort.(2022-04-11) Teira, Ramón; Diaz-Cuervo, Helena; Aragão, Filipa; Castaño, Manuel; Romero, Alberto; Roca, Bernardino; Montero, Marta; Galindo, Maria José; Muñoz-Sánchez, Maria Jose; Espinosa, Nuria; Peraire, Joaquim; Martínez, Elisa; de la Fuente, Belén; Domingo, Pere; Deig, Elisabeth; Merino, María Dolores; Geijo, Paloma; Estrada, Vicente; Sepúlveda, María Antonia; García, Josefina; Berenguer, Juan; Currán, AdriáStandard therapy for HIV treatment has consisted of two nucleoside analogue reverse transcriptase inhibitors (NRTI) paired with a third agent. Use of two-drug regimens (2DR) has been considered for selected patients in part to avoid toxicities associated with the use of NRTIs. This study aimed to compare the real-world outcomes of integrase inhibitor (INSTI)-based three-drug regimens (3DR) versus 2DR of dolutegravir (DTG) + rilpivirine (RPV) or DTG + lamivudine (3TC). All patients in the Spanish VACH cohort switching to INSTI-based 3DR or a 2DR consisting of DTG + RPV or DTG + 3TC between May 2, 2016 and May 15, 2019 were included. Kaplan-Meier curves and Cox proportional hazard models were used to assess time to/risk of discontinuation due to treatment failure (TF) (defined as virologic failure [VF], immunologic failure, or disease progression) and adverse events (AEs). Three secondary analyses were performed: (1) in restricting the analysis to patients who were virologically suppressed (HIV RNA Overall, 5047 3DR and 617 2DR patients were analyzed. Baseline characteristics differed between groups; 2DR patients were older, more treatment experienced, and more likely to be virologically suppressed at switch. Time to discontinuation due to TF was significantly shorter for 2DR (P = 0.002). The hazard ratio (HR) for discontinuation due to TF on 2DR vs 3DR was 2.33 (P = 0.003). No difference was observed for time to discontinuation (P = 0.908) or risk of discontinuation due to AEs (HR = 0.80; P = 0.488). Results were qualitatively similar in virologically suppressed patients, matched analysis, and for VF. In the real world, the risks of discontinuation due to TF and VF were more than two times higher in patients switching to DTG-based 2DR than INSTI-based 3DR, with no difference in discontinuation due to AEs. PublicationPrognostic Impact of Active Cigarette Smoking on Mortality in Patients with Acute Venous Thromboembolic Events, Findings from Real World Data.(2022-02-15) Giorgi-Pierfranceschi, Matteo; Monreal, Manuel; Di Micco, Pierpaolo; Francisco, Iria; Hernández-Blasco, Luis; Madridano, Olga; López-Sáez, Juan Bosco; Hernando, Elena; Meireles, Jose; Dentali, Francesco; The Riete Investigators,Background and Objectives: The influence of smoking habits on mortality, VTE recurrence, and major bleeding in patients receiving anticoagulant therapy for venous thromboembolism (VTE) has not been consistently evaluated. Materials and Methods: We used data from the RIETE (Registro Enfermedad TromboEmbólica) registry to compare mortality, VTE recurrence, and major bleeding risk in smoking versus non-smoking patients with acute VTE. Results: 50,881 patients (43,426 non-smoking and 7455 smoking patients) were included. After a median follow-up of 8.8 months, 7110 patients died (fatal PE 292 and fatal bleeding 281), 3243 presented VTE recurrence, and 1579 had major bleeding. At multivariate analysis, smoking behavior was associated with a higher hazard of death, (HR: 1.28; 95% CI: 1.19-1.40). The risk of VTE recurrence was marginally increased in smoking patients compared to non-smoking patients (1.14; 95% CI: 1.02-1.27). Major bleeding did not differ in smoking and non-smoking patients (1.15; 95% CI: 0.96-1.38). The presence of cancer did not appear to influence the association between smoking habits and death (HR: 1.34; 95% CI: 1.22-1.47 in cancer patients and HR: 1.23; 95% CI: 1.04, 1.45 in non-cancer patients, respectively) Conclusions: the risk of death after an acute episode of VTE appeared to be higher in smoking than in non-smoking patients and this risk is higher between patients presenting PE at the onset of symptoms. PublicationSuper-Responders in Moderate-Severe Psoriasis under Guselkumab Treatment: Myths, Realities and Future Perspectives.