Clinical complications after a traumatic brain injury and its relation with brain biomarkers.

We aimed to find out which are the most frequent complications for patients who suffer a traumatic brain injury (TBI) and its relation with brain biomarker levels. We conducted a hospital cohort study with patients who attended the Hospital Emergency Department between 1 June 2018 and 31 December 2020. Different variables were collected such as biomarkers levels after 6 h and 12 h of TBI (S100, NSE, UCHL1 and GFAP), clinical and sociodemographic variables, complementary tests, and complications 48 h and 7 days after TBI. Qualitative variables were analysed with Pearson's chi-square test, and quantitative variables with the Mann-Whitney U test. A multivariate logistic regression model for the existence of complications one week after discharge was performed to assess the discriminatory capacity of the clinical variables. A total of 51 controls and 540 patients were included in this study. In the TBI group, the mean age was 83 years, and 53.9% of the patients were male. Complications at seven days were associated with the severity of TBI (p < 0.05) and the number of platelets (p = 0.016). All biomarkers except GFAP showed significant differences in their distribution of values according to gender, with significantly higher values of the three biomarkers for women with respect to men. Patients with complications presented significantly higher S100 values (p < 0.05). The patient's baseline status, the severity of the TBI and the S100 levels can be very important elements in determining whether a patient may develop complications in the few hours after TBI.

Platelet levels and age are determinants of survival after mild-moderate TBI: A prospective study in Spain.

Introduction: Traumatic brain injury (TBI) is a very important reason for consultation in emergency departments. Methods: A hospital cohort study with patients who attended a hospital emergency department between June 1, 2018 and December 31, 2020 due to TBI was studied. Clinical and sociodemographic variables were recorded. The levels of biomarkers and management variables were used. Qualitative variables were analyzed using Pearson's chi-square test, and quantitative variables using the Mann-Whitney U-test. Survival analyses were performed by fitting a multivariable Cox regression model for patient survival during the follow-up of the study in relation to the patient's characteristics upon admission to the emergency department. Results: A total of 540 patients were included. The mean age was 83 years, and 53.9% of the patients were men. Overall, 112 patients (20.7%) died during the study follow-up. The mortality rate per 100 person-years was 14.33 (11.8-17.24), the most frequent mechanism being falls in the home, with none caused on public roads. The multivariable Cox proportional hazards model showed that survival after TBI was significantly associated with age, S100 levels, Charlson index, patient's institutionalized status, the place where the TBI occurred, and hemoglobin and platelet levels. Discussion: The most common profile for a patient with a TBI was male and aged between 80 and 90 years. The combination of the variables age, Charlson index, place of TBI occurrence, and hemoglobin and platelet levels could offer early prediction of survival in our population independently of TBI severity. With the data obtained, a therapeutic algorithm could be established for patients suffering from mild TBI, allowing the patient to be supervised at home, avoiding futile referrals to emergency services.

Impact of the "Zero Resistance" program on acquisition of multidrug-resistant bacteria in patients admitted to Intensive Care Units in Spain. A prospective, intervention, multimodal, multicenter study.

