Trials
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Colorectal surgery is frequently complicated by surgical site infections (SSIs). The most important consequences of SSIs are prolonged hospitalization, an increased risk of surgical reintervention and an increase in mortality. Perioperative intravenously administered antibiotic prophylaxis is the standard of care to reduce the risk of SSIs. In the last few decades, preoperative orally administered antibiotics have been suggested as additional prophylaxis to further reduce the risk of infection, but are currently not part of routine practice in most hospitals. The objective of this study is to evaluate the efficacy of a preoperative orally administered antibiotic prophylaxis (Pre-OP) in addition to intravenously administered perioperative antibiotic prophylaxis to reduce the incidence of deep SSIs and/or mortality after elective colorectal surgery. ⋯ To date, conclusive evidence on the added value of preoperative orally administered antibiotic prophylaxis in colorectal surgery is lacking. The PreCaution trial should determine the effects of orally administered antibiotics in preventing infectious complications in elective colorectal surgery.
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In the original publication [1] the last sentence in the last paragraph under 'Perspectives and implications' in the Discussions section needs to be removed. The correct version can be found in this Erratum.
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Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programmes for chronic LBP is that these programmes are not designed to change patients' behaviour toward an active lifestyle. Therefore, we will investigate the short- and long-term efficacy of a multimodal intervention, consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability, in patients with chronic, nonspecific LBP. ⋯ This study is significant as it will be the first study to investigate whether a multimodal intervention designed to increase physical activity levels reduces pain and disability, and increases physical activity levels compared to a control intervention in patients with chronic LBP.
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Complex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs. ⋯ Ethical approval has been obtained from the Monash University Human Research Ethics Committee and the aged care provider organisation. Research findings will be disseminated through conference presentations and peer-reviewed publications. SIMPLER will enable an improved understanding of the burden of medication use in RACFs and quantify the impact of regimen simplification on a range of outcomes important to residents and care providers.
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Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. ⋯ Overall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged.