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Optimal medical therapy decreases mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. Women have been underrepresented in clinical trials and not specifically evaluated. This study aimed to compare the safety and effectiveness of drug titration in women vs men.This post hoc gender study of the ETIFIC multicenter randomized trial included hospitalized patients with new-onset HF with reduced ejection fraction and New York Heart Association II-III and no contraindications to beta-blockers. A structured 4-month titration process was implemented in HF clinics. The primary endpoint was the mean relative dose (% of target dose) of beta-blockers achieved by women vs men. Secondary endpoints included the mean relative doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists, adverse events, and other clinical outcomes at 6 months.A total of 320 patients were included, 83 (25.93%) women and 237 (74.06%) men (76 vs 213 analyzed). The mean±standard deviation of the relative doses achieved by women vs men were as follows: beta-blockers 62.08%±30.72% vs 64.4%±32.77%, with a difference of-2.32% (95%CI,-10.58-5.94), P = .580; and mineralocorticoid receptor antagonists 79.85%±27.72% vs 67.29%±31.43%, P =.003. No other differences in drug dosage were found. Multivariate analysis showed nonsignificant differences. CV mortality was 1 (1.20%) vs 3 (1.26%), P=1, and HF hospitalizations 0 (0.00%) vs 10 (4.22%), P=.125.In a post hoc analysis from the HF-titration ETIFIC trial, we found nonsignificant gender differences in drug dosage, cardiovascular mortality, and HF hospitalizations. Trial registry number: NCT02546856.

Acute nontraumatic chest pain is a frequent reaso n for consultation in emergency departments and represents a diagnostic challenge. The objective is to estimate the risk of significant coronary artery disease (CAD) in patients with cardiogenic acute chest pain for whom the diagnosis of infarction was ruled out in the emergency department with a nondiagnostic ECG and negative high-sensitivity troponins. We prospectively recruited 1625 patients from emergency departments of seven Spanish hospitals. The outcome was presence of significant CAD determined by presence of ischaemia in functional tests or more than 70% stenosis in imaging tests. In this study, we developed a predictive model and evaluated its performance and clinical utility. The prevalence of significant CAD was 14% [227/1625; 95% confidence interval (CI), 12-16]. MAPAC Cardio-PreTest model included seven predictors: age, sex, smoking, history of hypertension, family history of CAD, history of hyperuricaemia, and type of chest pain. The optimism-adjusted model discrimination was C-statistic 0.654 (95% CI, 0.618-0.693). Calibration plot showed good agreement between the predicted and observed risks, and calibration slope was 0.880 (95% CI, 0.731-1.108) and calibration-in-the-large -0.001 (95% CI, -0.141 to 0.132). The model increased net benefit and improved risk classification over the recommended approach by the European Society of Cardiology [Net Reclassification Index (NRI) of events = 5.3%, NRI of nonevents = 7.0%]. MAPAC Cardio-PreTest model is an online prediction tool to estimate the individualised probability of significant CAD in patients with acute chest pain without a diagnosis of infarction in emergency department. The model was more useful than the current alternatives in helping patients and clinicians make individually tailored choices about the intensity of monitoring or additional coronary tests.

Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists.ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months.The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01.ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.

Resumen Introduccion y objetivos Los bloqueadores beta, inhibidores de la enzima de conversion de la angiotensina (IECA), antagonistas de los receptores de la angiotensina II (ARA-II) y antagonistas de receptores mineralocorticoides, disminuyen mortalidad y hospitalizaciones por insuficiencia cardiaca (IC) en pacientes con IC y fraccion de eyeccion del ventriculo izquierdo reducida. Efecto dosis-dependiente. Se recomienda titulacion cuidadosa. Sin embargo, las dosis suboptimas son habituales. Se comparo eficacia y seguridad de la titulacion de farmacos enfermeras de IC frente a cardiologos de IC. Metodos ETIFIC fue un ensayo de no inferioridad, multicentrico (20), abierto, controlado y aleatorizado. 320 pacientes hospitalizados con IC de debut, fraccion de eyeccion reducida y New York Heart Association II-III. Sin contraindicacion para bloqueadores beta, fueron aleatorizados 1:1, estratificados en bloques de 4 pacientes/hospital, 164 a titulacion de enfermeras de IC frente a 156 cardiologos de IC (analizados 144 frente a 145). El objetivo principal fue la dosis relativa media (% de dosis objetivo) de bloqueadores beta alcanzada a 4 meses. Los objetivos secundarios fueron: la dosis relativa media de IECA, ARA-II y antagonistas de receptores mineralocorticoides, variables asociadas, eventos adversos y resultados clinicos a 6 meses. Resultados La dosis relativa media ± desviacion estandar alcanzada por enfermeras de IC frente a cardiologos de IC: bloqueadores beta 71,09 ± 31,49% frente a 56,29 ± 31,32%, diferencia 14,8% (IC95%, 7,5-22,1); p Conclusiones ETIFIC es el primer ensayo aleatorizado multicentrico que prueba la no inferioridad de titulacion de farmacos por enfermeras de IC frente a cardiologos de IC. Las enfermeras especialistas consiguieron mayores dosis de bloqueadores beta/IECA con mas visitas y menos hospitalizaciones por IC. Registro del ensayo: NCT02546856.

