Mortalidad, riesgo cardiovascular y estado de salud actual de una cohorte de varones iniciada en el año 1968. Estudio Manresa / Mortality, cardiovascular risk, and health status in a male cohort initiated in 1968. The Manresa study

Objetivos: Analizar la mortalidad y sus causas en la cohorte Manresa de varones seguida durante 42 años; comparar el riesgo de mortalidad cardiovascular al inicio del seguimiento con la mortalidad acontecida; describir el estado de salud de los participantes al final del estudio. Métodos: Estudio observacional prospectivo. Se calculó la incidencia de mortalidad acumulada de la cohorte. La asociación de los factores de riesgo cardiovasculares (FRCV) con la mortalidad fue calculada mediante análisis de regresión logística de efectos mixtos. Se evaluó la curva ROC comparando cada ecuación predictiva con la mortalidad real. Se llevó a cabo un análisis descriptivo del estado de salud en la última encuesta del estudio. Resultados: Las defunciones fueron 457 (43%). La incidencia acumulada fue del 10,6% para las enfermedades cardiovasculares. Los factores de riesgo cardiovasculares asociados significativamente a la mortalidad cardiovascular fueron: edad, colesterol y tabaquismo. El uso de tablas para el cálculo del riesgo cardiovascular resultó ser útil, con pocas diferencias según la tabla utilizada. Entre los factores de riesgo cardiovasculares analizados en el último examen de salud, y por tanto en una población anciana, destacan la alta prevalencia de hipertensión y de actividad física regular, junto con la baja prevalencia en tabaquismo. Conclusión: La mortalidad cardiovascular se mantuvo alta, aunque ha pasado a ser la segunda causa tras las enfermedades tumorales. Se compararon en nuestro medio las predicciones de las tablas de riesgo de mortalidad cardiovascular con la mortalidad real durante más de 4 décadas, mostrándose la importancia de estimar el riesgo cardiovascular en la población adulta.(AU)

Objectives: To analyse mortality and its causes in the Manresa male cohort followed over 42 years; to compare the initial risk of cardiovascular mortality with actual mortality; and to describe the health status of the participants at the end of the study. Methods: Prospective observational study, in which an analysis of the cumulative incidence of mortality was performed. The association of cardiovascular risk factors with mortality was calculated with a logistic regression analysis of mixed effect. The risk of mortality of individuals was evaluated and compared with true cardiovascular mortality using ROC curves. At the end of the study, a descriptive analysis of CVRF and health status of participants in the last survey was performed. Results: The number of deaths was 457 (43%). Cumulative incidence for cardiovascular diseases was 10.6%. Cardiovascular risk factors significantly associated with cardiovascular mortality were age, cholesterol, and smoking. The use of risk score charts for cardiovascular mortality was found to be useful, and there were no differences between tables. In the last health screening of cardiovascular risk factors levels in an elderly population, a high prevalence was found of hypertension and of regular physical activity, together with a low prevalence of smoking. Conclusions: Cardiovascular mortality remained high, although it has become the second cause after tumoural diseases. The comparison of predictions from cardiovascular mortality risk tables with actual mortality rates in our area over more than 4 decades demonstrated the importance of assessing cardiovascular risk in the adult population.(AU)

[Mortality, cardiovascular risk, and health status in a male cohort initiated in 1968. The Manresa study]. / Mortalidad, riesgo cardiovascular y estado de salud actual de una cohorte de varones iniciada en el año 1968. Estudio Manresa.

OBJECTIVES: To analyse mortality and its causes in the Manresa male cohort followed over 42 years; to compare the initial risk of cardiovascular mortality with actual mortality; and to describe the health status of the participants at the end of the study. METHODS: Prospective observational study, in which an analysis of the cumulative incidence of mortality was performed. The association of cardiovascular risk factors with mortality was calculated with a logistic regression analysis of mixed effect. The risk of mortality of individuals was evaluated and compared with true cardiovascular mortality using ROC curves. At the end of the study, a descriptive analysis of CVRF and health status of participants in the last survey was performed. RESULTS: The number of deaths was 457 (43%). Cumulative incidence for cardiovascular diseases was 10.6%. Cardiovascular risk factors significantly associated with cardiovascular mortality were age, cholesterol, and smoking. The use of risk score charts for cardiovascular mortality was found to be useful, and there were no differences between tables. In the last health screening of cardiovascular risk factors levels in an elderly population, a high prevalence was found of hypertension and of regular physical activity, together with a low prevalence of smoking. CONCLUSIONS: Cardiovascular mortality remained high, although it has become the second cause after tumoural diseases. The comparison of predictions from cardiovascular mortality risk tables with actual mortality rates in our area over more than 4 decades demonstrated the importance of assessing cardiovascular risk in the adult population.

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up.

