[Impact of the COVID-19 pandemic on patient safety incident and medication error reporting systems]. / Impacto de la pandemia COVID-19 en los sistemas de notificación de incidentes de seguridad del paciente y errores de medicación.

BACKGROUND AND AIM: To determine the impact of the COVID-19 pandemic on the epidemiology of safety incidents (SI) and medication errors (ME) reported to the CISEMadrid notification system in the hospital and primary care settings of the Madrid Health Service (SERMAS). MATERIALS AND METHODS: Observational and descriptive study with a retrospective analysis of data including all CISEMadrid notifications from 01-Jan-2018 to 31-Dec-2020, from 33 hospitals and 262 health care centres of the SERMAS. The two periods in 2020 with the greatest increase in COVID-19 cases were identified to compare incidents reported in the pre-pandemic and pandemic periods. RESULTS: 36,494 incidents were reported. Comparing both periods, an overall decrease in pandemic notifications of 60.7% was observed, being higher in primary care, falling to 33% of previous levels. The reduction in notifications was similar in the peaks and valleys of the waves. The three most frequent SIs in both periods and care settings were: diagnostic tests, medical devices/equipment/clinical furniture and organisational management/citations. In ME, dose failure and inappropriate selection were the most frequent in both settings and periods. There were no relevant differences in patient consequences in both periods. CONCLUSIONS: During the pandemic, patient safety notifications decreased although the most frequent types remained the same, as did their impact on the patient, both in hospitals and in primary care. The safety culture of organisations is a critical aspect for the maintenance of reporting systems.

[EFQM Model in the hospitals of Madrid Regional Health Service: full self-assessment cycle]. / Modelo EFQM en los hospitales del Servicio Madrileño de Salud: ciclo completo de autoevaluación.

AIM: To analyse a complete cycle of self-assessment using the European Foundation for Quality Management (EFQM) Model in the hospitals of the Madrid Health Service as regards the fundamental concepts of excellence (FCE). METHOD: Descriptive study of the EFQM self-assessments of the entire public hospital sector identifying the methodology and the information on strengths, weaknesses, evidence, RADAR matrix (Results, Approach, Deployment, Assessment and Review), and the related FCEs in the enabling criteria and in the prioritised action plans. RESULTS: The self-assessment was carried out in 85% of the hospitals (29/34), 86% of them required specific training (25/29), with a total of 329 teaching hours and 833 people in training. Multidisciplinary working groups were required in 83% of the hospitals (24/29), with 123 groups and 857 people involved. There were 3,686 strengths and 3,197 weaknesses identified: strengths and weaknesses were 78% (2,869) and 74% (2,355), respectively, for the enabling criteria and 22% (817) and 26% (842), respectively, for the results criteria. The mean score was 404 points with a median of 399. The main FCEs were managing with agility, developing organisational capability, sustaining outstanding results, creating a sustainable future, succeeding through the talent of people, and adding value for customers, with harnessing creativity/innovation and leading with vision, inspiration and integrity being placed in lower positions. A total of 113 action plans were identified for all the hospitals. CONCLUSION: A complete EFQM self-assessment cycle of the entire public hospital sector of a Regional Health Service is provided, linking the analysis and action plans with the FCE of the EFQM Model.

Assessing the competences associated with a nursing Bachelor thesis by means of rubrics.

BACKGROUND: Writing a Bachelor thesis is the last step in obtaining a university degree. The thesis may be job- or research-orientated, but it must demonstrate certain degree-level competences. Rubrics are a useful way of unifying the assessment criteria. OBJECTIVES: To design a system of rubrics for assessing the competences associated with the Bachelor thesis of a nursing degree, to examine the system's reliability and validity and to analyse results in relation to the final thesis mark. DESIGN: Cross-sectional and psychometric study conducted between 2012 and 2014. SETTINGS: Nursing degree at a Spanish university. PARTICIPANTS: Twelve tutors who designed the system of rubrics. Students (n = 76) who wrote their Bachelor thesis during the 2013-2014 academic year. METHODS: After deciding which aspects would be assessed, who would assess them and when, the tutors developed seven rubrics (drafting process, assessment of the written thesis by the supervisor and by a panel, student self-assessment, peer assessment, tutor evaluation of the peer assessment and panel assessment of the viva). We analysed the reliability (inter-rater and internal consistency) and validity (convergent and discriminant) of the rubrics, and also the relationship between the competences assessed and the final thesis mark. RESULTS: All the rubrics had internal consistency coefficients >0.80. The rubric for oral communication skills (viva) yielded inter-rater reliability of 0.95. Factor analysis indicated a unidimensional structure for all but one of the rubrics, the exception being the rubric for peer assessment, which had a two-factor structure. The main competences associated with a good quality Bachelor thesis were written communication skills and the ability to work independently. CONCLUSION: The assessment system based on seven rubrics is shown to be valid and reliable. Writing a Bachelor thesis requires a range of degree-level competences and it offers nursing students the opportunity to develop their evidence-based practice skills.

