Protocol for the "four steps to control your fatigue (4-STEPS)" randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue

<p>Abstract</p> <p>Background</p> <p>Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent, severe and debilitating medically unexplained fatigue, leading to impaired functioning and lower quality of life. Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients. Based on the self-regulation (SR) theory of behaviour change, we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills, the "4-STEPS to control your fatigue" program.</p> <p>Methods/Design</p> <p>This is a multi-centre, randomised controlled trial (RCT) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association. Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue (ICF) and Chronic Fatigue Syndrome (CFS) will be recruited and randomly allocated to standard care (SC) or standard care plus a self-regulation based physical activity program (4-STEPS). Patients will be assessed at baseline, after the intervention (3 months) and at 12 months follow-up. The primary outcome is fatigue severity.</p> <p>Discussion</p> <p>The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue. If the program proves to be effective, it may be considered as an adjunctive treatment for these patients.</p> <p>Trial Registration</p> <p>ISRCTN: <a href="http://www.anzctr.org.au/ISRCTN70763996.aspx">ISRCTN70763996</a></p

Rapid syndromic PCR testing in patients with respiratory tract infections reduces time to results and improves microbial yield

Lack of rapid and comprehensive microbiological diagnosis in patients with community acquired pneumonia (CAP) hampers appropriate antimicrobial therapy. This study evaluates the real-world performance of the BioFire FilmArray Pneumonia panel plus (FAP plus) and explores the feasibility of evaluation in a randomised controlled trial. Patients presenting to hospital with suspected CAP were recruited in a prospective feasibility study. An induced sputum or an endotracheal aspirate was obtained from all participants. The FAP plus turnaround time (TAT) and microbiological yield were compared with standard diagnostic methods (SDs). 96/104 (92%) enrolled patients had a respiratory tract infection (RTI); 72 CAP and 24 other RTIs. Median TAT was shorter for the FAP plus, compared with in-house PCR (2.6 vs 24.1 h, p&lt; 0.001) and sputum cultures (2.6 vs 57.5 h, p&lt; 0.001). The total microbiological yield by the FAP plus was higher compared to SDs (91% (162/179) vs 55% (99/179), p&lt; 0.0001). Haemophilus infuenzae, Streptococcus pneumoniae and infuenza A virus were the most frequent pathogens. In conclusion, molecular panel testing in adults with CAP was associated with a signifcant reduction in time to actionable results and increased microbiological yield. The impact on antibiotic use and patient outcome should be assessed in randomised controlled trials

Online quality control with Raman spectroscopy in pharmaceutical tablet manufacturing

Quality testing for tablet composition and uniformity at the manufacturing stage is critical to the pharmaceutical industry. However, current off-line, destructive, wet chemistry analysis incurs significant costs and long test times. This paper introduces a methodology to form a population batch size for quality control sampling in tablet manufacturing for an alternative online testing technology, Raman spectroscopy. An approach is presented to determine the minimum testing batch size for quality control sampling based on the desirable confidence level, margin of error, testing rate, and production rate. Experiments with both traditional wet chemistry analysis and Raman spectroscopy are conducted. The results demonstrate that the quality of Raman spectroscopy is comparable to that of wet chemistry analysis. The proposed quality sampling methodology reduces the queue time by orders of magnitude for typical tablet batches of one to four million tablets awaiting test results following the tablet compaction process. Furthermore, it increases the tablet sample size, which subsequently raises the confidence level.Journal Articl