BACKGROUND: Patient self-management (PSM) of vitamin K antagonists (VKA) seems a very promising model of care for oral anticoagulation in terms of efficacy and safety. In comparison with other management models of VKA therapy, the number of scientific publications supporting the advantages of PSM is more limited. Currently, most of the scarce information comes from randomized clinical trials. Moreover, a small number of studies have assessed PSM of VKA therapy in real life conditions. METHODS: We analyzed clinical outcomes of 927 patients in a single center (6018.6 patient-years of follow-up). Recruitment took place between 2002 and 2017. All patients followed a structured training program, conducted by specialized nurses. RESULTS: Fifty percent of individuals had a mechanical heart valve (MHV), 23% suffered from recurrent venous thromboembolism (VTE) or high-risk thrombophilia, and 13% received VKA therapy because of atrial fibrillation (AF). Median follow-up was 6.5 years (range 0.1-15.97 years), median age was 58.1 years (IQR 48-65.9) and 46.5% were women. The incidence of major complications (either hemorrhagic or thromboembolic) was 1.87% patient-years (pt-ys) with a 95% CI of 1.54-2.27. The incidence of major thromboembolic events was 0.86% pt-ys (95% CI 0.64-1.13) and that of major hemorrhagic events was 1.01% pt-ys (95% CI 0.77-1.31). The incidence of intracranial bleeding was 0.22% pt-ys (95% CI 0.12-0.38). In terms of clinical indication for VKA therapy, the incidence of total major complications was 2.4% pt-ys, 2.0% pt-ys, 0.9% pt-ys and 1.34% pt-ys for MHV, AF, VTE and other (including valvulopathies and myocardiopathies), respectively. Clinical outcomes were worse in patients with multiple comorbidities, previous major complications during conventional VKA therapy, and in older individuals. The percentage of time in therapeutic range (TTR) was available in 861 (93%) patients. Overall, the mean (SD) of TTR was 63.6 ± 13.4%, being higher in men (66.2 ± 13.1%) than women (60.6 ± 13.2%), p < 0.05. CONCLUSIONS: In terms of clinically relevant outcomes (incidence of major complications and mortality), PSM in real life setting seems to be a very good alternative in properly trained patients.

Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).

BACKGROUND: Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy. METHODS: An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes. RESULTS: A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194). CONCLUSION: Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).

ANTECEDENTES: Varios estudios no aleatorizados y retrospectivos sugieren que la anastomosis intracorpórea (intracorporeal anastomosis, IA) tiene ventajas sobre la anastomosis extracorpórea (extracorporeal anastomosis, EA) en la colectomía laparoscópica derecha, pero no hay suficientes evidencias científicas. El objetivo del estudio fue comparar los resultados a corto plazo y definir los posibles beneficios de la anastomosis intracorpórea versus extracorpórea en la colectomía derecha laparoscópica electiva. MÉTODOS: Se realizó un ensayo clínico prospectivo y aleatorizado de mayo de 2015 a junio de 2018. El criterio de valoración principal fue la duración de la estancia hospitalaria. Los criterios de valoración secundarios fueron los eventos técnicos intraoperatorios y los resultados clínicos postoperatorios. RESULTADOS: Se aleatorizaron 140 pacientes. El tiempo quirúrgico fue más largo para la IA que para la EA (149,49 ± 27,24 versus 123,35 ± 36,56 min; P = 0,001). La longitud de la herida fue más corta en la IA (6,65 ± 1,21 versus 8,72 ± 1,44 cm; P < 0,001). La función digestiva se recuperó antes en la IA que en la EA (2,3 versus 3,3 días, P = 0,003) y la incidencia de íleo paralítico fue menor (13% versus 30%, P = 0,022). Los requisitos de analgesia postoperatoria fueron menores con la IA (39 ± 24,3 versus 53 ± 26; P < 0,001) y la puntuación de dolor (EVA) también fue menor (P < 0,035). El descenso de la hemoglobina en el postoperatorio y la hemorragia gastrointestinal baja fueron menores en la IA que en la EA (-8,83 ± 1,7 versus -17,07 ± 1,7 mg/dl; P = 0,001) y (2,8% versus 14%; P = 0,031), respectivamente. La clasificación de Clavien-Dindo mostró que la IA se asoció con resultados significativamente mejores que la EA: grado I (10% versus 27% P = 0,016); grado II (18% versus 35%, P = 0,0369). La puntuación del índice de complicación integral (comprehensive complication index, CCI) fue menor en el grupo IA (5,33 ± 9,2 versus 11,15 ± 14,34; P = 0,006). La estancia hospitalaria fue más corta en el grupo de IA pero sin diferencia significativa (5,65 ± 3,75 versus 6,58 ± 4,63 días; P = 0,194). CONCLUSIÓN: La IA presenta ventajas clínicas sobre la EA en la colectomía derecha laparoscópica.

Factores clínicos que afectan a la calidad de vida percibida en la reconstrucción artroscópica de las luxaciones acromioclaviculares / Clinical factors that affect perceived quality of life in arthroscopic reconstruction for acromioclavicular joint dislocation

Objetivo. Analizar los resultados de la reparación artroscópica de la luxación acromioclavicular en términos de calidad de vida percibida. Material y método. Estudio prospectivo de pacientes con luxación acromioclavicular grados iii-vde Rockwood, tratados artroscópicamente con un seguimiento medio de 25,4 meses. Se registraron los datos demográficos de la serie y se realizaron evaluaciones antes de la cirugía, a los 3 meses y a los 2 años con los cuestionarios validados Short Form-36 Health Survey (SF-36), escala visual analógica (EVA), The Disabilities of the Arm, Shoulder and Hand (DASH), Constant-Murley Shoulder Outcome Score (Constant) y Walch-Duplay Score (WD). Resultados. Se analizaron 20 pacientes, 17 hombres y 3 mujeres, con una edad media de 36,1 años. Según la clasificación de Rockwood, 3 pacientes fueron grado iii, 3 grado iv y 14 grado v. Se objetivó mejoría tanto funcional como clínica en todos los test clínicos analizados (SF-36, EVA y DASH) tanto a los 3 meses como a los 2 años (p<0,001). El valor final del test de Constant fue de 95,3±2,4 y el WD medio fue de 1,8±0,62. No se encontró que la calidad de vida percibida se viera afectada por ninguna variable a estudio, excepto por la evolución del DASH. Conclusiones. La calidad de vida percibida (valorada mediante el SF-36) en pacientes intervenidos artroscópicamente de luxación acromioclavicular grados iii-v no se ve influida por el sexo, la edad, el grado, el desplazamiento, la lateralidad, la evolución de la EVA, la puntuación del Constant ni por el WD. Sí se correlaciona con la evolución en el DASH (AU)

