Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease.

BACKGROUND: Adalimumab biosimilar MSB11022 (Idacio ®) has been approved for the same indications as its originator (Humira ®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce. METHODS: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index (HBI) have been usEd.) for Crohn's disease and Mayo Score for Ulcerative Colitis. Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab. RESULTS: No significant differences were observed in clinical disease activity (P=.317) or biochemical parameters [fecal calprotectin (P=.445) and C-reactive protein P=.661)] after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (P=.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects. CONCLUSIONS: Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.

Toxicity and effectiveness of carboplatin in obese or overweight patients.

OBJECTIVE: To evaluate the efficiency and toxicity of carboplatin using actual body weight in obese/overweight patients using the Calvert formula with Cockcroft-Gault for CrCl estimation. METHODS: We evaluated the association of BMI in regards to efficiency and toxicity in a retrospective cohort study of patients who started treatment with carboplatin between 2012 and 2013. Cohorts included obese/overweight patients and normal-weight patients. Efficiency was measured by overall survival, progression-free survival and response rate. Toxicity was measured by the proportion of dose reductions and delays of chemotherapy cycles. We utilized a bivariate and multivariate analysis. RESULTS: Eighty-six patients were included in the study (50% obese/overweight). There was not a statistically significant difference in effectiveness and toxicity between the two groups in BMI. In the multivariate analysis, BMI not was associated with overall survival (hazard ratio: 0.95, 95% CI: 0.54-1.66, p = 0.849), progression-free survival (hazard ratio: 0.91; 95% CI: 0.54-1.54; p = 0.732), cycle delays (odds ratio (OR): 1.47, 95% CI: 0.80-2.69, p = 0.218) or carboplatin dose reductions (OR: 0.87, 95% CI: 0.35-2.15, p = 0.760). Response rate was 53.5% in both groups. CONCLUSIONS: In our study, obese and overweight cancer patients did not show a statistically significant difference in terms of effectiveness and toxicity compared to normal-weight cancer patients who were treated with carboplatin using their actual body weight with the Calvert formula and Cockcroft-Gault for CrCl estimation. Therefore, it was appropriate to use the actual body weight for our patients.

Test de reserva de sangre preoperatorio en cesáreas electivas de bajo riesgo: ¿es realmente necesario? / Pre-operative blood reserve test in low-risk elective cesareans: Is it really necessary?

Objetivo: el test de tipaje y escrutinio se ha postulado en España como la prueba pretransfusional de elección en cirugía programada. Actualmente, solo el 1,1-1,7% de las pacientes a las que se realiza una cesárea precisan transfusión sanguínea. El objetivo fue valorar la necesidad de realizar test de reserva de sangre preoperatorio en las cesáreas electivas de bajo riesgo, atendiendo al análisis racional de sobrereserva, riesgo-beneficio y coste- efectividad e identificando los factores que comportaron una mayor pérdida hemática. Material y métodos: se diseñó un estudio observacional, descriptivo y retrospectivo. Se incluyó a 189 mujeres sometidas a cesárea electiva en el hospital de Dénia en el período entre 2015 y 2016. Todas ellas disponían de un test de reserva de sangre preoperatorio. Se excluyeron las cesáreas urgentes y las pacientes con indicación de cesárea electiva que iniciaron dinámica de parto o rotura prematura de membranas. Resultados: de las 189 cesáreas, únicamente una (0,005%) precisó transfusión sanguínea de manera preoperatoria, por presentar una hemoglobina de 7 g/dl. Todos los indicadores de reserva sanguínea mostraron sobrereserva en cesáreas electivas. El descenso de hemoglobina se asoció a una edad gestacional inferior a 40 semanas, mayor edad materna y mayor hemoglobina preoperatoria. Conclusiones: los datos obtenidos tras el análisis estadístico de la muestra nos han permitido eliminar el test de reserva de sangre preoperatorio en cesáreas electivas de nuestro protocolo. Se mantendrá en los diagnósticos con mayor riesgo de sangrado y según indicación del obstetra y/o anestesiólogo (AU)

