[Show abstract][Hide abstract] ABSTRACT: Object Traumatic brain injury (TBI) represents a large health and economic burden. Because of the inability of previous randomized controlled trials (RCTs) on TBI to demonstrate the expected benefit of reducing unfavorable outcomes, the IMPACT (International Mission on Prognosis and Analysis of Clinical Trials in TBI) and CRASH (Corticosteroid Randomisation After Significant Head Injury) studies provided new methods for performing prognostic studies of TBI. This study aimed to develop and externally validate a prognostic model for early death (within 48 hours). The secondary aim was to identify patients who were more likely to succumb to an early death to limit their inclusion in RCTs and to improve the efficiency of RCTs. Methods The derivation cohort was recruited at 1 center, Hospital 12 de Octubre, Madrid (1990-2003, 925 patients). The validation cohort was recruited in 2004-2006 from 7 study centers (374 patients). The eligible patients had suffered closed severe TBIs. The study outcome was early death (within 48 hours post-TBI). The predictors were selected using logistic regression modeling with bootstrapping techniques, and a penalized reduction was used. A risk score was developed based on the regression coefficients of the variables included in the final model. Results In the validation set, the final model showed a predictive ability of 50% (Nagelkerke R(2)), with an area under the receiver operating characteristic curve of 89% and an acceptable calibration (goodness-of-fit test, p = 0.32). The final model included 7 variables, and it was used to develop a risk score with a range from 0 to 20 points. Age provided 0, 1, 2, or 3 points depending on the age group; motor score provided 0 points, 2 (untestable), or 3 (no response); pupillary reactivity, 0, 2 (1 pupil reacted), or 6 (no pupil reacted); shock, 0 (no) or 2 (yes); subarachnoid hemorrhage, 0 or 1 (severe deposit); cisternal status, 0 or 3 (compressed/absent); and epidural hematoma, 0 (yes) or 2 (no). Based on the risk of early death estimated with the model, 4 risk of early death groups were established: low risk, sum score 0-3 (< 1% predicted mortality); moderate risk, sum score 4-8 (predicted mortality between 1% and 10%); high risk, sum score 9-12 (probability of early death between 10% and 50%); and very high risk, sum score 13-20 (early mortality probability > 50%). This score could be used for selecting patients for clinical studies. For example, if patients with very high risk scores were excluded from our study sample, the patients included (eligibility score < 13) would represent 80% of the original sample and only 23% of the patients who died early. Conclusions The combination of Glasgow Coma Scale score, CT scanning results, and secondary insult data into a prognostic score improved the prediction of early death and the classification of TBI patients.
Journal of Neurosurgery 09/2014; DOI:10.3171/2014.7.JNS131874 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective: To describe the demographic and clinical profiles of a cohort of environmentally representative severe traumatic brain injury (TBI) cases collected for the past 25 years and to analyse the changes that occurred by dividing the analysis period into 3 equal time periods. Material and methods: This was an observational cohort study of consecutive adult patients (>14 years of age) with severe closed TEI (Glasgow Coma Scale score [GCS] <= 8) who were admitted during the first 48 h after injury to the 12 de Octubre hospital from 1987 to 2012. The most relevant epidemiological and clinical variables reported in the literature were defined and compared in 3 equal time periods (1987-1995,1996-2004 and 2005-2014). Results: There was a 13% reduction in the frequency of severe TBI from the first to the last time period. An increase in the mean age from 35 to 43 years was observed, whereas the frequency of severe TBI according to sex remained approximately the same during the last decades of life. A distinct change was observed in the injury mechanism; traffic accidents decreased from 76% to 55%, particularly those involving 4-wheeled vehicles. However, falls increased significantly, especially in older women, and contusion and subdural haematoma were the most frequent structural injuries. Motor scores could not be reliably assessed for the last time period because of early intubation and sedative drug use. Conclusions: TBI epidemiology in Western countries has changed. This trend was also observed in our environment as an increase in mean age, which reflected the increase in falls among elderly patients.
[Show abstract][Hide abstract] ABSTRACT: Objetivo
Describir el perfil demográfico y clínico de una cohorte de TCE grave recogida en los últimos 25 años, representativa de nuestro medio y analizar los cambios que han sucedido a lo largo de estos años, dividiéndolos en tres periodos de tiempo iguales.
Material y métodos
Estudio observacional de cohorte de TCE grave cerrado (puntuación en la escala de Glasgow GCS≤8) adultos (>14 años) ingresados consecutivamente en las primeras 48 horas del traumatismo, en Hospital 12 de Octubre entre 1987 y 2012. Se definen las variables epidemiológicas y clínicas que han demostrado ser las mas relevantes en la literatura y se comparan en 3 periodos de tiempo equivalentes, 1987-1995, 1996-2004 y 2005-2014.