Risk stratification for adults infected with SARS-CoV-2 COVID-19 continues to be essential to inform decisions about individual patients and allocation of resources and treatment options. Accurate knowledge of individual risk of severe COVID-19 can make an important contribution to healthcare both on a population and a personal level. There are currently few tools and solutions that help medical professionals to predict the evolution of SARS-COV-2 infected patients. So far, risk models for severe COVID-19 outcomes have included age and clinical comorbidities. The first wave of the COVID-19 pandemic spread rapidly in Spain, one of Europe’s most affected countries. In this retrospective study we analyzed genotypic and phenotypic data from 659 patients in the Basque region of Spain during the first wave of COVID-19, and compared mild with severe COVID-19 cases. Using genetic variants data as well as clinical variables of the participants we built a prediction model of severe COVID-19. We obtained robust results in the training data set with 85% sensitivity, 67% specificity and an Area Under the Curve (AUC) of 0.78. In the validation set the AUC was 0.75. The main advantage of our model is that because it includes genetic variants it could be used with medical records to identify the critical population in advance.

Introduction Quantitative reverse transcription PCR (RT-qPCR) is the leading tool to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Given that it will almost certainly continue to coexist with other respiratory viruses in the coming years, our study aimed to design a multiplex PCR system not affected by supplier outages and with reduced cost compared to the existing commercially available kits. Methods and results In this study, combinations of four primers/probe sets were used to construct a flexible RT-qPCR assay which is capable of discriminating between SARS-CoV-2 and the seasonal human coronavirus HCoV-OC43, or even influenza A virus. Additionally, the human RPP30 gene was used as an internal control. To demonstrate the robustness of the assay, it was applied to a collection of 150 clinical samples. The results showed 100% sensitivity and specificity compared to the automatized system used at the hospital and were better when indeterminate samples were analysed. Conclusions This study provides an efficient method for the simultaneous detection of SARS-CoV-2, HCoV-OC43 and influenza A virus, and its efficacy has been tested on clinical samples showing outstanding results. Significance and impact of the study The multiplex RT-qPCR design offers an accessible and economical alternative to commercial detection kits for hospitals and laboratories with limited economic resources or facing situations of supply shortage.

SummaryBackgroundA SARS-CoV-2 protein-based heterodimer vaccine, PHH-1V, has been shown to be safe and welltolerated in healthy young adults in a first-in-human, Phase I/IIa study dose-escalation trial. Here, we report the interim results of the Phase IIb HH-2, where the immunogenicity and safety of a heterologous booster with PHH-1V is assessed versus a homologous booster with BNT162b2 at 14, 28 and 98 days after vaccine administration.MethodsThe HH-2 study is an ongoing multicentre, randomised, active-controlled, double-blind, non-inferiority Phase IIb trial, where participants 18 years or older who had received two doses of BNT162b2 were randomly assigned in a 2:1 ratio to receive a booster dose of vaccine —either heterologous (PHH-1V group) or homologous (BNT162b2 group)— in 10 centres in Spain. Eligible subjects were allocated to treatment stratified by age group (18-64 versus ≥65 years) with approximately 10% of the sample enrolled in the older age group. The primary endpoints were humoral immunogenicity measured by changes in levels of neutralizing antibodies (PBNA) against the ancestral Wuhan-Hu-1 strain after the PHH-1V or the BNT162b2 boost, and the safety and tolerability of PHH-1V as a boost. The secondary endpoints were to compare changes in levels of neutralizing antibodies against different variants of SARS-CoV-2 and the T-cell responses towards the SARS-CoV-2 spike glycoprotein peptides. The exploratory endpoint was to assess the number of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster. This study is ongoing and is registered withClinicalTrials.gov,NCT05142553.FindingsFrom 15 November 2021, 782 adults were randomly assigned to PHH-1V (n=522) or BNT162b2 (n=260) boost vaccine groups. The geometric mean titre (GMT) ratio of neutralizing antibodies on days 14, 28 and 98, shown as BNT162b2 active control versus PHH-1V, was, respectively, 1·68 (p+and CD8+T-cells expressing IFN-γ on day 14. There were 458 participants who experienced at least one adverse event (89·3%) in the PHH-1V and 238 (94·4%) in the BNT162b2 group. The most frequent adverse events were injection site pain (79·7% and 89·3%), fatigue (27·5% and 42·1%) and headache (31·2 and 40·1%) for the PHH-1V and the BNT162b2 groups, respectively. A total of 52 COVID-19 cases occurred from day 14 post-vaccination (10·14%) for the PHH-1V group and 30 (11·90%) for the BNT162b2 group (p=0·45), and none of the subjects developed severe COVID-19.InterpretationOur interim results from the Phase IIb HH-2 trial show that PHH-1V as a heterologous booster vaccine, when compared to BNT162b2, although it does not reach a non-inferior neutralizing antibody response against the Wuhan-Hu-1 strain at days 14 and 28 after vaccination, it does so at day 98. PHH-1V as a heterologous booster elicits a superior neutralizing antibody response against the previous circulating Beta and the currently circulating Omicron BA.1 SARS-CoV-2 variants in all time points assessed, and for the Delta variant on day 98 as well. Moreover, the PHH-1V boost also induces a strong and balanced T-cell response. Concerning the safety profile, subjects in the PHH-1V group report significantly fewer adverse events than those in the BNT162b2 group, most of mild intensity, and both vaccine groups present comparable COVID-19 breakthrough cases, none of them severe.FundingHIPRA SCIENTIFIC, S.L.U.

