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Background: 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. Objective: 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. Methods: 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. Results: 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). Conclusions: 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.

There is currently no unified policy on either breastfeeding support or enteral nutrition practices, as regards human milk (HM) in pre-term newborns. The aim of this study was to describe breastfeeding support measures, as well as the use of HM in very preterm infants in Spanish public hospitals.A questionnaire on enteral feeding practices was distributed. Data were analysed from units caring for newborns less than 32 weeks or 1,500g. A univariate analysis was performed comparing level ii and iii care units.There was a 91% response rate. A total of 93 units cared for infants less than 32 weeks or 1,500g (17 level ii and 76 level iii), and 49% of the units recorded the breastfeeding rate on discharge. Around 75% (70/93) had a guideline on managing HM (level iii 81 vs. level ii 47%, P=.002), and 25% had access to donor human milk. Just under half (46%) started trophic feeding in the first 6h. Target enteral feeding volume in stable preterm infants was ≥ 180ml/kg/day in 89% of the units (level iii 93% vs. level ii 70%, P =.017). HM fortifier was used in 96% of the units. In 92%, it was added when the required enteral volume was tolerated. In 59% of the units, adjustments in the quantity of fortifier were made according to weight, and in 36%, it depended on analytical criteria. Some units (9%) used pure protein fortifier.There is a marked variability in breastfeeding support measures and in feeding practices of preterm infants in Spanish neonatal units.

Different studies have related sexual and physical abuse during childhood and adolescence to the development of substance abuse disorders. Nevertheless, we are not aware of the role that other more common maltreatment types, such as neglect, will play among the most risky pattern of consumption: the polydrug use. A clinical sample of 655 adolescents, divided into two groups: polydrug users and non-polydrug users, were assessed on their pattern of drug consumption, history of childhood maltreatment, current psychopathology and their family history of alcoholism. Polydrug users had a greater prevalence of all types of maltreatment, although the most associated to this group were sexual abuse and emotional neglect. Other relevant variables to adolescent consumption were: the diagnosis of depressive disorder, the presence of anxiety traits and the family history of alcohol dependence. Polydrug users have higher risks of having had problems during infancy and adolescence, such as maltreatment and other psychopathological conditions, with the addition of family history of alcoholism. Accordingly, practitioners should take into account that those variables may influence polydrug abuse because it is the most risky pattern for subsequent dependence of substances, and they should always be considered during treatment., This research was funded by the “Plan Nacional Sobre Drogas” from the Ministry of Health, Social Services and Equality (Spain).

Patients with antiphospholipid syndrome (APS) have a hypercoagulable condition associated with the presence of antiphospholipid autoantibodies (aPL). Consensus antibodies for diagnosis are lupus anticoagulant, anti-beta2 glycoprotein I (B2GPI) and anticardiolipin (IgG or IgM). Circulating immunocomplexes (CIC) of B2GPI associated with IgM or IgG were reported. Isolated IgA aB2GPI antibodies have achieved high diagnostic value although specific CIC of B2GPI bounded to IgA (B2A-CIC) has still not been described. CIC detection assays are mainly based on interaction with complement and are not appropriate to detect B2A-CIC because IgA does not fix complement using the classical pathway.Sera from healthy blood donors (N= 247) and from patients with thrombosis background and isolate positive for IgA aB2GPI (N = 68) were studied in a case-control study. Two methods were applied, these being a capture ELISA to quantify specific B2A-CIC and quantification of total IgA anti-B2GPI after dissociating CIC.B2A-CIC values in APS-patients were 19.27 ± 2.6 AU vs 6.1 ± 0.4 AU in blood donors (p0.001). There were 36.4% B2A-CIC positive patients (cutoff 21 AU) versus 5.5% in blood donors (p0.001). Dissociated IgA aB2GPI levels (total IgA aB2GPI) were 146.8 ± 10.8 IU/mL in patients vs. 22.4 IU/mL in controls (p0.001). B2A-CIC was independent of B2GPI and autoantibodies IgA aB2GPI serum levels.B2A-CIC can be identified and quantified in an easy and reproducible manner using two complement-independent methods. The use of these tests in prospective studies will allow better understanding of the prognosis and outcome of patients.

Background Random safety audits (RSA) are a safety tool enabling prevention of adverse events, but they have not been widely used in hospitals. The aim of this study was to use RSAs to assess and compare the frequency of appropriate use of infusion pump safety systems in a Neonatal Intensive Care Unit (NICU) before and after quality improvement interventions and to analyse the intravenous medication programming data. Methods Prospective, observational study comparing the frequency of appropriate use of Alaris® CC smart pumps through RSAs over two periods, from 1 January to 31 December 2012 and from 1 November 2014 to 31 January 2015. Appropriate use was defined as all evaluated variables being correctly programmed into the same device. Between the two periods they were established interventions to improve the use of pumps. The information recorded at the pumps with the new security system, also extracted for one year. Results Fifty-two measurements were collected during the first period and 160 measurements during the second period. The frequency of appropriate use was 73.13 % (117/160) in the second period versus 0 % (0/52) in the first period (p

e21683 Background: Reported rates of FN with docetaxel (DTX) in PC patients are variable. This creates uncertainty regard the use of granulocyte colony-stimulating factor primary prophylaxis (G-CSF) in this setting. We conducted a meta-analysis of randomized clinical trials to determine the relative risk (RR) of FN in patients receiving DTX. Methods: To perform this analysis we systematically searched in PUBMED and MEDLINE database the following terms: “DTX”, “randomized clinical trial” and “prostate cancer” only for articles published between January 1996 and August 2016. Phase II-III clinical studies comparing DTX to non-DTX control arms (best supportive care [BSC] including non-cytotoxic therapy or mitoxantrone) for PC were included. The meta-analyses were performed by computing RRs with 95% confidence intervals (CI) using fixed-effects model with the Mantel-Haenszel method. Results: Seven studies (N = 5088 patients) were included. The global incidence of FN in patients treated with DTX was 10.7%. The RR of FN was higher in patients receiving DTX compared to patients did not receive DTX (RR 16.8 [95% CI 10.7; 26.4] p < 0.0001). 6.6% of patients with metastatic castration resistant prostate cancer (CRPC) treated with DTX developed FN, the RR of FN with DTX compared to mitoxantrone was 28.6 (95% CI 5.6; 145.1). 12.4% of patients with hormone-sensitive prostate cancer (HSPC) treated with DTX developed FN, the RR of FN was 15.3 (95% CI 9.6; 24.6) compared to BSC. There was no statistically significant differences in the rate of FN according to the hormone sensitivity (HSPC vs CRPC) (p = 0.7). In most studies the use of G-CSF was at the discretion of the investigator. Conclusions: This meta-analysis shows that DTX is associated with a significant increase in the relative risk of FN in patients with PC. The effectiveness of primary prophylactic G-CSF in this setting has not been fully established. The incidence reported here does not meet the threshold recommended by ESMO and ASCO guidelines for the use of prophylactic G-CSF. Special attention should be given to high risk groups for FN, including elderly patients and those with bone marrow involvement or previous radiotherapy/chemotherapy.

AIM To analyse the impact of octogenarian donors in liver transplantation. METHODS We present a retrospective single-center study, performed between November 1996 and March 2015, that comprises a sample of 153 liver transplants. Recipients were divided into two groups according to liver donor age: recipients of donors ≤ 65 years (group A; n = 102), and recipients of donors ≥ 80 years (group B; n = 51). A comparative analysis between the groups was performed. Quantitative variables were expressed as mean values and SD, and qualitative variables as percentages. Differences in properties between qualitative variables were assessed by χ2 test. Comparison of quantitative variables was made by t-test. Graft and patient survivals were estimated using the Kaplan-Meier method. RESULTS One, 3 and 5-year overall patient survival was 87.3%, 84% and 75.2%, respectively, in recipients of younger grafts vs 88.2%, 84.1% and 66.4%, respectively, in recipients of octogenarian grafts (P = 0.748). One, 3 and 5-year overall graft survival was 84.3%, 83.1% and 74.2%, respectively, in recipients of younger grafts vs 84.3%, 79.4% and 64.2%, respectively, in recipients of octogenarian grafts (P = 0.524). After excluding the patients with hepatitis C virus cirrhosis (16 in group A and 10 in group B), the 1, 3 and 5-year patient (P = 0.657) and graft (P = 0.419) survivals were practically the same in both groups. Multivariate Cox regression analysis demonstrated that overall patient survival was adversely affected by cerebrovascular donor death, hepatocarcinoma, and recipient preoperative bilirubin, and overall graft survival was adversely influenced by cerebrovascular donor death, and recipient preoperative bilirubin. CONCLUSION The standard criteria for utilization of octogenarian liver grafts are: normal gross appearance and consistency, normal or almost normal liver tests, hemodynamic stability with use of < 10 μg/kg per minute of vasopressors before procurement, intensive care unit stay < 3 d, CIT < 9 h, absence of atherosclerosis in the hepatic and gastroduodenal arteries, and no relevant histological alterations in the pre-transplant biopsy, such as fibrosis, hepatitis, cholestasis or macrosteatosis > 30%.

Background. Random safety audits (RSAs) are a safety tool but have not been widely used in hospitals.Objectives. To determine the frequency of proper use of equipment safety mechanisms in relation to monitoring and mechanical ventilation by performing RSAs. The study also determined whether factors related to the patient, time period, or characteristics of the area of admission influenced how the device safety systems were used.Methods. A prospective observational study was conducted in a level III-C Neonatal Intensive Care Unit (NICU) during 2012. 87 days were randomly selected. Appropriate overall use was defined when all evaluated variables were correctly programmed in the audited device.Results. A total of 383 monitor and ventilator audits were performed. The Kappa coefficient of interobserver agreement was 0.93. The rate of appropriate overall use of the monitors and respiratory support equipment was 33.68%. Significant differences were found with improved usage during weekends, OR 1.85 (1.12–3.06,p=0.01), and during the late shift (3 pm to 10 pm), OR 1.59 (1.03–2.4,p=0.03).Conclusions. Equipment safety systems of monitors and ventilators are not properly used. To improve patient safety, we should identify which alarms are really needed and where the difficulties lie for the correct alarm programming.

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.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.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 probability50%). 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 score13) would represent 80% of the original sample and only 23% of the patients who died early.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.

