Economic impact of outpatient follow-up using telemedicine vs in-person visits for patients in general surgery: A secondary analysis of a randomized clinical trial.

INTRODUCTION: Innovation in internet connectivity and the Covid 19 pandemic have caused a dramatic change in the management of patients in the medical field, boosting the use of telemedicine. A comparison of clinical outcomes and satisfaction between conventional face-to-face and telemedicine follow-up in general surgery, an economic evaluation is mandatory. The aim of the present study was to compare the differences in economic costs between these two outpatient approaches in a designed randomized controlled trial (RCT). METHODS: A RCT was conducted enrolling 200 patients to compare conventional in-person vs. digital health follow-up using telemedicine in the outpatient clinics in patients of General Surgery Department after their planned discharge. After a demonstration that no differences were found in clinical outcomes and patient satisfaction, we analyzed the medical costs, including staff wages, initial investment, patent's transportation and impact on social costs. RESULTS: After an initial investment of 7527.53€, the costs for the Medical institution of in-person conventional follow-up were higher (8180.4€) than those using telemedicine (4630.06€). In relation to social costs, loss of productivity was also increased in the conventional follow-up. CONCLUSION: The use of digital Health telemedicine is a cost-effective approach compared to conventional face-to-face follow-up in patients of General Surgery after hospital discharge.

Use of antidepressants in the treatment of chronic orofacial pain caused by temporomandibular disorders: A randomized controlled clinical trial.

BACKGROUND AND OBJECTIVE: Temporomandibular disorders (TMDs) are a common pathology, associated with pain in the facial territory and with associated psychological disorders, such as anxiety and depression. The aim of this study was to evaluate the efficacy of antidepressants in the treatment of pain associated with TMD. MATERIALS AND METHODS: Sixty four patients suffering from chronic orofacial pain, randomly distributed in 3 groups: control group treated with night splint, group treated with 10mg/day of citalopram and group treated with 25mg/day of amitriptyline. Pain intensity was assessed, randomly, by a single blinded evaluator, according to the VAS at baseline and after one, three, six and nine weeks. RESULTS: All groups showed a reduction of pain throughout the period of time evaluated, however, the group treated with amitriptyline showed the best pain reduction results 3.3±1.5, 1.5±1.4 and 0.9±1.3 at 3, 6 and 9 weeks, respectively. CONCLUSIONS: Low doses of amitriptyline appear to be a good therapeutic option in patients with TMDs suffering from chronic orofacial pain.

Efectos de Cinnamomum zeylanicum en niveles glucémicos en pacientes con diabetes tipo 2: ensayo clínico aleatorizado / Effects of Cinnamomum zeylanicum on glycemic levels in patients with type 2 diabetes: Randomized clinical trial

Objetivo: Evaluar el efecto del consumo de suplemento de Cinnamomum zeylanicum (canela) en los niveles glucémicos de adultos mexicanos con diabetes tipo 2. Métodos: Se realizó un ensayo clínico aleatorizado simple ciego con 30 pacientes >18 años con diabetes tipo 2, se aleatorizaron en los grupos: intervención y control; donde consumieron cápsulas con 2 gramos de C. zeylanicum o harina de trigo (placebo) diario por 12 semanas y se midieron variables antropométricas y bioquímicas (HbA1c, GPa, triglicéridos, colesterol total, HDL y LDL). Se utilizó el software IBM SPSS versión 23 y se aplicó la prueba T-Student y U-Mann Withney para muestras independientes (según el comportamiento de la variable) para las diferencias entre grupos, valores p<0.05 fueron considerados estadísticamente significativos. Resultados: No se observaron cambios significativos en HbA1c entre grupos (p>0.05). Sin embargo, post-tratamiento el grupo intervención disminuyó significativamente HbA1c al compararlo con su línea base (-0.41%, p=0.01) mientras que no se encontraron diferencias en el grupo control (+0.03%, p=0.64). No hubo diferencias significativas en variables antropométricas ni bioquímicas. Conclusiones: El consumo de 2 g de C. zeylanicum en mexicanos con diabetes tipo 2 no produjo cambios significativos entre grupos. Se sugieren nuevos estudios donde se evalúe el suplemento de canela con una muestra mayor. ClinicalTrials.gov; NCT04023539. (AU)

Objective: To evaluate the effect of Cinnamomum zeylanicum (cinnamon) supplement use on the glycemic levels of Mexican adults with type 2 diabetes. Methods: A single-blind randomized clinical trial was conducted with 30 patients over 18 years of age with type 2 diabetes. They were randomized into intervention and control groups where they took 2-gram capsules of Cinnamomum zeylanicum or wheat flour (placebo) daily for 12 weeks; then the anthropometric and biochemical variables HbA1c, FPG, triglycerides, total cholesterol, HDL and LDL were measured. IBM SPSS version 23 software was used and the Student's t-test and Mann-Whitney U test for independent samples (according to the behavior of the variable) were applied for differences between groups, p-values <0.05 were considered statistically significant. Results: No significant changes in HbA1c were seen between the two groups (p>0.05). However, post-treatment, the HbA1c value in the intervention group decreased significantly when compared to their baseline (-0.41%, p=0.01), while no differences were found in the control group (+0.03%, p=0.64). There were no significant differences in the anthropometric or biochemical variables. Conclusions: The consumption of 2 g of Cinnamomum zeylanicum in Mexican people with type 2 diabetes did not produce significant changes between the groups. New studies evaluating cinnamon supplementation on a larger sample size are suggested. ClinicalTrials.gov; NCT04023539. (AU)

AVIP Project (Prosthetic Virtual Friend): Study of clinical-functional outcomes and satisfaction with a mobile application in the perioperative management and follow-up of hip arthroplasty. / Proyecto AVIP (Amigo VIrtual Protésico): estudio de resultados clínico-funcionales y de satisfacción con una aplicación móvil en el manejo perioperatorio y seguimiento de implantes protésicos de cadera.

