Additive effects of a family history of schizophrenia spectrum disorders and an environmental risk score for the outcome of patients with non-affective first-episode psychosis.

BACKGROUND: First-episode psychotic disorders comprise a heterogeneous phenotype with a complex etiology involving numerous common small-effect genetic variations and a wide range of environmental exposures. We examined whether a family of schizophrenia spectrum disorder (FH-Sz) interacts with an environmental risk score (ERS-Sz) regarding the outcome of patients with non-affective first episode psychosis (NAFEP). METHODS: We included 288 patients with NAFEP who were evaluated after discharge from an intensive 2-year program. We evaluated three outcome measures: symptomatic remission, psychosocial functioning, and personal recovery. We analyzed the main and joint associations of a FH-Sz and the ERS-Sz on the outcomes by using the relative excess risk due to interaction (RERI) approach. RESULTS: A FH-Sz showed a significant association with poor symptomatic remission and psychosocial functioning outcomes, although there was no significant interaction between a FH-Sz and the ERS-Sz on these outcomes. The ERS-Sz did not show a significant association with poor symptomatic remission and psychosocial functioning outcomes, even though the magnitude of the interaction between ERS-Sz and FH-Sz with the later outcome was moderate (RERI = 6.89, 95% confidence interval -16.03 to 29.81). There was no association between a FH-Sz and the ERS-Sz and personal recovery. CONCLUSIONS: Our results provide further empirical support regarding the contribution of FH-Sz to poor symptomatic remission and poor psychosocial functioning outcomes in patients with NAFEP.

Quality of life of early-stage breast-cancer patients diagnosed with COVID-19 in the first three waves of the epidemic treated in the Spanish region of Navarre.

OBJECTIVES: To describe the Quality of Life (QOL) of breast-cancer patients diagnosed with COVID-19 and analyse its evolution, compare the QOL of these patients according to the COVID-19 wave in which they were diagnosed, and examine the clinical and demographic determinants of QOL. METHODS: A total of 260 patients with breast cancer (90.8% I-III stages) and COVID-19 (85% light/moderate) were included (February-September 2021) in this study. Most patients were receiving anticancer treatment (mainly hormonotherapy). Patients were grouped according to the date of COVID-19 diagnosis: first wave (March-May 2020, 85 patients), second wave (June-December 2020, 107 patients) and third wave (January-September 2021, 68 patients). Quality of Life was assessed 10 months, 7 months, and 2 weeks after these dates, respectively. Patients completed QLQ-C30, QLQ-BR45, and Oslo COVID-19 QLQ-PW80 twice over four months. Patients ≥65 also completed QLQ-ELD14. The QOL of each group and changes in QOL for the whole sample were compared (non-parametric tests). Multivariate logistic regression identified patient characteristics related to (1) low global QOL and (2) changes in Global QOL between assessments. RESULTS: Moderate limitations (>30 points) appeared in the first assessment in Global QOL, sexual scales, three QLQ-ELD14 scales, and 13 symptoms and emotional COVID-19 areas. Differences between the COVID-19 groups appeared in two QLQ-C30 areas and four QLQ-BR45 areas. Quality of Life improvements between assessments appeared in six QLQ-C30, four QLQ-BR45 and 18 COVID-19 questionnaire areas. The best multivariate model to explain global QOL combined emotional functioning, fatigue, endocrine treatment, gastrointestinal symptoms, and targeted therapy (R2  = 0.393). The best model to explain changes in global QOL combined physical and emotional functioning, malaise, and sore eyes (R2  = 0.575). CONCLUSIONS: Patients with breast cancer and COVID-19 adapted well to illness. The few differences between wave-based groups (differences in follow-up notwithstanding) may have arisen because the second and third waves saw fewer COVID restrictions, more positive COVID information, and more vaccinated patients.

Adherence of long-term breast cancer survivors to follow-up care guidelines: a study based on real-world data from the SURBCAN cohort.

