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Abstract Background The rising number of retracted randomised clinical trials (RCTs) is a concern over their trustworthiness. In today's digital landscape electronic observational data is easily accessible for research purposes. This emerging perspective, in tandem with the growing scrutiny of RCT credibility, may steer some researchers towards favouring non-randomized studies. It is crucial to emphasize the ongoing need for robust RCTs, shedding light on the areas within trial design that require enhancements and addressing existing gaps in trial execution. Main body Evidence-based medicine pivots on the nexus between empirical medical research and the theoretical and applied facets of clinical care. Healthcare systems regularly amass patient data, creating a vast reservoir of information. This facilitates large-scale observational studies, which may appear as potential substitutes for RCTs. These large-scale studies inherently possess biases that place them a notch below randomized evidence. Honest errors, data manipulation, lapses in professionalism, and methodological shortcomings tarnish the integrity of RCTs, compromising trust in trials. Research institutions, funding agencies, journal editors and other stakeholders have the responsibility to establish robust frameworks to prevent both deliberate and inadvertent mishandling of RCT design, conduct and analysis. Systematic reviews that collate robust RCTs are invaluable. They amalgamate superior evidence instrumental in improving patient outcomes via informed health policy decisions. For systematic reviews to continue to retain trust, validated integrity assessment tools must be developed and routinely applied. This way it will be possible to prevent false or untrustworthy research from becoming part of the recommendations based on the evidence. Conclusion High-quality RCTs and their systematic reviews play a crucial role in acquiring valid and reliable evidence that is instrumental in improving patient outcomes. They provide vital information on healthcare effectiveness, and their trustworthiness is key to evidence-based medicine.

Background: Endocrine disruptors (EDs) have emerged as potential contributors to the development of type-2 diabetes. Perfluorooctane sulfonate (PFOS), is one of these EDs linked with chronic diseases and gathered attention due to its widespread in food. Objective: To assess at baseline and after 1-year of follow-up associations between estimated dietary intake (DI) of PFOS, and glucose homeostasis parameters and body-mass-index (BMI) in a senior population of 4600 non-diabetic participants from the PREDIMED-plus study. Methods: Multivariable linear regression models were conducted to assess associations between baseline PFOS-DI at lower bound (LB) and upper bound (UB) established by the EFSA, glucose homeostasis parameters and BMI. Results: Compared to those in the lowest tertile, participants in the highest tertile of baseline PFOS-DI in LB and UB showed higher levels of HbA1c [β-coefficient(CI)] [0.01 %(0.002 to 0.026), and [0.06 mg/dL(0.026 to 0.087), both p-trend ≤ 0.001], and fasting plasma glucose in the LB PFOS-DI [1.05 mg/dL(0.050 to 2.046),p-trend = 0.022]. Prospectively, a positive association between LB of PFOS-DI and BMI [0.06 kg/m2(0.014 to 0.106) per 1-SD increment of energy-adjusted PFOS-DI was shown. Participants in the top tertile showed an increase in HOMA-IR [0.06(0.016 to 0.097), p-trend = 0.005] compared to participants in the reference tertile after 1-year of follow-up. Discussion: This is the first study to explore the association between DI of PFOS and glucose homeostasis. In this study, a high baseline DI of PFOS was associated with a higher levels of fasting plasma glucose and HbA1c and with an increase in HOMA-IR and BMI after 1-year of follow-up.

Abstract Background Cross-sectionally, older age and obesity are associated with increased coronavirus disease-2019 (COVID-19) risk. We assessed the longitudinal associations of baseline and changes in adiposity parameters with COVID-19 incidence in older adults at high cardiovascular risk. Methods This analysis included 6874 men and women (aged 55–75 years) with overweight/obesity and metabolic syndrome in the PREDIMED-Plus lifestyle intervention trial for cardiovascular risk reduction. Body weight, body-mass-index (BMI), waist circumference, waist-to-height ratio (WHtR), and a body shape index (ABSI) were measured at baseline and annual follow-up visits. COVID-19 was ascertained by an independent Event Committee until 31 December 2021. Cox regression models were fitted to evaluate the risk of COVID-19 incidence based on baseline adiposity parameters measured 5–6 years before the pandemic and their changes at the visit prior to censoring. Results At the time of censoring, 653 incident COVID-19 cases occurred. Higher baseline body weight, BMI, waist circumference, and WHtR were associated with increased COVID-19 risk. During the follow-up, every unit increase in body weight (HRadj (95%CI): 1.01 (1.00, 1.03)) and BMI (HRadj: 1.04 (1.003, 1.08)) was associated with increased COVID-19 risk. Conclusions In older adults with overweight/obesity, clinically significant weight loss may protect against COVID-19. Trial registration This study is registered at the International Standard Randomized Controlled Trial (ISRCT; http://www.isrctn.com/ISRCTN89898870 ).

The aim of our cross-sectional and longitudinal study is to assess the relationship between daytime and night-time sleep duration and health-related quality of life (HRQoL) in adults with metabolic syndrome after a 1-year healthy lifestyle intervention. Analysis of the data from 2119 Spanish adults aged 55–75 years from the PREDIMED-Plus study was performed. Sleep duration was assessed using a wrist-worn accelerometer. HRQoL was measured using the SF-36 questionnaire. Linear regression models adjusted for socioeconomic and lifestyle factors and morbidity were developed. In cross-sectional analyses, participants with extreme night-time sleep duration categories showed lower physical component summary scores in Models 1 and 2 [β-coefficient (95% confidence interval) p = 0.002. >9 h vs. 7–9 h: −1.1 (−2.0 to −0.3); p = 0.01]. Participants who sleep less than 7 h a night and take a nap are associated with higher mental component summary scores [β-coefficient (95% confidence interval) 6.3 (1.3 to 11.3); p = 0.01]. No differences between night-time sleep categories and 12-month changes in HRQoL were observed. In conclusion, in cross-sectional analyses, extremes in nocturnal sleep duration are related to lower physical component summary scores and napping is associated with higher mental component summary scores in older adults who sleep less than 7 h a night.

Background: The global issues of overweight and sedentary lifestyles require comprehensive responses from health systems. Despite this, health education remains fragmented and sporadic. This study aims to target primary school children to instil healthy habits using active learning strategies, with a specific focus on promoting a healthy diet and physical activity. Methods: This study employed problem-based learning (PBL) projects with fourth-grade primary students to encourage the acquisition of healthy habits. Conducted over four consecutive years at a two-line school, the study utilised an opportunity sample, evaluating intervention and control groups by comparing their corresponding scores. The control groups consisted of 54 students, while the intervention group included 159 students. Data collection involved pre-test and post-test questionnaires to measure outcomes. Results: Differential evaluation scores revealed significantly higher results in the intervention groups compared to the control groups, with an average score increase of 3.62 points in control groups and 6.94 points in intervention groups, particularly in attitudinal competencies. The strategies employed facilitated the development of crucial skills such as information search, synthesis, representation, analysis, decision making, teamwork, and intrapersonal awareness. Additionally, they significantly broadened the knowledge acquired regarding healthy habits. Conclusions: The problem-based learning approach proved effective in helping children understand the importance of making healthy choices and encouraged the integration of such habits into their daily lives. These findings suggest that active learning strategies can significantly enhance health education and promote long-term healthy behaviours among primary school children.

Background: The COVID-19 lockdown represented an immense impact on human health, which was characterized by lifestyle and dietary changes, social distancing and isolation at home. Some evidence suggests that these consequences mainly affected women and altered relevant ongoing clinical trials. The aim of this study was to evaluate the status and changes in diet, physical activity (PA), sleep and self-reported health status (SRH) as perceived by older adult men and women with metabolic syndrome during the COVID-19 lockdown. Methods: We analyzed data from 4681 Spanish adults with metabolic syndrome. We carried out a telephone survey during May and June 2020 to collect information on demographics, dietary habits, PA, sleep, SRH and anthropometric data. Results: The mean age of participants was 64.9 years at recruitment, and 52% of participants were men. Most participants (64.1%) perceived a decrease in their PA during confinement. Regarding gender-specific differences, a higher proportion of women than men perceived a decrease in their PA (67.5% vs. 61.1%), Mediterranean diet adherence (20.9% vs. 16.8%), sleep hours (30.3% vs. 19.1%), sleep quality (31.6% vs. 18.2%) and SRH (25.9% vs. 11.9%) (all p < 0.001). Conclusions: The COVID-19 lockdown affected women more negatively, particularly their self-reported diet, PA, sleep and health status.