OBJECTIVE: To analyze the clinical, quality of life, and healthcare quality outcomes obtained in a series of patients undergoing total hip arthroplasty (THA), who were empowered and monitored using the AVIP application. These results will be compared with a control group followed through a standard protocol. MATERIAL AND METHOD: Randomized clinical trial with parallel groups involving patients with an indication for THA. Clinical variables were measured and compared using the WOMAC and mHHS, pain assessed by the VAS, quality of life with the SF-12 test. Walking capabilities were analyzed using the Functional Gait Assessment Scale, along with satisfaction levels assessed through the SUCE questionnaire, and perceived anxiety levels related to the process. RESULTS: A total of 68 patients were evaluated, with 31 patients in the AVIP group and 33 in the Control group completing the follow-up. Both groups demonstrated improvement in clinical outcomes based on the WOMAC and mHHS hip tests, a reduction in perceived pain, and an enhancement in quality of life according to the SF-12 test. Patients in the AVIP study group exhibited non-inferiority in clinical outcomes and satisfaction compared to the control group, as well as lower anxiety levels and improved walking capabilities after the first month of follow-up. Notably, 82.25% of the follow-up visits for this group were conducted remotely. CONCLUSION: The implementation of a mHealth application like AVIP can be safely offered to selected patients undergoing hip arthroplasty, enabling effective monitoring and providing continuous information and training.

Pre-incisional local infiltration with levobupivacaine in laparoscopic cholecystectomy: a randomized and clinical trial.

OBJECTIVE: Laparoscopic cholecystectomy (LC), despite its minimally invasive nature, requires effective control of post-operative pain. The use of local anesthetics (LA) has been studied, but the level of evidence is low, and there is little information on important parameters such as health-related quality of life (HRQoL) or return to work. The objective of the study was to evaluate the efficacy of 0.50% levobupivacaine infiltration of incisional sites in reducing POP after LC. METHODS: This was a prospective, randomized, double-blind study. Patients undergoing elective LC were randomized into two groups: no infiltration (control group) and port infiltration (intervention group). POP intensity (numerical rating scale, NRS), need for rescue with opioid drugs, PONV incidence, HRQoL, and return to work data, among others, were studied. RESULTS: Two hundred and twelve patients were randomized and analyzed: 105 (control group) and 107 (intervention group). A significant difference was observed in the NRS values (control group mean NRS score: 3.41 ± 1.82 vs. 2.56 ± 1.96) (p < 0.05) and in the incidence of PONV (31.4% vs. 19.6%) (p = 0.049). CONCLUSIONS: Levobupivacaine infiltration is safe and effective in reducing POP, although this does not lead to a shorter hospital stay and does not influence HRQoL, return to work, or overall patient satisfaction.

OBJETIVO: la colecistectomía laparoscópica (CL), a pesar de su carácter mínimamente invasivo, requiere un control efectivo del dolor postoperatorio (POP). El uso de anestésicos locales (AL) ha sido estudiado pero el nivel de evidencia es bajo y existe poca información acerca de parámetros relevantes como la calidad de vida relacionada con la salud (CVRS) o la reincorporación laboral. El objetivo de este estudio es analizar la eficacia de la infiltración de los sitios incisionales con levobupivacaína 0,50% en la reducción del dolor postoperatorio tras la CL. MATERIAL Y MÉTODOS: estudio prospectivo, aleatorizado y doble ciego. Pacientes sometidos a CL programada fueron aleatorizados en dos grupos: sin infiltración (grupo control) y con infiltración preincisional (grupo intervención). La intensidad del dolor (escala de puntuación numérica, NRS), la necesidad de rescates con opioides, la incidencia de náuseas o vómitos postoperatorios (NVPO) y datos de CVRS o reincorporación laboral, entre otros, fueron recogidos. RESULTADOS: 212 pacientes fueron aleatorizados y analizados: 105 en el grupo control y 107 en el grupo de intervención. Se observó una diferencia estadísticamente significativa en la intensidad del dolor (puntuación media NRS: 3.41 ± 1.82 vs. 2.56 ± 1.96) (p < 0.05) y en la incidencia de NVPO (31.4% vs. 19.6%) (p = 0.049). CONCLUSIONES: La infiltración con levobupivacaína es segura y efectiva en la reducción del dolor postoperatorio, aunque esto no conlleva una menor estancia hospitalaria y no influye en los resultados de CVRS, reincorporación laboral o satisfacción del paciente.

Eficacia de la práctica de yoga y del ejercicio aeróbico frente al standard of care en pacientes con fibromialgia. Estudio FIB-YOGA-EA-SOC / Efficacy of Yoga Practice and Aerobic Exercise compared to Standard of Care in Patients with Fibromyalgia. FIB-YOGA-EA-SOC Study

Objetivo: evaluar los efectos de una intervención integral de yoga y de ejercicio aeróbico (EA) frente al ejercicio de la práctica habitual o standard of care (SOC) sobre el impacto general y la gravedad de la fibromialgia (FM). Métodos: ensayo clínico aleatorizado de tres brazos en mujeres diagnosticadas de FM (grupos: YOGA, serie de asanas de Satyananda Saraswasi (n= 31); EA, 7.000 pasos diarios (n= 31); SOC (n= 61)). Variables e instrumentos: datos antropométricos, sociodemográficos y clínicos; Fibromyalgia Impact Questionnaire (FIQ); dolor (Widespread pain Index -WPI-); gravedad de los síntomas (Symptom Severity Score -SSS-); calidad de vida (índice combinado de afectación en pacientes con FM -ICAF-); capacidad funcional (Fibromyalgia Health Assessment Questionnaire -FHAQ-). Para la comparación entre los grupos se utilizó la prueba t de Student . Resultados: se estudiaron 96 mujeres con FM. Con respecto al grupo SOC, se han observado mejorías estadísticamente significativas (p< 0,05), y a nivel clínico con las intervenciones YOGA y EA en el índice de dolor (WPI), impacto general y gravedad de la FM (FIQ), gravedad de los síntomas (SSS) y calidad de vida (ICAF). Sin embargo, no se observó una mejoría en la capacidad funcional (FHAQ). Comparando ambas intervenciones, YOGA versus EA, se vieron diferencias estadísticamente significativas en los síntomas específicos (SSS) y la calidad de vida (ICAF). Conclusiones: los profesionales de la salud se enfrentan a numerosos desafíos en el tratamiento de estos pacientes. Los hallazgos de este ensayo son prometedores respecto a los efectos beneficiosos del YOGA y EA para disminuir el dolor, el impacto general y gravedad, y gravedad de los síntomas, así como en mejorar la calidad de vida en pacientes con FM.(AU)

