Publications by authors named "Rosa Lillo"

27 Publications

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Estimating the COVID-19 Prevalence in Spain With Indirect Reporting via Open Surveys.

Front Public Health 2021 9;9:658544. Epub 2021 Apr 9.

IMDEA Networks Institute, Madrid, Spain.

During the initial phases of the COVID-19 pandemic, accurate tracking has proven unfeasible. Initial estimation methods pointed toward case numbers that were much higher than officially reported. In the CoronaSurveys project, we have been addressing this issue using open online surveys with indirect reporting. We compare our estimates with the results of a serology study for Spain, obtaining high correlations (R squared 0.89). In our view, these results strongly support the idea of using open surveys with indirect reporting as a method to broadly sense the progress of a pandemic.
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http://dx.doi.org/10.3389/fpubh.2021.658544DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8062708PMC
April 2021

Telemedicine for adult congenital heart disease patients during the first wave of COVID-19 era: a single center experience.

J Cardiovasc Med (Hagerstown) 2021 Apr 20. Epub 2021 Apr 20.

Dipartimento di Scienze Cardiovascolari e Toraciche, Fondazione Policlinico Universitario A. Gemelli IRCCS Catholic University of the Sacred Heart Department of Pediatric Cardiology and Cardiac Surgery - Bambino Gesù Hospital, Rome, Italy.

Aim: To summarize our experience on the implementation of a telemedicine service dedicated to adult congenital heart disease (ACHD) patients during the lockdown for the first wave of COVID-19.

Methods: This is a prospective study enrolling all ACHD patients who answered a questionnaire dedicated telematic cardiovascular examination.

Results: A total of 289 patients were enrolled, 133 (47%) were male, 25 (9%) were affected by a genetic syndrome. The median age was 38 (29-51) years, whereas the median time interval between the last visit and the telematic follow-up was 9.5 (7.5-11.5) months. Overall, 35 patients (12%) reported a worsening of fatigue in daily life activity, 17 (6%) experienced chest pain, 42 (15%) had presyncope and 2 (1%) syncope; in addition, 28 patients (10%) presented peripheral edema and 14 (5%) were orthopneic. A total of 116 (40%) patients reported palpitations and 12 had at least one episode of atrial fibrillation and underwent successful electrical (8) or pharmacological (4) cardioversion. One patient was admitted to the emergency department for uncontrolled arterial hypertension, five for chest pain, and one for heart failure. Two patients presented fever but both had negative COVID-19 nasal swab.

Conclusion: During the COVID-19 pandemic, the use of telemedicine dramatically increased and here we report a positive experience in ACHD patients. The postpandemic role of telemedicine will depend on permanent regulatory solutions and this early study might encourage a more systematic telematic approach for ACHD patients.
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http://dx.doi.org/10.2459/JCM.0000000000001195DOI Listing
April 2021

Right ventricular strain in Anderson-Fabry disease.

Int J Cardiol 2021 May 15;330:84-90. Epub 2021 Feb 15.

Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Catholic University of the Sacred Heart, Rome, Italy.

Background: 2D speckle tracking echocardiography (2DSTE) is superior to standard echocardiography in the assessment of subtle right ventricle (RV) systolic dysfunction. In this study we aimed to: 1) test the hypothesis that 2DSTE may unveil subtle RV systolic dysfunction in patients with Fabry disease; 2) investigate whether the physiologic difference between the 3-segment (RV-FWS) and the 6-segment (RV-GLS) RV strain (∆RV strain) is preserved in Fabry patients.

Methods And Results: Standard echocardiography and 2DSTE were performed in 49 Fabry patients and 49 age- and sex-matched healthy controls. Fabry patients were divided in two groups according to the presence/absence of left ventricular hypertrophy (LVH+: left ventricular wall thickness > 12 mm, 49% of total Fabry patients). RV systolic function assessed by standard echocardiography was normal in the majority of Fabry patients (92%) while RV-GLS and RV-FWS were impaired in about 40%. RV-GLS and RV-FWS were significantly worse in patients LVH+ vs LVH- and vs controls (RV-GLS: LVH+ vs LVH-: -18.4 ± -4.3% vs -23.8 ± -3.1% p<0.001; LVH+ vs controls: -18.4 ± -4.3% vs -23.9 ± -2.8% p<0.001; RV-FWS: LVH+ vs LVH-: -21.8 ± -5.3% vs -26.7 ± -3.8% p = 0.002, LVH+ vs controls -21.8 ± -5.3% vs -26.8 ± -3.9% p<0.001). No difference was found between LVH- patients and controls in both RV-GLS (p = 0.65) and RV-FWS (p = 0.79). ∆RV strain was similar among the groups.