Abstract Objective: To examine the cross-sectional and longitudinal (2-year follow-up) associations between dietary diversity (DD) and depressive symptoms. Design: An energy-adjusted dietary diversity score (DDS) was assessed using a validated FFQ and was categorised into quartiles (Q). The variety in each food group was classified into four categories of diversity (C). Depressive symptoms were assessed with Beck Depression Inventory-II (Beck II) questionnaire and depression cases defined as physician-diagnosed or Beck II >= 18. Linear and logistic regression models were used. Setting: Spanish older adults with metabolic syndrome (MetS). Participants: A total of 6625 adults aged 55–75 years from the PREDIMED-Plus study with overweight or obesity and MetS. Results: Total DDS was inversely and statistically significantly associated with depression in the cross-sectional analysis conducted; OR Q4 v. Q1 = 0·76 (95 % CI (0·64, 0·90)). This was driven by high diversity compared to low diversity (C3 v. C1) of vegetables (OR = 0·75, 95 % CI (0·57, 0·93)), cereals (OR = 0·72 (95 % CI (0·56, 0·94)) and proteins (OR = 0·27, 95 % CI (0·11, 0·62)). In the longitudinal analysis, there was no significant association between the baseline DDS and changes in depressive symptoms after 2 years of follow-up, except for DD in vegetables C4 v. C1 = (β = 0·70, 95 % CI (0·05, 1·35)). Conclusions: According to our results, DD is inversely associated with depressive symptoms, but eating more diverse does not seem to reduce the risk of future depression. Additional longitudinal studies (with longer follow-up) are needed to confirm these findings.

Abstract Background Water intake and hydration status have been suggested to impact cognition; however, longitudinal evidence is limited and often inconsistent. This study aimed to longitudinally assess the association between hydration status and water intake based on current recommendations, with changes in cognition in an older Spanish population at high cardiovascular disease risk. Methods A prospective analysis was conducted of a cohort of 1957 adults (aged 55–75) with overweight/obesity (BMI between ≥ 27 and < 40 kg/m2) and metabolic syndrome from the PREDIMED-Plus study. Participants had completed bloodwork and validated, semiquantitative beverage and food frequency questionnaires at baseline, as well as an extensive neuropsychological battery of 8 validated tests at baseline and 2 years of follow-up. Hydration status was determined by serum osmolarity calculation and categorized as < 295 mmol/L (hydrated), 295–299.9 mmol/L (impending dehydration), and ≥ 300 mmol/L (dehydrated). Water intake was assessed as total drinking water intake and total water intake from food and beverages and according to EFSA recommendations. Global cognitive function was determined as a composite z-score summarizing individual participant results from all neuropsychological tests. Multivariable linear regression models were fitted to assess the associations between baseline hydration status and fluid intake, continuously and categorically, with 2-year changes in cognitive performance. Results The mean baseline daily total water intake was 2871 ± 676 mL/day (2889 ± 677 mL/day in men; 2854 ± 674 mL/day in women), and 80.2% of participants met the ESFA reference values for an adequate intake. Serum osmolarity (mean 298 ± 24 mmol/L, range 263 to 347 mmol/L) indicated that 56% of participants were physiologically dehydrated. Lower physiological hydration status (i.e., greater serum osmolarity) was associated with a greater decline in global cognitive function z-score over a 2-year period (β: − 0.010; 95% CI − 0.017 to − 0.004, p-value = 0.002). No significant associations were observed between water intake from beverages and/or foods with 2-year changes in global cognitive function. Conclusions Reduced physiological hydration status was associated with greater reductions in global cognitive function over a 2-year period in older adults with metabolic syndrome and overweight or obesity. Future research assessing the impact of hydration on cognitive performance over a longer duration is needed. Trial registration International Standard Randomized Controlled Trial Registry, ISRCTN89898870. Retrospectively registered on 24 July 2014

Beverages are an important part of the diet, but their environmental impact has been scarcely assessed. The aim of this study was to assess how changes in beverage consumption over a one-year period can impact the environmental sustainability of the diet. This is a one-year longitudinal study of 55–75-year-old participants with metabolic syndrome (n = 1122) within the frame of the PREDIMED-Plus study. Food and beverage intake were assessed using a validated food frequency questionnaire and a validated beverage-specific questionnaire. The Agribalyse® 3.0.1 database was used to calculate environmental impact parameters such as greenhouse gas emission, energy, water, and land use. A sustainability beverage score was created by considering the evaluated environmental markers. A higher beverage sustainability score was obtained when decreasing the consumption of bottled water, natural and packed fruit juice, milk, and drinkable dairy, soups and broths, sorbets and jellies, soft drinks, tea without sugar, beer (with and without alcohol), and wine, as well as when increasing the consumption of tap water and coffee with milk and without sugar. Beverage consumption should be considered when assessing the environmental impact of a diet. Trial registration: ISRCTN, ISRCTN89898870. Registered 5 September 2013.

Introducción. A pesar de que la etapa universitaria es crucial para la adquisición de hábitos de vida que pueden repercutir en el estado de salud, se ha evidenciado una alimentación inadecuada en esta población. Objetivos. (1) Estudiar el nivel de adecuación a las recomendaciones de ingesta alimentarias en estudiantes de medicina, (2) determinar la adhesión a la Dieta Mediterránea (Diet Med) y (3) determinar las variables asociadas con el cumplimiento de las recomendaciones dietéticas. Metodología. Estudio descriptivo transversal. Se analizó la ingesta dietética de 225 estudiantes de medicina mediante un cuestionario de frecuencia de alimentos. Se calculó la ingesta de nutrientes mediante la utilización de tablas de composición de alimentos y el porcentaje de cumplimiento de micronutrientes (RDI para población adulta española). Se determinó la adhesión a la Diet Med y el riesgo cardiovascular. Se realizaron modelos regresión logística múltiple con objeto de determinar las variables asociadas con la adecuación nutricional. Resultados. Los estudiantes de medicina muestran una baja adhesión a la Diet Med así como una baja frecuencia del cumplimiento de las RDI de vitamina A, D y calcio. El cumplimiento con las recomendaciones se asoció positivamente con variables como el sexo femenino y la Diet Med en el caso de las recomendaciones de vitamina A, mientras que un mayor IMC y sedentarismo se asociaron negativamente con las de vitamina D. Conclusiones. Los hábitos alimentarios de los estudiantes de medicina pueden considerarse poco saludables, por lo que deben priorizarse intervenciones educativas y conductuales para mejorar el estilo de vida de esta población. Financiación. B.R.-G. is a Postdoctoral Investigator funded by the Junta de Andalucía (ref. RH-0069-2021).

In recent decades, the prevalence of non-communicable diseases (NCDs) such as obesity, type 2 diabetes mellitus, cancer and cardiovascular disease has increased worldwide [...]

Abstract Randomized clinical trials (RCTs) of lifestyle modification have reported beneficial effects of interventions, compared to control. Whether participation in the control group has benefits is unknown. To determine whether control group participants experience weight loss during the course of RCTs. After prospective registration (PROSPERO CRD42021233070), we conducted searches in Medline, Scopus, Web of Science, Cochrane library and Clinicaltrials.gov databases from inception to May 2021 without language restriction to capture RCTs on dietary advice or physical activity interventions in adults with overweight, obesity or metabolic syndrome. Data extraction and study quality assessment was performed by two independent reviewers. Weight loss in the control group, i.e., the difference between baseline and post-intervention, was pooled using random effects model generating mean difference and 95% confidence interval (CI). Heterogeneity was assessed using the I2 statistical test. Subgroup meta-analysis was performed stratifying by follow-up period, type of control group protocols and high-quality studies. Among the 22 included studies (4032 participants), the risk of bias was low in 9 (40%) studies. Overall, the controls groups experienced weight loss of − 0.41 kg (95% CI − 0.53 to − 0.28; I2 = 73.5% p

BackgroundIntimate partner violence (IPV) during pregnancy is a public health issue with wide-ranging consequences for both the mother and fetus, and interventions are needed. Therefore, the Stop Intimate Partner Violence in Pregnancy (STOP) cohort was established with the overall aim to identify pregnant women exposed to IPV through digital screening and offer women screening positive for IPV a digital supportive intervention. ObjectiveThe aim of this study was to (1) introduce the design and profile of the STOP cohort study, (2) assess the feasibility of implementing digital IPV screening among pregnant women, and (3) assess the feasibility of implementing a digital supportive intervention targeting pregnant women exposed to IPV. MethodsPregnant women attending antenatal care in the Region of Southern Denmark and in Andalucía, Spain were offered digital screening for IPV using validated scales (Abuse Assessment Screen and Women Abuse Screening Tool). Women who screened positive were eligible to receive a digital supportive intervention. The intervention consisted of 3-6 video consultations with an IPV counselor and a safety planning app. In Denmark, IPV counselors were antenatal care midwives trained by a psychologist specialized in IPV, whereas in Spain, the counselor was a psychologist. ResultsData collection started in February 2021 and was completed in October 2022. Across Denmark and Spain, a total of 19,442 pregnant women were invited for IPV screening and 16,068 women (82.65%) completed the screening. More women in Spain screened positive for exposure to IPV (350/2055, 17.03%) than in Denmark (1195/14,013, 8.53%). Among the women who screened positive, only 31.39% (485/1545) were eligible to receive the intervention with only 104 (21.4%) of these women ultimately receiving it. ConclusionsDigital screening for IPV among pregnant women is feasible in an antenatal care context in Denmark and Spain; however, a digital supportive intervention during pregnancy appears to have limited feasibility as only a minor subgroup of women who screened positive for eligibility received the intervention. More research is needed on how to best support pregnant women exposed to IPV if universal IPV screening is to be implemented in antenatal care.