Objective: to assess the effects of a comprehensive yoga and aerobic exercise (AE) intervention versus standard of care (SOC) exercise on the overall impact and severity of fibromyalgia (FM). Methods: three-arm randomised clinical trial in women diagnosed with FM (groups: YOGA, Satyananda Saraswasi asana series (n=31); AE, 7,000 steps per day (n= 31); SOC (n= 61)). Variables and instruments: anthropometric, sociodemographic and clinical data; Fibromyalgia Health Assessment Questionnaire (FIQ); pain (Widespread pain Index (WPI)); symptom severity (Symptom Severity Score (SSS); quality of life (Combined Index of Severity of Fibromyalgia (CISF)); functional capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ)). For comparison between groups, Student's t-test was used. Results: ininety-six women with FM were studied. With respect to the SOC group, statistically significant (p<0.05), and clinically significant improvements were observed with the YOGA and AE interventions in pain index (WPI), overall impact and severity of FM (FIQ), symptom severity (SSS) and quality of life (CISF). However, no improvement in functional capacity (FHAQ) was observed. Comparing both interventions, yoga versus AE, statistically significant differences were seen in specific symptoms (SSS) and quality of life (CISF). Conclusions: healthcare professionals face numerous challenges in the management of these patients. The findings of this trial are promising regarding the beneficial effects of YOGA and AE in decreasing pain, global impact and severity, and symptom severity, as well as improving quality of life in patients with FM.(AU)

EPICAP: intervención educativa mediante cápsulas audiovisuales en pacientes con epilepsia. Ensayo clínico aleatorizado / EPICAP: educational intervention using instructional clips in patients with epilepsy. A randomised clinical trial

Objetivos La educación sanitaria en pacientes con epilepsia influye positivamente en el autocontrol de la enfermedad, mejora su pronóstico y favorece el bienestar del paciente. El objetivo de este estudio fue evaluar una intervención educativa mediante cápsulas audiovisuales en pacientes con epilepsia en una unidad de monitorización videoelectroencefalográfica.Sujetos y métodosEs un ensayo clínico aleatorizado con dos grupos (intervención y control). Se reclutó a pacientes adultos con epilepsia que ingresaron en la unidad de monitorización videoelectroencefalográfica. Se crearon nueve vídeos sobre el diagnóstico y el tratamiento de la epilepsia, y recomendaciones de estilo de vida, que se administraron al grupo de intervención durante el ingreso. Se evaluó el conocimiento del paciente sobre su enfermedad con un cuestionario diseñado específicamente para este estudio. Se realizó una evaluación previa en el inicio del estudio, en el alta hospitalaria y a los tres meses, y se comparó el conocimiento sobre la epilepsia en ambos grupos en cada momento del estudio.ResultadosSe incluyó a 66 pacientes, con edad media de 39 ± 14,7 años (rango: 17-76) y una mediana de 8 años de evolución de la enfermedad (rango: 1-60 años). Un 53% eran mujeres. El tipo de epilepsia más frecuente fue el focal (95,5%). La puntuación media en el test preintervención fue de 57,2 ± 15,3. Los pacientes que recibieron la intervención educativa mostraron mejores puntuaciones en el postest en el alta hospitalaria (81,8 ± 11,2 frente a 62,8 ± 13,7; p = 0,001) y a los tres meses (76 ± 9,6 frente a 63,2 ± 12,8; p = 0,001).ConclusionesLa intervención educativa EPICAP mediante píldoras audiovisuales mejora de forma significativa el conocimiento de los pacientes sobre aspectos diagnósticos, terapéuticos y estilo de vida relacionados con la epilepsia. (AU)

AIMS. In patients with epilepsy health education has a positive influence on self-management of the disease, improves prognosis and enhances patient well-being. The aim of this study was to evaluate an educational intervention using instructional clips in patients with epilepsy in a video-electroencephalographic monitoring unit.SUBJECTS AND METHODSWe conducted a randomised clinical trial with two groups (intervention and control). Adult patients with epilepsy admitted to the video-electroencephalographic monitoring unit were recruited. Nine videos about the diagnosis and treatment of epilepsy, together with recommendations on lifestyle, were produced and administered to the intervention group while admitted. Patients’ knowledge of their disease was assessed by means of a questionnaire designed specifically for this study. A pre-assessment was conducted at the beginning of the study, at hospital discharge and at three months, and the knowledge of epilepsy in the two groups was compared at each time considered in the study.RESULTSSixty-six patients were included, with a mean age of 39 ± 14.7 years (range: 17-76) and a median of 8 years since disease onset (range: 1-60 years). Fifty-three per cent of the patients were women. Focal epilepsy was the most frequent type (95.5%). The mean score on the pre-intervention test was 57.2 ± 15.3. Patients who received the educational intervention showed better post-test scores at discharge from hospital (81.8 ± 11.2 versus 62.8 ± 13.7; p = 0.001) and at three months (76 ± 9.6 versus 63.2 ± 12.8; p = 0.001).CONCLUSIONSThe EPICAP educational intervention using instructional clips significantly improves patients’ knowledge of epilepsy-related diagnostic, therapeutic and lifestyle issues. (AU)

Intervenciones hacia la Prueba de Antígeno Prostático: Una revisión rápida de literatura / Interventions for Prostate-Specific Antigen Testing: A Rapid Literature Review

Objetivo: Identificar la mejor evidencia disponible relacionada a las intervenciones dirigidas hacia la aceptación de la prueba de antígeno prostático. Metodología: Revisión rápida de literatura, siguiendo los pasos establecidos por Tapia-Benavente, los cuales son: 1.- pregunta de investigación, para lo cual se utilizó la estructura PICO acotada a la definición del problema, intervención y resultado; 2.- búsqueda de bibliografía en bases de datos reconocidas; 3.- selección de estudios y extracción de datos; 4.- evaluación del riesgo de sesgo, para lo cual se utilizó la guía de comprobación de ensayos clínicos del grupo CONSORT; y 5.- la elaboración de la síntesis además de la conclusión de la evidencia encontrada. Resultados: La búsqueda rápida de literatura arrojó un total de 51 publicaciones de tres bases de datos, PubMed (27), EBSCO (13) y SCOPUS (11); de los cuales 11 cumplían con los criterios de inclusión. El 100% de los estudios indican un cambio significativo entre el grupo experimental y control (p < .05). Las estrategias más utilizadas incluyen la visita domiciliaria, conferencias, debates en grupo, lluvia de ideas, dinámicas de pregunta y respuesta con diapositivas, así como presentación de folletos educativos, mismos que se ejecutan en un periodo de un día, hasta seis meses. Conclusiones: Se hace evidente el vacío de conocimiento referente al desarrollo e implementación de estrategias para abordar la conducta de prevención relacionada al Cancer de Próstata hacia varones de pueblos originarios, así como la falta de modelos de intervención de enfermería enfocadas en este padecimiento. (AU)

Objective: To identify the best available evidence related to interventions for the acceptance of the prostate-specific antigen test. Methodology: Rapid literature review following the steps established by Tapia-Benavente, which are: 1.- research question, for which the PICO structure limited to the definition of the problem, intervention, and result was used; 2.- bibliography search in recognized databases; 3.- study selection and data extraction; 4.- bias risk assessment, for which the CONSORT group clinical trial verification guidelines were used; and 5.- preparation of a summary and conclusion of the evidence found. Results: The rapid literature search yielded a total of 51 publications from three databases, PubMed (27), EBSCO (13), and SCOPUS (11); 11 of which met the inclusion criteria. One hundred percent of the studies indicated a significant difference between the experimental and control groups (p < .05). The most frequently used strategies included home visits, conferences, group discussions, brainstorming, question-and-answer dynamics with slides, as well as the use of educational brochures, and were carried out in a period of one day and up to six months. Conclusions: There is an evident knowledge gap in the development and implementation of strategies for Prostate Cancer prevention behavior directed to indigenous men, as well as a lack of nursing intervention models focused on this disease. (AU)

Efficacy of a supervised exercise training program on five-year readmission rates in patients with acute coronary syndrome. A randomised controlled trial / Eficacia de un programa de entrenamiento con ejercicio supervisado sobre los reingresos a los 5 años en pacientes con síndrome coronario agudo. Ensayo clínico controlado y aleatorizado

Introduction and objectives: Exercise-based cardiac rehabilitation programmes can reduce mortality but their effects on readmission rates are unclear. The primary aim was to evaluate the efficacy of a supervised exercise-based cardiac rehabilitation programme on cardiac readmissions in patients with acute coronary syndrome at five years. Methods: We conducted an open, controlled, randomized, hospital-based clinical trial. Patients were assigned either to the control group (CG) who received standard care or to the intervention group (IG) who participated in a supervised exercise programme (3h per week of supervised exercise training for 10 weeks). Patients were evaluated at 5 years. Results: Seventy-six patients [41 CG, 35 IG, mean age 59.2 (SD 10.4), 82.9% men] were included. Cardiac readmission rates at 5 years were 24% in the CG compared to 9% in the IG (p=0.068), and readmission rates for all causes were 42% in the CG and 23% in the IG (p=0.085). Emergency care for cardiac disease was required more frequently in the CG (17% vs 11%, p=0.486). IG patients performed more regular and intensive exercise (62% vs. 33%, p=0.088). In both groups there were significant deterioration in systolic and diastolic blood pressure, body mass index, waist circumference, HbAc1, triglycerides, LDL and diet, and a significant increase in HDL. Conclusions: Patients who participated in the supervised exercise training programme were readmitted less often than controls for cardiac disease and for all causes at 5 years, the reduction was clinically meaningful although not statistically significant. Control of cardiovascular risk factors deteriorated in both groups.(AU)

Introducción y objetivos: Los programas de rehabilitación cardíaca basados en ejercicio físico pueden reducir la mortalidad, pero sus efectos en los reingresos hospitalarios no son concluyentes. El objetivo principal fue evaluar la eficacia de un programa de rehabilitación cardíaca supervisado basado en ejercicio en los reingresos cardíacos en pacientes con cardiopatía isquémica a los 5 años. Métodos: Ensayo clínico aleatorizado, abierto, controlado y de ámbito hospitalario. Los pacientes se asignaron al grupo control (GC), que recibió atención estándar, o al grupo intervención (GI), que participó en un programa de ejercicio supervisado (3 h por semana durante 10 semanas). Los pacientes fueron evaluados a los 5 años. Resultados: Setenta y seis pacientes (41 GC, 35 GI, edad media 59,2 [DE 10,4], 82,9% hombres) fueron incluidos. Los reingresos cardíacos a los 5 años fueron del 24% en el GC frente al 9% en el GI (p=0,068) y los reingresos por todas las causas fueron del 42% en el GC y el 23% en el GI (p=0,085). El GC asistió más a urgencias por motivo cardíaco (17% vs 11%; p=0,486). El GI realizó más ejercicio regular e intensivo (62% vs 33%; p=0,088). En ambos grupos hubo un deterioro significativo de presión arterial sistólica y diastólica, el índice de masa corporal, el perímetro abdominal, HbAc1, los triglicéridos, LDL y dieta, y un aumento significativo de HDL. Conclusiones: Los pacientes que participaron en el programa de entrenamiento de ejercicio supervisado fueron readmitidos con menos frecuencia que los controles por enfermedad cardíaca y por todas las causas a los 5 años; la reducción fue clínicamente relevante, aunque no estadísticamente significativa. El control de los factores de riesgo cardiovascular se deterioró en ambos grupos.(AU)

Efficacy of a supervised exercise training program on five-year readmission rates in patients with acute coronary syndrome. A randomised controlled trial.

INTRODUCTION AND OBJECTIVES: Exercise-based cardiac rehabilitation programmes can reduce mortality but their effects on readmission rates are unclear. The primary aim was to evaluate the efficacy of a supervised exercise-based cardiac rehabilitation programme on cardiac readmissions in patients with acute coronary syndrome at five years. METHODS: We conducted an open, controlled, randomized, hospital-based clinical trial. Patients were assigned either to the control group (CG) who received standard care or to the intervention group (IG) who participated in a supervised exercise programme (3h per week of supervised exercise training for 10 weeks). Patients were evaluated at 5 years. RESULTS: Seventy-six patients [41 CG, 35 IG, mean age 59.2 (SD 10.4), 82.9% men] were included. Cardiac readmission rates at 5 years were 24% in the CG compared to 9% in the IG (p=0.068), and readmission rates for all causes were 42% in the CG and 23% in the IG (p=0.085). Emergency care for cardiac disease was required more frequently in the CG (17% vs 11%, p=0.486). IG patients performed more regular and intensive exercise (62% vs. 33%, p=0.088). In both groups there were significant deterioration in systolic and diastolic blood pressure, body mass index, waist circumference, HbAc1, triglycerides, LDL and diet, and a significant increase in HDL. CONCLUSIONS: Patients who participated in the supervised exercise training programme were readmitted less often than controls for cardiac disease and for all causes at 5 years, the reduction was clinically meaningful although not statistically significant. Control of cardiovascular risk factors deteriorated in both groups.