Objective: Type and screen test has been implement in Spain as pre-transfusional elective test in programmed surgery. Currently, only 1.1-1.7% of patients undergoing cesarean section require blood transfusion. To assess the need to make a pre-operative blood reserve test in elective cesarean sections based on the rational analysis of over-reserve, risk-benefit and cost-effectiveness and identifying which factors lead to an increase in blood loss. Material and methods: An observational, descriptive and retrospective study was designed. 189 women were included to be operated by an elective cesarean section at Denia’s Hospital, between 2015 and 2016. All of them had a preoperative blood test reserve. Urgent cesarean sections and patients with elective cesarean section indication who started labor contractions or premature rupture of membranes were excluded. Results: Only one of the 189 women included (0.005%) was given a preoperative blood transfusion, because of the hemoglobin level was 7 g/dl. All blood reserve parameters show over-reserve in elective cesarean sections. The decrease of hemoglobin was associated with a gestational age less than 40 weeks, greater maternal age and greater preoperative hemoglobin. Conclusions: Data obtained after statistical analysis of the sample allowed us to remove the blood reserve test in elective cesarean sections of our protocol. It will be kept in diagnoses with greater bleeding risk and according to the obstetrician and/or anesthesiologist indications (AU)

CuidaCare: effectiveness of a nursing intervention on the quality of life's caregiver: cluster-randomized clinical trial.

BACKGROUND: In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life.Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking. METHODS/DESIGN: A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention.One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included.The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver.The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. DISCUSSION: Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov under code number NCT 01478295.

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting.

BACKGROUND: High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method--the EDUCORE method--is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; METHODS/DESIGN: This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure >or= 140 mmHg and/or diastolic >or= 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; DISCUSSION: The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting; TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov].

Valoración de hemoglobina glucosilada en sangre capilar frente a la obtenida en sangre venosa / No disponible

No disponible

Prevalencia de problemasde cuidados en poblaciónvulnerable / Prevalence of care problems in vulnerable population

Objetivos: estimar la prevalencia de problemas de cuidados en población vulnerablede un Área de Atención Primaria (AP).Material y métodos: estudio de diseño descriptivo transversal, realizado enun Área de Atención Primaria, durante el año 2007, con una población menorde 15 años y mayor de 75 años y con registro en Historia Clínica Informatizada(HCI). Se realiza una única medición en diciembre de 2007 delos diagnósticos enfermeros registrados en HCI de la aplicación corporativaOMI-AP. La explotación de datos se realiza a través de un lenguaje estructuradode consulta informática (SQL). Variables estudiadas: edad, sexo,etiqueta diagnóstica (NANDA II), número de consultas, duración del proceso(días) y motivo del alta de cuidados. Análisis estadístico: las variablescualitativas se describen con su distribución de frecuencias (%) y las variablescuantitativas se resumen con mediana y rango intercuartílico. El paqueteestadístico utilizado es el SPSS® versión 15.Resultados: población diana: 20,32% de la población total. Se diagnosticaron45.384 problemas; el 23,79% en población vulnerable. Diagnósticos prevalentes:ancianos: deterioro de la integridad cutánea (3,54%) y problemasde desempeño del rol cuidador (2,70% y 2,59%); niños: conductas generadorasde salud (32,97%). Ratio de visitas/diagnóstico: ancianos: 1,44 (1,00-1,93); niños: 1,2 (1,00 -1,51). Duración proceso: ancianos: 52 (18-73); niños:17 (7,3 – 36,6). Motivos alta: resolución (79%-85%), seguimiento controlado(14%-8,60%), no resolución (3%-0,5%), fallecimiento (3%-0%),abandono (1%-4,35%).Conclusiones: el sexo es un factor determinante del diagnóstico en ancianos.Los niños se mueven en diagnósticos positivos. La utilización de laetiqueta “Conductas generadoras de salud” crea dudas de buen uso a losinvestigadores. Destaca la presencia enfermera en situaciones de riesgo. Eltiempo de resolución se asocia a la dificultad de trabajar cambios actitudinalesy comportamientos saludables (AU)