Conclusions: In Fabry cardiomyopathy impaired RV-GLS and RV-FWS is a common finding, while RV strain is preserved in Fabry patients without overt cardiac involvement. The physiologic difference between RV-FWS and RV-GLS is maintained in Fabry patients, regardless of the presence of cardiomyopathy.
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http://dx.doi.org/10.1016/j.ijcard.2021.02.038DOI Listing
May 2021

Standard ECG for differential diagnosis between Anderson-Fabry disease and hypertrophic cardiomyopathy.

Heart 2021 Feb 9. Epub 2021 Feb 9.

Cardiology Unit, IRCCS, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola Hospital, University of Bologna, Bologna, Emilia-Romagna, Italy

Objectives: To evaluate the role of the ECG in the differential diagnosis between Anderson-Fabry disease (AFD) and hypertrophic cardiomyopathy (HCM).

Methods: In this multicentre retrospective study, 111 AFD patients with left ventricular hypertrophy were compared with 111 patients with HCM, matched for sex, age and maximal wall thickness by propensity score. Independent ECG predictors of AFD were identified by multivariate analysis, and a multiparametric ECG score-based algorithm for differential diagnosis was developed.

Results: Short PR interval, prolonged QRS duration, right bundle branch block (RBBB), R in augmented vector left (aVL) ≥1.1 mV and inferior ST depression independently predicted AFD diagnosis. A point-by-point ECG score was then derived with the following diagnostic performances: c-statistic 0.80 (95% CI 0.74 to 0.86) for discrimination, the Hosmel-Lemeshow χ 6.14 (p=0.189) for calibration, sensitivity 69%, specificity 84%, positive predictive value 82% and negative predictive value 72%. After bootstrap resampling, the mean optimism was 0.025, and the internal validated c-statistic for the score was 0.78.

Conclusions: Standard ECG can help to differentiate AFD from HCM while investigating unexplained left ventricular hypertrophy. Short PR interval, prolonged QRS duration, RBBB, R in aVL ≥1.1 mV and inferior ST depression independently predicted AFD. Their systematic evaluation and the integration in a multiparametric ECG score can support AFD diagnosis.
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http://dx.doi.org/10.1136/heartjnl-2020-318271DOI Listing
February 2021

Cardiac Output Measurement With Echocardiography and Pressure Recording Analytical Method in Pediatric Patients Admitted to the Cardiac Intensive Care Unit: A Retrospective Assessment of Bias Between the Two Methods.

J Cardiothorac Vasc Anesth 2021 May 2;35(5):1351-1357. Epub 2020 Dec 2.

Pediatric Cardiology, Department of Cardiology and Cardiac Surgery, Bambino Gesù Children's Hospital, Rome, Italy.

Objectives: This study aimed to compare, in a cohort of critically ill children with biventricular anatomy and no cardiovascular shunt, cardiac output (CO) and cardiac index (CI) assessed by echocardiography and a continuous pulse-contour method, MostCare, to measure the differences between these techniques (biasCO and biasCI), and their association with clinical variables.

Design: Retrospective study.

Setting: Tertiary pediatric cardiac intensive care unit.

Participants: Children admitted to the pediatric cardiac intensive care unit who underwent echocardiography with CO measurement.

Interventions: None.

Measurements And Main Results: Thirty-five patients were included. BiasCO was -0.02 (0.26) L/min (percentage error 36%). BiasCI was 0.07 (0.34) L/min/m (percentage error 18%). Biases and percentage errors were higher in 24 nonsupervised echocardiographies. A negative biasCO (overestimation by MostCare) was associated with post-surgical status (v cardiomyopathy), higher systolic arterial pressure, and spontaneous breathing (v intubation). When only absolute values were considered, biasCO correlated with age, weight, arterial pressure, and heart rate, whereas biasCI was associated with a femoral arterial cannula, no use of inotropes, and the absence of mechanical ventilation. After adjustment, biasCO remained independently associated with patients' body weight(p = 0.0001). BiasCI showed a nonlinear relationship with weight below 20 kg and above 40 kg.

Conclusions: Children with extreme low or high weights, those who are extubated, and those with a femoral cannula carry the highest bias. When younger patients are considered, CI should be evaluated instead of CO, because biases are better highlighted by indexing data on body surface area. In children, both echocardiography and MostCare may be responsible of inaccurate CO/CI assessment.
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http://dx.doi.org/10.1053/j.jvca.2020.11.065DOI Listing
May 2021

Evidence of evolution towards left midventricular obstruction in severe Anderson-Fabry cardiomyopathy.

ESC Heart Fail 2021 Feb 19;8(1):725-728. Epub 2020 Nov 19.

Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.