PURPOSE: To identify adherence to follow-up recommendations in long-term breast cancer survivors (LTBCS) of the SURBCAN cohort and to identify its determinants, using real-world data. METHODS: We conducted a retrospective study using electronic health records from 2012 to 2016 of women diagnosed with incident breast cancer in Spain between 2000 and 2006 and surviving at least 5 years. Adherence to basic follow-up recommendations, adherence according to risk of recurrence, and overall adherence were calculated based on attendance at medical appointments and imaging surveillance, by year of survivorship. Logistic regression models were fitted to depict the association between adherence and its determinants. RESULTS: A total of 2079 LTBCS were followed up for a median of 4.97 years. Of them, 23.6% had survived ≥ 10 years at baseline. We estimated that 79.5% of LTBCS were overall adherent to at least one visit and one imaging test. Adherence to recommendations decreased over time and no differences were found according to recurrence risk. Determinants of better overall adherence were diagnosis in middle age (50-69 years old), living in a more-deprived area, having fewer years of survival, receiving primary treatment, and being alive at the end of follow-up. CONCLUSION: We identified women apparently not complying with surveillance visits and tests. Special attention should be paid to the youngest and eldest women at diagnosis and to those with longer survival.

Location, morphology and invasiveness of lateral spreading tumors in the colorectum differ between two large cohorts from an eastern and western country.

BACKGROUND AND STUDY AIMS: Data from Japanese series show that surface morphology of laterally spreading tumors (LST) in the colon identifies lesions with different incidence and pattern of submucosal invasion. Such data from western countries are scarce. We compared clinical and histological features of LST in a western country and an eastern country, with special interest on mucosal invasiveness of LST, and investigated the effect of clinical factors on invasiveness in both countries. PATIENTS AND METHODS: Patients with LST lesions ≥20mm were included from a multicenter prospective registry in Spain and from a retrospective registry from the National Cancer Center Hospital East, Japan. The primary outcome was the presence of submucosal invasion in LST. The secondary outcome was the presence of high-risk histology, defined as high-grade dysplasia or submucosal invasion. RESULTS: We evaluated 1102 patients in Spain and 663 in Japan. Morphological and histological characteristics differed. The prevalence of submucosal invasion in Japan was six-fold the prevalence in Spain (Prevalence Ratio PR=5.66; 95%CI: 3.96, 8.08), and the prevalence of high-risk histology was 1.5 higher (PR=1.44; 95%CI: 1.31, 1.58). Compared to the granular homogeneous type and adjusted by clinical features, granular mixed, flat elevated, and pseudo-depressed types were associated with higher odds of submucosal invasion in Japan, whereas only the pseudo-depressed type showed higher risk in Spain. Regarding high-risk histology, both granular mixed and pseudo-depressed were associated with higher odds in Japan, compared with only the granular mixed type in Spain. CONCLUSION: This study reveals differences in location, morphology and invasiveness of LST in an eastern and a western cohort.

Multimorbidity clusters among long-term breast cancer survivors in Spain: Results of the SURBCAN study.

The disease management of long-term breast cancer survivors (BCS) is hampered by the scarce knowledge of multimorbidity patterns. The aim of our study was to identify multimorbidity clusters among long-term BCS and assess their impact on mortality and health services use. We conducted a retrospective study using electronic health records of 6512 BCS from Spain surviving at least 5 years. Hierarchical cluster analysis was used to identify groups of similar patients based on their chronic diagnoses, which were assessed using the Clinical Classifications Software. As a result, multimorbidity clusters were obtained, clinically defined and named according to the comorbidities with higher observed/expected prevalence ratios. Multivariable Cox and negative binomial regression models were fitted to estimate overall mortality risk and probability of contacting health services according to the clusters identified. 83.7% of BCS presented multimorbidity, essential hypertension (34.5%) and obesity and other metabolic disorders (27.4%) being the most prevalent chronic diseases at the beginning of follow-up. Five multimorbidity clusters were identified: C1-unspecific (29.9%), C2-metabolic and neurodegenerative (28.3%), C3-anxiety and fractures (9.7%), C4-musculoskeletal and cardiovascular (9.6%) and C5-thyroid disorders (5.3%). All clusters except C5-thyroid disorders were associated with higher mortality compared to BCS without comorbidities. The risk of mortality in C4 was increased by 64% (adjusted hazard ratio 1.64, 95% confidence interval 1.52-2.07). Stratified analysis showed an increased risk of death among BCS with 5 to 10 years of survival in all clusters. These results help to identify subgroups of long-term BCS with specific needs and mortality risks and to guide BCS clinical practice regarding multimorbidity.

Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions.

BACKGROUND AND AIMS: The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models. METHODS: A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies. RESULTS: DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets. CONCLUSIONS: The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT03050333.).

The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) questionnaire. A validation study with Spanish schizophrenia spectrum outpatients.

INTRODUCTION: The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) is a disease-specific subjective Quality of Life (QL) questionnaire for patients with schizophrenia. This study assesses the psychometric properties of the SQLS-R4 when applied to a sample of Spanish schizophrenia spectrum outpatients with stable disease. METHODS: The SQLS-R4 and EUROQOL-5D-5L were completed once by 168 schizophrenia and schizoaffective disorder patients. Of these, 61 also completed the WHOQOL-BREF and 50 completed the SQLS-R4 one week later. Psychometric evaluation of structure, reliability and validity was conducted. RESULTS: Multi-trait scaling confirmed the two multiitem scales. Internal consistency for the two scales (Cronbach’s coefficients>0.89) and the whole questionnaire (0.96) was adequate, as was test–retest reliability (intraclass correlation coefficients>0.79). Correlations with related areas of EUROQOL-5D-5L and WHOQOL-BREF (Spearman’s Rho>0.60) supported convergent validity. Divergent validity was confirmed through low correlations with less-related areas of these two questionnaires (Spearman’s Rho<0.30). Patients with higher levels of depression, more acute episodes and schizoaffective disorder had higher QL limitations. CONCLUSIONS: The SQLS-R4 is a reliable and valid instrument when applied to Spanish outpatients with stable disease. The results of our validation study concur with those of other psychometric studies performed in Europe and other cultural areas.

Socioeconomic inequalities in cardiometabolic control in patients with type 2 diabetes.

BACKGROUND: The aim of this study was to determine if the achievement of control targets in patients with type 2 diabetes was associated with personal socioeconomic factors and if these associations were sex-dependent. METHODS: This cross-sectional, population-based study was conducted in Spain. Glycated haemoglobin (HbA1c) level and other clinical parameters were obtained from electronic primary care records (n = 32,638 cases). Socioeconomic status was determined using education level and yearly income. Among patients, having their HbA1c level checked during the previous year was considered as an indirect measure of the process of care, whereas tobacco use and clinical parameters such as HbA1c, low-density lipoprotein cholesterol (LDL-c) and blood pressure (BP) were considered intermediate control outcomes. General linear mixed effect models were used to assess associations. RESULTS: The achievement of metabolic and cardiovascular control targets in patients with type 2 diabetes was associated with educational level and income, and socioeconomic gradients differed by sex. The probability of having had an HbA1c test performed in the previous year was higher in patients with lower education levels. Patients in the lowest income and education level categories were less likely to have reached the recommended HbA1c level. Males in the lowest education level categories were less likely to be non-smokers or to have achieved the blood pressure targets. In contrast, patients within the low income categories had a higher probability of reaching the recommended LDL-c level. CONCLUSIONS: Our results suggest the presence of socioeconomic inequalities in the achievement of cardiovascular and metabolic control that differed in direction and magnitude depending on the measured outcome and sex of the patient. These findings may help health professionals focus on high-risk individuals to decrease health inequalities.

A Scoring System to Determine Risk of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Lesions.

