Spanish Cohort Research Articles

Network analysis to prioritize issues for intervention to improve the health-related quality of life of people with HIV in Spain.

The objective is to assess the interconnectedness of a network of health-related quality of life (HRQoL) variables among people with HIV (PHIV) to identify key areas for which clinical interventions could improve HRQoL for this population. Between 2021 and 2023, we carried out a cross-sectional study within the Spanish CoRIS cohort. We conducted a weighted and undirected network analysis, which examines complex patterns of relationships and interconnections between variables, to assess a network of eight HRQoL dimensions from the validated Clinic Screening Tool for HIV (CST-HIV): anticipated stigma, psychological distress, sexuality, social support, material deprivation, sleep and fatigue, cognitive problems and physical symptoms. A total of 347 participants, predominantly male (93.1%), currently working (79.0%), self-reported homosexual (72.6%) and college-educated (53.9%), were included in the study. Psychological distress showed the highest centrality in the network, indicating its strong connections with sleep and fatigue, cognitive problems and social support within the HRQoL network. Psychological distress, sleep and fatigue, cognitive issues and social support were identified as key factors in an HRQoL network, indicating that interventions focused on these areas could significantly enhance overall well-being.

Clinical features and prognosis of prosthetic valve endocarditis due to Staphylococcus aureus.

Staphylococcus aureus prosthetic valve endocarditis (SAPVE) is a serious infection with high mortality. The main objective of this study was to identify factors associated with in-hospital mortality. From January 2008 to December 2021, consecutive patients from a Spanish cohort of infective endocarditis with a definitive diagnosis of SAPVE were analyzed. During the study period, 219 cases of definitive SAPVE were diagnosed, which accounted for 16.7% of a total of 1309 cases of definitive prosthetic valve endocarditis (PVE). Patients presented advanced age and marked comorbidity. There was a higher incidence of persistent bacteremia, septic shock, stroke, and acute kidney injury than in cases of PVE caused by other microorganisms. Methicillin resistance was not associated with differences in clinical presentation, echocardiographic findings, or mortality. Only 50.6% of the patients with surgical indications (88 patients) underwent surgery. Overall, in-hospital mortality was 47.9%. The variables associated with in-hospital mortality were age (OR:1.03, 95% CI: 1.00-1.05; p = 0.016), heart failure (OR:2.86, 95% CI: 1.53-5.32; p = 0.001), acute kidney injury (OR:2.42, 95%CI:1.28-4.58; p = 0.006), stroke (OR:3.53, 95%CI:1.79-6.96; p < 0.001) and surgery indicated but not performed (OR:2.01, 95%CI:1.06-3.8; p = 0.030). On the other hand, the performance of surgery per se in patients with SAPVE, regardless of whether there was a surgical indication according to the guidelines, was not associated with a reduction in in-hospital mortality. SAPVE is characterized by high mortality, which is more marked in patients who present a surgical indication but do not undergo surgery.

The role of big five traits and self-esteem on academic procrastination in Honduran and Spanish university students: A cross-cultural study

Academic procrastination, a prevalent issue in higher education, has been associated with various adverse outcomes. This study aims to discern and compare the degrees of academic procrastination among university students in Honduras and Spain while also investigating the relationship between academic procrastination and the Big Five personality factors alongside self-esteem. The sample comprised 457 university students, encompassing 237 Hondurans and 220 Spaniards. The research employed descriptive, comparative, correlational, and regression analyses. Honduran university students exhibited a significantly lower level of academic procrastination. Correlational analyses revealed that self-esteem and all Big Five personality factors, except for neuroticism in the Spanish cohort, displayed noteworthy associations with academic procrastination. Further regression analyses demonstrated that conscientiousness emerged as a significant predictor of procrastination in both samples. This study's findings can be pivotal in identifying students at risk of procrastination at an early stage. Additionally, the results can inform the development of intervention programs designed to mitigate procrastination tendencies among university students.

Early Occupational Therapy Intervention Programme and Coping Strategies and Burden in Caregivers of People with Sub-Acute Stroke: A Randomised Controlled Trial.