OBJECTIVE: To assess the impact of a multimodal interventional project ("Zero Resistance") on the acquisition of multidrug-resistant bacteria (MDR-B) during the patient's ICU stay. DESIGN: Prospective, open-label, interventional, multicenter study. SETTING: 103 ICUs. PATIENTS: Critically ill patients admitted to the ICUs over a 27-month period. INTERVENTIONS: Implementation of a bundle of 10 recommendations to prevent emergence and spread of MDR-B in the ICU. MAIN VARIABLE OF INTEREST: Rate of patients acquiring MDR-B during their ICU stay, with differentiation between colonization and infection. RESULTS: A total of 139,505 patients were included. In 5409 (3.9%) patients, 6020 MDR-B on ICU admission were identified, and in 3648 (2.6%) patients, 4269 new MDR-B during ICU stay were isolated. The rate of patients with MDR-B detected on admission increased significantly (IRR 1.43, 95% CI 1.31-1.56) (p<0.001) during the study period, with an increase of 32.2% between the initial and final monthly rates. On the contrary, the rate of patients with MDR-B during ICU stay decreased non-significantly (IRR 0.93, 95% CI 0.83-1.03) (p=0.174), with a 24.9% decrease between initial and final monthly rates. According to the classification into colonization or infection, there was a highly significant increase of MDR-B colonizations detected on admission (IRR 1.69, 95% CI 1.52-1.83; p<0.0001) and a very significant decrease of MDR-B-infections during ICU stay (IRR 0.67, 95% CI 0.57-0.80, p<0.0001). CONCLUSIONS: The implementation of ZR project-recommendations was associated with a significantly reduction an infection produced by MDR-B acquired during the patient's ICU stay.

Correction: Martinez-Gonzalez et al. Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form in Spanish Subjects. J. Clin. Med. 2020, 9, 2497.

In the original publication [...].

Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial.

The aim of this study was to assess the acceptability and feasibility of offering risk-based breast cancer screening and its integration into regular clinical practice. A single-arm proof-of-concept trial was conducted with a sample of 387 women aged 40-50 years residing in the city of Lleida (Spain). The study intervention consisted of breast cancer risk estimation, risk communication and screening recommendations, and a follow-up. A polygenic risk score with 83 single nucleotide polymorphisms was used to update the Breast Cancer Surveillance Consortium risk model and estimate the 5-year absolute risk of breast cancer. The women expressed a positive attitude towards varying the frequency of breast screening according to individual risk and, especially, more frequently inviting women at higher-than-average risk. A lower intensity screening for women at lower risk was not as welcome, although half of the participants would accept it. Knowledge of the benefits and harms of breast screening was low, especially with regard to false positives and overdiagnosis. The women expressed a high understanding of individual risk and screening recommendations. The participants' intention to participate in risk-based screening and satisfaction at 1-year were very high.

A Simple Scoring System to Differentiate Bacterial from Viral Infections in Acute Exacerbations of COPD Requiring Hospitalization.

Objective: Both bacteria and viruses may cause acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The objective of this study was to identify readily available clinical parameters to discriminate between them. Methods: During a winter period all consecutive patients with an AECOP who were hospitalized in a non-ICU general ward were prospectively enrolled. In addition to blood tests, cultures of spontaneous or induced sputum samples, and genome detection of respiratory viruses in nasopharyngeal swab samples using multiplex RT-PCR assays were obtained. Only patients with positive microbiological results (bacteria, virus, or both) were eventually included. Mixed infections (bacteria plus viruses) were categorized into the bacterial group due to therapeutic implications (ie, need for antibiotics). Demographic and routine clinical and analytical information was collected. Results: A total of 127 AECOPD patients out of 213 initially evaluated met inclusion criteria and were classified as having bacterial (70, 55.1%) or viral (57, 44.9%) infection. Although no single variable was useful to identify bacteria, the combination of serum C-reactive protein >70 mg/L (2 points), >1 day of symptoms (1.5 points), and a blood neutrophil count >9,500 x109/L (1 point) into a scoring system reached an AUC of 0.80 (95% CI=0.73-0.88) for bacterial etiologies. With this model, scoring 0 or 1 point significantly reduced the probability of a bacterial infection (likelihood ratio negative of 0.2), whereas summing up 2.5 points or more increased it sufficiently to be clinically meaningful (likelihood ratio positive >3.7). Viral infections resulted in fewer hospitalization days (78.9% of patients spent ≥3 days in hospital vs 95.7% of those with bacterial infections; P=0.008). Conclusion: A simple and easy to obtain score system can help clinicians in the decision of prescribing antibiotics in AECOPD patients.

Psychometric Validation of the Cardiff Wound Impact Schedule Questionnaire in a Spanish Population with Diabetic Foot Ulcer.

