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Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725) / Juan Pablo Botero Aguirre ; Andrés Felipe Valencia Quintero ; Natalia Andrea Ortíz Cano
Título : Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725) Tipo de documento : documento electrónico Autores : Juan Pablo Botero Aguirre, ; Andrés Felipe Valencia Quintero, ; Natalia Andrea Ortíz Cano, Fecha de publicación : 2020 Títulos uniformes : Trials Idioma : Inglés (eng) Palabras clave : Medication errors Drug-related problems Pharmacy service Hospital (clinical pharmacy services) Pharmacists Resumen : Background: According to WHO, medication error (ME) is a subject that requires attention at all levels of care to reduce severe and preventable damage related to medication use. Clinical pharmacy practice standards have been proposed around the world so that the pharmacist, as part of a multidisciplinary health team, can help improve patient safety; however, further evidence derived from adequate studies is needed to demonstrate this. This study aims to assess the effect of a clinical pharmacy practice model (CPPM) in preventing MEs associated with the medication use process. Methods: A prospective, stepped-wedge, cluster-randomized, controlled trial with a duration of 14 months will be performed to compare the effect of a CPPM along with the usual care process of patients in the Pablo Tobón Uribe Hospital (Medellin, Colombia). The study is designed as a cluster-randomized controlled trial, involving five hospital wards (clusters) and 720 patients. Medical wards are allocated to interventions using a stepped-wedge design. Clusters are initially assigned to the control group. After a 2-month observation period, hospital clusters were randomly allocated to the intervention group. Study outcomes will be assessed at baseline and at 2, 4, 6, 8, 10, and 12 months after randomization. The primary outcome will be to assess the effect of a CPPM on the incidence of medication errors associated with the medication use process. Drug-related problems and factors that contribute to the occurrence of MEs will be assessed as secondary outcomes. Statistical analyses will be performed using a mixed model, with the treatment group and time as fixed effects and the clustering structure as a random effect. Statistical analysis will be performed using Pearson chi-square tests and Student's t-tests, and a P value Mención de responsabilidad : J Granados, A Salazar-Ospina, J P Botero-Aguirre, A F Valencia-Quintero, N Ortiz, P Amariles Referencia : Trials. 2020;21(1):26. DOI (Digital Object Identifier) : 10.1186/s13063-019-3945-8 PMID : 31907009 Derechos de uso : CC BY En línea : https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3945-8 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5074 Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725) [documento electrónico] / Juan Pablo Botero Aguirre, ; Andrés Felipe Valencia Quintero, ; Natalia Andrea Ortíz Cano, . - 2020.
Obra : Trials
Idioma : Inglés (eng)
Palabras clave : Medication errors Drug-related problems Pharmacy service Hospital (clinical pharmacy services) Pharmacists Resumen : Background: According to WHO, medication error (ME) is a subject that requires attention at all levels of care to reduce severe and preventable damage related to medication use. Clinical pharmacy practice standards have been proposed around the world so that the pharmacist, as part of a multidisciplinary health team, can help improve patient safety; however, further evidence derived from adequate studies is needed to demonstrate this. This study aims to assess the effect of a clinical pharmacy practice model (CPPM) in preventing MEs associated with the medication use process. Methods: A prospective, stepped-wedge, cluster-randomized, controlled trial with a duration of 14 months will be performed to compare the effect of a CPPM along with the usual care process of patients in the Pablo Tobón Uribe Hospital (Medellin, Colombia). The study is designed as a cluster-randomized controlled trial, involving five hospital wards (clusters) and 720 patients. Medical wards are allocated to interventions using a stepped-wedge design. Clusters are initially assigned to the control group. After a 2-month observation period, hospital clusters were randomly allocated to the intervention group. Study outcomes will be assessed at baseline and at 2, 4, 6, 8, 10, and 12 months after randomization. The primary outcome will be to assess the effect of a CPPM on the incidence of medication errors associated with the medication use process. Drug-related problems and factors that contribute to the occurrence of MEs will be assessed as secondary outcomes. Statistical analyses will be performed using a mixed model, with the treatment group and time as fixed effects and the clustering structure as a random effect. Statistical analysis will be performed using Pearson chi-square tests and Student's t-tests, and a P value Mención de responsabilidad : J Granados, A Salazar-Ospina, J P Botero-Aguirre, A F Valencia-Quintero, N Ortiz, P Amariles Referencia : Trials. 2020;21(1):26. DOI (Digital Object Identifier) : 10.1186/s13063-019-3945-8 PMID : 31907009 Derechos de uso : CC BY En línea : https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3945-8 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5074 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD001304 AC-2020-008 Archivo digital Producción Científica Artículos científicos Disponible Documentos electrónicos
2020-008.pdfAdobe Acrobat PDF Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET) / Mauricio Estrada Castrillón