Caregivers of people who have suffered a stroke experience a great burden and may use disengagement coping strategies. We studied the influence of an early occupational therapy intervention programme in the process of hospital-to-home discharge after stroke (EOTIPS) in a Spanish cohort that improved patients' quality of life and caregivers' burden and coping strategies. EOTIPS was delivered by a single occupational therapist. We conducted a prospective randomised controlled trial that included 60 adults who suffered a stroke, of which 91.6% had a caregiver who agreed to be involved in their care (n = 55). Evaluations assessed the caregivers' burden and coping strategies within two weeks post-stroke and after a three-month follow-up. Statistical analyses included intent-to-treat analysis (considering dropouts as failures) and efficacy analysis, considering only end-of-treatment participants. The caregivers in the intervention group showed a significantly better evolution in the main outcome measure of burden (p = 0.019), as well as in the coping strategies of social support (p = 0.037) and social withdrawal (p ≤ 0.001), compared with the control group. EOTIPS was effective in improving the caregivers' burden and two coping strategies, and it could be considered as an applicable tool that can minimise the risk of suffering burden.

Switching of monoclonal antibodies against the calcitonin gene-related peptide or its receptor in migraine. Results from a Spanish Cohort

BackgroundSwitching between calcitonin gene-related peptide (CGRP) and monoclonal antibodies (mAbs) may be a beneficial strategy after discontinuation. The aim of this study was to evaluate switching outcomes of effectiveness/tolerability. MethodsRetrospective multicentric study of migraine patients who switched to another CGRP–mAb due to lack of tolerability or effectiveness (defined as <30% reduction of monthly headache days [MHD]). Assessment was performed before and 3 months after switch. The main outcome was the response rate of MHD. Secondary outcomes included other effectiveness/tolerability measures. Results90patients were included: 75(83.3%) women, 72(80%) chronic, and 18(20%) episodic migraine. Mean age was 45.9±11 years and mean duration of migraine was 29.2±12.4 years. Mean time under first mAb prior to switch was 10.4±4.9 months. Most frequent switches were erenumab-galcanezumab 38 (42.2%) and erenumab–fremanezumab 21 (23.3%). Lack of effectiveness (50/90, 55.6%) or tolerability (40/90, 44.4%) provoked switching. Most common adverse events (AEs) leading to discontinuation were constipation and flu-like syndrome in 16 (40%) patients each. Response rate (RR) of MHD 30%–50% occurred in 10 patients (11.1%), ≥50% in 32 (35.6%) and <30% in 48 (53.3%) patients. Significant reduction was proved after switch in MHD (20 [IQR:15–29] vs 13 [IQR:7–23]; p<.001) and monthly migraine days (15 [IQR:12–20] vs 10 [IQR:7–16]; p<.001). After switching, 38 (42.2%) experienced AEs, but tolerability improved in 50% of patients who discontinued due to lack of tolerability. RR compared between switches to different CGRP-mAb classes showed no differences. ConclusionSwitching may become an individualized strategy in migraine refractory patients who discontinue CGRP–mAbs due to lack of effectiveness/tolerability. In this study, supportive data are provided to the growing evidence of switch and future needs are highlighted.

Having any mental health condition before the COVID-19 pandemic as a risk factor of COVID-19 contagion during the first year of pandemic: A Spanish adult cohort.

Numerous studies suggest that subjects suffering from a mental health condition before the COVID-19 pandemic were at higher risk of contagion, but mostly are cross-sectional or retrospective. The BIOVAL-D-COVID-19 is a longitudinal cohort study design with 922 subjects who full filled two evaluations from an online survey of Spanish residents before and during the pandemic. Mental health conditions assessed were: Major Depressive Episode (MDE), Generalised Anxiety Disorder (GAD), Suicidal Thoughts and Behaviours (STB) and subthreshold of panic and bipolar disorder (BD). Mental health screening instruments used were: the Spanish version of the Composite International Diagnostic Interview (CIDI) version 3.0 for the evaluation of MDE, the GAD-7 scale to evaluate GAD; STB was evaluated with four items from the CIDI questionnaire. Panic Disorder and BD were screened from a modified and self-reported version of the CIDI. A bivariate plus five logistic regression models were developed for each mental health condition adjusted by socio-demographic variables; employment status; general and physical health; comorbidity; and including all previous variables and the other mental health conditions. We found in bivariate model that MDE; GAD and STB were statistically significant risk factors of contagion of COVID-19. The logistic regression models developed reveal that having a previous GAD (aOR 3.30 1.31-8.31) or STB (aOR 2.16 CI 95% 1.01-4.62) was statistically significant associated with COVID-19 contagion, independently of all variables included. MDE was not a risk factor of contagion when it was adjusted by comorbidity (aOR 0.99 CI 95% 0.47-2.09). It is recommended to detect those subjects with previous GAD or STB as vulnerable groups of infection to reduce contagion rates.