Background: Effective treatment of acute high blood pressure in neurocritical diseases is a current recommendation of guidelines to reduce mortality and severe disability. Clevidipine is a calcium channel blocker that showed effectiveness and safety for acute high blood pressure control in neurocritical patients. Materials and methods: Retrospective, observational and cross-sectional study in adult patients admitted to Intensive Care Unit for neurocritical disease requiring surgical or interventional treatment and presenting acute high blood pressure requiring urgent treatment with clevidipine as first line or rescue therapy after failure of different intravenous antihypertensive drugs. Primary endpoint was effectiveness of clevidipine treatment. Secondary endpoint was safety of clevidipine treatment. Analysis of subgroups described patient and treatment variables on effectiveness and safety of clevidipine, mortality, functional situation and major neurologic complications. Hematoma expansion, rebleeding and vasospasm were specific neurological complications described. Comparisons was made using Fisher, chi-square, t or Mann Whitney U test. Significance was set at the 5% level. Analysis was made using IBM SPSS Statistics 23.0 Results: thirty-three patients admitted to Intensive Care Unit fulfilled inclusion criteria and were included. Clevidipine showed a higher effectiveness and safety for acute high blood pressure control in our patients. Effectiveness was higher in patients with larger brain hematomas and severe aneurysmal subarachnoid hemorrhages treated with first line and early began of clevidipine within 24 hours of admission. Adverse events were mild, transient and more frequent in patients with first line treatment. Early and effective treatment were safe with lower major neurological complications. Mortality was lower in patients with first line and effective treatment. Hematoma expansion was seen in a higher number of patients. Rebleeding and vasospasm were less frequent. Conclusion: Clevidipine was effective and safe treatment of acute high blood pressure in neurocritical patients. Severity of neurocritical disease is a key factor but early and effective treatment could contribute to reduce mortality and major neurological complications. Nevertheless, our results need to take with caution because little size and design of our study. Trial registration: NCT05168059

The Coronavirus Disease 2019 (COVID-19) pandemic continues to pose a major public health threat especially in countries with low vaccination rates. To better understand the biological underpinnings of SARS-CoV-2 infection and COVID-19 severity we formed the COVID19 Host Genetics Initiative. Here we present GWAS meta-analysis of up to 125,584 cases and over 2.5 million controls across 60 studies from 25 countries, adding 11 new genome-wide significant loci compared to those previously identified. Genes in novel loci include SFTPD, MUC5B and ACE2, reveal compelling insights regarding disease susceptibility and severity.

To evaluate the effectiveness of vagino-rectal swab autotomy for prenatal screening for GBS infection and to identify the barriers and facilitators encountered by the pregnant woman for this intervention.Cross-sectional study of diagnostic tests.A total of 213 pregnant women who attended the primary care midwife's office in 6 health centers of the Basque Health Service/Osakidetza in Bizkaia, who met the inclusion criteria and agreed to participate in the study, participated in the study.The result of the vagino-rectal culture obtained by the pregnant woman was compared with the result of the vagino-rectal culture taken by the midwife in consultation on the same day, and the barriers and facilitators encountered by the women in the self-test were collected.Self-testing as a test for GBS was found to have a sensitivity of 93.3% (95% CI 78.7-98.2), a specificity of 99.4% (95% CI 96.5-99.9), a positive predictive value of 96% (95% CI 82.8-99.4) and a negative predictive value of 98.8% (95% CI 95.6-99.7). 27.3% of respondents encountered some difficulty in the collection, only 4.8% did not feel qualified, 84.2% felt comfortable, 99.5% considered the information provided to be adequate and complete, 94.7% did not find the steps to follow complicated, and 96% were satisfied with the study.Self-collection of vagino-rectal exudate for GBS detection has proved to be valid and reliable, which would make it possible to offer this option to pregnant women in the systematic screening for GBS infection.

Background Besides clinical signs and imaging, in recent years, biomarkers have proven to be a viable diagnostic resource for acute appendicitis (AA). Objective The objective of this study was to develop a clinical score including clinical signs and a combination of biomarkers to identify children with abdominal pain at low risk of AA. Design/methods We prospectively included children 2 to 14 years of age with abdominal pain suggestive of AA who presented to the emergency department between July 2016 and September 2017. A new score, the Pediatric Appendicitis Laboratory Score (PALabS) including clinical signs, leucocyte (WBC) and neutrophil (ANC) counts and plasma C-reactive protein (CRP) and calprotectin (CP) levels was developed and validated through secondary analyses of two distinct cohorts The validation sample included visits to a single pediatric emergency department from 2012 to 2013 and 2016 to 2017. Results The derivation sample included 278 children, 35.9% of whom had AA and the validation sample included 255 children, 49% of whom had AA. Using logistic regression, we created a 6-part score that consisted of nausea (3 points), history of focal right lower quadrant pain (4 points), ANC of ≥7500/μL (7 points), WBC of ≥10,000/μL (4 points), CRP ≥ 10.0 mg/L (2 points) and CP ≥ 0.50 ≥ ng/mL (3 points). This score exhibited a high discriminatory power (area under the curve: 0.88; 95% confidence interval: 0.84 to 0.92) and outperformed the PAS and Kharbanda scores (area under the curve: 0.76; 95% confidence interval: 0.71 to 0.82 and 0.82; 95% confidence interval: 0.77 to 0.87, respectively). A PALabS ≤6 had a sensitivity of 99.2% (95% confidence interval [CI]: 95.6–99.9), negative predictive value of 97.6% (95% CI: 87.7–99.6), and negative likelihood ratio of 0.03 (95% CI: 0.00–0.18) in the validation set. Conclusion In our validation cohort of patients with acute abdominal pain, the new score can accurately predict which children are at low risk of appendicitis and could be safely managed with close observation.

Objective High participation determines the success of colorectal cancer screening programmes in reducing incidence and mortality. The factors that determine participation must be studied from the perspective of professionals that implement the programme. The aim was to identify factors that facilitate or hinder the participation of the invited people in the bowel cancer screening programme of the Basque Country (Spain) from professional's perspective. Methods Qualitative design based on individual interviews and focus groups. Thirty-eight primary care professionals who implement the programme participated (administrative staff, nurses and general practitioners). Thematic analysis was performed. Results Professionals show high satisfaction with the programme, and they believe firmly in its benefits. Facilitators for participation include professionals' commitment to the programme, their previous positive experiences, their optimistic attitude towards the prognosis of cancer and their trust in the health system and accessibility. Barriers include invitees' lack of independence to make decisions, fear of a positive test result and patient vulnerability and labour mobility of the health professionals. Conclusions Professionals show a high degree of involvement and identify primary care is an appropriate place to carry out disease prevention. They identify the closeness to patients, the personal attitude and the characteristics of the health system as key factors that influence participation. Euskal Herriko Unibertsitatea; Spanish Ministry of Science, Innovation and Universities, Grant/Award Number: SEV-2017-0718; Spanish Ministry of Economy and Competitiveness MINECO and FEDER, Grant/Award Number: MTM2016-74931-P; Department of Education, Language Policy and Culture from the Basque Government, Grant/Award Numbers: BERC 2018-2021, IT620-13

Background To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity of BNT162b2 (Comirnaty, BioNTech, Mainz, Germany) administered as second dose in participants primed with ChAdOx1-S (Vaxzevria, AstraZeneca, Oxford, UK). Methods We did a phase 2, open-label, randomised, controlled trial on adults aged 18–60 years, vaccinated with a single dose of ChAdOx1-S 8–12 weeks before screening, and no history of SARS-CoV-2 infection. Participants were randomly assigned (2:1) to receive either BNT162b2 (0·3 mL) via a single intramuscular injection (intervention group) or continue observation (control group). The primary outcome was 14-day immunogenicity, measured by immunoassays for SARS-CoV-2 trimeric spike protein and receptor binding domain (RBD). Antibody functionality was assessed using a pseudovirus neutralisation assay, and cellular immune response using an interferon-γ immunoassay. The safety outcome was 7-day reactogenicity, measured as solicited local and systemic adverse events. The primary analysis included all participants who received at least one dose of BNT162b2 and who had at least one efficacy evaluation after baseline. The safety analysis included all participants who received BNT162b2. This study is registered with EudraCT (2021-001978-37) and ClinicalTrials.gov (NCT04860739), and is ongoing. Findings Between April 24 and 30, 2021, 676 individuals were enrolled and randomly assigned to either the intervention group (n=450) or control group (n=226) at five university hospitals in Spain (mean age 44 years [SD 9]; 382 [57%] women and 294 [43%] men). 663 (98%) participants (n=441 intervention, n=222 control) completed the study up to day 14. In the intervention group, geometric mean titres of RBD antibodies increased from 71·46 BAU/mL (95% CI 59·84–85·33) at baseline to 7756·68 BAU/mL (7371·53–8161·96) at day 14 (p

Background There has been increased interest in pain neuroscience education (PNE) as a therapeutic approach for the management of fibromyalgia (FM). Methods A multicentre randomized, open-label, controlled trial was conducted to assess the effectiveness of a structured group intervention based on PNE in patients with FM. A total of 139 patients were included in the study and randomized to the intervention group (7 group sessions of education in neurobiology of pain) or to the control group (treatment as usual only). The primary outcome was the improvement of functional status and pain measured with the Fibromyalgia Impact Questionnaire (FIQ), and secondary outcomes were the reduction in the impact of pain and other symptoms (catastrophizing, anxiety and depression) and number of patients reaching no worse than moderate functional impairment (FIQ score = 20% in 69.1% of patients (20.9% in the control group) and of >= 50% in 39.7% (4.5% in the control group). Also, 52.9% of patients had a FIQ

SUMMARYCOVID-19 manifests with a wide diversity of clinical phenotypes characterized by dysfunctional and exaggerated host immune responses. Many results have been described on the status of the immune system of patients infected with SARS-CoV-2, but there are still aspects that have not been fully characterized. In this study, we have analyzed a cohort of patients with mild, moderate and severe disease. We performed flow cytometric studies and correlated the data with the clinical features and clinical laboratory values of patients. Both conventional and unsupervised data analyses concluded that patients with severe disease are characterized, among others, by a higher state of activation in all T cell subsets, higher expression of perforin and granzyme B in cytotoxic cells, expansion of adaptive NK cells and the accumulation of activated and immature dysfunctional monocytes which are identified by a low expression of HLA-DR and an intriguing abrupt change in the expression pattern of CD300 receptors. More importantly, correlation analysis showed a strong association between the alterations in the immune cells and the clinical signs of severity. These results indicate that patients with severe COVID-19 have a broad perturbation of their immune system, and they will help to understand the immunopathogenesis of severe COVID-19 as well as could be of special value for physicians to decide which specific therapeutic options are most effective for their patients.

The steady increase in colorectal cancer (CRC) could be reversed through timely secondary prevention (screening) as a main strategy. The aims of this study were to determine the main features of CRC, survival rate and related factors for different types of identified CRCs in a population-based screening programme using the faecal immunochemical test (FIT).The CRCs in the susceptible population to be screened between 2009 and 2014 were identified and classified into four groups: (a) nonscreening-detected CRC (diagnosed before first screening invitation and nonparticipants), (b) screening-detected CRC, (c) interval cancer (IC) FIT (diagnosed between screening rounds after a negative FIT) and (d) IC colonoscopy (diagnosed before the colonoscopy surveillance, which is recommended after the screening colonoscopy). Patient demographics and epidemiological characteristics, tumour characteristics and survival were compared between the four groups.5909 individuals were diagnosed with a CRC. The median follow-up of survival was 4.6 years (range: 0-9 years). The study highlights a significant difference (P0.0001) in the 5-year survival in the screening-detected CRC group compared with those who had nonscreening-detected CRCs (90.1 vs. 66.7%). Although ICs are not desirable events, the 5-year survival rate is significantly higher with respect to nonparticipants (P0.0001) (76.3 vs. 60.5%), this being the group with the lowest survival rate.The significantly higher 5-year survival rate of 23.4% of the participants in the screening programme suggests that incidence and mortality rates of CRC will decrease in the near future for participants in screening programmes. A high participation rate is essential to achieve health benefits, irrespective of the type of participation.

Resumen Introduccion La colonoscopia es la prueba de confirmacion diagnostica/terapeutica del cancer colorrectal. La monitorizacion de la experiencia de las personas que se han realizado la prueba resulta de interes en la mejora de su calidad. El objetivo fue estudiar los factores relacionados con la experiencia y su relacion con los indicadores de calidad de las guias de practica clinica. Pacientes y metodos Se realizo un estudio transversal observacional, incluyendo indicadores de calidad y experiencia (cuestionario mGHAA9 adaptado e historia clinica) con una muestra de 432 participantes de entre 40-75 anos que se realizaron una colonoscopia en 2015. Analisis univariante y multivariante con regresion logistica multiple. Resultados La satisfaccion se asocio en el analisis multivariante con una valoracion del tiempo de espera para la colonoscopia como corto (OR = 3,80) (1,76-10,90; IC 95%), tener mas de 55 anos de edad (OR = 2,60) (1,19-5,68; IC 95%), una valoracion positiva de la experiencia de la preparacion (OR = 7,34) (3,15-17,09; IC 95%), no referir dolor o molestias durante el procedimiento (OR = 3,71) (1,03-13,40; IC 95%) (p = 0,006) y la realizacion de la exploracion en un hospital terciario (OR = 2,81) (1,17-6,72; IC 95%) (p = 0,020) Discusion El cuestionario mGHAA9 adaptado al castellano es util para estudiar los factores relativos a la experiencia. Hay aspectos de mejora en los tiempos de espera, limpieza colonica, satisfaccion con la preparacion y los problemas poscolonoscopia. Se deben implementar intervenciones que permitan mejorar la experiencia de las personas y la calidad de la colonoscopia.

Background The overall aim of this study was to describe trends in participation rates and detection of lesions in a colorectal cancer (CRC) screening programme, during three rounds, using faecal immunochemical test (FIT). Methods National registers were used to collect data on invitations for CRC screening in the Basque Country (Spain) from 2009 to 2014. Information about participation, age, gender and lesions in each round were collected. Results A total of 961.533 individuals were included in the analysis; respectively, 584.950, 298.143 and 78.440 in the first, second and third rounds. The average participation rate was 68.4% (66.8, 70.4 and 72.3%, respectively by round; P < 0.001) and the positivity rate was 6.3% (7, 5.5 and 5.4%, respectively by round; P < 0.001). The participation rate increased significantly with age and was found to be higher in women versus men. A total of 15.144 advanced adenomas and 2.131 CRCs were diagnosed, leading to a detection rate of 23.9 and 3.4‰, respectively. Regarding gender, men had the highest rates in all periods and rounds. The detection rate of advanced neoplasia was lower in the regular when compared with irregular paricipants. Conclusions In a CRC screening, this organization obtained high FIT participation rates. Older participants and women were associated with a higher participation. The detection rate of lesions was higher in men, independent on age and round.