Objective To evaluate semen quality of men with proven fertility in Spain over the last 3 decades. Methods We conduct a retrospective analysis of ejaculate samples of 992 men between 1985 and 2009. All patients had proven fertility as demonstrated by fathering at least 2 children and a semen analysis performed before they underwent vasectomy. A standardized procedure was used for the semen analysis. Semen volume, total sperm count, sperm concentration, motility, and percentage of morphologically normal spermatozoa were assessed. Mean values were calculated by examining microscopic fields of 100 spermatozoa. Results Statistically significant differences were found in all semen parameters analyzed. For the periods 1985-1990, 1990-2000, and 2000-2009, the mean (standard deviation [SD]) sperm concentration was 27.7 (22.97), 20.73 (14.79), and 20.18 (20.79) × 106 (P

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 TBI (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.

The aim of this study was to explore the effect of Holder pasteurization and frozen storage at -20°C after pasteurization on fat, total nitrogen, lactose, and energy content of breast milk. Both procedures are routinely practiced in human milk banks.A total of 34 samples of frozen breast milk, donated by 28 women, were collected. Once thawed, an aliquot of each sample was analyzed before pasteurization; the remaining milk was pasteurized (Holder method) and split into 8 aliquots. One aliquot was analyzed after pasteurization and the remainder frozen at -20°C and analyzed 30, 60, 90, 120, and 180 days later. For every aliquot, fat, total nitrogen, lactose, and energy content were determined using the device human Milk Analyzer.We observed a significant reduction in fat (3.5%; -0.17 (-0.29; -0.04) g/dL) and energy content (2.8%; -2.03 (-3.60; -0.46) g/dL) after pasteurization. A significant decrease over time was observed for fat, lactose and energy content. No significant changes were observed for nitrogen content. Mean differences between day 0 postpasteurization and day 180 were -0.13 (-0.21; -0.06) g/dL for fat, -0.08 (-0.13; -0.03) g/dL for lactose, and -1.55 (-2.38; -0.71) kcal/dL for energy content. The relative decreases were 2.8%, 1.7%, and 2.2%, respectively. Overall (postpasteurization + frozen storage), a 6.2% and 5% decrease were observed for fat and energy, respectively.Holder pasteurization decreased fat and energy content of human milk. Frozen storage at -20°C of pasteurized milk significantly reduced fat, lactose, and energy content of human milk.

Background Pretransplantation anti-major histocompatibility complex class I chain-related molecule A (MICA) sensitization is an uncommon event and its role on kidney graft evolution is not completely defined. Methods A retrospective study of patients transplanted between 2005 and 2011 in our center (n=727) was performed. Recipients were classified in four groups, according either to multiplexed flow cytometry-recorded anti-human leukocyte antigen (HLA) and anti-MICA antibodies or to percent panel-reactive antibody (PRA; by complement-dependent cytotoxicity) and anti-MICA antibodies. Results In the total cohort, 52 (7.15%) patients had preformed anti-MICA antibodies, and these were not related with anti-HLA, previous transplantations, or recipient female sex (potential pregnancies). Kaplan-Meier curves showed global allograft survival differences (P=0.042) mostly due to pronounced decrease in PRA+MICA+ group early after transplantation. Biopsy-proven allograft rejection rate increased after month 12 in PRA+MICA- group and was higher early after transplantation in PRA+MICA+ group (P=0.033). In paired comparisons, rejection incidence was superior in PRA+MICA- versus PRA-MICA- patients (17% vs. 7%; P=0.007) at 24 months, confirming the widely reported deleterious effect of PRA+ status, but at 3 months rejection was higher in PRA+MICA+ versus PRA-MICA- patients (14% vs. 2%; P=0.009). Among patients categorized according anti-HLA and anti-MICA antibodies, the most striking difference in rejection was observed at 3 months (8% in HLA-MICA+ vs. 2% in HLA-MICA- patients; P=0.032). In the multivariate analysis, HLA-MICA+ status at 3 months independently conferred the highest risk for rejection (odds ratio, 5.07; P=0.049). Conclusions Pretransplantation sensitization against MICA and HLA are independent events. Preformed anti-MICA antibodies independently increase risk for kidney rejection and enhance the deleterious effect of PRA+ status early after transplantation.

This report shows the effect of period of diagnosis and treatment in the breast cancer survival in a public hospital between 1999 and 2008. The main aim of this article is the knowledge of the different demographic, clinical and pathological variables among the women collected in our database in order to establish if there have been variations in the evolution of the survival rate in the this decade.2132 women were included in the Hospital Cancer Registry between 1999 and 2008. These patients were followed-up by the National Death Index Agency and the last date of medical consultation, up to 31st march 2011. Observed survival was estimated by the actuarial method, and the relative survival was calculated by the Ederer II method. Survival was presented by fixed time point, as such 1, 3 and 5 year, after diagnosis. Confidence Interval 95% was included.The average age at diagnosis was 59,9 ± 14,2 years old. At the time of diagnosis, 12,3% presented in situ carcinoma; 51,8% localized carcinoma; 30% positive lymph nodes and 5% disseminated carcinoma. 72,8% of the cases were ductal carcinomas and 11,8% lobular carcinomas. Surgery resection was applied in the 90,8% of the cases, chemotherapy was administered in 23,4% and radiotherapy in the 56,7%. The overall relative survival was 88% in 5 years; 99, 9% for "in situ" carcinoma, 94,3% for localized carcinoma, 83,7% for regional carcinomas and 25,7% for disseminated carcinoma. In the third year of follow-up, women diagnosed in 2008 presented a relative survival of 94,8% versus 89,5% of those diagnosed in 1999. However, during the follow-up the estimation fluctuated without any significant tendency as a whole or by stages.Evolution of relative survival per year of diagnosis didn't show any significant increase, even when it was compared across the cohorts of two five-years periods or when it was studied by cohorts of cancer stage at diagnosis. In a 10 year period, relative survival hasn't changed in the population treated in this hospital.