Interpretable artificial intelligence to optimise use of imatinib after resection in patients with localised gastrointestinal stromal tumours: an observational cohort study

Current guidelines recommend use of adjuvant imatinib therapy for many patients with gastrointestinal stromal tumours (GISTs); however, its optimal treatment duration is unknown and some patient groups do not benefit from the therapy. We aimed to apply state-of-the-art, interpretable artificial intelligence (ie, predictions or prescription logic that can be easily understood) methods on real-world data to establish which groups of patients with GISTs should receive adjuvant imatinib, its optimal treatment duration, and the benefits conferred by this therapy. In this observational cohort study, we considered for inclusion all patients who underwent resection of primary, non-metastatic GISTs at the Memorial Sloan Kettering Cancer Center (MSKCC; New York, NY, USA) between Oct 1, 1982, and Dec 31, 2017, and who were classified as intermediate or high risk according to the Armed Forces Institute of Pathology Miettinen criteria and had complete follow-up data with no missing entries. A counterfactual random forest model, which used predictors of recurrence (mitotic count, tumour size, and tumour site) and imatinib duration to infer the probability of recurrence at 7 years for a given patient under each duration of imatinib treatment, was trained in the MSKCC cohort. Optimal policy trees (OPTs), a state-of-the-art interpretable AI-based method, were used to read the counterfactual random forest model by training a decision tree with the counterfactual predictions. The OPT recommendations were externally validated in two cohorts of patients from Poland (the Polish Clinical GIST Registry), who underwent GIST resection between Dec 1, 1981, and Dec 31, 2011, and from Spain (the Spanish Group for Research in Sarcomas), who underwent resection between Oct 1, 1987, and Jan 30, 2011. Among 1007 patients who underwent GIST surgery in MSKCC, 117 were included in the internal cohort; for the external cohorts, the Polish cohort comprised 363 patients and the Spanish cohort comprised 239 patients. The OPT did not recommend imatinib for patients with GISTs of gastric origin measuring less than 15·9 cm with a mitotic count of less than 11·5 mitoses per 5 mm2 or for those with small GISTs (<5·4 cm) of any site with a count of less than 11·5 mitoses per 5 mm2. In this cohort, the OPT cutoffs had a sensitivity of 92·7% (95% CI 82·4-98·0) and a specificity of 33·9% (22·3-47·0). The application of these cutoffs in the two external cohorts would have spared 38 (29%) of 131 patients in the Spanish cohort and 44 (35%) of 126 patients in the Polish cohort from unnecessary treatment with imatinib. Meanwhile, the risk of undertreating patients in these cohorts was minimal (sensitivity 95·4% [95% CI 89·5-98·5] in the Spanish cohort and 92·4% [88·3-95·4] in the Polish cohort). The OPT tested 33 different durations of imatinib treatment (<5 years) and found that 5 years of treatment conferred the most benefit. If the identified patient subgroups were applied in clinical practice, as many as a third of the current cohort of candidates who do not benefit from adjuvant imatinib would be encouraged to not receive imatinib, subsequently avoiding unnecessary toxicity on patients and financial strain on health-care systems. Our finding that 5 years is the optimal duration of imatinib treatment could be the best source of evidence to inform clinical practice until 2028, when a randomised controlled trial with the same aims is expected to report its findings. National Cancer Institute.

Extrauterine growth restriction in very-low-birthweight infants: prevalence and concordance according to Fenton, Olsen, and INTERGROWTH-21st growth charts in a multicenter Spanish cohort