Objectives: to estimate the prevalence of care problems in vulnerable populationin a Primary Care (PC) Area.Material and methods: cross-sectional descriptive design, performed in a PrimaryCare Area, throughout 2007, with a population under the age of 15years and over the age of 75 years and with a registry in ComputerisedClinical History (CCH). One single measurement of nursing diagnosesrecorded in the CCH of the corporate application OMI-AP is recorded inDecember 2007. Data analysis is performed using a structured computerisedconsultation language (SQL). Studied variables: age, gender, diagnosticlabel (NANDA II), number of consultations, process duration (days)and reason for care discharge. Statistical analysis: qualitative variablesare described in terms of their frequency distribution (%) and quantitativevariables are summarised using median and interquartile range. The statisticalpackage used is SPSS® version 15.Results: target population: 20,32% of the total population. 45,384 problemswere diagnosed; 23,79% in vulnerable population. Prevalent diagnoses:elderly: deterioration of skin integrity (3,54%) and carer role problems(2,70% and 2,59%); children: health generating behaviours (32,97%).Consultations/diagnosis ratio: elderly: 1,44 (1,00-1,93); children: 1,2 (1,00-1,51). Process duration: elderly: 52 (18-73); children: 17 (7,3-36,6). Reasonsfor discharge reasons: resolution (79%-85%), controlled follow-up(14%-8,60%), no resolution (3%-0,5%), death (3%-0%), discontinuation (1%-4,35%).Conclusions: gender is a key factor of diagnosis in elderly patients. Childrenhave positive diagnoses. The use of the “Health generating behaviours”label creates good use doubts in researchers. The nursing presencein situations of risk stands out. The timeframe for resolution is associatedwith the difficulty of working on attitude changes and healthy habits (AU)

[Analysis of complaints in primary care using statistical process control]. / Análisis de las reclamaciones en atención primaria mediante el control estadístico de procesos.

OBJECTIVE: To analyze patient complaints in a Primary Health Care District (PHCD) using statistical process control methods compared to multivariate methods, as regards their results and feasibility of application in this context. MATERIAL AND METHOD: Descriptive study based on an aggregate analysis of administrative complaints. SETTING: Complaints received between January 2005 and August 2008 in the Customer Management Department in the 3rd PHCD Management Office, Madrid Health Services. Complaints are registered through Itrack, a computer software tool used throughout the whole Community of Madrid. MAIN VARIABLES: Total number of complaints, complaints sorted by Reason and Primary Health Care Team (PHCT), total number of patient visits (including visits on demand, appointment visits and home visits) and visits by PHCT and per month and year. STATISTICAL ANALYSIS: Multivariate analysis and control charts were used. RESULTS: 44-month time series with a mean of 76 complaints per month, an increasing trend in the first three years and decreasing during summer months. Poisson regression detected an excess of complaints in 8 out of the 44 months in the series. The control chart detected the same 8 months plus two additional ones. CONCLUSIONS: Statistical process control can be useful for detecting an excess of complaints in a PHCD and enables comparisons to be made between different PHC teams. As it is a simple technique, it can be used for ongoing monitoring of customer perceived quality.

Análisis de las reclamaciones en atención primaria mediante el control estadístico de procesos / Analysis of complaints in primary care using statistical process control

Objetivo: Analizar las reclamaciones de un área de atención primaria mediante técnicas de control estadístico de procesos, y compararlas con técnicas multivariables en cuanto a sus resultados y su factibilidad de aplicación en este medio. Material y método: Estudio descriptivo con análisis agregado de las reclamaciones administrativas. Período del estudio: reclamaciones recibidas desde enero de 2005 a agosto de 2008. Fuente de datos: la Unidad de Gestión de Usuarios de la Gerencia de Atención Primaria Área 3, Servicio Madrileño de Salud registra las reclamaciones en el programa track, utilizado en toda la Comunidad de Madrid. Mediciones principales: número total de reclamaciones, reclamaciones por motivo y por equipo de atención primaria, número de consultas totales (incluye consultas a demanda, concertadas y domicilio) y consultas por EAP, mes y año. Análisis estadístico: aplicación de técnicas multivariables y gráficos de control. Resultados: Serie temporal de 44 meses con una mediana de 76 reclamaciones/mes, una tendencia incremental en los primeros 3 años y descensos durante el verano. La regresión de Poisson permite detectar un exceso de reclamaciones en 8 de los 44 meses de la serie. El gráfico de control identifica los mismos puntos y 2 adicionales. Conclusiones: El control estadístico de procesos puede resultar útil para detectar excesos de reclamaciones en un área de salud y comparar entre unidades asistenciales. Su fácil aplicación permite realizar una monitorización continua de la calidad percibida por los usuarios (AU)