Introduction: The presence Pulmonary Hypertension (PH) in the pre-transplant evaluation period, had an increase in morbidity and mortality following heart transplant, secondary to right ventricular failure; however, in recent years it has been shown that the presence of PH while still reversible does not appear to be associated with this increase risk. The aim of this work is to study the efficacy and safety of sildenafil in order to evaluate the reversibility of PH associated with CHF in heart transplant candidates in relation to the clinical outcome after surgery. Methods and Results: Included were all heart transplant patients with PH who had previously undergone an acute vasodilator test and then chronic treatment with sildenafil, and the morbidity and mortality of these patients were compared to those of heart transplant patients without prior PH. Between September 2001 and April 2010, 165 orthotopic transplants were performed, 31 of these patients had out of proportion PH and 134 of them not. Patients with PH underwent an acute vasodilator test and then chronic treatment with sildenafil. There were no statistically significant differences observed in the subsequent evolution of the PH group vs. the non-PH group in terms of total mortality (22.6% vs. 24.6%), in-hospital mortality (6.5% vs. 8.2%), days in ICU (3-7 d vs. 4-7 d), need for vasoactive drugs (1-3 d vs. 1-4 d), need for counterpulsation balloon pump (53.4% vs. 46.4%) or need for hemodiafiltration (4.5% vs. 7%). Conclusion: In patients with out of proportion PH associated with CHF in pre-transplant evaluation, a positive response to the acute vasodilator test with sildenafil predicts mortality and morbidity similar to that of heart transplant patients with no prior PH.

Objective To compare the effects of calcitonin, etidronate, and alendronate in preventing bone loss during the first 2 years after heart transplant. Methods A total of 222 heart transplant recipients (mean [SD] age, 52.4 [10] years, 85% male) were evaluated. Patients with normal bone mineral density (reference group, n = 102) received 1000 mg/d calcium plus 800 IU/d vitamin D3. The rest were assigned to 200 IU/d of calcitonin (n = 42), 400 mg/d etidronate orally for 14 days quarterly (n = 33), or 10 mg/d alendronate (n = 45). All patients received calcium and vitamin D. Bone mineral density was assessed by dual-energy x-ray absorptiometry in the lumbar spine, the entire femur, and the femoral neck at baseline and 6, 12, and 24 months after transplant. Results At 2 years after transplant, bone mineral density in the lumbar spine had decreased in the reference group (−3.07%), calcitonin group (−0.93%), and etidronate group (−1.87%) but not in the alendronate group (+4.9%; P < .001). After 2 years, bone mineral density in the entire femur decreased in all groups (−3.2% in the reference group, −3.6% in the calcitonin group, −4.6% in the etidronate group, and −0.5% in the alendronate group) but bone loss was significantly lower in the alendronate group ( P < .001). Bone mineral density in the femoral neck also decreased in all groups. The incidence of vertebral fractures did not differ among groups. Adverse events were similar between groups. Conclusions Alendronate therapy in heart transplant recipients was associated with a significant increase in bone mineral density in the lumbar spine and less bone loss at the hip.

The objective of the study was to describe temporal patterns in the management of HIV-1 infected women and their newborns and the changes over time in the mother-to-child transmission (MTCT) rates and risk factors.A multicenter prospective observational study was performed in Madrid, Spain, from 2000 to 2007. Cohort period 1 (CP1) included births in 2000-2003 and cohort period 2 (CP2) included births in 2004-2007.Of the 803 HIV-infected women and their infants, 427 were in the CP1 and 376 in CP2. Almost all CP2 women received highly active antiretroviral therapy. More women in CP2 received antiretroviral treatment for ≥16 weeks during pregnancy (72.0% in CP1 vs. 84.8% in CP2; P0.001). Overall, no differences in trends in mode of delivery were observed. The proportion of women with vaginal deliveries who had undetectable viral loads increased from 31.1% in CP1 to 42.7% in CP2 (P = 0.02). Thirteen children (1.6%, 95% confidence interval: 0.68-2.55) were HIV-1 infected by MTCT. No changes in the rates of infection were observed over time. All the cases of MTCT occurred when antiretroviral treatment was not given or was given for16 weeks during pregnancy.Low MTCT rates were observed over time. Lack of timely provision of antiretroviral drugs was the main limitation to develop all preventive interventions available nowadays. Nonsustained control of viral load could be associated with residual transmission.