Multiple criteria and growth references have been proposed for extrauterine growth restriction (EUGR). We hypothesized that these may impact the diagnosis of EUGR. The objective was to evaluate the prevalence of EUGR with its different definitions and the concordance according to Fenton, Olsen, and INTERGROWTH-21st in very-low-birthweight (VLBW) infants. This is an observational, retrospective, and multicenter study including VLBW infants from the Spanish SEN1500 Network from 2011 to 2020. Patients with major congenital anomalies, embryopathies, and gestational age less than 24 weeks were excluded. EUGR prevalence was calculated at discharge with cross-sectional, longitudinal, “true” cross-sectional, and “true” longitudinal definitions. Concordance was assessed with Fleiss’ kappa coefficient. 23582 VLBW infants from 77 NICUs were included. In total, 50.4% were men with a median of gestational age of 29 (4) weeks. The prevalence of EUGR (cross-sectional, longitudinal, and “true”) was variable for weight, length, and head circumference. Overall, the prevalence was higher with Fenton and lower with Olsen (cross-sectional and “true” cross-sectional) and INTERGROWTH-21st (longitudinal and “true” longitudinal). Agreement among the charts by weight was good only for cross-sectional EUGR and moderate for longitudinal, “true” cross-sectional, and “true” longitudinal. Concordance was good or very good for EUGR by length and head circumference.Conclusions: The prevalence of EUGR with the most commonly used definitions was variable in the cohort. Agreement among growth charts was moderate for all the definitions of EUGR by weight except cross-sectional and good or very good for length and head circumference. The choice of reference chart can impact the establishment of the diagnosis of EUGR.What is known:• EUGR has been defined in the literature and daily practice considering weight, length and head circumference with multiple criteria (cross-sectional, longitudinal, and “true” definition)• Different growth charts have been used for EUGR diagnosisWhat is new:• Prevalence of EUGR is variable depending on the definition and growth chart used in our cohort of VLBW infants• For the most frequently EUGR criteria used, traditionally considering weight, concordance among Fenton, Olsen and INTERGROWTH-21st growth charts is only moderate for all the definitions of EUGR by weight except cross-sectional definition. Concordance among the charts is good or very good for the different criteria of EUGR by head circumference and length

Sex-specific impact of inflammation on traditional cardiovascular risk factors and atherosclerosis in axial spondyloarthritis. A multicentre study of 913 patients

IntroductionThe nature of the relationship between inflammation, cardiovascular (CV) risk factors and atherosclerosis in axial spondyloarthritis (axSpA) remains largely unknown and sex differences in this regard are yet to be...

Decoding depression by exploring the exposome-genome edge amidst COVID-19 lockdown

Risk of depression increased in the general population after the COVID-19 pandemic outbreak. By examining the interplay between genetics and individual environmental exposures during the COVID-19 lockdown, we have been able to gain an insight as to why some individuals are more vulnerable to depression, while others are more resilient. This study, conducted on a Spanish cohort of 9218 individuals (COVICAT), includes a comprehensive non-genetic risk analysis, the exposome, complemented by a genomics analysis in a subset of 2442 participants. Depression levels were evaluated using the Hospital Anxiety and Depression Scale. Together with Polygenic Risk Scores (PRS), we introduced a novel score; Poly-Environmental Risk Scores (PERS) for non-genetic risks to estimate the effect of each cumulative score and gene-environment interaction. We found significant positive associations for PERSSoc (Social and Household), PERSLife (Lifestyle and Behaviour), and PERSEnv (Wider Environment and Health) scores across all levels of depression severity, and for PRSB (Broad depression) only for moderate depression (OR 1.2, 95% CI 1.03–1.40). On average OR increased 1.2-fold for PERSEnv and 1.6-fold for PERLife and PERSoc from mild to severe depression level. The complete adjusted model explained 16.9% of the variance. We further observed an interaction between PERSEnv and PRSB showing a potential mitigating effect. In summary, stressors within the social and behavioral domains emerged as the primary drivers of depression risk in this population, unveiling a mitigating interaction effect that should be interpreted with caution.

Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence.

Aim: To describe the evolution of regorafenib use, since its approval, in patients with previously treated metastatic colorectal cancer (mCRC) in routine clinical practice in Spain.Methods: We extracted patient characteristics, dosing, safety and efficacy data for the Spanish cohorts of the CORRECT and CONSIGN trials, and the real-world CORRELATE study.Results: The Spanish cohorts represented 10.7-13.8% of the global cohorts. Efficacy and safety in the Spanish cohorts reflected findings from the global cohorts, with evidence of a flexible dosing approach being adopted in routine clinical practice.Conclusion: Regorafenib use in patients with mCRC has evolved in the real-world setting, emphasizing the need for further research evaluating dosing patterns that can optimize clinical outcomes in these patients.Clinical trial registration: The CORRECT trial is registered at ClinicalTrials.gov, number NCT01103323; the CONSIGN trial is registered at ClinicalTrials.gov, number NCT01538680; the CORRELATE study is registered at ClinicalTrials.gov, number NCT02042144.

External validation of three diabetes prediction scores in a Spanish cohort: does adding high risk for depression improve the validation of the FINDRISC score (FINDRISC-MOOD)?

