Diseño de un sistema de evaluación de la seguridad en transfusión sanguínea mediante la aplicación de la metodología AMFE

La seguridad del paciente es un aspecto fundamental de la asistencia sanitaria y debe ser objetivo básico en todo proceso asistencial. La atención sanitaria es cada vez más compleja y cada proceso asistencial supone la interacción de un número elevado de diferentes actuaciones profesionales, tecnologías diagnósticas, métodos terapéuticos y tecnologías de la información y comunicación. La combinación de todos estos factores se asocia a un riesgo creciente de efectos adversos y perjuicios involuntarios para el paciente. Este efecto adverso es el daño o lesión que se produce durante el proceso asistencial que no está directamente producido por la enfermedad en sí, sino que se puede considerar producido por el propio sistema sanitario. Aunque anteriormente se habían notificado efectos indeseables de manera ocasional y sin una sistematización, desde la publicación en 1999 del informe Errar es humano (To Err is Human: Building a Safer Health System) del Instituto de Medicina de EEUU, se ha producido una toma de conciencia acerca de la necesidad de comunicar, investigar y sobre todo anticipar los efectos adversos. Varios organismos internacionales (OMS, UE, OCDE), han adoptado estrategias para analizar los efectos adversos en la asistencia sanitaria y han establecido la seguridad asistencial como un objetivo prioritario mundial. El Plan de Calidad para el Sistema Nacional de Salud español establece la seguridad también como una de sus estrategias clave..

Impact of a patient blood management program within an Orthogeriatric care service

Patient blood management (PBM) performs multidisciplinary strategies to optimize red blood cell (RBC) transfusion. Orthogeriatric share care models (surgeon and geriatrician manage the patient together from admission) have the goal of improving outcomes in hip fracture patients. MATERIAL AND METHODS: A prospective observational study was conducted. Patients aged ≥70 years undergoing hip fracture (HF) surgery were consecutively included. When admitted on the orthogeriatric service a PBM protocol was applied based on: perioperative antithrombotic management, intravenous iron sucrose administration and restrictive transfusion criteria. Risk factors, clinical and functional effects of transfusion and its requirements were assessed to audit our model. RESULTS: A total of 383 patients participated (women, 78.8%; median age, 86 (82-90) years). 210 patients (54.8%) were transfused. Age (OR = 1.055, 95% CI 1.017-1.094; p = 0.004) and Hemoglobin (Hb) level on admission (OR = 0.497, 95% CI 0.413-0.597; p < 0.001) were found to be significant risk factors for transfusion. Transfusion increased length of stay (b = 1.37, 95% CI 0.543-2.196; p = 0.001) but did not have an effect on other variables. DISCUSSION: The PBM program established within an orthogeriatric service showed positive outcomes in terms of clinical complications, mortality, delirium or functional recovery in transfused patients, whereas it did not impact on shorter length of stay. The risk of transfusion on admission was predicted with the lower Hb levels on admission, along with the age of the patients. New measurements as homogenous restrictive transfusion criteria, a single-unit RBC transfusion and the assessment of the intravenous iron efficacy are need to be applied as a result of the high transfusion requirements.Sin financiación1.412 JCR (2018) Q4, 59/73 Hematology0.518 SJR (2018) Q3, 72/135 HematologyNo data IDR 2018UE

Response to Combined Antiretroviral Therapy According to Gender and Origin in a Cohort of Naive HIV-Infected Patients: GESIDA-5808 Study

We analyzed differences in response to combined antiretroviral therapy (cART) according to sex and geographic origin in a retrospective comparative study of Spanish-born and immigrant patients initiating cART. The primary endpoint was time to treatment failure (TTF), defined as virological failure, death, opportunistic infection, interruption of cART, or loss to follow-up. Late diagnosis was defined as a CD4+ cell count ≤ 200 cells/mm3 and/or AIDS at initiation of cART. Survival was analyzed using Kaplan-Meier analysis and Cox regression. We followed 1,090 patients, of whom 318 were women (45.6% immigrant women [IW]). At initiation of treatment, women had a higher CD4+ count than men (217 vs 190 cells/mm3), a lower viral load (4.7 vs 5 log), and fewer were late starters (49% vs 59%). The adjusted risk of TTF between women and men was not significantly different (hazard ratio [HR], 1.10; 95% CI, 0.79-1.53). TTF was shorter among IW than Spanish-born women (124 weeks [95% CI, 64-183] vs 151 [95% CI, 127-174]) and loss to follow-up was double that of Spanish-born women (25.5% vs 11.6%). Although response to cART was similar for both sexes, men started treatment later. IW were more frequently lost to follow-up and switched treatment. Measures to improve medical follow-up after initiation of cART should be promoted among this minority group. Response to Combined Antiretroviral Therapy According to Gender and Origin in a Cohort of Naïve HIV-Infected Patients: GESIDA-5808 Study. Available from: https://www.researchgate.net/publication/224971412_Response_to_Combined_Antiretroviral_Therapy_According_to_Gender_and_Origin_in_a_Cohort_of_Naive_HIV-Infected_Patients_GESIDA-5808_Study.2.304 JCR (2012) Q2, 122/261 Pharmacology & pharmacy; Q3, 42/70 Infectious disease