Mindfulness on Daily Life Coping in People Experiencing Psychosis: A Randomized Controlled Trial

ResumenAntecedentes/Objetivo: La Terapia Cognitivo-Conductual para la psicosis (TCCp) es un trata-miento eficaz mediado por el afrontamiento del estrés. Las Intervenciones Basadas en Min-dfulness (IBM) han demostrado efectos positivos en psicosis por lo que combinarlas con TCCp podría mejorar el afrontamiento. El estudio compara el efecto de la TCCp con TCCp+IBM sobre el afrontamiento en psicosis. Método: Cincuenta y seis participantes con psicosis fue-ron reclutados y asignados aleatoriamente a TCCp o TCCp+IBM. Los protocolos fueron sincro-nizados con las rutinas de los participantes. Las medidas incluyeron la entrevista PANSS y el inventario COPE. Los datos se analizaron con ANOVA de medidas repetidas y se calculó el RCI. Resultados: No hubo diferencias estadísticamente significativas entre grupos en el pre-trata-miento, sí las hubo en la interacción Tratamiento x Tiempo en Desconexión mental (F = 5,65, p = 0,021, η2 = 0,102), Aceptación (F = 7,69, p = 0,008, η2 = 0,133) y Supresión de distractores (F = 4,62, p = 0,037, η2 = 0,085). Conclusiones: La IBM fomenta estilos de afrontamiento en psicosis que la TCCp en solitario no. TCCp+IBM mejoró la aceptación del estresor y redujo la desconexión mental. La intervención es eficaz y viable en un contexto asistencial.

AbstractBackground/Objective: Cognitive Behavior Therapy for psychosis (CBTp) is a recommended treatment for psychoses whose effect is mediated by coping. Mindfulness (MBI) have shown positive effects in psychosis. This study examines the hypothesis that combining CBTp+MBI could improve coping with day-to-day life in psychosis better than CBTp alone in people attending a public community rehabilitation center. Method: Fifty-six outpatients were recruited and randomly allocated either to CBTp or CBTp+MBI. Measures Halabícomprised PANSS interview and COPE Inventory. Data were analyzed using a repeated measures ANOVA and RCI calculation. Results: There were no statistical differences between groups at pre-treatment. Significant statistical differences were found for the interaction Treatment x Time in Mental disengagement (F = 5.65, p = .021, η2 = .102), Acceptance (F = 7.69, p = .008, η2 = .133), and Suppressing competing activities (F = 4.62, p = .037, η2 = .085). Conclusions: MBI promotes specific coping styles in people who experience psychosis that otherwise are not improved with CBTp. Only the MBI group improved acceptance of the presence of the stressor and reduced mental disengagement from the context. The intervention is feasible and effective for public healthcare settings.

ACT em grupo para manejo de ansiedade entre universitários: ensaio clínico randomizado / Group therapy based on act for anxiety management among university students: randomized clinical trial / Terapia grupal basada en ACT para el manejo de la ansiedad entre estudiantes universitarios: ensayo clínico aleatorizado

Estima-se que um a cada cinco estudantes universitários ao redor do mundo apresenta algum tipo de transtorno psicológico, dentre os quais os transtornos de ansiedade são os mais prevalentes. Este estudo consiste em um ensaio clínico randomizado com o objetivo de avaliar a eficácia e efetividade de um protocolo semiestruturado de psicoterapia em grupo baseado nos princípios da Terapia de Aceitação e Compromisso (ACT) para o tratamento de ansiedade entre estudantes universitários. Os participantes foram alocados aleatoriamente entre os grupos intervenção e controle. Os níveis de ansiedade pré e pós-intervenção foram avaliados por meio do instrumento General Anxiety Disorders-7 (GAD-7). A amostra final do estudo foi composta por 15 pessoas, dentre as quais 10 foram alocadas no grupo intervenção e 5, no grupo controle. Os resultados foram analisados de duas formas: a) por protocolo (Per-protocol analysis); e b) por intenção de tratar (Intention-to-treat Analysis). Este tratamento reduziu a sintomatologia ansiosa em 39,7% entre os pacientes que completaram o tratamento (por protocolo, p=0,030) e em 30,8% entre todos alocados para o grupo intervenção (i.e., por intenção de tratar, incluindo os dropouts, p=0,035), enquanto os controles não tiveram redução significativa no mesmo período. Portanto, recomenda-se a utilização deste protocolo dentro do contexto universitário como uma alternativa viável ao acompanhamento individual em situações de transtornos de ansiedade. Pesquisas futuras com amostras maiores podem contribuir na consolidação deste protocolo.

One in every five university students around the world is estimated to have some type of psychological disorder, considering anxiety disorders as the most prevalent. This study consists in a randomized clinical trial aimed to evaluate efficacy and effectiveness of a semi-structured group psychotherapy protocol based on the principles of Acceptance and Commitment Therapy (ACT) for the treatment of anxiety among university students. Participants were randomly allocated in the intervention and control groups. Pre- and post-intervention anxiety levels were measured using the General Anxiety Disorders-7 (GAD-7) questionnaire. The study sample was composed of 15 people, 10 of whom were allocated to the intervention group and 5 to the control group. Results were analyzed in two ways: 1) Per protocol analysis; and 2) Intention-to-treat analysis. This treatment reduced anxiety symptoms by 39.7% among patients who completed treatment (Per protocol, p=0.003) and by 30.8% among all those allocated to the intervention group (i.e., by Intention-to-treat, including dropouts, p=0.035), whereas controls showed no significant reduction in same period. Therefore, we recommend the use of this protocol within the university context as a viable alternative to individual counselling in situations of anxiety disorders. Future research with larger samples may contribute to consolidate this protocol.

Se estima que uno de cada cinco estudiantes universitarios en todo el mundo tiene algún tipo de trastorno psicológico, entre los cuales los trastornos de ansiedad son los más frecuentes. Este estudio consiste en un ensayo clínico aleatorizado cuyo objetivo fue evaluar la eficacia y efectividad de un protocolo de psicoterapia grupal semiestructurada basado en los principios de la Terapia de Aceptación y Compromiso (ACT) para el tratamiento de la ansiedad en estudiantes universitarios. Se asignaron aleatoriamente a los participantes en los grupos de intervención y control. Los niveles de ansiedad antes y después de la intervención se midieron utilizando el instrumento General Anxiety Disorders-7 (GAD-7). La muestra final del estudio estuvo compuesta por 15 personas, de las cuales 10 fueron asignadas al grupo de intervención y 5 al grupo de control. Los resultados se analizaron de dos maneras: 1) por protocolo (Per protocol analysis); y 2) por intención de tratar (Intention-to-treat Analysis). Con este tratamiento los síntomas de ansiedad se redujeron en un 39,7% entre los pacientes que completaron el tratamiento (por protocolo, p=0,030) y en un 30,8% entre todos los asignados al grupo de intervención (es decir, por intención de tratar, incluidos los dropouts, p=0,035), mientras que los controles no tuvieron una reducción significativa en el mismo periodo. Por lo tanto, se recomienda utilizar este protocolo dentro del contexto universitario como una alternativa viable a lo asesoramiento individual en situaciones de trastornos de ansiedad. La investigación futura con muestras más grandes puede contribuir a la consolidación de esta modalidad.

Interpretation of clinical trials on the cardiovascular effects of hypoglycemic drugs in people with type 2 diabetes.

Randomized clinical trials on the cardiovascular effects of hypoglycemic drugs on people with type 2 diabetes mellitus began more than fifty years ago. In the last decade, the emergence of new classes of hypoglycemic drugs has led to the development of randomized clinical trials to assess their cardiovascular safety. Known as Cardiovascular Outcome Trials, they have provided a lot of new information that needs to be critically appraised if the knowledge obtained is to be applicable in clinical practice. To this end, the current article first comments on the guidelines to which these trials have adhered, then reviews some concepts for improving their interpretation (such as different types of analyses, the definition of objectives and the evaluation of their results), and concludes by mentioning the new guidelines to which future trials designed to evaluate the safety of new hypoglycemic drugs should adhere.

Interpretation of clinical trials on the cardiovascular effects of hypoglycemic drugs in people with type2 diabetes. / Interpretación de los ensayos clínicos sobre efectos cardiovasculares de los fármacos hipoglucemiantes en personas con diabetes tipo2.

Randomized clinical trials on the cardiovascular effects of hypoglycemic drugs on people with type2 diabetes mellitus began more than fifty years ago. In the last decade, the emergence of new classes of hypoglycemic drugs has led to the development of randomized clinical trials to assess their cardiovascular safety. Known as Cardiovascular Outcome Trials, they have provided a lot of new information that needs to be critically appraised if the knowledge obtained is to be applicable in clinical practice. To this end, the current article first comments on the guidelines to which these trials have adhered, then reviews some concepts for improving their interpretation (such as different types of analyses, the definition of objectives and the evaluation of their results), and concludes by mentioning the new guidelines to which future trials designed to evaluate the safety of new hypoglycemic drugs should adhere.

Brief psychological treatments for emotional disorders in Primary and Specialized Care: A randomized controlled trial / Tratamientos psicológicos breves para trastornos emocionales en Atención Primaria y Especializada: un ensayo clínico aleatorizado

Background/Objective Brief transdiagnostic psychotherapies are a possible treatment for emotional disorders. We aimed to determine their efficacy on mild/moderate emotional disorders compared with treatment as usual (TAU) based on pharmacological interventions. Method: This study was a single-blinded randomized controlled trial with parallel design of three groups. Patients (N = 102) were assigned to brief individual psychotherapy (n = 34), brief group psychotherapy (n = 34) or TAU (n = 34). Participants were assessed before and after the interventions with the following measures: PHQ-15, PHQ-9, PHQ-PD, GAD-7, STAI, BDI-II, BSI-18, and SCID. We conducted per protocol and intention-to-treat analyses. Results: Brief psychotherapies were more effective than TAU for the reduction of emotional disorders symptoms and diagnoses with moderate/high effect sizes. TAU was only effective in reducing depressive symptoms. Conclusions: Brief transdiagnostic psychotherapies might be the treatment of choice for mild/moderate emotional disorders and they seem suitable to be implemented within health care systems. (AU)

Antecedentes/Objetivo: Las psicoterapias breves son un posible tratamiento para los trastornos emocionales. Nuestro propósito fue determinar su eficacia en los trastornos emocionales leves/moderados en comparación con el tratamiento habitual basado en intervenciones farmacológicas. Método: Este estudio fue un ensayo clínico aleatorizado simple ciego con diseño paralelo de tres grupos. Los pacientes (N = 102) fueron asignados a psicoterapia breve individual (n = 34), psicoterapia breve grupal (n = 34) o tratamiento habitual (n = 34). Los participantes fueron evaluados antes y después del tratamiento con los siguientes instrumentos: PHQ-15, PHQ-9, PHQ-PD, GAD-7, STAI, BDI-II, BSI-18 y SCID. Se realizaron análisis por protocolo y por intención de tratar. Resultados: Las psicoterapias breves fueron más efectivas que el tratamiento habitual para la reducción de síntomas y diagnósticos de los trastornos emocionales. El tratamiento habitual solo fue efectivo en reducir los síntomas depresivos. Conclusiones: Las psicoterapias breves pueden ser el tratamiento de elección para los trastornos emocionales leves/moderados y podrían implementarse en los sistemas de salud. (AU)

O lugar dos ensaios clínicos aleatorizados na pesquisa em psicoterapia: uma crítica epistemológica / The place of Randomized Clinical Trials in psychotherapy research: an epistemological critique / La place des essais cliniques randomisé dans la recherche en psychothérapie: une critique épistémologique / El lugar de los Ensayos Clínicos Aleatorizados en la investigación en psicoterapia: una crítica epistemológica

Resumo O Ensaio Clínico Aleatorizado (ECA) é considerado o tipo de desenho metodológico com maior poder de verificação da eficácia das psicoterapias. Entretanto, especialmente a partir da segunda metade do século XX, muitas críticas direcionadas às concepções epistemológicas subjacentes às ditas "ciências duras" atingiram também, no âmbito das ciências da saúde, os estudos que adotavam esse desenho. Este artigo é uma reflexão crítica sobre algumas das objeções feitas aos ECAs, avaliando de que maneira e até que ponto estes poderiam se configurar como estratégia válida de investigação científica no contexto crítico apontado. Conclui-se que o ECA pode e deve ser utilizado - desde que em contexto crítico - por seu valor pragmático, enquanto produtor de predições e intervenções capazes de solucionar problemas clínicos, inevitavelmente definidos e estabelecidos a partir do ponto de vista particular de uma comunidade.

Abstract The randomized controlled clinical trial (RCT) is considered the type of methodological design with the greatest power to verify the efficacy of psychotherapies. However, especially from the second half of the twentieth century, many criticisms directed at the epistemological conceptions underlying the so-called "hard sciences" have also affected the studies that adopted this design. This article is a critical reflection on some of the objections made to randomized clinical trials, evaluating how and to what extent these trials could be configured as a valid scientific research strategy in this critical context. We concluded that the RCT should be used - as long as it is performed in a critical context - due to its pragmatic value, as a producer of predictions and interventions capable of solving clinical problems, inevitably defined and established from the particular point of view of a community.

Résumé L'essai clinique randomisé est considéré comme le type de conception méthodologique ayant le plus puissant pour vérifier l'efficacité des psychothérapies. Cependant, surtout depuis la seconde moitié du XXe siècle, de nombreuses critiques adressées aux conceptions épistémologiques qui sous-tendent les sciences dites « dures ¼ ont également affecté, dans le cadre des sciences de la santé, les études qui ont adopté cette conception. Cet article est une réflexion critique sur certaines des objections faites aux essais cliniques randomisés, évaluant comment et dans quelle mesure ceux-ci pourraient être configurés comme une stratégie valide de recherche scientifique dans le contexte critique signalé. On en conclu que l'ECA peut et doit être utilisé - à condition que ce soit dans un contexte critique - pour sa valeur pragmatique, en tant que producteur de prédictions et d'interventions capables de résoudre des problèmes cliniques, inévitablement définies et établies du point de vue particulier d'une communauté.

Resumen El ensayo clínico aleatorizado (ECA) se considera el tipo de diseño metodológico con mayor poder para verificar la eficacia de las psicoterapias. Sin embargo, especialmente desde la segunda mitad del siglo XX, muchas críticas dirigidas a las concepciones epistemológicas subyacentes a las llamadas "ciencias duras" también han afectado, dentro del alcance de las ciencias de la salud, los estudios que adoptan este diseño. Este artículo es una reflexión crítica sobre algunas de las objeciones hechas a los ECA, evaluando cómo y en qué medida podrían configurarse como una estrategia de investigación científica válida en este contexto crítico. Se concluye que el ECA puede y debe usarse, siempre y cuando se encuentre en un contexto crítico, por su valor pragmático como productor de predicciones e intervenciones capaces de resolver los problemas clínicos inevitablemente definidos y establecidos desde el punto de vista particular de una comunidade.

Comparación entre uso y no uso de antibióticos profilácticos en pancreatitis aguda grave: ensayo clínico aleatorizado: reporte preliminar / Comparison between use and non-use of prophylactic antibiotics in severe acute pancreatitis: randomized clinical trial: preliminary report

Resumen Introducción: La pancreatitis aguda es una enfermedad frecuente en el país, con una tasa de mortalidad de 10%-30%. La administración profiláctica de antibióticos ha sido parte del tratamiento de pancreatitis aguda grave (PAG), por la teórica prevención de complicaciones infecciosas y reducción de mortalidad. Sin embargo, la evidencia científica disponible es controversial. Objetivo: Demostrar que los antibióticos profilácticos no disminuyen las complicaciones locales y/o sistémicas, requerimiento de Unidad de Paciente Crítico (UPC), ni mortalidad en PAG. Definimos PAG como APACHE II ≥ 8 o PCR ≥ 150 o falla multiorgánica. Material y Método: Ensayo clínico aleatorizado, con aleatorización simple mediante tabla electrónica (uso o no uso de antibióticos profilácticos) de pacientes con PAG. En el grupo que usó antibióticos profilácticos se utilizó ciprofloxacino y metronidazol por 7 días. El resto del manejo no tuvo variación. Resultados: n = 71, dos grupos aleatorizados; Grupo 1 (n = 35), sin uso de antibióticos profilácticos, y grupo 2 (n = 36) con uso de profilaxis antibiótica. 12 pacientes (16%) requirieron UPC; 6 pacientes del grupo 1, y 6 del grupo 2 (p = 0,957). Siete pacientes (9,8%) tuvieron algún tipo de complicación, 3 en el grupo 1 y 4 en el grupo 2 (p = 0,516). El promedio de estancia hospitalaria fue 18,2 ± 9,5 días en el grupo 1, y 22,6 ± 29.2 días en el grupo 2 (p = 0,495). Mortalidad: 1 paciente (1,41%) en el grupo 2 (p = 0,493). Conclusión: En este reporte preliminar, el uso de antibióticos profilácticos en PAG no mostró reducir las complicaciones, necesidad de cama en UPC, ni la mortalidad.

Introduction: Acute pancreatitis is a common disease in the country, with a mortality rate of 10%-30%. The prophylactic administration of antibiotics has been part of the treatment of severe acute pancreatitis (SAP), due to the theoretical prevention of infectious complications and mortality reduction. However, the available scientific evidence is controversial. Objective: To demonstrate that prophylactic antibiotics do not reduce local and/or systemic complications, critical patient unit (CPU) requirement, or mortality in SAP. We define SAP as APACHE II ≥ 8 or PCR ≥ 150° or multiorgan failure. Material and Method: Randomized clinical trial, with simple randomization by electronic table (use or non-use of prophylactic antibiotics) of patients with SAP. In the group that used prophylactic antibiotics, ciprofloxacin and metronidazole were used for 7 days. Results: n = 71, two randomized groups; Group 1 (n = 35), without the use of prophylactic antibiotics, and group 2 (n = 36) with the use of antibiotic prophylaxis. 12 patients (16%) required CPU; 6 patients from group 1, and 6 from group 2 (p = 0.957). Seven patients (9.8%) had some type of complication, 3 in group 1 and 4 in group 2 (p = 0.516). The average hospital stay was 18.2 ± 9.5 days in group 1, and 22.6 ± 29.2 days in group 2 (p = 0.495). Mortality: 1 patient (1.41%) in group 2 (p = 0.493). Conclusion: In this preliminary report, the use of prophylactic antibiotics in SAP was not shown to reduce complications, need for bed in CPU, or mortality.

Effect of vitamin D3 supplementation on 25 OHD plasma levels in the presence of VDR gene polymorphisms / Efecto de la suplementación con vitamina D3 en los niveles plasmáticos de 25 OHD, en presencia de polimorfismos del gen VDR

The objective of this review was to investigate the effect of vitamin D3 supplementation on serum 25-hydroxyvitamin D concentration in individuals with single-nucleotide polymorphisms in the vitamin D receptor gene. The research was conducted on 241 articles found in the PubMed, Scopus, Science Direct, and Cochrane Library databases between November and December 2018. After article screening, three randomized double-blind placebo-controlled clinical trials were identified as eligible for this review. Participants were Australian, Brazilian, and Chinese individuals, who ingested doses of vitamin D3 ranging from 2000 IU to a megadose of 200,000 IU. The presence of the BB/Bb genotype of the BsmI polymorphism and the FokI G allele caused an increase in the serum concentrations of vitamin D after supplementation. Nonetheless, the few studies on this subject are not unanimous in their results. It is possible that differences among populations, sample sizes, doses, and time of supplementation have an impact on data and outcomes.

El objetivo de esta revisión fue investigar el efecto de la suplementación con vitamina D3 sobre la concentración sérica de 25-hidroxivitamina D en individuos con los polimorfismos de un solo nucleótido en el gen del receptor de la vitamina D. La investigación se realizó en 241 artículos encontrados en las bases de datos PubMed, Scopus, Science Direct y Cochrane Library entre noviembre y diciembre de 2018. Después de la selección del artículo, se identificaron tres ensayos clínicos aleatorios, controlados con placebo, doble ciego, como elegibles para esta revisión. Los participantes fueron australianos, brasileños y chinos, quienes ingirieron dosis de vitamina D3 que iban desde las 2000 UI hasta una megadosis de 200,000 UI. La presencia del genotipo BB / Bb del polimorfismo BsmI y el alelo FokI G causó un aumento en las concentraciones séricas de vitamina D después de la suplementación. No obstante, los pocos estudios sobre este tema no son unánimes en sus resultados. Es posible que las diferencias entre poblaciones, tamaños de muestra, dosis y tiempo de suplementación tengan un impacto en los datos y resultados de la investigación.

Effectiveness of omega-3 fatty acid supplementation in patients with Alzheimer disease: A systematic review and meta-analysis. / Efectividad de la suplementación de ácidos grasos omega-3 en pacientes con enfermedad de Alzheimer: revisión sistemática con metaanálisis.

INTRODUCTION: Alzheimer disease (AD) is a neurodegenerative disease characterised by progressive dementia associated with global cognitive dysfunction. METHODS: We conducted a systematic review and meta-analysis of clinical trials evaluating omega-3 supplementation in patients with AD. OBJECTIVE: To determine if there is scientific evidence of the effectiveness of omega-3 supplementation in improving cognitive function in patients with AD. SEARCH STRATEGY: We included only randomised controlled trials (RCTs) from the following databases: Medline, Cochrane Central, Cinahl, and LILACS. An electronic search was also conducted using Google Scholar. STUDY SELECTION: Six articles met the eligibility criteria. The risk of bias was assessed following the Cochrane method. CONCLUSION: There is no consistent evidence to support the effectiveness of omega-3 supplementation in improving cognitive function in AD patients in the short and medium term.

O estresse em mães de prematuros: ensaio clínico sobre atividade educativa / Educative activity and maternal stress of premature infant: controlled trial / El estrés en madres de prematuros: ensayo clínico sobre actividad educativa

Decorrente de eventos estressores na hospitalização, mães de recém-nascidos prematuros tornam-se vulneráveis para desenvolver a competência parental saudável. Objetivou-se comparar o nível de estresse de mães de recém-nascidos prematuros na hospitalização e após a alta hospitalar correlacionando-os aos níveis detectados na análise do conhecimento materno sobre os cuidados com o prematuro. Ensaio clínico randomizado, com mães de recém-nascidos prematuros hospitalizados em Unidade de Terapia Intensiva Neonatal, divididas em: Grupo de Intervenção-GI (atividades educativas) e Grupo Controle-GC (rotina). Mensurou-se o estresse materno pela Escala de Estresse Parental:UTIN (hospitalização) e Índice de Estresse Parental (após a alta hospitalar). Níveis de estresse do GI diminuíram 2,68 vezes em relação ao GC após a alta, contudo sem significância estatística quanto ao conhecimento materno entre os grupos. Para prevenir o estresse após a alta, em mães de prematuros, deve-se empoderá-las para cuidarem do filho

Mothers of preterm infants suffer stressful events during the hospitalization, making them vulnerable for not developing healthy parental competence. This study aimed to compare the stress level of mothers of preterm infants at hospital admission and after discharge, correlating them with the levels detected in the analysis of maternal knowledge about premature infants' care. This was a randomized clinical trial. Mothers of premature infants hospitalized in Neonatal Intensive Care Unit were divided in Intervention Group-IG (educative activities) and Control Group-CG (routine). Stress levels were measured by Parental Stress Scale:NICU (hospitalization) and Parental Stress Index (after hospital discharge). The stress levels of mothers that participated in IG decreased 2.68 times compared to CG after discharge; however, there was no statistical significance in the knowledge between the groups. Preventing stress after discharge in mothers of preterm infant requires empowering them to take care of their children

A raíz de acontecimientos estresantes en la hospitalización, las madres de recién nacidos prematuros se vuelven vulnerables para desarrollar la competencia parental saludable. Se objetivó comparar el nivel de estrés de madres de recién nacidos prematuros en la hospitalización y después del alta hospitalaria correlacionándolos a los niveles detectados en el análisis del conocimiento materno sobre los cuidados con el prematuro. En el estudio clínico aleatorizado, con madres de recién nacidos prematuros hospitalizados en Unidad de Terapia Intensiva Neonatal, divididas en: Grupo de Intervención-GI (actividades educativas) y Grupo Control-GC (rutina). Se midió el estrés materno por la Escala de estrés parental: UTIN (hospitalización) e índice de estrés parental (después del alta hospitalaria). Los niveles de estrés del GI disminuyeron 2,68 veces en relación con el GC después del alta, pero sin significancia estadística en cuanto al conocimiento materno entre los grupos. Para prevenir el estrés después del alta, en madres de prematuros, se deben empoderarlas para cuidar del hijo