BACKGROUND & AIMS: After endoscopic mucosal resection (EMR) of colorectal lesions, delayed bleeding is the most common serious complication, but there are no guidelines for its prevention. We aimed to identify risk factors associated with delayed bleeding that required medical attention after discharge until day 15 and develop a scoring system to identify patients at risk. METHODS: We performed a prospective study of 1214 consecutive patients with nonpedunculated colorectal lesions 20 mm or larger treated by EMR (n = 1255) at 23 hospitals in Spain, from February 2013 through February 2015. Patients were examined 15 days after the procedure, and medical data were collected. We used the data to create a delayed bleeding scoring system, and assigned a weight to each risk factor based on the ß parameter from multivariate logistic regression analysis. Patients were classified as being at low, average, or high risk for delayed bleeding. RESULTS: Delayed bleeding occurred in 46 cases (3.7%, 95% confidence interval, 2.7%-4.9%). In multivariate analysis, factors associated with delayed bleeding included age ≥75 years (odds ratio [OR], 2.36; P < .01), American Society of Anesthesiologist classification scores of III or IV (OR, 1.90; P ≤ .05), aspirin use during EMR (OR, 3.16; P < .05), right-sided lesions (OR, 4.86; P < .01), lesion size ≥40 mm (OR, 1.91; P ≤ .05), and a mucosal gap not closed by hemoclips (OR, 3.63; P ≤ .01). We developed a risk scoring system based on these 6 variables that assigned patients to the low-risk (score, 0-3), average-risk (score, 4-7), or high-risk (score, 8-10) categories with a receiver operating characteristic curve of 0.77 (95% confidence interval, 0.70-0.83). In these groups, the probabilities of delayed bleeding were 0.6%, 5.5%, and 40%, respectively. CONCLUSIONS: The risk of delayed bleeding after EMR of large colorectal lesions is 3.7%. We developed a risk scoring system based on 6 factors that determined the risk for delayed bleeding (receiver operating characteristic curve, 0.77). The factors most strongly associated with delayed bleeding were right-sided lesions, aspirin use, and mucosal defects not closed by hemoclips. Patients considered to be high risk (score, 8-10) had a 40% probability of delayed bleeding.

Quality of life in long-term premenopausal early-stage breast cancer survivors from Spain. Effects of surgery and time since surgery.

PURPOSE: More research is needed into Quality of Life (QoL) in young early-stage breast cancer patients in the long-term. Knowledge of long-term effects of surgery on QoL in breast cancer patients is limited. The purpose of this study was to assess QoL in premenopausal Spanish early- stage breast cancer patients over a long follow-up period and evaluate differences among surgery-treated groups and the influence of time on patient QoL. METHODS: 243 premenopausal stage I-III relapse-free breast cancer patients completed the EORTC QLQ-C30 and QLQ-BR23 questionnaire once during follow-up (5-20 years after surgery). Univariate and multivariate logistic regression analyses were performed to estimate the results. RESULTS: QoL mean scores were high in most areas (>80 points in functioning: <20 points in symptoms areas). Limitations were moderate (>30 points) in global QoL, sleep disturbance, future perspective, sexual areas, and hot flashes. Mastectomized patients had a 4-fold greater risk of low scores in body image. Patients with a longer follow-up showed lower systemic side effects, hot flashes and breast symptoms. CONCLUSIONS: QoL in Spanish premenopausal early-stage breast cancer patients in a long follow-up after surgery is high. Differences in QoL among surgery-treated groups are limited. Time since surgery influences treatment side effects.

An evaluation study of the determinants of future perspective and global Quality of Life in Spanish long-term premenopausal early-stage breast cancer survivors.

AIM OF THE STUDY: Quality of life (QL) is important in premenopausal long-term breast cancer survivors. In this study we assessed QL and factors associated with future perspective and global QL in premenopausal early-stage long-term breast cancer survivors from Spain. MATERIAL AND METHODS: 243 premenopausal stage I-IIIA relapse-free breast cancer patients who had received surgery 5-20 years previously completed EORTC QLQ-C30 and QLQ-BR23 questionnaires once during follow-up. Univariate and multivariate logistic regression analyses were performed. RESULTS: QL mean scores were high in most areas (> 80 in functioning; < 20 in symptoms). The main factors for future perspective were emotional and social functioning, fatigue, breast symptom, and body image. The main factors for global QL were fatigue, pain and physical functioning, and emotional and social functioning. The best logistic model to explain future perspective associated high emotional and social functioning and low breast symptoms with a lower risk of low future perspective (R(2) = 0.56). Higher scores in physical and emotional functioning and lower scores in fatigue were associated with a lower risk of low global QL (R(2) = 0.50). CONCLUSIONS: Psychological, social, and physical factors were found to be possible determinants of global QL and future perspective. QL in premenopausal early-stage long-term breast cancer survivors may benefit from multidisciplinary treatment.