Diabetic foot ulcers (DFU) negatively affect the quality of life (QoL) of people with diabetes. The Cardiff Wound Impact Schedule (CWIS) questionnaire has been designed to measure the QoL of people with chronic foot wounds. However, no studies have been specifically designed to validate this instrument in a Spanish population. In this prospective study, a total of 141 subjects with DFU were recruited. DFU was determined by performing physical examinations. Medical records were exhaustively reviewed to collect clinical variables. The CWIS was transculturally adapted by a group of experts and a group of patients with DFU. The SF-36 and EQ-5D generic instruments were used as reference tools. The questionnaires were administered at 7 days and 4, 12, and 26 weeks after the baseline assessment by personal interview with each of the study subjects. The psychometric properties of the instrument were assessed using statistical methods. The content validity had an average of 3.63 (90.7% of the maximum score of 4). The internal consistency of the CWIS subscales had a standardized Cronbach's alpha range from 0.715 to 0.797. The reproducibility was moderate with an intraclass correlation coefficient (ICC) range from 0.606 to 0.868. Significant correlations between CWIS domains and SF-36 and EQ-5D subscales were observed, demonstrating a good criterion validity of the CWIS questionnaire (p < 0.001). However, the construct validity of the CWIS was not validated with a comparative fit index (CFI) of 0.69, a root mean square error of approximation (RMSEA) of 0.09, and a standardized root mean square residual (SRMR) of 0.10. The sensitivity to changes over time was optimal in the three domains (i.e., social life, well-being, and physical symptoms) (p < 0.001). In conclusion, the Spanish version of the CWIS shows acceptable psychometric properties to assess the QoL of subjects with DFU, except for its construct validity.

Elección informada en el cribado del cáncer de mama: el papel del nivel educativo / Informed choice in breast cancer screening: the role of education

Objetivo: Evaluar el efecto de recibir información sobre los beneficios y los efectos adversos del cribado del cáncer de mama en la elección informada, en función del nivel educativo. Método: Análisis secundario de un estudio experimental aleatorizado y controlado, en cuatro programas de cribado en Cataluña y Canarias. Se analizaron 400 mujeres que iban a ser invitadas a participar por primera vez. El grupo de intervención recibió una herramienta informativa que mostraba los beneficios y los efectos adversos del cribado. El grupo control recibió un folleto estándar que recomendaba participar en el cribado. El nivel de estudios se agrupó en dos categorías: bajo y alto. La variable principal fue la elección informada definida como un conocimiento adecuado y la concordancia entre las actitudes y las intenciones. Resultados: La intervención produjo un mayor aumento del conocimiento en las mujeres con nivel educativo alto respecto a las de menor nivel educativo. Entre las mujeres que recibieron la intervención, la elección informada fue casi tres veces superior en las de nivel educativo alto (27% vs. 11%). No se observaron diferencias entre niveles educativos en los grupos de intervención y control en cuanto a conflicto decisional, confianza en la decisión, ansiedad y preocupación por el cáncer de mama. Conclusiones: Una herramienta informativa para el cribado del cáncer de mama tuvo mucho más impacto sobre la elección informada en las mujeres con nivel educativo alto. En aquellas con nivel educativo bajo mejoró la actitud frente al cribado y produjo un aumento en la intención de participar en él. (AU)

Objective: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. Method: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. Results: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. Conclusions: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened. (AU)

Clinical Usefulness of Anthropometric Indices to Predict the Presence of Prediabetes. Data from the ILERVAS Cohort.