Screening by means of biennial fecal occult blood test has provided a reduction in overall colorectal cancer mortality. Notwithstanding, we should not underestimate the harms that it can produce.The aim of this article is to identify the independent risk factors of complications after a screening colonoscopy.A six-year, nested case-control study was conducted. Mortality/complications within 30 days after colonoscopy were registered and its predictors identified through logistic regression.After 39,254 colonoscopies, the complication rate was 1.0%. Independent predictors were sex (OR 1.68 for men; CI 95% 1.18-2.39), ASA physical status classification system (OR 1.73 for ASA II-III; CI 95% 1.53-3.69), history of abdominal surgery (OR 2.37; CI 95% 1.72-4.08), diverticulosis (OR 2.89; CI 95% 1.94-4.30), inadequate cleansing (OR 29.35; CI 95% 6.52-132.17), detection of advanced neoplasia (AN) (OR 4.92; CI 95% 3.29-7.36), detection of stage I adenocarcinoma (OR 9.44; CI 95% 4.46-20.0), polyps in right colon OR 2.27 CI 95% 1.38-3.74) and complex polypectomy (OR 2.00; CI 95% 1.25-3.20). The logistic model explained 82% of the complications (CI 95% 0.798-0.854,Colonoscopy, with or without removal of a lesion, is an invasive procedure with a non-deniable risk of major complications. Factors like inadequate cleansing or detection of AN are determinants. Therefore, it is vital to know which aspects predict their appearance to implement countermeasures.

AIM To assess proportions, related conditions and survival of interval cancer (IC). METHODS The programme has a linkage with different clinical databases and cancer registers to allow suitable evaluation. This evaluation involves the detection of ICs after a negative faecal inmunochemical test (FIT), interval cancer FIT (IC-FIT) prior to a subsequent invitation, and the detection of ICs after a positive FIT and confirmatory diagnosis without colorectal cancer (CRC) detected and before the following recommended colonoscopy, IC-colonoscopy. We conducted a retrospective observational study analyzing from January 2009 to December 2015 1193602 invited people onto the Programme (participation rate of 68.6%). RESULTS Two thousand five hundred and eighteen cancers were diagnosed through the programme, 18 cases of IC-colonoscopy were found before the recommended follow-up (43542 colonoscopies performed) and 186 IC-FIT were identified before the following invitation of the 769200 negative FITs. There was no statistically significant relation between the predictor variables of ICs with sex, age and deprivation index, but there was relation between location and stage. Additionally, it was observed that there was less risk when the location was distal rather than proximal (OR = 0.28, 95%CI: 0.20-0.40, P < 0.0001), with no statistical significance when the location was in the rectum as opposed to proximal. When comparing the screen-detected cancers (SCs) with ICs, significant differences in survival were found (P < 0.001); being the 5-years survival for SCs 91.6% and IC-FIT 77.8%. CONCLUSION These findings in a Population Based CRC Screening Programme indicate the need of population-based studies that continue analyzing related factors to improve their detection and reducing harm.

IntroductionCurrent clinical practice is based on guidelines and local protocols that are informed by clinical evidence. This means that clinical variability is reduced, but can lead to inefficient clinical decision-making and can increase medical errors, decreasing patient's safety. The aim of the EXCON project is to investigate the innovative concept of Intelligent Clinical History (ICH), and to develop functional prototypes of high added-value in healthcare services.MethodsThe innovative EXCON project will take advantage of recent advances in technologies for coding, structuring and semantizing medical information. Thanks to this new structuring, the EXCON platform will be developed. The final users will be health professionals and other decision-makers. Doctors, nurses, epidemiologists and information specialists will be involved in the development and subsequent validation of the platform.ResultsThe EXCON platform identifies profiles of patients with a high probability of ischemic heart disease. In the sample analyzed (n = 4,700), 17 percent of patients were admitted to a cardiology unit with suspected coronary heart disease. Of the patients admitted, 53.7 percent did not have ischemic heart disease at discharge. If we apply the algorithm developed by the EXCON project, 24.8 percent of patients would not have been admitted and did not have ischemic heart disease.ConclusionsIn coming decades, patient management will be impacted by the application of new advanced data analytics tools. This will allow for safer and more efficient clinical management, decrease variability in clinical practice, and improve equity. That is why the development and assessment of these technologies is necessary.

Background: Stroke is a leading cause of severe and long-term disability in developed countries. Around 15 million people suffer a stroke each year, being most of them ischemic due to modifiable risk factors. Adequate self-management abilities may help to manage the consequences of stroke, but it is unknown which specific intervention could be effective to booster these self-management abilities. Objective: To evaluate the improvement of self-management in chronic stroke survivors using decision support and self-management system (STARR). Methods: A randomized, prospective, parallel group, open, and the unicentric pilot trial will be performed. Stroke survivors and their caregivers will be randomly allocated to STARR management or standard of care. Main inclusion criteria are mild to moderate disabled first stroke adult survivor, living at home, able to cope and follow the guidelines and devices, without socio-familial exclusion. All will get a conventional treatment in the acute and subacute phase; however, in the chronic period, cases will use the developed STARR App and Decision Support System. Measurements will be performed at baseline, at 3 months, and at 6 months. Outcome measures are patient-report outcome measure of self-management competency, physical function, risk factor reduction, healthcare resource utilization, knowledge of the condition, mood, and social isolation. Discussion: If effective, the results of this study will enable stroke patients and their caregivers to deal better with the everyday life obstacles of stroke, improve the adherence of the treatment, improve the control of cardiovascular risk, and, in consequence, reduce the recurrence of secondary strokes, the number of complications, the number of consultations, and readmissions; to ultimately reduce the health systems costs. Taking into consideration that the number of stroke survivors is increasing around the world, a large number of individuals could profit from this intervention.

Background and study aims: The European guidelines for quality assurance in colorectal cancer (CRC) screening have established high-risk (≥ 5 adenomas or an adenoma ≥ 20 mm) and intermediate-risk (3 – 4 adenomas or at least one adenoma 10 – 19 mm in size, or villous histology, or high grade dysplasia) groups with different endoscopic surveillance intervals. The aim of this study was to evaluate the difference in the incidence of advanced neoplasia (advanced adenoma or CRC) between the two risk groups. Patients and methods: This retrospective group study included patients meeting high- or intermediate-risk criteria for adenomas detected in CRC screening programs and the COLONPREV study before European guidelines were adopted in Spain (June 2011) with a 3-year surveillance recommendation according to Spanish guidelines. The primary outcome measure was the incidence of advanced neoplasia in patients undergoing surveillance. The secondary outcome measure was the CRC incidence. We used an adjusted proportional hazards regression model to control confounding variables. Results: The study included 5401 patients (3379 intermediate risk, 2022 high risk). Endoscopic surveillance was performed in 65.5 % of the patients (2.8 ± 1 years). The incidence of advanced neoplasia in the high- and intermediate-risk groups was 16.0 % (59.0 cases/1000 patient-years) and 12.3 % (41.2 cases/1000 patient-years), respectively. The CRC incidence was 0.5 % (1.4 cases/1000 patient-years) and 0.4 % (1 case/1000 patient-years), respectively. The advanced neoplasia and CRC attributable risk to the high risk group was of 3.7 % and 0.1 %, respectively. In the proportional hazards analysis, the risk of advanced neoplasia was greater in the high-risk group (hazard ratio [HR] 1.5, 95 % confidence interval [CI] 1.2 – 1.8), with no significant differences in the CRC incidence (HR 1.6, 95 %CI 0.6 – 3.8). Conclusions: Patients meeting high-risk criteria have a higher incidence of advanced neoplasia during endoscopic surveillance. No differences were found in the CRC incidence at a 3-year surveillance recommendation.

Resumen El fracaso ventilatorio agudo, especialmente en la enfermedad pulmonar obstructiva cronica, es una causa frecuente de ingreso en pacientes ancianos con pluripatologia y limitacion de esfuerzo terapeutico. Cada vez hay mas datos de la utilidad de la ventilacion mecanica no invasiva (VMNI) en este contexto. Nuestro centro desarrollo en 2010 una via clinica integrada urgencias-hospitalizacion para el uso de la VMNI en el fracaso ventilatorio agudo. El objetivo de este trabajo fue evaluar el resultado de la VMNI en el fracaso ventilatorio agudo en pacientes con orden de no intubar en un hospital de subagudos. Material y metodo Estudio observacional, con un ano de seguimiento. Las variables principales son la mortalidad al ingreso y al ano. Se recogen todos los casos que reciben VMNI, a traves de un registro especifico. Otras variables recogidas son: datos demograficos, clinicos y funcionales, enfermedad de base, situacion funcional basal, gasometria, estancia y reingresos. Resultados Se incluyeron 102 pacientes con una edad media de 81 anos, un indice de Charlson de 3,7 y un indice de Barthel de 54, estando el 22% institucionalizados. La mortalidad durante el ingreso fue del 33%. Entre los pacientes sin indicacion ajustada a protocolo, la mortalidad fue del 71%. La supervivencia global al ano fue del 46%, resultando asociada en el analisis estadistico multivariante a obesidad-hipoventilacion e indice de Barthel > 50. Conclusiones La VMNI es una tecnica de utilidad en pacientes ancianos con limitacion de esfuerzo terapeutico. A pesar de la severidad y la comorbilidad, se obtienen tasas aceptables de supervivencia. Los pacientes con mejor situacion funcional basal y obesidad-hipoventilacion tienen mayor supervivencia.

Purpose The aim of this study was to better understand the attitudes towards the use of technology to support chronic stroke survivors in a home-based setting. Methods A quantitative study was used on the data obtained from a face to face survey with the sample group, incorporating quantitative statistical analysis. Results Participants reported positive attitudes towards using technology for their own independent health management. The purpose of the home-based technology was different: source of information, supporting self-management, pharmacological treatment reminders… and differed according to age, educational level and survivor disability. Installing devices and sharing information remains a challenge. Conclusions 100% of stroke survivors living in the community with any type of disability, reported that they would like to use technology as a tool to help improve their health status.

IntroductionStroke is a leading cause of severe and long-term disability in developed countries. Around 15 million people suffer a stroke each year, most due to modifiable risk factors. Several reviews have shown that interventions mediating eHealth technologies can reduce the risk of suffering a stroke episode, improving the control of risk factors; nevertheless, all of them conclude that new and well-designed studies are needed.MethodsWe performed a prospective, randomized, parallel group and open, pilot trial. The study was carried out based on an initial sample of forty-three patients between 18 and 80 years old who have had an ischemic stroke. The control group got conventional treatment and the intervention group got conventional treatment and the assistance of STARR (the Decision SupporT and self-mAnagement system for stRoke survivoRs), as well as commercial wearables. The principal variable of the study was to evaluate the usability of the decision support system.ResultsAt month nine, the average score on the System Usability Scale in the intervention group was 64.7 and in month 12, 67.4, exceeding in both cases the margin of acceptability (50) and in the limit of “good” (68). When we analyzed clinical factors (systolic/diastolic blood pressure) as well as the analytical parameters related to prevention of reinfarction, we observed that the intervention group had good control of blood pressure and better analytical parameters, compared to the control group.ConclusionsTechnological support allowed participants to feel comfortable using the devices as well as resolving technical incidences by themselves after a training period. The self-management platform can be efficient in stroke survivors’ management of their disease condition, improving analytical and clinical parameters, which eventually can influence a decrease in associated comorbidities and, therefore, improvement of the disease. However, it should be noted that this type of platform is not useful for every patient profile, and studies in this regard should be expanded.