[Predictive value of pre-treatment hypoalbuminemia in prognosis of resected colorectal cancer]. / Valor predictivo de la hipoalbuminemia pre-tratamiento sobre el pronóstico del cáncer colorrectal resecado.

INTRODUCTION: Albuminemia is part of the antitumoral systemic inflammatory response. We therefore analyzed its possible value in establishing the preoperative prognosis of colorectal carcinoma (CRC). PATIENTS AND METHODS: We conducted a retrospective, observational study of a series of consecutive patients who underwent CRC resection. Univariate and multivariate analyses of survival curves were performed in patients with and without pre-treatment hypoalbuminemia (<3.5g/dl), both in the overall group of patients and in the subgroup of those with pTNM stage ii tumors. In addition, we compared the 5-year tumor-related mortality in patients with and without hypoalbuminemia. RESULTS: A total of 207 patients were reviewed (median follow-up: 81 months). In the overall multivariate analysis, survival curves were better in patients with normal albumin levels than in those with hypoalbuminemia (HR=2.82; CI 95%=[1.54-5.19]; P=.001). This better prognostic value of normal albumin levels was also significant in pTNM stage ii tumors: (HR=3.76; CI 95%=[1.40-10.08]; P=.009). The 5-year mortality index was lower in patients with normal albumin levels: overall series=18.8% vs 42.9% (OR=3.24; CI 95%=[1.48-7.12]; p=0.001); pTNM stage ii=13.3% vs 44.4% (OR=5.2; CI 95%=[1.36-20.34]; P=0.004). CONCLUSIONS: Pre-treatment hypoalbuminemia (<3.5g/dl) was independently related to shorter survival after tumor resection, both in the overall series of patients and in pTNM stage ii CRC. If these results are confirmed, hypoalbuminemia would be a simple and significant marker of poor prognosis, available at the initial diagnosis.

Effect of comorbidity and multimorbidity on adherence to follow-up recommendations among long-term breast cancer survivors.

OBJECTIVES: To study the impact of comorbidities, multimorbidity, and multimorbidity clusters on adherence to recommended follow-up guidelines among long-term breast cancer survivors. STUDY DESIGN: Retrospective cohort study based on 2078 women diagnosed with breast cancer from 2000 to 2006 and followed up from 2012 to 2016. MAIN OUTCOME MEASURES: Adherence to breast cancer follow-up recommendations (annual medical visit and imaging) was determined. Comorbidities were classified as acute/chronic. Multimorbidity was defined as the presence of two or more chronic comorbidities aside from breast cancer. Five multimorbidity clusters were considered. Multivariate logistic regression models were fitted to determine the relationship between adherence to recommendations and the presence of comorbidities and multimorbidity, considering both sociodemographic and clinical characteristics. RESULTS: Overall adherence to recommendations was 79.5 %. Adherence was lower among long-term breast cancer survivors with no comorbidities (75.8 %). Among multimorbidity clusters, adherence was highest in the anxiety and fractures cluster (84.3 %) and was lowest in the musculoskeletal and cardiovascular cluster (76.4 %). In adjusted multivariate models, multimorbidity was associated with higher levels of adherence (OR = 1.52 95 %CI 1.16-1.99), and adherence was highest in the metabolic and degenerative cluster (OR = 2.2 95 %CI 1.4-3.5). CONCLUSION: Adherence to follow-up recommendations was higher among long-term breast cancer survivors with multimorbidity than among those without. Adherence also differed by multimorbidity cluster. These results suggest suboptimal adherence to the current follow-up recommendations in certain groups, suggesting the need to adapt clinical practice guidelines to reflect patients' comorbidities and different characteristics.

Determinants of patient satisfaction with care in a Spanish oncology day hospital and its relationship with quality of life.

OBJECTIVE: This study evaluates satisfaction with care (SC) in cancer patients treated at a Spanish day hospital to identify SC determinants and assess the relationship between SC and quality of life. METHODS: One hundred seventy-six patients with different tumour sites and disease stages completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Cancer Outpatient Satisfaction with Care questionnaire for chemotherapy (OUT-PATSAT35 CT), the Oberst patients' perception of care quality and satisfaction scales, and an item on intention to recommend the hospital. Frequencies in the SC instruments, Spearman correlations between each scale of the OUT-PATSAT35 CT and overall satisfaction and between the subscales of OUT-PATSAT35 CT and of QLQ-C30 were calculated, and the determinants of patients' SC were calculated through multivariate regression models. RESULTS: Satisfaction with care was high: mean scores were >70 in all OUT-PATSAT35 CT areas except doctor availability and environment. These scores were in line with the other SC instruments. Correlation with overall satisfaction was high and statistically significant (p < 0.01) for all subscales, especially for the nurses domain, which also had higher SC scores. Correlations between the EORTC QLQ-C30 and the OUT-PATSAT35 CT were low (≤ 0.35). Younger patients and those with breast cancer showed significantly lower satisfaction in most subscales. Unmarried patients and patients that had undergone surgery reported lower satisfaction only in specific subscales. CONCLUSIONS: Satisfaction with care among cancer patients treated at the day hospital is high. Nurses play a key and successful role. Age and tumour location revealed stronger relationships with SC. Correlations between SC and quality of life indicate that these concepts are complementary.

Lifetime cannabis use and cognition in patients with schizophrenia spectrum disorders and their unaffected siblings.

The relationship between cannabis and cognitive performance is controversial. While both acute administration and long-term cannabis use impair cognitive performance in healthy subjects, several studies have shown improved cognitive outcomes in patients with schizophrenia spectrum disorders who use cannabis. The aim of this study was to determine the relationship between lifetime cannabis use, as assessed longitudinally over 10 years of follow-up in a sample of 42 patients and 35 of their unaffected siblings, and current cognitive performance. Forty-two healthy control subjects were assessed at follow-up with the same instruments. Stepwise linear regression revealed a negative effect of longitudinal cannabis use on performance in a social cognition task in the patient group. In the sibling group, lifetime cannabis use had a negative effect on processing speed and declarative memory performance. In the control group, cannabis use per se did not predict cognitive performance; however, when adding lifetime tobacco use to the model, we found a negative association between lifetime cannabis and tobacco use and processing speed and social cognition performance. Moreover, a lower IQ associated with current cannabis use predicted worse attentional performance in the control group. The differential pattern of associations between cannabis use and cognitive performance in patients compared with siblings and controls can be explained by the negative impact of illness on cognition.

Association of proximity to polluting industries, deprivation and mortality in small areas of the Basque Country (Spain).

BACKGROUND: The study is aimed at assessing social inequities in the location of polluting industries in the Basque Country, and at exploring if the effect on mortality of living near air polluting industries is modified by economic deprivation. METHODS: This is a cross-sectional ecological study that uses the census sections as analysis units. Mortality from all causes, lung cancer, respiratory diseases and ischaemic heart disease were studied. Ordinal logistic regression models were fitted to assess if proximity of census sections to polluting industries is associated with deprivation. Bayesian Poisson regression models were used to explore if the association between proximity to polluting industries and mortality is modified by socio-economic deprivation. RESULTS: Proximity to a polluting industry and deprivation are positively associated, showing a clear gradient across deprivation quintiles. In women, the risk associated with proximity to metal-processing industries grows as the deprivation of the area increases in the case of total and lung cancer mortality. In men, the interaction terms between proximity and deprivation are positive for total, ischaemic heart disease mortality, with a credibility level approaching 90%. High levels of deprivation are associated with greater risk of mortality, excepting lung cancer in women. CONCLUSION: There is a higher proportion of more deprived census sections around polluting industries in the Basque Country. Risks of mortality associated with proximity to polluting industries tend to be higher in more deprived areas.

Quality of life assessment by applying EORTC questionnaires to rectal cancer patients after surgery and neoadjuvant and adjuvant treatment.