Do HIV-Infected Immigrants Initiating HAART have Poorer Treatment-Related Outcomes than Autochthonous Patients in Spain? Results of the GESIDA 5808 Study

Objective: Currently, 12% of the Spanish population is foreign-born, and a third of newly diagnosed HIV-infected patients are immigrants. We determined whether being an immigrant was associated with a poorer response to antiretroviral treatment. Methods: Historical multicenter cohort study of naive patients starting HAART. The primary endpoint was time to treatment failure (TTF) defined as virological failure (VF), death, opportunistic disease, treatment discontinuation (D/C), or missing patient. Secondary endpoints were TTF expressed as observed data (TFO; censoring missing patients) and time to virological failure (TVF; censoring missing patients and D/C not due to VF). A multivariate analysis was performed to control for confounders. Results: A total of 1090 treatment-naive HIV-infected patients (387 immigrants and 703 autochthonous) from 33 hospitals were included. Most immigrants were from Sub-Saharan Africa (28.3%) or South-Central America/Caribbean (31%). Immigrants were significantly younger (34 y vs 39 y), more frequently female (37.5% vs 24.6%), with less HCV coinfection than autochthonous patients (7% vs 31.3%). There were no differences in baseline viral load (4.95 Log(10) vs 4.98 Log(10)), CD4 lymphocyte count (193.5/mu L vs 201.5/mu L), late initiation of HAART (56.4% vs 56.0%), or antiretrovirals used. Cox-regression analysis (HR; 95%CI) did not show differences in TTF (0.89; 0.66-1.20), TFO (0.95; 0.66-1.36), or TVF (1.00; 0.57-1.78) between immigrants and autochthonous patients. Losses to follow-up were more frequent among immigrants (17.8% vs 12.1; p=0.009). Sub-Saharan African patients and immigrant females had a significantly shorter TTF. Conclusions: The response to HAART among immigrant patients was similar to that of autochthonous patients, although they had a higher rate of losses to follow-up. Sub-Saharan Africans and immigrant females may need particular measures to avoid barriers hindering antiviral efficacy.1.923 JCR (2010) Q3, 23/33 Virology; Q4, 103/134 Immunology, 44/58 Infectious Disease

Intravenous iron, functional recovery and delirium in patients with hip fracture. FEDEREF study. Single-centre randomised, placebo-controlled, and double-blind clinical trial. 2014-001923-53: EudraCT number

There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system. On days 1, 3, and 5 from admission, the intervention group will receive 200mg Venofer® (iron sucrose) diluted in 100ml saline, and the control group 100ml saline, also on days 1, 3 and 5. Patients will received conventional treatment in ortho-geriatric unit of the Hospital Infanta Sofia. Functional variables (activities of daily living and walking), cognitive (cognitive status and delirium), surgical, demographic and clinical characteristics will be collected during admission in order to assess the impact of treatment. A safety analysis of the treatment will also performed. Patients will be followed-up at 3, 6, and 12 months. The study will attempt to provide evidence on the impact of the intravenous iron administration on functional recovery. It will be determined whether iron therapy negatively affects the incidence of post-operative delirium. Finally, report will be presented on the safety data of intravenous iron in elderly HF patients, as well as the impact on allogenic blood transfusion savings. The inclusion of elderly HF patients admitted to an ortho-geriatric unit, in a clinical trial, will help to improve the knowledge of the treatment impact on a usual scenario, and provide useful data for use in other units.Sin financiaciónNo data JCR 20180.244 SJR (2018) Q3, 77/114 Geriatrics and Gerontology, 1828/2844 Medicine (miscellaneous); Q4, 28/36 AgingNo data IDR 2018UE

High penetrance of inferior vena cava system atresia in severe thrombophilia caused by homozygous antithrombin Budapest 3 variant: Description of a new syndrome.