Existe una reducción de la frecuencia de TCE grave de un 13% entre el primer y último periodo de tiempo. Se aprecia un aumento de la edad media de 35 a 43 años, la frecuencia de TCE grave por sexo se iguala en las últimas décadas de la vida. Se aprecia un cambio en el mecanismo del trauma, el accidente de tráfico ha disminuido de un 76% a un 55%, sobre todo se ha reducido el accidente en vehículo-4 ruedas. Sin embargo, han aumentado notablemente las caídas, especialmente en mujeres de mayor edad, siendo la lesión estructural mas frecuente la contusión y el hematoma subdural. En el último periodo de tiempo no se pudo determinar con fiabilidad la puntuación motora, debido a la intubación precoz y el uso de drogas sedantes.
La epidemiología del TCE ha cambiado en los países occidentales, esta tendencia también se observa en nuestro medio, con un aumento de la edad media que refleja el aumento de caídas en la población de pacientes de edad avanzada.
[Show abstract][Hide abstract] ABSTRACT: To determine the impact of the expression of epidermal growth factor receptor (EGFR) on disease-free survival (DFS) and on pelvic relapse in patients with advanced cancer of the cervix receiving concurrent chemoradiotherapy.
In 112 consecutive patients with advanced cancer of the cervix (11 stage IB2-IIA, 25 IIB, 63 IIIB, 13 IVA) treated with chemoradiotherapy between December 1994 and September 2004, the expression of EGFR using histoimmunochemistry was measured and used in univariate and multivariate analysis, along with variables such as age, International Federation of Gynecology and Obstetrics Staging System for Epithelial Ovarian Cancer (FIGO) stage, histology, Eastern Cooperative Oncology Group (ECOG), tumor size, and ganglia involvement diagnosed with computerized axial tomography, treatment with cisplatin to evaluate its impact on DFS and pelvic relapse.
Of the 112 biopsies, 32 (28.6%) were negative or slightly positive (EGFR±) and 80 (71.4%) were moderate or intensely positive (EGFR++/+++). The overexpression of EGFR (++/+++) was significantly associated with an epidermoid histology (P < 0.0001), with a higher rate of pelvis relapse and a decreased DFS (hazard ratio [HR]: 2.31 [1.08-4.96]; P = 0.03). Overall, treatment with cisplatin increased DFS (HR: 0.51 [0.26-0.97]; P = 0.04).
Patients with tumors of the cervix and overexpression of the EGFR++/+++ show a higher probability of pelvic relapses and a decreased disease-free survival. The poor prognosis of these tumors may be a consequence of an increase in radio-resistance.
American journal of clinical oncology 08/2011; 34(4):395-400. DOI:10.1097/COC.0b013e3181e84634 · 2.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Time trends for cerebral palsy (CP) prevalence in children born > or =2,500 g vary across studies and scarce data exist on trends by subtype of CP. The objective of this study was to describe changes in prevalence of CP in infants born > or =2,500 g between 1980 and 1998 in Europe. Data were collated from the SCPE (Surveillance of Cerebral Palsy in Europe collaboration) common database. Poisson regression was used to test for change in prevalence over time. Birth year and register effects were explored and trends in prevalence were estimated by CP subtype and severity. Four thousand and two children with CP and birthweight > or =2,500 g were recorded in 15 population based-registers. The overall prevalence of CP was 1.16 per 1,000 live births (99% CI, 0.88-1.48) in 1980 and 0.99 (CI, 0.80-1.20) in 1998. The trend was not significant (P = .14), except in two registers. However, there were significant changes in the prevalence of spastic CP subtypes, with a decrease in the bilateral spastic form (P < .001), and an increase in the unilateral spastic form (P = .004). There was a concurrent reduction in neonatal mortality of children with birthweight > or =2,500 g: from 1.7 (CI, 1.4-2.1) to 0.9 (CI, 0.7-1.1) per 1,000 live births. In conclusion, for children born with birthweight > or =2,500 g, the prevalence of CP in Europe was stable in spite of changes by subtype and a significant decrease in neonatal mortality.
European Journal of Epidemiology 09/2010; 25(9):635-42. DOI:10.1007/s10654-010-9474-0 · 5.15 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To determine the impact of c-erb-B2 overexpression on disease-free survival (DFS) and local relapse in patients with advanced cervical cancer (CC) receiving concurrent chemoradiotherapy treatment.
A total of 136 patients with advanced CC (FIGO stage: IB2-IIA ; IIB ; IIIB ; IVA ; including both epidermoid  and adenocarcinoma ) were analyzed to determine c-erb-B2 levels by immunohistochemistry (c-erb-B2 antibody; Dako, Glostrup, Denmark). Only c-erb-B2+++ biopsies were considered positive. All patients received pelvic radiotherapy, brachytherapy, and concurrent chemotherapy with 2 different regimens: 48 patients were treated with tegafur (800 mg/d orally) and 88 with tegafur (same doses) plus 5 cycles of weekly cisplatin 40 mg/m/wk intravenously.
