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A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
No full textOur aim was to assess the value of nintedanib for non-idiopathic progressive fibrosing interstitial lung disease (non-IPF PF-ILD) and systemic sclerosis-associated ILD (SSc-ILD) in the Spanish context, using a multi-criteria decision analysis (MCDA). Following an adaptation of the Evidence and Value: Impact on DEcision Making (EVIDEM) MCDA methodology, the estimated value of nintedanib was obtained by means of an additive linear model that combined individual weights (100-points distribution) of criteria with the individual scoring of nintedanib in each criterion for every indication, assigned by a multidisciplinary committee of twelve clinicians, patients, pharmacists, and decision-makers. To assess the reproducibility, an alternative weighting method was applied, as well as a re-test of weights and scores at a different moment of time. The experts committee recognized nintedanib as an intervention with a positive value contribution in comparison to placebo for the treatment of non-IPF PF-ILD (0.50 ± 0.16, on a scale from -1 to 1) and SSc-ILD (0.40 ± 0.12), diseases which were considered as very severe and with high unmet needs. The drug was perceived as a treatment that provides an added therapeutic benefit for patients (0.06-0.07), given its proven clinical efficacy (0.05-0.06), slight improvements in patient-reported outcomes (0.01-0.02), and similar safety profile than placebo (-0.04-0.00), which will likely be positioned as a recommended therapy in the next clinical practice guidelines updates. Under this increasingly used methodology, nintedanib has shown to provide a positive value estimate for non-IPF PF-ILD and SSc-ILD when compared to placebo in Spain.S
Brain Structural and Functional Changes in Cognitive Impairment Due to Alzheimer's Disease.
No full textCognitive neuropsychology seeks a potential alignment between structural and functional brain features to explain physiological or pathological processes, such as Alzheimer's disease (AD). Several structural and functional brain changes occurring during the disease, including cognitive impairment, are found at the end of the patient's life, but we need to know more about what happens before its onset. In order to do that, we need earlier biomarkers at preclinical stages, defined by those biomarkers, to prevent the cognitive impairment. In this minireview, we have tried to describe the structural and functional changes found at different stages during AD, focusing on those features taking place before clinical diagnosis.S
Physical activity phenotypes and mortality in older adults: a novel distributional data analysis of accelerometry in the NHANES.
No full textPhysical activity is deemed critical to successful ageing. Despite evidence and progress, there is still a need to determine more precisely the direction, magnitude, intensity, and volume of physical activity that should be performed on a daily basis to effectively promote the health of individuals. This study aimed to assess the clinical validity of new physical activity phenotypes derived from a novel distributional functional analysis of accelerometer data in older adults. A random sample of participants aged between 65 and 80 years with valid accelerometer data from the National Health and Nutrition Examination Survey (NHANES) 2011-2014 was used. Five major clinical phenotypes were identified, which provided a greater sensitivity for predicting 5-year mortality and survival outcomes than age alone, and our results confirm the importance of moderate-to-vigorous physical activity. The new clinical physical activity phenotypes are a promising tool for improving patient prognosis and for directing to more targeted intervention planning, according to the principles of precision medicine. The use of distributional representations shows clear advantages over more traditional metrics to explore the effects of the full spectrum of the physical activity continuum on human health.S
Cross-cultural adaptation and psychometric validation of a Spanish version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.
No full textSuccessful deprescribing depends largely on factors related to the patient. The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was developed with the objective of evaluating the beliefs and attitudes of older adults and caregivers towards deprescribing. The present study was designed to validate a Spanish version of the rPATD questionnaire, both the versions for older adults and for caregivers, through a qualitative validation phase and the analysis of its psychometric properties. Cross-sectional validation study. Primary care settings in Málaga (Spain). A sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study. In the qualitative validation stage, the rPATD questionnaire was translated/back-translated and subjected to a cross-cultural adaptation to evaluate its face validity and feasibility. Next, its psychometric properties were assessed. Confirmatory factor analysis was used to evaluate construct validity. Internal consistency was determined using Cronbach's alpha test. Criterion validity through pre-established hypotheses from the Beliefs about Medicines Questionnaire (BMQ) Specific-Concerns Scale, and test-retest reliability were analysed. Confirmatory factor analysis verified the four-factor structure of the original rPATD questionnaire, with items loading into four factors: involvement, burden, appropriateness and concerns about stopping. The Cronbach's alpha coefficient of the factors ranged from 0.683 to 0.879. The burden, appropriateness and concerns about stopping factors were significantly correlated with the BMQ Specific-Concerns Score, except for the concerns about stopping factor in the older adults' version. The consistency of the items between administration times (test-retest reliability) showed weighted Cohen's kappa values ranging from moderate (>0.4) to very good (>0.8). The Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.S
Role of long non-coding RNAs in adipose tissue metabolism and associated pathologies.