Background Increasingly, neonatal clinics seek to minimize painful experiences and stress for premature infants. Fundoscopy performed with a binocular indirect ophthalmoscope is the reference examination technique for screening of retinopathy of prematurity (ROP), and it is associated with pain and stress. Wide-field digital retinal imaging is a recent technique that should be evaluated for minimizing infant pain and stress. Methods The purpose of the study was to assess and compare the impact of using a binocular indirect ophthalmoscope (BIO), or wide-field digital retinal imaging (WFDRI) on pain and stress in infants undergoing ROP screening examination. This was a comparative evaluation study of two screening procedures. Ophthalmologic examinations (N = 70) were performed on 24 infants with both BIO and WFDRI. Pain assessments were performed with two specific neonatal scales (Crying, requires oxygen, increased vital signs, expression and sleeplessness, CRIES and, Premature infant pain profile, PIPP) just prior to the examination, and 30 seconds, 1 hour, and 24 hours later after ending the examination. Results Changes over time were significantly different between BIO and WFDRI with both scales (PIPP score, p = .007, and CRIES score, p = .001). Median PIPP score (interquartile interval) at baseline was 4 (3–5). At 30 seconds the score was 8 (6–9) for BIO and 6 (5–7) for WFDRI, respectively. The increase in PIPP score between baseline and 30 seconds was significantly lower with WFDRI (p = .006). The median increase in CRIES score from baseline to 30 seconds was 1 point lower for WFDRI than for BIO (p Conclusions A transient short-term pain and stress response occurs with both BIO and WFDRI. Infants examined for screening of ROP with digital retinal imaging present less pain and stress at 30 seconds following completion of the exam when compared with binocular indirect ophthalmoscopy.

In neonatal units and human milk banks freezing breastmilk at less than -20 °C is the choice for preserving it. Scientific evidence in relation to the loss of nutritional quality during freezing is rare. Our main aim in this study is to determine the effect of freezing time up to 3 months on the content of fat, total nitrogen, lactose, and energy. Our secondary aim is to assess whether ultrasonic homogenization of samples enables a more suitable reading of breastmilk macronutrients with a human milk analyzer (HMA) (MIRIS, Uppsala, Sweden).Refrigerated breastmilk samples were collected. Each sample was divided into six pairs of aliquots. One pair was analyzed on day 0, and the remaining pairs were frozen and analyzed, one each at 7, 15, 30, 60, and 90 days later. For each pair, one aliquot was homogenized by stirring, and the other by applying ultrasound. Samples were analyzed with the HMA.By 3 months from freezing with the two homogenization methods, we observed a relevant and significant decline in the concentration of fat and energy content. The modification of total nitrogen and lactose was not constant and of lower magnitude. The absolute concentration of all macronutrients and calories was greater with ultrasonic homogenization.After 3 months from freezing at -20 °C, an important decrease in fat and caloric content is observed. Correct homogenization is fundamental for correct nutritional analysis.

In the attempt to establish the different incidence between cancer in anatomically whole stomachs and cancer in patients who have undergone a surgical procedure for morbid obesity, a review on the epidemiology of bariatric surgery and stomach cancer and a correlation with the global incidence of stomach cancer (comparing it with the median age of patients who developed neoplasms after bariatric surgery) have been conducted.This was a descriptive study of the gastric neoplasms located at the gastric pouch, bypassed stomach or in the esophagogastric junction, following bariatric surgery described in the medical literature.Twenty-one cases of gastric neoplasm located at the gastric pouch, in the bypassed stomach or in the esophagogastric junction were described after bariatric surgery.Bariatric surgery seems to produce a decrease in the incidence of cancer when comparing obese patients who were operated and obese patients who have not, so additional studies are needed to compare the cancer incidence between the general population and patients undergoing bariatric surgery. New studies will determine if it is necessary to focus on the early detection of pathological processes at the excluded digestive tract.

Background Acute urethritis is among the most common types of sexually transmitted diseases in men. The diagnosis usually requires microscopic evidence of urethritis, but sometimes urethral pathogens are detected in asymptomatic men without such evidence. The aims of this study were to assess the sensitivity of Gram stain in men with urethral symptoms and to relate it to the microorganisms isolated. Methods Between January 2006 and December 2007, 491 urethral samples were analysed. The authors assessed the presence of leukocytes by Gram stain and tested specifically for Chlamydia trachomatis , Ureaplasma urealyticum , Mycoplasma hominis and Trichomonas vaginalis , as well as analysing the results of conventional culture. Results The percentages of positive samples as a function of Gram category were two or less polymorphonuclear leukocytes (PMNLs)/high-power field (HPF) 25% (92/364), three to four PMNLs/HPF 32% (18/57) and five or more PMNLs/HPF 54% (38/70). Classing samples with more than two PMNLs/HPF as positive, the sensitivity, specificity and positive likelihood ratio for Gram stain were 38% (95% CI 30 to 46), 79% (95% CI 75 to 84) and 1.8 (95% CI 1.4 to 2.4), respectively. On the other hand, taking as positive five or more PMNLs/HPF, the sensitivity, specificity and positive likelihood ratio for Gram stain were 26% (95% CI 18 to 33), 91% (95% CI 87 to 94) and 2.7 (95% CI 1.8 to 4.2), respectively. The sensitivity of Gram stain to Neisseria gonorrhoeae , Chlamydia trachomatis and Ureaplasma urealyticum were 80% (95% CI 64 to 96), 23% (95% CI 8 to 39) and 11% (95% CI 2 to 20), respectively. Conclusion The low sensitivity of Gram stain means that negative results do not exclude the presence of urethritis in symptomatic patients.

