Prediction of platelet counts with ROTEM-sigma in cardiac surgery.

BACKGROUND: Excessive bleeding is common after cardiac surgery. According to transfusion algorithms based on ROTEM results (TEM International Inc., Munich, Germany), platelet transfusion is recommended when FIBTEM amplitude is normal and EXTEM amplitude is reduced. The aim of this study was to evaluate whether ROTEM (TEM International Inc.) parameters may predict accurately platelet counts in cardiac surgery patients, and to determine which of these parameters is the most useful for predicting platelet counts. METHODS: In this retrospective single center study data from 83 patients who underwent cardiac surgery were reviewed. We analyzed the results of patients for whom ROTEM (TEM International Inc.) and conventional laboratory tests were performed simultaneously. The derived ROTEM (TEM International Inc.) parameter PLTEM was used to estimate platelet count; PLTEM is calculated by subtracting FIBTEM from EXTEM. Correlation between ROTEM (TEM International Inc.) variables and platelet counts were determined. Logistic regression analyses were performed to predict platelet counts. RESULTS: ROTEM A5 values show a high linear correlation with MCF values. PLTEM has a strong linear correlation with platelet counts. According to our results for PLTEM A5<32 mm the probability of platelet count <150×109/L is 100%, for PLTEM A5<27 mm the probability of platelet count <100×109/L is nearly 80%, and for PLTEM A5<22 the probability of platelet count <75×109/L is 70%. CONCLUSIONS: This study demonstrates the reliability of considering early ROTEM (TEM International Inc.) results and the feasibility of using PLTEM A5 to predict platelet counts and so, improve our ability to decide the need of platelet transfusion in cardiac surgery patients.

Multicenter retrospective study to evaluate the impact of trabectedin plus pegylated liposomal doxorubicin on the subsequent treatment in women with recurrent, platinum-sensitive ovarian cancer.

Debulking surgery, followed by taxane/platinum-based chemotherapy has traditionally been the first-line treatment for advanced ovarian cancer. However, most patients will experience recurrence afterwards, and receive subsequent lines of therapy. It has been proposed that extending the treatment-free interval of platinum can improve the response to a subsequent platinum-based chemotherapy, and reduce associated toxicities in women with recurrent, platinum-sensitive ovarian cancer. The aim was to determine the impact, in clinical practice, of trabectedin with pegylated liposomal doxorubicin (trabectedin/PLD) on the subsequent platinum-based therapy in these patients, and to explore the prognosis for breast cancer gene status and the expression of diverse genes. This was a multicenter, retrospective, postauthorization study that involved 79 patients. Germline or somatic mutations of breast cancer gene 1/2 were present in 21.5%. The median time between trabectedin/PLD and the onset of the subsequent treatment was 6.7 months. The overall response rate during the trabectedin/PLD period was 36.7%. In the subsequent first-line platinum-based therapy, the overall response rate was 51.4%. Progression-free survival and overall survival were 11.8 and 25.4 months, respectively, from the onset of trabectedin/PLD treatment. Partially platinum-sensitive (between 6 and 12 months) and platinum-sensitive patients (treatment-free interval of platinum≥12 months) showed no differences in progression-free survival and overall survival. Grade 3 neutropenia and asthenia were reported in 15.2 and 10.1% of patients, respectively. Most frequent adverse events in more than 10% of patients were neutropenia (45.6%), asthenia (43.0%), nausea (25.3%), and anemia (13.9%). The intercalation with a nonplatinum regimen may improve the response to a subsequent platinum-based therapy in women with recurrent, platinum-sensitive ovarian cancer.

Eficacia de una estrategia combinada para mejorar el control del colesterol unido a lipoproteínas de baja densidad en pacientes con hipercolesterolemia. Ensayo clínico aleatorizado / Efficacy of a combined strategy to improve low-density lipoprotein cholesterol control among patients with hypercholesterolemia: a randomized clinical trial

Introducción y objetivos: Intervenciones diferentes pueden mejorar el control del colesterol unido a lipoproteínas de baja densidad (cLDL). El objetivo principal era evaluar la eficacia de una intervención combinada para mejorar el control del cLDL de pacientes con hipercolesterolemia. También se evaluó su eficacia para mejorar el cumplimiento (farmacológico, dieta y ejercicio). Métodos: Ensayo clínico aleatorizado, de grupos paralelos y multicéntrico (atención primaria) que incluyó a 358 adultos diagnosticados de hipercolesterolemia con tratamiento previo farmacológico o no. Se comparó a 178 sujetos que recibieron intervención combinada (material escrito, tarjetas autocumplimentadas y mensajes al móvil) frente a 178 controles. La variable principal de resultado fue la proporción de sujetos con adecuado control del cLDL (valores recomendados en las guías europeas de dislipemias y riesgo cardiovascular) a los 24 meses. Resultados: El grupo de intervención mostró una reducción media del cLDL significativamente superior a los 24 meses respecto al control, 23,8 mg/dl (IC95%, 17,5-30,1) y 14,6 mg/dl (IC95%, 8,9-20,4), respectivamente (p = 0,034). El promedio de la reducción del cLDL fue del 13,1 ± 28,6%. La proporción de sujetos con adecuado control al año fue significativamente superior en el grupo de intervención (43,7 frente a 30,1%; p = 0,011; RR = 1,46). En el grupo de intervención, el cumplimiento farmacológico fue significativamente superior (77,2 frente a 64,1%; p = 0,029) y de la práctica de ejercicio (64,9 frente a 35,8%; p < 0,001), aunque no de la dieta. Conclusiones: La intervención combinada consigue una reducción significativa de las cifras de cLDL (superior al 13% al cabo de 2 años) y mejora el grado de control de pacientes con hipercolesterolemia al año (AU)