A total of 32 (23.5%) biopsies were considered c-erb-B2-positive. Three-year and 5-year DFS were 61% and 58% for c-erb-B2-negative patients and 36% and 36% for c-erB2-positive patients, respectively (P = 0.02). Patients were stratified in 4 groups according to their c-erb-B2 status and whether they received cisplatin. The group of patients with c-erb-B2 overexpression that did not receive platinum treatment had a higher rate of pelvic relapse (P < 0.0001), associated with a decreased DFS (P = 0.0014).
c-erb-B2 overexpression may imply a poor prognosis for patients with advanced CC. Treatment with cisplatin-based radiochemotherapy improved outcome in these patients.
International Journal of Gynecological Cancer 01/2010; 20(1):164-72. DOI:10.1111/IGC.0b013e3181ad3e11 · 1.95 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The objective was to determine the impact of the coexpression of epidermal growth factor receptor (EGFR) and tumor marker c-erbB-2 on disease-free survival (DFS) and pelvic relapse-free survival (PRFS) in patients with locally advanced cervical cancer (LACC) receiving concurrent chemoradiotherapy.
The expression of EGFR and c-erbB-2 was assessed by immunohistochemistry, which was centralized and blinded to outcome. Univariate and multivariate analyses were used to evaluate the impact of EGFR and c-erbB-2 on DFS and PRFS.
170 patients with LACC were included and received concurrent chemoradiotherapy. 25 (15%) biopsies were considered EGFR and c-erbB-2 positive; 100 (59%) were either EGFR or c-erbB-2 positive, and 45 (26%) were EGFR and c-erbB-2 negative. The 3- and 5-year DFS was 39% each for EGFR- and c-erbB-2-positive patients, 54 and 49%, respectively, for EGFR- or c-erbB-2-positive patients, and 76 and 72%, respectively, for EGFR- and c-erbB-2-negative patients (p = 0.006). EGFR- and c-erbB-2-positive tumors were significantly associated with a decrease in PRFS (hazard ratio, HR, 3.99; 95% confidence interval, CI, 1.44-11.05, p = 0.007), and DFS (HR 2.9; 95% CI, 1.26-6.66, p = 0.01).
Patients with LACC coexpressing EGFR and c-erbB-2, and treated with concurrent chemoradiotherapy, had a worse clinical prognosis with shorter DFS and PRFS.
[Show abstract][Hide abstract] ABSTRACT: Definition of cerebral palsy (CP) has become more precise in recent years and, even if CP remains an umbrella term, a simple classification system for CP types has been proposed. CP is the commonest motor impairment in childhood. New validated motor scales for gross and fine motor functions describe a third of children with CP as severely impaired. Children with CP may also have associated impairments, other than motor, that deserve particular attention and support at school and work, and which are responsible for lower survival rates. The prevalence of CP, 2 per 1000 children, has remained remarkably stable over the last 30 years, particularly for term children who represent half of all children with CP. However, recently, a consistent downward trend has been seen in moderately and very low birth weight children. Prevention measures still seems difficult to define since CP is the result of multifactorial events. Decreasing multiple births and specific health actions during early infancy may have an impact. Followup programmes have been implemented to assess how the consequences of CP are best reduced.
Paediatrics and Child Health 09/2008; DOI:10.1016/j.paed.2008.05.015
[Show abstract][Hide abstract] ABSTRACT: Pediatric units, especially neonatal units, are highly vulnerable to error generally and to medication error in particular. Potential failures are distributed across the entire medication process, occurring mostly at the time of medication prescription and during preparation for drug administration.
To estimate the prevalence of violations of good prescribing practice before and after the implementation of several measures aimed at improving the quality of the medical prescription.
Before and after evaluation study with prospective data collection in a third level neonatal unit. 6,320 handwritten medical prescriptions for neonates admitted in the first study period and 1,435 in the second period were analyzed. Training on good prescribing practice and the implementation of a pocket PC-based automatic dosage calculation system were the interventions. The main outcome measure was the proportion of prescriptions with violations of good prescribing practice: incorrect dose, units, dose interval, route of administration or legibility.
Incorrect prescriptions decreased from 39.5% before the intervention to 11.9% after, with an adjusted prevalence ratio of 0.29 (0.25-0.34). The number of wrongly specified items on a single prescription decreased from 11.1% of the prescriptions with two or more wrongly specified items in the first period to 1.3% in the second period, with a prevalence ratio of 0.09 (0.05-0.14).
Violations of good prescribing practice are common in neonatal units. A simple intervention should improve the quality of handwritten medical prescriptions for newborns admitted to intensive care settings.