Aims: In Fabry cardiomyopathy, left ventricular outflow tract obstruction mimicking hypertrophic cardiomyopathy is a very rare finding, with few cases reported and successfully treated with cardiac surgery. In our population of patients with Fabry disease and severe left ventricular hypertrophy (LVH) at the time of diagnosis, we observed an evolution towards a midventricular obstructive phenotype.

Methods And Results: We present a case series of three classically affected Fabry male patients with significant diagnostic delay and severe cardiac involvement (maximal wall thickness >20 mm) at first evaluation. All patients developed midventricular obstructive form over time despite prompt initiation and optimal compliance to enzyme replacement therapy. The extension and distribution of the LVH, involving the papillary muscles, was the main mechanism of obstruction, unlike the asymmetric septal basal hypertrophy and the mitral valve abnormalities commonly seen as substrate of left ventricular outflow tract obstruction in hypertrophic cardiomyopathy.

Conclusions: Fabry cardiomyopathy can evolve over time towards a midventricular obstructive form due to massive LVH in classically affected men with significant diagnostic delay and severe LVH before enzyme replacement therapy initiation. This newly described cardiac phenotype could represent an adverse outcome of the disease.
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http://dx.doi.org/10.1002/ehf2.13101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835588PMC
February 2021

Successful Transcatheter Treatment of Left Pulmonary Artery to Left Atrium Communication Diagnosed in Adulthood.

Circ Cardiovasc Imaging 2020 11 6;13(11):e010668. Epub 2020 Nov 6.

Department of Cardiovascular and Thoracic Sciences (R.L., F.G., F.B., G.L., C.A., E.R., M.G., E.P., R.S., F.I., M.M., C.T.) Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

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http://dx.doi.org/10.1161/CIRCIMAGING.120.010668DOI Listing
November 2020

Variable selection with P-splines in functional linear regression: Application in graft-versus-host disease.

Biom J 2020 11 10;62(7):1670-1686. Epub 2020 Jun 10.

Department of Statistics, Universidad Carlos III de Madrid, Madrid, Spain.

This paper focuses on the problems of estimation and variable selection in the functional linear regression model (FLM) with functional response and scalar covariates. To this end, two different types of regularization (L and L ) are considered in this paper. On the one hand, a sample approach for functional LASSO in terms of basis representation of the sample values of the response variable is proposed. On the other hand, we propose a penalized version of the FLM by introducing a P-spline penalty in the least squares fitting criterion. But our aim is to propose P-splines as a powerful tool simultaneously for variable selection and functional parameters estimation. In that sense, the importance of smoothing the response variable before fitting the model is also studied. In summary, penalized (L and L ) and nonpenalized regression are combined with a presmoothing of the response variable sample curves, based on regression splines or P-splines, providing a total of six approaches to be compared in two simulation schemes. Finally, the most competitive approach is applied to a real data set based on the graft-versus-host disease, which is one of the most frequent complications (30% -50%) in allogeneic hematopoietic stem-cell transplantation.
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http://dx.doi.org/10.1002/bimj.201900189DOI Listing
November 2020

Undiagnosed Severe Late Complications of Repaired Tetralogy of Fallot.

Circ Cardiovasc Imaging 2020 06;13(6):e010273

Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy (R.L., E.P., F.G., A.M.L., M.G., F.C., M.M.).

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http://dx.doi.org/10.1161/CIRCIMAGING.119.010273DOI Listing
June 2020

Prognostic significance of right ventricular hypertrophy and systolic function in Anderson-Fabry disease.

ESC Heart Fail 2020 08 20;7(4):1605-1614. Epub 2020 May 20.

Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, Rome, 00168, Italy.

Aims: Right ventricular hypertrophy (RVH) is a common finding in Anderson-Fabry disease (AFD), but the prognostic role of right ventricular (RV) involvement has never been assessed. The aim of our study was to evaluate the prognostic significance of RVH and RV systolic function in AFD.