Introduction and objectives: Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise). Methods: A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months. Results: At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8 mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6 mg/dL [95%CI, 8.9-20.4]; P = .034). The mean LDL-C decrease was 13.1% ± 28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P = .011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P = .029) and exercise (64.9% vs 35.8; P < .001), but not to diet. Conclusions: The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year (AU)

Efficacy of a Combined Strategy to Improve Low-density Lipoprotein Cholesterol Control Among Patients With Hypercholesterolemia: A Randomized Clinical Trial.

INTRODUCTION AND OBJECTIVES: Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise). METHODS: A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months. RESULTS: At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6mg/dL [95%CI, 8.9-20.4]; P=.034). The mean LDL-C decrease was 13.1%±28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P=.011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P=.029) and exercise (64.9% vs 35.8; P<.001), but not to diet. CONCLUSIONS: The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year.

Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial.

BACKGROUND: Angiogenesis is a target in the treatment of ovarian cancer. Nintedanib, an oral triple angiokinase inhibitor of VEGF receptor, platelet-derived growth factor receptor, and fibroblast growth factor receptor, has shown activity in phase 2 trials in this setting. We investigated the combination of nintedanib with standard carboplatin and paclitaxel chemotherapy in patients with newly diagnosed advanced ovarian cancer. METHODS: In this double-blind phase 3 trial, chemotherapy-naive patients (aged 18 years or older) with International Federation of Gynecology and Obstetrics (FIGO) IIB-IV ovarian cancer and upfront debulking surgery were stratified by postoperative resection status, FIGO stage, and planned carboplatin dose. Patients were randomly assigned (2:1) via an interactive voice or web-based response system to receive six cycles of carboplatin (AUC 5 mg/mL per min or 6 mg/mL per min) and paclitaxel (175 mg/m(2)) in addition to either 200 mg of nintedanib (nintedanib group) or placebo (placebo group) twice daily on days 2-21 of every 3-week cycle for up to 120 weeks. Patients, investigators, and independent radiological reviewers were masked to treatment allocation. The primary endpoint was investigator-assessed progression-free survival analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01015118. FINDINGS: Between Dec 9, 2009, and July 27, 2011, 1503 patients were screened and 1366 randomly assigned by nine study groups in 22 countries: 911 to the nintedanib group and 455 to the placebo group. 486 (53%) of 911 patients in the nintedanib group experienced disease progression or death compared with 266 (58%) of 455 in the placebo group. Median progression-free survival was significantly longer in the nintedanib group than in the placebo group (17·2 months [95% CI 16·6-19·9] vs 16·6 months [13·9-19·1]; hazard ratio 0·84 [95% CI 0·72-0·98]; p=0·024). The most common adverse events were gastrointestinal (diarrhoea: nintedanib group 191 [21%] of 902 grade 3 and three [<1%] grade 4 vs placebo group nine [2%] of 450 grade 3 only) and haematological (neutropenia: nintedanib group 180 [20%] grade 3 and 200 (22%) grade 4 vs placebo group 90 [20%] grade 3 and 72 [16%] grade 4; thrombocytopenia: 105 [12%] and 55 [6%] vs 21 [5%] and eight [2%]; anaemia: 108 [12%] and 13 [1%] vs 26 [6%] and five [1%]). Serious adverse events were reported in 376 (42%) of 902 patients in the nintedanib group and 155 (34%) of 450 in the placebo group. 29 (3%) of 902 patients in the nintedanib group experienced serious adverse events associated with death compared with 16 (4%) of 450 in the placebo group, including 12 (1%) in the nintedanib group and six (1%) in the placebo group with a malignant neoplasm progression classified as an adverse event by the investigator. Drug-related adverse events leading to death occurred in three patients in the nintedanib group (one without diagnosis of cause; one due to non-drug-related sepsis associated with drug-related diarrhoea and renal failure; and one due to peritonitis) and in one patient in the placebo group (cause unknown). INTERPRETATION: Nintedanib in combination with carboplatin and paclitaxel is an active first-line treatment that significantly increases progression-free survival for women with advanced ovarian cancer, but is associated with more gastrointestinal adverse events. Future studies should focus on improving patient selection and optimisation of tolerability. FUNDING: Boehringer Ingelheim.

