10 research outputs found
The Nutrition in Early Life and Asthma (NELA) birth cohortstudy: Rationale, design, and methods
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© 2021 The Authors. Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.Background: Primary prevention strategies for asthma are lacking. Its inception probably starts in utero and/or during the early postnatal period as the developmental
origins of health and disease (DOHaD) paradigm suggests.
Objectives: The main objective of Nutrition in Early Life and Asthma (NELA) cohort
study is to unravel whether the following factors contribute causally to the developmental origins of asthma: (1) maternal obesity/adiposity and foetal growth; (2) maternal and child nutrition; (3) outdoor air pollution; (4) endocrine disruptors; and (5)
maternal psychological stress. Maternal and offspring biological samples are used to
assess changes in offspring microbiome, immune system, epigenome and volatilome
as potential mechanisms influencing disease susceptibility.
Population: Randomly selected pregnant women from three health areas of Murcia, a
south-eastern Mediterranean region of Spain, who fulfilled the inclusion criteria were
invited to participate at the time of the follow-up visit for routine foetal anatomy scan
at 19–22 weeks of gestation, at the Maternal-Fetal Medicine Unit of the “Virgen de
la Arrixaca” University Clinical Hospital over a 36-month period, from March 2015 to
April 2018.
Design: Prospective, population-based, maternal-child, birth cohort study.
Methods: Questionnaires on exposures and outcome variables were administered to
mothers at 20–24 gestation week; 32–36 gestation week; and delivery. Children wer
Red de Publicidad y Relaciones Públicas: de las bases a la especialización
Memoria final del proyecto de la red ESMA del curso académico 2006-2007. Instituto de Ciencias de la Educación de la Universidad de Alicante.El proyecto se inserta en el Programa de Redes de Investigación promovido por el Instituto de Ciencias de la Educación y el Vicerrectorado de Calidad y Armonización Europea de la Universidad de Alicante
Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World—MEMOGAL Study
Introduction
The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in cognitive function domains, to analyze subgroups by the low-density lipoprotein cholesterol (LDL-C) achieved, and differences between alirocumab and evolocumab.
Methods
This has a multicenter, quasi-experimental design carried out in 12 Spanish hospitals from May 2020 to February 2023. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA).
Results
Among 158 patients followed for a median of 99 weeks, 52% were taking evolocumab and 48% alirocumab; the mean change from baseline in MoCA score at follow-up was + 0.28 [95% CI (− 0.17 to 0.73; p = 0.216)]. There were no significant differences in the secondary endpoints—the visuospatial/executive domain + 0.04 (p = 0.651), naming domain − 0.01 (p = 0.671), attention/memory domain + 0.01 (p = 0.945); language domain − 0.10 (p = 0.145), abstraction domain + 0.03 (p = 0.624), and orientation domain − 0.05 (p = 0.224)—but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (p = 0.001). Neither were there any differences in the three stratified subgroups according to lowest attained LDL-C level—0–54 mg/dL, 55–69 mg/dL and ≥ 70 mg/dL; p = 0.454—or between alirocumab and evolocumab arms.
Conclusion
We did not find effect of monoclonal antibody PCSK9i on neurocognitive function over 24 months of treatment, either in global MoCA score or different cognitive domains. An improvement in delayed recall memory was shown. The study showed no differences in the cognitive function between the prespecified subgroups, even among patients who achieved very low levels of LDL-C. There were no differences between alirocumab and evolocumab.
Registration
ClinicalTtrials.gov Identifier number NCT04319081Open Access funding provided thanks to the CRUE-CSIC agreement with Springer NatureS
The Nutrition in Early Life and Asthma (NELA) birth cohort study: Rationale, design, and methods
Acceso restringidoBackground: Primary prevention strategies for asthma are lacking. Its inception probably starts in utero and/or during the early postnatal period as the developmental origins of health and disease (DOHaD) paradigm suggests. Objectives: The main objective of Nutrition in Early Life and Asthma (NELA) cohort study is to unravel whether the following factors contribute causally to the developmental origins of asthma: (1) maternal obesity/adiposity and foetal growth; (2) maternal and child nutrition; (3) outdoor air pollution; (4) endocrine disruptors; and (5) maternal psychological stress. Maternal and offspring biological samples are used to assess changes in offspring microbiome, immune system, epigenome and volatilome as potential mechanisms influencing disease susceptibility. Population: Randomly selected pregnant women from three health areas of Murcia, a south-eastern Mediterranean region of Spain, who fulfilled the inclusion criteria were invited to participate at the time of the follow-up visit for routine foetal anatomy scan at 19–22 weeks of gestation, at the Maternal-Fetal Medicine Unit of the “Virgen de la Arrixaca” University Clinical Hospital over a 36-month period, from March 2015 to April 2018. Design: Prospective, population-based, maternal-child, birth cohort study. Methods: Questionnaires on exposures and outcome variables were administered to mothers at 20–24 gestation week; 32–36 gestation week; and delivery. Children were surveyed at birth, 3 and 18 months of age and currently at 5 years. Furthermore, physical examinations were performed; and different measurements and biological samples were obtained at these time points. Preliminary results: Among the 1350 women invited to participate, 738 (54%) were finally enrolled in the study and 720 of their children were eligible at birth. The adherence was high with 612 children (83%) attending the 3 months’ visit and 532 children (72%) attending the 18 months’ visit. Conclusion: The NELA cohort will add original and unique knowledge to the developmental origins of asthma
Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study
Background Results from retrospective studies suggest that use of neuromuscular blocking agents during general
anaesthesia might be linked to postoperative pulmonary complications. We therefore aimed to assess whether the use
of neuromuscular blocking agents is associated with postoperative pulmonary complications.