Methods And Results: Forty-five AFD patients (56% male patients) with extensive baseline evaluation, including assessment of RVH and RV systolic function, were followed-up for an average of 51.2 ± 11.4 months. RV systolic function was assessed by standard and tissue Doppler echocardiography. Cardiovascular events were defined as new-onset atrial fibrillation (AF), sustained ventricular arrhythmias, heart failure, or pacemaker/implantable cardioverter defibrillator implantation; renal events were defined as progression to dialysis and/or renal transplantation or significant worsening of glomerular filtration rate; and cerebrovascular events were defined as transient ischaemic attack or stroke. Fourteen patients (31.1%) presented RVH, while RV systolic function was normal in all cases. During the follow-up period, 13 patients (28.8%, 11 male) experienced 18 major events, including two deaths. Cardiovascular events occurred in eight patients (17.7%). The most common event was pacemaker/implantable cardioverter defibrillator implantation (six patients, 13.3%), followed by AF (three cases, 6.6%). Only one case of worsening New York Heart Association class (from II to III and IV) was observed. Ischaemic stroke occurred in three cases (6.6%). Renal events were recorded in three patients (6.6%). At univariate analysis, several variables were associated with the occurrence of events, including RVH (HR: 7.09, 95% CI: 2.17 to 23.14, P = 0.001) and indexes of RV systolic function (tricuspid annular plane systolic excursion HR: 0.77, 95% CI: 0.62 to 0.96, P = 0.02; and RV tissue Doppler systolic velocity HR: 0.76, 95% CI: 0.61 to 0.93, P = 0.01). At multivariate analysis, proteinuria (HR:8.3, 95% CI: 2.88 to 23.87, P < 0.001) and left ventricular mass index (HR: 1.02, 95% CI: 1.00 to 1.03, P = 0.03) emerged as the only independent predictors of outcome.

Conclusions: RVH and RV systolic function show significant association with clinical events in AFD, but only proteinuria and left ventricular mass index emerged as independent predictors of outcome. Our findings suggest that RV involvement does not influence prognosis in AFD and confirm that renal involvement and left ventricular hypertrophy are the main determinant of major cardiac and non-cardiac events.
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http://dx.doi.org/10.1002/ehf2.12712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373914PMC
August 2020

Massive Coronary Microvascular Dysfunction in Severe Anderson-Fabry Disease Cardiomyopathy.

Circ Cardiovasc Imaging 2019 06 10;12(6):e009104. Epub 2019 Jun 10.

Department of Cardiovascular and Thoracic Sciences (F.G., R.L., E.P., F.C.), Fondazione Policlinico Universitario A. Gemelli IRCSS, Rome, Italy.

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http://dx.doi.org/10.1161/CIRCIMAGING.119.009104DOI Listing
June 2019

A novel predictive approach for GVHD after allogeneic SCT based on clinical variables and cytokine gene polymorphisms.

Blood Adv 2018 07;2(14):1719-1737

Department of Statistics, Universidad Carlos III de Madrid, Madrid, Spain.

Despite considerable advances in our understanding of the pathophysiology of graft-versus-host disease (GVHD), its prediction remains unresolved and depends mainly on clinical data. The aim of this study is to build a predictive model based on clinical variables and cytokine gene polymorphism for predicting acute GVHD (aGVHD) and chronic GVHD (cGVHD) from the analysis of a large cohort of HLA-identical sibling donor allogeneic stem cell transplant (allo-SCT) patients. A total of 25 SNPs in 12 cytokine genes were evaluated in 509 patients. Data were analyzed using a linear regression model and the least absolute shrinkage and selection operator (LASSO). The statistical model was constructed by randomly selecting 85% of cases (training set), and the predictive ability was confirmed based on the remaining 15% of cases (test set). Models including clinical and genetic variables (CG-M) predicted severe aGVHD significantly better than models including only clinical variables (C-M) or only genetic variables (G-M). For grades 3-4 aGVHD, the correct classification rates (CCR1) were: 100% for CG-M, 88% for G-M, and 50% for C-M. On the other hand, CG-M and G-M predicted extensive cGVHD better than C-M (CCR1: 80% vs. 66.7%, respectively). A risk score was calculated based on LASSO multivariate analyses. It was able to correctly stratify patients who developed grades 3-4 aGVHD ( < .001) and extensive cGVHD ( < .001). The novel predictive models proposed here improve the prediction of severe GVHD after allo-SCT. This approach could facilitate personalized risk-adapted clinical management of patients undergoing allo-SCT.
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http://dx.doi.org/10.1182/bloodadvances.2017011502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6058238PMC
July 2018

Pulmonary hypertension and clinical correlates in hypertrophic cardiomyopathy.

Int J Cardiol 2017 Dec 14;248:326-332. Epub 2017 Jul 14.

Cardiology Division, Clinical and Molecular Medicine Department, Sapienza University of Rome, Rome, Italy.

Background: Pulmonary hypertension (PH) in patients with hypertrophic cardiomyopathy (HCM) has been investigated in a small number of studies. Purpose of this study was to assess the prevalence and its association with outcome in a population of consecutive HCM outpatients.

Methods: We retrospectively analyzed data of 361 consecutive HCM outpatients in whom echocardiographic measurements of pulmonary artery systolic pressure (PASP) were available at initial and most recent evaluation. Four different clinical groups were specifically investigated: patients without left ventricular outflow tract obstruction (group A, 165), with obstruction (group B, 126), patients diagnosed at the age≥65 (group C, 50) and patients with end stage (ES) HCM (group D, 20).