Prediabetes is closely related to excess body weight and adipose distribution. For this reason, we aimed to assess and compare the diagnostic usefulness of ten anthropometric adiposity indices to predict prediabetes. Cross-sectional study with 8188 overweight subjects free of type 2 diabetes from the ILERVAS project (NCT03228459). Prediabetes was diagnosed by levels of glycated hemoglobin (HbA1c). Total body adiposity indices [BMI, Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) and Deurenberg's formula] and abdominal adiposity (waist and neck circumferences, conicity index, waist to height ratio, Bonora's equation, A body shape index, and body roundness index) were calculated. The area under the receiver-operating characteristic (ROC) curve, the best cutoff and the prevalence of prediabetes around this value were calculated for every anthropometric index. All anthropometric indices other than the A body adiposity were higher in men and women with prediabetes compared with controls (p < 0.001 for all). In addition, a slightly positive correlation was found between indices and HbA1c in both sexes (r ≤ 0.182 and p ≤ 0.026 for all). None of the measures achieved acceptable levels of discrimination in ROC analysis (area under the ROC ≤ 0.63 for all). Assessing BMI, the prevalence of prediabetes among men increased from 20.4% to 36.2% around the cutoff of 28.2 kg/m2, with similar data among women (from 29.3 to 44.8% with a cutoff of 28.6 kg/m2). No lonely obesity index appears to be the perfect biomarker to use in clinical practice to detect individuals with prediabetes.

[Informed choice in breast cancer screening: the role of education]. / Elección informada en el cribado del cáncer de mama: el papel del nivel educativo.

OBJECTIVE: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. METHOD: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. RESULTS: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. CONCLUSIONS: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened.

Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial.

INTRODUCTION: Personalised cancer screening aims to improve benefits, reduce harms and being more cost-effective than age-based screening. The objective of the DECIDO study is to assess the acceptability and feasibility of offering risk-based personalised breast cancer screening and its integration in regular clinical practice in a National Health System setting. METHODS AND ANALYSIS: The study is designed as a single-arm proof-of-concept trial. The study sample will include 385 women aged 40-50 years resident in a primary care health area in Spain. The study intervention consists of (1) a baseline visit; (2) breast cancer risk estimation; (3) a second visit for risk communication and screening recommendations based on breast cancer risk and (4) a follow-up to obtain the study outcomes.A polygenic risk score (PRS) will be constructed as a composite likelihood ratio of 83 single nucleotide polymorphisms. The Breast Cancer Surveillance Consortium risk model, including age, race/ethnicity, family history of breast cancer, benign breast disease and breast density will be used to estimate a preliminary 5-year absolute risk of breast cancer. A Bayesian approach will be used to update this risk with the PRS value.The primary outcome measures will be attitude towards, intention to participate in and satisfaction with personalised breast cancer screening. Secondary outcomes will include the proportions of women who accept to participate and who complete the different phases of the study. The exact binomial and the Student's t-test will be used to obtain 95% CIs. ETHICS AND DISSEMINATION: The study protocol was approved by the Drug Research Ethics Committee of the University Hospital Arnau de Vilanova. The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki and Good Clinical Practice.The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media. TRIAL REGISTRATION NUMBER: NCT03791008.

Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form in Spanish Subjects.

Diabetic foot ulcer (DFU) is a chronic complication that negatively affects the quality of life (QoL) of diabetic patients. In Spain, there is no specifically designed and validated instrument to assess the QoL of patients with DFU. Our aim was to adapt the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) questionnaire to a Spanish population and validate it. A prospective, observational design was used. The DFS-SF was administered by personal interview. The validated SF-36 and EQ-5D generic instruments were used as reference tools. The reliability, validity, and sensitivity to changes were assessed using standard statistical methods. A sample of 141 patients with DFU was recruited. The content validity was 3.46 on average (maximum score of 4). The internal consistency of the DFS-SF subscales showed a standardized Cronbach's α range between 0.720 and 0.948. The DFS-SF domains showed excellent reproducibility measures (intraclass correlation coefficient from 0.77-0.92). The criterion validity was good with significant correlations between each DFS-SF subscale and its corresponding SF-36 and EQ-5D subscales (p < 0.001). However, the questionnaire structure was not validated (comparative fit index = 0.844, root mean square error of approximation = 0.095, and standardized root mean square residual = 0.093). The instrument showed high sensitivity to ulcer changes over time (p < 0.001). The adapted and validated Spanish version of the DFS-SF questionnaire has good psychometric properties and shows good sensitivity to ulcer changes, although the construct validity was not optimal. The adapted questionnaire will be a useful tool specifically to assess the QoL in subjects with diabetic foot ulcers in the clinical and research settings in Spain.

The Mediterranean Diet is Associated with an Improved Quality of Life in Adults with Type 1 Diabetes.

This study aimed to assess the potential association between dietary patterns (i.e., the Mediterranean Diet (MedDiet) and healthy eating) and patient-reported quality of life (QoL) and treatment satisfaction (TS) in adults with type 1 diabetes (T1D). A food frequency questionnaire, the Audit of Diabetes-Dependent Quality of Life (ADDQoL-19), and the Diabetes Treatment Satisfaction Questionnaire-status version (DTSQ-s) were administered via personal interviews to 258 participants with T1D. Multivariable analysis showed that a moderate or high adherence to the MedDiet was associated with greater diabetes-specific QoL (ß = 0.32, 95% CI = 0.03; 0.61; p = 0.029). None of the dietary quality indexes (i.e., the alternate Mediterranean Diet Score (aMED) and the alternate Healthy Eating Index (aHEI)) were associated with the overall TS. However, the aHEI was positively associated with the specific items of TS "convenience" and "flexibility" (ß = 0.03, 95% CI = 0.00; 0.06; p = 0.042 and ß = 0.04; 95% CI = 0.01; 0.06; p = 0.011, respectively). On the other hand, the aHEI was negatively associated with the dimension "recommend to others" (ß = -0.5, 95% CI = -0.99; -0.02; p = 0.042). In conclusion, a moderate and high adherence to the MedDiet was associated with greater QoL. Although neither aMED nor aHEI were associated with the overall TS, some specific items were positively (i.e., "convenience", "flexibility") or negatively ("recommend to others") related to the aHEI. Further research is needed to assess how to improve medical nutrition therapy and its impact on patient-reported outcomes in people with T1D.

Poorer Quality of Life and Treatment Satisfaction is Associated with Diabetic Retinopathy in Patients with Type 1 Diabetes without Other Advanced Late Complications.

Diabetic retinopathy (DR) may potentially cause vision loss and affect the patient's quality of life (QoL) and treatment satisfaction (TS). Using specific tools, we aimed to assess the impact of DR and clinical factors on the QoL and TS in patients with type 1 diabetes. This was a cross-sectional, two-centre study. A sample of 102 patients with DR and 140 non-DR patients were compared. The Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) and Diabetes Treatment Satisfaction Questionnaire (DTSQ-s) were administered. Data analysis included bivariate and multivariable analysis. Patients with DR showed a poorer perception of present QoL (p = 0.039), work life (p = 0.037), dependence (p = 0.010), and had a lower average weighted impact (AWI) score (p = 0.045). The multivariable analysis showed that DR was associated with a lower present QoL (p = 0.040), work life (p = 0.036) and dependence (p = 0.016). With regards to TS, DR was associated with a higher perceived frequency of hypoglycaemia (p = 0.019). In patients with type 1 diabetes, the presence of DR is associated with a poorer perception of their QoL. With regard to TS, these subjects also show a higher perceived frequency of hypoglycaemia.

Effect of information about the benefits and harms of mammography on women's decision making: The InforMa randomised controlled trial.

BACKGROUND: In Spain, women invited to breast screening are not usually informed about potential harms of screening. The objective of the InforMa study is to assess the effect of receiving information about the benefits and harms of breast screening on informed choice and other decision-making outcomes, in women approaching the age of invitation to mammography screening. METHODS: Two-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public healthcare system were selected and randomised to intervention or control. In the second stage, women aged 49-50 years were randomly selected. The target sample size was 400 women. Women in the intervention arm received a decision aid (DA) with detailed information on the benefits and harms of screening. Women in the control arm received a standard leaflet that did not mention harms and recommended accepting the invitation to participate in the Breast Cancer Screening Program (BCSP). The primary outcome was informed choice, defined as adequate knowledge and intentions consistent with attitudes. Secondary outcomes included decisional conflict, worry about breast cancer, time perspective, opinions about the DA or the leaflet, and participation in the BCSP. RESULTS: In the intervention group, 23.2% of 203 women made an informed choice compared to only 0.5% of 197 women in the control group (p < 0.001). Attitudes and intentions were similar in both study groups with a high frequency of women intending to be screened, 82.8% vs 82.2% (p = 0.893). Decisional conflict was significantly lower in the intervention group. No differences were observed in confidence in the decision, anxiety, and participation in BCSP. CONCLUSIONS: Women in Spain lack knowledge on the benefits and harms of breast screening. Providing quantitative information on benefits and harms has produced a considerable increase in knowledge and informed choice, with a high acceptance of the informative materials. TRIAL REGISTRATION: Trial identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study.

Diagnostic Accuracy of Pleural Fluid Adenosine Deaminase for Diagnosing Tuberculosis. Meta-analysis of Spanish Studies. / Eficacia diagnóstica de la adenosina desaminasa en líquido pleural para diagnosticar tuberculosis. Metaanálisis de estudios españoles.

OBJECTIVE: To evaluate the usefulness of pleural fluid adenosine deaminase (ADA) for diagnosing tuberculous pleural effusions in the Spanish population, according to laboratory technique and cut-off point, and to compare the results with other populations. METHODS: Meta-analysis of diagnostic studies on pleural fluid ADA in the Spanish population, extracted from the PubMed and Embase databases from inception until July 2017, with no language restrictions. The overall diagnostic accuracy of ADA and that of each of the measurement techniques (Giusti, manual and automated kinetic methods) and selected cut-offs were analyzed. The QUADAS-2 tool was used to evaluate the quality of studies. A bivariate random effects model was used. Results were compared with those obtained from previous meta-analyses in non-Spanish populations. RESULTS: Sixteen studies in a total of 4,147 patients, 1,172 of whom had tuberculous pleural effusions, were included. ADA had 93% sensitivity, 92% specificity, positive likelihood ratio of 12, negative likelihood ratio of 0.08, and an area-under-the-curve of 0.968 for identifying tuberculosis. There were no differences in diagnostic accuracy between the techniques used for ADA measurement or the selected cut-offs. In 73 studies from non-Spanish populations a trend toward lower ADA sensitivity (88%, 95% CI:86%-90%) and specificity (88%, 95% CI: 86%-90%) was noted, but differences did not reach statistical significance. CONCLUSIONS: Pleural fluid ADA in the Spanish population shows good diagnostic accuracy (regardless of the measurement technique or cut-off), similar to that reported in non-Spanish populations.

Eficacia diagnóstica de la adenosina desaminasa en líquido pleural para diagnosticar tuberculosis. Metaanálisis de estudios españoles / Diagnostic Accuracy of Pleural Fluid Adenosine Deaminase for Diagnosing Tuberculosis. Meta-analysis of Spanish Studies

Objetivo: Determinar la utilidad de la adenosina desaminasa (ADA) pleural para diagnosticar derrame pleural tuberculoso en población española, según la técnica de medición y punto de corte utilizados, y compararla con la descrita para otras poblaciones. Métodos: Metaanálisis de estudios diagnósticos sobre ADA pleural en población española, extraídos de PubMed y Embase desde sus comienzos hasta julio de 2017, sin restricciones de lenguaje. Se analizó la eficacia diagnóstica global de la ADA, según sus técnicas de medición (Giusti, métodos cinéticos manuales y métodos cinéticos automatizados) y el punto de corte seleccionado. La herramienta QUADAS-2 evaluó la calidad de los estudios. Se utilizó un método bivariante de efectos aleatorios. Se compararon los resultados con los descritos en metaanálisis previos sobre población no española. Resultados: Se incluyeron 16 estudios, con 4.147 pacientes, de los que 1.172 tenían derrame pleural tuberculoso. La ADA tuvo una sensibilidad del 93%, especificidad del 92%, likelihood ratio positiva de 12, likelihood ratio negativa de 0,08, y área bajo la curva de 0,968 para identificar tuberculosis. No hubo diferencias de eficacia diagnóstica entre las técnicas de medición de ADA o el punto de corte escogido. En 73 estudios de población no española se observó una tendencia hacia una menor sensibilidad (88%, IC95%: 86-90%) y especificidad (88%, IC95% 86-90%) de la ADA, pero las diferencias no alcanzaron significación estadística. Conclusiones: La ADA pleural en población española tiene una buena precisión diagnóstica (independientemente de la técnica de medición o punto de corte empleados), similar a la reportada en población no española

Objective: To evaluate the usefulness of pleural fluid adenosine deaminase (ADA) for diagnosing tuberculous pleural effusions in the Spanish population, according to laboratory technique and cut-off point, and to compare the results with other populations. Methods: Meta-analysis of diagnostic studies on pleural fluid ADA in the Spanish population, extracted from the PubMed and Embase databases from inception until July 2017, with no language restrictions. The overall diagnostic accuracy of ADA and that of each of the measurement techniques (Giusti, manual and automated kinetic methods) and selected cut-offs were analyzed. The QUADAS-2 tool was used to evaluate the quality of studies. A bivariate random effects model was used. Results were compared with those obtained from previous meta-analyses in non-Spanish populations. Results: Sixteen studies in a total of 4,147 patients, 1,172 of whom had tuberculous pleural effusions, were included. ADA had 93% sensitivity, 92% specificity, positive likelihood ratio of 12, negative likelihood ratio of 0.08, and an area-under-the-curve of 0.968 for identifying tuberculosis. There were no differences in diagnostic accuracy between the techniques used for ADA measurement or the selected cut-offs. In 73 studies from non-Spanish populations a trend toward lower ADA sensitivity (88%, 95% CI:86%-90%) and specificity (88%, 95% CI: 86%-90%) was noted, but differences did not reach statistical significance. Conclusions: Pleural fluid ADA in the Spanish population shows good diagnostic accuracy (regardless of the measurement technique or cut-off), similar to that reported in non-Spanish populations

Changes in FIT values below the threshold of positivity and short-term risk of advanced colorectal neoplasia: Results from a population-based cancer screening program.

INTRODUCTION: Increased values in the fecal immunochemical test (FIT) are correlated with increasingly severe colorectal neoplasia, but little attention has been given to FIT values below the cut-off point (negative FIT, nFIT). We analysed the relationship between the concentrations of two consecutive nFIT and the risk of following screen-detected advanced neoplasia and interval cancer (IC) in a population-based colorectal cancer screening program. METHODS: FIT results were categorised into non-detectable nFIT (0-3.8 µg haemoglobin/g feces), low nFIT (3.9-9.9) and high nFIT (10.0-19.9). Multivariable adjusted logistic regression was used to estimate the odds ratios (OR) of advanced neoplasia and IC with the nFIT results in the first two screens. RESULTS: More than 90% of the 42,524 persons had non-detectable nFIT in the first and second screen; 4.5% and 5.8% had a low nFIT, respectively, and 2.2% and 2.9% had a high nFIT. The probability of testing positive and being diagnosed of advanced neoplasia or IC rose with increasing values of nFIT. Compared with those with two non-detectable nFIT results, the highest OR were found among those who had two high nFIT results (OR 21.75; 95% confidence interval: 12.44, 38.04) and those with one low nFIT and one high nFIT (ORs around 20). CONCLUSIONS: Participants with nFIT results above the detection limit of the test had an increased risk of advanced neoplasia and IC in subsequent participations. This information could be used in the design of personalised screening strategies.

