Bmc Med
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Clinical trial registries can improve the validity of trial results by facilitating comparisons between prospectively planned and reported outcomes. Previous reports on the frequency of planned and reported outcome inconsistencies have reported widely discrepant results. It is unknown whether these discrepancies are due to differences between the included trials, or to methodological differences between studies. We aimed to systematically review the prevalence and nature of discrepancies between registered and published outcomes among clinical trials. ⋯ Discrepancies between registered and published outcomes of clinical trials are common regardless of funding mechanism or the journals in which they are published. Consistent reporting of prospectively defined outcomes and consistent utilization of registry data during the peer review process may improve the validity of clinical trial publications.
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Previous studies have shown the prognostic value of stimulation elicited blood-oxygen-level-dependent (BOLD) signal in traumatic patients in vegetative state/unresponsive wakefulness syndrome (VS/UWS). However, to the best of our knowledge, no studies have focused on the relevance of etiology and level of consciousness in patients with disorders of consciousness (DOC) when explaining the relationship between BOLD signal and both outcome and signal variability. We herein propose a study in a large sample of traumatic and non-traumatic DOC patients in order to ascertain the relevance of etiology and level of consciousness in the variability and prognostic value of a stimulation-elicited BOLD signal. ⋯ The activation type and volume in auditory cortex elicited by SON-FV significantly correlated with VS/UWS patients' prognosis, particularly in patients with traumatic etiology, however, this could not be established in MCS patients. Repeated use of this simple fMRI task might help obtain more reliable prognostic information.
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It has been clear for some time that the development of telecare faces significant problems. Large scale studies and clinical trials seem to suggest that the cost and clinical effectiveness of telecare systems is doubtful, and the claim that these systems empower or enable service users often seems greatly overstated. The question that stems from this is, can these problems be overcome? Greenhalgh et al. have critiqued the construction of telecare as a generalised technological solution to problems of the delivery of care and have offered a new framework for defining quality in telecare and telehealth. ⋯ This is a valuable approach, and is part of a much wider transformation of the way in which policy and practice researchers conceptualise healthcare delivery as a problem of performativity. Recognising that this is an important shift, in this paper I argue that we also need to keep in mind the meso-level factors that structure new technology applications in practice. Please see the related article: http://dx.doi.org/10.1186/s12916-015-0279-6.
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Post-marketing withdrawal of medicinal products because of deaths can be occasioned by evidence obtained from case reports, observational studies, randomized trials, or systematic reviews. There have been no studies of the pattern of withdrawals of medicinal products to which deaths have been specifically attributed and the evidence that affects such decisions. Our objectives were to identify medicinal products that were withdrawn after marketing in association with deaths, to search for the evidence on which withdrawal decisions were based, and to analyse the delays involved and the worldwide patterns of withdrawal. ⋯ These results suggest that some deaths associated with these products could have been avoided. Manufacturers and regulatory authorities should expedite investigations when deaths are reported as suspected adverse drug reactions and consider early suspensions. Increased transparency in the publication of clinical trials data and improved international co-ordination could shorten the delays in withdrawing dangerous medicinal products after reports of deaths and obviate discrepancies in drug withdrawals in different countries.
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Review Meta Analysis
Comparative efficacy of serotonin (5-HT3) receptor antagonists in patients undergoing surgery: a systematic review and network meta-analysis.
Serotonin (5-HT3) receptor antagonists are commonly used to decrease nausea and vomiting for surgery patients. We conducted a systematic review on the comparative efficacy of 5-HT3 receptor antagonists. ⋯ Granisetron plus dexamethasone was often the most effective antiemetic, with the number needed to treat ranging from two to nine.