Gemcitabine plus capecitabine (Gem-Cape) biweekly in chemorefractory metastatic colorectal cancer.

PURPOSE: A proportion of patients with metastatic colorectal cancer (mCRC) are still able to continue with active therapy after their progression to fluoropyrimidines, oxaliplatin, and irinotecan regimens. Studies suggest that gemcitabine and fluoropyrimidines are synergic antimetabolites. The purpose was to evaluate gemcitabine-capecitabine (Gem-Cape) in heavily pretreated mCRC and to thus assess possible predictive factors for progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: This analysis was performed on 119 evaluable patients pretreated with fluoropyrimidines, oxaliplatin, irinotecan, and biological agents between June 2001 and July 2011. Patients received gemcitabine 1,000 mg/m(2) day 1 and capecitabine 1,000 mg/m(2) bid for 7 days every 2 weeks. RESULTS: The general characteristics were ECOG 0-1, 89 %; male, 68 %, and median age 63 years. In total, 61 % had received two chemotherapy lines, while 39 % had received three or more. Objective response rates and stable disease rates at 3 months were 6.72 and 37.81 %, equalling a clinical benefit of 44.53 %. The median PFS and OS were 2.87 months [95 % confidence interval (CI) 2.53-3.17 months] and 6.53 months (95 % CI 5.33-8.77), respectively. The most frequent toxicities were grades 1-2, anemia (22 %), thrombocytopenia (10 %), and hand-foot syndrome (9 %); grade ≥3, diarrhea (2 %), with no treatment-related discontinuations. No treatment-related deaths were reported. Statistical significance was obtained by subgroups, assessing clinical benefits and objective responses for PFS and OS. Moreover, patients under 65 tended to have a better PFS. CONCLUSION: These data suggest that Gem-Cape is a tolerable and feasible regimen, associated with clinical benefit in non-selected, heavily pretreated, mCRC patients.

Characteristics and associated factors in patient falls, and effectiveness of the lower height of beds for the prevention of bed falls in an acute geriatric hospital

Objetivos: Existen estudios sobre caídas de pacientes en instituciones de larga estancia pero hay muy pocos en centros de agudos. Objetivo: analizar las características y los factores asociados de las caídas, y la efectividad de la disminución de la altura de las camas para reducir la frecuencia y los daños por caídas en un Hospital de Agudos Geriátricos. Métodos: Estudio descriptivo y retrospectivo usando un sistema de notificación de incidentes obligatorio, el Global Trigger Tool del IHI, y las reclamaciones relacionadas a caídas de pacientes entre los años 2007 y 2011 en un hospital de agudos geriátricos de 200 camas. Resultados: La tasa de caídas fue de 5,4 por 1000 pacientes día (1,3% produjo fracturas), con 6 exitus (0.6%). Cerca de la mitad de las caídas ocurrieron en el turno de noche (42,4%) y fueron más frecuentes en las Unidades de agudos (42,9%). Un 7,5% de los pacientes tuvo una caída previa al ingreso. Se produjeron 3 (0,2%) reclamaciones patrimoniales atribuibles a posible negligencia clínica. Las caídas de cama con la bajada de altura se han reducido un 28,3%, siendo las caídas con da˜no 1,88 veces menos que las ocurridas sin la bajada de la altura (RR 0,53 CI 95% 0,83-0,34) (p = 0,006). Conclusiones: La prevención de caídas de pacientes es una tarea importante en las Unidades geriátricas con una potencial reducción de costes y daños, algunas medidas como la bajada de la altura de la cama mostraron una reducción significativa de las caídas (AU)

Objectives: Whereas several studies about patient falls have provided data for long-term healthcare institutions, less information is available for acute care centres. The objective was to analyze the characteristics of the patient falls and associated factors, and the effectiveness of the lower beds’ height to reduce the frequency and the harms of the patient falls in an acute geriatric hospital. Methods: A descriptive and retrospective study using a mandatory safety incident report, the IHI Global Trigger Tool, and the claims related to patient falls between 2007 and 2011 in a 200-bed university-associated geriatric hospital. Results: The falls rate was 5.4 falls per 1000 patient days (1.3% of falls led to fractures) and there was exitus in 6 patients (0.6%). Nearly half of the falls ocurred during the night shift (42.4%). By wards, falls were more frequent in acute geriatric wards (42.9%). A 7.5% of patients had a fall before admission. 3 (0.2%) claims due to possible clinical negligence were found. A reduction (28.3%) of bed falls with the lower height of the bed and a 1.88 times less falls with harm (RR 0.53; CI 95% 0.83-0.34) (p = 0.006) was observed. Conclusion: The prevention of patient falls is an important task in geriatric units with a potential reduction of harms and costs, some measures such as the lower height of the bed showed a significant reduction of the falls (AU)

Characteristics and associated factors in patient falls, and effectiveness of the lower height of beds for the prevention of bed falls in an acute geriatric hospital.