No full textThe incidence of obesity and its related disorders has increased dramatically in recent years and has become a pandemic. Adipose tissue is a crucial regulator of these diseases due to its endocrine capacity. Thus, understanding adipose tissue metabolism is essential to finding new effective therapeutic approaches. The "omic" revolution has identified new concepts about the complexity of the signaling pathways involved in the pathophysiology of adipose tissue-associated disorders. Specifically, advances in transcriptomics have allowed its application in clinical practice and primary or secondary prevention. Long non-coding RNAs (lncRNAs) have emerged as critical regulators of adipose tissue since they can modulate gene expression at the epigenetic, transcriptional, and post-transcriptional levels. They interact with DNA, RNA, protein complexes, other non-coding RNAs, and microRNAs to regulate a wide range of physiological and pathological processes. Here, we review the emerging field of lncRNAs, including how they regulate adipose tissue biology, and discuss circulating lncRNAs, which may represent a turning point in the diagnosis and treatment of adipose tissue-associated disorders. We also highlight potential biomarkers of obesity and diabetes that could be considered as therapeutic targets.This study was supported by the Spanish Ministry of Science and
Innovation (MCIN) (PID2020-114953RB-C21 to LH and DS, co-funded
by the European Regional Development Fund [ERDF], PID2020- 114343GA-100 to MA, and PID2019-110063RA-I00 to JP and MC), the Biomedical Research Centre in Pathophysiology of Obesity and Nutrition (CIBEROBN) (Grant CB06/03/0001 to LH), and the Merck Health Foundation (to LH). AC is a recipient of the Formación de Personal Investigador (FPI) doctoral fellowship from the MCIN. We thank MCarimen Soler-Vazquez for her expert assistance in the preparation of Fig. 1.S
Computerized clinical decision support systems for prescribing in primary care: main characteristics and implementation impact-protocol of an evidence and gap map.
No full textComputerized clinical decision support systems are used by clinicians at the point of care to improve quality of healthcare processes (prescribing error prevention, adherence to clinical guidelines, etc.) and clinical outcomes (preventive, therapeutic, and diagnostics). Attempts to summarize results of computerized clinical decision support systems to support prescription in primary care have been challenging, and most systematic reviews and meta-analyses failed due to an extremely high degree of heterogeneity present among the included primary studies. The aim of our study will be to synthesize the evidence, considering all methodological factors that could explain these differences, and build an evidence and gap map to identify important remaining research questions. A literature search will be conducted from January 2010 onwards in MEDLINE, Embase, the Cochrane Library, and Web of Science databases. Two reviewers will independently screen all citations, full text, and abstract data. The study methodological quality and risk of bias will be appraised using appropriate tools if applicable. A flow diagram with the screened studies will be presented, and all included studies will be displayed using interactive evidence and gap maps. Results will be reported in accordance with recommendations from the Campbell Collaboration on the development of evidence and gap maps. Evidence behind computerized clinical decision support systems to support prescription use in primary care has so far been difficult to be synthesized. Evidence and gap maps represent an innovative approach that has emerged and is increasingly being used to address a broader research question, where multiple types of intervention and outcomes reported may be evaluated. Broad inclusion criteria have been chosen with regard to study designs, in order to collect all available information. Regarding the limitations, we will only include English and Spanish language studies from the last 10 years, we will not perform a grey literature search, and we will not carry out a meta-analysis due to the predictable heterogeneity of available studies.S
Dysregulation of the splicing machinery in leukocytes from ankylosing spondylitis patients is associated to disease pathogenesis