Euskadiko Baheketa Programa 50 eta 69 urte bitarteko biztanleei zuzenduta dago. Gorozkietan ezkutuan dagoen odola detektatzeko testaren (FIT) bidez egiten da, bi urtean behin, eta kasu positiboetan kolonoskopia egiten da sedazioarekin. Metodoa: analisi-kita etxera bidalita gonbidatzen dira indibidualki ikerketako adin-taldeko biztanle oro. Osakidetzako Historia Elektroniko, Minbizi Erregistro eta Heriotza Erregistroko datuak erabiltzen dira informazio-iturri. 2009-2016 bitartean egindako gonbidapen guztien azterketa sexuaren eta adinaren arabera eta biziraupenaren azterketa 2014. urteraino. 2011ko Europako Kalitate Gidan azaltzen diren irizpide eta adierazleak erabiliaz. R eta SPSS aplikazioak erabili dira deskribapen estatistikoa eta biziraute kurbak (Kaplan-Meyer) lortzeko. Emaitzak: 1.426.846 baliozko gonbidapen, parte-hartzeak joera positiboa (p

Aim: Analyze clinical-radiological features and clinical course of M.kansasii pulmonary disease compared to other NTMs Methods: Retrospective, descriptive study of NTM pulmonary disease from 1997 to 2016. 2007 ATS criteria were fulfilled. We evaluated:demographic data, risk factors, symptomatology, radiology, coinfection, recurrence and overall mortality per year Results: 327cases of NTM lung disease:274(83.7%)M. Kansasii and 53(16.3%)other NTM. Comparison between them are seen in figure1.M. Kansasii group, patients were younger, males, smokers and with cancer. No differences were found in symptoms.M. kansasii was associated with more cavitation, unilaterality and upper lobes predominance. Other NTMs infections were associated with bronchiectasis, nodules or “tree in bud” infiltrates with middle lobes predominance and more coinfection. Rates of recurrence were similar in both groups and the overall-1year mortality rate, including NTMosis-related mortality and other causes mortality. Sputum conversion was maintained in 85.8% of M.kansasii vs 75.5% in other NTM and radiological resolution in 60%vs39% Conclusions: There are relevant differences between M. Kansasii lung infections and those caused by other NTMs:1. They appear to occur more in male smokers, in the fifth decade and with a history of neoplasia 2. They are associated with cavitation, unilaterality and upper lobe predominance 3. Sputum conversion and radiological resolution rates are higher

Recent studies suggest an increasing prevalence of nontuberculous mycobacteria (NTM) lung disease. The aim of the present study was to describe incidence rates of NTM lung disease and trends therein in our area over a 20-year period. This was a retrospective study of all cases of NTM lung disease between 1997 and 2016 that met the 2007 American Thoracic Society criteria. We analysed the annual incidence rates, species of mycobacteria isolated, trends over time and annual mortality in 327 patients. Mycobacterium kansasii was the most common mycobacterium isolated (84%), followed by Mycobacterium avium complex (MAC) (13%). We compared two periods: 1997–2006 (257 cases, 79%) and 2007–2016 (70 cases, 21%). The incidence rates tended to decrease across these years, with a peak of incidence in 2000 with 10.6 cases per 100 000. There was a clearly decreasing trend in M. kansasii infection, not only in the first period (incident rate ratio (IRR) 0.915, 95% CI 0.88–0.90; p, This epidemiological study shows a clear decrease in the incidence of nontuberculous mycobacterial lung disease, unlike other studies that have described an overall increase http://bit.ly/2ZH46nv

Objective To identify the incidence rate (IR) and epidemiologic trends of childhood type 1 diabetes mellitus (T1DM) in children aged 0 to 14-yr-old from 1990 to 2013, in the north of Spain (Biscay). Subjects and Methods A prospective-retrospective study was performed. Capture–recapture method was used: primary cases were ascertained from hospital register and a secondary independent data source was obtained from diabetes associations and public health plan database. Age and sex-standardized incidence rates were calculated using direct method, assuming an equal distribution in each age/sex group. In order to identify and analyse trends the period studied was divided into two (1990–2001 and 2002–2013) 11-year periods. The 95% confidence interval (CI) was estimated assuming the Poisson distribution. Results A total of 399 new cases were identified throughout the study. Mean age at diagnosis was 8.9 ± 3.7 yr. Completeness of ascertainment was 99.1%. Mean annual age-standardized IR was 10.7 (95% CI: 9.6–11.7). The mean incidence for the 0–4, 5–9 and 10–14 age groups was 5.1, 14.6 and 13.2 per 100,000 children/yr, respectively. The incidence rate trend in the whole group was not statistically significant. In the 10–14 age group we found a yearly average increase (2.5% [CI 95% 0.4–4.6]; P < 0.05) and analysing by sex, this statistically significant incidence trend was observed only in boys. We did not find a seasonal onset pattern. Conclusions The IR did not increase in this population during the period studied unlike the results in other Spanish regions and European Countries.