Objective The efficacy and safety of caplacizumab (CPLZ) for patients (pts) with immune-mediated thrombotic thrombocytopenic purpura (iTTP; also known as acquired TTP) were demonstrated in the Phase 3 HERCULES trial, with a 28-day follow-up period after end of treatment. Post-HERCULES (NCT02878603) evaluated the long-term outcomes of pts with iTTP treated with CPLZ during HERCULES, and the safety and efficacy of repeated CPLZ use for iTTP recurrence. Methodology Over 3 years’ follow-up, pts could receive CPLZ with therapeutic plasma exchange (TPE) and immunosuppressive therapy (IST) for iTTP recurrence. Safety was assessed during the overall study period in the intention-to-observe (ITO) population; TTP-related events (TTP-related mortality, recurrence, or major thromboembolic events) were assessed in pts without recurrence in HERCULES or prior to post-HERCULES (efficacy ITO population). Safety and efficacy were also evaluated during recurrences. Results Of 104 pts enrolled, incidences of adverse events (AEs) were similar between pts treated with CPLZ+TPE+IST during HERCULES (n=75) and pts treated with TPE+IST only (n=29). TTP-related events occurred in 4/49 pts (8%) randomized to CPLZ vs 11/29 pts (38%) randomized to placebo. The first recurrence episode was resolved/resolving for all 13 pts treated with CPLZ for recurrence, including 9 pts with repeat CPLZ. The safety profile of CPLZ for recurrence was consistent with HERCULES. Conclusion Over long-term follow-up, the safety profile of patients treated with CPLZ in combination with TPE+IST was generally similar to those who received IST+TPE only, with no observed increases in iTTP recurrence. Repeat use of CPLZ was efficacious, with no new safety concerns.
Recommendations for the use of neurophysiological techniques in the diagnosis of brain death from the Clinical Neurophysiology Society of the Communities of Valencia and Murcia ( Guía Recomendaciones para el empleo de técnicas neurofisiológicas en el diagnóstico de muerte encefálica de la Sociedad de Neurofisiología Clínica de las Comunidades de Valencia y Murcia)
In Spain organ transplantation constitutes one of the greatest challenges and teamwork of hospital centres. It is estimated that in the year 2020 Spain contributed 19% of all donors to the European Union. The confirmatory support diagnosis recommends by law some complementary techniques in certain cases, including neurophysiological techniques, especially the use of electroencephalogram and evoked potentials. These cases require the clinical neurophysiologist to make the right clinical and technical decisions for the correct performance and interpretation of the same. To date, there is no national consensus on the performance of these techniques. Updated bibliographic review on neurophysiological techniques (electroencephalogram and evoked potentials). Analysis by Delphi method and expert judgment of the working group of the Clinical Neurophysiology Society of the Communities of Valencia and Murcia. Neurophysiological techniques can be a support in the diagnosis of encephalic death, both confirmatory and to shorten observation times. In order to perform them, minimum technical standards are required to allow optimal performance of the studies, especially taking into account medication, hemodynamic situation, absence of hypothermia, and age group. We present the first guide in Spanish elaborated by the Society of Neurophysiology of the Communities of Valencia and Murcia for the performance in our hospitals of neurophysiological techniques in the diagnosis of brain death. https://neurologia.com/revista/75/S03
Pharyngoplasty represents one of the most widely performed surgical procedures for the treatment of obstructive sleep apnea (OSA) in the presence of palate–oropharyngeal collapse. The learning curve for pharyngoplasties is steep and success is conditional on the correct use of the sutures and the careful application of the surgical steps in a narrow surgical field. The use of synthetic models may be conveniently and safely employed for hands-on surgical practice in pharyngoplasties, especially when fresh frozen cadaveric specimens are not available. We present the “Pharyngolab”, a new simulator for pharyngoplasties.