BACKGROUND: Quality of Life (QoL) is a key element in rectal cancer (RC) patients. AIMS: this study assesses QoL in a sample of RC patients in their treatment follow-up period, and compares surgery modalities. PATIENTS AND METHODS: eighty four locally advanced RC patients who had received surgery and neoadjuvant chemoradiotherapy were included in the study. Of these, 70 had adjuvant chemotherapy. All patients completed the EORTC QLQ-C30 and the QLQ-CR29 once at least one year after completion of their treatment. Low anterior resection (LAR) patients also completed a Functional Evaluation questionnaire. RESULTS: QoL scores in the EORTC questionnaires for the sample as a whole were high in most dimensions, in line with the general population´s QoL values, although moderate limitations (> 30 points)were observed in urinary frequency, flatulence, impotence and sexual function. The scores for the Functional Evaluation were adequate (mean combined bowel function score of 18.2). LAR patients had a higher stool frequency than those with abdominoperineal resection (APR; p < 0.001). No differences in body image were found amongst LAR and APR patients. LAR patients with a lower anastomosis had higher faecal incontinence (p = 0.02), whereas those with a reservoir had better emotional functioning (p = 0.04) and higher faecal incontinence (p = 0.03). CONCLUSIONS: QoL scores and functional evaluation indicated patients had adapted to their disease and treatment. The few differences in QoL found between surgery modalities are in line with other recent studies and in contrast with earlier ones that suggested a lower QoL in APR patients.

Efficacy and Safety of Anakinra Plus Standard of Care for Patients With Severe COVID-19: A Randomized Phase 2/3 Clinical Trial.

Importance: COVID-19 pneumonia is often associated with hyperinflammation. The efficacy and safety of anakinra in treating patients with severe COVID-19 pneumonia and hyperinflammation are still unclear. Objective: To assess the efficacy and safety of anakinra vs standard of care alone for patients with severe COVID-19 pneumonia and hyperinflammation. Design, Setting, and Participants: The Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to COVID-19 (ANA-COVID-GEAS) was a multicenter, randomized, open-label, 2-group, phase 2/3 clinical trial conducted at 12 hospitals in Spain between May 8, 2020, and March 1, 2021, with a follow-up of 1 month. Participants were adult patients with severe COVID-19 pneumonia and hyperinflammation. Hyperinflammation was defined as interleukin-6 greater than 40 pg/mL, ferritin greater than 500 ng/mL, C-reactive protein greater than 3 mg/dL (rationale, ≥5 upper normal limit), and/or lactate dehydrogenase greater than 300 U/L. Severe pneumonia was considered if at least 1 of the following conditions was met: ambient air oxygen saturation 94% or less measured with a pulse oximeter, ratio of partial pressure O2 to fraction of inspired O2 of 300 or less, and/or a ratio of O2 saturation measured with pulse oximeter to fraction of inspired O2 of 350 or less. Data analysis was performed from April to October 2021. Interventions: Usual standard of care plus anakinra (anakinra group) or usual standard of care alone (SoC group). Anakinra was given at a dose of 100 mg 4 times a day intravenously. Main Outcomes and Measures: The primary outcome was the proportion of patients not requiring mechanical ventilation up to 15 days after treatment initiation, assessed on an intention-to-treat basis. Results: A total of 179 patients (123 men [69.9%]; mean [SD] age, 60.5 [11.5] years) were randomly assigned to the anakinra group (92 patients) or to the SoC group (87 patients). The proportion of patients not requiring mechanical ventilation up to day 15 was not significantly different between groups (64 of 83 patients [77.1%] in the anakinra group vs 67 of 78 patients [85.9%] in the SoC group; risk ratio [RR], 0.90; 95% CI, 0.77-1.04; P = .16). Anakinra did not result in any difference in time to mechanical ventilation (hazard ratio, 1.72; 95% CI, 0.82-3.62; P = .14). There was no significant difference between groups in the proportion of patients not requiring invasive mechanical ventilation up to day 15 (RR, 0.99; 95% CI, 0.88-1.11; P > .99). Conclusions and Relevance: In this randomized clinical trial, anakinra did not prevent the need for mechanical ventilation or reduce mortality risk compared with standard of care alone among hospitalized patients with severe COVID-19 pneumonia. Trial Registration: ClinicalTrials.gov Identifier: NCT04443881.

