To determine the association between ultra-processed food (UPF) intake and all-cause mortality in a representative sample of Spanish population.
Prospective cohort design in which follow-up lasted ...from baseline (1991) to mortality date or 31 December 2017, whichever was first. Dietary information was collected using a validated frequency questionnaire and categorised following the NOVA classification according to the extent of food processing. The association between consumption of UPF and mortality was analysed using Cox models. Isoenergetic substitution models were constructed to compare the health effects of the NOVA groups.
Cohort from the Diet and Risk of Cardiovascular Diseases (CVD) in Spain (DRECE) study, representative of the Spanish population.
Totally, 4679 subjects between 5 and 59 years old.
Average consumption of UPF was 370·8 g/d (24·4 % of energy intake). After a median follow-up of 27 years, 450 deaths occurred. Those who consumed the highest amount of UPF had higher risk of mortality. For every 10 % of the energy intake from UPF consumption, an increase of 15 % in the hazard of all-cause mortality was observed (HR 1·15; (95 % CI 1·03, 1·27); P-value = 0·012). Substitution of UPF with minimally processed foods was significantly associated with a decreased risk of mortality.
An increase in UPF consumption was associated with higher risk of all-cause mortality in a representative sample of the Spanish population. Moreover, the theoretical substitution of UPF with unprocessed or minimally processed foods leads to a decrease in mortality. These results support the need to promote diets based on unprocessed or minimally processed foods.
Front-of-pack labels can improve the ability of consumers to identify which foods are healthier, making them a useful public health tool. Nutri-Score is a front-of-pack labelling system adopted by ...several European countries. This system ranks foods according to their nutritional quality, but does not consider other dimensions such as the degree of food processing. The aim of this study is to compare the nutritional quality (as assessed by Nutri-Score) and the ultra-processing (as assessed by the NOVA classification) of foods in the Open Food Facts database. A simple correspondence analysis was carried out to study the relationship between the two systems. Ultra-processed foods (NOVA 4) were found in all Nutri-Score categories, ranging from 26.08% in nutritional category A, 51.48% in category B, 59.09% in category C, 67.39% in category D to up to 83.69% in nutritional category E. Given the negative effect that the consumption of ultra-processed foods has on different aspects of health, front-of-pack labelling with Nutri-Score should at least be accompanied by complementary labelling indicating the level of processing, such as the NOVA classification.
Immune checkpoint inhibitors (ICIs) are soluble antibodies that have dramatically changed the outcomes including overall survival in a subset of kidney tumors, specifically in renal cell carcinoma ...(RCC). To date, there is no a single predictive biomarker approved to be used to select the patients that achieve benefit from ICIs targeting. It seems reasonable to analyze whether the programmed death-ligand 1 (PD-L1) expression could be useful. To assess the role of PD-L1 expression as a potential predictive biomarker for benefit of ICIs in RCC patients, we performed a search of randomized clinical trials (RCTs) comparing ICIs (monotherapy or in combination with other therapies) to standard of care in metastatic RCC patients according to PRISMA guidelines. Trials must have included subgroup analyses evaluating the selected outcomes (progression-free survival (PFS) and overall survival (OS)) in different subsets of patients according to PD-L1 expression on tumor samples. Hazard ratios with confidence intervals were used as the measure of efficacy between groups. A total of 4635 patients (six studies) were included (ICIs arm: 2367 patients; standard of care arm: 2268 patients). Globally, PFS and OS results favored ICIs. Differential expression of PD-L1 on tumor samples could select a subset of patients who could benefit more in terms of PFS (those with higher levels; p-value for difference between subgroups: <0.0001) but it did not seem to impact in OS results (p-value for difference: 0.63). As different methods to assess PD-L1 positivity were used among trials, this heterogeneity could have an influence on the results. PD-L1 could represent a biomarker to test PFS in clinical trials but its value for OS is less clear. In this meta-analysis, the usefulness of PD-L1 expression as a predictive biomarker to select treatment in metastatic RCC patients was not clearly shown.
Urinary incontinence is one of the most serious complications of prostate cancer treatment. The objective of this study was to assess efficacy and safety of Adjustable Transobturator Male System ...(ATOMS) compared to Adjustable Continence Therapy (proACT) for male stress urinary incotinence according to literature findings.