Objective. To analyse the results of arthroscopic repair of acromioclavicular dislocation in terms of health-related quality of life. Material and method. Prospective study of patients with acromioclavicular dislocation Rockwood grade iii-v, treated arthroscopically with a mean follow up of 25.4 months. The demographics of the series were recorded and evaluations were performed preoperatively, at 3 months and 2 years with validated questionnaires as Short Form-36 Health Survey (SF-36), visual analogue scale (VAS), The Disabilities of the Arm, Shoulder and Hand (DASH), Constant-Murley Shoulder Outcome Score (Constant) and Walch-Duplay Score (WD). Results. Twenty patients, 17 men and 3 women with a mean age of 36.1 years, were analysed. According to the classification of Rockwood, 3 patients were grade iii, 3 grade iv and 14 grade v. Functional and clinical improvement was detected in all clinical tests (SF-36, VAS and DASH) at 3 months and 2 years follow up (P<.001). The final Constant score was 95.3±2.4 and the WD was 1.8±0.62. It was not found that the health-related quality of life was affected by any variable studied except the evolution of DASH. Conclusions. The health-related quality of life (assessed by SF-36) in patients undergoing arthroscopic repair of acromioclavicular joint dislocation grades iii-v was not influenced by gender, age, grade, displacement, handedness, evolution of the VAS, scoring of the Constant or by the WD. However, it is correlated with the evolution in the DASH score (AU)

Clinical factors that affect perceived quality of life in arthroscopic reconstruction for acromioclavicular joint dislocation. / Factores clínicos que afectan a la calidad de vida percibida en la reconstrucción artroscópica de las luxaciones acromioclaviculares.

OBJECTIVE: To analyse the results of arthroscopic repair of acromioclavicular dislocation in terms of health-related quality of life. MATERIAL AND METHOD: Prospective study of patients with acromioclavicular dislocation Rockwood grade iii-v, treated arthroscopically with a mean follow up of 25.4 months. The demographics of the series were recorded and evaluations were performed preoperatively, at 3 months and 2 years with validated questionnaires as Short Form-36 Health Survey (SF-36), visual analogue scale (VAS), The Disabilities of the Arm, Shoulder and Hand (DASH), Constant-Murley Shoulder Outcome Score (Constant) and Walch-Duplay Score (WD). RESULTS: Twenty patients, 17 men and 3 women with a mean age of 36.1 years, were analysed. According to the classification of Rockwood, 3 patients were grade iii, 3 grade iv and 14 grade v. Functional and clinical improvement was detected in all clinical tests (SF-36, VAS and DASH) at 3 months and 2 years follow up (P<.001). The final Constant score was 95.3±2.4 and the WD was 1.8±0.62. It was not found that the health-related quality of life was affected by any variable studied except the evolution of DASH. CONCLUSIONS: The health-related quality of life (assessed by SF-36) in patients undergoing arthroscopic repair of acromioclavicular joint dislocation grades iii-v was not influenced by gender, age, grade, displacement, handedness, evolution of the VAS, scoring of the Constant or by the WD. However, it is correlated with the evolution in the DASH score.

Señales de alarma precoces del trastorno del espectro autista en personas con síndrome de Down / Early warning signs of autism spectrum disorder in people with Down syndrome

Introducción. En la población general, el diagnóstico de trastornos del espectro autista (TEA) se realiza generalmente en una etapa temprana, mejorándose así el pronóstico. En las personas con síndrome de Down (SD), la falta de instrumentos específicos y adaptados para el diagnóstico, y la falta de experiencia de los profesionales, hace que el diagnóstico de TEA suela pasar desapercibido. Objetivo. Identificar señales de alarma «tempranas» de un posible diagnóstico de TEA en niños con SD en los primeros años de vida (de 0 a 4 años). Métodos. Estudio retrospectivo de cohortes: niños con SD y TEA (SD-TEA) y niños con SD y sin TEA (SD-noTEA) emparejados por sexo y edad. Se identificaron las siguientes señales de alarma tempranas: 1) ausencia de sonrisa social; 2) falta atención compartida; 3) falta de búsqueda de consuelo/protección; 4) ausencia de queja; 5) poco interés por el otro; 6) no señala; 7) no imita; 8) ausencia de balbuceo, vocalización; 9) expresión facial inapropiada; 10) rituales verbales o acciones repetitivas; 11) manierismos manos/dedos; 12) estereotipias; 13) interés sensorial, y 14) no integración de la mirada y la conducta. Seis investigadores, quienes no participaron en la identificación de las señales de alarma tempranas, seleccionaron aquellas que orientarían a un diagnóstico de TEA (análisis cualitativo). Se solicitó a los padres videos de las personas con SD en «actividad» entre los 0 y 4 años. Los mismos investigadores, cegados al diagnóstico de TEA y tras visualizar los videos, puntuaron las señales de alarma tempranas en 3 categorías: presencia/ausencia/no evaluable (análisis cuantitativo). Resultados. Durante el año 2013, se obtuvieron 12 videos de 12 personas con SD: 6 del grupo SD-TEA y 6 del grupo SD-noTEA. El análisis cualitativo identificó como señales de alarma temprana relacionadas con el diagnóstico de TEA: «no integración de la mirada», «no imita», «rituales verbales o acciones repetitivas» y «estereotipias»; y el análisis cuantitativo identificó: «falta de atención compartida» y «falta de interés por el otro». Conclusión. Ciertas «señales de alarma» pueden orientar hacia un diagnóstico de TEA en los primeros años de vida en niños con SD (AU)