Anemia causes hypo-oxygenation in the brain, which could lead to cognitive disorders. We examined dietary iron intake as well as anemia markers (i.e., hemoglobin, hematocrit, mean corpuscular volume) and diabetes coexistence in relation to neuropsychological function and quality of life. In this study, 6117 community-dwelling adults aged 55–75 years (men) and 60–75 years (women) with overweight/obesity and metabolic syndrome were involved. We performed the Mini-Mental State Examination (MMSE), the Trail Making Test parts A and B (TMT-A/B), Semantic Verbal Fluency of animals (VFT-a), Phonological Verbal Fluency of letter P (VFT-p), Digit Span Test (DST), the Clock Drawing Test (CDT), and the Short Form-36 Health Survey (SF36-HRQL test). Dietary iron intake did not influence neuropsychological function or quality of life. However, anemia and lower levels of anemia markers were associated with worse scores in all neurophysiological and SF36-HRQL tests overall, but were especially clear in the MMSE, TMT-B (cognitive flexibility), and the physical component of the SF36-HRQL test. The relationships between anemia and diminished performance in the TMT-A/B and VFT tasks were notably pronounced and statistically significant solely among participants with diabetes. In brief, anemia and reduced levels of anemia markers were linked to inferior cognitive function, worse scores in different domains of executive function, as well as a poorer physical, but not mental, component of quality of life. It was also suggested that the coexistence of diabetes in anemic patients may exacerbate this negative impact on cognition. Nevertheless, dietary iron intake showed no correlation with any of the outcomes. To make conclusive recommendations for clinical practice, our findings need to be thoroughly tested through methodologically rigorous studies that minimize the risk of reverse causality.

Abstract Background Recent lifestyle changes include increased consumption of highly processed foods (HPF), which has been associated with an increased risk of non-communicable diseases (NCDs). However, nutritional information relies on the estimation of HPF consumption from food-frequency questionnaires (FFQ) that are not explicitly developed for this purpose. We aimed to develop a short screening questionnaire of HPF consumption (sQ-HPF) that integrates criteria from the existing food classification systems. Methods Data from 4400 participants (48.1% female and 51.9% male, 64.9 ± 4.9 years) of the Spanish PREDIMED-Plus (“PREvention with MEDiterranean DIet”) trial were used for this analysis. Items from the FFQ were classified according to four main food processing-based classification systems (NOVA, IARC, IFIC and UNC). Participants were classified into tertiles of HPF consumption according to each system. Using binomial logistic regression, food groups associated with agreement in the highest tertile for at least two classification systems were chosen as items for the questionnaire. ROC analysis was used to determine cut-off points for the frequency of consumption of each item, from which a score was calculated. Internal consistency of the questionnaire was assessed through exploratory factor analysis (EFA) and Cronbach’s analysis, and agreement with the four classifications was assessed with weighted kappa coefficients. Results Regression analysis identified 14 food groups (items) associated with high HPF consumption for at least two classification systems. EFA showed that items were representative contributors of a single underlying factor, the “HPF dietary pattern” (factor loadings around 0.2). We constructed a questionnaire asking about the frequency of consumption of those items. The threshold frequency of consumption was selected using ROC analysis. Comparison of the four classification systems and the sQ-HPF showed a fair to high agreement. Significant changes in lifestyle characteristics were detected across tertiles of the sQ-HPF score. Longitudinal changes in HPF consumption were also detected by the sQ-HPF, concordantly with existing classification systems. Conclusions We developed a practical tool to measure HPF consumption, the sQ-HPF. This may be a valuable instrument to study its relationship with NCDs. Trial registration Retrospectively registered at the International Standard Randomized Controlled Trial Registry ( ISRCTN89898870 ) on July 24, 2014.

BackgroundThe COVID-19 pandemic has affected the implementation of most ongoing clinical trials worldwide including the PREDIMED-Plus study. The PREDIMED-Plus is an ongoing, multicenter, controlled intervention trial, aimed at weight-loss and cardiovascular disease prevention, in which participants were randomized (1:1 ratio) to an intervention group (energy-reduced Mediterranean diet, promotion of physical activity, and behavioral support) or to a control group (Mediterranean diet with usual care advice). When the pandemic began, the trial was in the midst of the planned intervention. The objective of this report was to examine the effects of the pandemic on the delivery of the intervention and to describe the strategies established to mitigate the possible adverse effects of the pandemic lockdown on data collection and adiposity.MethodsWe assessed the integrity of the PREDIMED-Plus trial during 5 identified periods of the COVID-19 pandemic determined according to restrictions dictated by the Spanish government authorities. A standardized questionnaire was delivered to each of the 23 PREDIMED-Plus recruiting centers to collected data regarding the trial integrity. The effect of the restrictions on intervention components (diet, physical activity) was evaluated with data obtained in the three identified lockdown phases: pre lockdown, lockdown proper, and post lockdown.ResultsDuring the lockdown (March/2020-June/2021), 4,612 participants (48% women, mean age 65y) attended pre-specified yearly follow-up visits to receive lifestyle recommendations and obtain adiposity measures. The overall mean (SD) of the proportions reported by each center showed that 40.4% (25.4) participants had in-person visits, 39.8% (18.2) participants were contacted by telephone and 35% (26.3) by electronic means. Participants’ follow-up and data collection rates increased across lockdown periods (from ≈10% at onset to ≈80% at the end). Compared to pre-lockdown, waist circumference increased during (0.75 cm [95% CI: 0.60–0.91]) and after (0.72 cm [95% CI: 0.56–0.89]) lockdown. Body weight did not change during lockdown (0.01 kg [95% CI: –0.10 to 0.13) and decreased after lockdown (-0.17 kg [95% CI: –0.30 to –0.04]).ConclusionMitigating strategies to enforce the intervention and patient’s follow-up during lockdown have been successful in preserving the integrity of the trial and ensuring its continuation, with minor effects on adiposity.Clinical trial registrationhttps://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

Objectives: We evaluated breast cancer (BC) care quality indicators (QIs) in clinical pathways and integrated health care processes. Methods: Following protocol registration (Prospero no: CRD42021228867), relevant documents were identified, without language restrictions, through a systematic search of bibliographic databases (EMBASE, Scopus, Web of Science, MEDLINE), health care valuable representatives and the World Wide Web in April 2021. Data concerning QIs, measurement tools and compliance standards were extracted from European and North American sources in duplicate with 98% reviewer agreement. Results: There were 89 QIs found from 22 selected documents (QI per document mean 13.5 with standard deviation 11.9). The Belgian (38 QIs) and the EUSOMA (European Society of Breast Cancer Specialists) (34 QIs) documents were the ones that best reported the QIs. No identical QI was identified in all the documents analysed. There were 67/89 QIs covering processes (75.3%) and 11/89 (12.4%) for each structure and outcomes QIs. There were 21/89 QIs for diagnosis (30.3%), 43/89 for treatment (48.3%), and 19/89 for staging, counselling, follow-up and rehabilitation (21.4%). Of 67 process QIs and 11 outcome QIs, 20/78 (26%) did not report a minimum standard of care. Shared decision making was only included as a QI in the Italian document. Conclusion: More than half of countries have not established a national clinical pathway or integrated breast cancer care process to achieve the excellence of BC care. There was heterogeneity in QIs for the evaluation of BC care quality. Over two-thirds of the clinical pathways and integrated health care processes did not provide a minimum auditable standard of care for compliance, leaving open the definition of best practice. There is a need for harmonisation of BC care QIs.