No full textBackground: Ankylosing spondylitis (AS) is a chronic inflammatory disease, of unknown aetiology, associated to the development of several comorbidities such as atherosclerosis. Splicing is a post-transcriptional process involved in the RNA maturation. Recent studies have revealed that a pathological dysregulation of the splicing machinery or spliceosome is associated to several human diseases. Yet, the spliceosome alterations have not been described in AS. Objectives: 1) To analyze whether dysregulation of the spliceosome is present in AS. 2) To evaluate the association between the alteration of this process and the clinical, inflammatory, oxidative, and atherogenic profiles present in this pathology. Methods: Fourteen AS patients and 14 healthy donors (HDs) were included in the study. Disease function and activity status were analyzed using the BASFI and BASDAI. The expression of selected components of the major-(n=12) and minor-spliceosome (n=4), and splicing factors (n=28) was evaluated in purified monocytes, lymphocytes and neutrophils from patients and HDs (n=14 each) by Fluidigm methodology. Oxidative stress, inflammation and atherogenesis were evaluated by flow cytometry and RT-PCR. Endothelial function was determined by the post occlusive hyperaemia test using Laser-Doppler.S
Circadian clock gene variants and their link with chronotype, chrononutrition, sleeping patterns and obesity in the European prospective investigation into cancer and nutrition (EPIC) study.
No full textThe circadian clock is involved in the control of daily rhythms and is related to the individual's chronotype, i.e., the morningness-eveneningness preference. Knowledge is limited on the relationship between circadian genes, chronotype, sleeping patterns, chronutrition and obesity. The aim was to explore these associations within the EPIC-Spain cohort study. There were 3183 subjects with information on twelve genetic variants of six genes (PER1, PER2, PER3, CRY1, NR1D1, CLOCK). Their association was evaluated with: chronotype and sleeping duration/quality (assessed by questionnaires), chrononutrition (number of meals and timing of intake assessed by a diet history), and also anthropometric measures of obesity at early and late adulthood (in two points in time), such as weight and waist circumference (assessed by physical measurements). Multivariable logistic and linear regression as well as additive genetic models were applied. Odds ratios (ORs), β coefficients, and p-values corrected for multiple comparisons were estimated. Genetic risk scores (GRS) were built to test gene-outcome associations further. At nominal significance level, the variant rs2735611 (PER1 gene) was associated with a 11.6% decrease in long-term weight gain (per-allele β = -0.12), whereas three CLOCK gene variants (rs12649507, rs3749474 and rs4864548), were associated with a ∼20% decrease in waist circumference gain (per-allele β ∼ -0.19). These and other associations with body measures did not hold after multiple testing correction, except waist-to-hip ratio and rs1801260, rs2070062 and rs4580704 (CLOCK gene). Associations with chrononutrition variables, chronotype and sleep duration/quality failed to reach statistical significance. Conversely, a weighted GRS was associated with the evening/late chronotype and with all other outcomes (p Genetic variants of some circadian clock genes could explain the link between genetic susceptibility to the individual's chronotype and obesity risk.The authors are thankful to the study participants of the EPICSpain chronodiet study. We also acknowledge the collaboration of
Biobank Network of the Region of Murcia, BIOBANC-MUR, registered on the Registro Nacional de Biobancos with registration
number B.0000859. BIOBANC-MUR is supported by the “Instituto
de Salud Carlos III" (project PT20/00109), by “Instituto Murciano de
Investigacion Biosanitaria Virgen de la Arrixaca, IMIB ” and by
“Consejeria de Salud de la Comunidad Autonoma de la Regi on de
Murcia". Also, we acknowledge the Basque Biobank, which belongs
to the Basque Government, Department of Health, with registration
number B.0000140, and the BIOBANCO del Principado de Asturias
with registration number B.0000827. The genotyping was performed at the Spanish National Cancer Research Centre, in the
HumanGenotyping lab, a member of CeGen, PRB3 and is supported
by grant PT17/0019, of the PE IþDþi 2013e2016, funded by ISCIII
and ERDF.S
Prevalence, Incidence, and Risk Factors for Intestinal Colonization Due to Fluoroquinolone-Resistant ST131 Escherichia coli: a Longitudinal Study in Highly Dependent, Long-Term Care Facility Residents.