Introduction. In general population, the current trend is to make the diagnosis of Autism Spectrum Disorders (ASD) at an early stage, which it is crucial to improve the prognosis. In contrast, in Down syndrome (DS) population, the ASD diagnosis is frequently delayed, having negative consequences on the overall development of the children who suffer. Objective. To identify «early warning signals» for the detection of the ASD in DS in the first years of life (0 to 4 years). Methods. Retrospective cohort study: SD with an ASD diagnosis (SD-ASD) and healthy-DS (SD-noASD) matched by sex and age. Early warning signals were identified and selected from different questionnaires for ASD of general population: 1. Lack of social smile; 2. Shared care foul; 3. Lack of finding comfort/protection; 4. Lack of complaint; 5. Little interest for the others; 6. No pointing; 7. Non-imitation; 8. Lack of babbling/vocalization; 9. Inappropriate facial expression; 10. Presence of rituals as repetitive actions or repetitive sentences; 11. Mannerisms hands/fingers; 12. Stereotypes; 13. Lack of interest sensory; and 14. Non-integration of the look. Six investigators, who did not participate in the identification of the «early warning signals», selected those that would guide a diagnosis of ASD (qualitative analysis). Parents were asked for videos of people with DS in «activity» between 0 and 4 years. The same investigators, blinded to the diagnosis of ASD and after watching the videos, scored the «early warning signals» in three categories: presence / absence / non-evaluable (quantitative analysis). Results. During the year 2013, 12 videos of 12 people with SD were obtained: 6 from SD-ASD group and 6 from the SD-noASD group. The qualitative analysis identified as early warning signals related to the diagnosis of ASD: «non-integration of the look», «non-imitation», «presence of rituals as repetitive actions or repetitive sentences» and «stereotypies», and the quantitative analysis: «shared care foul» and «little interest for the others». Conclusion. Certain «warning signals» may lead to a diagnosis of ASD in the first years of life in children with DS (AU)

Predictive model of mortality in patients with spontaneous bacterial peritonitis.

BACKGROUND: Hospital mortality in patients with spontaneous bacterial peritonitis (SBP) is high despite albumin treatment, particularly in those with worse liver and/or renal function. AIM: To determine the independent predictive factors of in-hospital mortality and to create and validate a predictive model of mortality in patients with SBP. METHODS: We analysed all cirrhotic patients with high-risk SBP (serum urea ≥11 mmol/L and/or serum bilirubin ≥68 µmol/L) between 2001 and 2011. We developed a predictive model of in-hospital mortality and validated this in a different cohort. RESULTS: We included 118 high-risk SBP episodes treated with antibiotics and albumin. In-hospital mortality was 33/118 (28%). The independent predictive factors of in-hospital mortality at SBP diagnosis were serum urea, blood leucocyte count, Child-Pugh score and mean arterial pressure. A predictive model including these four variables showed a discrimination accuracy (AUC) of 0.850, 95% CI 0.777-0.922. A cut-off point of 0.245 showed a sensitivity of 0.85 and specificity of 0.75. The in-hospital mortality was 28/49 (57.1%) in patients with a model value ≥0.245, and 5/69 (7.2%) in patients with a model value <0.245 (P < 0.001). The validation series included 161 patients with an in-hospital mortality of 40/161 (24.8%), 30/77 (39.0%) in patients with a model value ≥0.245, and 10/84 (11.9%) in those with a model value <0.245 (P < 0.001). CONCLUSIONS: We developed and validated a predictive model of mortality that includes serum urea, blood leucocyte count, Child-Pugh score and mean arterial pressure in high-risk patients with spontaneous bacterial peritonitis. These findings may help to identify patients who would benefit from additional therapeutic strategies.

Evaluación del dolor durante la movilización y la aspiración endotraqueal en pacientes críticos / Evaluation of pain during mobilization and endotracheal aspiration in critical patients

OBJETIVOS: 1) Evaluar la prevalencia de dolor durante 2 procedimientos de enfermería, y 2) analizar la utilidad de ciertos signos vitales y del índice biespectral (BIS) para detectar dolor. MÉTODOS: Estudio prospectivo, observacional y analítico de medidas repetidas en pacientes con ventilación mecánica y sedación. Los procedimientos evaluados fueron la aspiración endotraqueal y la movilización con giro. El dolor se evaluó mediante la Behavioral Pain Scale. Valores más o igual se consideraron dolorosos. Se registraron distintos signos fisiológicos y los valores del BIS. Una variación porcentual > 10% se consideró clínicamente relevante. RESULTADOS: Se analizaron 146 procedimientos en 70 pacientes. La prevalencia de dolor durante los procedimientos fue del 94%. Los signos vitales y los valores del BIS aumentaron significativamente durante los procedimientos respecto el reposo, pero solo la variación del BIS alcanzó relevancia clínica. En un subgrupo de pacientes que recibieron analgesia preventiva antes de los procedimientos, el dolor disminuyó significativamente respecto a los pacientes que no recibieron analgesia preventiva (−2 [RIQ: {−5}-0] vs. 3 [RIQ: 1-4]; p<0,001, respectivamente). CONCLUSIONES: Los procedimientos evaluados son dolorosos. La variación de los signos vitales no es un buen indicador de dolor. La variación del BIS podría ser útil, pero precisa nuevas investigaciones. La administración de analgesia preventiva disminuye la prevalencia de dolor durante los procedimientos

OBJECTIVES: 1) To assess the prevalence of pain during nursing care procedures, and 2) to evaluate the usefulness of certain vital signs and the bispectral index (BIS) in detecting pain. METHODS: A prospective, observational analytical study was made of procedures (endotracheal aspiration and mobilization with turning) in critically ill sedated patients on mechanical ventilation. The Behavioral Pain Scale was used to assess pain, with scores of more or equal 3 indicating pain. Various physiological signs and BIS values were recorded, with changes of > 10% being considered clinically relevant. RESULTS: A total of 146 procedures in 70 patients were analyzed. Pain prevalence during the procedures was 94%. Vital signs and BIS values increased significantly during the procedures compared to resting conditions, but only the changes in BIS were considered clinically relevant. In the subgroup of patients receiving preemptive analgesia prior to the procedure, pain decreased significantly compared to the group of patients who received no such analgesia (−2 [IQR: {−5}-0] vs. 3 [IQR: 1-4]; P<.001, respectively). CONCLUSIONS: The procedures evaluated in this study are painful. Changes in vital signs are not good indicators of pain. Changes in BIS may provide useful information about pain, but more research is needed. The administration of preemptive analgesia decreases pain during the procedures

[Evaluation of pain during mobilization and endotracheal aspiration in critical patients]. / Evaluación del dolor durante la movilización y la aspiración endotraqueal en pacientes críticos.