Título : Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET) Tipo de documento : documento electrónico Autores : Mauricio Estrada Castrillón, Fecha de publicación : 2018 Títulos uniformes : Trials Idioma : Inglés (eng) Palabras clave : Aerobic exercise exercise training glucose metabolism disorders hyperinsulinemia. insulin resistance interval training metabolic syndrome myokines risk factors skeletal muscle Resumen : Background: Evidence of the efficacy of high-intensity, low-volume interval training (HIIT-low volume) in treating insulin resistance (IR) in patients with metabolic disorders is contradictory. In addition, it is unknown whether this effect is mediated through muscle endocrine function, which in turn depends on muscle mass and fiber type composition. Our aims were to assess the efficacy of HIIT-low volume compared to continuous aerobic exercise (CAE) in treating IR in adults with metabolic syndrome (MS) and to establish whether musclin, apelin, muscle mass and muscle composition are mediators of the effect. Methods: This is a controlled, randomized, clinical trial using the minimization method, with blinding of those who will evaluate the outcomes and two parallel groups for the purpose of showing superiority. Sixty patients with MS and IR with ages between 40 and 60 years will be included. A clinical evaluation will be carried out, along with laboratory tests to evaluate IR (homeostatic model assessment (HOMA)), muscle endocrine function (serum levels of musclin and apelin), thigh muscle mass (by dual energy x-ray absorptiometry (DXA) and thigh muscle composition (by carnosine measurement with proton magnetic resonance spectroscopy (1H–MRS)), before and after 12 weeks of a treadmill exercise program three times a week. Participants assigned to the intervention (n = 30) will receive HIIT-low volume in 22-min sessions that will include six intervals at a load of 90% of maximum oxygen consumption (VO2 max) for 1 min followed by 2 min at 50% of VO2 max. The control group (n = 30) will receive CAE at an intensity of 60% of VO2 max for 36 min. A theoretical model based on structural equations will be proposed to estimate the total, direct and indirect effects of training on IR and the proportion explained by the mediators. Discussion: Compared with CAE, HIIT-low volume can be effective and efficient at improving physical capacity and decreasing cardiovascular risk factors, such as IR, in patients with metabolic disorders. Studies that evaluate mediating variables of the effect of HIIT-low volume on IR, such as endocrine function and skeletal muscle structure, are necessary to understand the role of skeletal muscle in the pathophysiology of MS and their regulation by exercise. Trial registration: NCT03087721. High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET). Registered on 22 March 2017, retrospectively registered. Mención de responsabilidad : Jaime Gallo-Villegas, Juan Carlos Aristizabal, Mauricio Estrada, Luis H Valbuena, Raul Narvaez-Sanchez, Jorge Osorio, Daniel C Aguirre-Acevedo, Juan C Calderón Referencia : Trials. 2018 Feb 27;19(1):144. DOI (Digital Object Identifier) : 10.1186/s13063-018-2541-7 PMID : 29482601 Derechos de uso : CC BY En línea : https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2541-7 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4187 Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET) [documento electrónico] / Mauricio Estrada Castrillón, . - 2018.
Obra : Trials
Idioma : Inglés (eng)
Palabras clave : Aerobic exercise exercise training glucose metabolism disorders hyperinsulinemia. insulin resistance interval training metabolic syndrome myokines risk factors skeletal muscle Resumen : Background: Evidence of the efficacy of high-intensity, low-volume interval training (HIIT-low volume) in treating insulin resistance (IR) in patients with metabolic disorders is contradictory. In addition, it is unknown whether this effect is mediated through muscle endocrine function, which in turn depends on muscle mass and fiber type composition. Our aims were to assess the efficacy of HIIT-low volume compared to continuous aerobic exercise (CAE) in treating IR in adults with metabolic syndrome (MS) and to establish whether musclin, apelin, muscle mass and muscle composition are mediators of the effect. Methods: This is a controlled, randomized, clinical trial using the minimization method, with blinding of those who will evaluate the outcomes and two parallel groups for the purpose of showing superiority. Sixty patients with MS and IR with ages between 40 and 60 years will be included. A clinical evaluation will be carried out, along with laboratory tests to evaluate IR (homeostatic model assessment (HOMA)), muscle endocrine function (serum levels of musclin and apelin), thigh muscle mass (by dual energy x-ray absorptiometry (DXA) and thigh muscle composition (by carnosine measurement with proton magnetic resonance spectroscopy (1H–MRS)), before and after 12 weeks of a treadmill exercise program three times a week. Participants assigned to the intervention (n = 30) will receive HIIT-low volume in 22-min sessions that will include six intervals at a load of 90% of maximum oxygen consumption (VO2 max) for 1 min followed by 2 min at 50% of VO2 max. The control group (n = 30) will receive CAE at an intensity of 60% of VO2 max for 36 min. A theoretical model based on structural equations will be proposed to estimate the total, direct and indirect effects of training on IR and the proportion explained by the mediators. Discussion: Compared with CAE, HIIT-low volume can be effective and efficient at improving physical capacity and decreasing cardiovascular risk factors, such as IR, in patients with metabolic disorders. Studies that evaluate mediating variables of the effect of HIIT-low volume on IR, such as endocrine function and skeletal muscle structure, are necessary to understand the role of skeletal muscle in the pathophysiology of MS and their regulation by exercise. Trial registration: NCT03087721. High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET). Registered on 22 March 2017, retrospectively registered. Mención de responsabilidad : Jaime Gallo-Villegas, Juan Carlos Aristizabal, Mauricio Estrada, Luis H Valbuena, Raul Narvaez-Sanchez, Jorge Osorio, Daniel C Aguirre-Acevedo, Juan C Calderón Referencia : Trials. 2018 Feb 27;19(1):144. DOI (Digital Object Identifier) : 10.1186/s13063-018-2541-7 PMID : 29482601 Derechos de uso : CC BY En línea : https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2541-7 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4187 Reserva
Reservar este documentoEjemplares(1)
Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000801 AC-2018-088 Archivo digital Producción Científica Artículos científicos Disponible Documentos electrónicos
2018-088.pdfAdobe Acrobat PDF