Integrating genomic alterations in diffuse large B-cell lymphoma identifies new relevant pathways and potential therapeutic targets.

Genome studies of diffuse large B-cell lymphoma (DLBCL) have revealed a large number of somatic mutations and structural alterations. However, the clinical significance of these alterations is still not well defined. In this study, we have integrated the analysis of targeted next-generation sequencing of 106 genes and genomic copy number alterations (CNA) in 150 DLBCL. The clinically significant findings were validated in an independent cohort of 111 patients. Germinal center B-cell and activated B-cell DLBCL had a differential profile of mutations, altered pathogenic pathways and CNA. Mutations in genes of the NOTCH pathway and tumor suppressor genes (TP53/CDKN2A), but not individual genes, conferred an unfavorable prognosis, confirmed in the independent validation cohort. A gene expression profiling analysis showed that tumors with NOTCH pathway mutations had a significant modulation of downstream target genes, emphasizing the relevance of this pathway in DLBCL. An in silico drug discovery analysis recognized 69 (46%) cases carrying at least one genomic alteration considered a potential target of drug response according to early clinical trials or preclinical assays in DLBCL or other lymphomas. In conclusion, this study identifies relevant pathways and mutated genes in DLBCL and recognizes potential targets for new intervention strategies.

Comparative analysis between 2 periods of acute myocardial infarction after a decade in Mallorca. IBERIA Study (996-1998) and Infarction-Code (2008-2010). / Análisis comparativo de 2 registros de infarto agudo de miocardio tras una década de cambios. Estudio IBERICA (1996-1998) y Código Infarto-Illes Balears (2008-2010).

OBJECTIVE: To investigate the differences in mortality at 28 days and other prognostic variables in 2 periods: IBERICA-Mallorca (1996-1998) and Infarction Code of the Balearic Islands (IC-IB) (2008-2010). DESIGN: Two observational prospective cohorts. SETTING: Hospital Universitario Son Dureta, 1996-1998 and 2008-2010. PATIENTS: Acute coronary syndrome with ST elevation of≤24h of anterior and inferior site. MAIN VARIABLES OF INTEREST: Age, sex, cardiovascular risk factors, site of AMI, time delays, reperfusion therapy with fibrinolysis and primary angioplasty, administration of acetylsalicylic acid, beta blockers and angiotensin converting enzyme inhibitors. Killip class, malignant arrhythmias, mechanical complications and death at 28 days were included. RESULTS: Four hundred and forty-two of the 889 patients included in the IBERICA-Mallorca and 498 of 847 in the IC-IB were analyzed. The site and Killip class on admission were similar in both cohorts. The main significant difference between IBERICA and IC-IB group were age (64 vs. 58 years), prior myocardial infarction (17.9 vs. 8.1%), the median symtoms to first ECG time (120 vs. 90min), median first ECG to fibrinolysis time (60 vs. 35min), fibrinolytic therapy (54.8 vs. 18.7%), patients without revascularization treatment (45.9 vs. 9.2%), primary angioplasty (1.0% vs. 92.0%). The mortality at 28 days was lower in the IC-IB (12.2 vs. 7.2%; hazard ratio 0.560; 95% CI 0.360-0.872; P=.010). CONCLUSION: The 28-day mortality in acute coronary syndrome with ST elevation in Mallorca has declined in the last decade, basically due to increased reperfusion therapy with primary angioplasty and reducing delays time to reperfusion.

Bioassessment of trace element contamination of Mediterranean coastal waters using the seagrass Posidonia oceanica.

A large scale survey of the trace element (TE) contamination of Mediterranean coastal waters was performed from the analysis of Ag, As, Cd, Cu, Hg, Ni and Pb in the bioindicator Posidonia oceanica, sampled at 110 sites differing by their levels of exposure to contaminants. The holistic approach developed in this study, based on the combined utilization of several complementary monitoring tools, i.e. water quality scale, pollution index and spatial analysis, accurately assessed the TE contamination rate of Mediterranean coastal waters. In particular, the mapping of the TE contamination according to a new proposed 5-level water quality scale precisely outlined the contamination severity along Mediterranean coasts and facilitated interregional comparisons. Finally, the reliability of the use of P. oceanica as bioindicator species was again demonstrated through several global, regional and local detailed case studies. NB: The designations employed and the presentation of the information in this document do not imply the expression of any opinion whatsoever on the part of the authors concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

A B-cell epigenetic signature defines three biologic subgroups of chronic lymphocytic leukemia with clinical impact.

Prospective identification of patients with chronic lymphocytic leukemia (CLL) destined to progress would greatly facilitate their clinical management. Recently, whole-genome DNA methylation analyses identified three clinicobiologic CLL subgroups with an epigenetic signature related to different normal B-cell counterparts. Here, we developed a clinically applicable method to identify these subgroups and to study their clinical relevance. Using a support vector machine approach, we built a prediction model using five epigenetic biomarkers that was able to classify CLL patients accurately into the three subgroups, namely naive B-cell-like, intermediate and memory B-cell-like CLL. DNA methylation was quantified by highly reproducible bisulfite pyrosequencing assays in two independent CLL series. In the initial series (n=211), the three subgroups showed differential levels of IGHV (immunoglobulin heavy-chain locus) mutation (P<0.001) and VH usage (P<0.03), as well as different clinical features and outcome in terms of time to first treatment (TTT) and overall survival (P<0.001). A multivariate Cox model showed that epigenetic classification was the strongest predictor of TTT (P<0.001) along with Binet stage (P<0.001). These findings were corroborated in a validation series (n=97). In this study, we developed a simple and robust method using epigenetic biomarkers to categorize CLLs into three subgroups with different clinicobiologic features and outcome.

Multiorgan failure in the serious trauma patient.

Multiorgan failure remains one of the leading causes of late morbidity and mortality after severe trauma. In the early phase, it is related with an uncontrolled hyper-inflammation state, whereas in the late phase (>72 h), septic complications play a major role. We review the underlying pathophysiology, the evaluation with different scales and the clinical factors associated with multiorgan failure, as well as potential treatment options.

Variability in glutenin subunit composition of Mediterranean durum wheat germplasm and its relationship with gluten strength.

The allelic composition at five glutenin loci was assessed by one-dimensional sodium dodecyl sulphate polyacrylamide gel electrophoresis (1D SDS-PAGE) on a set of 155 landraces (from 21 Mediterranean countries) and 18 representative modern varieties. Gluten strength was determined by SDS-sedimentation on samples grown under rainfed conditions during 3 years in north-eastern Spain. One hundred and fourteen alleles/banding patterns were identified (25 at Glu-1 and 89 at Glu-2/Glu-3 loci); 0·85 of them were in landraces at very low frequency and 0·72 were unreported. Genetic diversity index was 0·71 for landraces and 0·38 for modern varieties. All modern varieties exhibited medium to strong gluten type with none of their 13 banding patterns having a significant effect on gluten-strength type. Ten banding patterns significantly affected gluten strength in landraces. Alleles Glu-B1e (band 20), Glu-A3a (band 6), Glu-A3d (bands 6 + 11), Glu-B3a (bands 2 + 4+15 + 19) and Glu-B2a (band 12) significantly increased the SDS-value, and their effects were associated with their frequency. Two alleles, Glu-A3b (band 5) and Glu-B2b (null), significantly reduced gluten strength, but only the effect of the latter locus could be associated with its frequency. Only three rare banding patterns affected gluten strength significantly: Glu-B1a (band 7), found in six landraces, had a negative effect, whereas banding patterns 2 + 4+14 + 15 + 18 and 2 + 4+15 + 18 + 19 at Glu-B3 had a positive effect. Landraces with outstanding gluten strength were more frequent in eastern than in western Mediterranean countries. The geographical pattern displayed from the frequencies of Glu-A1c is discussed.