Objective: To analyze patient complaints in a Primary Health Care District (PHCD) using statistical process control methods compared to multivariate methods, as regards their results and feasibility of application in this context. Material and method: Descriptive study based on an aggregate analysis of administrative complaints. Setting: Complaints received between January 2005 and August 2008 in the Customer Management Department in the 3 rd PHCD Management Office, Madrid Health Services. Complaints are registered through track, a computer software tool used throughout the whole Community of Madrid. Main variables: Total number of complaints, complaints sorted by Reason and Primary Health Care Team (PHCT), total number of patient visits(including visits on demand, appointment visits and home visits) and visits by PHCT and per month and year. Statistical analysis: Multivariate analysis and control charts were used. Results: 44-month time series with a mean of 76 complaints per month, an increasing trend in the first three years and decreasing during summer months. Poisson regression detected an excess of complaints in 8 out of the 44 months in the series. The control chart detected the same 8 months plus two additional ones. Conclusions: Statistical process control can be useful for detecting an excess of complaints in a PHCD and enables comparisons to be made between different PHC teams. As it is a simple technique, it can be used for ongoing monitoring of customer perceived quality (AU)

Serie temporal de los accidentes laborales atendidos en un hospital de agudos y su relación con la meteorología y la polución atmosférica / Time series of industrial accidents attended in an acute hospital care and its relation to meteorology and atmospheric pollution

Introducción: La siniestralidad es un proceso en muchas ocasiones complejo en el que entran diversos factores de riesgo, tanto inherentes al trabajo como a circunstancias exteriores (organización, climatología, etc.).Objetivos: Describir la tendencia y factores relacionados de los accidentes de trabajo (A.T.) atendidos en un hospital de agudos de Madrid durante el trienio 2005-07 y su relación con la meteorología y la polución atmosférica.Metodología: Estudio ecológico. Se analizaron los A.T. atendidos en el Servicio de Urgencias del Hospital Universitario de la Princesa de Madrid, durante el trienio 2005-07. Las variables analizadas fueron variables de calendario, climáticas y niveles de contaminación. Se realizó un estudio descriptivo y univariante y se modelizó por medio de una Regresión de Poisson. La medida de asociación fue el Riesgo Relativo con sus Intervalos de Confianza al 95 %.Resultados: La tendencia es estacionaria disminuyendo en el año 2007. El calor es un factor de riesgo, temperaturas superiores a 25 º C. aumenta la siniestralidad un 19 %. La presión atmosférica se comporta como efecto protector. Las variables de contaminación no fueron significativas.Conclusiones: Durante el año 2007, la siniestralidad laboral atendida en el servicio de Urgencias del hospital ha disminuido. Los A.T. tienen una relación con temperaturas elevadas y presión atmosférica (AU)

Introduccion: The work accident rate is in several occasions a complex process in wich divers safety factors take place, inherente to the job /profesión as well as external circumstances (organization, climatology, etc)Objectives: To describe the tendency and factors wich are linked to the occupational Hazard, admitted toa cute hospital in Madrid during the 2005-2007 triennium and its relations with meteorology and environmental pollution.Methodology: Ecologic study. Occupational injuries admitted in the accident and emergency department at the University Hospital “La Princesa” in Madrid were analysed Turing the 2005-2007 triennium. The variables analysed were calendar variable, climatic and levels of environmental pollution. A descrptive and univariant study was carried out under the assumption of a Poisson regresión. The measure of association was relative Risk with its Confidence Interval Applet at 95%.Results: The tendency is stabillized but weaning in 2007. Heat is a risk factor, temperaturas above 25 Degress Celsius increases the work accident rate by 19%. Atmospheric pressure behaves as a protective effect. However, the variables for contamination weren’t significant.Conclusion: During 2007, work accident rate atended in the accident and emergency department at the Hospital has diminish. Occupational Hazard is related to high temperaturas and atmospheric pressure (AU)