Carotenoid intake has been reported to be associated with improved cardiovascular health, but there is little information on actual plasma concentrations of these compounds as biomarkers of cardiometabolic risk. The objective was to investigate the association between circulating plasma carotenoids and different cardiometabolic risk factors and the plasma fatty acid profile. This is a cross-sectional evaluation of baseline data conducted in a subcohort (106 women and 124 men) of an ongoing multi-factorial lifestyle trial for primary cardiovascular prevention. Plasma concentrations of carotenoids were quantified by liquid chromatography coupled to mass spectrometry. The associations between carotenoid concentrations and cardiometabolic risk factors were assessed using regression models adapted for interval-censored variables. Carotenoid concentrations were cross-sectionally inversely associated with serum triglyceride concentrations [−2.79 mg/dl (95% CI: −4.25, −1.34) and −5.15 mg/dl (95% CI: −7.38, −2.93), p-values = 0.0002 and

BackgroundDiets high in acid load may contribute to kidney function impairment. This study aimed to investigate the association between dietary acid load and 1-year changes in glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (UACR).MethodsOlder adults with overweight/obesity and metabolic syndrome (mean age 65 ± 5 years, 48% women) from the PREDIMED-Plus study who had available data on eGFR (n = 5,874) or UACR (n = 3,639) at baseline and after 1 year of follow-up were included in this prospective analysis. Dietary acid load was estimated as potential renal acid load (PRAL) and net endogenous acid production (NEAP) at baseline from a food frequency questionnaire. Linear and logistic regression models were fitted to evaluate the associations between baseline tertiles of dietary acid load and kidney function outcomes. One year-changes in eGFR and UACR were set as the primary outcomes. We secondarily assessed ≥ 10% eGFR decline or ≥10% UACR increase.ResultsAfter multiple adjustments, individuals in the highest tertile of PRAL or NEAP showed higher one-year changes in eGFR (PRAL, β: –0.64 ml/min/1.73 m2; 95% CI: –1.21 to –0.08 and NEAP, β: –0.56 ml/min/1.73 m2; 95% CI: –1.13 to 0.01) compared to those in the lowest category. No associations with changes in UACR were found. Participants with higher levels of PRAL and NEAP had significantly higher odds of developing ≥10% eGFR decline (PRAL, OR: 1.28; 95% CI: 1.07–1.54 and NEAP, OR: 1.24; 95% CI: 1.03–1.50) and ≥10 % UACR increase (PRAL, OR: 1.23; 95% CI: 1.04–1.46) compared to individuals with lower dietary acid load.ConclusionsHigher PRAL and NEAP were associated with worse kidney function after 1 year of follow-up as measured by eGFR and UACR markers in an older Spanish population with overweight/obesity and metabolic syndrome.

Metabolic syndrome (MetS) is one of the most important medical problems around the world. Identification of patient´s singular characteristic could help to reduce the clinical impact and facilitate individualized management. This study aimed to categorize MetS patients using phenotypical and clinical variables habitually collected during health check-ups of individuals considered to have high cardiovascular risk. The selected markers to categorize MetS participants included anthropometric variables as well as clinical data, biochemical parameters and prescribed pharmacological treatment. An exploratory factor analysis was carried out with a subsequent hierarchical cluster analysis using the z-scores from factor analysis. The first step identified three different factors. The first was determined by hypercholesterolemia and associated treatments, the second factor exhibited glycemic disorders and accompanying treatments and the third factor was characterized by hepatic enzymes. Subsequently four clusters of patients were identified, where cluster 1 was characterized by glucose disorders and treatments, cluster 2 presented mild MetS, cluster 3 presented exacerbated levels of hepatic enzymes and cluster 4 highlighted cholesterol and its associated treatments Interestingly, the liver status related cluster was characterized by higher protein consumption and cluster 4 with low polyunsaturated fatty acid intake. This research emphasized the potential clinical relevance of hepatic impairments in addition to MetS traditional characterization for precision and personalized management of MetS patients.

ObjectiveTo evaluate the effect of Non-alcoholic fatty liver disease (NAFLD) status in the impact of lifestyle over Health-related quality of life (HRQoL) in patients with metabolic syndrome (MetS).MethodsBaseline and 1 year follow up data from the PREDIMED-plus cohort (men and women, 55-75 years old with overweight/obesity and MetS) were studied. Adherence to an energy-restricted Mediterranean Diet (er-MeDiet) and Physical Activity (PA) were assessed with a validated screeners. Hepatic steatosis index (HSI) was implemented to evaluate NAFLD while the SF-36 questionnaire provided HRQoL evaluation. Statistical analyses were performed to evaluate the influence of baseline NAFLD on HRQoL as affected by lifestyle during 1 year of follow up.ResultsData from 5205 patients with mean age of 65 years and a 48% of female participants. Adjusted linear multivariate mixed regression models showed that patients with lower probability of NAFLD (HSI < 36 points) were more responsive to er-MeDiet (β 0.64 vs β 0.05 per er-MeDiet adherence point, p< 0.01) and PA (β 0.05 vs β 0.01 per MET-h/week, p = 0.001) than those with high probability for NAFLD in terms Physical SF-36 summary in the 1 year follow up. 10 points of er-MeDiet adherence and 50 MET-h/week were thresholds for a beneficial effect of lifestyle on HRQoL physical domain in patients with lower probability of NAFLD.ConclusionThe evaluation of NAFLD by the HSI index in patients with MetS might identify subjects with different prospective sensitivity to lifestyle changes in terms of physical HRQoL (http://www.isrctn.com/ISRCTN89898870).

Abstract It remains unclear whether caffeinated beverages could have deleterious renal effects in elderly population with underlying comorbid conditions. We investigated the associations between coffee, tea, or caffeine intake and 1-year changes in glomerular filtration rate (eGFR) in a large Spanish cohort of overweight/obese elderly with metabolic syndrome (MetS). This prospective analysis includes 5851 overweight/obese adults (55–75 years) with MetS from the PREDIMED-Plus study. We assessed coffee, tea, and caffeine consumption from a validated food-frequency questionnaire and creatinine-based eGFR using the Chronic Kidney Disease Epidemiology Collaboration equation. Multivariate-adjusted regression models were applied to test associations between baseline coffee, tea, or caffeine intake and 1-year eGFR changes. Caffeinated coffee (> 2 cups/day) and tea (at least 1 cup/day) drinkers had 0.88 and 0.93 mL/min/1.73 m2 greater eGFR decrease respectively, compared to those with less than 1 cup/day of coffee consumption or non-tea drinkers. Furthermore, caffeinated coffee consumption of > 2 cups/day was associated with 1.19-fold increased risk of rapid eGFR decline > 3 mL/min/1.73 m2 (95% CI 1.01–1.41). Similarly, individuals in the highest (median, 51.2 mg/day) tertile of caffeine intake had a 0.87 mL/min/1.73 m2 greater eGFR decrease. Decaffeinated coffee was not associated with eGFR changes. In conclusion, higher consumption of caffeinated coffee, tea, and caffeine was associated with a greater 1-year eGFR decline in overweight/obese adults with MetS.

Background: High-quality, well-reported clinical practice guidelines (CPGs) and consensus statements (CSs) underpinned by systematic reviews are needed. We appraised the quality and reporting of CPGs and CSs for breast cancer (BC) treatment. Methods: Following protocol registration (Prospero no: CRD42020164801), CPGs and CSs on BC treatment were identified, without language restrictions, through a systematic search of bibliographic databases (MEDLINE, EMBASE, Web of Science, Scopus, CDSR) and online sources (12 guideline databases and 51 professional society websites) from January 2017 to June 2020. Data were extracted in duplicate assessing overall quality using AGREE II (% of maximum score) and reporting compliance using RIGHT (% of total 35 items); reviewer agreement was 98% and 96% respectively. Results: There were 59 relevant guidance documents (43 CPGs, 16 CSs), of which 20 used systematic reviews for evidence synthesis. The median overall quality was 54.0% (IQR 35.9–74.3) and the median overall reporting compliance was 60.9% (IQR 44.5–84.4). The correlation between quality and reporting was 0.9. Compared to CSs, CPGs had better quality (55.4% vs 44.2%; p = 0.032) and reporting (67.18% vs 44.5%; p = 0.005). Compared to subjective methods of evidence analysis, guidance documents that used systematic reviews had better quality (76.3% vs 51.4%; p = 0.001) and reporting (87.1% vs 59.4%; p = 0.001). Conclusion: The quality and reporting of CPGs and CSs in BC treatment were moderately strong. Systematic reviews should be used to improve the quality and reporting of CPGs and CSs.

Background Cardio-vascular disease and depression are thought to be closely related, due to shared risk factors. The aim of the study was to determine the association between cardio-vascular risk (CVR) factors and depressive status in a population (55–75 years) with metabolic syndrome (MetS) from the PREDIMED-Plus trial. Methods and findings Participants were classified into three groups of CVR according to the Framingham-based REGICOR function: (1) low (LR), (2) medium (MR) or (3) high/very high (HR). The Beck Depression Inventory-II (BDI-II) was used to assess depressive symptoms at baseline and after 2 years. The association between CVR and depressive status at baseline (n = 6545), and their changes after 2 years (n = 4566) were evaluated through multivariable regression models (logistic and linear models). HR women showed higher odds of depressive status than LR [OR (95% CI) = 1.78 (1.26, 2.50)]. MR and HR participants with total cholesterol Conclusions Improving cardiovascular health could prevent the onset of depression in the elderly. Diabetes and total cholesterol in individuals at high CVR, may play a specific role in the precise response. International Standard Randomized Controlled Trial (ISRCTN89898870).