Efecto a largo plazo de los estanoles vegetales en el perfil lipídico de pacientes con hipercolesterolemia. Ensayo clínico aleatorizado / Long-term effects of plant stanols on the lipid profile of patients with hypercholesterolemia. A randomized clinical trial

Introducción y objetivos. El consumo de estanoles vegetales puede contribuir a un mejor control a largo plazo del colesterol. El objetivo es evaluar la eficacia del aporte de estanoles vegetales, a dosis de 2 g/día, en la reducción de las cifras de colesterol unido a lipoproteínas de baja densidad de los pacientes con hipercolesterolemia. Métodos. Se realizó un ensayo clínico aleatorizado, a doble ciego y controlado con placebo, en el que se incluyó a 182 sujetos adultos diagnosticados de hipercolesterolemia. Se administró yogur líquido con 2 g de estanoles vegetales a 91 sujetos del grupo intervención y yogur no suplementado a 91 del grupo control. La variable principal fue la variación del perfil lipídico a los 12 meses. Resultados. En comparación con el placebo, a los 12 meses se observó una disminución significativamente superior del colesterol unido a lipoproteínas de baja densidad en el grupo que tomó estanoles: 13,7 (intervalo de confianza del 95%, 3,2-24,1) mg/dl (p = 0,011). En este grupo fue significativamente superior la proporción de sujetos que redujeron en más del 10% sus cifras de colesterol unido a lipoproteínas de baja densidad (riesgo relativo = 1,7; intervalo confianza del 95%, 1,1-2,7). En el grupo tratado, el colesterol unido a lipoproteínas de baja densidad descendió, en promedio, un 11,0 ± 23,9%. Conclusiones. Los resultados confirman que la administración de estanoles vegetales en dosis de 2 g/día durante 1 año produce una reducción significativa (ligeramente superior al 10%) de las concentraciones de colesterol unido a lipoproteínas de baja densidad en sujetos con hipercolesterolemia (AU)

Introduction and objectives. Plant stanol consumption may improve long-term cholesterol control. The aim of the present study was to evaluate the effectiveness of 2 g/day of plant stanols in reducing low-density lipoprotein cholesterol levels in patients with hypercholesterolemia. Methods. This randomized, double-blind, and placebo-controlled study included 182 adults diagnosed with hypercholesterolemia. A yogurt drink containing 2 g of plant stanols was administered to 91 participants in the intervention group; 91 participants in the control group received unsupplemented yogurt. The primary end point was the change in the lipid profile at 12 months. Results. Low-density lipoprotein cholesterol levels at 12 months were significantly more reduced in the stanol intervention group than in the control group: 13.7 (95% confidence interval, 3.2-24.1) mg/dL (P = .011). A reduction of more than 10% in low-density lipoprotein cholesterol was achieved by a significantly higher proportion of participants in the intervention group (relative risk = 1.7; 95% confidence interval, 1.1-2.7). In this group, the mean (standard deviation) level of low-density lipoprotein cholesterol decreased by 11.0% (23.9%). Conclusions. Our results confirm that administration of plant stanols at a dosage of 2 g/day for 12 months significantly reduces (by slightly more than 10%) the concentrations of low-density lipoprotein cholesterol in individuals with hypercholesterolemia (AU)

Effectiveness of a combined strategy to improve therapeutic compliance and degree of control among patients with hypercholesterolaemia: a randomised clinical trial.

BACKGROUND: In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner's practice. METHODS/DESIGN: A randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain's Autonomous Regions (Comunidades Autónomas), covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy. DISCUSSION: Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02314663.

Long-term Effects of Plant Stanols on the Lipid Profile of Patients With Hypercholesterolemia. A Randomized Clinical Trial.

INTRODUCTION AND OBJECTIVES: Plant stanol consumption may improve long-term cholesterol control. The aim of the present study was to evaluate the effectiveness of 2g/day of plant stanols in reducing low-density lipoprotein cholesterol levels in patients with hypercholesterolemia. METHODS: This randomized, double-blind, and placebo-controlled study included 182 adults diagnosed with hypercholesterolemia. A yogurt drink containing 2g of plant stanols was administered to 91 participants in the intervention group; 91 participants in the control group received unsupplemented yogurt. The primary end point was the change in the lipid profile at 12 months. RESULTS: Low-density lipoprotein cholesterol levels at 12 months were significantly more reduced in the stanol intervention group than in the control group: 13.7 (95% confidence interval, 3.2-24.1) mg/dL (P=.011). A reduction of more than 10% in low-density lipoprotein cholesterol was achieved by a significantly higher proportion of participants in the intervention group (relative risk=1.7; 95% confidence interval, 1.1-2.7). In this group, the mean (standard deviation) level of low-density lipoprotein cholesterol decreased by 11.0% (23.9%). CONCLUSIONS: Our results confirm that administration of plant stanols at a dosage of 2 g/day for 12 months significantly reduces (by slightly more than 10%) the concentrations of low-density lipoprotein cholesterol in individuals with hypercholesterolemia. Trial registration (www.ClinicalTrials.gov): Current Controlled Trials NCT01406106.