Results: PH was identified in 41 (11.4%) of the 361 patients at initial evaluation while it has been recognized in 25 (7,8% [1.1%/year]) during a median follow-up of 3.4years. Analysis of subgroups showed that prevalence of PH increased from patient group A to D (8%, group A, 19%, group B, 28% group C, 70%, group D, respectively, p<0,01). During follow-up, patients with PH showed a significant higher HCM-related mortality (p=0.01) and morbidity (p<0.001) as compared with those without PH, but in multivariable analysis, PH resulted an independent risk factor only for HCM-related morbidity (HR=2.50, 95% CI 1.08-5.79, p=0.03).

Conclusion: PH affects a significant proportion of patients with HCM. Its prevalence varies according to different clinical profiles. It is associated with an unfavorable clinical outcome and is an independent predictor of morbidity.
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http://dx.doi.org/10.1016/j.ijcard.2017.07.010DOI Listing
December 2017

Additional technician tasks and turnaround time in the clinical Stat laboratory.

Biochem Med (Zagreb) 2016 ;26(2):243-7

Department of Radiology, University of Virginia, Charlottesville, VA, USA.

Introduction: Many additional tasks in the Stat laboratory (SL) increase the workload. It is necessary to control them because they can affect the service provided by the laboratory. Our aim is to calculate these tasks, study their evolution over a 10 year period, and compare turnaround times (TAT) in summer period to the rest of the year.

Materials And Methods: Additional tasks were classified as "additional test request" and "additional sample". We collected those incidences from the laboratory information system (LIS), and calculated their evolution over time. We also calculated the monthly TAT for troponin for Emergency department (ED) patients, as the difference between the verification and LIS registration time. A median time of 30 minutes was our indicator target. TAT results and tests workload in summer were compared to the rest of the year.

Results: Over a 10-year period, the technologists in the SL performed 51,385 additional tasks, a median of 475 per month. The workload was significantly higher during the summer (45,496 tests) than the rest of the year (44,555 tests) (P = 0.019). The troponin TAT did not show this variation between summer and the rest of the year, complying always with our 30 minutes indicator target.

Conclusion: The technicians accomplished a significant number of additional tasks, and the workload kept increasing over the period of 10 years. That did not affect the TAT results.
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http://dx.doi.org/10.11613/BM.2016.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910278PMC
August 2016

Ten years of preanalytical monitoring and control: Synthetic Balanced Score Card Indicator.

Biochem Med (Zagreb) 2015 ;25(1):49-56

Department of Radiology, University of Virginia, Charlottesville, VA, USA.

Introduction: Preanalytical control and monitoring continue to be an important issue for clinical laboratory professionals. The aim of the study was to evaluate a monitoring system of preanalytical errors regarding not suitable samples for analysis, based on different indicators; to compare such indicators in different phlebotomy centres; and finally to evaluate a single synthetic preanalytical indicator that may be included in the balanced scorecard management system (BSC).

Materials And Methods: We collected individual and global preanalytical errors in haematology, coagulation, chemistry, and urine samples analysis. We also analyzed a synthetic indicator that represents the sum of all types of preanalytical errors, expressed in a sigma level. We studied the evolution of those indicators over time and compared indicator results by way of the comparison of proportions and Chi-square.

Results: There was a decrease in the number of errors along the years (P<0.001). This pattern was confirmed in primary care patients, inpatients and outpatients. In blood samples, fewer errors occurred in outpatients, followed by inpatients.

Conclusion: We present a practical and effective methodology to monitor unsuitable sample preanalytical errors. The synthetic indicator results summarize overall preanalytical sample errors, and can be used as part of BSC management system.
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http://dx.doi.org/10.11613/BM.2015.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4401317PMC
March 2015

Customising turnaround time indicators to requesting clinician: a 10-year study through balanced scorecard indicators.

J Clin Pathol 2014 Sep;67(9):797-801

Aim: The purpose of this study is, first to present a 10-year monitoring of postanalytical turnaround time (TAT) adapted to different clinicians and patient situations, second to evaluate and analyse the indicators results during that period of time, and finally to show a synthetic appropriate indicator to be included in the balanced scorecard management system.

Methods: TAT indicator for routine samples was devised as the percentage of certain key tests that were verified before a specific time on the phlebotomy day. A weighted mean synthetic indicator was also designed. They were calculated for inpatients at 15:00 and 12:00 and for primary care patients only at 15:00. The troponin TAT of emergency department patients, calculated as the difference between the troponin verification and registration time, was selected as the stat laboratory TAT indicator.

Results: The routine and stat TAT improved along the 10-year study period. The synthetic indicator showed the same trend.

Conclusions: The implementation of systematic and continuous monitoring over years, promoted a continuous improvement in TAT which will probably benefit patient outcome and safety.
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http://dx.doi.org/10.1136/jclinpath-2014-202333DOI Listing
September 2014

Patient identification errors: the detective in the laboratory.