Background and Aims: Plant-forward dietary patterns have been associated with cardiometabolic health benefits, which, in turn, have been related to cognitive performance with inconsistent findings. The objective of this study was to examine the relationship between baseline adherence to three a priori dietary patterns (Mediterranean, DASH, and MIND diets) with 2-year changes in cognitive performance in older adults with overweight or obesity and high cardiovascular disease risk.Methods: A prospective cohort analysis was conducted within the PREDIMED-Plus trial, involving 6,647 men and women aged 55–75 years with overweight or obesity and metabolic syndrome. Using a validated, semiquantitative 143-item food frequency questionnaire completed at baseline, the dietary pattern adherence scores were calculated. An extensive neuropsychological test battery was administered at baseline and 2-year follow-up. Multivariable-adjusted linear regression models were used to assess associations between 2-year changes in cognitive function z-scores across tertiles of baseline adherence to the a priori dietary patterns.Results: Adherence to the Mediterranean diet at baseline was associated with 2-year changes in the general cognitive screening Mini-Mental State Examination (MMSE, β: 0.070; 95% CI: 0.014, 0.175, P-trend = 0.011), and two executive function-related assessments: the Trail Making Tests Part A (TMT-A, β: −0.054; 95% CI: −0.110, − 0.002, P-trend = 0.047) and Part B (TMT-B, β: −0.079; 95% CI: −0.134, −0.024, P-trend = 0.004). Adherence to the MIND diet was associated with the backward recall Digit Span Test assessment of working memory (DST-B, β: 0.058; 95% CI: 0.002, 0.114, P-trend = 0.045). However, higher adherence to the DASH dietary pattern was not associated with better cognitive function over a period of 2 years.Conclusion: In older Spanish individuals with overweight or obesity and at high cardiovascular disease risk, higher baseline adherence to the Mediterranean dietary pattern may be associated with better cognitive performance than lower adherence over a period of 2 years.

Maternal caffeine consumption is associated with adverse gestational outcomes. The aim of this study was to assess the intake of caffeine and factors associated with the non-adherence to caffeine intake recommendations in a cohort of 463 women before (T0) and in each trimester of gestation (T1, T2, and T3), by using validated questionnaires. Caffeine intake (median (mg/day), IQR) was 100.0 (181.1) at T0, 9.42 (66.2) at T1, 12.5 (65.6) at T2, and 14.0 (61.1) at T3 (p < 0.001). Non-compliance prevalence (intake > 200 mg/day) was 6.2% at T1, 4.2% at T2, and 2.7% at T3. Not being an active smoker at T1 (OR = 0.17; 95% CI 0.05–0.59) and T2 (OR = 0.22; 95% CI 0.09–0.52), adherence to the Mediterranean Diet at T1 (OR = 0.50; 95% CI 0.28–0.88) and T2 (OR = 0.39; 95% CI 0.15–1.02), and moderate physical activity at T1 (OR = 0.50; 95% CI 0.28–0.88) were inversely associated with caffeine consumption. Although caffeine intake may be considered low, intake prevalence increases throughout pregnancy. Although the main source of caffeine during pregnancy is coffee, attention must be also paid to the increasingly intake of chocolate, of which the effect during pregnancy is controversial. Smoking, non-adherence to a good quality diet, and light physical activity are associated with a higher caffeine intake and a lower compliance with caffeine intake recommendations. Perinatal dietary and lifestyle educational policies are needed.

IntroductionType 2 diabetes has been linked to greater cognitive decline, but other glycemic parameters such as prediabetes, diabetes control and treatment, and HOMA-IR and HbA1c diabetes-related biomarkers have shown inconsistent results. Furthermore, there is limited research assessing these relationships in short-term studies. Thus, we aimed to examine 2-year associations between baseline diabetes/glycemic status and changes in cognitive function in older participants at high risk of cardiovascular disease.MethodsWe conducted a 2-year prospective cohort study (n=6,874) within the framework of the PREDIMED-Plus study. The participants (with overweight/obesity and metabolic syndrome; mean age 64.9 years; 48.5% women) completed a battery of 8 cognitive tests, and a global cognitive function Z-score (GCF) was estimated. At baseline, participants were categorized by diabetes status (no-diabetes, prediabetes, and

Non-alcoholic fatty liver disease (NAFLD) includes a spectrum of liver alterations that can result in severe disease and even death. Consumption of ultra-processed foods (UPF) has been associated with obesity and related comorbidities. However, the link between UPF and NAFLD has not been sufficiently assessed. We aimed to investigate the prospective association between UPF consumption and liver health biomarkers. Methods: We followed for 1 year 5867 older participants with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus trial. A validated 143-item semi-quantitative food frequency questionnaire was used to evaluate consumption of UPF at baseline, 6, and 12 months. The degree of processing for foods and beverages (g/day) was established according to the NOVA classification system. The non-invasive fatty liver index (FLI) and hepatic steatosis index (HSI) were used to evaluate liver health at three points in time. The associations between changes in UPF consumption (percentage of total daily dietary intake (g)) and liver biomarkers were assessed using mixed-effects linear models with repeated measurements. Results: In this cohort, UPF consumption at baseline was 8.19% (SD 6.95%) of total daily dietary intake in grams. In multivariable models, each 10% daily increment in UPF consumption in 1 year was associated with significantly greater FLI (β 1.60 points, 95% CI 1.24;1.96 points) and HSI (0.43, 0.29; 0.57) scores (all p-values < 0.001). These associations persisted statistically significant after adjusting for potential dietary confounders and NAFLD risk factors. Conclusions: A higher UPF consumption was associated with higher levels of NAFLD-related biomarkers in older adults with overweight/obesity and MetS.

Background: Intimate partner violence (IPV) affects outcomes of mothers and their offspring. This systematic review collated the worldwide literature on the prevalence rates of different types of IPV in pregnancy.Methods: Two reviewers independently identified cross sectional and cohort studies of IPV prevalence in pregnancy in online databases (PubMed, WOS and Scopus), selected and extracted data [participants' country, study quality, measurement tool (validation and purpose) and rates of IPV in pregnancy]. We considered a high quality study if it had a prospective design, an adequate sampling method, a sample size estimation, a response rate > 90%, a contemporary ascertainment of IPV in the index pregnancy, and a well-developed detailed IPV tool. We performed random effects meta-analysis and explored reasons for heterogeneity of rates.Results: One hundred fifty-five studies were included, of which 44 (28%) met two-thirds of the quality criteria. Worldwide prevalence of physical (126 studies, 220,462 participants), psychological (113 studies, 189,630 participants) and sexual (98 studies, 155,324 participants) IPV in pregnancy was 9.2% (95% CI 7.7–11.1%, I2 95.9%), 18.7% (15.1–22.9%, I2 98.2%), 5.5% (4.0–7.5%, I2 93.4%), respectively. Where several types of IPV were reported combined, the prevalence of any kind of IPV (118 studies, 124,838 participants) was 25.0% (20.3, 30.5%, I2 98.6%). IPV rates varied within and between continents, being the highest in Africa and the lowest in Europe (p < 0.001). Rates also varied according to measurement purpose, being higher for diagnosis than for screening, in physical (p = 0.022) and sexual (p = 0.014) IPV.Conclusions: IPV prevalence in pregnancy varies across countries, with one-quarter of mothers exposed on average globally. Routine systematic antenatal detection should be applied worldwide.Systematic Review Registration: identifier: CRD42020176131.