Rationale and Methodology of the SARAH Trial: Long-Term Cardiovascular Outcomes in Patients With Resistant Hypertension and Obstructive Sleep Apnea / Justificación y metodología del ensayo clínico SARAH: evolución cardiovascular a largo plazo en pacientes con hipertensión resistente y apnea obstructiva del sueño

Introduction: Patients with resistant hypertension (RH) have a high risk of developing cardiovascular events; therefore, new therapeutic approaches to better control blood pressure may be useful in improving cardiovascular outcomes. The prevalence of obstructive sleep apnea (OSA) is very high among patients with RH. Continuous positive airway pressure (CPAP) has been shown to be an effective treatment for reducing blood pressure in patients with RH. Nevertheless, the long-term effect of CPAP treatment on cardiovascular outcomes has not been explored. The main objective of the SARAH study is to assess the impact of OSA and its treatment on cardiovascular outcomes (morbidity and mortality) in patients with RH. Methods: This study is a multi-center, prospective, observational cohort study. A total of 1371 patients with RH will be enrolled in the study and followed once a year for five years. At inclusion, ambulatory blood pressure monitoring (ABPM) and a sleep study will be performed in all subjects. Socio-demographic, clinical and cardiovascular variables will be collected at baseline and follow-up. Subsequently, subjects with OSA will be managed according to local standard practice. Based on the OSA diagnosis and its treatment, three cohorts of subjects with RH will be defined: non-OSA, treated OSA and non-treated OSA. Conclusions: This study will contribute to elucidating the long-term impact of OSA treatments on blood pressure control and cardiovascular outcomes in patients with RH. These results will contribute to improve the cardiovascular prognosis of patients with RH

Introducción: Los pacientes con hipertensión resistente (HR) tienen un elevado riesgo de desarrollar eventos cardiovasculares; así, las nuevas estrategias terapéuticas para el control de la presión arterial podrían ser útiles para mejorar los resultados cardiovasculares. La prevalencia de la apnea obstructiva del sueño (AOS) es muy elevada entre los pacientes con HR. Se ha demostrado que la presión positiva continua en la vía aérea (CPAP) constituye un tratamiento efectivo para reducir la presión arterial en pacientes con HR. Sin embargo, todavía no se han estudiado los efectos a largo plazo del tratamiento con CPAP sobre los resultados cardiovasculares. El principal objetivo del estudio SARAH es evaluar el impacto de la AOS y su tratamiento en los resultados cardiovasculares (morbilidad y mortalidad) en pacientes con HR. Métodos: Este es un estudio observacional prospectivo multicéntrico en el que se incluirán 1.371 pacientes con HR, a los cuales se les realizará seguimiento una vez al año durante 5 años. En el momento de la inclusión se realizará a todos los pacientes monitorización ambulatoria de la presión arterial (MAPA), así como un estudio de sueño. Se recogerán las variables sociodemográficas, clínicas y cardiovasculares tanto al inicio del estudio como durante el seguimiento. Posteriormente, los individuos con AOS serán tratados de acuerdo con la práctica clínica estándar de cada centro. Se definirán 3 grupos en función del diagnóstico de AOS y su tratamiento: sin AOS, con AOS en tratamiento, con AOS sin tratar. Conclusiones: Este estudio contribuirá a averiguar el impacto a largo plazo del tratamiento de la AOS en el control de la presión arterial y los resultados cardiovasculares en pacientes con HR. Asimismo, estos resultados contribuirán a mejorar el pronóstico cardiovascular de los pacientes con HR

Correction: The modality of dialysis does not influence atheromatous vascular disease progression or cardiovascular outcomes in dialysis patients without previous cardiovascular disease.

[This corrects the article DOI: 10.1371/journal.pone.0186921.].