ObjectivesTo evaluate the external validity of the FINDRISC, DESIR and ADA risk scores for the prediction of diabetes in a Spanish population aged >45 years and to test the possible...

X-Linked hypophosphatemia. Data from a Spanish adult population cohort.

X-linked hypophosphatemia (XLH) represents the most prevalent cause of hereditary hypophosphatemia. X-linked hypophosphatemia causes an elevation of fibroblast growth factor 23 (FGF23), a hormone responsible for inducing hyperphosphaturia, and reduced active vitamin D synthesis. Challenges in diagnosis and the absence of well-defined clinical guidelines have resulted in higher rates of late diagnoses. While numerous reports focus on pediatric X-linked hypophosphatemia patients, studies in adults are limited. Multicenter, cross-sectional, observational study of a cohort of adult patients diagnosed with X-linked hypophosphatemia. The study identified demographic, clinical, genetic, laboratory variables, treatments used, comorbidities, and complications. Twenty patients diagnosed with X-linked hypophosphatemia were collected. The median age at diagnosis was 11 (1-56) years and at data collection was 44 (21-68) years. Fifty percent of cases were diagnosed in adulthood. Main clinical manifestation was osteoarticular pain, in 75% of cases, and no relation to age at diagnosis, height, phosphorus, or parathyroid hormone (PTH) levels was observed (p > 0.05). Lower limb deformities were associated with reduced stature and earlier diagnosis (p < 0.05). Sixty percent of patients reported pain requiring chronic medication and no significant correlation was found with other variables. Anxiety and depression were found in an important number of patients. FGF23 levels were not related to any of the clinical variables studied (p > 0.05). This is the largest study on adult patients with X-linked hypophosphatemia in southern Europe. It mayoffer valuable insights into the natural progression and course of the condition in adults, which can aid in better clinical management.

Training in cataract surgery in Spain: analysis of the results of a survey of the European Board of Ophthalmology in a Spanish cohort

IntroductionA survey conducted by the European Board of Ophthalmology (EBO) revealed significant differences in the surgical training of the ophthalmology residents in Europe, including a disparity between the sexes and a variation in the experience on cataract surgery (CC) between them. This study is about the Spanish sub-cohort of the survey, and its objective is to present and analyse the peculiarities of ophthalmology training in Spain within the European context, as well as discussing ways to harmonise and improve that training throughout the EU. MethodsWe analyse data of the Spanish participants in the EBO exams, defining subgroups by the Autonomous Communities existing in Spain. Results93 of 135 requested participants (68.9%) responded. A 60.2% passed the EBO exam between 2021 and 2022, being mostly women (65.59%) aged 31 years old on average. The 91.4% were right-handed, coming from 13 of the 17 Spanish autonomous communities, although mostly from the Community of Valencia, Madrid and Catalonia. Respectively, 16.1%, 3.2% and 8.7% of the respondents said they have completed 10 or more training sessions on animal eyes, synthetic eyes and through the virtual reality simulator. This training was correlated with greater self-confidence in the management of a posterior capsular tear during surgery (p .025). All respondents manifested to have already performed stages of the CC. The average number of operations reported was 181.6 with regional disparities. A significant difference is observed between the sexes against women (−28.3%, p 0.03). DiscussionOphthalmologists in Spain, much more than other European countries, have greater opportunities for surgical training, with surgical procedures during the residency, that nearly triples those made by the others. Spanish women refer, like their European colleagues, to be in disadvantage in learning opportunities about cataract surgery. The Simulation Based Medical Education (SBME) allows to respond to the training deficit and complements the training on the patient. Although we demonstrate a significant correlation between the number of procedures carried out and self-confidence to operate simple cases, the SBME would be a complementary tool in self-confidence in front of a complication like capsular rupture. ConclusionSpain massively adopts the model named by us "surgery for all”, despite the underrepresentation of women in this area, emphasising a need for cultural change that the SBME could facilitate.