Quality of life in Spanish postmenopausal breast cancer patients with localized disease who finish endocrine treatment: a prospective study.

OBJECTIVE: In this article, the quality of life (QOL) of Spanish postmenopausal early-stage breast cancer patients who have finished endocrine therapy (ET), QOL changes after endocrine therapy cessation, and the differences between two endocrine therapy modalities (tamoxifen or aromatase inhibitor [AI]) are studied. More QOL information after endocrine therapy cessation is needed. METHODS: A prospective cohort study was performed. Participating in the study were 158 postmenopausal patients who had received tamoxifen or AI for 5 years. In some cases, endocrine therapy may have changed during those 5 years.Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR45 questionnaires at baseline, after 6 months, and after 1 year of follow-up. Patients older than 65 years also completed the QLQ-ELD14. Linear mixed-effect models were used to evaluate longitudinal changes in QOL and differences in QOL between endocrine therapy modalities. RESULTS: QOL scores for the whole sample throughout follow-up were high (>80/100 points) in most QOL areas. Moderate limitations (>30 points) occurred in the QLQ-BR45 in sexual functioning and sexual enjoyment, future perspective, and joint symptoms. Moderate limitations also occurred in the QLQ-ELD14 in worries about others, maintaining purpose, joint stiffness, future worries, and family support. In those who had finished endocrine therapy, pain was reduced in all three assessments conducted during the 1-year follow-up period in both groups. Tamoxifen patients showed better QOL in functioning (role functioning, global QOL, financial impact), symptoms (pain), and emotional areas (future perspective and worries about others) than AI patients but worse QOL in skin mucosis symptoms. CONCLUSIONS: The results of this study show that postmenopausal early-stage breast cancer patients adapted well to their disease and endocrine therapy treatment. QOL improvements in the 1-year follow-up period appeared in one key area: pain. Differences between endocrine therapy modalities suggested QOL was better in the tamoxifen group than in the AI group.

"Geographical distribution of risk genotypes in pediatric patients with celiac disease in Spain".

Celiac disease is strongly associated with HLA DQ, specifically with haplotypes. DRB1*03-DQA1*05:01/DQB1*02:01 (DQ2.5),DRB1*07-DQA1*02:01/DQB1*02:02 (DQ2.2), DRB1*11-DQA1*05:05/DQB1*03:01 (DQ7.5), and DRB1*04-DQA1*03:01/DQB1*03:02 (DQ8). The distribution of these risk haplotypes in patients with celiac disease is different in the geographical areas investigated. A high frequency of DRB1*07- DQA1*02:01/DQB1*02:02 (DQ2.2) and DRB1*11-DQA1*05:05/DQB1*03:01 (DQ7.5), has been described in Southern Europe. We analyzed 2102 confirmed CD cases with information on both DQB1* alelles and their distribution by geographical area in Spain. According to the presence of this haplotype in one or two chromosomes, the genotype is classified in: DQ2 homozygous, DQ2 heterozygous (cis or trans), DQ8 homozygous, DQ8/DQ2.5, DQ 2.2 homozygous and genotype known as "half DQ2". Two different patterns of risks related to CD were identified. In the Basque Country and Navarre, the Mediterranean Area (Aragon, Catalonia, Valencia, Balearic Islands, and Murcia), the South of Spain (Andalucía and Extremadura), and the Canary Islands, higher frequency of DQ2.5 trans, and more than 80% of DQ2.5/DQ2.2 homozygosis were described. The Cantabrian Coast (Cantabria, Asturias, and Galicia) and Central Areas (Castilla-León and Castilla-La Mancha) showed a higher percentage of DQ2.5/DQ2.5 homozygosis and a lower DQ2.5 in trans frequency, as in Northern Europe. Madrid has an intermediate model between the two described above. 17 cases (0.8%) did not carry any CD risk haplotypes.