Resumen: Introducción: En España, un tercio de los menores y dos tercios de los adultos padecen exceso de peso, una condición que genera un sobrecoste médico directo de 2000 millones de euros. El entorno alimentario obesogénico causa obesidad al promover el consumo de bebidas azucaradas y de alimentos ultraprocesados. Por ello, proponemos cinco políticas prioritarias con el PODER de revertir la epidemia de obesidad y de enfermedades no transmisibles asociadas a ella, mediante la creación de entornos alimentarios saludables. El PODER de las políticas alimentarias: P (Publicidad): regulación de la publicidad de alimentos y bebidas no saludables dirigida a menores por todos los medios y prohibición de patrocinios de congresos o eventos deportivos y avales de asociaciones científicas o profesionales de la salud. O (Oferta): promoción de una oferta 100% saludable en máquinas expendedoras de centros educativos, sanitarios y deportivos.D (Demanda): implantación de un impuesto, al menos del 20%, a las bebidas azucaradas, acompañado de subvenciones o bajadas de impuestos a alimentos saludables y disponibilidad de agua potable a coste cero en todos los centros y espacios públicos. E (Etiquetado): aplicación efectiva del Nutri-Score mediante el uso de incentivos, regulación y mecanismos de contratación pública. R (Reformulación): reformular los acuerdos de reformulación con la industria con objetivos más ambiciosos y de obligado cumplimiento. Reflexión final: Las cinco intervenciones propuestas, aplicadas con éxito en otros países, contribuirán a concienciar a la población y tendrán un impacto positivo en la salud y en la economía, por una reducción de los costes sanitarios de la obesidad y un aumento de la productividad laboral. Estas medidas deberían formar parte de una gran transformación del sistema alimentario, con políticas agroalimentarias que fomenten una producción sostenible de alimentos saludables. Abstract: Introduction: In Spain, one third of all children and two-thirds of adults suffer from excess weight, a condition that generates a direct excess medical cost of 2000 million Euros. Obesogenic food environments cause obesity by promoting the consumption of sugar-sweetened beverages and ultra-processed foods. Accordingly, we propose five priority policies capable of reversing the epidemic of obesity and related non-communicable diseases through the creation of healthy food environments. The power (PODER in Spanish) of food policies: Advertising (Publicidad): regulation of unhealthy food and drink advertisements carried by all media and targeted at children, and prohibition of sponsorships of congresses, conferences or sports events and endorsements by scientific associations or health professionals. Supply (Oferta): promotion of a 100% healthy supply of goods on sale in vending machines sited at educational, health and sports centres. Demand (Demanda): levying a tax of at least 20% on sugar-sweetened beverages, accompanied by subsidies or reduced taxes on healthy foods and availability of drinking water free of charge at all public venues and areas. Labelling (Etiquetado): effective application of the Nutri-Score through the use of incentives, regulation and public-tender mechanisms. Reformulation (Reformulación): revising and redrawing reformulation agreements with the industry, setting more ambitious goals and mandatory compliance. A final thought: These five proposed interventions, all of which have been successfully applied in other countries, will serve to raise population awareness and have a positive impact on health and the economy, through reducing the health care costs of obesity and enhancing work productivity. These measures should form part of a wide-ranging transformation of the food system, with agri-food policies that foster the sustainable production of healthy foods. Palabras clave: Política alimentaria, Impuestos, Publicidad alimentaria, Etiquetado alimentario, Obesidad, Enfermedades no transmisibles, Keywords: Food policy, Taxes, Food advertising, Food labelling, Obesity, Non-transmissible diseases

Lifestyle changes are causing an exponential increase in the prevalence of obesity and metabolic syndrome (MetS) worldwide. The most frequent complications of these are the development of diabetes (T2D) and cardiovascular disease (CVD). Accurate tools are needed to classify the cardiovascular risk (CVR) in the MetS population. In recent years, numerous biomarkers of bone metabolism have been associated with CVR. The aim of this study was to determine the levels of undercarboxylated osteocalcin (ucOC) in a cohort of patients with MetS and to analyse its association with MetS parameters and CVR as well as with T2D prevalence. A longitudinal study was conducted in which a MetS population was followed for one year. Weight change, adherence to the Mediterranean diet (MedDiet), ucOC levels, MetS parameters and CVR were analysed and CVR was calculated using different scores. Our results showed a decrease of CVR associated with a better adherence to the MetDiet resulting in higher HDL-C and ucOC levels though the improvement of MetS risk factors. This bone protein appeared as a potential biomarker to classify CVR in the MetS population, especially for MetS patients without prevalent T2D. Furthermore, ucOC serum levels could be good predictors of T2D prevalence.

Abstract Background Different diets during pregnancy might have an impact on the health, reflected in the birthweight of newborns. The consumption of fruits and vegetables during pregnancy and the relationship with newborn health status have been studied by several authors. However, these studies have shown inconsistent results. Purpose: We assessed whether certain foods were related to the risk of small for gestational age (SGA). Methods A matched by age (± 2 years) and hospital 1:1 case-control study of 518 pairs of pregnant Spanish women in five hospitals was conducted. The cases were women with an SGA newborn at delivery (neonates weighting less than the 10th percentile, adjusted for gestational age at delivery and sex, were diagnosed as SGA). The control group comprised women giving birth to babies adequate for gestational age (AGA). Mothers who gave birth to babies large for gestational age (LGA) were excluded. Data were gathered concerning demographic characteristics, socioeconomic status, toxic habits and diet. A food frequency questionnaire (FFQ) comprising 137 items was completed by all participants. The intake of vegetables, legumes and fruits was categorized in quintiles (Q1–Q5). Crude values and and adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using conditional logistic regression. The variables for adjustment were as follows: preeclampsia, education, smoking, weight gain per week during pregnancy, fish intake and previous preterm/low birthweight newborns. Results Total pulse intake showed an inverse association with the risk of SGA (trend p = 0.02). Women with an intake of fruits above 420 g/day (Q5), compared with women in Q1 (≤ 121 g/day) showed a decreased risk of SGA (AOR = 0.63, 95% CI = 0.40–0.98). The total consumption of vegetables was not associated with the risk of SGA. The intake of selenium was assessed: a protective association was observed for Q3–5; a daily intake above 60 μg was associated with a lower risk of SGA (AOR = 0.39, 95% CI: 0.22–0.69). Conclusions Fruits, pulses and selenium reduce the risk of SGA in Spanish women.

Resumen: Objetivo: Cuantificar el impacto de reducir el consumo de carnes rojas y procesadas sobre la mortalidad cardiovascular y la mortalidad total de la población adulta española, basado en 5 revisiones publicadas. Participantes y mediciones principales: Se define la exposición como el consumo de ≥ 3 raciones/semana de carnes rojas o procesadas, y se consideran cuatro escenarios de población expuesta (30-60%). Con datos del Instituto Nacional de Estadística, se calcula la mortalidad ponderada en población española de 40-80 años y, utilizando los riesgos relativos (RR) y los intervalos de confianza (IC) al 95% publicados en 5 revisiones (RR = 0,88; IC 95%: 0,84-0,93 para mortalidad por todas las causas y RR = 0,92; IC 95%: 0,90-0,93 para la mortalidad cardiovascular), se calculó la tasa de mortalidad en expuestos y no expuestos. Multiplicando esas tasas por el número de expuestos, se obtuvo el número de muertes atribuibles. Resultados: Asumiendo un 60% de población española de 40-80 años expuesta, el número de muertes anuales de causa cardiovascular que se podrían evitar consumiendo

We evaluated the relationship between the dietary diversity score (DDS) and all-cause, CVD and cancer mortality in an adult Mediterranean population. We analyzed the data of 1540 participants from the Valencia Nutrition Survey. The DDS was estimated using a validated food frequency questionnaire and was categorized into quartiles (Q), where the first quartile indicates the lowest dietary diversity. Deaths were ascertained during an 18-year follow-up period. Cox regression models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI). There were 403 deaths during the follow-up period (40% due to CVD). An inverse association was observed between the DDS and all-cause and CVD mortality. Compared with participants in the lowest DDS quartile (Q1), participants in the highest DDS quartile (Q4) showed 32% and 45% less risk of death for all-cause and CVD mortality, in sex- and age-adjusted models, respectively. Regarding the food groups in the DDS, an inverse association was identified between total vegetable consumption diversity and all-cause and CVD mortality in the highest quartiles, (Q3 vs. Q1, HR: 0.70; 95% CI: 0.50, 0.99) and (Q4 vs. Q1, HR: 0.52; 95% CI: 0.30, 0.91), respectively. This study suggests that a higher diversity in food intake, particularly in vegetables, may be associated with a lower risk of all-cause and CVD mortality. This association should be further investigated in other wider populations.

