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3 result(s) for "Multi-centred randomized controlled trial"
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SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449)
Background Single centre studies support No Touch (NT) saphenous vein graft (SVG) harvesting technique. The primary objective of the SUPERIOR SVG study was to determine whether NT versus conventional (CON) SVG harvesting was associated with improved SVG patency 1 year after coronary artery bypass grafting surgery (CABG). Methods Adults undergoing isolated CABG with at least 1 SVG were eligible. CT angiography was performed 1-year post CABG. Leg adverse events were assessed with a questionnaire. A systematic review was performed for published NT graft patency studies and results aggregated including the SUPERIOR study results. Results Two hundred and-fifty patients were randomized across 12-centres (NT 127 versus CON 123 patients). The primary outcome (study SVG occlusion or cardiovascular (CV) death) was not significantly different in NT versus CON (NT: 7/127 (5.5%), CON 13/123 (10.6%), p  = 0.15). Similarly, the proportion of study SVGs with significant stenosis or total occlusion was not significantly different between groups (NT: 8/102 (7.8%), CON: 16/107 (15.0%), p  = 0.11). Vein harvest site infection was more common in the NT patients 1 month postoperatively (23.3% vs 9.5%, p  < 0.01). Including this study’s results, in a meta-analysis, NT was associated with a significant reduction in SVG occlusion, Odds Ratio 0.49, 95% Confidence Interval 0.29–0.82, p  = 0.007 in 3 randomized and 1 observational study at 1 year postoperatively. Conclusions The NT technique was not associated with improved patency of SVGs at 1-year following CABG while early vein harvest infection was increased. The aggregated data is supportive of an important reduction of SVG occlusion at 1 year with NT harvesting. Trial registration NCT01047449 .
A national school-based health lifestyles interventions among Chinese children and adolescents against obesity: rationale, design and methodology of a randomized controlled trial in China
Background The prevalence of obesity among children and adolescents has been rapidly rising in Mainland China in recent decades, both in urban and rural areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited rigid data regarding children and adolescent overweight prevention in China are available. A national random controlled school-based obesity intervention program was developed in the mainland of China. Methods/Design The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7–18 years from 7 provinces in China. In each center, about 12–16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary = 1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control = 1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program. Discussion This is the first and largest multi-centered school-based obesity intervention program with the consideration of geographical and social-demographic characteristics of the rapidly increased obesity prevalence of Chinese children and adolescent. The intervention is based on Social Cognitive Theory and Social-Ecological Model of Health, and follows a stepwise approach guided by PRECEDE-PROCEED (P-P) Model and Intervention Map. The results of and lesson learned from this study will help guide future school-based national childhood obesity prevention programs in Mainland China. Trial registration January 22, 2015; Registration number: NCT02343588
Homeopathic research after the Lancet meta analysis—A moment for introspection
Interest in, and use of, alternative medicine in general and homeopathy in particular are at all-time highs, and rising.5-9 Courses in alternative medicine are offered in many US medical schools8 and a large proportion of medical students express interest in learning about CAM.6 Doctors are referring patients to CAM at ever-growing rates.9 The number of homeopaths in all western nations is burgeoning. [...]convincing proof of the homeopathic effect at this point would fall upon receptive ears. In light of the above, we call for a renewed effort at performing the ultimate series of homeopathic randomised controlled trials (RCTs). Because RCT remain the central pillar of evidence-based medicine, we believe that we at this stage concentrate our resources on this study design.