A systematic review and meta-analysis on adjustable devices ATOMS and ProACT is presented. Studies on female or neurogenic incontinence were excluded. Differences between ATOMS and proACT in primary objective: dryness status (no-pad or one safety pad/day) after initial device adjustment, and in secondary objectives: improvement, satisfaction, complications and device durability, were estimated using random-effect model. Statistical heterogeneity among studies included in the meta-analysis was assessed using tau2, Higgins´s I2 statistics and Cochran´s Q test.
Combined data of 41 observational studies with 3059 patients showed higher dryness (68 vs. 55%; p = .01) and improvement (91 vs. 80%; p = .007) rate for ATOMS than ProACT. Mean pad-count (-4 vs. -2.5 pads/day; p = .005) and pad-test decrease (-425.7 vs. -211.4 cc; p < .0001) were also significantly lower. Satisfaction was higher for ATOMS (87 vs. 56%; p = .002) and explant rate was higher for proACT (5 vs. 24%; p < .0001). Complication rate for ProACT was also higher, but not statistically significant (17 vs. 26%; p = .07). Mean follow-up was 25.7 months, lower for ATOMS than ProACT (20.8 vs. 30.6 months; p = .02). The rate of working devices favoured ATOMS at 1-year (92 vs. 76; p < .0001), 2-years (85 vs. 61%; p = .0008) and 3-years (81 vs. 58%; p = .0001). Significant heterogeneity was evidenced, due to variable incontinence severity baseline, difficulties for a common reporting of complications, different number of adjustments and time of follow-up and absence of randomized studies.
Despite the limitations that studies available are exclusively descriptive and the follow-up is limited, literature findings confirm ATOMS is more efficacious, with higher patient satisfaction and better durability than ProACT to treat male stress incontinence.
The antiphospholipid syndrome (APS) is defined by simultaneous presence of vascular clinical events and antiphospholipid antibodies (aPL). The aPL considered as diagnostics are lupus anticoagulant ...and antibodies anticardiolipin (aCL) and anti-ß2 glycoprotein-I (aB2GP1). During recent years, IgA aB2GP1 antibodies have been associated with thrombotic events both in patients positive, and mainly negative for other aPL, however its value as a pro-thrombotic risk-factor in asymptomatic patients has not been well defined.
To test the role of IgA anti B2GP1 as a risk factor for the development of APS-events (thrombosis or pregnancy morbidity) in asymptomatic population with a 5-year follow-up.
244 patients isolated positive for anti-beta2-glycoprotein I IgA (Group-1 study) and 221 negative patients (Group-2 control) were studied. All the patients were negative for IgG and IgM aCL.
During the follow-up, 45 patients (9.7%) had APS-events, 38 positive for IgA-aB2GP1 and 7 negative (15.6% vs 3.2%, p<0.001). The incidence rate of APS-events was 3.1% per year in IgA-aB2GP1 positive patients and 0.6% per year in the control group. Arterial thrombosis were the most frequent APS-events (N = 25, 55%) and were mainly observed in Group-1 patients (21 vs 4, p = 0.001). Multivariate analysis were shown as independent risk-factors for the development of APS-events, age, sex (men) and presence of IgA-aB2GP1 (odds ratio 5.25, 95% CI 2.24 to 12.32).
The presence of IgA-aB2GP1 in people with no history of APS-events is the main independent risk factor for the development of these types of events, mainly arterial thrombosis.
Objectives
Imported Chagas disease (CD) is an emerging health problem in Europe due to immigration from endemic countries. Although WHO currently recommends two different serological methods to ...establish diagnosis, new tools like the ARCHITECT Chagas assay have potential for use as a single diagnostic test. Our objective was to determine an optimal signal‐to‐cut‐off (S/CO) value for the ARCHITECT Chagas assay to diagnose CD with a single test.
Methods
A retrospective study conducted at the 12 de Octubre University Hospital (Madrid, Spain). All patients with requests for Chagas screening between January 2014 and August 2017 were consecutively included. All samples were routinely tested with the ARCHITECT assay. Negative samples (S/CO < 0.8) required no further testing. Immunochromatographic testing (ICT) and/or indirect immunofluorescence (IFI) was used to confirm samples with S/CO ≥ 0.8. Receiver operator characteristic (ROC) curve analysis determined the ARCHITECT S/CO value that yielded 100% specificity and positive predictive value. SPSS software, version 22.0 was used for data analysis.
Results
A total of 4153 samples were analysed; 361 (8.69%) gave a reactive ARCHITECT Chagas result. 261/361 (72.3%) were women; median age was 38 years old (2–79). 92.8% were Bolivian. A total of 307 (85.0%) were confirmed as cases of Chagas; 52 (14.4%) were not infected; two (0.6%) were not evaluable. Seroprevalence was 7.39%. An S/CO ≥ 3.80 yielded 100% specificity (95% confidence interval CI, 0.93–1.00) and 100% positive predictive value (95% CI, 0.99–1.00).