OBJECTIVES: 1) To assess the prevalence of pain during nursing care procedures, and 2) to evaluate the usefulness of certain vital signs and the bispectral index (BIS) in detecting pain. METHODS: A prospective, observational analytical study was made of procedures (endotracheal aspiration and mobilization with turning) in critically ill sedated patients on mechanical ventilation. The Behavioral Pain Scale was used to assess pain, with scores of ≥3 indicating pain. Various physiological signs and BIS values were recorded, with changes of >10% being considered clinically relevant. RESULTS: A total of 146 procedures in 70 patients were analyzed. Pain prevalence during the procedures was 94%. Vital signs and BIS values increased significantly during the procedures compared to resting conditions, but only the changes in BIS were considered clinically relevant. In the subgroup of patients receiving preemptive analgesia prior to the procedure, pain decreased significantly compared to the group of patients who received no such analgesia (-2 [IQR: {-5}-0] vs. 3 [IQR: 1-4]; P<.001, respectively). CONCLUSIONS: The procedures evaluated in this study are painful. Changes in vital signs are not good indicators of pain. Changes in BIS may provide useful information about pain, but more research is needed. The administration of preemptive analgesia decreases pain during the procedures.

Pelvic MRI findings in relapsed prostate cancer after radical prostatectomy.

PURPOSE/OBJECTIVE: Little is known about the clinical impact of using multiparametric MRI to plan early salvage radiotherapy after radical prostatectomy. We aimed to evaluate the incidence and location of recurrence based on pelvic multiparametric MRI findings and to identify clinical variables predictive of positive imaging results. MATERIALS AND METHODS: We defined radiological criteria of local and lymph node malignancy and reviewed records and MRI studies of 70 patients with PSA recurrence after radical prostatectomy. We performed univariate and multivariate analysis to identify any association between clinical, pathological and treatment-related variables and imaging results. RESULTS: Multiparametric MRI was positive in 33/70 patients. We found local and lymph node recurrence in 27 patients and 7 patients, respectively, with a median PSA value of 0.38 ng/ml. We found no statistically significant differences between patients with positive and negative multiparametric MRI for any variable. Shorter PSADT was associated with positive lymph nodes (median PSADT: 5.12 vs 12.70 months; p: 0.017). CONCLUSIONS: Nearly half the patients had visible disease in multiparametric MRI despite low PSA. Positive lymph nodes incidence should be considered when planning salvage radiotherapy, particularly in patients with a short PSADT.

Mohs micrographic surgery for basal cell carcinomas: results of a Spanish retrospective study and Kaplan­Meier survival analysis of tumour recurrence.

BACKGROUND: Mohs micrographic surgery (MMS) is a specialized procedure usually limited to specific indications (e.g. high-risk basal cell carcinomas [BCCs]). OBJECTIVE: To determine the recurrence rate of MMS for BCC at a tertiary referral centre in Barcelona, Spain. METHODS: Review of medical records of patients undergoing 534 consecutive MMS interventions for confirmed BCCs. The main outcome measure was biopsy-proven recurrence of BCC at the same anatomical location after MMS. RESULTS: A total of 489 patients underwent MMS for 534 BCCs from April 1999 to December 2011. The patients' mean age was 66 years. The most frequent location was the nasal/perinasal region (38.4%, n = 205). The surgical interventions of 47.9% (n = 256) were for primary BCCs and 52.1% (n = 278) procedures were for recurrent or residual BCCs. The mean follow-up was 30.5 months (range 1­145 months). Thirty-two recurrences were identified in total. The raw recurrence rate following MMS for primary BCCs was 1.2% (3/256) compared to 10.4% (32/278) for recurrent BCC. On multivariate analysis (Cox proportional hazard model) only prior treatment (P = 0.018, hazard ratio [HR] 4.68 with 95% confidence intervals [CI] 1.30­16.79), multiple prior treatments (P = 0.013, HR 2.72 [95%CI 1.24­5.96]), and healing by secondary intention (P = 0.041, HR 2.88 [95%CI 1.04­7.97]) were independent prognostic factors of recurrence after MMS. LIMITATIONS: The limitations of our study are those of a retrospective study. CONCLUSION: Mohs micrographic surgery for primary high-risk BCCs has a high success rate but the cumulative probability of recurrence increases significantly when tumours with recurrences are referred for MMS.

Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial.