INTRODUCTION: Healthcare management is oriented toward single diseases, yet multimorbidity is nevertheless the rule and there is a tendency for certain diseases to occur in clusters. This study sought to identify comorbidity patterns in patients with chronic diseases, by reference to number of comorbidities, age and sex, in a population receiving medical care from 129 general practitioners in Spain, in 2007. METHODS: A cross-sectional study was conducted in a health-area setting of the Madrid Autonomous Region (Comunidad Autónoma), covering a population of 198,670 individuals aged over 14 years. Multiple correspondences were analyzed to identify the clustering patterns of the conditions targeted. RESULTS: Forty-two percent (95% confidence interval [CI]: 41.8-42.2) of the registered population had at least one chronic condition. In all, 24.5% (95% CI: 24.3-24.6) of the population presented with multimorbidity. In the correspondence analysis, 98.3% of the total information was accounted for by three dimensions. The following four, age- and sex-related comorbidity patterns were identified: pattern B, showing a high comorbidity rate; pattern C, showing a low comorbidity rate; and two patterns, A and D, showing intermediate comorbidity rates. CONCLUSIONS: Four comorbidity patterns could be identified which grouped diseases as follows: one showing diseases with a high comorbidity burden; one showing diseases with a low comorbidity burden; and two showing diseases with an intermediate comorbidity burden. This study was partially supported by the CENIT Program (MICINN-CDTI) [CEN-2007-1010 ‘‘Digital personal environment for health and wellbeing – AmiVital’’ project], a grant from the Ministry of Health & Consumer Affairs [FIS PI08-0435], and the MOBIS Program of the Spanish Vodafone Foundation . The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Sí

To determine the effectiveness and safety of saturation biopsies for prostate cancer detection of and to identify predictive variables for cancer.We conducted a retrospective transversal study in which we analyzed 144 saturation biopsies (January '06 - July '09).at least two sets of biopsies without evidence of malignancy and Prostate Specific Antigen (PSA)levels10 ng/ml or PSA kinetics suggestive of malignancy (rate0.75 ng/ml/year)and patients with atypia in a previous biopsy.The variables analyzed were: age, abnormal digital rectal examination (DRE), total PSA, free/total PSA ratio, prostate volume, PSA density, previous histopathology, number of cylinders obtained and complications. Statistical analysis was performed using the Chi-square test, Student's t-test and logistic regression.Mean age was 66 years (SD ± 6.4), mean total PSA 14.4 ng/ml (SD ± 12.6), mean free/total PSA ratio 0.09 (SD ± 0.09), mean prostate volume 61.6 cc (SD ± 27.4), mean PSA density 0.27 (SD ± 0.26) and mean number of cylinders obtained 30.45 (SD ± 3.8). We diagnosed 32% of the patients with prostatic adenocarcinoma. We observed PSA density was higher in the prostate cancer group, 0.39 (SD ± 0.36), compared to 0.21 (SD ± 0.18) in patients without cancer (p=0.003). Adenocarcinoma was found in 58% of the biopsies in patients with suspicious DRE, compared to 28% with normal DRE (p=0.009). Mean prostate volume in the prostate cancer group was 52.5 (SD ± 24.7)compared to 66.0 (SD ± 27.7)in the group without cancer (p=0.006). In the multivariate analysis, the PSA density (p=0.02; 95% CI 1.36 - 37.36) was the only variable that independently predicted the presence of adenocarcinoma. No statistically significant differences were found in either univariate or multivariate analysis for the remaining variables analyzed. The incidence of complications was similar to that described in the literature for other series.Saturation biopsy is safe and effective for detection of prostate cancer. PSA density was the only factor that was shown to be independent predictive variable for tumor diagnosis.

The aim of this study was to investigate the effect of risedronate (RIS) on bone loss and bone turnover markers after liver transplantation (LT). Patients with osteopenia or osteoporosis within the first month after LT were randomized to receive RIS 35 mg/week plus calcium 1000 mg/day and vitamin D(3) 800 IU/day (n = 45) or calcium and vitamin D(3) at same dosages (n = 44). Primary endpoint was change in bone mineral density (BMD) 6 and 12 months after LT. Secondary endpoints included changes in serum β-CrossLaps (β-CTX) and procollagen type 1 amino-terminal peptide (P1NP) and fracture rate. Spine X-rays were obtained at baseline and after 12 months. There was no significant difference in BMD changes between both treatment groups at any sites; either at 6 or 12 months. Spine BMD increased in both groups at 12 months vs. baseline (P = 0.001). RIS patients had a significant increase in intertrochanteric BMD at 12 months (P0.05 vs. baseline). Serum β-CTX decreased in both groups (P0.01), with significant differences between groups at 3 months. No significant difference in vertebral fracture incidence was found. After 12 months, BMD improved at lumbar spine and did not change at hip in both groups. Significant differences between both groups were not found. Other factors (calcium and vitamin D replacement, early prednisone withdrawal) seem to have also positive effects in BMD.

To investigate whether radical nephrectomy (RN) and nephron-sparing surgery (NSS) for T1 renal cell carcinoma influence renal function, oncological outcome or survival rate.A retrospective study was performed, including 290 nephrectomies for tumours of a diameter of less than 7 cm; 174 radical nephrectomies were compared to 116 nephron-sparing surgeries. Preoperative and pathological data were compared between the two groups. The glomerular filtration rate was estimated using the abbreviated Modification of Diet and Renal Disease (MDRD4) study equation. The evolution of renal function was analysed from 6 months to 4 years after surgery, and the oncological outcomes were evaluated by means of cancer and non-cancer survival curves.The results showed a major impairment in renal function in the RN group compared to those who underwent NSS (25 vs 7 ml/min/1.73 m², 6 months after surgery), a difference that was maintained over time. Moreover, patients undergoing RN had a greater chance of developing renal failure. Overall, the survival curves showed a higher mortality rate for the RN group (p = 0.034), although the cancer-specific mortality rate did not show any statistically significant differences (p = 0.079).For stage T1 renal cortical tumours, NSS should, whenever possible, be regarded as the primary therapeutic option, given that it obtains similar oncological outcomes to RN and preserves renal function, which seems to translate into a lower overall mortality rate.

