BMJ open
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Randomized Controlled Trial
Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.
Low back pain (LBP) is one of the largest and most frequent public health problems worldwide. Photobiomodulation therapy (PBMT) is a frequently used non-pharmacological therapy for the treatment of musculoskeletal disorders. However, there is little high-quality scientific evidence that demonstrates the effectiveness of PBMT in the treatment of patients with chronic LBP in the short, medium and long term. Therefore, the objective of this clinical trial is to evaluate the effects of PBMT in patients with chronic non-specific LBP in the short, medium and long term. ⋯ The study was approved by the Research Ethics Committee of Universidade Cidade de São Paulo. The results will be disseminated through scientific publications and presentations at national and international scientific meetings.
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Multicenter Study Comparative Study Pragmatic Clinical Trial
Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial.
Postoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery. ⋯ Ethical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.
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Randomized Controlled Trial
Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill.
In-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown. ⋯ Appropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.
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Advanced life support (ALS) is thought to be associated with improved survival in prehospital trauma care when compared with basic life support (BLS). However, evidence on the benefits of prehospital ALS for patients with trauma is controversial. Therefore, we aim to clarify if ALS improves mortality in patients with trauma when compared with BLS by conducting a systematic review and meta-analysis of the recent literature. ⋯ Our study does not require ethical approval as it is based on findings of previously published articles. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and publications for patient information.
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Randomized Controlled Trial Multicenter Study
Secondary analysis of frequency, circumstances and consequences of calculation errors of the HEART (history, ECG, age, risk factors and troponin) score at the emergency departments of nine hospitals in the Netherlands.
The HEART score can accurately stratify the risk of major adverse cardiac events (MACE) in patients with chest pain. We investigated the frequency, circumstances and potential consequences of errors in its calculation. ⋯ Our results show that the HEART score was incorrectly calculated in 15% of patients, leading to inappropriate risk categorisation in 5.8% which may have led to suboptimal clinical decision-making and management. Actions should be taken to improve the score's use in daily practice.