Conclusions
Using S/CO ≥ 3.80, the ARCHITECT Chagas could be used as a single test for diagnosis of chronic CD in Bolivian immigrants. Patients with S/CO between 0.80 and 3.80 would require additional testing.
Objectifs
La maladie de Chagas (MC) importée est un problème de santé émergent en Europe dû à l'immigration en provenance des pays d'endémie. Bien que l’OMS recommande actuellement deux méthodes sérologiques différentes pour établir le diagnostic, de nouveaux outils comme le test Architect Chagas pourraient être utilisés comme test unique de diagnostic. Notre objectif était de déterminer une valeur seuil optimale du signal (S/CO) pour le test Architect Chagas afin de pouvoir diagnostiquer la MC à l'aide d'un seul test.
Méthodes
Une étude rétrospective menée à l'Hôpital Universitaire du 12 octobre, à Madrid, en Espagne. Tous les patients requérant un dépistage de la MC entre janvier 2014 et août 2017 ont été inclus consécutivement. Tous les échantillons ont été testés en routine avec le test Architect. Les échantillons négatifs (valeur S/CO < 0,8) n'ont pas nécessité de test supplémentaire. Le test immunochromatographique (ICT) et/ou à immunofluorescence indirecte (IFI) ont été utilisés pour confirmer les échantillons avec une valeur S/CO > 0,8. L'analyse de la courbe caractéristique du récepteur (ROC) a permis de déterminer la valeur S/CO du test Architect donnant une spécificité et une valeur prédictive positive de 100%. Le logiciel SPSS, version 22.0, a été utilisé pour l'analyse des données.
Résultats
4153 échantillons ont été analysés; 361 (8,69%) ont donné un résultat réactif avec Architecte Chagas. 261/361 (72,3%) provenaient de femmes; l’âge médian était de 38 ans (2 à 79). 92,8% étaient des boliviens. 307 (85,0%) ont été confirmés comme des cas de Chagas; 52 (14,4%) n’étaient pas infectés; 2 (0,6%) n’étaient pas évaluables. La séroprévalence était de 7,39%. Une valeur S/CO > 3,80 donnait une spécificité de 100% (IC95%: 0,93‐1,00) et une valeur prédictive positive de 100% (IC95%: 0,99‐1,00).
Conclusions
En utilisant une valeur S/CO de 3,80, le test Architecte Chagas pourrait être utilisé comme un test unique pour le diagnostic de la MC chronique chez les immigrants boliviens. Les patients avec une valeur S/CO comprise entre 0,80 et 3,80 nécessiteraient des tests supplémentaires.
Studies specifically designed to determine the profile of psychiatric symptoms among COVID-19 patients are limited and based on case series, self-report questionnaires, and surveys. The objective of ...the study was to identify and classify the neuropsychological symptoms of hospitalized COVID-19 patients during the first wave of the pandemic in one of the most important front-line tertiary hospitals from Spain, and to analyze its correlation with diagnosed mental disorders, as well as to explore potential risk factors associated with mental health problems. This observational, cohort study involved data from COVID-19 patients at the University Hospital 12 de Octubre (Madrid, Spain) from February to May 2020. First, patients underwent a semistructured phone interview (screening phase), based on the Mini International Neuropsychiatric Interview (MINI). Then the confirmation of the diagnosis (confirmation phase) was performed in patients who reported a mental disorder development or worsening. A factorial analysis was performed to identify groups of symptoms. A tetrachoric matrix was created, and factorial analysis, by a principal component analysis, was employed upon it. Factors showing values >1.0 were selected, and a varimax rotation was applied to these factors. Symptoms most frequently identified in patients were anosmia/ageusia (54.6%), cognitive complaints (50.3%), worry/nervousness (43.8%), slowing down (36.2%), and sadness (35.4%). Four factors were identified after the screening phase. The first ("anxiety/depression") and second ("executive dysfunction") factors explained 45.4 and 11.5% of the variance, respectively. Women, age between 50 and 60 years, duration in the hospital (more than 13 days), and psychiatric history showed significant higher levels (number of symptoms) in the factors. This study reports the factor structure of the psychiatric symptoms developed by patients with a confirmed diagnosis of SARS-CoV2 during the first wave of the COVID-19. Three item domains (anxiety, depression, and posttraumatic stress disorder symptoms) were loaded together on one factor, whereas sleep disturbance stood up as a separate factor. Interestingly, the item anosmia/ageusia was not captured by any factor. In conclusion, an increase in neuropsychiatric morbidity is expected in the upcoming months and years. Therefore, screening for early symptoms is the first step to prevent mental health problems associated with this pandemic.