Several versions of Folstein's minimental test (MMSE, Minimental State Examination) exist in Spanish. One of them is the 37-point MMSE (MMSE-37), which is adapted to people with a low cultural level. AIM. To study the interobserver and test-retest reliability of the MMSE-37.Interobserver reliability was studied in three professional observers who simultaneously administered the MMSE-37 to 40 patients from a community setting. Test-retest reliability was obtained in 35 patients by administering the MMSE-37 on two occasions 2-3 months apart. Statistics used: intraclass correlation coefficient (ICC), Bland-Altman difference plot method, and kappa index.Interobserver reliability study: multiple ICC of 0.99 (95% confidence interval, CI 95% = 0.99-0.99); kappa index of 0.84 (CI 95% = 0.72-0.97); the degree of agreement between the individual responses was 1 for 'pathological outcome', 0.79 for 'probably pathological outcome', 0.37 for 'probably normal outcome' and 0.89 for 'normal outcome'; ICC0.99 (CI 95% = 0.99-0.99) between all the pairs of observers. The systematic differences in the mean score between the pairs of observers did not exceed the score of 0.1, which represents a bias of 0.47% after removing the scale. Test-retest reliability study: ICC of 0.92 (CI 95% = 0.87-0.96), kappa index of 0.84 (CI 95% = 0.54-1.00) and mean difference in the magnitude of disagreement of 0.34 (CI 95% = -2.80-3.49), 1% of the percent error in the magnitude of the disagreement.The MMSE-37 shows a high degree of test-retest reliability and reliability among professional observers, as in other versions of the MMSE.

Introduction: Second-trimester fetal screening for congenital heart defects (CHD) included in routine obstetric care provides relevant information for decision making. The aim of this study was to describe the clinical practice of prenatal detection of CHD in terms of the process and results. Methods: The characteristics and results of ultrasound screening for major CHD were documented using data provided by hospitals for a national survey in Spain over the period of 2004–2006. Sixty-seven percent of eligible centers (56/83), covering 36% of total births nationwide, responded to the survey; 33 of these returned complete data regarding the screening results. Results: The number of major CHD occurring in the centers which provided data with results of screening was 1,060. The overall prenatal detection rate of major CHD was 65.7% (95% CI 57.8–74.7), but the detection rate in the routine second-trimester scan was 52.6% (95% CI 45.6–60.8). In 61% of these cases the parents chose to terminate the pregnancy. Two independent predictors of increased detection by center were identified: first, the uniformity and systematic character of the examination of the heart showing at least the 4-chamber view and outflow tracts (prevalence ratio 1.3, 95% CI 1.0–1.8) and second, the local availability of specialists in fetal echocardiography (prevalence ratio 1.4, 95% CI 1.1–1.9). Conclusions: The detection of major CHD in the first half of pregnancy has an important impact on parental decision making. The prenatal screening program for CHD should be globally strengthened in terms of qualifications and methodological approaches. To improve its performance locally, close collaboration with fetal heart specialists should be promoted.

Liver steatosis in chronic hepatitis C (CHC) is related to viral and metabolic factors and likely to genetic factors. The aim of this study was to know if hyperhomocysteinemia and methylenetetrahydrofolate reductase (MTHFR)-C677T polymorphisms are associated with liver steatosis in nonalcoholic patients with CHC.In 54 consecutive patients with CHC, alcohol consumption less than 40g/week, and no other causes of liver disease, a liver biopsy was performed. All variables were obtained at the time of biopsy. MTHFR-C677T was also performed in 128 healthy subjects, with age and gender similar to the patients.Liver steatosis was found in 33 patients (61%), 30 of them having a mild degree. Hyperhomocysteinemia was more prevalent in patients with steatosis (61% vs 24%; p=0.008) and overweight tended to be more prevalent in the same patients (61% vs 33%; p=0.05). All patients with virus C genotype 3 had steatosis. Viral load, liver inflammatory and fibrosis score were not different in patients with and without steatosis. MTHFR-C677T polymorphism was similar in controls and cases and in cases with and without steatosis. A multiple logistic regression showed that hyperhomocysteinemia was associated with liver steatosis after adjustment for age and sex (OR: 3.94; 95% CI: 1.09-14.29), and adjustment for overweight (OR: 4.43; 95% CI: 1.27-15.51).In nonalcoholic patients with CHC mild liver steatosis is frequent, and is associated with hyperhomocysteinemia. An association between steatosis and MTHFR-C677T polymorphism was not found.