BACKGROUND: Postoperative blood loss in patients after total knee arthroplasty may cause local and systemic complications and influence clinical outcome. The aim of this study was to assess whether fibrin glue or tranexamic acid reduced blood loss compared with routine hemostasis in patients undergoing total knee arthroplasty. METHODS: A randomized, single-center, parallel, open clinical trial was performed in adult patients undergoing primary total knee arthroplasty. Patients were divided into four groups. Group 1 received fibrin glue manufactured by the Blood and Tissue Bank of Catalonia, Group 2 received Tissucol (fibrinogen and thrombin), Group 3 received intravenous tranexamic acid, and Group 4 (control) had no treatment other than routine hemostasis. The primary outcome was total blood loss collected in drains after surgery. Secondary outcomes were the calculated hidden blood loss, transfusion rate, preoperative and postoperative hemoglobin, number of blood units transfused, adverse events, and mortality. RESULTS: One hundred and seventy-two patients were included. The mean total blood loss (and standard deviation) collected in drains was 553.9 ± 321.5 mL for Group 1, 567.8 ± 299.3 mL for Group 2, 244.1 ± 223.4 mL for Group 3, and 563.5 ± 269.7 mL for Group 4. In comparison with the control group, Group 3 had significantly lower total blood loss (p < 0.001), but it was not significantly lower in Groups 1 and 2. The overall rate of patients who had a blood transfusion was 21.1% (thirty-five of 166 patients analyzed per protocol). Two patients required transfusion in Group 3 compared with twelve patients in Group 4 (p = 0.015). No significant difference was observed between the two fibrin glue groups and the control group with regard to the need for transfusion. There was no difference between groups with regard to the percentage of adverse events. CONCLUSIONS: Neither type of fibrin glue was more effective than routine hemostasis in reducing postoperative bleeding and transfusion requirements, and we no longer use them. However, this trial supports findings from previous studies showing that intravenous tranexamic acid can decrease postoperative blood loss.

Adalimumab for the treatment of psoriasis in real life: a retrospective cohort of 119 patients at a single Spanish centre.

BACKGROUND: Patients with moderate-to-severe psoriasis treated with adalimumab in daily clinical practice are different from those in clinical trials, and outcomes may differ in different geographical settings. OBJECTIVES: To analyse the efficacy, retention of treatment and adverse events in a cohort of such patients at a referral centre in Barcelona, Spain. METHODS: Data from a cohort of 119 consecutive patients treated between January 2008 and March 2013 were retrospectively collected. Drug survival was analysed by the Kaplan-Meier method with log-rank test and Cox regression. RESULTS: The mean duration of treatment was 25 months (median 22, range 2-60). The 75% improvement in Psoriasis Area and Severity Index (PASI 75) response rates at 16 weeks, 6 months and 1 year of treatment were 64%, 58% and 53%, respectively (intention-to-treat analysis). The corresponding PASI 90 values were 49%, 52% and 50%. Biologic-naive patients (41%) had significantly higher PASI 75 and PASI 90 response rates at 6 months and 1 year. On multivariate analysis, only PASI 90 response at 6 months was significantly associated with treatment retention (P = 0.0009), with a hazard ratio of 7.3 (95% confidence interval 2.3-23.6). Forty-eight adverse events (AEs) occurred in 29 patients, and were serious in eight (0.032 events per patient-year). Paradoxical flares of psoriasis or arthritis were seen in five patients. Infections accounted for seven serious AEs, and were the reason for discontinuation in two patients. CONCLUSIONS: PASI 90 response at 6 months was the only independent variable predicting drug survival on multivariate analysis. Infections, including de novo infection by Mycobacterium tuberculosis, accounted for seven serious AEs.

Risk of early breastfeeding cessation among symmetrical, small for gestational age infants.

BACKGROUND: Many studies have shown that children born small for gestational age are at a metabolic disadvantage. Breastfeeding is associated with reduced risk of developing metabolic syndrome. OBJECTIVE: To determine whether ponderal index, weight, length or head circumference at birth affect early exclusive breastfeeding discontinuation. DESIGN: Information from medical records of full-term infants attending the same paediatric clinic was used to examine the relationship between birth size and failure to breastfeed within 28 days after birth. Details of demographics and diagnoses were prospectively recorded. Feeding method was assessed at each child visit by their healthcare provider. Feeding practices were compared between infants of high, normal and low ponderal index at birth. RESULTS: Multivariate models (p's ≤ 0.02) confirmed that the chance of exclusive breastfeeding continuation within 4 weeks of life was less in infants whose birth weight was below 2780 g or whose neonatal head circumference was < 33 cm. Birth length did not account for this effect. Ponderal index was not associated with a higher risk of early discontinuation of exclusive breastfeeding. CONCLUSIONS: This study reports that birth weight ≥ 2780 g and head circumference at birth ≥ 33 cm are independent predictors of breastfeeding onset success.

Efectos hemodinámicos y antipiréticos del paracetamol, metamizol y dexketoprofeno en pacientes críticos / Hemodynamic and antipyretic effects of paracetamol, metamizol and dexketoprofen in critical patients

Objetivo: El objetivo fue estudiar los efectos antipiréticos y hemodinámicos de 3 fármacos diferentes utilizados para tratar la fiebre en pacientes críticos. Material y método: Diseño: estudio prospectivo, observacional, en una UCI de 16 camas de un Hospital Universitario. Pacientes: 150 pacientes que tuvieron un episodio febril (temperatura> 38oC). Intervención: 50 recibieron paracetamol, 50 metamizol y 50 dexketoprofeno. Se determinaron la temperatura axilar, presión arterial sistólica, diastólica y media, frecuencia cardíaca, presión venosa central y saturación de oxígeno, en situación basal y a los 30, 60 y 120 minutos tras la administración del fármaco. También se registró la temperatura a los 180 minutos después de haber iniciado el fármaco. La diuresis y las necesidades de tratamiento vasodilatador y vasoconstrictor durante el tratamiento también se registraron. Resultados: Las características de los pacientes, la temperatura y la hemodinámica basal fueron similares en todos los grupos. Observamos un descenso significativo de al menos un grado en la temperatura después de 180 minutos en 38 pacientes tratados con dexketoprofeno (76%), en 36 con metamizol (72%), y en 20 con paracetamol (40%) (p< 0,001). Después de 120 minutos, la media del descenso de la presión arterial media fue de 8,5 ± 13,6mmHg con paracetamol, 14,9 ± 11,8mmHg con metamizol y 16,8 ± 13,7mmHg con dexketoprofeno (p=0,005). Conclusiones: Dexketoprofeno fue el fármaco antipirético más efectivo, a las dosis estudiadas. Aunque los 3 fármacos redujeron la tensión arterial media, la reducción con paracetamol fue menos pronunciada (AU)