Healthcare management is oriented toward single diseases, yet multimorbidity is nevertheless the rule and there is a tendency for certain diseases to occur in clusters. This study sought to identify ...comorbidity patterns in patients with chronic diseases, by reference to number of comorbidities, age and sex, in a population receiving medical care from 129 general practitioners in Spain, in 2007.
A cross-sectional study was conducted in a health-area setting of the Madrid Autonomous Region (Comunidad Autónoma), covering a population of 198,670 individuals aged over 14 years. Multiple correspondences were analyzed to identify the clustering patterns of the conditions targeted.
Forty-two percent (95% confidence interval CI: 41.8-42.2) of the registered population had at least one chronic condition. In all, 24.5% (95% CI: 24.3-24.6) of the population presented with multimorbidity. In the correspondence analysis, 98.3% of the total information was accounted for by three dimensions. The following four, age- and sex-related comorbidity patterns were identified: pattern B, showing a high comorbidity rate; pattern C, showing a low comorbidity rate; and two patterns, A and D, showing intermediate comorbidity rates.
Four comorbidity patterns could be identified which grouped diseases as follows: one showing diseases with a high comorbidity burden; one showing diseases with a low comorbidity burden; and two showing diseases with an intermediate comorbidity burden.
Immune checkpoint inhibitors (ICIs) as monotherapy in different solid tumors showed an early detrimental effect in a subset of patients reflected by the early crossover of the progression-free ...survival (PFS) curves. Currently, combination therapies with ICIs added to chemotherapy or targeted therapy are expanding the landscape of metastatic solid tumors. We have examined the benefits and risks of adding ICIs to the standard of care (SOC) versus SOC alone.
A search of randomized clinical trials (RCTs) comparing ICIs combinations versus the corresponding SOC in different metastatic tumors according to the PRISMA guidelines was performed. Selected endpoints included PFS, time-to-response (TTR), overall survival (OS), overall response rate (ORR), and ≥ grade 3 adverse events (AEs). Subgroup analyses based on backbone treatment and tumor type were included.
A total of 10536 patients (19 studies) were included (ICIs-arm: 5596 patients; SOC-arm: 4940 patients). Globally, PFS, OS, and ORR results favored ICIs-arm. No differences in terms of TTR were found between arms. ICI-arm was associated with a slight increase of ≥ G3 AEs (relative risk: 1.07). The results in multiple myeloma patients are controversial in favor of ICIs combinations.
Adding ICIs to SOC benefits a greater number of patients, prolonging survival with no early detrimental effect. The toxicity profile is safe, with a mild increase of high-grade manageable AEs.
Aims
This systematic review aims to evaluate the effect of continuous glucose monitoring (CGM) on maternal and neonatal outcomes in gestational diabetes mellitus (GDM).
Methods
Two authors conducted ...a systematic search using PubMed, Embase, CENTRAL, CINAHL, Scopus, Web of Science, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The inclusion criteria for the systematic review were randomized clinical trials that compared the effects of CGM and blood glucose monitoring (BGM) in women with GDM. A restricted maximum likelihood random‐effects model was used for the meta‐analysis. The measures of effect were risk ratios for categorical data and mean differences for continuous data.
Results
Of the 457 studies reviewed, six randomized clinical trials met the inclusion criteria. A total of 482 patients were included in the meta‐analysis. The use of CGM was associated with lower HbA1c levels at the end of pregnancy (mean difference: −0.22; 95%CI −0.42 to −0.03) compared to BGM. Women using CGM also had less gestational weight gain (mean difference: −1.17, 95%CI −2.15 to −0.19), and their children had lower birth weight (mean difference: −116.26, 95%CI −224.70 to −7.81). No differences were observed in the other outcomes evaluated.
Conclusion
Women with GDM using CGM may achieve lower average blood glucose levels, lower maternal weight gain and infant birth weight than women using BGM. Nevertheless, current evidence is limited by the low number of studies and the small sample sizes of these studies. Larger clinical trials are needed to better understand the effects of CGM in GDM.
Registration
PROSPERO registration ID CRD42021225651.
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