Clinical Practice Guidelines and Recommendations by the World Association of Perinatal Medicine and Perinatal Medicine Foundation: Reporting Suspected Findings from Fetal Central Nervous System Examination.

These guidelines follow the mission of the World Association of Perinatal Medicine, in collaboration with the Perinatal Medicine Foundation, which brings together groups and individuals worldwide, with the aim to improve prenatal detection of central nervous system anomalies and the appropriate referral of pregnancies with suspected fetal anomalies. In addition, this document provides further guidance for healthcare practitioners with the goal of standardizing the description of ultrasonographic abnormal findings.

Impact of residential greenness on myocardial infarction in the population with diabetes: A sex-dependent association?

Living in urban areas with abundant greenness might provide health benefits in general population. Literature suggests that sex/gender plays a role in the association between greenness and health outcomes. But the impact of greenness in populations with moderate to high cardiovascular risk, such as persons with diabetes, is still unknown. Our aim was to evaluate the relationship between urban greenness and myocardial infarction incidence in persons with type 2 diabetes in Barcelona (Catalonia, Spain), and seek potential gender/sex differences in this association. This retrospective cohort study is based on data from the System for the Development of Research in Primary Care (SIDIAP database). We used Cox models to estimate if a 0.01 increase in Normalized Difference Vegetation Index (NDVI) at census tract level was associated to reduced risk of developing a myocardial infarction. Models were adjusted by demographic and clinical characteristics at individual level, and by environmental and socioeconomic variables at census tract level. Amongst 41,463 persons with diabetes and 154,803.85 person-years of follow-up, we observed 449 incident cases of acute myocardial infarction. For each 0.01 increment in NDVI the risk of developing a myocardial infarction decreased by 6% (Hazard Ratio, HR = 0.94; 95%CI, 0.89-0.99) in the population with diabetes. When stratifying by sex, we observed a significant association only in men (HR = 0.91; 95%CI, 0.86-0.97). People with diabetes living in urban greener areas might benefit from reduced cardiovascular risk, specially men. We observed sex/gender disparities, which could be related to different exposures and activities performed in green spaces between men and women. Further studies are needed to confirm sex/gender disparities between greenness exposure and cardiovascular outcomes. Our findings contribute to improve the health of people with diabetes who should be recommended to spent time and exercise in green areas.

Reducing health inequities affecting immigrant women: a qualitative study of their available assets.

BACKGROUND: Immigrant women often experience health inequities, whether for reasons of gender, country of origin, or socioeconomic status. The view of immigrant women has always focussed on their needs, without taking into account their available assets. A salutogenic approach incorporating an assets analysis could provide a new perspective on the design of health promotion interventions to reduce health inequities. The study objective was to identify the assets of this group of women as a necessary first step in changing the paradigm used in such health promotion interventions. METHODS: This qualitative study combined focus groups, in-depth interviews, and a photovoice session. The aim was to describe the assets of this group, based on Antonovsky's salutogenic approach and assets model. Qualitative results were interpreted with a phenomenological focus, identifying each individual's internal, community, and institutional assets. RESULTS: The self awareness of skills was linked to a person's description of herself as being optimistic, having religious beliefs, and having motivations and objectives in life, for herself, her family or her children. Being motivated helped the women to persist in doing or learning things that could be useful in confronting difficult situations. Another selfawareness skill was feeling useful to others, whether this was due to religious beliefs about their role in life or to the importance of the mutual support of interpersonal relationships. CONCLUSIONS: High optimism, strong capacity for struggle and self-initiative, the importance of religious beliefs, social support, and concern for their children's future were described as assets of immigrant women. Identification of these assets allows us to develop more in-depth knowledge and better tools for health promotion programs and policies intended to reduce health inequities in this population of immigrant women.

[Translated article] Pharmaceutical care in respiratory diseases: Current situation and opportunities for hospital pharmacy in Spain.