(2022-09-10) Ruiz-Villaverde, Ricardo; Vasquez-Chinchay, Fiorella; Rodriguez-Fernandez-Freire, Lourdes; C Armario-Hita, Jose; Pérez-Gil, Amalia; Galán-Gutiérrez, ManuelA fast skin clearance is the main goal to achieve in psoriasis treatment. Patients that present a fast and exceptional improvement with treatment are called super-responders (SR). There is no consensus on the definition of SR with respect to psoriasis. Included herein is a retrospective analysis of a multicenter, observational study of real clinical practices including patients with moderate-to-severe plaque PSO undergoing treatment with Guselkumab (GUS). This cross-sectional analysis includes information on patients between February 2019 to February 2022. A SR is a patient that achieved a PASI = 0 at weeks 12 and 24. Analyses have been performed "as observed" using GraphPad Prism version 8.3.0 for Windows (GraphPad Software, San Diego, CA, USA, At baseline, the PASI is significantly correlated with VAS_pruritus, BSA, and DLQI, while DLQI is significantly correlated with VAS_pruritus. Significant correlations increase in number and magnitude over the follow-up time. In relation to the univariate logistic models carried out, only three variables showed a significant association with the super-responder variable: depression, VAS_pruritus, and DLQI.SR patients, who show a faster evolution in PASI and BSA improvement than non-SRs. Based on the results obtained, it would be possible to also include DLQI and VAS_pruritus in the broader concept of the SR. PublicationAtopic Dermatitis: Background, Objectives and Future Perspectives (Superresponders).(2022-08-04) Ruiz-Villaverde, Ricardo; Domínguez-Cruz, Javier; Navarro-Triviño, Francisco J; Galán-Gutiérrez, Manuel; Armario-Hita, Jose Carlos; Pereyra-Rodriguez, Jose JuanIn this Special Issue entitled Atopic Dermatitis: New Perspectives, we have tried to collect research of special interest related mainly to the incorporation of pathophysiological aspects and therapeutic novelties in this regard [...]. PublicationLong-Term Effectiveness and Safety of Biologic and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review.(2022-07-30) Ayen-Rodríguez, Angela; Pereyra-Rodríguez, José-Juan; Navarro-Triviño, Francisco J; Alcantara-Luna, Sara; Domínguez-Cruz, Javier; Galán-Gutiérrez, Manuel; Vilar-Palomo, Samuel; Armario-Hita, Jose Carlos; Ruiz-Villaverde, RicardoAtopic dermatitis (AD) is a genetically based chronic inflammatory dermatosis associated with multiple triggers and complex pathophysiological mechanisms. Nowadays, an authentic therapeutic revolution is taking place with the incorporation of biological drugs for the treatment of moderate and severe atopic dermatitis. A new systematic revision (RS) is necessary to support decision-making for specialists treating AD. A literature search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials was performed between 1 January 2000 and 30 April 2022. Phase III randomized clinical trials (RCTs) of EMA-approved molecules were included. The main variables analyzed were a 75% improvement in the Eczema Area and Severity Index (EASI 75) and the number of patients who reached 0 in the Investigator Global Assessment (IGA) (fully cleared patients) or IGA 1 (almost cleared patients) at the end of the study period (week 48-60). The risk of bias was analyzed with the Cochrane Risk of Bias Assessment (ROB-2) tool, focused on the primary objectives. Before carrying out the study, the protocol was registered in PROSPERO with the number CRD42022331109. A total of 3299 studies were systematically identified via databases and registers (442 from PubMed/MEDLINE, 2857 from Embase and 719 from CENTRAL). Finally, five publications containing seven RCTs were included in the final sample of detailed data extraction and data analyses. Regarding efficacy, the best results are obtained with Upadacitinib 30 mg (84.7% (77.3-92.1)) at 52 weeks, slightly improving its results when TCS is added (84.9% (80.3-89.5)). These results are replicated in the measurement of vIGA 0/1 for Updacitinib 30 mg + TCS, where 65.5% (55.7-75.2) of patients maintain it at 52 weeks. Of the four drugs, no long-term safety results have been reported for baricitinib. In relation to the safety findings, there were no significant differences in the dropout rates for this reason in the remaining three drugs. Today, different therapeutic options for AD patients can be prescribed. Individualizing the treatment allows for better therapeutic consistency, in addition to being cost-efficient to avoid primary therapeutic failures. The results of the present SR may provide us with a useful basis for the preparation of management guidelines for the use of new generation therapies in moderate to severe atopic dermatitis. PublicationEffectiveness and Safety of Tecneplase vs. Alteplase in the Acute Treatment of Ischemic Stroke.