Bmc Med
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Randomized Controlled Trial
Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial.
Placebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery. ⋯ Optimizing patients' expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine.
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Randomized Controlled Trial
Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.
The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. ⋯ This study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions.
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Editorial Comment Randomized Controlled Trial
Benefits of the Mediterranean diet beyond the Mediterranean Sea and beyond food patterns.
Abundant and growing evidence has accrued to demonstrate that the traditional Mediterranean diet is likely to be the ideal dietary pattern for the prevention of cardiovascular disease. A landmark randomized trial (PREDIMED) together with many well-conducted long-term observational prospective cohort studies support this causal effect. A new, large British cohort study by Tong et al. assessing the association between adherence to the Mediterranean diet and cardiovascular disease was recently published in BMC Medicine. ⋯ These findings support the transferability of this dietary pattern beyond the shores of the Mediterranean Sea. The authors provided measures of population impact in cardiovascular prevention and estimated that 19,375 cases of cardiovascular death would be prevented each year in the UK by promoting the Mediterranean Diet. Please see related article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0677-4 .
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Randomized Controlled Trial
The CARE Plus study - a whole-system intervention to improve quality of life of primary care patients with multimorbidity in areas of high socioeconomic deprivation: exploratory cluster randomised controlled trial and cost-utility analysis.
Multimorbidity is common in deprived communities and reduces quality of life. Our aim was to evaluate a whole-system primary care-based complex intervention, called CARE Plus, to improve quality of life in multimorbid patients living in areas of very high deprivation. ⋯ It is feasible to conduct a high-quality cluster randomised control trial of a complex intervention with multimorbid patients in primary care in areas of very high deprivation. Enhancing primary care through a whole-system approach may be a cost-effective way to protect quality of life for multimorbid patients in deprived areas.
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Randomized Controlled Trial Comparative Study
Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial.
Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR). ⋯ Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.