OBJECTIVE: Respiratory diseases present a challenge for the healthcare system due to their prevalence and clinical impact. The aim of this study was to explore the current situation of hospital pharmacy in the field of respiratory diseases. METHOD: Observational, cross-sectional study, with a national scope, divided into 2 parts. In an initial phase, the activity and level of pharmaceutical care in respiratory diseases was evaluated through an online questionnaire using REDCap. The survey was addressed to department chiefs and consisted of 17 items, divided into 2 modules: general data and general activity. The second phase was open to hospital pharmacists, with the aim of exploring their opinion on care, training, and improvement needs. The number of items in this phase was 19, divided into 5 modules: general data, pharmaceutical care, competencies, training, and degree of satisfaction. RESULTS: In the first phase, 23 hospitals were included. Most of them (n=20) had a pharmacist in charge of respiratory diseases. However, a large proportion of them dedicated less than 40% of their working day to this activity. The pharmacist's activity occurred at the level of external patients (n=21), hospitalised patients (n=16), and secondarily in management (n=8). Integration is greater in pathologies such as asthma, IPF, pulmonary hypertension, and bronchiectasis. Participation in committees was present in 15 hospitals, with variability in pathologies and degree of involvement. In the second phase, 164 pharmacists participated, who considered pharmaceutical care in cystic fibrosis, asthma, and lung transplant as a priority. 51% considered integration to be adequate and 91% considered it necessary to implement prioritisation criteria. Professional competencies ranged from 6.5 to 6.9 out of 10 points. Only 45% of participants had received specific training in the last 4 years, indicating greater priority for asthma, pulmonary hypertension, and IPF. CONCLUSIONS: Most centers have pharmacists specialised in respiratory diseases. However, there is room for improvement in terms of subspecialisation, participation in multidisciplinary committees, implementation of prioritisation criteria, diversification in pathologies treated, as well as greater specific training in this area.

Pharmaceutical care in respiratory diseases: Current situation and opportunities for Hospital Pharmacy in Spain. / Atención farmacéutica en enfermedades respiratorias: situación y oportunidades de la farmacia hospitalaria en España.

OBJECTIVE: Respiratory diseases present a challenge for the healthcare system due to their prevalence and clinical impact. The aim of this study was to explore the current situation of hospital pharmacy in the field of respiratory diseases. METHOD: Observational, cross-sectional study, with a national scope, divided into 2 parts. In an initial phase, the activity and level of pharmaceutical care in respiratory diseases was evaluated through an online questionnaire using REDCap. The survey was addressed to department chiefs and consisted of 17 items, divided into 2 modules: general data and general activity. The second phase was open to hospital pharmacists, with the aim of exploring their opinion on care, training, and improvement needs. The number of items in this phase was 19, divided into 5 modules: general data, pharmaceutical care, competencies, training and degree of satisfaction. RESULTS: In the first phase, 23 hospitals were included. Most of them (n=20) had a pharmacist in charge of respiratory diseases. However, a large proportion of them dedicated less than 40% of their working day to this activity. The pharmacist's activity occurred at the level of external patients (n=20), hospitalized patients (n=16), and secondarily in management (n=8). Integration is greater in pathologies such as asthma, IPF, pulmonary hypertension, and bronchiectasis. Participation in committees was present in 15 hospitals, with variability in pathologies and degree of involvement. In the second phase, 164 pharmacists participated, who considered pharmaceutical care in cystic fibrosis, asthma and lung transplant as a priority. Fifty-one percent considered integration to be adequate and 91% considered it necessary to implement prioritization criteria. Professional competencies ranged from 6.5-6.9 out of 10 points. Only 45% of participants had received specific training in the last four years, indicating greater priority for asthma, pulmonary hypertension and IPF. CONCLUSIONS: Most centers have pharmacists specialized in respiratory diseases. However, there is room for improvement in terms of sub specialization, participation in multidisciplinary committees, implementation of prioritization criteria, diversification in pathologies treated, as well as greater specific training in this area.

Sex matters in the association between cardiovascular health and incident dementia: evidence from real world data.

BACKGROUND: Cardiovascular health has been associated with dementia onset, but little is known about the variation of such association by sex and age considering dementia subtypes. We assessed the role of sex and age in the association between cardiovascular risk and the onset of all-cause dementia, Alzheimer's disease, and vascular dementia in people aged 50-74 years. METHODS: This is a retrospective cohort study covering 922.973 Catalans who attended the primary care services of the Catalan Health Institute (Spain). Data were obtained from the System for the Development of Research in Primary Care (SIDIAP database). Exposure was the cardiovascular risk (CVR) at baseline categorized into four levels of Framingham-REGICOR score (FRS): low (FRS < 5%), low-intermediate (5% ≤ FRS < 7.5%), high-intermediate (7.5% ≤ FRS < 10%), high (FRS ≥ 10%), and one group with previous vascular disease. Cases of all-cause dementia and Alzheimer's disease were identified using validated algorithms, and cases of vascular dementia were identified by diagnostic codes. We fitted stratified Cox models using age parametrized as b-Spline. RESULTS: A total of 51,454 incident cases of all-cause dementia were recorded over a mean follow-up of 12.7 years. The hazard ratios in the low-intermediate and high FRS groups were 1.12 (95% confidence interval: 1.08-1.15) and 1.55 (1.50-1.60) for all-cause dementia; 1.07 (1.03-1.11) and 1.17 (1.11-1.24) for Alzheimer's disease; and 1.34 (1.21-1.50) and 1.90 (1.67-2.16) for vascular dementia. These associations were stronger in women and in midlife compared to later life in all dementia types. Women with a high Framingham-REGICOR score presented a similar risk of developing dementia - of any type - to women who had previous vascular disease, and at age 50-55, they showed three times higher risk of developing dementia risk compared to the lowest Framingham-REGICOR group. CONCLUSIONS: We found a dose‒response association between the Framingham-REGICOR score and the onset of all dementia types. Poor cardiovascular health in midlife increased the onset of all dementia types later in life, especially in women.

Intrapartum ultrasound in maternal lateral versus semi-recumbent posture. A repeated measures study.

OBJECTIVE: This study aimed to assess whether intrapartum ultrasound (ITU) measurements in maternal lateral posture are superimposable to ITU measurements in semi-recumbent position. STUDY DESIGN: A single-center, repeated measures design was used. Women in the second stage of labor were randomized to ITU first in semi-recumbent followed by ITU in side-lying posture without and with contraction, or inversely. The angle of progression (AOP) and the head-perineum distance (HPD) between contractions (AOP1 and HPD1) and with contraction (AOP2 and HPD2) were measured in each maternal posture. The differences between AOP1 and AOP2 (dAOP), and between HPD1 and HPD2 (dHPD) were calculated. RESULTS AND CONCLUSIONS: Forty-two women participated in the study. A generalized estimating equation model showed that AOP1 (-3.00°; 95 % CI -5.77 to -0.23; p = 0.03) and AOP2 (-4.14°; 95 % CI -7.20 to -1.08; p = 0.008) were lower in semi-recumbent compared to maternal lateral posture. HPD1 (+1.43 mm; 95 % CI 0.05-2.81; p = 0.042) and HPD2 (+1.53 mm; 95 % CI 0.17-2.89; p = 0.03) were higher in semi-recumbent position. Differences in the ITU measurements in maternal lateral posture compared to semi-recumbent position are small. Monitoring the second stage of labor with ITU in lateral maternal posture is possible.

Axes of social inequities in COVID-19 clinical trials: A systematic review.

Objective: The representativeness of participants is crucial to ensure external validity of clinical trials. We focused on the randomized clinical trials which assessed COVID-19 vaccines to assess the reporting of age, sex, gender identity, race, ethnicity, obesity, sexual orientation, and socioeconomic status in the results (description of the participants' characteristics, loss of follow-up, stratification of efficacy and safety results). Methods: We searched the following databases for randomized clinical trials published before 1st February 2022: PubMed, Scopus, Web of Science, and Excerpta Medica. We included peer-reviewed articles written in English or Spanish. Four researchers used the Rayyan platform to filter citations, first reading the title and abstract, and then accessing the full text. Articles were excluded if both reviewers agreed, or if a third reviewer decided to discard them. Results: Sixty three articles were included, which assessed 20 different vaccines, mainly in phase 2 or 3. When describing the participants' characteristics, all the studies reported sex or gender, 73.0% race, ethnicity, 68.9% age groups, and 22.2% obesity. Only one article described the age of participants lost to follow-up. Efficacy results were stratified by age in 61.9%, sex or gender in 26.9%, race and/or, ethnicity in 9.5%, and obesity in 4.8% of the articles. Safety results were stratified by age in 41.0%, and by sex or gender in 7.9% of the analysis. Reporting of gender identity, sexual orientation or socioeconomic status of participants was rare. Parity was reached in 49.2% of the studies, and sex-specific outcomes were mentioned in 22.9% of the analysis, most of the latter were related to females' health. Conclusions: Axes of social inequity other than age and sex were hardly reported in randomized clinical trials that assessed COVID-19 vaccines. This undermines their representativeness and external validity and sustains health inequities.

[Comparative survival study between the old and new bronchogenic carcinoma classification]. / Estudio comparativo de supervivencias entre la actual y la antigua clasificación del carcinoma broncogénico.

INTRODUCTION: A new classification of bronchogenic carcinoma has been made by the International Association for the Study of Lung Cancer (IASLC) and published by Frank C. Detterbeck et al in the journal Chest (2009). The Thoracic Surgery Department of the Gerona (Spain) University Hospital has re-staged a series of patients with bronchogenic carcinoma who had attempted curative surgery, with the aim of comparing the survival (survival for T, survival for M, and survival by disease staging) between the old and new classification, and also to determine whether these changes in survival are statistically significant. Another one of the objectives of the study is to see whether there is agreement between the current survival of our surgical series and that published by the IASLC. PATIENTS AND METHODS: Data on 855 patients who had attempted bronchogenic carcinoma curative surgery were entered into a data base. They were radiologically, clinically and histologically staged according to the new and old staging. Survival was calculated according to the T, M, N, and histology stages. A statistical analysis was performed using the SPSS program and the changes in survival between both classifications were analysed. RESULTS: No statistically significant changes were observed in survival (P=.58) with the new classification in stage IIA, but there were statistically significant changes in survival (P=.0001) in stage IIIB. DISCUSSION: The study confirms that the current TNM classification is useful, since it shows changes in survival in 2 histological stages (one of them statistically significant). The survival data of our series now fits better with those provided by the IASLC.

COVID-19 pandemic, as experienced in the surgical service of a district hospital in Spain.

The coronavirus disease 2019, which is caused by severe acute respiratory syndrome coronavirus 2, was first identified in December 2019 in Wuhan, China, and has since spread rapidly, evolving into a full-blown pandemic. We would like to report our experience after 1 year of this pandemic in the surgical service of a district hospital in Spain. There have been many changes (including new protocols) that our service and the hospital have undergone, to adapt to the new situation. We believe that this experience can be useful for other professionals who have lived and are living a similar situation.

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study.

Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women's relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women's participation in clinical trials.

Influence of Ventricular Wringing on the Preservation of Left Ventricular Ejection Fraction in Cardiac Amyloidosis.

