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Randomised control trial

Jobbe P L Leenen, Judith E K R Hentzen, Henrietta D L Ockhuijsen
It has been a standard practice to perform mechanical bowel preparation (MBP) prior to colorectal surgery to reduce the risk of colorectal anastomotic leakages (CAL). The latest Cochrane systematic review suggests there is no benefit for MBP in terms of decreasing CAL, but new studies have been published. The aim of this systematic review and meta-analysis is to update current evidence for the effectiveness of preoperative MBP on CAL in patients undergoing colorectal surgery. Consequently, PubMed, MEDLINE, Embase, CENTRAL and CINAHL were searched from 2010 to March 2017 for randomised controlled trials (RCT) that compared the effects of MBP in colorectal surgery on anastomotic leakages...
March 21, 2018: Updates in Surgery
Annabel Allison, Ian R White, Simon Bond
Treatment switching in a randomised controlled trial occurs when participants change from their randomised treatment to the other trial treatment during the study. Failure to account for treatment switching in the analysis (i.e. by performing a standard intention-to-treat analysis) can lead to biased estimates of treatment efficacy. The rank preserving structural failure time model (RPSFTM) is a method used to adjust for treatment switching in trials with survival outcomes. The RPSFTM is due to Robins and Tsiatis (1991) and has been developed by White et al...
December 4, 2017: R Journal
Carlos J Chaccour, Sergi Alonso, Rose Zulliger, Joe Wagman, Abuchahama Saifodine, Baltazar Candrinho, Eusébio Macete, Joe Brew, Christen Fornadel, Hidayat Kassim, Lourdes Loch, Charfudin Sacoor, Kenyssony Varela, Cara L Carty, Molly Robertson, Francisco Saute
Background: Most of the reduction in malaria prevalence seen in Africa since 2000 has been attributed to vector control interventions. Yet increases in the distribution and intensity of insecticide resistance and higher costs of newer insecticides pose a challenge to sustaining these gains. Thus, endemic countries face challenging decisions regarding the choice of vector control interventions. Methods: A cluster randomised trial is being carried out in Mopeia District in the Zambezia Province of Mozambique, where malaria prevalence in children under 5 is high (68% in 2015), despite continuous and campaign distribution of long-lasting insecticide-treated nets (LLINs)...
2018: BMJ Global Health
Lucie D Cluver, Franziska Meinck, Janina I Steinert, Yulia Shenderovich, Jenny Doubt, Rocio Herrero Romero, Carl J Lombard, Alice Redfern, Catherine L Ward, Sibongile Tsoanyane, Divane Nzima, Nkosiyapha Sibanda, Camille Wittesaele, Sachin De Stone, Mark E Boyes, Ricardo Catanho, Jamie McLaren Lachman, Nasteha Salah, Mzuvukile Nocuza, Frances Gardner
Objective: To assess the impact of 'Parenting for Lifelong Health: Sinovuyo Teen', a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. Design: Pragmatic cluster randomised controlled trial. Setting: 40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Participants: 552 families reporting conflict with their adolescents (aged 10-18)...
2018: BMJ Global Health
Chris Moore, Jenna Bulger, Matt Morgan, Timothy Driscoll, Alison Porter, Saiful Islam, Mike Smyth, Gavin Perkins, Bernadette Sewell, Timothy Rainer, Prabath Nanayakkara, Chukwudi Okolie, Susan Allen, Greg Fegan, Jan Davies, Theresa Foster, Nick Francis, Fang Gao Smith, Gemma Ellis, Tracy Shanahan, Robin Howe, Helen Snooks
Background: Sepsis is a common condition which kills between 36,000 and 64,000 people every year in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve the health and well-being of people with sepsis. Paramedics frequently come into contact with patients with sepsis and are well placed to provide early diagnosis and treatment.We aim to determine the feasibility of undertaking a fully powered randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics obtaining blood cultures from and administering IV antibiotics to patients with sepsis, so we can make a decision about whether to proceed to a fully powered randomised controlled trial, which will answer questions regarding safety and effectiveness for patients and benefit to the National Health Service (NHS)...
2018: Pilot and Feasibility Studies
Joan T Merrill, William R Shanahan, Morton Scheinberg, Kenneth C Kalunian, David Wofsy, Renee S Martin
BACKGROUND: Targeted inhibitors of B-cell activating factor (BAFF) have been evaluated in phase III trials in over 4000 patients with systemic lupus erythematosus (SLE). Post hoc analyses of these studies identify greater treatment effect in patients entering with higher disease activity, greater corticosteroid doses, anti double-stranded DNA (dsDNA) and low complement C3 or C4. OBJECTIVES: To evaluate the efficacy and safety of blisibimod, a BAFF inhibitor, in a population of patients with SLE enriched for high disease activity...