Background: The objective was to study the antipyretic and hemodynamic effects of three different drugs used to treat fever in critically ill patients. Methods: Design and setting: Prospective, observational study in a 16-bed, general ICU of a university hospital. Patient population: We studied 150 patients who had a febrile episode (temperature> 38oC): 50 received paracetamol, 50 metamizol and 50 dexketoprofen. Interventions: None. Body temperature, systolic, diastolic and mean arterial pressure, heart rate, central venous pressure and oxygen saturation were determined at baseline and at 30, 60 and 120minutes after infusion of the drug. Additionally, we recorded temperature 180minutes after starting drug infusion. Diuresis and the need for or change of dose of vasodilator or vasoconstrictor drugs were also recorded. Results: Patient characteristics, baseline temperature and hemodynamics were similar in all groups. We observed a significant decrease of at least 1oC in temperature after 180minutes in 38 patients treated with dexketoprofen (76%), in 36 with metamizol (72%), and in 20 with paracetamol (40%) (p< 0.001). After 120minutes, the mean decrease in mean arterial pressure was 8.5±13.6mmHg with paracetamol, 14.9 ± 11.8mmHg with metamizol, and 16.8 ± 13.7mmHg with dexketoprofen (p=0.005). Conclusions: Dexketoprofen was the most effective antipyretic agent at the doses tested. Although all three drugs reduced mean arterial pressure, the reduction with paracetamol was less pronounced (AU)

Encuesta sobre la satisfacción de los pacientes dependientes de heroína de la Comunidad de Valencia con los centros de tratamiento con metadona / A survey about the satisfaction of heroin-dependent patients from Valencia region (Spain) with methadone treatment centres

Objetivo. Valorar multidimensionalmente la satisfacción de los pacientes dependientes de heroína con los centros de tratamiento con metadona de la Comunidad de Valencia. Método. Se solicitó a 278 pacientes que llegaron consecutivamente a los 12 centros (9 convencionales y 3 unidades móviles) seleccionados aleatoriamente, su participación en una encuesta que incluía la Escala de Verona para valorar la Satisfacción con los Servicios en los centros de Tratamiento con Metadona (VSSS-MT). Resultados. Ciento sesenta y seis (59,7%) pacientes aceptaron participar. La media global de las puntuaciones en la VSSS-MT fue 3,5 (DT = 0,6), siendo el rango de puntuaciones de dicha escala 1-5 (1: malísima y 5: excelente). El porcentaje de pacientes que se sintió satisfecho (VSSS-MT > 3) fue, por categorías, el siguiente: valoración global, 82,4%; intervenciones básicas 80,6%; intervenciones específi cas 59,3%; habilidades de los trabajadores sociales 66,3%; habilidades de los psicólogos 71,7%. En un análisis de regresión múltiple, los predictores independientes de la satisfacción con el tratamiento de mantenimiento con metadona (TMM) fueron: hallarse en régimen de take-home o dosis para llevar a casa, un menor número de días desde el último ajuste de dosis, y recibir el TMM en un centro convencional -y no en unidad móvil-. Este modelo de regresión explicó el 9% de la varianza de las puntuaciones totales de la VSSS-MT. Conclusiones. Los pacientes dependientes de opioides de la Comunidad de Valencia se sienten ligeramente satisfechos con los centros de tratamiento con metadona. Las variables más intensamente asociadas con tal satisfacción explican un limitado porcentaje de la varianza de la puntuación global de la VSSS-MT (AU)

Objective. To multidimensionally assess heroin-dependent patients' satisfaction with methadone treatment centres from Valencia Region (Spain). Method. An independent interviewer recruited 278 consecutively arriving patients from 12 randomly selected centres (9 conventional centres and 3 mobile methadone clinics) to participate in a survey that included the Verona Service Satisfaction Scale for Methadone Treatment (VSSS-MT). Results. One hundred sixty-six (59.7%) patients agreed to participate. Mean overall VSSS-MT score was 3.5 (SD = 0.6), on a 1-5 point scale (1 = terrible; 5 = excellent). The percentage of patients who felt satisfied (VSSS-MT scores > 3) was, by category: overall satisfaction, 82.4%; basic interventions, 80.6%; specific interventions, 59.2%; social worker skills, 66.3%; psychologist skills, 71.6%. In a multiple regression analysis, methadone take-home privileges, lower number of days from the last dose adjustment, and being treated in a conventional (not mobile) methadone clinic appeared as independent predictors of satisfaction with methadone maintenance treatment. This regression model accounted for 9% of the variance in VSSS-MT overall scores. Conclusions. The survey results show that heroin-dependent patients from Valencia Region are slightly satisfied with methadone treatment centres. The variables most strongly related to this satisfaction accounted for only a limited amount of the variance in VSSS-MT overall scores (AU)

[Viscosity changes in thickened water due to the addition of highly prescribed drugs in geriatrics]. / Cambios en la viscosidad del agua con espesantes por la adición de fármacos altamente prescritos en geriatría.