BACKGROUND: The purpose of this work was to determine the influence of myocardial wringing on ventricular function in patients with cardiac amyloidosis (CA). METHODS: Fifteen healthy volunteers (group 1) and 34 patients with CA (17 with left ventricular ejection fractions [LVEFs] ≥ 53% [group 2] and 17 with LVEFs < 53% [group 3]) were evaluated using two-dimensional speckle-tracking echocardiography. A control group of mass-matched patients (n = 20) with left ventricular (LV) hypertrophy and LVEFs ≥ 53% was also included. Longitudinal strain (LS), circumferential strain, and LV twist and torsion were calculated. Deformation index (DefI), a new parameter of wringing, calculated as twist/LS, that takes into account actions that occur simultaneously during LV systole (i.e., longitudinal shortening and twist), was evaluated. Torsional and wringing parameters were calculated according to LVEF. RESULTS: Lower global values of LS and circumferential strain were observed among patients with CA (LS: group 1, -20.6 ± 2.5%; group 2, -11.6 ± 4.1%; group 3, -9.0 ± 3.1%; circumferential strain: group 1, -22.7 ± 4.9%; group 2, -14.4 ± 8.0%; group 3, -13.6 ± 3.8%; P < .001 for both). Torsion did not vary between group 2 and group 1 (2.5 ± 1.1°/cm vs 2.7 ± 0.8°/cm, P = NS). In contrast, DefI was greater in group 2 than in group 1 (-1.8 ± 0.8°/% vs -1.0 ± 0.3°/%, P < .01). Torsion and DefI were lower in group 3 (1.2 ± 0.7°/cm and -1.1 ± 0.6°/%, respectively, P < .001 for both) than in group 2. DefI was similar in patients with LV hypertrophy (-1.7 ± 0.6°/%, P = NS) and group 2. CONCLUSIONS: In patients with CA, preservation of LVEF depends on greater ventricular wringing. DefI, a parameter that integrates the twist and the simultaneous longitudinal shortening of the left ventricle, is a more accurate indicator of the efficacy of this mechanism.

Continuity of care and monitoring pain after discharge: patient perspective.

AIM: This paper is a report of a study conducted to evaluate, from the patients' perspective, a Liaison and Continuity of Care Programme coordinating care provision between a hospital and primary care centres. BACKGROUND: Promoting continuity of care between hospitals and primary care improves quality of care, patient satisfaction and decreases further hospitalizations. However, inadequate pain management is common after discharge. METHOD: A sample of patients from the Liaison and Continuity of Care Programme were included in a longitudinal study in 2007. We conducted standardized telephone interviews at 24 hours, 7 days, 1 and 3 months after discharge. Outcome measures included readmission, time between hospital discharge and readmission, information level at discharge, patient satisfaction, queries about care and information related to perceived state of health and pain. RESULTS: Eighty-three adult patients (average age 69.3, 50.6% males) who needed continued care at discharge were followed. Ten participants died during follow-up, and seven required readmission. A total of 49.4% of patients stated that they had understood the information given at discharge very well or perfectly. At 24 hours after discharge, 30% already had doubts about their state of health and the management of their condition. In relation to perceived health, only 25.3% stated that this was good or very good. Prevalence of pain 24-hours after discharge was 58.3% in surgical patients and 17.1% in other patients. CONCLUSION: The preparation and education of patients and family members should be improved before discharge, and appropriate written information must be given, especially if a patient has pain or requires complex care.

Assessing relative post-release mortality for the transparent goby fishery: Environmental drivers and the utility of vitality metrics.

The target species (Aphia minuta and Pseudaphya ferreri) of the transparent goby fishery on Mallorca Island (Balearic Islands, western Mediterranean) are currently discarded when the maximum daily catch is exceeded or when the sorting process is unworkable. The mortality suffered by this discarded fraction remains unknown, although it may be important for resource management. Accordingly, the aims of this study were to (1) assess the environmental drivers of the relative post-release survival of the discarded target species and (2) test the correlations between post-release survival and two behavior-related variables (swimming speed and its increase after a stimulus, assessed via video recording). To do so, mortality of the target species from 47 hauls sampled under normal fishing boat operations was monitored when the gear was onboard and after a few hours. At the reference level (an average depth of 25.7 m and temperature of 15.7 ºC), the immediate survival was 99.9% (95% CI: 97.9 to 100%), but the estimated post-release survival decreased to 47.2% (33.8 to 65.8%). Relative post-release mortality doubled when the water temperature increased by 2.8 ºC or when the fishing depth increased up to 32 m. Furthermore, the swimming speed of the target species was significantly correlated with the estimated post-release survival; thus, this vitality metric may offer a promising strategy for more easily estimating post-release mortality in other fisheries.

Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial.

OBJECTIVES: The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case. 3. To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women. The secondary objectives are: 1. To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women. 2. To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women. 3. To assess the safety and tolerability of HCQ in pregnant women. 4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy. 5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group. 6. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2. TRIAL DESIGN: Randomized double-blind placebo-controlled two-arm multicentre clinical trial to evaluate the safety and efficacy of HCQ to prevent and/or minimize SARS-CoV-2 infection during pregnancy. Participants will be randomized to receive a 14-day oral treatment course of HCQ or placebo, ratio 1:1. PARTICIPANTS: Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case. Inclusion criteria Women will be invited to participate in the trial and sign an informed consent if they meet the following inclusion criteria. • Presenting with fever (≥37.5°C) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache) OR being contact* of a SARS-CoV-2 confirmed or suspected case in the past 14 days • More than 12 weeks of gestation (dated by ultrasonography) • Agreement to deliver in the study hospitals Exclusion criteria • Known hypersensitivity to HCQ or other 4-amonoquinoline compounds • History of retinopathy of any aetiology • Concomitant use of digoxin, cyclosporine, cimetidine • Known liver disease • Clinical history of cardiac pathology including known long QT syndrome • Unable to cooperate with the requirements of the study • Participating in other intervention studies • Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours) The study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results. Assignment of participants to study groups will be as follows: • SARS-CoV-2-PCR confirmed, infected pregnant women: a. symptomatic (n=100) b. asymptomatic (n=100) • SARS-CoV-2 PCR negative pregnant women in contact* with a SARS-CoV-2-infected confirmed or suspected case (n=514). *The ECDC definition of close contact will be followed. The trial will be conducted in five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau, in Barcelona, and HM Puerta del Sur and Hospital Universitario de Torrejón, in Madrid. INTERVENTION AND COMPARATOR: Participants will be randomized to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days) or placebo (2 tablets for three days, followed by one tablet for 11 days). MAIN OUTCOMES: The primary outcome is the number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start (one week after treatment is completed). RANDOMISATION: Allocation of participants to study arms will be done centrally by the trial's Sponsor (the Barcelona Institute for Global Health, ISGlobal) by block randomization. This method will ensure balanced allocation to both arms. The electronic CRF will automatically assign a study number to each participant, depending on her study group and recruitment site. Each number will be related to a treatment number, which assigns them to one of the study arms. BLINDING (MASKING): Participants, caregivers, investigators and those assessing the outcomes will be blinded to group assignment. Study tablets (HCQ and placebo) will be identically packaged in small opaque bottles. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm. TRIAL STATUS: Protocol version 1.0, from May 8th, 2020. Recruitment is ongoing (first patient recruited the 19th May 2020 and recruitment end anticipated by December 2020). TRIAL REGISTRATION: EudraCT number: 2020-001587-29, registered 2 April 2020. Clinicaltrials.gov identifier: NCT04410562 , retrospectively registered 1 June 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Validation Of Cancer Diagnoses In Electronic Health Records: Results From The Information System For Research In Primary Care (SIDIAP) In Northeast Spain.

BACKGROUND: Electronic health records are becoming an increasingly valuable resource for epidemiology but their data quality needs to be quantified. We aimed to validate twenty-five types of incident cancer cases in the Information System for Research in Primary Care (SIDIAP) in Catalonia with the population-based cancer registries of Girona and Tarragona as the gold-standard. METHODS: We calculated the sensitivity, positive predictive values (PPV), and the time-difference between the date of diagnosis entered into the SIDIAP and into the registries. We added hospital discharge cancer diagnoses to the SIDIAP to assess sensitivity changes. RESULTS: We identified 27,046 incident cancer diagnoses in the SIDIAP from 2009-2015 among the 949,841 residents of Girona and Tarragona. The cancer types with the highest sensitivity were breast (89%, 95% CI: 88-90%), colorectal (81%, 95% CI: 80-82%), and prostate (81%, 95% CI: 80-83%). Trachea, bronchus and lung cancers had the highest PPV (76%, 95% CI: 74%-78%) followed by stomach (72%, 95% CI: 68-75%) and pancreas (71%, 95% CI: 67-75%). Most cancer diagnoses were reported with less than three months of difference between the SIDIAP and the registries. More cases were registered first in the registries than in the SIDIAP. By adding cancer diagnoses based on hospital discharge data, sensitivity increased for all cancers, especially for gallbladder and biliary tract for which the sensitivity increased by 21%. CONCLUSION: The SIDIAP includes 76% of the cancer diagnoses in the cancer registries but includes a considerable number of cases that are not in the registries. The SIDIAP reports most of the cancer diagnoses within a three-month period difference from the date of diagnosis in the cancer registries. Our results support the use of the SIDIAP cancer diagnoses for epidemiological research when cancer is the outcome of interest. We recommend adding hospital discharge data to the SIDIAP to increase data quality, particularly for less frequent cancer types.

Comparing the catch composition, profitability and discard survival from different trammel net designs targeting common spiny lobster (Palinurus elephas) in a Mediterranean fishery.

In the Balearic Islands, different trammel net designs have been adopted to promote fisheries sustainability and reduce discards. Here, we compare the catch performance of three trammel net designs targeting the spiny lobster Palinurus elephas in terms of biomass, species composition and revenue from commercial catches and discards. Designs differ in the netting fiber type (standard polyfilament, PMF, or a new polyethylene multi-monofilament, MMF) and the use of a guarding net or greca, a mesh piece intended to reduce discards. Catches were surveyed by an on-board observer from 1,550 netting walls corresponding to 70 nets. The number of marketable species captured indicated that the lobster trammel net fishery has multiple targets, which contribute significantly to the total revenue. The discarded species ranged from habitat-forming species to elasmobranches, but the magnitude of gear-habitat interactions on the long term dynamics of benthos remains unclear. No relevant differences in revenue and weight of discards were detected after Bayesian analyses. However, the species composition of discards was different when using greca. Interestingly, high immediate survival was found for discarded undersized lobsters, while a seven day survival assessment, using captive observation, gave an asymptotic estimate of survival probability as 0.64 (95% CI [0.54-0.76]). Therefore, it is recommended that it would be beneficial for this stock if an exemption from the EU landing obligation regulation was sought for undersized lobsters in the Balearic trammel net fishery.

Air Pollution, Noise, Blue Space, and Green Space and Premature Mortality in Barcelona: A Mega Cohort.

Introduction: Cities often experience high air pollution and noise levels and lack of natural outdoor environments, which may be detrimental to health. The aim of this study was to evaluate the effects of air pollution, noise, and blue and green space on premature all-cause mortality in Barcelona using a mega cohort approach. Methods: Both men and women of 18 years and above registered on 1 January 2010 by the Sistema d'Informació pel Desenvolupament de la Investigació en Atenció Primària (SIDIAP) and living in the city of Barcelona were included in the cohort and followed up until 31 December 2014 or until death (n = 2,939,067 person years). The exposure assessment was conducted at the census tract level (n = 1061). We assigned exposure to long term ambient levels of nitrogen dioxides (NO2), nitrogen oxides (NOx), particulate matter with aerodynamic diameter less than 2.5 µm (PM2.5), between 2.5 µm and 10 µm (PM2.5⁻10, i.e., coarse particulate matter), less than 10 µm (PM10) and PM2.5 light absorption (hereafter referred to as PM2.5 absorbance) based on land use regressions models. Normalized Difference Vegetation Index (NDVI) was assigned based on remote sensing data, percentage green space and blue space were calculated based on land use maps and modelled road traffic noise was available through the strategic noise map for Barcelona. Results: In this large prospective study (n = 792,649) in an urban area, we found a decreased risk of all-cause mortality with an increase in green space measured as NDVI (hazard ratio (HR) = 0.92, 95% CI 0.89⁻0.97 per 0.1) and increased risks of mortality with an increase in exposure to blue space (HR = 1.04, 95% CI 1.01⁻1.06 per 1%), NO2 (HR = 1.01, 95% CI 1.00⁻1.02 per 5 ug/m³) but no risk with noise (HR = 1.00, 95% CI 0.98⁻1.02 per 5 dB(A)). The increased risks appeared to be more pronounced in the more deprived areas. Results for NDVI, and to a lesser extent NO2, remained most consistent after mutual adjustment for other exposures. The NDVI estimate was a little attenuated when NO2 was included in the model. The study had some limitations including e.g., the assessment of air pollution, noise, green space and socioeconomic status (SES) on census tract level rather than individual level and residual confounding. Conclusion: This large study provides new insights on the relationship between green and blue space, noise and air pollution and premature all-cause mortality.