Neurocognitive and Seizure Outcomes of Selective Amygdalohippocampectomy versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy.

Objective. To report our institutional seizure and neuropsychological outcomes for a series of patients with mesial temporal lobe epilepsy (mTLE) undergoing anterior temporal lobectomy (ATL) or selective amygdalohippocampectomy (SelAH) between 2004 and 2011. Methods. A retrospective study of patients with mTLE was conducted. Seizure outcome was reported using time-to-event analysis. Cognitive outcome was reported using the change principal in component factor scores, one each, for intellectual abilities, visuospatial memory, and verbal memory. The Boston Naming Test was used for naming assessment. Language dominant and nondominant resections were compared separately. Student's t-test was used to assess statistical significance. Results. Ninety-six patients (75 ATL, 21 SelAH) were included; fifty-four had complete neuropsychological follow-up. Median follow-up was 40.5 months. There was no statistically significant difference in seizure freedom or any of the neuropsychological outcomes, although there was a trend toward greater postoperative decline in naming in the dominant hemisphere group following ATL. Conclusion. Seizure and neuropsychological outcomes did not differ for the two surgical approaches which is similar to most prior studies. Given the theoretical possibility of SelAH sparing language function in patients with epilepsy secondary to mesial temporal sclerosis and the limited high-quality evidence creating equipoise, a multicenter randomized clinical trial is warranted.

Seguimiento de la adherencia al tratamiento antidepresivo en pacientes que inician su consumo / Adherence to patients antidepressant treatment and the factors associated of non-compiance

OBJETIVO: Conocer la adherencia al tratamiento en pacientes que inician fármacos antidepresivos y analizar los factores asociados al incumplimiento, tanto clínicos como sociodemográficos. DISEÑO: Estudio observacional longitudinal prospectivo. Emplazamiento: Consultas de atención primaria y de salud mental de tres áreas sanitarias de Castilla-La Mancha. Participantes: Un total de 185 pacientes mayores de 18 años que iniciaron tratamiento antidepresivo. Mediciones principales: Cumplimiento terapéutico (test Haynes-Sackett, Morisky-Green, recuento de comprimidos y MEMS), efectos adversos, intensidad de los síntomas depresivos, características sociodemográficas y otras características relacionadas con los antidepresivos o con los participantes. RESULTADOS: Tras 6 meses del inicio del tratamiento antidepresivo, el 46,9% (IC 95%: 36,5-57,3) mostró un cumplimiento inadecuado mediante el método de recuento de comprimidos, y el 28,6% (IC 95%: 19,1-38,0) con el cuestionario de Morisky-Green. A los 15 días la falta de adherencia fue del 48,5% (IC 95%: 40,6-56,4) y del 33,5% (IC 95%: 26,1-41,0), respectivamente. El 38,4% (IC 95%: 31,1-45,7) manifestó algún efecto secundario durante el seguimiento. Mediante un modelo de riesgos proporcionales de Cox las variables relacionadas con incumplimiento fueron menor edad, nivel de instrucción inferior a enseñanza secundaria, prestación farmacéutica como pensionista, no recibir tratamiento psicoterápico, consumir menor número de fármacos no antidepresivos y frecuentación ≤ 3 visitas al médico de familia los 3 meses previos al inicio del estudio. CONCLUSIONES: El incumplimiento del tratamiento antidepresivo es elevado en atención primaria desde las primeras semanas tras iniciarlo. Constituyen factores condicionantes del mismo los relacionados con características sociodemográficas y con otras características de los pacientes como tipo de financiación de prestación farmacéutica y frecuentación a las consultas

OBJETIVE: To know the adherence to treatment in patients who initiate antidepressant drugs and to analyze the determinant factors of non-compliance, so much clinical as sociodemographic. DESIGN: Prospective longitudinal observational study. Location: Primary Health Care and Mental Health Surgeries of three Castilla-La Mancha Areas. Participants: 185 adults patients who were started in antidepressant treatment were evaluated. Measurements: Treatment adherence (test Haynes-Sackett, test Morisky-Green, count of tablets and MEMS), adverse effects, intensity of depressive symptoms, sociodemographic characteristics and other characteristics related to antidepressants or participants. RESULTS: After 6 months of beginning antidepressing treatment, 46.9% (95% IC: 36.5-57.3) showed an inadequate fulfilment by pill count method and 28.6% (95% IC: 19.1-38.0) with Morisky-Green's questionnaire. To 15 days the lack of adherence was 48.5% (95% IC: 40.6-56.4) and of 33.5% (95% IC: 26.1-41.0). The 38.4% (95% IC: 31.1-45.7) demonstrated some side effect during the follow-up. Using proportional risk model of Cox the variables related to compliance were: younger age, level of instruction lower than secondary studies, free medicines for pensioner, no psychotherapeutic treatment, consume a fewer antidepressants drugs and a frequency ≤ 3 visits to the family doctor 3 months previous to the study. CONCLUSIONS: The non-compliance of antidepressant treatment in primary care is high from the first weeks after initiating it. The conditioning factors are related to sociodemographic characteristics and other patient characteristics as type of financing of pharmaceutical benefit and frequentness at primary care

[Adherence to patients antidepressant treatment and the factors associated of non-compiance]. / Seguimiento de la adherencia al tratamiento antidepresivo en pacientes que inician su consumo.