March 21, 2018: Annals of the Rheumatic Diseases
Wendy Moyle, Cindy Jones, Jenny Murfield, Lukman Thalib, Elizabeth Beattie, David Shum, Siobhan O'Dwyer, M Cindy Mervin, Brian Draper
OBJECTIVES: The robotic seal, PARO, has been used as an alternative to animal-assisted therapies with residents with dementia in long-term care, yet understanding of its efficacy is limited by a paucity of research. We explored the effects of PARO on motor activity and sleep patterns, as measured by a wearable triaxial accelerometer. STUDY DESIGN: Cluster-randomised controlled trial, involving 28 facilities in Queensland, Australia. Nine facilities were randomised to the PARO group (individual, non-facilitated, 15-min sessions three afternoons per week for 10 weeks), 10 to a plush toy (PARO with robotic features disabled) and nine to usual care...
April 2018: Maturitas
Carolyn E Wilshire, Tom Kindlon, Robert Courtney, Alem Matthees, David Tuller, Keith Geraghty, Bruce Levin
BACKGROUND: The PACE trial was a well-powered randomised trial designed to examine the efficacy of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome. Reports concluded that both treatments were moderately effective, each leading to recovery in over a fifth of patients. However, the reported analyses did not consistently follow the procedures set out in the published protocol, and it is unclear whether the conclusions are fully justified by the evidence...
March 22, 2018: BMC Psychology
Gunnar Elke, Frank Bloos, Darius Cameron Wilson, Frank Martin Brunkhorst, Josef Briegel, Konrad Reinhart, Markus Loeffler, Stefan Kluge, Axel Nierhaus, Ulrich Jaschinski, Onnen Moerer, Andreas Weyland, Patrick Meybohm
BACKGROUND: This study assessed the ability of mid-regional proadrenomedullin (MR-proADM) in comparison to conventional biomarkers (procalcitonin (PCT), lactate, C-reactive protein) and clinical scores to identify disease severity in patients with sepsis. METHODS: This is a secondary analysis of a randomised controlled trial in patients with severe sepsis or septic shock across 33 German intensive care units. The association between biomarkers and clinical scores with mortality was assessed by Cox regression analysis, area under the receiver operating characteristic and Kaplan-Meier curves...
March 21, 2018: Critical Care: the Official Journal of the Critical Care Forum
E Bethan Davies, Emmeline Beever, Cris Glazebrook
BACKGROUND: Medical students face many barriers to seeking out professional help for their mental health, including stigma relating to mental illness, and often prefer to seek support and advice from fellow students. Improving medical students' mental health literacy and abilities to support someone experiencing a mental health problem could reduce barriers to help seeking and improve mental health in this population. Mental Health First Aid (MHFA) is an evidence-based intervention designed to improve mental health literacy and ability to respond to someone with a mental health problem...
March 21, 2018: BMC Medical Education
Stewart A Vella, Christian Swann, Marijka Batterham, Katherine M Boydell, Simon Eckermann, Andrea Fogarty, Diarmuid Hurley, Sarah K Liddle, Chris Lonsdale, Andrew Miller, Michael Noetel, Anthony D Okely, Taren Sanders, Joanne Telenta, Frank P Deane
BACKGROUND: There is a recognised need for targeted community-wide mental health strategies and interventions aimed specifically at prevention and early intervention in promoting mental health. Young males are a high need group who hold particularly negative attitudes towards mental health services, and these views are detrimental for early intervention and help-seeking. Organised sports provide a promising context to deliver community-wide mental health strategies and interventions to adolescent males...
March 21, 2018: BMC Public Health
L A Dowd, B J Wheeler, H S Al-Sallami, R S Broadbent, L K Edmonds, N J Medlicott
AIM: To describe the current clinical practices and attitudes of neonatologists towards paracetamol treatment of PDA in Australia (AU) and New Zealand (NZ). METHOD: A web-based survey of all neonatologists registered under the 2017 Australia New Zealand Neonatal Network (ANZNN) was conducted. RESULTS: The response rate for the survey was 67%, (141/210). Of those respondents, 37% stated their unit had a written policy outlining how to treat patent ductus arteriosus (PDA)...
March 21, 2018: Journal of Maternal-fetal & Neonatal Medicine
Omorogieva Ojo, Osarhumwese Osaretin Ojo, Fajemisin Adebowale, Xiao-Hua Wang
BACKGROUND: The increasing prevalence of diabetes in the United Kingdom and worldwide calls for new approaches to its management, and diets with low glycaemic index have been proposed as a useful means for managing glucose response. However, there are conflicting reports and differences in the results of studies in terms of their effectiveness. Furthermore, the impact of low-glycaemic index diets and their long-term use in patients with type 2 diabetes remains unclear. OBJECTIVES: The objective of this study was to conduct a systematic review and meta-analysis of the effect of low-glycaemic index diets in patients with type 2 diabetes...