Association of Classic Cardiovascular Risk Factors and Lifestyles With the Cardio-ankle Vascular Index in a General Mediterranean Population.

INTRODUCTION AND OBJECTIVES: The cardio-ankle vascular index (CAVI) assesses arterial stiffness. We aimed to describe the distribution of CAVI in a Mediterranean population, to determine the proportion of CAVI ≥ 9 by sex and coronary risk level, and to assess the association of CAVI with classic cardiovascular risk factors and lifestyle patterns. METHODS: This cross-sectional study was based on the population of Girona province. The CAVI was measured using the VaSera VS-1500. RESULTS: Of 2613 individuals included in this study, the prevalence of CAVI ≥ 9 was 46.8% in men and 36.0% in women and significantly increased with coronary risk: from 21.1% and 24.8%, respectively to 76.7%, in the low-risk group, and 61.9% in the high-risk group. The CAVI increased with age in both sexes, being higher in men across all age groups. In men, CAVI ≥ 9 was associated with hypertension (OR, 2.70; 95%CI, 1.90-3.87) and diabetes (OR, 2.38; 95%CI, 1.52-3.78), body mass index (BMI) ≤ 25 to < 30 (OR, 0.44; 95%CI, 0.27-0.72) and BMI ≥ 30 (OR, 0.28; 95%CI, 0.14-0.58), and physical activity (OR, 0.66; 95%CI, 0.47-0.92). In women, CAVI ≥ 9 was associated with hypertension (OR, 2.22; 95%CI, 1.59-3.09), hypercholesterolemia (OR, 1.40; 95%CI, 1.01-1.94), and BMI ≥ 30 (OR, 0.38; 95%CI, 0.20-0.71). CONCLUSIONS: The CAVI increases with age and is higher in men than in women. This index is associated with classic risk factors and coronary risk. It could be a good predictive biomarker, but further follow-up studies are required to assess its added value to cardiovascular risk stratification.

Differences in cardio-ankle vascular index in a general Mediterranean population depending on the presence or absence of metabolic cardiovascular risk factors.

BACKGROUND AND AIMS: The main aim of this study is to describe the differences in the cardio-ankle vascular index (CAVI) in individuals with metabolic cardiovascular risk factors or a previous history of vascular diseases (WCVRF) compared to healthy individuals (free of risk factors and previous history of vascular diseases; FCVRF) in a general Mediterranean population. The secondary aim is to describe the proportion of CAVI≥9 depending on the cardiovascular risk category in both CVRF groups by sex. METHODS: The study is a descriptive analysis of 2613 participants randomly selected in the Girona province (Catalonia, Spain). RESULTS: CAVI mean differences between sexes and age categories in both CVRF groups followed the same pattern, the FCVRF group (men 25.2%; women 14.4%) in turn had a lower prevalence of CAVI≥9 than the WCVRF group (men 57.9%; women 51.8%). The percentage of men and women with CAVI≥9 with low risk was 13.9% and 11.3% in the FCVRF group, and 31.8% and 42.0% in the WCVRF group; with moderate risk, it was 55.8% and 10.0% in the FCVRF group and 60.3% and 49.0% in the WCVRF group. CONCLUSIONS: In both sexes, FCVRF groups had a lower prevalence of CAVI≥9 as well as lower mean CAVI scores, across all 10 year-age categories from 40 to 69 years, than WCVRF groups. Moreover, CAVI≥9 was frequent in individuals with low and moderate coronary risk in the WCVRF group but also in the FCVRF group. These results suggest that CAVI assessment to detect asymptomatic arteriosclerosis could be a useful tool to improve cardiovascular risk stratification.