In many countries there are strong incentives for initiation of treatment with biosimilars in biologic‐naïve patients and non‐medical switch of ongoing treatment with originators, but real‐world data regarding the outcome of these treatments are scarce. The objective of this study is to analyze the drug survival of biosimilar adalimumab for treatment of psoriasis in real world clinical practice, and to determine if there are differences between treatment courses with transition from the originator (switch) or initiated with the biosimilar without switching (de novo treatment). A multicenter retrospective observational study was carried out in patients with psoriasis vulgaris, consecutively treated according to clinical practice with biosimilar adalimumab, in 17 Spanish hospitals between October 2016 and February 2021. Drug survival from start of treatment to last visit when discontinuation due to lack/loss of efficacy or adverse events was recorded, was analyzed with Kaplan‐Meier curves. Total follow‐up was recorded, and univariate and multivariate analyses with Cox proportional hazards regression model were carried out. Overall, 581 patients treated with biosimilar adalimumab were included in the study. On univariate analysis, increased drug survival was associated with male sex (HR = 1.874, p<0.001), age ≤ 65 (HR =1.673, p=0.012), coexisting psoriatic arthritis (HR=2.080,p=0.001) and switch from the originator (HR = 6.153, p<0.001). These associations were confirmed in multivariate analysis. In Spanish real world clinical practice, drug survival of adalimumab biosimilar is longer in males, younger patients, patients with psoriatic arthritis, and patients who switch from adalimumab originator (compared to biologic‐naïve patients who start adalimumab biosimilar as their first biologic). This article is protected by copyright. All rights reserved.
Background The survival of patients with systemic lupus erythematosus (SLE) has increased in recent years, but they have higher morbidity and mortality than the general population. Purpose To study the prevalence of comorbidities in patients with SLE and its relationship with damage, gender and treatments received. Methods Cross-sectional multicenter descriptive study of a cohort of adult patients with SLE. Results We studied 3,656 patients, 90.3% women, mean age (±SD) at diagnosis of 35.2(±14.7) years and duration of SLE of 142.6(±100.8) months. We analyzed 27 comorbidities. 79.73% of the patients presented any, with the maximum accumulated being 14. The most frequent were smoking, dyslipidemia and arterial hypertension. 38.05% of patients accumulated damage. Males accumulated more comorbidities (85.48% vs. 79.1%, p=0.003) and damage (47.03% vs. 37.11%, p<0.001). The first criterion for SLE appeared at a younger age in patients who did not have comorbidities: 27.73(±12.04) years vs. 34.47(±14.76) years; p<0.001. We found that there is a positive correlation between the number of comorbidities and the number of systems with damage (Spearman’s Rho = 0.478, p<0.001). There is a positive correlation between the number of comorbidities and damaged systems with the number of hospitalizations by disease activity (Rho=0.265 and 0.396 respectively, p<0.001 in both contrasts) as well as with the number of serious infections (Rho=0.299 and 0.307 respectively, p <0.001 in both contrasts). We found more patients without comorbidities in those who did not receive glucocorticoids (9.94% vs. 15.48%, p<0.001) and more patients with comorbidities in those who did not receive antimalarials (89.1% vs. 81.78%, p<0.001). There were significant differences in the presence of comorbidities in those treated with cyclophosphamide, mycophenolate, azathioprine or rituximab. Conclusions A high percentage of patients with SLE have comorbidities. With few exceptions, they are more frequent in males. The onset of SLE was later in patients with more comorbidities. We found variations in comorbidities depending on the treatments received.
Cognitive biases have been demonstrated to be important in developing and maintaining psychosis. However, self-report measures for everyday clinical practice have been developed only recently. We aimed to study one of these instruments for assessing cognitive biases: the Davos Assessment of Cognitive Biases Scale (DACOBS). In a Spanish sample of 84 patients diagnosed with schizophrenia-spectrum disorders and 152 healthy controls, we examined a) the factor structure using Confirmatory Factor Analysis (CFA) to test the original one-, three- and seven-factor solutions, b) the reliability (Cronbach's alpha), c) the discriminative power (Multivariate Analysis of Covariance - MANCOVA) and d) the relationships of cognitive biases with positive psychotic-like experiences (PPLEs) in healthy individuals and with psychotic symptoms in schizophrenia-spectrum patients. The CFA revealed that the seven-factor solution achieved the best fit. The DACOBS overall scale (Cronbach's alpha = .92) and subscales obtained good internal consistencies. MANCOVA, controlling for age and education, demonstrated that all subscales differentiated between healthy controls and psychotic patients (Wilks' Lambda = 0.87; F7, 226 = 4.70; p < .000; partial eta squared = 0.13). In addition, the DACOBS showed high correlations with PPLEs (controls) and moderate correlations with positive and general symptoms (patients), demonstrating its predictive validity. Concluding, the DACOBS proved to be a psychometrically suitable instrument for assessing cognitive biases in psychosis and adequately differentiated between patients and healthy individuals within the Spanish population. Norm scores are provided.