[Barriers and challenges of the functional healthcare risk management units in hospitals of Madrid health service]. / Barreras y retos de las unidades funcionales de gestión de riesgos sanitarios en los hospitales del Servicio Madrileño de Salud.

OBJECTIVE: To identify the barriers and challenges for the effective development of risk management units in hospitals of the Madrid Health Service. MATERIAL AND METHODS: Descriptive cross-sectional study aimed at the management teams and members of the functional units of 31 hospitals in the Madrid Health Service. A self-administered questionnaire requesting answers in free text was used, identifying up to five barriers and challenges, and their prioritization by awarding from 1-5 points according to their importance. A discourse analysis was then conducted, grouping common themes and sorting them according to their score. RESULTS: The overall response rate was 94%. The most frequently identified barriers were lack of time (21%), inadequate safety culture (13%), lack of publication of their activities (10%), and lack of training (10%). The most important challenge was developing the training (18%), followed by improving the culture (17%), communication of safety activities (11%), and achieve leadership from the managers of the services (11%). CONCLUSIONS: According to the study conditions, the main identified barrier identified was the lack of available time, and the principal challenge found was promoting a proactive learning culture.

Genetic improvement of bread wheat yield and associated traits in Spain during the 20th century.

A collection of 26 wheat genotypes widely grown in Spain during the 20th century was evaluated in eight contrasting environments in order to quantify breeding achievements in yield and associated traits. From 1930 to 2000, yield increased at a rate of 35·1 kg/ha/yr or 0·88%/yr, but estimations of relative genetic gain (RGG) were environment-dependent. RGG estimated for yield were positively associated with the average minimum daily temperatures from sowing to heading in the testing environments (R(2) = 0·81; P < 0·01). The number of grains/spike and the number of spikes/m(2) increased at a rate of 0·60%/yr and 0·30%/yr, respectively, while grain weight remained unchanged. The present study detected two main episodes of yield improvement during the century. The first one coincided with the introduction, during the 1950s, of the first improved cultivars derived from intra-specific crosses, which increased the yield of landraces by 30% due to an increase of c. 58% in the number of grains/spike, accompanied by a 16% reduction in grain weight. These initial cultivars (termed 'old-bred' in a previous study by Sanchez-Garcia et al. 2012) exhibited a higher harvest index (HI), increased from 0·25 to 0·40, but maintained the same aboveground biomass at maturity as the landraces (despite reducing both plant height and the number of tillers/plant) due to increases in the proportion of tillers bearing spikes. The second yield gain occurred after the introduction, in the early 1970s, of semi-dwarf germplasm from CIMMYT (International Maize and Wheat Improvement Centre) and some French cultivars. This new germplasm further reduced plant height, improved HI up to 0·45 and increased the number of tillers/plant while maintaining their rate of fertility, thus resulting in a yield gain of c. 37%. The cultivars released during the last decade of the century did not contribute to significant yield improvements.

[Assessment of patient safety reporting system in Madrid health services (primary care and hospitals)]. / Evaluación del sistema de información de seguridad del paciente de los centros sanitarios del Servicio Madrileño de Salud (Atención Primaria y Hospitales).

OBJECTIVES: Improve the patient safety reporting system of the Functional Units of Health Risk Management (UFGRS) in Madrid health services, analysing the opinion of the UFGRS about its content, completion and usefulness, detecting the difficulties and identifying the areas for improvement. METHOD: A descriptive study was conducted using a questionnaire addressed to the 45 UFGRS of the Madrid Health Services. RESULTS: The questionnaire, with a scale of 1 to 5, received responses with an average higher than 3.70: contents (3.77); how to complete the form (3.72); clarity of data shown in the report (3.94) and the overall usefulness of the information (3.77). The most significant difficulties found were related to the excess and reiteration of the information requested. As regards areas for improvement, the most notable was the demand for more refining and analysis of the information about safe practices, the execution of two types of format for reporting results in order to facilitate dissemination among the centres and the review of the classification of safety incidents. Knowing the opinion of the Functional Units of the information system may improve the usefulness of the report as far as accessibility, presentation and exchange of information on patient safety is concerned.