OBJECTIVE: To know the adherence to treatment in patients who initiate antidepressant drugs and to analyze the determinant factors of non-compliance, so much clinical as sociodemographic. DESIGN: Prospective longitudinal observational study. LOCATION: Primary Health Care and Mental Health Surgeries of three Castilla-La Mancha Areas. PARTICIPANTS: 185 adults patients who were started in antidepressant treatment were evaluated. MEASUREMENTS: Treatment adherence (test Haynes-Sackett, test Morisky-Green, count of tablets and MEMS), adverse effects, intensity of depressive symptoms, sociodemographic characteristics and other characteristics related to antidepressants or participants. RESULTS: After 6months of beginning antidepressing treatment, 46.9% (95%IC: 36.5-57.3) showed an inadequate fulfilment by pill count method and 28.6% (95%IC: 19.1-38.0) with Morisky-Green's questionnaire. To 15 days the lack of adherence was 48.5% (95%IC: 40.6-56.4) and of 33.5% (95%IC: 26.1-41.0). The 38.4% (95%IC: 31.1-45.7) demonstrated some side effect during the follow-up. Using proportional risk model of Cox the variables related to compliance were: younger age, level of instruction lower than secondary studies, free medicines for pensioner, no psychotherapeutic treatment, consume a fewer antidepressants drugs and a frequency ≤ 3 visits to the family doctor 3 months previous to the study. CONCLUSIONS: The non-compliance of antidepressant treatment in primary care is high from the first weeks after initiating it. The conditioning factors are related to sociodemographic characteristics and other patient characteristics as type of financing of pharmaceutical benefit and frequentness at primary care.

Follow up of patients who start treatment with antidepressants: treatment satisfaction, treatment compliance, efficacy and safety.

BACKGROUND: Measuring satisfaction with treatment has proved useful to ascertain the treatment features that are most important to the patients, and to explain increased treatment compliance. However, there are few studies that relate satisfaction to other clinical or self-perceived health status indicators. Recent studies have shown the close relationship between satisfaction with treatment, treatment compliance, and effectiveness. This study attempts to design and validate a scale to evaluate satisfaction with antidepressant drug therapy, assess treatment compliance (self-reported, validated questionnaire, drug accountability and electronic monitorization system), assess efficacy in reducing depressive symptoms and safety in patients who initiate antidepressant drug therapy, as well as to establish predictors of satisfaction, compliance and effectiveness with these drugs. METHODS/DESIGN: This is an observational longitudinal study with a cohort of adults initiating treatment with antidepressant drugs. A multi-centre study will be performed in which 20 Primary Care practices from Castilla-La Mancha are expected to participate. An initial interview and follow-up visits at 15 days, 1, 3, 6, 9 and 12 months will be conducted with all study participants. 706 subjects will be studied (95% confidence interval, precision ± 3%, expected rate of non-compliance 50%, expected non-responders and lost to follow up rate 15%). The following measurements will be performed: development and validation of a scale of satisfaction with antidepressant therapy, participant and antidepressant characteristics, treatment compliance evaluation (Haynes-Sackett Test, Morisky-Green Test, drug accountability and Medication Event Monitoring System), depression symptom reduction (Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale), observation of adverse effects, and beliefs about treatment (The Beliefs about Medicines Questionnaire). DISCUSSION: Antidepressant drugs are an extraordinarily important therapeutic group in the pharmacy composition; economic repercussions and social impact associated to their use is clear. Despite their well-established efficacy in clinical trials, treatment non-compliance is a major obstacle to their effectiveness in clinical practice. The proposed study brings about useful conclusions to improve the results of these drugs. Additionally, devising a scale specifically designed to evaluate satisfaction with antidepressant treatment could be of interest in healthcare outcomes research.

Medicalización de la vida (II) / Medicalisation of every-day life (II)

La medicalización de la vida es uno de los problemas que actualmente contribuyen a la masificación de las consultas del Médico de Familia y de los Servicios de Urgencias, provocando, a la vez, dificultades para proporcionar una atención de alta calidad y frustración en una buena parte de los profesionales. Entendemos por medicalización el proceso de convertir situaciones que han sido siempre normales en cuadros patológicos y pretender resolver, mediante la medicina, situaciones que no son médicas, sino sociales, profesionales o de las relaciones interpersonales. Los profesionales sanitarios son, a la vez, actores y victimas de dicho proceso. La medicalización tiene como principales consecuencias la trasformación de personas sanas en enfermos, el aumento de daños iatrogénicos, el consumo de recursos sanitarios y la pérdida de eficacia y eficiencia de los mismos. Entre las actuaciones recomendadas cabe destacar acciones encaminadas a regular las expectativas de la población, delimitar el campo de acción de la medicina, fomentar el autocuidado y actuar de acuerdo con las evidencias sanitarias existentes (AU)