Objectives To systematically review and quantify the effect of motor vehicle crashes (MVCs) in pregnancy on maternal and offspring outcomes.Design Systematic review and meta-analysis of observational data searched from inception until 1 July 2018. Searching was from June to August 2018 in Medline, Embase, Web of Science, Scopus, Latin-American and Caribbean System on Health Sciences Information, Scientific Electronic Library Online, TRANSPORT, International Road Research Documentation, European Conference of Ministers of Transportation Databases, Cochrane Database of Systematic Reviews and Cochrane Central Register.Participants Studies were selected if they focused on the effects of exposure MVC during pregnancy versus non-exposure, with follow-up to verify outcomes in various settings, including secondary care, collision and emergency, and inpatient care.Data synthesis For incidence data, we calculated a pooled estimate per 1000 women. For comparison of outcomes between women involved and those not involved in MVC, we calculated ORs with 95% CIs. Where possible, we statistically pooled the data using the random-effects model. The quality of studies used in the comparative analysis was assessed with Newcastle–Ottawa Scale.Results We included 19 studies (3 222 066 women) of which the majority was carried out in high-income countries (18/19). In population-level studies of women involved in MVC, maternal death occurred in 3.6 per 1000 (95% CI 0.25–10.42; 3 studies, 12 000 women; Tau=1.77), and fetal death or stillbirth in 6.6 per 1000 (95% CI 3.81–10.12; 8 studies, 47 992 women; I2=92.6%). Pooled incidence of complications per 1000 women involved in MVC was labour induction (276.43), preterm delivery (191.90) and caesarean section (166.65). Compared with women not involved in MVC, those involved had increased odds of placental abruption (OR 1.43, 95% CI 1.27–1.63; 3 studies, 1 500 825 women) and maternal death (OR 202.27; 95% CI 110.60–369.95; 1 study, 1 094 559 women).Conclusion Pregnant women involved in MVC were at higher risk of maternal death and complications than those not involved.PROSPERO registration number CRD42018100788.

Abstract Background The development and implementation of effective physical activity (PA) intervention programs is challenging, particularly in older adults. After the first year of the intervention program used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial, we assessed the initial effectiveness of the PA component. Methods PREDIMED-Plus is an ongoing randomized clinical trial including 6874 participants randomized to an intensive weight-loss lifestyle intervention based on an energy-restricted Mediterranean diet (MedDiet), physical activity promotion and behavioral support and to a control group using MedDiet recommendations but without calorie restriction or PA advice. Body mass index (BMI) and waist circumference (WC) are measured by standard clinical protocols. Duration and intensity of PA is self-reported using the validated REGICOR Short Physical Activity Questionnaire. The primary endpoint of the PREDIMED-Plus trial is a combined cardiovascular outcome: myocardial infarction (acute coronary syndromes with positive troponin test), stroke, or cardiovascular mortality. The present study involved secondary analysis of PA data (n = 6059; mean age 65 ± 4.9 years) with one-year changes in total, light, and moderate-to-vigorous PA within and between intervention groups as the outcome. Generalized estimating equation models were fitted to evaluate time trends of PA, BMI, and WC within groups and differences between intervention and control groups. Results After 12 months, average daily MVPA increased by 27.2 (95%CI 5.7;48.7) METs-min/day and 123.1 (95%CI 109.7–136.6) METs-min/day in the control and intervention groups, respectively. Total-PA, light-PA, and MVPA increased significantly (p

Abstract This study cross-sectionally examines in the elderly population: (a) the association of type 2 diabetes with executive function (EF); (b) the effect of BMI on both type 2 diabetes and EF; (c) the association between glycaemia control and EF in type 2 diabetes. 6823 older individuals with overweight/obesity and metabolic syndrome participating in the PREDIMED-PLUS study, were assessed with a battery of cognitive tests and a medical interview. ANOVA showed a significantly worse performance on EF in type 2 diabetes vs. non-diabetic individuals. Two complementary models were displayed: (1) in the whole sample, the presence of type 2 diabetes, depressive symptoms and BMI had a direct negative effect on EF, while apnoea had an indirect negative effect; (2) in the diabetes subsample, higher illness duration was associated with worse performance in EF. Participants with type 2 diabetes and HbA1c

The association between ultra-processed food (UPF) and risk of cardiometabolic disorders is an ongoing concern. Different food processing-based classification systems have originated discrepancies in the conclusions among studies. To test whether the association between UPF consumption and cardiometabolic markers changes with the classification system, we used baseline data from 5636 participants (48.5% female and 51.5% male, mean age 65.1 ± 4.9) of the PREDIMED-Plus (“PREvention with MEDiterranean DIet”) trial. Subjects presented with overweight or obesity and met at least three metabolic syndrome (MetS) criteria. Food consumption was classified using a 143-item food frequency questionnaire according to four food processing-based classifications: NOVA, International Agency for Research on Cancer (IARC), International Food Information Council (IFIC) and University of North Carolina (UNC). Mean changes in nutritional and cardiometabolic markers were assessed according to quintiles of UPF consumption for each system. The association between UPF consumption and cardiometabolic markers was assessed using linear regression analysis. The concordance of the different classifications was assessed with intra-class correlation coefficients (ICC3, overall = 0.51). The highest UPF consumption was obtained with the IARC classification (45.9%) and the lowest with NOVA (7.9%). Subjects with high UPF consumption showed a poor dietary profile. We detected a direct association between UPF consumption and BMI (p = 0.001) when using the NOVA system, and with systolic (p = 0.018) and diastolic (p = 0.042) blood pressure when using the UNC system. Food classification methodologies markedly influenced the association between UPF consumption and cardiometabolic risk markers.

Carotenoids are pigments contained mainly in fruit and vegetables (F&V) that have beneficial effects on cardiometabolic health. Due to their lipophilic nature, co-ingestion of fat appears to increase their bioavailability via facilitating transfer to the aqueous micellar phase during digestion. However, the extent to which high fat intake may contribute to increased carotenoid plasma concentrations is still unclear. The objective was to examine the degree to which the consumption of different amounts of both carotenoid-rich foods and fats is associated with plasma carotenoid concentrations within a Mediterranean lifestyle context (subsample from the PREDIMED-Plus study baseline) where consumption of F&V and fat is high. The study population was categorized into four groups according to their self-reported consumption of F&V and fat. Carotenoids were extracted from plasma samples and analyzed by HPLC-UV-VIS-QqQ-MS/MS. Carotenoid systemic concentrations were greater in high consumers of F&V than in low consumers of these foods (+3.04 μmol/L (95% CI: 0.90, 5.17), p-value = 0.005), but circulating concentrations seemed to decrease when total fat intake was very high (−2.69 μmol/L (−5.54; 0.16), p-value = 0.064). High consumption of F&V is associated with greater systemic levels of total carotenoids, in particular when fat intake is low-to-moderate rather than very high.

One-year dietary quality change according to the preceding maximum weight in a lifestyle intervention program (PREDIMED-Plus trial, 55–75-year-old overweight or obese adults; n = 5695) was assessed. A validated food frequency questionnaire was used to assess dietary intake. A total of 3 groups were made according to the difference between baseline measured weight and lifetime maximum reported weight: (a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM. Data were analyzed by General Linear Model. All participants improved average lifestyle. Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns. People at maximum weight are the most benefitted in the short term by a weight management program. Long term weight loss efforts may also reduce the effect of a weight management program.

Background. Body weight dissatisfaction is a hindrance to following a healthy lifestyle and it has been associated with weight concerns. Objectives. The aim of this study was to assess the association between the adherence to the Mediterranean lifestyle (diet and exercise) and the desired body weight loss in an adult Mediterranean population with overweight. Methods. Cross-sectional analysis in 6355 participants (3268 men; 3087 women) with metabolic syndrome and BMI (Body mass index) between 27.0 and 40.0 kg/m2 (55–75 years old) from the PREDIMED-Plus trial. Desired weight loss was the percentage of weight that participants wished to lose. It was categorized into four cut-offs of this percentage (Q1: n = 1495; Q2: 10–15%, n = 1804; Q3: n = 1470; Q4: ≥20%, n = 1589). Diet was assessed using a validated food frequency questionnaire and a 17-item Mediterranean diet questionnaire. Physical activity was assessed by the validated Minnesota-REGICOR and the validated Spanish version of the Nurses’ Health Study questionnaire. Results. Participants reporting higher percentages of desired weight loss (Q3 and Q4) were younger, had higher real and perceived BMI and were more likely to have abdominal obesity. Desired weight loss correlated inversely to physical activity (Q1: 2106 MET min/week; Q4: 1585 MET min/week. p < 0.001) and adherence to Mediterranean diet (Q1: 8.7; Q4: 8.3. p < 0.001). Conclusions. In older Mediterranean individuals with weight excess, desired weight loss was inversely associated with Mediterranean lifestyle adherence. Deeply rooted aspects of the MedDiet remained similar across groups. Longitudinal research is advised to be able to establish causality.

The purpose of this study is to evaluate the effect of a Mediterranean diet supplemented with extra virgin olive oil and nuts on dry eye parameters. The participants in this study were randomized into one of the two interventional arms: (1) a standard intervention group, a Mediterranean diet supplemented with extra virgin olive oil and nuts; and (2) an intensive intervention group, based on a hypocaloric Mediterranean diet and an intensive lifestyle program with physical activity and weight-loss goals. In both groups, common dry eye tests were conducted at baseline and after six months: the Ocular Surface Disease Index (OSDI), the Dry Eye Scoring System (DESS), tear break-up time (TBUT), the Schirmer’s test, and the Oxford staining grade. Sixty-seven eyes were examined. After six months, dry eye parameters improved in both groups; differences between groups were favorable for the intensive intervention group. The implementation of a Mediterranean diet pattern was beneficial for the selected patients with dry eye, and could be beneficial for patients with dry eye in general. Behavioral support for diet adherence and the promotion of healthy lifestyles (exercise) and weight loss (calorie restriction) have an added positive effect.

