23 research outputs found
Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials: The PeriOperative Epidural Trial (POET) Pilot Study
Get PDFEarly randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada.After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or = 45 years old, had an expected hospital stay > or = 48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group) and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group) and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5+/-0.3 (mean+/-SEM) subjects per week per centre; 112/494 (22.7%) eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5%) of 49 subjects in the epidural group crossed over to the IV group; seven (14.3%) were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8%) of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0%) of 101 subjects were successfully followed up until 30 days after their surgery.Of the criteria we defined for the feasibility of a full-scale trial, only the follow-up target was met. The other feasibility outcomes did not meet our preset criteria for success. The results suggest that a large multicentre trial may not be a feasible design to study the perioperative effects of neuraxial blockade.ClinicalTrials.gov NCT 0221260 Controlled-Trials.com ISRCTN 35629817
Can we improve management and control of chronic diseases?.
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Objetivo: Investigar la efectividad de diferentes estrategias destinadas a mejorar la calidad y los resultados de las intervenciones en el tratamiento de las enfermedades crónicas.
MetodologÃa: Revisión sistemática de la bibliografÃa.
Criterios de inclusión: Ensayos clÃnicos en lengua inglesa o española que evalúen la efectividad de distintas intervenciones para mejorar los resultados asistenciales del asma, la diabetes, la hipertensión y la insuficiencia cardÃaca. Las intervenciones se clasifican de acuerdo con un modelo conceptual en 6 categorÃas: cambios organizativos, participación comunitaria, sistemas de información, diseño de la práctica clÃnica, apoyo a la toma de decisiones y de autocontrol. Los resultados evaluados fueron: utilización de servicios de salud, tratamiento clÃnico, resultados clÃnicos, calidad de vida, satisfacción e indicadores de capacidad de autocontrol.
Resultados: Se incluyeron 37 estudios que incorporaban 38 intervenciones. Las intervenciones más frecuentes son las que investigan los cambios en el de diseño asistencial, seguidas de las que analizan el efecto de los sistemas de información y apoyo a la toma de decisiones. Las intervenciones más complejas en número de intervenciones, incluido el apoyo para el autocontrol, mostraron una mayor probabilidad de tener efectos positivos en el tratamiento y en los resultados clÃnicos. Pocas intervenciones consiguen mejoras en utilización de servicios, aunque sà se observaron sustanciales mejoras en los resultados percibidos.
Conclusiones: Para mejorar la calidad asistencial y la efectividad en el control de las enfermedades crónicas es preciso adoptar una visión sistemática que incluya un sistema sanitario proactivo y pacientes protagonistas activos del tratamiento de su enfermedad. Los programas asà diseñados deben combinar, al menos, estrategias organizativas, de diseño asistencial y de autocontrol.
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To evaluate the effectiveness of interventions aimed at improving the quality and outcome of chronic disease management.
Systematic review of the literature.
Clinical trials in English and Spanish that assess the effectiveness of 1 or more strategies for improving quality and outcome in asthma, diabetes, hypertension, and congestive heart failure. Interventions were classified in line with a conceptual model in 6 categories: organizational changes, community participation, information systems, clinical practice design, decision-making support, and self-management. The outcomes considered were: health service utilization, chronic disease management, clinical outcomes, quality of life, satisfaction, and self-management indicators.
Thirty seven studies with 38 interventions were included. The most common interventions were those that investigated changes in health care design, followed by those analysing information systems and decision-making support. The most complex interventions, in terms of the overall number of strategies, including support for self-management, showed more likelihood of positive effects in clinical management and clinical outcomes. Few interventions achieved improvements in use of health care services, though patients perceived substantial improvements.
In order to improve quality and effectiveness of chronic disease management, it is necessary to take a systematic view including proactive health care systems and patients taking an active role in managing their disease. These programmes should combine, at the least, organizational strategies, design of clinical practice and patient self-management.S