Oral anticoagulant treatment in atrial fibrillation: the AFIRMA real-world study using natural language processing and machine learning

IntroductionOral anticoagulation (OAC) is key in atrial fibrillation (AF) thromboprophylaxis, but Spain lacks substantial real-world evidence. We aimed to analyze the prevalence, clinical characteristics, and treatment patterns among patients with AF undertaking OAC, using natural language processing (NLP) and machine learning (ML). Materials and methodsThis retrospective study included AF patients on OAC from 15 Spanish hospitals (2014–2020). Using EHRead® (including NLP and ML), and SNOMED_CT, we extracted and analyzed patient demographics, comorbidities, and OAC treatment from electronic health records. AF prevalence was estimated, and a descriptive analysis was conducted. ResultsAmong 4,664,224 patients in our cohort, AF prevalence ranged from 1.9% to 2.9%. A total of 57,190 patients on OAC therapy were included, 80.7% receiving Vitamin K antagonists (VKA) and 19.3% Direct-acting OAC (DOAC). The median age was 78 and 76 years respectively, with males constituting 53% of the cohort. Comorbidities like hypertension (76.3%), diabetes (48.0%), heart failure (42.2%), and renal disease (18.7%) were common, and more frequent in VKA users. Over 50% had a high CHA2DS2-VASc score. The most frequent treatment switch was from DOAC to acenocoumarol (58.6% to 70.2%). In switches from VKA to DOAC, apixaban was the most chosen (35.2%). ConclusionsUtilizing NLP and ML to extract RWD, we established the most comprehensive Spanish cohort of AF patients with OAC to date. Analysis revealed a high AF prevalence, patient complexity, and a marked VKA preference over DOAC. Importantly, in VKA to DOAC transitions, apixaban was the favored option.

Ki67 as a prognostic factor in male breast cancer (male BC): Results from a large GEICAM Spanish cohort of male BC.

556 Background: Male BC management is based, by default, on evidence produced from female BC. There is a high need to validate gender specific performance of established prognostic biomarkers. We present here descriptive results from a large, country specific, registry of Male BC. Methods: GEICAM/2016-04 (NCT03800355) is a retrospective, observational study including Male BC pts diagnosed from 2000 to 2019 in 51 Spanish sites. Data from BC diagnosis until 10-Mar-2020 was collected from medical charts; biological specimens were obtained. Pts and tumors characteristics, therapies, and outcomes were analyzed. Molecular subtypes were categorized as hormonal receptor positive (HR+)/HER2 negative (HER2−), triple negative (TN) (HR−/HER2−), and HER2+ (any HR). Results: 773 pts were analyzed, at first diagnosis, 721 (93%) had early BC (EBC) (stages I [28%], II [41%], III [21%]), and 52 (7%) de novo metastatic BC; median age was 66 (23-96) years; median body mass index was 28 (18-50) Kg/m2 (overweight), with obesity in 4% as prior medical history. Previous history of other cancers: 20 (3%) pts were diagnosed with prostate cancer (PC) and 20 (3%) pts with skin cancer (melanoma and non-melanoma). BC family history was reported in 212 (35%) pts, 56 (9%) PC, and 35 (6%) ovarian cancer. Germline genetic testing for hereditary risk was performed in 238 (31%) pts, with BRCA1/2 mutations present in 46 (19%) pts (BRCA1 in 6, BRCA2 in 39, and both in 1); BRCA1/2 mutations were observed in 9 (33%) HER2+ pts and 32 (18%) HR+/HER2− pts. Of EBC pts, 322 (45%) were node-positive, 274 (38%) had T2 tumors; 4% had breast conserving surgery, and 42% sentinel lymph node biopsy; 42% received adjuvant radiation therapy; 336 (47%) adjuvant and 44 (6%) neoadjuvant chemotherapy, 609 (84%) adjuvant endocrine therapy, mainly tamoxifen (72%); and 6% pts did not receive any systemic therapy. Morphologically, invasive carcinoma of no special type was reported in 89% pts, and 52% were grade 2. Per local pathological assessment, 97% estrogen receptor positive (ER+), 90% progesterone receptor positive (PgR+), 84% androgen receptor positive; 51% presented Ki67 index expression ≥20%, and 11% HER2+. Frequency according to molecular subtype: 599 (77%) HR+/HER2−, 75 (10%) HER2+, 6 (1%) TN, and 93 (12%) unknown. With a median follow-up of 64 months, medians of invasive disease-free survival (iDFS) and distant DFS (dDFS) were not statistically different in HR+/HER2− vs HER2+ pts and according to levels of Ki67 index expression (&lt;20% vs. ≥20%). In a Cox multivariate model, stage I-II vs III and age were statistically significant (p&lt;0.05) for both iDFS and dDFS. Conclusions: HR+/HER2− is the most common Male BC subtype, with ER and PgR highly positive, and 20% as median Ki67 index. No statistically significant differences were observed in terms of iDFS and dDFS based on level of Ki67 index expression. Clinical trial information: NCT03800355 .