No full textEscherichia coli ST131 clade C is an important driver for fluoroquinolone resistance (FQ-R). We conducted a prospective observational study in residents from two long-term care facilities (LTCFs) in Seville, Spain, in 2018. Fecal swabs and environmental samples were obtained. E. coli isolates were screened for clade C, FQ-R ST131 by PCR, and molecular typing by PFGE; representatives from pulsotypes were studied by whole-genome-sequencing (WGS) and assigned to lineages (cgSTs). Prevalence of colonization at each time point, incidence density, and risk factors for acquisition were studied. Seventy-six FQ-R ST131 E. coli isolates belonging to 34 cgSTs were obtained; 24 belonging to subclade C1 (116 isolates, 65.9%) and 10 to C2 (60, 34.1%). C1 lineages showed lower virulence scores than C2 (median [IQR], 19 [18 to 20] versus 21 [20 to 21.5], P = 0.001) and higher number of plasmids (4 [3 to 5] versus 2 [2 to 3], P = 0.01). aac(6')-Ib-cr and blaOXA-1 were less frequent in C1 than C2 (2 [8.3%] versus 6 [60%], P = 0.003 for both); ESBL genes were detected in eight (33.3%) C1 (5 blaCTX-M-27) and three (30%) C2 (all blaCTX-M-15). Of the 82 residents studied, 49 were colonized at some point (59.7%), with a pooled prevalence of 38.6%. Incidence density of new lineage acquisition was 2.22 per 100 resident weeks (1.28 and 0.93 C1 and C2 subclades, respectively). Independent risk factors for acquisitions were having a colonized roommate (HR = 4.21; 95% CI = 1.71 to 10.36; P = 0.002) and urinary or fecal incontinence (HR = 2.82; 95% CI = 1.21 to 6.56; P = 0.01). LTCFs are important reservoirs of clade C ST131 E. coli. The risk factors found suggest that cross-transmission is the most relevant transmission mechanisms. IMPORTANCE We aimed at investigating the microbiological and epidemiological features of clade C fluoroquinolone-resistant ST131 E. coli isolates colonizing highly dependent residents in long-term care facilities (LTCFs) during 40 weeks and the risk factors of acquisition. Isolates from C1 and C2 subclades were characterized in this environment. The clonality of the isolates was characterized and they were assigned to lineages (cgSTs), Resistance genes, virulence factors, and plasmids were also described. This study suggests that cross-transmission is the most relevant transmission mechanisms; however, environmental colonization might also play a role. We believe the data provide useful information to depict the epidemiology of these bacteria by merging detailed microbiological and epidemiological information.S
Renal Function Impact in the Prognostic Value of Galectin-3 in Acute Heart Failure.
No full textGalectin-3 (Gal-3) is an inflammatory marker associated with the development and progression of heart failure (HF). A close relationship between Gal-3 levels and renal function has been observed, but data on their interaction in patients with acute HF (AHF) are scarce. We aim to assess the prognostic relationship between renal function and Gal-3 during an AHF episode. This is an observational, prospective, multicenter registry of patients hospitalized for AHF. Patients were divided into two groups according to estimated glomerular filtration rate (eGFR): preserved renal function (eGFR ≥ 60 mL/min/1.73 m2) and renal dysfunction (eGFR We included 1,201 patients in whom Gal-3 values were assessed at admission. The median value of Gal-3 in our population was 23.2 ng/mL (17.3-32.1). Gal-3 showed a negative correlation with eGFR (rho = -0.51; p Gal-3 is a marker of high mortality in patients with acute HF and renal dysfunction. Renal function influences the prognostic value of Gal-3 levels, which should be adjusted by eGFR for a correct interpretation.Bio-Merieux provided the reagents for Galectin-3 analysis free of charge. The company was not involved in the study design, data collection and statistical exploitation, or manuscript writing.S