OBJECTIVES: Whereas several studies about patient falls have provided data for long-term healthcare institutions, less information is available for acute care centres. The objective was to analyze the characteristics of the patient falls and associated factors, and the effectiveness of the lower beds' height to reduce the frequency and the harms of the patient falls in an acute geriatric hospital. METHODS: A descriptive and retrospective study using a mandatory safety incident report, the IHI Global Trigger Tool, and the claims related to patient falls between 2007 and 2011 in a 200-bed university-associated geriatric hospital. RESULTS: The falls rate was 5.4 falls per 1000 patient days (1.3% of falls led to fractures) and there was exitus in 6 patients (0.6%). Nearly half of the falls ocurred during the night shift (42.4%). By wards, falls were more frequent in acute geriatric wards (42.9%). A 7.5% of patients had a fall before admission. 3 (0.2%) claims due to possible clinical negligence were found. A reduction (28.3%) of bed falls with the lower height of the bed and a 1.88 times less falls with harm (RR 0.53; CI 95% 0.83-0.34) (p=0.006) was observed. CONCLUSION: The prevention of patient falls is an important task in geriatric units with a potential reduction of harms and costs, some measures such as the lower height of the bed showed a significant reduction of the falls.

Impacto de la historia clínica electrónica sobre los errores de medicación / Impact of computerized physician order entry on medication errors

Introducción. Hay pocos datos sobre el impacto que tiene la historia clínica electrónica sobre la frecuencia y severidad de los errores de medicación en pacientes agudos geriátricos. Material y métodos. Estudio analítico y descriptivo pre- y postimplementación de la historia clínica electrónica (HCE). Periodo de estudio: 6 años, usando un sistema de notificación voluntario para detectar los errores de medicación con el formulario IR2 del Servicio Nacional Inglés de Salud, el Global Trigger Tool y las rondas intinerantes con el Servicio de Farmacia usando las categorías de severidad del National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index Categorizing Errors. Resultados. Se detectaron un total de 1.887 errores de medicación (1.553 pacientes) en el periodo de estudio y representó el primer evento adverso notificado (29,3%). Se encontraron 8,5 eventos adversos por 100 admisiones (0,24 en las categorías E a la I) y los errores de prescripción representaron un 27,6%. Para los fármacos dispensados, los eventos adversos fueron 2,07 veces más frecuentes en el periodo de 3 años (2007-2009) con la HCE que el periodo de 3 años con la historia clínica en papel (2004-2006), siendo más frecuente debido a antibióticos (1,92 veces), antitérmicos (2,21 veces) y opiáceos (2,72 veces). Para errores serios y por dosis dispensadas, hubo 5,18 veces menos de errores serios en el periodo relativo a la HCE, omisión de fármaco (46,8 veces menos frecuente), dosis equivocada (10,53 veces) y antibióticos (10,84 veces). Conclusión. Se han encontrado errores de medicación frecuentes en los pacientes agudos geriátricos. Se observó un incremento en los errores de medicación y una disminución en la severidad de los mismos en relación a la implantación de la historia clínica electrónica. Por este motivo, la implementación de la historia clínica electrónica debe ser monitorizada (AU)

Background. Information is scarce on the impact of the clinical electronic record on the frequency and severity of medication errors in acute geriatric patients. Material and methods. An analytical and descriptive pre-post study was conducted on the implementation of computerized provider order entry systems (CPOE), over a 6 year period. A voluntary reporting system was used to detect the medication errors using the IR2 report form of the UK National Health Service, the Global Trigger Tool and the walk rounds with the Pharmacy Service. The severity categories were taken from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index Categorizing Errors. Results. A total of 1887 medication errors (1553 patients) were detected in the period of study, and represented the first adverse event reported (29.3%). 8.5 adverse events per 100 admissions were found (0.24 in the categories E through I) and the prescription errors represented a 27.6%. By drugs dispensed, adverse events were 2.07 times more frequent in the 3 year period (2007-2009) with electronic clinical record than in the 3 year period with the hand-written system (2004-2006), being more frequent with antibiotics (1.92 times), antipyretic (2.21 times) and opiates (2.72 times). For serious errors and by doses dispensed, there were 5.18 times less frequent serious errors in the period related to the electronic record, drug omission (46.8 times less frequent), wrong dose (10.53 times) and antibiotics (10.84 times). Conclusion. Frequent medication errors were found in acute geriatric patients. An increase in medication errors and a decline in the severity of the detected errors were found in relationship to the electronic clinical record. For these reasons, the implementation of the electronic clinical record should be monitored (AU)