Association between the consumption of ultra-processed foods and the incidence of peptic ulcer disease in the SUN project: a Spanish prospective cohort study

PurposeConsumption of ultra-processed foods (UPF) has increased despite potential adverse health effects. Recent studies showed an association between UPF consumption and some gastrointestinal disorders. We evaluated the association between UPF consumption and peptic ulcer disease (PUD) in a large Spanish cohort.MethodsWe conducted a prospective analysis of 18,066 participants in the SUN cohort, followed every two years. UPF was assessed at baseline and 10 years after. Cases of PUD were identified among participants reporting a physician-made diagnosis of PUD during follow-ups. Cases were only partially validated against medical records. Cox regression was used to assess the association between baseline UPF consumption and PUD risk. Based on previous findings and biological plausibility, socio-demographic and lifestyle variables, BMI, energy intake, Helicobacter pylori infection, gastrointestinal disorders, aspirin and analgesic use, and alcohol and coffee consumption were included as confounders.We fitted GEE with repeated dietary measurements at baseline and after 10 years of follow-up. Vanderweele’s proposed E value was calculated to assess the sensitivity of observed associations to uncontrolled confounding.ResultsDuring a median follow-up of 12.2 years, we recorded 322 new PUD cases (1.56 cases/1000 person-years). Participants in the highest baseline tertile of UPF consumption had an increased PUD risk compared to participants in the lowest tertile (HR = 1.52, 95% CI: 1.15, 2.00, Ptrend=0.002). The E-values for the point estimate supported the observed association. The OR using repeated measurements of UPF intake was 1.39 (95% CI: 1.03, 1.87) when comparing extreme tertiles.ConclusionThe consumption of UPF is associated with an increased PUD risk.

Clinical risk factors associated with cardiac events in children with BrS-SCN5A

Abstract Introduction between 20-30% of patients with Brugada syndrome (BrS) are carriers of deleterious genetic variants in the SCN5A gene. However, the risk factors for cardiac events in these patients remain under consideration, especially in the paediatric population, with many risk factors being still undetermined. Objectives to investigate and evaluate individual clinical risk factors associated with cardiac events in children with BrS-SCN5A. Methods a Spanish retrospective single-centre paediatric cohort study was conducted including 41 BrS patients under 21 years of age carrying rare variants in the SCN5A gene. Demographic, clinical, genetic, and therapeutic variables were collected. Descriptive and univariate analyses were performed to identify independent risk factors for cardiac events. Outcomes were defined as cardiac syncope, ventricular tachycardia/fibrillation (VT/VF), sudden cardiac death (SCD), and appropriate shock in ICD. Results Nearly 20% of BrS-SCN5A patients presented with cardiac events. Five patients showing cardiogenic syncope, 4-SCD, 3-VT and 2 appropriate shocks in the ICD. The presence of bradycardia and bradyarrhythmia in baseline EKG (P&amp;lt;0.05), AV block type 1 (P&amp;lt;0.02), type 1 Brugada pattern in fever EKG (P&amp;lt;0.02), atrial fibrillation(P&amp;lt;0.05), arrhythmias in febrile episodes (P&amp;lt;0.05), progressive cardiac conduction defect (PCCD; P&amp;lt;0.001), sick sinus syndrome (SSS; P=0.001) and overlap phenotype (P&amp;lt;0.001) were predictor of cardiac events in this cohort. Conclusions We have identified several statistically significant independent risk factors associated with cardiac events and worse phenotype severity in BrS-SCN5A children from a single-centre Spanish cohort. These results may help to improve prognosis assessment, establish accurate risk stratification, and prevent SCD in children with BrS-SCN5A. Future studies in large cohorts of different ethnicities are crucial to strengthen our risk factors in paediatric cohorts at high risk of malignant arrhythmias.