Background: There is a need to better understand the experience of patients living with Alzheimer's disease (AD) in the early stages. Objective: The aim of the study was to evaluate the perception of quality of life in patients with early-stage AD. Methods: A multicenter, non-interventional study was conducted including patients of 50–90 years of age with prodromal or mild AD, a Mini-Mental State Examination (MMSE) score ≥22, and a Clinical Dementia Rating-Global score (CDR-GS) of 0.5.–1.0. The Quality of Life in Alzheimer ’s Disease (QoL-AD) questionnaire was used to assess health-related quality of life. A battery of self-report instruments was used to evaluate different psychological and behavioral domains. Associations between the QoL-AD and other outcome measures were analyzed using Spearman’s rank correlations. Results: A total of 149 patients were included. Mean age (SD) was 72.3 (7.0) years and mean disease duration was 1.4 (1.8) years. Mean MMSE score was 24.6 (2.1). The mean QoL-AD score was 37.9 (4.5). Eighty-three percent (n = 124) of patients had moderate-to-severe hopelessness, 22.1% (n = 33) had depressive symptoms, and 36.9% (n = 55) felt stigmatized. The quality of life showed a significant positive correlation with self-efficacy and negative correlations with depression, emotional and practical consequences, stigma, and hopelessness. Conclusion: Stigma, depressive symptoms, and hopelessness are frequent scenarios in AD negatively impacting quality of life, even in a population with short disease duration and minimal cognitive impairment.
The clinical course of COVID-19 is highly variable. It is therefore essential to predict as early and accurately as possible the severity level of the disease in a COVID-19 patient who is admitted to the hospital. This means identifying the contributing factors of mortality and developing an easy-to-use score that could enable a fast assessment of the mortality risk using only information recorded at the hospitalization. A large database of adult patients with a confirmed diagnosis of COVID-19 (n = 15,628; with 2,846 deceased) admitted to Spanish hospitals between December 2019 and July 2020 was analyzed. By means of multiple machine learning algorithms, we developed models that could accurately predict their mortality. We used the information about classifiers’ performance metrics and about importance and coherence among the predictors to define a mortality score that can be easily calculated using a minimal number of mortality predictors and yielded accurate estimates of the patient severity status. The optimal predictive model encompassed five predictors (age, oxygen saturation, platelets, lactate dehydrogenase, and creatinine) and yielded a satisfactory classification of survived and deceased patients (area under the curve: 0.8454 with validation set). These five predictors were additionally used to define a mortality score for COVID-19 patients at their hospitalization. This score is not only easy to calculate but also to interpret since it ranges from zero to eight, along with a linear increase in the mortality risk from 0% to 80%. A simple risk score based on five commonly available clinical variables of adult COVID-19 patients admitted to hospital is able to accurately discriminate their mortality probability, and its interpretation is straightforward and useful.
Resistant maltodextrin (RMD) was added at increasing concentrations (0%, 2.5%, 5% and 7.5%) before pasteurisation to orange juice to analyse its potential protective effect on the health-related bioactive compounds of pasteurised orange juice throughout its storage time. Samples were characterised in terms of basic physico-chemical properties and bioactive compounds at the beginning of the storage. Higher concentrations of RMD proved to better preserve the bioactive compounds of orange juice, thus obtaining a higher antioxidant capacity (AC). Stability of all samples was determined by measuring the same parameters at days 0, 15, 45, 75, 105, 136 and 170 of storage. °Brix and pH were very stable in all samples along storage, while all bioactive compouds had negative variations. However, RMD addition slightly improved ascorbic acid, vitamin C, total phenols, and total carotenoids retention, improving then its AC. This effect was greater in the 5% RMD-added samples. All bioactive compounds showed a positive Pearson's correlation coefficient with AC. Colour variations were also measured at days 105 and 170. All samples had a positive variation of all colour parameters, being this clearer at day 170. This work enlights the potential functionality of RMD to better preserve the health-related compounds of pasteurised orange juice.