Impact of computerized physician order entry on medication errors.

BACKGROUND: Information is scarce on the impact of the clinical electronic record on the frequency and severity of medication errors in acute geriatric patients. MATERIAL AND METHODS: An analytical and descriptive pre-post study was conducted on the implementation of computerized provider order entry systems (CPOE), over a 6 year period. A voluntary reporting system was used to detect the medication errors using the IR2 report form of the UK National Health Service, the Global Trigger Tool and the walk rounds with the Pharmacy Service. The severity categories were taken from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index Categorizing Errors. RESULTS: A total of 1887 medication errors (1553 patients) were detected in the period of study, and represented the first adverse event reported (29.3%). 8.5 adverse events per 100 admissions were found (0.24 in the categories E through I) and the prescription errors represented a 27.6%. By drugs dispensed, adverse events were 2.07 times more frequent in the 3 year period (2007-2009) with electronic clinical record than in the 3 year period with the hand-written system (2004-2006), being more frequent with antibiotics (1.92 times), antipyretic (2.21 times) and opiates (2.72 times). For serious errors and by doses dispensed, there were 5.18 times less frequent serious errors in the period related to the electronic record, drug omission (46.8 times less frequent), wrong dose (10.53 times) and antibiotics (10.84 times). CONCLUSION: Frequent medication errors were found in acute geriatric patients. An increase in medication errors and a decline in the severity of the detected errors were found in relationship to the electronic clinical record. For these reasons, the implementation of the electronic clinical record should be monitored.

[Walkrounds and briefings in the improvement of the patient safety]. / Walkrounds y Briefings en la mejora de la seguridad de los pacientes.

OBJECTIVE: Training, to increase the safety culture, the reporting of adverse events, and to implement improvements using WalkRounds and Briefings. MATERIAL AND METHODS: Monte Naranco Hospital, hospital with 200 beds and mainly with geriatric patients. METHOD: Patient safety surveys and evaluations of the leaders. DESIGN: face-to-face 1/2h interviews with the healthworkers (3-5 people), and in the changes of shifts from 2004-2009. Analysis tools: a) Patient safety surveys (University of Texas and Agency for Healthcare Research and Quality - AHRQ); b) WalkRounds and Briefings forms; c) classification of contributory factors, and the severity of adverse events. RESULTS: Surveys were conduted on 36.9% and 33.8% of the healthworkers, respectively). WalkRounds training: 84 healthworkers. Number of WalkRounds: with Pharmacy Service (493), and with Patient Complaints Service (147), and Briefings: 307. Reporting of adverse events: Medication errors (71.1%), equipment (7.2%), others (21.7%). Contributory factors Working environment (30.1%), work team (29.2%), others (40.7%). In the post-briefing survey 86.7% of the healthworkers thought that it was a useful tool. New needs: feedback of the personnel with control charts. CONCLUSIONS: WalkRounds and Briefings allow a higher number of adverse events (more than 20%) to be detected, and are useful for the training of healthworkers. There is better feedback and there was less problems with equipment and outpatient units. Face-to-face communication with the healthworkers is a key element in patient safety and helps to know the needs to the front line wards.

[Antimicrobial drugs errors: the silent epidemic in patient safety]. / Errores en el uso de antimicrobianos: la epidemia silenciosa para la seguridad de pacientes.

