RESUMEN
Emergency care needs to be underpinned by the highest quality evidence. However, research involving critically ill patients in the emergency setting has unique ethical, logistical and regulatory issues. Informed consent is a well-established principle in conventional research. In this article, we discuss informed consent as it pertains to the difficulties of research in the emergency setting. Alternatives to informed consent are discussed. Human research ethics committees require a greater understanding of consent issues in emergency care research for Australia to remain competitive internationally.
Asunto(s)
Servicios Médicos de Urgencia/tendencias , Ética en Investigación , Consentimiento Informado/normas , Investigación/normas , Australia , Servicios Médicos de Urgencia/métodos , Servicio de Urgencia en Hospital/organización & administración , Humanos , Consentimiento Informado/éticaRESUMEN
This perspective article summarises the experience of conducting a multicentre research project. We describe expected and unexpected hurdles we experienced as well as suggesting possible solutions for researchers embarking on multicentre studies.
Asunto(s)
Analgesia/normas , Servicio de Urgencia en Hospital , Estudios Multicéntricos como Asunto , Manejo del Dolor/normas , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Regulación Gubernamental , Humanos , Satisfacción del Paciente , QueenslandRESUMEN
OBJECTIVES: We aimed to provide 'adequate analgesia' (which decreases the pain score by ≥2 and to <4 [0-10 scale]) and determine the effect on patient satisfaction. METHODS: We undertook a multicentre, cluster-randomised, controlled, intervention trial in nine EDs. Patients with moderate pain (pain score of ≥4) were eligible for inclusion. The intervention was a range of educational activities to encourage staff to provide 'adequate analgesia'. It was introduced into five early intervention EDs between the 0 and 6 months time points and at four late intervention EDs between 3 and 6 months. At 0, 3 and 6 months, data were collected on demographics, pain scores, analgesia provided and pain management satisfaction 48 h post-discharge (6 point scale). RESULTS: Overall, 1317 patients were enrolled. Logistic regression (controlling for site and other confounders) indicated that, between 0 and 3 months, satisfaction increased significantly at the early intervention EDs (OR 2.2, 95% CI 1.5 to 3.4 [P < 0.01]) but was stable at the control EDs (OR 0.8, 95% CI 0.5 to 1.3 [P = 0.35]). Pooling of data from all sites indicated that the proportion of patients very satisfied with their pain management increased from 42.9% immediately pre-intervention to 53.9% after 3 months of intervention (difference in proportions 11.0%, 95% CI 4.2 to 17.8 [P = 0.001]). Logistic regression of all data indicated that 'adequate analgesia' was significantly associated with patient satisfaction (OR 1.4, 95% CI 1.1 to 1.8 [P < 0.01]). CONCLUSIONS: The 'adequate analgesia' intervention significantly improved patient satisfaction. It provides a simple and efficient target in the pursuit of best-practice ED pain management.
RESUMEN
OBJECTIVE: To compare the effectiveness of three corticosteroid regimens in children with mild to moderate croup. METHODS: Double-blinded, randomized comparative trial with parallel design, conducted in the ED of a paediatric tertiary care hospital. Children aged 6 months to 6 years presenting to the ED with croup were eligible for inclusion if their Westley croup score was 2 or more. They were randomized to receive a single oral dose of either prednisolone 1 mg/kg, dexamethasone 0.15 mg/kg or dexamethasone 0.6 mg/kg. Primary outcome measures were the magnitude and rate of reduction in Westley croup score, rate of return for medical care with ongoing croup, and further treatment with steroids in the week following index presentation. Secondary outcome measures were the proportion of subjects requiring admission or salvage therapy, such as nebulized adrenaline, during index presentation. RESULTS: A total of 99 children, aged 6-79 months, were enrolled (mean age: 1.7 years). Thirty-four patients were randomized to receive prednisolone 1 mg/kg, 34 to receive dexamethasone 0.15 mg/kg, and 31 to receive dexamethasone 0.6 mg/kg. Baseline characteristics of the three groups were similar. The parents of 86 patients (87%) were available for follow-up telephone interview at 1 week. There were no significant differences in primary or secondary outcome measures between the three treatment groups. CONCLUSIONS: Both prednisolone 1 mg/kg and low-dose dexamethasone (0.15 mg/kg) were found not to differ in efficacy from the currently recommended 0.6 mg/kg dexamethasone. The use of these corticosteroid regimens in treating patients with mild to moderate croup is thus supported.