Clin Biochem 2013 Nov 16;46(16-17):1767-9. Epub 2013 Aug 16.

Clinical Laboratory Department, Hospital Universitario de San Juan, San Juan de Alicante, Spain; Biochemistry and Molecular Pathology Department, Universidad Miguel Hernandez, Elche, Spain. Electronic address:

Background: The eradication of errors regarding patients' identification is one of the main goals for safety improvement. As clinical laboratory intervenes in 70% of clinical decisions, laboratory safety is crucial in patient safety. We studied the number of Laboratory Information System (LIS) demographic data errors registered in our laboratory during one year.

Methods: The laboratory attends a variety of inpatients and outpatients. The demographic data of outpatients is registered in the LIS, when they present to the laboratory front desk. The requests from the primary care centers (PCC) are made electronically by the general practitioner. A manual step is always done at the PCC to conciliate the patient identification number in the electronic request with the one in the LIS. Manual registration is done through hospital information system demographic data capture when patient's medical record number is registered in LIS. Laboratory report is always sent out electronically to the patient's electronic medical record. Daily, every demographic data in LIS is manually compared to the request form to detect potential errors.

Results: Fewer errors were committed when electronic order was used. There was great error variability between PCC when using the electronic order.

Conclusions: LIS demographic data manual registration errors depended on patient origin and test requesting method. Even when using the electronic approach, errors were detected. There was a great variability between PCC even when using this electronic modality; this suggests that the number of errors is still dependent on the personnel in charge of the technology.
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http://dx.doi.org/10.1016/j.clinbiochem.2013.08.005DOI Listing
November 2013

Reducing preanalytical laboratory sample errors through educational and technological interventions.

Clin Lab 2012 ;58(9-10):911-7

Clinical Laboratory Department, University Hospital of San Juan, Alicante, Spain.

Background: A correct preanalytical phase procedure is critical to get an adequate sample and consequently to achieve the most reliable laboratory results, promoting patient safety. Continuous laboratory staff changes create the need to establish improvement strategies to reduce the error risk. The objective was to show how the numbers of preanalytical errors related to unsuitable samples in a hospital setting decrease following two improvement strategies related to new technology and educational actions and how their effects were measured by monitoring indicators.

Methods: Samples were drawn by the laboratory and other hospital departments' nurses without previous patient appointment, therefore, prior tube preparation was not available before the phlebotomy. Corrective measures for these activities were established: educational program for nurses and a system of custom labels, which correlate each laboratory test in the Laboratory Information System (LIS) with the corresponding tube. Three phases were defined based on the implementation dates of the improvement actions to be assessed. The set of indicators designed to monitor the improvement related to clotted, hemolyzed, insufficient, and uncollected samples. Data were collected and indicators calculated from the LIS using a data warehouse application. Patient satisfaction with respect to phlebotomy was also measured annually using a scoring survey.

Results: There was a reduction in all types of preanalytical sample errors related to the improvement strategies adopted. The indicators demonstrated that the unavailable, insufficient, and clotted samples decreased between two- and three-fold, whereas hemolysis errors benefited more from these improvement strategies. Patient satisfaction with the laboratory and phlebotomy procedures improved over the past several years as based on the annual satisfaction surveys.

Conclusions: The educational program for nursing personnel is relevant and important as can be seen in the decrease of sample errors and the resulting quality improvement. The custom label system minimizes the potential oversight of forgetting to draw a tube, which happens frequently when operating without appointments, by printing the labels according to requested tests. Detection, identification, and monitoring of the error and implementing strategies to improve preanalytical quality reduces error numbers and thereby improves patient safety and health system outcomes.
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December 2012

Comparing quantile residual life functions by confidence bands.

Lifetime Data Anal 2012 Apr 16;18(2):195-214. Epub 2011 Nov 16.

Department of Statistics and Operational Research, Universidad de Vigo, 36310, Vigo, Pontevedra, Spain.

In this article we present a nonparametric method for constructing confidence bands for the difference of two quantile residual life (qrl) functions. These bands provide evidence for two random variables ordering with respect to the qrl order. The comparison of qrl functions is of importance, specially in the treatment of cancer when there exists a possibility of benefiting from a new secondary therapy. A qrl function is the quantile of the remaining life of a surviving subject, as it varies with time. We show the applicability of this approach in Medicine and Ecology. A simulation study has been carried out to evaluate and illustrate the performance and the consistency of this new methodology.
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http://dx.doi.org/10.1007/s10985-011-9208-yDOI Listing
April 2012

[Variability of preanalytical errors between decentralized phlebotomy centers: a challenge for patient safety].