Gender dysphoria affects 0.5% of people worldwide. Transgender men display a divergence between the female genetic sex and the gender male identity. To the best of our knowledge, we describe the first case report with regard to a transgender man with a dichorionic diamniotic twin pregnancy obtained by artificial insemination using donor sperm as a monoparental family, presenting early fetal growth restriction of both twins. The patient is a 35-year-old transgender man who had previously received gender-affirming hormone therapy based on testosterone for five years and had a prior bilateral mastectomy as gender-affirming surgery. Whether assisted reproductive techniques have any influence on obstetrical outcomes among these patients and whether prior long-term intake of gender-affirming hormone therapy has an impact on pregnancy and obstetrical outcomes remain to be elucidated.
Cladribine is a disease-modifying selective immune reconstitution oral therapy for adult patients with highly active relapsing multiple sclerosis (RMS). It was approved in the USA in 2019 and in Europe in 2017, thus there are still gaps in existing guidelines for using cladribine tablets in clinical practice. Nine experts with extensive experience in managing patients with multiple sclerosis in Spain identified some of the unanswered questions related to the real-life use of cladribine tablets. They reviewed the available clinical trial data and real-world evidence, including their own experiences of using cladribine, over the course of three virtual meetings held between November 2020 and January 2021. This article gathers their practical recommendations to aid treatment decision-making and optimise the use of cladribine tablets in patients with RMS. The consensus recommendations cover the following areas: candidate patient profiles, switching strategies (to and from cladribine), managing response to cladribine and safety considerations.
IntroductionThe aim of this study was to reach consensus on the use of PROs (patient-reported outcome measures) in people living with HIV (PLHIV).MethodsA scientific committee of professionals with experience in PROMs methodology issued recommendations and defined the points to support by evidence. A systematic review of the literature identified the coverage, utility, and psychometric properties of PROMs used in PLHIV. A Delphi survey was launched to measure the degree of agreement with the recommendations of a group of practicing clinicians and a group of patient representatives.ResultsFour principles and ten recommendations were issued; however, the results of the Delphi showed significant differences in the opinion between health professionals and PLHIV, and polarization within collectives, hampering consensus.Conclusions Despite a wealth of evidence on the benefit of PROMs, there are clear barriers to their use by healthcare professionals in HIV care. Intervention on these barriers is paramount to allow truly patient-centered care.Graphical abstract
Our modified barbed pharyngoplasty is the fusion of different ideas and techniques that started with the barbed reposition pharyngoplasty described by Vicini et al. Nevertheless, some changes have been made in accordance with the coaxial tubes’ theory proposed by Mantovani and incorporate the supratonsillar fat extraction performed in the Australian pharyngoplasty and in the relocation pharyngoplasty. These modifications involve more loops in the lateral pharyngeal walls and the soft palate, possibly optimizing surgical results.
To investigate the relationship of ambient temperature and atmospheric pressure (AP) at patient discharge after an episode of acute heart failure (AHF) with very early post-discharge adverse outcomes. We analyzed 14,656 patients discharged after an AHF episode from 26 hospitals in 16 Spanish cities. The primary outcome was the 7-day post-discharge combined adverse event (emergency department -ED- revisit or hospitalization due to AHF, or all-cause death), and secondary outcomes were these three adverse events considered individually. Associations (adjusted for patient and demographic conditions, and length of stay -LOS- during the AHF index episode) of temperature and AP with the primary and secondary outcomes were investigated. We used restricted cubic splines to model the continuous non-linear association of temperature and AP with each endpoint. Some sensitivity analyses were performed. Patients were discharged after a median LOS of 5 days (IQR = 1-10). The highest temperature at discharge ranged from - 2 to 41.6 °C, and AP was from 892 to 1037 hPa. The 7-day post-discharge combined event occurred in 1242 patients (8.4%), with percentages of 7-day ED-revisit, hospitalization and death of 7.8%, 5.1% and 0.9%, respectively. We found no association between the maximal temperature and AP on the day of discharge and the primary or secondary outcomes. Similarly, there were no significant associations when the analyses were restricted to hospitalized patients (median LOS = 7 days, IQR = 4-11) during the index event, or when lag-1, lag-2 or the mean of the 3 post-discharge days (instead of point estimation) of ambient temperature and AP were considered. Temperature and AP on the day of patient discharge are not independently associated with the risk of very early adverse events during the vulnerable post-discharge period in patients discharged after an AHF episode.
Introduction Prolonged intravenous infusion of beta-lactams increase the clinical cure rate compared to conventional administration in critical or septic patients. This study aimed to determine chemical stability and physical compatibility of meropenem at conditions used in clinical practice to evaluate the stability of the preparation during its administration and the possibility of anticipated preparation. Methods Admixtures in study were: (i) meropenem 6 g in 0.9% sodium chloride (NS) in infusor of 2 mL/h 50 mL or 10 mL/h 240 mL; (ii) meropenem 1 or 2 g in NS in infusion bag of 250 mL. Temperatures of study were: (i) infusor: 4.5 °C, 32 °C or 12 h at 4.5 °C followed by 32 °C; (ii) Infusion bag: 4.5 °C, 24.5 °C or 6 h at 4.5 °C followed by 24.5 °C. Time of study was 5–6 days in infusor and 1 day in infusion bag. Chemical stability was evaluated by high performance liquid chromatography and physical compatibility by measuring pH and visual inspection. Results Chemical stability and physical compatibility of meropenem in admixtures in infusors were reduced at high meropenem concentration and high temperature. Admixtures in infusion bag show chemical stability and physical compatibility for at least 1 day. Conclusion Administration of meropenem 6 g in infusion of 24 h in 240 mL of 0.9% NaCl in infusor of 10 mL/h could be possible if the admixture is infused at 4.5 °C. Extended infusion of meropenem 1 or 2 g in 0.9% NaCl in infusion bag (250 mL) in 3–4 h is also feasible. Anticipated preparation of the admixtures in infusion bag is possible with a stability of 24 h.
Introduction Breast milk is the optimal food during the first months of life. The main objective was to analyse the factors associated with not initiating breastfeeding in terms of maternal lifestyles, epidemiological characteristics and information on breastfeeding. Material and method Observational analytical study of cases and controls in 6 primary care centres. The sample included women with a child under 5 years, with an estimated necessary sample size of 166 cases (women who did not initiate breastfeeding) and 166 controls (women who began breastfeeding). Sociodemographic and maternal lifestyle variables were measured before and during pregnancy, such as physical activity using the BPAAT questionnaire, diet with the MEDAS-14 questionnaire, and tobacco and alcohol consumption. We assessed the information and opinions about breastfeeding as well as previous experience with it. Results The study included 348 women (174 cases and 174 controls) with a mean age of 33.4 years (SD, 5.4). The variables independently associated with not initiating breastfeeding were: absence of previous experience with breastfeeding (odds ratio [OR], 12.75), making the decision during pregnancy or delivery (OR, 10.55), not being married or in a partnership (OR, 3.42) and being sedentary for periods of 2 hours or greater/day during pregnancy (OR, 1.77). Conclusions In our study, the determining factors associated with not initiating breastfeeding were the lack of previous experience with breastfeeding, the timing of the decision about breastfeeding, and marital status. When it came to lifestyle, only a sedentary lifestyle was associated with not initiating breastfeeding, while dietary or other habits had no influence.
Introduction and objectives The sliding between internal and external segments of the myocardium assumes opposite directions in their movements, during the systolic and suction phases of the heart, generating friction. Our objective was to considerer the possibility of the existence of a lubricant that prevents friction wear in myocardial torsion and detorsion movements. Methods Twenty-four hearts were used: (a) Fifteen two-year-old bovine hearts weighing 800–1000 g. (b) 9 human hearts (two 16- and 23-week gestation embryos, one from a 10-year-old child weighing 250 g and 6 from adults, with an average weight of 300 g). In the hearts 5 transverse, 2 cm thick sections were made from base to apex to analyze the hyaluronic acid. All samples were subjected to histochemical analysis with Alcian blue staining, a reliable marker to identify the presence of hyaluronic acid, as an antifriction mechanism and even to provide a semi-quantitative assessment. Results In all the hearts analyzed, hyaluronic acid was found in the cleavage planes between the myocardial bundles. Histological and histochemical studies of the myocardium and its ducts (Thebesian and Langer) have shown that hyaluronic acid could be considered the antifriction effect, which flows throughout the myocardial thickness. Conclusions This process involves opposite directions of the muscle segments and of these against the septal area. Sliding between these segments assumes opposite courses during the phases of the cardiac cycle (systole and suction) generating friction. In order to carry out this work, there is an antifriction lubricating mechanism represented by the venous Thebesian and Langer ducts together with the presence of hyaluronic acid. It is understandable that the fascicles of the myocardium, one on top on the other but in discordant directions, implies that the friction between them without a lubricating mechanism would be a decrease in the capacity of movement due to friction.
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