#777 Renal recovery for patients with ANCA-associated vasculitis and low eGFR in a Spanish cohort

Abstract Background and Aims Renal failure secondary to ANCA-associated vasculitis (AAV) represents a clinical and therapeutic challenge [1]. Fifteen percent to 38% of the patients develop end-stage kidney disease within 5 years, and once patients need dialysis, 29% to 82% die or remain on dialysis 3 to 6 months after its initiation [2]. Therefore, effectively managing renal vasculitis and preventing patients from reaching dialysis have important consequences [2]. A post hoc analysis of ADVOCATE trial examined outcomes in a patient subgroup with severe renal insufficiency (i.e., estimated glomerular filtration rate (eGFR) ≤20 ml/min per 1.73 m2) at enrollment into the trial, and observed an average eGFR increase of 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0,003) [2]. This study aimed to compare the average eGFR increase in our cohort of AAV with severely reduced GFR (&amp;lt;20 ml/min) treated with different induction treatment schemes. Method We performed a retrospective study which included 19 patients with the diagnosis of AAV and severe renal insufficiency at onset with eGFR between 15 to 20 ml/min per 1.73 m2. We analyzed the eGFR increase after 12 months of follow-up, according to the induction treatment scheme: cyclophosphamide, rituximab, a combination of cyclophosphamide and rituximab and other (prednisone alone, prednisone with plasma exchange or prednisone with mycophenolic acid). We compared our results to those obtained in the avacopan and prednisone groups in the ADVOCATE trial. Results In the subgroup of eGFR between 15 to 30 ml/min per 1.73 m2, patients had at enrollment a mean eGFR of 21 ± 5 ml/min per 1.73 m2 and after 12 months of follow-up the mean eGFR was 41 ± 23 ml/min per 1.73 m2 with an increase of 20 ± 23 ml/min per 1.73 m2. In the subgroup of eGFR between 15 to 20 ml/min per 1.73 m2, patients had at enrollment a mean eGFR of 17 ± 2 ml/min per 1.73 m2 and after 12 months of follow-up, the mean eGFR was 35 ± 20 ml/min per 1.73 m2 with an increase of 18 ± 21 ml/min per 1.73 m2. After 12 months of follow-up, the mean increase of eGFR was 18, 17, 10 and 23 ml/min per 1.73 m2 in the cyclophosphamide, rituximab, a combination of cyclophosphamide and rituximab and other groups, respectively. We compared our results with the post hoc analysis of the ADVOCATE trial in Table 1 and our results are similar to the avacopan group and better than the prednisone group (p &amp;lt; 0.05). Conclusion In our cohort of eGFR between 15 to 20 ml/min per 1.73 m2 at enrollment, the mean increase in eGFR after 12 months of follow-up was similar to the avacopan group and greater than the prednisone group in the ADVOCATE trial.

#1426 Association of intradialytic hypertension and mortality in a cohort of Spanish population

Abstract Background and Aims Intradialytic hypertension (IH) has been identified as an independent mortality risk factor in hemodialysis (HD) patients. The are a lack of a standardized definition of (IH). Recently, a definition of IH ≥30% of baseline sessions with an increase in pre-to post-HD systolic blood pressure (SBP) of ≥10 mmHg had the highest adjusted risk of mortality, compared with other threshold-based definitions (Singh AT, et al. Hypertension 2022;79:855–62) in American population. The aim of these study is to evaluate this definition of IH in our Spanish population. Method We conduct a retrospective multicenter non-interventional study in a Spanish cohort of patients receiving HD (3 sessions PER week) between 1-July 2021 and 30-June 2023 in Fresenius Medical Care Spain. Pre-post-HD SBP, HD parameters and blood test data were averaged over the 90-day exposure period from 1-April-2021 to 30-Jun- 2021. Cox models were fit to examine the association of ID ≥10 mmHg with all-cause mortality in the univariate and multivariate model adjusted for potential confounding variables. Results 3221 patients met the inclusion criteria, 59.6% men, median age 74 years. The mean of SBP pre HD systolic during the exposure period was 140.6 ± 21 mmHg. The mean follow-up was 22 months. 1620 (50.3%) met the definition of IH,379 (22.4%) of patients with IH died during the follow-up period, compared with 302 of 1587 (19%) individuals who did not meet criteria for IH. In the cox multivariate model, patients with IH, had a significant association with mortality HR: 1.19 [1.01-1.41]) p &amp;lt; 0.05 in a model adjusted for age, Charlson Index, weight loss, vintage, ultrafiltration, vascular access, OL-HDF and malnutrition, among others (Table 1). Conclusion Patients with IH (defined as ≥30% of baseline sessions with an increase in pre-to post-HD systolic blood pressure of ≥10 mmHg) have been associated with all-cause mortality (HR 1.19 [1.01-1.41]) in Spanish HD population, similar to previous studies in the American population.