INTRODUCTION: Prescribed drugs and the mistakes in the administration to patient is the first cause of adverse events in the hospitals. The aim of this study has been to evaluate antimicrobial drug mistakes in one of our hospital wards in a two year period 2005 and 2006. METHODS: All the errors were reported through the National Health Service IR2 form (England) on a voluntary basis and classified by means of process, type of errors, their causes and contributory factors, as well as the severity. We analyzed the economic costs. RESULTS: . A 1.3% of the inpatients had an antimicrobial error in the administration to the patient (0.84 by 1,000 prescribing orders). Classified by processes, the administration (32.4%) and dispensation (44.1%) were the most frequent errors. By type of error: the erroneous medication (32.4%), the main root cause the human factors (58.8 %) and the contribution factor due to design of tasks (55.9 %). The 5.9% of errors were severe events, mainly in the group of the betalactamic drugs, and mainly by parenteral administration (50%). Conclusions. Antimicrobial drug errors, frequent and sometimes severe, suppose a silent epidemic not being detected without the patient safety methodology. They represent a high cost for a hospital.

HER-2 status determination in breast carcinomas. A practical approach.

Accurate evaluation of HER-2 status is crucial in the selection of breast carcinoma patients for trastuzumab (Herceptin) treatment. Various laboratory methods have been used for this purpose. The aim of the present work was to analyse the results obtained in the routine practice by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) in determination of HER-2 status. Five hundred and three cases of breast invasive ductal carcinoma were selected to analyse the HER-2 overexpression by immunohistochemistry (HercepTest, Dako). HercepTest 2+ equivocal cases (60) were studied by FISH (PathVysion, Vysis) to determine HER-2 gene amplification. HER-2 overexpression determined by Herceptest was shown in 97/503 cases (19%). FISH performed on equivocal cases demonstrated HER-2 amplification in 11/60 tumours (18%). IHC and FISH together showed HER-2 overexpression/gene amplification in 21% of breast invasive carcinomas. Immunohistochemical determination of HER-2 status represents an easy and standardized method that (in contrast to FISH) can be performed in all pathology laboratories without need of any special microscope and enabling to check the morphologic features of the cells analysed. However, in order to assure the reliability of the results, standardization of fixation protocols, automation of the immunohistochemical procedure, and training of pathologists in the interpretation of the results (scoring criteria) should be a priority. Equivocal HercepTest cases must be analysed by FISH preferably in a reference laboratory.

Phase II Clinical Trial With Pegylated Liposomal Doxorubicin (CAELYX(R)/Doxil(R)) and Quality of Life Evaluation (EORTC QLQ-C30) in Adult Patients With Advanced Soft Tissue Sarcomas: A study of the Spanish Group for Research in Sarcomas (GEIS).

BACKGROUND: Pegylated liposomal doxorubicin (PLD), a formulation with pharmacokinetic differences with respect to doxorubicin (DXR), might benefit patients with advanced soft tissue sarcoma (STS) pretreated with DXR. PATIENTS AND METHODS: Patients with measurable and progressive STS received PLD at 35 mg/(2) every 3 weeks. Quality of life before and during treatment was assessed with EORTC QLQ-C30. RESULTS: Twenty-eight patients, 22 DXR-pretreated, were given 140 cycles (median 3, range 1-18). Activity in 27 patients (5 GIST): one complete and one partial remission (both non-GIST and without prior DXR), 12 stabilizations and 13 progressions (response rate 7.4%, 95% CI: 0-17%). Grade 3 toxicity: palmar-plantar erythrodysesthesia (19% of patients), stomatitis (4%) or cutaneous (4%). Neutropenia grade>/=3 was detected in 16% of patients. Median relative dose intensity was 95%. Progression-free rate at 3 and 6 months was, respectively, 48 and 22%, median progression-free survival 5.8 months and median overall survival 8.7 months. QLQ-C30 at baseline and at weeks 6-11 in 23 and 13 patients, respectively, showed good reliability and validity. Quality of life did not seem to worsen during therapy. CONCLUSIONS: PLD did not induce objective remissions in 22 STS patients pretreated with DXR, but progression-free rate figures support the use of this agent in patients who have not progressed under a DXR-containing regimen. The toxicity observed was comparable to that of other PLD schedules.

["Sacroiliitis" as the initial manifestation of hepatocarcinoma]. / "Sacroileítis" como manifestación inicial de un hepatocarcinoma.

The hepatocellular carcinomas rarely develop in absence of a previous hepatopathy and their first clinical manifestations are not related, in general, to the metastasis located at the bones of the pelvic girdle. We present a multifocal hepatocarcinoma in a 17-year-old woman without known risk factors, whose initial manifestation was a clinical radiological picture suggesting left sacroiliitis. We stress this rare manifestation preceding the diagnosis of neoplasia two years later.