Medicalisation of every-day life is one of the problems currently contributing to the massification of visits to Doctors' surgeries or Hospital Emergency Departments, thus making it difficult to provide high quality healthcare and causing frustration for many health professionals. Medicalisation is understood as being the process of turning normal human conditions into medical conditions or diseases and trying to resolve them through medicines. Such conditions are not medical, but social or professional conditions or issues related to interpersonal relationships. Health professionals are both the actors and the victims of this process. The main consequences of medicalisation are: transforming healthy persons into patients, increasing iatrogenic harm and the consumption of healthcare resources and loss of efficacy and efficiency of the same. Amongst the recommended actions we emphasise those directed towards regulating the expectations of the population, restricting the field of action of medicine, encouraging self-care and acting according to current healthcare evidence (AU)

Effect of plant sterols on the lipid profile of patients with hypercholesterolaemia. Randomised, experimental study.

BACKGROUND: Studies have been conducted on supplementing the daily diet with plant sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and, consequently, cardiovascular risk. However, clinical practice guidelines on hypercholesterolaemia state that there is not sufficient evidence to recommend their use in subjects with hypercholesterolaemia. The main objective of this study is to determine the efficacy of the intake of 2 g of plant sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that determine a greater reduction in lipid levels in subjects receiving plant sterol ester supplements. METHODS/DESIGN: Randomised, double-blind, placebo controlled experimental trial carried out at family doctors' surgeries at three health centres in the Health Area of Albacete (Spain). The study subjects will be adults diagnosed with "limit" or "defined" hypercholesterolaemia and who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of liquid yoghurt containing 2 g of plant sterol ester per container will be administered daily after the main meal, for a period of 24 months. The control group will receive a daily unit of yogurt not supplemented with plant sterol esters that has a similar appearance to the enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and 24 months. The secondary variables are: change in cardiovascular risk, adherence to the dairy product, adverse effects, adherence to dietary recommendations, frequency of food consumption, basic physical examination data, health problems, lipid-lowering medication, physical activity, smoking habits and socio-demographic variables. DISCUSSION: If plant sterol ester supplements were effective a sounder recommendation for the consumption of plant sterols in subjects with hypercholesterolaemia could be made.

Medicalización de la vida (I) / Medicalisation of every-day life (I)

La medicalización de la vida es uno de los problemas que actualmente contribuyen a la masificación de las consultas del Médico de Familia y de los Servicios de Urgencias, provocando, a la vez, dificultades para proporcionar una atención de alta calidad y frustración en una buena parte de los profesionales. Entendemos por medicalización el proceso de convertir situaciones que han sido siempre normales en cuadros patológicos y pretender resolver, mediante la medicina, situaciones que no son médicas, sino sociales, profesionales o de las relaciones interpersonales. La medicalización es un proceso continuo que se autoalimenta y crece de forma constante, facilitado por una situación en la que la sociedad va perdiendo toda capacidad de resolución y su nivel de tolerancia. Su origen es multifactorial, existiendo diversas causas y actores implicados (sociedad, medios de comunicación, industria farmacéutica, políticos, gestores y profesionales sanitarios), jugando el sector sanitario un papel fundamental en dicho proceso. Los profesionales sanitarios son, a la vez, actores y victimas de dicho proceso. Presentamos en este documento una reflexión sobre el proceso de medicalización de la vida y los factores intervinientes(AU)

Medicalisation of every-day life is one of the problems currently contributing to the massification of visits to the Doctors’ surgeries or Hospital Emergency Departments, thus making it difficult to provide high quality healthcare and causing frustration for many health professionals. Medicalisation is understood as being the process of turning normal human conditions into medical conditions and trying to resolve them through medicines. Such conditions are not medical, but social or professional conditions or having to do with interpersonal relationships. Medicalisation is an on-going process that feeds on itself and is steadily growing, aided by a situation in which society is losing all ability of resolution and tolerance. Its origin is multifactorial, and there are several causes and actors implicated (society, the media, the pharmaceutical industry, politicians, managers and health professionals), the health sector playing a key role in this process. Health professionals are both the actors and the victims of this process. We present a reflection on the process of medicalisation of every-day life and the intervening factors(AU)

Functional status of elderly people with hearing loss.

