Lancet
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Randomized Controlled Trial Multicenter Study Clinical Trial
Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Australia/New Zealand Heart Failure Research Collaborative Group.
In patients with heart failure, beta-blocker therapy improves left-ventricular function after 3-6 months of treatment, but effects of such treatment on symptoms and exercise performance are inconsistent, and the longer-term effects on death and other serious clinical events remain uncertain. We have investigated these issues in a double-blind, placebo-controlled, randomised trial of the beta-adrenergic blocker carvedilol (which also has alpha 1-blocking properties). ⋯ The beneficial effects of carvedilol on left-ventricular function and size were maintained for at least a year after the start of treatment, but carvedilol had no effect on exercise performance, symptoms, or episodes of worsening heart failure. There was an overall reduction in events resulting in death or hospital admission, and a year of treatment with carvedilol resulted in the avoidance of one such serious event among every 12-13 (SE 5) of these patients with chronic stable heart failure.
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Data about the frequency of adverse events related to inappropriate care in hospitals come from studies of medical records as if they represented a true record of adverse events. In a prospective, observational design we analysed discussion of adverse events during the care of all patients admitted to three units of a large, urban teaching hospital affiliated to a university medical school. Discussion took place during routine clinical meetings. We undertook the study to enhance understanding of the incidence and scope of adverse events as a basis for preventing them. ⋯ This study shows that there is a wide range of potential causes of adverse events that should be considered, and that careful attention must be paid to errors with interactive or administrative causes. Healthcare providers' own discussions of adverse events can be a good source of data for proactive error prevention.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barré syndrome. Plasma Exchange/Sandoglobulin Guillain-Barré Syndrome Trial Group.
The relative efficacy of plasma exchange (PE) and intravenous immunoglobulin (IVIg) for the treatment of Guillain-Barré syndrome has not been established. We compared PE with IVIg, and with a combined regimen of PE followed by IVIg, in an international, multicentre, randomised trial of 383 adult patients with Guillain-Barré syndrome. ⋯ In treatment of severe Guillain-Barré syndrome during the first 2 weeks after onset of neuropathic symptoms, PE and IVIg had equivalent efficacy. The combination of PE with IVIg did not confer a significant advantage.
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Clinical Trial Controlled Clinical Trial
Field trial of a locally produced, killed, oral cholera vaccine in Vietnam.
Several studies have shown that orally administered killed cholera vaccines are safe and protective in populations at risk of cholera in developing countries. However, these vaccines have not been adopted for use in developing countries because of their expense and limited efficacy in young children. We have tested an inexpensive, killed whole-cell cholera vaccine developed and produced in Vietnam. ⋯ These findings suggest that oral killed whole-cell vaccines can confer substantial protection against El Tor cholera in young children, who are at highest risk of cholera in endemic settings. An inexpensive, locally produced, and effective oral cholera vaccine may be within reach of the limited health-care budgets of poor countries with endemic cholera, if our findings can be replicated in a randomised double-blind trial.