A single primer pair gives a specific ortholog amplicon in a wide range of Cyanobacteria and plastid-bearing organisms: applicability in inventory of reference material from collections and phylogenetic analysis.

The scarcity of universally applied molecular markers for algae has resulted in the development of multiple, independent and not easily comparable systems. The goal of this work is to increase the number of available molecular markers and to generate easily comparable systems. Thereby, we have designed a primer pair capable of amplifying a broad range of organisms: Cyanobacteria, Chlorophyta, Chlorarachniophyta, Cryptophyta, Euglenida, Glaucophyta, Rhodophyta, Stramenopiles and Streptophyta including plants. This primer pair can amplify a portion of the 23S rRNA gene with sufficient variability to identify reference material form collections across a broad range of taxa and perform phylogenetic studies alongside other available markers.

[Use of the EFQM red threads in the health public health system]. / Utilización de los ejes transversales del modelo EFQM en el ámbito sanitario público.

OBJECTIVE: To analyse the use of transversal axes (TA) of the EFQM Model in the self- assessment of the service organisations in an Autonomous Community and to describe the self assessment results for the health care system (HCS) as a whole. MATERIAL AND METHODS: Descriptive study divided in two phases: 1) evaluation of the use of the EFQM model in the HCS, and 2) analysis of the methodology using TA. All (37) of the self-assessment reports corresponding to Primary Care and Hospitals in 2007 were analysed. A quantitative analysis was performed on the strengths (S) and areas of improvement (AI) identified, stratifying them according to level of care, centre and EFQM criteria and TA. RESULTS: The use of the EFQM in the HCS reaches 84% of the organizations (32/37), and 94% deploy improvement plans (30/32). A total of 3543 S and 3573 AI were described for the HCS as a whole. From the total identified S, enablers reach 67.66%. Results according to TA the organization management axes are the dominant ones: people, clients, process and communication. Application difficulties derive from the organizations' leadership in quality management, the training strategies for deployment, the innovation character of the model in certain settings and the potential workload generated. CONCLUSIONS: TA are perceived as a feasible work method to gather and synthesize AI. However it requires appropriate training to optimize its use.

[Hemodynamic variability caused by pressure-volume plotting and alveolar recruitment maneuvers in patients with adult respiratory distress syndrome]. / Variaciones hemodinámicas inducidas por la realización de una curva presión-volumen y una maniobra de reclutamiento alveolar en pacientes con síndrome de distrés respiratorio agudo.

OBJECTIVES: The plotting of pressure-volume curves and the performance of alveolar recruitment maneuvers are common practices in the care of patients with adult respiratory distress syndrome (ARDS), even though potentially harmful hemodynamic effects are associated with sustaining a high intrathoracic pressure. Our aim was to analyze hemodynamic and ventilatory changes related to these 2 maneuvers and to assess the short-term effectiveness of recruitment. PATIENTS AND METHODS: The patients had ARDS and were being monitored with a catheter connected to a PiCCO system. All measurements were taken in sinus rhythm and with adequate vascular filling. Values recorded during plotting of the quasistatic pressure-volume curve and the recruitment maneuver (sustained airway pressure of 40 cm H2O) were the cardiac index, mean arterial pressure, heart rate, systolic volume index, and oxygen saturation (SpO2). Blood gas measurements were recorded before the maneuvers and 15 minutes afterwards. RESULTS: All parameters decreased significantly in the 14 patients studied. The mean (SD) maximum decreases, from which all patients recovered within 2 minutes, were as follows: cardiac index, 26% (16%); mean arterial pressure, 6% (6%); heart rate, 4% (5%), systolic volume index, 21% (15%); and SpO2, 3% (3%). Significant increases in PaO2 (7% [6%]) and the ratio of PaO2 to the fraction of inspired oxygen were recorded after the recruitment maneuver (P=.016 and P=.014, respectively), but the changes were not clinically significant. CONCLUSIONS: The hemodynamic disturbances associated with the alveolar recruitment maneuver based on sustaining a high end-expiratory pressure and the minor improvement in oxygenation achieved as a result suggest that the routine use of that maneuver in ARDS patients is of questionable value.