The objective is to determine the prevalence of hearing loss in people over 65 years of age, to describe the functional status of people with hearing loss and to identify the need for hearing aid use. In a cross-sectional study, a random sample of 1387 people aged 65 years and over was selected. The primary study variables were: hearing level by audiometric assessment, self-perceived hearing loss, screening for hypoacusia using the Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) and physical, cognitive and emotional functional status. Using the HHIE-S it was determined that 11.3% of the subjects had severe hearing handicap. According to the Ventry/Weinstein criteria 43.6% had hearing handicap. When asked about the use of hearing aids, 4.5% of the study subjects said they used them, although 41.9% had hearing loss of 35 dB or more in their better ear. The variables associated with the need for a hearing aid were age >75 years (odds ratio=OR=3.2), ADL dependence (OR=2.7), cognitive impairment (OR=2.0), multiple health problems (OR=1.8), male sex (OR=1.6) and single/widowed (OR=1.5). In conclusion, there is a high prevalence of hearing loss associated with other functional limitations. Of those people who would benefit from a hearing aid (more than a third of people over 65 years old), 89.3% do not own one. The screening of hearing loss needs to be improved.

Satisfacción con el tratamiento antidepresivo: validación del cuestionario "ESTA" / Validation of Questionnaire "ESTA", designed to assess the satisfaction with antidepressant treatment. Spain

Fundamento: No existen cuestionarios para evaluar la satisfacción con el tratamiento antidepresivo, el cual repercute en la calidad de vida relacionada con la salud. El objetivo fue desarrollar y validar un instrumento específico para valorar la satisfacción con el tratamiento antidepresivo, determinando su validez convergente respecto a su efectividad clínica, cumplimiento de expectativas, adherencia terapéutica y tolerabilidad. Métodos: Estudio observacional longitudinal donde 168 pacientes iniciaron tratamiento antidepresivo y fueron evaluados durante un año. Las variables incluyeron efectos adversos, cumplimiento e intensidad de síntomas depresivos. En el cuestionario para la Evaluación de la Satisfacción con el Tratamiento Antidepresivo (ESTA), de 11 ítems respondidos mediante escala Likert, se evaluó su fiabilidad, validez de construcción y concurrente con mediciones relacionadas conceptualmente con dicho constructo. Resultados: El α de Cronbach osciló entre 0,936 y 0,951. En el análisis factorial un solo factor explicó el 63,76% de la varianza. La puntuación media del cuestionario ESTA osciló entre 40,0 y 44,7 puntos, observándose una correlación negativa respecto a las escalas de Hamilton (-0,321/-0,601) y Montgomery-Asberg (-0,491/-0,307). La satisfacción con el tratamiento antidepresivo al cabo de un mes fue 39,5 en incumplidores y 44,3 en cumplidores. En quienes presentaron efectos adversos fue 39,2 frente a 43,3 de quienes no los presentaron. En la primera visita (15 días) la puntuación fue 40,0; al mes 42,6; a los 3 meses 44,4 y a los 6 meses 44,5. Estas diferencias fueron estadísticamente significativas para p<0,05. En el análisis de fiabilidad test-retest el coeficiente de correlación intraclase fue 0,908. Conclusiones: El cuestionario ESTA, diseñado para evaluar la satisfacción con el tratamiento antidepresivo, es válido y fiable, constituyendo un instrumento de medición centrado en el paciente complementario a la valoración clínica de la efectividad del tratamiento antidepresivo (AU)

Background: We have no questionnaires to assess satisfaction with antidepressant treatment, which affects the health related quality of life. The objective was to develop and validate a specific instrument to assess satisfaction with antidepressant treatment, determining convergent validity regarding clinical effectiveness, fulfillment of expectations, adherence and tolerability. Methods: Longitudinal observational study where 168 patients started antidepressant treatment and were followed for one year. The variables included adverse effects, compliance and intensity of depressive symptoms. The questionnaire for the Evaluation of Antidepressant Treatment Satisfaction (ESTA) consists of 11 items answered using Likert scale. We evaluated its reliability, construct validity and concurrent validity with conceptually related measures with the construct assessed. Results: The Cronbach's alpha statistic ranged between 0.936 and 0.951. In the factor analysis one factor accounted for 64.11% of the variance. The average score of the questionnaire ranged from 40.0 to 44.7 points, showing a negative correlation regarding the Hamilton scale (-0.321 / -0.601) and Montgomery-Asberg scale (-0.491 / -0.307). After a month, the antidepressant treatment satisfaction was 39.5 points in noncompliant patients and 44.3 in compliers. In those who had adverse effects was 39.2 versus 43.3 for those who had not. At the first visit (15 days) the score was 40.0, in a month 42.6, in 3 months 44.4 and in 6 months 44.5. These differences were statistically significant (p <0.05). In test-retest analysis, intraclass correlation coefficient was 0.908. Conclusions: The questionnaire, designed to assess satisfaction with antidepressant treatment, is valid and reliable, and provides a patient-centered instrument which is complementary to the clinical assessment of the effectiveness of antidepressant treatment (AU)

Usefulness of extraperitoneal laparoscopic paraaortic lymphadenectomy for lymph node recurrence in gynecologic malignancy.