Enferm Clin 2010 Jan-Feb;20(1):36-9. Epub 2009 Oct 25.

Laboratorio de Análisis Clínicos, Hospital Universitario de San Juan de Alicante, Alicante, España.

Objective: The aim of the study is to show the most frequent preanalytical sample errors from distinct decentralized phlebotomy centers.

Method: The study was conducted from May 2005 to March 2008. In this period 36,2054 requests and 2,880,742 tests were received from the 16 decentralized phlebotomy centers. When an unsuitable sample is received specific coded results are registered as test results to inform the physician that an error had occurred and a new specimen collection is recommended. We used the the request number, which is specific for each phlebotomy center to ascertain where the samples with errors had been drawn, The preanalytical errors were identified by looking for coded results and were collected automatically from the LIS using a software program based on OLAP's cube (Omnium Roche Diagnostic), obtaining number and type of preanalytical error for each sample. The errors are calculated as number per million samples requested. Analysis of data was carried out using Microsoft Excel 2003. Categorical variables were expressed as frequency and percentage.

Results: The highest number of incidences occurred in urine samples (52%), followed by coagulation (21%), haematology (17%) and biochemistry (10%). With regard to the type of error, the largest proportion of errors was due to failures of process (62%).

Conclusions: The high incidence of preanalytical errors and variability between centers suggests that there is a need to standardize the drawing practice.
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http://dx.doi.org/10.1016/j.enfcli.2009.07.009DOI Listing
September 2010

Flow cytometric assessment of hematopoietic cell subsets in cryopreserved preterm and term cord blood, influence of obstetrical parameters, and availability for transplantation.

Am J Hematol 2006 Jun;81(6):397-410

Service of Pediatrics, Hospital de Móstoles, Móstoles, Madrid, Spain.

Objective: The aim of this study was to characterize the lymphocyte and the hematopoietic stem and progenitor cell (HPC) subsets of cryopreserved premature cord blood (PCB) compared to term cord blood (TCB) by flow cytometry, to study the influence of birth conditions, and to assess its availability for transplantation.

Materials And Methods: Four-color flow cytometric analysis was performed on 43 PCB and 40 TCB cryopreserved samples using a panel of 24 different mAbs, directed against lymphoid and HPC surface markers. The CB volume was estimated by the weight of the newborn to determine the absolute MNC and CD34(+) cell content/CB sample. Clinical and obstetrical data were recovered. Statistical comparisons and a multiple regression analysis were performed.

Results: No consistent differences were found in the mononuclear cell (MNC) or CD34(+) cell concentration (x10(6)/L) between PCB and TCB. The percentage of primitive HPC (CD34(+)CD38(-), CD34(+)CD38(-)CD90(-)HLA-DR(-), CD34(+)CD38(-)CD90(-)HLA-DR(+)) and primitive lymphoid progenitors (CD34(+)CD7(+), CD34(+)CD7(+)CD19(-)CD117(-)) were higher in PCB than in TCB. Correspondingly, TCB had an increased percentage of committed HPC. No sample of PCB contained >2 x 10(7) MNC/kg (and only 48% had >1 x 10(5) CD34(+) cells) for a recipient of 20 kg body wt, as the minimum threshold recommended for CB transplantation. Obstetrical factors modulated mainly lymphocyte subsets and fewer HPC subpopulations. Acute fetal distress increased CD34(+) cells, especially the immature subsets. Maternal treatment with dexamethasone and intrauterine growth retardation decreased CD3(+) cells. No other obstetrical factors played a detrimental effect on CB cells if used for transplantation.

Conclusion: PCB is richer in immature cells both in lymphocyte and HPC populations, and its use for transplantation, at least in special cases, should be reconsidered.
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http://dx.doi.org/10.1002/ajh.20598DOI Listing
June 2006

Tumor cells as cellular vehicles to deliver gene therapies to metastatic tumors.

Cancer Gene Ther 2005 Apr;12(4):341-9

Unidad de Hematopoyesis y Terapia Génica, CIEMAT/Fundación Marcelino Botín, Madrid, Spain.

A long-pursued goal in cancer treatment is to deliver a therapy specifically to metastases. As a result of the disseminated nature of the metastatic disease, carrying the therapeutic agent to the sites of tumor growth represents a major step for success. We hypothesized that tumor cells injected intravenously (i.v.) into an animal with metastases would respond to many of the factors driving the metastatic process, and would target metastases. Using a model of spontaneous metastases, we report here that i.v. injected tumor cells localized on metastatic lesions. Based on this fact, we used genetically transduced tumor cells for tumor targeting of anticancer agents such as a suicide gene or an oncolytic virus, with evident antitumoral effect and negligible systemic toxicity. Therefore, autologous tumor cells may be used as cellular vehicles for systemic delivery of anticancer therapies to metastatic tumors.
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http://dx.doi.org/10.1038/sj.cgt.7700801DOI Listing
April 2005

Transforming growth factor-beta1 down-regulates expression of chemokine stromal cell-derived factor-1: functional consequences in cell migration and adhesion.