Regulatory T lymphocytes (Treg) suppress activation of the immune system and prevent pathological autoreactivity, giving them a relevant role in transplantation. In this study, we compared the proportion of Treg in a group of kidney transplant recipients with those in a control group. We used flow cytometry and labeling with monoclonal CD4, CD25, and FoxP3 antibodies to analyze the percentage of Treg lymphocytes in peripheral blood in a group of 68 patients at more than 12 years since transplantation and in 16 untransplanted healthy controls. In addition to the laboratory determinations, we analyzed the effect of some clinical parameters on the percentage of Treg in the transplanted group with a previous history of hepatitis C virus infection and undergoing immunosuppressive treatment. The percentage of Treg levels observed in the transplanted group was significantly lower than that in the control group (1.53% vs 2.89% CD4+ T cells; P = .0022). The percentage of Treg cells was significantly lower among patients treated with mycophenolate mofetil (1.12%) than other drug combinations. We also compared the percentage of Treg between transplant recipients treated with immunosuppressive monotherapy and those treated with combined immunosuppression, observing a higher percentage among patients with monotherapy.

The cannabinoid receptor-1 (CNR-1) and endogenous agonists of this receptor are present in the central and peripheral nervous systems including the gastrointestinal nervous system. The surgically rejected specimens of human colorectal cancers and paired normal tissues were studied to detect mutations in the CNR1 gene by sequencing method. The results were compared to clinicopathological parameters and correlated with overall survival time. Sixty-three colorectal cancer patients, who underwent surgical excision of colorectal carcinoma, were included in this study. The coding region of the CNR1 gene was studied: a nucleotide change (G--A) at position 1359 was identified by direct sequencing of PCR. Thirty-eight patients had the G/G genotype (wild type) in tumor areas and 25 patients had G/A heterozygous or A/A homozygous genotype. Univariate analysis revealed 2 independent variables associated with CNR1 gene mutation. The results show that the patients with Dukes stage C and D had a 2.9 times (p = 0.04) and patients that were lymph node positive had 2.8 times (p = 0.05) greater probability of nucleotide change in CNR1 gene. Genotype G/A plus A/A had a shorter overall survival time than G/G wild-type patients (p0.05). Indeed nontumor paired colorectal tissues showed nucleotide change. A large number of patients with mutation in the CNR1 gene were observed. These preliminary findings highlight the importance of further studies in the use of cannabinoid analogs as receptor ligands to analyze potential therapeutic effects.

Objective: 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. Methods: 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. Results: 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). Conclusion: Patients with LACC coexpressing EGFR and c-erbB-2, and treated with concurrent chemoradiotherapy, had a worse clinical prognosis with shorter DFS and PRFS.

Objective:To investigate the clinical significance of lymphoid neogenesis (LN) in rheumatoid arthritis (RA), the clinicopathological correlates of this process and its evolution after anti-tumour necrosis factor (TNF)α therapy in a large series of synovial tissues were analysed.Methods:Arthroscopic synovial biopsies from 86 patients with RA were analysed by immunohistochemistry. LN was defined as the presence of large aggregates of lymphocytes with T/B cell compartmentalisation and peripheral node addressin (PNAd) positive high endothelial venules. Clinical variables at baseline and after prospective follow-up were compared in LN positive and negative RA subsets. The evolution of LN and its correlation with the clinical course in a subgroup of 24 patients that underwent a second arthroscopic biopsy after anti-TNFα therapy was also analysed.Results:LN was present in 49% of RA synovial tissues. Patients with LN had a significantly higher disease duration and a higher previous use of anti-TNFα agents. During prospective follow-up, the proportion of patients achieving good or moderate European League Against Rheumatism (EULAR) 28-joint Disease Activity Score (DAS28) responses was significantly lower in patients who were LN positive despite a significantly higher use of anti-TNFα agents. By multivariate logistic regression analysis, LN remained as an independent negative predictor of response to therapy. In the subgroup of patients rebiopsied after anti-TNFα therapy, reversal of LN features occurred in 56% of the patients and correlated with good clinical responses.Conclusions:Synovial LN in RA predicts a lower response to therapy. LN features can be reversed after a short period of anti-TNFα therapy in parallel to good clinical responses.

Background Real time safety auditing (RTSA) has not been widely used in hospitals. There is insufficient information on its use as a tool for patient safety. Aim To determine the frequency of appropriate use of the security systems in technological equipment for monitoring and respiratory support through RTSA. To estimate whether the characteristics of the patient, time or location influence the frequency of appropriate use. Methods Prospective observational study conducted during 2012 in a tertiary NICU. 115 days were randomly selected. Two monitoring or respiratory devices were randomly selected each study day. Information about time, location and patient characteristics was collected. Appropriate use was defined as all evaluated items correctly programmed on the same device. Results A total of 94 pulse oximeter, 104 multi-measurement monitor, 53 conventional ventilator, 64 high frequency oscillatory ventilator and 68 CPAP audits were performed. Kappa coefficient of inter-observer agreement was 0.93. Audits revealed appropriate use of equipment in 33.68% of cases. During non-working days it was 43.02% compared to 30.98% on working days (p 0.03). During afternoon shifts it was 38.65% compared to 30% on morning shifts (p 0.07). Patient characteristics, location and month did not have a significant influence. In the adjusted analysis the OR of appropriate use for non-working days was 1.85 (1.11–3.06) and for afternoon shifts 1.59 (1.03–2.47). Conclusions Frequency of appropriate use of security systems in the equipment surveyed was low. Surprisingly, when there are fewer doctors in the unit (non-working days and afternoons) the use of technology improves.