March 19, 2018: Nutrients
Daniel G Couch, Henry Maudslay, Brett Doleman, Jonathan N Lund, Saoirse E O'Sullivan
Background: Clinical trials investigating the use of cannabinoid drugs for the treatment of intestinal inflammation are anticipated secondary to preclinical literature demonstrating efficacy in reducing inflammation. Methods: We systematically reviewed publications on the benefit of drugs targeting the endo-cannabinoid system in intestinal inflammation. We collated studies examining outcomes for meta-analysis from EMBASE, MEDLINE and Pubmed until March 2017. Quality was assessed according to mSTAIR and SRYCLE score...
March 19, 2018: Inflammatory Bowel Diseases
Emmanuel Marret, Raphael Cinotti, Laurence Berard, Vincent Piriou, Jacques Jobard, Benoit Barrucand, Dragos Radu, Samir Jaber, Francis Bonnet
BACKGROUND: Thoracic surgery for lung resection is associated with a high incidence of postoperative pulmonary complications. Controlled ventilation with a large tidal volume has been documented to be a risk factor for postoperative respiratory complications after major abdominal surgery, whereas the use of low tidal volumes and positive end-expiratory pressure (PEEP) has a protective effect. OBJECTIVE: To evaluate the effects of ventilation with low tidal volume and PEEP on major complications after thoracic surgery...
March 19, 2018: European Journal of Anaesthesiology
Walid Ben-Nafa, Wendy Munro
INTRODUCTION: Lateral epicondylitis is a common musculoskeletal disorder of the upper limb. Corticosteroid injection has been widely used as a major mode of treatment. However, better understanding of the pathophysiology of the disease led to a major change in treating the disease, with new options including platelet-rich plasma (PRP) are currently used. Objectives/research aim: To systematically evaluate the effect of corticosteroid versus PRP injections for the treatment of LE. HYPOTHESIS: PRP injections provide longer-term therapeutic effect and less rate of complications compared to corticosteroid injection...
2018: SICOT-J
Eloise G Harrison, Jennifer L Keating, Prue E Morgan
INTRODUCTION: Restless legs syndrome (RLS) is a sensorimotor disorder characterised by an uncomfortable urge to move the legs. Management is primarily pharmacological. Effects for non-pharmacological, non-surgical options are published but lack systematic examination. OBJECTIVES: To synthesise results of non-pharmacological/non-surgical treatment compared to no-treatment controls or alternative treatment for RLS on any relevant outcome. METHODS: Databases and reference lists of reviews were searched for randomised controlled trials (RCTs) comparing non-pharmacological treatment to alternative or no treatment controls for idiopathic RLS...
March 21, 2018: Disability and Rehabilitation
Ellen G H M van den Heuvel, Jan M J M Steijns
The relevance of dairy produce for the diminishment of osteoporotic risk is still a matter of scientific debate due to the outcome of a few single observational studies. This review will address the most robust point estimate on the role of dairy products, as reported in systematic reviews and meta-analyses on randomised controlled trials in the case of bone mineralisation or prospective studies in the case of fracture risk. Plain dairy products or those fortified with Ca and/or vitamin D improve total body bone mineral content (BMC) by 45-50 g over 1 year when the daily baseline Ca intake is lower than 750 mg in Caucasians and Chinese girls...
March 21, 2018: Nutrition Research Reviews
Joan Webster, Sarah Northfield, Emily N Larsen, Nicole Marsh, Claire M Rickard, Raymond J Chan
INTRODUCTION: Many patients are discharged from hospital with a peripherally inserted central catheter in place. Monitoring the peripherally inserted central catheter insertion site for clinical and research purposes is important for identifying complications, but the extent to which patients can reliably report the condition of their catheter insertion site is uncertain. The aim of this study was to assess the inter-observer agreement between nurses and patients when assessing a peripherally inserted central catheter site...
March 1, 2018: Journal of Vascular Access
Rhoda N Ndanuko, Linda C Tapsell, Karen E Charlton, Elizabeth P Neale, Marijka J Batterham
BACKGROUND/OBJECTIVES: In addition to weight-loss, healthy dietary patterns and lower sodium intakes can help reduce blood pressure (BP), but individualised dietary advice may be necessary to achieve these effects. This study aimed to examine the impact of individualised dietary advice on BP in the intensive phase of a weight-loss trial. SUBJECTS/METHODS: Secondary analysis of baseline and 3-month data from the HealthTrack randomised controlled trial (n = 211)...
March 20, 2018: European Journal of Clinical Nutrition
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