Blood 2003 Sep 29;102(6):1978-84. Epub 2003 May 29.

Centro de Investigaciones Biológicas, Department of Immunology, Velázquez 144, 28006 Madrid, Spain.

Chemokine stromal cell-derived factor-1 (SDF-1) is expressed by bone marrow (BM) stromal cells and plays key roles in BM cell migration. Modulation of its expression could affect the migratory capacity of cells trafficking the BM, such as hematopoietic progenitor and leukemic cells. Transforming growth factor-beta1 (TGF-beta1) is present in the BM environment and constitutes a pivotal molecule controlling BM cell proliferation and differentiation. We used the BM stromal cell line MS-5 as a model to investigate whether SDF-1 expression constitutes a target for TGF-beta1 regulation and its functional consequences. We show here that TGF-beta1 down-regulates SDF-1 expression, both at the mRNA level, involving a decrease in transcriptional efficiency, and at the protein level, as detected in lysates and supernatants from MS-5 cells. Reduction of SDF-1 in supernatants from TGF-beta1-treated MS-5 cells correlated with decreased, SDF-1-dependent, chemotactic, and transendothelial migratory responses of the BM model cell lines NCI-H929 and Mo7e compared with their responses to supernatants from untreated MS-5 cells. In addition, supernatants from TGF-beta1-exposed MS-5 cells had substantially lower efficiency in promoting integrin alpha4beta1-mediated adhesion of NCI-H929 and Mo7e cells to soluble vascular cell adhesion molecule-1 (sVCAM-1) and CS-1/fibronectin than their untreated counterparts. Moreover, human cord blood CD34+ hematopoietic progenitor cells displayed SDF-1-dependent reduced responses in chemotaxis, transendothelial migration, and up-regulation of adhesion to sVCAM-1 when supernatants from TGF-beta1-treated MS-5 cells were used compared with supernatants from untreated cells. These data indicate that TGF-beta1-controlled reduction in SDF-1 expression influences BM cell migration and adhesion, which could affect the motility of cells trafficking the bone marrow.
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http://dx.doi.org/10.1182/blood-2002-10-3190DOI Listing
September 2003

Transforming growth factor-beta1 down-regulates expression of chemokine stromal cell-derived factor-1: functional consequences in cell migration and adhesion.

Blood 2003 Sep 29;102(6):1978-84. Epub 2003 May 29.

Centro de Investigaciones Biológicas, Department of Immunology, Velázquez 144, 28006 Madrid, Spain.

Chemokine stromal cell-derived factor-1 (SDF-1) is expressed by bone marrow (BM) stromal cells and plays key roles in BM cell migration. Modulation of its expression could affect the migratory capacity of cells trafficking the BM, such as hematopoietic progenitor and leukemic cells. Transforming growth factor-beta1 (TGF-beta1) is present in the BM environment and constitutes a pivotal molecule controlling BM cell proliferation and differentiation. We used the BM stromal cell line MS-5 as a model to investigate whether SDF-1 expression constitutes a target for TGF-beta1 regulation and its functional consequences. We show here that TGF-beta1 down-regulates SDF-1 expression, both at the mRNA level, involving a decrease in transcriptional efficiency, and at the protein level, as detected in lysates and supernatants from MS-5 cells. Reduction of SDF-1 in supernatants from TGF-beta1-treated MS-5 cells correlated with decreased, SDF-1-dependent, chemotactic, and transendothelial migratory responses of the BM model cell lines NCI-H929 and Mo7e compared with their responses to supernatants from untreated MS-5 cells. In addition, supernatants from TGF-beta1-exposed MS-5 cells had substantially lower efficiency in promoting integrin alpha4beta1-mediated adhesion of NCI-H929 and Mo7e cells to soluble vascular cell adhesion molecule-1 (sVCAM-1) and CS-1/fibronectin than their untreated counterparts. Moreover, human cord blood CD34+ hematopoietic progenitor cells displayed SDF-1-dependent reduced responses in chemotaxis, transendothelial migration, and up-regulation of adhesion to sVCAM-1 when supernatants from TGF-beta1-treated MS-5 cells were used compared with supernatants from untreated cells. These data indicate that TGF-beta1-controlled reduction in SDF-1 expression influences BM cell migration and adhesion, which could affect the motility of cells trafficking the bone marrow.
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http://dx.doi.org/10.1182/blood-2002-10-3190DOI Listing
September 2003