Monitoring sedation in critically ill patients: bispectral index, Ramsay and observer scales.

BACKGROUND AND OBJECTIVE: Sedation is commonly required by critically ill patients and inadequate sedation may be hazardous. Traditionally, subjective scales have been used for monitoring sedation. Bispectral index has been proposed, although its utility in the intensive care unit is debated. Our aim was to evaluate the depth of sedation in intubated surgical critically ill patients by means of two sedation scales (Ramsay and Observer's Assessment of Alertness and Sedation) and bispectral index. METHODS: Sedation was assessed prospectively in 50 postoperative intubated patients requiring at least 24 h of sedation (35 propofol, 15 midazolam/fentanyl), every 8 h for a 24 -h period. The bispectral index value recorded was the mean value obtained during a 10-min observation period, whenever the quality signal index was above 75% and the electromyographic signal was below 25%. RESULTS: Most of the patients (78%) were oversedated (bispectral index < 60). The three sedation scores (global data) correlated significantly (P < 0.001). This correlation was lost in the midazolam group in which the patients were also significantly more sedated than the propofol group (P = 0.001). The correlation between the bispectral index and the scales in the midazolam group reappeared when the measurements with a Ramsay = 6 or an Observer's Assessment of Alertness and Sedation = 1 were excluded. CONCLUSIONS: Sedation should be monitored routinely in intensive care units. The Ramsay and the Observer's Assessment of Alertness and Sedation scales showed equal efficacy. Bispectral index might prove useful for discriminating between deeper levels of sedation.

Development of a citrus genome-wide EST collection and cDNA microarray as resources for genomic studies.

A functional genomics project has been initiated to approach the molecular characterization of the main biological and agronomical traits of citrus. As a key part of this project, a citrus EST collection has been generated from 25 cDNA libraries covering different tissues, developmental stages and stress conditions. The collection includes a total of 22,635 high-quality ESTs, grouped in 11,836 putative unigenes, which represent at least one third of the estimated number of genes in the citrus genome. Functional annotation of unigenes which have Arabidopsis orthologues (68% of all unigenes) revealed gene representation in every major functional category, suggesting that a genome-wide EST collection was obtained. A Citrus clementina Hort. ex Tan. cv. Clemenules genomic library, that will contribute to further characterization of relevant genes, has also been constructed. To initiate the analysis of citrus transcriptome, we have developed a cDNA microarray containing 12,672 probes corresponding to 6875 putative unigenes of the collection. Technical characterization of the microarray showed high intra- and inter-array reproducibility, as well as a good range of sensitivity. We have also validated gene expression data achieved with this microarray through an independent technique such as RNA gel blot analysis.

Pressure-volume curve variations after a recruitment manoeuvre in acute lung injury/ARDS patients: implications for the understanding of the inflection points of the curve.

BACKGROUND AND OBJECTIVE: Although the pressure-volume (P-V) curve has been proposed in the management of mechanically ventilated patients, its interpretation remains unclear. Our aim has been to study the variations of the P-V curve after a recruitment manoeuvre (RM). Our hypothesis was that the lower inflection point (LIP) represents the presence of compressive atelectases, so it should not change after lung recruitment, while the upper inflection point (UIP) reflects reabsorptive atelectases, and an effective recruitment should result in changes at this level. METHODS: Two P-V curves (quasi-static method) separated by an RM (40 cmH2O, two consecutive manoeuvres) were plotted in 35 postoperative patients with criteria of acute lung injury/acute respiratory distress syndrome (ARDS). LIP, UIP and expiratory inflection point (EIP) were defined as the first point where the curve consistently starts to separate from the line. RESULTS: One to six measurements were obtained per patient (73 procedures). Neither the lower nor the EIPs varied significantly after the RM (P = 0.11 and 0.35, respectively). An UIP was observed in 18 curves (25%) before the RM and disappeared on nine occasions after the recruitment. Similar results were obtained when first measurements only were analysed, and when the cause (pulmonary vs. extrapulmonary), severity of lung injury or duration of mechanical ventilation at first measurement were studied. CONCLUSIONS: An RM does not modify the LIP significantly, but induces the disappearance of the UIP in 50% of the cases in which this point is found.