Healthy lifestyle factors, such as physical activity (PA) and Mediterranean diet (MD), decrease the likelihood of developing metabolic syndrome (MetS). The aim of this study was to report main lifestyle components and related factors according to the MetS severity. Cross-sectional analysis was done of baseline lifestyle factors from 5739 participants with overweight/obesity and MetS features (aged 55–75 years) included in the PREDIMED-PLUS primary cardiovascular prevention randomized trial. Participants were categorized in tertiles according to a validated MetS severity score (MetSSS). Anthropometrics, visceral adiposity index, dietary nutrient intake, biochemical marker levels, as well as a Dietary Inflammatory Index and depression symptoms (Beck Depression Inventory-II) were measured. Diet quality was assessed using a 17-item energy-restricted MD questionnaire. Duration and intensity of PA was self-reported using the Minnesota-REGICOR Short Physical Activity Questionnaire. Sedentary behaviours were measured using the Spanish version of the Nurses’ Health Study questionnaire. The 30 s chair stand test was also assessed. Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA). Highest MetSSS participants tended to a pro-inflammatory dietary pattern and tended to lower MD adherence. In addition, they showed lower carbohydrate and nut intake and higher intake of protein, saturated and trans fatty acids, cholesterol, iodine, sodium, red and processed meat products, other oils different from olive oil and spirit alcoholic drinks. The highest MetS severity score was associated with lower moderate and vigorous LTPA and higher sedentary time and depression risk, as they tended to a pro-inflammatory dietary pattern and lower MD adherence.

We assessed if a 17-item score capturing adherence to a traditional Mediterranean diet (MedDiet) was associated with better health-related quality of life among older Spanish men and women with overweight or obesity harboring the metabolic syndrome. We analyzed baseline data from 6430 men and women (age 55-70 years) participating in the PREDIMED-Plus study. PREDIMED-Plus is a multi-centre randomized trial testing an energy-restricted MedDiet combined with promotion of physical activity and behavioral therapy for primary cardiovascular prevention compared to a MedDiet alone. Participants answered a 36-item questionnaire about health-related quality of life (HRQoL) and a 17-item questionnaire that assessed adherence to an MedDiet. We used ANCOVA and multivariable-adjusted linear regression models to compare baseline adjusted means of the quality of life scales according to categories of adherence to the MedDiet. Higher adherence to the MedDiet was independently associated with significantly better scores in the eight dimensions of HRQoL. Adjusted differences of > = 3 points between the highest and the lowest dietary adherence groups to the MedDiet were observed for vitality, emotional role, and mental health and of > = 2 points for the other dimensions. In conclusion, this study shows a positive association between adherence to a MedDiet and several dimensions of quality of life.

El objetivo fue analizar los conocimientos sobre la higiene de las manos de los profesionales del Sistema Sanitario Público Andaluz (España). Estudio mediante encuestas en 2011, utilizando el Hand Hygiene Knowledge Questionnaire for Health-Care Workers con la técnica de análisis de clases latentes. La media de respuestas correctas fue de 17,51 ± 3,68. Las preguntas con porcentajes de respuestas correctas más bajos son las referidas a la prevención, mediante la higiene de las manos, de la transmisión de microorganismos después de la exposición al paciente y aquellas relacionadas con la utilización de preparados de base alcohólica. Se obtuvo un modelo de 7 clases latentes. Principales diferencias socio-demográficas: los profesionales con conocimientos más bajos suelen ser hombres, jóvenes y no sanitarios; el haber recibido formación previa no discrimina a los que presentan excelentes conocimientos. Concluimos que la revisión de los programas de formación en higiene de las manos es necesaria para mejorar los conocimientos sobre aspectos conceptuales de la transmisión de microorganismos a través de las manos.

Limited data exists on the interrelationships between physical activity (PA), sedentary behaviors and sleep concerning cardiometabolic risk factors in aged adults at high cardiovascular disease risk. Our aim was to examine independent and joint associations between time spent in leisure-time PA, sedentary behaviors and sleep on the prevalence of obesity, type 2 diabetes (T2D) and components of the metabolic syndrome (MetS) in Mediterranean individuals at high cardiovascular risk. Cross-sectional analyses were performed on baseline data from 5776 Spanish adults (aged 55-75y in men; 60-75y in women) with overweight/obesity and MetS, from October 2013 to October 2016, in the PREDIMED-PLUS trial. Employing multivariable-adjusted Cox regression with robust variance and constant time (given the cross-sectional design), higher prevalence of obesity, T2D and abdominal obesity as component of the MetS were associated with greater time in TV-viewing (Relative Risk, RR: 1.02, 95%CI: 1.01, 1.03; RR:1.04, 95%CI: 1.02, 1.06 and RR: 1.01 95%CI: 1.00, 1.02; respectively, all P < .01). Conversely, greater time in moderate-vigorous PA (MVPA) was associated with lower prevalence of obesity, T2D, abdominal obesity and low HDL-cholesterol (RR: 0.95, 95%CI: 0.93, 0.97; RR: 0.94, 95%CI: 0.89, 0.99; RR: 0.97, 95%CI: 0.96, 0.98; and RR: 0.95, 95%CI: 0.91, 0.99, respectively, all P < .05). For these outcomes, theoretically substituting 1-h/day of MVPA for 1-h/day TV-viewing was also significantly associated with lower prevalence (RR 0.91 to 0.97, all P < .05). Similar lower RR in these outcomes was observed when substituting 1-h/day of MVPA for 1-h/day of sleeping. Longer time watching TV and not meeting MVPA recommendations were jointly associated with higher RR of the prevalence of obesity and T2D. We concluded that, in senior individuals at high cardiovascular risk, greater time spent on MVPA and fewer on sedentary behaviors was inversely associated with prevalence of obesity, T2D, and some of the components of MetS.

Dietary guidelines emphasize the importance of a varied diet to provide an adequate nutrient intake. However, an older age is often associated with consumption of monotonous diets that can be nutritionally inadequate, increasing the risk for the development or progression of diet-related chronic diseases, such as metabolic syndrome (MetS). To assess the association between dietary diversity (DD) and nutrient intake adequacy and to identify demographic variables associated with DD, we cross-sectionally analyzed baseline data from the PREDIMED-Plus trial: 6587 Spanish adults aged 55−75 years, with overweight/obesity who also had MetS. An energy-adjusted dietary diversity score (DDS) was calculated using a 143-item validated semi-quantitative food frequency questionnaire (FFQ). Nutrient inadequacy was defined as an intake below 2/3 of the dietary reference intake (DRI) forat least four of 17 nutrients proposed by the Institute of Medicine (IOM). Logistic regression models were used to evaluate the association between DDS and the risk of nutritionally inadequate intakes. In the higher DDS quartile there were more women and less current smokers. Compared with subjects in the highest DDS quartile, those in the lowest DDS quartile had a higher risk of inadequate nutrient intake: odds ratio (OR) = 28.56 (95% confidence interval (CI) 20.80−39.21). When we estimated food varietyfor each of the food groups, participants in the lowest quartile had a higher risk of inadequate nutrient intake for the groups of vegetables, OR = 14.03 (95% CI 10.55−18.65), fruits OR = 11.62 (95% CI 6.81−19.81), dairy products OR = 6.54 (95% CI 4.64−9.22) and protein foods OR = 6.60 (95% CI 1.96−22.24). As DDS decreased, the risk of inadequate nutrients intake rose. Given the impact of nutrient intake adequacy on the prevention of non-communicable diseases, health policies should focus on the promotion of a healthy varied diet, specifically promoting the intake of vegetables and fruit among population groups with lower DDS such as men, smokers or widow(er)s.

The aim of the study was to evaluate sleep duration and sleep variability in relation to serum uric acid (SUA) concentrations and SUA to creatinine ratio. This is a cross-sectional analysis of baseline data from 1842 elderly participants with overweight/obesity and metabolic syndrome in the (Prevención con Dieta Mediterránea) PREDIMED-Plus trial. Accelerometry-derived sleep duration and sleep variability were measured. Linear regression models were fitted to examine the aforementioned associations. A 1 hour/night increment in sleep duration was inversely associated with SUA concentrations (β = −0.07, p = 0.047). Further adjustment for leukocytes attenuated this association (p = 0.050). Each 1-hour increment in sleep duration was inversely associated with SUA to creatinine ratio (β = −0.15, p = 0.001). The findings of this study suggest that longer sleep duration is associated with lower SUA concentrations and lower SUA to creatinine ratio.