(2022-09-17) Estella, Ángel; Pérez Ruiz, Miriam; Serrano, Juan JoséNot all hospitals have interventional radiology services. This fact implies that in centers where this resource is not available, the treatment of stroke in the acute phase must be adapted and individualized. The aim of the study is to determine and compare the combined effect of thrombolysis and thrombectomy effectiveness and safety of tenecteplase versus alteplase in the acute treatment of ischemic stroke in patients who are candidates for endovascular therapy according to clinical practice guidelines. This paper details a retrospective multicenter cohort study of patients with ischemic stroke admitted in three hospitals between 2018 and 2020. The main outcome variables were the degree of recanalization and the functional outcome at 3 months; safety variables were mortality and the occurrence of intracranial hemorrhage (ICH). In total, 100 patients were included, 20 of which were treated with tenecteplase (TNK) and 80 with alteplase (rtPA). Of those treated with TNK, 75% obtained a successful recanalization compared to 83.8% in those treated with rtPA (OR 0.58; 95% CI 0.18-1.88; p = 0.56). No differences were found in obtaining an excellent functional result at 3 months (35% TNK vs. 58.8% rtPA; p = 0.38). Tenecteplase showed worse neurological results after 24 h (unfavorable result of 70% with TNK vs. 45% with rtPA; OR = 5.4; 95% CI 1.57-18.6). No significant differences were identified in mortality; 17.5% with rtPA and 20% with TNK (p = 0.79), nor in the appearance of intracranial hemorrhage ICH (15.2% with rtPA vs. 30% with TNK (p = 0.12). In our series, there were not significant differences shown regarding effectiveness and safety between tenecteplase and alteplase. PublicationUse of Sonophoresis with Corticosteroids in Carpal Tunnel Syndrome: Systematic Review and Meta-Analysis.(2022-07-17) Martin-Vega, Francisco Javier; Vinolo-Gil, Maria Jesus; Perez-Cabezas, Veronica; Rodríguez-Huguet, Manuel; Garcia-Munoz, Cristina; Gonzalez Medina, GloriaCarpal tunnel syndrome is a neuropathic disease. It is one of the most frequent musculoskeletal pathologies affecting the upper limbs. One of most frequently used non-surgical treatments is corticosteorids. There are several alternatives for corticosteroids administration. One of them is phonophoresis, this being an effective and painless method of treatment. A systematic review and meta-analysis have been conducted over the use of phonophoresis with corticosteroids for the treatment of carpal tunnel syndrome compared to other non-surgical treatment methods. Keywords from Medical Subjects Headings (MeSH) were used in the following databases: Wos, Scopus, CINHAL, SciELO and PeDro. A total of 222 potentially relevant articles were retrieved. Eleven articles analysing the efficacy of phonophoresis with corticosteroids in reducing pain symptoms in individuals with carpal tunnel syndrome were included, 10 of which were used to conduct the meta-analysis. A conclusion could not be reached as to the application of phonophoresis with corticosteroids being better than other treatment methods, except for the perception of pain and an improved motor and sensory nerve conduction in cases of mild to moderate carpal tunnel syndrome. PublicationPlasma Levels of Mid-Regional Proadrenomedullin Accurately Identify H1N1pdm09 Influenza Virus Patients with Risk of Intensive Care Admission and Mortality in the Emergency Department.(2022-01-10) Valenzuela-Méndez, Blanca; Valenzuela-Sánchez, Francisco; Rodríguez-Gutiérrez, Juan Francisco; Bohollo-de-Austria, Rafael; Estella, Ángel; Martínez-García, Pilar; González-García, María Ángela; Rello, JordiEarly identification of severe viral pneumonia in influenza virus A (H1N1pdm09) patients is extremely important for prompt admission to the ICU. The objective is to evaluate the usefulness of MR-proadrenomedullin (MR-proADM) compared to C reactive protein (CRP), procalcitonin (PCT), and ferritin in the prognosis of influenza A pneumonia. This prospective, observational, multicenter study included one hundred thirteen patients with confirmed influenza virus A (H1N1pdm09) admitted to an Emergency Department and ICUs of six hospitals in Spain. Measurements and Main Results: one-hundred thirteen patients with confirmed influenza virus A (H1N1pdm09) were enrolled. Seventy-five subjects (mortality 29.3%) with severe pneumonia caused by influenza A H1N1pdm09 virus (H1N1vIPN) were compared with 38 controls (CG).The median MR-proADM levels at hospital admission were 1.2 nmol/L (IQR (0.8-2.6) vs. 0.5 nmol/L (IQR 0.2-0.9) in the CG (p = 0.01), and PCT levels were 0.43 μg/L (IQR 0.2-1.2) in the H1N1vIPN group and 0.1 μg/L (IQR 0.1-0.2) in the CG (p 1.2 nmol/L at hospital admission were significant predictive factors for ICU and 90-day mortality (HR: 1.3). Conclusions: the initial MR-proADM, ferritin, CRP, and PCT levels effectively determine adverse outcomes and risk of ICU admission and mortality in patients with influenza virus pneumonia. MR-proADM has the highest potency for survival prediction. PublicationHigh First Trimester Levels of TSH as an Independent Risk Factor for Gestational Diabetes Mellitus: A Retrospective Cohort Study.