Atresia of inferior vena cava (IVC) is a rare congenital malformation associated with high risk of venous thrombosis that still has unknown etiology, although intrauterine IVC thrombosis has been suggested to be involved. The identification of IVC atresia in a case with early idiopathic venous thrombosis and antithrombin deficiency caused by the homozygous SERPINC1 c.391C > T variant (p.Leu131Phe; antithrombin Budapest 3) encouraged us to evaluate the role of this severe thrombophilia in this vascular abnormality. We have done a cross-sectional study in previously identified cohorts of patients homozygous for the Budapest 3 variant (N = 61) selected from 1118 patients with congenital antithrombin deficiency identified in two different populations: Spain (N = 692) and Hungary (N = 426). Image analysis included computed tomography and phlebography. Atresia of the IVC system was observed in 17/24 cases (70.8%, 95% confidence interval [CI]: 48.9%-87.3%) homozygous for antithrombin Budapest 3 with available computed tomography (5/8 and 12/16 in the Spanish and Hungarian cohorts, respectively), 16 had an absence of infrarenal IVC and one had atresia of the left common iliac vein. All cases with vascular defects had compensatory mechanisms, azygos-hemiazygos continuation or double IVC, and seven also had other congenital anomalies. Short tandem repeat analysis supported the specific association of the IVC system atresia with SERPINC1. We show the first evidence of the association of a severe thrombophilia with IVC system atresia, supporting the possibility that a thrombosis in the developing fetal vessels is the reason for this anomaly. Our hypothesis-generating results encourage further studies to investigate severe thrombophilic states in patients with atresia of IVC

Assessment of plasma chitotriosidase activity, CCL18/PARC concentration and NP-C suspicion index in the diagnosis of Niemann-Pick disease type C : A prospective observational study

Niemann-Pick disease type C (NP-C) is a rare, autosomal recessive neurodegenerative disease caused by mutations in either the NPC1 or NPC2 genes. The diagnosis of NP-C remains challenging due to the non-specific, heterogeneous nature of signs/symptoms. This study assessed the utility of plasma chitotriosidase (ChT) and Chemokine (C-C motif) ligand 18 (CCL18)/pulmonary and activation-regulated chemokine (PARC) in conjunction with the NP-C suspicion index (NP-C SI) for guiding confirmatory laboratory testing in patients with suspected NP-C. In a prospective observational cohort study, incorporating a retrospective determination of NP-C SI scores, two different diagnostic approaches were applied in two separate groups of unrelated patients from 51 Spanish medical centers (n = 118 in both groups). From Jan 2010 to Apr 2012 (Period 1), patients with ≥2 clinical signs/symptoms of NP-C were considered 'suspected NP-C' cases, and NPC1/NPC2 sequencing, plasma chitotriosidase (ChT), CCL18/PARC and sphingomyelinase levels were assessed. Based on findings in Period 1, plasma ChT and CCL18/PARC, and NP-C SI prediction scores were determined in a second group of patients between May 2012 and Apr 2014 (Period 2), and NPC1 and NPC2 were sequenced only in those with elevated ChT and/or elevated CCL18/PARC and/or NP-C SI ≥70. Filipin staining and 7-ketocholesterol (7-KC) measurements were performed in all patients with NP-C gene mutations, where possible. In total across Periods 1 and 2, 10/236 (4%) patients had a confirmed diagnosis o NP-C based on gene sequencing (5/118 [4.2%] in each Period): all of these patients had two causal NPC1 mutations. Single mutant NPC1 alleles were detected in 8/236 (3%) patients, overall. Positive filipin staining results comprised three classical and five variant biochemical phenotypes. No NPC2 mutations were detected. All patients with NPC1 mutations had high ChT activity, high CCL18/PARC concentrations and/or NP-C SI scores ≥70. Plasma 7-KC was higher than control cut-off values in all patients with two NPC1 mutations, and in the majority of patients with single mutations. Family studies identified three further NP-C patients. This approach may be very useful for laboratories that do not have mass spectrometry facilities and therefore, they cannot use other NP-C biomarkers for diagnosis