Methods We did a multicentre, prospective observational cohort study. Patients were recruited from 211 hospitals in
28 European countries. We included patients (aged ≥18 years) who received general anaesthesia for any in-hospital
procedure except cardiac surgery. Patient characteristics, surgical and anaesthetic details, and chart review at discharge
were prospectively collected over 2 weeks. Additionally, each patient underwent postoperative physical examination
within 3 days of surgery to check for adverse pulmonary events. The study outcome was the incidence of postoperative
pulmonary complications from the end of surgery up to postoperative day 28. Logistic regression analyses were
adjusted for surgical factors and patients’ preoperative physical status, providing adjusted odds ratios (ORadj) and
adjusted absolute risk reduction (ARRadj). This study is registered with ClinicalTrials.gov, number NCT01865513.
Findings Between June 16, 2014, and April 29, 2015, data from 22803 patients were collected. The use of neuromuscular
blocking agents was associated with an increased incidence of postoperative pulmonary complications in patients who
had undergone general anaesthesia (1658 [7·6%] of 21694); ORadj 1·86, 95% CI 1·53–2·26; ARRadj –4·4%, 95% CI
–5·5 to –3·2). Only 2·3% of high-risk surgical patients and those with adverse respiratory profiles were anaesthetised
without neuromuscular blocking agents. The use of neuromuscular monitoring (ORadj 1·31, 95% CI 1·15–1·49;
ARRadj –2·6%, 95% CI –3·9 to –1·4) and the administration of reversal agents (1·23, 1·07–1·41; –1·9%, –3·2 to –0·7)
were not associated with a decreased risk of postoperative pulmonary complications. Neither the choice of sugammadex
instead of neostigmine for reversal (ORadj 1·03, 95% CI 0·85–1·25; ARRadj –0·3%, 95% CI –2·4 to 1·5) nor extubation at
a train-of-four ratio of 0·9 or more (1·03, 0·82–1·31; –0·4%, –3·5 to 2·2) was associated with better pulmonary outcomes.
Interpretation We showed that the use of neuromuscular blocking drugs in general anaesthesia is associated with an
increased risk of postoperative pulmonary complications. Anaesthetists must balance the potential benefits of
neuromuscular blockade against the increased risk of postoperative pulmonary complications
Chronic coronary syndromes without standard modifiable cardiovascular risk factors and outcomes: the CLARIFY registry
Background and Aims:
It has been reported that patients without standard modifiable cardiovascular (CV) risk factors (SMuRFs—diabetes, dyslipidaemia, hypertension, and smoking) presenting with first myocardial infarction (MI), especially women, have a higher in-hospital mortality than patients with risk factors, and possibly a lower long-term risk provided they survive the post-infarct period. This study aims to explore the long-term outcomes of SMuRF-less patients with stable coronary artery disease (CAD).
Methods:
CLARIFY is an observational cohort of 32 703 outpatients with stable CAD enrolled between 2009 and 2010 in 45 countries. The baseline characteristics and clinical outcomes of patients with and without SMuRFs were compared. The primary outcome was a composite of 5-year CV death or non-fatal MI. Secondary outcomes were 5-year all-cause mortality and major adverse cardiovascular events (MACE—CV death, non-fatal MI, or non-fatal stroke).
Results:
Among 22 132 patients with complete risk factor and outcome information, 977 (4.4%) were SMuRF-less. Age, sex, and time since CAD diagnosis were similar across groups. SMuRF-less patients had a lower 5-year rate of CV death or non-fatal MI (5.43% [95% CI 4.08–7.19] vs. 7.68% [95% CI 7.30–8.08], P = 0.012), all-cause mortality, and MACE. Similar results were found after adjustments. Clinical event rates increased steadily with the number of SMuRFs. The benefit of SMuRF-less status was particularly pronounced in women.
Conclusions:
SMuRF-less patients with stable CAD have a substantial but significantly lower 5-year rate of CV death or non-fatal MI than patients with risk factors. The risk of CV outcomes increases steadily with the number of risk factors