INTRODUCTION: Dysphagia is a swallowing disorder with a high incidence in the geriatric patient related with an increased risk for undernutrition and pneumonia due to bronchial aspiration. In this condition, it is usual to add commercial thickeners in liquids, as well as the addition of drugs in this mixture to improve their administration. However, there are no studies regarding the possible change in viscosity produced by their addition. OBJECTIVES: To assess the change in viscosity of water thickened with commercial products by adding the drugs frequently used in elderly patients. METHODS: Samples of water mixed with the commercial thickener Resource (modified corn starch) or Nutilis (modified corn starch, maltodextrin, and gums: tara, xhantan, and guar) to achieve an intermediate consistence as "honey". The viscosity of these samples was measured as well as for similar samples to which one of the following drugs was added: galantamine, rivastigmin, ciprofloxacin, cholecalciferol, memantine, fosfomycin, calcium, and amoxicillin/clavulanic acid. RESULTS: In the samples with Resource thickener we observed decreased viscosity by adding galantamine, memantine, fosfomycin or calcium, and increased viscosity with amoxicillin/clavulanic acid. The viscosity of the samples with Nutilis® decreased with galantamine, rivastigmine, amoxicillin/clavulanic acid, fosfomycin and calcium. CONCLUSION: The viscosity of water with commercial thickeners may be affected by some drugs or their preservatives, which may influence the swallowing capability. It is recommended to perform further in vitro and in vivo studies in order to adjust these formulations if necessary.

Cambios en la viscosidad del agua con espesantes por la adición de fármacos altamente prescritos en geriatría / Viscosity changes in thickened water due to the addition of highly prescribed drugs in geriatrics

Introducción: La disfagia es una alteración de la deglución con una elevada incidencia en el paciente geriátrico relacionada con un aumento del riesgo de desnutrición y neumonía por broncoaspiración. La adición de espesantes comerciales en líquidos es frecuente en esta situación, así como la adición de fármacos en esta mezcla para facilitar su administración. Sin embargo, no existen estudios referentes al posible cambio de viscosidad producido por la adición de los mismos. Objetivos: Evaluar la variación ejercida sobre la viscosidad del agua espesada con preparados comerciales al añadir fármacos frecuentemente utilizados en pacientes de edad avanzada. Métodos: Se prepararon muestras de agua con espesante comercial Resource® (almidón de maíz modificado) o Nutilis® (almidón modificado de maíz, maltodextrina y gomas: tara, xantana y guar) para conseguir consistencia intermedia tipo "miel". Se midió la viscosidad de estas muestras y para muestras similares a las que se había añadido alguno de los siguientes fármacos: galantamina, rivastigmina, ciprofloxacino, colecalciferol, memantina, fosfomicina, calcio y amoxilina/clavulánico. Resultados: En las muestras con espesante Resource® se observó una disminución de la viscosidad al añadir galantamina, memantina, fosfomicina o calcio, y un aumento de la viscosidad con amoxicilina/clavulánico. La viscosidad de la muestras con Nutilis® disminuyó con galantamina, rivastigmina, amoxicilina/clavulánico, fosfomicina y calcio. Conclusión: La viscosidad del agua con espesantes comerciales puede verse afectada por algunos fármacos o sus excipientes, lo que puede incidir en la capacidad de deglución de los mismos. Es aconsejable realizar más estudios in vitro e in vivo para valorar ajustar dichas pautas en caso necesario (AU)

Introduction: Dysphagia is a swallowing disorder with a high incidence in the geriatric patient related with an increased risk for undernutrition and pneumonia due to bronchial aspiration. In this condition, it is usual to add commercial thickeners in liquids, as well as the addition of drugs in this mixture to improve their administration. However, there are no studies regarding the possible change in viscosity produced by their addition. Objectives: To assess the change in viscosity of water thickened with commercial products by adding the drugs frequently used in elderly patients. Methods: Samples of water mixed with the commercial thickener Resource® (modified corn starch) or Nutilis® (modified corn starch, maltodextrin, and gums: tara, xhantan, and guar) to achieve an intermediate consistence as "honey". The viscosity of these samples was measured as well as for similar samples to which one of the following drugs was added: galantamine, rivastigmin, ciprofloxacin, cholecalciferol, memantine, fosfomycin, calcium, and amoxicillin/clavulanic acid. Results: In the samples with Resource® thickener we observed decreased viscosity by adding galantamine, memantine, fosfomycin or calcium, and increased viscosity with amoxicillin/clavulanic acid. The viscosity of the samples with Nutilis® decreased with galantamine, rivastigmine, amoxicillin/clavulanic acid, fosfomycin and calcium. Conclusion: The viscosity of water with commercial thickeners may be affected by some drugs or their preservatives, which may influence the swallowing capability. It is recommended to perform further in vitro and in vivo studies in order to adjust these formulations if necessary (AU)

[Hemodynamic and antipyretic effects of paracetamol, metamizol and dexketoprofen in critical patients]. / Efectos hemodinámicos y antipiréticos del paracetamol, metamizol y dexketoprofeno en pacientes críticos.

BACKGROUND: The objective was to study the antipyretic and hemodynamic effects of three different drugs used to treat fever in critically ill patients. DESIGN AND SETTING: Prospective, observational study in a 16-bed, general ICU of a university hospital. PATIENT POPULATION: We studied 150 patients who had a febrile episode (temperature>38°C): 50 received paracetamol, 50 metamizol and 50 dexketoprofen. INTERVENTIONS: None. Body temperature, systolic, diastolic and mean arterial pressure, heart rate, central venous pressure and oxygen saturation were determined at baseline and at 30, 60 and 120minutes after infusion of the drug. Additionally, we recorded temperature 180minutes after starting drug infusion. Diuresis and the need for or change of dose of vasodilator or vasoconstrictor drugs were also recorded. RESULTS: Patient characteristics, baseline temperature and hemodynamics were similar in all groups. We observed a significant decrease of at least 1°C in temperature after 180minutes in 38 patients treated with dexketoprofen (76%), in 36 with metamizol (72%), and in 20 with paracetamol (40%) (p<0.001). After 120minutes, the mean decrease in mean arterial pressure was 8.5±13.6mmHg with paracetamol, 14.9±11.8mmHg with metamizol, and 16.8±13.7mmHg with dexketoprofen (p=0.005). CONCLUSIONS: Dexketoprofen was the most effective antipyretic agent at the doses tested. Although all three drugs reduced mean arterial pressure, the reduction with paracetamol was less pronounced.