(2022-06-29) Fernández Alba, Juan Jesús; Castillo Lara, María; Jiménez Heras, José Manuel; Moreno Cortés, Rocío; González Macías, Carmen; Vilar Sánchez, Ángel; San Laureano, Florentino Carral; Moreno Corral, Luis JavierAlthough numerous articles have found an association between alterations in thyroid function and the risk of gestational diabetes mellitus (GDM), other studies have failed to demonstrate this association. This may be due to the different cut-off points used to define subclinical hypothyroidism. We aim to clarify the role of thyroid stimulating hormone (TSH) level in GDM within pregnant women with normal free thyroxine (fT4) levels. This retrospective cohort study was performed in 6775 pregnant women. The association between TSH and GDM was assessed by bivariate and multivariate logistic regression. Pregnant women with subclinical hypothyroidism are at significantly greater risk for GDM when compared with euthyroid pregnant women (OR = 1.85; 95% CI = 1.36-2.52). We have also observed that TSH levels increase the risk of GDM within euthyroid pregnant women, since the TSH levels between 2.5 and 4.71 showed a higher risk of GDM than those whose TSH levels are between 0.31 and 2.49 (OR = 1.54; 95% CI = 1.28-1.84). In addition, pregnant women with positive thyroid antibodies have almost 2.5 times the risk of developing GDM (OR = 2.47; 95% CI = 1.57-3.89). Our results support that in pregnant women with normal fT4 levels, higher first trimester TSH level implies a higher risk of GDM. PublicationEffects of Peripheral Electromagnetic Fields on Spasticity: A Systematic Review.(2022-06-28) Vinolo-Gil, Maria Jesus; Rodríguez-Huguet, Manuel; García-Muñoz, Cristina; Gonzalez-Medina, Gloria; Martin-Vega, Francisco Javier; Martín-Valero, RocíoElectromagnetic fields are emerging as a therapeutic option for patients with spasticity. They have been applied at brain or peripheral level. The effects of electromagnetic fields applied to the brain have been extensively studied for years in spasticity, but not so at the peripheral level. Therefore, the purpose of our work is to analyze the effects of electromagnetic fields, applied peripherally to spasticity. A systematic review was conducted resulting in 10 clinical trials. The frequency ranged from 1 Hz to 150 Hz, with 25 Hz being the most commonly used and the intensity it was gradually increased but there was low homogeneity in how it was increased. Positive results on spasticity were found in 80% of the studies: improvements in stretch reflex threshold, self questionnaire about difficulties related to spasticity, clinical spasticity score, performance scale, Ashworth scale, spastic tone, Hmax/Mmax Ratio and active and passive dorsal flexion. However, results must be taken with caution due to the large heterogeneity and the small number of articles. In future studies, it would be interesting to agree on the parameters to be used, as well as the way of assessing spasticity, to be more objective in the study of their effectiveness. PublicationEffectiveness of Myofunctional Therapy in Ankyloglossia: A Systematic Review.(2022-09-28) González Garrido, María Del Puerto; Garcia-Munoz, Cristina; Rodríguez-Huguet, Manuel; Martin-Vega, Francisco Javier; Gonzalez-Medina, Gloria; Vinolo-Gil, Maria JesusAnkyloglossia is a pathology of the tongue in which the frenulum appears anchored to the floor of the mouth. The treatment of choice for this pathology is frenectomy, but myofunctional therapy is emerging in recent years as a complement to surgical intervention. This systematic review aims to synthesize the scientific evidence and assess its quality regarding the use of myofunctional therapy in ankyloglossia. The Cochrane Central Register of Controlled Trials, Physiotherapy Evidence Database, Pubmed, Web of Science and Scopus were searched. Study quality was determined using the PEDro scale, STROBE statement and single-case experimental design scale. Eleven studies were selected. Based on the studies included in this review, surgery is more effective than myofunctional therapy, although better results are achieved if both are combined. Improvements have been found in maternal pain, weight gain of babies, duration of breastfeeding, tongue mobility, strength and endurance, sleep apnea, mouth breathing and snoring, quality of life, clenching teeth, myofascial tension, pain after surgery and speech sound production. These findings must be taken with caution because of the small number of articles and their quality. Future clinical trials using larger sample sizes and with higher methodological quality are needed.