OBJECTIVE: The aim of this study was to evaluate the safety and feasibility of extraperitoneal laparoscopic paraaortic lymphadenectomy for suspected lymph node recurrence of gynecological cancers. DESIGN: Descriptive study. SETTING: Unit of Gynecologic Oncology of an acute-care teaching hospital in Barcelona, Spain. POPULATION: Between December 2002 and October 2007, eight women underwent extraperitoneal laparoscopic paraaortic lymphadenectomy for suspected lymph node recurrence, detected by magnetic resonance image (MRI), computed tomography (CT) scan or 18F-fluorodeoxyglucose positron emission tomography (PET) scanning. The suspicious nodes were removed through an extraperitoneal laparoscopic approach. RESULTS: The median age of patients was 66.5 years (range: 54-74). The median operating time was 157.5 minutes (range: 120-240). The median blood loss was 112.5 mL (range: 50-150). The mean nodal yield was 9.4+/-4.72 (range: 1-16). There were no intraoperative or postoperative complications. The median hospital stay was two days. Histological examination revealed metastasis in seven of eight patients. CONCLUSIONS: The extraperitoneal laparoscopic paraaortic lymphadenectomy for lymph node recurrence of gynecological cancers is a safe and feasible procedure which should be considered where there is isolated involvement of retroperitoneal lymph nodes. This procedure is a minimally invasive technique that allows an excellent approach to the paraaortic lymph nodes.

Impact of extraperitoneal lymphadenectomy on treatment and survival in patients with locally advanced cervical cancer.

During the last years, and coinciding with the beginning of the concomitant treatment with radio-chemotherapy, a better control of local cervical cancer has been reached, although failures in the systemic control of the illness have been more frequent. One of the main causes is not treating the illness at the level of the para-aortic lymph nodes, basically because their affectation is unknown and because imaging tests have a high percentage of false negative results. At this time, it is when laparoscopic para-aortic lymphadenectomy arises, in order to be able to know the extension of the illness better before treatment. A extraperitoneal laparoscopic approach is described in order to reduce complications derived from a possible extended irradiation. Between August 2001 and October 2007, a total of 69 patients with bulky and locally advanced cervical cancer (FIGO stages IB2, IIA > 4 cm and IIB-IVA) underwent extraperitoneal laparoscopic lymphadenectomy for surgical staging. Extraperitoneal aortic lymphadenectomy by laparoscopic approach is a technique with low morbidity. Special laparoscopic material is not required and if it is performed by a team trained in technical endoscopics it is not difficult. Radio-chemotherapy treatment began immediately after laparoscopy because of its minimal aggression.

Factores de riesgo de Caídas en ancianos / Risk factors for falls in the elderly

Objetivo. Determinar los factores de riesgo asociados a las caídas de los pacientes mayores de 65 años residentes en la comunidad. Diseño. Estudio observacional de casos y controles. Emplazamiento. Consultas de Atención Primaria. Participantes. 69 pacientes de 65 o más años con antecedentes de caídas durante el año anterior (casos) fueron comparados con otros 69 pacientes de igual edad, pero sin dichos antecedentes (controles). Mediciones principales. Circunstancias de las caídas (número de caídas en el último año, causa aparente, necesidad de ayuda o de asistencia sanitaria y consecuencias, etc), práctica de ejercicio físico, apoyo social, hábitos tóxicos, enfermedades, difi cultades visuales o auditivas, consumo de medicación (fármacos predisponentes, automedicación y cumplimiento), situación funcional (índice de Katz), variables antropométricas y datos sociodemográfi cos. Resultados. En los casos fueron signifi cativamente más frecuentes las siguientes exposiciones: sexo femenino (OR: 2,9), obesidad (OR: 2,3), consumo diario de alcohol (OR: 2,8), enfermedades neurológicas (OR: 4,1), Diabetes Mellitus (OR: 2,2) e incapacidad funcional (OR: 4,2). Conclusiones. Entre los factores predisponentes de caídas en los ancianos aparecen factores de riesgo modifi cables como son la obesidad y el consumo diario de alcohol. La diabetes y las enfermedades neurológicas, especialmente demencias y secuelas de ACV, son las enfermedades relacionadas con mayor frecuencia

Objective. To determine the risk factors associated to falls in community-dwelling individuals of over 65 years Design. Observational study of cases and controls. Setting. Primary care centres. Participants. 69 patients aged 65 years or over with a history of falls in the previous year (cases) were compared with another 69 patients of the same age who had no history of falls (controls). Main measurements. Circumstances of the fall (number of falls in the last year, apparent cause, need for help or healthcare and consequences, etc.), physical exercise, social support, toxic habits, diseases, sight or hearing diffi culties, medication (predisposing drugs, self medication and compliance), performance status (Katz index), anthropometric and sociodemographic data. Results. The following factors were more frequent in the cases: female sex (OR: 2,9), obesity (OR: 2,3), daily alcohol consumption (OR: 2,8), neurological disease (OR: 4,1), Diabetes Mellitus (OR: 2,2) and functional incapacity (OR: 4,2). Conclusions. Some of the predisposing factors for falls in the elderly can be modifi ed, such as obesity and daily alcohol consumption. Diabetes and neurological diseases, especially dementia and CVA sequelae are the most frequently related diseases